复方中成药保济丸的HPLC-DAD指纹图谱研究

目的：用逆向回溯方式试验研究保济丸高效液相色谱指纹图谱,缩短试验周期,提高工作效率,建立整体特征的质量评价方法。方法：采用HPLC-DAD检测,Zorbax SB-C₁₈色谱柱,以乙腈-0.5%冰醋酸为流动相在30 ℃柱温下进行非线性梯度洗脱,从成品的指纹图谱回溯确认相关的药材在指纹图谱中的归属。结果：建立的高效液相色谱指纹图谱中可检出44个特征峰,其中35个色谱峰分别溯源到葛根、化橘红、厚朴、菊花等10味药材,22个色谱峰可明确化学成分的归属,色谱的整体构建了保济丸的指纹图谱。结论：建立的HPLC-DAD指纹图谱表达了保济丸可测组分的整体特征,提高了对中药复方制剂质量控制的专属性,在鉴别和评价商品内在质量方面的作用远大于任选1,2种指标成分测定含量的作用。逆向回溯的研究模式扩展了大复方中药质量研究的思路。

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

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.