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目的制备祛斑膏,建立其质量控制方法。方法采用薄层色谱法鉴别祛斑膏中丹参、白芷;采用高效液相色谱法对制剂中丹参酮ⅡA进行含量测定,Hypersil C18色谱柱(4.6 mm×150 mm,5μm),流动相为甲醇-水(75:25),流速1 mL.min-1,检测波长270 nm,柱温30℃。结果丹参、白芷的薄层鉴别斑点清晰、专属性强;丹参酮ⅡA在0.021~0.105μg之间呈良好的线性关系(r=0.999 9,n=5),平均回收率为99.63%,RSD为0.37%(n=9)。结论该文所建立的方法操作简单、专属性强、重复性好、结果准确可靠,可作为控制祛斑膏质量的方法。
Aim To prepare the cream and establish its quality control method. Methods Thin layer chromatography was used to identify Salviae Miltiorrhizae and Angelica dahurica. The content of tanshinone Ⅱ A in the preparation was determined by high performance liquid chromatography (Hypersil C18) column (4.6 mm × 150 mm, 5 μm) with methanol-water 75:25), flow rate 1 mL.min-1, detection wavelength 270 nm, column temperature 30 ℃. Results The spots of Danshen and Angelica dahurica were clear and specific. Tanshinone ⅡA showed a good linear relationship (r = 0.999 9, n = 5) with the average recovery of 99.63% and RSD of 0.37 % (n = 9). Conclusion The method established in this paper is simple, specific and reproducible, and the results are accurate and reliable. It can be used as a method to control the quality of lightening creams.