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Solid particles loaded with polypeptide protein drugs, double enteric solid preparations containing the particles, preparation method and application thereof

A solid particle and polypeptide protein technology, which is applied in the direction of peptide/protein components, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of increasing costs, complicated preparation processes, and limited production scale, etc. problems, to achieve the effect of easy realization, simple preparation process and improved stability

Active Publication Date: 2021-02-26
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Generally speaking, the preparation process is relatively complicated, which limits the scale of production and increases the cost

Method used

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  • Solid particles loaded with polypeptide protein drugs, double enteric solid preparations containing the particles, preparation method and application thereof
  • Solid particles loaded with polypeptide protein drugs, double enteric solid preparations containing the particles, preparation method and application thereof
  • Solid particles loaded with polypeptide protein drugs, double enteric solid preparations containing the particles, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0060] Preparation Example 1 Preparation of Eudragit S100-coated insulin granules

[0061] Dissolve 100mg of SNAC in 1mL of 0.01M NaOH, and dissolve 10mg of insulin (Ins) in 1mL of 0.01M NaOH aqueous solution and add to the SNAC solution to form a homogeneous solution (A); add 500mg of Eudragit S100 to 48mL of tert-butanol medium (containing 5mL water), heated appropriately to make it fully dissolve to form a homogeneous solution (B); slowly add A to B, vortex mix at 500r / min to form a homogeneous solution, and use spray freeze-drying technology to prepare Eudragit S100 package of insulin granules.

preparation Embodiment 2

[0062] Preparation Example 2 Preparation of Eudragit S100-coated insulin granules containing protease inhibitors

[0063] Dissolve 100mg of SNAC in 1mL of 0.01M NaOH, and dissolve 10mg of Ins and 10mg of aprotinin in 1mL of 0.01M NaOH aqueous solution and add them to the SNAC solution to form a homogeneous solution (A); add 500mg of Eudragit S100 to 23mL of tert In butanol (containing 2mL water), heat appropriately to make it fully dissolve to form a homogeneous solution (B); slowly add A to B, vortex mix at 500r / min to form a homogeneous solution, and use spray freeze-drying technology to prepare Eudragit Insulin granules coated with S100.

preparation Embodiment 3

[0064] Preparation Example 3 Preparation of Eudragit S100-coated insulin granules containing protease inhibitors

[0065] Dissolve 200mg of SNAC in 1mL of 0.01M NaOH, and dissolve 10mg of Ins and 10mg of aprotinin in 1mL of 0.01M NaOH aqueous solution and add them to the SNAC solution to form a homogeneous solution (A); add 400mg of Eudragit S100 to 23mL of tert In butanol (containing 2mL water), heat appropriately to make it fully dissolve to form a homogeneous solution (B); slowly add A to B, vortex mix at 500r / min to form a homogeneous solution, and use spray freeze-drying technology to prepare Eudragit Insulin granules coated with S100.

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Abstract

The invention relates to a solid particle loaded with polypeptide and protein drugs, a double enteric solid preparation containing the solid particle, a preparation method and application thereof. The solid particles include polypeptide protein drugs, absorption enhancers and protease inhibitors. The double enteric-coated solid preparation prepared by the invention can resist the degradation of polypeptide protein drugs by gastric acid and gastrointestinal tract enzymes when taken orally, and has colon localization effect, and can effectively promote the absorption of polypeptide protein drugs in the intestinal tract.

Description

technical field [0001] The present invention relates to the field of biopharmaceuticals, more specifically, to a solid particle loaded with polypeptide protein drugs, a double enteric solid preparation containing the solid particle, and a preparation method and application thereof. Background technique [0002] Peptide protein drugs, such as insulin, human growth hormone, and calcitonin, are administered by injection. However, there are many disadvantages in injection administration, such as the short biological half-life of insulin, and 1-2 insulin injections per day will cause side effects such as local redness, swelling, subcutaneous nodules, subcutaneous fat atrophy, etc., which bring great pain and pain to patients. inconvenient. Therefore, research on safe, convenient, cheap and effective oral administration preparations to replace injections will greatly facilitate patients. [0003] However, if insulin and other peptide protein drugs are taken orally directly witho...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K47/32A61K47/38A61K47/18A61K38/28A61K38/22A61K38/23
CPCA61K9/0002A61K9/5015A61K9/5026A61K9/5047A61K9/5052A61K38/22A61K38/23A61K38/28
Inventor 甘勇胡磊范未伟郭仕艳朱春柳王瑞
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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