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目的:研究银杏酮酯自微乳化软胶囊的质量控制方法。方法:采用TLC方法对银杏内酯A、银杏内酯B进行薄层鉴别研究;采用HPLC方法测定方中槲皮素、山奈素与异鼠李素的含量,计算总黄酮醇苷的含量。结果:银杏内酯A与银杏内酯B薄层鉴别具有较好的专属性;槲皮素回归方程为A=110973C-160122,r=0.9995,线性范围为0.163~1.141μg,平均回收率为99.25%,RSD为0.44%;山奈素回归方程为A=97764C-182398,r=0.9995,线性范围为0.2196~1.5372μg,平均回收率为99.20%,RSD为0.43%;异鼠李素回归方程为A=92938C-36124,r=0.9998,线性范围为0.0552~0.3864μg,平均回收率为99.31%,RSD为0.25%。结论:所建标准可用于该制剂的质量控制。
Objective: To study the quality control method of ginkgo ketoester self-microemulsifying soft capsules. Methods: TLC method was used to identify bilobalide A and ginkgolide B in the thin layer. HPLC method was used to determine the contents of quercetin, kaempferol and isorhamnetin in the formula and the total flavonol glycoside content was calculated. RESULTS: The ginkgo lactone A and ginkgolide B thin layer had good specificity; the quercetin regression equation was A = 11010C-160122, r = 0.9995, the linear range was 0.163 ~ 1.141μg, and the average recovery was 99.25. %, RSD was 0.44%; Kaints regression equation was A=97764C-182398, r=0.9995, the linear range was 0.2196~1.5372μg, the average recovery was 99.20%, RSD was 0.43%; isorhamnetin regression equation was A The linear range was 0.0552-0.3864 μg, the average recovery was 99.31%, and the RSD was 0.25%. Conclusion: The established criteria can be used for quality control of the formulation.