Describe in detail
In a broad sense, the present invention relates to control the method and apparatus of compounding pharmaceutical, wherein the preparation finish by one or more dispensing machine, this dispensing machine can with respect to interconnective Control Computer of dispensing machine or blood processor long range positioning.With reference to figure 1, Control Computer orcontroller 10 have enough big memorizer to be used for data base's form storage drug data and the function software that is used to control dispensing machine and otherancillary equipment.Computer 10 is multi-user, multitask computer preferably, it have by communication connect 22 withdispensing machine 12,14 and 16 and the communication interface that is connected with 20 of other ancillary equipment such asprinter 18, it can be wireless or wired connecting 22, can be the ingredient of LAN, wide area network, the Internet or thistriplicity.Computer 10 has display 23 andkeyboard 25, and common attribute and the feature of other present business computer.
Other ancillary equipment can comprise the treatment facility of instruction that is suitable for importing prescription and input operation Control Computer software ofdumb terminal 24, other input equipment such asportable computer 26 with keyboard and display and other.Computer can be positioned at the zones of different of health institution such as hospital, and the perhaps different floors of hospital are perhaps even in different hospitals.In Fig. 1, dispensingmachine 12 and 14 andprinter 18 andterminal 24 be arranged in the B of hospital, and the miscellaneous equipment shown in the figure is arranged in the A of hospital.As shown in the figure, preferred, near every dispensing machine or associating dispensing machine, a printer is arranged all, be used to print the label on the prescription medicine that is attached topreparation.Control Computer 10 is preferred to be connected with hospitaltotal computer 28, and the total computer of hospital is used for foundation and writes down account bill and other function.
The present invention is suitable for controlling dispensing machine, and forexample dispensing machine 12,14 and 16.In the B of hospital, use two machines to represent the associating use, for example above-mentioned AUTOMIX and MICROMIX dispensing machine, but this example not only with two kinds of compounding pharmaceutical dissimilar dispensing machines.Like this, dispensingmachine 12 can be a kind of dispensing machine that is suitable for carrying the large volume additive, and dispensingmachine 14 can be a kind of dispensing machine that is suitable for carrying the small size additive.In addition, dispensingmachine 16 can not only be suitable for the drug component carrying large volume but also be suitable for carrying small size quantity.
With reference to figure 2, there is shown the three-dimensional view of low speed flow module dispensing machine, it is suitable for carrying the drug component of small size, for example trace nutrient and other medicines from independent source container 30.But, the prescription medicine can by one independent, be suitable for carrying thedispensing machine 16 of large volume and small size additive to prepare, perhaps finish by being connected to many dispensing machines on the independentfinal bag 46.
In one embodiment, when the needs pinpoint accuracy, for example when the additive of small size joins among the PN, be transported to the independent intermediate receptacle orfunnel 34 suspended fromloading unit assembly 36 byindependent conduit 32 from the fluid of container 30.Loading unit assembly 36 weighs up the gross weight offunnel 34 and provides output signal, and this signal is used for being illustrated in the amount of fluid of any given time funnel 34.Funnel 34 be close and be connected tomanometer tube 38,manometer tube 38 is connected to pressure apparatus or locking device such as valve 40.The preferred independent peristaltic pump of pressure apparatus, it can optionally produce normal pressure or negative pressure infunnel 34, with the direction and the flow of control fluid turnover funnel 34.Funnel 34 also is connected tooutlet 42, andoutlet 42 extends to second locking device, 44, thesecond locking devices 44 betweenfunnel 34 and final bag or container 46.By selectivityoperation locking device 40 and 44 and pressure apparatus, can be pumped into funnel to fluid and therefrom transfer out.These same sections in the machine also can be controlled mobile direction, therefore can deliver fluids intofinal bag 46, also can shift out fluid from final bag to be used to washfunnel 34.
This to be suitable for carrying the detail operations of an example of dispensing machine of small size drug component be to be described in the United States Patent (USP) 5228485 in April nineteen ninety at least, and this patent is entrusted to same agent of the present invention, at this as special list of references.Having compared some and improved at present commercial MICROMIX dispensing machine and 5228485 patents, but be describe in the patent therewith similar certainly.
Dispensingmachine 12 also can comprise utilize other method of work for example independent or with measure method that volume carries and unite the one or more pumping mechanisms or the switching mechanism of use, come the assembly of feeding additive, the commercialization that also can comprise the BAXA company of standardized equipment such as the state of Colorado Englewood equipment that makes up a prescription.
Referring to Fig. 3, represented the dispensingmachine 50 of another embodiment, it is particularly suitable for carrying the large volumeadditive.Dispensing machine 50 comprises a plurality ofpumping plants 52, and it is pumped intofinal container 58 to fluid fromindependent source container 56 with interchangeable conveyer device 54.This to be suitable for carrying the detail operations of an example of small size medicament dispensing machine be to be described in United States Patent (USP) 4712590 and 5927349 in 1999 at least, and this patent is entrusted to same agent of the present invention, at this as special list of references.Having compared some and improved at present commercial AUTOMIX dispensing machine and the patent 5228485 and 5927349, but be describe in the patent therewith similar certainly.Prepare prescription
In an example that uses preferred embodiment of the present invention process, doctor or other health worker or health care group determine patient's non-enteral nutrition needs and leave prescription.Then the pharmacists need convert prescription to concrete quantity or concentration that additive among patient's the PN is given in medication.These quantity change according to different patients.For example, can not receive the fluidic patient of a large amount of non-intestinals, the fluid that just needs minimum number is to satisfy nutritional need.Restricted patient's a example is a neonatal patient.In order to use the additive of aequum with the less form of cumulative volume, the additive concentration level in thefinal bag 46 can be than the height among the PN, in case use the more dilute agent.This higher concentration can make the chance that other additive compatibility problem occurs among the PN increase, and surpasses the limit that patient can receive.
Referring to Fig. 4 a, in a preferred embodiment, the pharmacists imports controller to patient's recognition data such as patient's identification card number with keyboard 25 (square frame 70).Then,controller 10 is from the data storage station such as in-house computer system 28 is asked and the specific data (square frame 72) of reception patient, and shows these information on display 23.In a preferred embodiment, by preferred one type the patient's particular datas that use ofcontroller 10 be type of patient, for example premature infant, neonate, department of pediatrics or adult or the like.In a further embodiment, the health worker directly imports patient's particulardata memorizer controller 10 or there.
Controller 10 has also kept the preferable range that different pharmaceutical in thefinal bag 46 can receive concentration level in memorizer.In one embodiment,controller 10 has also kept the used drug concentrations scope of different patient's types in data storage, and is provided with the preferred concentration range for that is used for those concrete patients.In a further embodiment, kept the value range corresponding with patient's attribute in data storage, as different patient age and body weight,controller 10 is provided with the preferred concentration range for of corresponding patient's particular community scope.
In a further embodiment, also contain with good grounds predetermined patient's material elements in the controller,, regulate the algorithm of concentration range as patient age.
Therefore, according to the concrete data of patient, whethercontroller 10 assessment preferred range are suitable for patient's particular type, then can regulate these scopes (square frame 74).
Then the health worker imports prescription (square frame 76), for example by usingkeyboard 25 to finish.When the input prescription, the health worker is provided with the concentration level of drug solution, so that the PN of preparation will be corresponding withprescription.Controller 10 can allow prescription to import with several different-formats.As an example,controller 10 can receive each component in the final drug solution of input percent, per unit volume concentration or with the corresponding quantity of unit patient body weight.
When the health worker imported prescription,controller 10 was according to the concentration (square frame 78) of predetermined range check input.If the concentration of input goes beyond the scope, ondisplay 23, show error message.In addition, the component form of health worker's input is incorrect, then shows mistake or warning message, caution health worker on display.The example of incorrect form is, the concentration of input is the concentration of per unit patient body weight, and patient's body weight is not as the part input of the concrete data of patient.
In another embodiment, after all concentration inputs, the various components ofcontroller 10 checks drop on the outer component of component set point for those, with the error message demonstration of highlight.
In a further embodiment, the template that in memorizer, has kept the various prescriptions of corresponding different patient's types.Then pharmacists orcontroller 10 access this template, perhaps receive this template, or adjust this template.In other embodiment, previous patient's prescription is kept in the memorizer.Then pharmacists orcontroller 10 access previous prescription, perhaps accept previous prescription as current prescription, or adjust previous prescription and as current prescription.
When showing alarm, although concentration goes beyond the scope, whether this concentration is required still can make medical judgment by the health worker.Under some default situation,controller 10 can allow the health worker to remove alarm (square frame 82).Controller 10 allows to remove a factor or some factor is united appearance.A factor is whether the health worker who imports prescription has the right to remove special alarm.Before removing was accepted, each alarm all needed the authority of different brackets.Some alarm can not be eliminated.
Health worker's the identity and the foundation of Permission Levels are thatcontroller 10 needs and the unique password realization of input at quarter in due course by entering, and the above-mentioned suitable moment is for example in the beginning of login prescription or when alarm occurs (square frame 84).Other method of setting up health worker's identity also is fine, as key card, retina scanning or similar method.
Except the authority of setting up the health worker, in order to verify that the health worker has discerned and received error message and for the purpose of reservation record,controller 10 need be input to the reason of removing in the annotations window that is presented on the display 23.For some alarm situations, even reasonable grounds is arranged,controller 10 does not allow any removing (square frame 86) yet.Compatibility grouping
Preferred embodiment of the present invention assessment component, the component solution that is in contact with one another and the preparation compatibility that is contained in the solution in thefinal solution bag 46 after finishing therein in process for preparation.
In the present invention, the assessment to the PN of final preparation is the conventional process of pharmacists's routine.The pharmacists forms the medicine of final preparation and the document contrast that comprises the information relevant with the compatibility.Under a lot of situations, can not be in the document enough specific to the definite type in the drug prepared, this just needs the pharmacists to make professional judgment to decide whether drug prepared is compatible.
According to the present invention, mainly concentrate in the preparation of non-enteric nutrient for the comprehensive compatibility assessment of complicated medicine, this assessment comprises that very widely PN screening and calcium phosphate dissolubility screen.
This process preferably includes the first screening step, promptly the scope of all PN additives andcontroller 10 settings is compared, and this just comprises the step of setting preferred concentration range for as mentioned above.
Second step comprises the data base of the basis set branch of aminoacid, glucose and fat and institute's testing drug is contrasted.The aminoacid contrast is the concrete trade mark.The foundation of drug data base is by to the test of medicine and utilize published document.Drug data base preferably includes the concentration of stable and labile drug, provides study condition such as time and temperature simultaneously.Preferably, the medicine that the data base comprises has the source component of discerning, for example aminoacid of trademark naming.
In second step, prescription medicine and the contrast of data base's medicine.Preferably, at first compare with medicine with source component of discerning.If the prescription medicine drops in the scope of stablizing medicine, the present invention does not produce prompting to the pharmacists with regard to carrying out next step.This scope is set by some deviates, for example the corresponding concentration level of solvent in percent by setting quantity or setting and the stable medicine.
But, with the labile drug that comprises among the data base (departing from solvent quantity one setting value) coupling (or mixed stability and unstable coupling) but be decided to be latent instability by the medicine of the first screening step with plus or minus preferably.
In embodiments of the present invention, if prescription medicine and labile drug coupling are then carried out other step, whether the study condition of for example screening coupling medicine is identical with present condition.The present invention proposes a caution to the pharmacists, and promptly the prescription medicine is the latent instability medicine under the study condition of coupling medicine.
In a further embodiment, with the data base in any stable or unmatched medicine of labile drug that comprises to reappraise.When this process of execution, ignore amino acid whose trade mark, this medicine and entire database contrast.Correlated result adopts the step identical with above-mentioned steps to handle.Preferably, provide one about ignoring the caution of aminoacid trade mark in data base's medicine to the pharmacists.If reappraise after the entire database medicine still can not with database matching, the present invention will provide an information warning to the pharmacists, not have the tested mistake of similar PN before promptly.
Consider the screening of calcium phosphate dissolubility again, calcium salt and phosphatic dissolubility depend on a lot of variablees in identical solution, comprise form, order by merging, pH value, amino acid concentration, other additive and the time of temperature, salt, but are not limited thereto.Formerly the pharmacists contrasts the specific solubility curve of calcium salt and phosphatic ultimate density and given aminoacid brand and ultimate density in the technology.
In the present invention, the screening to the calcium phosphate dissolubility in complicated process for preparation is finished bycontroller 10, promptly calcium salt and phosphatic ultimate density is all contrasted with a series of known compatibilitys.The pharmacists is this series of values input store, perhaps previous input database.This series of values that the present invention uses is with the compatibility of sorting of aminoacid brand and ultimate density.For example, for a given aminoacid brand, have in the calcium phosphate solubility table with solution be compatible calcium salt and the phosphate concn of 1%, 2% and 4% final aminoacid.The present invention has determined the dissolubility boundary that is exceeded, and if surpass this boundary and just produce a caution to the pharmacists.
In another embodiment,controller 10 produces a representative for the curve of the calcium phosphate dissolubility of specific amino acids and be presented on thedisplay 23, and also provided the design of the prescription medicine of relative this solubility curve, left compatible prescription to help the pharmacists.
But, whether the medicine in determining final bag is compatible, the compatibility in also must the assessment process for preparation.For example, must the assessment a kind of solution and the compatibility of second solution when contacting.Second fluid is present in common pipeline, middle mixing chamber or final bag.In order to overcome this potential problem, the pharmacists can adopt whole rules to be used for process for preparation.For example, usually all diluent are at first added final bag, so that all additives in the final bag play the effect of diluent as much as possible when other component adds in the bag.But this practice has reduced the ability of washing this diluent in process for preparation.
According to a key character of the present invention,Control Computer 10 can be utilized the known compatibility of component, makes the parallel preparation in final bag or middle mixing chamber of this compatible components.In addition, can be with finishing flushing process with the forward and backward compatible source solution of flushing solution partly that flows through of flushing.Therefore, the heavy addition agent is transported to final container or bag, or mixing chamber in the middle of being transported to, and a small amount of additive is as flush fluid simultaneously.This compatibility screening and parallel preparation can make the speed of compounding pharmaceutical of the present invention reach the fastest degree, thereby can more effectively use dispensing machine and Control Computer.
According to a key character of the present invention, utilize the drug compatibility test to set up the data base, the data base comprises a plurality of groups, represents the relation of the concentration and the compatibility on the drug test basis.In an example, according to present know-how, there is the medicine group of 7 identifications to list in the following table 1.Should be understood that, even arranged when group, perhaps or even same composition when under variable concentrations, having several groups, when the knowledge obtained more about various component compatibilities, can tell more medicine group in each independent component.
Table 1
The compatibility of group
Group | Compatible | Inconsistent |
??1 | ?1,2,3,6 | ?4,5,7 |
??2 | ?1,2,3,4,6,7 | ?5 |
??3 | ?1,2,3,4,6 | ?5,7 |
??4 | ?2,3,4,6 | ?1,5,7 |
??5 | ?6 | ?1,2,3,4,5,7 |
??6 | ?1,2,3,4,5,6,7 | ?- |
??7 | ?2,6,7 | ?1,3,4,5 |
On the basis of test result, can draw compatibility group, and be included among the data base of Control Computer, can use data base's information to carry out process for preparation like this.Preferably, the data base only is stored in the Control Computer, and do not distribute to other memorizer, thereby when obtaining other knowledge and information, can control, manage and revise the data base reliably by medical history, follow-on test and other medicine or component adding data base.
In the preferred embodiment of the invention, based on the data base, controller is divided into compatibility group to the fluid logic in the source container 30 (Fig. 2) ground, and no matter the physical location among their in dispensingmachine 12,14,16 one.
In another embodiment of the present invention, controller will calculate concrete prescription, at present group number and these groups are lined up the ordering of compatibility group, in these group intermediate demands flushings so that total flushing decreased number to minimum degree.
In yet another embodiment of the present invention, controller utilizes other input, as the physical constraint of system, determines appropriate preparation order, thereby more effectively uses source solution as flushing liquor, and do not use the flushing liquor of final bag.The example of physical constraint comprises the volume of medial compartment or funnel 34 and is used for the flush volume of this chamber.
In an example, medial compartment has the flush volume of funnel and the 30ml of volume 60ml.If prescription needs thegroup 1 of 5ml, thegroup 2 of 20ml, thegroup 3 of 20ml, thegroup 4 of 55ml and thegroup 6 of 40ml, then the preparation ofcontroller 10 employings isgroup 1,group 2,group 3,group 6 in proper order and organizes 4, rather than top order.
Whengroup 1,group 2,group 3 and 10ml organize 6 parts and are full offunnel 34, the funnel that evacuation section is full of before adding remaininggroup 6, afterfunnel 34 is full of for the first time,group 6 fluids of remaining at least 30ml, this part organizes 6 fluids can be used as flushing liquor, thereby does not need the flushing liquor of final bag.
Controller also can use other ordering relation and algorithm, to reach user's needs, for example can distribute to other compatible group to the volume of a group to reduce chamber or the inferior minimum degree of counting to offunnel 34 dischargings.
In this regard and reaffirm repeatedly as mentioned above, though table 1 comprises 7 independently groups, wish more to organize according to more advanced knowledge and test definition.Compare with all other component utilized, the exact number of group finally is the function of advanced person's compatibility knowledge, is envisioned that a large amount of groups will be defined.
This will make Control Computer can more accurately control preparation steps, improve the efficient of preparation, accelerate the speed of preparation.In addition, along with data base's complicated increase, the data base also can be proprietary, the control in independent storaging position data storehouse is protected greatly to it exactly, but for example, if the data base distributes to the processor of every dispensing machine, just do not had this protection.Preparation program
Fig. 4 b-h shows the hybrid plan or the method for another embodiment of the present invention, this scheme or method recognize and mix and use fluid preferably the use of final bag flushing liquor to be reduced to the probability of minimum degree, wherein shows the preferred embodiment of at least one dispensing machine work of definition with method that the nutrient formulation medicine is provided.The beginning of Fig. 4 b method for expressing or process (square frame 100), it occurs after prescription input Control Computer.
In another preferred embodiment of the present invention, atfirst controller 10 filters out prescription according to above-mentioned one or more methods.
Next step is to determine the scheme of making up a prescription (square frame 102), and this part depends on the kind of the equipment that makes up a prescription at present.
At this on the one hand, as mentioned above, only there is flow at high speed module dispensing machine 12 (Fig. 1) in hospital, other health-care facilities or pharmacy, are suitable for carrying under suitable flow at high speed speed the fluid of large volume.But, also have in health-care facilities under the situation of low speed flowmodule dispensing machine 12, just can be under the low speed flowing velocity delivered solution, can add the medicine of very little volume or quantity in the bag substantially.Therefore, under the situation of selecting large volume and small size dispensing machine especially for use, controller is determined preparation program (square frame 102), promptly determines to use which kind of scheme.Used program can be controlled flow at high speed speed (square frame 104), for example control flow at high speed module dispensing machine, and low speed flowing velocity (square frame 106), for example control low speed flow module dispensing machine, also can control high and low speed flowing velocity (square frame 108), for example two kinds of machines all will use, and perhaps independent dispensingmachine 16 is suitable for the conveying of large volume and small size simultaneously.
Beginning is only with reference to flow at high speed, and controller only begins for calculatings (square frame 104) of making up a prescription of the flow at high speed equipment of making up a prescription, and comprising several calculating, will carry out this program for every kind of large volume medicine as a part of final bag.If use the weight number of medicine when carrying, do not use the volume number to carry when promptly carrying, just comprise calculating according to proportion, promptly the volume number conversion is become the weight number.In this regard, the linear module the when prescription opened uses input, i.e. the gram number of final solution, milliliter number or percent, if weighing of the medicine of carrying depended in the conveying of dispensing machine, this just needs software that these linear modules are converted to weight.For example, flow at high speedmodule dispensing machine 14 and the preparation of low speed flowmodule dispensing machine 12 operating weight units perhaps change middle or final container weight.
After calculating was finished,line 110 extended to Fig. 4 c, determined at this whether the prescription that contains lipid should at first be transported to lipid final bag (square frame 112), and this is set by the user.In this regard, the user wishes that lipid at first or at last is transported to final bag, and this is that the user can specified selection fully.This appointment is preferably according to standard, and standard is at first to set up before the dispensing machine in facility turns round.
This comprises all additives is ranked into compatibility group that this is to finish by the common medicine that divides into groups, shown in above-mentioned table 1.If lipid at first is transported to final bag, then determine the number and the required Xian's times N (square frame 114) of dashing of compatibility subgroup, then program is specified the order of carrying large volume, wherein at first carries lipid.In case determined order, thenline 118 extends to Fig. 4 d, is sent to dispensing machine (square frame 120) in this instruction of operating dispensing machine.
In addition,controller 10 can use other user to set conveyance fluid, comprises that reflection mixes the setting (square frame 116,124) of the general rule of TPN.About mixing the general rule of whole non-enteral nutritions, comprise following content:
1. before calcium salt, add phosphate;
2. the volume of determining to add according to calcium solution in the fashionable TPN bag of calcium phosphate dissolubility;
3. unless need lipid as last additive, calcium should be the last additive that adds the TPN bag, if possible carries out once flushing always;
4. compatibility group is arranged according to the serial number identical with order by merging, unless identify specific exception.
If dispensingmachine 14 has independent pipe that each source solution is led to final bag,controller 10 is set the pumpings order, joins in the final bag to guarantee fluid, mainly determine the pumping order be the fluid that enters bag with bag in the existing fluidic compatibility.
Referring to Fig. 4 c, if lipid is not at first to enter final bag, also determine the number of compatibility group, and the number of times (square frame 122) of required flushing, use one or more compound methods to determine to carry and produce the conveying instruction (square frame 120) that is sent to dispensing machine byline 126 final steps that represent, that extend to Fig. 4 d with the order that lipid is washed.
Seeing only has the low speed flowing circuit again, and it starts from only having the mobile preparation of low speed to calculate (square frame 106), and this is to be used to prepare the hybrid medicine prescription, and for example, this process is to use low speed flow module dispensing machine to finish.Even may have the flow at high speed equipment that makes up a prescription at the same area, if the amount of final bag to be added is quite little, then select the low speed dispensing machine that flows usually for use, for example be used for neonatal prescription or considerably less injection.
Begin to judge in the final bag and whether contained lipid (square frame 130).The reason of carrying out this judgement is, the prescription that has might be by two stages preparations, and the mobile component of large volume has been transported in the bag, then this bag is put into the nutrient of input trace on the low speed flow module.If in the bag lipid has been arranged, how to enter funnel or the middle mixing chamber that is present on the low speed flow module dispensing machine as for final bag flushing liquor, this will produce difference.
Program judges the bag whether contain lipid from prescription, if having, then checks whole mixing prescription, judges that lipid is whether in final bag or will be added in final bag.If then send the user notes whether whether having the lipid muddiness in hybrid medicine prescription subsequently inquiry (square frame 132).This is because if use the fluid in the final bag to wash, some lipid will remain in the funnel.These lipids are transported in a plurality of bags of back, and its quantity enough produces visible muddiness in solution.If in the current bag lipid is arranged, there is not lipid in the next bag, the not flushing of surface that contact with material in two bags, lipid just may make next bag muddy, and particularly previous bag is all the more so when having used final bag flushing liquor.Unit does not wish under the situation of lipid muddiness in health care, and needn't prepare this moment, but still be retained in the task, in other time preparation (square frame 134).If hospital receives the lipid muddiness, then, illustrate in funnel, to have lipid muddiness (square frame 136) by printer prints information warning (or by visual display).
If final bag does not contain lipid (square frame 130), if perhaps contain lipid but be indifferent to lipid muddiness (square frame 136), use dissolubility and compatibility table, continue to calculate preparation, what need keep firmly in mind is that flushing liquor can come from final bag (square frame 138).This step be for calculate, design these calculating be for the flushing a number of times be reduced to minimum level, so that efficient is brought up to maximum, this can use above-mentioned a kind of method.When carrying out this step, line 140 extends to Fig. 4 d, and then the conveying instruction to dispensing machine is sent to dispensing machine (square frame 142).
Height among the 4b with the aid of pictures again and low speed flow branch, initial step is to start device for formulating (square frame 108), and this need carry out conversion Calculation, with reference to the description (square frame 104) that only has flow at high speed to do,line 144 extends to Fig. 4 c, determines the number (square frame 146) of compatibility group and flushing at this.Basically, if whether this judgement is according to preparing of being write in the prescription, to have problems in the prescription.
Then judge (square frame 152) to whether containing lipid in the final bag.Lipid if desired, then to whether at first, last or carry lipid to judge (square frame 154) with other optimal way.Whether be at first, carry lipid at last or in the mode of optimizing, this, the mode of this design is in program if being user's preferential selection, in a single day the user defines this selection, and after this this selects with prescription irrelevant.Optimize and to mean usually always and at first add lipid.Like this, the preparation standard of user's foundation is determined the path of execution in step at first.If at first or in the mode of optimizing add,line 156 extends to Fig. 4 d and Fig. 4 e, and this step will be described below.If do not contain lipid in the final bag,line 158 extends to Fig. 4 d and Fig. 4 e, and step wherein is described below.If need lipid at last,line 160 extends to Fig. 4 d, and judging does not have whether the lipid prescription is stable (square frame 162).
If there is not lipid prescription medicine instability, program prompts user, if the last adding of lipid then can not prepare prescription, and the prompting user would need the pharmacists to check (square frame 164).Then, program judges whether that lipid at first is transported in the final bag (square frame 166), if not, the result does not carry out preparing (square frame 168).If at first carry lipid, thenline 170 extends to Fig. 4 e, calculates the flushing number that comprises the lipid volume, and lipid at first is transported to final bag (square frame 172).
Seeing square frame 162 again, is stable if there is not lipid prescription medicine, and program is calculated all dissolubility that contain lipid, and lipid is transported to final bag (square frame 174) (Fig. 4 d) at last.Do not contain the calculating (square frame 174) of lipid dissolubility, based on calculating the volume calculation calcium phosphate dissolubility that may lack than the volume in the original screening thing.Therefore, for example, if 50ml lipid is arranged in the PN of cumulative volume 200ml, the assessment of calcium phosphate dissolubility will be carried out on 150ml.
Back (square frame 172 and 174) has been calculated in compatibility group and flushing, and program judges whether remove the outer cumulative volume of lipid surpasses funnel volume (square frame 176).Ifline 178 extends to Fig. 4 f, judge that in this program whether lipid be at first to add (square frame 180), if, program judge the washing time of source container flushing liquor whether can remain can the reception order flushing (square frame 182).If can, program enters compatible group, continues preparation, and required flushing liquor is from selected source container (square frame 184), and instruction is sent to dispensing machine (square frame 186).As mentioned above, the step of describing in thesquare frame 182 and 184 though can be divided into independent step on flow chart, is actually and is mutually related.This is because washing time is the function of compatibility group, in order to tell the place that flushing occurs, must determine compatibility group as mentioned above.
If the cumulative volume of removing lipid is no more than the volume of funnel, use the low speed flow module can finish preparation, in the funnel of low speed flow module dispensing machine, also can finish.Program judges whether to stop the source flushing liquor of drug solution to be used for final flushing liquor (square frame 188), if, then produce and stop, when final bag is prepared and be transported to the source flush volume of basic components and all other components in funnel, then, carry instruction to be sent to dispensing machine (square frame 192) with the preservation partial flushing funnel (square frame 190) that is transported to final bag flushing liquor.
In order to judge whether the source flushing liquor is stopped in when mixing in the funnel of the flushing liquor that dilution effect is not housed, and just needs the present fluid of screening, and to confirm whether allow to stop any material, whether the hybrid medicine that promptly obtains is stable.And, consider used quantity to finish flushing, the capacity of funnel is important.For example, if the volume of funnel is 50ml, and only have 30ml to be prevented from, then the funnel flushing is incomplete, and whether the user can make about this is enough judgements.Also considered to use purging method from the final flushing liquor of source component, for example sterilized water, glucose or aminoacid use the solution in the final bag to carry out the centre flushing, and the source flushing liquor of drug component is arranged in the final bag, it is retained in the final bag and is used for final flushing, and funnel is cleaned as much as possible.
If there are not enough source flushing liquors, program judges whether to remain with any amount of source flushing liquor and is used for final flushing (square frame 194).If, just keeping the source flushing liquor and be used for final flushing, all other components are prepared in funnel, with the partial flushing funnel of preserving (square frame 196).Then carry instruction to be sent to dispensing machine (square frame 198).
Be not used for final flushing if keep any amount of source flushing liquor, just preparation (square frame 200) in the funnel of not doing any flushing of all components, instruction is sent to dispensing machine (square frame 202).
It should be noted thatsquare frame 152, if answer is not have lipid in the final bag, long-pending the extending to above the volumetrical path of funnel of hypothetical population judges whether at first to add lipid in the flow chart in thesquare frame 180, and this actual can not application is not because there is lipid.In this case, execution instep 182 and 184 o'clock source flushing liquors are from source container and/or final bag.As mentioned above, needs have been deleted in controller flushing of preferentially selecting for use and the preparation order to final bag flushing liquor.
Get back tosquare frame 204, if answer is negated, if perhaps contain lipid in the medicine, just at first carry lipid, need the flushing liquor (square frame 182) in the final bag, program judges whether lipid adds (square frame 206) at last, if not, whether program inquiry lipid muddiness can accept (square frame 208), if not, then can not continue preparation (square frame 210).If can accept, program produces the prompting (square frame 212) about the lipid muddiness.
If lipid can be carried at last, then program judges whether that the washing time of source flushing liquor can satisfy flushing and can carry out the acceptable order, and wherein once flushing is from final bag (square frame 214).If can, then analyze the compatibility group of prescription, carry out process for preparation, carry out between flushing in due course, preferred final rinse solution uses final bag, and source component (square frame 216) is used in all other flushing.In this manner, promptly use the inclusions flushing of final bag, the component in the final bag is diluted as wide as possible, makes the ultimate source container obtain flushing simultaneously.This instruction is sent to dispensing machine (square frame 218).
If whether the answer ofsquare frame 214,line 220 extends to Fig. 4 g, and program judges whether that flushing subtracts 2, the number that (N-2) multiply by the flushing of source component can satisfy can the acceptance order flushing, wherein definite twice flushing is from final bag (square frame 222).If then carry out the step (square frame 224) of compatibility group and the step (square frame 226) that instruction is sent to dispensing machine again.If not, judge that then flushing subtracts 3 number, (N-3) (square frame 228) is if carry out Analysis of Compatibility (square frame 230) and instruction and be sent to dispensing machine (square frame 232).If not, N-4 is made judgement (square frame 234).If being judged as of square frame 234 is to carry out Analysis of Compatibility (square frame 236) and instruction once more and be sent to dispensing machine (square frame 238).If be judged as on online 240 not, program judges whether that then the source flushing liquor can satisfy final flushing (square frame 242), if carry out Analysis of Compatibility (square frame 244) once more and prepare instruction being sent to dispensing machine (square frame 246).
If not, program judges whether to stop the source solution of some to make to remove outer volume required less than funnel volume (square frame 248) of lipid.If answer then stops molten source, suitable source for being, drug component is prepared in funnel, and this part component of prevention is used to wash funnel (square frame 250), and move instruction is to dispensing machine (square frame 252).If not, program judges whether lipid (square frame 254) is arranged in the prescription, and if not, program is carried out preparation, and all flushings come from final bag (square frame 256), and instruction is sent to dispensing machine (square frame 258).If but had lipid, program would judge whether to be concerned about lipid muddiness (square frame 259).If not, provide warning prompt (square frame 260), if then do not carry out preparation (square frame 262).After providing warning prompt, continue preparation, all flushings come from final bag (square frame 256), carry instruction to be sent to dispensing machine (square frame 258).
When instruction is sent to dispensing machine (square frame 192,186 or the like), dispensing machine and controller use several method and measure to prepare.For example,controller 10 sends to instruction on the controller as dispensingmachine 12,14,16 parts, perhaps controller straightforward manipulation dispensing machine, the perhaps method of combination in any, perhaps similar methods.
Except according to the preparation program that carries out in conjunction with the described mode of flow chart 4a-4h, the present invention also has other function.About this point,Control Computer 10 is checked the composition of every prescription medicine, and these prescription medicines are lined up formation in order and existed, and instruction is sent on the dispensing machine of compounding pharmaceutical.By checking the composition of every prescription medicine in the formation, determine that those contain the medicine of lipid, for example, those medicines that contain lipid are divided into one group, thereby do not relate to the lipid muddiness, preparation to the last contains the medicine of lipid.
As described in United States Patent (USP) 4653010, the prescription medicine can be according to component ordering or grouping commonly used.In embodiments of the present invention, can determine other grouping of required medicine, for example patient's type according to similar mode.The rearrangement of this prescription medicine in formation has the effect of productivity gain, because medical institutions' demand and this effect of needs.
Another important feature of the present invention relates to the ability ofcomputer 10, promptly by the volume that adds every kind of component in the prescription medicine is increased predetermined quantity, user-defined excess volume is regulated, make the medicine that obtains identical with prescription, but volume is slightly high, set or relate to the required volume of degree of accuracy thereby compensation reaches the manager, the drug level that in prescription, needs very hour, thereby in fact the medicine of correct number flows to patient with required concentration.
Another key character of the present invention is the ability thatcomputer 10 receives the convertible option of user, when activating, can be replaced the higher concentration component of dilution by above-mentioned low concentration component.Do not have a lot of patients under the situation of fluid restriction, with compatible flushing liquor, sterilized water for example dilutes the solution of higher concentration, will obtain the minimum prescription medicine of latent instability degree.In another one embodiment of the present invention, particularly when patient fluid limits, by considering that other component removes or minimize dilute solution as diluted fluid,controller 10 is determined stability of drug, uses above-mentioned method to determine during the medicine preparation and the stability after preparing.
In another embodiment of the inventive method, carry out the preparation program of thefinal bag 46 of excessive filling.As mentioned above, for the quantity that compensates medicine is wished excessive filling since the medication system this part can not medication.Even for example after medication, some solution is retained in the final bag.
According to feature of the present invention, designed the volume required method of excessive filling of setting especially.The volume settings of excessive filling becomes absolute value as an example, according to percent or the like, so that final bag has required especially volume.When this prescription of preparation, the new quantity of the method calculating drug component makes new medicine be equivalent to the prescription medicine fully but volume is bigger.
For definite appropriate group component, the medicine thatcontroller 10 obtains according to different standard inspections judges whether the medicine that obtains can medication.For example, for the patient's who limits fluid, excessive filling will make the quantity of medicinal fluid surpass the quantity that is allowed.Produce this moment and report to the police, and error message is shown to the user.
In a further embodiment, the volume of medicine is adjusted or advised adjusting tocontroller 10, avoids the quantity of one or more components to be lower than predetermined concentration, for example corresponding to dispensingmachine 12,14,16 desired minimum exact values.As an example, the quantity of component is 90% of minimum recommended value.Then controller increases the cumulative volume of medicine, makes the quantity of component reach minimum recommended value, and the prompting user has only the medication of part gained medicine to patient.
Should be understood that in the different preferred embodiments of the present invention, the arrangement of these steps can change.For example, the judgement of final medicine stability can be carried out before or after appropriate preparation program is judged.Report
Dispensingmachine 12,14,16 in process for preparation and the preparation after can both withcontroller 10 communications.For example, the sensor of describing in the United States Patent (USP) 5927349 detects wrong source flow of solution and crosses aconduit 32, just transmits alarm signal, and this United States Patent (USP) at this as a reference.Similarly, in process for preparation or after the preparation, the accurate quantity that is transported tofinal bag 46 Chinese medicine components is sent tocontroller 10.
Receive the quantity of carrying component during the preparation,controller 10 is provided as notebook data to the pharmacists, perhaps these data is sent to thecomputer system 28 ofhospital.Controller 10 can be adjusted to notebook data, so that the actual cost of the medicine that provided to be provided.As an example, some component enters container, only can receive once before abandoning.Therefore, if the used quantity of this component is lower than the quantity in container,controller 10 will be indicated the cost of entire container, rather than in medicine the cost of used that part of component.
From as can be seen above, described the method and apparatus that improved control prepares non-intestinal medicine above, thereby can faster, more effectively prepare non-intestinal medicine, and do not sacrificed any safety.And several characteristic wherein provides extra safety.The present invention has carried out extensive analysis to drug component, utilized known drug component feature, controlled dispensing machine in a new way, thereby these prescription medicines can reliably and safely be prepared, with known preparation principle contradiction not, but also consistent with the preferential selection of certain user's definition.
Described different embodiments of the invention though illustrate, should be understood that,, other modification, substituted and conversion is conspicuous for persons skilled in the art.