Stable pharmaceutical composition containing ethinylestradiol and norethindrone acetate

A technology of norethindrone acetate and composition, which is applied in the field of pharmaceutical preparations, can solve problems such as oxidative degradation and drug effect decline, and achieve the effects of improving stability, ensuring stability, and improving overall stability
CN114129573AActive Publication Date: 2022-03-04北京联嘉医药科技开发有限公司

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
北京联嘉医药科技开发有限公司
Publication Date
2022-03-04

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Abstract

The invention discloses a stable pharmaceutical composition containing ethinylestradiol and norethindrone acetate. Vitamin E is added, so that the stability of ethinylestradiol is improved; and by using a specific amount of vitamin E, the production of related substances of ethinylestradiol and norethindrone acetate is controlled at the same time, and the overall stability of the compound preparation is improved.
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Description

technical field

[0001] The invention relates to the field of pharmaceutical preparations. The invention provides a pharmaceutical composition for female contraception or treatment and prevention of climacteric syndrome with good stability. Background technique

[0002] Oral contraceptives usually contain a combination of synthetic progestin and estrogen. Both of these two hormone compounds can promote the maturation of female accessory sex organs and the emergence of secondary sexual characteristics, and maintain normal sexual desire and reproductive function. The compound preparation of estrogen ethinyl estradiol and progestin norethindrone acetate (optical rotation -32° to -38°) can be used for female contraception and treatment or prevention of menopausal syndrome.

[0003] Ethinyl estradiol is an orally bioavailable estrogen, which is used in almost all modern combined oral contraceptive formulations. The content in a single dose product is usually less than 100µg, and...

Claims

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