Study on formulation process of Shaodanyigan Granule

Objective: To ascertain the best formulation process of Shaodanyigan Granule. Methods: By determinating hygroscopicity,granulation and dissolubility, the appropriate excipient and its formula were selected. Result: The best excipient and its formula were one extract and two excipients which consisted of lactose and mannitol (4∶1, w/w). The made granules have low hygroscopicity and high granulation and high dissolubility. And its critical relative humidity is 72% or so. Conclusion: The experimental results provide the basis of the ascertainment of formulation process and the control of production enviroment of Shaodanyigan Granule