Testosterone undecanoate capsule and preparation method thereof

A technology of testosterone undecanoate and capsules, which is applied in the field of testosterone undecanoate capsules and its preparation, can solve the problems of low bioavailability, difficult preparation, and severe pain of soft capsule dosage forms, and achieve the improvement of bioavailability and preparation process Convenience and the effect of increasing the release rate

Inactive Publication Date: 2017-05-31
ZHEJIANG XIANJU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to solve the technical problems of slow human body absorption of testosterone undecanoate oil injection form, severe and long-lasting pain during injection; low bioavailability, large side effects and difficult preparation of soft capsule formulations

Method used

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  • Testosterone undecanoate capsule and preparation method thereof
  • Testosterone undecanoate capsule and preparation method thereof
  • Testosterone undecanoate capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1, a kind of testosterone undecanoate capsule, comprises

[0022]

[0023] Make 1000 grains, the preparation method is as follows:

[0024] ①Add 150g of glyceryl monostearate into 15ml of ethanol, heat to 60°C, add 50g of testosterone undecanoate to dissolve it, take it out, and spray dry to obtain a solid dispersion of testosterone undecanoate;

[0025] ②According to the prescription amount, add micropowder silica gel and starch and mix evenly;

[0026] ③ Fill the mixture into the No. 0 capsule shell and pack it.

Embodiment 2

[0027] Embodiment two: a kind of testosterone undecanoate capsule, comprises

[0028]

[0029] Make 1000 grains, the preparation method is as follows:

[0030] ①Add 80g of glyceryl monostearate to 20ml of ethanol, heat to 60°C, add 50g of testosterone undecanoate and 1.5g of sodium lauryl sulfate to dissolve it, take it out, and spray dry it to obtain a solid dispersion of testosterone undecanoate body;

[0031] ② Add micropowder silica gel and starch according to the prescription amount and mix evenly;

[0032] ③ Fill the mixture into the No. 0 capsule shell and pack it.

Embodiment 3

[0033] Embodiment three: a kind of testosterone undecanoate capsule, comprises

[0034]

[0035] Make 1000 grains, the preparation method is as follows:

[0036] ①Add 50g of PEG6000 into 30ml of acetone, heat to 60°C, add 100g of testosterone undecanoate to dissolve, and spray dry to obtain a solid dispersion of testosterone undecanoate;

[0037] ②According to the prescription amount, add micropowder silica gel and starch and mix evenly;

[0038] ③ Fill the mixture into the No. 0 capsule shell and pack it;

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Abstract

The invention discloses a testosterone undecanoate capsule. The testosterone undecanoate capsule comprises the following components in percentage by mass: 15-65% of testosterone undecanoate, 13-68% of carrier, 10-30% of organic solvent, 0.5-3.0% of surfactant, 1.0-3.0% of micropowder silica gel and 5.0-20% of starch. The invention also discloses a preparation method of the testosterone undecanoate capsule. According to the invention, the testosterone undecanoate active compound is innovatively dispersed in a molecular form in the carrier material based on a solid dispersion technology, so that no troubles in the aspects of crystal form and granularity exist, and the in vivo release rate of the drug is greatly increased, thereby improving the bioavailability of the product. Thus, as a male hormone supplement preparation having the minimal side effect, the testosterone undecanoate has huge market prospects in the present era with the problem of population ageing.

Description

technical field [0001] The invention relates to a testosterone undecanoate capsule and a preparation method thereof. Background technique [0002] Testosterone undecanoate injection is suitable for testosterone replacement therapy for male hypogonadism, such as after orchiectomy, anorchioid, hypopituitarism, endocrine impotence, male menopausal symptoms (decreased sexual desire, mental and physical strength, etc.), Some infertility and aplastic anemia caused by spermatogenesis dysfunction. At present, the main dosage forms of testosterone undecanoate on the domestic market are oil injections, soft capsules, etc. Among them, testosterone undecanoate oil injections are mainly used in clinical practice, because testosterone undecanoate is difficult to dissolve in water, this product can only be prepared as oil injections in clinical practice When the oily needle is injected intramuscularly, since the oily solvent is not quickly absorbed by the body like water, its absorption r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/568A61K47/36A61K47/10A61K47/14A61K47/04A61P15/10A61P15/08A61P7/06
CPCA61K9/4816A61K9/4825A61K9/485A61K9/4858A61K9/4866A61K31/568
Inventor 黄强
Owner ZHEJIANG XIANJU PHARMA
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