ケノデオキシコール酸製剤の比較試験

概要

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Three brands of chenodeoxycholic acid (RE, CH, CO) were compared by the following tests: net weight variation, content uniformity (by neutralization titration and HPLC methods), dissolution, impurity content (determination of ursodesoxycholic acid and cholic acid by HPLC, and of acetic acid ethyl ester and ethanol supposed to be residual solvents by gas chromatography), and cholesterol solubilization in vitro. The results are as follows: 1) All the 3 preparations showed little weight and content variations, suggesting their exact filling amount; especially. RE indicated the smallest content of vehicle and the lowest deviation. 2) RE showed the most rapid dissolution, while CH and CO seemed to dissolve slowly, because they were filled by compression in #3 capsules. 3) Ursodesoxycholic acid and cholic acid were detected as impurities in the 3 preparations, and acetic acid ethyl ester in CH and CO. The quantities of these impurities were minute. 4) No difference in cholesterol solubilization was found among the 3 preparations.
日本医療薬学会の論文
1985-02-20