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目的:研究温肾胶囊的质量控制方法。方法:采用薄层色谱法对温肾胶囊中的当归进行定性鉴别;高效液相色谱法对胡芦巴碱进行定性、定量。色谱柱为KromasilC18(150mm×4.6mm,5μm);流动相为甲醇-0.05%十二烷基磺酸钠溶液-冰醋酸(20∶80∶0.1);流速为1.0mL·min-1;检测波长为265nm;柱温为室温。结果:薄层方法可检出当归;胡芦巴碱在5～100mg·mL-1范围内线性关系良好,平均回收率为100.46%(RSD为1.4,n=6)。结论:本法操作简便、灵敏、准确,可用于对温肾胶囊的质量控制。
Objective: To study the quality control method of Wenshen Capsule. Methods: The qualitative identification of Angelica sinensis in Wenshen Capsules was performed by thin-layer chromatography. Quercus falcata was qualitatively and quantitatively determined by high performance liquid chromatography. The column was Kromasil C18 (150mm×4.6mm, 5μm); the mobile phase was methanol-0.05% sodium dodecyl sulfate solution-glacial acetic acid (20:80:0.1); flow rate was 1.0mL·min-1; detection wavelength 265 nm; column temperature room temperature. RESULTS: The thin-layer method could detect Angelica sinensis. Fenugreekine had good linearity in the range of 5 to 100 mg.mL-1. The average recovery was 100.46% (RSD was 1.4, n=6). Conclusion: This method is simple, sensitive, accurate and can be used to control the quality of Wenshen Capsule.