雷公藤制剂中雷公藤红素及雷公藤总三萜的测定  

Assay of tripterine and Tripterygium wilfordii total triterpenoids in Tripterygium wilfordii preparations

作　　者：薛璟[1,2] 贾晓斌[1,2] 谭晓斌[1] 贾东升[1] 蒋俊[1] 王慕旸[3] 张陆勇[3] 

机构地区：[1]江苏省中医药研究院中药新型给药系统重点实验室,国家中医药管理局中药口服制剂释药系统重点研究室,南京210028 [2]南京中医药大学,南京210046 [3]中国药科大学,南京210009

出　　处：《中华中医药杂志》2010年第7期1105-1108,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中医药行业科研专项(No.200707008)~~

摘　　要：目的:建立雷公藤制剂中雷公藤红素及雷公藤总三萜的含量测定方法。方法:采用超高效液相色谱法,以BEH C18色谱柱(1.7μm,2.1×50mm),甲醇-1%冰醋酸水溶液(70:30)为流动相,流速0.4mL/min,于250nm处测定雷公藤红素的含量;另外采用比色法,以香草醛-冰醋酸-高氯酸显色,于425nm波长处测定吸收度,测定雷公藤总三萜含量。结果:以超高效液相色谱法测定雷公藤红素,浓度在5.0-80.0μg/mL范围内呈现了良好的线性关系(r=0.9996),平均回收率(n=9)为99.01%;以比色法测定雷公藤总三萜(以雷公藤红素计),浓度在20.0-100.0μg/mL范围内呈现了良好的线性关系(r=0.9989),平均回收率(n=9)为99.86%。测得市售雷公藤制剂中雷公藤红素含量在19.54-772.64μg/片,雷公藤总三萜含量在4.27-8.90mg/片。结论:两方法均准确可靠,可用于雷公藤制剂质量分析控制。市售雷公藤制剂中雷公藤红素及雷公藤总三萜含量差异较大,应该加强其质量控制、保障用药安全有效。Objective：To develop methods for the determination of tripterine and Tripterygium wilfordii total triterpenoids in Tripterygium wilfordii preparations. Methods：The UHPLC analysis was used with an BEH C18 column （1.7μm,2.1×50 mm） ,using methanol-1%HAc （70：30） as mobile phase. The detection wavelength was 250nm and the flow rate was 0.4mL/min. A colrimetric method was established for the essay of the total triterpenoids with Vanillin-HAc-Perchloric acid as the coloring reagent and measuring of the absorbance at 425nm. Results：The calibration curves were linear in the ranges from 5.0 to 80.0μg/mL （r=0.9996） for tripterine with UHPLC and from 20.0-100.0μg/mL （r=0.9989） for the total triterpenoids （calculated as tripterine） with colorimetric method. The average recoveries （n=9） were 99.01% and 99.86%,respectively. The contents of tripterine and tripterygium total triterpenoids of the OTC Tripterygium preparations were found to be in the range from 19.54-772.64μg/tablet and 4.27-8.90mg/tablet,respectively.Conclusion：Both methods were found to be accurate and reliable with very good ruggedness. They can be used for the assay and quality control of the Tripterygium wilfordii preparations. The contents of tripterine and Tripterygium wilfordii total triterpenoids of the OTC Tripterygium wilfordii preparations 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：雷公藤制剂 雷公藤红素 雷公藤总三萜 超高效液相色谱法 比色法 

分 类 号：R286[医药卫生—中药学]