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目的为选取适宜的珍珠明目滴眼液内包材、修订贮存条件提供建议。方法采用气相色谱法,通过影响因素考察试验、加速稳定性试验、冰片含量与贮存时间的相关性分析等,考察适合珍珠明目滴眼液的内包材以及贮存条件。结果龙脑、异龙脑、樟脑的含量受温度、光照、生产日期等影响,聚酯(PET)材料密封性能良好,能更好地防止冰片的挥散。结论建议采用聚酯(PET)作为本品的内包材,并将贮存条件修订为密封,置凉暗处。
Objective To select the appropriate Pearl Mingmu eye drops packaging material, modify the storage conditions to provide advice. Methods Gas chromatography was used to study the inner packing materials and the storage conditions for pearl eye drops by influencing factor investigation, accelerated stability test, the correlation between the content of borneol and the storage time. Results The contents of borneol, isoborneol and camphor were affected by temperature, light and production date. PET (PET) material had good sealing performance and better prevented the volatilization of borneol. Conclusions Polyester (PET) is recommended as an inner wrapper for this product and the storage conditions are revised to a sealed, cool, dark place.