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目的建立神经性皮炎凝胶剂的质量控制方法。方法采用薄层色谱法对制剂中苦参、黄柏、木贼进行定性鉴别;运用高效液相色谱法对制剂主药苦参中苦参碱及氧化苦参碱进行含量测定。采用Inertsil氨基柱(4.6 mm×250 mm,5μm),乙腈-无水乙醇-3%磷酸水溶液(79:10:11)为流动相,流速1.0 m L·min-1;检测波长205 nm;柱温25℃。结果苦参、黄柏、木贼的定性鉴别方法专属性强,阴性无干扰;苦参碱在0.0132~0.066mg·m L-1范围内线性关系良好(r=0.9998),平均加样回收率为95.98%,RSD=1.04%;氧化苦参碱在0.0456~0.228mg·m L-1范围内线性关系良好(r=0.9999),平均加样回收率为95.45%,RSD=1.20%。结论所建立的定性定量方法操作简便、准确、稳定且无干扰,可用于该制剂的质量控制。
Objective To establish a quality control method for neurodermatitis gel. Methods TLC, TLC, HPLC and HPLC were used to determine the content of matrine and oxymatrine in Sophora flavescens. The mobile phase consisted of an Inertsil column (4.6 mm × 250 mm, 5 μm) and acetonitrile-absolute ethanol-3% phosphoric acid solution (79:10:11) with a flow rate of 1.0 mL · min- Temperature 25 ℃. Results The qualitative identification methods of Sophora flavescens, Phellodendron amurense and Equisethe had strong specificity and negative non-interference; the linear relationship of matrine in the range of 0.0132-0.066 mg · m L-1 was good (r = 0.9998), the average recovery was 95.98%, RSD = 1.04%. Oxymatrine showed good linearity (r = 0.9999) in the range of 0.0456 ~ 0.228 mg · m L-1 with an average recovery of 95.45% and RSD = 1.20%. Conclusion The established qualitative and quantitative method is simple, accurate, stable and non-interfering and can be used for the quality control of this preparation.