海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2015年
1期
45-46
,共2页
沈婷婷%李世芳%刘瑾%蒋洁莹
瀋婷婷%李世芳%劉瑾%蔣潔瑩
침정정%리세방%류근%장길형
灵通颗粒%常规法%方法学验证
靈通顆粒%常規法%方法學驗證
령통과립%상규법%방법학험증
Lingtong Grain%The Routine Method%Method Validation
目的:建立灵通颗粒的微生物限度检查方法。方法按《中国药典》2010版附录微生物限度检查法的指导原则,采用常规法对灵通颗粒的三个批号进行微生物限度检查。细菌、霉菌及酵母菌采用平皿法计数。控制菌采用比照法检验。结果各试验菌的回收率大于70%,控制菌检查中试验组检出试验菌。结论建立的灵通颗粒微生物限度检查方法准确可靠,可行性强,能有效地对其进行微生物限度的测定。
目的:建立靈通顆粒的微生物限度檢查方法。方法按《中國藥典》2010版附錄微生物限度檢查法的指導原則,採用常規法對靈通顆粒的三箇批號進行微生物限度檢查。細菌、黴菌及酵母菌採用平皿法計數。控製菌採用比照法檢驗。結果各試驗菌的迴收率大于70%,控製菌檢查中試驗組檢齣試驗菌。結論建立的靈通顆粒微生物限度檢查方法準確可靠,可行性彊,能有效地對其進行微生物限度的測定。
목적:건립령통과립적미생물한도검사방법。방법안《중국약전》2010판부록미생물한도검사법적지도원칙,채용상규법대령통과립적삼개비호진행미생물한도검사。세균、매균급효모균채용평명법계수。공제균채용비조법검험。결과각시험균적회수솔대우70%,공제균검사중시험조검출시험균。결론건립적령통과립미생물한도검사방법준학가고,가행성강,능유효지대기진행미생물한도적측정。
ABSTRACT:OBJECTIVE To establish a method of microbial limit test of Lingtong grain .METHODS Accord-ing to the China Pharmacopoeia 2010 Edition appendix of microbial limit test method guideline ,the routine method was used to determine the microbial limits of Lingtong grain .The plating method can be used to take the number of bacterial,mould,saccharomycetes.The antithesis method was taken for the test of control bacteria .RESULTS The recovery of the strain rate was more than 70%, the experimental group were verified by test bacteria in the control bacteria detection.CONCLUSION The established Lingtong grain of microbial limit test method is accurate ,relia-ble,feasible,and can carry out the measurement of microbial limit effectively .