灯盏花素滴丸成型工艺研究

Study on moulding technics of breviscapine drop pills

目的 了解不同基质与冷却剂、不同药物与基质的比例、不同药液的温度、不同滴头的内外径大小、不同的滴速和滴距以及冷却剂的温度对滴丸滴制的难易程度、丸形、沉降状况以及成丸的溶散时间和滴丸的重量差异系数的影响。方法 以滴制的难易程度、丸形、沉降状况以及成丸的溶散时间和滴丸的重量差异系数作为评价标准 ,对基质和冷却剂的种类、药物与基质的比例、药液温度的选择用正交试验法 ,对滴头的内外径大小、滴速、滴距以及冷却剂温度的选择用筛选法 ,优选出最佳试验方案和滴制条件。结果 以聚乙二醇 6 0 0 0∶聚乙二醇 4 0 0 0 (1∶4 )混合液作为基质 ,冷却剂选择二甲基硅油 :液体石蜡 (3∶2 ) ,原料灯盏花素与基质以 1∶5配比 ,药液温度为 80℃的试验方案为最佳试验方案 ;以冷却温度为 0～ 5℃ ,滴口内外径为 4 .5 / 7.0mm的滴头 ,滴口距冷却液面为 5cm ,滴速 30滴 /min的滴制条件为最佳滴制条件。结论 本试验优选出的试验方案和滴制条件滴制成的滴丸 ,成品率高 ,符合滴丸剂的质量标准。

OBJECTIVE To find out the effect of matrix, refrigerant,proportion of drug and matrix, size of internal and external diameter, dropping speed and space, temperature of drug and refrigerant on dropping process,pill-shape, sedimentation, resolving time and coefficient of heavy variation. METHOD Using orthogonal test for the choice of matrix and refrigerant, proporation of drug and matrix, temperature of drug. Using screening for size of internal and external diameter of burette, dropping speed and space, and temperature of refrigerant. With the dropping process, pill-shape, sedimentation, resolving time and coefficient of drop pill heavy variation as the evaluation quota to decide the best experimental methods and dropping condition.RESULTS The optimized project was as follow: the matrix contained PEG6000-PEG4000(1∶4), the refrigerant was consisted of dimethylsilicon oil and liquid-paraffin(3∶2), the rate of breviscapine to matrix was 1∶5 and the remperature of drug was 80℃, the internal and external diameter of burette was 4.5mm and 7.0mm, respectively, the burette was 5cm above the surface of refrigerant 5cm. Drug was dropped into refrigerant of 0℃ to 5℃ at 30 drops per minute.CONCLUSION Experimental methods and dropping condition of drop pills with high finished product rate and good quality.