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目的:考察不同厂家卡马西平片体外溶出度与崩解时限及生物利用度的相关性。方法:按中国药典1995年版要求测定其含量、崩解时限、溶出度。紫外分光光度法测家兔的血药浓度计算其动力学参数T_(max)、C_(max)和AUC。结果:四个厂家的卡马西平片质量均符合中国药典1995年版规定。崩解时限、溶出度、T_(max)、C_(max)、AUC均有显著性差异。结论:不同厂家的卡马西平片的体外溶出度与崩解时限有相关性,与T_(max)、C_(max)、AUC无相关性。
OBJECTIVE: To investigate the correlation between in vitro dissolution rate, disintegration time and bioavailability of carbamazepine tablets in different manufacturers. Methods: According to the requirements of Chinese Pharmacopoeia 1995 edition its content, disintegration time, dissolution. Ultraviolet spectrophotometry was used to measure the plasma concentration of T_ (max), C_ (max) and AUC. Results: The quality of carbamazepine tablets of the four manufacturers all met the requirements of the Chinese Pharmacopoeia 1995 edition. Disintegration time, dissolution, T_ (max), C_ (max), AUC were significantly different. Conclusion: The in vitro dissolution of carbamazepine tablets from different manufacturers has a correlation with the disintegration time, and has no correlation with T max, C max and AUC.