雷公藤多苷片中雷公藤总内酯及雷公藤内酯醇的测定  

Assay of tripterygium total lactones and triptolide in Tripterygium tablets

作　　者：庄莹[1] 宋敏[1] 杭太俊[1] 潘丽[1] 张正行[1] 

机构地区：[1]中国药科大学药物分析教研室,南京210009

出　　处：《药物分析杂志》2008年第1期36-40,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：建立雷公藤多苷片中雷公滕总内酯及雷公藤内酯醇的含量测定方法。方法:采用比色法,以3,5-二硝基苯甲酸显色,于540 nm 波长处测定吸收度,测得雷公藤总内酯含量;另外采用高效液相色谱法,使用 ODS 柱(4.6 mm×250 mm,5μm),流动相 A 为甲醇,流动相 B 为甲醇-0.01mol·L^(-1)磷酸二氢钾水溶液(20∶80),采用梯度洗脱,于218 nm 处检测,测定雷公滕内酯醇的含量。结果:以比色法测定雷公藤总内酯(以雷公藤内酯醇计),浓度在8～40mg·L^(-1)范围内呈现良好的线性关系(r=0.9998),平均回收率(n=9)为100.6%;以高效液相色谱法测定雷公藤内酯醇,浓度在10～100 mg·L^(-1)范围内线性关系良好(r=0.9999),平均回收率(n=9)为99.6%。测得市售雷公藤多苷片中雷公藤总内酯含量在0.061%～0.363%范围内,雷公滕内酯醇含量在0.002%～0.200%范围内。结论:两方法均准确可靠、耐用性良好,可用于雷公藤多苷片质量分析控制。市售雷公藤多苷片中雷公藤总内酯及雷公藤内酯醇含量差异较大,应该加强其质量控制、保障用药安全与有效。Objective： To develop methods for the determination of Tripterygium total lactones and tnptolide m Tripterygium tablets. Methods：A colorimetric method was established for the assay of the total lactones with 3,5 - dinitrobenzoic acid as the coloring reagent and measuring of the absorbance at 540 nm. The HPLC analysis for triptolide was carried on an ODS column（4.6 mm ×250 mm,5 μm） with gradient elution by the mobile phase consisting of A（methanol） and B [ methanol -0.01 mol · L ^-1 potassium dihydrogen phosphate solution（20： 80） ] and UV detection at 218 nm. Results：The calibration curves were linear in the ranges from 8 to 40 mg · L^-1 （ r =0.9998） for the total lactones（ calculated as triptolide） with colorimetric method and from 10 to 100 mg ·L^-1（ r = 0. 9999 ） for triptolide with HPLC. The average recoveries （ n = 9） were 100.6% and 99.6% , respectively. The contents of Tripterygium total lactones and triptolide of the OTC tripterygium tablets were found to be in the range from O. 061% to 0.363% and from 0.002% to 0. 200% ,respectively. Conclusion：Both methods are found to be accurate and reliable with very good ruggedness. They can be used for the assay and quality control of the Tripterygium tablets. The contents of tripterygium total lactones and triptolide of the OTC tripterygium tablets were found to be in great diverse. In order to make safe and effective usage of the drug, much more attention should be paid to their quality control.

关 键 词：雷公藤多苷片 雷公藤总内酯 雷公藤内酯醇 比色法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]