[1]张丽琴,梅 群,肖植国,等.克拉霉素片溶出度检测方法分析[J].医学信息,2018,31(16):126-127130.[doi:10.3969/j.issn.1006-1959.2018.16.039]
　ZHANG Li-qin,MEI Qun,XIAO Zhi-guo,et al.Analysis of Dissolution Test of Clarithromycin Tablets[J].Journal of Medical Information,2018,31(16):126-127130.[doi:10.3969/j.issn.1006-1959.2018.16.039]
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克拉霉素片溶出度检测方法分析()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
31卷
期数:
2018年16期
页码:
126-127130
栏目:
药物与临床
出版日期:
2018-08-15

文章信息/Info

Title:
Analysis of Dissolution Test of Clarithromycin Tablets
文章编号:
1006-1959（2018）16-0126-03
作者:
张丽琴; 梅 群; 肖植国; 吕 晋
云南省曲靖市食品药品检验检测中心，云南 曲靖 655000
Author(s):
ZHANG Li-qin; MEI Qun; XIAO Zhi-guo; LV Jin
Food and Drug Inspection and Testing Center,Qujing 655000,Yunnan,China
关键词:
克拉霉素; 高效液相色谱法; 溶出度; 标准优化
Keywords:
Key words：Clarithromycin; High performance liquid chromatography; Dissolution; Standard optimization
分类号:
R927
DOI:
10.3969/j.issn.1006-1959.2018.16.039
文献标志码:
A
摘要:
目的 优化克拉霉素片溶出度检测方法。方法 采用ZORBAX SB-C18（4.6 mm×150 mm，5 μm）色谱柱，流动相：磷酸盐缓冲液∶乙腈（60∶40），流速：1.0 ml/min，检测波长：210 nm；柱温：45 ℃，进样量：50 μl。在药典方法基础上去掉稀释步骤，以每批次6片样品分别经溶出仪溶出后直接经高效液相色谱仪测定后按外标法以限度计算溶出度。结果 本法与药典方法相比较，溶出度结果一致，均大于限度80%，符合限度要求。结论 本研究方法可以作为克拉霉素片溶出度的质量控制方法。
Abstract:
Abstract：Objective To optimize the dissolution test of Clarithromycin tablets.Methods ZORBAX SB-C18(4.6mmx150mm,5μm) chromatographic column was used,mobile phase:phosphate buffer solution:acetonitrile(60:40),flow rate:1.0 ml/min,detection wavelength:210nm,column temperature:45℃,injection volume:50μL.We removed dilution steps on the basis of the Pharmacopoeia method,dissolution of 6 tablets in each batch was determined by high performance liquid chromatography after dissolution by dissolution analyzer, and the dissolution was calculated by external standard method.Results Compared with the Pharmacopoeia method,the dissolution rate was consistent with the limit of 80%,meeting the limit requirement.Conclusion This method can be used as a quality control method for dissolution of clarithromycin tablets.

参考文献/References:

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更新日期/Last Update: 2018-08-15