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目的考察3种医用塑料包材对双柏喷膜剂中各成分的吸附性,选择合适双柏喷膜剂的包装材料。方法将双柏喷膜剂分装在聚对苯二甲酸乙二醇酯(PET)、聚丙烯(PP)、高密度聚乙烯(HDPE)塑料喷雾瓶中,分别进行影响因素试验与常规留样试验,分别对样品溶液进行性状检查、喷瓶材料性质考察、喷瓶内部颜色检查,筛选较佳包材进行相容性长期试验,观察喷瓶内壁颜色变化以及采用HPLC法测定药物质量浓度和瓶壁吸附药物的量。结果 3种包材载药后颜色变化程度:HDPE>PP>PET,PP瓶出现硬度、冲击强度下降;PET瓶对蒽醌类成分芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚等产生微量吸附,其他成分均未产生吸附;贮存在PET瓶中的双柏喷膜剂,各成分除在水溶液中不稳定的大黄酚、大黄素甲醚外,其他药物的量均稳定。结论 PET适宜作为双柏喷膜剂的包装材料。
Objective To investigate the adsorption of three kinds of medical plastic packaging materials on the components of Shuangbo Spray Film, and select the suitable packaging material of Shuangbo Spray Film. Methods Double cyprimer was divided into polyethylene terephthalate (PET), polypropylene (PP) and high density polyethylene (HDPE) plastic spray bottle, respectively influential factor test and routine sample retention Tests were carried out on the sample solution tracer, spraying the nature of the material inspection, spray bottle internal color inspection, selection of better packaging materials for long-term compatibility test, observe the bottle spray wall color change and the use of HPLC method for the determination of drug concentration and bottle The amount of drug adsorbed on the wall. Results The color change degree of the three kinds of packaging materials after loading: HDPE> PP> PET, the hardness and the impact strength of PP bottles decreased; the PET bottles had no effect on the anthraquinones such as aloe emodin, rhein, emodin, chrysophanol, Ether and other trace adsorption, no adsorption of other ingredients; stored in the PET bottle double cyprimecide, each component except in the aqueous solution of unstable chrysophanol, physcion, the amount of other drugs are stable. Conclusion PET suitable as Shuangbo spray film packaging materials.