摘要
目的考察pH值对氟马西尼注射液质量的影响,为氟马西尼注射液生产过程中pH值控制提供依据。方法分别制备pH值为3.0、3.4、3.8、4.2、4.6和5.0的氟马西尼注射液,与参比制剂同时置于长期和加速稳定性试验箱中,于1、3和6个月后取样检测关键质量指标,评估不同pH的氟马西尼注射液和参比制剂的稳定性差异。结果所有样品的性状、溶液澄清度与颜色、可见异物和不溶性微粒在稳定性考察期间未改变,含量无显著变化;有关物质项下杂质A增长趋势明显,未检出其他杂质。当pH值在3.8~4.6时,自制氟马西尼注射液中杂质A增长相对缓慢,与参比制剂中杂质A增长趋势一致。结论氟马西尼注射液pH值在3.8~4.6时稳定性更好,生产过程中应将pH值控制在3.8~4.6。
Objective To determine the effect of pH values on the quality of flumazenil injection and provide a basis for the control of pH during the production process.Methods Flumazenil injections with pH values of 3.0,3.4,3.8,4.2,4.6 and 5.0 were prepared and placed in the long-term and accelerated stability test chambers together with the reference preparations.The samples were taken out after 1,3,6 months and the key indicators were tested to evaluate the stability differences between flumazenil injections with different pH values and reference preparations.Results The characteristics,clarity and color of solution,visible particles and insoluble particles of all samples did not change during the stability test,and the content did not change obviously.Impurity A obviously tended to increase while no other impurities were detected in the related substances.When the pH value ranged 3.8~4.6,the growth of impurity A in the self-made flumazenil injections relatively slowed down,which was similar to that in the reference preparation.Conclusion Flumazenil injection is more stable when the pH value ranges 3.8~4.6.
作者
郭丹峰
金怡平
肖利辉
袁金桥
GUO Dan-feng;JIN Yi-ping;XIAO Li-hui;YUAN Jin-qiao(Harvest(Hunan)Pharmaceutical Co.,Ltd.,Changsha 410217)
出处
《中南药学》
CAS
2024年第2期433-436,共4页
Central South Pharmacy
基金
湖南省自然科学基金项目(No.2021JJ80014)。
