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.%目的 分析市售三磷酸腺苷二钠片的质量,并探讨其质量标准.方法 抽取浙江省内流通销售的三磷酸腺苷二钠片47批次,采用紫外分光光度法、高效液相色谱法对其进行含量测定,考察释放度检验、紫外鉴别及含量的影响因素.结果 47批次样品中,含量及释放度各有1批次不合格;其他46批次含量测定结果介于96.7％ ～117.6％,总核苷酸量介于102％ ～127％;紫外鉴别均符合标准规定.三磷酸腺苷(T3)的比值与含量、总核苷酸密切相关;平均释放度与总核苷酸含量呈正相关;T3值的变化会导致一磷酸腺苷(T1)、其他峰(溶剂峰除外)(Tx)变化.对放置5个月的样品进行再检验,发现总核苷酸、T3和含量均下降,T1、二磷酸腺苷(T2)、Tx含量均增加;对不同时间、地点抽取的同一批次样品含量检测结果完全不同.结论 对于三磷酸腺苷二钠片现有的标准,释放度限度可以适当提高,含量测定建议增加T3、Tx比值的限度范围或总核苷酸量的限度.
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