Stable norethindrone ethinylestradiol compound tablet and preparation method thereof

Abstract

The invention relates to an oral contraceptive compound tablet which comprises norethindrone diacetate, ethinylestradiol, a filling agent, a disintegrating agent and a lubricating agent, and the filling agent comprises lactose and microcrystalline cellulose. According to the invention, by selecting the proper filler composition, on the basis of ensuring the quick release requirement of the compound tablet, the diacinesterone related impurities generated in a tabletting process are effectively controlled, and a guarantee is provided for clinical safe medication.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a compound tablet of norethindrone diacetate and ethinyl estradiol. Background technique [0002] At present, the commonly used female contraceptive methods include intrauterine device, drug contraception and external contraception. Among them, hormonal contraceptives have been used since the launch of Enovid, the first combined oral contraceptive (COC) in the United States in the 1960s. It has been shown to be a reliable contraceptive, and its main effect is to inhibit ovulation. Hormonal contraception is divided into oral contraceptives, long-acting contraceptives, family visit contraceptives and sustained-release contraceptives. Among them, COC includes compound short-acting oral contraceptives and compound long-acting oral contraceptives. Because of its high contraceptive efficiency, safety and ease of use, it is the most commonly used reversible contraceptive choice for women of chi...

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Problems solved by technology

[0006] At present, there is no literature report on the effective inhibition of norethindrone diacetate-relat

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