不同雷公藤制剂雷公藤甲素、雷公藤内酯甲及雷公藤总内酯含量的比较  

Determination of triptolide, wilforlide and total triptolides in various Tripterygium Wilfordii preparations

作　　者：王爱武[1] 王楠楠 刘帅[1] 侯宁[1] 

机构地区：[1]山东大学附属省立医院药剂科,济南250021 [2]莱州市食品药品监督管理局,山东莱州261400

出　　处：《中南药学》2015年第10期1081-1085,共5页Central South Pharmacy

摘　　要：目的比较雷公藤片、雷公藤多苷片、昆明山海棠片中雷公藤甲素、雷公藤内酯甲及雷公藤总内酯日用量的差异,为该类制剂的质量控制及临床应用评价提供参考。方法采用HPLC法测定雷公藤甲素、雷公藤内酯甲的含量,采用紫外分光光度法测定雷公藤总内酯的含量,比较不同厂家3种成分日用量的差异。雷公藤甲素以甲醇-水（45：55）为流动相,柱温为30℃,检测波长为218 nm;雷公藤内酯甲以乙腈-水（85：15）为流动相,柱温为30℃,检测波长为210 nm。结果雷公藤片中雷公藤甲素、雷公藤内酯甲及雷公藤总内酯3种成分的含量为最高,其次为雷公藤多苷片,昆明山海棠片最低,雷公藤甲素仅为雷公藤片的1/50、雷公藤内酯甲及总内酯为雷公藤片的1/8~1/10。临床上雷公藤甲素最高用量为53μg·d-1、最低用量仅为1.8μg·d-1,雷公藤内酯甲最高用量为1.2 mg·d-1、最低用量为0.1 mg·d-1,雷公藤总内酯最高用量为8.4mg·d-1、最低用量为1.3 mg·d-1。同一厂家不同批号的雷公藤片雷公藤甲素相差近5倍、雷公藤内酯甲相近、总内酯相差近1倍。结论不同雷公藤片、雷公藤多苷片、昆明山海棠片中雷公藤甲素、雷公藤内酯甲及雷公藤总内酯的日用量存在明显差异,以雷公藤片最高、其次为雷公藤多苷片、昆明山海棠片为最低。同一厂家不同批号的雷公藤片之间、雷公藤多苷片之间及不同厂家的雷公藤多苷片之间所测成分均有一定的差异,但不同厂家的昆明山海棠片相差不大。Objective To compare the differences in the day dosage of triptolide, wilforlide and total triptolides from Tripterygium wilfordii tablets, Tripterygium glycosides tablets, and Kunming Shanhaitang tablets, and provide refer- ence for the preparation and clinical evaluation. Methods Triptolide and wilforlide were determined by HPLC, and the content of the total triptolides was detected by ultraviolet spectrophotometric method to compare with the daily us- age of triptolide, wilforlide and total triptolides in Tripterygium wilfordii tablets, Tripterygium glycosides tablets, and and Kunming Shanhaitang tablets from different manufacturers. Methanol-water （45 ： 55） was used as the mobile phase for triptolide, the eolumn temperature was 30℃, the detection wavelength was 218 nm. Acetonitrile and water （85 ： 15） was used as the mobile phase for wilforlide, the column temperature was 30 ℃ , the detection wavelength was 210 nm. Results The contents of triptolide, wilfodide and total triptolides from Tripterygium Wilfordii npter- ygium Wilfordii tablets were the highest, followed by Tripterygium glycosides tablets, and Kunming Shanhaitang tablet. In Kunming Shanhaitang tablets triptolide was 1/50 of Tripterygium wilfordii tablets, wilforlide and total triptolides from tripterygium wilfordii was 1/8 - 1/10 of Tripterygium wilfordii tablets. Clinical triptolide had the highest dosage of 53 μg·d^-1, The minimum amount of 1.8μg·d^-1; wilforlide had the highest dosage of 1.2 mg· d^-1, and the minimum amount of 0.1 mg·d^- 1, total triptolides from tripterygium wilfordii had the highest dosage of 8.4 mg · d^ - 1, and the minimum amount of 1.3 mg· d^ - 1. Different batches from the same manufacturer of triptolide in Tripterygium wil- fordii tablets showed nearly 5 times difference, while wilforlide similar, total triptolides from tripterygium wilfordii nearly had 1 time difference. Conclusion The daily usage of triptolide, wilforlide and total triptolides in Tripterygium wilfordii tablets, Tripterygium glyc

关 键 词：雷公藤甲素 雷公藤内酯甲 雷公藤总内酯 高效液相色谱法 紫外可见分光光度法 雷公藤片 雷公藤多苷片 昆明山海棠片 

分 类 号：R917[医药卫生—药物分析学]