广东紫荆皮的质量标准研究及其易混品辨析

Quality standard study of Cortex Phyllanthus emblica L. and differentiation from its adulterants

目的研究广东紫荆皮的质量标准。方法采用2015年版《中国药典》中方法对广东紫荆皮药材中的水分、灰分及浸出物进行了测定,对广东紫荆皮药材薄层鉴别的条件及指标成分的质量分数测定条件进行了优化。结果测得广东紫荆皮药材中水分不得超过15.5%,总灰分不得超过9.24%,70%(体积分数)乙醇热浸出物不得少于27.5%;以羽扇豆醇、没食子酸为对照品的薄层鉴别斑点清晰、分离度好。羽扇豆醇的质量分数测定在0.216 0~10.80μg内与峰面积呈良好的线性关系,r=0.999 9,平均回收率为96.9%(RSD=2.1%,n=6),样品平均质量分数为12.40 mg/g;而其混淆品未检出此成分。结论本方法简便、专属性强、重复性好,能区分广东紫荆皮及其混淆品,为评价广东紫荆皮药材的质量标准提供科学依据。

Objective To investigate differentiation of Cortex Phyllanthus emblica L. from its adulterants and its quality standard. Methods In this paper, the moisture, ash and extract of Cortex Phyllanthus emblica L. were determined according to the 2015 edition of Chinese Pharmacopoeia. The conditions of the thin layer chromatography identification and its content determination were optimized. Results The determination of moisture in Cortex Phyllanthus emblica L. should not exceed 15.5%, the total ash content should not exceed 9.24%, and the 70% ethanol extract should not be less than 27.5%.The TLC with lupeol, gallic acid as its reference substance spots were clear and well separated, which could well differentiate it from its adulterants. The HPLC peak area showed a good linear relationship in 0.2160-10.80 μg, r=0.9999 （ n=6） , the average recovery was 96.9% （ RSD=2.1%, n=6） , and the average content of samples was 12.40 mg/g, while no lupeol was detected in its adulterants. Conclusion The methods are simple, specific, reproducible, and could accurately distinguish Cortex Phyllanthus emblica L. from its adulterants, and it provide the scientific basis to evaluate its quality.