CN1186096C - Hemostatics powder and preparation thereof - Google Patents
Hemostatics powder and preparation thereof Download PDFInfo
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- CN1186096C CN1186096C CNB011420715A CN01142071A CN1186096C CN 1186096 C CN1186096 C CN 1186096C CN B011420715 A CNB011420715 A CN B011420715A CN 01142071 A CN01142071 A CN 01142071A CN 1186096 C CN1186096 C CN 1186096C
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Abstract
The present invention discloses a powdery hemostatic and a preparation method thereof, which relates to a medicine and a preparation method thereof. The present invention aims to provide a powdery hemostatic capable of stanching blood quickly and effectively and being changed with an ease and a preparation method thereof. The preparation method comprises: (1) collagen fibers used as the raw material is filled in a gas generator and fixed with an aldehyde substance crosslinking agent at 40 to 50DEG C for 20 to 100 minutes; (2) the collagen fibers are washed by a water solution of glycerol; (3) the washed collagen fibers are put in a closed container and stirred at 30 to 35DEG C for 24 to 72 hours, and an excess quantity of a drying agent and alcohols and hydrochloric acid are added to the closed container; (4) the treated collagen fibers are washed with a water solution of glycerol and dried in vacuum; and (5) the collagen fibers are ground into powder with a grinder so as to obtain the powdery hemostatic. The powdery hemostatic can quickly and effectively stanch blood; the method for changing the hemostatic is simple; the powdery hemostatic does not have side effect; and the powdery hemostatic can promote wounds to heal and rehabilitate and can be absorbed by organism tissues.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, particularly relate to a kind of powder preparation stypticum thing and preparation method thereof.
Background technology
Employed clinically at present conventional powder preparation stypticum, main component is an inorganic matter, is at the most to add some therein to have the material (as thrombin) that promotes coagulation process.These hemorrhage bleeding stopping period are long, and side effect is arranged again, in addition can not be by reasons such as body tissue absorptions, and the application of many aspects is restricted.The haemostatic medicament that can not be absorbed by body tissue, the one, can not be applied to internal organs of the body and surgical operation, the 2nd, the complexity of changing dressings need be removed former medicine when changing dressings, and the tissue that is healing is destroyed.Another big defective of conventional powder preparation stypticum thing is, promoting aspect hemorrhage wound healing and the reparation obviously not enoughly, and the wound surface after the treatment is still waiting to improve in flatness and with the aspects such as colour contrast of wound surface surrounding tissue.
Collagen is the rich in protein of animal body intensive amount, is the main component of extracellular matrix.Collagen have antigenicity low, big with the cell affinity, produce characteristics such as hemagglutinative function with platelet, be widely used at field of medicaments.Have been found that 20 kinds of collagen-types that gene are different at present, its maximum feature is the structure of three collagen helixs.With the maximum type i collagen of amount is example, and tropocollagen molecule about 95% is three coiled strand fields, and remaining about 5% is the terminal peptide chain structure field of non-collagen.The antigenicity of collagen is low, mainly is because three coiled strand fields of collagen lack tyrosine residue, the antigenicity of collagen product in the market, and the removal of impurity is outer mainly from the peptide chain of collagen N and C terminal.
Research and development based on the curable product of collagen, a lot of achievements have been obtained, as collagen being made different dosage forms such as solution, gel, powder, sponge, fiber, thin film, or carry out various modifications, make it have different medical or medical functions.
Summary of the invention
The purpose of this invention is to provide a kind of simple powder preparation stypticum thing that can stop blooding quickly and effectively, change dressings.
A kind of powder preparation stypticum, it is to produce with the method that may further comprise the steps:
1) with the collagen fiber raw material, places gas generator, use aldehyde material cross-linking agent fixedly 20-100 minute down for 40-50 ℃;
2) clean with glycerine water solution, the ratio of weight and number of G ﹠ W is glycerol: water=0.1-10: 90-99.9 in the glycerine water solution;
3) collagen fiber with above-mentioned cleaning place hermetic container, and 30-35 ℃ was stirred 24-72 hour down, be added with excessive desiccant, pure and mild hydrochloric acid solution in the hermetic container;
4) will be through the collagen fiber of above-mentioned processing, be that the glycerine water solution of glycerol: water=0.1-10: 90-99.9 cleans vacuum drying with ratio of weight and number;
5) be ground to powder with pulverizer and promptly get powder preparation stypticum.
Aldehyde material in the described step 1) is preferably formaldehyde, methyl-glyoxal or glutaraldehyde; Desiccant in the described step 3) is preferably Na
2SO
4Or CaCl
2, alcohol is preferably methanol, ethanol or isopropyl alcohol, and the mass concentration of hydrochloric acid solution is 0.1-10%.
In order to make the powder preparation stypticum better effects if of producing, described collagen fiber raw material obtains in order to following method:
1) animal tissue's machinery that will be rich in collagen protein is removed impurity such as epidermal area, muscle and fat, cleans up after the pulverizing;
2) dilute alkaline soln and the defat of alcohols material solution washing of usefulness pH8.5-10.5;
3) be dissolved in the dilute acid soln of pH5.5-6.5;
4) in above-mentioned solution, add the compound protease of forming by gastric enzyme, pancreatin and three kinds of protease of carase, the specific activity of compound protease is a gastric enzyme: pancreatin: carase=1: 1: 0.5, the weight ratio of collagen protein and compound protease is 100-1000: 1,30-35 ℃ following stir culture 10-15 hour;
5) add NaCl in the supernatant of centrifugal collection, make concentration reach 2mol/L, 0-10 ℃ was stirred 10-20 hour down, collects the precipitate that obtains;
6) precipitate being dissolved in mass concentration is in the 0.1-0.5% acetic acid solution, centrifugal collection supernatant;
7) add NaCl in the supernatant again, make concentration reach 1mol/L, stir and obtain precipitate; Repetitive operation 3-4 time obtains the purpose product.
Described step 2) dilute alkaline soln in is by sodium hydroxide, and sodium bicarbonate and water are formed, and their ratio of weight and number is a sodium hydroxide: sodium bicarbonate: water=0.1-1: 5-10: 89-94.9; The alcohols material aqueous solution is by ethanol, and isopropyl alcohol and water are formed, and their ratio of weight and number is an ethanol: isopropyl alcohol: water=5-10: 2-5: 85-93; Dilute acid soln in the described step 3) is formic acid, acetic acid, propanoic acid or hydrochloric acid.
Another object of the present invention provides a kind of production can stop blooding quickly and effectively, change dressings method of simple powder preparation stypticum thing.
For achieving the above object, the present invention by the following technical solutions, a kind of preparation method of powder preparation stypticum may further comprise the steps:
A kind of preparation method of powder preparation stypticum may further comprise the steps:
1) with the collagen fiber raw material, places gas generator, use aldehyde material cross-linking agent fixedly 20-100 minute down for 40-50 ℃;
2) clean with glycerine water solution;
3) collagen fiber with above-mentioned cleaning place hermetic container, and 30-35 ℃ was stirred 24-72 hour down, be added with excessive desiccant, pure and mild hydrochloric acid solution in the hermetic container;
4) will clean vacuum drying with glycerine water solution through the collagen fiber of above-mentioned processing;
5) be ground to powder with pulverizer and promptly get powder preparation stypticum.
Described collagen fiber raw material is commercially available collagen primary product.
In order to make the powder preparation stypticum better effects if of producing, described collagen fiber raw material obtains in order to following method:
1) animal tissue's machinery that will be rich in collagen protein is removed impurity such as epidermal area, muscle and fat, cleans up after the pulverizing;
2) dilute alkaline soln and the defat of alcohols material solution washing of usefulness pH8.5-10.5;
3) be dissolved in the dilute acid soln of pH5.5-6.5;
4) add compound protease in above-mentioned solution, the weight ratio of collagen protein and compound protease is 100-1000: 1,30-35 ℃ following stir culture 10-15 hour;
5) add NaCl in the supernatant of centrifugal collection, make concentration reach 2mol/L, 0-10 ℃ was stirred 10-20 hour down, collects the precipitate that obtains;
6) precipitate being dissolved in mass concentration is in the 0.1-0.5% acetic acid solution, centrifugal collection supernatant;
7) add NaCl in the supernatant again, make concentration reach 1mol/L, stir and obtain precipitate; Repetitive operation 3-4 time obtains the purpose product.
Described compound protease by specific activity is: gastric enzyme: pancreatin: three kinds of protease of carase=1: 1: 0.5 are formed.
Described aldehyde material cross-linking agent is preferably formaldehyde, methyl-glyoxal or glutaraldehyde.
The proportioning of the glycerine water solution of described cleaning usefulness is G ﹠ W, and their ratio of weight and number is glycerol: water=0.1-10: 90-99.9.
The excessive desiccant that adds in the described hermetic container is preferably Na
2SO
4Or CaCl
2Alcohol is preferably methanol, ethanol or isopropyl alcohol; The concentration of hydrochloric acid solution is 0.1-10%.
The powder preparation stypticum that obtains through the packing,
60It behind the Co radiation sterilization finished product.
Powder preparation stypticum of the present invention can stop blooding quickly and effectively, and the method for changing dressings is simple, has no side effect, and can promote wound healing and reparation, can also be absorbed by body tissue.Bleeding stopping period is short, can use oligemia, alleviates patient's painful and loss.In the time of need changing dressings, needn't remove original medicine on the wound surface, directly on wound surface, cover for the second time and add medicine and get final product.The collagen of collagen original washing powder agent hemorrhage after by modification is formed, have the advantages that to promote fibroblast activity and various growth factor activities, and the fibre structure on the microcosmic, can be used as the support (scaffolds) of cell and tissue growth, the wound surface after the hemostasis is repaired well.
In gas generator, material is carried out crosslinked fixing, can avoid the objectionable impurities (as half chemical compound of the ring in the glutaraldehyde solution) in the cross-linking agent solution to enter in the material, make the biology performance of powder preparation stypticum of the present invention very excellent.Crosslinked by collagen fiber makes the collagen aggregation chemically stable that becomes.
The processing of alcohols material, the isoelectric point, IP of raising hemorrhage.It has been generally acknowledged that the skin covering of the surface of cell has negative charge (as platelet), according to principle of opposite sex attraction, the product of the present invention of higher isoelectric point has the hematoblastic ability of very strong absorption, thereby accelerates hemostasis speed.
The chemical modification of hydrochloric acid helps improving the adhesion of haemostatic medicament and wound tissue.
The processing of glycerol has improved the pliability of material, and the hardness that reduces wound surface stimulates, to reduce patient's misery.
The present invention will be further described below in conjunction with specific embodiment.
The specific embodiment
Embodiment 1,
Produce haemostatic medicament of the present invention with the original structure of animal, concrete steps are as follows:
1, will be rich in the tissue (Corii Sus domestica, Corii Bovis seu Bubali, heel string etc.) of collagen protein, machinery is removed impurity such as epidermal area, muscle and fat, cleans with tap water and pure water respectively after the pulverizing;
Water=0.5: 7.5: 92) and alcohols material aqueous solution (ratio of weight and number, ethanol: isopropyl alcohol: water=7: 4: 89) 2, the dilute alkaline soln of preparation pH10 (ratio of weight and number, sodium hydroxide: sodium bicarbonate:;
3, with the dilute alkaline soln and the resulting animal tissue of the alcohols material solution washing first step of above-mentioned preparation, make its defat;
4, it is dissolved in the dilute formic acid solution of pH6.0 ± 0.1;
5, add compound protease in above-mentioned solution, the weight ratio of collagen protein and compound protease is 800: 1, and compound protease by specific activity is: gastric enzyme: pancreatin: three kinds of protease of carase=1: 1: 0.5 are formed, 33 ℃ of following stir culture 13 hours;
6, centrifugal, and collect supernatant, in supernatant, add NaCl, make concentration reach 2mol/L, 5 ℃ were stirred 15 hours down, collected the precipitate that obtains, and were the collagen fiber raw material;
7, with the collagen fiber raw material, place gas generator, use formaldehyde fixed 60 minutes down for 45 ℃;
8, use glycerol: the glycerine water solution of water=5: 95 cleans;
9, the collagen fiber with above-mentioned cleaning place hermetic container, and 32 ℃ were stirred 60 hours down, are added with excessive desiccant Na in the hermetic container
2SO
4, methanol and 8% hydrochloric acid solution;
10, will use glycerol through the collagen fiber of above-mentioned processing: the glycerine water solution of water=8: 92 cleans, vacuum drying;
11, be ground to powder with pulverizer and promptly get powder preparation stypticum of the present invention;
12, the powder preparation stypticum that obtains through the packing,
60It behind the Co radiation sterilization finished product.
Embodiment 2
Produce haemostatic medicament of the present invention with commercially available collagen fiber, concrete steps are as follows:
1, with commercially available collagen fiber raw material, places gas generator, fix 90 minutes with glutaraldehyde under 45 ℃;
2, use glycerol: the glycerine water solution of water=1: 99 cleans;
3, the collagen fiber with above-mentioned cleaning place hermetic container, and 34 ℃ were stirred 30 hours down, are added with excessive desiccant CaCl in the hermetic container
2, isopropyl alcohol and 3% hydrochloric acid solution;
4, will use glycerol through the collagen fiber of above-mentioned processing: the glycerine water solution of water=3: 97 cleans, vacuum drying;
5, be ground to powder with pulverizer and promptly get powder preparation stypticum of the present invention;
6, the powder preparation stypticum that obtains through the packing,
60It behind the Co radiation sterilization finished product.
The efficacy experiment of embodiment 3, hemorrhage of the present invention
Hemorrhage of the present invention is used for rabbit ear portion and viscus hemostasis and therapeutic effect to be observed.The hemorrhage wound surface of ear is of a size of 2 * 1cm, the dirty excision 1 * 1cm tissue of going up of liver (spleen), and experimental group hemorrhage of the present invention, the used hemorrhage main component of matched group is a gelatin, and bleeding stopping period is an arithmetic equal value, and haemostatic effect is as shown in table 1.After the hemostasis of internal organs of the body wound surface, sew up the abdominal cavity, regularly put to death animal, carry out absorbing in the body and the tissue slice observation.The result shows that hemorrhage of the present invention was absorbed fully by body about 60 days, the no abnormal phenomenon of wound surface local organization.Especially after the hemostasis of ear's wound surface, not only wound healing is fast, and wound surface part, healing back is smooth, does not have remarkable color distortion with surrounding tissue.
The haemostatic effect of table 1 rabbit ear vein, liver, spleen
Group n bleeding stopping period (s) gross hemostasis rate
The other liver spleen % of ear
Experimental group 20 20 30 40 100
Matched group 20 60 65 70 100
Claims (13)
1, a kind of powder preparation stypticum, it is to produce with the method that may further comprise the steps:
1) with the collagen fiber raw material, places gas generator, use aldehyde material cross-linking agent fixedly 20-100 minute down for 40-50 ℃;
2) clean with glycerine water solution, the ratio of weight and number of G ﹠ W is glycerol: water=0.1-10: 90-99.9 in the glycerine water solution;
3) collagen fiber with above-mentioned cleaning place hermetic container, and 30-35 ℃ was stirred 24-72 hour down, be added with excessive desiccant, pure and mild hydrochloric acid solution in the hermetic container;
4) will be through the collagen fiber of above-mentioned processing, be that the glycerine water solution of glycerol: water=0.1-10: 90-99.9 cleans vacuum drying with ratio of weight and number;
5) be ground to powder with pulverizer and promptly get powder preparation stypticum.
2, a kind of powder preparation stypticum according to claim 1 is characterized in that: the aldehyde material in the described step 1) is formaldehyde, methyl-glyoxal or glutaraldehyde; Desiccant in the described step 3) is Na
2SO
4Or CaCl
2, alcohol is methanol, ethanol or isopropyl alcohol, the mass concentration of hydrochloric acid solution is 0.1-10%.
3, a kind of powder preparation stypticum according to claim 1 and 2 is characterized in that: described collagen fiber raw material obtains in order to following method:
1) animal tissue's machinery that will be rich in collagen protein is removed impurity such as epidermal area, muscle and fat, cleans up after the pulverizing;
2) dilute alkaline soln and the defat of alcohols material solution washing of usefulness pH8.5-10.5;
3) be dissolved in the dilute acid soln of pH5.5-6.5;
4) in above-mentioned solution, add the compound protease of forming by gastric enzyme, pancreatin and three kinds of protease of carase, the specific activity of compound protease is a gastric enzyme: pancreatin: carase=1: 1: 0.5, the weight ratio of collagen protein and compound protease is 100-1000: 1,30-35 ℃ following stir culture 10-15 hour;
5) add NaCl in the supernatant of centrifugal collection, make concentration reach 2mol/L, 0-10 ℃ was stirred 10-20 hour down, collects the precipitate that obtains;
6) precipitate being dissolved in mass concentration is in the 0.1-0.5% acetic acid solution, centrifugal collection supernatant;
7) add NaCl in the supernatant again, make concentration reach 1mol/L, stir and obtain precipitate; Repetitive operation 3-4 time obtains the purpose product.
4, a kind of powder preparation stypticum according to claim 3, it is characterized in that: the dilute alkaline soln described step 2) is by sodium hydroxide, sodium bicarbonate and water are formed, and their ratio of weight and number is a sodium hydroxide: sodium bicarbonate: water=0.1-1: 5-10: 89-94.9; The alcohols material aqueous solution is by ethanol, and isopropyl alcohol and water are formed, and their ratio of weight and number is an ethanol: isopropyl alcohol: water=5-10: 2-5: 85-93; Dilute acid soln in the described step 3) is formic acid, acetic acid, propanoic acid or hydrochloric acid.
5, a kind of preparation method of powder preparation stypticum may further comprise the steps:
1) with the collagen fiber raw material, places gas generator, use aldehyde material cross-linking agent fixedly 20-100 minute down for 40-50 ℃;
2) clean with glycerine water solution;
3) collagen fiber with above-mentioned cleaning place hermetic container, and 30-35 ℃ was stirred 24-72 hour down, be added with excessive desiccant, pure and mild hydrochloric acid solution in the hermetic container;
4) will clean vacuum drying with glycerine water solution through the collagen fiber of above-mentioned processing;
5) be ground to powder with pulverizer and promptly get powder preparation stypticum.
6, the preparation method of a kind of powder preparation stypticum according to claim 5 is characterized in that: described collagen fiber raw material is commercially available collagen primary product.
7, the preparation method of a kind of powder preparation stypticum according to claim 5 is characterized in that: described collagen fiber raw material obtains in order to following method:
1) animal tissue's machinery that will be rich in collagen protein is removed impurity such as epidermal area, muscle and fat, cleans up after the pulverizing;
2) dilute alkaline soln and the defat of alcohols material solution washing of usefulness pH8.5-10.5;
3) be dissolved in the dilute acid soln of pH5.5-6.5;
4) add compound protease in above-mentioned solution, the weight ratio of collagen protein and compound protease is 100-1000: 1,30-35 ℃ following stir culture 10-15 hour;
5) add NaCl in the supernatant of centrifugal collection, make concentration reach 2mol/L, 0-10 ℃ was stirred 10-20 hour down, collects the precipitate that obtains;
6) precipitate being dissolved in mass concentration is in the 0.1-0.5% acetic acid solution, centrifugal collection supernatant;
7) add NaCl in the supernatant again, make concentration reach 1mol/L, stir and obtain precipitate; Repetitive operation 3-4 time obtains the purpose product.
8, the preparation method of a kind of powder preparation stypticum according to claim 7, it is characterized in that: the dilute alkaline soln described step 2) is by sodium hydroxide, sodium bicarbonate and water are formed, and their ratio of weight and number is a sodium hydroxide: sodium bicarbonate: water=0.1-1: 5-10: 89-94.9; The alcohols material aqueous solution is by ethanol, and isopropyl alcohol and water are formed, and their ratio of weight and number is an ethanol: isopropyl alcohol: water=5-10: 2-5: 85-93; The dilute acid soln of described step 3) is formic acid, acetic acid, propanoic acid or hydrochloric acid.
9, according to the preparation method of claim 7 or 8 described a kind of powder preparation stypticums, it is characterized in that: described compound protease by specific activity is: gastric enzyme: pancreatin: three kinds of protease of carase=1: 1: 0.5 are formed.
10, according to the preparation method of any one described a kind of powder preparation stypticum among the claim 5-8, it is characterized in that: described aldehyde material cross-linking agent is formaldehyde, methyl-glyoxal or glutaraldehyde.
11, according to the preparation method of any one described a kind of powder preparation stypticum among the claim 5-8, it is characterized in that: the proportioning of the glycerine water solution of described cleaning usefulness is G ﹠ W, and their ratio of weight and number is glycerol: water=0.1-10: 90-99.9.
12, according to the preparation method of any one described a kind of powder preparation stypticum among the claim 5-8, it is characterized in that: the excessive desiccant that adds in the described hermetic container is Na
2SO
4Or CaCl
2Alcohol is methanol, ethanol or isopropyl alcohol; The concentration of hydrochloric acid solution is 0.1-10%.
13, according to the preparation method of any one described a kind of powder preparation stypticum among the claim 5-8, it is characterized in that: the powder preparation stypticum that obtains through the packing,
60It behind the Co radiation sterilization finished product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011420715A CN1186096C (en) | 2001-09-10 | 2001-09-10 | Hemostatics powder and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB011420715A CN1186096C (en) | 2001-09-10 | 2001-09-10 | Hemostatics powder and preparation thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1406628A CN1406628A (en) | 2003-04-02 |
| CN1186096C true CN1186096C (en) | 2005-01-26 |
Family
ID=4676603
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB011420715A Expired - Fee Related CN1186096C (en) | 2001-09-10 | 2001-09-10 | Hemostatics powder and preparation thereof |
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| CN (1) | CN1186096C (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101224311B (en) * | 2008-02-01 | 2011-10-05 | 北京工业大学 | Preparing method of compound collagen hemostatic material |
| CN104258454B (en) * | 2014-10-23 | 2016-06-08 | 北京积水潭医院 | A kind of medical multifunctional hemostatic material and preparation method thereof |
| CN111518198A (en) * | 2020-06-12 | 2020-08-11 | 戴东升 | Collagen and preparation method thereof |
| CN114681659B (en) * | 2020-12-31 | 2023-04-18 | 广州迈普再生医学科技股份有限公司 | Composite styptic powder and preparation method and application thereof |
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2001
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