药学实践杂志
藥學實踐雜誌
약학실천잡지
THE JOURNAL OF PHARMACEUTICAL PRACTICE
2014年
4期
282-283,317
,共3页
何进%任雪%曹家辅%安晔%刘瑞霞
何進%任雪%曹傢輔%安曄%劉瑞霞
하진%임설%조가보%안엽%류서하
水调散%微生物限度检查%方法验证
水調散%微生物限度檢查%方法驗證
수조산%미생물한도검사%방법험증
Shuitiaosan powder%microbacteria limit determination%method validation
目的:对水调散微生物限度检查方法进行验证。方法采用平皿计数法,通过5种阳性对照菌回收率实验进行细菌、真菌及酵母菌计数方法的验证;采用相同的实验条件,观察金黄色葡萄球菌、铜绿假单胞菌在实验组、阳性对照组和阴性对照组中的检出情况验证控制菌检查方法。结果用离心沉淀法对细菌、真菌及酵母菌计数时,各实验菌回收率在70%以上;控制菌检查采用离心沉淀法,实验组和阳性对照组检出金黄色葡萄球菌、铜绿假单胞菌,阴性对照组未检出菌株。结论该方法简便可行,结果准确,适合于水调散制剂微生物限度检查。
目的:對水調散微生物限度檢查方法進行驗證。方法採用平皿計數法,通過5種暘性對照菌迴收率實驗進行細菌、真菌及酵母菌計數方法的驗證;採用相同的實驗條件,觀察金黃色葡萄毬菌、銅綠假單胞菌在實驗組、暘性對照組和陰性對照組中的檢齣情況驗證控製菌檢查方法。結果用離心沉澱法對細菌、真菌及酵母菌計數時,各實驗菌迴收率在70%以上;控製菌檢查採用離心沉澱法,實驗組和暘性對照組檢齣金黃色葡萄毬菌、銅綠假單胞菌,陰性對照組未檢齣菌株。結論該方法簡便可行,結果準確,適閤于水調散製劑微生物限度檢查。
목적:대수조산미생물한도검사방법진행험증。방법채용평명계수법,통과5충양성대조균회수솔실험진행세균、진균급효모균계수방법적험증;채용상동적실험조건,관찰금황색포도구균、동록가단포균재실험조、양성대조조화음성대조조중적검출정황험증공제균검사방법。결과용리심침정법대세균、진균급효모균계수시,각실험균회수솔재70%이상;공제균검사채용리심침정법,실험조화양성대조조검출금황색포도구균、동록가단포균,음성대조조미검출균주。결론해방법간편가행,결과준학,괄합우수조산제제미생물한도검사。
Objective To validate the determination method of microbacteria limit of Shuitiaosan powder .Methods Plate counting method was used .The method of counting bacteria and mould was validated by the recovery rates with 5 control strains .The method of checking control bacteria was validated by observing cultivation of Staphylococcus aureus and Pseudomonas aeruginosa in the test group, positive control group and negative control group in the same environment .Results The recovery rate of every trail strains was higher than 70%when centrifugal sedimentation methods were used in the counting bacteria and mould .To the examination of con-trol bacteria , Staphylococcus aureus and Pseudomonas aeruginosa were detected by the centrifugal sedimentation methods .The tested strains were observed in the test group and in the positive control group .No strains were observed in the negative control group .Con-clusion The methods are simple , feasible, reliable and can be used for the examination of microbacteria limit .