辐照环境中盐酸氨溴索注射液的稳定性研究

徐靖; 赵德华; 武小赟; 邓婷; 管海燕

doi:10.11889/j.1000-3436.2018.rrj.36.030701

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辐照环境中盐酸氨溴索注射液的稳定性研究

辐射交叉学科研究 | 更新时间：2021-12-10

- 辐照环境中盐酸氨溴索注射液的稳定性研究
- Study on the stability of ambroxol hydrochloride injection under irradiation environment
- 辐射研究与辐射工艺学报 2018年36卷第3期
- 作者机构：
  
  1.陆军军医大学第三附属医院野战外科研究所药剂科重庆 400042
  2.绵阳市第三人民医院绵阳 621000
  3.重庆市药品技术审评认证中心重庆 401120
- 作者简介：
  
  [ "徐靖, 男, 1982年8月出生, 2005年毕业于第三军医大学, 主要从事药物分析、药物临床试验、新药研究, 主管药师, E-mail:xjl821121@163.com", "XU Jing (male) was born in August 1982, and graduated from Third Military Medical University in 2005, majoring in pharmaceutical analysis, clinical trials and new drug research, pharmacist-in-charge.E-mail:xjl821121@163.com" ]
  管海燕, 硕士, 高级工程师, E-mail:guanhaiyan83@163.com GUAN Haiyan, master's degree, senior engineer.E-mail:guanhaiyan83@163.com
- 基金信息：
- DOI：10.11889/j.1000-3436.2018.rrj.36.030701
  中图分类号：
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徐靖, 赵德华, 武小赟, 等. 辐照环境中盐酸氨溴索注射液的稳定性研究[J]. 辐射研究与辐射工艺学报, 2018,36(3):030701-6.

Jing XU, Dehua ZHAO, Xiaoyun WU, et al. Study on the stability of ambroxol hydrochloride injection under irradiation environment[J]. Journal of Radiation Research and Radiation Processing, 2018,36(3):030701-6.
徐靖, 赵德华, 武小赟, 等. 辐照环境中盐酸氨溴索注射液的稳定性研究[J]. 辐射研究与辐射工艺学报, 2018,36(3):030701-6. DOI： 10.11889/j.1000-3436.2018.rrj.36.030701.

Jing XU, Dehua ZHAO, Xiaoyun WU, et al. Study on the stability of ambroxol hydrochloride injection under irradiation environment[J]. Journal of Radiation Research and Radiation Processing, 2018,36(3):030701-6. DOI： 10.11889/j.1000-3436.2018.rrj.36.030701.

摘要

为考察盐酸氨溴索注射液在辐照环境中的稳定性，将注射液分别经,60,Coγ射线（吸收剂量2、4、8、16、26、34 kGy）辐照、光照（4 500±500）lx、紫外线（UV）辐照、高温（40、60℃）处理10 d，以颜色、澄明度、盐酸氨溴索浓度、有关物质为指标，考察其稳定性。结果表明：注射液在γ射线辐照、光照、UV、60℃高温环境中盐酸氨溴索浓度显著下降（,p,<, 0.01）；且注射液经γ射线辐照、UV辐照后降解生成多种极性较大的未知物质，颜色变为红棕色；盐酸氨溴索浓度在各种处理后的储存过程中仍会持续下降。研究结果表明，盐酸氨溴索注射液在γ射线辐照、UV环境中极不稳定，且在两种环境中产生的效应相近。

Abstract

Ambroxol hydrochloride injections were irradiated with ,60,Co γ-rays at different absorbed doses (2, 4, 8, 16, 26, and 34 kGy), exposed to light (4 500±500) lx, and ultraviolet, and stored under high temperature (40, 60℃) for 10 d. The color, clarity, drug concentration, and related substances of injection were inspected. It was found that injection drug concentration significantly decreased under γ-irradiation, light exposure, UV radiation, and high temperature (60℃) (,p,<, 0.01). The injection solution color changed to red brown due to the generation of unknown polarization-related substances under irradiation and UV environment, and drug content continued to decrease upon storage. It is shown that ambroxol hydrochloride injection is extremely unstable and is similarly affected under irradiation and UV environment.

关键词

盐酸氨溴索辐照紫外线高温光照高效液相色谱稳定性

Keywords

Ambroxol hydrochlorideRadiationUVHigh temperatureLightHigh performance liquid chromatography (HPLC)Stability

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