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Compound preparation of antituberculosis medicaments, and preparation method thereof

A compound preparation and anti-tuberculosis technology, which is applied in the field of medicine and can solve the problems of limited mobility and industrialized production.

Active Publication Date: 2011-04-20
SHENYANG HONGQI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, the fluidity of the material will greatly limit the industrial production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0032] Prescription 1:

[0033] Rifampicin: 120g

[0034] Isoniazid: 100g

[0035] Pyrazinamide: 300g

[0036] Ethambutol: 200g

[0037] Microcrystalline Cellulose: 50g

[0038] Croscarmellose Sodium: 75g

[0039] Magnesium stearate: 5g

[0040] Coating prescription

[0041] Coating powder 25.5g

[0042] Appropriate amount of water

[0043] Preparation of tablet core: Mix rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride, microcrystalline cellulose, and croscarmellose sodium evenly, perform dry granulation, granulate, and then After adding magnesium stearate, mix well and press 1000 tablets.

[0044] Prescription 2:

[0045] Rifampicin: 90g

[0046] Isoniazid: 60g

[0047] Pyrazinamide: 300g

[0048] Ethambutol: 150g

[0049] Croscarmellose Sodium: 130g

[0050] Magnesium stearate: 10g

[0051] Coating prescription:

[0052] Coating powder 22.2g

[0053] Appropriate amount of water

[0054] Preparation of tablet core: Mix rifampicin, isoniazid, pyr...

example 2

[0058] Prescription 1

[0059] Rifampicin: 60g

[0060] Isoniazid: 50g

[0061] Pyrazinamide: 150g

[0062] Ethambutol: 100g

[0063] Lactose: 15g

[0064] Crospovidone: 50g

[0065] Magnesium stearate: 3.5g

[0066] Coating prescription:

[0067] Coating powder 12.9g

[0068] Appropriate amount of water

[0069] Preparation of the tablet core: Mix isoniazid, rifampicin, pyrazinamide, ethambutol hydrochloride, lactose, and crospovidone evenly, perform dry granulation, granulate, and add magnesium stearate After mixing, press 1000 tablets.

[0070] Prescription 2:

[0071] Rifampicin: 45g

[0072] Isoniazid: 30g

[0073] Pyrazinamide: 150g

[0074] Ethambutol: 75g

[0075] Lactose: 5g

[0076] Crospovidone: 40g

[0077] Magnesium stearate: 5.5g

[0078] Coating prescription:

[0079] Coating powder 10.6g

[0080] Appropriate amount of water

[0081] Preparation of tablet core: Mix rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride with lactose ...

example 3

[0086] Prescription 1

[0087] Rifampicin: 120g

[0088] Isoniazid: 100g

[0089] Pyrazinamide: 300g

[0090] Ethambutol: 200g

[0091] Hydroxypropyl cellulose: 90g

[0092] Magnesium stearate: 10g

[0093] Coating prescription:

[0094] Coating powder 24.6g

[0095] Appropriate amount of water

[0096] Preparation of tablet core: Mix isoniazid, rifampicin, pyrazinamide, ethambutol hydrochloride and hydroxypropyl cellulose evenly, perform dry granulation, granulate, and mix well after adding magnesium stearate Then press 1000 pieces.

[0097] Prescription 2:

[0098] Rifampicin: 90g

[0099] Isoniazid: 60g

[0100] Pyrazinamide: 300g

[0101] Ethambutol: 150g

[0102] Hydroxypropyl cellulose: 120g

[0103] Magnesium stearate: 7g

[0104] Coating prescription:

[0105] Coating powder 21.9g

[0106] Appropriate amount of water

[0107] Process 2: Mix rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride and hydroxypropyl cellulose evenly, perform dry gr...

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Abstract

The invention belongs to the technical field of medicines, and provides a compound preparation of antituberculosis medicaments, and a preparation method thereof. Rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride as four leading antituberculosis medicaments are prepared into the compound preparation according to specific mixture ratio. The method comprises the steps of evenly mixingthe leading drugs with an appropriate quantity of disintegrant and diluent, performing dry-process granulation, finishing granules, adding other auxiliary materials to the granules and preparing the obtained product into a suitable preparation. The invention solves the problems that patients are difficult to cooperate closely and complete normal chemotherapys because the antituberculosis medicaments are high in dosage, large in dosage form and troublesome in medicine-taking method, and the compound preparation and the preparation method accord with global tuberculosis direct-observation short-range supervision chemotherapy strategy (DOTS) recommended by the WHO. The antituberculosis fixed-dose compound preparation has important significance for simplifying medicine-taking method, carryingout the DOTS and controlling tuberculosis prevalence.

Description

technical field [0001] The invention relates to the technical field of medicine, and relates to a compound preparation of an anti-tuberculosis drug 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. . Since the 1990s, the global incidence of tuberculosis has risen rapidly. The International Union Against Tuberculosis and Lung Diseases (IUATLD) and the World Health Organization (WHO) listed six drugs, rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride, streptomycin, and thiosemicarbazide. Listed as the main first-line anti-tuberculosis drugs. Streptomycin is generally used for injection. In my country, thiosemicarbazide has long been eliminated due to it...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4965A61K9/20A61K9/48A61K47/38A61K47/12A61P31/06A61K31/496A61K31/4409A61K31/133
Inventor 庞大海李妍妍王卓韩文忠姜维钢
Owner SHENYANG HONGQI PHARMA
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