CAJ | 학술논문

通过对清瘟败毒颗粒剂制备过程中黄连、黄芩提取工艺的优选，辅料种类和用量的选择，制剂成型及初步稳定性的考察，确定了清瘟败毒颗粒的最佳制备工艺为：黄连加10倍、8倍、8倍水，煎煮3次，分别煎煮1．5 h 、1．5 h 和1 h ；黄芩加8倍、8倍、8倍量水，煎煮3次，均为1 h ；其余12味，加水温浸1 h ，煎煮2次，第1次加10倍水，煎煮2 h ，第2次加8倍量水，煎煮1 h ，滤过，合并滤液，减压浓缩至密度为1．08～1．10，合并所有稠膏和黄芩苷粉，加辅料适量制成颗粒。通过加速稳定性试验和长期稳定性试验确定产品的稳定性。结果表明，在上述条件下制备的清瘟败毒颗粒在聚酯/铝/聚乙烯药品包装用复合膜的包装下，其长期稳定性试验和加速稳定性试验中各项指标均符合药典规定，显示产品稳定性良好。
통과대청온패독과립제제비과정중황련、황금제취공예적우선，보료충류화용량적선택，제제성형급초보은정성적고찰，학정료청온패독과립적최가제비공예위：황련가10배、8배、8배수，전자3차，분별전자1．5 h 、1．5 h 화1 h ；황금가8배、8배、8배량수，전자3차，균위1 h ；기여12미，가수온침1 h ，전자2차，제1차가10배수，전자2 h ，제2차가8배량수，전자1 h ，려과，합병려액，감압농축지밀도위1．08～1．10，합병소유주고화황금감분，가보료괄량제성과립。통과가속은정성시험화장기은정성시험학정산품적은정성。결과표명，재상술조건하제비적청온패독과립재취지/려/취을희약품포장용복합막적포장하，기장기은정성시험화가속은정성시험중각항지표균부합약전규정，현시산품은정성량호。
Through the optimized extraction of coptis and radix scutellariae techniques in preparing Qingwen Baidu Particles ,selction of classes and dosage of accessories ,study on the molding and stability , the best preparation technics for the particles were assured as :boiling the coptis 1 .5h ,1 .5h and 1h after adding 10 times ,10 times and 8 times quantity of water ;boiling the radix scutellariae 1h for three times af-ter adding 8 times quantity of water each ;immerse the other 12 kinds of herbs for 1h ,boiling them for 2h after adding 10 times quantity of water and 1h after adding 8 times quantity of water ;screen all and in-tegrate them ,contentrate with vaccum to 1 .08 ~ 1 .10 ,mix all thick paste and scutellariae powder ,mold into particles with other accessories .The stability of the product was tested by acceleration stability test and longterm stability test .The results showed that particles processed and prepared in PET /aluminum /PE composite membrane wholly matched the dedical standard criteron and revealed fine stability .