Brown J, Madit N, Cole E T, Wilding I R, Cadé D
Pharmaceutical Profiles Limited, Highfields Science Park, Nottingham, UK.
Pharm Res. 1998 Jul;15(7):1026-30. doi: 10.1023/a:1011973909815.
To evaluate if the cross-linking of gelatin affects in vivo capsule disintegration.
Scintigraphic investigation in nine healthy volunteers to provide for a real time visualisation of capsule disintegration.
The moderately stressed capsules failed the USP dissolution specification for acetaminophen capsule when tested in water and conventional SGF but passed with the addition of pepsin. Moderately stressed capsules started to disintegrate at 10 +/- 6 minutes (range 6 to 24 minutes) compared to 8 +/- 2 minutes (range 5 to 11 minutes) for the unstressed capsule.
The results of the study clearly demonstrate that with the incisive technique of gamma scintigraphy there are no differences in the in vivo disintegration properties of moderately stressed and unstressed capsules.
评估明胶交联是否会影响胶囊在体内的崩解。
对九名健康志愿者进行闪烁扫描研究，以实时观察胶囊崩解情况。
适度受压的胶囊在水中和常规模拟胃液（SGF）中测试时，对乙酰氨基酚胶囊未达到美国药典的溶出标准，但加入胃蛋白酶后通过了测试。适度受压的胶囊在10±6分钟（范围为6至24分钟）开始崩解，而未受压的胶囊在8±2分钟（范围为5至11分钟）开始崩解。
该研究结果清楚地表明，采用γ闪烁扫描这种精确技术，适度受压和未受压的胶囊在体内崩解特性上没有差异。
