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五氟利多是CP95版收载的药品,系抗精神病药。药典标准对溶出度没作质量控制要求,但卫生部对药品的仿制报批要求必须进行溶出度质量研究,以确保仿制药品的临床疗效。1.仪器与试药 岛津UV—2401PC分光光度计(日本岛津制作所)。 岛津AEG—220电子分析天平(日本岛津制作所)。 RCZ—5A型智能药物溶出仪(天津大学精密仪器厂制造)。
Pentafluoro is CP95 version of the drug contained, the Department of antipsychotics. Pharmacopoeia standards for dissolution of quality control did not make the request, but the Ministry of Health on the pharmaceutical generic approval requirements must be studied dissolution quality in order to ensure the clinical efficacy of generic drugs. 1. Instruments and reagents Shimadzu UV-2401PC spectrophotometer (Shimadzu Corporation). Shimadzu AEG-220 electronic analytical balance (Shimadzu, Japan). RCZ-5A intelligent drug dissolution apparatus (Tianjin University Precision Instrument Factory).