毛蕊异黄酮葡萄糖苷自微乳给药系统的制备及质量控制
Evaluation and Analysis of Drug-Use in Hospitals of China（2017）
Abstract
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.
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Key words
Calycosin-7-glucoside,Self microemulsifying drug delivery system,Quality evaluation
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