Method of evaluation of the bitterness of clarithromycin dry syrup.
Method of evaluation of the bitterness of clarithromycin dry syrup.
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克拉霉素干糖浆苦味评价方法
DOI：
10.1248/cpb.50.147
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发表时间：
2002
影响因子：
1.7
通讯作者：
Y. Kawashima
中科院分区：
文献类型：
--
作者：
T. Yajima;Y. Fukushima;S. Itai;Y. Kawashima
采用多种方法对克拉霉素干糖浆的苦味度进行了评价。使用倒置法、振摇法和桨法，未观察到苦味与溶解量之间的合理相关性。使用内径为0.76 cm、高为5 cm的填充有CAM干糖浆的微型柱进行释放试验。然后测量通过微柱的测试溶液中CAM的释放速率以评价苦味。在使用微柱的释放测试中CAM的释放速率与CAM干糖浆的苦味的感官测试的结果良好相关。溶解速率常数定义为从单位空隙表面溶解的CAM的百分比乘以空隙体积，与测试溶液的线速度成反比。影响苦味评价的关键因素是柱的空隙体积和供试品溶液的线速度。最佳线速度为0.048-0.021 cm/min，最佳空隙率为0.27-0.12 cm ~ 3。此外，CAM干糖浆的苦味阈值被定义为一半志愿者在感官测试中识别苦味的浓度。使用微型柱发现该阈值为135微克/毫升。
The degree of bitterness of clarithromycin (CAM) dry syrup was evaluated using several methods. Using the inversion method, shaking method, and paddle method, a reasonable correlation between the bitter taste and the amount dissolved was not observed. A mini-column with inner diameter of 0.76 cm and height of 5 cm packed with CAM dry syrup was used for the release test. The release rate of CAM in test solution, which passed through the mini-column, was then measured to evaluate bitterness. The release rate of CAM in the release test using the mini-column correlated well with the results of a sensory test for the bitterness of CAM dry syrup. The dissolution rate constant, defined as the percentage of CAM dissolved from the unit void surface multiplied by the void volume, was inversely proportional to the linear velocity of the test solution. The critical factors affecting evaluation of bitterness were the void volume of the column and linear velocity of the test solution. The optimum linear velocity and void volume were 0.048-0.021 cm/min and 0.27-0.12 cm3, respectively. In addition, the threshold of bitterness of CAM dry syrup was defined as the concentration at which half of the volunteers recognized bitterness in the sensory test. This threshold was found to be 135 microg/ml using the mini-column.