cremophor RH40及labrafil M 1944 CS的鼻黏膜毒性考察

孟亚飞; 张伟玲; 李彤彤; 王亚静; 郑银; 张曦

doi:10.13422/j.cnki.syfjx.2014200020

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cremophor RH40及labrafil M 1944 CS的鼻黏膜毒性考察

工艺与制剂 | 更新时间：2024-01-04

- cremophor RH40及labrafil M 1944 CS的鼻黏膜毒性考察
- Evaluation of Nasal Mucosa Toxicity of Cremophor RH40 and Labrafil M 1944 CS
- 中国实验方剂学杂志 2014年20卷第20期页码：20-23
- 作者机构：
- 作者简介：
- 基金信息：
  
  国家“重大新药创制”科技重大专项（2012ZX09304007）;天津市科技特派员项目（201306）
- DOI：10.13422/j.cnki.syfjx.2014200020
  中图分类号： R283.6;R285.5
- 纸质出版日期：2014
- 稿件说明：
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孟亚飞, 张伟玲, 李彤彤, 等. cremophor RH40及labrafil M 1944 CS的鼻黏膜毒性考察[J]. 中国实验方剂学杂志, 2014,20(20):20-23.

MENG Ya-fei, ZHANG Wei-ling, LI Tong-tong, et al. Evaluation of Nasal Mucosa Toxicity of Cremophor RH40 and Labrafil M 1944 CS[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(20): 20-23.
孟亚飞, 张伟玲, 李彤彤, 等. cremophor RH40及labrafil M 1944 CS的鼻黏膜毒性考察[J]. 中国实验方剂学杂志, 2014,20(20):20-23. DOI： 10.13422/j.cnki.syfjx.2014200020.

MENG Ya-fei, ZHANG Wei-ling, LI Tong-tong, et al. Evaluation of Nasal Mucosa Toxicity of Cremophor RH40 and Labrafil M 1944 CS[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(20): 20-23. DOI： 10.13422/j.cnki.syfjx.2014200020.

摘要

目的：考察乙醇-油酸聚乙二醇甘油酯（labrafil M 1944 CS）和聚氧乙烯氢化蓖麻油40（cremophor RH40）的鼻黏膜毒性，探讨其在鼻腔给药系统中应用的可行性。方法：以山梨糖醇酐油酸酯（span-80）和聚山梨酯-80（tween-80）为参比，采用在体蟾蜍上腭模型，光学显微镜下观察纤毛持续运动时间，考察cremophor RH40和labrafil M 1944 CS的纤毛毒性作用；运用家兔血细胞溶血试验，考察cremophor RH40和labrafil M 1944 CS对细胞膜完整性的影响。结果：体积分数为1%时，4种表面活性剂对纤毛运动的影响顺序为cremophor RH40 < labrafil M 1944 CS < tween-80 < span-80；cremophor RH40的细胞膜毒性最小，tween-80和span-80次之，而labrafil M 1944 CS的影响最大；cremophor RH40对细胞膜完整性无影响用量为tween-80和span-80的15倍。结论：在一定体积分数下cremophor RH40的鼻黏膜毒性作用较小，可应用于鼻腔给药制剂的研制。

Abstract

Objective: Nasal mucosa toxicity of cremophor RH40 and labrafil M 1944 CS were investigated

in order to explore feasibility of their application in nasal drug delivery system. Method: Compared with span-80 and tween-80

safety of surfactant was evaluated by testing cilia movement of in situ toad palate model and hemolysis test of erythrocyte membrane in rabbits. Result: When concentrations of these four kinds of surfactants were 1%

their effect on cilia movement was in order of cremophor RH40 < labrafil M 1944 CS < tween-80 < span-80. By survey of toxic effects on cell membranes

cremophor RH40 had little cell membrane toxicity

tween-80 and span-80 had moderate cell membrane toxicity

but labrafil M 1944 CS had serious cell membrane toxicity.Dosage of cremophor RH40 that had no effect on integrity of cell membrane was 15 times the amount of tween-80 and span-80. Conclusion: Cremophor RH40 has little toxic effect on nasal mucosa under a certain range of concentration that can be applied in nasal drug delivery system.

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