|本期目录/Table of Contents|

[1]戴学文,王姿婧,刘 青,等.复方更昔洛韦眼用凝胶剂制备及质量控制[J].天津医科大学学报,2014,20(06):490-493.
　DAI Xue-wen,WANG Zi-jing,LIU Qing,et al.Preparation and content determination of compound ganciclovir ophthalmic gel[J].Journal of Tianjin Medical University,2014,20(06):490-493.
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复方更昔洛韦眼用凝胶剂制备及质量控制(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06期
页码:
490-493
栏目:
技术与方法
出版日期:
2014-11-20

文章信息/Info

Title:
Preparation and content determination of compound ganciclovir ophthalmic gel
文章编号:
1006-8147（2014）06-0490-04
作者:
戴学文; 王姿婧; 刘 青; 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):
DAI Xue-wen;  WANG Zi-jing;   LIU Qing;   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:
更昔洛韦; 地塞米松; 眼用凝胶剂; 含量; 高效液相色谱法
Keywords:
ganciclovir;  dexamethasone;  ophthalmic gel;  content;  HPLC
分类号:
R9
DOI:
-
文献标志码:
A
摘要:

目的：制备复方更昔洛韦眼用凝胶剂，并建立该制剂的质量控制方法。方法：经处方筛选，确定了该处方的组成；采用高效液相色谱法同时测定复方更昔洛韦眼用凝胶剂中更昔洛韦和地塞米松的含量：TIANHE? Kromasil C18色谱柱(200 mm×4.6 mm，5 μm)；流动相：甲醇-水（70:30），流速为0.8 mL/min；检测波长：248 nm；柱温：室温。结果：更昔洛韦在4.08~28.56 ?g/mL的浓度范围内与峰面积线性良好（r=0.999 8），地塞米松在4.96~24.60 ?g/mL的浓度范围内与峰面积线性良好（r=0.999 8）。加样回收试验中，更昔洛韦和地塞米松的平均回收率分别为100.74%、100.44%，RSD分别为1.04%、1.17%。结论：该凝胶剂制备方法简单，易于操作；其检测方法简便、准确、快速，重复性好，可作为复方更昔洛韦眼用凝胶剂的质量控制方法。

Abstract:
Objective : To prepare the compound ganciclovir ophthalmic gel and establish an appropriate method to determine its contents . Methods: The composition of the prescription was defined by prescription screening. The content of ganciclovir and dexamethasone were determined in the ophthalmic gel simultaneously by HPLC method, in which a TIANHE?Kromasil C18 column (200 mm×4.6 mm, 5 μm) was used. And the mobile phase composition was methanol-water (70:30). The flow rate was 0.8 mL/min, and the detecting wavelength was 248 nm. Column temperature was set at room temperature. Results: The detection concentration of ganciclovir showed a fine linearity with peak areas between 4.08~56?g/mL(r=0.999 8) while the detection concentration of dexamethasone showed a fine linear relation with peak areas(r=0.9998）between 4.96~24.60 ?g/mL. In the recovery test, the average recoveries of ganciclovir and dexamethasone were 100.74% and 100.44%, respectively. And the corresponding RSD values were 1.04% and 1.17%, respectively. Conclusion: The gel preparation method is convenient and easy to operate. The detection method in this study is simple, and accurate with high sensitivity, so it is appropriate to be used in the quality control of the compound ganciclovir ophthalmic gel.

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备注/Memo

备注/Memo:
作者简介 戴学文（1992-），女，硕士在读，研究方向：药物制剂与质量控制研究；通信作者：房志仲，E-mail:fangzhizhong@tijmu.edu.cn。
更新日期/Last Update: 2014-12-03