目的 為做好冠心寧注射液安全性再評價工作提供數(shù)據(jù)參考。方法 采用不同給藥劑量，按《中國藥典》2010年版一部附錄方法進行異常毒性檢查、過敏反應(yīng)檢查及降壓物質(zhì)檢查，根據(jù)樣品注射后動物反應(yīng)情況，進行分級評價。結(jié)果 異常毒性檢查：不同廠家的樣品原液異常毒性檢查結(jié)果差異明顯，A、D及F 3個廠家的產(chǎn)品異常毒性較小，均未出現(xiàn)動物死亡，其中A與F兩個廠家均只有一批樣品得3分；B廠的產(chǎn)品異常毒性變化較大，13批樣品中，除一批樣品未見明顯毒性反應(yīng)外，有8批樣品出現(xiàn)動物死亡，占總數(shù)的53.3%；C和E廠的產(chǎn)品表現(xiàn)出較大的異常毒性，得分在2～5分，D廠產(chǎn)品最穩(wěn)定，13批樣品得分集中分布在2～3分，沒有出現(xiàn)動物死亡情況；選用樣品1︰2的稀釋液，71批樣品中，僅有1批出現(xiàn)動物死亡；不同來源、不同品種動物反應(yīng)結(jié)果基本一致。降壓物質(zhì)檢查：冠心寧注射液有一定的降壓作用，注射0.2 mL/kg樣品原液，降壓幅度大于組胺對照（0.1 μg/kg）組，選用樣品1︰3的稀釋液，71批樣品中，僅B廠有4批樣品不合格，經(jīng)換貓再試，有1批樣品仍不合格，3批合格。過敏反應(yīng)檢查：取不同廠家樣品24批進行過敏反應(yīng)檢查，結(jié)果均未出現(xiàn)明顯的過敏反應(yīng)。結(jié)論 不同廠家、同一廠家不同生產(chǎn)批號的冠心寧注射液異常毒性、降壓物質(zhì)檢查結(jié)果存在差異，可增加異常毒性、降壓物質(zhì)檢查來控制其質(zhì)量。

Objective To provide the data for re-evaluation on the security of Guanxinning Injection. Methods Testing for abnormal toxicity, allergen, and depressor substances was performed in different doses, according to the methods in the appendix of Chinese Pharmacopoeia 2010; And the grading evaluation was recorded by the animals’ reactions after sample injection. Results In the examination of abnormal toxicity, toxicity of samples from different manufacturers varied widely. The samples from A, D, and F manufacturers had less toxic, in which no animal was dead. Among them A and F only had one batch with getting three points; Sample from B manufacturer had unstable and abnormal toxicity, and animal deaths occurred in eight among 13 batches of samples except that one batch had no significant toxicity, accounting for 53.3%; Samples from C and E manufacturers showed a greater abnormal toxicity, scored two to five points; Sample from D manufacturer was the most stable. Scoring between two and three points was concentrated among 13 batches, there was no animal death; Among 71 batches of samples dilution in 1 : 2 was selected, animal deaths occurred in only one batch; The results are basically the same from different sources and varieties of animals. In buck physical examination, Guanxinning Injection has antihypertensive effect and samples in a dose of 0.2 mL/kg had more significant effect on controlling blood pressure than histamine (0.1 μg/kg). While the dilution in 1 : 3, only four batches of B manufacturer have failed, and the experiments were repeated using cats, the results were still unsatisfactory, among which one batch failed and three batches were qualified; In allergy check, 24 batches of samples from different manufacturers had no obvious abnormal reaction. Conclusion There is difference of abnormal toxicity test and buck physical examination among Guanxinning Injections produced by different manufacturers. It suggests that abnormal toxicity test and buck physical examination can be used to control the quality.