鼻爽清洗液的急性毒性、过敏性及刺激性实验

Experiments of Acute Toxicity, Hypersensibility and Irritation on Bishuangqing Lotion

目的初步研究鼻爽清洗液的安全性。方法在预试验的基础上,选择豚鼠30只,随即分为空白对照组、纯化水组和鼻爽清洗液组,均分笼正常饲养10天,后两组在24小时内分别分3次,12mL/20g|次,灌服纯化水和鼻爽清洗液,观察最大耐受量及全身中毒表现及死亡情况,判断鼻爽清洗液的急性毒性;白兔8只,随机分为鼻爽清洗液组、纯化水组、阳性对照组和空白对照组,每组2只,均分笼常规饲养,前三组分别用鼻爽清洗液(20mL)、纯化水(20mL)和阳性致敏物(20mL)滴鼻,1次|4h,用药3次。末次给药后24h处死动物,取出鼻粘膜,和空白对照组进行对比观察鼻粘膜水肿、结痂等,评估鼻爽清洗液的过敏性及刺激性。结果豚鼠全部存活,与空白对照组对比观察,均未见明显毒副反应;白兔鼻粘膜刺激的总平均分值为0.1,属于无刺激性,并与三个对照组对比观察,鼻粘膜未见过敏反应。结论结果表明,鼻爽清洗液对鼻粘膜无刺激性,急性毒性和过敏性甚小或无,提示可供临床疗效观察。

Objective Preliminary safety evaluation of the Bishuangqing lotion （BSQ）. Methods 30 of Cavia procellus were divided into 3 groups： control, water and BSQ group by the method of randomization. Normally breeded for 10 days, the last two groups were treated respectively with water and BSQ （12mL/20g/times） 3 times within 24h. The maximum tolerable dose, integral intoxicated status, and death rate were used as indexes to evaluate the acute toxicity of BSQ. 8 of Albino rabbits were divided into 4 groups （each 2 rabbits）： BSQ, water, positive control and blank control by the method of randomization, and which were respectively treated with BSQ 20mL, water20mL and positive sensitizing agent 20mL, 3 times by one time every 4h. At the point of 24h after last treatment, the animals were executed for their nasal mucosa, and the conditions ofmucosal edema, incrustation, and et al. were compared with blank groups＇ for evaluating the hypersensibility and irritation. Results Cavia procellus are all alive, and had no apparent adverse reaction when compared with control one. The nasal mucous membrane of experimental group of Albino rabbit exhibits nonirritant for their population irritation mean is 0.1, and no anaphylaxis when compared with other three groups. Conclusion Results show that BSQ with none of irritation and acute toxicity, and few or none hypersensibility, and can be explored into clinical observation.