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Method for preparing insulin preparation for oral using

A manufacturing method and insulin technology, which can be used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of strong toxicity, poor stability, and expensive purification of finished products.

Inactive Publication Date: 2009-03-11
CONCERN O3 COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The disadvantage of this method is that the adhesive is highly toxic and the finished product must be decontaminated costly
[0010] The disadvantage of this approach is that the resulting preparation has poor stability against the action of digestive enzymes, resulting in low insulin activity into the blood
[0012] The disadvantage of this method is that the process of extracting ovomucoid and modifying the cross-linked polymer with ovomucoid is complex and expensive, and the internal medicine curative effect of the obtained preparation is poor.

Method used

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  • Method for preparing insulin preparation for oral using
  • Method for preparing insulin preparation for oral using
  • Method for preparing insulin preparation for oral using

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A 10% aqueous solution was prepared with polyethylene oxide with a molecular weight of 1.5kDa, and then it was irradiated with a dose of 5.0Mrad by an accelerated electron current. Insulin was added to the irradiated solution to a final concentration of 10 mg / ml (10:1 ratio of polyethylene oxide to insulin). The mixture was stirred for 10 minutes to prepare a light milky white solution-like insulin preparation. The yield rate is 98%.

Embodiment 2

[0022] Prepare a 50.0% aqueous solution with polyethylene oxide with a molecular weight of 0.4kDa, and then irradiate it with a dose of 1.0Mrad by decelerating gamma rays. Insulin was added to the irradiated solution to a final concentration of 1 mg / ml (polyethylene oxide:insulin ratio 500:1). The mixture was stirred for 30 minutes to prepare a transparent solution-like insulin preparation. The yield rate is 97%.

Embodiment 3

[0024] A 5% aqueous solution was prepared with polyethylene oxide with a molecular weight of 15kDa, and then it was irradiated with a dose of 2.5Mrad by an accelerated electron current. Insulin was added to the irradiated solution to a final concentration of 10 mg / ml (polyethylene oxide:insulin ratio 5:1). The mixture was stirred for 15 minutes to prepare an insulin preparation in the form of light milky white solution. The yield rate is 99%.

[0025] Table 1 lists the results of the study on the hypoglycemic effect of the insulin compound preparation containing radioactive polyethylene oxide on Wistar rats. Use polyoxyethylene-modified porcine insulin to give experimental group rats a one-time intragastric administration of 1ml (ingredients: porcine insulin 30 IU / mL, 1500% radioactivated polyoxyethylene 12.5% ​​by mass, the ratio of polyoxyethylene to insulin 125: 1) 1 ml of porcine insulin was intragastrically administered to rats in the test group once, with an effective ...

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Abstract

The invention relates to pharmacology and medicine, in particular to endocrinology. The inventive method consists in introducing insulin into a 1-50% aqueous solution of a polymer, the molar mass of which ranges from 0.4 to 40 kDa and which is pre-irradiated by an ionizing radiation dose of 1.0 to 5.0 Mrad, in such a way that the final concentration thereof ranges from 1 to 10 mg / ml at a ratio between polyethylene oxide and insulin equal to (1-500):1 and in agitating the mixture until a homogeneous transparent and slightly opalescent solution is obtained. Said method makes it possible to obtain a pharmaceutical composition comprising a biologically active insulin which exhibits a high hypoglycemic activity when enterally administered.

Description

technical field [0001] The present invention relates to pharmacology, internal medicine, especially endocrinology, for the manufacture of oral insulin preparations. Background technique [0002] Insulin is a polypeptide hormone with a molecular weight of about 6000. It affects all types of material exchange in the body, including enhancing the ability of glucose to penetrate body tissues, enhancing the ability of body tissues to utilize glucose, reducing the glycogen content in the liver, increasing the glycogen content in muscles, and increasing protein. synthesis rate etc. [0003] The main method of injecting insulin into the human body is subcutaneous injection or intramuscular injection of insulin preparations. Oral administration (intestinal absorption) is the most convenient method for patients, but this attempt has not been successful because insulin is easily broken down by digestive enzymes and loses its activity. [0004] Compared with injection preparations, t...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K47/48A61K41/00
CPCA61K41/0019A61K47/48215A61K38/28A61K47/60A61K41/17A61P1/18A61P3/10
Inventor 安德里·维拉迪米洛维奇·阿尔塔莫诺夫彼得·伊万诺维奇·洛迪奥诺夫
Owner CONCERN O3 COMPANY