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Establishment of microbial limit test method for three kinds of external use preparations containing calamine |
XU Dan1 LI Si1 YI Wei2 WU Jingjing1 JIANG Jingyi1 |
1.Department of Pharmaceutical Preparation, General Hospital of Eastern Theater Command of Chinese People’s Liberation Army, Jiangsu Province, Nanjing 210002, China; 2.Drug Instrument Supervision and Inspection Station, Wuxi Joint Logistics Support Centre, Jiangsu Province, Nanjing 210002, China
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Abstract Objective To establish a microbial limit test method for Calamine Pigment, Calamine and Sulfur Pigment, and Phenolic Calamine Pigment. Methods According to microbial counting method and control bacteria inspection method of 2020 edition Chinese Pharmacopoeia requirements, the applicability tests were carried out by plate method, medium dilution method, and membrane filtration method. Results The total number of aerobic bacteria: the medium dilution method was used for Calamine Pigment, Calamine and Sulfur Pigment, the membrane filtration method was used for Phenolic Calamine Pigment; the total number of mold and yeasts: the medium dilution method was used for the three preparations; the control bacteria test: the routine method was used for Calamine Pigment, the medium dilution method and routine method were used for Calamine and Sulfur Pigment, the membrane filtration method and routine method were used for Phenolic Calamine Pigment. Conclusion The microbial limit test can meet 2020 edition Chinese Pharmacopoeia requirements, and can be used in the quality evaluation of Calamine Pigment, Calamine and Sulfur Pigment, and Phenolic Calamine Pigment.
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