Validation for determination method of microbacteria limit of Shuitiaosan powder
10.3969/j.issn.1006-0111.2014.04.011
- VernacularTitle:水调散微生物限度检查的方法验证
- Author:
Jin HE
1
;
Xue REN
;
Jiafu CAO
;
Ye AN
;
Ruixia LIU
Author Information
1. 沈阳军区总医院药剂科
- Keywords:
Shuitiaosan powder;
microbacteria limit determination;
method validation
- From:
Journal of Pharmaceutical Practice
2014;(4):282-283,317
- CountryChina
- Language:Chinese
-
Abstract:
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 .
