洛伐他汀制剂溶出度试验方法的建立

Analysis and evaluation of lovastatin praeparatum dissolution

目的:建立洛伐他汀制剂溶出度试验方法,考察了数批洛伐他汀制剂的溶出度。方法:采用转篮或桨法,以含2%十二烷基硫酸钠的磷酸盐溶液(pH为7.0)为溶出介质,依法操作,溶出液色谱条件为使用Alltima C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.01%磷酸(60:40),检测波长为238 nm。结果:洛伐他汀在4.88～195.2μg·m L^(-1)范围内呈良好的线性关系,r=0.9999,采用此方法检测13个厂家31批样品溶出度,30%批次的溶出结果在标准限度以下。结论:溶出试验方法更能体现药品的生物利用度,溶出液测定方法准确、重现性好、操作简单,对全国样品考察结果显示,方法能有效控制产品质量。

Objective：To establish a test method for the dissolution of lovastatin praeparatum.And we inspected the determination of many batches of lovastatin praeparatum in the country.Methods：The method of dissolution was apparatus 1 and 2,the medium was phosphate buffer including 2%sodium dodecyl sulfate.And the chromatographic condition of column was Alltima C18（250 mm×4.6 mm,5μm） column the mobile phase was acetonitrile -0.01% phosphoric acid（60：40）,the wavelength of UV detector was 238 nm.Results：The standard curve of lovastatin was linear（r = 0.9999） in the range from 4.88 to 195.2μg·mL^-1.Thirty - one batches samples of thirteen factory were detected using this method,and the batches whose results below limit were about 30%in total.Conclusion： The dissolution test method shows more biological availability than before,and the assay method is accurate,highly specific and widely applicable.Through the investigation of the samples from the whole country,it is shown that the method developed on this study can be applicable to all the samples and effectively control the quality of product.