姜竹茹配方颗粒质量标准研究  

Study on Quality Standards of Ginger-fried Bambusae Caulis In Taenias Formula Granules

作　　者：赵淑淑 俞杰 姚俊霞 黄琪 许豪杰 ZHAO Shushu;YU Jie;YAO Junxia;HUANG Qi;XU Haojie(Zhejiang Jolly Pharmaceutical Co.,Ltd,Zhejiang Deqing 313200,China)

机构地区：[1]浙江佐力药业股份有限公司,浙江德清313200

出　　处：《中国医药导刊》2022年第7期702-706,共5页Chinese Journal of Medicinal Guide

基　　金：浙江省中医药管理局中药配方颗粒科研专项(项目编号:浙中医〔2017〕11号;项目名称:中药配方颗粒产业化及临床应用关键技术研究)。

摘　　要：目的:采用高效液相色谱(HPLC)法建立姜竹茹配方颗粒的指纹图谱及含量测定方法,旨在完善姜竹茹配方颗粒质量控制方法。方法:指纹图谱研究中,采用Welch Ultimate AQ-C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸溶液为流动相梯度洗脱,流速1.0 mL·min^(-1),柱温30℃,检测波长280 nm。采用“中药色谱指纹图谱相似度评价软件系统2012年版130723版本”软件进行指纹图谱分析。含量测定研究中,以乙腈-0.1%磷酸溶液(13∶87)为流动相,流速1.0 mL·min^(-1),柱温30℃,检测波长308 nm。结果:与17批标准汤剂形成的对照图谱进行比较,4批供试品共有4个共有峰,对照图谱相似度均大于0.85;含量测定中,4-香豆酸在12.6~6990.7 ng(r^(2)=0.9998)范围内呈现良好的线性关系,平均加样回收率分别为94.73%(RSD=0.58%)。结论:该方法简便、准确,重现性良好,可为姜竹茹配方颗粒的质量控制提供参考。Objective:To establish quality standard of ginger-fried Bambusae Caulis In Taenias formula granules through the HPLC fingerprint spectrum and the determination of the content,to improve its quality control methods.Methods:The HPLC analysis was carried out using a column of Welch Ultimate AQ-C18(4.6 mm×250 mm,5μm)with the temperature of 30℃.The mobile phase was consisted of acetonitrile-0.1%phosphoric acid solution with gradient elution at a flow rate of 1.0 mL·min^(-1),and the detection wavelength was 280 nm.Fingerprint spectrum analysis was performed using Chinese Medicine Chromatographic Fingerprint Spectrum Similarity Evalution System software(2012.130723 version).The 4-coumaric acid was tested with the detection wavelength of 308nm.The mobile phase was consisted of acetonitrile-0.1%phosphoric acid solution(13∶87)with gradient elution at a flow rate of 1.0 mL·min^(-1),column temperature 30℃.Results:Compaired with the fingerprints of 17 batches of ginger-fried Bambusae Caulis In Taenias standard decoction,there were four common peaks in the 4 batches of ginger-fried Bambusae Caulis In Taenias formula granules tested,with the similarities greater than 0.85.Good linearities of 4-coumaric acid was achieved in the ranges of 12.6~6990.7 ng(r^(2)=0.9998).The average recoveries was 94.73%(RSD=0.58%).Conclusion:The method is convenient,accurate and with good repeatability,and it can provide reference evidence for quality control of ginger-fried Bambusae Caulis In Taenias formula granules.

关 键 词：姜竹茹配方颗粒 指纹图谱 4-香豆酸 质量研究 

分 类 号：R927[医药卫生—药学] R286