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Medicinal composition containing abiraterone acetate and preparation technology thereof

A technology of solid composition and adhesive, applied in the field of medicine, can solve the problems of affecting the quality of preparations, uneven mixing, etc.

Inactive Publication Date: 2012-10-24
HAINAN SHENGKE LIFE SCI RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The routine use of surfactants as co-solvents is to directly mix with other auxiliary materials and / or add to the dissolution medium. The disadvantage of direct mixing with auxiliary materials is that due to the small amount of sodium lauryl sulfate, direct mixing will cause Inhomogeneous mixing, which affects the quality of the formulation

Method used

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  • Medicinal composition containing abiraterone acetate and preparation technology thereof
  • Medicinal composition containing abiraterone acetate and preparation technology thereof
  • Medicinal composition containing abiraterone acetate and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1 Abiraterone acetate sheet preparation

[0018]

[0019] Preparation process: Weigh the prescribed amount of abiraterone acetate: lactose (1:1), pulverize to obtain a co-powder, add the prescribed amount of microcrystalline cellulose, croscarmellose sodium (internal addition) and pass through an 80-mesh sieve Mix well. Put the above mixed powder in a dry grinding cup, add an appropriate amount of soft material made of 5% povidone K90 aqueous solution containing 0.1% SDS in the prescription amount, granulate with a 18-mesh sieve, dry until the moisture is lower than 5%, 24-mesh Sieve for granulation, add croscarmellose sodium, magnesium stearate and silicon dioxide, mix well; press into tablets to obtain.

Embodiment 2

[0038] The preparation of embodiment 2 Abiraterone Acetate Tablets

[0039]

[0040]

[0041] Preparation process: Weigh the prescribed amount of abiraterone acetate: lactose (1:1), pulverize to obtain a co-powder, add the remaining amount of lactose, microcrystalline cellulose, croscarmellose sodium (internal addition) over 80 Mesh sieve to mix. Put the above mixed powder in a dry grinding cup, add an appropriate amount of soft material made of 5% povidone K90 aqueous solution containing 0.1% SDS in the prescription amount, granulate with a 18-mesh sieve, dry until the moisture is lower than 5%, 24-mesh Sieve for granulation, add croscarmellose sodium, magnesium stearate and silicon dioxide, mix well; press into tablets to obtain.

Embodiment 2-1

[0042] The preparation of embodiment 2-1 Abiraterone acetate sheet

[0043]

[0044] Preparation process: Weigh the prescribed amount of abiraterone acetate: lactose (1:1), pulverize to obtain a co-powder, add the remaining amount of lactose, microcrystalline cellulose, croscarmellose sodium (internal addition) over 80 Mesh sieve to mix. Put the above mixed powder in a dry grinding cup, add an appropriate amount of soft material made of 5% povidone K90 aqueous solution containing 0.1% SDS in the prescription amount, granulate with a 18-mesh sieve, dry until the moisture is lower than 5%, 24-mesh Sieve for granulation, add croscarmellose sodium, magnesium stearate and silicon dioxide, mix well; press into tablets to obtain.

[0045] Embodiment 2-2 Dissolution comparative study of embodiment 2 and comparative example 2-1

[0046]Measure the abiraterone acetate sheet prepared by the embodiment of the present invention 2 and its comparative example, take 900ml, 0.25% SDSpH4.5...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a medicinal composition containing abiraterone acetate and a preparation technology of the medicinal composition. The medicinal composition comprises abiraterone acetate, a solubilizer, a binder and a disintegrating agent and can be prepared into tablets, granules or capsules. The invention is characterized in that the abiraterone acetate and hydrophilic auxiliary materials are crushed based on a proportion, and the dissolution rate and bioavailability of the medicine are effectively improved, the medicinal composition can be used for treating the prostate cancer.

Description

1. Technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition containing abiraterone acetate and a preparation process, belonging to the technical field of medicine. 2. Background technology [0002] Abiraterone acetate is an oral cytochrome oxidase P450 (CYP450) c17 inhibitor, which reduces androgen levels by inhibiting the key enzyme in androgen synthesis - CYP450c17, and has no effect on androgens in the testis and other parts of the body. It has inhibitory effect and is used in the treatment of advanced prostate cancer. Its structural formula is: [0003] [0004] Abiraterone acetate is a lipophilic compound, easily soluble in organic solvents such as tetrahydrofuran, dichloromethane, especially alcohols; almost insoluble in water at pH2-12 at 20°C; slightly soluble in 0.1N hydrochloric acid, BCS classification belongs to Four types, so improving its dissolution rate an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61P5/28A61P35/00
Inventor 肖博郭夏宋雪梅
Owner HAINAN SHENGKE LIFE SCI RES INST
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