【摘要】 目的建立测定环维黄杨星D-PEG10000(CVB-D-PEG)含量的方法,并研究其体外的稳定性。方法采用HPLC法,色谱柱为C18柱,流动相为20 mmo.lL-1磷酸氢二纳(磷酸调pH2.95)-乙腈(26:74),柱温为40℃,检测波长为210 nm。结果CVB-D-PEG 0.15~4.80 mg.ml-1与峰面积有良好的线性关系(r2=0.9996);其在光照条件下,8 h内稳定,在水、甲醇溶液中72 h内稳定,在pH2、7、7.8的缓冲液中24 h内不稳定,pH5的缓冲液中24 h内较稳定;在人工胃液、大鼠胃肠共孵液中2.5 h内均不稳定,人工肠液中2.5 h内基本稳定。结论所建方法能准确有效地测定CVB-D-PEG的含量,此药在酸碱环境中稳定性差。更多还原

【Abstract】 OBJECTIVE To establish a method for the determination of CVB-D-PEG,and study its stability.METHODS An HPLC method was adopted with a C18 column,and the mobile phase consisted of 20 mmol·L-1 Na2HPO4(pH2.95 adjusted by H3PO4)-acetonitrile.The UV detection was set at 210 nm,and column temperature was 40℃.It’s stability in vitro was investigated.RESULTS The calibration curve of CVB-D-PEG was linear within the range of 0.15-4.80 mg·ml-1(r2=0.9996).CVB-D-PEG was stable under illumination of 8 h,dissolvent of water and methanol in 72 h and in buffer solution of pH5 in 24 h,but unstable in buffer solution of pH 2,7 and 7.8 in 24 h.It was unstable in artificial gastric juice,artificial gastric juice incutated with rat stomach and artificial intestinal juice incutated with rat intestine,but stable in artificial intestinal juice in 2.5 h.CONCLUSION The method is reliable and accurate for quantitive analysis.CVB-D-PEG is unstable.更多还原