Molecular Formula | C17H28 |
Molar Mass | 232.404 |
Physical and Chemical Properties | This strain is a white or gray-white loose body obtained by extracting the lyophilized preparation from the plasma or serum of healthy people with hepatitis B vaccine. After the liquid preparation and the lyophilized preparation are dissolved, the solution should be a clear liquid, nearly colorless or light yellow, with slightly opalescent light. However, it should not contain foreign matter or precipitate that cannot be scattered. This product contains a variety of antibodies in normal human blood, mainly against measles, hepatitis A Virus, influenza, mumps, rubella, polio, encephalitis B, herpes, vaccinia Virus antibody, also contains a small amount of anti-typhoid, pertussis, scarlet fever and other bacterial antibodies and anti-diphtheria, tetanus antitoxin. To enhance the role of body fluids, mainly for the Prevention of Virus diseases. The serum half-life of this product is 18-20 days, and the biological half-life is 340H. |
Use | It is used for hypogonadism and cryptorchidism caused by hypophysis insufficiency in men, for dysfunctional uterine bleeding and habitual abortion caused by luteal phase insufficiency. Combined with gonadotropin extracted from horse serum and urine of menopausal women, it can induce ovulation and treat infertility. Can also treat skin pruritus, neurodermatitis.Adverse reactions and contraindications: more commonly induced ovarian cysts or mild to moderate ovarian enlargement, abdominal or pelvic pain, indigestion, edema, urine volume reduction, Nausea, Vomit. Male precocious puberty may occur occasionally. Less common breast enlargement, Head Pain, excitability, depression, fatigue, etc. Have asthma, epilepsy, heart disease, renal damage with caution. There are pituitary hyperplasia or tumor, precocious puberty, thrombophlebitis and other disabled. |
This product is human chorionic gonadotropin extracted from urine of pregnant women. The titer should not be less than 4500 units per lmg.
According to the method under the item of potency measurement, the measurement result should be able to increase the weight of the uterus of the minor female mice.
three female mice weighing 18 to 20g were collected and the ovaries were removed. After 2 to 3 weeks, subcutaneous injection of sodium chloride injection containing 1250 units of this product in each lml 4 times, each 0.2, the first day in the afternoon, the second day in the afternoon, on the morning of the third day, the vagina of each mouse was washed with a small amount of sodium chloride injection on the morning of the fourth day, the fifth day and the sixth day, respectively, no positive reaction (positive reaction refers to the majority of keratinocytes or epithelial cells in the smear).
take 0.lg of this product, precision weighing, set in the top empty bottle, Precision Add 2ml of water to dissolve, seal, as a test solution; Take the appropriate amount of anhydrous ethanol, precision weighing, A solution containing 0.25mg per 1 ml was prepared by quantitative dilution with water, and 2ml was accurately weighed, placed in a headspace bottle, and sealed as a reference solution. According to the determination method of residual solvent (General 0861 second method), polyethylene glycol is used as the stationary liquid; The initial temperature is 60°C, the maintenance time is 5 minutes, and the temperature is raised to 200°C at the rate of 50°C per minute for 15 minutes; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibrium temperature was 90°C and the equilibrium time was 20 minutes. The reference solution and the test solution were injected in Headspace respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, the residual amount of ethanol should comply with the provisions.
take this product, according to the moisture determination method (General 0832 first method 1) determination, containing water shall not pass.
take this product, add 0.9% sodium chloride solution to dissolve and dilute the solution containing lOmg per lml, according to the kit instructions, should be negative.
take this product, add sodium chloride injection to dissolve and dilute the solution containing 2000 units per lml, check according to law (General 1141), should comply with the provisions.
take this product, check according to law (General Principles 1143), the amount of endotoxin per 1 unit of chorionic gonadotropin should be less than 0.010EU.
the appropriate amount of this product and the standard of cashmere promoting hormone is accurately weighed, and the potency is as indicated, respectively, 0.1% sodium chloride solution containing 0.9% bovine serum albumin was added to dissolve and quantitatively dilute to make a solution containing 10 units per 1 ml, which was newly prepared. The result of the determination of chorionic gonadotropin bioassay (General rule 1209) shall be 80% to 125% of the nominal value.
gonadotropins.
shading, sealing, storage in cold place.
This product should be extracted from the urine of healthy people, and the production process should comply with the requirements of the current version of "good manufacturing practice. This product in the production process need to be appropriate processing methods, in order to make any Virus such as hepatitis Virus, human immunodeficiency Virus, such as removal or inactivation.
This product is a freeze-dried sterile stain of chorionic gonadotropin plus suitable excipients. The potency should be between 80% and 125% of the labeled amount.
This product is a white lyophilized cake or powder.
take 5 pieces of this product, add the 0.1% sodium chloride solution containing 0.9% bovine serum albumin to the indicated titer, and transfer the whole child to the same 100ml measuring flask, dilute to the scale with the above solution and shake well. Take the appropriate amount of children with precision, and quantitatively dilute with the above solution to make a solution containing 10 units per lml, which is ready for use. Take the appropriate amount of cashmere promoting element standard, and prepare with the same method. Determination of chorionic gonadotropin by bioassay (General rule 1209).
chorionic gonadotropin.
(1)500 units (2) 1000 units (3)2000 units (4)3000 units (5)5000 units
sealed and kept in a cool dark place.