An ultrathin high-strength nanofiber pharmaceutical casing and a preparation method thereof

Abstract

The application provides the technical field of medical materials and particularly relates to a kind of ultra-thin high-strength nanofiber medicinal casing and a preparation method thereof.The preparation method comprises the following steps: (1) preparing pretreated raw materials; (2) adding a complex enzyme to the pretreated raw materials for enzymolysis, enzymolysis at 35-40 DEG C for 5-8 h, enzyme inactivation, to obtain an enzymolysis product; (3) adding a complex bacteria to the enzymolysis product for anaerobic fermentation, fermentation at 35-40 DEG C for 10-12 h, sterilization, to obtain a fermentation product; (4) rinsing the fermentation product with clean water for 5-8 times, to obtain a casing semi-finished product; (5) mixing nanocellulose, soybean phospholipid and water to prepare a liquid, spraying the liquid on the casing semi-finished product, drying, to obtain an ultra-thin high-strength nanofiber medicinal casing.The casing prepared by the application can be used to wrap traditional Chinese medicine compositions.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical materials, and particularly relates to an ultrathin high-strength nanofiber medicinal casing and a preparation method thereof. BACKGROUND

[0002] Traditional Chinese medicine compositions often face packaging and selling problems due to their diversified ingredients and complex preparation processes. Traditional Chinese medicine preparations such as decoctions and powders are difficult to accurately control the dosage for each time of taking, increasing the complexity and uncertainty of use. Some consumers are not very accepting of the appearance and taking method (such as decoction) of traditional Chinese medicine, especially the younger generation who prefer convenient and fast modern drug forms.

[0003] After being wrapped with a plastic packaging bag, the solid particles or powders of the traditional Chinese medicine composition are prone to waste due to improper operation, causing inconvenience to the patient. The solid particles or powders of the traditional Chinese medicine are prone to spilling due to slight shaking or pouring when opening the packaging bag. Especially during the moving process (such as carrying out), the packaging bag is more likely to be damaged or improperly opened, resulting in drug spilling. The spilled drug in the external environment not only wastes, but also may be contaminated, affecting the drug efficacy and even causing health hazards. For special groups such as the elderly or children, the inconvenience of operation is more obvious.

[0004] In order to solve the above problems, casing can be considered for wrapping. The casing can form an effective barrier to protect the traditional Chinese medicine ingredients from the external environment, such as moisture resistance and oxidation resistance, thereby prolonging the shelf life and maintaining the drug efficacy. It helps to improve the trust and purchase willingness of consumers, especially suitable for international market promotion.

[0005] However, wrapping traditional Chinese medicine with sheep casing may indeed bring a series of technical challenges and potential problems. The following are some major technical problems and their possible effects on drug efficacy: too much residue on the surface of sheep casing, too thick thickness affecting taste; may also cause adverse reactions. Natural sheep casing is thick, especially in the untreated case, which will significantly affect the taste when taking and increase the difficulty of swallowing. Sheep casing itself has a unique animal odor, which may make some patients difficult to accept, especially in the case of long-term taking.

[0006] Therefore, there is an urgent need for an ultrathin high-strength nanofiber medicinal casing and a preparation method thereof. SUMMARY

[0007] The purpose of the present application is to provide an ultrathin high-strength nanofiber medicinal casing and a preparation method thereof.

[0008] In order to achieve the above purpose, the present application provides the following technical solutions:

[0009] A preparation method of an ultra-thin high-strength nanofiber medicinal casing, comprising the following steps:

[0010] (1) Soak the sheep intestines in warm water at 25-30°C for 20-25h, place the soaked sheep intestines with the inner wall outward on a flat wooden board, use a casing scraper to scrape off the mucosa layer and muscle layer of the intestines, rinse the scraped casing with water, then evenly sprinkle refined salt on the casing, marinate for 10-15h, and clean with clean water to obtain pretreated raw materials;

[0011] (2) Add a complex enzyme to the pretreated raw materials for enzymolysis, and enzymolyze at 35-40°C for 5-8h, then inactivate the enzyme to obtain an enzymolysis product;

[0012] (3) Add a complex bacteria to the enzymolysis product for anaerobic fermentation, and ferment at 35-40°C for 10-12h, then sterilize to obtain a fermentation product;

[0013] (4) Rinse the fermentation product with clean water for 5-8 times to obtain a casing semi-finished product;

[0014] (5) Mix nanocellulose, soybean phospholipid and water to prepare a liquid, spray the liquid on the casing semi-finished product, and dry to obtain an ultra-thin high-strength nanofiber medicinal casing.

[0015] Further, the weight ratio of the sheep intestines to the warm water in step (1) is 1:(10-15).

[0016] Further, the complex enzyme comprises papain, ficin and bromelain;

[0017] Further, the amount of papain in the pretreated raw materials is 100-110U / mL; the amount of ficin in the pretreated raw materials is 120-130U / mL; and the amount of bromelain in the pretreated raw materials is 80-90U / mL.

[0018] The present application uses enzymes that can break down protein components in the sheep intestines, particularly those that are tightly bound with impurities. This helps to loosen and remove impurities attached to the surface of the sheep intestines or embedded in its structure. The enzymes gradually break down the connective tissue in the sheep intestines, making them softer and easier to handle. This not only facilitates the subsequent fermentation step, but also reduces the risk of mechanical damage. Through the action of enzymes, many impurities on the surface and inside the sheep intestines are broken down into smaller molecules, which are easier to wash away, thereby improving the overall cleanliness.

[0019] Further, the complex bacteria comprises Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium longum.

[0020] Further, the amount of Lactobacillus casei is 10 7 -10 8CFU / mL pretreated raw material; the amount of Lactobacillus plantarum is 10 9 -10 10 CFU / mL pretreated raw material; the amount of Bifidobacterium longum is 10 8 -10 9 CFU / mL pretreated raw material.

[0021] Further, 1 part by weight of nanocellulose, 4-5 parts by weight of soybean phospholipid and 100 parts by weight are mixed to prepare a liquid.

[0022] During the anaerobic fermentation process, the complex bacteria produce various metabolites such as organic acids, enzymes, etc., which can further degrade the remaining macromolecular substances, including incompletely decomposed proteins, polysaccharides and lipids. The organic acids (such as lactic acid) produced during fermentation can create an acidic environment, which helps to dissolve certain minerals and impurities, further purifying the sheep intestine.

[0023] Through the dual action of enzymolysis and fermentation, the non-essential components in the sheep intestine are gradually removed, resulting in a significant reduction in thickness. This is crucial for the manufacture of ultra-thin high-strength nanofiber medicinal casings. The present application can form a reinforcing film on the surface of the sheep intestine through the spraying and drying process of nanocellulose and soybean phospholipid, thereby improving the overall tensile strength.

[0024] Further, dry at 80-85℃ until the moisture content is 7-9%.

[0025] Further, the amount used for spraying is 50-60g / m 2 .

[0026] The present application provides an ultra-thin high-strength nanofiber medicinal casing prepared by the preparation method.

[0027] The use method of the medicinal casing of the present application is as follows: the traditional Chinese medicine composition is wrapped with the casing, then packaged with an outer package, and stored in a cold state. When taking, open the outer package and take directly.

[0028] Compared with the prior art, the advantages and beneficial effects of the present application are:

[0029] 1、The present application sequentially performs enzymolysis and fermentation, which can remove impurities on the sheep intestine and reduce the thickness of the casing. Through enzymolysis, many impurities on the surface and inside of the sheep intestine are decomposed into smaller molecules, which are easier to be washed away, thereby improving the overall cleanliness. The complex bacteria produce various metabolites such as organic acids, enzymes, etc., which can further degrade the remaining macromolecular substances, including incompletely decomposed proteins, polysaccharides and lipids.

[0030] 2. The spraying and drying process of nanocellulose and soybean phospholipid can form a reinforcing film on the surface of the sheep intestine, thereby improving the overall tensile strength. Nanocellulose has excellent mechanical properties and high specific surface area, and can form a strong and light protective layer on the surface of the sheep intestine, significantly improving the tensile strength and durability. Soybean phospholipid, as a natural amphiphilic molecule, can increase flexibility and biocompatibility. DETAILED DESCRIPTION

[0031] The technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0032] The raw materials used in the following embodiments of the present application are all commercially available:

[0033] Papain, enzyme activity 1200u / mg. Shanghai Yuan Ye Biotechnology Co., Ltd.

[0034] Papain, enzyme activity 1200u / mg. Shanghai Yuan Ye Biotechnology Co., Ltd.

[0035] Ficus protease, enzyme activity 100u / mg. Shanghai Yuan Ye Biotechnology Co., Ltd.

[0036] Cheese lactobacillus, product number CICC 25035, China Industrial Microbial Strain Preservation and Management Center.

[0037] Lactobacillus plantarum, product number CCTCC AB 2022356, China Typical Culture Collection Center.

[0038] Bifidobacterium longum, product number CICC 25033, China Industrial Microbial Strain Preservation and Management Center.

[0039] Nanocellulose, Hubei Xiyu Hong Biological Medicine Technology Co., Ltd.

[0040] Soybean phospholipid, Guangdong Mingcheng Biological Technology Co., Ltd.

[0041] Example 1

[0042] The present embodiment provides a preparation method of ultra-thin high-strength nanofiber medicinal casing, comprising the following steps:

[0043] (1) soaking sheep intestines in warm water at 28℃ for 24h, placing the inner wall of the soaked sheep intestines outward on a flat wooden board, scraping the mucosa layer and muscle layer of the intestines with an intestinal scraping machine, rinsing the scraped intestinal casing with water, then evenly sprinkling refined salt on the intestinal casing, marinating for 12h, and cleaning with clean water to obtain pretreated raw materials;

[0044] (2) adding a compound enzyme to the pretreated raw materials for enzymolysis at 37℃ for 6h, inactivating the enzyme, and obtaining an enzymolysis product; the compound enzyme includes papain, ficin and bromelain; the amount of papain in the pretreated raw materials is 105U / mL; the amount of ficin in the pretreated raw materials is 125U / mL; and the amount of bromelain in the pretreated raw materials is 85U / mL.

[0045] (3) adding a compound bacteria to the enzymolysis product for anaerobic fermentation at 36℃ for 11h, sterilizing, and obtaining a fermentation product; the compound bacteria includes Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium longum. The amount of Lactobacillus casei is 10 7 CFU / mL of pretreated raw materials; the amount of Lactobacillus plantarum is 10 10 CFU / mL of pretreated raw materials; and the amount of Bifidobacterium longum is 10 9 CFU / mL of pretreated raw materials.

[0046] (4) rinsing the fermentation product with clean water for 7 times to obtain an intestinal casing semi-finished product;

[0047] (5) preparing a material liquid by mixing 1 part by weight of nanocellulose, 5 parts by weight of soybean phospholipid and 100 parts by weight; spraying the material liquid on the intestinal casing semi-finished product, the spraying usage being 55g / m 2 , and drying at 83℃ until the water content is 8%; and obtaining an ultrathin high-strength nanofiber medicinal casing.

[0048] Example 2

[0049] The embodiment provides a preparation method of an ultrathin high-strength nanofiber medicinal casing, comprising the following steps:

[0050] (1) soaking sheep intestines in warm water at 25℃ for 20h, placing the inner wall of the soaked sheep intestines outward on a flat wooden board, scraping the mucosa layer and muscle layer of the intestines with an intestinal scraping machine, rinsing the scraped intestinal casing with water, then evenly sprinkling refined salt on the intestinal casing, marinating for 15h, and cleaning with clean water to obtain pretreated raw materials;

[0051] (2) adding a complex enzyme to the pretreated raw material for enzymolysis, 40°C for 8h, enzyme inactivation, to obtain an enzymolysis product; the complex enzyme includes papain, ficin and bromelain; the amount of papain in the pretreated raw material is 100U / mL; the amount of ficin in the pretreated raw material is 130U / mL; the amount of bromelain in the pretreated raw material is 80U / mL.

[0052] (3) adding a complex bacteria to the enzymolysis product for anaerobic fermentation, 40°C for 10h, sterilization, to obtain a fermentation product; the complex bacteria includes Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium longum. The amount of Lactobacillus casei is 10 8 CFU / mL of pretreated raw material; the amount of Lactobacillus plantarum is 10 9 CFU / mL of pretreated raw material; the amount of Bifidobacterium longum is 10 9 CFU / mL of pretreated raw material.

[0053] (4) rinsing the fermentation product with clean water for 8 times to obtain a casing semi-finished product;

[0054] (5) mixing 1 part by weight of nanocellulose, 4 parts by weight of soybean phospholipid and 100 parts by weight to prepare a liquid; spraying the liquid on the casing semi-finished product, the spraying amount is 50g / m 2 , drying at 85°C until the water content is 9%; obtaining a nanofiber pharmaceutical casing with ultra-thin and high strength.

[0055] Comparative Example 1

[0056] The difference between this comparative example and Example 1 is that no fermentation is performed.

[0057] Comparative Example 2

[0058] The difference between this comparative example and Example 1 is that no enzymolysis is performed.

[0059] Comparative Example 3

[0060] The difference between this comparative example and Example 1 is that the complex enzyme is replaced by ficin.

[0061] Comparative Example 4

[0062] The difference between this comparative example and Example 1 is that the amount of papain in the pretreated raw material is 85U / mL; the amount of ficin in the pretreated raw material is 105U / mL; the amount of bromelain in the pretreated raw material is 125U / mL.

[0063] Comparative Example 5

[0064] The difference between this comparative example and Example 1 is that the complex bacteria is replaced by Lactobacillus casei.

[0065] Comparative Example 6

[0066] The difference between the present comparative example and Example 1 is that the amount of Lactobacillus casei is 10 10 CFU / mL of pretreated raw material; the amount of Lactobacillus plantarum is 10 7 CFU / mL of pretreated raw material; the amount of Bifidobacterium longum is 10 10 CFU / mL of pretreated raw material.

[0067] Performance test

[0068] The enteric coating prepared in Examples 1-2 and Comparative Examples 1-6 was subjected to performance test. The tensile strength of the single-layer enteric coating was determined using a universal material testing machine. The thickness of the enteric coating was determined using a micrometer.

[0069] Table 1 Performance test results

[0070]

[0071]

[0072] From the above performance test results, it can be seen that by controlling suitable fermentation and enzymatic conditions, the enteric coating of Examples 1-2 still maintains good strength, and is thinner, and has no odor.

[0073] In Comparative Example 1, no fermentation was performed, and in Comparative Example 2, no enzymatic hydrolysis was performed, and the thickness of the enteric coating increased, and there was an odor.

[0074] In Comparative Example 3, a single enzyme was used, and the thickness of the enteric coating increased, and there was an odor.

[0075] In Comparative Example 4, the amount of enzyme used was different, and the thickness of the enteric coating increased.

[0076] In Comparative Example 5, a single strain was used for fermentation, and the thickness of the enteric coating increased, and there was an odor.

[0077] In Comparative Example 6, the amount of strain used was different, and the thickness of the enteric coating increased.

[0078] The above experimental results further demonstrate the importance of the technical solutions defined in the present application to its technical effects.

[0079] The above is a preferred embodiment of the present application, and it should be noted that for those skilled in the art, without departing from the principles of the present application, a number of improvements and refinements can be made, and these improvements and refinements should also be considered within the scope of protection of the present application.

Claims

1. A method for preparing an ultra-thin high-strength nanofiber pharmaceutical casing, characterized in that, The method comprises the following steps: (1) soaking sheep intestines in warm water at 25-30℃ for 20-25h, placing the soaked sheep intestines with the inner wall outward on a flat wooden board, scraping the mucosa and muscle layers of the intestines with a scraping machine, rinsing the scraped intestines, evenly sprinkling refined salt on the intestines, marinating for 10-15h, and cleaning with clean water to obtain pretreated raw materials; (2) adding a compound enzyme to the pretreated raw materials for enzymolysis at 35-40℃ for 5-8h, inactivating the enzyme, and obtaining an enzymolysis product; the compound enzyme comprises papain, ficin and bromelain; the amount of papain in the pretreated raw materials is 100-110U / mL; the amount of ficin in the pretreated raw materials is 120-130U / mL; and the amount of bromelain in the pretreated raw materials is 80-90U / mL; (3) adding complex bacteria to the enzymatic product for anaerobic fermentation, fermentation at 35-40℃ for 10-12h, sterilization, to obtain a fermentation product; the complex bacteria include Lactobacillus casei, Lactobacillus plantarum and Bifidobacterium longum; the amount of Lactobacillus casei is 10 7 -10 8 CFU / mL of pretreated raw materials; the amount of Lactobacillus plantarum is 10 9 -10 10 CFU / mL of pretreated raw materials; the amount of Bifidobacterium longum is 10 8 -10 9 CFU / mL of pretreated raw materials; (4) rinsing the fermentation product with clean water for 5-8 times to obtain an intestine casing semi-product; (5) mixing nanocellulose, soybean phospholipid and water to prepare a liquid, spraying the liquid on the intestine casing semi-product, drying, and obtaining an ultrathin high-strength nanofiber medicinal casing.

2. The process for the preparation of ultra-thin high strength nanofibrous pharmaceutical casing as claimed in claim 1, wherein, The weight ratio of the sheep intestines to the warm water in step (1) is 1: (10-15).

3. The process for the preparation of ultra-thin high strength nanofibrous pharmaceutical casing as claimed in claim 1, wherein, 1 part by weight of nanocellulose, 4-5 parts by weight of soybean phospholipid and 100 parts by weight of water are mixed to prepare a liquid.

4. The process for the preparation of ultra-thin high strength nanofiber pharmaceutical casing as claimed in claim 1, wherein, Drying at 80-85℃ until the water content is 7-9%.

5. The method for preparing ultrathin, high-strength nanofiber pharmaceutical casings according to claim 1, characterized in that, The spraying usage is 50-60g / m².

6. An ultrathin high-strength nanofiber medicinal casing prepared by the preparation method according to any one of claims 1-5.

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