化藥注射劑中的不溶性微?？赡軓脑o包材料、生產過程、儲存運輸，以及使用過程中引入?？刂谱⑸鋭┲胁蝗苄晕⒘５漠a生是減少輸液不良反應、保障用藥安全的重要措施。通過參考有關注射劑中不溶性微粒的國內外藥典標準、指導原則和研究文獻，探討不溶性微粒產生的主要原因，并提出有效控制策略和相關建議，以期為控制化藥注射劑的質量提供相應參考。

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.

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