麻黄饮片的质量标准研究

Analysis of the Quality of Prepared Slices of Herba Ephedrae

目的比较不同产地麻黄饮片质量,制定麻黄饮片质量的参考标准。方法采用HPLC法测定各饮片的麻黄碱和伪麻黄碱含量,依照《中国药典》2000年版一部的方法测定各饮片的浸出物、灰分、水分、杂质及灰屑等;并采用经验法进行加速稳定性试验。结果麻黄碱含量生品为0.995%～1.589%,蜜炙品为0.855%～1.557%;伪麻黄碱含量生品为0.560%～2.087%,蜜炙品为0.508%～1.902%;水溶性浸出物生品为8.83%～18.30%,蜜炙品为14.81%～27.45%;醇溶性浸出物生品为7.74%～18.83%,蜜炙品为14.15%～27.34%;总灰分生品为6.49%～10.29%,蜜炙品为6.34%～10.24%;酸不溶灰分生品为0.19%～0.42%,蜜炙品为0.18%～0.42%;平均含水量生品为8.10%(s=0.3961),蜜炙品为4.02%(s=0.4674);平均所含杂质及灰屑量生品为2.02%(s=0.1954),蜜炙品为2.01%(s=0.2209)。结论该研究为建立完整、科学的麻黄饮片质量标准提供了参考依据。

Objective To compare the quality of prepared slices of Herba Ephedrae from different producing areas and to establish reference quality criterion of Herba Ephedrae.Methods Determined the content of Ephedrine and Pseudoephedrine in Herba Ephedra Prepared Herbal by HPLC.According to Chinese Pharmacopeia of 2000-year edition,extract,ash,water,impurity and foreign substance were detected; accelerated stability test was performed according to experience.Results The content of Ephedrine in Herba Ephedra is 0.995 %～1.589 %,honey-fried HerbaEphedra is 0.855 %～1.557 %;the content of Pseudoephedrine in Herba Ephedra is 0.560 %～2.087 %,honey-fried Herba Ephedra is 0.508 %～1.902 %; water-soluble extract was 8.83 %～18.30 %and 14.81%～27.45 %, alcohol-soluble extract was 7.74 %～18.83 %and 14.15 %～27.34 %, the total ash content was 6.49 %～10.29 %and 6.34 %～10.24 %and acid-insoluble ash was 0.19 %～0.42 %and 0.18 %～0.42 %in Herba Ephedrae and honey-prepared Herba Ephedrae respectively.The average water content was 8.10 %(s=0.3961)and 4.02 %(s=0.4674)and average content of impurity and foreign substance was 2.02 %(s=0.1954)and 2.01 %(s=0.2209)in Herba Ephedrae and honey-prepared Herba Ephedrae respectively.Conclusion This research will provide a reference criterion for the quality control of prepared slices of Herba Ephedrae.