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Drug composition containing abiraterone acetate and preparation method and application of drug composition

A technology of abiraterone acetate and composition, which is applied in the direction of drug combination, medical preparations containing active ingredients, medical preparations with non-active ingredients, etc., can solve the problems such as complex preparation process of compound preparations, and achieve the improvement of drug biological Utilization, increase penetrability, and meet the effect of long-term storage

Pending Publication Date: 2019-12-06
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The compound can reduce the effect of food and give up the requirement of taking medicine on an empty stomach, and can increase the oral bioavailability by up to 5 times, but the preparation process of the compound preparation is complicated

Method used

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  • Drug composition containing abiraterone acetate and preparation method and application of drug composition
  • Drug composition containing abiraterone acetate and preparation method and application of drug composition
  • Drug composition containing abiraterone acetate and preparation method and application of drug composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] The present embodiment provides a pharmaceutical composition containing abiraterone acetate, comprising the following components:

[0118]

[0119] This embodiment further provides an abiraterone acetate capsule, which uses the above-mentioned pharmaceutical composition as the content, and the content is filled in the capsule shell.

[0120] The preparation method is provided as follows:

[0121] Take hydrogenated castor oil, glycerol monooleate, and polyoxyethylene castor oil EL35, then add abiraterone acetate, sonicate for 10 minutes under dark conditions, use mechanical stirring (300rpm), stir for 20 minutes, make it fully dissolved, and then add propylene glycol And ethanol until it forms a transparent and uniform self-emulsifying solution, filled in soft capsules or sealed in hard capsules under nitrogen protection conditions for storage.

Embodiment 2

[0123] The present embodiment provides a pharmaceutical composition containing abiraterone acetate, comprising the following components:

[0124]

[0125]

[0126] This embodiment further provides an abiraterone acetate capsule, which uses the above-mentioned pharmaceutical composition as the content, and the content is filled in the capsule shell.

[0127] The preparation method is provided as follows:

[0128] Take Span 80, hydrogenated castor oil, glycerol monooleate, polyoxyethylene castor oil EL35, then add abiraterone acetate, use mechanical stirring (300rpm), stir for 25min, make it fully dissolved, then add BHA, BHT, propylene glycol And ethanol until it forms a transparent and uniform self-emulsifying solution, filled in soft capsules or sealed in hard capsules under nitrogen protection conditions for storage.

Embodiment 3

[0130] The present embodiment provides a pharmaceutical composition containing abiraterone acetate, comprising the following components:

[0131]

[0132] This embodiment further provides an abiraterone acetate capsule, which uses the above-mentioned pharmaceutical composition as the content, and the content is filled in the capsule shell.

[0133] The preparation method is provided as follows:

[0134] Take medium-chain triglycerides, glycerol monolinoleate, polyoxyethylene 40 hydrogenated castor oil, add abiraterone acetate, use mechanical stirring (300rpm), stir for 30min, make it fully dissolved, then add diethylene glycol mono Ethyl ether, BHT, and BHA are treated to form a transparent and uniform self-emulsifying solution, filled in soft capsules or sealed in hard capsules under nitrogen protection conditions for storage.

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Abstract

The invention relates to the technical field of drug preparations, in particular to a drug composition containing abiraterone acetate, and a preparation method and application of the drug composition.The drug composition is prepared from an active ingredient, namely the abiraterone acetate and accessories including one or more oil phases, one or more emulsifiers and one or more co-emulsifiers. After being orally taken, the drug composition meets gastrointestinal fluid to be spontaneously dispersed under gastrointestinal peristalsis to form O / W-type nanoemulsion. The formed nanoemulsion is small in particle size, the permeability of intestinal epithelial cells is improved, and the bioavailability of drugs can be significantly improved. Compared with microemulsion, a self-emulsified solution has higher stability, and the requirement of long-term preservation can be met. The drug composition is stable in content. Compared with an original drug Zytiga, the difference before and after mealis significantly reduced; and a capsule can be further prepared from the drug composition, and the capsule is stable in property.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing abiraterone acetate and a preparation method and application thereof. Background technique [0002] Abiraterone acetate is a white to off-white, non-hygroscopic crystalline powder; the chemical name is (3β)-17-(3-pyridyl)androst-5,16-dien-3-yl acetate, Its molecular formula is C 26 h 33 NO 2 . Abiraterone acetate is converted in vivo to the androgen biosynthesis inhibitor abiraterone, which inhibits 17α-hydroxylase / C17,20-lyase (CYP17). It can be used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-containing chemotherapy. However, abiraterone acetate is a lipophilic compound, its octanol-water partition coefficient is 5.12 (LogP), the pKa of aromatic nitrogen is 5.19, it is almost insoluble in water (less...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K9/48A61K47/44A61K47/14A61K47/10A61K31/58A61P35/00
CPCA61K9/1075A61K9/4808A61K9/4858A61K47/44A61K47/14A61K47/10A61K31/58A61P35/00A61P35/04A61P13/08A61K9/08A61K47/26A61K9/107
Inventor 刘玲洁程泽能易木林李瑛
Owner HUNAN HUIZE BIO PHARMA CO LTD
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