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目的建立润燥止痒片质量标准。方法在原剂型标准基础上对苦参、桑叶的薄层色谱鉴别方法进行改进;采用高效液相色谱法对苦参碱进行含量测定。结果薄层图谱斑点清晰,阴性无干扰;苦参碱进样量在0.1022～2.0440μg范围内线性关系良好,r=0.9999,平均加样回收率为99.36%,RSD为1.92%(n=6)。结论该法操作简便,结果可靠,重现性好,可用于该药的质量控制。
Objectives To establish the Runzao antipruritic tablets quality standards. Methods The TLC method of Sophora flavescens and mulberry leaf was improved on the basis of the original dosage form. The content of matrine was determined by high performance liquid chromatography. The results showed that the spots of the TLC were clear and negative. The matrine injection showed a good linearity in the range of 0.1022-2.0440μg (r = 0.9999) with an average recovery of 99.36% and RSD of 1.92% (n = 6) . Conclusion The method is simple, reliable, reproducible and can be used for the quality control of the drug.