双柏喷膜剂塑料包材吸附性研究  

Adsorption studies on plastic packaging materials of Shuangbai Film Spraying Agent

作　　者：欧斯健[1] 朱小凤 何坦 张龙开[1] 刘东辉[1] 魏刚[1] 

机构地区：[1]广州中医药大学新药开发研究中心,广东广州510006 [2]广西梧州制药集团股份有限公司,广西梧州543004 [3]广州白云山中一药业有限公司,广东广州510530

出　　处：《中草药》2013年第18期2537-2541,共5页Chinese Traditional and Herbal Drugs

基　　金：国家"十一五"科技支撑计划项目(2008BAI53B074)

摘　　要：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 components adsorbability of Shuangbai Film Spraying Agent （SFSA） packaged by three types of plastic medicinal materials, and to optimize the packaging material for SFSA. Methods SFSA was dispensed in polyethylene terephthalate （PET）, polypropylene （PP）, and high density polyethylene （HDPE） plastic spraying bottles and the factors influencing test and conventional sample test were carried out. The characteristics of sample solution and spraying bottles and the internal color of spraying bottles were inspected, the optimal packaging material was screened for compatibility long-term test, the wall color changes of spraying bottles were observed, and the contents of drug concentration and the bottle wall adsorption were determined by HPLC. Results The degree of change in color after six months of the three types of drug packaging material was HDPE 〉 PP〉 PET; The hardness and impact strength of PP bottle decreased. PET bottles only adsorbed small quantities of aloe-emodin, rhein, emodin, chrysophanol, emodin, and none of the other ingredients. The chrysophanol and emodin were unstable in the aqueous solution, and the contents of other indicator components of SFSA in the PET bottle were stable. Conclusion PET is suitable to be the packaging materials of SFSA.

关 键 词：双柏喷膜剂 聚对苯二甲酸乙二醇酯 相容性试验 吸附性 蒽醌 

分 类 号：R283.6[医药卫生—中药学]