Dutasteride soft capsule medicine composition

A technology of dutasteride and composition, applied in the field of pharmaceutical preparations, can solve problems such as drug migration problems of dutasteride soft capsules that have not been found, and achieve the effects of improving drug migration, low industrialization cost, and small capsule size

Active Publication Date: 2020-10-13
四川奥邦投资有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] No method has been found that can improve the drug migration o

Method used

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  • Dutasteride soft capsule medicine composition
  • Dutasteride soft capsule medicine composition
  • Dutasteride soft capsule medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093]

[0094]After adding prescription amounts of caprylic capric macrogol glyceride, dibutyl hydroxytoluene and dutasteride in a water bath at 60°C, stir to obtain the content.

[0095] Add the prescribed amount of sodium lauryl sulfate, glycerin and purified water into the glue tank, heat the interlayer temperature to 75°C; add the prescribed amount of titanium dioxide, yellow iron oxide, and appropriate amount of purified water into the clean container, and The colloid mill circulates and grinds for 10 minutes, disperses evenly and puts it into the glue tank, rinses it with an appropriate amount of purified water, and then adds it to the glue tank together. Keep the temperature of the glue solution at 70°C, add the prescribed amount of gelatin, start stirring, control the vacuum degree of the glue tank to -0.08±0.005MPa, make the gelatin completely melt into liquid in the glue tank, and stop stirring when there are no gelatin particles , After there are no bubbles in t...

Embodiment 2

[0099]

[0100] After adding prescription amounts of caprylic capric macrogol glyceride, dibutyl hydroxytoluene and dutasteride in a water bath at 60°C, stir to obtain the content.

[0101] Add the prescribed amount of sodium lauryl sulfate, glycerin and purified water into the glue tank, heat the interlayer temperature to 75°C; add the prescribed amount of titanium dioxide, yellow iron oxide, and appropriate amount of purified water into the clean container, and The colloid mill circulates and grinds for 10 minutes, disperses evenly and puts it into the glue tank, rinses it with an appropriate amount of purified water, and then adds it to the glue tank together. Keep the temperature of the glue solution at 70°C, add the prescribed amount of gelatin, start stirring, control the vacuum degree of the glue tank to -0.08±0.005MPa, make the gelatin completely melt into liquid in the glue tank, and stop stirring when there are no gelatin particles , After there are no bubbles in ...

Embodiment 3

[0105]

[0106] After adding prescription amounts of caprylic capric macrogol glyceride, dibutyl hydroxytoluene and dutasteride in a water bath at 60°C, stir to obtain the content.

[0107] Add the prescribed amount of sodium lauryl sulfate, glycerin and purified water into the glue tank, heat the interlayer temperature to 75°C; add the prescribed amount of titanium dioxide, yellow iron oxide, and appropriate amount of purified water into the clean container, and The colloid mill circulates and grinds for 10 minutes, disperses evenly and puts it into the glue tank, rinses it with an appropriate amount of purified water, and then adds it to the glue tank together. Keep the temperature of the glue solution at 70°C, add the prescribed amount of gelatin, start stirring, control the vacuum degree of the glue tank to -0.08±0.005MPa, make the gelatin completely melt into liquid in the glue tank, and stop stirring when there are no gelatin particles , After there are no bubbles in ...

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Abstract

The invention discloses a dutasteride soft capsule medicine composition. Contents of the dutasteride soft capsule medicine composition comprise dutasteride, an oil phase and an antioxidant. A capsulecase comprises gelatin, glycerin, a surfactant, an opacifier and a pigment, wherein the surfactant is one or two kinds of materials of lauryl sodium sulfate or sodium stearate. The dutasteride soft capsule medicine composition using the recipe provided by the invention has the advantage that the migration of the dutasteride in the contents towards the capsule case can be effectively prevented.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition of dutasteride soft capsules. Background technique [0002] Dutasteride (DUTASTERIDE, 17β-N-(2,5-bis(trifluoromethyl))phenylcarbamoyl-4-aza-5α-androst-1-en-3-one) is a A new dual inhibitor of 5α reductase, which can inhibit both 5α reductase I and 5α reductase II, is mainly used for the treatment of benign prostatic hyperplasia in men. A large number of clinical trials have shown that dutasteride can significantly reduce the level of dihydrotestosterone in human blood and prostate in the long-term compared with finasteride, and can continuously and effectively reduce the volume of the prostate. Its structural formula is as follows: [0003] [0004] Dutasteride is a highly lipophilic molecule. In order to ensure that dutasteride has a good dissolution rate and bioavailability, the original research company GlaxoSmithKline prep...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/10A61K47/42A61K31/58A61K47/20A61K47/14A61P13/08
CPCA61K9/4816A61K9/4825A61K9/4866A61K31/58A61K47/10A61K47/20A61P13/08
Inventor 董凌云
Owner 四川奥邦投资有限公司
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