[1]宋伟杰,曾皓月,龙莎,等.采用原研制剂制备米诺膦酸片及体外溶出度的一致性考察[J].华侨大学学报(自然科学版),2018,39(1):70-74.[doi:10.11830/ISSN.1000-5013.201706032]
　SONG Weijie,ZENG Haoyue,LONG Sha,et al.Preparation of Minodronic Acid Tablets Using Innovator Products and In VitroConsistency Investigation of Their Dissolubility[J].Journal of Huaqiao University(Natural Science),2018,39(1):70-74.[doi:10.11830/ISSN.1000-5013.201706032]
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采用原研制剂制备米诺膦酸片及体外溶出度的一致性考察()
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《华侨大学学报（自然科学版）》[ISSN:1000-5013/CN:35-1079/N]

卷:
第39卷
期数:
2018年第1期
页码:
70-74
栏目:
出版日期:
2018-01-17

文章信息/Info

Title:
Preparation of Minodronic Acid Tablets Using Innovator Products and In VitroConsistency Investigation of Their Dissolubility
文章编号:
1000-5013(2018)01-0070-05
作者:
宋伟杰1; 2;  曾皓月1; 2;  龙莎2;  王立强1; 2;  乔凤敏3;  方美娟4
1. 华侨大学 生物医学学院, 福建 泉州 362021;2. 解放军211医院, 黑龙江 哈尔滨 150080;3. 福建太平洋制药有限公司, 福建 泉州 362021;4. 厦门大学 药学院, 福建 厦门 361102
Author(s):
SONG Weijie1; 2;  ZENG Haoyue1; 2;  LONG Sha2; WANG Liqiang1; 2;  QIAO Fengmin3;  FANG Meijuan4
1. School of Biomedical Sciences, Huaqiao University, Quanzhou 362021, China; 2. No. 211 Hospital of PLA, Harbin 150080, China; 3. Fujian Pacific Pharmaceuticals Limited, Quanzhou 362021, China; 4. School of Pharmaceutical Science, Xiamen University, Xiamen 361102, China
关键词:
米诺膦酸片;  溶出曲线;  一致性评价;  相似因子
Keywords:
minodronic acid tablets;  dissolution curves;  consistency evaluation;  similarity factors
分类号:
R944
DOI:
10.11830/ISSN.1000-5013.201706032
文献标志码:
A
摘要:
制备米诺膦酸片,并以原研制剂为参比制剂,采用f2相似因子法对两者体外溶出度的一致性进行考察.建立合适的体外溶出度测定方法,研究参比制剂的溶出情况,通过单因素试验对辅料的用量进行筛选,制备出米诺磷酸片.比较自制品与原研制剂在不同溶出介质中的溶出行为,评价两者体外溶出行为的相似性.结果表明:制备的米诺膦酸片剂与原研制剂在4种不同pH值溶出介质中的溶出相似因子f2均大于50;制备的米诺膦酸片剂与原研制剂体外溶出行为相似.
Abstract:
To prepare minodronic acid tablets, in vitro dissolution profile was investigated by f2 similarity factor with the innovator products as a reference. The in vitro dissolution test method was established and the dissolution profile of innovator products was investigated, and then minodronic acid tablets were prepared by screening excipient dosage using single factor experiment. By comparing the dissolution behavior of the test tablets with the innovator products in four kinds of dissolution medium, the similarity was evaluated. The results showed that the dissolution similarity factor f2 of the minodronic acid tablets and innovator products in four dissolution media with different pH values were all larger than 50. Besides, the dissolution behavior in vitro of the prepared tablets was similar to that of the innovator products.

参考文献/References:

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备注/Memo

备注/Memo:
收稿日期: 2017-06-13
通信作者: 王立强(1970-),男,教授,博士,主要从事药剂学和创新药物研发的研究.E-mail:wlq1599@163.com.
基金项目: 国家自然科学基金资助项目(81302652); 福建省自然科学基金资助项目(2015J01342)
更新日期/Last Update: 2018-01-20