10厂家小剂量阿司匹林肠溶片含量及水杨酸限量对比分析

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英文篇名：Determination of the Content of Apirisn and Limit of Salicylic Acid in Low-Dosage Aspirin Enteric-Coated Tablets from 10 Manufacturers 作者：刘泳珊 ; 陈小祝 ; 梁伟光 ; 张焰明 ; 聂鑫 英文作者：LIU Yongshan;CHEN Xiaozhu;LIANG Weiguang;ZHANG Yanming;NIE Xin;People' s Hospital of Nanhai District in Foshan City;Foshan University; 关键词：紫外分光光度法 ; 小剂量 ; 阿司匹林 ; 含量测定 ; 水杨酸 ; 限量 英文关键词：ultraviolet spectrophotometry;;low-dosage;;aspirin;;content determination;;salicylic acid;;limit 中文刊名：YYGZ 英文刊名：China Pharmaceuticals 机构：广东省佛山市南海区人民医院;佛山科学技术学院; 出版日期：2019-07-30 出版单位：中国药业 年：2019 期：v.28;No.490 基金：广东省佛山市医学类科技攻关项目[2014AB00258] 语种：中文; 页：YYGZ201915013 页数：3 CN：15 ISSN：50-1054/R 分类号：39-41

摘要

目的评价国内部分厂家小剂量阿司匹林肠溶片的质量。方法采用紫外分光光度法,阿司匹林的检测波长为275 nm及325 nm,水杨酸的检测波长为304 nm。结果阿司匹林和水杨酸质量浓度的线性范围分别为20. 08～100. 40μg/m L(r=0. 999 2)和8. 006 4～24. 019 2μg/m L(r=0. 999 0);测得10个厂家阿司匹林含量为标示量的92. 31%～99. 91%,水杨酸的限量范围为0. 32%～3. 18%。结论紫外分光光度法可简便、快速、准确地测定小剂量阿司匹林肠溶片中阿司匹林的含量及水杨酸的限量。部分厂家的小剂量阿司匹林肠溶片中阿司匹林的含量及游离水杨酸的限量不合格。
        Objective To evaluate the quality of low-dosage Aspirin Enteric-Coated Tablets from some manufacturers in China.Methods Ultraviolet spectrophotometry was adopted. The detection wavelength of aspirin was 275 and 325 nm,and that of salicylic acid was 304 nm. Results The linear range of aspirin was 20. 08-100. 40 μg/m L( r = 0. 999 2),and that of salicylic acid was 8. 006 4-24. 019 2 μg/m L( r = 0. 999 0). The determination results showed that the content of aspirin was in the range of 92. 31%-99. 91%of labeled amount and the limit of salicylic acid was in the range of 0. 32%-3. 18% from 10 manufacturers. Conclusion Ultraviolet spectrophotometry is a simple,rapid and accurate method for determining the content of aspirin and the limit of salicylic acid in low-dosage Aspirin Enteric-Coated Tablets. The content of aspirin and the limit of free salicylic acid in low-dosage Aspirin Enteric-Coated Tablets from some manufacturers don't meet the prescribed requirement according to the Chinese Pharmacopeia.

引文

[1] PUHAN MA,YU T,STEGEMAN I,et al. Benefit-harm analysis and charts for individualized and preference-sensitive prevention:example of low dose aspirin for primary prevention of cardiovascular disease and cancer[J]. BMC Medicine,2015,13:250-261.
    [2]李萍.小剂量阿司匹林口服致消化道出血68例临床分析[J].山东医药,2014,54(35):72-73.
    [3]任仲玉,任德旺,任仲杰,等.小剂量阿司匹林所致出血等不良反应状况调查[J].中国药物评价,2013,30(5):288-290.
    [4]严海密,姥志强,孙斌,等.小剂量肠溶阿司匹林致消化道出血临床观察[J].临床荟萃,2003,18(8):453-454.
    [5] LIN KJ,DE CATERINA R,GARCA RODRGUEZ LA. Lowdose aspirinand upper gastrointestinal bleeding in primary versus secondary cardiovascular prevention:a population-based,nested case-control study[J]. Circ Cardiovasc Qual Outcomes,2014,7(1):70-77.
    [6] MC ALINDON ME,MULLER AF,FILIPOWICZ B. Effect o f allopurinol,sulphasalazine,and vitamin Conasprin induced gastroduodenal injury in human volunteers[J]. Gut,1996,38(4):518-524.
    [7]纪宝华.关注80岁以上老年人抗血小板和抗凝治疗[J].中华内科杂志,2008,47(7):531-532.
    [8]陈东尔.小剂量阿司匹林致上消化道出血患者83例临床分析[J].当代医学,2012,18(25):135-136.
    [9]田敏,郎宗娥,李雪梅.小剂量阿司匹林致不良反应的文献分析及护理[J].全科护理,2014,12(25):2209-2212.
    [10]池秀珍.双波长紫外分光光度法测定阿司匹林肠溶片含量[J].海峡药学,2002,14(1):27-28.
    [11]盖轲,郑阿利,荔瑞琴,等.紫外分光光度法测定小剂量阿司匹林肠溶片的含量[J].中国药师,2006,7(9):643-644.
    [12]王晨霞,舒余琪.紫外分光光度法阿司匹林肠溶片中阿司匹林的含量测定[J].广东化工,2014,41(23):200-201.
    [13]仵淑红.两种方法测定阿司匹林肠溶片含量的比较[J].中国现代医药杂志,2016,18(6):45-47.
    [14]李飞玲. HPLC与UV测定阿司匹林肠溶片中阿司匹林和水杨酸的含量[J].长治医学院学报,2011,25(1):11-13.
    [15]国家药典委员会.中华人民共和国药典(二部)[M].北京:中国医药科技出版社,2015:546.