Full
Outline
To establish a method of stimulating human ovarian granulosa cells KGN to secrete progesterone (PG) by human menopausal gonadotropin (HMG), based on the mechanism of estrogen stimulating the production of progesterone in ovarian granulosa cells in mammalian, to evaluate the titer of follicle-stimulating hormone (FSH), the active component of HMG.
KGN cells were stimulated with different concentrations of HMG solution, the content of PG in the secreted supernatant was detected, and the biological activity assay of FSH in vitro was established. According to the 9101 analysis method verification and 9401 biological products bioactivity/potency determination method verification guiding principles in the General Rules of the fourth part of Chinese Pharmacopoeia, the established method was validated in terms of specificity, precision and durability. The national standard of HMG was used as the benchmark to detect the potency of HMG international standard and preparation (qualified and unqualified).
Different concentrations of HMG displayed effect on KGN cells in a time- and dose-dependent manner.
The specificity, precision and durability of the method meet the requirements of the General Principles of the fourth part of Chinese Pharmacopoeia. Based on HMG national standard, the titers of HMG international standard and HMG for injection can be effectively determined, with consistent results with the pharmacopoeia method.
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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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