毛蕊异黄酮葡萄糖苷自微乳给药系统的制备及质量控制

摘要

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 mV(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.%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 mV(n=3).毛蕊异黄酮苷的进样量在0.207~3.105 μg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.