目的 制备马甲子总三萜固体分散体（TTPR-SD）并考察其溶出性能。方法 以马甲子素和白桦脂酸的溶出率为指标，采用单因素实验考察不同载体材料和不同制备方法对TTPR-SD中药物溶出的影响，采用正交试验筛选最佳制备工艺；采用傅里叶红外光谱（FT-IR）和X射线衍射（X-ray）分析药物的存在状态。结果 采用溶剂法制备固体分散体，以PVPK30为载体，药物/载体比例为1∶5，超声10 min，磁力搅拌温度80℃时，马甲子素和白桦脂酸在60 min的累积溶出率分别达到89.19%和80.49%；马甲子总三萜以无定型状态存在于PVPK30中，与载体以氢键的形式结合。结论 马甲子总三萜制成固体分散体能显著提高其溶出性能。

Objective To prepare total triterpene of Paliurus ramosissimus solid dispersions (TTPR-SD) and study their dissolution properties in vitro. Methods The dissolution of paliurusene and betulinic acid were used as indicators to examine the effect of different carrier materials and different preparation methods on drug dissolution in total triterpenoid solid dispersions by single factor. The preparation technology parameters of total triterpenes of P. ramosissimus solid dispersion were optimized by orthogonal design. Existential state of drugs in this solid dispersion was analyzed by FT-IR and X-ray. Results The solid dispersion was prepared by solvent method with PVPK30 as carrier, the ratio of drug to carrier was 1:5, ultrasonic for 10 min, and the magnetic stirring temperature was 80℃. The cumulative dissolution of paliurusene and betulinic acid within 60 min was achieved 89.19% and 80.49%, respectively. The drug dispersed in the PVPK30 in an amorphous state, and combined with the carrier in the form of hydrogen bonds. Conclusion The prepared solid dispersion can significantly improve the dissolution properties of total triterpene of P. ramosissimus.

国家重大新药创制项目（2018ZX09731013）；四川省重大科技专项（2017SZDZX005）；四川省公益性科研院所基本科研业务专项（A-2017N-31）