舒必利分散片的制备及质量控制

目的:制备舒必利分散片并建立其质量控制方法。方法:正交试验考察处方中组分的影响因素,以崩解时限为指标对舒必利分散片处方进行优选;采用紫外分光光度法测定分散片中舒必利的含量和溶出度,测定波长为291nm。结果:最佳处方为崩解剂交联聚乙烯吡咯烷酮(PVPP)-XL用量10%(内加),PVPP-XL10用量2%(外加),填充剂微晶纤维素用量20%,黏合剂PVP浓度5%。优选处方的分散片崩解时间小于1min,分散均匀,通过2目筛;舒必利检测浓度线性范围为20~120mg.L-1(r=0.9999),平均回收率99.96%(RSD=0.66%,n=6);样品在15min时累积溶出百分率大于95%。结论:该分散片符合《中国药典》2005年版的相关规定。

Preparation and Quality Control of Sulpiride Dispersible Tablets

OBJECTIVE: To prepare sulpiride dispersible tablet and to establish a method for its quality control. METHODS: The influencing factors in the formula of sulpiride dispersible tablets were investigated by orthogonal design and the formula were optimized with disintegration time as parameters. The content and the dissolubility of the sulpiride dispersible tablets were determined by UV spectrophotometry at a wavelength of 291nm. RESULTS: The optimized formula of the tablets were as follows: the formula ratios of disintegrating agent PVPP-XL(added internally), PVPP-XL10(apposition), loading agent microcry stalline cellulose and PVP were 10%, 2%,20% and 5%, respectively. The optimized dispersible tablet could disintegrate uniformly in less than 1 minute and mesh through No. 2 screen. The linear range of sulpiride was 20～120mg·L-1 (r=0.999 9), the average recovery was 99.96% with RSD at 0.66%(n=6). The cumulative dissolution percentages of the sample at minute 15 were above 95%. CONCLUSION: The dispersible tablets prepared are in conformity with the standards specified in Chinese Pharmacopoeia(2005).