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Finasteride capsule and preparation method thereof

A technology of finasteride and capsules, applied in the field of finasteride capsules and preparation thereof, can solve problems such as changing and affecting the effect of drug treatment, and achieves reduction of operation time, reduction of the risk of damage to the main drug, and convenient adjustment. Effect

Active Publication Date: 2014-11-26
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, the crystal form of a compound is directly related to its solubility, product stability, and product efficacy. It is an effective way to increase the solubility of insoluble compounds through organic solvents, but it is necessary to always pay attention to the stability of the product to prevent crystallization. Type changes cause changes in drug efficacy and affect the therapeutic effect of drugs

Method used

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  • Finasteride capsule and preparation method thereof
  • Finasteride capsule and preparation method thereof
  • Finasteride capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Direct powder filling process

[0026] prescription:

[0027]

[0028] Process:

[0029] Pass the microcrystalline cellulose, pregelatinized starch PC-10, crospovidone, magnesium stearate, and sodium lauryl sulfate through an 80-mesh sieve for use; pass the raw materials through a 100-mesh sieve for use; weigh according to the above prescription Take the raw and auxiliary materials, mix the weighed finasteride with the same amount of microcrystalline cellulose by the equal volume addition method, and then sieve and mix with the rest of the auxiliary materials; place the mixed powder in a multi-directional motion mixer for total mixing , Set the mixing speed to 1100r / min, and the mixing time to 30min; detect the properties and content of the intermediates, and fill the capsules after meeting the internal control quality standards. Example 2: Direct powder filling process

Embodiment 2

[0029] Pass the microcrystalline cellulose, pregelatinized starch PC-10, crospovidone, magnesium stearate, and sodium lauryl sulfate through an 80-mesh sieve for use; pass the raw materials through a 100-mesh sieve for use; weigh according to the above prescription Take the raw and auxiliary materials, mix the weighed finasteride with the same amount of microcrystalline cellulose by the equal volume addition method, and then sieve and mix with the rest of the auxiliary materials; place the mixed powder in a multi-directional motion mixer for total mixing , Set the mixing speed to 1100r / min, and the mixing time to 30min; detect the properties and content of the intermediates, and fill the capsules after meeting the internal control quality standards. Example 2: Direct powder filling process

[0030] prescription:

[0031]

[0032]

[0033] Process:

[0034] Pass the microcrystalline cellulose, pregelatinized starch PC-10, crospovidone, magnesium stearate, and sodium lauryl sulfate t...

Embodiment 3

[0034] Pass the microcrystalline cellulose, pregelatinized starch PC-10, crospovidone, magnesium stearate, and sodium lauryl sulfate through an 80-mesh sieve for use; pass the raw materials through a 100-mesh sieve for use; weigh according to the above prescription Take the raw and auxiliary materials, mix the weighed finasteride with the same amount of microcrystalline cellulose by the equal volume addition method, and then sieve and mix with the rest of the auxiliary materials; place the mixed powder in a multi-directional motion mixer for total mixing , Set the mixing speed to 1000r / min, and the mixing time to 15min; detect the properties and content of the intermediate, and fill the capsule after meeting the internal control quality standard. Example 3: Direct powder filling process

[0035] prescription:

[0036]

[0037] Process:

[0038] Pass lactose, pregelatinized starch PC-10, microcrystalline cellulose, sodium starch glycolate, crospovidone, talc, and sodium lauryl sulfa...

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Abstract

The invention discloses a finasteride capsule and a preparation method thereof, and belongs to the technical field of medicinal preparations. The content of the finasteride capsule is composed of finasteride and medicinal auxiliaries, wherein the medicinal auxiliaries comprise a filler, a disintegrating agent, a lubricant and a surfactant and does not contain liquid solvent, and the filler comprises pregelatinized starch PC-10. Based on the process of directly filling powder, each component of the medicinal auxiliaries is screened by a 80-mesh screen, while finasteride is screened by a 100-mesh screen; the filler in the medicinal auxiliaries is weighed in the ratio, is subjected to equivalent increasing mixing with finasteride, and is uniformly mixed with other medicinal auxiliary components to fill the capsule. Functional auxiliaries can be screened without liquid solvent by optimizing the formula and the process, the compound solubility can be improved to meet the requirements on dissolution rate and stability, and the quality in accordance with an original development preparation can be achieved, so that the product quality can be guaranteed, and the treatment effect of the finasteride capsule can be relatively effectively played.

Description

Technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a finasteride capsule and a preparation method thereof. Background technique [0002] Drug therapy is the main treatment method for mild to moderate benign prostatic hyperplasia, mainly combined treatment with 5α-reductase inhibitors, α-adrenergic receptor blockers and prostate drugs. 5α-reductase inhibitors such as finasteride are the most widely used drugs with ideal therapeutic effects for patients with benign prostatic hyperplasia and male alopecia. According to data from Minai.com, the market sales of finasteride have been increasing steadily. 120 million in 2013 increased to 170 million in 2013. [0003] The original formulation of finasteride was developed by Merck, and domestically produced by its subsidiary Merck & Co., Ltd., the current dosage forms of finasteride include tablets, capsules and dispersible tablets. It can be seen from the results of solubi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/58A61P13/08
Inventor 刘艳红王正雄邓霞飞唐维刘红华方智胡婷
Owner 武汉人福药业有限责任公司
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