Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (8): 884-887.
DOI: 10.19803/j.1672-8629.20230305

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Clinical compatibility of bromhexine injectable preparations

LIU Yi1, LIU Xiaoqiang2, YAO Xiao2, LI Xuantang1, GUO Xianhui1, GENG Ying1,*, PEI Yusheng1   

  1. 1Institute for Chemical Drug Control, National Institutes for Food and Drug Control‚ NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629‚ China;
    2Changzhou Institute for Drug Control, Changzhou Jiangsu 213002‚ China
  • Received:2023-05-18 Online:2024-08-15 Published:2024-08-21

Abstract: Objective To investigate the causes of turbidity that occurs during infusion of bromhexine injectable preparations. Methods Representative clinical compatibility tests for verification were carried out in combination with bromhexine solubility analysis, and the relevant compatibility of non therapeutic drugs was observed. Results The solubility of bromhexine was highly correlated with the pH environment. Combined with confirmatory clinical compatibility tests of compound sodium chloride injection and multiple electrolytes injection, it was confirmed that bromhexine injectable preparations were likely to become turbid when the environmental pH value of the clinical compatibility medication was slightly alkaline. Conclusion The turbidity of bromhexine injectable preparations is chiefly due to pH rather than the infusion solvent, suggesting the need to attach importance to clinical compatibility of non-therapeutic drugs.

Key words: bromhexine, injection, clinical compatibility, solubility, pH, sodium chloride injection, non therapeutic drugs, electrolytes, solvent

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