目的:对吸入用乙酰半胱氨酸溶液药包材的质量现状进行分析,为保障其质量提供更合理的依据。方法:对包装吸入用乙酰半胱氨酸溶液的玻璃安瓿的平均线热膨胀系数、折断力、内表面的侵蚀程度、元素的迁移、透光率以及制剂中有关物质进行研究。结果:A制剂(原研药)、B制剂、C制剂均采用棕色中硼硅玻璃安瓿作为包装,D制剂采用无色低硼硅玻璃安瓿作为包装。A制剂安瓿的折断力小于B、C、D制剂。总体来说,中硼硅玻璃安瓿与药物的相容性好于低硼硅玻璃安瓿;棕色玻璃包装制剂的有关物质经过光照试验后几乎没有变化,无色玻璃的各个杂质均有一定程度的增加。结论:适宜的药包材对吸入用乙酰半胱氨酸溶液产品质量有重要影响,采用棕色中硼硅玻璃包材,可以有效降低易分解药品的有关物质,提高药品的稳定性,从而延长药品的生命周期。
Objective: To provide reasonable quality control of packaging materials for inhaled acetycysteine solution by analyzing their quality status. Methods: The average coefficient of linear thermal expansion, breaking force, corrosion degree of inner surface, migration of elements and transmittance of glass ampoules for inhaled acetycysteine solution were studied. Related substances in acetycysteine solution for inhalation were also examined. Results: Products from company A (original drug), company B and company C were packed in brown middle borosilicate glass ampoules, while product from company D was packed in colorless low borosilicate glass ampoules. The breaking force of ampoules from company A was less than that from companies B, C and D. In general, the compatibility of middle borosilicate glass ampoules with acetycysteine solution for inhalation was better than that of low borosilicate glass ampoules. The related substances of brown glass packaging preparations showed no change after illumination test while the impurities of colorless glass packaging preparation increased. Conclusion: Appropriate packaging materials have an important impact on the quality of acetylcysteine solution for inhalation. Brown middle borosilicate glass packaging materials can effectively reduce the related substances of easily decomposed drugs, improve the stability of drugs and prolong the life cycle of drugs.
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