化學藥品注射劑生產(chǎn)過程使用的塑料組件系統(tǒng)與藥液接觸后可能產(chǎn)生相關(guān)浸出物，進而影響產(chǎn)品質(zhì)量甚至危害患者安全。結(jié)合國內(nèi)外已發(fā)布的相關(guān)標準及指南，對化學藥品注射劑生產(chǎn)用的塑料組件系統(tǒng)（如硅膠管、濾器等）相容性研究的一般思路進行介紹。認為制劑申請人作為責任主體，應基于風險評估及必要時的試驗研究，確認化學藥品注射劑生產(chǎn)中使用的塑料組件系統(tǒng)的適用性。總結(jié)了目前申報資料中發(fā)現(xiàn)的相容性研究存在的問題，以期為藥品研發(fā)及生產(chǎn)企業(yè)提供指導和幫助。

Plastic components and systems used in the manufacturing of chemical injection products may lead to the accumulation of leachables, which could impact product quality or patient safety. Based on the published guidelines and standards, this article will introduce the recommended method for plastic component and systems compatibility studies (such as silicone tube, filter). Drug product applicants should be responsible for the suitability of plastic components and systems through risk assessment and experiments if necessary. The author also summarized several wrong methods found in the technical documents. The main objective of this article is to guide the applicant to implement compatibility studies with a scientific and reasonable manner.

R944.2