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USP中,用物理方法称重的“重量差异”(Weight Variation;以下简称WV)来控制制剂的含量均匀度,始于第14版,用化学方法测定含量的“含量均匀度”(Content Uniformity,以下简作CU)则是从1965年的17版开始的;1985年的21版又将两者统一到同一实质内容的专题“剂量单位的均匀度”(Uniformity of Dosage Units)下,随后,第一、二增补本又对部分内容作了修正。含量均匀是制剂的基本质量要求之一,也是溶出度与生物利用度研究试验的前提要求,从检定进展而言,是重量差异检查的延伸。
USP, the “Weight Variation” (hereinafter referred to as WV) weighed by the physical method is used to control the content uniformity of the formulation, starting from the fourteenth edition, and the content uniformity of content is determined chemically (Content Uniformity, The following abbreviation CU) started from the 17th edition in 1965; in 1985, the 21st edition unifies the two into the same substantive topic “Uniformity of Dosage Units” One or two supplements This section also made some amendments. Content uniformity is one of the basic quality requirements of the preparation, but also a prerequisite for dissolution and bioavailability of the pilot study, in terms of the progress of the test is an extension of the weight difference test.