乳香药材、乳香酸提取物及其制剂的特征图谱质量控制研究

Specific Chromatogram Study of Boswellia Carteri,Boswellic Acid Extractive and Its Preparation

目的建立乳香药材、乳香酸提取物及其制剂痹络通片的HPLC-ELSD特征图谱,为乳香药材、乳香酸提取物及其制剂的质量控制以及工艺评价提供有效的方法。方法色谱分离采用Fortis C18色谱柱,以甲醇-1%冰醋酸水溶液为流动相,梯度洗脱,蒸发光散射检测器,ELSD条件:漂移管温度:80!C;气流流速:2.1L.min-1。对多批乳香药材、提取物及其制剂进行HPLC检测和方法学考察,并采用"中药色谱指纹图谱相似度评价系统"软件(2004A版)对其进行相似度分析。结果所建立的HPLC特征图谱能够对乳香药材、提取物及其制剂各组分进行良好分离,具有较好的精密度、重复性和稳定性;经相似度评价,确定各组分平均相似度大于0.9。结论采用HPLC建立的特征图谱方法简单,重复性好,能够准确分析乳香药材、提取物及其制剂的物质组成以及有效物质群的变化,可用于乳香药材、提取物及其制剂的质量控制和工艺评价。

Objective To establish the specific chromatogram of Boswellia Carteri, boswellic acid extractive, and Biluotong tablet, so as to provide an effective way for quality control and process evaluation of Boswellia Carteri, boswellic acid extractive, and its preparation. Methods Fortis C18 column was adopted with the mobile phase consisting of methanol and 1% glacial acetic acid aqueous solution in gradient mode. The detection was Evaporative Light Scattering Detector （ELSD）. The gas flow rate was 2.1 L· min-1 under the temperature of 80 ℃. The methodology examination was studied, and several batches of Boswellia Carteri, boswellic acid extractive, and its preparation were determined by HPLC. The similar degree was analyzed with＂ Similarity Evaluation System for Chromatographic Fingerprint of TCM （Version 2004 A） ＂. Results The components of Boswellia Carteri, boswellic acid extractive, and its preparation could be separated well using HPLC method. The developed method was precise, reproducible and stable. By similar degree calculating, the similarity degree of the samples was more than 0.9. Conclusion The established method is simple, accurate and reproducible in the components determination of Boswellia Carteri, boswellic acid extractive, and its preparation, which can be used for the quality control and process evaluation of Boswellia Carteri, boswellic acid extractive, and its preparation.