3种市售中药复方制剂消炎利胆片的HPLC指纹图谱研究  

Study on HPLC Fingerprint of Three TCM Prescription Named Xiaoyanlidan Tablet in Market

作　　者：姚志红[1,2] 潘宇明[1,2] 戴毅[1,2] 陈妍[1,2] 屠风娟[2,3] 高昊[1,2] 姚新生[1,2,3] 

机构地区：[1]暨南大学中药及天然药物研究所,广州510632 [2]中药药效物质基础及创新药物研究广东省高校重点实验室,广州510632 [3]沈阳药科大学天然药物化学教研室,沈阳110016

出　　处：《中国药学杂志》2010年第20期1530-1534,共5页Chinese Pharmaceutical Journal

基　　金：广州市中药现代化重大专项资助项目(2004Z1-E5011)

摘　　要：目的建立3种市售中药复方制剂消炎利胆片的HPLC指纹图谱,并对多批次产品的质量进行初步评价。方法采用C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水(分别含体积分数0.1%的甲酸)为流动相进行梯度洗脱,流速1.00 mL.min-1,检测波长254 nm,柱温25℃;建立消炎利胆片的HPLC指纹图谱,通过比对各组方中药提取物的HPLC图谱,确定消炎利胆片HPLC指纹图谱中主要色谱峰的组方中药来源;通过比对化学分离制得的对照品的保留时间,对部分主要色谱峰进行明确化学指认;利用中药指纹图谱相似度评价系统对3个厂家的24批市售产品进行相似度评价。结果所建立的消炎利胆片指纹图谱具有较好的精密度、重现性和稳定性,在可检出的40个色谱峰中,31个色谱峰的组方中药来源得到明确,7个色谱峰得到化学指认。相同厂家不同批次市售消炎利胆片指纹图谱的相似度不低于0.954;3个厂家的24批市售消炎利胆片指纹图谱的相似度为0.845～0.987,然而,剪切图谱(脱水穿心莲内酯出峰前的指纹图谱,即0～69 min)的相似度仅为0.478～0.896。结论所建立的HPLC指纹图谱表达了上述3种市售消炎利胆片中多组分的整体特征,为评价市售消炎利胆片的质量提供了可靠的实验数据。OBJECTIVE To develop a HPLC fingerprint chromatogram of a traditional Chinese medicine（TCM） prescription named Xiaoyanlidan Tablet（XYLD） for the evaluation of the quality of its products.METHODS The method was developed on a C18 column（4.6 mm×250 mm,5 μm） by gradient elution with acetonitrile-water（both containing 0.1%（V/V） formic acid） as mobile phase at a flow rate of 1.00 mL·min-1 with the detection wavelength at 254 nm and column temperature at 25 ℃.The HPLC fingerprint chromatogram of XYLD was set up and the origin of main peaks were clarified by comparing with overlapping chromatograms of three compositive crude herbs.Furthermore,some of the main peaks were identified by comparing the retention time with those of chemical reference substance.The similarity assay of 24 batches of XYLD from 3 different manufactures was carried out to evaluate their quality by TCM fingerprint similarity evaluation system.RESULTS The HPLC fingerprint chromatogram of XYLD was established with good stability,precision and reproducibility.Among forty detected peaks in the HPLC fingerprint chromatogram of XYLD,the source of thirty-one peaks was revealed and seven of them were identified.The similarity of XYLD tablet was above 0.954 within the products by the same manufacture.However,the similarity was about 0.845 to 0.987.The similarity droped to 0.478 to 0.896 within the cut chromatogram（eluates before dehydroandrographolide,0 to 69 min）.CONCLUSION The HPLC fingerprint chromatogram represented the profile of multiple chemical substances in XYLD tablet,which would contribute to its quality control.

关 键 词：消炎利胆片 中药复方制剂 高效液相色谱法指纹图谱 

分 类 号：R284[医药卫生—中药学]