中国药物警戒 ›› 2013, Vol. 10 ›› Issue (2): 74-76.

• 辛夷毒效研究 • 上一篇    下一篇

辛夷不同组分滴鼻液制剂安全性试验研究

吕莉莉1, 钱晓路2,孙蓉1   

  1. 1.山东省中医药研究院,山东济南250014；
    2.山东中医药大学,山东济南250355
  • 收稿日期:2012-11-07 修回日期:2016-03-09 出版日期:2013-02-08 发布日期:2016-03-09
  • 通讯作者: 孙蓉,女,研究员,博士生导师,中药药理与毒理。 E-mail：sunrong107@163.com
  • 作者简介:吕莉莉,女,副研究员,中药药理与毒理。
  • 基金资助:
    国家重大新药创制重大专项课题,中药复方药理学研究与药效评价关键技术研究（2009ZX09502-015）；山东省科技攻关课题,辛夷抗过敏性鼻炎的实验与临床研究,（1997）年第971226313号。

Experimental Study on Safety in Guinea Pig about the Different Components of Flos Magnolia Nose Drop

LV Li-li1, QIAN Xiao-lu2 ,SUN Rong1   

  1. 1.Shandong Research Academy of TCM, Shandong Jinan 250014, China;
    2.Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China
  • Received:2012-11-07 Revised:2016-03-09 Online:2013-02-08 Published:2016-03-09

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摘要： 目的 观察比较辛夷不同组分滴鼻液制剂的急性毒性和多次给豚鼠鼻腔滴入所产生的黏膜刺激反应情况,以确定临床用药毒性和有无黏膜刺激性,为辛夷滴鼻液的临床安全使用提供实验依据。方法 急性毒性实验：豚鼠随机分成药物不同组分高剂量组,赋形剂组及空白对照组,每组8只,分别滴入辛夷不同组分滴鼻液、赋形剂液适量于豚鼠鼻腔内,持续固定30min,即刻观察豚鼠急性毒性症状谱,连续观察7 天。黏膜刺激性实验：豚鼠随机分成辛夷不同组分滴鼻液组、赋形剂组及空白对照组,每组8只,分别滴入辛夷不同组分滴鼻液、赋形剂和蒸馏水适量于豚鼠鼻腔内,连续1 周,观察鼻黏膜刺激性程度。结果 给豚鼠鼻腔滴入辛夷不同组分滴鼻液相当于临床60kg 人日用剂量的60 倍时,豚鼠无一死亡,对豚鼠未引起急性毒性反应,并且未出现明显的鼻黏膜刺激性。结论 急性毒性实验和黏膜刺激性实验结果表明辛夷不同组分滴鼻液制剂具有较高的安全性。

关键词: 关键字：辛夷不同组分滴鼻液, 急性毒性实验, 黏膜刺激性实验, 安全性

Abstract: Objective To study the safety of the different components of Flos Magnolia Nose Drop in guinea pig and to provide experimental data for safe use in clinical. Methods The acute toxicity experiment: The different components of Flos Magnolia Nose Drop were administrated to guinea pig and the acute toxic symptoms were observed. The mucosal irritation experiment: The different components of Flos Magnolia Nose Drop were administrated to guinea pig' nasal cavity and the degree of nasal irritation was observed. Results We did not find the chronic toxicity and the mucosal irritation to guinea pig' nasal cavity after given Flos Magnolia Nose Drop for7 days. Conclusion The acute toxicity test and the mucosal irritation test showed that the Flos Magnolia Nose Drop was safe.

Key words: different components of Flos Magnolia Nose Drop, acute toxicity experiment, mucosal irritation experiment, safety

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