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Home > Wen Yuan (High School Edition) > 2023 No.04 > 《化学口服固体制剂混合均匀度和中控剂量单位均匀度研究技术指导原则》转化及其应用难点研究

  • 《化学口服固体制剂混合均匀度和中控剂量单位均匀度研究技术指导原则》转化及其应用难点研究

    Author(s)：

    郭文驿 杨康 刘曼 成非凡 符凌

    Publication Title：

    Wen Yuan (High School Edition) 2023 No.04

    Affiliations：

    扬子江药业集团江苏紫龙药业有限公司

    Abstract：

    CDE发布的《化学口服固体制剂混合均匀度和中控剂量单位均匀度研究技术指导原则（试行）》对于制药企业的药物研发和生产均具有重要的意义。为生产企业进行《化学口服固体制剂混合均匀度和中控剂量单位均匀度研究技术指导原则》转化与运用提供指导，明确混合均匀度和中控剂量单位均匀度研究策略，解决转化运用过程中的难点问题。

    Keywords：

    混合均匀度；中控剂量单位均匀度；混合取样；压片/填充取样

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    [1] 郭文驿,杨康,刘曼,成非凡,符凌.《化学口服固体制剂混合均匀度和中控剂量单位均匀度研究技术指导原则》转化及其应用难点研究[J].Wen Yuan (High School Edition),2023(04),.

文渊(高中版)
Wen Yuan (High School Edition)

Language: 中文

CN：11-9276/G

ISSN：2096-6288

Publication Frequency: 月刊

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