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Pharmaceutical composition containing desogestrel and ethinylestradiol as well as preparation method and application of pharmaceutical composition

A technology of desogestrel and ethinyl estradiol, which is applied in the field of medicine, can solve the problems affecting the chemical stability of desogestrel and ethinyl estradiol, affecting the safety of patients taking medicine, complex preparation process, etc., and achieves simple and easy-to-control production process, ensuring the safety and effectiveness of medication, and shortening the process time

Active Publication Date: 2022-04-01
NOVAST LABORATORIES (CHINA) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method of the drug granules described in this patent needs to use an organic solvent to prepare a drug-containing solution, and then remove the organic solvent by heating; the preparation process is complex, time-consuming, and requires high equipment. At the same time, there are residual solvents in the product. affecting the safety of patients taking the drug
In addition, the heating process may also affect the chemical stability of desogestrel and ethinyl estradiol
[0004] According to the original product According to the instruction manual, the original research product is added with the antioxidant α-tocopherol to improve the stability of the product; since α-tocopherol is an oily liquid, it must be dissolved in an organic solvent before it can be added to the drug-containing granules, indicating that the original research product cannot avoid the use of organic solvents

Method used

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  • Pharmaceutical composition containing desogestrel and ethinylestradiol as well as preparation method and application of pharmaceutical composition
  • Pharmaceutical composition containing desogestrel and ethinylestradiol as well as preparation method and application of pharmaceutical composition
  • Pharmaceutical composition containing desogestrel and ethinylestradiol as well as preparation method and application of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] This embodiment provides a pharmaceutical composition comprising desogestrel and ethinyl estradiol, the preparation raw materials of the pharmaceutical composition comprising desogestrel and ethinyl estradiol include the following components by weight percentage:

[0066]

[0067]

[0068] The preparation method of the pharmaceutical composition comprising desogestrel and ethinyl estradiol comprises the following steps:

[0069] (1) passing desogestrel, ethinyl estradiol and sulfite through a 40-mesh sieve, and passing the diluent through a 20-mesh sieve;

[0070] (2) Mix the sieved desogestrel, ethinyl estradiol, sulfite and the diluent accounting for 30% of the total weight of the diluent obtained in step (1), and mix at 15 rpm for 14 minutes to obtain a mixture 1;

[0071] (3) Mix the mixture 1 obtained in step (2) with a diluent accounting for 30% of the total weight of the diluent, and mix at 15 rpm for 14 minutes to obtain a mixture 2;

[0072] (4) Mix the ...

Embodiment 2

[0077] This embodiment provides a pharmaceutical composition comprising desogestrel and ethinyl estradiol, the preparation raw materials of the pharmaceutical composition comprising desogestrel and ethinyl estradiol include the following components by weight percentage:

[0078]

[0079]

[0080] The preparation method of the pharmaceutical composition comprising desogestrel and ethinyl estradiol comprises the following steps:

[0081] (1) Pass desogestrel, ethinyl estradiol and sulfite through a 50-mesh sieve, and pass the diluent through a 25-mesh sieve;

[0082] (2) Mix the sieved desogestrel, ethinyl estradiol, sulfite and diluent accounting for 25% of the total weight of the diluent obtained in step (1), and mix at 20 rpm for 18 minutes to obtain a mixture 1;

[0083] (3) Mix the mixture 1 obtained in step (2) with a diluent accounting for 25% of the total weight of the diluent, and mix at 20 rpm for 18 minutes to obtain a mixture 2;

[0084] (4) Mix the mixture 2 ...

Embodiment 3

[0088] This embodiment provides a pharmaceutical composition comprising desogestrel and ethinyl estradiol, the preparation raw materials of the pharmaceutical composition comprising desogestrel and ethinyl estradiol include the following components by weight percentage:

[0089]

[0090]

[0091] The preparation method of the pharmaceutical composition comprising desogestrel and ethinyl estradiol comprises the following steps:

[0092] (1) Pass desogestrel, ethinyl estradiol and sulfite through a 60-mesh sieve, and pass the diluent through a 30-mesh sieve;

[0093] (2) The sieved desogestrel, ethinyl estradiol, sulfite and the diluent accounting for 35% of the total weight of the diluent obtained in step (1) were mixed, and mixed for 20 min at 25 rpm to obtain a mixture 1 ;

[0094] (3) Mix the mixture 1 obtained in step (2) with a diluent accounting for 35% of the total weight of the diluent, and mix at 25 rpm for 20 minutes to obtain a mixture 2;

[0095] (4) Mix the...

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Abstract

The invention provides a pharmaceutical composition containing desogestrel and ethinylestradiol. The pharmaceutical composition containing desogestrel and ethinylestradiol is prepared from the following raw materials: desogestrel, ethinylestradiol, sulfite, a lubricant, a disintegrating agent and a diluent. The pharmaceutical composition containing the desogestrel and the ethinylestradiol, provided by the invention, is prepared by a dry mixing and direct tabletting process, and oxidative degradation of the desogestrel and the ethinylestradiol can be effectively controlled, so that the stability of the pharmaceutical composition containing the desogestrel and the ethinylestradiol is improved; according to the pharmaceutical composition containing desogestrel and ethinylestradiol provided by the invention, impurities are measured by high performance liquid chromatography, and the total amount of the impurities is lower than 0.1% of the total peak area of an active drug within 24 months, so that the content of active drug components is effectively maintained, and the medication safety and effectiveness of a patient are ensured.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing desogestrel and ethinyl estradiol, a preparation method and application thereof. Background technique [0002] Desogestrel is the third-generation progestogen developed by Organon Company in the Netherlands. Its main purpose is to compound with estrogen (such as ethinyl estradiol) to prepare compound oral contraceptives. Compared with other first-generation and second-generation oral contraceptives composed of progesterone and estrogen, it has higher efficacy and lower side effects. Since desogestrel and ethinyl estradiol are easily oxidatively degraded, the problem of drug stability increases the difficulty of the product development. [0003] US5527543A discloses a method for preparing drug granules containing one or more steroids, which is an original research product The U.S. patent of the described drug-containing parti...

Claims

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Application Information

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IPC IPC(8): A61K31/567A61P15/18
Inventor 陈艳钱云飞钱云刘曼曼
Owner NOVAST LABORATORIES (CHINA) LTD
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