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目的:分析正清风痛宁注射液中原料与辅料亚硫酸氢钠的配伍合理性。方法:采用液相色谱法测定正清风痛宁注射液中杂质及主成分含量,采用离子色谱测定正清风痛宁注射液中亚硫酸根含量,比较原样品与经过影响因素试验(高温40℃、60℃或光照4 500 Lx)样品中有关物质的变化、主成分峰的变化及亚硫酸根离子的变化,并用LC-MS对杂质峰进行了结构确认。结果:正清风痛宁注射液中杂质为原料药物与辅料亚硫酸氢钠的加成杂质。结论:正清风痛宁注射剂中采用亚硫酸氢钠作为抗氧剂属于配伍不合理。
Objective: To analyze the rationality of compatibility of raw materials and auxiliary sodium bisulfite in Zhengqing Fengtongning injection. Methods: The contents of impurities and main components in Zhengqing Fengtongning injection were determined by liquid chromatography. The content of sulfite in Zhengqing Fengtongning injection was determined by ion chromatography. Compared with the original samples and the influencing factors (high temperature 40 ℃, 60 ℃ or light 4 500 Lx) samples of the changes in the relevant substances, the main component peak changes and changes in sulfite ion, and LC-MS impurity peaks were confirmed. Results: Zhengqing Fengtongning injection of impurities as raw materials and additives sodium bisulfite addition impurities. Conclusion: It is unreasonable to use sodium bisulfite as an antioxidant in Zhengqing Fengtongning injection.