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Finasteroid oral preparation and method for preparing same

A technology of androstide oral emulsion and finasteride is applied in the field of 5-alpha reductase activity inhibitor drug finasteride oral preparation and its preparation field, which can solve the difficulty of affecting industrialized production control, affecting treatment effect, and preparation specifications. Small and other problems, to achieve the effect of improving human bioavailability, high drug dissolution, and fast onset

Inactive Publication Date: 2011-08-31
HANGZHOU XIANDA MEDICINE TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because finasteride is not easy to dissolve in water, and the preparation specifications are small, the process difficulty of its conventional preparations (tablets, capsules) mainly lies in the dissolution rate and content uniformity, so the difficulty of controlling industrial production is firstly affected, followed by The resulting quality fluctuations affect its therapeutic effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] finasteride 5g labrafac cc (medium chain triglycerides) 145g

[0019] Gelatin 80g Glycerin 40g Purified Water 90g Methylparaben 0.1g

[0020] Preparation method: take labrafac cc, add finasteride, stir evenly, grind with a colloid mill for 15 minutes, release, measure the drug content, and let it stand for later use; For swelling, heat to 60°C in the sol tank, keep warm for 40 minutes, add methylparaben, stir evenly, vacuumize for 10 minutes, release the glue, keep warm at 50°C for later use, put the prepared medicine into the rubber bucket Inject the soft capsule unit into the soft capsule unit, drip or press to make soft capsules, send them to the capsule shaper, dry them at 10°C for 3 hours, release the capsules, dry them at 20°C for 24 hours, wipe off the lubricating oil on the surface of the capsules, After packaging, the finished product is obtained after passing the inspection.

Embodiment 2

[0022] Finasteride 1g Soybean Oil 100g Perilla Oil 49g

[0023] Gelatin 120g Glycerin 80g Purified water 100g Ethylparaben 0.1g

[0024] Preparation method: mix soybean oil and perilla oil, then add finasteride, stir evenly, grind with a colloid mill for 20 minutes, release, measure the drug content, stand for later use; add gelatin and glycerin to pure water, calculate Put it into the sol tank, fully swell, heat it to 60°C in the sol tank, keep it warm for 30 minutes, add ethylparaben, stir evenly, evacuate for 20 minutes, release the glue, keep it warm at 50°C for standby, and prepare it Put the medicinal liquid into the rubber barrel, pour it into the soft capsule unit, press it to make soft capsules, send it to the capsule shaper, dry it at 15°C for 63 hours, release the capsules, dry it at 20°C for 36 hours, and wipe off the capsules. Surface lubricating oil, packaging, and finished product after passing the inspection.

Embodiment 3

[0026] Finasteride 0.5g Olive Oil 120g Polysorbate-80 1.5g

[0027] Preparation method: Add polysorbate-80 to olive oil, then add finasteride, stir evenly, grind with a colloid mill for 20 minutes, release, measure the drug content, and stand for later use; after accurately measuring the prepared drug solution , filled into hard capsule shells, packaged, and the finished product is obtained after passing the inspection.

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Abstract

The invention relates to a non-finasteride oral preparation and preparation method, specifically which consists of main drug non-finasteride and medicinal findings. Its contents are oily liquid or semi-solid, and it can be made of soft capsules, liquid-filled capsules and oral emulsion. The important contribution of the invention is preparing the steroidal hormone compounds into liquid or semi-solid in agent preparation early period, avoiding occupational hazard caused by dust flying, protecting workers involving in manufacture;In addition, non-finasteride is the combination of lipophilic compounds, oily liquid or semi-solid drugs and supplies, it can increase the drug dissolution rate, improve bioavailability. The application of the invention can improve labor protection, and also can provide better curative effect in clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an oral preparation of finasteride, a 5-alpha reductase activity inhibitor, and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) is a special histopathological disease characterized by hyperplasia of stromal and epithelial cells, BPH can lead to benign prostatic enlargement (BPH) and benign prostatic obstruction ( BPO). BPH is a common disease in elderly men, and research results show that most men over the age of 50 have different degrees of benign prostatic hyperplasia. A sample survey of male residents over 40 years old in Beijing in 1994 showed that 37.6% had symptoms of BPH. From 1990 to 1991, BPH patients accounted for 13.6% of the inpatients in urology departments of 20 large urban hospitals across the country. With the continuous development of my country's economy, the continuous improvement of people's livin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/58A61K9/48A61K9/107A61P13/08
Inventor 叶虹
Owner HANGZHOU XIANDA MEDICINE TECH
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