Pyrazinamide tablet and preparation method thereof

Abstract

The invention belongs to the field of pharmaceutic preparations and specifically relates to a pyrazinamide tablet and a preparation method thereof. The ingredient of the pyrazinamide tablet provided by the invention comprises corn starch, pre-gelled starch and magnesium stearate. The preparation method comprises the following steps: adopting a fluidized bed one-step pelletizing process for preparing grains, and then additionally adding lubricant magnesium stearate, thereby obtaining the pyrazinamide tablet. According to the method provided by the invention, the grains with uniform size, excellent liquidity and compression molding property can be prepared on the basis of the reducing of ingredient dosage, and the pyrazinamide tablet with low weight and stable product quality is finally prepared. The pyrazinamide tablet prepared according to the method provided by the invention is beneficial to the intake of patients and is capable of obviously enhancing the adaptability of the patientsso as to reduce the drug resistance. The fluidized bed pelletizing process is capable of saving production time and meets the requirements of GMP specification. The quality of the prepared pyrazinamide tablet is controllable and the stability of the products is guaranteed.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pyrazinamide tablet and a preparation method thereof. Background technique [0002] Tuberculosis, commonly known as "consumption", is a chronic infectious disease that poses a serious threat to human health. According to the World Health Organization, about one-third of the world's population is infected with tuberculosis disease. Developing countries in Asia and Africa account for the majority of infections. To control the emergence of drug-resistant TB, the World Health Organization recommends the use of fixed-dose combinations in tablet form. Pyrazinamide (PZA), as an effective anti-tuberculosis drug, is used clinically and is an important first-line anti-tuberculosis drug. It has a special killing effect on Mycobacterium tuberculosis in cells or in a static state, and pyrazinamide has the strongest antibacterial effect between pH 5.0 and 5.5. The m...

AI Technical Summary

Problems solved by technology

The disadvantages of the pulping or boiling method are: the temperature required for gelatinization is relatively high, and it is difficult to operate in large-scale production, and it is easy to disperse unevenly, resulting in unstable product quality; It is not easy to make judgments in the actual production process, especially for researchers with insufficient research and development experience. In addition, the granulation effect of wet granulation is acceptable when the prescription ratio is appropriate, but this study shows that The granulation effect of the prescription with significantly reduced amount of excipients (excipients) is unsatisfactory, probably because pyrazinamide has poor fluidity, and formulations with less excipients are not easy to mix evenly after wet granulation, resulting in product quality difference

[0005] Therefore, a preparation method suitable for pyrazinamide tablets with a small amount of excipients is developed to solve the problems of difficulty in swallowing and easy splitting caused by excessive pyrazinamide tablets, so that the obtained pyrazinamide tablets are small in size and stable in quality

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