| 引用本文: | 张桢珍,余露山.聚山梨酯80预处理工艺对普拉洛芬滴眼液有关物质的影响[J].中国现代应用药学,2025,42(7):9-16. |
| zhangzhenzhen,yulushan.Influences of Polysorbate 80 Pretreatment Process on Related Substances in Pranoprofen Eye Drops[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(7):9-16. |
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| 摘要: |
| 目的 研究辅料聚山梨酯80及其预处理工艺对普拉洛芬滴眼液有关物质的影响。方法 采用全因子实验设计分析辅料聚山梨酯80预处理加热时间、碱性条件对普拉洛芬滴眼液有关物质的影响，考察其他不同类型辅料共同预处理所产生的作用，同时通过阿伦尼乌斯方程的应用，建立稳定性预测模型。结果 辅料聚山梨酯80能加快普拉洛芬滴眼液中氧化杂质的生成；当辅料聚山梨酯80与硼砂和依地酸二钠共同预处理2 h时，普拉洛芬滴眼液中的杂质含量最低；通过稳定性预测模型，预测优化工艺后的普拉洛芬滴眼液在25 ℃下可存放36个月。结论 当制剂中含有辅料聚山梨酯80时，应结合主成分性质进行处方工艺开发，若主成分易被氧化，可采用适当的预处理工艺降低聚山梨酯80对有关物质的影响。 |
| 关键词: 普拉洛芬滴眼液 聚山梨酯80 氧化杂质 预处理工艺 |
| DOI： |
| 分类号:R944.1 |
| 基金项目: |
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| Influences of Polysorbate 80 Pretreatment Process on Related Substances in Pranoprofen Eye Drops |
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zhangzhenzhen, yulushan
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Zhejiang University
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| Abstract: |
| OBJECTIVE To investigate the influence of the auxiliary ingredient polysorbate 80 and its pretreatment process on related substances found in pranoprofen eye drops. METHODS A full factorial experimental design was employed to analyze the effects of such as polysorbate 80 pretreatment heating time and alkaline conditions on related substances in pranoprofen eye drops，the study also examined the effects of pretreatment with other types of excipients. Additionally, the stability prediction model was established using the Arrhenius equation. RESULTS Polysorbate 80, as an auxiliary ingredient, accelerates the generation of oxidative impurities in pranoprofen eye drops. The lowest content of impurities was observed when polysorbate 80 was co-treated with boric acid and disodium edetate for 2 hours. The stability prediction model projected that optimized processing would allow pranoprofen eye drops to maintain stability for 36 months at 25 ℃. CONCLUSION When formulating preparations containing polysorbate 80, it is essential to consider the characteristics of the main components during prescription process development. If the main components are prone to oxidation, appropriate pretreatment process can be employed to mitigate the impact of polysorbate 80 on related substances. |
| Key words: pranoprofen eye drops polysorbate 80 oxidative impurities pretreatment process |
