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Pharmaceutical composition comprising rifamoin and isoniazid

A technology of isoniazid and composition, applied in the field of pharmaceutical compositions containing rifampicin and isoniazid, can solve the problems of complicated operation and high cost, and achieve the effects of simple process, convenient operation and increased stability

Inactive Publication Date: 2007-07-04
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The technical problem to be solved by the present invention is to provide a pharmaceutical composition containing rifampicin and isoniazid with good stability, and overcome the defects of complicated operation and high cost in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1 Rifampin and isoniazid compound film-coated tablet

[0032] 1000 tablet prescription:

[0033] Rifampicin 300g

[0034] Isoniazid 150g

[0035] Potassium dihydrogen phosphate 6g

[0036] Dipotassium hydrogen phosphate 12g

[0037] Microcrystalline Cellulose 40g

[0038] Povidone 10g

[0039] Croscarmellose Sodium 7.5g

[0040] Magnesium Stearate 6g

[0041] Preparation method: pass rifampin, isoniazid, microcrystalline cellulose, povidone, croscarmellose sodium, potassium dihydrogen phosphate, and dipotassium hydrogen phosphate through 80-mesh sieve respectively, and weigh according to the prescription amount Take the above powder and 4g of magnesium stearate and mix them evenly, use a dry granulation machine to take dry granules, take the dry granules and mix them with 2g of magnesium stearate evenly, and press them into tablets, controlling the tablet weight to be 520mg to 540mg. Plain tablets are film-coated with Opadry coating material.

Embodiment 2

[0042] Example 2 Rifampicin, isoniazid and pyrazinamide compound film-coated tablet

[0043] 1000 tablet prescription:

[0044] Rifampicin 120g

[0045] Isoniazid 80g

[0046] Pyrazinamide 250g

[0047] Citric acid 2g

[0048] Disodium hydrogen phosphate 9g

[0049] Microcrystalline Cellulose 45g

[0050] Povidone 10g

[0051] Croscarmellose Sodium 8g

[0052] Magnesium Stearate 5g

[0053]Preparation method: pass the raw materials and auxiliary materials through 80-mesh sieve respectively, weigh 3g of magnesium stearate, weigh other raw materials and auxiliary materials according to the prescription amount, mix them evenly, and take dry granules with a dry granulation machine, take the dry granules and 2g hard Magnesium fatty acid is mixed evenly and compressed into tablets, and the weight of the tablets is controlled at 520mg to 540mg. Plain tablets are film-coated with Opadry coating material.

Embodiment 3

[0054] Example 3 Compound Capsules of Rifampicin, Isoniazid and Pyrazinamide

[0055] 1000 Capsules Prescription:

[0056] Rifampicin 60g

[0057] Isoniazid 40g

[0058] Pyrazinamide 125g

[0059] Povidone 5g

[0060] Acetic acid 0.1g

[0061] Ammonium acetate 5g

[0062] 15g pregelatinized starch

[0063] Magnesium Stearate 5g

[0064] Preparation method: Weigh the prescribed amount of povidone, acetic acid, and sodium acetate and dissolve them in 50ml of water to make an adhesive. Pass the solid raw materials and auxiliary materials through an 80-mesh sieve, weigh the raw materials and auxiliary materials except magnesium stearate according to the prescription, mix them evenly, and wet granulate with the prepared binder. After drying, take the dry granules and 5g hard Magnesium fatty acid is mixed evenly, and filled with No. 2 capsules.

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PUM

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Abstract

The invention involves a drug combinations including rifampin and isoniazid, the combination contains pH modifier of 0.1% ~ 10% (w / w). Said pH regulator is selected from weak acid- weak acid salt buffer system, weak alkali- weak alkali salt buffer system or weak acid salt- weak alkali salt buffer system. The drug combination in the invention can effectively reduce the product of polymer-3-formyl rifamycin SV isoniazone caused by rifampin and isoniazid degradation, and increased drug stability. The method of the invention has advantages as: operation is convenient, process is simple, equipment needs not improvment and the cost is low.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition containing rifampicin and isoniazid, in particular to a pharmaceutical composition containing rifampicin and isoniazid with a pH regulator. Background technique: [0002] The compound preparation containing rifampicin and isoniazid is recommended by WHO (World Health Organization) as the drug of choice for the treatment of tuberculosis worldwide, and its efficacy and safety have been confirmed by years of clinical research. Compared with the separate use of single preparations, it has the advantages of convenient administration, less adverse reactions, low drug resistance, and high patient compliance. [0003] However, the compound preparation containing rifampicin and isoniazid has poor stability. During production and storage, rifampicin and isoniazid are easily degraded, thereby affecting the quality of the product. The reasons are as follows: [0004] 1. Rifampicin aqueous solution is very un...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K9/14A61K9/20A61K9/48A61P31/06A61K31/4409
Inventor 王曦李永胜
Owner CHONGQING HUAPONT PHARMA
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