抄録
Microcrystalline sulpyrine labeled with 113m Indium was used in the preparation of suppositories. The particles of 113m In-sulpyrine, varying in size from 1-20 μm, were suspended in cacao butter by fusion at 40-60°. The final preparation contained 5% of the 113m In-labeled particles in the cacao butter. In order to determine the uniformity of the particle suspension in the suppository, the suppository was sliced into 5 fractions of equal height along the long axis. Each fraction was then examined for uniformity.
Suppositories prepared in the plastic molds had wide variation in the uniformity of the suspended particles. The effect of fusion temperature between 40 and 60° and cooling at 4° on uniformity was examined. The greatest deviation was consistently observed at higher temperature. At 40°, for example, the deviation from the mean of the upper fraction was -6%, and of the bottom fraction +10%. At 60°, the variation of deviation increased to -16 and +31%, respectively. When fusion was effected at 40° followed by cooling at -20°, the coefficient of variation (C. V.) was 4.5%, as compared with 20% in the fusion at 60° and cooling at 4°. With the metal mold, fusion temperature between 40-60° followed by cooling at 4° gave similar results. In all instances C. V. of the particle distribution was smaller than that obtained under the optimal conditions for the plastic mold (<4.5%).Therefore, for the preparation of suppositories of microcrystalline sulpyrine in cacao butter, metal molds are better than plastic molds in yielding consistent products over a wide range of fusion and cooling temperature.
