伐昔洛韦分散片的处方筛选研究

目的:筛选和优化伐昔洛韦分散片的处方。方法:以崩解时限为考察指标,以交联聚乙烯吡咯烷酮(PVPP)浓度及加入方法、粘合剂聚维酮(PVP-K30)浓度、羧甲基淀粉钠(CMS-Na)的用量为因素,采用L9(34)正交试验表设计试验方案,对伐昔洛韦分散片处方进行筛选,并与普通片进行体外溶出度比较。结果:最佳处方为PVPP(内加)4.0%、PVP-K301.0%、CMS-Na5.0%;按优化处方制备的伐昔洛韦分散片在3min内完全崩解,溶出度明显优于普通片。结论:优化处方达到《中国药典》规定要求。

On Formula Optimization for Valaciclovir Dispersible Tablets

OBJECTIVE:To optimize the formula of valaciclovir dispersible tablets.METHODS:A L 9(3 4)orthogonal design was performed to optimize the formula of valaciclovir dispersible tablets with disintegrating time as parameter of investigation,and with the concentration of crospovidone(PVPP)and the method of its adding,the concentration of binder polyvidone(PVP-K 30)and the dosage of sodium carboxymethyl starch(CMS-Na)as factors,the dissolution of dispersible tablets was compared with common tablets.RESULTS:The optimized formula were the following,PVPP(added internally)4.0%,PVP-K 30 1.0% and CMS-Na 5.0%.The optimized valaciclovir dispersed tablets disintegrated completely within 3 min,its dissolu-bility was turned out to be superior to that of the common tablets.CONCLUSION:The dissolution of the optimized dispersed tablets is up to the standard of Chinese Pharmacopoeia.