| Because bleeding is one of the common symptoms of surgery and warfare,and one of the causes of death.Effective,rapid and timely hemostasis can significantly reduce the mortality rate of patients,which is the hotspot of military medicine and emergency medicine at home and abroad.Traditional suture,compression and electrocoagulationare currently used in the surgical.Suture hemostasis can be effective inbleeding with large blood vessels,but the effect of traditional suture on the extensive wound bleeding is limited.The suture process easily lead to tissue cutting broken;The process of electrocoagulation is easy to produce smoke and eschar formation,there is postoperative complications and easy to cause adhesion.Absorbable hemostatic material is a class of biological materials that can be applied to the wound to achieve hemostasis by accelerating blood coagulation and can be degraded by the body.The products of the topical hemostatic agents:Avitene（?）（Davol）,Arista（?）,Flo Seal（?）,Surgicel（?）,Bio Glue（?）,Quik Clot（?）and domestic products including MPH?by Hangzhou Xiehe Medical Equipment Corporation,Shunshi?hemostatic powder.Topical hemostasis are mostly composed of oxidized cellulose,Regenerated cellulose,starch and other plant polysaccharides,gelatin,collagen and so on.Currently listed products are composed of a wide range of hemostatic materials but there are still some shortcomings.Some hemostatic agent’s effect is not ideal,some products are expensive so that hemostatic products can not be widely used.Our research group developed a hemostatic powder product that is composed of sodium carboxymethyl cellulose and potato starch,the introduction of sodium carboxymethyl cellulose can enhance the hemostatic effect of starch,reduce the complication of postoperative adhesions and accelerate the wound healing.Animal experiment was conducted to study the hemostatic effect of the product in order to provide the basis for clinical application.The main research contents are as follows:Part I:IntroductionThis paper introduces the present situationtopical hemostatic agents and introduces the anti-clotting effect of polysaccharides such as starch and carboxymethyl cellulose,as well as the research and development products designed by this research group,and the research significance,content innovation and Technical route to introduce.Part II:Study on the hemostatic effect of compound microporous polysaccharide hemostatic productsObject:To study the hemostatic effect of compound microporous polysaccharide products in animal model,and to observe the indexes including bleeding volume and hemostasis time,so as to provide the basis for clinical application.Methods:Using the bleeding model of liver,kidney,femoral artery,femoral vein,muscle and skin of New Zealand rabbits,the hemostasis effectof our research group products,the products of MPH?andgauze presswere compared(the intervention measure of group Ais product developed by our research group,Group B is MPH?,group C is negative control group by gauze compression only).After making the bleeding model and free bleeding for 2 seconds,the hemostasis agent was sprayed on the wound and compress with 200g weight on gauze,and the hemostatic effect was observed every 30s.After complete hemostasis,calculate the amount of blood using the gauze weight difference before and after hemostasis.The pathologic tissues of the wound were taken after surgery at 3d,7d,14d and complete healing.The pathological changes of the liver,kidney and muscle of New Zealand rabbits were observed after hematoxylin-eosin staining.Results:In the model of liver hemorrhage,the hemostasis effect was good,the bleeding volume of test group was 3.721g,positive group was 7.562g,the negative control group was 12.420g.Time to stop bleeding in Liver bleeding of group A,B,C group were 206s,361s,643s,compound microporous polysaccharide hemostatic powder significantly reduced volume bleeding and hemostasis time.In the model of renal hemorrhage,the hemostasis time of group A,group B and group C was 143s,172s and 367s respectively,the bleeding volume was 1.900g,2.118g,3,675g,thehemostatic effect of compound microporous polysaccharide hemostatic powder and the positive control group was significantly better than that of the blank control group,but there was no significant difference between the experimental group and the positive control group.In the model of femoral vein hemorrhage,the hemostasis time was 186s,170s and 220s in group A,B and C,respectively,and the bleeding volume was 3.823g,3.627g,5.872g,The hemostatic effect of the compound microporous polysaccharide hemostatic powder and the positivecontrol group was significantly better than that of the blank control group,but there was no significant difference between the experimental group and the positive control group.In the model of femoral artery hemorrhage,the hemostasis time of group A,group B and group C was 153s,236s and 443s respectively,the bleeding volume was 5.639g,4.223g,4.128g,The hemostasistime the compound microporous polysaccharide hemostatic powder and the positive control group was significantly shorter than that of the blank control group,but there was no significant difference in the amount of bleeding between the test group,the positive control group and the blank control group.In the model of muscle hemorrhage,the hemostasis time of group A,group B and group C was 105s,81s and 247s respectively,the bleeding volume was 0.405g,0.252g,0.276g.The hemostasis effect ofthe compound microporous polysaccharide hemostatic powder and the positive group was significantly better than the blank control group,but there was no significant difference in the amount of bleeding between the experimental group,the positive group and the blank control group.Conclusion:The compound microporous polysaccharide products developed byourexperiment group significantly reduced the hemostatic time and the amount of bleeding in the liver,kidney and femoral vein hemorrhage model of New Zealand rabbitsand showed good hemostatic effect.In the model of femoral artery hemorrhage and muscle hemorrhage model,compound microporous polysaccharide hemostatic powder significantly reduced the hemostatic time,but the amount of bleeding in the test group,positive group and blank group showed no significant difference,suggesting that hemostatic effect of hemostatic powder for femoral artery and muscle showed certain defect.Through the above five bleeding model,we can see hemostatic effect of the compound microporous polysaccharide hemostatic powder as a kind of medical hemostatic material,compound microporous polysaccharide hemostatic powder is derived from potato starch and sodium carboxymethyl cellulose,is a safe and convenient,no heat damage,wound effusion,no neurotoxicity,does not affect the wound healing of a class of hemostatic material,has a huge market potential.This product is commercially available potato starch as raw material,rich source preparation process is simple,suitable for mass production,is expected to become a new hemostatic material.Hemorrhage material can quickly stop bleeding and its ability to absorb,promote coagulation capacity and tissue adhesion,the product also has some shortcomings,that the goods on the tissue adhesion is relatively weak,hemostatic effect depends mainly on oppression,so later The study can further improve the hemostatic effect by enhancing the adhesion of hemostatic powder.PartⅢ:Pyrogen examination of compound polysaccharide hemostatic powderObjective:To evaluate the safety of the compound polysaccharide hemostatic powder to provide the basis for the establishment of pyrogen test and ensure the safety of its clinical application,.Methods:Take three batches of compound polysaccharide hemostatic powder products,the extract of sample is made according to the biological evaluation the medical device:take 3g of hemostatic powder and add desiccant saline water with amount of its absorbency.After the powder became gelatinous,30 ml desiccant saline water is added.After incubation at 37℃for 24 h,the supernatant is centrifuged at 3000 r/minand the rabbits are treated with 10 ml/kg extract.The temperature of the rabbits is observed.Results:The sum of body temperature of three batches of rabbits is lower than0.6℃,which is in accordance with the requirements of Pharmacopoeia. |
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