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

张桢珍; 刘超; 胡婷霞; 余露山

doi:10.13748/j.cnki.issn1007-7693.20233106

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

Influences of Polysorbate 80 Pretreatment Process on Related Substances in Pranoprofen Eye Drops

摘要

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。
方法采用全因子试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，同时应用阿伦尼乌斯方程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。

Abstract:
OBJECTIVE To investigate the influence of the excipient polysorbate 80 and its pretreatment process on related substances in pranoprofen eye drops.
METHODS A full factorial experimental design was utilized to analyze the effects of heating time and alkaline conditions during polysorbate 80 pretreatment on related substances. The interaction effects with other excipients during co-pretreatment were investigated. Additionally, a stability prediction model was established based on the Arrhenius equation.
RESULTS Polysorbate 80 accelerates the formation of oxidative impurities in pranoprofen eye drops. The minimal impurity level was achieved when polysorbate 80 was co-treated with borax and disodium edetate for 2 h. The stability prediction model indicated that the optimized formulation could maintain stability for 36 months at 25 ℃.
CONCLUSION When formulating preparations containing polysorbate 80, pretreatment processes should be specifically designed according to API characteristics. For oxidation-prone actives, appropriate pretreatment of polysorbate 80 can effectively reduce its impact on related substances.

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