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This article focuses on the key experimental operations in the study about the applicability of microbial limit testing methods for drugs，summarizing literature and experience from the preparation of test solution，design of methods for microbial counting and control bacteria inspection，operation of microbial recovery test，bacterial liquid concentration counting，and operational methods for controlling bacterial & fungal purity. Emphasis was placed on the preparation methods of water-soluble test samples with strong antibacterial effects，non-oil and fat test samples that were not easily soluble and dispersed，and the test solution for oil and fat test samples. Detailed introduction of the sequential experimental plan for methods of aerobic bacterial count，mold & yeast count，and control bacterial inspection were introduced. Four operational methods for adding bacteria about membrane filtration were explained，and the impact of different ways of adding bacteria on the results of the method was analyzed. Summarized three counting methods for bacterial & fungal concentrations. Detailed sharing of operational experience on controlling the purity of bacterial solution. Summarized the current status about research on the applicability of microbial limit testing methods of drugs. Four suggestions for the future development of research on the applicability of microbial limit testing methods for drugs have been proposed：（1） Unify the operation about bacteria adding method in membrane filtration，scientific and reasonable；（2）Strengthen supervision of pharmaceutical production enterprises and review of microbial limit testing methods for drugs；（3）Unify the microbial limit testing methods for the drugs of the national sampling plan，and gradually collect and bind into a book；（4）Strengthen the research on the applicability of microbial limit testing methods for excipients.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 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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