CN110665049B - Method for preparing hemostatic starch microspheres by ultrasonic - Google Patents
Method for preparing hemostatic starch microspheres by ultrasonic Download PDFInfo
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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
- A61L24/08—Polysaccharides
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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
- A61L24/001—Use of materials characterised by their function or physical properties
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
- C08B31/08—Ethers
- C08B31/12—Ethers having alkyl or cycloalkyl radicals substituted by heteroatoms, e.g. hydroxyalkyl or carboxyalkyl starch
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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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
Abstract
The invention relates to a method for preparing hemostatic starch microspheres by ultrasonic, which comprises the steps of dissolving sodium hydroxide in an isopropanol aqueous solution, controlling the proportion of isopropanol and water to enable starch to be in a solid state, adding a cross-linking agent under ultrasonic stirring for cross-linking reaction, and after the reaction is finished, carrying out suction filtration, washing, drying and sterilization to obtain the hemostatic starch microspheres. The preparation method provided by the invention has the advantages of simple and stable process and less waste liquid generation, and the prepared hemostatic starch microspheres have good hemostatic effect.
Description
Technical Field
The invention relates to the field of biomedical materials, in particular to a method for preparing hemostatic starch microspheres by ultrasonic.
Background
The hemostatic starch microsphere is a hemostatic material prepared by cross-linking reaction of plant starch serving as a raw material, and has the advantages of rapid hemostasis, good biocompatibility and capability of being degraded and absorbed by a human body. The hemostatic starch microspheres have double hemostatic mechanisms, can absorb water in blood, concentrate the blood and enable platelets to aggregate on one hand, thereby achieving the hemostatic effect; on the other hand, the starch microspheres can expand rapidly after absorbing water, have certain adhesiveness and can form a physical barrier to accelerate hemostasis.
The traditional hemostatic starch microspheres are prepared by an emulsification crosslinking process, the process needs to repeatedly wash water-soluble impurities and oil-soluble impurities, the process is complicated, and the product cost is high.
The patent document with publication number CN102406956, entitled starch hemostatic microsphere and preparation method thereof, discloses a starch hemostatic microsphere and preparation method thereof, adding activated starch alkaline solution into mixed solution of surfactant and vegetable oil to form a water-in-oil emulsification system, adding cross-linking agent for cross-linking reaction, washing with ethyl acetate, absolute ethyl alcohol and distilled water in sequence after the reaction is completed, and has the disadvantages of complex process, large organic solvent consumption and high product cost.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a novel method for preparing the hemostatic starch microspheres by ultrasonic, isopropanol water is used as a reaction medium to carry out heterogeneous solid-liquid reaction, the process is simple and stable, waste liquid is less generated, and the prepared hemostatic starch microspheres have a good hemostatic effect.
To solve the technical problems, the technical scheme provided by the invention is as follows:
a method for preparing hemostatic starch microspheres by ultrasound comprises the following steps:
(1) preparing an alkaline solution: weighing a certain amount of sodium hydroxide, adding the sodium hydroxide into an isopropanol aqueous solution, and ultrasonically stirring to dissolve, wherein the volume ratio of isopropanol to water is 80: 20-90: 10;
(2) alkalizing starch: adding potato starch into the alkaline solution in the step (1), and carrying out ultrasonic stirring for 10-40 min to carry out an alkalization reaction;
(3) and (3) crosslinking reaction: after the alkalization reaction is finished, adding a cross-linking agent epichlorohydrin, and carrying out the cross-linking reaction under ultrasonic stirring;
(4) and (3) post-treatment: and after the crosslinking reaction is finished, standing for layering, separating the microspheres on the lower layer, adjusting the pH to be neutral, washing for 2-5 times by using 70-95% ethanol water solution, drying and sterilizing to obtain the hemostatic starch microspheres.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: the concentration of the sodium hydroxide in the alkaline solution in the step (1) is 0.008 g/ml-0.02 g/ml.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: in the step (2), the adding amount of the potato starch is 2-6 times of the mass of the sodium hydroxide in the alkaline solution.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: and (3) adding the crosslinking agent epichlorohydrin in the step (3) in an amount of 1/20-1/10 of the mass of the starch.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: in the step (3), the crosslinking reaction time is 8-12 h, and the reaction temperature is 45-50 ℃.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: the specific operation of adjusting the pH to be neutral in the step (4) is to add ethanol aqueous solution with concentration of 70% -95% 2-5 times of the volume of the microspheres to the separated lower-layer microspheres, and adjust the pH to be neutral by dripping acidic solution.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: the drying in the step (4) is vacuum drying, and the drying temperature is 45-50 ℃.
Further, the method for preparing the hemostatic starch microsphere by using the ultrasound comprises the following steps: the sterilization in the step (4) is radiation sterilization.
The grain diameter of the hemostatic starch microsphere prepared by the invention is 50-150 μm.
The following is a description of the process and principles of the present invention:
the technical scheme provided by the invention is heterogeneous solid-liquid reaction, isopropanol water is used as a reaction medium, the proportion of isopropanol and water is controlled, so that starch is not dissolved in the isopropanol water, and then the starch is directly subjected to crosslinking reaction under the condition of ultrasonic stirring; after the reaction is finished, the reaction product is still solid, and the hemostatic starch microspheres are obtained by suction filtration, washing and drying, have no oil phase, do not need to be repeatedly washed to remove the oil phase, oil-soluble impurities and the like, and only need to be subjected to suction filtration, washing and drying. The technical scheme provided by the invention has the advantages of simple process, good stability, obvious reduction of the using amount of the organic solvent for washing, less generated waste liquid, contribution to saving resources and protecting environment and corresponding reduction of the product cost.
In the invention, the volume ratio of the isopropanol to the water has great influence on the reaction, the water content is too high, the starch is dissolved, and the product yield is reduced; the reaction is difficult to proceed because the water content is too low, the sodium hydroxide is not dissolved, and the sodium hydroxide concentration is too low.
The invention has the following beneficial effects:
(1) the technical scheme provided by the invention has simple and stable process and can realize industrial production.
(2) The technical scheme provided by the invention generates less waste liquid, is beneficial to saving resources and protecting environment, and reduces the product cost.
(3) The hemostatic starch microspheres prepared by the technical scheme provided by the invention have good hemostatic effect.
Drawings
FIG. 1 is a scanning electron micrograph of the hemostatic starch microspheres prepared in example 1.
Detailed Description
The technical solution of the present invention is illustrated by the following specific examples, but the examples are not to be construed as limiting the scope of the present invention.
Example 1:
(1) preparing an alkaline solution: weighing 15g of sodium hydroxide, adding the sodium hydroxide into 1000ml of isopropanol aqueous solution, and ultrasonically stirring for dissolving, wherein the volume ratio of isopropanol to water is 85: 15;
(2) alkalizing starch: weighing 35g of potato starch, adding the potato starch into the alkaline solution in the step (1), and carrying out ultrasonic stirring for 10min to carry out an alkalization reaction;
(3) and (3) crosslinking reaction: adding 2g of cross-linking agent epichlorohydrin into the starch dispersion system obtained in the step (2) in batches, carrying out ultrasonic stirring at 45 ℃, and carrying out cross-linking reaction for 8 hours;
(4) and (3) post-treatment: and after the crosslinking reaction is finished, standing for layering, separating the lower layer microspheres, adding 80% ethanol water solution, adjusting the pH to 7.2, filtering, washing for 3 times by using the 80% ethanol water solution, performing suction filtration, drying and sterilizing to obtain the hemostatic starch microspheres. The appearance of the product is shown in figure 1.
Example 2:
(1) preparing an alkaline solution: weighing 20g of sodium hydroxide, adding the sodium hydroxide into 1000ml of isopropanol aqueous solution, and ultrasonically stirring for dissolving, wherein the volume ratio of isopropanol to water is 80: 20;
(2) alkalizing starch: weighing 80g of potato starch, adding the potato starch into the alkaline solution in the step (1), and carrying out ultrasonic stirring for 40min to carry out an alkalization reaction;
(3) and (3) crosslinking reaction: adding 6g of cross-linking agent epichlorohydrin into the starch dispersion system obtained in the step (2) in batches, carrying out ultrasonic stirring at 50 ℃, and carrying out cross-linking reaction for 12 hours;
(4) and (3) post-treatment: and after the crosslinking reaction is finished, standing for layering, separating the lower layer microspheres, adding 70% ethanol aqueous solution, adjusting the pH to 7.1, filtering, washing for 3 times by using 75% ethanol aqueous solution, filtering, drying and sterilizing to obtain the hemostatic starch microspheres.
Example 3:
(1) preparing an alkaline solution: weighing 8g of sodium hydroxide, adding the sodium hydroxide into 1000ml of isopropanol aqueous solution, and ultrasonically stirring for dissolving, wherein the volume ratio of isopropanol to water is 90: 10;
(2) alkalizing starch: weighing 45g of potato starch, adding the potato starch into the alkaline solution in the step (1), and carrying out ultrasonic stirring for 20min to carry out an alkalization reaction;
(3) and (3) crosslinking reaction: adding 4.5gl crosslinking agent epichlorohydrin into the starch dispersion system obtained in the step (2) in batches, carrying out ultrasonic stirring at 50 ℃, and carrying out crosslinking reaction for 10 hours;
(4) and (3) post-treatment: and after the crosslinking reaction is finished, standing for layering, separating the lower layer microspheres, adding 90% ethanol aqueous solution, adjusting the pH to 7.5, filtering, washing for 3 times by using 80% ethanol aqueous solution, filtering, drying and sterilizing to obtain the hemostatic starch microspheres.
Test example: research on hemostatic effect of small pig liver injury
(1) Test subjects: test products: hemostatic starch microspheres prepared in examples 1-3;
comparison products: american Alristat styptic powder (Arista).
(2) Animals and materials: 24 Tibet miniature pigs are used for experiments and are randomly divided into 4 groups, each group has 6 pigs, the female and male pigs are unlimited, and the weight is 25 +/-3 kg; .
(3) The method comprises the following steps: the liver was exposed by an operation using experimental Tibet miniature pigs as model animals, and wounds of 1cm × 1cm and 3mm in depth were made on the anterior, posterior and left lobes of the right lobe thereof, respectively, and blood flowed out in a gushing state at the wound site. And (3) after the wound is finished, performing compression hemostasis for 30s by using a conventional method, performing hemostasis by using the hemostatic starch microsphere/Arista, assisting with moderate compression, observing for 3min, and inspecting the hemostasis effect.
(4) As a result: the hemostatic starch microspheres prepared in the embodiments 1 to 3 can effectively stop bleeding within 3min, and no significant difference exists among test sample groups; the test sample and the positive control American Alisita styptic powder (Arista) have no obvious difference.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (7)
1. A method for preparing hemostatic starch microspheres by ultrasound is characterized by comprising the following steps: the method comprises the following steps:
(1) preparing an alkaline solution: weighing a certain amount of sodium hydroxide, adding the sodium hydroxide into an isopropanol aqueous solution, and ultrasonically stirring to dissolve, wherein the volume ratio of isopropanol to water is 80: 20-90: 10;
(2) alkalizing starch: adding potato starch into the alkaline solution in the step (1), and carrying out ultrasonic stirring for 10-40 min to carry out an alkalization reaction;
(3) and (3) crosslinking reaction: after the alkalization reaction is finished, adding a cross-linking agent epichlorohydrin, and carrying out the cross-linking reaction under ultrasonic stirring;
(4) and (3) post-treatment: after the crosslinking reaction is finished, standing and layering, separating the microspheres on the lower layer, adjusting the pH to be neutral, drying and sterilizing the microspheres for 2-5 times by using 70-95% ethanol water solution to obtain the hemostatic starch microspheres; wherein:
the concentration of the alkaline solution in the step (1) is 0.008 g/ml-0.02 g/ml;
in the step (3), the crosslinking reaction time is 8-12 h, and the reaction temperature is 45-50 ℃.
2. The method for ultrasonically preparing hemostatic starch microspheres of claim 1, wherein: in the step (2), the adding amount of the potato starch is 2-6 times of the mass of the sodium hydroxide in the alkaline solution.
3. The method for ultrasonically preparing hemostatic starch microspheres of claim 1, wherein: in the step (3), the mass ratio g/g of the starch to the cross-linking agent is 100: 5-10.
4. The method for ultrasonically preparing hemostatic starch microspheres of claim 1, wherein: the specific operation of adjusting the pH to be neutral in the step (4) is to add ethanol aqueous solution with concentration of 70% -95% 2-5 times of the volume of the microspheres to the separated lower-layer microspheres, and adjust the pH to be neutral by dripping acidic solution.
5. The method for ultrasonically preparing hemostatic starch microspheres of claim 1, wherein: the drying in the step (4) is vacuum drying, and the drying temperature is 45-50 ℃.
6. The method for ultrasonically preparing hemostatic starch microspheres of claim 1, wherein: the sterilization in the step (4) is radiation sterilization.
7. The method for preparing the hemostatic starch microspheres by using the ultrasound as described in any one of the above items, is characterized in that: the grain size of the hemostatic starch microspheres is 50-150 μm.
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