Background technology
Peritoneal dialysis be the kidney replacement therapy important way it, the application proportion at present clinical is increasing, for vast nephrotic has alleviated burden and misery, has improved quality of life.But the big quantity research of clinical practice shows gradually, water sodium is removed and is reduced, increase of patients undergoing peritoneal dialysis volume overload and water salt are too much, it is the hypertensive main cause of peritoneal dialysis patient, the cardiovascular complication that thereupon brings, oneself becomes the peritoneal dialysis long-term treatment and withdraws from a high common cause of rate height and cardiovascular event incidence rate and mortality rate.Everybody more and more recognizes the importance of keeping good capacity condition of patient and the control of water salt.Wherein, the peritoneal dialysis liquid product Na ion concentration that is used for the patient is too high, causes sodium ion clearance rate reduction in the body, then is the major reason that can not ignore." Chinese blood purification " 2005,4 (3); Report the exploration that this is carried out in the documents such as 2007,6 (11), but do not drawn clear conclusions.
A cardinal principle of peritoneal dialysis is that the Na ion concentration in the dialysis solution should be lower approximately than the Na ion concentration in the blood plasma, to help the removing of sodium ion.So in order to improve the clinical safety and the hommization of treatment, seek a kind of peritoneal dialysis solution of low sodium, seem very necessary.Na ion concentration in the blood of human body is about 130～140mmol/L.This product Na ion concentration of present domestic ministry standard is 141mmol/L, and the Na ion concentration of the commercially available import peritoneal dialysis liquid product that uses is 132mmol/L.
At the problems referred to above, in publication number is the Chinese patent literature of CN1953754, the low-sodium peritoneal dialysis liquid that a kind of sodium ions content is 121～129mmol/l had been proposed once.But it also simultaneously must contain hydrion and bicarbonate ion on the one hand, its liquid by two kinds of independent packaged forms is formed on the other hand, can only adopt when clinical practice two kinds of packing liquids mixing backs are used, otherwise both do not met clinical requirement, and can form precipitation yet because of the reaction of relevant ions to ion concentration.The peritoneal dialysis solution of this low sodium that contains bicarbonate ion in the preparation, can not use common film material and the special film material of essential use, to solve the stability problem that bicarbonate radical decomposes the pH that produces, therefore increased the difficulty of preparation, increase cost, influenced the further expansion and the popularization of clinical application range.
Summary of the invention
At above-mentioned situation, the present invention will provide a kind of peritoneal dialysis solution of low sodium content of not bicarbonate ion-containing.
As above-mentioned, the maximum characteristics of low-sodium peritoneal dialysis liquid of the present invention are not contain bicarbonate ion in the solution, and it consists of:
Sodium ion 124～128mmol/L,
Calcium ion 1～2mmol/L,
Magnesium ion 0.2～0.8mmol/L,
Chloride ion 90～110mmol/L,
Lactate ion 37～47mmol/L,
Isotonic agent is an amount of.
Wherein, the Na ion concentration in the above-mentioned low-sodium peritoneal dialysis liquid is preferably 125～126mmol/L.
Said isotonic agent is at least a in glucose, mannitol, aminoacid, dextran, hetastarch or the glucose polymer in the low-sodium peritoneal dialysis liquid of the present invention, wherein preferably glucose and/or glucose polymer.According to the selection of using needs and/or different isotonic agents, its consumption generally is controlled in conventional 320～400 (mmol/L) scope with the osmotic pressure with solution and gets final product.
After the low sodium abdomen of the above-mentioned form of the present invention is touched the usual manner production of dialysis solution by present like product, owing to wherein do not contain bicarbonate ion, may be packaged in the container for using, safe ready not only, reduced pollution, and overcome fully for solving bicarbonate radical and decompose the difficult problem that the stability problem that produces pH must use special membrane material in the preparation, reduced cost, help the further expansion of clinical practice and popularize.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away under the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
The specific embodiment
Embodiment 1
In preparing tank, drop into glucose 15g, sodium chloride 5.05g, calcium chloride 0.26g, magnesium chloride 0.051g, sodium lactate 4.48g, after the stirring and dissolving, add active carbon 1g, boil absorption after about 10 minutes, filter decarburization, cooling, regulate pH value to 4.5～7.0, after-teeming is penetrated water to full dose (1000ml, as follows), fill in dialyzate bag, 115 ℃, the 30 minutes sterilization low-sodium peritoneal dialysis liquids that get product.
Embodiment 2
In preparing tank, drop into mannitol 12.5g, sodium chloride 5.10g, calcium chloride 0.26g, magnesium chloride 0.071g, sodium lactate 4.48g, after the stirring and dissolving, add active carbon 1.5g, boil absorption after about 10 minutes, filter decarburization, cooling, regulate pH value to 4.5～7.0, after-teeming is penetrated water to full dose, fill in dialyzate bag, 121 ℃, the 12 minutes sterilization low-sodium peritoneal dialysis liquids that get product.
Embodiment 3
In preparing tank, drop into sodium chloride 4.95g, calcium chloride 0.26g, magnesium chloride 0.15g, sodium lactate 5.00g, after the stirring and dissolving, add active carbon 1.0g, boil absorption after about 15 minutes, filter decarburization, cool off standby; Add the aminoacid 3.8g of amount of preparation in another preparing tank, nitrogen filled protection keeps little and boiled 15 minutes; filter, mixed electrolyte liquid is regulated pH value to 4.5～7.0; after-teeming is penetrated water to full dose, fill in dialyzate bag, 121 ℃, the 12 minutes sterilization low-sodium peritoneal dialysis liquids that get product.
Embodiment 4
In preparing tank, drop into sodium chloride 5.10g, calcium chloride 0.26g, magnesium chloride 0.15g, sodium lactate 4.48g, after the stirring and dissolving, add active carbon 1.0g, boil absorption after about 15 minutes, filter decarburization, cool off standby; The dextran 20g that in another preparing tank, adds amount of preparation, the active carbon that adds 1% (w/v), keeping little boiled 15 minutes, filter decarburization, mixed electrolyte liquid is regulated pH value to 4.5～7.0, and after-teeming is penetrated water to full dose, fill in dialyzate bag, 117 ℃, the 30 minutes sterilization low-sodium peritoneal dialysis liquids that get product.
Embodiment 5
In preparing tank, drop into sodium chloride 5.10g, calcium chloride 0.26g, magnesium chloride 0.051g, sodium lactate 5.00g, after the stirring and dissolving, add active carbon 1.5g, boil absorption after about 15 minutes, filter decarburization, cool off standby; Hetastarch 60g (the molecular weight 20000～30000 that in another preparing tank, adds amount of preparation, substitution value 0.4～0.7), the active carbon that adds 0.1% (w/v), keep little and boiled 12 minutes, filter decarburization, mixed electrolyte liquid, regulate pH value to 4.5～7.0, after-teeming is penetrated water to full dose, fill in dialyzate bag, 117 ℃, the 30 minutes sterilization low-sodium peritoneal dialysis liquids that get product.
Embodiment 6
In preparing tank, drop into sodium chloride 4.90g, calcium chloride 0.26g, magnesium chloride 0.15g, sodium lactate 4.48g, after the stirring and dissolving, add active carbon 1.0g, boil absorption after about 15 minutes, filter decarburization, cool off standby; The glucose polymer 75g (starch hydrolysate that in another preparing tank, adds amount of preparation, molecular weight 13000～20000, remove molecular weight less than 13000 with greater than 20000 starch products with ultrafilter membrane), add the active carbon of 0.1% (w/v), keep little and boiled 12 minutes, filter decarburization, mixed electrolyte liquid is regulated pH value to 4.5～7.0, and after-teeming is penetrated water to full dose, fill in dialyzate bag, 121 ℃, the 12 minutes sterilization low-sodium peritoneal dialysis liquids that get product.
With the contrast test that clinical use has been carried out in low-sodium peritoneal dialysis liquid of the present invention and the commercial like product of using at present, the result is as shown in table 1.
By the analysis of statistical data of table 1 as can be seen, low-sodium peritoneal dialysis liquid of the present invention obviously is better than commercially available sample in retention of sodium and water, this is extremely important for improving patient quality of life, because retention of sodium and water not only causes peritonitis easily, but also can cause the danger that uremia produces, so being one, the peritoneal dialysis solution of low sodium selects preferably.
The clinical comparison result of the test of the different peritoneal dialysis solutions of table 1
| Project | Product of the present invention | Commercially available sample 1 | Commercially available sample 2 |
| Na ion concentration | 126mmol/L | 132mmol/L | 141mmol/L |
| Patient | 30 examples | 30 examples | 30 examples |
| Time | 2 years | 2 years | 2 years |
| Produce peritonitis | 3 examples | 7 examples | 8 examples |
| Water retention | 2 examples | 8 examples | 5 examples |
| Sodium retention | 2 examples | 6 examples | 8 examples |
| Ultrafiltration volume | Identical | Identical | Identical |
| Nephritis | 1 example | 3 examples | 5 examples |
| Hypertension | 0 example | 0 example | 2 examples |
| Uremia | 1 example | 5 examples | 6 examples |