Journal of Radiation Research and Radiation Proces ›› 2018, Vol. 36 ›› Issue (3): 30701-030701.doi: 10.11889/j.1000-3436.2018.rrj.36.030701

• RADIATION INTERDISCIPLINARY RESEARCH • Previous Articles     Next Articles

Study on the stability of ambroxol hydrochloride injection under irradiation environment

XU Jing1, ZHAO Dehua2, WU Xiaoyun3, DENG Ting3, GUAN Haiyan3   

  1. 1. Department of Pharmacy, Third Affiliated Hospital, Institute of Surgery Research, Army Medical University, Chongqing 400042, China;
    2. The Third People's Hospital of Mianyang, Mianyang 621000, China;
    3. Chongqing Technical Center for Drug Evaluation & Certification, Chongqing 401120, China
  • Received:2018-01-22 Revised:2018-02-28 Online:2018-06-20 Published:2018-06-21

Abstract:

Ambroxol hydrochloride injections were irradiated with 60Co 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.

Key words: Ambroxol hydrochloride, Radiation, UV, High temperature, Light, High performance liquid chromatography (HPLC), Stability

CLC Number: 

  • R917