摘要
目的建立扶正化瘀胶囊(丹参、虫草菌丝、绞股蓝、桃仁、五味子、松花粉)指纹图谱,并进行多成分定量分析,为全面评价扶正化瘀胶囊质量提供依据。方法采用高效液相色谱法,Kromasil C18柱(250 mm×4.6 mm,5μm),乙腈-甲醇-0.2%磷酸水溶液梯度洗脱,检测波长280 nm,柱温30℃,体积流量0.8 mL/min,测定10个批次的扶正化瘀胶囊,建立指纹图谱,并对部分特征峰进行归属及定量分析。结果各批次胶囊剂相似度在0.97以上;标定了15个特征峰,确定了12个特征峰的峰归属;通过对照品比对,确定了第9号峰及第13号峰分别为原儿茶醛和丹酚酸B,并对其定量分析;10批胶囊剂中原儿茶醛和丹酚酸B的含有量差异较大,说明不同批次的胶囊剂质量受多种因素影响,有较大的差别。结论建立了扶正化瘀胶囊HPLC定量指纹图谱,为其全面的质量控制提供了科学依据。
AIM To establish an HPLC fingerprint of Fuzheng Huayu Capsule（Salviae miltiiorrhizae Radix et Rhizoma,Cordyceps,Gynostemmae pentaphylli Herba,Persicae Semen,Schisandrae chinemis Fructus,Pini Pollen）,and to make a quantitative analysis.METHODS HPLC experiments were performed on Kromasil C18（250 mm×4.6 mm,5 μm）,eluted with acetonitrile-methanol-0.2% phosphoric acid as the mobile phases in gradient elution mode.The detection wavelength was set at 280 nm.The flow rate was 0.8 mL/min.Ten batches of Fuzheng Huayu Capsule were detected to establish fingerprints,respectively.RESULTS The similarity among batches was more than 0.97.The twelve of fifteen automatic common peaks matching could be traced back to its origins.Compared with reference substance,No.9 peak was protocatechu aldehyde and No.13 peak was salvianolic acid B.There were great differences in the contents of protocatechu aldehyde and salvianolic acid B among the ten batches of Fuzheng Huayu Capsule.CONCLUSION The method is high sensitive,stable and reproducible and provides the basis for the overall assessment of the quality of Fuzheng Huayu Capsule.
出处
《中成药》
CAS
CSCD
北大核心
2012年第3期389-393,共5页
Chinese Traditional Patent Medicine
基金
上海市科委科技攻关计划(08DZ1971100)
上海市教委重点学科(J50302)
关键词
扶正化瘀胶囊
HPLC
定量指纹图谱
质量评价
Fuzheng Huayu Capsule
full-quantified HPLC fingerprint
quality assessment
