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A preparation method of compound rifampicin preparation

A rifampicin and compound technology, which is applied in the field of preparation of compound rifampicin preparations, can solve the problems such as the decline in the quality of FDC preparations

Inactive Publication Date: 2006-11-22
高华
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 3. Since FDC preparations have the above-mentioned insurmountable degradation problems in accordance with the ordinary compound preparation manufacturing method, the quality of FDC preparations will easily decline during the manufacturing, storage and transportation of FDC preparations. Therefore, the product quality of FDC preparations Strict control should be carried out. The focus should be not only to control the dissolution rate, release rate, content and other conventional indicators of each drug component, but more importantly, to control the degradation products of each drug component.
However, due to improvements in some places, there will also be unavoidable defects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Preparation and in vitro drug release characteristics of isoniazid enteric-coated granules:

[0038] 1. Preparation of isoniazid enteric-coated granules

[0039] The prescription composition of isoniazid granules: 75g of isoniazid, 6g of starch, and an appropriate amount of 5% povidone (K30) solution.

[0040] Granulation: Weigh each raw material and auxiliary material according to the above prescription, pass through a 100-mesh sieve, mix evenly, granulate with 5% povidone (K30) solution, dry in an oven at 60°C, sieve, granulate, and set aside.

[0041] Preparation of enteric coating solution: take 5 g of hydroxypropylmethyl phthalate, add 100 ml of acetone / ethanol solution (3 / 7) to dissolve, add 0.5 g of diethyl phthalate, and dissolve evenly.

[0042] Preparation of enteric-coated granules: Put the prepared granules in the coating pan, roll the coating pan, spray the enteric coating solution while blowing hot air, wrap the granules until the weight of the ...

Embodiment 2

[0048] Example 2 Preparation and in vitro drug release characteristics of rifampicin enteric-coated granules

[0049] 1. Preparation of rifampicin enteric-coated granules

[0050] The prescription composition of rifampicin granules: rifampicin 150g, microcrystalline cellulose 45g, vitamin C 3g, sodium carboxymethyl starch 2g.

[0051] Granulation: Weigh each raw material and auxiliary material according to the above prescription, pass through an 80-mesh sieve, mix evenly, dry granulate, granulate, and set aside.

[0052] Preparation of film coating solution: take 3 g of hydroxypropyl methylcellulose and 3 g of polyethylene glycol 4000, and dissolve them evenly with 70% ethanol solution.

[0053] Preparation of film coating: put the prepared granules in the coating pan, roll the coating pan, spray the film coating solution while blowing hot air, wrap until the granules increase in weight to about 3%, take them out and dry them in an oven at 50°C for 1 Hour.

[0054] Preparat...

Embodiment 3

[0062] Example 3 Preparation and in vitro drug release characteristics of rifampicin gastric soluble granules

[0063] 1. Preparation of rifampicin gastric soluble granules

[0064] The prescription composition of rifampicin granules: rifampicin 150g, microcrystalline cellulose 30g, vitamin C 3g, low-substituted hydroxypropyl cellulose 10g.

[0065] Granulation: Weigh each raw material and auxiliary material according to the above prescription, pass through an 80-mesh sieve, mix evenly, dry granulate, granulate, and set aside.

[0066] Preparation of gastric soluble coating solution: take 9 g of gastric soluble film coating premix, add 100 ml of 50% ethanol solution and dissolve evenly.

[0067] Preparation of gastric soluble granules: put the prepared granules in the coating pan, roll the coating pan, spray the gastric soluble coating liquid while blowing hot air, wrap until the weight of the granules increases to about 4%, take them out and dry them in an oven at 50°C Take...

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Abstract

The preparation process of new compound rifampicin preparation features that rifampicin, isoniazide, pyrazinamide and ethambutol hydrochloride are first prepared into granule, then coated and finally encapsulated. The preparation process can isolate the medicine components at most to avoid the avoid close contact of medicine components in the solid preparation environment so as to ensure the stability of the compound rifampicin preparation.

Description

technical field [0001] This application is actually a continuation application that has obtained patent authorization. The invention patent title that the inventor has obtained authorization is "a drug delivery system for compound rifampicin preparation". Its patent application number is 03101211.6, and its authorized patent certificate number is 208518, this application is based on the further deepening of the research, in order to overcome the minor defects of the patent 03101211.6, and on the basis of it, a new method for preparing a compound rifampicin preparation was invented. technical background [0002] In order to prevent the occurrence of drug-resistant tuberculosis, the World Health Organization (WHO) recommended 12 standardized prescription combinations of fixed-dose compound (FDC) preparations to the world in its No. 1 (Volume 79, No. 1) announcement in 2001. While recommending the standard prescription of FDC preparations, WHO emphasize...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/20A61K9/36A61K9/48A61K31/133A61K31/4409A61P31/06
Inventor 和琳琳王伟李思思高艺歌
Owner 高华
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