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Rifampicin antituberculosis drug compound preparation and preparation method thereof

An anti-tuberculosis drug, rifampicin technology, applied in the field of medicine, can solve problems such as rifampicin instability

Inactive Publication Date: 2012-10-17
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

One of the technical problems to be solved in the present invention is to disclose the preparation method of compound solid preparation containing rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride, to overcome the interaction between rifampicin and isoniazid , to solve the instability of rifampicin and other issues

Method used

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  • Rifampicin antituberculosis drug compound preparation and preparation method thereof
  • Rifampicin antituberculosis drug compound preparation and preparation method thereof
  • Rifampicin antituberculosis drug compound preparation and preparation method thereof

Examples

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Effect test

example 1

[0024] Example 1 Rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride bilayer tablet

[0025] prescription:

[0026]

[0027] Preparation of double-layer tablet: pass rifampicin alone through a 100-mesh sieve, and perform hot-melt granulation with polyethylene glycol 6000 to obtain dry granules A; pass pyrazinamide, isoniazid and ethambutol hydrochloride through a 80-mesh sieve screen. Mix pyrazinamide, isoniazid, ethambutol hydrochloride, microcrystalline cellulose, 2 / 3 prescription amount of low-substituted hydroxypropyl cellulose and 1 / 2 prescription amount of magnesium stearate, and dry Granules, whole grains, get Granule B. Then mix 1 / 6 of the prescription amount of low-substituted hydroxypropyl cellulose with granule A evenly, and then mix 1 / 6 of the prescription amount of low-substituted hydroxypropyl cellulose with 1 / 2 of the prescription amount of magnesium stearate and granule B Mix evenly, and use a double-layer tablet press machine to compress the...

example 2

[0033] Example 2 Rifampicin, Isoniazid, Pyrazinamide and Ethambutol Hydrochloride Bilayer Tablet

[0034] prescription:

[0035]

[0036] Preparation of double-layer tablets: pass rifampicin alone through a 100-mesh sieve, mix evenly with 2 / 3 of the prescription amount of low-substituted hydroxypropyl cellulose and microcrystalline cellulose, and granulate by dry granulation technology to obtain granule A; Pass pyrazinamide, isoniazid and ethambutol hydrochloride through a 80-mesh sieve, mix evenly with the starch of the prescription amount, add 5% starch slurry to prepare a soft material, pass through a 16-mesh nylon sieve to prepare wet granules, and place in an oven (about 55°C) and ventilated and dried, and then sized with a 16-mesh nylon sieve to obtain Granule B. Then mix the remaining 1 / 3 of the prescription amount of low-substituted hydroxypropyl cellulose with 1 / 3 of the prescription amount of magnesium stearate and granule A, and then mix 2 / 3 of the prescription ...

example 3

[0041] Example 3 Three-layer tablet of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride

[0042]

[0043] Preparation of three-layer tablet: pass rifampicin alone through a 100-mesh sieve, mix evenly with 1 / 3 of the prescription amount of low-substituted hydroxypropyl cellulose and 1 / 3 of the prescription amount of microcrystalline cellulose, and use dry granulation technology to prepare Granules to obtain Granule A; Pyrazinamide, ethambutol hydrochloride, and isoniazid were passed through an 80-mesh sieve, and isoniazid, ethambutol hydrochloride, 2 / 3 of the prescription amount of microcrystalline cellulose and 2 / 3 The low-substituted hydroxypropyl cellulose in the prescribed amount was mixed evenly, and granulated by dry granulation technology to obtain granule B. Mix pyrazinamide with the prescribed amount of starch evenly, add 5% starch slurry to prepare soft materials, pass through a 16-mesh nylon sieve to prepare wet granules, put them in an oven (about...

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Abstract

The invention belongs to the field of medicine technology, and relates to a preparation method of an antituberculosis drug compound preparation containing rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride. The method comprises steps of: first granulating rifampin by a dry granulation technology; granulating two or three selected from isoniazid, pyrazinamide and ethambutol hydrochloride by a wet or a dry granulation technology; and compressing the granules into four layer tablets containing rifampin, isoniazid, pyrazinamide and ethambutol hydrochloride. The aim of the method is to avoid degradation caused or accelerated by close contact of the rifampicin and other drugs in the preparation, thus ensuring the stability of the compound rifampicin preparation.

Description

technical field [0001] The invention relates to the technical field of medicine, specifically an invention related to anti-tuberculosis drugs and various preparation processes thereof, a compound preparation of rifampicin anti-tuberculosis drugs and a preparation method thereof. Background technique [0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis, which can invade many organs, and pulmonary tuberculosis is the most common form of lung involvement. Tuberculosis is not only an ancient disease, but also an urgent public health and social problem facing the world. question. Since the 1990s, the global incidence of tuberculosis has risen rapidly. The International Association Against Tuberculosis and the World Health Organization have listed six drugs, rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride, streptomycin and thiosemicarbazide, as important first-line anti-tuberculosis drugs. Streptomycin is generally used for inj...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K31/496A61K31/4409A61K31/133A61K9/20A61P31/06
Inventor 孙长山毕开顺王思玲徐晖
Owner SHENYANG PHARMA UNIVERSITY
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