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Orally administered danazol sustained-release capsule and preparation method thereof

A technology of danazol and capsules, which is applied in the field of medicine, can solve the problems of affecting the therapeutic effect, long medication cycle, missed doses, and wrong doses, and achieve safe and effective treatment, easy to purchase in large quantities, and prevent rapid dissolution and release.

Inactive Publication Date: 2012-01-04
JIANGSU LIANHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the large number of daily doses and the long cycle of taking the medicine, the patient feels very inconvenient, and it is very easy to cause missed doses and wrong doses, which will affect the therapeutic effect.
In addition, adverse reactions such as headache, lower extremity edema, and hoarseness occur from time to time due to the phenomenon of peaks and valleys in the blood drug caused by taking the regular-release dosage form.

Method used

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  • Orally administered danazol sustained-release capsule and preparation method thereof
  • Orally administered danazol sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Prescription (by weight)

[0017] Danazol 26.9 parts

[0018] Hypromellose K4M 8.1 parts

[0019] Microcrystalline cellulose 26.9 parts

[0020] Acrylic No. 3 resin 5.4 parts

[0021] Mannitol 32.3 parts

[0022] Magnesium stearate 0.54 parts

[0023] method

[0024] Weigh danazol, hypromellose K4M, microcrystalline cellulose, acrylic acid No. 3 resin, and mannitol according to the above-mentioned prescription ratio, mix evenly in equal increments, pass through a 200-mesh sieve, and mix with 8% polyvinylpyrrolidone K25 ethanol liquid is made into soft material, granulated with 20-mesh sieve, dried at 50-60°C, added with magnesium stearate, packed in capsules.

Embodiment 2

[0026] Prescription (by weight)

[0027] Danazol 40.6 parts

[0028] Hypromellose E15 4.06 parts

[0029] Ethyl cellulose 20.3 parts

[0030] Cellulose acetate phthalate 4.06 parts

[0031] Lactose 30.5 parts

[0032] Magnesium stearate 0.4 parts

[0033] method

[0034] Weigh danazol, hypromellose E15, ethyl cellulose, cellulose acetate phthalate, and lactose according to the prescription ratio, mix them in equal increments, pass through a 200-mesh sieve, and mix them with 10% starch slurry Made into soft material, granulated with 20-mesh sieve, dried at 50-60°C, added with magnesium stearate, packed in capsules.

Embodiment 3

[0036] Prescription (by weight)

[0037] Danazol 42.4 parts

[0038] Hypromellose K10M 4.24 parts

[0039] Sodium carboxymethylcellulose 4.24 parts

[0040] Ethyl cellulose 21.2 parts

[0041] Mannitol 27.6 parts

[0042] Micropowder silica gel 0.42 parts

[0043] method

[0044] Weigh danazol, hypromellose K10M, sodium carboxymethyl cellulose, ethyl cellulose and mannitol respectively according to the prescription ratio, mix them in equal increments, pass through a 200-mesh sieve, and use 10% starch slurry Made into soft materials, granulated with a 20-mesh sieve, dried at 50-60°C, added with micronized silica gel, and packed in capsules.

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Abstract

The invention provides an orally administered danazol sustained-release capsule and a preparation method thereof. The orally administered danazol sustained-release capsule mainly comprises danazol and a sustained-release frame material, wherein the mass proportion of the danazol to the sustained-release frame material is 1:(0.32-2.1). The orally administered danazol sustained-release capsule also can comprise a thinning agent and a flow aid. The orally administered danazol sustained-release capsule provided by the invention has steady in-vitro release rate and in-vivo blood concentration, exhibits excellent sustained-release property; when applied in clinic, the administration frequency can be reduced, the orally administered danazol sustained-release capsule is convenient to administer, side effects can be reduced, and the orally administered danazol sustained-release capsule is particularly suitable for patients who take drugs for a long time.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an oral sustained-release preparation of hormone drugs, more specifically to an oral danazol sustained-release capsule and a preparation method thereof. Background technique [0002] Danazol, also known as danazol, anconazole, ethinyl testosterol, ethinyl androstenazole, chemical name 17α-pregna-2,4-diene-20-alkyno[2,3-d]isox Azulene-17β alcohol, which is a synthetic androgen, has weak androgenic activity, and has protein assimilation and anti-estrogen effects. It belongs to gonadotropin inhibitors and is used clinically to treat endometriosis and fibrous cysts. Sexual mastopathy, hereditary angioedema, gynecomastia, precocious puberty, thrombocytopenic purpura, hemophilia, and lupus erythematosus, etc. [0003] The commercially available danazol preparation is danazol capsule, which is a capsule dosage form of regular release. For the treatment of endometriosis, orally twice ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/58A61K47/38A61P7/04A61P7/10A61P15/00A61P15/14A61P37/02
Inventor 贺曾佑
Owner JIANGSU LIANHUAN PHARMA
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