Establishment of Microbial Limit Test Methods for 15 Hospital Oral Antibacterial Preparations
Objective To establish microbial limit test methods for 15 hospital oral antibacterial preparations.Methods With the Chlorhexidine Acetate Orally Disintegrating Tablets,Chlorhexidine Acetate Pigment,Compound Tinidazole Solution,Iodine Glycerol,Formaldehyde and Cresol Pigment,Boric Acid Glycerine Pigment,Artificial Saliva,Desensitizing Paste,Mummification Paste,Xinshefenquan Paste,Surgicalis Paste,Metronidazole Pellicles,Compound Clindamycin Membrane,New Paraformaldehyde Devitalizing Paste and Paraformaldehyde Dental Pulp Devitalizing Agent as the samples(preparations 1-15),the plating method,membrane filtration method and medium dilution method based on the general principles 1105,1106 and 1107 of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ)were used to perform the recovery test of five common bacteria(Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans,Aspergillus niger)and applicability test of control bacteria(Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli).Results The aerobic bacterial count could be detected by the membrane filtration method for preparations 1-5,9-11,14-15,and that could be detected by the plating method for other preparations.The mold and yeast count could be detected by the plating method for preparations 1-3,6-8,12-13,and that could be detected by the membrane filtration method for other preparations.The recovery ratio of test bacteria was in the range of 0.5 to 2.0.The control bacteria could be detected by the membrane filtration method for preparations 1-3,5,9-11,14-15,and that could be detected by the medium dilution method for other preparations.The corresponding positive bacteria in the test group could be detected normally.Conclusion The established method is suitable for microbial limit test of the above 15 hospital oral antibacterial preparations.
国家科技期刊平台
NSTL
万方数据
维普
