Microbial Limit Test Methodology Validation Studies Of 40 Proprietary Chinese Medicines

Objective:To establish the method of microbial limit inspection standard of 40 proprietary Chinese medicinesMethods:The bacteria Recovery test is difficult and important,the design of the method follows from simple to complex,single to union,possible to minimize the samples may be contaminated steps.Adding bacteria recovery experiments In turn from conventional method,sample dilution,sample dilution adding medium dilution,to membrane filtration method.Using the Isopropyl myristate to dissolve the oil samples,twain 80 as activator for the sample not-oil sample and not dissolve in water.Methods of design to consider the influence of the subsidence of bacteria,and B cleanliness settlement bacteria limit is 5 cfu / 4 hours.Results:Sensitive strain experiment recovery ratio is 0.5 ~ 2,The total number of aerobe bacteria recovery experiment of Staphylococcus aureus,bacillus subtilis,pseudomonas aeruginosa,candida albicans and aspergillus Nige with 3 batches samples.Total number of mold and yeast and bacteria recovery experiment of Candida albicans and aspergillus Niger with 3 batches samples.Bacteria recovery ratio are within 0.5 ~ 2.Control bacteria test group can check out the corresponding test.Conclusion: The established 40 traditional methods through the methodology validation,conform to the Chinese pharmacopoeia 2015 edition of the relevant provisions of the general principles of the four,the method are feasible.