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OBJECTIVE To establish an evaluation method for the release of mupirocin ointment in vitro, according to the quality research of ointment preparations at home and abroad and the technical guidelines for generic drugs. METHODS The diffusion cell method was adopted, the release membrane was polyethersulfone membrane, the receiving medium was sodium dihydrogen phosphate buffer solution with pH 7.4, the rotation speed was 600 r·min-1, and the sample size was 300 mg. The concentration of mupirocin in the receiving solution at different time points was determined by HPLC method, and the cumulative release and release rate were calculated. The particle size morphology and particle size distribution of mupirocin ointment from different manufacturers were determined by particle size analyzer. The viscosity of preparations from different manufacturers was determined by rheometer. RESULTS The determination method for the release of mupirocin ointment in vitro was established, and the precision, durability and discrimination of this method were good, and the consistency evaluation was made for preparations from different manufacturers. There were great differences in particle size distribution and viscosity between different manufacturers. CONCLUSION The differences in particle size distribution between different manufacturers reflect the differences in preparation production process, and the differences in viscosity reflect the differences in preparation prescription, both of them can affect the release rate of mupirocin ointment in vitro.
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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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