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| Study on applicability test of microbial limit test method for Fukang Gel |
| GAN Can-yun CHEN Hai-hong YANG Hai-yan |
| Department of Pharmacy,Hangzhou Hospital of Traditional Chinese Medicine,Zhejiang Province,Hangzhou 310007,China |
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Abstract Objective To establish a suitable microbial limit test method for Fukang Gel.Methods According to the 4 general principles 1105,1106,and 1107 of Chinese Pharmacopoeia 2015 edition,routine method and medium dilution method were used respectively to verify the microbial limit test of Fukang Gel.The recovery rates of five test bacteria,Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger were used as indicators,the total number of Aerobic bacteria,Fungi and Yeasts was investigated,and the detection methods of Staphylococcus aureus and Pseudomonas aeruginosa were established.Results The total number of Aerobic bacteria counted by conventional plate method showed that the recovery rates of Staphylococcus aureus and Pseudomonas aeruginosa were low,which were not in the range of 0.5-2.0 stipulated in the Pharmacopoeia and did not meet the requirements.The total number of Aerobic bacteria counted by medium dilution method showed that the recovery rates of Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger all met the requirements.The average recoveries of Candida albicans and Aspergillus niger counted by the total number of fungi and yeasts by plate method and medium dilution method were within the range of 0.5-2.0 prescribed in the Pharmacopoeia,which met the requirements.Two kinds of control bacteria were not detected in the test solution group and negative group by routine method.Staphylococcus aureus was not detected in the test group,Pseudomonas aeruginosa could be detected,and there was interference of bacteriostasis,so the method was not feasible.Pseudomonas aeruginosa and Staphylococcus aureus could be detected in the test group by medium dilution method.Both the test solution group and the negative control group showed negative,no interference,and the method was feasible.The results of three batches of samples validation showed that the total number of Aerobic bacteria,Fungi and Yeasts were in accordance with the standard,but Staphylococcus aureus and Pseudomonas aeruginosa were not detected.Conclusion Fukang Gel can be used for microbial limit test by medium dilution method.
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