正清风痛宁注射液安全性研究

The Safety Evaluation of Zhengqingfengtongning injection

目的为了考察正清风痛宁注射液的安全性和评价质量标准中安全性项目设置的合理性。方法采用豚鼠用药的过敏试验、被动皮肤过敏试验、用猫进行降压物质检查及用兔进行肌肉刺激试验。结果在12．5mg／ml浓度下豚鼠无全身性过敏反应和被动皮肤过敏反应；猫最大无降压浓度为0．125mg／ml；对家兔肌肉刺激反应小于2级。结论本品各安全性项目检查符合规定，现行质量标准安全性项目设置基本合理。

Objective To investigate the safety of Zhengqingfengtongning injection and evaluate the rationality of security project in the quality standards. Methods The safety of the Zhengqingfengtongning injection was studied with active systemic anaphylaxis（ASA）, passive cutaneous anaphylaxis（PCA） in guinea pig, the depressor substance test in cat and muscle stimulation test in rabbit. Results ASA and PCA reaction didn＇t occur at the dose of 12.5 mg/ml; maximum concentration without blood pressure reduction was 0.125 mg/ml in cat; In rabbit muscle stimulation test,the response was less than level 2. Conclusion The results showed that Zhengqingfengtongning injection was safe for clinical use, and the safety project in quality standard was reasonable.