CN109833302A - A kind of stable Montelukast sodium chewable tablet and preparation method thereof - Google Patents
A kind of stable Montelukast sodium chewable tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of stable Montelukast sodium chewable tablets, which includes Montelukast Sodium and adhesive, moreover, the preparation method of the chewable tablets includes: that Montelukast Sodium and adhesive are first configured to mixed solution, then use wet granulation.Meanwhile the present invention also provides the preparation methods of the chewable tablets.Preparation method provided by the invention is simply controllable, Yi Fang great, favorable reproducibility, and obtained Montelukast sodium chewable tablet appearance luster is uniform, and differences between batches are small, and In Vitro Dissolution release is stablized.
Description
Technical field
The invention belongs to pharmaceutical drug substance preparation process technical fields, and in particular to a kind of leukotriene receptor antagonists Meng Lusi
Special sodium chewable tablets and preparation method thereof.
Background technique
Montelukast Sodium is developed by Merck company earliest, and the preparation variety listed at present has Montelukast Sodium piece, Meng
Montelukast sodium chewable tablets and Montelukast Sodium particle, trade name(Singulair).
Chinese patent CN101365450A discloses a kind of Montelukast sodium chewable tablet, it is by Montelukast Sodium, hydroxypropyl
Cellulose, sodium starch glycollate, mannitol, coloured iron oxide, Aspartame, lauryl sodium sulfate, flavouring agent and tristearin
Sour magnesium passes through compression forming after wet granulation technology.
Chinese patent CN101773481A discloses a kind of Montelukast sodium chewable tablet, it is fine by Montelukast Sodium, crystallite
Element, mannitol, PVP K30, zinc stearate and opacifier are tieed up, the opacifier is iron oxide red, iron oxide yellow or dioxy
Change titanium, and passes through wet granulation technology.
Chinese patent CN103494781A discloses a kind of Montelukast sodium chewable tablet, and formula composition is montelukast
Sodium, microcrystalline cellulose, mannitol, polylactic acid, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, red oxidation
Iron, Aspartame, by using powder vertical compression technique.
Chinese patent CN103494785A discloses a kind of Montelukast sodium chewable tablet, takes Montelukast Sodium, mannitol, friendship
Join sodium carboxymethylcellulose, red ferric oxide and aspartame, pulverize and sieve and be uniformly mixed, the anhydrous second of 5% adhesive is added
Alcoholic solution wet granulation, after dry whole grain, with tabletting after strawberry essence and magnesium stearate total mix.
Chinese patent CN104146975A discloses a kind of Montelukast sodium chewable tablet preparation method, and this method auxiliary material includes
Mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, Aspartame, red ferric oxide, magnesium stearate,
Hydroxypropyl cellulose is configured to aqueous solution in invention, is prepared using wet granulation technology by cherry essence.
Montelukast sodium chewable tablet disclosed in Chinese patent CN105287413A, which is characterized in that it uses wet granulation
The raw material of micronization is added in mannitol first by montelukast sodium raw materials after micronization processes for technique, forms sweet dew
Alcohol-medicinal composition is uniformly mixed, granulation then with microcrystalline cellulose, cherry essence, Aspartame, temptation red aluminum color ingot,
After dry whole grain with tabletting after disintegrating agent and lubricant total mix.
Montelukast Sodium presses Biopharmaceutics Classification system BCS II, i.e., low molten hypertonic class drug.The dissolution rate of compound is
The rate-limiting factor that its gastrointestinal tract absorbs, and the Relationship Between Size of insoluble drug is to the contact area of drug and gastro-intestinal Fluid, thus shadow
Ring the dissolution rate of drug.Secondly, Montelukast sodium chewable tablet belongs to small dimension tablet, and for small dimension tablet, content is equal
Evenness is one of the index of priority control in formulation manufacturing processes, and the granularity of raw material can significantly affect the attribute of product, therefore,
For Montelukast sodium chewable tablet, the control of granularity is particularly critical.From the point of view of presently disclosed Montelukast sodium chewable tablet technique,
Have and use wet granulation technology, also uses technique of direct powder compression, and for bulk pharmaceutical chemicals, there is narration to be micronized
Pre-treatment, also have through Control granularity range of being simply sieved.All exist centainly for above-mentioned raw materials granularity control method
Problem, the present inventor have found that raw material has hygroscopicity, for what is crushed or be sieved when studying the physicochemical property of Montelukast Sodium
Environmental requirement is relatively high, in the case where not controlling humidity, increase moisture absorption speed of the particle due to specific surface area after crushing or being sieved
Rate can dramatically increase, and be easy to cause between particle and particle and be mutually adhered, in the case where controlling ambient humidity, dry caused powder
Particle surface can increase after broken or sieving, and Electrostatic Absorption is serious, and material collection is more difficult, lose more.
For oral solid formulation, In Vitro Dissolution test is usually used in instructing the exploitation of pharmaceutical preparation, in particular by comparing
The method of imitated preparation and reference preparation a plurality of dissolution curve similitude in vitro, can reduce in imitated preparation and reference preparation body
Inequivalence risk, therefore, exploitation In Vitro Dissolution method are most important.From the point of view of presently disclosed patent, for Montelukast Sodium
Chewable tablets, the selection of dissolving-out method add one into dissolution medium all referring to the method for United States Pharmacopeia and Japanese Pharmacopoeia dissolution rate
Determine the lauryl sodium sulfate (SDS) of concentration (0.5%), but the method for dissolution rate cannot all reflect formulation development mistake
Influence of the auxiliary material and technique to product in journey selects 0.01% Tween 80 as dissolution medium additive, develops after study
New dissolving-out method, compared to 0.5% lauryl sodium sulfate additive, the tween of low concentration is more convincing, research
It is more scientific and reasonable.Respectively to embodiment 1 (reference example one), 1 (reference example of CN104146975A embodiment in CN103494785A
Two), embodiment is carried out referring to implementation in CN105287413A embodiment 1 (reference example three), compare its in 0.5%SDS and
Dissolution situation in 0.01% Tween 80 medium, is as follows:
In 0.01% Tween medium, reference example one, reference example two, the f2 factor of reference example three are respectively as follows: 48,45,39
Lower than 50, and since 15min each point is all larger than 85% in 0.5%SDS, can determine that for dissolved corrosion it is similar.By above data
It is found that the SDS dissolution medium of high concentration does not have distinction, product prescription and conducting a research for technique are not instructed to anticipate
Justice.
The chemical structure of Montelukast Sodium is shown below:
It is anionic surface activity drug that structure, which prompts Montelukast Sodium, in a solvent, especially in water molten
It is similar with anionic Surfactant to solve property.About the property description road of montelukast in Drugs@FDA: montelukast has
Surface-active property is capable of forming autocorrelation structure in water, and under the concentration lower than 5mg/ml, its own correlation is unknown
It is aobvious, and be precipitated from water in the form of free acid.As can be seen that Montelukast Sodium solubility in low concentration is small, when concentration is big
When critical micelle concentration, since there are the effect of itself solubilising, solubility can accordingly become larger, therefore, in Japanese PMDA about
The solubility of Montelukast Sodium in water is 200~250mg/ml (20 DEG C of measuring temperature).
Summary of the invention
Inventor developed a kind of preparation that is stable, can control Montelukast sodium chewable tablet release in vitro and its preparations
Method, process avoids montelukast sodium raw materials are crushed or are sieved pre-treatment the drawbacks of, and raw material is configured to solution shape
State is added medicine to by spraying, and not only uniformity of dosage units is guaranteed, controls the release of drug in the medium by the dosage of adhesive, can
Reach similar in vitro to reference preparation, and stablizes.Meanwhile the technique one-step palletizing, produce time-consuming short, technique favorable reproducibility, color
Damp uniform, technological parameter is easy to control.
The object of the present invention is to provide a kind of stable Montelukast sodium chewable tablets.
It is a further object of the present invention to provide the preparation methods of above-mentioned chewable tablets.
In embodiments of the invention, the present invention provides a kind of stable Montelukast sodium chewable tablet, the chewable tablets
Comprising Montelukast Sodium and adhesive, moreover, the preparation method of the chewable tablets includes: first to prepare Montelukast Sodium and adhesive
At mixed solution, wet granulation is then used.
In embodiments of the invention, a kind of stable Montelukast sodium chewable tablet provided by the invention, the chewable tablets
Comprising Montelukast Sodium and adhesive, also comprising filler, disintegrating agent, wetting agent, lubricant, sweetener, corrigent and coloring
At least one of agent.
In a preferred embodiment of the invention, a kind of stable Montelukast sodium chewable tablet provided by the invention, wherein
It is described to be configured to mixed solution and refer to be dissolved in or be suspended in solvent respectively for Montelukast Sodium and adhesive, then the two is mixed
It closes；Either adhesive is first dissolved in or is suspended in solvent, adds Montelukast Sodium.
In a preferred embodiment of the invention, a kind of stable Montelukast sodium chewable tablet provided by the invention, wherein
The adhesive is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, povidone, gelatin, sodium alginate or polyethylene glycol, excellent
It is preferably hydroxypropyl cellulose that selection of land, which is hydroxypropyl cellulose or hydroxypropyl methylcellulose,.
In a preferred embodiment of the invention, a kind of stable Montelukast sodium chewable tablet provided by the invention, wherein
The Montelukast sodium chewable tablet is to be prepared from raw materials including the following parts by weight:
In a preferred embodiment of the invention, a kind of stable Montelukast sodium chewable tablet provided by the invention, wherein
The solvent is selected from the mixed solvent of water, ethyl alcohol, isopropanol or two of them to three kinds, it is preferable that is selected from water or second
The aqueous solution of alcohol or ethyl alcohol is preferably water.
In a preferred embodiment of the invention, the present invention provides a kind of stable Montelukast sodium chewable tablets, wherein
The chewable tablets includes Montelukast Sodium and hydroxypropyl cellulose, moreover, the preparation method of the chewable tablets includes: first by montelukast
Sodium and hydroxypropyl cellulose are configured to aqueous solution, then use wet granulation.
In more preferred of the invention, the present invention provides a kind of stable Montelukast sodium chewable tablet,
In, the preparation method includes: the aqueous solution that hydroxypropyl cellulose is configured to 0.1 weight of weight %~10 %, by Meng Lu
Take charge of the aqueous solution that special sodium prepares 0.5 weight of weight %~25 %；And both aqueous solutions are mixed.
In more preferred of the invention, the present invention provides a kind of stable Montelukast sodium chewable tablet,
In, the preparation method includes: that above-mentioned hydroxypropyl cellulose aqueous solution and montelukast sodium water solution are mixed into capable preparation
Afterwards, carry out wet granulation with the remaining auxiliary material in addition to magnesium stearate, it is dry after again with magnesium stearate total mix, tabletting.
On the other hand, of the invention to provide a kind of stable Montelukast sodium chewable tablet preparation method, including following step
It is rapid:
The raw material for weighing following parts by weight takes the hydroxypropyl cellulose in raw material that purified water is added, is configured to 0.1 weight %
The aqueous solution of~10 weight %；It takes the Montelukast Sodium in raw material that purified water is added, is configured to 0.5 weight of weight %~25 %'s
Aqueous solution, and above two aqueous solution is mixed；
Take microcrystalline cellulose, mannitol, croscarmellose sodium, red ferric oxide, aspartame, cherry essence mixing
Uniformly, it is added in fluidized bed, sprays into the granulating mixture of above two aqueous solution and drying, the technological parameter of fluidized bed granulation
Are as follows: 40~60 DEG C of inlet air temperature, 40~80m of intake3/ h, temperature of charge are controlled at 25~30 DEG C；The technique of fluidized bed drying
Parameter are as follows: 40~60 DEG C of inlet air temperature, 40~80m of intake3/ h, dry end point moisture is less than 1.5 weight %；Particle is crossed 30
Mesh screen whole grain is added magnesium stearate total mix 5-10 minutes, is pressed into tablet with rotary tablet machine；
The Montelukast sodium chewable tablet is to be prepared from raw materials including the following parts by weight:
Measure the In Vitro Dissolution curve of the Montelukast sodium chewable tablet of the application, In Vitro Dissolution experiment condition are as follows:
| Device | Dissolving-out method: paddle method |
| Revolving speed and dissolution medium | 50rpm (0.01% Tween 80 pH1.0, pH4.0, pH6.8) |
Dissolution curve similarity determination standard:
PH1.0 (50rpm, 0.01% Tween 80) reference preparation is put down in 120 minutes Average dissolutions and at final time point
Time point corresponding to equal dissolution rate 1/2 makes the difference of both preparation and reference preparation Average dissolution by oneself in ± 12% range
Interior or f2 is more than or equal to 50；
PH4.0 (50rpm, 0.01% Tween 80), f2 are more than or equal to 46；
PH6.8 (50rpm, 0.01% Tween 80), when reference preparation Average dissolution is 40% and 85% corresponding nearby
Between point, self-control preparation and reference preparation Average dissolution difference in ± 15% range or f2 be more than or equal to 50.
Test result shows that Montelukast sodium chewable tablet provided by the invention and preparation method thereof is avoided to montelukast
The drawbacks of sodium raw materials crushing or sieving pre-treatment, and raw material is configured to solution state and adds medicine to by spraying, and uniformity of dosage units is protected
Card；Meanwhile the release of drug in the medium is controlled by the dosage of adhesive, it can reach similar in vitro to reference preparation.It should
Technique one-step palletizing, production is time-consuming short, and technique favorable reproducibility, uniform color, technological parameter is easy to control.Moreover, the present invention provides
The Montelukast sodium chewable tablet uniformity grind (Singulair) and in the prior art reference example better than original significantly.
Specific embodiment
1 Montelukast sodium chewable tablet of embodiment
Montelukast Sodium is taken, purified water 46.8g is added, is configured to the aqueous solution of 10 weight %, takes hydroxypropyl cellulose, add
Enter 171g purified water, is configured to the aqueous solution of 3.41 weight %, the two is mixed.Take microcrystalline cellulose, mannitol, crosslinking carboxylic first
Mixing machine is added in base sodium cellulosate, red ferric oxide, aspartame, cherry essence, is uniformly mixed and is transferred to fluidized bed, sprays into Meng
The granulation of the aqueous solution of montelukast sodium and hydroxypropyl cellulose, drying are added less than 1.5 weight % with 30 mesh screen whole grains to moisture
Enter magnesium stearate total mix 8 minutes, is pressed into tablet with rotary tablet machine.Dissolve out testing result such as following table 1-3:
1 0.01% tween pH1.0 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 |
| Singulair | 20 | 33 | 43 | 59 | 68 | 73 | 79 | 84 |
| Embodiment 1 | 25 | 39 | 48 | 65 | 75 | 81 | 88 | 92 |
2 0.01% tween pH4.0 each point of table accumulates the amount of dissolution %
3 0.01% tween pH6.8 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 180 | 240 | 300 | 360 |
| Singulair | 27 | 37 | 43 | 54 | 59 | 63 | 69 | 73 | 78 | 80 | 82 | 84 |
| Embodiment 1 | 35 | 40 | 48 | 56 | 62 | 66 | 72 | 76 | 81 | 84 | 86 | 87 |
Embodiment 1 and RLD comparison, the f2 value in the medium of pH1.0,4.0,6.8 are respectively as follows: 59,61,69, and
Each point dissolution difference is determined as similar within limit in pH1.0 and 6.8 media.
2 Montelukast sodium chewable tablet of embodiment
Montelukast Sodium is taken, purified water 46.8g is added, is configured to the aqueous solution of 10 weight %, takes hydroxypropyl cellulose, add
Enter 171g purified water, is configured to the aqueous solution of 5 weight %, the two is mixed.Take microcrystalline cellulose, mannitol, cross-linked carboxymethyl
Mixing machine is added in sodium cellulosate, red ferric oxide, aspartame, cherry essence, is uniformly mixed and is transferred to fluidized bed, sprays into Meng Lu
The aqueous solution for taking charge of special sodium and hydroxypropyl cellulose is pelletized, dry to be added to moisture less than 1.5 weight % with 30 mesh screen whole grains
Magnesium stearate total mix 8 minutes, tablet was pressed into rotary tablet machine.Dissolve out testing result such as following table 4-6:
4 0.01% tween pH1.0 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 |
| Singulair | 20 | 33 | 43 | 59 | 68 | 73 | 79 | 84 |
| Embodiment 2 | 22 | 36 | 44 | 62 | 70 | 76 | 82 | 87 |
5 0.01% tween pH4.0 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 180 | 240 | 300 | 360 |
| Singulair | 6 | 10 | 13 | 20 | 25 | 30 | 36 | 42 | 48 | 52 | 55 | 58 |
| Embodiment 2 | 8 | 11 | 12 | 19 | 23 | 27 | 33 | 38 | 44 | 48 | 51 | 53 |
6 0.01% tween pH6.8 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 180 | 240 | 300 | 360 |
| Singulair | 27 | 37 | 43 | 54 | 59 | 63 | 69 | 73 | 78 | 80 | 82 | 84 |
| Embodiment 2 | 25 | 34 | 39 | 52 | 57 | 60 | 67 | 71 | 76 | 78 | 80 | 81 |
Embodiment 2 and RLD comparison, the f2 value in the medium of pH1.0,4.0,6.8 are respectively as follows: 79,67,72, and
Each point dissolution difference is determined as similar within limit in pH1.0 and 6.8 media.
3 Montelukast sodium chewable tablet of embodiment
Montelukast Sodium is taken, purified water 46.8g is added, is configured to the aqueous solution of 10 weight %, takes hydroxypropyl cellulose, add
Enter 171g purified water, is configured to the aqueous solution of 6.56 weight %, the two is mixed.Take microcrystalline cellulose, mannitol, crosslinking carboxylic first
Mixing machine is added in base sodium cellulosate, red ferric oxide, aspartame, cherry essence, is uniformly mixed and is transferred to fluidized bed, sprays into Meng
The granulation of montelukast sodium hydroxypropyl cellulose aqueous solution, it is dry to be added hard less than 1.5 weight % with 30 mesh screen whole grains to moisture
Fatty acid magnesium total mix 8 minutes, tablet was pressed into rotary tablet machine.Dissolve out testing result such as following table 7-9:
7 0.01% tween pH1.0 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 |
| Singulair | 20 | 33 | 43 | 59 | 68 | 73 | 79 | 84 |
| Embodiment 3 | 10 | 22 | 33 | 55 | 65 | 71 | 78 | 82 |
8 0.01% tween pH4.0 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 180 | 240 | 300 | 360 |
| Singulair | 6 | 10 | 13 | 20 | 25 | 30 | 36 | 42 | 48 | 52 | 55 | 58 |
| Embodiment 3 | 3 | 8 | 10 | 15 | 20 | 25 | 31 | 36 | 42 | 46 | 49 | 51 |
9 0.01% tween pH6.8 each point of table accumulates the amount of dissolution %
| t/min | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 180 | 240 | 300 | 360 |
| Singulair | 27 | 37 | 43 | 54 | 59 | 63 | 69 | 73 | 78 | 80 | 82 | 84 |
| Embodiment 3 | 18 | 28 | 34 | 46 | 52 | 58 | 64 | 68 | 73 | 76 | 78 | 79 |
Embodiment 2 and RLD comparison, the f2 value in the medium of pH1.0,4.0,6.8 are respectively as follows: 63,61,57, and
Each point dissolution difference is determined as similar within limit in pH1.0 and 6.8 media.
Comparative example
Embodiment 1 (reference example one), CN104146975A embodiment in Singulair, CN103494785A are compared respectively
1 (reference example two), CN105287413A embodiment 1 (reference example three) and the embodiment of the present application, test sample uniformity of dosage units and
Impurity, Comparative result such as the following table 10:
The 10 sample size uniformity of table and defects inspecting
Compare Singulair and reference example, the embodiment tablet content uniformity is obviously partially excellent, in relation to substance controlled level and
Reference example is suitable, but also below Singulair.
Claims (10)
1. a kind of stable Montelukast sodium chewable tablet, which includes Montelukast Sodium and adhesive, moreover, the chewable tablets
Preparation method include: that Montelukast Sodium and adhesive are first configured to mixed solution, then use wet granulation.
2. chewable tablets as described in claim 1, wherein first Montelukast Sodium and adhesive are dissolved in respectively or are suspended in molten
Agent, then the two is mixed；Either adhesive is first dissolved in or is suspended in solvent, adds Montelukast Sodium.
3. chewable tablets as claimed in claim 1 or 2, wherein described adhesive is selected from hydroxypropyl cellulose, hypromellose
Element, povidone, gelatin, sodium alginate or polyethylene glycol, it is preferable that be hydroxypropyl cellulose or hydroxypropyl methylcellulose, more preferably
Ground is hydroxypropyl cellulose.
4. chewable tablets as claimed in claim 2, wherein the solvent is selected from water, ethyl alcohol, isopropanol or two of them to three
The mixed solvent of kind, it is preferable that be the aqueous solution of water or ethyl alcohol or ethyl alcohol, be water preferably.
5. chewable tablets as claimed in claim 4, wherein the preparation method includes: that hydroxypropyl cellulose is configured to 0.1
Montelukast Sodium is prepared the 0.5 weight % aqueous solution of weight %~25 by the aqueous solution of the weight of weight %~10 %；And by both
Aqueous solution mixing.
6. chewable tablets as described in claim 1, wherein the wet granulation, which is selected from, uses fluidized bed or high shear wet
The mode of granulator is pelletized, and preferably fluid bed process is pelletized.
7. such as chewable tablets of any of claims 1-6, the Montelukast sodium chewable tablet also include selected from filler,
At least one of disintegrating agent, wetting agent, lubricant, sweetener, corrigent, colorant.
8. chewable tablets as claimed in claim 7, wherein the chewable tablets is made of the supplementary material of following parts by weight:
9. Montelukast sodium chewable tablet as claimed in claim 8, wherein the preparation method of the chewable tablets includes: to take Meng Lusi
Special sodium and hydroxypropyl cellulose are configured to aqueous solution respectively, spare after mixing, will mix except the remaining auxiliary material after magnesium stearate
It is even, it is added in fluidized bed, it is 0.5 weight that the aqueous solution of penetrating Montelukast Sodium and hydroxypropyl cellulose, which is pelletized and dried to moisture,
The weight % of %~1.5 is measured, magnesium stearate total mix, tabletting is added in whole grain.
10. a kind of preparation method of stable Montelukast sodium chewable tablet, comprising the following steps:
The raw material for weighing following parts by weight takes the hydroxypropyl cellulose in raw material that purified water is added, is configured to 0.1 weight %~10
The aqueous solution of weight %；It takes the Montelukast Sodium in raw material that purified water is added, is configured to the water-soluble of 0.5 weight of weight %~25 %
Liquid, and above two aqueous solution is mixed；
Take microcrystalline cellulose, mannitol, croscarmellose sodium, red ferric oxide, aspartame, cherry essence mixing equal
It is even, it is added in fluidized bed, sprays into the granulating mixture of above two aqueous solution and drying, the technological parameter of fluidized bed granulation are as follows:
40~60 DEG C of inlet air temperature, 40~80m of intake3/ h, temperature of charge are controlled at 25~30 DEG C；The technological parameter of fluidized bed drying
Are as follows: 40~60 DEG C of inlet air temperature, 40~80m of intake3/ h, dry end point moisture is less than 1.5 weight %；Particle is crossed into 30 meshes
Net whole grain is added magnesium stearate total mix 5-10 minutes, is pressed into tablet with rotary tablet machine；
The Montelukast sodium chewable tablet is to be prepared from raw materials including the following parts by weight:
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111000813A (en) * | 2020-01-06 | 2020-04-14 | 国药集团致君（深圳）坪山制药有限公司 | Montelukast sodium chewable tablet and preparation method thereof |
| CN111840233A (en) * | 2020-07-29 | 2020-10-30 | 浙江诺得药业有限公司 | Montelukast sodium solid dispersion, preparation method and application thereof |
| CN112386578A (en) * | 2020-10-26 | 2021-02-23 | 石药集团欧意药业有限公司 | Montelukast sodium chewable tablet and preparation method thereof |
| CN115531330A (en) * | 2022-08-30 | 2022-12-30 | 嘉实（湖南）医药科技有限公司 | Preparation method of montelukast sodium chewable tablet |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111000813A (en) * | 2020-01-06 | 2020-04-14 | 国药集团致君（深圳）坪山制药有限公司 | Montelukast sodium chewable tablet and preparation method thereof |
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| CN111840233B (en) * | 2020-07-29 | 2022-05-06 | 浙江诺得药业有限公司 | Montelukast sodium solid dispersion, preparation method and application thereof |
| CN112386578A (en) * | 2020-10-26 | 2021-02-23 | 石药集团欧意药业有限公司 | Montelukast sodium chewable tablet and preparation method thereof |
| CN115531330A (en) * | 2022-08-30 | 2022-12-30 | 嘉实（湖南）医药科技有限公司 | Preparation method of montelukast sodium chewable tablet |
| CN115531330B (en) * | 2022-08-30 | 2023-10-27 | 嘉实（湖南）医药科技有限公司 | Preparation method of montelukast sodium chewable tablet |
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