藏药五味金色丸的质量标准研究

Quality Standard Study on Tibetan Medicine Wuwei Jinse Pill

关键词:  五味金色丸  质量标准  显微鉴别  薄层色谱法  高效液相色谱法

Key words:  Wuwei Jinse pill  quality standard  microscopic identification  TLC  HPLC

摘要:

目的 建立藏药五味金色丸的定性定量检测方法，为其质量标准的提高提供依据。方法 采用显微鉴别方法，对制剂中诃子、波棱瓜子、木香、石榴子进行鉴别。采用薄层色谱法（TLC），对制剂中诃子、波棱瓜子、木香、石榴子进行定性鉴别。采用HPLC多波长同时测定没食子酸、鞣花酸、herpetrione和herpetotriol的含量。结果 显微鉴别特征明显；TLC定性鉴别方法专属性强，各色谱斑点清晰且分离度较好，且阴性对照均无干扰；HPLC含量测定结果显示，没食子酸在0.092 0~1.840 4 mg（r=0.998 8）、鞣花酸在0.237 4~4.747 2mg（r=0.999 1）、herpetrione在0.013 6~0.272 2 mg（r=0.998 1）、herpetotriol在0.002 1~0.041 0 mg（r=0.996 3）内与峰面积均呈良好线性关系，平均回收率（n=9）分别为99.32%（RSD=1.69%），99.25%（RSD=1.42%），98.49%（RSD=1.67%）和97.50%（RSD=1.83%）。结论 本方法操作简便，重现性好，结果准确可靠，可用于五味金色丸的质量控制。

Abstract:

OBJECTIVE To establish the qualitative and quantitative detection methods for Tibetan medicine Wuwei Jinse pill, and to provide the basis for improving its quality standard. METHODS The microscopic identification method was used to identify Terminalia chebula, Herpetospermum caudigerum, Aucklandiae Radix and pomegranate seed in the preparation. Thin layer chromatography(TLC) was used for qualitative identification of Terminalia chebula, Herpetospermum caudigerum, Aucklandiae Radix and pomegranate seed in the preparation. The contents of gallic acid, ellagic acid, herpetrione and herpetotriol were determined simultaneously with multi-wavelength by HPLC. RESULTS Microscopic identification features were obvious. The TLC qualitative identification methods were established with strong specificity, the TLC spots were clear, separating degree was perfect and negative control had not any interference. According to the HPLC analysis, the line range for gallic acid, ellagic acid, herpetrione and herpetotriol were 0.092 0-1.840 4 μg(r=0.998 8), 0.237 4-4.747 2 μg(r=0.999 1), 0.013 6-0.272 2 μg(r=0.998 1), and 0.002 1-0.041 0 μg(r=0.996 3), respectively. And the average recoveries(n=9) were 99.32% (RSD=1.69%), 99.25%(RSD=1.42%), 98.49%(RSD=1.67%) and 97.50%(RSD=1.83%) respectively. CONCLUSION These methods are simple, accurate and repeatable, and can be used for quality control of Wuwei Jinse pill.