心舒口服液毛细管电泳指纹图谱的研究

Fingerprints of Xinshu Oral Liquid by HPCE

目的对心舒口服液的质量控制方法进行研究。方法采用高效毛细管电泳法建立以10批当归道地药材,10批川芎道地药材,10批红花道地药材,10批心舒口服液为样品的指纹图谱,比较研究制剂与药材指纹图谱之间的相关性,并与单味药材水煎液、各药材阴性对照液的指纹图谱进行比较,通过比较在线紫外光谱和迁移时间的方法,对口服液与各药材的水煎液、阴性对照液的指纹图谱中各指纹峰进行一一归属。结果分别建立标准指纹图谱,初步确定样品制剂与原料药材指纹图谱之间的相关性,最终建立复方中药制剂的质量控制方法。结论在心舒口服液指纹谱中,27个指纹峰中有14个指纹峰来自当归,10个指纹峰来自川芎(其中7个指纹峰是当归与川芎所共有的),9个指纹峰来自红花。

Objective To develop a method of quality control for fingerprints of Xinshu Oral Liquid. Methods Based on electrophoregram of ten batches of genuine Radix Angelicae Sinensis （RAS）, ten batches of genuine Rhizorna Chuanxiong （RC）, and ten batches of genuine Flos Carthami （FC） by high performance capillary electrophoresis （HPCE） to compare the fingerprints between Xinshu Oral Liquid and the genuine medicinal herbs, single herb decoction, nagetive control herb solution, respectively. The fingerprint assignment was made by comparing the UV spectra and relative migration time. Results To compare the fingerprints of ten samples from different batches and single herb, the correlation of peaks between fingerprings was found. Finally the standard fingerprints and the method of quality control were established. Conclusion Based on the fingerprints of ten batches of prearations, an average electrophoregram was used as the standard fingerprint. There are 27 ＂common peaks＂ in the fingerprint, among them 14 from RAS, ten from RC （in which seven are commnon） and nine from FC.