空膠囊對溶離度試驗之影響－－空膠囊含水率對其崩解時間之影響及巿售品之含水率調查

EFFET OF EMPTY CAPSULE ON DRUG DISSOLUTION-EFFECT OF WATER CONTENT ON DISINTEGRATION TIME OF EMPTY CAPSULE

依日本藥典第十一版，溶離度試驗方法二 paddle 的規格，將空膠囊置於特製輔助膠囊沉降用之不鑄鋼網籃中，擲入以水為媒液的容器中，測定其崩解時間（定義為膠囊沉入水中至破損時，放出第一個汽泡所經的時間。）進行空膠囊溶度試驗本實驗發現，在設定條件下空膠囊含水率與崩解時間之間有負相關性，相關係數為0.9790（Y=80.2-1.7X，P<0.01），即當空膠囊含水率增加時，其崩解時間隨之減少。同時對市售0號1號及2號空膠囊進行含水率與崩散時間之測試，其結果經統計學ANOVA Test檢定其P>0.05，即空膠囊大小不影響其含水率與崩解時間。

The disintegration time of empty hard capsule was determined by the paddle method of JP XI. They were put in stainless sinkers, then submerged in water. When capsules were about to decompose, several fine bubbles would be seen. The disintegration time of empty hard capsule was defined as the duration between the submergence time of the capsule and the release time of the first bubble. Negative correlation was found between the disintegration time and the water content at the range of 1.72%～34.0%. The equation of calibration curve was: Y =80.2-1.7X (the correlation coefficient was 0.9790, P < 0.01), which meant the disintegration time decreased as the water content increased. Both the disintegration time and the water content of different size of capsules (0#, 1# and 2#) were also examined. Results showed that the size of empty hard capsule was not related to neither the disintegration time nor the water content (ANOV A test, F <1).