CN108057021B - A kind of Montelukast sodium granules and preparation method thereof - Google Patents
A kind of Montelukast sodium granules and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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Abstract
The invention discloses a kind of Montelukast sodium granules and preparation method thereof, are related to montestron sodium formulation art.Montelukast sodium granules provided by the invention are made by raw material by dry granulation or fluidized bed granulation；The raw material is by weight percentage, it contains following component: Montelukast receives 0.5%-1.5%, mannitol 35%-65%, Lactis Anhydrous 15%-45%, microcrystalline cellulose 10-30%, adhesive 0%-20%, corrigent 0.5%-3.5% and lubricant 0.5%-5% for being used when using fluidized bed granulation；The features such as Montelukast sodium granules not only have absorption fast, and melting is good, effective rapid, convenient to take comfortable, in good taste, and it is also with good stability.
Description
Technical field
The present invention relates to montestron sodium formulation arts, in particular to a kind of Montelukast sodium granules and its system
Preparation Method.
Background technique
Asthma is a kind of chronic inflammation disease with the characteristics of tracheae high response and Reversible airway obstruction.Leukotriene
One of the important medium of bronchial asthma, it for asthma generation, development play key effect, some researches show that no matter
The reaction caused by it exactly likes the pathological change of asthma in vivo or in vitro, and in asthma patient no matter action period or stationary phase
Its level is above normal person.Leukotriene receptor antagonists becomes the new way for the treatment of asthma.
Montelukast is a kind of high specific Leukotrienes sputum receptor antagonist, it block Leukotrienes sputum with
Interaction between receptor, so that tracheae be blocked to achieve the purpose that Control of asthma to the reaction of leukotriene.Biochemistry and pharmacology
Bioassay shows that montelukast has the compatibility and selectivity of height to CysLTI receptor.Montelukast can be effectively
The physiological effect of LTC4, LTD4 and the LTE4 produced LTC4 in conjunction with CysLTI receptor, LTD4 and LTE4 is inhibited to act on and nothing times
What receptor agonist activity.Montelukast receive be montelukast sodium salt, due to its unique chemical structure, its oral bio benefit
Expenditure, clinical efficacy and safety are superior to previous similar drugs.
It is by Merck & Co., Inc.'s development and production that Montelukast, which is received, is current asthma medications best-selling in the world.1998
It has been listed successively in multiple countries and regions since year, existing dosage form has Film coated tablets, granule, chewable tablets.In technique
Wet granulation is mostly used, drying time is long, the bad control of drying temperature, easily migrates soluble component in drying process, causes
Content decline, related substance increase, and tablet stability obtained is poor, light-exposed easy to change, decomposition.
Summary of the invention
The purpose of the present invention is to provide a kind of Montelukast sodium granules, with preferable stability.
Another object of the present invention is to provide a kind of preparation method of Montelukast sodium granules, which is used
Dry granulation, prepared Montelukast sodium granules, stability with higher.
Another object of the present invention is to provide the preparation method of another Montelukast sodium granules, which is adopted
With using fluidized bed granulation, prepared Montelukast sodium granules, stability with higher.
The present invention is implemented as follows:
A kind of Montelukast sodium granules are made by raw material by dry granulation or fluidized bed granulation；
The raw material by weight percentage, contains following component:
Montelukast receives 0.5%-1.5%,
Mannitol 35%-65%,
Lactis Anhydrous 15%-45%,
Microcrystalline cellulose 10-30%,
Adhesive 0%-20% for being used when using fluidized bed granulation,
Corrigent 0.5%-3.5%,
Lubricant 0.5%-5%.
Montelukast Sodium is asthma urgent need medicine, and specification is smaller, and bulk pharmaceutical chemicals mobility is poor, is unable to reach filling requirement, because
Its mobility need to be improved when this granulation and reach the filling requirement of granule.It is logical
The present invention optimizes the formula of Montelukast sodium granules, rationally reduces the usage amount of mannitol, improves montelukast
The mobility of sodium raw materials, and corrigent is added and promotes mouthfeel, keep its convenient to take；And use dry granulation or fluidized bed granulation side
Montelukast sodium granules are made in raw material by method, so that finished product is with good stability.
Dry and moisture in production process can avoid using dry granulation, Montelukast is improved to the stability influence of this product
The stability of sodium granules.
Dehydrated alcohol is moisture free adhesive, for using when using fluidized bed granulation, aqueous medium is avoided to bond
The use of agent, temperature reduces the damp and hot influence to finished product setting when can reduce dry.
Further, in some embodiments of the present invention, adhesive is dehydrated alcohol.
It is used in fluidized bed granulation method using dehydrated alcohol as adhesive, temperature reduces damp and hot right when further decreasing dry
The influence of finished product setting.
Further, in some embodiments of the present invention, corrigent be selected from aspartame, honey element, vanilla,
One or more of cherry essence, lemon extract, flavoring banana essence.
Further, in some embodiments of the present invention, lubricant is selected from magnesium stearate, zinc stearate, stearic acid
One or more of calcium.
A kind of preparation method of Montelukast sodium granules as described above comprising: by after sieving montestron sodium,
Lactis Anhydrous, mannitol, microcrystalline cellulose and corrigent are uniformly mixed, and granulation makes grain fineness 8-80 mesh, and lubrication is added
Agent is uniformly mixed, dispenses to obtain the final product.
Further, in some embodiments of the present invention, montestron sodium and Lactis Anhydrous cross 90-100 mesh, sweet
Dew alcohol, microcrystalline cellulose and corrigent cross 70-90 mesh.
Further, in some embodiments of the present invention, pressure when granulation is 2-25MPa.
The preparation method uses dry granulation, avoids influence of the moisture to finished product, dry granulation is only by bulk pharmaceutical chemicals, auxiliary material
It is suppressed on dry granulating machine after mixing, avoids that wet binder is added, improve the stability of shaped article.
A kind of preparation method of Montelukast sodium granules as described above comprising: by after sieving montestron sodium,
Lactis Anhydrous, mannitol, microcrystalline cellulose and corrigent are uniformly mixed, and are sucked in fluidized bed, spraying using top-jet-type, are added
Adhesive, granulation, obtains particle, dry, and control moisture content is 2-10%, and lubricant is added, and is uniformly mixed, dispenses to obtain the final product.
The preparation method uses fluidized bed granulation, and fluidized bed granulation is by conventional mixing, wet granulation, dry three steps
One step completed method in a closed container is concentrated on, due to completing in closed container, reduces the pollution of outer bound pair drug.
Uniform using particle made from fluidized bed granulation, mobility, compressibility are good, can reach distribution using fluidized bed granulation
Effect more evenly.
Further, in some embodiments of the present invention, spray velocity 0.2-1.5ml/min when granulation, air blast
Rate is 0.2-5L/min and 10-30 DEG C of heating temperature.
Further, in some embodiments of the present invention, adhesive therefor is dehydrated alcohol.
Using dehydrated alcohol as adhesive, the addition of moisture can be avoided as far as possible, ethyl alcohol volatility is larger, in drying process
Temperature will not be too high, reduces influence of the temperature to product, is conducive to the stability for improving molding Montelukast sodium granules.
The invention has the following advantages:
Montelukast sodium granules provided by the invention are made by raw material by dry granulation or fluidized bed granulation；It should
Raw material by weight percentage, contains following component: Montelukast receives 0.5%-1.5%, mannitol 35%-65%, anhydrous
Lactose 15%-45%, microcrystalline cellulose 10-30%, the adhesive 0%-20% for being used when using fluidized bed granulation, are rectified
Taste agent 0.5%-3.5% and lubricant 0.5%-5%；The Montelukast sodium granules not only have absorption fast, and melting is good,
It is effective rapidly, it is convenient to take comfortable, it is in good taste the features such as, and it is also with good stability.
The preparation method of Montelukast sodium granules provided by the invention, the preparation method use dry granulation, prepared
The use that adhesive is avoided in journey avoids moisture from improving the stability of product to the influence of finished product.
In addition, another preparation method of Montelukast sodium granules provided by the invention, the preparation method is using fluidisation
Bed is pelletized, and adhesive is used in preparation process, avoids the influence for avoiding moisture to finished product using aqueous medium adhesive, improves Meng
The stability of Rust sodium granules.
Specific embodiment
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention
Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds
The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase
Product.
Feature and performance of the invention are described in further detail with reference to embodiments.
Embodiment 1
Montelukast sodium granules provided in this embodiment are made by raw material using dry granulation, by weight percentage
Meter, raw material includes following ingredient:
Montelukast receives 0.5%,
Mannitol 35%,
Lactis Anhydrous 43.5%,
Microcrystalline cellulose 20%,
Corrigent 0.5%,
Lubricant 0.5%.
Wherein, corrigent is honey element, and lubricant is magnesium stearate.
Preparation method: it receives by formula measurement Montelukast and is sieved with 100 mesh sieve respectively with Lactis Anhydrous, is uniformly mixed；Take sweet dew
After alcohol, microcrystalline cellulose and corrigent cross 80 meshes respectively, then receives with Montelukast and be uniformly mixed with the mixture of Lactis Anhydrous；
Total mixture is placed in dry granulating machine, parameter is set, pressure 20Mpa, motor speed 30rpm adjust material all in one piece sieve mesh number,
So that lubricant is added up to 20 mesh in grain fineness, intermediates content is measured；The particle of system is added in granular filling machine hopper,
Adjustment divides metering device, sets every Packing Unit as 0.5g, is dispensed, both.
The effect of Montelukast sodium granules provided in this embodiment is shown in Table 1.
Embodiment 2
Montelukast sodium granules provided in this embodiment are made by raw material using dry granulation, and material composition is the same as real
Apply example 1.
Preparation method: it receives by formula measurement Montelukast and is sieved with 100 mesh sieve respectively with Lactis Anhydrous, is uniformly mixed；Take sweet dew
After alcohol, microcrystalline cellulose and corrigent cross 80 meshes respectively, then receives with Montelukast and be uniformly mixed with the mixture of Lactis Anhydrous；
Total mixture is placed in dry granulating machine, parameter is set, pressure 2Mpa, motor speed 30rpm adjust material all in one piece sieve mesh number,
So that lubricant is added up to 10 mesh in grain fineness, intermediates content is measured；The particle of system is added in granular filling machine hopper,
Adjustment divides metering device, sets every Packing Unit as 0.5g, is dispensed, both.
The effect of Montelukast sodium granules provided in this embodiment is the same as embodiment 1.
Embodiment 3
Montelukast sodium granules provided in this embodiment are made by raw material using fluidized bed granulation, by weight percentage
Than meter, raw material includes following ingredient:
Montelukast receives 0.5%,
Mannitol 35%,
Lactis Anhydrous 43.5%,
Microcrystalline cellulose 20%,
Adhesive 2%
Corrigent 0.5%,
Lubricant 0.5%.
Wherein, corrigent is honey element, and lubricant is magnesium stearate.
Preparation method:
After the auxiliary materials such as raw material montestron sodium, Lactis Anhydrous, mannitol, microcrystalline cellulose, corrigent are sieved with 100 mesh sieve,
It is uniformly mixed；Total mixture material is sucked in fluidized bed, spraying using top-jet-type, using dehydrated alcohol as adhesive, setting is spraying
20 DEG C of heating temperature, so that pellet moisture 5%, lubricant is added, in measurement in speed 1.5ml/min, blast rate 3L/min
Mesosome content；The particle of system is added in granular filling machine hopper, adjustment divides metering device, sets every Packing Unit and carries out as 0.5g
Packing both obtained.
The effect of Montelukast sodium granules provided in this embodiment is shown in Table 1.
Embodiment 4
Montelukast sodium granules provided in this embodiment are made by raw material using fluidized bed granulation, by weight percentage
Than meter, raw material includes following ingredient:
Montelukast receives 0.5%,
Mannitol 35%,
Lactis Anhydrous 43.5%,
Microcrystalline cellulose 20%,
Adhesive 2%
Corrigent 0.5%,
Lubricant 0.5%.
Wherein, corrigent is honey element, and lubricant is magnesium stearate.
Preparation method:
After the auxiliary materials such as raw material montestron sodium, Lactis Anhydrous, mannitol, microcrystalline cellulose, corrigent are sieved with 100 mesh sieve,
It is uniformly mixed；Total mixture material is sucked in fluidized bed, spraying using top-jet-type, using dehydrated alcohol as adhesive, setting is spraying
Speed 0.2ml/min, blast rate 0.2L/min, so that pellet moisture 10%, is added lubricant, are surveyed by 15 DEG C of heating temperature
Determine intermediates content；The particle of system is added in granular filling machine hopper, adjustment divides metering device, sets every Packing Unit as 0.5g
It is dispensed and was both obtained.
The effect of Montelukast sodium granules provided in this embodiment is the same as embodiment 3.
Embodiment 5
Montelukast sodium granules provided in this embodiment are made by raw material using fluidized bed granulation, by weight percentage
Than meter, raw material includes following ingredient:
Montelukast receives 5%,
Mannitol 58.5%,
Lactis Anhydrous 15%,
Microcrystalline cellulose 20%,
Adhesive 0%,
Corrigent 0.5%,
Lubricant 1%.
Wherein, corrigent is honey element, and lubricant is magnesium stearate.
Preparation method: with embodiment 1.
The effect of Montelukast sodium granules provided in this embodiment is the same as embodiment 1.
Embodiment 6
Montelukast sodium granules provided in this embodiment are made by raw material using fluidized bed granulation, by weight percentage
Than meter, raw material includes following ingredient:
Montelukast receives 5%,
Mannitol 58.5%,
Lactis Anhydrous 15%,
Microcrystalline cellulose 20%,
Adhesive 0%,
Corrigent 0.5%,
Lubricant 1%.
Preparation method: with embodiment 2.
The effect of Montelukast sodium granules provided in this embodiment is the same as embodiment 1.
Embodiment 7
Montelukast sodium granules provided in this embodiment are made by raw material using fluidized bed granulation, by weight percentage
Than meter, raw material includes following ingredient:
Montelukast receives 5%,
Mannitol 58.5%,
Lactis Anhydrous 15%,
Microcrystalline cellulose 20%,
Adhesive 5%,
Corrigent 0.5%,
Lubricant 1%.
Preparation method: by the auxiliary materials mistake such as raw material montestron sodium, Lactis Anhydrous, mannitol, microcrystalline cellulose, corrigent
After 100 meshes, it is uniformly mixed；Total mixture material is sucked in fluidized bed, it is spraying using top-jet-type, it is bonding with dehydrated alcohol
Spray velocity 1ml/min, blast rate 2.5L/min is arranged in agent, and 25 DEG C of heating temperature, so that pellet moisture 5%, addition is moistened
Lubrication prescription measures intermediates content；The particle of system is added in granular filling machine hopper, adjustment divides metering device, sets every packaging
Amount is that 1.0g is dispensed, both.
The effect of Montelukast sodium granules provided in this embodiment is the same as embodiment 3.
Embodiment 8
Montelukast sodium granules provided in this embodiment are made by raw material using fluidized bed granulation, by weight percentage
Than meter, raw material includes following ingredient:
Montelukast receives 5%,
Mannitol 58.5%,
Lactis Anhydrous 15%,
Microcrystalline cellulose 20%,
Adhesive 5%,
Corrigent 0.5%,
Lubricant 1%.
Preparation method: by the auxiliary materials mistake such as raw material montestron sodium, Lactis Anhydrous, mannitol, microcrystalline cellulose, corrigent
After 100 meshes, it is uniformly mixed；Total mixture material is sucked in fluidized bed, it is spraying using top-jet-type, it is bonding with dehydrated alcohol
Agent is arranged spray velocity 1.5ml/min, blast rate 3L/min, 25 DEG C of heating temperature, so that pellet moisture 10%, is added
Lubricant measures intermediates content；The particle of system is added in granular filling machine hopper, adjustment divides metering device, sets every packet
Loading amount is that 1.0g is dispensed, both.
The effect of Montelukast sodium granules provided in this embodiment is the same as embodiment 3.
Experimental example
According to 2015 editions the 4th progress Dependent Stability investigations of Chinese Pharmacopoeia, comparing embodiment 1 and 3 and comparative example
The Montelukast Sodium particle of (conventional wet granulation) and bulk pharmaceutical chemicals is in high temperature (60 DEG C), high humidity (RH92.5%) and illumination
It is respectively placed under the conditions of (5000lxl) and investigates within 30 days related substance growth pattern, concrete outcome see the table below, and verify the embodiment of the present invention
The stability of montelukast sodium granules obtained.
From the above results, the Montelukast Sodium particle that the embodiment of the present invention 1 and 3 provides is in high temperature (60 DEG C), high humidity
(RH92.5%) after and respectively placing 30 days under the conditions of illumination (5000lx), Montelukast prepared by the present invention receives oral disintegrating tablet ratio by passing
The impurity of Montelukast Sodium particle made from system wet granulation is less, and impurity increasess slowly, and increment is also less, and stability is more
It is high；It can be seen that Montelukast Sodium particle can be improved in the preparation method of Montelukast Sodium particle provided in an embodiment of the present invention
The stability of finished product.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (8)
1. a kind of Montelukast sodium granules, which is characterized in that it is made by raw material by dry granulation or fluidized bed granulation；
The raw material by weight percentage, contains following component:
Montelukast receives 0.5%,
Mannitol 35%,
Lactis Anhydrous 43.5%,
Microcrystalline cellulose 20%,
Adhesive 2% for being used when using fluidized bed granulation,
Corrigent 0.5%,
Lubricant 0.5%；
Described adhesive is dehydrated alcohol.
2. Montelukast sodium granules according to claim 1, which is characterized in that the corrigent be selected from aspartame,
One or more of honey element, vanilla, cherry essence, lemon extract, flavoring banana essence.
3. Montelukast sodium granules according to claim 1, which is characterized in that the lubricant be selected from magnesium stearate,
One or more of zinc stearate, calcium stearate.
4. the preparation method of Montelukast sodium granules as described in claim 1, characterized in that it comprises: after sieving
Montestron sodium, Lactis Anhydrous, mannitol, microcrystalline cellulose and corrigent be uniformly mixed, granulation makes grain fineness 8-
Lubricant is added in 80 mesh, is uniformly mixed, dispenses to obtain the final product.
5. the preparation method according to claim 4, which is characterized in that montestron sodium and Lactis Anhydrous cross 90-100 mesh
Sieve, mannitol, microcrystalline cellulose and corrigent cross 70-90 mesh.
6. preparation method according to claim 4 or 5, which is characterized in that pressure when granulation is 2-25 MPa.
7. the preparation method of Montelukast sodium granules as described in claim 1, characterized in that it comprises: after sieving
Montestron sodium, Lactis Anhydrous, mannitol, microcrystalline cellulose and corrigent be uniformly mixed, suck in fluidized bed, using top
Spray formula is spraying, and adhesive is added, and granulation obtains particle, dry, and control moisture content is 2-10%, and lubricant is added, and is uniformly mixed,
It dispenses to obtain the final product；Adhesive therefor is dehydrated alcohol.
8. preparation method according to claim 7, which is characterized in that spray velocity 0.2-1.5ml/min, drum when granulation
Airspeed is 0.2-5L/min and 10-30 DEG C of heating temperature.
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| CN110787133A (en) * | 2018-08-01 | 2020-02-14 | 北京万全德众医药生物技术有限公司 | Montelukast sodium granules and preparation process thereof |
| CN111110679A (en) * | 2018-10-31 | 2020-05-08 | 长春海悦药业股份有限公司 | Pharmaceutical composition containing montelukast sodium |
| CN112386578B (en) * | 2020-10-26 | 2022-11-22 | 石药集团欧意药业有限公司 | Montelukast sodium chewable tablet and preparation method thereof |
| CN114652688B (en) * | 2020-12-23 | 2023-08-22 | 鲁南制药集团股份有限公司 | Montelukast sodium chewable tablet and preparation method thereof |
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| CN101732268B (en) * | 2010-01-09 | 2012-12-05 | 鲁南制药集团股份有限公司 | Montelukast sodium tablet and preparation method thereof |
| KR20140125492A (en) * | 2013-04-19 | 2014-10-29 | 주식회사 에스텍파마 | Granule composition containing sodium montelukast and its preparing method and chewable tablet |
| JP6575031B2 (en) * | 2014-07-28 | 2019-09-18 | 日本ケミファ株式会社 | Montelukast sodium preparation |
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