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硝酸甘油舌下片的稳定性研究。

Stability study of nitroglycerin sublingual tablets.

作者信息

Page D P, Carson N A, Buhr C A, Flinn P E, Wells C E, Randall M T

出版信息

J Pharm Sci. 1975 Jan;64(1):140-7. doi: 10.1002/jps.2600640133.

Abstract

Nitroglycerin sublingual tablets were studied over a 1-year period to determine tablet stability in terms of loss of strength, uniformity of tablets, and degradation of the drug itself. Tablets from six different firms were analyzed by a semiautomated procedure. The samples included two molded tablets and four compressed tablets, ranging in age at the time of initial assay from 40 days to over 1 year. The results indicated that there is a loss of strength of nitroglycerin tablets and that refrigeration slows down this loss. The study also indicated that these tablets were stable during the year of testing in terms of tablet uniformity and degradation of nitroglycerin.

摘要

对硝酸甘油舌下片进行了为期1年的研究,以确定片剂在强度损失、片剂均匀性和药物本身降解方面的稳定性。采用半自动程序对来自6家不同公司的片剂进行了分析。样品包括2片模制片和4片压制片,初始测定时的保存期限从40天到1年以上不等。结果表明,硝酸甘油片存在强度损失,冷藏可减缓这种损失。该研究还表明,在为期一年的测试中,这些片剂在片剂均匀性和硝酸甘油降解方面是稳定的。

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