hplc 法测定人血浆中得力生注射液华蟾酥毒基及酯蟾毒配基浓度.docVIP

精品论文 参考文献 HPLC 法测定人血浆中得力生注射液华蟾酥毒基及酯蟾毒配基浓度 唐静黄毅兰 （凉山彝族自治州第一人民医院药剂科615000） 【摘要】目的：改进HPLC 法测定得力生注射液中华蟾酥毒基和酯蟾毒配基血药浓度的方法。方法：以炔诺酮为内标，采用乙酸乙酯提取的方法处理血浆。色谱柱：phenomenexC-18 柱（250times;4.60mm，5mu;m）；流动相：乙腈:水（55:45）；流速：0.8ml/min；柱温：40℃；进样量：20mu;l；检测波长：296nm。结果：酯蟾毒配基在48.25~9650mu;gmiddot;L-1范围线性良好(r=0.9996)；华蟾酥毒基在51~1530mu;gmiddot;L-1(r=0.9998)。方法的提取回收率＞90％，日内和日间RSD＜10％。样品3次冻融及提取后在24h内稳定性良好。结论：本方法操作简便、灵敏度和准确度高、重现性好，适用于得力生注射液中华蟾酥毒基和酯蟾毒配基的体内药物浓度测定和药动学研究。 【关键词】得力生注射液，HPLC，华蟾酥毒基，酯蟾毒配基，血浆，药物浓度 【中图分类号】R2 【文献标号】A 【文章编号】1671-8725（2014）12-0013-02 Improvement of HPLC Method in the Determination of Resibufogenin and Cinobufaginin Delisheng injectin in Human PlasmaTANG Jing,HUANG Yi lan（JIN Rong,YE YunDept. of Pharmacy,The Affiliated Hospital of Luzhou Medical College,Luzhou 646000,China）abstract:Objective：To improve the HPLC method in the Determination of Resibufogenin and Cinobufagin in Delisheng injectin in Human Plasma.Methods：Using norethisterone as internal standard,the plasma was extracted with ethyl acetate. The determination was carried out using an phenomenexC-18 column（250times;4.60mm，5mu;m）with a solvent system: acetonitrile-water (55:45). The flow rate was 0.8ml/min, column temperature was 40℃,sample size was 20mu;l, detectiong wavelength was at 296nm. Results：The linear range of resibufogenin was 48.25~9650mu;gmiddot;L-1(r=0.9996), The Cinobufaginwas 48.25~9650mu;gmiddot;L-1 (r=0.9998).The recovery of extraction was more than 90％.Both the intra-day RSD and inter-day RSD were less than10％.The sample showed a good stability within 24 hours after three freeze-thaw cycles and extractions. Conclusion：The method is simple,sensitive,accurateand reproducible,and suitable for the determination and pharmacokinetic study of telmisartan in human plasma.Keyword：Delisheng injection；HPLC；Resibufogenin；Cinobufagin；Plasma；Plasma drug level 得力生注射液是我国第一个获得中药二类新药证书的复方抗癌注射液，由人参、黄芪、蟾酥、斑蟊四味中药经现代科学技术提炼加工而成，配合放化疗具有协同增效作用，并能够预防化疗导致的骨髓抑制[1]。通过对其组方中蟾酥的有效成分华