目的 探究包装系统对固体制剂稳定性的协同影响。方法 以盐酸西替利嗪片为模型药物,分别采用单因素对比及正交试验,考察包装材料、HDPE瓶尺寸、干燥剂装量、铝箔封口处理在加速稳定性条件下的作用。通过测定贮存6个月内脆碎度、水分等指标,分析不同包装系统对药品制剂贮存稳定性的影响。结果 单因素试验显示,铝塑包装的防潮性能更优,溶出度下降较缓（约10%）,但杂质总量增幅（0.23%）略高于HDPE瓶（0.19%）。HDPE瓶包装系统中,瓶体积与脆碎度、水分呈正相关,1~3 g干燥剂可将水分控制在2.3%~2.9%（无干燥剂组达4.7%）,铝箔封口防止水分吸收和脆碎度上升的作用最为显著（封口组：水分为2.6%,脆碎度维持在0.09%;对照组：水分增至7.7%,脆碎度增至0.23%）。正交试验表明,在铝箔封口与干燥剂的协同下,HDPE瓶能有效延缓药物溶出度的下降并抑制杂质的生成,使其优于铝塑包装。结论 通过合理地优化瓶子尺寸、干燥剂装量与密封处理等,可显著提升HDPE瓶的阻隔性能,进而提高药品的贮藏稳定性。
Abstract
The work aims to investigate the synergistic effects of packaging systems on the stability of solid oral dosage forms. Cetirizine hydrochloride tablets were selected as the model drug. Single-factor comparison and orthogonal experiments were conducted to investigate the effects of packaging materials, HDPE bottle size, desiccant loading, and sealing status under accelerated stability conditions. By measuring indicators such as friability and moisture content over a 6-month storage period, the impact of different packaging systems on the storage stability of pharmaceutical formulations was analyzed. Single-factor experiments showed that, aluminum-plastic blister packaging provided more stable moisture control and a slower decline in dissolution rate (10%), although the increase in total impurities (0.23%) was slightly higher than that observed in HDPE bottles (0.19%). Among the HDPE bottles, bottle volume was positively correlated with brittleness and moisture content. Using 1-3 g of desiccant effectively controlled moisture within 2.3%-2.9%, while the desiccant-free group showed significantly higher moisture (4.7%). Aluminum foil sealing demonstrated the most significant effect in preventing moisture absorption and reducing brittleness (sealed group: moisture content 2.6%, brittleness maintained at 0.09%; control group: moisture content increased to 7.7%, brittleness increased to 0.23%). Orthogonal experiments demonstrated that, through the synergistic effect of aluminum foil sealing and desiccant, HDPE bottles effectively delayed the decline in drug dissolution rate and suppressed impurity formation, outperforming aluminum-plastic packaging. This study indicates that by optimizing bottle size, desiccant loading, and sealing treatment, the barrier properties of HDPE bottles can be significantly enhanced, thereby improving storage stability.
关键词
固体制剂 /
包装因素 /
稳定性 /
协同影响
Key words
solid preparations /
packaging factors /
stability /
synergistic effect
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