|本期目录/Table of Contents|

[1]任 静,杨金荣,许煜静.市售不同厂家格列齐特缓释片的体外释放度比较[J].天津医科大学学报,2015,21(04):351-354.
　REN Jing,YANG Jin-rong,XU Yu-jing.Comparison of release rates of gliclazide sustained- release tablets of different manufactures in different dissolution mediums[J].Journal of Tianjin Medical University,2015,21(04):351-354.
点击复制

市售不同厂家格列齐特缓释片的体外释放度比较(PDF)
分享到：

《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
21卷
期数:
2015年04期
页码:
351-354
栏目:
技术与方法
出版日期:
2015-07-15

文章信息/Info

Title:
Comparison of release rates of gliclazide sustained- release tablets of different manufactures in different dissolution mediums
文章编号:
1006-8147（2015）04-0351-04
作者:
 任 静; 杨金荣; 许煜静
 (天津医科大学药学院，天津市临床药物关键技术重点实验室，天津 300070)
Author(s):
 REN Jing ; YANG Jin-rong ;  XU Yu-jing
 (School of Pharmacy, Tianjin Medical University,Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics (Theranostics)， Tianjin 300070，China)
关键词:
 ; 格列齐特; 缓释; 释放度 ;  质量综合评价
Keywords:
 ; gliclazide;  sustained-released;  release rate;  comprehensive evaluation of the qulity
分类号:
R927
DOI:
-
文献标志码:
A
摘要:
目的：考察市售6个不同厂家格列齐特缓释片（A、B、C、D、E、F）体外释放度并与达美康缓释片进行比较，为全面评价药品质量提供依据。方法：按照《中华人民共和国药典》2010版有关格列齐特缓释片释放度测定的规定，采用第一法，以pH 7.4磷酸盐缓冲盐（PBS），pH 4.5 PBS和水为释放介质，用高效液相色谱法测定释放度，计算累积释放百分率，并绘制溶出曲线，与达美康进行比较，计算出相似因子；进行释药曲线拟合，确定释药机制比较溶出参数。结果：6个厂家产品在pH 7.4 PBS中释放度均符合要求，除E厂家外其余厂家产品与达美康相似因子均大于50，但只有D厂家在3种不同介质中，均与达美康格列齐特缓释片相似因子大于50，溶出参数T50，Td与达美康差异也较小。结论：仅有少数厂家的释放曲线在3种介质中与原研厂家相似，建议与原研厂家释放曲线不一致的相关厂家应对影响制剂释放的辅料及生产工艺进行改进，提高产品质量。
Abstract:
Objective : To investigate the release rates of different gliclazide sustained-released tablets in vitro by comparing them with that of dlamicronmr to provide the basis for a comprehensive evaluation of the qulity of gliclazide sustained- release tablets. Methods: According to China pharmacopie (2010 edition), the release rates of different gliclazide sustained-released tablets in 3 different dissolution mediums with pH 7.4, pH4.5 and 7 were determined by using intellectual diffusion meter (ZRS-8). HPLC was used to test the concentration, calculate the cumulative dissolution percentage and draw the dissolution curve .The differences in dissolution curves were compared by similarity factor. And the parameters of m, T50 and Td were calculated and compared with those of dlamicronmr. Results: The f2 factors of six manufactures’ products with dlamicronmr were greater than 50 except for E tablets in dissolution medium with pH 7.4. Only f2 factors of D tablet were greater than 50 in 3 different dissolution mediums and the differences in the parameters of m,T50 and Td were smaller. The differences in batches in B tablet were greater and in A tablet smaller. Conclusion: Few manufacturers’ drugs have similar characters with original drug in all 3 different dissolution mediums. The pharmaceutical manufacturers should improve the product quality by changing the formula） and manufacturing process.

参考文献/References:

［1］卢骏,吴涛,胡建平,等.格列齐特缓释片的制备及体外释放度［J］.中国医药工业杂志，2004,35(7):410

［2］谢沐风. 如何科学、客观地制订溶出度试验质量标准［J］.中国医药工业杂志，2012,43(3):A23

［3］张启明, 谢沐风, 宁保明, 等. 采用多条溶出曲线评价口服固体制剂的内在质量[J]. 中国医药工业杂志，2009, 40(2):308

［4］国家食品药品监督管理局标准，YBH03642006格列齐特缓释片［S］

［5］Shah V P,Tsong Y,Shathe P,et al.In vitro dissolution profile comparision -statistics of the simalarity factor,f2［J］.Pharmaceut Res, 1998,15(6):8891

［6］王志强，吴继禹，张秀华.用Excel软件对溶出数据进行多种曲线拟合和处理［J］.海峡药学，2006,18(1):47

［7］张莉，夏运岳.用电子表格Excel计算药物溶出度Weibull分布参数［J］.药学进展，2002,26(1):8

［8］刘瑞新，李学林，王青晓.威布尔溶出曲线的 4 种非线性拟合方法比较［J］.中国医院药学杂志，2009,29(15):1315

［9］方积乾.卫生统计学［M］.第6版.北京：人民卫生出版社，2008:105-105

［10］陈健,朱盛山,蔡延渠,等.口服缓控释制剂数学模型研究概述［J］.中草药，2011,42(8):1625

相似文献/References:

[1]张 茜,李洪发,刘俊玲,等. 快速扩弓后牙齿及牙槽骨变化的锥体束CT研究[J].天津医科大学学报,2014,20(01):57.
　ZHANG Qian,LI Hong- fa,LIU Jun-ling,et al. Study on cone beam computed tomography study of tooth and alveolar bone changes after rapid maxillary expansion treatment [J].Journal of Tianjin Medical University,2014,20(04):57.
[2]马长辉,杨万松.血清丙氨酸转氨酶与ST段抬高型心肌梗死的相关性研究[J].天津医科大学学报,2014,20(02):116.
　MA Chang-hui,YANG Wan-song.Clinical study of serum alanine aminotransferase in patients with acute ST-segment elevation myocardial infarction[J].Journal of Tianjin Medical University,2014,20(04):116.
[3]李 颖 综述,夏 天 审校. 肥胖相关性肾病的研究进展[J].天津医科大学学报,2014,20(02):165.
[4]牛 健,于晓旭,李 雪,等.重组 CARDs TX 融合蛋白的表达纯化与复性[J].天津医科大学学报,2014,20(03):184.
　NIU Jian,YU Xiao-xu,LI Xue,et al.Expression, purification and renaturation of recombinant CARDs TX fusion protein[J].Journal of Tianjin Medical University,2014,20(04):184.
[5]陈清刚,钱 明,王 毅,等.首发精神分裂症患者与超高危人群认知功能的对照研究[J].天津医科大学学报,2014,20(03):216.
　CHEN Qing gang,QIAN Ming,WANG Yi,et al.Control study of cognitive function in ultra-high risk population of schizophrenia and first-episode schizophrenia patients[J].Journal of Tianjin Medical University,2014,20(04):216.
[6]单立新,高 越,王学菊.血清Cys C、RBP、尿mALb/ Cr检测在糖尿病肾病早期诊断中的价值[J].天津医科大学学报,2014,20(03):241.
[7]班新超,孙保存,谷彦军,等. CXCR4和CathepsinD在恶性纤维组织细胞瘤中的表达及意义[J].天津医科大学学报,2014,20(04):264.
　BAN Xin-chao,SUN Bao-cun,GU Yan-jun,et al.Expression of CXCR4 and CathepsinD in malignant fibrous histiocytoma and their biological significance[J].Journal of Tianjin Medical University,2014,20(04):264.
[8]谭艳萍,吴校伟,刘 寅,等. 冠心病合并糖尿病患者药物涂层支架术后观察[J].天津医科大学学报,2014,20(05):414.
[9]叶剑飞 综述. microRNAs与肿瘤研究的新进展[J].天津医科大学学报,2014,20(05):416.
[10]李 姗,严海泓,章 萍,等. 长春新碱致双手麻木与麻痹性肠梗阻1例报道[J].天津医科大学学报,2014,20(05):373.

备注/Memo

备注/Memo:
作者简介 任静(1989-)，女，硕士在读，研究方向：药物缓控释制剂研究与质量控制；

通信作者：许煜静,E-mail：xuyujing@tmu.edu.cn。

更新日期/Last Update: 2015-07-17