Isulin solid granular, its preparation method and its use in preparing medicine for treating diabetes

A technology of solid particles and insulin, which is applied in drug combination, metabolic diseases, and pharmaceutical formulations, etc. It can solve the problems of insulin digestion and damage, difficulty in lowering blood sugar, etc., and achieve the effects of protecting insulin, taking it conveniently, and lasting drug effect

Inactive Publication Date: 2006-05-24
INST OF BIOMEDICAL ENG CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The present invention aims to solve the problem that insulin is easily digested and destroyed in the gastrointestinal tract, so it is difficult to enter the body through the intestinal tract to exert a hypoglycemic effect, and provides a solid insulin particle and a preparation method thereof and the use of the solid particle in preparing and treating diabetes drug application

Method used

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  • Isulin solid granular, its preparation method and its use in preparing medicine for treating diabetes
  • Isulin solid granular, its preparation method and its use in preparing medicine for treating diabetes
  • Isulin solid granular, its preparation method and its use in preparing medicine for treating diabetes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042]Mix 50mg of porcine insulin with 100mg of polyethylene glycol 2000, add 1ml of distilled water, adjust the pH to 8.0 with NaOH, and dissolve completely to obtain solution A; dissolve 250mg of polylactic acid and its copolymer (PLGA) in 10ml of dichloromethane to obtain a solution B; take another 0.2 g of chitosan, add 20ml of distilled water to obtain solution C; add A to B in an ultrasonic disperser and mix, perform ultrasonic emulsification, and the power of ultrasonic generation is 30-50 watts; continue to emulsify for 5-15 minutes to obtain an emulsion D: Add emulsion D to solution C under high-speed stirring, mix with a high-speed stirrer at a stirring speed of 2000-6000 rpm, and continue stirring for 5-15 minutes to obtain emulsion E. Volatilize the dichloromethane in the emulsion E under stirring in a fume hood, it takes 2-3 hours, the temperature is 20-30°C, the stirring speed is 100-1000 rpm, continue to stir and add 0.05 grams of sodium tripolyphosphate dropwise...

Embodiment 2

[0044] Mix 50mg of porcine insulin with 50mg of hydroxypropyl cyclodextrin, add 1ml of distilled water, and adjust the pH to 8.0 with NaOH to obtain solution A; take 200mg of polylactic acid and its copolymer (PLGA) and dissolve it in 8ml of ethyl acetate to obtain Solution B; take another 0.2 g of polyvinyl alcohol and add 20 ml of distilled water to obtain solution C; add A to B in an ultrasonic disperser and mix for ultrasonic emulsification, with ultrasonic generation power of 30-50 watts; continue emulsification for 5-15 minutes, To obtain emulsion D; add emulsion D to solution C under high-speed stirring, mix with a high-speed stirrer at a stirring speed of 2000-6000 rpm, and continue stirring for 5-15 minutes to obtain emulsion E. Use electromagnetic stirring in the fume hood to volatilize the dichloromethane in the emulsion E under stirring. It takes 2-3 hours at a temperature of 20-30°C and a stirring speed of 100-1000 rpm to obtain a solidified insulin particle suspoe...

Embodiment 3

[0046] Mix 50mg of porcine insulin with 50mg of polyethylene glycol 2000, add 1ml of distilled water, and adjust the pH to 8.0 with NaOH to obtain solution A; take 200mg of polylactic acid and its copolymer (PLGA), dissolve it in 8ml of ethyl acetate to obtain solution B; take another 0.2 g of polyvinyl alcohol, add 20 ml of distilled water to obtain solution C; add A to B and mix in an ultrasonic disperser, and carry out ultrasonic emulsification with an ultrasonic generation power of 30-50 watts; continue emulsification for 5-15 minutes to obtain Emulsion D: Add emulsion D to solution C under high-speed stirring, mix with a high-speed stirrer at a stirring speed of 2000-6000 rpm, and continue stirring for 5-15 minutes to obtain emulsion E. Use electromagnetic stirring in the fume hood to volatilize the dichloromethane in the emulsion E under stirring. It takes 2-3 hours at a temperature of 20-30°C and a stirring speed of 100-1000 rpm to obtain a solidified insulin particle su...

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Abstract

The invention discloses an insulin solid particle, a preparation method thereof and an application of the solid particle in preparing a medicine for treating diabetes, which belongs to a pharmaceutical preparation containing insulin. Insulin, stabilizers, biodegradable polymers and intestinal mucosal absorption promoters are used as raw materials to prepare solid particles with a particle size of 0.2-50 microns in a double-layer composite structure, filled in enteric-coated capsules, or wrapped in enteric-coated films The oral insulin enteric-coated capsule preparation or oral insulin enteric-coated tablet preparation for the treatment of diabetes made in this way can be taken orally 1-3 times a day, which can replace the injection of insulin preparations and achieve the same hypoglycemic effect. The insulin enteric-coated capsule or enteric-coated tablet prepared by the method has the characteristics of convenient administration, long-lasting drug effect and high bioavailability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing insulin, in particular to an insulin solid particle, a preparation method thereof and an application of the solid particle in preparing a drug for treating diabetes. Background technique [0002] At present, insulin is still administered by injection in the treatment of diabetes. For diabetics who need long-term medication, injection will bring pain and inconvenience to the patient. In order to overcome these disadvantages, efforts have been made to develop oral insulin. Because insulin is easily digested and destroyed in the gastrointestinal tract, it is difficult for it to enter the body through the intestinal tract to exert its hypoglycemic effect. Protease inhibitors can reduce the destruction of insulin, thereby significantly increasing the absorption of insulin in the intestine. But protease inhibitors also inhibit the body's digestion and absorption of protein. [0003] US Pate...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/16A61K9/48A61P3/10
Inventor 宋存先孙洪范杨菁
Owner INST OF BIOMEDICAL ENG CHINESE ACAD OF MEDICAL SCI
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