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目的:研究交泰丸活性组分自微乳化系统的组方和质量控制方法。方法:考察盐酸小檗碱在不同辅料中的溶解度及乳化剂和助乳化剂对肉桂油的乳化能力,确定最佳处方;以盐酸小檗碱和桂皮醛为指标,用HPLC法测定两者在自微乳化系统中的含量。结果:交泰丸自微乳化最佳处方为OP-(1,2-丙二醇)-肉桂油-黄连生物碱,其比例为4∶8∶3∶6;形成微乳的平均粒径为15.8nm,自微乳化处方中盐酸小檗碱的含量≥20.0%,桂皮醛的含量≥10.0%。结论:交泰丸活性组分自微乳化系统形成的微乳粒径小,稳定性好;以盐酸小檗碱和桂皮醛为质量控制指标,方法准确可行。
Objective: To study the composition and quality control methods of the self-microemulsifying system of Jiaotai Pill. METHODS: The solubility of berberine hydrochloride in different excipients and the emulsifying ability of emulsifiers and co-emulsifiers on cinnamon oil were investigated. The best prescription was determined. The berberine hydrochloride and cinnamaldehyde were used as indexes to determine the two by HPLC. Content in the self-microemulsifying system. RESULTS: The best prescription for self-microemulsification of Jiaotai Pill was OP-(1,2-propanediol)-Cinnamon oil-Coptis alkaloids in a ratio of 4:8:3:6; the average particle size of the formed microemulsion was 15.8 nm. The content of berberine hydrochloride in the self-microemulsifying formulation is ≥20.0%, and the content of cinnamic aldehyde is ≥10.0%. Conclusion: The microemulsion formed by the self-microemulsifying system of Jiaotai Pill has small particle size and good stability. The berberine hydrochloride and cinnamon aldehyde are the quality control indexes, and the method is accurate and feasible.