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本文研究的方法是一个新的溶出度测定方法。它是根据硫酸粘菌素分子中含有多种氨基酸,可与茚三酮缩合产生兰紫色的原理,建立本制剂的溶出度分光光度定量测定法,在565nm波长处有最大的吸收值。当每毫升含625~1250u时与吸光度呈线性关系,r=0.9950,方法回收率为99.5%,CV值为2.87%,并对本方法最大吸收值无干扰,呈邑稳定性,溶剂的选择,茚三酮试剂的用量以及呈色反应的加热时间等进行全面考察。同时对溶出度的测试条件进行了研究。试验表明:采用转篮法,转速120rpm/分,磷酸缓冲液(pH7.0)500毫升为介质液,每个转篮投入2片,时间为45分钟。该方法快速,简便,可靠,宜收藏在药典中控制产品质量。
The method studied in this paper is a new method for the determination of dissolution. It is based on the principle of colistin molecules containing a variety of amino acids, with ninhydrin condensation blue purple, the dissolution of the preparation of the spectrophotometric determination of the maximum absorption at 565nm wavelength. When the content of 625 ~ 1250u / ml was linear with the absorbance, r = 0.9950, the recovery rate was 99.5% and the CV value was 2.87% .It had no interference with the maximum absorption value of this method, , The choice of solvent, the amount of ninhydrin reagent and the heating time of the color reaction to conduct a comprehensive study. At the same time the dissolution test conditions were studied. Experiments show that: using basket method, the speed of 120rpm / min, phosphate buffer solution (pH7.0) 500 ml of medium solution, each basket into 2, the time was 45 minutes. The method is rapid, simple and reliable and should be stored in Pharmacopoeia to control product quality.