Megestrol acetate Preparation and Application

Megestrol acetate as progestin on pituitary gonadotropin releasing a certain extent, but more than levonorgestrel and norethindrone weak. Does not have estrogen and androgen-like activity, but there are obvious anti-estrogen effect. In combination with estrogen to suppress ovulation. Animal teratogenicity study in rabbits showed that the stillbirth rate has increased and teratogenic effects.
Preparation:
Method name: megestrol acetate - Determination of megestrol acetate - High Performance Liquid Chromatography
Application: This method uses HPLC megestrol acetate content. This method applies to megestrol acetate.
Principle of the method: the test sample was dissolved in methanol and diluted to a certain concentration of the solution into the liquid chromatographic separation with UV absorbance detector at the wavelength of 288nm at the detection of megestrol acetate absorption value, calculate its content.
Reagents:
1 methanol (HPLC grade)
2 water (HPLC grade)
Equipment:
1 instruments
1.1 HPLC
1.2 Columns: octadecylsilane bonded silica as a filler, number of theoretical plates megestrol acetate peak should not be less than 2000.
1.3 UV absorption detector
2 chromatographic conditions
2.1 Mobile phase: methanol: water = 70 30
2.2 detection wavelength: 288nm
2.3 column temperature: room temperature
Sample Preparation:
1 standard solution: take megestrol acetate amount, accurately weighed, set 100 mL volumetric flask, dissolved in methanol and diluted to the mark, shake, the precise amount 2mL, set 10 mL volumetric flask, dissolved in methanol and diluted to the mark, shake.
2  Preparation of the test solution: take megestrol acetate 20mg, accurately weighed, in 100 mL flask, dissolved in methanol and diluted to the mark, shake, the precise amount 2mL, set 10mL volumetric flask, dissolved in methanol and diluted to the mark, shake.
Steps: precision drawing reference solution and the test solution 10μL injection high performance liquid chromatography with UV absorbance detector at the wavelength of 288nm at the determination of the absorption of megestrol acetate, calculate its content.

Application:Oral
1 treatment of amenorrhea, 1 4mg, 2 to 3 times a day, even serving 2 to 3 days, stopping 2 to 7 days, that withdrawal bleeding.
(2) the treatment of functional bleeding, a second 4mg, every 8 hours, once every three days reduction, reduction does not exceed the original dose of 1/2 until the daily maintenance dose of 4mg, a total of 20 days.
3. The treatment of endometriosis, a second 4mg, 2 times a day for 7 to 3 times a day after each 4mg, 7 to 2 times a day at a later date. 1 8mg, and then served on the 7th, and then increased to a daily 20mg, 6 weeks for a course of treatment.
4 breast cancer, a sub-40mg, 4 times a day, the daily amount of 160mg, for 2 consecutive months.
5 endometrial cancer, 1 10 ~ 80mg, 4 times a day, the daily amount of 40 ~ 320mg, or one 160mg, day 1.
[Preparation and specification] megestrol acetate tablets: ① 4mg; ② 160mg.



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