不同软管包材对清香止痛霜质量稳定性的影响  

Effects of Different Packging Materials on the Stability of Qingxiang Zhitong Shuang

作　　者：刘东文[1] 潘见欢[1] 李子鸿[1] 李怀国[1] 庄学潮[1] 郑芳昊[1] 

机构地区：[1]广东佛山市中医院,佛山528000

出　　处：《中国药事》2016年第10期997-1003,共7页Chinese Pharmaceutical Affairs

基　　金：2015年度佛山市科技创新平台资助项目(编号2015AG10006)

摘　　要：目的:考察不同软管包材对清香止痛霜质量稳定性的影响。方法:建立气相色谱法(GC)测定清香止痛霜中水杨酸甲酯的含量,并进行方法学验证。分别采用金属铝管、塑料软管和复合软管3种不同材质的软管包材对清香止痛霜进行灌装,参照《中国药典》的要求进行加速和长期稳定性试验,观察制剂基本性状和包材管壁性质的变化,并测定水杨酸甲酯的含量变化。结果:本试验成功建立了GC法测定水杨酸甲酯的含量。从外观上观察,金属铝管易导致清香止痛霜的膏体变质和管壁变形,主要表现为膏体颜色变为灰白色,管壁逐渐变黑;采用塑料软管和复合软管包装的制剂,外观无明显变化。含量测定结果表明,金属铝管包装的制剂中水杨酸甲酯含量下降速度最快,塑料软管次之,复合软管包装的制剂中水杨酸甲酯含量较稳定,下降速度最慢。结论:复合软管相比金属铝管和塑料软管具有更高的耐蚀性和低透气性,比较适合作为清香止痛霜的包装材料。Objective： To observe the effects of three different packing materials on the stability of Qingxiang Zhitong Shuang. Methods： A gas chromatography（GC） was developed for the content determination of methyl salicylate in Qingxiang Zhitong Shuang, and verified by methodology test. The stability of Qingxiang Zhitong Shuang packing with aluminium hose, polyethylene hose and composites, which consisted of aluminum foil and polyethylene, were measured by both accelerate test and long-term test with reference to Chinese Pharmacopoeia. In addition, the change of methyl salicylate content was determined. Results： A GC method for determining the content of methyl salicylate was successfully established. From the observation of appearance, metal aluminum tube easily led to metamorphism and deformation of the tube shell. As a result, the cream turned into grey, and the tube shell became dark. No obvious change in appearance was found by using plastic hose for packaging. The content determination results showed that methyl salicylate declined quickly in the preparation of metal aluminum tube packaging, followed by plastic hose, and the content was most stable in the preparation of compound tube packing. Conclusion： The color and shell of hose and the methyl salicylate content of QingxiangZhitong Shuang packing with aluminum or polyethylene could be influenced gradually, while it was quite stable packing with composites. Composite tube could be used for packing Qingxiang Zhitong Shuang.

关 键 词：清香止痛霜 药品包装材料 金属铝管 塑料软管 复合软管 药品质量稳定性 水杨酸甲酯 气相色谱分析 

分 类 号：R954[医药卫生—药学]