双氯芬酸钠注射液的肌肉刺激性试验

Muscle Stimulation Experiment of Diclofenac Sodium Injection

考察双氯芬酸钠注射液的肌肉刺激性,为临床安全用药提供参考。采用同体左、右侧自身比对法,对日本大耳白兔进行股四头肌注射给药,经折算,供试品双氯芬酸钠注射液给药剂量为14.39mg/kg,等体积9mg/mL氯化钠注射液用作阴性对照,每天1次,连续3d。自给药起到给药后第19天,观察试验兔的一般状况,进行注射部位解剖及组织病理学检查,综合评价其肌肉刺激性。双氯芬酸钠注射液注射后1周内对股四头肌有较强的刺激性,在给药19d后肌肉损伤可以完全恢复。双氯芬酸钠注射液符合我国《化学药物刺激性、过敏性和溶血性研究技术指导原则》中注射剂对于肌肉刺激性的要求,可用于肌内注射。

To provide the reference for security of drug usage in clinical practice,the muscle stimulation of diclofenac sodium injection was evaluated.The diclofenac sodium injection was injected into quadriceps femoris of rabbit limbs,and self-control between left and right muscle tissue was used.The medication dose was 14.39 mg/kg,and equivoluminal sodium chloride injection (9 g/L) was used as negative control,once a day for three consecutive days.The general situation of the rabbits and the symptoms at the injection site were observed,and anatomical dissection and histopathological examination were performed from the first injection until the 19th day after injection.Muscle stimulation of diclofenac sodium injection in rabbits was assessed comprehensively.The results showed that diclofenac sodium injection had a significant muscle stimulation during the first week of injection,while the muscle injury could recover completely on 19th day after injection.The results showed that diclofenac sodium injection conformed to the criteria of "Guidance for Chemical Drug Development on Irritation,Anaphylaxis and Hemolysis Test",which could be given through muscle injection.