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目的:制备茯苓皮总三萜分散片,建立其含量测定方法,并考察其体外溶出行为。方法:采用单因素考察和正交试验法,确定茯苓皮总三萜分散片的制备工艺;采用HPLC法对制剂中松苓新酸、去氢依布里酸进行含量测定;比较分散片与普通片的体外溶出行为。结果:确定了茯苓皮总三萜分散片的处方和制备工艺,HPLC方法学考察显示该研究建立的含量测定方法可用于松苓新酸、去氢依布里酸的含量测定;茯苓皮总三萜分散片的溶出度优于普通片。结论:茯苓皮总三萜分散片的制备工艺稳定、可控,所建立的质量控制方法可行。
OBJECTIVE: To prepare the total triterpenoid dispersible tablets of Poria cocos and to establish a method for the determination of its content. The dissolution behavior in vitro was also investigated. Methods: The single-factor study and orthogonal test were used to determine the preparation process of Triterpen-total triterpene dispersible tablets. HPLC was used to determine the content of tranexamic acid and dehydroepic acid in the preparation. In vitro dissolution behavior. Results: The prescription and preparation technology of Triterpen Ephedra Dispersible Tablets were determined. HPLC methodological study showed that the method of determination of the content of Triterpenoids can be used for the determination of the content of Song Ling neotinic acid, The dissolution of terpene dispersible tablets is superior to ordinary tablets. Conclusion: The preparation process of the total triterpene dispersible tablets of Poria cocos was stable and controllable, and the quality control method was established.