Process for preparing compound antituberculous preparation

Abstract

The invention provides a process for preparing a compound antituberculous preparation. Active ingredients are rifampicin and isoniazide and one of mixtures of isoniazide + pyrazinamide and isoniazide + pyrazinamide + gatifloxacin. The process includes that the rifampicin and a part of pharmaceutic adjuvant are sieved and mixed to be subjected to dry granulating, or rifampicin and any other active ingredients except for isoniazide are mixed with corresponding amount of pharmaceutic adjuvant to be subjected to the dry granulating, then the isoniazide, residual active ingredients and corresponding quantity of pharmaceutic adjuvant are sieved and mixed to be subjected to dry granulating or wet granulating, and finally the residual pharmaceutic adjuvant and two types of granules are mixed for a secondary tabletting to obtain the preparation. The process for preparing the compound antituberculous preparation has the advantages that by means of granulation step by step, the contact between the rifampicin and isoniazide is reduced, the amount of impurity hydrazone generated through reaction between the isoniazide and the rifampicin can be effectively reduced, the bioavailability of the isoniazide and the rifampicin is greatly improved, and the medication effectiveness and safety for mass patients with tuberculosis are guaranteed.

Description

technical field [0001] The present invention relates to the field of medical technology, in particular to a compound antibiotic containing one of rifampin and isoniazid, a mixture of isoniazid+pyrazinamide, and a mixture of isoniazid+pyrazinamide+gatifloxacin. Preparation process of tuberculosis preparations. Background technique [0002] Tuberculosis is an ancient infectious disease, and its harm to human beings in history is shocking. Before liberation, the folks called tuberculosis tuberculosis, and there was a saying that "ten tuberculosis and nine deaths". Since the 1990s, tuberculosis has "resurrected" around the world. Many countries, including countries with better tuberculosis epidemic control, have experienced slow decline or severe rebound of the epidemic to varying degrees. The incidence rate has increased by 1.1% per year. Tuberculosis has once again It has become a major infectious disease that threatens human health, a serious public health problem and a maj...

AI Technical Summary

Problems solved by technology

The study found that the active ingredients rifampicin and isoniazid in the compound preparation have serious incompatibility, and the two are prone to polymerization reaction to form impurity hydrazone. This reaction will undoubtedly have a negative impact on the quality of the preparation and the bioavailability of the drug. The traditional The preparation process often ignores this point, which increases the impurities of the preparation, and the bioavailability of the active ingredient is correspondingly reduced.

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