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Research and application of a novel sustained release preparation adjuvant

A release excipient, a new type of technology, applied in the field of medicine

Inactive Publication Date: 2016-07-06
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the article mainly takes soybean protein as the research object, and does not conduct relevant investigations on animal proteins such as whey protein WPI. Research on the physical and chemical properties of protein, such as powder properties and other practical problems

Method used

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  • Research and application of a novel sustained release preparation adjuvant
  • Research and application of a novel sustained release preparation adjuvant
  • Research and application of a novel sustained release preparation adjuvant

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0043] Example 1: Preparation of succinylated WPI whey protein isolate excipient

[0044] Maintain the temperature at 35°C-65°C, dissolve 100g of WPI whey protein isolate in 800ml of distilled water, keep the pH of the solution between 7.0-11.0 during the dissolution process, and add the corresponding anhydride, continue to keep the pH value of the solution between 7.0-11.0, measure the degree of protein acylation by methods such as o-phthalaldehyde method or ninhydrin method, and obtain the protein with the target degree of acylation, and the pH value is finally Stabilize between 8.0-8.5 for more than 30 minutes to terminate the reaction. Dialyze the acylated protein solution at 4°C for 24 hours with a dialysis bag with a molecular cut-off of 1000DA, and then dry it.

[0045] The preparation process of other auxiliary materials such as acetylated or succinylated whey protein WPC and soybean protein is the same as that shown in Example 1.

Embodiment 2

[0046] Example 2: Preparation of WPI protein excipient diclofenac sodium sustained-release tablets with different degrees of succinylation (taking 0.4g / tablet as an example)

[0047] According to the method shown in Example 1, WPI whey protein isolate adjuvant materials with acylation degrees of 35%, 50%, and 85% were prepared respectively.

[0048] Precisely weigh 40g of diclofenac sodium (taking 10% drug loading as an example), add the prescribed amount of microcrystalline cellulose (5%), precisely weigh the prescribed amount of WPI acylated protein excipients, and mix the powder evenly and use Shanghai Tianfan Instruments to manufacture Diclofenac sodium sustained-release tablets were prepared by direct compression on a tablet press at room temperature.

[0049] 1) Simulate the gastrointestinal tract environment with different pH, according to the requirements of the appendix of "Chinese Pharmacopoeia" 2010 edition, investigate the release of this example in the gastric jui...

Embodiment 3

[0054] Example 3: Preparation of sustained-release tablets of allicin derivatives with different succinylation degrees WPI excipients

[0055] According to the method shown in Example 1, WPI whey protein isolate protein supplements with acylation degrees of 0%, 35%, 40%, 55%, 70%, 85%, and 100% were prepared respectively.

[0056] Precisely weigh 40g of allicin derivatives (10% drug loading as an example), add the prescribed amount of micropowder silica gel (0.5%), precisely weigh the prescribed amount of WPI acylated protein excipients, mix the powder evenly, and use Shanghai Tianfan Pharmaceutical Machinery to manufacture Sustained-release tablets were prepared by direct compression on the tablet press of the factory at room temperature.

[0057] 4) Simulate the gastrointestinal tract environment with different pH, according to the requirements of the appendix of "Chinese Pharmacopoeia" 2010 edition, investigate the release of this example in the gastric juice environment, a...

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Abstract

The invention discloses a novel, wide source, good biocompatibility, safe and nontoxic sustained-release preparation auxiliary material. This excipient is obtained from whey protein isolate, whey protein concentrate, or other mixtures containing one or more of the above proteins through succinylation or acetylation modification. release preparations. In the present invention, different acid anhydrides are used to acylate samples, and common drying techniques such as freeze drying, spray drying, blast drying and the like can be used to prepare auxiliary materials. The excipient enters the environment of the human body and can form a gel-like retardation layer outside the drug, thereby controlling the slow release of the drug in the human gastrointestinal tract, and is widely used in the preparation of sustained and controlled release preparations for drugs with short biological half-lives. and development.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to the application of a novel auxiliary material with good biocompatibility, safety and non-toxicity, wide sources and the effect of slow and controlled release. Background technique [0002] Pharmaceutical excipients play an inestimable role in the development of pharmaceutical preparations, and the development of new pharmaceutical excipients can push preparations into a new field. Biodegradable materials are one of the research hotspots in the field of medicine in recent years. Its good biocompatibility, non-toxic safety and other characteristics provide a broad space for its application in the field of medicine. Therefore, it is of great practical value to study a new type of biodegradable material for the field of pharmaceutical preparations. [0003] Natural degradable polymer materials such as cellulose and polysaccharides have been widely used. [0004] As a major nutr...

Claims

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Application Information

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IPC IPC(8): A61K47/42A61K9/22
Inventor 王淑君张瑜陈浩宇
Owner SHENYANG PHARMA UNIVERSITY
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