摘要
目的建立桉油精和薄荷脑的气相色谱含量测定方法,以研究不同药用复合膜包装感冒咳嗽颗粒和清喉利咽颗粒,确立最适宜包装。方法采用HP-Innowax毛细管柱(30 m×0.25 mm×0.15μm);柱温:初始温度60℃,保持2 min,然后以20℃/min升温至200℃;进样口温度:200℃;检测器温度:220℃;载气为氮气;流速1 mL/min;分流比10∶1。结果桉油精在0.507~50.700μg/mL、薄荷脑在0.515~51.500μg/mL线性范围内具有良好的线性关系,相关系数(r)均为0.9999,在加速3个月后,纯铝膜包装的感冒咳嗽颗粒中桉油精的含量约是镀铝膜和纯塑膜的2~3倍;纯铝膜和镀铝膜包装的清喉利咽颗粒中薄荷脑的含量相当,约是纯塑膜的2倍。结论纯铝膜包装的感冒咳嗽颗粒和清喉利咽颗粒颗粒最优,镀铝膜次之,纯塑膜最差。
Objective To establish a gas chromatography method for determination of eucalyptol and menthol,to study the packaging of cold and cough granules and qinghou liyan granules with different pharmaceutical composite films,and to establish the most appropriate packaging.Methods The HP-Innowax capillary column(30 m×0.25 mm×0.15μm)was used.The column temperature:60℃,held for 2 min,increased at a rate of 20℃/min to 200℃.The inlet temperature was 200℃and the detector temperature was 220℃.Nitrogen was selected as the carrier gas with a flow rate of 1.0 mL/min and the split flow ratio was 10:1.Results Eucalyptol showed good linearity of eucalyptol at concentration of 0.507-50.700μg/mL,menthol showed good linearity of menthol at concentration of 0.515-51.500μg/mL,with their correlation coefficients(r)of 0.9999.After 3 months of acceleration,the content of eucalyptol in cold cough granules packed with pure aluminum film is about 2-3 times that of aluminum coated film and pure plastic film,and the content of menthol in qinghou liyan granules packed with pure aluminum film and aluminum coated film is equivalent,about twice that of pure plastic film.Conclusion Cold cough granules and qinghou liyan granules packed with pure aluminum film are the best,followed by aluminum coated film,and pure plastic film is the worst.
作者
熊马剑
饶艳春
左军凤
XIONG Majian;RAO Yanchun;ZUO Junfeng(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
出处
《药品评价》
CAS
2023年第4期417-420,共4页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2019JS28)。
关键词
药物包装
药用复合膜
气相色谱法
桉油精
薄荷脑
Drug packaging
Medicinal composite films
Gas chromatography
Eucalyptol
Menthol
