|
|
|
| Some problems and Suggestions in content determination of Theophylline sustained-release capsules |
| CHEN Haidong1,QIN Zhigao2,and Pang Yuna3. |
1. Deparment of Pharmacy,Guangxi Zhuang Autonomous Region Hospital of Chinese People’s Armed Police Forces,Nanning 53000,China;
2.Nanning Institute for Food and Drug Control,Nanning 530001,China;
3. Deparment of Pharmacy,Poeople＇s Hospital of Bobai City.Guangxi 537600,China |
|
|
|
|
Abstract Objective To suggest and propose amendments for content determination of theophylline sustained-release capsules standard.Methods The system suitability parameters of two chromatographic condition and the content determination results were compared, and use method of theophylline reference substance was explored.Results The original standardmethod and the improved methods of chromatographic peak of retention timerespectively were 23.2 min and 6.2 min;Peak width respectively were 1.21 min and 0.62 min;Peak height respectively were 124.1 mV and 328.6 mV. There was no significant difference (P<0.01) between system suitability parameters of the two methods and the results of content determination, but the former method was easy to cause failure of analysis instrument, long cycle, and cost of analysis greatly increased. Intended method of improve went avoided the arising of the above situation. In addition, the original stipulated method of theophylline reference substance use is unreasonable, the method for improving the use of reference substance routine is suggested, and can further reduce the cost.Conclusion A method for improve can be used to replace the original standard method.
|
|
Received: 09 January 2013
|
|
|
|
|
|
| [1] |
国家药典委员会.《国家药品标准》(新药转正标准第48册)[S].北京:人民卫生出版社,2005:119.
|
| [2] |
王金库.茶碱缓释片的工艺研究[J].医学信息,2009,22(11):2472-2473.
|
| [3] |
国家药典委员会.中华人民共和国药典(二部)[S].北京:化学工业出版社,2000:附录32,42.
|
| [4] |
覃志高,李如栋,莫小英,等.己烯雌酚片含量测定中色谱条件与系统适用性试验的改进[J].中国药品标准,2009,10(2):91-94.
|
| [5] |
中华人民共和国卫生部.GB 5413.5-2010 婴幼儿食品和乳品中乳糖、蔗糖的测定[S].北京:中国标准出版社,2010:2.
|
| [6] |
中华人民共和国卫生部.GB/T 5009.8-2008 食品中蔗糖的测定[S].北京:中国标准出版社,2008:1.
|
| [7] |
国家药典委员会.中华人民共和国药典(二部)[S]. 北京:中国科技出版社,2010:ⅩⅦ.
|
|
|
|
2013, Vol. 24 
