摘要
目的:建立复方蜘蛛香凝胶贴膏(Compound Zhizhuxiang Gel Plaster,CZGP)的质量控制及多元成分含量测定方法。方法:采用薄层色谱法对凝胶贴膏中橙皮苷(hesperidin,HSP)、木香烃内酯(costunolide,CL)及去氢木香内酯(dehydrocostus lactone,DCL)进行定性鉴别;以HSP为内标,采用一测多评法,利用HPLC法测定HSP、CL及DCL的含量,并对CZGP进行含膏量、耐热性、含量均匀度及黏附力检查。结果:薄层色谱中,各成分与对照品在相同位置显示相同颜色的斑点,清晰可见,分离效果良好;HSP、CL和DCL分别在13.20~1689.00μg·mL^(–1)(r=0.9996)、2.85~365.40μg·mL^(–1)(r=0.9998)、4.14~530.40μg·mL^(–1)(r=0.9999)内线性关系良好,平均加样回收率分别为97.820%、101.38%、102.19%,RSD分别为1.62%、1.36%、1.42%,测得3个成分的含量分别为11.183、1.7070、1.9210 mg·g^(–1),且一测多评法和外标法结果接近,可见一测多评法可用于制剂的含量测定;每贴CZGP平均含膏量为24.300 g,黏附力、耐热性及含量均匀度检查均符合《中国药典》(2020年版)要求。结论:所建立的质量控制方法稳定可靠,能有效控制CZGP的质量。
OBJECTIVE To establish a quality control method for the Compound Zhizhuxiang Gel Plaster(CZGP) and a method for the determination of the contents of multiple components.METHODS Thin-layer chromatography(TLC) was used to qualitatively identify hesperidin(HSP),costunolide(CL) and dehydrocostus lactone(DCL) in the CZGP.Their contents were determined via a quantitative analysis of multi-components with a single-marker(QAMS) using high-performance liquid chromatography(HPLC) with HSP as the internal standard.Meanwhile,CZGP was also examined with the amount of paste contained,heat-resistant properties,content homogeneity and the initial adhesive force.RESULTS In the TLC of each component,the same colour spots at the same position as the control product were clearly visible,with a good separation effect.HSP,CL and DCL respectively in the range of 13.20^(–1) 689.00 μg·mL^(–1)(r=0.999 6),2.85–365.40 μg·mL^(–1)(r=0.999 8),4.14–530.40μg·mL^(–1)(r=0.999 9) showed a good linear relationship.Their average sample recovery rate was 97.820%,101.38%,and 102.19%,respectively.The relative standard deviation(RSD) was 1.62%,1.36%,and 1.42%,respectively.The measured content was 11.183,1.707 0 and 1.921 0 mg·g^(–1),respectively.QAMS obtained the similar finding as that of the external standard method,suggesting the feasibility of the former.The average paste content of each CZGP was 24.300 g,and the adhesion,heat resistance and content homogeneity were all complied with the requirements of the Chinese Pharmacopoeia(2020 Edition).CONCLUSION The established quality control method is stable and reliable,and it can effectively control the quality of CZGP.
作者
梅佳华
赵济
薛蕊
周益
杨丽娟
罗丽琴
查学志
马云淑
MEI Jiahua;ZHAO Ji;XUE Rui;ZHOU Yi;YANG Lijuan;LUO Liqin;ZHA Xuezhi;MA Yunshu(Yunnan University of Chinese Medicine,Yunnan Key Laboratory of Southern Medicinal Utilization,Yunnan Kunming 650500,China;The Key Laboratory of External Drug Delivery System and Preparation Technology in University of Yunnan Province,Yunnan Key Laboratory of Dai and Yi medicines,Engineering Research Center for Medicine and Food Homologous Beverage of Yunnan Province,Yunnan Kunming 650500,China)
出处
《中国医院药学杂志》
北大核心
2025年第2期161-166,共6页
Chinese Journal of Hospital Pharmacy
基金
国家自然科学基金资助项目(编号:82174065)
云南省科技厅社会发展专项-重点研发计划项目(编号:202303AC100025)
云南省教育厅科学研究基金项目(编号:2024Y379)。
关键词
复方蜘蛛香凝胶贴膏
质量控制
一测多评法
橙皮苷
木香烃内酯
去氢木香内酯
Compound Zhizhuxiang Gel Plaster
quality control
quantitative analysis of multi-components with a single-marker(QAMS)
hesperidin
costunolide
dehydrocostus lactone
