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目的:提高完善生肌软膏的质量标准。方法:采用TLC法对处方中的龙血竭、乳香进行鉴别;采用HPLC法测定磺胺嘧啶银的含量。色谱柱为Wondasil C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(8∶92),检测波长为254nm,流速:1.0 ml·min~(-1),柱温:30℃,进样量为5μl。结果:薄层色谱斑点清晰,专属性强,重复性好。磺胺嘧啶在40.97~1 024.18μg·ml~(-1)范围内质量浓度与峰面积线性关系良好(r=0.999 9),平均回收率为100.17%,RSD=0.64%(n=6)。结论:本方法操作方便、专属性强、回收率高、结果准确,可用于该制剂的质量控制。
Objective: To improve the quality standard of myogenic ointment. Methods: TLC method was used to identify dragon’s blood and frankincense; the content of sulfadiazine silver was determined by HPLC. The column was Wondasil C18 (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid solution (8:92), the detection wavelength was 254 nm, the flow rate was 1.0 ml · min -1, 30 ℃, injection volume of 5μl. Results: Thin-layer chromatography spots clear, specific and reproducible. The linear range was 40.97 ~ 1 024.18μg · ml -1. The average recovery of sulfadiazine was 100.17% with RSD of 0.64% (n = 6). Conclusion: The method is easy to operate, specificity, high recovery, accurate results and can be used for the quality control of the preparation.