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Method for preparing insulin oral formulation

An insulin and solution technology, applied in the field of preparation of oral insulin preparations, can solve the problems of poor repeatability, unstable drug effect, low insulin bioavailability, etc., and achieve the effects of short action time, low blood sugar, and small molecular weight

Inactive Publication Date: 2005-03-16
于晓玲
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main reason is that the bioavailability of insulin in oral preparations is low, the drug effect is unstable, and the reproducibility is poor

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0017] Its preparation method is prepared according to the following steps:

[0018] (1) Acrylic resin III is dissolved in absolute ethanol solution to make solution A; wherein the content of acrylic resin III is 30mg / ml;

[0019] (2) Slowly add insulin into solution A under stirring to make solution B, wherein the insulin content is 15u / ml;

[0020] (3) Dissolve sodium taurocholate in liquid paraffin, put 20 mg of sodium taurocholate into each milliliter of liquid paraffin, and slowly add the resulting mixture into solution B under stirring to fully disperse it Prepare solution C in solution B; Wherein sodium taurocholate content is 3mg / ml, and liquid paraffin content is 0.1mg / ml;

[0021] (4) Dissolve gelatin in distilled water, put 5 mg of gelatin per milliliter of distilled water, and slowly add the mixed solution obtained after fully dissolving into solution C under stirring to make the insulin microspheres encapsulated for the first time, which is called solution D ; w...

example 2

[0026] Its preparation method is prepared according to the following steps:

[0027] (1) Acrylic resin III is dissolved in absolute ethanol solution to make solution A; wherein the content of acrylic resin III is 40mg / ml;

[0028] (2) Slowly add insulin into solution A under stirring to make solution B, wherein the insulin content is 18u / ml;

[0029] (3) Dissolve sodium taurocholate in liquid paraffin, add 35 mg of sodium taurocholate per milliliter of liquid paraffin, and slowly add the resulting mixture into solution B under stirring to fully disperse it Prepare solution C in solution B; Wherein sodium taurocholate content is 4.5mg / ml, and liquid paraffin content is 0.15mg / ml;

[0030] (4) Dissolve gelatin in distilled water, put 12.5 mg of gelatin per milliliter of distilled water, and slowly add the mixed solution obtained after fully dissolving into solution C under stirring to make the first encapsulated insulin microspheres called solution D; Wherein the gelatin conte...

example 3

[0035] Its preparation method is prepared according to the following steps:

[0036] (1) Acrylic resin III is dissolved in absolute ethanol solution to make solution A; wherein the content of acrylic resin III is 50mg / ml;

[0037] (2) Slowly add insulin into solution A under stirring to make solution B, wherein the insulin content is 20u / ml;

[0038] (3) Dissolve sodium taurocholate in liquid paraffin, add 50 mg of sodium taurocholate per milliliter of liquid paraffin, and slowly add the resulting mixture into solution B under stirring to fully disperse it Prepare solution C in solution B; Wherein sodium taurocholate content is 6mg / ml, and liquid paraffin content is 0.2mg / ml;

[0039] (4) Dissolve gelatin in distilled water, put 20 mg of gelatin into each milliliter of distilled water, and slowly add the mixed solution obtained after fully dissolving into solution C under stirring to make the insulin microspheres encapsulated for the first time, which is called solution D ; ...

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PUM

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Abstract

Disclosed is a method for preparing insulin oral formulation which comprises, (1) dissolving acrylic resin III in anhydrous alcohol solution, obtaining solution A, (2) charging insulin into the solution A to obtain solution B, (3) dissolving sodium taurocholate in liquid paraffin, charging into solution B to obtain solution C, (4) dissolving gelatin into distilled water, charging into solution C to obtain a first enveloped insulin microballoons, which is called solution D, (5) charging equal amount of fluid wax with solution C into solution D to obtain solution E, (6) dissolving acetylsalicylic acid into distilled water to form miscible liquid, charging equal amount of miscible liquid of gelatin and distilled water into another solution A, charging into solution E, finally obtaining a second enveloped insulin microballoon solution.

Description

technical field [0001] The invention relates to a preparation method of a medicine for treating diabetes, in particular to a preparation method of an insulin oral preparation. Background technique [0002] Diabetes is one of the three major diseases in the contemporary world, and its incidence has gradually increased in recent years in my country. At present, it is conservatively estimated that there are 120 million people in the world, and there are more than 10 million diabetic patients in my country. Insulin is currently the trump card drug for the treatment of this disease. Because insulin is easily destroyed by proteolytic enzymes in the gastrointestinal tract, and has a large molecular weight, it is easy to polymerize and the low permeability of the gastrointestinal mucosa, so it is ineffective when taken orally. Injection and intravenous administration. Since diabetes is a lifelong disease, especially insulin-dependent diabetes and severe diabetes, insulin needs to ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K38/28A61P3/10
Inventor 于晓玲
Owner 于晓玲
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