影响乳剂基质——中药原粉栓剂的融变时间与耐热性因素的探讨

Study on the thaw and heat-resistance of the suppositories prepared from Chinese herb-powder with latex base

目的探讨影响乳剂(O/W型)基质-中药原粉栓剂融变时间与耐热性的因素及其变化规律。方法采用正交设计方法,改变乳剂基质中甘油-水的比例和中药原粉加入量,制得4种基质、16组栓剂样品;检查栓剂外观、重量差异;测定栓剂的融变时间与放置37℃未软化时间。结果16组栓剂的外观适宜、重量差异符合规定,栓剂的融变时间和37℃耐热时间随着基质中甘油-水的比例减少及栓剂中药材原粉用量增加程度不同地延长。结论基质中甘油-水的比例与栓剂中药材原粉用量都明显影响栓剂的融变时间和耐热性,中药材原粉用量尤其明显。融变时间与耐热性均较适宜的乳剂基质-中药原粉栓剂中的明胶-甘油-水比例是2:14:2,栓剂中药原粉不宜多于0.3g。

Objective To research into the affecting factors about the thaw time and heat-resistance of the suppositories prepared from Chinese herb-powder with latex base suitable. Method According to orthogonal design, four kinds of emulsion-bases(latex)and 16 groups of suppositories were prepared, in which the proportion of glycerin and water was changed meanwhile the one of gelatin and oil and the amounts of Chinese herb-powder were also changed (0,0.1,0.3,0.5g) respectively in order, to examine the extended times of the thaw and heat-resistance(37℃) of the suppositories. Results Sixteen groups of the suppositories all had proper appearance and rigidity at room temperature, moreover they also accorded with the regulation about weight differences, and almost thawed during 60 minutes, and resisted to the temperature of 37℃ more longer. Conclusion The thaw time and heat-resistance of the suppositories were affected by the amounts of glycerin,water and Chinese herb-powder, especially the later one. To get more excellent suppositories, it would be selected to increase the proportions of glycerin,water and decrease the amounts of Chinese herb-powder or substitute with the extract properly.