新血府逐瘀软胶囊质量标准HPLC指纹图谱定性研究  

Qualitative Research of HPLC Fingerprint for the Quality Standard of Xin Xuefu Zhuyu Capsules

作　　者：白小英 陈静 张红[2] 吉中强 张伟 

机构地区：[1]青岛市中医医院制剂实验室,山东青岛266033 [2]山东中医药大学中药学院,山东济南250014 [3]青岛市中医医院心内科,山东青岛266033

出　　处：《世界中西医结合杂志》2017年第4期515-519,共5页World Journal of Integrated Traditional and Western Medicine

基　　金：青岛市2012年度医药科研指导计划(2012-WSZD057)

摘　　要：目的建立中药复方制剂新血府逐瘀软胶囊HPLC共性指纹图谱,为其质量标准评价提供依据。方法采用Thermo C_(18)(4.6 mm×250 mm,5μm)色谱柱,以乙腈(A)-0.2%甲酸溶液(B)为流动相进行梯度洗脱,以254 nm为检测波长,对14批次新血府逐瘀软胶囊内容物样品HPLC图谱进行采集和相似度分析比较。同时,采用图谱对照法,以保留时间为参数,比对样品共有HPLC图谱、对照品HPLC图谱和单味对照药材HPLC图谱,对可辨析的18个共有峰成分进行指认和药材来源进行追溯。结果以峰形可辨析的18个共有成分峰的相对保留时间为匹配点,14批次样品色谱图相似度在0.938~0.985之间,RSD值为1.25%,各批次样品之间HPLC图谱有良好的相似性,并建立新血府逐瘀软胶囊样品内容物HPLC共有指纹图谱。比对指认出9个共有峰成分分别为熊果酸、绿原酸、羟基红花黄色素A、芍药苷、阿魏酸、金丝桃苷、柚皮苷、橙皮苷和新橙皮苷;追溯出HPLC共有指纹图谱中红花、赤芍、山楂、枳实等四味药材的存在。结论新建立的中药复方制剂新血府逐瘀软胶囊HPLC共性指纹图谱方法准确可靠,为全面控制制剂质量提供了依据。Objective To establish HPLC fingerprint of the compound herbal preparation,xin xuefu zhuyu capsules and provide the evidences for the evaluation of its quality standard. Methods Adopting Thermo C18（ 4. 6 mm × 250 mm,5 μm）,acetonitrile（ A）-0. 2% formic acid（ B） as mobile phase for the gradient elution,at 254 nm,HPLC was collected from the content samples of 14 batches of xin xuefu zhuyu capsules and the similarity was compared and analyzed. With the fingerprint comparison method,taking the retention time as the parameter,the common HPLC fingerprint of the samples,HPLC fingerprint of the reference and HPLC fingerprint of single reference herbal material were compared. The 18 peak components which were identifiable were pointed and the source of herbal materials were traced. Results The relevant retention time of 18 identifiable common peaks was taken as the match point. The similarity of chromatogram among 14 batches of samples was in the range from 0. 938 to 0. 985,RSD 1. 25%. HPLC fingerprints are good in similarity among different batches. The common fingerprint of the sample contents was established in xin xuefu zhuyu capsules. Nine common peak components were pointed,i. e. ursolic acid,chlorogenic acid,hydroxyl safflower yellow-A,paeoniflorin,ferulic acid,hyperin,naringin,hesperidin and new hesperidin. Four herbal materials were traced with common HPLC fingerprint,i. e. safflower carthamus,radix paeoniae rubra,fructus crataegi and fructus aurantii immaturus. Conclusion The HPLC common fingerprint method is accurate and reliable,which provides the evidence for the overall quality control of xin xuefu zhuyu capsules.

关 键 词：新血府逐瘀软胶囊 HPLC指纹图谱 共有峰 相似度评价 

分 类 号：R286[医药卫生—中药学]