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

卷:

24卷

期数:

2018年01期

页码:

78-82

栏目:

技术与方法

出版日期:

2018-01-20

文章信息/Info

Title:

?Quality control of fast-dissolving oral films of folic acid

文章编号:

1006-8147(2018)01-0078-05

作者:

周禹宏; 张金芬; 房志仲

(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):

ZHOU Yu-hong;  ZHANG Jin-fen;  FANG Zhi-zhong

(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:

叶酸; 口腔速溶膜剂; 高效液相色谱法; 质量控制

Keywords:

folic acid; fast-dissolving oral films; HPLC; quality control

分类号:

R927.11

DOI:

-

文献标志码:

A

摘要:

目的：建立叶酸口腔速溶膜剂的质量控制方法。方法：利用HPLC法测定叶酸口腔速溶膜剂的含量及膜剂的含量均匀度。色谱条件：Innoval ODS-2 C18色谱柱（250 mm×4.6 mm, 5 μm）；流动相:甲醇-0.054 mol/L磷酸二氢钾溶液（调节pH=6.3±0.1）（8:92）；检测波长:λ=254 nm；流速1.0 mL/min；进样量为20 μL；柱温为(30±1 )℃。结果：叶酸在40.0～260.0 μg/L的浓度范围内线性关系良好（R=0.999 8），平均加样回收率为99.02%，RSD为0.41%。结论：该色谱测定条件及含量测定方法能够简单有效地测定叶酸口腔速溶膜剂的含量及含量均匀度。

Abstract:

Objective: To establish an appropriate method to determine contents of fast-dissolving oral films of folic acid. Methods: Content and content uniformity of fast-dissolving oral films of folic acid were determined by an HPLC method, in which a Innoval ODS-2 C18 column (250 mm×4.6 mm, 5 μm) was used as stationary phase and a mix of methanol-0.054 mol/L KH₂PO₄ (adjusted to pH 6.3±0.1 with 0.5% NH₃?H₂O) was used as mobile phase. The detection wavelength was 254 nm and the flow rate was 1.0 mL/min. Column temperature was set at 30 ℃. Results: The concentration detection of folic acid showed a fine linearity between 40.0-120.0 μg/L (R=0.999 8), the average recoveries of folic acid was 99.02%, and corresponding RSD value was 0.41%. Conclusion: The detection method in this study is simple and accurate, so it could be used in the quality control of the fast-dissolving oral films of folic acid.

参考文献/References:

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相似文献/References:

[1]姜明月,于敏,李文,等.叶酸对N2a-APP695细胞Tau蛋白及其Ser396位点磷酸化的调控[J].天津医科大学学报,2013,19(05):365.

备注/Memo

备注/Memo:

作者简介 周禹宏（1991-），女，硕士在读，研究方向：药物制剂与质量控制；通信作者：房志仲，E-mail：fangzhizhong@tijmu.edu.cn。

常用功能

更新日期/Last Update: 2018-01-23