盐酸依匹斯汀胶囊溶出度试验方法的建立及溶出曲线的评价

Establish the dissolution of epinastine hydrochloride capsules and evaluation of dissolution curve

目的:建立盐酸依匹斯汀胶囊溶出度试验方法,并与市售产品进行溶出曲线评价,考察其有效性。方法:采用篮法,以水为溶出介质,转速为75 r·min-1,并对其与市售产品进行溶出曲线评价。溶出液色谱条件:色谱柱为Agilent Zorbax SB-CN柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.05 mol.L-1磷酸盐缓冲溶液(35∶65);流速为1.0 mL·min-1;检测波长为220 nm;柱温为30℃。结果:盐酸依匹斯汀在0.10～24.12μg.mL-1范围内呈良好线性关系,r=0.999 9,因此采用此法检测本品溶出度,能达到要求,并且与市售产品溶出曲线相似。结论:溶出度的考察更能体现药品的有效性,该方法专属、灵敏、简便,可用于测定盐酸依匹斯汀胶囊的溶出度。

Objective：To establish the dissolution test method of epinastine hydrochloride capsules and evaluation of dissolution curve with commercial products, and examine its effectiveness. Methods：The method of dissolution was basket, with water as the dissolution medium, and rotate speed was 75 r·min^-1, and the dissolution curve in the evaluation of commercial products. And the chromatographic condition of column was Agilent Zorbax SB-CN （250 mm×4.6 mm,5 μm） column, with the mobile phase consisting of acetonitrile-0.05 mol. L^-1 phosphate solution （buffer solution：dissolve 6.8 g of sodium dihydrogen phosphate in 1 000 mL water, add exactly 3 mL of tri- ethylamine,shake,adjusted to pH（4.5±0.1 ）with phosphate acid）（35±65） ;The flow rate was 1.0 mL.min-1 ,the detection wavelength at 220 nm,the column temperature was 30℃. Results： The method of dissolution of epinastine hydrochloride Capsules with a good linear range of 0.10±24.12 μg·mL^-1 （ r = 0. 999 9 ） , and the resuhs can meet the requirement, and dissolution curve similarity with the commercially products. Conclusion：The dissolution test method shows more biological availability than before, and the method is sensitive, specific, simple. It can be Used for determine the dissolution of epinastine hydrochloride capsules.