About Longdanxiegan microbial limit test method validation.docVIP

 PAGE \* MERGEFORMAT 7 About Longdanxiegan microbial limit test method validation [Abstract] Objective: To establish a Longdanxiegan microbial limit test method. Methods: Pharmacopoeia of the conventional method and the dilution method, by verifying whether the method adopted for the recognition of the drug for * bacteria, mold and yeast to control bacteria checks. Results: bacteria, fungi and yeasts in the method validation recoveries above 70%; control method validation bacteria strains detected in the positive control, negative control bacteria were not detected. Conclusion: Longdanxiegan Microbiology Limit test for bacteria, mold and yeast count can be used conventional method or dilution method to check, control bacteria can be used conventional method for detecting checks. [Keywords:] microbial limits; authentication When creating a microbial limit test of drugs should be carried out bacteria, mold and yeast count method validation, the method used to confirm the drug for the bacteria, mold and yeast determined. Verification tests with the tested products bacteria, mold and yeast counts at the same time. 1 Materials 1.1 Medium Nutrient agar medium, agar rose sodium, lactose bile medium, bile salt lactose fermentation medium, nutrient broth, modified liquid medium Martin, Martin improved agar medium, MUG medium, indole test fluid. 1.2 bacteria Escherichia coli [CMCC (B) 44102], Staphylococcus aureus [CMCC (B) 26003], Bacillus subtilis [CMCC (B) 63501], Candida albicans [CMCC (F) 98001], Aspergillus niger [CMCC (F) 98003]. 1.3 for the test materials Longdanxiegan. 2 Preparation of bacterial suspension 2.1 Escherichia coli, Staphylococcus aureus, Bacillus subtilis bacterium preparation Take Escherichia coli, Staphylococcus aureus, Bacillus subtilis nutrient agar slant culture was inoculated in 10ml nutrient broth, 35 ~ 37 ℃ for 18 to 24 hours; take 1ml culture medium plus 0.9% sterile chlorine sodium solution, 9ml, incr