|本期目录/Table of Contents|

[1]胡晨,邓紫薇,王旭,等. 复方奥美拉唑胶囊质量控制方法的研究[J].天津医科大学学报,2014,20(03):243-246.
　HU Chen,DENG Zi-wei,WANG Xu,et al.Study of the quality control of the compound omeprazole capsule[J].Journal of Tianjin Medical University,2014,20(03):243-246.
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 复方奥美拉唑胶囊质量控制方法的研究(PDF)
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
20卷
期数:
2014年03期
页码:
243-246
栏目:
技术与方法
出版日期:
2014-05-20

文章信息/Info

Title:
Study of the quality control of the compound omeprazole capsule
文章编号:
1006-8147(2014)03-0243-04
作者:
胡晨1; 2; 邓紫薇3; 王旭3; 房志仲3
（1.天津医科大学一中心临床学院，天津 300192；2.天津市第一中心医院药学部，天津 300192；3.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):
HU Chen1; 2; DENG Zi-wei3; WANG Xu3; FANG Zhi-zhong3
(1.The First Center Clinical College, Tianjin Medical University, Tianjin 300192,China；2.Department of Pharmacy, The First Center Hopital of Tianjin, Tianjin 300192,China;3.College of Pharmacy, Tianjin Medical University,Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics (Theranostics)，Tianjin 300070，China)
关键词:
奥美拉唑; 复方胶囊; 含量测定; 质量控制
Keywords:
omeprazole;  compound capsule;  determination of content;  quality control
分类号:
-
DOI:
-
文献标志码:
A
摘要:
目的：建立复方奥美拉唑胶囊的质量控制方法。方法：紫外分光光度法和高效液相色谱法测定复方奥美拉唑胶囊中奥美拉唑的含量。结果：分光光度法在302 nm波长下测定奥美拉唑的吸光度，在2~17 μg/mL的浓度范围内，线性关系良好。回收率试验为100.63%，RSD为1.12 % (n=9)；高效液相色谱法，色谱柱： Kromasil-C18柱(200 mm×4.6 mm，5 ?m)，流动相为甲醇-水-磷酸-三乙胺=60:40:0.12:0.3，流速为0.8 mL/min，检测波长为302 nm，奥美拉唑在2 ~30 ?g/mL的浓度范围内线性良好，回收率试验100.64%，RSD为1.1%，含量为标示量的99.36%，RSD为0.57%。结论：所建立的分析方法可用于复方奥美拉唑胶囊的质量控制。
Abstract:
Objective: To develop a method for controlling the quality of compound omeprazole capsules. Methods: HPLC and ultraviolet spectrophotometry method were adopted to determine the contents of omeprazole in compound omeprazole capsules. Results：The concentration of omeprazole was determined by ultraviolet spectrophotometric method under 302 nm wavelength. The linear range of omeprazole was 2~17 μg/mL (r＝0.9998) and the average recovery rate was 100.63% (RSD=1.12 %, n=9). The concentration of omeprazole was determined by HPLC; column was represented by Kromasil-C18 (200 mm×4.6 mm, 5 ?m) while mobile phase: methanol- water –phosphoric acid-triethylamine was 60:40:0.12:0.3; the examine wavelength was 302 nm and velocity of flow was 0.8 mL/min; the injection volume was 20 ?L. At the concentration of omeprazole between 2~30 ?g/mL, it indicated a fine linear relationship with peak area, with the average recovery rate of 100.64% (RSD=1.1%). The content of omeprazole was 99.36% in labeled amount (RSD=0.57%). Conclusion: The methods can be used for quality control of compound omeprazole capsules.

参考文献/References:

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[8] 王旭，李美珍，卢欣，等.3种HPLC色谱条件下测定奥美拉唑含量方法的比较[J].天津医科大学学报，2012，18(4): 510
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备注/Memo

备注/Memo:
作者简介 胡晨（1985-）男，硕士在读，研究方向：临床药学；通信作者：房志仲，E-mail:fangzhizhong@tijmu.edu.cn。
更新日期/Last Update: 2014-05-12