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

目的:研究卡马西平片所致不良反应与产品质量的内在联系。方法:参照2010版《中国药典》(二部),分析比较9个厂家卡马西平片的含量、有关物质和溶出度。结果:9厂家卡马西平片含量均符合规定,但存在一定差异(94.5%～106.1%)。国产的8种卡马西平片显示了相似的有关物质图谱,与合资厂家A的有关物质图谱存在显著性差异;国产的8种卡马西平片在0.5h和1.0h的累积百分溶出度接近,差异无统计学意义(P>0.05),但与合资厂家A比较,溶出速率较快,且存在显著性差异(P<0.01)。结论:不同厂家的卡马西平片呈现出不良反应的差异,可能与制剂内在质量(比如有关物质和溶出度)相关。

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（P0.05）.They were faster than that of joint venture manufacturer A,there was significant difference（P0.01）.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.