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目的评价盐酸克林霉素注射液注射给药的安全性。方法采用家兔耳缘静脉血管刺激性试验、肌肉刺激性试验、体外溶血性试验、豚鼠全身主动过敏试验和大鼠被动皮肤过敏试验等方法进行研究。结果盐酸克林霉素注射液静脉滴注对给药部位血管无明显刺激作用,肌内注射给药对注射部位有一定的刺激性;豚鼠全身主动过敏反应和大鼠被动皮肤过敏反应为阴性;对家兔红细胞无溶血和凝集作用。结论试验所用的盐酸克林霉素注射液临床静脉滴注给药安全性较好,肌内注射给药对注射部位具有刺激性。
Objective To evaluate the safety of injection of clindamycin hydrochloride injection. Methods Rabbit ear vein irritation test, muscle irritation test, in vitro hemolytic test, guinea pig systemic active allergy test and rat passive skin allergy test were conducted. Results Intravenous infusion of clindamycin hydrochloride injection had no obvious stimulating effect on the blood vessels of the administration site. The intramuscular injection had some irritation on the injection site. The guinea pig systemic active anaphylaxis reaction and the rat passive skin anaphylaxis were negative. Rabbit red blood cells without hemolysis and agglutination. Conclusion Clinical trials of clindamycin hydrochloride injection intravenous injection is safe, intramuscular injection of injection site irritation.