盐酸左西替利嗪片溶出度测定条件的研究(1)
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[摘要] 目的：摸索盐酸左西替利嗪片体外溶出度测定条件。方法：依据《中国药典》2010年版和有关的参考文献，采用正交试验，考察溶出介质(0.1 mol/L盐酸溶液、pH 6.8的磷酸盐缓冲液及水)、转速(50、75、100 r/min)、取样时间(5、15、30 min)三个因素对盐酸左西替利嗪片体外溶出度测定的影响，采用紫外分光光度法，在230 nm波长下测定吸光度并计算溶出度。结果：盐酸左西替利嗪检测浓度为2~10 μg/ml(r=0.999 8)，平均回收率为99.98%，RSD=0.28%；选择桨法，以水为溶出介质，转速为75 r/min，取样时间点为30 min是盐酸左西替利嗪片溶出度测定条件。结论：本法简便、可靠、准确，适合盐酸左西替利嗪片溶出度的测定。
[关键词] 盐酸左西替利嗪片；溶出度；正交试验；紫外分光光度法
[中图分类号] R917 [文献标识码] A [文章编号] 1673-7210(2011)11(c)-034-03
Conditions test of Levocetirizine Dihydrochloride Tablets dissolution
ZHAO Hui, WU Yan, LIU Liping, ZHANG Fucheng
Department of Pharmacy, General Hospital of Air Force, Beijing 100142, China
[Abstract] Objective: To explore the conditions test of Levocetirizine Dihydrochloride Tablets dissolution in vitro. Methods: According to the methods of Chinese Pharmacopoeia (2010 edition) and other references, the influence to the dissolution conditions of Levocetirizine Dihydrochloride Tablets, such as dissolution mediums (0.1 mol/L hydrochloric acid solution, pH 6.8 phosphate buffer solution, water as medium), rotation speeds (50, 75, 100 r/min), and sampling time (5, 15, 30 min) were investigated by orthogonal experiment. The absorbance and release rate of solution were determined by UV spectrophotometry at 230 nm. Results: The assay displayed a good linearity over the concentration range of 2-10 μg/ml (r=0.999 8) with an average recovery was 99.98% (RSD=0.28%). Paddle method was adopted by using water as the solvent, and the rotation speed at 75 r/min with sampling time was 30 min. Conclusion: The method is simple, reliable and accurate, and it can be applied to determine dissolution of Levocetirizine Dihydrochloride Tablets.
[Key words] Levocetirizine Dihydrochloride Tablets; Dissolution; Orthogonal experiment; UV spectrophotometry
过敏性疾病是一种常见病、多发病，药物治疗是控制过敏反应的主要手段，目前临床上常用H1受体拮抗剂。盐酸左西替利嗪片作为新型抗组胺药，具有口服吸收迅速、受体选择性高、临床疗效强、副作用小、安全性好等多方面优点[1-2]，是治疗过敏性疾病的首选药物。本文采用正交试验，对溶出介质、转速及取样时间点3个影响因素进行考察，建立了适宜的溶出方法，并采用紫外分光光度法测定体外溶出度，为产品的质量控制提供依据。
1 仪器与试药 ......
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