[1]杨阳,林琪,张雨凝,等.盐酸维拉佐酮片的制备及体外溶出度的一致性考察[J].华侨大学学报(自然科学版),2020,41(4):510-517.[doi:10.11830/ISSN.1000-5013.201911022]
　YANG Yang,LIN Qi,ZHANG Yuning,et al.Preparation of Verazosone Hydrochloride Tablets and Consistency Investigation of Their Dissolubility In Vitro[J].Journal of Huaqiao University(Natural Science),2020,41(4):510-517.[doi:10.11830/ISSN.1000-5013.201911022]
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盐酸维拉佐酮片的制备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41卷
期数:
2020年第4期
页码:
510-517
栏目:
出版日期:
2020-07-20

文章信息/Info

Title:
Preparation of Verazosone Hydrochloride Tablets and Consistency Investigation of Their Dissolubility In Vitro
文章编号:
1000-5013(2020)04-0510-08
作者:
杨阳1;  林琪1;  张雨凝1;  吴振2;  王立强1
1. 华侨大学 生物医学学院, 福建 泉州 362021;2. 厦门大学 药学院, 福建 厦门 361102
Author(s):
YANG Yang1;  LIN Qi1;  ZHANG Yuning1;  WU Zhen2;  WANG Liqiang1
1. School of Biomedical Sciences, Huaqiao University, Quanzhou 362021, China; 2. School of Pharmaceutical Sciences, Xiamen University, Xiamen 361102, China
关键词:
盐酸维拉佐酮片;  体外溶出度;  一致性评价;  相似因子
Keywords:
verrazolone hydrochloride tablets;  dissolution in vitro;  consistency evaluation;  similarity factors
分类号:
R971.43
DOI:
10.11830/ISSN.1000-5013.201911022
文献标志码:
A
摘要:
以原研制剂为参考,采用直接压片法制备盐酸维拉佐酮片;运用高效液相色谱法,建立合适的体外溶出度测定方法,对两者的体外溶出行为进行一致性评价.通过单因素试验对辅料的用量进行筛选并确定最佳处方,制备出盐酸维拉佐酮片.然后,以原研药为参比制剂,考察自制品在醋酸溶液(pH=3.1)、水、磷酸盐缓冲液(pH=6.8)、盐酸溶液(pH=1.0)中的溶出情况,并计算相似因子(f2),评价自制品与参比制剂溶出行为的相似性.结果表明:自制品与原研制剂在4种溶出介质中的溶出行为相似,f2均大于50.所建立的溶出度曲线测定方法准确、可靠,可为盐酸维拉佐酮片仿制药的一致性评价提供参考.
Abstract:
Reference to the original preparation, verazodone hydrochloride tablets were prepared by direct compression method. A high performance liquid chromatography method for the determination of dissolution in vitro was established to evaluate the consistency of the dissolution behavior in vitro. Single factor test was used to screen the dosage of excipients and determine the best prescription to prepare verazodone hydrochloride tablets. Then, the dissolution of the self-made product in acetic acid solution(pH=3.1), water, phosphate buffer solution(pH=6.8), and hydrochloric acid solution(pH=1.0)was investigated respectively, and the similarity factors were calculated to evaluate the dissolution behavior of the self-made product and the reference product. The results shows that the dissolution behavior of the self-made product was similar to that of the original preparation in four dissolution media, and the f2 was greater than 50. Therefore, the established dissolution curve is accurate and reliable, which can provide reference for the consistency evaluation of verazodone hydrochloride tablets.

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备注/Memo

备注/Memo:
收稿日期: 2019-11-06
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: 国家重点研发计划项目(2016YFE0101700); 福建省高校产学合作项目(2019Y4007); 华侨大学研究生科研创新能力培育计划资助项目(18013071025)
更新日期/Last Update: 2020-07-20