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目的研究茵陈四逆散分散片的处方工艺。方法以茵陈四逆散提取物为模型药物,以分散均匀性为指标,采用正交设计法筛选茵陈四逆散分散片最佳的处方和制备工艺,并以绿原酸为指标测定的绿原酸的累积溶出率。结果优化的茵陈四逆散分散片处方工艺为:浸膏∶淀粉=1∶1,80%微晶纤维(MCC),20%淀粉,8%交联聚维酮(PVPP),0.2%硬脂酸镁和0.2%微粉硅胶,粉末直接压片,硬度控制在50N左右,分散均匀性测定结果为137s;绿原酸5min累积溶出率可达71.1%,30min完全溶出。结论茵陈四逆散分散片崩解快,分散均匀,有效成分溶出速率快。
Objective To study the prescription process of Yinchen Sini scattered tablets. Methods Taking Yinchen Sini Powder as model drug, the best prescription and preparation technology of Yinchen Sini Powder was selected by orthogonal design method with the uniformity of dispersion as an indicator, and chlorogenic acid was used as the index Cumulative dissolution rate of chlorogenic acid. Results The prescription of Yinchen Sini Powder dispersible tablets was: extract: starch = 1: 1, 80% MCC, 20% starch, PVPP, 0.2% Magnesium stearate and 0.2% fine silica powder. The powder was directly compressed and the hardness was controlled at about 50N. The dispersion uniformity was 137s. The cumulative dissolution rate of chlorogenic acid reached 71.1% within 5min and was completely dissolved after 30min. Conclusion Yinchen Sini Powder disperse tablet disintegration fast, uniform dispersion, dissolution rate of active ingredient fast.