Compound preparation containing rifampicin and isoniazid and its preparing method

A compound preparation and isoniazid technology are applied in directions such as medical preparations containing active ingredients, pharmaceutical formulations, organic active ingredients, etc., and can solve problems such as reduction of active ingredient content, impact on product quality, and no reports on production methods.

Inactive Publication Date: 2006-10-18
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This preparation method will cause the active ingredients rifampicin and isoniazid to produce polymers (impurities) during the preparation process, which will reduce the content of the active ingredients and increase the impurities, which will affect the quality of the product.
[0004] According to the SDA online search, several similar products have been approved by the SDA for production and marketing, but there are no such products on the market. At present, the common anti-tuberculosis compound preparations in the domestic market are the imported products Weifeite and Weifeining, Weifeite It is a compound preparation of sugar-coated tablets made by mixing three active ingredients of rifampicin, isoniazid and pyrazinamide. Weifeining is a compound preparation of sugar-coated tablets made by mixing two active ingredients of rifampicin and isoniazid. There are above-mentioned defectives equally, do not see the report of production method simultaneously

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] (per 1000 pieces)

[0034] Inner Tablet Prescription:

[0035] Rifampicin 120g

[0036] Starch 10g

[0037] Hypromellose 8g

[0038] Cross-linked polyvinylpyrrolidone 4g

[0039] Povidone K 30 1.25g

[0040] Magnesium Stearate 1g

[0041] Outer prescription:

[0042] Isoniazid 80g

[0043] Hypromellose 150g

[0044] Starch 100g

[0045] Cross-linked polyvinylpyrrolidone 3g

[0046] Povidone K 30 1.5g

[0047] Magnesium Stearate 2g

[0048] Inner tablet film coating prescription:

[0049] Hydroxypropyl Methyl Cellulose 1.5g

[0050] Polyethylene glycol 6000 1.5g

[0051] 95% ethanol 72ml

[0052] Distilled water 8ml

[0053] Preparation Process

[0054] (1) Preparation of inner layer sheet:

[0055] Granulation: Pass the rifampicin main drug and auxiliary materials through 80 mesh sieve respectively, add the raw materials and auxiliary materials into a three-phase mixer, stir for several minutes to make them completely mixed eve...

Embodiment 2

[0062] (per 1000 pieces)

[0063] Inner Tablet Prescription:

[0064] Rifampicin 120g

[0065] Starch 10g

[0066] Hypromellose 8g

[0067] Cross-linked polyvinylpyrrolidone 4g

[0068] Povidone K 30 1.25g

[0069] Magnesium Stearate 1g

[0070] Outer prescription:

[0071] Isoniazid 80g

[0072] Pyrazinamide 250g

[0073] Starch 20g

[0074] Cross-linked polyvinylpyrrolidone 3g

[0075] Povidone K 30 1.5g

[0076] Magnesium Stearate 2g

[0077] (3) Prescription of inner film film coating:

[0078] Hydroxypropyl methylcellulose 2910 1.5g

[0079] Polyethylene glycol 6000 1.5g

[0080] 95% ethanol 72ml

[0081] Distilled water 8ml

[0082] The preparation process is the same as in Example 1.

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PUM

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Abstract

The invention discloses a compound preparation containing rifampicin isoniazid and a preparation method thereof. The compound preparation containing rifampicin and isoniazid of the present invention is a double-layered chip containing rifampicin in a chip and an outer layer containing isoniazid and pyrazinamide. The preparation of the invention not only greatly reduces the polymer (3-methylrifamycin SV isoniazone) produced by rifampicin and isoniazid, but also statistical analysis and bioequivalence verification show that isoniazid, The above pharmacokinetic parameters of rifampicin and pyrazinamide were not significantly different between the two tablets (p>0.05), and the two tablets were bioequivalent.

Description

technical field [0001] The invention relates to a medicine for treating pulmonary tuberculosis, in particular to a preparation containing rifampicin and isoniazid and a preparation method thereof. Background technique [0002] Rifampicin, its chemical name is 3-[[(4-methyl-1-piperazinyl)imino]methyl]-rifamycin, and its general structural formula is C 43 h 58 N 4 o 12 , Isoniazid, its chemical name is 4-pyridinyl hydrazide, and its general structural formula is: C 6 h 7 N 3 O. Containing rifampicin and isoniazid compound preparations, it is clinically used to treat tuberculosis and is recommended by WHO as the first drug to treat tuberculosis worldwide. Its advantages are patient compliance, less adverse reactions, reduced drug resistance, lower recurrence rate and easy clinical monitoring. [0003] Compound preparations containing rifampicin and isoniazid active ingredients currently on the market include tablets and capsules. Whether it is a tablet or a capsule pre...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K31/4409A61P31/06
Inventor 周明慧
Owner SHANGHAI SINE PHARMA LAB
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