祖师麻止痛喷雾剂对豚鼠的长期毒性研究

Studies on Long-term Toxicity of Zushima Zhitong Spray in Guinea Pigs

目的:观察祖师麻止痛喷雾剂对豚鼠的长期毒性,为临床安全用药提供依据。方法:将50只豚鼠随机分为空白对照组、高剂量完整皮肤组、高剂量破损皮肤组、低剂量完整皮肤组、低剂量破损皮肤组,连续给药4周。随时观察记录其一般情况,用药后做血液学及血液生化指标检查,计算脏器系数并进行组织病理学检查。结果:祖师麻止痛喷雾剂各剂量组未见毒性反应,与空白对照组比较差异均无统计学意义(P>0.05),停药后也未见药物延迟性毒性反应。结论:长期给予豚鼠祖师麻止痛喷雾剂无明显毒性,推论临床拟用剂量安全。

Objective： To study the long-term toxicity of Zushima Zhitong spray in guinea pigs and provide data for the clinical ad- ministration. Method ： Fifty guinea pigs were randomly divided into 5 groups ： control group, high-close group of intact skin, high-dose group of damaged skin, low-dose group of intact skin and low-dose group of damaged skin. The last four groups were treated with drug for consecutive 4 weeks. The general conditions of guinea pigs were observed at any time. The blood analysis and biochemical examination were performed after the administration. The organ coefficient was calculated and pathological change was observed. Result： No toxic reaction was observed in all groups of Zushima Zhitong spray compared with the control group. The delayed toxicity reaction did not exhibit after the drug administration. Conclusion： Zushima Zhitong spray has no significant toxicity for long-term administration in guinea pigs, suggesting the safety of designed doses in clinic application.