[關(guān)鍵詞]
[摘要]
化藥注射劑中的不溶性微??赡軓脑o包材料、生產(chǎn)過程、儲存運(yùn)輸,以及使用過程中引入??刂谱⑸鋭┲胁蝗苄晕⒘5漠a(chǎn)生是減少輸液不良反應(yīng)、保障用藥安全的重要措施。通過參考有關(guān)注射劑中不溶性微粒的國內(nèi)外藥典標(biāo)準(zhǔn)、指導(dǎo)原則和研究文獻(xiàn),探討不溶性微粒產(chǎn)生的主要原因,并提出有效控制策略和相關(guān)建議,以期為控制化藥注射劑的質(zhì)量提供相應(yīng)參考。
[Key word]
[Abstract]
Insoluble particles in chemical injections may originate from the drug substance, pharmaceutical excipients, packaging materials, manufacture process, storage, transportation, and clinical application. Controlling the production of insoluble particles in injections is an important measure to reduce adverse reactions and ensure drug safety. Referring to the pharmacopoeias of different countries, relevant regulations and guidances, and research literature on insoluble particles in chemical injections, this paper discusses the causes of insoluble particles, and puts forward effective control strategies and relevant suggestions, so as to provide theoretical supports for controlling the quality of chemical injections.
[中圖分類號]
R97
[基金項目]