Kitazawa S, Johno I, Ito Y, Teramura S, Okado J
J Pharm Pharmacol. 1975 Oct;27(10):765-70. doi: 10.1111/j.2042-7158.1975.tb09397.x.
The effects of hardness on disintegration and dissolution characteristics of uncoated caffeine tablets made at eight different pressure levels were studied. The disintegration times were determined using the J.P. VIII procedure with disks and the dissolution rate measurements were performed with the U.S.P.XVIII procedure (U.S.P. method) and the J.P. VIII disintegration test apparatus (J.P. method). A good correlation between the hardness and the disintegration times was obtained. The dissolution rate constants were determined from the equation of Noyes & Whitney (1897) and a good correlation between the hardness and the dissolution rate constants was obtained. The hardness governed the dissolution over all the stages from tablet to the smallest particles after the breakage by disintegration. The dissolution rates of the J.P. method were greater than those of the U.S.P. method.
研究了硬度对在八个不同压力水平下制备的未包衣咖啡因片剂的崩解和溶出特性的影响。崩解时间采用日本药局方第八版圆盘法测定，溶出速率测量采用美国药典第十八版方法（USP法）和日本药局方第八版崩解试验装置（JP法）进行。硬度与崩解时间之间获得了良好的相关性。溶出速率常数由诺伊斯-惠特尼方程（1897年）确定，硬度与溶出速率常数之间获得了良好的相关性。从片剂到崩解破碎后最小颗粒的所有阶段，硬度都控制着溶出。JP法的溶出速率大于USP法。
