紫杉醇液体软胶囊制剂质量控制研究  

Study on quality control of docetaxel solution softgel

作　　者：许晓乐[1] 王春华[2] 潘欣 张伟[1] 

机构地区：[1]南通大学医学院药理学教研室,南通226001 [2]南通大学第二附属医院 [3]南通迈特生物工程有限公司

出　　处：《南通大学学报（医学版）》2010年第3期174-176,共3页Journal of Nantong University(Medical sciences)

基　　金：江苏南通国际科技合作项目(W2007001)

摘　　要：目的:对紫杉醇液体软胶囊进行质量控制考察。方法:系统考察不同条件下本品的稳定性,条件分别为高温(40℃)、4500lx强光试验考察10d,室温(25℃)试验考察3m。建立一个HPLC法用于稳定性试验中紫杉醇和降解产物的含量测定。色谱条件为:色谱柱Symmetry-C18(3.9mm×250mm,5μm),以乙腈-水(15∶85)为流动相,流速为1.0ml/min,测定波长227nm。结果:除室温避光条件外,紫杉醇液体软胶囊中紫杉醇含量均有明显下降。建立的HPLC法在0.12～0.6μg时线性方程为Y=(2.83e+005)X-(3.21e+004),r=0.999898,RSD为0.3%。结论:紫杉醇液体软胶囊制剂贮放条件应为室温避光、质量可控。Objective：To investigate the quality control of docetaxel solution softgel.Methods：Samples of docetaxel were put under different conditions（25℃,40℃and strong light of 4500 lx） to determine the content of docetaxel and its degradation products by HPLC method.HPLC analyses were performed by using symmetry-C18（250 mm×3.9 mm,5μm） and mobile phase composed of water-acetonitrile（85∶15） .The detection wavelength was 227 nm and the flow rate was 1.0 ml/min. Results：The content of docetaxel decreased remarkably under all the experimental conditions,except for 25℃without light. The calibration curve was linear within the range of 0.12～0.6μg with the calibration equation Y=2.83e＋005X-3.21e＋004,r=0.999898,and RSD was 0.3%.Conclusion：After thorough investigation of the storage conditions affecting the stability of solution softgel,it is suggested that docetaxel should be stored at 25℃without light and its quality could be controlled.

关 键 词：紫杉醇液体软胶囊 稳定性 高效液相色谱 加拿大红豆杉 

分 类 号：R979.1[医药卫生—药品]