头孢泊肟酯片体外溶出曲线研究 |
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引用本文: | 张聪,程婵婵,郝洁,姚路路,卞梦芹,周冰,李焕娟,周德刚.头孢泊肟酯片体外溶出曲线研究[J].中国兽药杂志,2023,57(2):47-52. |
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作者姓名: | 张聪 程婵婵 郝洁 姚路路 卞梦芹 周冰 李焕娟 周德刚 |
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作者单位: | 洛阳惠中兽药有限公司,,,,,,,洛阳惠中兽药有限公司 |
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摘 要: | 建立头孢泊肟酯片溶出度测定方法,通过比较自制头孢泊肟酯片与参比制剂的溶出曲线,评价两种制剂体外溶出行为是否一致。测定自制制剂及参比制剂在盐酸溶液(pH=1.5)、甘氨酸-氯化钠-盐酸溶液(pH=3.0)、醋酸盐缓冲液(pH=4.0)、磷酸盐缓冲液(pH=6.8)的溶出曲线,并通过计算相似因子(f2)评价溶出曲线的相似性。在4种溶出介质中,3批自制制剂与参比制剂溶出曲线均相似。本研究建立的溶出试验方法能有效控制自制头孢泊肟酯片的质量,自制制剂与参比制剂体外溶出行为基本一致。
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关 键 词: | 头孢泊肟酯片 参比制剂 溶出曲线 一致性评价 |
收稿时间: | 2022/7/22 0:00:00 |
修稿时间: | 2023/1/4 0:00:00 |
Study on Dissolution Curves of Cefpodoxime Proxetil Tablets in Vitro |
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Institution: | Luoyang Huizhong Animal Medicine Co., Ltd.,,,,,,, |
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Abstract: | A dissolution test assay for cefpodoxime proxetil tablets was established to evaluate the consistency of in vitro dissolution behaviors of self-developed cefpodoxime proxetil tablets and reference preparations by comparing the dissolution curves of the two preparations. The dissolution curves of self-developed preparations and reference preparations in hydrochloric acid solution (pH=1.5), glycine-sodium chloride-hydrochloric acid solution (pH=3.0), acetate buffer (pH=4.0) and phosphate buffer (pH=6.8) were determined and the similarity of dissolution curves was evaluated by calculating similarity factor (f2). Results show that the dissolution curves of three batches of self-developed preparations and reference preparations were similar in all four dissolution media. In conclusion, the dissolution test method established in this study can effectively control the quality of self-developed cefpodoxime proxetil tablets. The in vitro dissolution behaviors of self-developed cefpodoxime proxetil tablets were basically consistent with that of reference preparations. |
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Keywords: | cefpodoxime proxetil tablets reference preparations dissolution curves consistency evaluation |
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