|本期目录/Table of Contents|

[1]陆 铮,戴学文,王姿婧,等.环索奈德鼻用凝胶剂制备及质量控制[J].天津医科大学学报,2014,20(05):408-410.
　LU Zheng,DAI Xue-wen,WANG Zi-jing,et al. Study on preparation and content determination of nasal gel of ciclesonide[J].Journal of Tianjin Medical University,2014,20(05):408-410.
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环索奈德鼻用凝胶剂制备及质量控制()
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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05期
页码:
408-410
栏目:
技术与方法
出版日期:
2014-09-20

文章信息/Info

Title:
 Study on preparation and content determination of nasal gel of ciclesonide
文章编号:
1006-8147(2014)05-0408-03
作者:
陆 铮1; 戴学文2; 王姿婧2; 刘 青2; 房志仲2
 （1.天津市南开医院药剂科，天津 300100；2.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):
 LU Zheng1; DAI Xue-wen2; WANG Zi-jing2; LIU Qing2; Fang Zhi-zhong 2
(1.Departerment of Pharmacy,Tianjin Nankai Hospital,Tianjin 300100，China；2.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:
环索奈德; 鼻用凝胶剂; 质量控制; 高效液相测定法
Keywords:
 ; ciclesonide; nasal gels; content determination; HPLC
分类号:
R94
DOI:
-
文献标志码:
A
摘要:
目的：制备环索奈德鼻用凝胶剂，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。采用高效液相色谱方法，测定鼻用凝胶剂中环索奈德的含量。色谱柱为TIANHE? Kromasil C18柱(200 mm×4.6 mm，5 ?m)，以甲醇-乙腈-水(70:25:5)为流动相，流速为0.8 mL/min，检测波长为250 nm，柱温为室温，进样量为20 ?L。结果：环索奈德的检测浓度在10.20~51.00 ?g/mL范围内与峰面积呈良好的线性关系（r=0.999 9），80%、100%、120%的平均回收率分别为100.75%、100.06%、100.78%，RSD分别为1.40%、0.59%、0.62%（n=3）。结论: 该凝胶剂制备方法简单，基质易得；质控方法简便、准确、可靠，可用于环索奈德鼻用凝胶剂的质量控制方法。
Abstract:
Objective : To prepare the nasal gel of ciclesonide, and establish an appropriate method to determine the content of ciclesonide in the nasal gel. Methods: Define the composition of the prescription by prescription screening. Determine the content of ciclesonide by HPLC method, in which a TIANHE? Kromasil C18 column (200 mm × 4.6 mm, 5 μm) was used. The mobile phase composition was methanol-acetonitrile-water (70:25:5), and the flow rate was 0.8 mL/min. The detection wavelength was 250 nm. The injection volume was 20 ?L and the column temperature was set at room temperature. Results: The detection concentration of ciclesonide showed a fine linear relationship with peak area between 10.20 ?g/mL and 51.00 ?g/mL(r=0.999 9). In the recovery tests, the average recoveries of ciclesonide at 80%, 100% and 120% were 100.75%, 100.06%,100.78%, respectively, and RSD values were 1.40%, 0.59% and 0.62% (n=3). Conclusion: The preparation method of the gel is simple, and the matrix is easy to get. The detection method is convenient,accurate and reliable, so it is appropriate to be used in the content determination of nasal gel of ciclesonide.

参考文献/References:

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[3] Mohar D, Berger W E, Laforce C,et al. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis[J]. Allergy Asthma Proc,2012,33(1):19

[4] 王桂玲，李婷，郑黎，等.新型环索奈德胶囊型干粉吸入剂的研制及其质量研究[J].中国新药杂志，2007，16(11):872

[5] 朱静，韩光.RP- HPLC法测定环索奈德含量及有关物质的研究[J].现代医药卫生，2008，24(8):1236

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相似文献/References:

[1]陆 铮,戴学文,王姿婧,等.环索奈德鼻用凝胶剂制备及质量控制[J].天津医科大学学报,2014,20(05):408.
　LU Zheng,DAI Xue-wen,WANG Zi-jing,et al. Study on preparation and content determination of nasal gel of ciclesonide[J].Journal of Tianjin Medical University,2014,20(05):408.

备注/Memo

备注/Memo:
作者简介 陆铮（1977-），男，本科，药师，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: 2014-09-26