托西酸舒他西林分散片的处方工艺优化

目的筛选托西酸舒他西林分散片处方工艺。方法以崩解剂交联聚乙烯吡咯烷酮（PVPP）、填充剂微晶纤维素（MCC）和润湿剂十二烷基硫酸钠（SDS）的用量为考察因素，分散片的崩解时间和润湿时间为评价指标进行正交试验，确定最佳处方。结果筛选的托西酸舒他西林分散片最佳处方为PVPP、MCC、SDS用量分别为5％、30％、2％，所制制剂约在42S内崩解完全，药物在15min内基本溶出。结论经筛选的处方工艺合理可行，制备的托西酸舒他西林分散片质量可靠。

Optimization of formula and preparation procedure of sultamicillin tosilate dispersible tablets

Objective To optimize the formula and preparation process of sultamicillin tosilate dispersible tablets and to investigate their related indexes. Methods Contents of cros-povidone （PVPP）, MCC and SDS were used as factors, and disintegrating time （td） and wetting time （t） were used as the evaluation indexes to carry out the orthogonal experiment to optimize the formula. Results The optimized formula for the sultamicillin tosilate dispersible tablets were as follows： contents of PVPP, MCC, and SDS were 5 %, 30 %, and 2%, respectively. The prepared dispersible tablets disintegrated completely within 42 s, and the drug dissolute within 15 min. Conclusion The formula for sultamicillin tosilate dispersible tablets is reasonable, and the technology is feasible with good quality.