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目的 :制备替硝唑分散片并控制其质量。方法 :以低取代羟丙基纤维素、可溶性淀粉、硬脂酸镁、聚乙烯吡咯烷酮K3 0 为辅料研制该分散片。紫外分光光度法测定该分散片中替硝唑的含量 ,测定波长为 317nm。结果 :分散均匀性试验表明该分散片在 1min内均匀分散并通过 2号筛。替硝唑浓度在 6～ 2 4mg·L-1范围内与吸收度呈良好线性关系 ,r =0 .9999。平均回收率为 99.5 9% ,RSD为 0 .5 1% (n =5 )。结论 :该分散片符合中国药典 2 0 0 0年版的规定 ,质量控制方法可靠。
Objective: To prepare tinidazole dispersible tablets and control its quality. METHODS: The dispersible tablets were prepared with low-substituted hydroxypropylcellulose, soluble starch, magnesium stearate and polyvinylpyrrolidone K30 as excipients. The content of tinidazole in the dispersible tablets was measured by UV spectrophotometry. The determination wavelength was 317nm. Results: Dispersion uniformity test showed that the dispersible tablets dispersed uniformly in 1min and passed through No. 2 sieve. Tinidazole concentration in the range of 6 ~ 24mg · L-1 and absorbance showed a good linear relationship, r = 0.9999. The average recovery was 99.5 9% with a RSD of 0.51% (n = 5). Conclusion: The dispersible tablet conforms to the Chinese Pharmacopoeia 2000 edition, and the quality control method is reliable.