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[摘要]
目的 研究前列地尔注射液的稳定性,为其生产、包装、贮存、运输条件提供理论依据。方法 采用高效液相色谱法,测定前列地尔注射液中前列地尔及其有关物质A1的量,并考察强光照(4 500 lx)、高温(40℃、60℃)、加速、长期试验对其稳定性的影响,分别测定各项指标与原始数据进行比较。结果 前列地尔和A1的线性、精密度、稳定性、回收率均符合要求;强光及高温条件下放置较长时间(10 d),前列地尔注射液色泽则明显加深,pH值几乎没改变,含量明显降低,同时降解成的有关物质则明显增加;25℃加速试验6个月,其pH值略有下降。3批样品在4℃下存放,长期试验12个月后,其外观性状、有关物质及含量等各项指标均符合相关要求。结论 前列地尔注射液对光、热不稳定,容易降解,本品应避光、冷藏贮存,有效期可暂定为1年。
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[Abstract]
Objective To study the stability of Alprostadil Injection, and provide theoretical basis for its production, packaging, storage, and transportation conditions. Methods The contents of PGE1 and A1 in Alprostadil Injection were determined by HPLC method through strengthen test, accelerated test, and longterm test. The stability of Alprostadil Injection was investigated. Results Linearity, precision, stability, and recovery rate of E1 and A1 met the requirements; Placed for 10 d under high light and high temperature conditions, the color was obviously deepened, the pH value was almost unchanged, the content decreased significantly and degradation of related substances increased significantly; At 25 ℃ and after 6 months of acceleration test, the PH value decreased slightly and the content changed obviously. Three batches of samples were stored at 4℃ and long-term tested after 12 months, its appearance traits, related substances, and content of the indicators were in line with the relevant requirements. Conclusion Alprostadil Injection is unstable to light and heat, easy degradation, this product should be stored in dark and cold conditions, with the validity for one year.
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