中国药房2011，Vol.22Issue(36)：3442-3444,3.
9种不同厂家卡马西平片的含量、有关物质和溶出度分析
Comparison of Carbamazepine Tablets from 9 Manufacturers in Content, Related Substances and Dissolution
李玲 1田宁 1付胜楠 1宋玮娟 1游秀华 1吴传斌 1胡海燕1
作者信息
- 1. 中山大学药学院药剂学与制药工程实验室/广东省创新药物制剂工程技术研究开发中心,广州市510006
- 折叠
摘要
Abstract
OBJECTIVE: To investigate the correlation between adverse drug reactions and product quality of carbamazepine tablets. METHODS: According to the Chinese Pharmacopoeia (2010 edition, volume Ⅱ), the content, related substances and dissolution of Carbamazepine tablets were compared among 9 manufacturers. RESULTS: The content of Carbamazepine tablets from 9 factories met the requirement in spite of discrepancies among them (94.5% -106.1% ). Carbamazepine tablets from 8 domestic companies showed similar spectrograms of related substances which was completely different from that of joint venture manufacturer A. Additionally, Carbamazepine tablets from 8 domestic companies showed dissolution rate at 0.5 h and 1.0 h, there was no statistical significance (P>0.05). They were faster than that of joint venture manufacturer A, there was significant difference (P< 0.01). CONCLUSION: The difference in clinical adverse reaction of Carbamazepine tablets produced by different manufacturers may be strongly related to product quality such as related substances and dissolution.关键词
卡马西平/不良反应/质量相关性/有关物质/溶出度Key words
Carbamazepine/ Adverse drug reaction/ Quality correlation/ Related substances/ Dissolution分类
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李玲,田宁,付胜楠,宋玮娟,游秀华,吴传斌,胡海燕..9种不同厂家卡马西平片的含量、有关物质和溶出度分析[J].中国药房,2011,22(36):3442-3444,3.
