CN102266293B - Ambroxol hydrochloride sustained-release dry suspension and preparation method thereof - Google Patents
Ambroxol hydrochloride sustained-release dry suspension and preparation method thereof Download PDFInfo
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- CN102266293B CN102266293B CN 201110205054 CN201110205054A CN102266293B CN 102266293 B CN102266293 B CN 102266293B CN 201110205054 CN201110205054 CN 201110205054 CN 201110205054 A CN201110205054 A CN 201110205054A CN 102266293 B CN102266293 B CN 102266293B
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Abstract
The invention discloses an ambroxol hydrochloride sustained-release dry suspension, which is prepared from the following components in percentage by weight: 20 to 60 percent of sustained-release micro-pills, 39.9 to 79.5 percent of suspending aid and 0.1 to 0.5 percent of flavoring agent, wherein the sustained-release micro-pills are prepared by wrapping a sustained-release coating layer outside medicine-carrying pill cores, and the medicine-carrying pill cores comprise 10 to 30 weight percent of ambroxol hydrochloride and 70 to 90 weight percent of pharmaceutic adjuvant. The ambroxol hydrochloride sustained-release dry suspension can be released continuously for 24 hours, can be taken by adding proper amount of warm water, is particularly suitable for treating phlegm eliminating treatment of acute and chronic respiratory tract diseases in olds, children and people who have difficulty in swallowing, and can increase the compliance of administration of patients. The invention also discloses a preparation method for the ambroxol hydrochloride sustained-release dry suspension.
Description
Technical field
The present invention relates to the preparation technique field of ambroxol hydrochloride, relate in particular to a kind of ambroxol hydrochloride sustained-release dry suspension and preparation method thereof.
Background technology
Ambroxol hydrochloride (Ambroxol hydrochloride) has another name called AMB, is a kind of new glutinous expectorant dissolving medicine, can promote the emptying motion of bronchus cilium, is conducive to airway secretions and discharges.Be mainly used in clinically the treatment of eliminating the phlegm of acute and chronic respiratory tract disease, particularly chronic bronchitis.Its phlegm-dispelling functions is strong, is domestic and international one of widely used expectorant clinically.Ambroxol hydrochloride is except having powerful mucus dissolution, and its maximum characteristics are that it can stimulate alveolar type II cells, promotes the synthetic and secretion of alveolar surfactant, thereby effectively strengthens the mucus transhipment, promotes expectoration.Also have in addition the removing oxygen-derived free radicals, reduce inflammatory mediator, pulmonary function is had unique protective effect.
A kind of ambroxol hydrochloride sustained-release pellet of patent that ambroxol hydrochloride tablet, capsule, syrup, slow releasing capsule etc. ambroxol hydrochloride sustained-release preparation is arranged and the preparation method (patent No.: 200910082237) of having gone on the market at present, it adopts extrusion-spheronization to prepare plain ball, the element pill directly is 1mm～2mm, bag slow release film-coat.Ambroxol hydrochloride liquid slow releasing preparation and preparation method thereof (patent No.: 200310105249.0), adopt ion exchange resin medicine carrying, ethyl cellulose or acrylic resin coating.Ambroxol hydrochloride has good effect for the acute and chronic respiratory tract disease, phlegm-dispelling functions is strong, go up commercially available tablet, capsule, slow releasing capsule etc. for old man, child and had the patient of dysphagia to have the poor problem of Compliance, the syrup existence and stability is poor, perishable, the problem of unsuitable long term store.
Summary of the invention
The object of the invention is to overcome the shortcoming and defect of prior art, a kind of ambroxol hydrochloride sustained-release dry suspension is provided, effect is lasting, bioavailability is high, medicining times is few, can solve old man, child and the poor difficult problem of dysphagia patients Compliance.Based on this, the present invention also provides a kind of preparation method of ambroxol hydrochloride sustained-release dry suspension.
For solving above technical problem, technical scheme of the present invention is:
A kind of ambroxol hydrochloride sustained-release dry suspension, by weight percentage, made by slow-release micro-pill 20%～60%, suspending agent 39.9%～79.5%, correctives 0.1%～0.5%: described coated pellets is by carrying a pill core, cover the sustained release coating layer outward and make, and described year pill core comprises that percentage by weight is 10%～30% ambroxol hydrochloride and 70%～90% pharmaceutic adjuvant.
Wherein, the sustained release coating layer is made by sustained release coating material and additive, and described sustained release coating material comprises one or more the mixture in methacrylic resin copolymer, EudragitNE30D, EudragitRS30D, EudragitRL30D, ethyl cellulose, the Sulisi.
Wherein, additive comprises antiplastering aid, porogen, plasticizer.
Wherein, described antiplastering aid is Pulvis Talci, described porogen is one or more the mixture in lactose, polyvinylpyrrolidone, polyethylene glycol 6000, the hydroxypropyl emthylcellulose, and described plasticizer is one or more the mixture in diethyl phthalate, dibutyl phthalate, triethyl citrate, the glycerol.
Wherein, the weightening finish of the coating of sustained release coating layer is 20%～80%.
Wherein, by weight percentage, in the described sustained release coating layer, antiplastering aid is 50%～100% of sustained release coating material dry weight, and porogen is 3%～30% of sustained release coating material dry weight, and plasticizer is 10%～30% of sustained release coating material dry weight.
Wherein, described suspending agent is one or more the mixture in microcrystalline Cellulose-cross-linking sodium carboxymethyl cellulose, xanthan gum, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, sodium alginate, the carbomer.
Wherein, described correctives is one or more the mixture in aspartame, cyclamate, the saccharin sodium.
The preparation method of ambroxol hydrochloride sustained-release dry suspension provided by the invention comprises the steps:
1) be 10%～30% ambroxol hydrochloride and 70%～90% pharmaceutic adjuvant mix homogeneously with mass percent, with suitable amount of adhesive soft material processed, make and carry a pill core, then dry, filter out less than 80 purposes and carry pill core, for subsequent use; Perhaps adopt the centrifugal method of making ball, binding agent is sprayed onto ambroxol hydrochloride and pharmaceutic adjuvant powder surface, under the effect of centrifugal force, form gradually and carry pill core, filter out less than 80 purposes and carry pill core, for subsequent use;
Year pill core that 2) will filter out, the method bag slow release film-coat of employing side spray or end spray forms slow-release micro-pill;
3) with slow-release micro-pill 30 ℃～50 ℃ lower ripenings 10～14 hours.
4) slow-release micro-pill after the ripening and suspending agent, correctives are pressed following weight ratio mix homogeneously:
Slow-release micro-pill 20%～60%, suspending agent 39.9%～79.5%, correctives 0.1%～0.5%.
Wherein, step 2) in, micropill is placed fluid bed, bag slow release film-coat forms and carries pill core;
Wherein, step 2) is specially: will carry pill core and place fluid bed, adopt the mode of end spray, the sustained release coating liquid that configures is sprayed onto the surface of carrying pill core, the sustained release coating material is methacrylic resin polymer EudragitNE30D, EudragitRS30D, EudragitRL30D, one or more mixture in the ethyl cellulose, the coating weightening finish is 20%～80%, difference according to coating material, need to add antiplastering aid in the coating solution, plasticizer, porogen, its consumption calculates according to the dry weight of sustained release coating material, the antiplastering aid consumption is 50%～100%, and plasticizer consumption is 10%～20%, and the porogen consumption is 3%～30%.Device parameter in the coating process, intake are 20～30HZ, and inlet temperature is 25～35 ℃, and atomizing pressure is 1.0bar, and hydrojet speed is 2～4g/min.
Step 3) in, thermostatic drying chamber is adopted in ripening, is about to slow-release micro-pill and inserts in the thermostatic drying chamber, with the coated micropill of ripening and suspending agent, correctives mix homogeneously.
Ambroxol hydrochloride sustained-release dry suspension of the present invention is comprised of a year pill core, sustained-release coating layer, suspending agent, correctives, can lasting release in 24 hours, this product adds an amount of warm water and can take after mixing it with water, the treatment of eliminating the phlegm that is particularly suitable for old man, child, swallows inconvenient crowd's acute and chronic respiratory tract disease has increased the compliance that the patient takes medicine.
Ambroxol hydrochloride sustained-release dry suspension of the present invention has solved the drawback that related preparations exists in the prior art, its slow-release micro-pill by many tiny coatings forms, and adds suspending agent, correctives, and warm water stirs and can take, improved the compliance that the patient takes medicine, solved old man, child and the patient of dysphagia has been arranged, owing to added correctives, delicious, be particularly suitable for children taking, owing to not adding sugary adjuvant, do not rise sugar, be more suitable for taking of diabetics.Particle diameter is even, and release is stable, and is less to the gastrointestinal zest, can lasting release in 24 hours, and bioavailability is high.Preparation of the present invention adopts pharmaceutic adjuvant to be preferably excipient, and preferred the employing extruded-round as a ball method preparation, solved the problem that traditional slow-release dry suspension adopts resin medicine-feeding dissolvent residual, improved the safety that the patient takes medicine.
Slow-release dry suspension of the present invention can 24 hours near constant speed release medicine, blood drug level is steady, has solved the sufferings of taking medicine of the patient with dysphagia.
The present invention adopts and extrudes-round as a ball method or the standby pill core that carries of medicine-feeding legal system, particle diameter is less than more than 80 orders, then adopt fluid bed bag sustained-release coating layer, compare with the preparation method of existing slow-release dry suspension, technique is simple, be easy to industrialized great production, and avoid with an organic solvent, safety is higher.
Description of drawings
Fig. 1 is the releasing curve diagram of the embodiment of the invention one～embodiment three gained preparation vitro releases.
The specific embodiment
In order to make those skilled in the art understand better technical scheme of the present invention, the present invention is described in further detail below in conjunction with the drawings and specific embodiments.
Embodiment one
1, carries the preparation of pill core
The proportioning of carrying each component of pill core is as follows:
In other embodiments, the proportioning of hydrochloric acid bromine rope, starch, microcrystalline Cellulose also can be: hydrochloric acid bromine rope 20g, starch 80g, microcrystalline Cellulose 100g; Perhaps hydrochloric acid bromine rope 50g, starch 50g, microcrystalline Cellulose 100g.
Preparation process:
The method mix homogeneously that adopts equivalent to increase progressively ambroxol hydrochloride and starch, microcrystalline Cellulose, adopt aqueous solution to make soft material as binding agent, employing is extruded-round as a ball machine-processed micropill, the sieve plate particle diameter is 0.2mm, then dry in 50 ℃ baking oven, sieve, choose less than 80 purpose micropills, carry out next step coating process.
2, bag sustained-release coating layer
The coating process: the Sulisi of recipe quantity is added to the water, it is fully disperseed, stir 30min, form sustained release coating liquid, for subsequent use; To carry pill core and place fluid bed, various process parameters will be set, constantly adjust each parameter in the experimentation, guarantee the state of fluidisation, then adopt the sustained release coating liquid for preparing to carry out coating, coating increases weight to 15%, and the slow-release micro-pill behind the coating is placed 40 ℃ of baking oven ripenings 12 hours.
Above-mentioned technological parameter arranges as follows: intake can be set in 20HZ～30HZ, as can be 20HZ, 22HZ, 24HZ, 26HZ, 28HZ, 30HZ, is set as 21HZ in the present embodiment; Inlet temperature can arrange in 25 ℃～35 ℃ scope, as can be 25 ℃, 26 ℃, 28 ℃, 30 ℃, 32 ℃, 35 ℃, is set as 35 ℃ in the present embodiment; Atomizing pressure: 1.0bar; Hydrojet speed can arrange in the scope of 2g/min～4g/min, as can be 2g/min, 3g/min, 3.4g/min 4g/min, this enforcement is set as 2g/min.
3, suspending agent, correctives add
Ambroxol hydrochloride sustained-release pellet and microcrystalline Cellulose-sodium carboxymethyl cellulose CL-611, aspartame are adopted equivalent increment method mix homogeneously, and incorporation time is 30min, granule packing and get final product.In the present embodiment, suspending agent is microcrystalline Cellulose-cross-linking sodium carboxymethyl cellulose CL-611, in other embodiments, can select one or more mixture in xanthan gum, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, sodium alginate, the carbomer.In the present embodiment, correctives is aspartame, in other embodiments, can select cyclamate or saccharin sodium.
Embodiment two
1, carries the preparation of pill core
The proportioning of carrying each component in the pill core is as follows:
Annotate: above percentage ratio is weight percentage.
The preparation process of carrying pill core is as follows:
The method mix homogeneously that adopts equivalent to increase progressively ambroxol hydrochloride and lactose, microcrystalline Cellulose, put into multifunctional fluidized bed in, adopt centrifugal method to make ball, under centrifugal state, spray into binding agent, hydrojet speed is looked the wet degree of doing of drug powder and is suitably regulated, and makes drug powder under the effect of centrifugal force and binding agent, forms gradually tiny micropill, dry in 50 ℃ baking oven, sieve, choose less than 80 purpose micropills, carry out coating.
The technological parameter of aforementioned setting is: rotary speed is 300r/min, and intake can be set in the scope of 20HZ～30HZ, is 27HZ in the present embodiment, in other embodiments, also can be 20HZ, 22HZ, 23HZ, 25HZ, 26HZ, 30HZ; Inlet temperature can be set in 30 ℃～40 ℃, and the present embodiment is 36 ℃, in other embodiments, also can be 30 ℃, 32 ℃, 33 ℃, 34 ℃, 37 ℃, 40 ℃; Hydrojet speed can be set in 4g/min～8g/min, and this enforcement is set as 5g/min, in other embodiments, also can be 4g/min, 6g/min, 7g/min, 8g/min; Atomizing pressure is 2.0bar.
2, bag sustained-release coating layer
The component of bag sustained-release coating layer is as follows:
Pulvis Talci, the PVPk30 of recipe quantity be added to the water stir 30min, add especially that strange NE30D aqueous dispersion fully disperses it, continue to stir 30min, form sustained release coating liquid, for subsequent use.To carry pill core and place fluid bed, and regulate various process parameters, and constantly adjust each parameter in the experimentation, and guarantee the state of fluidisation, and then adopt the sustained release coating liquid for preparing to carry out coating, coating increases weight to 30%.
Aforesaid various process parameters is set: intake can be set in 20HZ～30HZ, is set as 26HZ in the present embodiment; Inlet temperature can arrange in 25 ℃～35 ℃ scope, is set as 31 ℃ in the present embodiment; Atomizing pressure: 1.0bar; Hydrojet speed can arrange in the scope of 2g/min～4g/min, and this enforcement is set as 3g/min.
3, suspending agent, correctives add
Ambroxol hydrochloride sustained-release pellet and xanthan gum, cyclamate are adopted equivalent increment method mix homogeneously, and incorporation time is 30min, granule packing and get final product.In the present embodiment, suspending agent is xanthan gum, in other embodiments, can select one or more mixture in microcrystalline Cellulose-cross-linking sodium carboxymethyl cellulose CL-611, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, sodium alginate, the carbomer.In the present embodiment, correctives is cyclamate, in other embodiments, can select aspartame or saccharin sodium.
Embodiment three
1, carries the preparation of pill core
Preparation process:
With the method mix homogeneously that ambroxol hydrochloride and lactose, microcrystalline Cellulose adopt equivalent to increase progressively, adopt aqueous solution to make soft material as binding agent, adopt and extrude-round as a ball machine-processed micropill, the sieve plate particle diameter is 0.2mm, and is dry in 50 ℃ baking oven, sieves, choose less than 80 purpose micropills, carry out coating.
2, bag sustained-release coating layer
With the Pulvis Talci of recipe quantity, be added to the water and stir 30min, adding triethyl citrate, Eudragit RS 30D, RL30D aqueous dispersion fully disperse it, continue to stir 30min, form sustained release coating liquid, and be for subsequent use.To carry pill core and place fluid bed, various process parameters is set, and constantly adjust each parameter in the experimentation, and guarantee the state of fluidisation, and then adopt the sustained release coating liquid for preparing to carry out coating, coating increases weight to 40%.
The various process parameters that arranges: intake can be set in 20HZ～30HZ, is set as 28HZ in the present embodiment; Inlet temperature can arrange in 25 ℃～35 ℃ scope, is set as 26 ℃ in the present embodiment; Atomizing pressure: 1.0bar; Hydrojet speed can arrange in the scope of 2g/min～4g/min, and this reality is revolved and is set as 4g/min.
3, suspending agent, correctives add
Ambroxol hydrochloride sustained-release pellet and polyvinylpyrrolidone, saccharin sodium are adopted equivalent increment method mix homogeneously, and incorporation time is 30min, granule packing and get final product.In the present embodiment, suspending agent is polyvinylpyrrolidone, in other embodiments, can select one or more mixture in microcrystalline Cellulose-cross-linking sodium carboxymethyl cellulose CL-611, hydroxypropyl emthylcellulose, xanthan gum, sodium alginate, the carbomer.In the present embodiment, correctives is saccharin sodium, in other embodiments, can select aspartame or cyclamate.
Get preparation that preparation example one, embodiment two, embodiment three make as sample, according to the detection method of Chinese Pharmacopoeia 2010 editions, adopt the PH7.5 dissolution medium, carry out vitro release and measure, its release profiles as shown in Figure 1.
As can be seen from Figure, this product 3 batch samples in 24 hours, discharge all with, near constant release.
Upward the present invention is described in detail, uses specific case in the literary composition principle of the present invention and embodiment are set forth, the explanation of above embodiment just is used for helping understanding method of the present invention and core concept thereof.Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention, can also carry out some improvement and modification to the present invention, these improvement and modification also fall in the protection domain of claim of the present invention.
Claims (8)
1. ambroxol hydrochloride sustained-release dry suspension, it is characterized in that, by weight percentage, by slow-release micro-pill 20% ~ 60%, suspending agent 39.9%～79.5%, correctives 0.1%～0.5% is made, described slow-release micro-pill covers the sustained release coating layer outward by a year pill core to be made, described year pill core comprises that percentage by weight is 10%～30% ambroxol hydrochloride and 70%～90% pharmaceutic adjuvant, described pharmaceutic adjuvant is lactose, starch, the mixture of one or more in the microcrystalline Cellulose, the sustained release coating layer is made by sustained release coating material and additive, and described sustained release coating material is selected from the methacrylic resin copolymer, ethyl cellulose, the mixture of one or more in the Sulisi.
2. ambroxol hydrochloride sustained-release dry suspension according to claim 1 is characterized in that, described additive comprises antiplastering aid, porogen, plasticizer.
3. ambroxol hydrochloride sustained-release dry suspension according to claim 2, it is characterized in that, described antiplastering aid is Pulvis Talci, described porogen is one or more the mixture in lactose, polyvinylpyrrolidone, polyethylene glycol 6000, the hydroxypropyl emthylcellulose, and described plasticizer is one or more the mixture in diethyl phthalate, dibutyl phthalate, triethyl citrate, the glycerol.
4. ambroxol hydrochloride sustained-release dry suspension according to claim 1 is characterized in that, the coating weightening finish of sustained release coating layer is 20%～80%.
5. ambroxol hydrochloride sustained-release dry suspension according to claim 2, it is characterized in that, by weight percentage, in the described sustained release coating layer, antiplastering aid is 50%～100% of sustained release coating material dry weight, porogen is 3%～30% of sustained release coating material dry weight, and plasticizer is 10%～30% of sustained release coating material dry weight.
6. ambroxol hydrochloride sustained-release dry suspension according to claim 1, it is characterized in that, described suspending agent is one or more the mixture in microcrystalline Cellulose-cross-linking sodium carboxymethyl cellulose, xanthan gum, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, sodium alginate, the carbomer.
7. ambroxol hydrochloride sustained-release dry suspension according to claim 1 is characterized in that, described correctives is one or more the mixture in aspartame, cyclamate, the saccharin sodium.
8. the preparation method of an ambroxol hydrochloride sustained-release dry suspension as claimed in claim 1 is characterized in that, comprises the steps:
1) be 10%～30% ambroxol hydrochloride and 70%～90% pharmaceutic adjuvant mix homogeneously with percentage by weight, with suitable amount of adhesive soft material processed, make and carry a pill core, then dry, filter out less than 80 purposes and carry pill core, for subsequent use; Perhaps adopt the centrifugal method of making ball, binding agent is sprayed onto ambroxol hydrochloride and pharmaceutic adjuvant powder surface, under the effect of centrifugal force, form gradually and carry pill core, filter out less than 80 purposes and carry pill core, for subsequent use;
Year pill core that 2) will filter out, the method bag slow release film-coat of employing side spray or end spray forms slow-release micro-pill;
3) with slow-release micro-pill 30 ℃ ~ 50 ℃ lower ripenings 10～14 hours.
4) slow-release micro-pill after the ripening and suspending agent, correctives are pressed following weight ratio mix homogeneously:
Slow-release micro-pill 20% ~ 60%, suspending agent 39.9%～79.5%, correctives 0.1%～0.5%.
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| CN102600095B (en) * | 2011-12-29 | 2015-11-25 | 北京科信必成医药科技发展有限公司 | A kind of ambroxol sustained-release preparation and preparation method thereof |
| CN102772391B (en) * | 2012-08-16 | 2014-04-09 | 乐普药业股份有限公司 | Ambroxol hydrochloride sustained release capsule and preparation method thereof |
| CN106420625B (en) * | 2015-08-12 | 2021-02-26 | 北京科信必成医药科技发展有限公司 | Stable ambroxol hydrochloride taste masking granules and preparation method thereof |
| CN105832671A (en) * | 2016-04-13 | 2016-08-10 | 中国药科大学 | Dry suspension for controlled-release of medicine and preparation method of dry suspension |
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