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中药复方制剂——保济丸的高效液相色谱-二极管阵列检测指纹图谱研究

[Study of HPLC-DAD fingerprint on complex traditional Chinese medicine proprietary preparation-Baoji pills].

作者信息

Wang Xiang-hong, Xie Pei-shan, Tian Run-tao, Huang Xiao-dan, Zheng Rong-bo, Qin Chun-mei, Yu Qiong-xi

机构信息

Zhuhai Chromap Institute of Herbal Medicine Research, Zhuhai 519085, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2007 Sep;32(17):1748-51.

Abstract

OBJECTIVE

Based on 'Back-tracking' method, identification and quality evaluation of complex traditional Chinese medicine (TCM) preparation of Baoji pills (BJP) were carried out by HPLC fingerprint analysis.

METHOD

HPLC-DAD fingerprint of BJP was conducted with Zorbax SB-C18 column and non-linear elution with the mobile phase consisted of acetonitrile-0.5% glacial acetic acid at column temperature 30 degrees C and detective wavelengths of 250 nm and 283 nm. From the established chromatographic pattern of BJP, track backward to the corresponding crude herbal drugs in the formula, attribution ofmost peaks in the BJP fingerprint can be disclosed.

RESULT

The BJP HPLC fingerprint consisted of 44 peaks among which 35 peaks were assigned by parallel comparison with the fingerprint of the 10 corresponding crude drugs in the formula such as pueraria, pummelo peel, and magnolia bark, etc. and 22 peaks we reidentified by comparison with the chemical reference substances.

CONCLUSION

The established HPLC fingerprint represents the whole character of BJP, which enhanced the specialty for control and assessment of the product quality. It exemplified much more effective for quality control than selecting any marker for qualitative or quantitative testing target. And the Back-tracking' experimental method extended the study mentality for complex formula TCM products chromatographic fingerprinting analysis.

摘要

目的

基于“追溯”法,采用高效液相色谱指纹图谱分析法对保济丸这一复杂中药制剂进行鉴别及质量评价。

方法

采用Zorbax SB-C18色谱柱,以乙腈-0.5%冰醋酸为流动相进行非线性洗脱,柱温30℃,检测波长为250nm和283nm,建立保济丸的高效液相色谱-二极管阵列检测器指纹图谱。从所建立的保济丸色谱图出发,反向追溯至配方中的相应中药材,可揭示保济丸指纹图谱中多数峰的归属。

结果

保济丸高效液相色谱指纹图谱共由44个峰组成,其中35个峰通过与配方中10味相应中药材(如葛根、柚皮、厚朴等)的指纹图谱进行平行比较得以归属,22个峰通过与化学对照品比较得以鉴定。

结论

所建立的高效液相色谱指纹图谱体现了保济丸的整体特征,增强了产品质量控制与评价的专属性。相较于选择任何单一指标进行定性或定量检测,该方法在质量控制方面更为有效。并且“追溯”实验方法拓展了复杂复方中药产品色谱指纹图谱分析的研究思路。

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