成分分析

HPLC-VWD-ELSD 法同时测定黄甲软肝颗粒中6 个成分的含量*

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  • 1.盈科瑞(珠海)创新医药制造有限公司,珠海 519040;
    2.北京盈科瑞药物研究院有限公司,北京 102200;
    3.盈科瑞(横琴)药物研究院有限公司,国家中药现代化工程技术研究中心新型递药系统分中心, 广东省雾化吸入制剂工程技术研究中心,珠海 519000;
    4.吉林大学珠海学院,珠海 519041
第一作者:Tel:(0756)6969093;E-mail:wangzongquan@ykrskj.com
** 张保献 Tel:(0756)6969093;E-mail:zhangbaoxian@ykrskj.com ;滕利荣 Tel:(0756)7626296;E-mail:tenglirong@jlu.edu.cn

收稿日期: 2020-07-07

  网络出版日期: 2024-07-11

基金资助

*广东省重点领域研发计划项目(2019B020201006); 国家“重大新药创制”科技重大专项项目(2017ZX09301017); 首届中国横琴科技创业大赛项目

Simultaneous determination of six components in Huangjia Ruangan granules by HPLC-VWD-ELSD*

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  • 1. Yingkerui (Zhuhai) Innovative Pharmaceutical Manufacturing Co.,Ltd,Zhuhai 519040,China;
    2. Beijing Yingkerui Pharmaceutical Research Institute Co.,Ltd,Beijing 102200,China;
    3. Yingkerui (Hengqin) Pharmaceutical Research Institute Co.,Ltd,New Drug Delivery System Sub Center of National Research Center for Modern Engineering and Technology of Traditional Chinese Medicine,Engineering Technology Research Center of Guangdong Aerosol Inhalation Preparation,Zhuhai 519000,China;
    4. Zhuhai College of Jilin University,Zhuhai 519041,China

Received date: 2020-07-07

  Online published: 2024-07-11

摘要

目的: 采用高效液相色谱-紫外检测器-蒸发光散射检测器(HPLC-VWD-ELSD)法同时测定黄甲软肝颗粒中没食子酸、葛根素、芍药苷、三七皂苷R1、黄芪甲苷和丹参酮 ⅡA 的含量。方法: 采用Waters Symmetry C18 色谱柱(250 mm×4.6 mm,5 μm),流动相为甲醇(A)-0.1% 醋酸水溶液(B),梯度洗脱,流速为1.0 mL·min-1。没食子酸、葛根素和丹参酮 ⅡA 采用VWD 进行检测,检测波长为270 nm;芍药苷,三七皂苷R1 和黄芪甲苷采用ELSD 进行检测,漂移管温度为70 ℃,载气流速2.0 L·min-1结果: 没食子酸、葛根素、芍药苷、三七皂苷R1、黄芪甲苷和丹参酮 ⅡA 进样量分别在1.444~28.88、2.118~42.36、1.074~21.48、0.218 0~4.360、0.115 1~2.302 和0.066 70~1.334 μg 范围内与峰面积呈良好的线性关系;平均回收率(n=6)分 别为93.8%、98.8%、97.5%、103.0%、100.6% 和96.6%,RSD 分别为1.4%、0.55%、3.3%、4.0%、3.9% 和2.3%。 5 批黄甲软肝颗粒中上述6 个成分的含量测定结果分别为2.612~3.203、9.155~10.342、7.044~9.863、0.622~0.841、1.529~1.697 和0.719~0.957 mg·g-1结论: 所建立的方法简便、快捷,重复性好,可用于黄甲软肝颗粒中6 个成分的含量测定,为黄甲软肝颗粒全面的质量控制提供科学依据。

本文引用格式

王宗权, 黄朝情, 黄志辉, 李艳英, 高进, 黄能听, 刘军, 张保献, 滕利荣 . HPLC-VWD-ELSD 法同时测定黄甲软肝颗粒中6 个成分的含量*[J]. 药物分析杂志, 2021 , 41(7) : 1148 -1154 . DOI: 10.16155/j.0254-1793.2021.07.05

Abstract

Objective: To develop a method of high performance liquid chromatography-variable wavelength detector-evaporative light scattering detection( HPLC-VWD-ELSD) for simultaneous determination of gallic acid,puerarin,paeoniflorin,notoginsenoside R1,astragaloside and tanshinone ⅡA in Huangjia Ruangan granules. Methods: HPLC assay was performed on a Waters Symmetry-C18 column( 250 mm×4.6 mm,5 μm) with a mixture of methanol and 0.1% aqueous acetic acid as the mobile phase in gradient elution at the flow rate of 1.0 mL·min-1. Detection wavelength for gallic acid,puerarin and tanshinone ⅡA was set at 270 nm and ELSD was used for detection of paeoniflorin,notoginsenoside R1 and astragaloside. The temperature of the drift tube was maintained at 70 ℃ and the nebulizing gas flow rate was 2.0 L·min-1. Results: The linear ranges of gallic acid, puerarin,paeoniflorin,notoginsenoside R1,astragaloside and tanshinone ⅡA were 1.444-28.88,2.118-42.36, 1.074-21.48,0.218 0-4.360,0.115 1-2.302 and 0.066 70-1.334 μg,respectively. The average recoveries (n=6) were 93.8% with RSD of 1.4%,98.8% with RSD of 0.55%,97.5% with RSD of 3.3%,103.0% with RSD of 4.0%,100.6% with RSD of 3.9%,96.6% with RSD of 2.3%,respectively. The contents of the above-mentioned components in 5 samples were 2.612-3.203,9.155-10.342,7.044-9.863,0.622-0.841,1.529-1.697 and 0.719-0.957 mg·g-1,respectively. Conclusion: The method is simple,rapid and reproducible. It can be used for the determination of the six components in Huangjia Ruangan granules,providing a scientific basis for the comprehensive quality control of Huangjia Ruangan granules.

参考文献

[1] 索贞,任敏,周好田. 黄芪的化学成分及现代药理[J]. 现代医院,2005,5(9):85
SUO Z,REN M,ZHOU HT.Chemical component and modern pharmacology of Radix Astragali Seu Hedysri[J]. Mod Hosp, 2005,5(9):85
[2] ELABD H,WANG HP,SHAHEEN A,et al.Huangqi( Astragali Radix) nanoparticles markedly improve immune and antioxidative responses;and protection against Aeromonas veronii in Nile tilapia Oreochromis niloticus[J]. Fish Shelltish Immunol,2020,97: 248
[3] 罗飘,楚世峰,陈乃宏. 黄芪在肝纤维化治疗中的研究进展[J]. 神经药理学报,2018,8(6):43
LUO P,CHU SF,CHEN NH.Research progress of Astragalus membranaceus in the treatment of liver fibrosis[J]. Acta Neuropharmacol,2018,8(6):43
[4] WANG Z,LI Q,XIANG M,et al.Astragaloside alleviates hepatic fibrosis function via PAR2 signaling pathway in diabetic rats[J]. Cell Physiol Biochem,2017,41(3):1156
[5] SHEARER A M,RANA R,AUSTIN K,et al.Targeting liver fibrosis with a cell-penetrating protease-activated receptor-2( PAR2) pepducin[J]. J Biol Chem,2016,29(44):23188
[6] 张晔,吕金朋,孙佳明,等. 鳖甲抗肝纤维化研究进展[J]. 吉林中医药,2018,38(6):673
ZHANG Y,LÜ JP,SUN JM,et al.Research progress of the anti-liver fibrosis of trionycis carapax[J]. Jilin J Chin Med,2018,38(6):673
[7] 闫迪,苏姣,冯全生. 鳖甲防治肝纤维化研究进展[J]. 世界最新医学信息文摘,2018,18(28):115
YAN D,SUN J,FENG QS.Research progress on prevention and treatment of liver fibrosis by turtle shell[J]. World Latest Med Inf, 2018,18(28):115
[8] JUNG S,SON H,HWANG CE,et al.Ganoderma lucidum ameliorates non-alcoholic steatosis by upregulating energy metabolizing enzymes in the liver[J]. J Clin Med,2018,7(6): 152
[9] 付永明,麻大鹏. 我国灵芝种质资源及生产技术研究[J]. 种子科技,2018,32(6):47
FU YM,MA DP.Study on germplasm resources and production technology of Ganoderma lucidum in China[J]. Hortic Seed Ind, 2018,32(6):47
[10] ZHU M,CHANG Q,WANG LK,et al.Triterpene antioxidants from Ganoderma lucidum[J]. Phytother Res,1999,13(6):529
[11] 张谊,王立晖,王惠霞,等. 丹参酮ⅡA 在肝脏疾病中的作用及其新剂型的研究进展[J]. 中国药理学通报,2020,36(5):596
ZHANG Y,WANG LH,WANG HX,et al.Research progress on action and new dosage form of tanshinone ⅡA inliver diseases[J]. Chin Pharmacol Bull,2020,36(5):596
[12] PENG XD,DAI LL,HUANG CQ,et al.Relationship between anti-fibrotic effect of Panax notoginseng saponins and serum cytokines in rat hepatic fibrosis[J]. Biochem Biophys Res Commun,2009,388(1):31
[13] 刘亮,周知午. 三七总苷对酒精性肝损伤大鼠肝脏TGF-β1/ Smads、CTGF mRNA 表达的影响[J]. 中南药学,2013,11(12): 890
LIU L,ZHOU ZW.Effect of Panax notoginsenosides on expression of TGF-β1/Smads and CTGF mRNA in rats with alcoholic liver disease[J]. Cent South Pharm,2013,11(12):890
[14] 任正肖,车萍,李紫薇,等. 葛根素药理作用的研究进展[J]. 山东化工,2019,48(19):74
REN ZX,CHE P,LI ZW,et al.Research progress on pharmacological effect of puerarin[J]. Shandong Chem Ind,2019, 48(19):74
[15] 高雪岩,孙建宁,王文全,等. 赤芍总苷的制备及其对小鼠肝损伤的保护作用[J]. 中国实验方剂学杂志,2010,16(18):183
GAO XY,SUN JN,WANG WQ,et al.Preparation of total glycosides of Paeonia lactiflora and research on its hepatoprotective effects in mice[J]. Chin J Exp Tradit Med Form,2010,16(18):183
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