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目的:建立中药退黄外洗液的质量标准。方法:采用薄层色谱(TLC)法对方中大黄、薄荷脑进行定性鉴别;采用高效液相色谱(HPLC)法对制剂中栀子苷进行含量测定。结果:TLC斑点清晰,分离度好、专属性强。栀子苷进样浓度在5.46～81.9μg.mL-1范围内与峰面积积分值呈良好线性关系(r=0.9998);平均回收率为98.38%,RSD=1.53%(n=6)。结论:所建标准可用于中药退黄外洗液的质量控制。
Objective: To establish the quality standard of the traditional Chinese medicine for removing jaundice. METHODS: TLC method was used to qualitatively identify rhubarb and menthol in each other. The content of geniposide in the preparation was determined by high performance liquid chromatography (HPLC). Results: TLC spots are clear, with good resolution and specificity. The jasminoidin concentration in the range of 5.46-81.9μg.mL-1 showed a good linear relationship with the integral value of the peak area (r=0.9998); the average recovery was 98.38% and the RSD was 1.53% (n=6). Conclusion: The established standard can be used for the quality control of the traditional Chinese medicine huanghuangwai lotion.