参苓胃炎合剂的质量标准提升及应用

Improvement and application of quality standards for Shenling Weiyan mixture

目的通过增加医院制剂参苓胃炎合剂中陈皮、木香的薄层鉴别、黄芩中黄芩苷的定量测定等研究,完善其质量控制方法与标准。方法参照《中华人民共和国药典》2015年版中相关方法,并进行优化,建立了参苓胃炎合剂中鉴别陈皮、木香药材的TLC法并进行方法学考察;同时建立测定参苓胃炎合剂中指标性成分黄芩苷的HPLC法。采用Diamonsil C18色谱柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.2%磷酸水(52:48),体积流量为1 ml/min,柱温为35℃,检测波长为280 nm进行分析并进行方法学考察。结果 TLC鉴别方法专属性强并能够有效鉴别陈皮和木香药材;定量测定方法学研究结果表明,黄芩苷的量在0.32μg^10.24μg内与峰面积值呈良好的线性关系,回归方程为y=634 964x+171 117,r=0.996 9;平均回收率为103.07%,RSD为1.90%;3批样品定量测定结果表明,该样品中黄芩苷为59.00μg/g^60.76μg/g。结论建立的质量控制方法专属性强、稳定性好,完善并提升了参苓胃炎合剂的质量标准。

Objective To improve the quality standards of hospital prepared Shenling Weiyan mixture by increasing the TLC of Pericarpium Citri Reticulatae, Aucklandiae Radix and quantitative determination of baicalin. Methods According to the methods recorded in General of Chinese Pharmacopeia(2015 edition), TLC methods of Pericarpium Citri Reticulatae and Aucklandiae Radix were established for the identification and methodological investigation in Shenling Weiyan mixture. At the same time, HPLC method of ingredient baicalin was also established. The content of baicalin was analyzed by high performance liquid chromatography on a Diamonsil C18 column(150 mm×4.6 mm, 5 μm) with methanol-0.2% phosphoric acid(52:48) at a flow rate of 1 ml/min, the column temperature was 35 ℃, and the detection wavelength was 280 nm. Results The methods of TLC identification were highly specific and could effectively identify the materials of Pericarpium Citri Reticulatae and Aucklandiae Radix. Quantitative determination methodological results showed that it has a good linear correlation in the range of 0.32 μg-10.24 μg with the regression equation of y=634 964x+171 117, r=0.996 9. The average recovery was 103.07%(RSD=1.90%). The content of baicalin from three different batches of Shenling Weiyan mixture was with 59.00 μg/g-60.76 μg/g. Conclusion The established quality control method is specific and stable, and it has supplied and improved the quality standard of Shenling Weiyan mixture.