中国药业2018，Vol.27Issue(2)：35-37,3.DOI:10.3969/j.issn.1006-4931.2018.02.009
三磷酸腺苷二钠片质量标准提高研究
Improvement of Quality Standard for Adenosine Disodium Triphosphate Tablets
摘要
Abstract
Objective To analyze the quality of marketed Adenosine Disodium Triphosphate Tablets and investigate its quality standard.Methods Totally 47 batches of Adenosine Disodium Triphosphate Tablets in in circulation and sales in Zhejiang Province were selected and the contents were determined by ultraviolet(UV)spectrophotometer and HPLC.Results In 47 batches of samples,the content and release degree were unqualified in 1 batch,respectively,the results of the content determination of the other 46 batches were between 96.7％ and 117.6％,the total nucleotide acid ranged from 102％ to 127％,the UV identification was in accordance with the standard.The ratio of adenosine triphosphate(T3) was closely related to the content and total nucleotides,and the average release degree was positively correlated with the total nucleotide content,the change in T3 value would lead to the changes in adenosine monophosphate ( T1 ) and the other peaks ( excepted solvent peaks,Tx ).5 months after the sample was placed,the retest results of the samples showed that the total nucleotides,T3 and content decreased,and the content of T1,adenosine diphophate ( T2 ),and Tx increased.The test results of the same batch sample were completely different for different time and place.Conclusion For the existing standard of Adenosine Dis-odium Triphosphate Tablets,the release limit can be improved properly,it is suggested that the limits range of T3,Tx ratio or the limit of total nucleotide acid should be increased in the content determination.关键词
三磷酸腺苷二钠片/高效液相色谱法/质量标准/释放度Key words
Adenosine Disodium Triphosphate Tablets/HPLC/quality standard/release degree分类
医药卫生引用本文复制引用
董勇,谢浙裕,朱琳娇,陈运动..三磷酸腺苷二钠片质量标准提高研究[J].中国药业,2018,27(2):35-37,3.基金项目
浙江省绍兴市科技计划项目[2015B70039]. （）
