降脂通便胶囊质量标准的提高  

Improvement of quality standard of Jiangzhi Tongbian capsules

作　　者：鲁晓光 黄海欣 张桂平 张玉洁 孙云峰[2] LU Xiao-guang HUANG Hai-xin ZHANG Gui-ping ZHANG Yu-jie SUN Yun-feng(Nanyang City in Henan Province Institute for Food and Drug Control, Nanyang 473061, China Basic Medical College of Liaoning University of Traditional Chinese Medicine, Shenyang 110847, China)

机构地区：[1]河南省南阳市食品药品检验所,南阳473061 [2]辽宁中医药大学基础医学院,沈阳110847

出　　处：《药物分析杂志》2016年第12期2241-2250,共10页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:降脂通便胶囊质量控制方法的提高。方法:采用显微鉴别方法,对制剂中大黄、人参、灵芝、肉桂进行鉴别。采用TLC,对制剂中大黄、人参、肉桂进行定性鉴别并检查大黄的真伪。采用HPLC,对制剂中甘草进行定性鉴别,对制剂中酒大黄中总大黄素和总大黄酚的总量以及结合蒽醌中大黄素和大黄酚的总量进行定量;色谱柱为Welch Materials Eclipse XB-C_(18)(4.6 mm×250 mm,5μm),流动相为乙腈-甲醇-0.1%磷酸溶液(42∶23∶35),流速1.0 m L·min^(-1),检测波长254 nm,柱温35℃。结果:定性鉴别方法专属性强,效果佳。采用HPLC法进行含量测定,大黄素质量在13.02~130.2 ng范围内与峰面积呈良好的线性关系(r=0.999 7),大黄酚质量在30.29~302.88 ng范围内与峰面积呈良好的线性关系(r=1.000);测定总大黄素和总大黄酚总量的平均回收率(n=6)为103.4%(RSD=1.3%),测定游离大黄素和游离大黄酚总量的平均回收率(n=6)为101.9%(RSD=1.0%)。10批样品,总大黄素和总大黄酚的总量为3.70~5.55 mg·粒^(-1),结合蒽醌中大黄素和大黄酚的总量为1.55~3.08 mg·粒^(-1)。结论:本方法提高完善了降脂通便胶囊的质量标准,可更有效地控制其质量。Objective： To improve the quality control method of Jiangzhi Tongbian capsules.Methods： Microscopic identification method was adopted to identify Rhei Radix et Rhizoma, Ginseng Radix et Rhizoma, Ganoderma and Cinnamomi Cortex in the preparation;TLC was adopted to qualitatively identify Rhei Radix et Rhizoma, Ginseng Radix et Rhizoma, Cinnamomi Cortex, and to check the authenticity of rhubarb in the preparation;HPLC was adopted to qualitatively identify Glycyrrhizae Radix et Rhizoma, and to determine the total content of total emodin and total chrysophanol, and the total content of emodin and chrysophanol in combined anthraquinone in the preparation of wine-treated rhubarb.The Welch Materials Eclipse XB-C18 （4.6 mm×250 mm, 5 μm） was used as the analytical column.Methanol-acetonitrile-0.1% phosphoric acid solution （42：23：35） was used as the mobile phase at a flow rate of 1.0 mL·min-1.The detection wavelength was 254 nm, and the column temperature was 35.Results： The established identification methods properly reflected a good specificity.The good linear range of emodin was 13.02-130.2 ng （r=0.999 7）.The good linear range of chrysophanol was 30.29-302.88 ng （r=1.000）.When the total content of total emodin and total chrysophanol was determined, the average recovery was 103.4% （n=6） and the RSD was 1.30%.When the total content of free emodin and free chrysophanol was determined, the average recovery was 101.9% （n=6） and the RSD was 1.0%.For the 10 batches of samples, the amount of total emodin and total rhubarb phenol was 3.70-5.55 mg per capsule, and the amount of emodin and rhubarb phenol in combined anthraquinone was 1.55-3.08 mg per capsule.Conclusion： The method improved the quality standard of Jiangzhi Tongbian capsules, and could be more effective to control its quality.

关 键 词：降脂通便胶囊 大黄 人参 灵芝 肉桂 甘草 土大黄苷 大黄素 大黄酚 显微鉴别 薄层色谱 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]