|本期目录/Table of Contents|

[1]上官可可,李美珍,杨金荣,等.复方呋塞米螺内酯胶囊质量控制方法的研究[J].天津医科大学学报,2016,22(01):80-83.
　SHANGGUAN Ke-ke,LI Mei-zhen,YANG Jin-rong,et al.Study of the quality control of the compound furosemide and spironolactone capsules[J].Journal of Tianjin Medical University,2016,22(01):80-83.
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
22卷
期数:
2016年01期
页码:
80-83
栏目:
技术与方法
出版日期:
2016-01-20

文章信息/Info

Title:

Study of the quality control of the compound furosemide and spironolactone capsules

文章编号:
1006-8147（2016）01-0080-04
作者:
上官可可1; 李美珍2;  杨金荣2; 房志仲2
(1.天津医科大学第二医院药剂科,天津 300211;2.天津医科大学药学院药剂学教研室,天津市临床药物关键技术重点实验室,天津 300070)
Author(s):
SHANGGUAN Ke-ke1;  LI Mei-zhen2; YANG Jin-rong2; FANG Zhi-zhong2
(1.Department of Pharmacy, The Second Hospital, Tianjin Medical University, Tianjin 300211 ,China；2.Department of Pharmacy, 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:
呋塞米; 螺内酯; 高效液相色谱法; 质量控制
Keywords:
furosemide; spironolactone; HPLC; quality control
分类号:
R927.2
DOI:
-
文献标志码:
A
摘要:

目的：建立复方呋塞米螺内酯胶囊（FuSpirC）的质量控制方法。方法：用高效液相色谱法测定复方制剂中呋塞米和螺内酯的含量。结果：色谱柱：Kromasil C18柱(200 mm×4.6 mm，5 ?m)，流动相为甲醇:0.02 mol/L磷酸二氢钾（67:33）(0.85%磷酸调节pH至4.3)，流速0.8 mL/min，检测波长为239 nm，呋塞米、螺内酯分别在5～35 ?g/mL、20～80 ?g/mL浓度范围线性关系良好，呋塞米平均回收率分别为98.29%(RSD = 0.08%，n=3)、99.20%(RSD=0.48%，n=3)、99.18% (RSD = 0.36%，n=3)，螺内酯平均回收率分别为101.76%(RSD = 0.13%，n=3)、101.35% (RSD = 0.52%，n=3）、101.67%(RSD = 0.27%，n=3)，平均回收率的RSD均小于2%，符合方法学要求，呋塞米、螺内酯平均含量分别为94.79%、 99.76%，均符合要求。结论：所建立方法可用于复方呋塞米螺内酯胶囊的质量控制。

Abstract:
Objective: To develop a method for controlling the quality of compound FuSpirC. Methods: High Performance Liquid Chromatography was used to determine the contents of furosemide and spironolactone in compound FuSpirC. Results: Column was represented by Kromasil-C18(200 mm×4.6 mm，5 ?m), mobile phase was methanol: 0.02 mol/L potassium dihydrogen phosphate (67:33) (used 0.85% phosphoric acid adjust PH 4.3), flow rate 0.8 mL/min, detected wavelength was 239 nm, the concentrations of furosemide and spironolactone were 5～35 ?g/mL and 20～80 ?g/mL, respectively, and were in good linear relationship. The average recovery rate of furosemide were 98.29%(RSD = 0.08%，n=3)，99.20%(RSD = 0.48%，n=3)，99.18%(RSD = 0.36%，n=3), while spironolactone were 101.76%(RSD = 0.13%，n=3)，101.35%（RSD = 0.52%，n=3），101.67%(RSD = 0.27%，n=3), the average recovery of RSD was less than 2%, conformed to the requirement of the methodology. The content of furosemide and spironolactone were 94.79% and 99.76%，conformed to the requirements. Conclusion: The methods can be used for quality control of compound FuSpirC.

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相似文献/References:

[1]李美珍,上官可可,杨金荣,等.复方呋塞米螺内酯胶囊的处方筛选[J].天津医科大学学报,2016,22(02):171.
　LI Mei-zhen,SHANGGUAN Ke-ke,YANG Jin-rong,et al.Optimizing prescription of the compound furosemide and spironolactone capsules[J].Journal of Tianjin Medical University,2016,22(01):171.

备注/Memo

备注/Memo:

作者简介 上官可可（1989-）男，硕士在读，研究方向：临床药理学；通信作者：房志仲， E-mail:fangzhizhong@tmu.edu.cn。

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更新日期/Last Update: 2016-01-26