亲水发酵剂对己酮茶碱缓释片化学稳定性的研究

IF 2.6 3区 数学 Q1 MATHEMATICS, INTERDISCIPLINARY APPLICATIONS Journal of Systems Science & Complexity Pub Date : 2008-11-08 DOI:10.1109/CANS.2008.35
E. Mircia, S. Imre, E. Sipos, V. Avrigeanu, A. Popovici, G. Hancu
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引用次数: 1

摘要

研究了己酮茶碱改性缓释片的热稳定性和化学稳定性。本实验研究观察了温度和湿度对己酮茶碱配方稳定性的影响。采用高效液相色谱法测定亲水基质新型控释片(HPMC、HPC、HEC)中己酮茶碱的含量。色谱柱为C18,流动相为水:乙腈70:30 (V/V),紫外检测波长为280 nm。按照美国药典的药用规定进行了“体外”溶出度试验;使用机器nr.2(带桨);溶解环境为1000 ml水,恒温37±0.5℃。在所有的实验中,转速都是每分钟50转。所研究的片剂在稳定室中保存,温度为40±2℃,相对湿度为75±5%。在不同的时间间隔(1个月、3个月、6个月)预提样品,完成溶出度试验和己酮茶碱的定量测定。通过对实验结果的评价,观察了各制剂中己酮茶碱的稳定性。
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Study of Pentoxifylline Chemical Stability from Modified Release Tablets with Hydrophilic Mould
Thermal and chemical stability of pentoxifylline from modified release tablets were studied. This experimental study observed the influence of temperature and humidity on the stability of pentoxifylline from the proposed formulations. The paper describes the HPLC determination of pentoxifylline from new controlled release tablets with hydrophilic matrix (HPMC, HPC, HEC). A C18 column with a mobile phase containing water : acetonitrile 70:30 (V/V) and UV detection at 280 nm was used. The "in vitro" dissolution test was carried out regarding the officinal stipulations of USP; the machine nr.2 was used (with paddles); as dissolution environment 1000 ml water, a constant temperature of 37 plusmn 0.5degC was kept. In all experiences, the rotation speed was 50 rpm. The studied tablets were kept in the stability chamber at a temperature of 40 plusmn 2degC and a relative humidity of 75 plusmn 5%. At different time intervals (a month, three months, six months), samples were prelevated to accomplish the dissolution test and the quantitative determination of pentoxifylline. From the evaluation of the experimental results, we observed the stability of pentoxifylline from all the prepared tablets.
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来源期刊
Journal of Systems Science & Complexity
Journal of Systems Science & Complexity 数学-数学跨学科应用
CiteScore
3.80
自引率
9.50%
发文量
90
审稿时长
6-12 weeks
期刊介绍: The Journal of Systems Science and Complexity is dedicated to publishing high quality papers on mathematical theories, methodologies, and applications of systems science and complexity science. It encourages fundamental research into complex systems and complexity and fosters cross-disciplinary approaches to elucidate the common mathematical methods that arise in natural, artificial, and social systems. Topics covered are: complex systems, systems control, operations research for complex systems, economic and financial systems analysis, statistics and data science, computer mathematics, systems security, coding theory and crypto-systems, other topics related to systems science.
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