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Abiraterone acetate tablet medicine composition and preparation method thereof

A technology of abiraterone acetate and tablets, which is applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve problems such as unsuitability for large-scale industrial production, low dissolution rate of samples, and complicated preparation process. Achieve the effects of increasing the dissolution surface area, no solvent residue, and simple preparation process

Inactive Publication Date: 2019-01-04
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN106539765 adopts the dissolution method to prepare the solid dispersion of abiraterone acetate and povidone. In this method, copovidone is first heated to 80°C for dissolution, then abiraterone acetate is added, stirred until completely dissolved, and then rapidly cooled to 0--10 ℃, placed for 15-20 hours to become brittle and fragile, crushed, and sieved to obtain a solid dispersion. There are problems such as complicated preparation process, long time-consuming, and unsuitable for large-scale industrial production.
[0009] In summary, abiraterone acetate is a drug that is insoluble in water, and the absorption of the drug mainly depends on the dissolution rate of the drug. In the preparation process of the existing abiraterone acetate tablet, the dissolution rate of the sample is not high, and the micronization treatment causes Loss of raw materials, prone to agglomeration, and other defects that are not suitable for large-scale industrial production, there is an urgent need for an abiraterone acetate tablet with strong operability, simple preparation process and high dissolution rate of the prescription process

Method used

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  • Abiraterone acetate tablet medicine composition and preparation method thereof
  • Abiraterone acetate tablet medicine composition and preparation method thereof
  • Abiraterone acetate tablet medicine composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0033]Embodiment 1. a kind of preparation containing abiraterone acetate solid dispersion, its prescription is composed as follows:

[0034]

[0035] The preparation steps of embodiment 1:

[0036] (1) Abiraterone acetate and copovidone are mixed uniformly to make a physical mixture;

[0037] (2) Set the extrusion temperature of the twin-screw hot-melt extruder to 100°C, start the screw when the preset temperature is reached, add the physical mixture in step (1) into the extruder, and extrude through the screw strips;

[0038] (3) Pulverizing the strip in step (2), crossing a 40-mesh sieve to obtain a solid dispersion with uniform particle size distribution;

[0039] (4) Mix the solid dispersion obtained in step (3) with diluent, binder, disintegrant, lubricant by weight percentage in the prescription;

[0040] (5) Compress the mixture in step (4) into tablets.

[0041] Abiraterone acetate sheet of embodiment 1 and test example and Comparison of dissolution curves of ...

Embodiment 2

[0042] Embodiment 2. a kind of preparation containing abiraterone acetate solid dispersion, its prescription is composed as follows:

[0043]

[0044] The preparation steps of embodiment 2: same as embodiment 1.

[0045] Abiraterone acetate sheet of embodiment 2 and Comparison of dissolution curves of tablets in different dissolution media Figure 1~4 shown.

Embodiment 3

[0046] Embodiment 3. a kind of preparation containing abiraterone acetate solid dispersion, its prescription is composed as follows:

[0047]

[0048] The preparation steps of embodiment 3:

[0049] (1) Abiraterone acetate and copovidone are mixed uniformly to make a physical mixture;

[0050] (2) Set the extrusion temperature of the twin-screw hot-melt extruder to 130°C, start the screw when the preset temperature is reached, add the physical mixture in step (1) into the extruder, and extrude through the screw strips;

[0051] (3) Pulverizing the strip in step (2), crossing a 60-mesh sieve to obtain a solid dispersion with uniform particle size distribution;

[0052] (4) Mix the solid dispersion obtained in step (3) with diluent, binder, disintegrant, lubricant by weight percentage in the prescription;

[0053] (5) Compress the mixture in step (4) into tablets.

[0054] Abiraterone acetate sheet of embodiment 3 and Comparison of dissolution curves of tablets in diffe...

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Abstract

The invention relates to an abiraterone acetate tablet medicine composition and a preparation method thereof, and belongs to the technical field of medicine preparations. According to an abiraterone acetate tablet, firstly, a hot melting extruding technology is adopted for preparing a solid dispersion body of abiraterone acetate and copovidone, then the solid dispersion body, a diluent, an adhesive, a disintegrating agent and a lubricating agent are prepared into a mixture, and finally the mixture is prepared into tables. The prepared abiraterone acetate tablets improve the dissolution rate and bioavailability of a peroral solid preparation and have larger clinic application value; in addition, the prepared abiraterone acetate tablets are stable in quality, controllable and convenient to conduct industrialized production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of an abiraterone acetate tablet as a drug for treating prostate cancer and a preparation method thereof. Background technique [0002] Prostate cancer is one of the most common malignant tumors in men. In recent years, the incidence of prostate cancer in my country has been on the rise. Prostate cancer is also described as a "silent killer". It is not easy to be found in the early stage, and the disease is usually developed to an advanced stage when it is diagnosed. , The main symptoms are hematuria, dysuria and bone pain. Prostate cancer is a hormone-dependent malignant tumor. Studies have shown that androgen plays an important role in the occurrence and development of prostate cancer. Currently, first-line endocrine therapy (including surgery, chemical anti-androgen castration, or combined androgen deprivation therapy) is the standard tre...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/58A61K47/32A61P35/00A61K9/14
CPCA61K9/146A61K9/2027A61K9/2054A61K31/58
Inventor 赵娜娜郑晓清杨清敏汪文化张明会
Owner QILU PHARMA
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