毛蕊异黄酮葡萄糖苷自微乳给药系统的制备及质量控制

Study on Self-Microemulsifying Drug Delivery System of Calycosin-7-glucoside and Quality Evaluation

目的:制备毛蕊异黄酮苷自微乳给药系统并建立其质量评价方法。方法:以乳化剂OP-10、聚氧乙烯醚(40)和二乙二醇单乙基醚制备毛蕊异黄酮苷自微乳给药系统,考察其外观、粒径分布、Zeta电位及稳定性;采用高效液相色谱法建立毛蕊异黄酮苷自微乳的质量评价方法。结果:所得自微乳稳定性良好,平均粒径为32.21 nm,电动电势为-19.43 m V(n=3)。毛蕊异黄酮苷的进样量在0.207~3.105μg范围内具有良好的线性关系,平均回收率为99.90%(n=9),RSD=0.79%。结论:该制剂制备工艺简便,质量稳定可控,符合良好的自微乳制剂的要求。

OBJECTIVE： To establish the self-Microemulsifying drug delivery system of calycosin-7-glucoside and quality evaluation method. METHODS： The Calycosin-7-glucoside-SMEDDS was prepared with OP-10 emulsifier,Cremophor RH40 and Transcutol P,and the appearance,size distribution,Zeta potential and stability were examined.The contents of Calycosin-7-glucosidecwas determined by HPLC. RESULTS： The Calycosin-7-glucoside-SMEDDSwas stable,the average particle size and Zeta potential were 32. 21 nm and-19. 43 m V（ n = 3）,respectively. The linear ranges of Stanozolol was 0. 207 μg-3. 105 μg. The average recovery of Trenbolone Acetate was 99. 90%（ n = 9）,RSD = 0. 79%. CONCLUSIONS： The preparation technique of the microemulsion is simple and feasible,and the quality is stable and controllable,which meets the needs of good SMEDDS formulation.