加拿大市场上某些品牌甲苯磺丁脲的比较研究。II. 药学方面。
A COMPARATIVE STUDY OF SOME BRANDS OF TOLBUTAMIDE AVAILABLE IN CANADA. II. PHARMACEUTICAL ASPECTS.
作者信息
LU F C, RICE W B, MAINVILLE C W
出版信息
Can Med Assoc J. 1965 May 29;92(22):1166-9.
Pharmaceutical analyses were carried out on 26 lots of tolbutamide from 21 manufacturers. All lots were found to be satisfactory with respect to identity and strength. Disintegration time of 24 lots ranged from one to 35 minutes, with 72 and 83 minutes for the other two. The time to 90% dissolution in intestinal solution (pH 7.5) ranged from five to 69 minutes in all except two lots for which the times were 99 and over 120 minutes. While the clinical significance of these findings cannot be ascertained in the absence of data from controlled studies, the evidence does not suggest that most of the non-proprietary products available in Canada would not be satisfactory for the purpose intended.
对来自21家制造商的26批甲苯磺丁脲进行了药物分析。所有批次在鉴别和含量方面均被认定为合格。24批产品的崩解时间为1至35分钟，另外两批的崩解时间分别为72分钟和83分钟。在肠液（pH 7.5）中达到90%溶解的时间，除两批产品分别为99分钟和超过120分钟外，其他所有批次的时间范围为5至69分钟。虽然在缺乏对照研究数据的情况下无法确定这些结果的临床意义，但现有证据并不表明加拿大市面上的大多数非专利产品不符合预期用途。
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