トラネキサム酸製剤およびアルクロフェナック製剤の品質試験

概要

論文の詳細を見る
Commercial tranexamic acid preparations (of 4 manufacturers) and alclofenac preparations (2 manufacturers) were evaluated by disintegration test (J.P.VIII), weight variation test (J.P.VIII) and measurement of content. In the quantitative test, gas chromatography was employed for tranexamic acid preparations, and spectrophotometry for alclofenac preparations. Content of tranexamic acid was within the range of J.P. standard, with the difference of about 6% between the products. In the weight variation test, standard deviation between the products ranged from 2.22% (min.) to 10.89% (max.). All preparations tested showed similar disintegration times within the range of 3-4 minutes. There were some products containing cis form. Of alclofenac preparations, samples and products in the market were compared as for their content, disintegration times and weight variation. The test results came up to the J.P. standard in both groups. But weight variation of samples was 13.1%, standing far above 6.2% for the products in the market.
日本医療薬学会の論文
1977-05-20