CN116173316A - Anti-adhesion preparation, device, preparation method and application thereof - Google Patents
Anti-adhesion preparation, device, preparation method and application thereof Download PDFInfo
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- CN116173316A CN116173316A CN202310312148.8A CN202310312148A CN116173316A CN 116173316 A CN116173316 A CN 116173316A CN 202310312148 A CN202310312148 A CN 202310312148A CN 116173316 A CN116173316 A CN 116173316A
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Images
Classifications
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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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
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- A—HUMAN NECESSITIES
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
- Y02W90/00—Enabling technologies or technologies with a potential or indirect contribution to greenhouse gas [GHG] emissions mitigation
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Abstract
The invention belongs to the technical field of biomedical materials, and particularly relates to an anti-adhesion preparation, an anti-adhesion device, a preparation method and application thereof. The device comprises a prefilled syringe and an anti-adhesion agent preloaded in the prefilled syringe; the anti-adhesion preparation consists of water-soluble gel and a solid membrane mixed in the water-soluble gel. The viscosity of the water-soluble gel is 1.01X10 ‑3 Pa﹒s～9.99×10 6 Pa·s; the thickness of the solid membrane is 0.01-2 mu m;the area of the solid membrane is 0.1mm 2 ～50cm 2 The method comprises the steps of carrying out a first treatment on the surface of the Cutting the prepared solid membrane, adding the cut solid membrane into the prepared water-soluble gel, uniformly mixing, and pre-filling the mixture into a syringe to obtain the anti-adhesion device filled with the anti-adhesion preparation. The product of the invention can be applied like gel at will, can be used for minimally invasive surgery through a microcatheter, has the characteristic of good anti-adhesion effect of the membrane, overcomes the defects of the gel and the membrane, prevents tissue and organ adhesion after surgery, has no cytotoxicity and meets clinical requirements.
Description
Technical Field
The invention belongs to the technical field of biomedical materials, and particularly relates to an anti-adhesion preparation, an anti-adhesion device, a preparation method and application thereof.
Background
Post-operative tissue adhesion is a common phenomenon after clinical surgery that causes adjacent tissues or organs that are originally separated to adhere together through abnormal connective tissue after surgery, and is considered to be a pathological phenomenon that necessarily occurs during the healing process of tissues. Factors causing adhesion are serosa damage, ischemia, hemorrhage, chemical irritation, inflammation, foreign matter residue, etc. caused by surgery. Adhesion can occur in any body part after surgery, particularly after surgery such as the abdomen, pelvic cavity, tendons in the body, and the spine.
Adhesions following abdominal, pelvic surgery occur during wound healing and their formation is related to an imbalance between peritoneal fibrin deposition and fibrin degradation. Adhesion can lead to serious clinical complications such as intestinal obstruction, infertility, chronic pelvic pain and the like, seriously affect the operation effect and the life quality, and increase the economic and mental burden of patients.
Tendon injury in hand and foot surgery is common injury, and according to clinical data statistics, the adhesion rate of the repaired tendon is about 30%. Wherein the adhesion of the flexor tendon sheath region can reach 50%. Severely stuck persons need to undergo a debonding procedure to restore hand function, but cannot prevent sticking again.
The postoperation scar adhesion of lumbar vertebra seriously affects the prognosis and operation effect of patients, and adhesion causes such as operation wound, local inflammatory reaction, vascular permeability change and the like, so that the occurrence of adhesion is prevented from becoming a research hot spot in spinal surgery.
The existing methods for preventing adhesion are as follows, (1) minimally invasive techniques are selected as much as possible, so that the irritation and damage are reduced as much as possible, and the operation time is shortened. (2) Anti-infective agents such as antibiotics, anti-inflammatory agents, anticoagulants, fibrinolytic agents, etc. are used. (3) Films, gels, and the like, made of degradable polymeric materials, are used for preventing postoperative adhesions, including natural polymeric materials such as hyaluronic acid, cellulose, chitosan, derivatives thereof, and the like, and synthetic polymeric materials such as polyethylene glycol and copolymers thereof, polylactic acid and copolymers thereof, polyglycolic acid and copolymers thereof, polycaprolactone and copolymers thereof, and the like. In recent years, the above materials are widely used in surgical operations including abdominal operations, pelvic operations, hand and foot operations, spinal operations, and the like.
Products in the form of preparations such as hydrogels, films and the like are common in the existing anti-blocking products. The hydrogel and the membrane have the following defects in clinical use, (1) the hydrogel has strong fluidity and is not easy to fix in a use part. (2) The anti-blocking effect of the hydrogel is poor. (3) Hydrogels are often used in abdominal pelvic surgery, diaphragms are often used in hand and foot surgery, and minimally invasive surgery is limited in use. (4) During minimally invasive surgery, the membrane products cannot be conveyed through an endoscope, and only hydrogel anti-adhesion liquid can be used.
The invention aims to provide an anti-adhesion preparation application product capable of solving the problems, which can be applied like gel at will, can be used for minimally invasive surgery through a microcatheter and has the characteristic of good anti-adhesion effect of a membrane.
Disclosure of Invention
In order to solve the problems, the invention provides an anti-adhesion preparation, an anti-adhesion device, a preparation method and application thereof. The device is matched with the anti-adhesion preparation prepared specifically for use, so that the anti-adhesion preparation is smeared like gel at will, can be used for minimally invasive surgery through a microcatheter, has the characteristic of good anti-adhesion effect of the membrane, and overcomes the defects of the gel and the membrane.
The specific preparation scheme of the invention is as follows:
an anti-blocking preparation comprises the following components: water-soluble gel, solid membrane;
preferably, the water-soluble gel comprises the following component materials: at least one of chitosan and its derivatives, cellulose and its derivatives, hyaluronic acid and its derivatives, alginic acid and its derivatives, starch and its derivatives, xanthan gum and its derivatives, gelatin, carbomer, polyethylene glycol, including but not limited to the above components.
The preparation method of the water-soluble gel comprises the following steps: the composition is prepared by dissolving the component materials in isotonic aqueous solution of pure water/normal saline (sodium chloride injection)/phosphate buffer solution, and the dissolution can be accelerated by stirring, heating and the like during the dissolution.
Preferably, the solid membrane comprises the following component materials: at least one of polyglycolide, polylactide-co-glycolic acid, polylactide-co-caprolactone, polylactide-co-glycolide, polyurethane, polycaprolactone, polyglycolic acid, polyethylene terephthalate, polyglycolic acid, polydioxanone, polyanhydride, fibroin, including but not limited to the above ingredients.
Preferably, the preparation method of the solid membrane adopts any one of casting method, electrostatic spinning, non-woven preparation, freeze-drying, tabletting after freeze-drying, direct tabletting, melting, plastic sucking, blow molding and extrusion.
Preferably, the preparation method of the anti-blocking preparation in the invention is as follows:
cutting the prepared solid membrane into a certain size and shape according to 1mL: (0.1 cm) 2 ～10cm 2 ) Adding into the prepared water-soluble gel, stirring and mixing uniformly to obtain the final product.
The water-soluble gel has a certain viscosity, and the viscosity is inversely related to the size of a solid membrane added into the water-soluble gel; when the viscosity is larger, the area of the added membrane is smaller, and when the viscosity is smaller, the area of the added membrane is larger.
Preferably, the viscosity of the water-soluble gel is 1.01X10 -3 Pa﹒s～9.99×10 6 And mPa.s.
The solid membrane has a certain shape and thickness.
Preferably, in the device, the solid membrane may be solid or hollow.
Preferably, the shape of the solid membrane is any one of rectangle, circle, ellipse, square, pentagon, hexagon, polygon and irregular shape.
Preferably, the thickness of the solid membrane is in the range of 0.01-2 μm.
Preferably, the area of the solid membrane is 0.1mm 2 ～50cm 2 Between them.
The invention also provides an anti-adhesion device filled with the anti-adhesion preparation, which comprises a pre-filling syringe and the anti-adhesion preparation pre-filled in the pre-filling syringe.
The prefilled syringe comprises a push head, a push rod, a piston, an empty cylinder, an injection head, a protective cap and a smearing brush; the injection head is provided with external threads at one end close to the empty cylinder, the protective cap and the smearing brush are provided with internal threads, and the protective cap or the smearing brush is installed and fixed at the front end of the injector through a thread structure for use. The brush head of the smearing brush is a fan-shaped brush head, and the outlet of the smearing brush is arranged at the bottom of the fan-shaped brush head. The smearing brush is made of silica gel, is soft and can not cause mechanical damage when in use.
When the smearing brush is used, the protective cap at the front end of the device is taken down, the smearing brush is arranged at the front end of the device, and the smearing brush is screwed down to prevent falling.
The pre-filled anti-blocking preparation consists of water-soluble gel and solid membrane mixed therein.
The invention also provides a preparation method of the anti-adhesion device filled with the anti-adhesion preparation, which comprises the following steps:
cutting the prepared solid membrane into a certain size and shape according to a certain volume area ratio, such as 1mL: (0.1 cm) 2 ～10cm 2 ) Adding the mixture into the prepared water-soluble gel, uniformly mixing, and filling the mixture into a prefilled syringe according to the specification of 0.5-50 mL/branch; the prefilled syringe may be configured with a brush.
The anti-adhesion preparation and the anti-adhesion device can be applied to the prevention of tissue and organ adhesion after operation, and can be used as a pharmaceutical preparation or an auxiliary preparation; including application to the prevention of postoperative adhesion in surgical operations such as abdominal surgery, pelvic surgery, hand and foot surgery, spinal surgery and the like. The above is merely an example, and is not limited to the above application scenario.
The invention has the following beneficial effects:
1. the anti-blocking preparation has a certain viscosity, and the viscosity is controllable and is 1.01X10 -3 Pa﹒s～9.99×10 6 Pa is between s; the viscosity is inversely related to the size of the solid film added into the membrane, when the viscosity is larger, the size of the added membrane is smaller, and when the viscosity is smaller, the added membrane is larger and can be better fixed at a use position when in use;
2. the invention has high usability in operation, short operation time of 8-9 minutes; the postoperative anti-adhesion effect is good, and the non-adhesion (-) is generally observed in an anti-adhesion test; the product is nontoxic, and shows a 1-grade cytotoxicity-free result in cytotoxicity test, thereby meeting clinical requirements;
3. the application scene is many, can be smeared like gel at will, can be used for minimally invasive surgery through the microcatheter, and has the characteristic of good anti-adhesion effect of the membrane;
4. the cutting shape of the solid membrane is not limited, and the solid membrane can be rectangular, round, oval, square, pentagonal, hexagonal, polygonal, irregular and the like, and can be solid patterns and hollow patterns, and the operation is simple and convenient;
5. the prefilled syringe can be provided with a smearing brush, so that the smearing convenience is further enhanced.
Drawings
FIG. 1 is a block diagram of an anti-blocking device;
wherein, in the drawings, the parts represented by the reference numerals are as follows:
1 push head, 2 push rod, 3 piston, 4 empty cylinder, 5 injection head, 6 protective cap and 7 smearing brush.
Detailed Description
1. Description of the embodiments
Examples 1 to 24
An anti-blocking preparation comprises the following components: water-soluble gel, solid film.
The preparation method of the water-soluble gel with different components comprises the following steps:
(1) Preparation of carboxymethyl chitosan gel
Carboxymethyl chitosan is taken and dissolved in physiological saline in a proportion of 60mg/mL, and the dissolution can be accelerated by stirring, heating and other modes during the dissolution.
(2) Preparation of carboxymethyl cellulose gel
Sodium carboxymethylcellulose is taken and dissolved in phosphate buffer solution in a proportion of 30mg/mL, and the dissolution can be accelerated by stirring, heating and other modes during the dissolution.
(3) Preparation of sodium hyaluronate gel
Sodium hyaluronate is taken and dissolved in purified water in a proportion of 100mg/mL, and the dissolution can be accelerated by stirring, heating and other modes during the dissolution.
(4) Preparation of sodium carboxymethyl starch gel
Sodium hyaluronate is dissolved in physiological saline at a ratio of 10mg/mL, and the dissolution can be accelerated by stirring, heating and the like during the dissolution.
(5) Preparation of xanthan gum gel
Dissolving xanthan gum in purified water at a ratio of 1mg/mL, and stirring and heating to accelerate dissolution.
(6) Preparation of carbomer gel
Carbomer is taken and dissolved in purified water in a proportion of 2mg/mL, and after stirring until dissolved, alkaline solution is added to adjust the pH value to be neutral.
Examples 1-24 differ in the water-soluble gel composition, see in particular tables 1-4 below;
the preparation method of the solid membrane comprises the following steps:
(1) Preparation of membrane by electrostatic spinning method
The method comprises the following steps of (1) mixing the polylactide and polycaprolactone in a mass ratio of 5:5, dissolving the mixture in the trifluoroethanol with the mass concentration of 25% (w: w), and stirring the mixture until the mixture is completely dissolved to obtain an electrostatic spinning solution;
placing the electrostatic spinning solution into a push injector of electrostatic spinning equipment, setting the spinning voltage to be 25kv, the push injection speed to be 10ml/h, the receiving distance to be 15cm, and obtaining the electrostatic spinning film after electrostatic spinning for 2 hours, wherein the thickness is between 0.01mm and 2.0 mm.
(2) Melt process for preparing films
Taking polycaprolactone, preparing the polycaprolactone into a film in a molten state, wherein the thickness of the film is between 0.01 and 2.0 mm.
(3) Casting method for preparing film
And (3) dissolving the poly (lactide-co-glycolide) copolymer in dichloromethane, preparing a film by a tape casting method, and keeping the thickness of the film between 0.01mm and 2.0mm after the solvent is volatilized.
(4) Freeze-drying method for preparing film
Taking the poly lactide-co-glycolic acid, dissolving in dioxane, freeze-drying, taking out, and freeze-drying to obtain the membrane with the thickness of 0.01-2.0 mm. After freeze-drying, whether to continue tabletting can be determined according to the requirement.
Examples 1-24 solid membranes were prepared differently, see in particular tables 1-4 below.
The preparation method of the anti-adhesion material comprises the following steps:
cutting the prepared solid membrane into a certain size and shape according to 1mL: (0.1 cm) 2 ～10cm 2 ) Adding the mixture into the prepared water-soluble gel in proportion, and stirring and mixing uniformly.
The water-soluble gel has a viscosity of 1.01X10 -3 Pa﹒s～9.99×10 6 A range of mPas; the viscosity of the polymer is inversely related to the size of a solid membrane added into the polymer; when the viscosity is larger, the added membrane is smaller in size, and when the viscosity is smaller, the added membrane is larger.
Cutting outThe solid membrane can be solid or hollow, and the shape is any one of rectangle, circle, ellipse, square, pentagon, hexagon, polygon and irregular shape; the thickness of the solid membrane is in the range of 0.01-2 mu m. The area of the solid membrane is 0.1mm 2 ～50cm 2 Between them.
An anti-adhesion device filled with anti-adhesion materials comprises a pre-filling syringe and an anti-adhesion agent pre-filled in the pre-filling syringe; the pre-filled anti-blocking preparation consists of water-soluble gel and solid membrane mixed therein.
The preparation method of the anti-adhesion device filled with the anti-adhesion material comprises the following steps:
filling the prepared anti-adhesion material into a prefilled syringe according to the specification of 0.5-50 mL/branch; the prefilled syringe may be provided with 1 or more paint brushes; and then packaging and sterilizing.
The prefilled syringe comprises a push head (1), a push rod (2), a piston (3), an empty cylinder (4), an injection head (5), a protective cap (6) and a smearing brush (7); the injection head (5) is provided with external threads at one end close to the hollow cylinder (4), the protective cap (6) and the smearing brush (7) are provided with internal threads, and the protective cap (6) or the smearing brush (7) is installed and fixed at the front end of the injector through a thread structure.
The application brush is used under the condition and the using method are as follows: before use, the size of the operation area is used for judging whether the brush (7) needs to be smeared. When the anti-adhesion operation is carried out after tendon operation, a smearing brush (7) is not needed due to the smaller operation area; when the anti-adhesion device is used, the device is taken out from the packaging box, the front end protective cap (6) is removed, the push rod (2) is pushed to extrude the anti-adhesion product, and the anti-adhesion product is uniformly smeared on a required position by utilizing the front end of the device. When the abdomen and pelvis operation is performed, the device is taken out from the packaging box, the front end protective cap (6) is removed, the next smearing brush (7) is installed and fixed at the front end of the device, the push rod (2) is pushed to extrude the anti-adhesion product, and the product is smeared on a required position uniformly by utilizing the smearing brush (7).
TABLE 1 examples 1-6 gel compositions and method for preparing membranes
TABLE 2 gel compositions of examples 7-12 and method for preparing the membrane
TABLE 3 gel compositions of examples 13-18 and method for preparing the membrane
TABLE 4 gel compositions and film preparation methods of examples 19-24
TABLE 5 gel compositions and membrane preparation methods in comparative examples 1-12
Note that: in the above examples and comparative examples, the preparation steps were as follows:
1. a gel of a certain concentration was prepared according to the above procedure.
2. After the membrane is prepared, the membrane is cut into a certain shape and area, and can be solid or hollow.
3. Adding the membrane into the gel according to a certain proportion, and uniformly mixing to obtain the anti-adhesion preparation.
4. The anti-adhesion material is filled into the prefilled syringe according to a certain specification, and 1 or more smearing brushes can be arranged.
5. And (5) carrying out irradiation sterilization after packaging.
6. The anti-blocking formulations of comparative examples 1 to 6 were prepared by filling only the gel, without mixing the film, and the rest was the same as in example.
7. Preparation of anti-blocking formulations of comparative examples 7 to 12 only the film was cut into a certain area and then packaged in a blister without adding gel, and irradiation sterilization was performed after packaging.
2. Anti-blocking test examples 1-24 and comparative examples 1-12 were used to conduct anti-blocking tests using a chicken for aviation, and the tests used were left toe II, III. The test animals were anesthetized by intravenous injection of 1% pentobarbital sodium wings, and 1.5 cm linear skin incisions were made from the sides of proximal phalanges of the II and III toes. Tendon sheaths of flexor muscles were cut, deep toe flexor muscles were blunt separated, and tendons were cut laterally with a surgical blade, and tendon suturing was performed using a modified Kessler method. After suturing, examples 1 to 24 and comparative examples 1 to 6 were uniformly applied to both sides of the suture opening at about 1cm, and the tendons were uniformly applied around the tendon when applied. Comparative examples 7 to 12 were wound around the suture site with a wrapping length of about 1cm, and the tendon was wrapped completely around the suture. After the anti-adhesion treatment, fascia, muscle, skin and the like are sequentially sutured. The model group is directly sutured without using anti-adhesion materials after tendon suturing. The time of operation of each test animal was recorded during the test, and the operator was asked for ease of use of the sample. Samples were taken after 8 weeks and observed for tissue adhesion. The blocking criteria were as follows: substantially observing no blocking (-); the tendon has fine fiber bundles and peripheral adhesion (+); the tendon (++) can be removed only by separating one part of the medium-degree fiber bundle adhesion with a knife; the adhesion is severe and the adhesive is not cured, the periphery is separated by a knife free tendon (+++).
The results are summarized below:
table 6 example anti-blocking test results
TABLE 7 results of anti-blocking test for comparative examples and model groups
According to the anti-blocking test results in tables 6-7, the invention and the gel materials are easy to use and convenient to operate, as the usability and the operation time are known. The anti-adhesion effect of the invention is obviously better than that of gel materials and also better than that of membrane materials.
3. Cytotoxicity test:
taking examples 1-24 and comparative examples 1-12 reference GB/T16886.5-2017 medical device biological evaluation part 5: in vitro cytotoxicity assays were performed as follows: examples 1-24, comparative examples 1-6 were added to the leaching medium in a ratio of 0.1 g/ml. Comparative examples 7 to 12 according to 6cm 2 /ml (film thickness of 0.5mm or less) or 3cm 2 /ml (0.5 mm-1.0 mm) or 1.25cm 2 The leaching medium is added in a ratio of/ml (greater than 1.0 mm). Leaching medium: the leaching temperature of the MEM culture medium containing serum is 37+/-1 ℃ and the leaching time is 24 hours+/-2 hours. The extract was subjected to the method prescribed in GB/T16886.5-2017 to quantitatively evaluate cytotoxicity.
Table 8 example cytotoxicity results
TABLE 9 comparative cytotoxicity results
The cytotoxicity criteria were:
cytotoxicity class 1 indicates no cytotoxicity; cytotoxicity grade 2 indicates slight cytotoxicity; cytotoxicity grade 3 represents moderate cytotoxicity; grade 4 cytotoxicity indicates severe cytotoxicity.
As is clear from tables 8 to 9, the cytotoxicity results of examples and comparative examples were all 1-grade, and the samples were free from cytotoxicity, high in safety, and satisfactory in clinical requirements.
Claims (10)
1. An anti-blocking preparation comprises the following components: water-soluble gel, solid membrane;
the viscosity of the water-soluble gel is 1.01X10 -3 Pa﹒s～9.99×10 6 Pa is between s;
the solid membrane has a certain shape and thickness; the shape is any one of rectangle, circle, ellipse, square, pentagon, hexagon, polygon and irregular shape; the thickness of the solid membrane is in the range of 0.01-2 mu m;
the area of the solid membrane is 0.1mm 2 ～50cm 2 Between them;
the anti-adhesion preparation is prepared by uniformly stirring and mixing water-soluble gel and a solid membrane.
2. The anti-blocking formulation of claim 1, wherein the water-soluble gel comprises the following materials: at least one of chitosan and its derivatives, cellulose and its derivatives, hyaluronic acid and its derivatives, alginic acid and its derivatives, starch and its derivatives, xanthan gum and its derivatives, gelatin, carbomer, and polyethylene glycol;
the water-soluble gel is prepared by dissolving component materials in pure water/normal saline/phosphate buffer solution.
3. The anti-blocking formulation of claim 1, wherein the solid film comprises the following materials: at least one of polyglycolide, polylactide-co-glycolic acid, polylactide-co-caprolactone, polylactide-co-glycolide, polyurethane, polycaprolactone, polyglycolic acid, polyethylene terephthalate, polyglycolic acid, polydioxanone, polyanhydride, fibroin;
the preparation method of the solid membrane adopts any one of casting method, electrostatic spinning, non-woven preparation, freeze-drying, tabletting after freeze-drying, direct tabletting, melting, plastic sucking, blow molding and extrusion.
4. An anti-adhesion device containing an anti-adhesion agent, characterized in that the device comprises a pre-filled syringe, the anti-adhesion agent of claim 1;
the prefilled syringe is preloaded with an anti-blocking formulation as defined in claim 1.
5. The anti-adhesion device filled with the anti-adhesion agent according to claim 4, wherein the pre-filled syringe comprises a push head (1), a push rod (2), a piston (3), an empty cylinder (4), an injection head (5), a protective cap (6) and a smearing brush (7); the injection head (5) is provided with external threads at one end close to the hollow cylinder (4), the protective cap (6) and the smearing brush (7) are provided with internal threads, and the protective cap (6) or the smearing brush (7) is installed and fixed at the front end of the injector through a thread structure.
6. An anti-blocking device comprising an anti-blocking formulation according to claim 4, wherein the viscosity of the water-soluble gel in the anti-blocking formulation is inversely related to the size of the solid film sheet incorporated therein.
7. The anti-blocking device according to claim 4, wherein the solid membrane is any one of a solid graphic membrane and a hollow graphic membrane.
8. A method for preparing an anti-adhesion device containing an anti-adhesion agent, comprising the following steps:
the prepared solid membrane was cut according to 1mL:0.1cm 2 ～10 cm 2 Proportionally adding the mixture into the prepared water-soluble gel, uniformly mixing, and filling the mixture into a prefilled syringe according to the specification of 0.5-50 mL/branch; the prefilled syringe may be provided with a brush (7).
9. Use of the anti-adhesion agent of claim 1 for preventing tissue and organ adhesion after surgery.
10. Use of the anti-adhesion device of claim 4 for preventing tissue and organ adhesion after surgery.
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