正交试验设计法优化泛昔洛韦分散片处方的研究

Study on Optimization of Famciclovir Dispersible Tablets Prescription by Orthogonal Experimental Design

通过正交试验对泛昔洛韦分散片处方进行优化,为该处方的设计提供依据。以崩解时限作为研究的考察指标,采用正交试验考察交联聚维酮(PVPP)浓度、聚乙烯吡咯烷酮(PVP-K_(30)浓度以及羧甲淀粉钠(CMS-Na)的用量对不同处方泛昔洛韦分散片崩解时限的影响。并根据结果将自制的泛昔洛韦分散片与市售药物进行体外溶出实验对比,观察与市售药物溶出的不同。通过正交试验优化后得到的最佳处方是:当内加PVPP浓度为5%,PVP-K_(30)浓度为1.0%,CMS-Na的用量为5.0%时泛昔洛韦分散片的崩解时限低于3min,而溶出也比市售泛昔洛韦分散片的溶出效果好。本次研究对泛昔洛韦分散片的处方进行优化,效果较好,达到《中国药典》规定的要求。

To improve the famciclovir dispersible tablet prescription through the orthogonal test, provide the basis for design of the prescription. To research the disintegration time as examining index, through the orthogonal test, examining the influence on disintegration time in famcielovir dispersible tablets prescription, by PVPP concentration and the concentration of PVP K30 - as well as the dosage of CMS - Na. And according to the results of dissolution in vitro experiments, observe the difference betweeen homemade famcielovir dispersible tablets and commercially available drug in vit/＇o experiments. The best prescription was optimized through orthogonal test： when the PVPP concentration was 5 %, the concentration of PVP K30 - 1.0~ , the amount of CMS - Na was 5.0% of generic fameiclovir dispersible tablet disintegration time is lower than 3min, and the dissolution effect is better than generic ever sold dispersible tablet. To study and optimize the famcielovir dispersible tablet prescription, the effect is good, reach the requirements of the ＂Chinese pharmacopoeia＂.