不同厂家青霉素Ⅴ钾片溶出度分析和溶出曲线相似性评价

Analysis for the dissolution and similarity of stripping curve of penicillin Ⅴ potassium tablets from different manufacturers

目的对国内10个厂家48批次青霉素Ⅴ钾片的体外溶出度结果进行分析并进行溶出曲线相似性评价。方法采用紫外分光光度法测定不同厂家青霉素Ⅴ钾片的体外溶出度,并采用相似因子(f2)法,取原研厂家的青霉素V钾片为参比制剂,对A、B、D厂家药品在4种溶出介质中进行溶出曲线相似性评价。结果各厂家药品溶出度结果都符合药典规定,A、B、D厂家与参比制剂在不同溶出介质中溶出曲线相似性略有不用。结论药典溶出度方法遍普适用于各厂家青霉素Ⅴ钾片的溶出度检查,对溶出曲线相似性结果研究可以较客观地反映国内各厂家青霉素Ⅴ钾片的情况并为青霉素V钾片今后的仿制药质量和工艺提供参考建议。

Objective To analyze the results of dissolution in vitro of 48 batches of penicillin V potassium tablets from 10 domestic manufacturers,and to evaluate the similarity of stripping curve of penicillin V potassium tablets. Methods Ultraviolet（ UV） specrophotometry method was used to determine in vitro dissolution of penicillin Ⅴ potassium tablets from different manufacturers. In addition,the penicillin V potassium tablets of the original manufacturer were used as reference preparations,and similarity factor（ f2） method was used to assess the similarity of stripping curve of penicillin V potassium tablets made by A,B and D manufacturers. Results The detection results of drug dissolution of several manufacturers were consistent with the criteria of Chinese Pharmacopoeia,however,the similarity of stripping curve of penicillin V potassium tablets made by A,B and D manufacturers in different dissolution media was little different,as compared with that of reference preparations. Conclusion The dissolution method of Chinese Pharmacopoeia is generally applicable to the dissolution determination of penicillinⅤpotassium tablets from different manufacturers,and the detection results of similarity of stripping curve of penicillin V potassium tablets may from different manufacturers similarity of the dissolution profiles to the reference preparation can objectively reflect the quality of penicillinⅤpotassium tablets from different domestic manufacturers,and may provide references and suggestion for production technology and quality of generic preparations in the future.