CAJ | 학술논문

目的：建立解毒止泻结肠缓释微丸释放度的检查方法并进行方法学验证。方法采用高效液相色谱法测定制剂中槲皮素的含量，参照《中国药典》2010年版的规定研究本制剂的释放度检查方法并进行方法学验证。结果依次在人工胃液、人工肠液、人工结肠液中对微丸进行释放度考察，人工胃液2h不释放，人工肠液3h内释放在15%以内，人工结肠液5 h释放完全。结论该法简单、灵敏、准确，可有效监控本品的质量。
목적：건립해독지사결장완석미환석방도적검사방법병진행방법학험증。방법채용고효액상색보법측정제제중곡피소적함량，삼조《중국약전》2010년판적규정연구본제제적석방도검사방법병진행방법학험증。결과의차재인공위액、인공장액、인공결장액중대미환진행석방도고찰，인공위액2h불석방，인공장액3h내석방재15%이내，인공결장액5 h석방완전。결론해법간단、령민、준학，가유효감공본품적질량。
Pbjective To establish a method for the dissolution of Jiedu Zhixie Colon—targeted Sustained—release Pellets,and prove that the method is reliable and durable. Methods The content of quercetin was determined by HPLC, the dissolution test of pellets was researched and avalidated according to requirement in China phannacopeia 2010 Edition. ResuIts The release in vitro was studied in the artificial gastric fluid,artificial intestinal fluid and artificial colon fluid in sequence. Quercetin was not released in artificial gastric fluid,less than 15% in artificial intestinal fluid,slowly in artificial colon fluid and completely at 5 h. ConcIusion This method was simple,sensitive and accurate. It can be used for the quality control of pellets.