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In this paper, the author investigated and compared the domestic and foreign laws and regulations and current pharmacopoeias of different countries related to the storage conditions of chemical drugs, then put forward some thoughts and suggestions in combination with the existing problems of the storage conditions of chemical drugs, so as to provide reference for the establishment and standardization of the storage conditions of chemical drugs.

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本文对国内外有关化学药品贮藏条件的法规指南、现行药典进行调研和对比分析,结合已上市药品贮藏条件表述存在的问题,提出化学药品贮藏条件制定的考虑与建议,以期为化学药品贮藏条件规范化提供参考。

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任连杰,男,博士,主任药师,主要从事药品审评工作。E-mail:
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陈淼,女,硕士,主管药师,主要从事药品审评工作。E-mail:

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陈淼,女,硕士,主管药师,主要从事药品审评工作。E-mail:

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浅析化学药品贮藏条件的制定
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陈淼 , 任连杰
中国新药杂志 | 新药注册与审评技术 2023,32(2): 174-180
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中国新药杂志 | 新药注册与审评技术 2023, 32(2): 174-180
浅析化学药品贮藏条件的制定
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陈淼 , 任连杰
作者信息
  • 国家药品监督管理局药品审评中心,北京 100022
  • 陈淼,女,硕士,主管药师,主要从事药品审评工作。E-mail:

通讯作者:

任连杰,男,博士,主任药师,主要从事药品审评工作。E-mail:
Considerations on the establishment of storage conditions of chemical drugs
Miao CHEN , Lian-jie REN
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
出版时间: 2023-01-30
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本文对国内外有关化学药品贮藏条件的法规指南、现行药典进行调研和对比分析,结合已上市药品贮藏条件表述存在的问题,提出化学药品贮藏条件制定的考虑与建议,以期为化学药品贮藏条件规范化提供参考。

化学药品  /  贮藏条件  /  稳定性研究  /  制定  /  规范

In this paper, the author investigated and compared the domestic and foreign laws and regulations and current pharmacopoeias of different countries related to the storage conditions of chemical drugs, then put forward some thoughts and suggestions in combination with the existing problems of the storage conditions of chemical drugs, so as to provide reference for the establishment and standardization of the storage conditions of chemical drugs.

chemical drugs  /  storage conditions  /  stability studies  /  establishment  /  standardization
陈淼, 任连杰. 浅析化学药品贮藏条件的制定. 中国新药杂志, 2023 , 32 (2) : 174 -180 .
Miao CHEN, Lian-jie REN. Considerations on the establishment of storage conditions of chemical drugs[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 174 -180 .
2023年第32卷第2期
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  • 首发时间:2026-03-05
  • 出版时间:2023-01-30
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  • 录用日期:2022-12-23
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作者信息
    国家药品监督管理局药品审评中心,北京 100022

通讯作者:

任连杰,男,博士,主任药师,主要从事药品审评工作。E-mail:
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2种不同金属材料的力学参数

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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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