为保证制剂含量的均匀性,各国药典原来都是用装量差异作相对控制。对含有辅料的制剂,这方法并不能保证含量均匀。因此直接测定含量来检查含量的均匀度,已日益引起各国的重视,现美、英和日本的新版药典,都有了规定。 注射用更生霉素是抗肿瘤抗生素,毒性大,剂量小,每瓶含主药仅0.2mg,以1000倍蔗糖作稀释剂,湿法混粉,干燥,分压而成,均匀混粉的难度大。 测定时每批取样10瓶,先分别称定其装量,再分别移至10ml量瓶中,加甲醇适量,充份振摇,使更生霉素溶解,用甲醇稀释至刻度,取上清液,用分光光度法,在442nm In order to ensure the uniformity of formulation content, the pharmacopoeias of all countries originally used the difference of loading capacity for relative control. For preparations containing excipients, this method does not guarantee uniform content. Therefore, direct determination of content to check the uniformity of content has drawn increasing attention from all countries, and the new pharmacopoeias of the United States, Britain and Japan all have provisions. Injection of dactinomycin is antitumor antibiotics, toxicity, small dose, each bottle containing the main drug only 0.2mg 1000 times sucrose as diluent, wet mixing powder, drying, partial pressure, the difficulty of uniform powder Big. Determination of each batch of 10 samples, respectively, first set its volume, and then were moved to 10ml volumetric flask, add appropriate amount of methanol, shaking thoroughly, so that the determination of daunorubicin dissolved, diluted with methanol to the mark, the supernatant , Using spectrophotometry at 442 nm