硝酸甘油片在不同条件下的稳定性研究

The stability of nitroglycerin tablets in different packaging conditions

本文对硝酸甘油片在不同包装条件下的含量变化进行了较系统的研究,结果为:硝酸甘油片在投药纸袋中,T_(0.9)^(18℃)=4.1d、T_(0.9)^(25℃)=1.7d、T_(0.9)^(31℃)=1.5d;在保健盒中,T_(0.9)^(18℃)=10.5d、T_(0.9)^(25℃)=4.8d、T_(0.9)^(31℃)=2.7d;在开盖情况下,T_(0.9)^(18℃)=4.4d、T_(0.9)^(25℃)=1.7d、T_(0.9)^(31℃)=1.1d;在玻璃瓶中T_(0.9)^(室温)=161.6d、T_(0.9)^(5℃)=435.9d,说明硝酸甘油片不稳定,极易受温度、湿度、包装等诸因素的影响而使含量下降,故对该药应低温保存,并改进投药和摆药方式。建议药厂改进其制造工艺和包装。

The content changes of nitroglycerin tablets indifferent packagings was studied. When nitroglyc-erin tablets in envelope, it was shown that 18℃t_(0.9)=4.1d, 25℃t_(0.9)=1.7d, 31℃t_(0.9)=1.5d; in healthcare box, 18℃t_(0.9)=10.5d, 25℃t_(0.9)=4.8d, 31℃t_(0.9)=2.7d; under exposure state, 18℃t_(0.9)=4.4d,25℃t_(0.9)=1.7d, 31℃t_(0.9)=1.1d; and in glass bot-tle, room temperature t_(0.9)=161.6d, 5℃t_(0.9)=435.9d; These results showed that nitroglycerintablets are not in the state of stability, and its con-tent that can be easily influenced by many factorssuch as temperature, humidity or package. Hence,the medicine should be stored in lower temperatureand the methods that the medicine is given and putalso should be improved. It is suggested that thepharmaceutical factory that produces nitroglycerintablets should improve its manufacturing technologyand package.