CN102949372A - Nicergoline pill and preparation method thereof - Google Patents
Nicergoline pill and preparation method thereof Download PDFInfo
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- CN102949372A CN102949372A CN2011102484142A CN201110248414A CN102949372A CN 102949372 A CN102949372 A CN 102949372A CN 2011102484142 A CN2011102484142 A CN 2011102484142A CN 201110248414 A CN201110248414 A CN 201110248414A CN 102949372 A CN102949372 A CN 102949372A
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- nicergoline
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Abstract
The invention discloses a nicergoline pill and a preparation method thereof. Preparation comprises nicergoline, diluent, disintegrant, adhesive, lubricant and film coating premixing agent. The preparation method includes uniformly mixing the diluent with the internally added disintegrant; preparing blank particles in proper quantity by the adhesive, drying, pelleting and reserving; independently pelleting main drug by the proper adhesive, quickly drying, pelleting and reserving at lower temperature; uniformly mixing the main drug particles with the blank particles, adding externally added auxiliaries, mixing totally, pressing, coating a thin film and packaging. Accordingly, flowability of the particles is guaranteed, the drug can be dissolved beneficially, and more importantly, the problems that content of the main drug and the auxiliaries is lowered and relevant substances are increased due to the high drying temperature and long time in pelleting are avoided. Compared with the prior art, the nicergoline pill has the advantages of reasonable components, simplicity in process, unique preparation method, high dissolving degree, good stability of the preparation, low cost and the like.
Description
Technical field
The present invention relates to a kind of have alpha-receptor retardation and vasodilative effect, be used for improving low and the affective disorder of being intended to that cerebral infarction sequela causes, and be used for the treatment of tablet of vascular dementia and preparation method thereof, belong to technical field of medicine.
Background technology
China has begun progressively to step into senescence country, according to estimates, from 2003 to 2010, is China's aged tendency of population accelerated period, and the population more than 60 years old of China will rise to 1.73 hundred million, and the proportion of aging population rises to 12.54%.The demand of the curing senile dementia medicine that meanwhile, aged tendency of population is brought is also in always steady-state growth.Nicergoline (Nicergoline) has α receptor retardation and vasorelaxation action, can strengthen the metabolism of brain cell energy, increases the utilization of oxygen and glucose; Promote the conversion of neurotransmitter dopamine and strengthen nerve conduction; Simultaneously can also strengthen brain protein biosynthesis, improve brain function etc.Nicergoline passes through the extensive application of many decades clinically, has the characteristics such as evident in efficacy, widely applicable, few side effects for diseases such as cerebrovascular disease and brain insufficiencys.
Because nicergoline is unstable in preparation granulation drying course to damp and hot responsive, easily cause content, related substance to raise, thereby affect product quality and curative effect.Adopt direct compression technique, all higher to the requirement of flowability, compressibility and the sheeting equipment of adjuvant, obviously increased production cost.
Summary of the invention
Purpose of the present invention is intended to overcome defects; a kind of nicergoline tablets and preparation method thereof is provided; we adopt respectively granulation of principal agent and adjuvant; be that nicergoline is granulated separately with suitable binding agent; at a lower temperature flash baking; mix with the blank granule that adjuvant is made, so both guaranteed the flowability of granule, bake out temperature is high, overlong time and cause the degraded of principal agent simultaneously to have avoided again principal agent and adjuvant to granulate together.Through checking made tablet appearance, uniformity of dosage units, dissolution, related substance etc. all to meet the regulation of its quality standard, accelerated test and long-time stability are investigated the result and are shown, preparation stability is good.
Technical scheme of the present invention is as follows:
Nicergoline tablets comprises principal agent and adjuvant, it is characterized in that every contains following component and parts by weight: nicergoline 10～30%, and diluent 20～70%, disintegrating agent 2～10%, the hypromellose solution of binding agent 1～2% is an amount of, 5～10%PVPk
3080% alcoholic solution is an amount of, lubricant 0.3～4.0%, and film coating pre-mix dose 2～5%, the solvent of coating materials are 50～95% ethanol, solid content 8～12%.Described diluent comprises one or more in starch, pregelatinized Starch, lactose, the microcrystalline Cellulose, described disintegrating agent comprises one or more in hyprolose, microcrystalline Cellulose, the carboxymethyl starch sodium, contains hypromellose 8～12%, opacifier 1～3%, anti-blushing agent 0.5～3% in the described film coating pre-mix dose.
The preparation method of nicergoline tablets of the present invention may further comprise the steps:
1. supplementary material is pulverized, and all crosses 80～120 mesh sieves, and is for subsequent use.
With diluent, in the disintegrating agent mix homogeneously, with 5～10%PVPk
3080% alcoholic solution is made blank granule in right amount, in oven dry more than 60 ℃, and 20 mesh sieve granulate, for subsequent use.
With nicergoline with 1～2% an amount of moistening of hypromellose solution, 50 mesh sieves are granulated, and are in oven dry below 40 ℃, with 24 mesh sieve granulate, for subsequent use.
4. granules of main drug and blank granule are diluted the method mix homogeneously that progressively increases with equivalent, it is always mixed that adding adds disintegrating agent, lubricant.
5. the detection granule content calculates sheet heavy, tabletting, and film coating (weightening finish 2～5%) is packed and be get final product.
The invention has the advantages that:
1. principal agent and adjuvant are granulated respectively, principal agent is with having the multifrequency natures such as film former, binding agent, disintegrating agent, and the solution-treated with inert excipients hypromellose 1～2% of surface-active action, both increased the flowability of principal agent, be conducive to again the stripping of medicine, the more important thing is avoided principal agent and adjuvant to granulate together bake out temperature is high, overlong time and the content that causes, related substance raise.
2. the present invention has reasonable recipe, and technique is simple, and method for making is unique, and dissolution is high, better stability of preparation, and the characteristics such as cost is low have guaranteed the product quality in effect duration effectively.
The specific embodiment:
Embodiment 1
Nicergoline tablets, 1000 prescription and preparation method are as follows:
Prescription:
Nicergoline 10g
Starch 42g
Microcrystalline Cellulose 38g
Hyprolose 5g
10%PVPk
3080% alcoholic solution is an amount of
2% hypromellose solution is an amount of
Carboxymethylstach sodium 4g
Magnesium stearate 0.5%
Make 1000
Preparation method:
1. supplementary material is pulverized, and crosses respectively 80～100 mesh sieves, and is for subsequent use.
2. accurately take by weighing starch, microcrystalline Cellulose, hyprolose mix homogeneously by recipe quantity, use 10%PVPk
3080% alcoholic solution is granulated as binding agent, in oven dry more than 60 ℃, and 20 mesh sieve granulate, for subsequent use.
3. accurately take by weighing nicergoline by recipe quantity, an amount of moistening of hypromellose solution with 2%, 50 mesh sieves are granulated, and are in oven dry below 40 ℃, with 24 mesh sieve granulate, for subsequent use.
4. granules of main drug and blank granule are diluted the method mix homogeneously that progressively increases with equivalent, the carboxymethylstach sodium, the magnesium stearate that add recipe quantity are always mixed.
5. the detection granule content calculates sheet heavy, tabletting, and film coating (weightening finish 2～5%) is packed and be get final product.
Embodiment 2
Nicergoline tablets, 1000 prescription and preparation method are as follows:
Prescription:
Nicergoline 10g
Starch 30g
Lactose 50g
Hyprolose 5g
10%PVPk
3080% alcoholic solution is an amount of
2% hypromellose solution is an amount of
Carboxymethylstach sodium 4g
Magnesium stearate 0.5%
Make 1000
Preparation method:
1. supplementary material is pulverized, and crosses respectively 80～100 mesh sieves, and is for subsequent use.
2. accurately take by weighing starch, lactose, hyprolose mix homogeneously by recipe quantity, use 10%PVPk
3080% alcoholic solution is granulated as binding agent, in oven dry more than 60 ℃, and 20 mesh sieve granulate, for subsequent use.
3. accurately take by weighing nicergoline by recipe quantity, an amount of moistening of hypromellose solution with 2%, 50 mesh sieves are granulated, and are in oven dry below 40 ℃, with 24 mesh sieve granulate, for subsequent use.
4. granules of main drug and blank granule are diluted the method mix homogeneously that progressively increases with equivalent, the carboxymethylstach sodium, the magnesium stearate that add recipe quantity are always mixed.
5. the detection granule content calculates sheet heavy, tabletting, and film coating (weightening finish 2～5%) is packed and be get final product.
Embodiment 3
Nicergoline tablets, 1000 prescription and preparation method are as follows:
Prescription:
Nicergoline 30g
Starch 40g
Microcrystalline Cellulose 70g
Hyprolose 7.5g
10%PVPk
3080% alcoholic solution is an amount of
2% hypromellose solution is an amount of
Carboxymethylstach sodium 5g
Magnesium stearate 0.5%
Make 1000
Preparation method:
1. supplementary material is pulverized, and crosses respectively 80～100 mesh sieves, and is for subsequent use.
2. accurately take by weighing starch, microcrystalline Cellulose, hyprolose mix homogeneously by recipe quantity, use 10%PVPk
3080% alcoholic solution is granulated as binding agent, in oven dry more than 60 ℃, and 20 mesh sieve granulate, for subsequent use.
3. accurately take by weighing nicergoline by recipe quantity, an amount of moistening of hypromellose solution with 2%, 50 mesh sieves are granulated, and are in oven dry below 40 ℃, with 24 mesh sieve granulate, for subsequent use.
4. granules of main drug and blank granule are diluted the method mix homogeneously that progressively increases with equivalent, the carboxymethylstach sodium, the magnesium stearate that add recipe quantity are always mixed.
5. the detection granule content calculates sheet heavy, tabletting, and film coating (weightening finish 2～5%) is packed and be get final product.
Claims (6)
1. a nicergoline tablets comprises principal agent and adjuvant, it is characterized in that every contains following component and parts by weight: nicergoline 10～30%, and diluent 20～70%, disintegrating agent 2～10%, the hypromellose solution of binding agent 1～2% is an amount of, 5～10%PVPk
3080% alcoholic solution is an amount of, lubricant 0.3～4.0%, film coating pre-mix dose 2～5%, the solvent of coating materials are 50～95% ethanol, solid content 8～12% contains hydroxypropyl emthylcellulose 8～12%, opacifier 1～3%, anti-blushing agent 0.5～3% in the described film coating pre-mix dose.
2. the preparation method of nicergoline tablets according to claim 1 is characterized in that, comprises the steps:
1) supplementary material is pulverized, and all crosses 80～120 mesh sieves, and is for subsequent use;
2) with diluent, in the disintegrating agent mix homogeneously, with 5～10%PVPk
3080% alcoholic solution is made blank granule in right amount, in oven dry more than 60 ℃, and 20 mesh sieve granulate, for subsequent use;
3) with nicergoline with an amount of moistening of 1～2% Gonak, 30 mesh sieves are granulated, and are in oven dry below 40 ℃, with 24 mesh sieve granulate, for subsequent use;
4) granules of main drug and blank granule are diluted the method mix homogeneously that progressively increases with equivalent, it is always mixed that adding adds disintegrating agent, lubricant;
5) detect granule content, calculate sheet heavy, tabletting, film coating (weightening finish 2～5%) is packed and be get final product.
3. nicergoline tablets according to claim 1 and 2 is characterized in that, described diluent comprises one or more in starch, pregelatinized Starch, lactose, the microcrystalline Cellulose.
4. nicergoline tablets according to claim 1 and 2 is characterized in that, described disintegrating agent comprises one or more in hypromellose, microcrystalline Cellulose, the carboxymethyl starch sodium.
5. nicergoline tablets according to claim 1 and 2 is characterized in that, described lubricant comprises one or more in Pulvis Talci, the magnesium stearate.
6. nicergoline tablets according to claim 1 and 2, it is characterized in that, principal agent and adjuvant are granulated respectively, principal agent is with having the multifrequency natures such as film former, binding agent, disintegrating agent, and the solution-treated with inert excipients hypromellose 1～2% of surface-active action is granulated, in oven dry below 40 ℃, granulate, for subsequent use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102484142A CN102949372A (en) | 2011-08-26 | 2011-08-26 | Nicergoline pill and preparation method thereof |
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| CN2011102484142A CN102949372A (en) | 2011-08-26 | 2011-08-26 | Nicergoline pill and preparation method thereof |
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| CN102949372A true CN102949372A (en) | 2013-03-06 |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103550165A (en) * | 2013-10-19 | 2014-02-05 | 浙江华海药业股份有限公司 | Medicinal composition containing rivaroxaban and preparation method thereof |
| CN104586806A (en) * | 2014-12-26 | 2015-05-06 | 东北制药集团沈阳第一制药有限公司 | Levetiracetam sustained release tablet as well as preparation method thereof |
| CN105055361A (en) * | 2015-08-19 | 2015-11-18 | 河北智同医药控股集团有限公司 | Methyl ergometrine maleate tablets and preparation method thereof |
| WO2017006290A1 (en) * | 2015-07-08 | 2017-01-12 | Kunshan Rotam Reddy Pharmaceutical Co., Ltd | Modified release nicergoline compositions |
| CN107823167A (en) * | 2017-12-15 | 2018-03-23 | 湖南千金协力药业有限公司 | A kind of silybin meglumine tablets and preparation method thereof |
| CN108992414A (en) * | 2018-06-15 | 2018-12-14 | 昆药集团股份有限公司 | The preparation method and purposes of a kind of Colon and rectum positioning release medicine pharmaceutical composition and its preparation |
| CN110051639A (en) * | 2019-03-15 | 2019-07-26 | 河北嘉迈医药科技有限公司 | A kind of fater disintegration type nicergoline tablets and preparation method thereof |
| CN111904938A (en) * | 2020-05-15 | 2020-11-10 | 山东方明药业集团股份有限公司 | Preparation method of nicergoline tablets |
| CN113081993A (en) * | 2021-04-15 | 2021-07-09 | 海南通用三洋药业有限公司 | Preparation method of nicergoline tablets |
| CN115068435A (en) * | 2022-08-03 | 2022-09-20 | 昆山龙灯瑞迪制药有限公司 | Preparation method of nicergoline tablets |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101584673A (en) * | 2009-07-13 | 2009-11-25 | 浙江京新药业股份有限公司 | Levetiracetam tablet and preparation method |
-
2011
- 2011-08-26 CN CN2011102484142A patent/CN102949372A/en active Pending
Patent Citations (1)
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| CN101584673A (en) * | 2009-07-13 | 2009-11-25 | 浙江京新药业股份有限公司 | Levetiracetam tablet and preparation method |
Non-Patent Citations (2)
| Title |
|---|
| 何仲贵: "《药物制剂注解》", 31 October 2009, 人民卫生出版社, article "药物制剂注解", pages: 168-170 * |
| 王效山等: "《制药工艺学》", 31 July 2003, 北京科学技术出版社, article "制药工艺学", pages: 279 * |
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103550165B (en) * | 2013-10-19 | 2019-07-16 | 浙江华海药业股份有限公司 | A kind of pharmaceutical composition and preparation method thereof containing razaxaban |
| CN103550165A (en) * | 2013-10-19 | 2014-02-05 | 浙江华海药业股份有限公司 | Medicinal composition containing rivaroxaban and preparation method thereof |
| CN104586806A (en) * | 2014-12-26 | 2015-05-06 | 东北制药集团沈阳第一制药有限公司 | Levetiracetam sustained release tablet as well as preparation method thereof |
| CN104586806B (en) * | 2014-12-26 | 2018-03-13 | 东北制药集团沈阳第一制药有限公司 | A kind of levetiracetam sustained-release tablets and preparation method thereof |
| WO2017006290A1 (en) * | 2015-07-08 | 2017-01-12 | Kunshan Rotam Reddy Pharmaceutical Co., Ltd | Modified release nicergoline compositions |
| CN106333927A (en) * | 2015-07-08 | 2017-01-18 | 昆山龙灯瑞迪制药有限公司 | Modified-release nicergoline composition |
| CN105055361A (en) * | 2015-08-19 | 2015-11-18 | 河北智同医药控股集团有限公司 | Methyl ergometrine maleate tablets and preparation method thereof |
| CN105055361B (en) * | 2015-08-19 | 2018-02-23 | 河北智同医药控股集团有限公司 | A kind of methylergonovine maleate tablet and preparation method thereof |
| CN107823167A (en) * | 2017-12-15 | 2018-03-23 | 湖南千金协力药业有限公司 | A kind of silybin meglumine tablets and preparation method thereof |
| CN108992414A (en) * | 2018-06-15 | 2018-12-14 | 昆药集团股份有限公司 | The preparation method and purposes of a kind of Colon and rectum positioning release medicine pharmaceutical composition and its preparation |
| CN108992414B (en) * | 2018-06-15 | 2021-07-06 | 昆药集团股份有限公司 | Colorectal targeted drug release pharmaceutical composition, and preparation method and application of preparation thereof |
| CN110051639A (en) * | 2019-03-15 | 2019-07-26 | 河北嘉迈医药科技有限公司 | A kind of fater disintegration type nicergoline tablets and preparation method thereof |
| CN110051639B (en) * | 2019-03-15 | 2021-08-31 | 河北嘉迈医药科技有限公司 | Rapidly disintegrating nicergoline tablet and preparation method thereof |
| CN111904938A (en) * | 2020-05-15 | 2020-11-10 | 山东方明药业集团股份有限公司 | Preparation method of nicergoline tablets |
| CN113081993A (en) * | 2021-04-15 | 2021-07-09 | 海南通用三洋药业有限公司 | Preparation method of nicergoline tablets |
| CN115068435A (en) * | 2022-08-03 | 2022-09-20 | 昆山龙灯瑞迪制药有限公司 | Preparation method of nicergoline tablets |
| CN115068435B (en) * | 2022-08-03 | 2023-04-25 | 昆山龙灯瑞迪制药有限公司 | Preparation method of nicergoline tablet |
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Application publication date: 20130306 |