畲药十二时辰的质量标准研究

Quality Standard of She Medicine Clematis florida var.Plena

目的 建立畲药十二时辰的质量标准,为其质量控制和开发提供参考。方法 对十二时辰进行性状、显微特征、薄层色谱鉴别;参照《中华人民共和国药典》2020年版相关规定,对十二时辰水分、灰分、浸出物进行测定;以齐墩果酸为对照物质,采用高效液相色谱法对其含量进行检测。结果 十二时辰药材在性状、显微和TLC鉴别方面均有专属性特征;6批不同采收期的十二时辰水分平均值为11.79%,总灰分平均值为3.16%,酸不溶性灰分平均值为0.34%,热浸法水溶性浸出物含量为31.46%;含量测定齐墩果酸平均质量分数为1.72%。结论 该研究结果可为畲药十二时辰的质量标准的制定提供依据,暂定本品水分不得超过14.0%,总灰分不得超过4.00%,酸不溶性灰分不得超过0.40%,浸出物含量不得低于25.00%。

OBJECTIVE To establish the quality standard of Clematis florida var.Plena,and provide reference for its quality control and development.METHODS The characters,microscopic characteristics and thin layer chromatography of Clematis florida var.Plena were identified.According to the relevant provisions of the 2020 edition of the Pharmacopoeia of the People′s Republic of China,the moisture,ash and extract of Clematis florida var.Plena were determined.With oleanolic acid as the reference substance,the content was detected by high performance liquid chromatography.RESULTS Clematis florida var.Plena medicinal materials had specific characteristics in character,microscopic and TLC identification.The average moisture content of 6 batches of different harvest time was 11.79%,the average total ash content was 3.16%,the average acid-insoluble ash content was 0.34%,and the water-soluble extract content was 31.46%.The average mass fraction of oleanolic acid was 1.72%.CONCLUSION The results of this study can provide a basis for the formulation of the quality standard of Clematis florida var.Plena.It is tentatively stipulated that the water content of this product should not exceed 14.0%,the total ash content should not exceed 4.00%,the acid-insoluble ash content should not exceed 0.40%,and the extract content should not be less than 25.00%.