绞股蓝饮片的质量标准研究

Study on Quality Standard for Decoction Pieces of Gynostemmae Herba

目的:对绞股蓝饮片进行定性、定量研究,为建立绞股蓝饮片的质量标准提供参考及依据。方法:按照2020版《中华人民共和国药典:四部》中规定的方法对10批绞股蓝饮片进行性状鉴别、显微鉴别、薄层鉴别及水分、灰分、浸出物测定,并采用高效液相色谱法测定其绞股蓝皂苷XLIX与人参皂苷Rb1的含量。结果:绞股蓝饮片各鉴别方法专属性强,其水分、总灰分、酸不溶性灰分及水溶性浸出物的含量分别为9.64%~11.19%、8.95%~12.84%、0.17%~1.51%及22.21%~32.26%,绞股蓝皂苷XLIX与人参皂苷Rb1的含量分别为0.12%~0.98%、0.02%~0.30%。初步拟定绞股蓝饮片的水分、总灰分及酸不溶性灰分的含量分别不得高于13.0%、15.0%、2.0%,水溶性浸出物、绞股蓝皂苷XLIX及人参皂苷Rb1的含量分别不得低于18.0%、0.10%、0.01%。结论:该实验所建立的绞股蓝饮片定性、定量方法,可为绞股蓝饮片质量标准的制定提供参考及实验依据。

Objective:To establish the quality standards for decoction pieces of gynostemmae herba.Methods:The identification of character,microscopy and TLC,as well as the test of water,total ash,acid insoluble ash and water soluble extracts were performed for 10 batches of gynostemmae herba according to Pharmacopoeia of the People’s Republic of China:Volume IV,2020 Edition.In addition,the contents of gypenoside XLIX and ginsenoside Rb1 in gynostemmae herba were determined by HPLC.Results:The identification methods of gynostemma pentaphyllum decoction pieces have strong specificity,the contents of water,total ash,acid insoluble ash,water soluble extracts,gypenoside XLIX and ginsenoside Rb1 were 9.64%~11.19%,8.95%~12.84%,0.17%~1.51%,22.21%~32.26%,0.12%~0.98%and 0.02%~0.30%,respectively.The preliminarily proposed contents of water,total ash and acid insoluble ash were no more than 13.0%,15.0%and 2.0%,while the preliminarily proposed contents of water soluble extracts,gypenoside XLIX and ginsenoside Rb1 were no less than 18.0%,0.10%and 0.01%,respectively.Conclusion:The established quality standards for decoction pieces of gynostemmae herba can be used for its quality control and evaluation.