Studies on the Preparation of Digestive Enzyme Tablest (IV)

소화효소제(消化酵素劑)의 제조(製造)에 관(關)한 연구(硏究) 제4보(第4報)

Since the active center of digestive enzymetic preparations, while under storage, lose their activity and potency by the exposure to moisture, colorization, solidifying and other physical changes. It is more important than beautiful package form that protected packaging form from moisture to get a pharmaceutical safety preparations and to maintain a definite potency. Then, in order to get a desirable conditions of storage and packaging, we used shellac and $AEA^{\circledR}$ as a coating base, and blister package, foil and bottle container as a packaging material. Temperature were set on room temperature and $37^{\circ}C$, moisture was adjusted to 40% RH and 80 % RH as a accelerated conditions. Accelerated test was carried out 6 times. The results are as follows: 1) The effect of packaging conditions give great influence on the maintenace of the stable potency. 2) Best result was produced with bottle container package. 3) $AEA^{\circledR}$ is more useful than shellac as a coating base of prevention from moisture. 4) Absorption of moisture gave considerable effects on potency and it has a limited point. 5) Difference in potency between optimal and worst condition is 472 u/2T, and difference in effective period is about 44 months.