摘要
目的九华痔疮栓收载于《卫生部药品标准》中药成方制剂第十八册,方中大黄为君药,主要的活性成分是蒽醌类成分,而质量标准未对产品中大黄蒽醌类成分进行质量控制。为了进一步完善九华痔疮栓的质量标准,研究建立HPLC法测定九华痔疮栓中大黄素和大黄酚的含量。方法采用Wondasil C18(4.6 mm×250 mm,5μm)色谱柱;以甲醇-0.1%磷酸溶液(70∶30)为流动相;流速1.0 mL/min;检测波长254 nm;柱温30℃。结果大黄素在0.008288~0.248 64μg范围内呈良好的线性关系(r=0.999 99),平均回收率(n=6)为99.6%;大黄酚在0.021 8~0.654μg范围内呈良好的线性关系(r=0.999 98),平均回收率(n=6)为95.4%。结论该定量方法简便、准确,重复性好,可作为九华痔疮栓的质量控制方法。
Objective Jiuhua Zhichuang suppositories was included in the 18 th volume of TCM prescription preparation of ministry of health drug standard, Rhubarb is the king of the prescription, and the main active ingredient is anthraquinone.The quality standard did not control the anthraquinones in rhubarb. To further improve the quality standard of jiuhua Zhichuang suppositories,HPLC method was established to determine the content of Emodin and Chrysophanol in jiuhua Zhichuang suppositories.Methods The analytical column Wondasil C18 column(4.6 mm×250 mm, 5 μm) was adopted, and the mobile phase was methanol-0.1%phosphoric(70:30) at the flow rate of 1.0 mL/min, and the detecting wavelength was 254 nm, the column temperature was 30℃. Results Emodin curves were linear in the range of 0.008 288~0.24 864 μg(r=0.999 99),and the average recovery(n=6) was 99.6%;Chrysophanol curves were linear in the range of 0.0218~0.654 μg(r=0.999 98), and the average recovery(n=6) was 95.4%. Conclusion The quantitative method is simple, accurate and reproducible, and can be used for quality control of Jiuhua Zhichuang Suppositories.
作者
沈小钟
崔穗旭
郑晓娜
李淑娴
吴良发
SHEN Xiaozhong;CUI Suixu;ZHENG Xiaona;LI Shuxian;WU Liangfa(School of Traditional Chinese Medicine, Guangdong Food and Drug Vocational College, Guangzhou Guangdong 510520, China;Jiangxi Provincial Institute for Drug Control/Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality, Nanchang Jiangxi 330029, China)
出处
《中国继续医学教育》
2019年第15期156-158,共3页
China Continuing Medical Education
基金
广东省科技计划项目(2017A030222010)
广东省教育厅特色创新类科研项目(2017GKTSCX030)
关键词
HPLC法
九华痔疮栓
大黄素
大黄酚
含量
定量方法
HPLC
Jiuhua Zhichuang Suppositories
emodin
chrysophanol
determination
quantity