摘要
目的考察4种市售头孢泊肟酯片的体外溶出度,评价其片剂质量。方法采用《中华人民共和国药典》(2000年版)溶出度测定法第2法,以盐酸溶液(9→1000)为溶剂,转速分别为100和50r·min1,进行溶出度测定实验。采用紫外分光光度法测定溶出量,测定波长为263nm。计算累积溶出率。结果线性范围为3～18μg·mL-1,r=0.9996。45min内4种待测药物在盐酸溶液(9→1000)中的累积溶出百分率均>70.0%。转速为100r·min1时,4种头孢泊肟酯片30min溶出率均>90.0%;转速为50r·min1时,4种头孢泊肟酯片45min内的溶出率均>70.0%。结论4种被测头孢泊肟酯片均符合质量标准,但不同生产厂家的产品之间有差异。
Objective To compare the qualities of four cefpodoxime proxetil tablets in terms of dissolution. Method The content of cefpodoxime proxetil was determined by UV spectrophotometry at 263 nm. Hydrochloric acid (9→1 000), distilled water and pH 7.4 phosphate buffer was used as the solvents. The paddle rotated at 100 or 50 r·min -1 . The accumulative release was calculated and the Weibull’s equation was used to model the main dissolution parameters. Results The range of linearity was 3-18 μg·mL -1 , r=0. 999 6. The accumulated release in hydrochloric acid solution at 45 min was over 70.0%, and in distilled water or pH 7.4 phosphae buffer was below 70.0%. The accumulated release of four cefpodoxime proxetil in hydrochloric acid solution at 30 min was over 90.0% when the paddle rotated at 100 r·min -1 , and the accumulated release of four cefpodoxime proxetil at 45 min was over 70.0% when rotated at 50 r·min -1 . Conclusion The four cepodoxime proxetil tablets are within the quality standards, but there is quality difference among them.
出处
《医药导报》
CAS
2005年第5期378-379,共2页
Herald of Medicine
关键词
头孢泊肟酯片
溶出度
体外
Cefpodoxime proxetil tablet
Dissolution,external
