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【目的】建立益气聪明丸的质量控制方法,提高益气聪明丸质量标准。【方法】选取市面上3个主要生产厂家的益气聪明丸各2批,采用显微镜观察方中葛根、黄芪、蔓荆子、黄柏、党参5味药以进行显微鉴别;采用薄层色谱法对方中黄芪、升麻、白芍、黄柏进行定性鉴别;采用高效液相色谱法测定益气聪明丸中葛根素、芍药苷含量。【结果】方中葛根、黄芪、蔓荆子、黄柏、党参5味药显微特征明显,易于鉴别。方中黄芪、升麻、白芍、黄柏薄层色谱斑点清晰,阴性无干扰。高效液相色谱法(HPLC)测定结果显示方中葛根素在0.001 12~3.506 76μg范围内有良好的线性关系,平均回收率为98.2%[相对标准偏差(s_R)=1.4%,N=9];芍药苷在0.003 33~3.328μg范围内有良好的线性关系,平均回收率为98.4%(s_R=1.8%,N=9)。不同厂家益气聪明丸中葛根素、芍药苷含量存在较大差异。【结论】所建立的定性、定量方法简便易行、重现性好,专属性强,可有效控制益气聪明丸质量。
【Objective】 To establish the quality control method of Yiqi Clever Pills and improve the quality standard of Yiqi Clever Pills. 【Method】 Two batches of Yiqi Cleverine pills from 3 major manufacturers in the market were selected. Microspheres were used to observe Radix Puerariae, Astragalus membranaceus, Vitex negundo, Cortex Phellodendri, Radix Codonopsis Pilosulae and other five herbs for microscopic identification. By thin layer chromatography The other side of astragalus, cimicifugua, white peony root, Phellodendron for qualitative identification; Determination of high-performance liquid chromatography qi puerarin puerarin, paeoniflorin content. 【Result】 Radix puerariae, Astragalus membranaceus, Vitex negundo, Cortex Phellodendri, Radix Codonopsis pilosulae with obvious microscopic features were easy to identify. Fang Astragalus, cimicifuga, white peony root, cork TLC spots clear, negative non-interference. The results of HPLC showed that there was a good linear relationship between puerarin in the range of 0.001 12 ~ 3.506 76 μg and the average recovery was 98.2% [relative standard deviation (s_R) = 1.4%, N = 9] ; Paeoniflorin in the range of 0.003 33 ~ 3.328μg has a good linear relationship, the average recovery was 98.4% (s_R = 1.8%, N = 9). Different manufacturers Yiqi clever pill puerarin, paeoniflorin content there is a big difference. 【Conclusion】 The established qualitative and quantitative methods are simple, reproducible and specific, which can effectively control the quality of Yiqi Clever Pills.