硫酸粘菌素片溶出度测定方法研究

STUDY ON THE DISSOLUTION FOR CoLISTIN SULAFATE TABLETS

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。

A new dissolution method for Colistin sulfate tablets was developed based on the color reaction of Amino acids in Colistin with ninhydrin at certain condition,The study involved the optimization of heating time,the concentration of tlie ninhvdrin used and the select-ion of its solvents.The study showed linear relationship between conc-entrations of 625～1250u Colistin and the maxium absobance at 565 nm.The correlation coefflcient was 0.9950.The recovery rate was 99.5%with CV. 2.87%,The established dissolution method for Colistin tablets was applyed to the Colistin tablets to evaluate the quality of the Colis-tin sulfate tablets commercailly avaiiable.