长春西汀注射液含量测定及长期稳定性研究

目的建立长春西汀注射液的含量测定方法并考察其长期稳定性,确保临床用药安全有效。方法取长春西汀注射液市售包装3个批次,根据注册批准的贮存条件贮存,分别于生产后第0,3,6,9,12,18和24个月末取样,测定长春西汀及有关物质的含量,对长春西汀注射液的长期稳定性做出评价。结果长春西汀注射液在规定的贮存条件下存放24个月,其含量测定及有关物质检测符合质量标准。结论该方法可用于长春西汀注射液的含量测定,在规定贮存条件下长春西汀注射液长期稳定性良好。

Study on the content determination and long-term stability of Vinpocetine Injections

Objective To establish a quantitative method and investigate the long-term stability of Vinpocetine Injections, therefore to ensure the injection clinical use safely and effectively.Methods 3 batches Vinpocetine Injections were investigated under the approved storage conditions.At the end of 0,3,6,9,12,18 and 24 month,the samples were taken respectively and the content of vinpocetine and related substances were tested to evaluate the long-term stability of Vinpocetine Injections.Results After stored in the specified conditions for 24 months,the content determination and related substances of Vinpocetine Injections met the quality specification.Conclusion Vinpocetine Injections have a good long-term stability under the specified conditions.