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目的制备乙胺吡嗪利福异烟片,并对乙胺吡嗪利福异烟片进行质量和稳定性研究。方法用干法制粒压片制得乙胺吡嗪利福异烟片;采用HPLC法对主药成分利福平、异烟肼、吡嗪酰胺、盐酸乙胺丁醇的含量和稳定性进行考察;采用比色法对利福平的溶出度进行考察。结果乙胺吡嗪利福异烟片不同批次间4种主药的含量符合《中华人民共和国药典》规定,稳定性试验表明,样品质量均未见明显改变,暂定本品有效期为2年。溶出度试验表明,利福平45min的溶出度大于标示质量的70%(w),且同一批次和不同批次间的溶出度均一性良好。结论制备的乙胺吡嗪利福异烟片的含量均匀,产品稳定性好且溶出度符合要求。
OBJECTIVE To prepare ethylamine pyrazole rifampicin tablets, and to study the quality and stability of ethylamine pyrazine purpure tablets. Methods The tablets of ethyopyrazole and rifampicin were prepared by dry granulation, and the content and stability of rifampicin, isoniazid, pyrazinamide and ethambutol were studied by HPLC The dissolution of rifampicin was examined by colorimetry. Results The contents of 4 main drugs of different batches of ethylamine pyrazofuran diferent tobacco tablets conformed to the regulations of Pharmacopoeia of the People’s Republic of China. The stability tests showed that no significant changes were found in the quality of the samples, and the validity of this product was tentatively estimated to be 2 years . Dissolution tests showed that dissolution of rifampicin for 45 min was greater than 70% of the indicated mass (w) and homogeneity of dissolution between the same batch and different batches was good. Conclusion The contents of ethylamine pyrazole and rifampicin tablets were uniform, and the stability of the product was good and the dissolution rate met the requirements.