A kind of preparation method containing rifampicin compound preparation

Abstract

The invention belongs to the field of medicinal preparations, and particularly relates to a preparing method for a compound preparation containing rifampicin.The preparing method includes the steps that rifampicin, other active components and a hot melting film-forming material are prepared into solid coated particles, the solid coated particles are further prepared in various dosage forms, and for example, the solid coated particles are loaded into capsules to prepare a capsule preparation or tabletted and coated to prepare film-coated tablets.According to the purpose, all the active components in the prescription are isolated, it is avoided that medicine makes close contact in a preparation environment to be degraded, and stability of the compound rifampicin preparation is ensured.The preparing method is simple and stable in process and high in reproducibility, polymers generated by rifampicin and other active components like isoniazide are greatly reduced, and the product curative effect is ensured; it is indicated by analyzing test results of preparation stability that the preparation is stable in quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a preparation method of a compound preparation containing rifampicin. Background technique [0002] Rifampicin, whose chemical name is 3-[[(4-methyl-1-piperazinyl)imino]methyl]-rifamycin, is clinically used in the treatment of tuberculosis, especially containing rifampicin , The compound preparation of isoniazid is the drug of choice recommended by WHO for the treatment of tuberculosis. [0003] In order to prevent the occurrence of drug-resistant tuberculosis, the World Health Organization (WHO) recommended 12 standardized prescription combinations of fixed-dose compound preparations (FDC) to the world in the No. 1 announcement in 2001. While recommending the standard prescription of FDC preparations, WHO emphasizes that when manufacturing FDC preparations, the product quality of FDC preparations and the bioavailability of rifampicin in FDC preparations must not be lo...

AI Technical Summary

Problems solved by technology

However, the implementation of the above-mentioned proposition needs to granulate and coat different components separately, which seriously increases the workload of workers in actual industrial production, prolongs the process time, and increases the production burden on production equipment and sites. Fampicin or isoniazid is enteric-coated, so that it is released in the upper part of the small intestine, and other active ingredient particles are released in the stomach. This method can also prevent rifampicin from contacting with other active ingredients, which can theoretically reduce the risk of rifampicin. However, the operation of this solution is cumbersome. Different components are granulated separately and then mixed with or without coating. Due to the loss of materials during the process, the weight gain of the particles after coating, and the combination Problems such as powder mixing uniformity will inevitably affect the ratio of the ingredients of the prescription, and even lead to changes in the ratio of the active ingredients of the compound, affecting the efficacy of the drug; and the fluidity of the coated or uncoated particles during filling Different, so it is difficult to ensure that the ingredients are mixed evenly, and it is difficult to ensure the uniformity of the content of the preparation

In addition, due to the hydrolysis characteristics of the active ingredient itself, the implementation of granule coating is greatly limited. In addition, the thickness of the granule coating layer also needs to be strictly controlled. If it is too thick, the granules will increase more, which will affect the subsequent mixing of various components. If the layer is too thin, the mechanical strength is not enough, and the particle breaks or the coating is damaged due to the impact force during the mixing movement. The occurrence of the above two situations will seriously affect the stability of the preparation.

However, in the actual production process, the thickness control of the granule coating layer is difficult to monitor and control

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