CN105456220A - Ambroxol and salbutamol enteric-coated tablet - Google Patents
Ambroxol and salbutamol enteric-coated tablet Download PDFInfo
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- CN105456220A CN105456220A CN201510902176.0A CN201510902176A CN105456220A CN 105456220 A CN105456220 A CN 105456220A CN 201510902176 A CN201510902176 A CN 201510902176A CN 105456220 A CN105456220 A CN 105456220A
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- enteric
- ambroxol
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- coatel tablets
- albuterol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Biophysics (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to an ambroxol and salbutamol enteric-coated tablet, and belongs to the field of a pharmaceutical preparation. The enteric-coated tablet, which is added with proper amounts of poloxamer 188, meglumine and mannitol, can significantly improve the stability and the bioavailability of ambroxol hydrochloride and salbutamol sulfate in a preparation; and the enteric-coated tablet is stable in quality and significant in effect, and the enteric-coated tablet is capable of effectively treating such diseases of respiratory system as acute and chronic bronchitis, asthma and the like.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of ambroxol albuterol enteric coatel tablets and preparation method thereof.
Background technology
Respiratory system disease is a kind of commonly encountered diseases, frequently-occurring disease, and major lesions is in trachea-bronchial epithelial cell, pulmonary and thoracic cavity, and the many coughs of pathological changes the lighter, chest pain, breathing are influenced, severe one dyspnea, anoxia, even respiratory failure and lethal.Account for the 3rd at the mortality rate in city, then account for first place in rural area.What more should pay attention to is, due to atmospheric pollution, smoking, aged tendency of population and other factors, chronic obstructive pulmonary disease both domestic and external is made (to be called for short chronic obstructive pulmonary disease, comprise chronic bronchitis, emphysema, pulmonary heart disease), bronchial asthma, pulmonary carcinoma, pulmonary's dispersivity interstitial fibrosis, and the sickness rate of the disease such as pulmonary infection, mortality rate are growing on and on.
According to the statistical number of national urbans in 2006 and the rural area top ten principal disease cause of death, respiratory system disease (not comprising pulmonary carcinoma) accounts for the 4th (13.1%) in the Death causes in city, accounts for the 3rd (16.4%) in rural area.The physical and chemical factor caused due to atmospheric pollution, smoking, Industrial Economic Development, biotic factor inhale people and the factor such as population ages is aging, the sickness rate of respiratory system disease as pulmonary carcinoma, bronchial asthma in recent years is obviously increased, and chronic obstructive pulmonary disease remains high (more than 8% in more than 40 years old crowd).Though pulmonary tuberculosis rate controls to some extent, in recent years have again and increase trend.Pulmonary thromboembolism has constituted important health care problem, and pulmonary hypertension also receives publicity in recent years day by day.The disease incidences such as pulmonary Diffuse interstitial fibrosis and immunocompromised pulmonary infection day by day increase.The major causes of death of acquired immune deficiency syndrome (AIDS) is pulmonary infection, particularly pneumocystis carinii pneumonia.Since the end of the year 2002, severe acute respiratory syndrome (the severe acute respiratory syndrome broken out in China and world wide, SARS) epidemic situation, the young and the middle aged is born in due to multiple, its infectiousness is strong, and case fatality rate is high, lacks again medicine targetedly, thus cause the fear of the masses, bring about great losses to national economy simultaneously.The current human and bird fluenza case fatality rate occurred in multiple country is more than 60%.And bird flu virus to invade target organ main in human body be also lung.It is very large that this is just illustrating that respiratory system disease is still our people's health hazard, and it prevents and treats arduous task.
Ambroxol hydrochloride (AmbroxolHydrochloride) is also known as AMB, chemistry trans-4-[(2-amino 3 by name, 5-dibromo-benzyl) amino] cyclohexanol hydrochloridumi, it is active metabolite (the N-demethyl of expectorant bromhexine, trans hydroxyl is introduced in cyclohexyl para-position), toxicity is lower than bromhexine, and activity is higher than bromhexine.Ambroxol hydrochloride is the mucolytic researched and developed by German Boehringer Ingelheim company, first this medicine went on the market in Germany in early 1980s, in succession go on the market in many countries such as France, Italy, Japan, Spain subsequently, it is the glutinous expectorant lytic agent of a new generation, can expectoration be improved, and there is the effect promoting pulmonary surfactant and Airway secretion and ciliary movement.Ambroxol hydrochloride can regulate mucus to secrete with glutinous slurry clinically, and activation fibre swing is easy to dilute sputum, and strengthening mucus outwards transports, and be easy to discharge, it also can promote that pulmonary surfactant synthesizes, and to maintain alveolar tension, ensures lung functions index; Promote that antibiotic is to tissue infiltration, to improve concentration, strengthen bactericidal action; Antioxidation, reduces inflammatory mediator release, with the reaction that reduces inflammation; Work in coordination with bronchus spasmolysis material, to improve the curative effect of spasmolytic medicine.Therefore, this medicine can be widely used in the acute and chronic respiratory tract disease with respiratory tract abnormal secretion clinically, the particularly treatment of eliminating the phlegm of chronic bronchitis, the auxiliary treatment of transient respiratory distress of the newborn disease and pulmonary surgery, have that toxicity is low, determined curative effect can with antibiotic and with producing the advantages such as good synergy, be one of the most frequently used expectorant.In recent years in the emphasis hospital administration rank of China main cities, it ranked forefront always.Existing dosage form has oral liquid, tablet, capsule, micropill etc.
Salbutamol sulfate (SalbutamolSulfate) has another name called salbutamol, its main component is albuterol, chemistry 1-(4-hydroxyl-3-hydroxymethyl phenyl)-2-(tert-butylamine base) ethanol by name, a kind of β-adrenoreceptor analeptic of exciting bronchial smooth muscle of high selectivity, bronchial smooth muscle is relaxed, thus removes bronchial muscular spasm.Comparatively strong to bronchiectatic activity, and more weak to the β1-receptor effect of heart, be anti-asthmatic safer, the most frequently used at present.Be applicable to prevent and treat bronchial asthma, the bronchospasm of asthmatic bronchitis and emphysematic patients, the symptoms such as the dyspnea that alleviation causes because of airway obstructive diseases such as bronchial asthma, chronic bronchitis and emphysema, its advantage is rapid-action, patient symptom can be improved rapidly, spasmolytic, relieving asthma, eliminate the phlegm, shortcoming acts on lasting, only plays the effect alleviating patient's symptoms of asthma; Long period application can cause beta-receptor to regulate downwards, makes patient occur losing quick to beta receptor agonist, even invalid to treating asthma drug resistance phenomenon.Present existing dosage form has tablet, controlled release tablet, aerosol etc.
There is the dosage form such as solution and granule containing ambroxol hydrochloride and salbutamol sulfate in prior art, but had no the report of enteric coatel tablets.
In addition, salbutamol sulfate and ambroxol hydrochloride be active component in same minimum preparation unit, when preserving for a long time, due to chemical compatible change may be there is between each composition, easy generation by-product, therefore can reduce effect or increase side effect, product stability is not ideal enough.
Summary of the invention
Consider the synergism of ambroxol hydrochloride and salbutamol sulfate, namely object of the present invention is to provide a kind of safe and effective, steady quality, and patient adaptability is strong, Be very effective, effectively can treat the ambroxol albuterol enteric coatel tablets of the respiratory system disease such as acute/chronic bronchitis and asthma.
Under study for action, we surprisingly find, the PLURONICS F87, meglumine and the mannitol that add in appropriate amount when the preparation of preparation, can significantly improve stability and the bioavailability of ambroxol hydrochloride and salbutamol sulfate in preparation, the Clinical practice for medicine is significant.
The technical scheme that the present invention solves this technical problem is:
A kind of ambroxol albuterol enteric coatel tablets, be made up of label and enteric coat layer, wherein enteric coat layer comprises the enteric material that weight is 10-20g, and label is made up of the component of following weight:
Salbutamol sulfate: 6-8g;
Ambroxol hydrochloride: 12-15g;
PLURONICS F87: 12-15g;
Meglumine: 10-15g;
Mannitol: 15-20g;
Filler: 50-80g;
Disintegrating agent: 5-10g;
Binding agent: appropriate;
Lubricant: appropriate.
Optimizing prescriptions is: enteric coat layer comprises the enteric material that weight is 15g, and label is made up of the component of following weight percents:
Salbutamol sulfate: 8g;
Ambroxol hydrochloride: 12g;
PLURONICS F87: 15g;
Meglumine: 10g;
Mannitol: 15g;
Filler: 60g;
Disintegrating agent: 8g;
Binding agent: appropriate;
Lubricant: appropriate.
Described filler is selected from one or more in starch, lactose and dextrin.
Described disintegrating agent is selected from one or more in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose and sodium alginate.
Described binding agent is selected from one or more in starch, pregelatinized Starch, hyprolose, hypromellose and polyvidone.
Described lubricant is selected from one or more in magnesium stearate, Pulvis Talci and micropowder silica gel.
Described enteric material is selected from one or more in CAP, methacrylic acid copolymer, cellulose acetate benzenetricarboxylic acid ester and hydroxypropyl cellulose phthalate ester.
Preparation method is:
1) take the supplementary material of recipe quantity, cross 80-120 mesh sieve respectively for subsequent use;
2) get the binding agent after sieving and enteric material adds distilled water respectively, make binder solution and Coating Solution;
3) by salbutamol sulfate, ambroxol hydrochloride, PLURONICS F87, meglumine, mannitol, filler and the disintegrating agent after sieving by equal increments method mix homogeneously, add above-mentioned binder solution and make soft material;
4) after granulating with 40 mesh sieves, dry 30-60min at 50-70 DEG C, crosses 20 mesh sieve granulate, adds the rear tabletting of lubricant mixing, obtained label;
5) with above-mentioned Coating Solution, fluidized bed coating is carried out to obtained label, be drying to obtain.
Preferred preparation method is:
1) take the supplementary material of recipe quantity, cross 100 mesh sieves respectively for subsequent use;
2) get the binding agent after sieving and enteric material adds distilled water respectively, make binder solution and Coating Solution;
3) by salbutamol sulfate, ambroxol hydrochloride, PLURONICS F87, meglumine, mannitol, filler and the disintegrating agent after sieving by equal increments method mix homogeneously, add above-mentioned binder solution and make soft material;
4) after granulating with 40 mesh sieves, dry 60min at 60 DEG C, crosses 20 mesh sieve granulate, adds the rear tabletting of lubricant mixing, obtained label;
5) with above-mentioned Coating Solution, fluidized bed coating is carried out to obtained label, be drying to obtain.
The invention has the beneficial effects as follows that the active component content of described ambroxol albuterol enteric coatel tablets significantly increases; Stability significantly improves; Therefore steady quality, Be very effective, can effectively treat the respiratory system disease such as acute/chronic bronchitis and asthma.
Detailed description of the invention
Below in conjunction with specific embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, the usually conveniently conditioned disjunction condition of advising according to manufacturer.Unless otherwise indicated, otherwise all percent, ratio, ratio or number by weight.
Unless otherwise defined, all specialties used in literary composition and scientific words and one skilled in the art the same meaning be familiar with.In addition, any method similar or impartial to described content and material all can be applicable in the inventive method.The use that better implementation method described in literary composition and material only present a demonstration.
Embodiment 1
Prescription: (1000)
Label:
Salbutamol sulfate: 8g;
Ambroxol hydrochloride: 12g;
PLURONICS F87: 15g;
Meglumine: 10g;
Mannitol: 15g;
Lactose: 60g;
Carboxymethyl starch sodium: 8g;
Hypromellose: appropriate;
Magnesium stearate: appropriate.
Enteric coat layer: CAP 15g.
Preparation method:
1) take the supplementary material of recipe quantity, cross 100 mesh sieves respectively for subsequent use;
2) get the hypromellose after sieving and enteric material CAP adds distilled water respectively, make binder solution and Coating Solution;
3) by salbutamol sulfate, ambroxol hydrochloride, PLURONICS F87, meglumine, mannitol, lactose and the carboxymethyl starch sodium after sieving by equal increments method mix homogeneously, add above-mentioned binder solution and make soft material;
4) after granulating with 40 mesh sieves, dry 60min at 60 DEG C, crosses 20 mesh sieve granulate, adds the rear tabletting of magnesium stearate mixing, obtained label;
5) with above-mentioned Coating Solution, fluidized bed coating is carried out to obtained label, be drying to obtain.
Embodiment 2
Prescription: (1000)
Label:
Salbutamol sulfate: 6g;
Ambroxol hydrochloride: 15g;
PLURONICS F87: 12g;
Meglumine: 12g;
Mannitol: 15g;
Starch: 80g;
Microcrystalline Cellulose: 8g;
Polyvidone: appropriate;
Magnesium stearate: appropriate.
Coatings: hydroxypropyl cellulose phthalate ester 15g.
Preparation method:
1) take the supplementary material of recipe quantity, cross 100 mesh sieves respectively for subsequent use;
2) get the polyvidone after sieving and enteric material hydroxypropyl cellulose phthalate ester adds distilled water respectively, make binder solution and Coating Solution;
3) by salbutamol sulfate, ambroxol hydrochloride, PLURONICS F87, meglumine, mannitol, starch and the microcrystalline Cellulose after sieving by equal increments method mix homogeneously, add above-mentioned binder solution and make soft material;
4) after granulating with 40 mesh sieves, dry 60min at 60 DEG C, crosses 20 mesh sieve granulate, adds the rear tabletting of magnesium stearate mixing, obtained label;
5) with above-mentioned Coating Solution, fluidized bed coating is carried out to obtained label, be drying to obtain.
Embodiment 3
Prescription: (1000)
Label:
Salbutamol sulfate: 8g;
Ambroxol hydrochloride: 15g;
PLURONICS F87: 15g;
Meglumine: 10g;
Mannitol: 20g;
Dextrin: 80g;
Low-substituted hydroxypropyl cellulose: 10g;
Hypromellose: appropriate;
Micropowder silica gel: appropriate.
Coatings: cellulose acetate benzenetricarboxylic acid ester 20g.
Preparation method:
1) take the supplementary material of recipe quantity, cross 100 mesh sieves respectively for subsequent use;
2) get the hypromellose after sieving and enteric material cellulose acetate benzenetricarboxylic acid ester adds distilled water respectively, make binder solution and Coating Solution;
3) by salbutamol sulfate, ambroxol hydrochloride, PLURONICS F87, meglumine, mannitol, dextrin and the low-substituted hydroxypropyl cellulose after sieving by equal increments method mix homogeneously, add above-mentioned binder solution and make soft material;
4) after granulating with 40 mesh sieves, dry 40min at 60 DEG C, crosses 20 mesh sieve granulate, adds the rear tabletting of micropowder silica gel mixing, obtained label;
5) with above-mentioned Coating Solution, fluidized bed coating is carried out to obtained label, be drying to obtain.
Embodiment 4 stability test
Comparative example 1 adopts preparation method identical with embodiment; Prescription is as follows: (1000)
Label:
Salbutamol sulfate: 8g;
Ambroxol hydrochloride: 12g;
Lactose: 60g;
Carboxymethyl starch sodium: 8g;
Hypromellose: appropriate;
Magnesium stearate: appropriate.
Enteric coat layer: CAP 15g.
Comparative example 2 adopts preparation method identical with embodiment; Prescription is as follows: (1000)
Label:
Label:
Salbutamol sulfate: 8g;
Ambroxol hydrochloride: 12g;
Mannitol: 15g;
Lactose: 60g;
Carboxymethyl starch sodium: 8g;
Hypromellose: appropriate;
Magnesium stearate: appropriate.
Enteric coat layer: CAP 15g.
1. accelerated stability test
Embodiment 1, comparative example 1 and comparative example 2 gained ambroxol albuterol enteric coatel tablets are put intensity of illumination 4500lx condition lower 10 days respectively, and respectively at sampling in the 0th, 5,10 day, every quality index such as detection level, related substance, the results are shown in Table 1.
Table 1 ambroxol albuterol enteric coatel tablets influence factor result of the test
Result shows: each component content is without significant change under intense light conditions for ambroxol albuterol enteric coatel tablets prepared by the present invention, and stability is significantly better than comparative example.Trace it to its cause, be because the ordinary adjuvants in comparative example cannot play support and Stabilization to active component preferably, and then cause, between each composition, chemical compatible change to occur, easily produce by-product; And the content due to active component is greater than general prior art level, causes stability more greatly to reduce.
2. accelerated test
Embodiment 1 gained ambroxol albuterol enteric coatel tablets are placed in 40 DEG C, the constant temperature of RH20%, constant humidity cabinet 6 months, respectively at the 0th, sampling in 1,2,3,6 month, measure every quality index such as character, content, related substance, the results are shown in Table 2.
Table 2 ambroxol albuterol enteric coatel tablets accelerated test result
Result shows: ambroxol albuterol enteric coatel tablets 40 DEG C, place 6 months under the condition of RH20%, compared with 0 month, except related substance slightly increases, other every quality index have no significant change, and steady quality is reliable, conforms with the regulations.
The foregoing is only preferred embodiment of the present invention, and be not used to limit substantial technological context of the present invention, substantial technological content of the present invention is broadly defined in the right of application, any technology entities that other people complete or method, if with application right define identical, also or a kind of change of equivalence, be all covered by being regarded as among this right.
Claims (6)
1. ambroxol albuterol enteric coatel tablets, are made up of label and enteric coat layer, and wherein enteric coat layer comprises the enteric material that weight is 10-20g, and label is made up of the component of following weight:
Salbutamol sulfate: 6-8g;
Ambroxol hydrochloride: 12-15g;
PLURONICS F87: 12-15g;
Meglumine: 10-15g;
Mannitol: 15-20g;
Filler: 50-80g;
Disintegrating agent: 5-10g;
Binding agent: appropriate;
Lubricant: appropriate.
2. the preparation method of a kind of ambroxol albuterol enteric coatel tablets according to claim 1, is characterized in that: described filler is selected from one or more in starch, lactose and dextrin.
3. the preparation method of a kind of ambroxol albuterol enteric coatel tablets according to claim 1, is characterized in that: described disintegrating agent is selected from one or more in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose and sodium alginate.
4. the preparation method of a kind of ambroxol albuterol enteric coatel tablets according to claim 1, is characterized in that: described binding agent is selected from one or more in starch, pregelatinized Starch, hyprolose, hypromellose and polyvidone.
5. the preparation method of a kind of ambroxol albuterol enteric coatel tablets according to claim 1, is characterized in that: described lubricant is selected from one or more in magnesium stearate, Pulvis Talci and micropowder silica gel.
6. the preparation method of a kind of ambroxol albuterol enteric coatel tablets according to claim 1, is characterized in that: described enteric material is selected from one or more in CAP, methacrylic acid copolymer, cellulose acetate benzenetricarboxylic acid ester and hydroxypropyl cellulose phthalate ester.
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| CN201510902176.0A CN105456220A (en) | 2015-12-08 | 2015-12-08 | Ambroxol and salbutamol enteric-coated tablet |
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| CN201510902176.0A CN105456220A (en) | 2015-12-08 | 2015-12-08 | Ambroxol and salbutamol enteric-coated tablet |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101099729A (en) * | 2006-07-03 | 2008-01-09 | 天津康鸿医药科技发展有限公司 | Oral solid preparation containing ambroxol hydrochloride and salbutamol active components |
| CN102085188A (en) * | 2011-01-14 | 2011-06-08 | 寿光富康制药有限公司 | Novel lansoprazole enteric pellet and preparation method thereof |
| CN103070864A (en) * | 2012-12-06 | 2013-05-01 | 华润赛科药业有限责任公司 | Repaglinide and metformin hydrochloride medicinal composition and its preparation method |
| CN103239719A (en) * | 2012-08-24 | 2013-08-14 | 药源药物化学（上海）有限公司 | Metformin compound pharmaceutical composition and preparation method thereof |
-
2015
- 2015-12-08 CN CN201510902176.0A patent/CN105456220A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101099729A (en) * | 2006-07-03 | 2008-01-09 | 天津康鸿医药科技发展有限公司 | Oral solid preparation containing ambroxol hydrochloride and salbutamol active components |
| CN102085188A (en) * | 2011-01-14 | 2011-06-08 | 寿光富康制药有限公司 | Novel lansoprazole enteric pellet and preparation method thereof |
| CN103239719A (en) * | 2012-08-24 | 2013-08-14 | 药源药物化学（上海）有限公司 | Metformin compound pharmaceutical composition and preparation method thereof |
| CN103070864A (en) * | 2012-12-06 | 2013-05-01 | 华润赛科药业有限责任公司 | Repaglinide and metformin hydrochloride medicinal composition and its preparation method |
Non-Patent Citations (1)
| Title |
|---|
| 杨亚军: "《兰索拉唑片剂的研究》", 《中国优秀硕士论文全文数据库医药卫生科技辑》 * |
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Application publication date: 20160406 |