CN104784157B - A kind of montelukast oral membrane agent of stabilization - Google Patents
A kind of montelukast oral membrane agent of stabilization Download PDFInfo
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Abstract
The present invention relates to a kind of montelukast oral membrane agents of stabilization.The oral thin film contains a effective amount of montelukast or its pharmaceutically acceptable salt, contains the drug stabilizing agent including at least edetic acid(EDTA) and/or edetate and pharmaceutically acceptable auxiliary material.The montelukast oral film agent dose according to the invention for being formulated acquisition is accurate, stable quality, it can effectively prevent oxidation, the degradation of active ingredient, in addition, the oral thin film is vivid with color, good mouthfeel, the Compliance of patient in oral cavity the advantages that flash melt, can be improved without drinking water, the patient of particularly suitable infant and dysphagia takes.
Description
Technical field
The present invention relates to a kind of montelukast oral thin film formulations of stabilization, belong to pharmaceutical technology field.
Background technology
Entitled [R- (E)] -1- of Montelukast Sodium chemistry [[[1- [3- [2- [the chloro- 2- quinoline of 7-] vinyl] phenyl -3- [2-
(1- hydroxyl -1- Methylethyls) phenyl] propyl] sulphur] methyl] cyclopropaneacetic acid sodium, structural formula is as follows：
Montelukast Sodium is a kind of potent, selective leukotriene D receptor antagonist, can the various stimulations of selective depression because
Inflammatory factor leukotriene polypeptide caused by plain (sulfur dioxide, movement and cold air etc.) and various allergens (pollen, soft flocks etc.)
Increase, so as to inhibit speed hair mutually and tardy phase inflammatory reaction, it is (bronchoconstriction, viscous to mitigate or prevent a series of reaction of air flues
Liquid secretion, vasopermeability increase and eosinophil accumulation), be widely used in bronchial asthma, exercise-induced asthma,
The prevention and long-term treatment of allergic rhinitis, especially paediatrics respiratory disease are that treating asthma removes suction in recent years both at home and abroad
Enter the long-term control medications that can be uniquely used alone outside hormone.
Montelukast Sodium by MSD Corp. of the U.S. (MSD) is developed and synthesized first, is listed first in Mexico in 1997,
Then in more than 70 country's listings such as the U.S., Europe, China.Montelukast Sodium 43.052 hundred million dollars of worldwide sales in 2012,
Domestic 2012 annual sales amounts are 2.137 hundred million yuan, 2013 2.588 hundred million yuan, increase by 21.09% on a year-on-year basis, international and domestic market pin
Sell that volume is big and rapid development.Dosage form has been listed at present includes ordinary tablet, chewable tablets and granule.Due to Montelukast Sodium ordinary tablet
Must first be disintegrated under one's belt could start to discharge drug, work slow, take also not aspect.And as pediatric drugs, particularly with 2
Infant within year, it is poor to the compliance of chewable tablets or granule, easily occur spitting medicine phenomenon, it is difficult to realize correct dose medication
And affect the treatment, largely effect on clinical practice of the Montelukast Sodium oral preparation in paediatrics.
Oral instant membrane is called the molten film of mouth, is a kind of oral drugs thin film formulations in rapid oral dissolution.With other
The oral solid formulation of type is compared, and oral thin film preparation has many advantages, such as novel appearance, special taste；It takes
It is convenient；Rapid oral dissolution is not easy to spue；Absorb quick, rapid-onset；Supplementary product consumption is few, simple for process；Swallow conveniently,
Asphyxia etc. will not be caused.In view of oral thin film preparation has many advantages, such as, therefore have become domestic external preparation research and development
One of hot fields.Have listed ten several oral thin film preparations in the world at present, such as Ondansetron oral thin film,
Dextromethorphan oral cavity membrane agent, risperidone orally membrane agent, donepezil hydrochloride orally membrane agent etc..
By Montelukast Sodium exploitation into color is vivid, the molten film of mouth of good mouthfeel, without can be in oral cavity with water when taking
Interior flash melt, and patient can greatly improve the Compliance of patient, particularly suitable baby according to the quick and convenient medication of the state of an illness
Child and the patient of dysphagia take.In addition, because mucous membrane of mouth enriches, the absorption speed of drug can be improved by developing into the molten film of mouth
Rate is conducive to the rapid recovery of the patient's condition.
However, Montelukast Sodium chemical constitution is complicated, active group is more, and formulation products are easy during production or storage
It is influenced by oxygen or illumination, oxidation reaction and isomerization reaction occurs, generate specific impurities sulfoxide and cis-isomer, and made
Because product thickness is thin, surface area is big after into the molten film of mouth, being more vulnerable to external environment (oxidation, high temperature, illumination) influences and degrades.
If the molten film preparation of mouth to be developed into must by exploring repeatedly, well-designed overcome drug existing for the molten film preparation of mouth
The unfavorable factors such as active constituent stability is bad.
A kind of Montelukast sodium film-like preparation is disclosed in the prior art, mainly by the way that active constituents of medicine is supported on
On acid and/or alkaline membrane band, film strips become effervesce film after meeting water, generate a large amount of bubbles, benumb smell and taste masking, and accelerate medicine
Object dissolves out.The technology does not provide suggestion for product stability aspect.
A kind of method that Montelukast Sodium dissolving film is formed directly on surface of package is also disclosed in the prior art.The skill
Art is mainly expounded the method for directly forming film in surface of package, not to providing suggestion in terms of product stability.
For the stability problem of Montelukast Sodium film, disclose in the prior art a kind of using BHT (Butylated Hydroxytoluene)
Make antioxidant with BHA (Butylated Hydroxyanisole), while be combined potassium dihydrogen phosphate and dipotassium hydrogen phosphate as antioxidant synergist to improve Meng Lu
The stability of the special sodium of department.However, BHT and BHA has the response feature of phenol, the metal of trace or illumination can make its discoloration, live
Property lose.Water is both practically insoluble in, needs to dissolve using organic solvent in technical process, and recent studies have found that, it is long-term to take
There is the risk for inducing cancer with BHA, as a kind of pediatric drugs, security risks are higher.
The present invention is directed to select a kind of higher stabilizer of safety to overcome the molten film production of Montelukast Sodium mouth and storage
The degradation of period active ingredient, and pass through this product flash melt, bright-colored and taste good advantage in oral cavity, improve infant
Medication compliance.
Invention content
In view of the problems of the existing technology and shortcoming, the present invention provide a kind of stability good montelukast oral
Membrane agent.
The present invention provides a kind of montelukast oral membrane agent of stabilization, which is characterized in that includes active constituent Meng Lusi
Special or its pharmaceutically acceptable salt, drug stabilizing agent and other pharmaceutically acceptable auxiliary materials, the drug stabilizing agent is at least
Including edetic acid(EDTA) and/or edetate.
The montelukast oral membrane agent of the present invention, it is preferred that the active constituent is Montelukast Sodium.
In the oral thin film of the present invention, the weight percent of drug stabilizing agent is 0.01%~10%, preferably
0.25%~5%, more preferable 0.5%~2%.
The montelukast oral membrane agent of the present invention, the edetate are selected from natrium adetate, EDTAP dipotassium ethylene diamine tetraacetate, according to ground
One of sour calcium disodium, edetate sodium and edetate trisodium or arbitrary combination.
The montelukast oral membrane agent of the present invention, other described pharmaceutically acceptable auxiliary materials include film forming agent, plasticising
Agent, colorant, corrigent and other auxiliary materials.The film forming agent be selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl alcohol,
One of polyoxyethylene, gelatin, xanthans, sodium alginate or arbitrary combination.The plasticizer is selected from polyethylene glycol, glycerine, the third two
One of alcohol, polysorbate or arbitrary combination.The colorant is selected from one of titanium dioxide, pigment, color lake or arbitrary combination.
The corrigent is selected from Sucralose, Aspartame, stevioside, saccharin, mannitol, xylitol, sorbierite, menthol, essence
One of or arbitrary combination.Other described auxiliary materials include preservative and/or saliva stimulant；The preservative is selected from benzoic acid
One of sodium, potassium sorbate, methyl hydroxybenzoate, ethylparaben or arbitrary combination；The saliva stimulant is selected from citric acid, winestone
One of acid, malic acid, mannitol or arbitrary combination.
The montelukast oral membrane agent of the present invention shows unusual stabilization after adding in the drug stabilizing agent of the present invention
Property, the degradation of active constituent is substantially reduced.The oral thin film is placed 6 months under 40 DEG C and 75% relative humidities
Relatively in relation to substance without significant change compared with 0 day, specific degradation impurity sulfoxide incrementss are no more than 0.1%, far below having listed
(standard requirement sulfoxide must not exceed Montelukast Sodium oral preparation such as chewable tablets import registered standard required standard limit
2.5%).
Even if the present invention oral thin film 60 DEG C more acutely under conditions of place 10 days compared with 0 day relatively in relation to object
For matter still without significant change, specific degradation impurity sulfoxide incrementss are still no more than 0.1%, still far below having listed Montelukast Sodium mouth
Formulation such as chewable tablets import registered standard required standard limit (standard requirement sulfoxide must not exceed 2.5%).
The montelukast oral membrane agent of the present invention has the advantages that：
With vivid color and good taste, it is easy to be received by patient especially infant patient, and after taking not
Any discomfort can be generated；
Without drinking-water can in oral cavity flash melt, and discharge active constituents of medicine, avoid patient's Tibetan medicine, spit medicine；
With good physical property, the production that disclosure satisfy that product in intensity, toughness etc. (is such as cut, is packed
Processing step), preserve, transport and during Clinical practice convenient for taking；
Has good medicine stability.
The molten film of montelukast mouth provided by the present invention can not only improve the Clinical practice compliance of existing listing dosage form,
And clinical onset of action rate can be improved, there is very high clinical development and use value.Available for bronchial asthma, movement
The prevention and long-term treatment of induction property asthma, allergic rhinitis, especially paediatrics respiratory disease.
Description of the drawings
Fig. 1 Montelukast Sodium oral quick-dissolving film preparations of the present invention and the stripping curve of commercially available Montelukast sodium chewable tablet compare
Figure.
Specific embodiment
It is further illustrated the present invention below by embodiment.It should be understood to：The embodiment of the present invention is only used for
Illustrate the present invention and provide rather than limitation of the present invention, to the simple of the present invention under the premise of technical solution of the present invention
Improvement all belongs to the scope of protection of the present invention.
Test example 1
With reference to the related substance-measuring methods of Montelukast sodium chewable tablet import registered standard X20010209, it is protected from light operation.Color
Spectral condition is filler with phenyl bonded silica, and column temperature is 50 DEG C, Detection wavelength 255nm, and flow rate of mobile phase is 1.5ml/ points
Clock, sampling volume are 20 μ L, and using linear gradient elution, specific elution program is as follows：
Mobile phase A：0.2% trifluoroacetic acid aqueous solution
Mobile phase B：Methyl-acetonitrile (60：40)
| Time (minute) | Mobile phase A (%) | Mobile phase B (%) |
| 0 | 48 | 52 |
| 5 | 45 | 55 |
| 12 | 45 | 55 |
| 22 | 25 | 75 |
| 23 | 25 | 75 |
| 25 | 48 | 52 |
| 35 | 48 | 52 |
It measures in accordance with the law, sulfoxide must not cross 2.5%；Cis-isomer must not cross 0.1%；Ketone group methanol must not cross 0.1%；Its
He must not cross 0.1% by single impurity；Total impurities must not cross 2.7%.
Influence of 1 natrium adetate of embodiment to product stability
* it uses but is removed in technical process in prescription.
Preparation process：The each component in addition to Montelukast Sodium and filmogen is dissolved or divided under stiring under the conditions of being protected from light
It dissipates in water, adds in Montelukast Sodium stirring and dissolving, obtain containing drug solns；Filmogen is added in, stirs to being completely dissolved, obtains drug containing
Glue；Deaeration is stirred under vacuum, drug containing glue after deaeration is spread evenly across with scraper on polyester belt, after heat drying
Certain size is cut into, obtains the pink molten film of Montelukast Sodium mouth.
Comparative example 1
* it uses but is removed in technical process in prescription.
Preparation process：The each component in addition to Montelukast Sodium and filmogen is dissolved or divided under stiring under the conditions of being protected from light
It dissipates in water, adds in Montelukast Sodium stirring and dissolving, obtain containing drug solns；Filmogen is added in, stirs to being completely dissolved, obtains drug containing
Glue；Deaeration is stirred under vacuum, drug containing glue after deaeration is spread evenly across with scraper on polyester belt, after heat drying
Certain size is cut into, obtains the pink molten film of Montelukast Sodium mouth.
In comparative example 1, polyethylene glycol 400 or glycerine is respectively adopted or polyoxyethylene sorbitan monoleate makees plasticizer, wherein poly- second
The molten film-strength of gained Montelukast Sodium mouth and toughness are poor when glycol 400 or glycerine dosage are 5%, and gently folding is i.e. disconnected for film, it is difficult to full
Foot cutting or packing instructions, when dosage continues to increase to 10%, physical property is obviously improved, using Intelligent electronic tensil testing machine
(XLW types, Jinan blue light mechanical ＆ electrical technology Co., Ltd) measures pull-off force and is all higher than 15N.And polyoxyethylene sorbitan monoleate dosage for 5% or
The gained molten film of Montelukast Sodium mouth, pull-off force are all higher than 15N when 10%, and intensity and toughness are good.
The sample of embodiment 1 and comparative example 1 is respectively placed under 40 DEG C and 75% relative humidities and places 30 days, in
0th, sampling in 15,30 days is measured according to the method for test example 1.As a result it is as follows：
Result of the test shows to be respectively adopted polyethylene glycol 400 or glycerine or polyoxyethylene sorbitan monoleate as plasticizer, 40 DEG C of high temperature
Under the conditions of place 30 days, impurity sulfoxide and total impurities increase sharply；And after adding in stabilizer natrium adetate, the life of impurity sulfoxide
Into being substantially reduced, the stability of product is greatly improved.
Influence of the 2 different amounts natrium adetate of embodiment to product stability
* it uses but is removed in technical process in prescription.
Preparation process：The each component in addition to Montelukast Sodium and filmogen is dissolved or divided under stiring under the conditions of being protected from light
It dissipates in water, adds in Montelukast Sodium stirring and dissolving, obtain containing drug solns；Filmogen is added in, stirs to being completely dissolved, obtains drug containing
Glue；Deaeration is stirred under vacuum, drug containing glue after deaeration is spread evenly across with scraper on polyester belt, after heat drying
Certain size is cut into, obtains the pink molten film of Montelukast Sodium mouth.
Comparative example 2
| Title | Dry matter ratio |
| Montelukast Sodium | 20.8% |
| Hydroxypropyl methylcellulose | 52.96% |
| Hydroxypropyl cellulose | 13.24% |
| Polyoxyethylene sorbitan monoleate | 5% |
| Sucralose | 1% |
| Cherry essence | 3.5% |
| Red ferric oxide | 0.5% |
| Titanium dioxide | 3% |
| Purified water * |
* it uses but is removed in technical process in prescription.
Preparation process：The each component in addition to Montelukast Sodium and filmogen is dissolved or divided under stiring under the conditions of being protected from light
It dissipates in water, adds in Montelukast Sodium stirring and dissolving, obtain containing drug solns；Filmogen is added in, stirs to being completely dissolved, obtains drug containing
Glue；Deaeration is stirred under vacuum, drug containing glue after deaeration is spread evenly across with scraper on polyester belt, after heat drying
Certain size is cut into, obtains the pink molten film of Montelukast Sodium mouth.
The sample of embodiment 2 and comparative example 2 is respectively placed under 40 DEG C and 75% relative humidities and is placed 30 days,
It is measured in sampling in 0,15,30 day according to the method for test example 1.As a result it is as follows：
Result of the test shows to place 30 days under 40 DEG C of hot conditions, is added without natrium adetate prescription impurity sulfoxide and total
Impurity significantly increases；It adds in natrium adetate prescription impurity sulfoxide and total impurities is only increased slightly；And natrium adetate dosage is big
When 0.5% compared with 0 day, without significant change, stability significantly improves for prescription impurity sulfoxide and total impurities.
Another Example 1 and the sample of comparative example 1 are respectively placed under 60 DEG C of more drastic conditions and place 10 days, in 0,5,
Sampling in 10 days is measured according to the method for test example 1.As a result it is as follows：
Result of the test shows to place 10 days under 60 DEG C of hot conditions, is added without natrium adetate prescription impurity sulfoxide and total
Impurity significantly increases；It adds in 0.25% natrium adetate prescription impurity sulfoxide and total impurities increase significantly slows down；And edetic acid(EDTA) two
When sodium dosage is more than 0.5% compared with 0 day, prescription impurity sulfoxide and total impurities are only increased slightly, and stability significantly improves.
Influence of the 3 variety classes stabilizer of embodiment to product stability
* it uses but is removed in technical process in prescription.
Preparation process：The each component in addition to Montelukast Sodium and filmogen is dissolved or divided under stiring under the conditions of being protected from light
It dissipates in water, adds in Montelukast Sodium stirring and dissolving, obtain containing drug solns；Filmogen is added in, stirs to being completely dissolved, obtains drug containing
Glue；Deaeration is stirred under vacuum, drug containing glue after deaeration is spread evenly across with scraper on polyester belt, after heat drying
Certain size is cut into, obtains the pink molten film of Montelukast Sodium mouth.
The sample of Example 3 is placed under 40 DEG C and 75% relative humidities and places 30 days, is pressed in sampling in 0,15,30 day
It is measured according to the method for test example 1.As a result it is as follows：
Result of the test shows the addition common antioxidant such as BHT or BHA or sodium pyrosulfite, and different prescriptions are respectively at 40 DEG C
Under the conditions of place 30 days, each prescription impurity sulfoxide and total impurities significantly increase, wherein BHT and BHA combination can slightly reduce sulfoxide
Generation, but compared with natrium adetate its to product stability improve degree it is still relatively low.
Embodiment 4
* it uses but is removed in technical process in prescription.
Preparation process：The each component in addition to Montelukast Sodium and filmogen is dissolved or divided under stiring under the conditions of being protected from light
It dissipates in water, adds in Montelukast Sodium stirring and dissolving, obtain containing drug solns；Filmogen is added in, stirs to being completely dissolved, obtains drug containing
Glue；Deaeration is stirred under vacuum, drug containing glue after deaeration is spread evenly across with scraper on polyester belt, after heat drying
Certain size is cut into, obtains the pink molten film of Montelukast Sodium mouth.
The sample of 2 prescription III of embodiment and embodiment 4 are respectively placed under 40 DEG C and 75% relative humidities and place 6
It a month, is measured in 0,1,3, sampling in June according to the method for test example 1.As a result it is as follows：
Result of the test shows that sample is made as stabilizer using natrium adetate or EDTAP dipotassium ethylene diamine tetraacetate, at 40 DEG C and 75%
Placed under relative humidities 6 months compared with 0 day relatively in relation to substance without significant change, especially specific degradation impurity sulfoxide increases
Dosage is no more than 0.1%, far below having listed Montelukast Sodium oral preparation such as chewable tablets import registered standard required standard
Limit (standard requirement sulfoxide must not exceed 2.5%) can ensure the safe medication of children.
The molten film dissolving time limit assay method of 2 Montelukast Sodium mouth of test example
Appoint film 6 of getting it filled, take 1 every time, be gently placed in 37 ± 1 DEG C of artificial salivas, under static condition, observation this product is complete
The time of fully dissolved.
According to the above method, the dissolving time limit of 2 prescription III of embodiment and 4 sample of embodiment is measured, as a result the two dissolving time limit
It is each about 30s.The molten film of Montelukast Sodium mouth developed reaches rapidly-soluble target.
Above-mentioned sample is placed on the tongue of oral cavity, the obtained molten film of Montelukast Sodium mouth can in being dissolved completely in 5s-15s,
Discharge Montelukast Sodium；In addition the obtained molten film of Montelukast Sodium mouth slightly sweet taste and cherry flavor, taste is good, is easy to connect
By.
The comparison of 3 stripping curve of test example
According to 4 prescription I of 2 prescription III of embodiment and embodiment, Montelukast Sodium oral thin film is prepared, by gained film
Montelukast Sodium mouth molten film (specification 5mg) of the size for 2 × 1.5cm, about 50 μm of thickness is cut into, while with commercially available Montelukast Sodium
Chewable tablets (5mg specifications, Merck ＆ Co., Inc.) is as control drug.To contain the aqueous solution 900ml of 0.5% lauryl sodium sulfate to be molten
Go out medium, rotating speed is 50 turns per minute, and the stripping curve of the two is measured using paddle method.As a result, it has been found that according to prepared by the present invention
The dissolution rate of the molten film of Montelukast Sodium mouth be apparently higher than presently commercially available Montelukast sodium chewable tablet, specific test result is shown in
Fig. 1.
Claims (6)
1. a kind of montelukast oral membrane agent, which is characterized in that consist of the following compositions：Active constituent Montelukast Sodium, medicine
Object stabilizer and other pharmaceutically acceptable auxiliary materials, the drug stabilizing agent are edetic acid(EDTA) and/or edetate；In the mouth
The weight percent of drug stabilizing agent is 0.5%~2% in chamber membrane agent；
Other described pharmaceutically acceptable auxiliary materials are made of film forming agent, plasticizer, colorant, corrigent and other auxiliary materials；
Other described auxiliary materials refer to preservative and/or saliva stimulant；
The plasticizer is selected from polyethylene glycol 400, glycerine or polyoxyethylene sorbitan monoleate, and when selecting polyethylene glycol 400 or glycerine, uses
It is 5% to measure, and when selecting polyoxyethylene sorbitan monoleate, dosage is 5% or 10%.
2. montelukast oral membrane agent according to claim 1, which is characterized in that the edetate is selected from edetic acid(EDTA)
One of disodium, EDTAP dipotassium ethylene diamine tetraacetate, CaEDTA, edetate sodium and edetate trisodium or arbitrary combination.
3. montelukast oral membrane agent according to claim 1, which is characterized in that it is fine that the film forming agent is selected from hydroxypropyl first
Tie up one of element, hydroxypropyl cellulose, polyvinyl alcohol, polyoxyethylene, gelatin, xanthans, sodium alginate or arbitrary combination.
4. montelukast oral membrane agent according to claim 1, which is characterized in that the colorant is selected from titanium dioxide
One of titanium, pigment, color lake or arbitrary combination.
5. montelukast oral membrane agent according to claim 1, which is characterized in that the corrigent is selected from trichlorine sugarcane
One of sugar, Aspartame, stevioside, saccharin, mannitol, xylitol, sorbierite, menthol, essence or arbitrary combination.
6. montelukast oral membrane agent according to claim 1, which is characterized in that the preservative is selected from benzoic acid
One of sodium, potassium sorbate, methyl hydroxybenzoate, ethylparaben or arbitrary combination；The saliva stimulant is selected from citric acid, winestone
One of acid, malic acid, mannitol or arbitrary combination.
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| US20170258710A1 (en) * | 2016-03-11 | 2017-09-14 | Intelgenx Corp. | Montelukast transmucosal film |
| US9949934B1 (en) * | 2016-10-20 | 2018-04-24 | Intelgenx Corp. | Device and method of treating conditions associated with neuroinflammation |
| KR20190128637A (en) * | 2017-03-30 | 2019-11-18 | 인텔젠스 코프. | Therapeutic Methods and Apparatus for Improved Bioavailability of Leukotriene Receptor Antagonists |
| KR20200039677A (en) | 2017-07-05 | 2020-04-16 | 장인 무코케어 파마슈티컬 컴퍼니 리미티드 | Topical formulations comprising a combination with montelukast and mussel adhesion proteins |
| CN114557981A (en) * | 2022-03-02 | 2022-05-31 | 山东新时代药业有限公司 | Montelukast oral cavity dissolving film agent and preparation process thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973532A (en) * | 2012-12-28 | 2013-03-20 | 南京瑞尔医药有限公司 | Stable montelukast sodium tablet and preparation method thereof |
| CN103393624A (en) * | 2013-02-21 | 2013-11-20 | 上海现代药物制剂工程研究中心有限公司 | Montelukast sodium membrane-shape preparation |
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| KR101077468B1 (en) * | 2011-03-04 | 2011-11-07 | (주)차바이오앤디오스텍 | Stable orodispersible film formulation |
| WO2013100564A1 (en) * | 2011-12-26 | 2013-07-04 | 에스케이케미칼 주식회사 | Film for oral administration containing montelukast or pharmaceutically acceptable salt thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973532A (en) * | 2012-12-28 | 2013-03-20 | 南京瑞尔医药有限公司 | Stable montelukast sodium tablet and preparation method thereof |
| CN103393624A (en) * | 2013-02-21 | 2013-11-20 | 上海现代药物制剂工程研究中心有限公司 | Montelukast sodium membrane-shape preparation |
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