益气聪明丸质量标准提高研究

【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。

Improvement of Quality Standard of Yiqi Congming Pills

Objective To establish the methods for controlling quality of Yiqi Congming Pills, and to improve the quality standard for the pills. Methods Yiqi Congming Pills were sampled from the products of 3 mainpharmaceutical companies in China market, 2 batched from each company. Radix Puerariae, Radix Astragali, Fructus Viticis, Cortex Phellodendri Chinensis, Radix Codonopsis in Yiqi Congming Pills were observed under microscope for microscopic identification. Radix Astragali, Rhizoma Cimicifugae, Radix Paeoniae Alba, and Cortex Phellodendri Chinensis were identified by thin-layer chromatography (TLC) for qualitative differentiation. The contents of puerarin and paeoniflorin in Yiqi Congming Pills were determined by high performance liquid chromatography(HPLC). Results The microscopic characteristics of Radix Puerariae, Radix Astragali, Fructus Viticis, Cortex Phellodendri Chinensis, Radix Codonopsis in the pills were obvious and were easy for discrimination. The spots in thin-layer chromatography (TLC) chromatograms of Radix Astragali, Rhizoma Cimicifugae, Radix Paeoniae Alba, and Cortex Phellodendri Chinensis were clear without interference of negative reference. Puerarin had a good linearity in the range of 0.00112~3.50676μg, and the average recovery rate was 98.2%(sR=1.4%, N=9 ). Paeoniflorin had a good linearity in the range of 0.00333 ~ 3.328 μg, and the average recovery rate was 98.4%(sR = 1.8%, N = 9). Great differences existed in the contents of puerarin and paeoniflorin of Yiqi Congming Pills from the three pharmaceutical companies. Conclusion The established qualitative and quantitative methods are of accuracy, credibility and repeatability, and are effective for controling the quality of Yiqi Congming Pills.