盐酸司他斯汀分散片的处方工艺研究

目的采用L9(34)正交设计研究盐酸司他斯汀分散片的处方工艺,优选最佳处方工艺。方法采用湿法制粒压片优选工艺条件,以微晶纤维素、聚乙烯吡咯烷酮和羧甲基淀粉钠用量为考察因素,以分散片的分散时间和10 min溶出度为考察指标,优选最佳处方组成。结果优选出的最佳处方为微晶纤维素用量40%、聚乙烯吡咯烷酮2%、羧甲基淀粉钠10%,所制备的片剂与普通片比较,溶出速度更快。结论通过研究筛选出了合适的盐酸司他斯汀分散片处方工艺。

Pharmaceutical formula research of setastine hydrochloride dispersible tablets

Objective To optiimize the formula of setastine hydrochloride dispersible tablets by L9 （34） orthogonal design. Methods The tablets were prepared by wet granulation method. The percent of microcellous, polyvinylpyrrolidone and sodium starch glycolate in tablet were selected as factors, The quality evaluation parameters were dispersible time and the dissolution in 10 minute. The optimum formula was selected. Results The optimum formula was 40% microcellous,2% polyvinylpyrrolidone and 10% sodium starch glycolate in tablet. The dissolution curve showed that the dissolution speed of dispersible tablet was more quickly than common tablet. Conclusion The selected formula of setastine hydrochloride dispersible tablets is qualified.