注射用舒尼铂(冻干粉)的制剂安全性初步研究  

Preliminary Study on the Preparation Safety of Suniplatin (Lyophilized Powder) for Injection

作　　者：徐红花 廖伟 刘瑞 杨坤芬 廖文平 XU Honghua;LIAO Wei;LIU Rui;YANG Kunfen;LIAO Wenping(Yunnan Institute of Materia Medica,Kunming 650111,China;Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation,Kunming 650111,China)

机构地区：[1]云南省药物研究所,云南昆明650111 [2]云南省中药和民族药新药创制企业重点实验室,云南昆明650111

出　　处：《云南师范大学学报（自然科学版）》2022年第6期52-56,共5页Journal of Yunnan Normal University:Natural Sciences Edition

基　　金：国家重大新药创制专项资助项目(2009ZX09103-109);云南省新药开发专项资助项目(2014BC010)。

摘　　要：采用体外溶血试验、大鼠血管刺激性试验、小鼠异常毒性试验、豚鼠主动全身过敏和被动皮肤过敏试验,观察注射用舒尼铂(冻干粉)用5%葡萄糖注射液配制后,在最大溶解浓度12.0 mg/mL及以下浓度注射给药的制剂安全性.试验结果表明,注射用舒尼铂(冻干粉)在12.0 mg/mL及以下浓度无溶血反应,静脉注射对小鼠无异常毒性反应,对豚鼠全身或皮肤也无过敏反应,6.0 mg/mL和12.0 mg/mL浓度对大鼠尾静脉仅有轻微且可逆的刺激性反应,用于静脉注射具有较好的安全性.In vitro hemolysis test, vascular irritation test in rats, abnormal toxicity test in mice, active systemic allergy test and passive skin allergy test in guinea pigs were used to observe the safety of suniplatin(lyophilized powder) for injection after being prepared with 5% glucose injection at a maximum dissolved concentration of 12.0 mg/mL or less.The test results showed that suniplatin(lyophilized powder) for injection had no hemolytic reaction and no abnormal toxic reaction to mice and no allergic reaction to the whole body or skin of guinea pigs at the concentration of 12.0 mg/mL and below.And at the concentration of 6.0 mg/mL and 12.0 mg/mL,it had only slight and reversible irritant reaction to rat tail vein.Overall, it has highly safety to use for intravenous injection.

关 键 词：铂类抗癌药物 溶血 血管刺激 异常毒性 过敏性 制剂安全 

分 类 号：R979.1[医药卫生—药品] R994.39[医药卫生—药学]