目的建立乳乐康凝胶膏剂的质量标准。方法采用薄层色谱法鉴别方中蜂房、乳香、没药、丁香、姜黄、细辛、荜茇等药材,采用高效液相色谱法测定方中的姜黄素的含量。色谱柱:KromasilC18(4.6mm×250mm,5μm)键合硅胶柱;流动相:0.4%磷酸-乙腈(45:55);检测波长:430nm;流速:1.0ml/min;柱温:30℃。结果TLC色谱斑点清晰,阴性无干扰;姜黄素在1.972—15.776μg/ml范围内呈良好的线性关系,r=1,平均加样回收率为97.33%,RSD=0.98%(n=9)。结论该方法准确、可靠,重现性好,可以用于控制乳乐康凝胶膏剂的质量。
Objective To establish quality standards for Rulekang cataplasm. Methods TLC method was used to distinguish Fengfang, Ruxiang, Moyao, Dingxiang, Jianghang, Xixin and Bibo. HPLC was used for the content determination of Curcumin. The column was Kromasil C18 column (4.6 mm ×250 ram, 5 μm) ; mobile phase were 0.4% Phosphate-acetonitrile (45:55 ) ; the detection wavelength was at 430 nm; the flow rate was 1.0 ml/min and the column temperature was at 30 ℃, respectively. Results The TLC spots were clear and negative without interference; Curcumin show a good linear relationship in the range of 1. 972 - 15. 776 μg/ml, r = 1, the average recovery was 97.33% with RSD =0.98% (n = 9 ). Conclusion The method is accurate, reliable, with good reproducibility, and can be used as quality control for Rulekang cataplasm.