Background technology
For now a lot of coagulation disorderses and the hemorrhage patient of parenchymal viscera, only use conventional surgical technique hemostasis can not play good effect, therefore the investigation and application of Medical absorbable hemostatic material obtains and develops fast.Therefore, reasonable employment hemostatic material on the basis fully understanding various hemostatic material performance, and by adding hemostatic factor, effect hemostatic material being reached get twice the result with half the effort.
Existing hemostasis article have sponge, relevant with the ability of sponge absorbing blood by the porous of sponge, conventional gelfoam to be attached on bleeding part and to absorb the blood being about himself weight 45 times, and due to the even porous of conventional gelfoam, capturing platelet and coagulation cascade is activated, thus changing into former for soluble fibrin the insoluble fibrin net making stopped bleeding.
Disclose a kind of containing hyaluronic hemostatic composition at CN200580026942.6 (publication number is CN101001649A), in this hemostatic composition except hyaluronic acid, also containing biomaterial, as gelatin, collagen protein, chitin, chitosan, alginate, cellulose, oxidized cellulose, oxidized regenerated cellulose, carboxymethyl cellulose (CMC), hydroxyethyl-cellulose (HEC), polyglycolic acid, poly-acetic acid, its derivant and composition thereof.Its haemostatic effect is better than existing sponge.The biomaterial that this patent proposes to use is comparatively complicated, comparatively loaded down with trivial details when practical operation.
Known based on prior art:
Thrombin is a kind of important composition factor in body blood coagulation system, has played important function in the hemostatic mechanism when body is subject to wound.
Thrombin is a kind of serine protease, is also the main effects protease in blood coagulation cascade reaction, shows the characteristic of coagulant and anticoagulant.The anastalsis of thrombin: one, thrombin is as factor Ⅱ a, first, second stage through blood coagulation can not be needed and directly act on Fibrinogen, make it to change fibrin into, make blood rapid solidification, filling petechia and reach the object of hemostasis.Because it acts on the final tache of hemostasis, therefore do not need other many polyfactorial participations; Two, activate factor VII, the latter can make soluble fiber albumen change slightly solubility fibrin into, forms sludged blood; Three, strengthen the activity of fibrin stabilizing factor and V, the latter is at Ca2+participate in lower promotion blood clotting enzymes factor Ⅹ a with lipoid to be formed, make prothombin be thrombin; Four, promote that irreversible gathering and intra platelet free calcium effect occur platelet, accelerate blood coagulation; Five, promote that epithelial cell generates, reduce wound surface and ooze out, wound healing time can be made to shorten half.
Chitosan is the product of chitin deacetylase base, is a kind of natural cation high molecular polysaccharide, and its abundance, nontoxic, pollution-free and degradable, has been widely used in the numerous areas such as chemical industry, food, cosmetics, environmental protection and medicine.But chitosan is only soluble in some acid medium, limit its range of application.To chitosan carry out chemical modification carboxymethyl chitosan, O-CMC, N-carboxymethyl chitosan and CMC three kinds of products can be obtained according to the position of substitution difference of carboxymethyl.Compared with chitosan, carboxymethyl chitosan is a kind of macromolecule aminopolysaccharide, there is carboxyl and amino simultaneously, there is good buffer effect of fuluic acid, good biocompatibility, non-immunogenicity, has no side effect, have effects such as promoting wound healing, therefore carboxymethyl chitosan is all widely used in biomaterial, medicine, health food etc. simultaneously.
Hyaluronate sodium (HyaluronicAcidSodiumSalt), being a kind of polymolecular straight chain polysaccharide, is the necessary material of human body, is extensively present in tissue and extracellular matrix, and serous coat is its synthesising part.There is the effect of tytosis space, stabilized cell structure, covering and Cell protection, can: 1. suppress tissue migration; 2. fibrinogen deposition is reduced; 3. intercept and lubrication; 4. antiinflammatory and the effect of promotion tissue repair.Thus excess fibre organization formation can be suppressed, prevent the generation of adhesion, reduce postoperative complication, promote the effect of wound healing.
Through retrieval, the report used with about hyaluronic acid, thrombin, carboxymethyl chitosan is as follows:
CN201110021515.6 (publication number is CN102600495A) relates to a kind of absorbable hemostatic composition its preparation method, selects chitosan, collagen and hyaluronic acid to be main hemostatic substrate, obtains required hemostatic composition by hybrid technique.
CN200810025839.5 (publication number is CN101485899A) relates to thrombin-chitosan self-assembling nano particles Preparation method and use.Chitosan is added acetic acid aqueous solution and forms chitosan solution by the present invention; Thrombin is joined buffer and form thrombin solution; Thrombin solution is mixed homogeneously with chitosan solution, after adding cross-linking agent stirring, is poured in liquid paraffin and stirs, then add dispersant, emulsifying; Add after cross-linking agent carries out cross-linking reaction by water-bath again, filter, after washing with acetone, then with washing with alcohol dehydration, last vacuum drying, obtains thrombin-chitosan self-assembling nano particles.Use acetic acid as solvent and with acetone as detergent in this patent, operationally there is certain danger.
CN201410444308.5 (publication number is CN104189941A) discloses a kind of chitosan gel rubber hemostatic material and preparation method thereof, the gel hemostatic material obtained by chitosan, cross-linking agent and thrombin three compound.Achieve quick-acting haemostatic powder in body, wound healing slow release thrombin reach the effects such as secondary that postoperative motion causes is hemorrhage, there is the feature of antibacterial bacteriostatic simultaneously, effectively can prevent traumatic infection.The deacetylation of described chitosan is between 85%-99.9%, and mean molecule quantity, between 20000-100000, has solubility.Described cross-linking agent comprise DF-PEG (two 4-aldehyde benzoic acid macrogol esters), oxidation beta-schardinger dextrin-, DF-PVA (two 4-aldehyde benzoic acid polyvinyl alcohol ester) list divide or mixture.In this patent, DF-PEG, oxidation beta-schardinger dextrin-, DF-PVA employ one, two kinds or three kinds of mixed cross-linkers, there is potential safety hazard, if cross-linking agent process is incomplete, after human contact, enters human body, can injure or worsen the immune system of people.
Given this, the present invention is proposed.
Summary of the invention
The object of the invention is to add hemostatic factor on the haemostatic membrane basis of anti, make haemostatic membrane anti, antibacterial, hemostasis basis on stop blooding more effectively and rapidly.
Haemostatic membrane provided by the invention, its raw material comprises: thrombin and be selected from hyaluronate sodium, carboxymethyl chitosan one or both, but do not comprise hyaluronic acid and thrombin.
Concrete, described haemostatic membrane raw material comprises the composition of following weight portion: thrombin 0.05-8 part and be selected from hyaluronate sodium 0-20 part (preferred 0.5-20 part), carboxymethyl chitosan 0.1-8 part one or both, but do not comprise hyaluronate sodium and thrombin.
Preferably, described haemostatic membrane raw material comprises following composition: thrombin 0.1-6.0 part and be selected from hyaluronate sodium 1.5-12 part, carboxymethyl chitosan 0.25-6.0 part one or both, but do not comprise hyaluronate sodium and thrombin.
Further preferably, described haemostatic membrane raw material comprises following composition: thrombin 1.0-6.0 part and be selected from hyaluronate sodium 1.5-7.5 part, carboxymethyl chitosan 2.0-6.0 part one or both, but do not comprise hyaluronate sodium and thrombin.
Further preferred, described haemostatic membrane raw material comprises following composition: thrombin 2.5-6.0 part and be selected from hyaluronate sodium 1.5-3.0 part, carboxymethyl chitosan 5.0-6.0 part one or both, but do not comprise hyaluronate sodium and thrombin.
Further preferred, described haemostatic membrane raw material comprises following composition: thrombin 6.0 parts, hyaluronate sodium 1.5 parts and carboxymethyl chitosan 6.0 parts.
Further preferred, described haemostatic membrane raw material comprises following composition: carboxymethyl chitosan 6.0 parts and thrombin 6.0 parts.
In above-mentioned haemostatic membrane:
Described weight portion can be the known unit of weights of field of medicaments such as μ g, mg, g, kg, also can be its multiple, as 1/10,1/100,10 times, 100 times etc.
Thrombin is white or the lyophilizing block of off-white color or powder, and every 1mg must not tire and is less than 10U, in use, can select the thrombin of different size as required.
The molecular weight of described hyaluronate sodium is 50 ~ 3,000,000 dalton.
The molecular weight of described carboxymethyl chitosan is 1 ~ 1,000,000 dalton.
Present invention also offers the preparation method of above-mentioned haemostatic membrane, the method comprises the following steps:
1) hyaluronate sodium (HA) is directly dissolved in purified water, obtains sodium hyaluronate solution;
2) carboxymethyl chitosan is directly dissolved in purified water, obtains carboxymethyl chitosan solution;
3) by step 1) obtain hyaluronate sodium and step 2) mixing of the carboxymethyl chitosan solution that obtains, then according to proportioning, thrombin is added wherein, to stir or to spread the uniform spreading of mode that spills in the mixed solution loaded in mould; Or,
Thrombin is joined step 2) carboxymethyl chitosan solution that obtains, then by step 1) solution that obtains joins wherein, mix homogeneously;
4) by three kinds of raw-material mixed solutions, lyophilization.
Preferably, the method comprises the following steps:
1) hyaluronate sodium (HA) is directly dissolved in purified water, obtains the sodium hyaluronate solution that concentration is 0.5-10%;
2) carboxymethyl chitosan is directly dissolved in purified water, obtains the carboxymethyl chitosan solution that concentration is 0.1-10%;
3) according to proportioning, by step 1) obtain hyaluronate sodium and step 2) mixing of the carboxymethyl chitosan solution that obtains, then according to proportioning, thrombin is added wherein, stir; Or,
Thrombin is joined step 2) carboxymethyl chitosan solution that obtains, then by step 1) solution that obtains joins wherein, mix homogeneously;
4) load in mould by three kinds of raw-material mixed solutions, lyophilization, cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, and dry 24h.
In said method:
When form in do not comprise hyaluronate sodium time, step 1) and relate to hyaluronate sodium step omission.
Present invention also offers the application of above-mentioned haemostatic membrane in the medical apparatus and instruments preparing hemostasis and antiseized sort out and classify.
Haemostatic membrane provided by the invention has following advantage:
1, consider from compatibility, in haemostatic membrane provided by the invention, hyaluronic acid, carboxymethyl chitosan combine, wherein:
Carboxymethyl chitosan makes chitosan by chitin de-acetyl under acid or alkali condition, then by chitosan under proper condition (under being generally alkali condition) to produce in chloroacetate reaction and form.Carboxymethyl chitosan has good water solublity, film property, degradability, antibiotic property and biological characteristics, and has certain application to it at biomedical sectors such as burn adjuvant, anti-tissue adhesion material, pharmaceutical carrier, enzyme inhibitors.Carboxymethyl chitosan, as a kind of conventional immobilized enzyme medium, is proved the heat stability that can improve enzyme.By being compounded in by thrombin, chitosan is expected to improve the stability of thrombin.
The effects such as the mechanical barrier of hyaluronate sodium, lubrication, suppression are hemorrhage and ooze out make it can be used for surgery Film with Preventing Adhesion.The surgical prophylaxis tissue adhesions such as abdominal cavity, pelvic cavity, tendon and dura mater are widely used at present.Clinical practice proves, its can useful effect in adhesion position, not affecting normal wound healing, have good biocompatibility and degradability, is a kind of desirable surgery Film with Preventing Adhesion biomaterial.
Utilize carboxymethyl chitosan as the medium of fixing thrombin, improve the stability of thrombin, add adherence preventing material hyaluronate sodium simultaneously, hemostasis in body can be reached fast and effectively prevent wound surface adhesion and infection.
2, preparation method aspect, this method all adopts purified water to dissolve raw material on preparation, avoids acetic acid, formic acid is the danger of solvent, do not add cross-linking agent simultaneously, decrease the incomplete hidden danger of cross-linking agent process.Adopt cryodesiccated method to be prepared, directly the solution of preparation is loaded mould, carry out lyophilizing, easy and simple to handle, be applicable to producing.
3, material used in the present invention is natural macromolecular material, all can be absorbed by the body, be free from side effects to health, very safe.
4, by adding hemostatic factor, shortening the bleeding stopping period of operation, greatly improving the efficiency of operation.
5, chitosan and hyaluronate sodium all adopt purified water to dissolve, and more convenient operation, to human body safety.
6, be applicable to the hemostasis that all kinds of surgical operation oozes hemorrhagic trauma, good biocompatibility, there is bonding wound, the effect of the healing of hemostasis and promotion wound.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
Thrombin is lyophilizing block or the powder of white or off-white color, purchased from Yige Pharmaceutical Co., Ltd., Hunan Prov.;
The molecular weight of hyaluronate sodium is 100-200 ten thousand dalton, purchased from Bloomage Freda Biopharm Co., Ltd.;
The molecular weight of carboxymethyl chitosan is 1-30 ten thousand dalton, purchased from Hai Lian bio tech ltd, Dezhou.
Embodiment 1: compound hemostatic film
1, form: hyaluronate sodium 12.0g, carboxymethyl chitosan 0.25g and thrombin 0.05g.
2, preparation method:
1) taking hyaluronate sodium 12.0g is dissolved in purified water 300ml, and uniform stirring makes it dissolve completely (concentration is 4%);
2) taking carboxymethyl chitosan 0.15g is dissolved in purified water 150ml, and uniform stirring makes it dissolve completely (concentration is 0.1%);
3) take thrombin lyophilized powder 0.05g to be dissolved in the solution that step 2 obtains, obtain new soln;
4) solution obtained in step 3 is mixed with the solution in step 1, stir.
5) mixed solution in step 4 is loaded in mould, put into freeze dryer and carry out lyophilization (cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, dry 24h), obtain haemostatic membrane.
Carry out structure investigation to the haemostatic membrane of preparation, its macrostructure is shown in Fig. 1, and Fig. 2 (electromicroscopic photograph, its enlargement ratio is 100 times) is shown in microstructure.
The macrostructure of compound hemostatic film is the shape of sponge as can be seen from Figure 1, effective absorbing blood;
The microcosmic of compound hemostatic film is also the structure of porous as can be seen from Figure 2, carries out the hemostasis of physics more effectively and rapidly.
Embodiment 2: compound hemostatic film
1, form: hyaluronate sodium 7.5g, carboxymethyl chitosan 2.0g and thrombin 0.5g.
2, preparation method:
1) taking hyaluronate sodium 7.5g is dissolved in purified water 300ml, and uniform stirring makes it dissolve completely (concentration is 2.5%);
2) taking carboxymethyl chitosan 2.0g is dissolved in purified water 150ml, and uniform stirring makes it dissolve completely (concentration is 1.3%);
3) take thrombin lyophilized powder 0.5g to be dissolved in the solution that step 2 obtains, obtain new soln;
4) solution obtained in step 3 is mixed with the solution in step 1, stir.
5) mixed solution in step 4 is loaded in mould, put into freeze dryer and carry out lyophilization (cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, dry 24h), obtain haemostatic membrane.
Embodiment 3: compound hemostatic film
1, form: hyaluronate sodium 6.0g, carboxymethyl chitosan 3.0g and thrombin 1.0g.
2, preparation method:
1) taking hyaluronate sodium 6.0g is dissolved in purified water 300ml, and uniform stirring makes it dissolve completely (concentration is 2%);
2) taking carboxymethyl chitosan 3.0g is dissolved in purified water 150ml, and uniform stirring makes it dissolve completely (concentration is 2%);
3) take thrombin lyophilized powder 1.0g to be dissolved in the solution that step 2 obtains, obtain new soln;
4) solution obtained in step 3 is mixed with the solution in step 1, stir.
5) mixed solution in step 4 is loaded in mould, put into freeze dryer and carry out lyophilization (cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, dry 24h), obtain haemostatic membrane.
Embodiment 4: compound hemostatic film
1, form: hyaluronate sodium 3.0g, carboxymethyl chitosan 5.0g and thrombin 2.5g.
2, preparation method:
1) taking hyaluronate sodium 3.0g is dissolved in purified water 300ml, and uniform stirring makes it dissolve completely (concentration is 1%);
2) taking carboxymethyl chitosan 5.0g is dissolved in purified water 150ml, and uniform stirring makes it dissolve completely (concentration is 3.3%);
3) take thrombin lyophilized powder 2.5g to be dissolved in the solution that step 2 obtains, obtain new soln;
4) solution obtained in step 3 is mixed with the solution in step 1, stir.
5) mixed solution in step 4 is loaded in mould, put into freeze dryer and carry out lyophilization (cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, dry 24h), obtain haemostatic membrane.
Embodiment 5: compound hemostatic film
1, form: hyaluronate sodium 1.5g, carboxymethyl chitosan 6.0g and thrombin 6.0g.
2, preparation method:
1) taking hyaluronate sodium 1.5g is dissolved in purified water 300ml, and uniform stirring makes it dissolve completely (concentration is 0.5%);
2) taking carboxymethyl chitosan 6.0g is dissolved in purified water 150ml, and uniform stirring makes it dissolve completely (concentration is 4%);
3) take thrombin lyophilized powder 6.0g to be dissolved in the solution that step 2 obtains, obtain new soln;
4) solution obtained in step 3 is mixed with the solution in step 1, stir.
5) mixed solution in step 4 is loaded in mould, put into freeze dryer and carry out lyophilization (cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, dry 24h), obtain haemostatic membrane.
Embodiment 6: compound hemostatic film
1, form: carboxymethyl chitosan 6.0g and thrombin 6.0g.
2, preparation method:
1) taking carboxymethyl chitosan 6.0g is dissolved in purified water 150ml, and uniform stirring makes it dissolve completely (concentration is 4%);
2) take thrombin lyophilized powder 6.0g to be dissolved in the solution that step 1 obtains, obtain new soln;
3) load in mould after the mixed solution in step 2 being settled to 450ml, put into freeze dryer and carry out lyophilization (cryodesiccated condition is :-30 DEG C, freezing 4h, then in 30 DEG C, dry 24h), obtain haemostatic membrane.
Experimental example 1: thrombin activity detects
1, experimental procedure:
1) according to embodiment 4, compound hemostatic film is cut into the size of 2cm × 2.5cm, with the normal saline moistening of 2ml, obtains sample 1;
2) according to the content of the carboxymethyl chitosan in embodiment 4 and thrombin, prepare new haemostatic membrane, be cut into the size of 2cm × 2.5cm equally, with the normal saline moistening of 2ml, obtain sample 2;
3) according to the content of the hyaluronate sodium in embodiment 4 and thrombin, prepare new haemostatic membrane, be cut into the size of 2cm × 2.5cm equally, with the normal saline moistening of 2ml, obtain sample 3;
4) according to step 1) content of thrombin in the sample that obtains, by the normal saline moistening of thrombin lyophilized powder 2ml, obtain sample 4;
5) by step 1), 2), 3) activity of sample determination first day thrombin that obtains;
6) by step 1), 2), 3) sample that obtains puts into ageing oven (aging condition: 45 DEG C, humidity 60%) simultaneously, takes out sample, the thrombin activity of working sample after one week.
2, experimental result: first day thrombin activity is in table 1; After one week, thrombin activity is in table 2
Table 1: first day thrombin activity
| Sample 1 | Sample 2 | Sample 3 | Sample 4 |
| Thrombin activity | 90.0U | 85.0U | 90.0U | 90.0U |
Table 2: thrombin activity after a week
| Sample 1 | Sample 2 | Sample 3 | Sample 5 |
| Thrombin activity | 75.0U | 74.0U | 0U | 0U |
As can be seen from table 1, table 2, hyaluronate sodium to the stability of thrombin without effect; The activity of carboxymethyl chitosan to thrombin has stability action.
Experimental example 2: external clotting time
1, experimental procedure
1) 27, test tube is got;
2) the compound hemostatic film obtained by embodiment 1 ~ 6 is cut into the size of 2cm × 2.5cm, with the normal saline moistening of 2ml, obtains sample 1, sample 2, sample 3, sample 4, sample 5, sample 6 respectively;
3) according to the content of the hyaluronate sodium in embodiment 1 and carboxymethyl chitosan, the haemostatic membrane of thrombin is not added in preparation, the haemostatic membrane obtained is cut into 2cm × 2, the size of 5cm, with the normal saline moistening of 2ml, obtains reference substance 1 respectively;
5) according to the thrombin amount in embodiment 1, by not containing the normal saline moistening of the thrombin lyophilized powder 2ml of hyaluronate sodium and carboxymethyl chitosan, reference substance 2 is obtained respectively;
6) according to the carboxymethyl chitosan in embodiment 1 and thrombin amount, haemostatic membrane will not be prepared into containing hyaluronic acid sodium raw materials, then use the normal saline moistening of 2ml, obtain reference substance 3;
7) the sample 1-6 of preparation and reference substance 1-3 is put into ageing oven aging (aging condition is: temperature 45 C, humidity 60%), after one week, take out sample and reference substance;
8) by pig intravenous anesthesia artery intubate, add blood to 10ml in each test tube to rapidly each pipe, start timing simultaneously.
9) tilt once every 20s test tube under room temperature, when no longer flowing to blood, stop timing.Obtain whole blood clotting time.
2, experimental result: in table 3
Table 3: the sample setting time of adding thrombin
As seen from Table 3: the compound hemostatic film obtained by embodiment 1-6, when being cut to size 2cm × 2.5cm, after adding the fresh Sanguis sus domestica of 10ml, its average time of stopping blooding is at 3min; Sample 1 finds out that compared with reference substance 1 bleeding stopping period obviously shortens after adding thrombin; Sample 1 finds out that compared with matched group 2, matched group 3 thrombin activity can keep certain stability in the carboxymethyl chitosan of compound hemostatic film.
Result shows: the present invention adds suitable thrombin and contributes to improving clotting time on the hyaluronate sodium of proportioning identical with embodiment 1-6 and the basis of carboxymethyl chitosan, can ensure the stability of thrombin simultaneously.
Experimental example 3: compound hemostatic film zoopery
1, experimental technique:
1) animal modeling: inject 3% pentobarbital sodium by 30 ~ 40mg/kg body weight dose from rabbit auricular vein, fixing on operating-table after anesthesia, abdominal part cropping, sterilization, 5cm otch under costal margin on the left of 75% ethanol disinfection drape tailing edge, cut off skin, peritoneum successively to open abdomen and enter abdominal cavity, expose liver, mark at liver verso surface scalpel the incision that 1 is about 1cm, dark 0.3cm.
2) bleeding time and amount of bleeding measure: blot cutting part blood with the dry gauze weighed rapidly after modeling, and according to grouping immediately in the most obvious hemorrhage position lay compound hemostatic film (what hemostatic material is blank group do not let alone), start timing, compel wound surface 15s with hand to lift (blank group gauze pressing wound surface 15s), observe each group of hemostatic material process of setting, until flow out without fresh blood, writing time, continuity is observed 2min and is oozed out without fresh blood, and writing time is bleeding stopping period before.If there is fresh blood to flow out in 2min, then re-press 15s at once, repeat above-mentioned steps, until stop blooding successfully.Excess blood in operation (i.e. the front gauze quality of gauze quality-hemostasis after amount of bleeding=hemostasis) is collected with the sterile gauze of known weight in whole process.Record amount of bleeding and bleeding stopping period, and within 14 days, observe the bonding situation of hemostatic material and wound surface after a procedure.
2, experiment grouping:
Get healthy qualified new zealand rabbit 15,3 groups are divided at random according to body weight, often organize 5, male and female dual-purpose, be respectively test sample group (the compound hemostatic film that embodiment 5 provides, 2cm × 4cm/ is only), like product matched group (absorbable hemostatic film, 2cm × 4cm/ only), blank group (being left intact).Animal grouping and numbering are in table 4.
The grouping of table 4 animal and numbering
| Group | Number of animals | Test sample/reference substance title | Dosage (cm/ only) |
| Blank group | 1～5 | Nothing | 0 |
| Like product matched group | 6～10 | Absorbable hemostatic film | 2×4 |
| Test sample group | 11～15 | Compound hemostatic film | 2×4 |
Note: compound hemostatic film is preparing according to embodiment 1; Absorbable hemostatic film is prepared from by hyaluronate sodium and carboxymethyl chitosan.
3, experimental result: in table 5
The zooperal result of table 5
| n | Bleeding time (S) | Amount of bleeding (g) |
| Blank group | 5 | 361±57 | 2.17±0.67 |
| Like product matched group | 5 | 68±10.6 | 0.30±0.26 |
| Test sample group | 5 | 19.6±3.6 | 0 |
Table 5 result shows: compared with blank group, the bleeding time of test sample group significantly shortens (P<0.05), and amount of bleeding also significantly reduces (P<0.05).Compared with like product group, the bleeding time of test sample group significantly shortens (P<0.05), and amount of bleeding also declines to some extent.
Result shows: compare with like product group with blank group, and it is fast and reduce the effect of amount of bleeding that test sample has anthemorrhagic speed, uses and remain as seen without naked eyes in vivo after 14 days, do not produce tissue adhesion's phenomenon; And the Degradation of test sample is suitable in like product.
Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.