絨促性素（HCG）自將康孕婦尿中提取、精制而成的一種天然促性腺激素，具有類似黃體生成素的功能。對女性可促進卵泡的成熟及排卵，并維持黃體的功能。對男性，能剌激睪丸間質(zhì)細胞的發(fā)育，增加雄激素分泌，促使睪丸下降和男性第二性征發(fā)育。與尿促性素合用，可模擬生理性的促黃體生成素高峰，而促發(fā)排卵。臨床上絨促性素至今仍是治療月經(jīng)失調(diào)、無排卵性不孕癥、先兆流產(chǎn)和習慣性活產(chǎn)、隱睪癥、男性性功能低下等的首選藥物。此外，它還廣泛應用于性保健，計劃生育事業(yè)以及漁業(yè)和畜牧業(yè)的生產(chǎn)。
|
性狀 |
白色或類白色粉末 |
|
鑒別 |
符合規(guī)定 |
|
活性 |
不少于5,000 IU/mg |
|
水分 |
不多于5% |
|
細菌內(nèi)毒素 |
不多于0.01 EU/HCG IU |
|
異常毒*性 |
符合規(guī)定 |
|
殘留溶劑 |
0.5% |
|
人類免疫缺陷病毒I型和II型抗原 |
陰性 |
|
乙肝病毒表面抗原 |
陰性 |
|
丙肝病毒抗體 |
陰性 |
HCG is a natural gonadotropin extracted and refined from the urine of healthy pregnant women, which has a function similar to luteinizing hormone. For women, the maturation and ovulation of follicles can be promoted, and the function of the yellow body is maintained. For men, it stimulates the development of interstitial cells in the testes, increases androgen secretion, and promotes testicular decline and the development of second sexual characteristics in men. In combination with menotrophin, it can simulate the peak of bio-rational provonomic serotoin and promote ovulation. Clinical chorionic gonadotrophin is still the preferred drug for the treatment of menstrual disorders, no ovulation infertility, pre-eclampsia and habitual live births, cryptotestism, and low male sexual function. In addition, it is widely used in sexual health care, family planning and fisheries and livestock production.
|
Appearance |
White to yellowish-white powder |
|
Identification |
Conform with regulation |
|
Activity |
Not less than 5,000 IU/mg |
|
Water |
Not more than 5.0% |
|
Bacterial endotoxins |
Not more than 0.01 EU/HCG IU |
|
Abnormal toxicity |
Conform with regulation |
|
Residual Solvent |
0.5% |
|
HIV I+II antigen |
Negative |
|
Hepatitis B surface antigen |
Negative |
|
HCV antibodies |
Negative |
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