摘要
目的建立肺热清解煮散的质量标准。方法采用薄层色谱法对制剂中桑白皮、野菊花和地龙进行定性鉴别;采用高效液相色谱法测定制剂中阿魏酸、桑皮苷A、芦丁的含量,色谱柱为Hypersil ODS2 C_(18)柱(250 mm×4.6 mm,5μm),阿魏酸、桑皮苷A、芦丁测定的流动相分别为乙腈-0.3%磷酸水溶液(23∶77,V/V)、乙腈-0.1%磷酸水溶液(10∶90,V/V)、乙腈-0.1%磷酸水溶液(34∶66,V/V),流速为1.0 mL/min,柱温为30℃,检测波长为316 nm(阿魏酸)、238 nm(桑皮苷A)、280 nm(芦丁),进样量为5μL。结果样品中桑白皮、野菊花、地龙的薄层色谱分离效果良好,特征斑点显色清晰,且阴性对照无干扰。阿魏酸、桑皮苷A、芦丁的质量浓度分别在0.0320~0.3200 mg/mL、0.0083~0.0500 mg/mL、0.0520~0.3100 mg/mL范围内与峰面积积分值线性关系良好(r≥0.9997,n=6);精密度、稳定性、重复性试验结果的RSD均低于3.0%(n=6);平均加样回收率分别为99.39%,99.52%,99.63%,RSD分别为2.72%,1.08%,0.70%(n=6)。结论该方法操作简便、重复性好、结果准确,可用于肺热清解煮散的质量控制。
Objective To establish the quality standard of Feire Qingjie Zhusan.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Mori Cortex,Chrysanthemi Indici Flos and Pheretima in the preparation.High-performance liquid chromatography(HPLC)method was used to determine the contents of ferulic acid,melanoside A,and rutin in the preparation.The chromatographic column was HypersilODS2 C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.3%phosphoric acid aqueous solution(23∶77,V/V)for ferulic acid,acetonitrile-0.1%phosphoric acid aqueous solution(10∶90,V/V)for melanoside A,and acetonitrile-0.1%phosphoric acid aqueous solution(34∶66,V/V)for rutin,the flow rate was 1.0 mL/min,the column temperature was 30℃,the detection wavelengths were 316 nm(ferulic acid),238 nm(melanoside A),and 280 nm(rutin),the injection volume was 5μL.Results The TLC chromatograms of Mori Cortex,Chrysanthemi Indici Flos and Pheretima in the sample showed a good separation effect,clear characteristic spots,and no interference from the negative control.The linear ranges of ferulic acid,melanoside A,and rutin were 0.0320-0.3200 mg/mL,0.0083-0.0500 mg/mL,and 0.0520-0.3100 mg/mL(r≥09997,n=6),respectively.The RSDs of precision,stability,and repeatability test results were all lower than 3.0%(n=6).The average recoveries of ferulic acid,melanoside A,and rutin were 99.39%,99.52%,and 99.63%,with RSDs of 2.72%,1.08%,and 0.70%(n=6),respectively.Conclusion The method is simple,has good repeatability,and accurate results,which can be used for quality control of Feire Qingjie Zhusan.
作者
赖岳晓
刘佩沂
郑雪青
黄洁莹
田素英
梅全喜
LAI Yuexiao;LIU Peiyi;ZHENG Xueqing;HUANG Jieying;TIAN Suying;MEI Quanxi(Huangpu People′s Hospital,Zhongshan,Guangdong,China 528400;Guangdong Pharmaceutical University,Guangzhou,Guangdong,China 510006;Guangdong Cosmetics Engineering&Technology Research Center,Zhongshan,Guangdong,China 528458;The Seventh School of Clinical Medicine,Guangzhou University of Chinese Medicine,Shenzhen,Guangdong,China 518100;The Third Hospital Affiliated to Guangzhou University of Chinese Medicine,Guangzhou,Guangdong,China 510378)
出处
《中国药业》
CAS
2024年第21期80-84,共5页
China Pharmaceuticals
基金
广东省中山市第三批社会公益与基础研究专项(医疗卫生重大、重点项目)[2021B3017]
广东省中山市中医药传承创新发展示范试点项目[20240319]。
关键词
肺热清解煮散
阿魏酸
桑皮苷A
芦丁
质量标准
Feire Qingjie Zhusan
ferulic acid
melanoside A
rutin
quality standard Vol.33,No.21,November 5,2024
作者简介
第一作者:赖岳晓,男,大学本科,主任中药师,研究方向为医院制剂,电子信箱:hpyylyx@126.com;通信作者:田素英,女,硕士,副教授,研究方向为中药开发应用,电子信箱:zsxqtsy@126.com。
