CN104784139A - Preparation method of finasteride coating tablet - Google Patents
Preparation method of finasteride coating tablet Download PDFInfo
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- CN104784139A CN104784139A CN201410021508.XA CN201410021508A CN104784139A CN 104784139 A CN104784139 A CN 104784139A CN 201410021508 A CN201410021508 A CN 201410021508A CN 104784139 A CN104784139 A CN 104784139A
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- finasteride
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Abstract
The invention relates to a preparation method of a finasteride coating tablet. The preparation method comprises the following steps: (1) pretreatment; (2) pelleting; (3) drying; (4) whole grain blending; (5) tabletting; (6) coating; and (7) packaging. By the use of the prepared finasteride coating tablet, a medicine itself can achieve moistureproof, light-proof and air-isolating effects, stability of the medicine can be enhanced, bitter taste of the medicine can be well covered, stimulation is minimized, the medicine has a good taste, and drug release parts can be effectively controlled.
Description
Technical field
The present invention relates to the preparation method of a kind of medicine containing organic effective component configuration product, particularly a kind of preparation method of finasteride coated tablet.
Background technology
Finasteride is a kind of 4-aza steroid, it be testosterone metabolism become stronger dihydrotestosterone process in the specific inhibitor of desmoenzyme-II type 5a-reductase.And benign prostatic hyperplasia or be called prostate hyperplasia and depend on that in prostate, testosterone is to the conversion of dihydrotestosterone.This medicine effectively can reduce blood and intraprostatic dihydrotestosterone.Finasteride does not have affinity to androgen receptor.Medicine is called: Tamsulosin, Finasteride.
In addition finasteride does not have affinity to androgen receptor, does not have androgenic, androgen antagonist sample, estrogen-like, estrogen antagonist sample or gestagenic action yet.Testosterone in peripheral tissues can be hindered to resemble the two ratio of androgen to the suppression of this enzyme, the level of testosterone in blood circulation can be made to raise about 10 ~ 15%, but still in physiological range.Finasteride can make dihydrotestosterone concentration in serum decline rapidly, makes it remarkable minimizing in administration in 24 hours.
Containing II type 5α-reductase in hair follicle, in the alopecia district scalp of male baldness patient, hair follicle tails off, and dihydrotestosterone increases.Give the dihydrotestosterone lowering of concentration that finasteride can make in these patient's scalps and serum.The man of congenital deficiency II type 5α-reductase can not suffer from male baldness.The result of these data and clinical research confirms that finasteride can suppress scalp hair follicles to diminish, reverse hair loss process.
Drug coating is generally applied to solid forms preparation, can be divided into powder coating, coating of pellets, granule coating, tablet coating, capsule coating etc. according to coating material difference.Sugar coating, half film coating, film-coat, enteric coated and special material coating etc. is divided into according to coating material difference.Due to packaging technique difference be divided into spray coating, dip coating, dry-pressing coating, coating electrostatic, lamination coating, be wherein most widely used with spray coating.Water solublity coating, gastric solubility coating, slow-releasing coating, enteric coatings etc. are divided into by coating object difference.Chinese patent CN200310105470.6 discloses a kind of finasteride drop pill and preparation method thereof, Chinese patent CN200510062238.8 discloses a kind of Finasteroid oral agent and preparation method thereof, and Chinese patent CN200910238188.2 discloses a kind of oral cavity disintegration tablet containing finasteride and preparation method thereof.But all can not solve and rely on that other packages reach protection against the tide, lucifuge, isolated air to increase the problem of medicine stability, and can not cover the bitterness of medicine well, greatly, mouthfeel is not good in stimulation; And cannot the problem at effective Drug controlled release position.
Summary of the invention
The object of the invention is to solve above-mentioned deficiency, a kind of preparation method of finasteride coated tablet is provided.
The technical scheme realizing the object of the invention is: a kind of preparation method of finasteride coated tablet, is characterized in that: comprise (1) pre-treatment; (2) granulate; (3) dry; (4) granulate always mixes; (5) tabletting; (6) coating; (7) pack.
The preparation method of above-mentioned finasteride coated tablet, described (1) pre-treatment, be specially: before feeding intake, check supplementary material appearance character, should without phenomenons such as caking, foreign bodies, if there is above situation to occur, pregelatinized Starch, microcrystalline Cellulose 100 order stainless steel meshs are sieved, finasteride, lactose, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate 40 order stainless steel meshs sieve.
The preparation method of above-mentioned finasteride coated tablet, described (2) granulate, be specially: take recipe quantity finasteride and pregelatinized Starch, microcrystalline Cellulose, lactose, PVP, sodium lauryl sulphate, 1/2 carboxymethylstach sodium, micropowder silica gel be mixed evenly, with mixer mixing 10min, add appropriate purified water, stir discharging in 3-4 minute, granulate with 20 mesh sieves.
The preparation method of above-mentioned finasteride coated tablet, described (3) are dry, are specially: wet granular heated-air circulation oven is dry, and temperature controls at 65-75 DEG C, and dry 3 ± 0.5 hours, pellet moisture controlled at 2.0-5.0%.
The preparation method of above-mentioned finasteride coated tablet, described (4) granulate always mixes, and is specially: by granule on oscillating granulator with 18 mesh sieve granulate, add magnesium stearate, 1/2 carboxymethylstach sodium V-shaped mixer always mixed 30 minutes.
The preparation method of above-mentioned finasteride coated tablet, described (5) tabletting, is specially: calculate according to granule content and answer tabletting weight, use tabletting machine.
The preparation method of above-mentioned finasteride coated tablet, described (6) coating, is specially: plain sheet after the assay was approved, uses high-efficiency coating pan coating.
Beneficial effect of the present invention: finasteride coated tablet prepared by the present invention, medicine self can realize protection against the tide, lucifuge, isolated air effect, and to increase the problem of medicine stability, this external enwergy covers the bitterness of medicine well, and reduce and stimulate, mouthfeel is good; And can the problem at effective Drug controlled release position.
Detailed description of the invention
(embodiment 1) takes each main ingredient according to following proportioning, total amount 200 grams:
(1) plain sheet is:
(2) coating is:
Gastric solubleness Opadry 2.9%;
75% ethanol 97.1%.
Supplementary material appearance character is checked before feeding intake, without phenomenons such as caking, foreign bodies, if there is above situation to occur, pregelatinized Starch, microcrystalline Cellulose should be sieved with 100 order stainless steel meshs, finasteride, lactose, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate 40 order stainless steel meshs sieve.Then take recipe quantity finasteride and pregelatinized Starch, microcrystalline Cellulose, lactose, PVP, sodium lauryl sulphate, 1/2 carboxymethylstach sodium, micropowder silica gel be mixed evenly, with mixer mixing 10min, add appropriate purified water, stir discharging in 3-4 minute, granulate with 20 mesh sieves.Wet granular is dry with heated-air circulation oven, and temperature controls at 65 DEG C, and dry 3 ± 0.5 hours, pellet moisture controlled 3.0%.By granule on oscillating granulator with 18 mesh sieve granulate, add magnesium stearate, 1/2 carboxymethylstach sodium V-shaped mixer always mixed 30 minutes.Calculate according to granule content and answer tabletting weight, use tabletting machine.Element sheet after the assay was approved, uses high-efficiency coating pan coating.Finally pack warehouse-in.
(embodiment 2) takes each main ingredient according to following proportioning, total amount 200 grams:
(1) plain sheet is:
(2) coating is:
Gastric solubleness Opadry 5.3%;
75% ethanol 94.7%.
Supplementary material appearance character is checked before feeding intake, without phenomenons such as caking, foreign bodies, if there is above situation to occur, pregelatinized Starch, microcrystalline Cellulose should be sieved with 100 order stainless steel meshs, finasteride, lactose, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate 40 order stainless steel meshs sieve.Then take recipe quantity finasteride and pregelatinized Starch, microcrystalline Cellulose, lactose, PVP, sodium lauryl sulphate, 1/2 carboxymethylstach sodium, micropowder silica gel be mixed evenly, with mixer mixing 10min, add appropriate purified water, stir discharging in 3-4 minute, granulate with 20 mesh sieves.Wet granular is dry with heated-air circulation oven, and temperature controls at 70 DEG C, and dry 3 ± 0.5 hours, pellet moisture controlled 2.0%.By granule on oscillating granulator with 18 mesh sieve granulate, add magnesium stearate, 1/2 carboxymethylstach sodium V-shaped mixer always mixed 30 minutes.Calculate according to granule content and answer tabletting weight, use tabletting machine.Element sheet after the assay was approved, uses high-efficiency coating pan coating.Finally pack warehouse-in.
(embodiment 3) takes each main ingredient according to following proportioning, total amount 200 grams:
(2) coating is:
Gastric solubleness Opadry 5.9%;
75% ethanol 94.1%.
Supplementary material appearance character is checked before feeding intake, without phenomenons such as caking, foreign bodies, if there is above situation to occur, pregelatinized Starch, microcrystalline Cellulose should be sieved with 100 order stainless steel meshs, finasteride, lactose, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate 40 order stainless steel meshs sieve.Then take recipe quantity finasteride and pregelatinized Starch, microcrystalline Cellulose, lactose, PVP, sodium lauryl sulphate, 1/2 carboxymethylstach sodium, micropowder silica gel be mixed evenly, with mixer mixing 10min, add appropriate purified water, stir discharging in 3-4 minute, granulate with 20 mesh sieves.Wet granular is dry with heated-air circulation oven, and temperature controls at 75 DEG C, and dry 3 ± 0.5 hours, pellet moisture controlled 4.0%.By granule on oscillating granulator with 18 mesh sieve granulate, add magnesium stearate, 1/2 carboxymethylstach sodium V-shaped mixer always mixed 30 minutes.Calculate according to granule content and answer tabletting weight, use tabletting machine.Element sheet after the assay was approved, uses high-efficiency coating pan coating.Finally pack warehouse-in.
(embodiment 4) takes each main ingredient according to following proportioning, total amount 200 grams:
Supplementary material appearance character is checked before feeding intake, without phenomenons such as caking, foreign bodies, if there is above situation to occur, pregelatinized Starch, microcrystalline Cellulose should be sieved with 100 order stainless steel meshs, finasteride, lactose, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate 40 order stainless steel meshs sieve.Then take recipe quantity finasteride and pregelatinized Starch, microcrystalline Cellulose, lactose, PVP, sodium lauryl sulphate, 1/2 carboxymethylstach sodium, micropowder silica gel be mixed evenly, with mixer mixing 10min, add appropriate purified water, stir discharging in 3-4 minute, granulate with 20 mesh sieves.Wet granular is dry with heated-air circulation oven, and temperature controls at 75 DEG C, and dry 3 hours, pellet moisture controlled 5.0%.By granule on oscillating granulator with 18 mesh sieve granulate, add magnesium stearate, 1/2 carboxymethylstach sodium V-shaped mixer always mixed 30 minutes.Calculate according to granule content and answer tabletting weight, use tabletting machine.Element sheet after the assay was approved, uses high-efficiency coating pan coating.Finally pack warehouse-in.
Above-described specific embodiment; object of the present invention, technical scheme and beneficial effect are further described; be understood that; the foregoing is only specific embodiments of the invention; be not limited to the present invention; within the spirit and principles in the present invention all, any amendment made, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (7)
1. a preparation method for finasteride coated tablet, is characterized in that: comprise (1) pre-treatment; (2) granulate; (3) dry; (4) granulate always mixes; (5) tabletting; (6) coating; (7) pack.
2. the preparation method of finasteride coated tablet according to claim 1, it is characterized in that: described (1) pre-treatment, be specially: before feeding intake, check supplementary material appearance character, should without phenomenons such as caking, foreign bodies, if there is above situation to occur, pregelatinized Starch, microcrystalline Cellulose 100 order stainless steel meshs are sieved, finasteride, lactose, micropowder silica gel, carboxymethyl starch sodium, magnesium stearate, adopts 40 order stainless steel meshs to sieve.
3. the preparation method of finasteride coated tablet according to claim 1, it is characterized in that: described (2) granulate, be specially: take recipe quantity finasteride and pregelatinized Starch, microcrystalline Cellulose, lactose, PVP, sodium lauryl sulphate, 1/2 carboxymethylstach sodium, micropowder silica gel be mixed evenly, with mixer mixing 10min, add appropriate purified water, stir discharging in 3-4 minute, granulate with 20 mesh sieves.
4. the preparation method of finasteride coated tablet according to claim 1, it is characterized in that: described (3) are dry, are specially: wet granular heated-air circulation oven is dry, and temperature controls at 65-75 DEG C, dry 3 ± 0.5 hours, pellet moisture controlled at 2.0-5.0%.
5. the preparation method of finasteride coated tablet according to claim 1; it is characterized in that: described (4) granulate always mixes; be specially: by granule on oscillating granulator with 18 mesh sieve granulate, add magnesium stearate, 1/2 carboxymethylstach sodium V-shaped mixer always mixed 30 minutes.
6. the preparation method of finasteride coated tablet according to claim 1, is characterized in that: described (5) tabletting, is specially: calculate according to granule content and answer tabletting weight, use tabletting machine.
7. the preparation method of finasteride coated tablet according to claim 1, is characterized in that: described (6) coating, is specially: plain sheet after the assay was approved, uses high-efficiency coating pan coating.
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| CN201410021508.XA CN104784139A (en) | 2014-01-17 | 2014-01-17 | Preparation method of finasteride coating tablet |
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| CN201410021508.XA CN104784139A (en) | 2014-01-17 | 2014-01-17 | Preparation method of finasteride coating tablet |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109893512A (en) * | 2017-12-08 | 2019-06-18 | 湖北舒邦药业有限公司 | A kind of preparation method of finasteride tablet and prepared finasteride tablet |
| CN110507661A (en) * | 2019-06-14 | 2019-11-29 | 唐安平 | A kind for the treatment of of allopecia composition |
| CN110623935A (en) * | 2019-10-24 | 2019-12-31 | 仁和堂药业有限公司 | Preparation process of finasteride tablets |
| CN110638773A (en) * | 2019-10-29 | 2020-01-03 | 仁和堂药业有限公司 | Production method of captopril tablets |
| CN115671062A (en) * | 2021-07-30 | 2023-02-03 | 湖北舒邦药业有限公司 | Finasteride tablet with raw material granularity controlled and production process thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101590047A (en) * | 2008-05-29 | 2009-12-02 | 北京奥萨医药研究中心有限公司 | The pharmaceutical composition that contains amlodipine and epristeride |
| CN101892133A (en) * | 2010-07-22 | 2010-11-24 | 兰州泰坦电子科技有限责任公司 | Effervescent tablet for removing pesticide residue on fruits and vegetables and preparation method and use method thereof |
| CN104784047A (en) * | 2014-01-16 | 2015-07-22 | 南京瑞尔医药有限公司 | Finasteride composition |
-
2014
- 2014-01-17 CN CN201410021508.XA patent/CN104784139A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101590047A (en) * | 2008-05-29 | 2009-12-02 | 北京奥萨医药研究中心有限公司 | The pharmaceutical composition that contains amlodipine and epristeride |
| CN101892133A (en) * | 2010-07-22 | 2010-11-24 | 兰州泰坦电子科技有限责任公司 | Effervescent tablet for removing pesticide residue on fruits and vegetables and preparation method and use method thereof |
| CN104784047A (en) * | 2014-01-16 | 2015-07-22 | 南京瑞尔医药有限公司 | Finasteride composition |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109893512A (en) * | 2017-12-08 | 2019-06-18 | 湖北舒邦药业有限公司 | A kind of preparation method of finasteride tablet and prepared finasteride tablet |
| CN110507661A (en) * | 2019-06-14 | 2019-11-29 | 唐安平 | A kind for the treatment of of allopecia composition |
| CN110623935A (en) * | 2019-10-24 | 2019-12-31 | 仁和堂药业有限公司 | Preparation process of finasteride tablets |
| CN110638773A (en) * | 2019-10-29 | 2020-01-03 | 仁和堂药业有限公司 | Production method of captopril tablets |
| CN115671062A (en) * | 2021-07-30 | 2023-02-03 | 湖北舒邦药业有限公司 | Finasteride tablet with raw material granularity controlled and production process thereof |
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Application publication date: 20150722 |