目的 通過膠塞相容性研究，分析影響注射用鹽酸頭孢替安溶液澄清度的因素，以便采取針對性措施提高藥品質(zhì)量。方法 通過測定樣品的濁度值及膠塞遷移出的指征性成分——抗氧劑2，6-二叔丁基對甲酚（BHT）的量，探討膠塞成分遷移與藥物澄清度的關(guān)系；通過膠塞相容性加速試驗，討論影響膠塞成分遷移的因素。結(jié)果 濁度值與BHT 遷移量、貯存時間顯著正相關(guān)（P<0.01）；頭孢替安規(guī)格越小，膠塞對其澄清度影響越大（P<0.01）。影響膠塞成分遷移的因素為膠塞的質(zhì)量、儲存溫度及放置狀態(tài)。結(jié)論 應(yīng)通過提高膠塞質(zhì)量或包裝設(shè)計、降低貯藏溫度、保持正置等措施以降低膠塞成分遷移，解決小規(guī)格產(chǎn)品澄清度不合格的問題。

Objective Through the compatibility study on rubber plug, to analyze the influences on clarity of Cefotiam Hydrochloride for Injection solution, in order to take corresponding measures to improve the quality of drugs. Methods By measuring the turbidity of the sample and the content of antioxidant 2, 6-butylated hydroxytoluene (BHT) that migrated out of rubber plug, the correlation between the rubber plug component migration and clarity of solution was explored. Results The turbidity value was positively related to BHT migration and storage time (P < 0.01); Rubber plug effect on the clarification was larger when cefotiam specification is smaller (P < 0.01). Factors affecting the component migration were quality of rubber plug, temperature, and drug placement status. Conclusion Through the improvement of the quality of rubber plug or packaging design, reducing the storage temperature, and keeping the drug placement status, the rubber plug component migration could be reduced, so as to solve the clarity unqualified problem of the small specification product.