低密度聚乙烯滴眼剂瓶与药物的相容性研究

Study on the Compatibility of LDPE Eye Drops Bottle with Drugs

目的:分别从三个方面考察药包材与盐酸羟苄唑滴眼液之间的相容性,为今后类似药物相容性研究提供参考数据。方法:模拟厂家处方,配制样品,灌装至低密度聚乙烯滴眼剂瓶中。(1)于不同时间测定盐酸羟苄唑滴眼液的pH值;(2)采用GC-MS方法考察滴眼液瓶身与样品是否含邻苯二甲酸酯类塑化剂成分;(3)考察低密度聚乙烯瓶对抑菌剂三氯叔丁醇的吸附情况。结果:(1)盐酸羟苄唑滴眼液pH值的未发生变化;(2)在盐酸羟苄唑滴眼液未检测到塑化剂邻苯二甲酸酯类;(3)瓶身对三氯叔丁醇有吸附。结论:低密度聚乙烯不会被盐酸羟苄唑滴眼液溶解,没有塑化剂析出,但此材料对抑菌剂三氯叔丁醇有吸附;因此,可以考虑将低密度聚乙烯作为盐酸羟苄唑类药物的包装材料,但要进行处理,以防止对抑菌剂三氯叔丁醇的吸附。

Objective:The compatibility between drug packaging materials and dobenzazole hydrobenzole eye drops was investigated from three aspects,it can provide reference data for the study of compatibility of similar drugs in the future.Methods:We simμLate manufacturer's prescription and preparate sample,then the sample was filled into low density polyethylene eye drops bottle.(1)Determinate pH value of hydrochloride eye drops at different time points;(2)GC-MS was used to determine whether phthalate plasticizers were present in the bottle and sample of eye drops;(3)The adsorption of trichloro tert butyl alcohol on LDPE bottles was investigated.Results:(1)The pH value of dobenzazole hydrochloride eye drops did not change;(2)No plasticizer phthalates were detected in the eye drops of dobenzazole hydrochloride;(3)Trichloro tert butyl alcohol is adsorbed on the bottle body.Conclusion:LDPE will not be dissolved by hydrochloride eye drops,and no plasticizer was precipitated,however,this material can adsorb trichloro tert butyl alcohol;above all,LDPE can be considered as packaging material of hydrochloride on the basis of treatment,prevent the adsorption of antibacterial agent trichloro tert butyl alcohol.