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Medicinal preparation containing repaglinide and preparation of medicinal preparation

A pharmaceutical preparation and pharmacy technology, applied in the field of pharmaceutical preparations, can solve the problems of ensuring the dissolution stability of a small dose of insoluble drug repaglinide without any measures, and achieve the effects of good content uniformity, increased dissolution rate, and simple process

Active Publication Date: 2013-07-03
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] CN101756971 discloses an oral solid pharmaceutical composition of metformin hydrochloride repaglinide. The preparation method is to dissolve repaglinide with ethanol as a binder, and wet granulate metformin and suitable auxiliary materials. Although the preparation process is simple, It is more suitable for domestic industrial production, but no measures are taken in the prescription process to ensure the dissolution of small doses of insoluble drug repaglinide and the stability of the two main components

Method used

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  • Medicinal preparation containing repaglinide and preparation of medicinal preparation
  • Medicinal preparation containing repaglinide and preparation of medicinal preparation

Examples

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Effect test

Embodiment 1

[0050]

[0051] Preparation:

[0052] Weigh the prescribed amount of meglumine, dissolve in water and then add 95% ethanol, slowly add the prescribed amount of repaglinide, poloxamer 188 and povidone k30, stir to dissolve, and set aside. Mix the prescribed amount of metformin hydrochloride, povidone k30, sorbitol, polyethylene glycol 6000, microcrystalline cellulose 101 and croscarmellose sodium, add the drug-containing binder solution to make a soft material, 28 Mesh sieve for granulation.

[0053] Granulation conditions: temperature 18-26°C, relative humidity 45-65%; stirring speed: 130±30rpm; granulation time: 5 minutes.

[0054] After the granulation is completed, ventilate and dry at 40°C until the water content is 2-3%, add magnesium stearate and mix evenly, press into tablets, make Opadry 295F620019 into a 10% aqueous solution, and coat the product with a weight gain of 3%.

Embodiment 2

[0056]

[0057] Preparation:

[0058] Take the prescription amount of meglumine, add 95% ethanol after dissolving in water, slowly add the prescription amount of repaglinide and povidone k30, stir to dissolve, set aside. Mix the prescribed amount of metformin hydrochloride, povidone k30, sorbitol, polyethylene glycol 6000, microcrystalline cellulose 101 and croscarmellose sodium, add the drug-containing binder solution to make a soft material, 28 Mesh sieve for granulation.

[0059] Granulation conditions: temperature 18-26°C, relative humidity 45-65%; stirring speed: 130±30rpm; granulation time: 5 minutes.

[0060] After the granulation is completed, ventilate and dry at 40°C until the water content is 2-3%, add magnesium stearate and mix evenly, press into tablets, make Opadry 295F620019 into a 10% aqueous solution, and coat the product with a weight gain of 3%.

Embodiment 3

[0062]

[0063] Preparation:

[0064] Take the prescription amount of meglumine, add 95% ethanol after dissolving in water, slowly add the prescription amount of repaglinide and povidone k30, stir to dissolve, set aside. Mix the prescribed amount of metformin hydrochloride, povidone k30, mannitol, microcrystalline cellulose 101 and sodium carboxymethyl starch evenly, add the drug-containing binder solution to make a soft material, and granulate with a 28-mesh sieve.

[0065] Granulation conditions: temperature 18-26°C, relative humidity 45-65%; stirring speed: 130±30rpm; granulation time: 5 minutes.

[0066] After the granulation is completed, ventilate and dry at 40°C until the water content is 2-3%, add magnesium stearate and mix evenly, press into tablets, make Opadry 295F620019 into a 10% aqueous solution, and coat the product with a weight gain of 3%.

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Abstract

The invention relates to a preparation method of a medicinal preparation of repaglinide. The preparation method comprises the following steps: (a) dissolving meglumine and repaglinide in alcohol and water to prepare an adhesive solution; (b) mixing pharmaceutically acceptable adjuvant materials to prepare a mixture; (c) adding the adhesive solution to the mixture obtained in the step b, and performing wet granulation; and (d) preparing the medicinal preparation. The invention further relates to application of meglumine as a repaglinide stabilizer in the medicinal preparation containing repaglinide.

Description

[0001] This application claims the priority of the Chinese invention patent application 201110452023.2 filed on December 29, 2011, entitled "Pharmaceutical Preparation Containing Metformin and Repaglinide and Preparation Method thereof". technical field [0002] The invention relates to the field of pharmaceutical preparations, more specifically, to a pharmaceutical preparation containing repaglinide and a preparation method thereof. Background technique [0003] Diabetes is a disease caused by excessive accumulation of glucose in the blood. It is also called "silent killer" abroad. Once suffering from diabetes, life expectancy will be reduced by as much as ten years, and possible complications can occur throughout the body. Diabetes is divided into type 1 diabetes, type 2 diabetes, gestational diabetes and other special types of diabetes. Type 2 diabetes accounts for about 95% of diabetic patients. At present, most patients with type 2 diabetes are usually treated with dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/451A61K47/18A61P3/10A61K31/155
Inventor 闫学文万英杨慧君成仁基
Owner BEIJING HANMI PHARMA CO LTD
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