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Comparative study of four methods for detecting microbial count recovery rate on sheet drug packaging materials*
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Fan SHE1, Rui ZHOU1, Ming-huan JIAO2, Gang LIU1, Xing GAO3
Chinese Journal of Pharmaceutical Analysis | 2024, 44(6) : 1040 - 1045
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(6): 1040-1045
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Comparative study of four methods for detecting microbial count recovery rate on sheet drug packaging materials*
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Fan SHE1, Rui ZHOU1, Ming-huan JIAO2, Gang LIU1, Xing GAO3
Affiliations
  • 1.Drug Testing Monitoring and Evaluation Center, Yangling Agricultural High-Tech Industrial Demonstration Zone, Yangling 712100, China
  • 2.Xi'an Wanlong Pharmaceutical Co., Ltd., Yangling 712100, China
  • 3.Shaanxi Institute for Food and Drug Control, Xi’an 710065, China
Published: 2024-06-30 doi: 10.16155/j.0254-1793.2024.06.15
Outline
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Objective:

To establish a simple and practical microbiological counting method suitable for sheet drug packaging materials by comparing the results of four sampling methods.

Methods:

The samples of artificial contamination of sheet drug packaging materials were prepared by standard strain adding method. The surface microorganisms were collected by wiping method prescribed by national drug packaging container (material) standard, as well as by self-designed washing method, direct inoculation method and contact dish method. The corresponding recovery rate was calculated. The results of 4 sampling methods were analyzed by one way analysis of variance (ANOVA).

Results:

From high to low, the recovery rate was as follows: contact dish method, direct inoculation method, wiping method and washing method. There were significant differences in the recovery rates of contact dish method, wiping method and washing method (P<0.05). The recovery rate of contact dish method was slightly higher than that of direct inoculation method, but there was no significant difference between them (P>0.05). There was no significant difference in the recoveries of medicinal film, aluminum foil and hard sheet among the four methods (P>0.05).

Conclusion:

The contact dish method is simple, sensitive and accurate, and can be used for the examination of the microbial limit counting method of sheet drug packaging materials.

contact dish method  /  sheet drug packaging materials  /  microbial count  /  recovery rate  /  direct inoculation method  /  Wiping method  /  Washing method
Fan SHE, Rui ZHOU, Ming-huan JIAO, Gang LIU, Xing GAO. Comparative study of four methods for detecting microbial count recovery rate on sheet drug packaging materials*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (6) : 1040 -1045 . DOI: 10.16155/j.0254-1793.2024.06.15
Year 2024 volume 44 Issue 6
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Article Info
doi: 10.16155/j.0254-1793.2024.06.15
  • Receive Date:2023-12-08
  • Online Date:2026-03-13
  • Published:2024-06-30
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History
  • Received:2023-12-08
Affiliations
    1.Drug Testing Monitoring and Evaluation Center, Yangling Agricultural High-Tech Industrial Demonstration Zone, Yangling 712100, China
    2.Xi'an Wanlong Pharmaceutical Co., Ltd., Yangling 712100, China
    3.Shaanxi Institute for Food and Drug Control, Xi’an 710065, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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