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米索前列醇(Misoprostol)是前列腺素E_1类的一种衍生物,现临床已广泛将其与米非司酮联合用于抗早孕,效果显著。我公司是国内最先生产米非司酮的厂家,其配伍用药米索前列醇一直依赖进口,1998年我们与上海市计划生育科学研究所合作开发该产品。在摸索其溶出度测定方法时,参照含量测定方法,建立了本方法,确定20分钟时溶出度限度为标示量的80％,并采用本方法对自制品与进口产品进行了比较,结果显示自制品与进口产品一致。
Misoprostol, a derivative of the prostaglandin E 1 class, has been clinically clinically used in combination with mifepristone for anti-early pregnancy with significant results. My company is the first domestic producer of mifepristone manufacturers, the compatibility of misoprostol has been dependent on imports, in 1998 we and the Shanghai Institute of Family Planning Science and Technology to develop the product. In exploring the dissolution of its determination method, the reference content determination method, the method was established to determine 20 minutes when the dissolution limit of 80% of the labeled amount, and the use of the method of self-made products and imported products were compared, the results show that since Products and imports the same.