CN112354000A - Gelatin compound hemostatic and preparation method thereof - Google Patents

Gelatin compound hemostatic and preparation method thereof Download PDF

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Publication number
CN112354000A
CN112354000A CN202011371269.2A CN202011371269A CN112354000A CN 112354000 A CN112354000 A CN 112354000A CN 202011371269 A CN202011371269 A CN 202011371269A CN 112354000 A CN112354000 A CN 112354000A
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gelatin
hemostatic
blood
embolization
compound hemostatic
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Chinese (zh)
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欧阳林
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Ninth Hospital Of Joint Service Support Force Of Chinese Pla
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Ninth Hospital Of Joint Service Support Force Of Chinese Pla
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/104—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4833—Thrombin (3.4.21.5)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0005—Ingredients of undetermined constitution or reaction products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0015—Medicaments; Biocides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21005—Thrombin (3.4.21.5)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254—Enzymes, proenzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/30—Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding

Abstract

The invention discloses a gelatin compound hemostatic and a preparation method thereof, wherein the compound hemostatic is prepared by mixing gelatin, Yunnan white drug powder and blood coagulation enzyme. The hemostatic material takes gelatin and blood coagulase as raw materials and Yunnan white drug powder as an auxiliary material, so that the hemostatic effect is prolonged, the effects of diminishing inflammation, diminishing swelling, promoting blood circulation, removing blood stasis and relieving pain are achieved, and the rehabilitation of later-period wound tissues is facilitated. Clinical tests prove that the application of the gelatin compound hemostatic can achieve the embolization hemostasis at the level of capillary networks and venules in wound tissues, effectively target embolization and protect residual functions of organs, and is superior to the embolization effect of PVA and microcoils at the level of arterioles.

Description

Gelatin compound hemostatic and preparation method thereof
Technical Field
The invention relates to the technical field of medical materials, in particular to a gelatin compound hemostatic and a preparation method thereof.
Background
For traumatic fracture or organ rupture hemorrhage, the first-line treatment method is to use interventional technique to perform endovascular embolization hemostasis. The interventional embolization hemostasis method is more and more accepted and recommended to be preferred in clinic at home and abroad. The embolizing materials include autologous blood clots (short-acting embolizing agents), gelatin sponges (medium-acting embolizing agents), PVA, coils, and colloidal adhesive embolizing agents (long-acting embolizing agents). However, the current embolization agent administered through the arterial route only has a remarkable effect on controlling arterial bleeding, but capillary vessel network and venous network bleeding caused by extensive contusion and laceration in deep soft tissues of retroperitoneum, pelvic cavity, thigh and other parts often makes clinical treatment and restraint incompetent, the existing compression hemostasis method cannot achieve the effect, surgical incision hemostasis is very troublesome, and the curative effect is difficult to predict and control. Equally important, primary and secondary complications, such as pain at bleeding sites, bruising after acute haemostasis and inflammatory reactions, all seriously affect the recovery from injury.
In the current clinical intervention treatment, the common embolism hemostasis materials also comprise permanent embolism materials such as polyvinyl alcohol Particles (PVA), spring rings and the like, and the materials have the effects of embolism hemostasis at the level of middle and small arteries, difficult micronization so as to reach and pass through the level of capillary vessel networks and play a role in hemostasis and blood coagulation at the level of the capillary vessels and small vein networks.
In conclusion, the current clinical effective hemostasis technology aiming at the bleeding of the deep soft tissue or organ trauma is worthy of further research and innovation.
Disclosure of Invention
The invention aims to provide a gelatin compound hemostatic which has the effects of continuously diminishing inflammation, relieving pain and removing blood stasis and promoting the recovery of injured tissues and a preparation method thereof, realizes the aim of achieving the hemostasis and blood coagulation of a whole blood piping system in tissues by targeted artery administration,
in order to achieve the purpose, the invention adopts the following technical scheme:
a gelatin compound hemostatic is prepared by mixing gelatin, Yunnan white drug powder and blood clotting enzyme.
Furthermore, the dosage ratio of the gelatin to the Yunnan white drug powder to the blood coagulation enzyme is 1 plus or minus 0.05g to 1U, and the dosage ratio of the gelatin to the Yunnan white drug powder to the blood coagulation enzyme is preferably 1g to 1U.
Furthermore, the gelatin and the Yunnan white drug powder are both prepared into powder, and the particle size is less than 100 microns.
The preparation method of the gelatin compound hemostatic comprises the following steps: preparing gelatin and Yunnan white drug powder with particle size less than 100 μm, mixing gelatin powder, Yunnan white drug powder and blood coagulase, and storing under sterile condition.
The gelatin compound hemostatic comprises the following main components: gelatin, blood coagulase and Yunnan white drug powder, the pharmacological properties of the three components are as follows: (1) gelatin: mechanical embolism for hemostasis, and middle-term embolism agent, which can degrade and absorb biological materials. Meanwhile, the composition has the functions of carrying the hemagglutinase and Yunnan white drug powder. (2) And (3) a blood coagulation enzyme: white-eyebrow snake or pallas pit viper prothrombin. (3) Yunnan Baiyao: stopping bleeding, relieving inflammation, eliminating swelling, promoting blood circulation, removing blood stasis, and relieving pain.
The product dosage form is as follows: powder, bottled (2 g/bottle).
The usage of the gelatin compound blood stopping medicine comprises the following steps: the usage and dosage are selected according to clinical conditions. (1) External use: the powder is directly sprayed on the wound surface or the wound after the open or exposed wound loses blood. (2) Oral administration: hematemesis, hematochezia, and hemoptysis, the powder is administered with warm water, 1/2 bottles (1 g) once, 2 times a day, and 1/4 doses of children under 16 years old. (3) Intravascular perfusion through a catheter: a bottle (2g) is dissolved in 20ml of normal saline, then diluted with 20ml of iodine contrast agent, and mixed solution of 40ml is used, and in the process of embolization of perfusion solution, the appearance of casting mould of peripheral arteriole is the reference evidence for stopping continuous perfusion.
The existing gelatin embolization agent is granular, the grain diameter is more than 100 microns, and the embolization can only be carried out at the level of a larger arterial blood vessel because the current gelatin embolization agent is difficult to or impossible to transport through a microcatheter, so that the embolization effect is poor in targeting property, and the hemorrhage of deep or hidden tissues, the hemorrhage of capillary vessels and the hemorrhage of venule layers are difficult to effectively stanch; in addition, the blood flow rate of a larger arterial blood vessel is high, so that the embolic agent is easily flushed away or brought to other parts and organs, and the embolization of a diseased part is insufficient, so that ectopic false embolization complications are caused; the blood coagulation enzyme is a rapid coagulant, has good acute-phase coagulation promoting effect, can better help deep or hidden tissue bleeding and capillary and venule layer bleeding, but has short drug effect action time, and the fibrinogen is reduced due to a large amount of blood loss of a patient, so that the blood coagulation enzyme can not play a role; the hemostatic material of the invention takes gelatin and blood coagulase as raw materials and Yunnan white drug powder as an auxiliary material, thereby prolonging the hemostatic efficacy, having the efficacies of diminishing inflammation, reducing swelling, promoting blood circulation, removing blood stasis and relieving pain, and being beneficial to the recovery of later-period wound tissues.
The hemostatic material can be delivered to the arterial vessel end of a bleeding part through a microcatheter, and reaches the small-micro artery, the capillary vessel-venous network in the tissue, the tissue around the blood vessel and the gap through blood flow, thereby not only being capable of quickly controlling the bleeding of a complicated or hidden part, but also being capable of reducing the secondary injury caused by an injury control operation, and also being capable of diminishing inflammation, relieving pain and removing blood stasis.
Detailed Description
Example 1
A preparation method of gelatin compound hemostatic; 1) preparing gelatin, Yunnan white drug powder and thrombin into powder with particle size less than 100 μm; 2) mechanically mixing the three raw materials (gelatin powder 1g, Yunnan Baiyao powder 1g, and hemagglutinating enzyme 1U) at a certain proportion, and aseptically drying and storing.
Example 2
A preparation method of gelatin compound hemostatic; 1) preparing gelatin, Yunnan white drug powder and thrombin into powder with particle size less than 100 μm; 2) mechanically mixing the three raw materials according to a certain proportion (gelatin powder 1.05g, Yunnan Baiyao powder 0.95g, and hemagglutination enzyme 1U), and performing aseptic drying and storage.
Example 3
A preparation method of gelatin compound hemostatic; 1) preparing gelatin, Yunnan white drug powder and thrombin into powder with particle size less than 100 μm; 2) mechanically mixing the three raw materials according to a certain proportion (gelatin powder 0.95g, Yunnan Baiyao powder 05g and hemagglutination enzyme 1U), and performing aseptic drying and storage.
Example 4
The usage of the gelatin compound blood stopping medicine: the usage and dosage are selected according to clinical conditions. (1) External use: the powder is directly sprayed on the wound surface or the wound after the open or exposed wound loses blood. (2) Oral administration: hematemesis, hematochezia, and hemoptysis, the powder is administered with warm water, 1/2 bottles (1 g) once, 2 times a day, and 1/4 doses of children under 16 years old. (3) Intravascular perfusion through a catheter: a bottle (2g) is dissolved in 20ml of normal saline, then diluted with 20ml of iodine contrast agent, and mixed solution of 40ml is used, and in the process of embolization of perfusion solution, the appearance of casting mould of peripheral arteriole is the reference evidence for stopping continuous perfusion.
Application example
The experimental design scheme is as follows: the gelatin compound hemostatic prepared in example 1 is adopted to carry out peripheral embolism treatment through artery when the group A personnel are on duty in emergency treatment, and PVA particles or micro spring rings are adopted to carry out peripheral embolism treatment through artery when the group B personnel are on duty in emergency treatment.
Test time: from 2019, 9, month 1 to 11, month 30.
The evaluation index of the curative effect is as follows: blood stopping effect in interventional therapy (DSA contrast diagnosis), postoperative hemorrhage (CT enhanced scan diagnosis), and organ infarction degree (CT enhanced scan diagnosis, index for evaluating organ function protection degree).
And (3) test results: during the test period, 13 patients with traumatic blood loss of abdominal basin deep soft tissue and organs are treated in the interventional department of the hospital. Group a treated 6 cases (1 case of kidney rupture by fall, 1 case of spleen rupture and spleen rupture in car accident, 2 cases of liver rupture by impact, 1 case of extensive contusion and laceration of soft tissue of pelvic posterior wall in pelvis fracture by earth collapse), group B treated 7 cases (1 case of kidney rupture by fall, 1 case of extensive contusion and laceration of soft tissue of pelvic posterior wall in fracture at multiple parts of the whole body, 1 case of extensive contusion and laceration of soft tissue of pelvic posterior wall in car accident, 1 case of liver rupture by fall and car accident, and 1 case of spleen rupture by extrusion and violent impact). DSA contrast showed consistent good blood discontinuation in groups a and B, with no significant difference. CT enhancement scanning for 24 hours after operation shows that the group A has no bleeding performance, and 4 cases in the group B still have contrast agent enhancement in deep soft tissue contusion and laceration areas (contrast agent leakage reflects tissue bleeding, 1 case of general multiple fractures caused by falling and pelvic wall soft tissue widespread contusion and laceration, 1 case of pelvic fracture and pelvic wall soft tissue widespread contusion and laceration in car accidents, and 1 case of liver rupture caused by falling and car accidents). CT enhancement scanning for 3 days after operation shows that 5 patients with broken parenchymal organs (1 patient with broken kidney, 1 patient with broken spleen and 1 patient with broken spleen respectively and 2 patients with broken liver) in the group A achieve the embolism hemostasis of the parenchymal organs at the level of the internal section, and only have inflammatory exudation reaction outside the envelope of the embolism section; in group B, 5 patients with parenchymal organ rupture (1 single kidney rupture caused by falling, 1 liver rupture caused by falling and traffic accident, and 1 spleen rupture caused by extrusion and violent impact) only reach the embolism of the (liver) lobe artery and the whole organ (kidney and spleen) trunk artery, the surgical total resection of the kidney and spleen is assisted after the intervention operation, and the vein embolism is carried out to achieve the obvious inflammation exudation of the liver margin.
And (4) test conclusion: the gelatin compound hemostatic can achieve the embolization hemostasis of capillary networks and venule networks in wound tissues, effectively targets embolization and protects residual functions of organs, and is superior to the embolization effect of PVA and microcoils at arteriolar level.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be able to cover the technical solutions and the inventive concepts of the present invention within the technical scope of the present invention.

Claims (5)

1. The gelatin compound hemostatic is characterized by being prepared by mixing gelatin, Yunnan white drug powder and blood clotting enzyme.
2. The gelatin compound hemostatic according to claim 1, wherein the dosage ratio of the gelatin to the Yunnan white drug powder to the blood clotting enzyme is 1 plus or minus 0.05g to 1U.
3. The gelatin compound hemostatic according to claim 2, wherein the dosage ratio of the gelatin to the Yunnan white drug powder to the blood clotting enzyme is 1g:1g: 1U.
4. The gelatin compound hemostatic according to claim 1, wherein the particle size of the Yunnan white drug powder is less than 100 microns.
5. The method for preparing the gelatin compound hemostatic as claimed in any one of claims 1 to 4, which comprises the following steps: pulverizing gelatin into gelatin powder with particle size less than 100 μm, and mixing with Yunnan white drug powder and blood clotting enzyme at a certain proportion.
CN202011371269.2A 2020-11-30 2020-11-30 Gelatin compound hemostatic and preparation method thereof Pending CN112354000A (en)

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CN101537094A (en) * 2009-04-28 2009-09-23 徐樊 Chinese medicine hemostatic powder
CN105126152A (en) * 2015-10-07 2015-12-09 中国海洋大学 Gelatin chitosan composite styptic powder
CN109498831A (en) * 2018-10-31 2019-03-22 四川大学 A kind of negatively charged injectable type gelatine microsphere base gel hemostatic material and its preparation method and application
CN109821059A (en) * 2019-04-16 2019-05-31 大连医科大学附属第一医院 A kind of preparation method of absorbable fluid gelatin hemostatic material
CN111569143A (en) * 2020-05-14 2020-08-25 山东省科学院生物研究所 Snake venom prothrombin activator and rapid hemostatic material based on same

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Application publication date: 20210212