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Oral insulin medicament and preparation method thereof

A technology for insulin and drugs, which is applied in the field of oral insulin drugs and its preparation, can solve the problems of intestinal mucosal cell damage, low bioavailability, and influence on use, and achieve the effects of good resistance to protease degradation, good dispersion performance, and easy absorption

Active Publication Date: 2009-12-02
江苏平衡生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most of the research on insulin oral preparations at home and abroad focuses on finding insulin stabilizers, absorption enhancers, and microcapsules, microspheres, liposomes or double emulsions that use macromolecules as carriers and add protease inhibitors, but these The general problem of preparations is poor absorption and low bioavailability
[0003] For a long period of time, people have used secondary cholic acid as an absorption enhancer for insulin, and its effect is better than that of commonly used absorption enhancers such as Tween and azone. damage, which affects its use

Method used

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  • Oral insulin medicament and preparation method thereof
  • Oral insulin medicament and preparation method thereof
  • Oral insulin medicament and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The activity test of the insulin extracted in the pig gallbladder bile of embodiment 1

[0020] 1. Confirmation of insulin and C-peptide in porcine bile by isotope radioimmunoassay

[0021] Animal specimens: take the bile of 1000 live pig gallbladders in fractions, use isotope radioimmunoassay method to detect the insulin and C-peptide in the bile, and take the average value as follows:

[0022] The average value of insulin in porcine gallbladder bile: 400±60iu / ml

[0023] The average value of radioactive C-peptide: 21±5ng / ml

[0024] Two, the comparison between gallbladder bile extraction insulin high performance liquid chromatography separation figure and standard pure insulin (see figure 1 )

[0025] figure 1 The upper picture is the liquid chromatogram of standard pure insulin, the middle picture is the liquid chromatogram of insulin extracted from porcine gallbladder bile, and the lower picture is the liquid chromatogram of the mixture of standard pure insulin ...

Embodiment 2

[0045] Embodiment 2 Preparation of oral insulin medicine

[0046] Take egg yolk lecithin 200mg, sodium taurocholate 20mg, glycocholic acid 40mg, bilirubin 0.5mg, cholesterol 3mg, soak with 30% (v / v) ethanol solution 10-20ml, soak for 30 minutes, fully stir. Take 1 mg of insulin powder and dissolve it with a weak alkaline solution. After it is completely dissolved, add it to the above solution. Continue to stir, then add double-distilled water, continue to stir evenly, so that each ml of liquid contains 8U of insulin, and then put the solution in a water bath at 35-120°C to incubate 3 times, each time for about 1 hour, and the temperature of the water bath is gradually increased . After the liquid temperature drops to room temperature, add an appropriate amount of protamine. Place at 4°C overnight, centrifuge at 1000rmp for 5 minutes, discard the precipitate and keep the supernatant. Prepare a transparent, light yellow, low viscosity oral insulin drug solution.

Embodiment 3

[0047] The preparation of embodiment 3 oral insulin medicine

[0048] Take soybean lecithin 270mg, sodium taurocholate 28mg, glycocholic acid 120mg, bilirubin 1mg, cholesterol 2mg, soak with 10-20ml, 30% (v / v) ethanol solution for 30 minutes, fully stir. Take 1 mg of insulin powder and dissolve it with a weak alkaline solution. After it is completely dissolved, add it to the above solution. Continue to stir, then add double-distilled water, continue to stir evenly, so that each ml of liquid contains 8U of insulin, and then put the solution in a water bath at 35-120°C to incubate 3 times, each time for about 1 hour, and the temperature of the water bath is gradually increased . After the liquid temperature drops to room temperature, add an appropriate amount of protamine. Place at 4°C overnight, centrifuge at 1000rmp for 5 minutes, discard the precipitate and keep the supernatant. Prepare a transparent, light yellow, low viscosity oral insulin drug solution.

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Abstract

The invention relates to an oral insulin medicament for treating type II diabetes, which contains insulin, primary bile acid, lecithin, cholesterol and bilirubin. The oral insulin medicament comprises the following components by weight: 1 weight portion of insulin, 30 to 100 weight portions of primary bile acid, 100 to 300 weight portions of lecithin, 1 to 3 weight portions of cholesterol, 0.08 to 0.8 weight portion of bilirubin, and 50 weight portions of bile acid. The invention prepares the insulin medicament which satisfies physiological characteristics of organisms according to the bionics, and proves the administration of the insulin medicament through an oral way has exact therapeutic effect on the type II diabetes through animal experiments and clinical trials. The medicament satisfies the physiological characteristics of the organisms, can ensure that blood sugar keeps relatively steady within 24 hours without hypoglycemic reaction, can also ensure that the lecithin in bodies of type II diabetic patients is reduced and the metabolic disturbance of the bile acid is gradually corrected when the blood sugar is reduced, and has preventing and treating effect on complicating diseases caused by the type II diabetes.

Description

technical field [0001] The invention relates to an oral insulin drug for treating type II diabetes and a preparation method thereof. technical background [0002] Insulin (Insulin, Ins.) has been used as a hypoglycemic biochemical drug for the treatment of diabetes for 88 years. So far, it is still the drug of choice for patients with insulin-dependent diabetes mellitus (IDDM), and it is also the drug of choice for more and more non-insulin-dependent diabetes mellitus. (NIDDM) patients essential medicine. The current clinical treatment is more inclined to use insulin as early as possible for patients with type II diabetes (2DM), so that the islet cells can be repaired and the complications caused by diabetes can be better reduced. However, since insulin is a polypeptide drug, it will be degraded by proteolytic enzymes in the gastrointestinal tract and not absorbed, so oral treatment is almost ineffective. For this reason, insulin injections (iv and hip) are commonly used in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K47/38A61P3/10
Inventor 薛南荣何执静
Owner 江苏平衡生物医药科技有限公司
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