神经药理学报

神经药理学报 ›› 2021, Vol. 11 ›› Issue (4): 21-.DOI: 10.3969/j.issn.2095-1396.2021.04.005

• 实验方法学 • 上一篇    下一篇

尼莫地平注射液（无乙醇型）血管刺激性研究

孙亚美，程晓波，侯继祥，张丹，赵博册，林佳亮，李炜，沈丽霞

吴翠栓1 张 强3   

  1. 1. 北京德立福瑞医药科技有限公司，北京，102100，中国

    2. 河北北方学院，张家口，075000，中国

    3. 北京大学，北京，100000，中国

  • 出版日期:2021-08-26 发布日期:2021-08-26
  • 通讯作者: 吴翠栓，博士，正高级工程师；研究方向：创新制剂开发及产业化；E-mail：cuishuanw@126.com 张强，博士，教授；研究方向：分子药剂学与创新制剂临床转化；E-mail：zqdodo@bjmu.edu.cn
  • 作者简介:孙亚美，本科，研究员；E-mail：1774528548@qq.com
  • 基金资助:

    中关村科技园区颠覆性技术研发和成果转化项目

Study on Vascular Irritation of Nimodipine Injection (Ethanol-Free Type)

SUN Ya-mei，CHENG Xiao-bo，HOU Ji-xiang，ZHANG Dan，ZHAO Bo-ce，LIN Jia-liang，LI Wei，SHEN Li-xia，WU Cui-shuan，ZHANG Qiang   

  1. 1. Beijing Delivery Pharmaceutical Technology Co.，Ltd，Beijing，102100，China

    2. Hebei North University，Zhangjiakou，075000，China

    3. Peking University，Beijing，100000，China

  • Online:2021-08-26 Published:2021-08-26

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摘要：

目的：采用家兔耳缘静脉注射法考察尼莫地平注射液（无乙醇型）对家兔的血管刺激性。方法：将家兔分为阴性对照组（5% 葡萄糖注射液组）、尼莫地平注射液（无乙醇型）组、市售尼莫地平注射液组、空白制剂组，分别采用耳缘静脉注射给药方法，给药剂量为0.47 mg·kg-1，观察家兔的整体状态、耳部的静脉血管及周围组织的变化，并对耳部进行病理学评价。结果：5% 葡萄糖注射液组对血管无刺激性，空白制剂组及尼莫地平注射液（无乙醇型）组的血管刺激等级为轻度，而市售尼莫地平注射液组动物的血管刺激等级为严重。结论：尼莫地平注射液（无乙醇型）的血管刺激性显著小于市售尼莫地平注射液，去除制剂中乙醇可以显著改善尼莫地平注射液的血管刺激性。

关键词: 尼莫地平, 无乙醇型注射液, 血管刺激性

Abstract:

Objective：The rabbit ear-margin intravenous injection method was used to investigate the vascular irritation of nimodipine injection（ethanol-free type） in rabbits. Methods：The rabbits were randomly divided into the negative control group （5% glucose injection group），the nimodipine injection （ethanol-free type） group，the commercially available nimodipine injection group，and the blank preparation group. Nimodipine injections were administered through ear veins and the dosage was 0.51 mg·kg-1.The overall condition of the rabbits，the changes in the veins and blood vessels of the ears and the surrounding tissues were observed，and the ears were pathologically evaluated. Results：The 5% glucose injection group has no irritation to blood vessels. The vascular irritation grades of the blank preparation group and nimodipine  injection（ non-ethanol type） group are mild，while the vascular irritation grades of animals in the commercially available nimodipine injection group are severe. Conclusion：The vascular irritation of nimodipine injection（ ethanol-free type） is significantly less than that of commercially available nimodipine injection. Removal of ethanol in the preparation can significantly improve the vascular irritation of nimodipine injection.

Key words: nimodipine injection, ethanol-free injection, vascular irritation

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