CN106727301A - A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof - Google Patents

A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof Download PDF

Info

Publication number
CN106727301A
CN106727301A CN201611242931.8A CN201611242931A CN106727301A CN 106727301 A CN106727301 A CN 106727301A CN 201611242931 A CN201611242931 A CN 201611242931A CN 106727301 A CN106727301 A CN 106727301A
Authority
CN
China
Prior art keywords
ambroxol
sustained release
mixed suspension
suspension preparation
release mixed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201611242931.8A
Other languages
Chinese (zh)
Inventor
梁卓旺
苏丽
徐亮亮
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jiangsu Xianke Pharmaceutical Co Ltd
Original Assignee
Jiangsu Xianke Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jiangsu Xianke Pharmaceutical Co Ltd filed Critical Jiangsu Xianke Pharmaceutical Co Ltd
Priority to CN201611242931.8A priority Critical patent/CN106727301A/en
Publication of CN106727301A publication Critical patent/CN106727301A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides a kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof, it is characterized in that the sustained release mixed suspension preparation is made up of ambroxol coated granule and suspending system, the pastille particulate film coating gained that the ambroxol coated granule by ambroxol hydrochloride and resin formed after ion exchange, the suspending system is made up of suspending agent, flavouring, PH conditioning agents, preservative, pigment and purified water, and preparation method is comprised the following steps:The resin carrier and film coating of ambroxol are first prepared, then ambroxol coated granule addition suspending system is prepared into pastille suspension;The present invention is compared with other formulations, and convenient drug administration, bioavilability is high, and curative effect stabilization is lasting, and toxic and side effect is small, it is easy to the medication of children, old man and dysphagia patients.

Description

A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof
Technical field
The present invention relates to pharmaceutical technology field, more particularly to a kind of breathing problem eliminating the phlegm sustained release mixed suspension preparation and its system Preparation Method.
Background technology
China's air pollution in recent years is serious, causes the incidence of disease of diseases of respiratory system and case fatality rate to remain high, at present, It has been the dead the third-largest factor of China human mortality.Therefore, the exploitation for the treatment of medicament for treating respiratory system thing also turns into drug research One pith.In the case of respiratory tract infection (such as chronic bronchitis breathing problem), often produce a large amount of Sputum, the presence of phlegm blocks respiratory tract, easily causes cough, pants, or even causes to have difficulty in breathing, especially children and old man Often there is spitting difficult so the application of expectorant is very necessary.Ambroxol hydrochloride series is clinically to act on most strong at present Expectorant, its curative effect is extremely affirmed both at home and abroad, market sale increase it is steady in have into.
Ambroxol hydrochloride is the respiratory mucus conditioning agent of a new generation, with very strong phlegm-dispelling functions, and to alveolar surface The synthesis and secretion of active material have significant facilitation.Suitable for acute and chronic breathing problem (such as acute and chronic branch gas Guan Yan, bronchial astehma, bronchiectasis, pulmonary tuberculosis etc.) thick sputum, the dys-expectoration that cause.
Ambroxol hydrochloride belongs to mucolytic agent, can stimulate bronchial mucous gland, increases the secretion of neutral mucopolysacchauide, reduces The synthesis of acid mucopolysaccharide simultaneously promotes it to be metabolized, so that the reason of respiratory mucus stops property tends to normal, is conducive to sputum to arrange Go out.Zoopery and clinical test confirm that the viscosity of sputum can reduce by more than 50% after medication.Ambroxol hydrochloride activation mucus is fine Hair function, is conducive to the discharge of airway secretions, experiment to show that ciliary beat frequency increased 10.8% after medication.
Compared with the first generation and second generation expelling phlegm drugses, ambroxol hydrochloride in addition to being acted on powerful mucolysis, its Maximum feature is that it can stimulate II types alveolar epithelial cells and clara cell, increases the synthesis of alveolar surfactant and divides Secrete, so as to effectively strengthen mucus transport, promote expectoration.Also there is ambroxol hydrochloride many protections to make to respiratory system With:
1st, the free dioxygenase gene of antioxidation reactivity is in many PUD Ds such as idiopathic fibrosis, adult's breathing Distress syndrome, all plays an important role in the morbidity of cystic fibrosis.Strengthening antioxidant defense mechanisms in these diseases can It can be a kind of feasible therapy approach.Ambroxol can remove oxide OH-, HOCl, weaken BHR, stimulate thin The secretion of cellular surface active material.
2nd, the release ambroxol of inflammatory mediator is reduced to people's body of gland mast cell (1000nnol/L) and skin that activate respectively The inhibiting rate of skin mast cell (100mmol/L) histamine releasing can reach more than 50%.It is different from N-acetylcystein, ammonia Bromine rope can not only suppress the release of leucocyte and mast cell acute mediators, can also reduce basophilic granulocyte release immune Instrumentality-cell factor.Can be applied to the treatment of abnormalism respiratory disease.
3rd, the Effect study to airway smooth muscle shows that ambroxol has cough inhibitory action, and histamine is induced The usual flesh contraction of air flue becomes apparent from.Mechanical irritation induces cat cough reflex, and intraperitoneal application ambroxol suppresses cough anti- The effective percentage penetrated reaches 51.6%, and oral availability is 37.04%.When ambroxol concentration reaches 10-4mol/L, the lung of cavy Smooth muscle is completely loose.
Additionally, ambroxol hydrochloride can also increase drug concentration of the antibiotic in air flue, antibiotic is assisted to penetrate into bronchus In secretion, strengthen the sterilizing ability of antibiotic.Ambroxol hydrochloride clinic apply for many years, phlegm-dispelling functions by force, and with compared with Good tolerance and security.
In recent years, the study hotspot of ambroxol hydrochloride is turned to for chest, abdominal postoperative prevention pulmonary infection, atelectasis. The particularly preoperative patient with branch or other basic PUD Ds slowly, Post operation is reduced due to body fluid, and stomach tube retains, and is crouched The reasons such as bed, wound pain, cause thick sputum to be difficult expectoration, and serious causes pulmonary infection even threat to life.
The content of the invention
It is an object of the present invention to provide a kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof.Will The technical problem of solution is the shortcoming and defect for overcoming prior art, convenient drug administration, bioavilability are high, curative effect stabilization is lasting, Toxic and side effect is small, can solve the problem that the problem of children, the validity of old man and dysphagia patients medication, security and compliance.
To solve above technical problem, the technical scheme is that:
A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm, containing ambroxol coated granule and suspending system, by weight Percentage said preparation contains following composition:Ambroxol coated granule is 0.5%~10%, and suspending system is 90%~99.5%.
In ambroxol coated granule of the invention, contain ambroxol, ion exchange resin, coating material and plasticizer.
In suspending system of the invention, contain suspending agent, flavouring, PH conditioning agents, preservative, pigment and purified water.
In ambroxol coated granule of the invention, described ion exchange resin from styrene cationic ion-exchange resin, Propylene weak acid cation exchange resin, metering system weak acid cation exchange resin, it is described in one or more mixture;Bag Clothing material selection ethyl cellulose, cellulose acetate, shellac, polyvinyl acetate phthalic acid ester, butanedioic acid acetic acid hydroxypropyl Cellulose, it is described in one or more mixture;Plasticizer selects dibutyl phthalate, phthalic acid diethyl Ester, Macrogol 4000, dibutyl sebacate, triethyl citrate, it is described in one or more mixture.
In suspending system of the invention, described suspending agent selects Hydroxypropyl methylcellulose, methylcellulose, carboxymethyl cellulose Plain sodium, glycerine, xanthans, tragacanth, PVP K90, microcrystalline cellulose, sodium alginate, Carbomer, it is described in One or more mixture;Flavouring selects sucrose, mannitol, high fructose corn syrup, maltose, fructose, A Sipa Smooth, essence, it is described in one or more mixture;PH conditioning agents select citric acid, sodium citrate, potassium citrate, mountain Pears acid, lactic acid, malic acid, it is described in one or more mixture;Preservative selects methyl hydroxybenzoate, ethyl hydroxy benzoate, hydroxyl Phenylpropyl alcohol ester, butyl hydroxybenzoate, benzoic acid, Sodium Benzoate, it is described in one or more mixture;Pigment from amaranth, It is carmine, lure red, quinoline yellow, lemon yellow, sunset yellow, bright basket, indigo basket, it is described in one or more mixture.
The preparation method of sustained release mixed suspension preparation of the invention, comprises the following steps:
Step 1 takes appropriate ion exchange resin, 80~100 mesh is crossed after suitably being embathed with 15~50% ethanol waters wet Sieve, drying;Take in ambroxol hydrochloride and dried resin addition purified water, water removal is placed in being done in 30 DEG C~70 DEG C baking ovens after question response It is dry.
Step 2 takes coating material and plasticizer is leached in 80~90% appropriate ethanol waters, with this solution to step The rapid 1 ambroxol resin for obtaining is coated:Ambroxol resin is placed in fluidized-bed coating machine, starts fluid bed, with made Standby coating solution is to the ambroxol coated granule obtained by its top spray coating, collection.
Step 3 sequentially adds purified water, suspending agent, flavouring, PH conditioning agents, preservative, color in suitable container Element, fully stirring, mixing, is subsequently adding ambroxol coated granule, stirs and evenly mixs, and is eventually adding purified water to full dose.
The present invention compared with prior art, solves the drawbacks of related sustained release preparation is present in the prior art, and it is by many Tiny pastille is coated resin particle composition, adds suspending agent, flavouring, PH conditioning agents, preservative, pigment and purified water to be made Sustained release suspension oral formulations, improve the biddability of patient's medication, solve children, old man and have the compliance of dysphagia patients Property, due to adding flavouring, it is particularly suitable for children taking.Preparation of the invention drug release stabilization, to the excitant of intestines and stomach more It is small, can be high 12 hours close to constant speed release medicine, bioavilability.
Specific embodiment
In order that those skilled in the art more fully understands technical scheme, with reference to embodiment to this hair It is bright to be described in further detail.
Embodiment 1:
Prescription:
Preparation technology:
Step 1 takes the styrene cationic ion-exchange resin of recipe quantity, and 100 are crossed after suitably being embathed with 30% ethanol water Mesh wet screening, drying;Take in ambroxol hydrochloride and dried resin addition purified water, water removal is placed in being done in 70 DEG C of baking ovens after question response It is dry.
Step 2 takes ethyl cellulose and diethyl phthalate is leached in 85% appropriate ethanol water, uses this The ambroxol resin that solution is obtained to step 1 is coated:Ambroxol resin is placed in fluidized-bed coating machine, starts fluidisation Bed, with prepared coating solution to the ambroxol coated granule obtained by its top spray coating, collection.
Step 3 sequentially adds appropriate purified water, Hydroxypropyl methylcellulose, sucrose, glycerine, citric acid, oxybenzene in a reservoir Ethyl ester, amaranth, essence, fully stirring, mixing, are subsequently adding ambroxol coated granule, stir and evenly mix, and are eventually adding purified water To full dose, obtain final product.
Embodiment 2:
Prescription:
Preparation technology:
Step 1 takes the propylene weak acid cation exchange resin of recipe quantity, and 80 mesh are crossed after suitably being embathed with 25% ethanol water Wet screening, drying;Take in ambroxol hydrochloride and dried resin addition purified water, water removal is placed in being dried in 60 DEG C of baking ovens after question response.
Step 2 takes cellulose acetate and dibutyl sebacate is leached in 80% appropriate ethanol water, uses this solution The ambroxol resin obtained to step 1 is coated:Ambroxol resin is placed in fluidized-bed coating machine, starts fluid bed, used Prepared coating solution is to the ambroxol coated granule obtained by its top spray coating, collection.
Step 3 sequentially add in a reservoir appropriate purified water, Hydroxypropyl methylcellulose, glycerine, sorbic acid, aspartame, Methyl hydroxybenzoate, Nipasol, lemon yellow, essence, fully stirring, mixing, are subsequently adding ambroxol coated granule, stir and evenly mix, Purified water to full dose is eventually adding, is obtained final product.
Embodiment 3:
Prescription:
Preparation technology:
Step 1 takes the styrene cationic ion-exchange resin and propylene weak acid cation exchange resin of recipe quantity, uses 50% ethanol The aqueous solution crosses 80 mesh wet screenings, drying after suitably embathing;Take in ambroxol hydrochloride and dried resin addition purified water, removed water after question response It is placed in being dried in 45 DEG C of baking ovens.
Step 2 insect-taking glue and triethyl citrate are leached in 87% appropriate ethanol water, with this solution to step The 1 ambroxol resin for obtaining is coated:Ambroxol resin is placed in fluidized-bed coating machine, starts fluid bed, with prepared Coating solution to its top spray be coated, collect obtained by ambroxol coated granule.
Step 3 sequentially adds appropriate purified water, tragacanth, high fructose corn syrup, malic acid, benzene first in a reservoir Sour sodium, famille rose, stirring, fully mix, and are subsequently adding ambroxol coated granule, stir and evenly mix, and are eventually adding purified water to complete Amount, obtains final product.
Embodiment 4:
Prescription:
Preparation technology:
Step 1 takes the metering system weak acid cation exchange resin of recipe quantity, mistake after suitably being embathed with 35% ethanol water 100 mesh wet screenings, drying;Take in ambroxol hydrochloride and dried resin addition purified water, water removal is placed in 70 DEG C of baking ovens after question response Dry.
Step 2 takes polyvinyl acetate phthalic acid ester and dibutyl sebacate, triethyl citrate are leached in appropriate In 90% ethanol water, the ambroxol resin obtained to step 1 with this solution is coated:Ambroxol resin is placed in fluidisation In bed seed-coating machine, start fluid bed, with prepared coating solution to the ambroxol coated granule obtained by its top spray coating, collection.
Step 3 sequentially adds appropriate purified water, xanthans, sucrose, mannitol, potassium citrate, benzene first in a reservoir Acid, ethyl hydroxy benzoate, sunset yellow, essence, fully stirring, mixing, are subsequently adding ambroxol coated granule, stir and evenly mix, and finally add Enter purified water to full dose, obtain final product.
Embodiment 5:
Prescription:
Preparation technology:
Step 1 takes the styrene cationic ion-exchange resin of recipe quantity, and 80 mesh are crossed after suitably being embathed with 40% ethanol water Wet screening, drying;Take in ambroxol hydrochloride and dried resin addition purified water, water removal is placed in being dried in 60 DEG C of baking ovens after question response.
Step 2 takes butanedioic acid acetic acid HPMC and Macrogol 4000 is leached in 80% appropriate ethanol water In solution, the ambroxol resin obtained to step 1 with this solution is coated:Ambroxol resin is placed in fluidized-bed coating machine In, start fluid bed, with prepared coating solution to the ambroxol coated granule obtained by its top spray coating, collection.
Step 3 sequentially add in a reservoir appropriate purified water, sodium carboxymethylcellulose, PVP K90, Mannitol, maltose, sodium citrate, benzoic acid, the red, lemon yellow of temptation, essence, stirring, fully mixing are subsequently adding ambroxol Coated granule, stirs and evenly mixs, and is eventually adding purified water to full dose, obtains final product.
Extracorporeal releasing test:
Subjects:Inventive samples and commercially available ambroxol hydrochloride oral liquid in above-described embodiment 1.
Content of the test:Release data of both contrasts under different sample times.
Testing conditions:According to ultraviolet-visible light photometry (two annex IVA of Chinese Pharmacopoeia version in 2015), in the ripple of 248nm Strong point mensuration absorbance.
Dissolution medium:0.5M KCl 900ml.
Dissolution determination method:According to two annex release degree the first methods of determination method of Chinese Pharmacopoeia 2015 edition, using dissolution The degree subtraction unit of determination method second, rotating speed is 75 turns per minute, samples 15ml (samplings at 1 hour, 4 hours and 12 hours respectively Simultaneously not to supplementing dissolution medium in solution), filtration, precision is measured during subsequent filtrate 10ml puts 50ml measuring bottles, plus purified water is to carving Degree, shakes up, and determines trap.Another 80 DEG C of drying under reduced pressure of learning from else's experience are appropriate to the ambroxol hydrochloride reference substance of constant weight, accurately weighed, plus Water is made in every 1ml the solution containing about 75ug, is measured in the same method, and calculates the dissolution rate of each sample under different dissolution times.Knot Fruit see the table below:
The preferred embodiment for the present invention is the foregoing described, so it is not limited to the present invention.Those skilled in the art couple Embodiment disclosed herein can carry out the improvement without departing from scope and spirit.

Claims (10)

1. a kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm, it is characterised in that the preparation by ambroxol coated granule and Suspending system is constituted, by weight percentage:Ambroxol coated granule is 0.5%~10%, and suspending system is 90%~99.5%;
The ambroxol coated granule includes ambroxol, ion exchange resin, coating material and plasticizer;The suspending system bag Include suspending agent, flavouring, PH conditioning agents, preservative, pigment and purified water.
2. sustained release mixed suspension preparation according to claim 1, it is characterised in that ion exchange resin selects styrene cation Exchanger resin, propylene weak acid cation exchange resin, metering system weak acid cation exchange resin, it is described in one or more Mixture.
3. sustained release mixed suspension preparation according to claim 1, it is characterised in that coating material selects ethyl cellulose, acetic acid Cellulose, shellac, polyvinyl acetate phthalic acid ester, butanedioic acid acetic acid HPMC, it is described in one or two with On mixture.
4. sustained release mixed suspension preparation according to claim 1, it is characterised in that plasticizer from dibutyl phthalate, Diethyl phthalate, Macrogol 4000, dibutyl sebacate, triethyl citrate, it is described in one or more Mixture.
5. sustained release mixed suspension preparation according to claim 1, it is characterised in that suspending agent selects Hydroxypropyl methylcellulose, methyl Cellulose, sodium carboxymethylcellulose, glycerine, xanthans, tragacanth, PVP K90, microcrystalline cellulose, marine alga Sour sodium, Carbomer, it is described in one or more mixture.
6. sustained release mixed suspension preparation according to claim 1, it is characterised in that flavouring selects sucrose, mannitol, Gao Guoyu Rice syrup, maltose, fructose, aspartame, essence, it is described in one or more mixture.
7. sustained release mixed suspension preparation according to claim 1, it is characterised in that PH conditioning agents from citric acid, sodium citrate, Potassium citrate, sorbic acid, lactic acid, malic acid, it is described in one or more mixture.
8. sustained release mixed suspension preparation according to claim 1, it is characterised in that preservative from methyl hydroxybenzoate, ethyl hydroxy benzoate, Nipasol, butyl hydroxybenzoate, benzoic acid, Sodium Benzoate, it is described in one or more mixture.
9. sustained release mixed suspension preparation according to claim 1, it is characterised in that pigment selects amaranth, famille rose, temptation Red, quinoline yellow, lemon yellow, sunset yellow, bright basket, indigo basket, it is described in one or more mixture.
10. it is according to claim 1 sustained release mixed suspension preparation preparation method, it is characterised in that:
Step 1 takes appropriate ion exchange resin, 80~100 mesh wet screenings is crossed after suitably being embathed with 15~50% ethanol waters, is dried It is dry;Take in ambroxol hydrochloride and dried resin addition purified water, water removal is placed in being dried in 30 DEG C~70 DEG C baking ovens after question response;
Step 2 takes coating material and plasticizer is leached in 80~90% appropriate ethanol waters, with this solution to step 1 The ambroxol resin for obtaining is coated:Ambroxol resin is placed in fluidized-bed coating machine, starts fluid bed, with prepared Coating solution is to the ambroxol coated granule obtained by its top spray coating, collection;
Step 3 sequentially adds purified water, suspending agent, flavouring, PH conditioning agents, preservative, pigment in suitable container, stirs Mix, fully mix, be subsequently adding ambroxol coated granule, stir and evenly mix, be eventually adding purified water to full dose.
CN201611242931.8A 2016-12-25 2016-12-25 A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof Pending CN106727301A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201611242931.8A CN106727301A (en) 2016-12-25 2016-12-25 A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201611242931.8A CN106727301A (en) 2016-12-25 2016-12-25 A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof

Publications (1)

Publication Number Publication Date
CN106727301A true CN106727301A (en) 2017-05-31

Family

ID=58923732

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201611242931.8A Pending CN106727301A (en) 2016-12-25 2016-12-25 A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof

Country Status (1)

Country Link
CN (1) CN106727301A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109771372A (en) * 2019-03-26 2019-05-21 江苏四环生物制药有限公司 A kind of dextromethorphan hydrobromide sustained-release suspension and preparation method thereof
CN114129514A (en) * 2021-11-15 2022-03-04 华萃国际生物科技(广东)有限公司 Suspension drop and preparation method and application thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1546008A (en) * 2003-12-02 2004-11-17 沈阳药科大学 Ambroxol hydrochloride liquid sustained release preparation and preparation method thereof
CN105663038A (en) * 2016-02-03 2016-06-15 北京诺康达医药科技有限公司 Liquid slow-release preparation and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1546008A (en) * 2003-12-02 2004-11-17 沈阳药科大学 Ambroxol hydrochloride liquid sustained release preparation and preparation method thereof
CN105663038A (en) * 2016-02-03 2016-06-15 北京诺康达医药科技有限公司 Liquid slow-release preparation and preparation method thereof

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
刘宏飞 等: "盐酸氨溴索药物树脂混悬剂的制备及物理稳定性的研究", 《中国新药杂志》 *
曾环想 等: "右美沙芬树脂口服缓释混悬液的制备及其释药特性研究", 《中国新药杂志》 *
许真玉 等: "离子交换树脂控释混悬剂的研究进展", 《沈阳药科大学学报》 *
顾觉奋: "离子交换树脂药物载体在给药系统中的应用", 《离子交换与吸附》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109771372A (en) * 2019-03-26 2019-05-21 江苏四环生物制药有限公司 A kind of dextromethorphan hydrobromide sustained-release suspension and preparation method thereof
CN114129514A (en) * 2021-11-15 2022-03-04 华萃国际生物科技(广东)有限公司 Suspension drop and preparation method and application thereof

Similar Documents

Publication Publication Date Title
AU2014305430B2 (en) Application of andrographolide in the preparation of a pharmaceutical for treatment of inflammatory bowel disease, andrographolide enteric targeting micropellet, and method for preparation thereof
CN101836952A (en) Ambroxol injection and preparation method thereof
WO2006030297A1 (en) Taste masked granules comprising clarithromycin, hydrocolloids and a coating
CN106963777B (en) Preparation method and application of baicalin-berberine compound
CN106727301A (en) A kind of sustained release mixed suspension preparation of breathing problem eliminating the phlegm and preparation method thereof
CN102008667B (en) Preparation method for traditional Chinese medicine composition with antibacterium and antiphlogosis efficacies
CN103479583B (en) Potassium sodium dehydroandroan drographolide succinate enteric dry suspension and preparation method thereof
CN102908331A (en) Duloxetine hydrochloride enteric capsules and preparation method thereof
CN114272213A (en) Florfenicol powder and preparation method thereof
CN104922140B (en) A kind of tylonolide composition and its application in treating or preventing fowl upper disease
CN101869595A (en) Preparation method and quality detection method of liquorice and gall oral liquid
CN107362354A (en) A kind of oral insulin nanometer formulation and preparation method thereof
CN106727302A (en) A kind of sustained release preparation for kobadrin and preparation method thereof
CN106389562A (en) Pudilan Xiaoyan granules, preparation method thereof, and product quality control method
CN107019739A (en) Blue oral liquid of a kind of cordate houttuynia a kind of reed mentioned in ancient books and preparation method thereof and product quality control method
CN104069133B (en) A kind of water solublity Lachnum melanin and the purposes as decorporation lead medicine thereof
CN102579536A (en) Enteric Panax Notoginseng total saponin preparation and preparation method thereof
CN106361718B (en) The colon target biology adhesion tablet of monosialotetrahexose ganglioside sodium
CN113413402B (en) Application of plum blossom extract in preparation of medicine for treating helicobacter pylori infection disease
CN104721234A (en) Periplaneta Americana extract product ion-activated in-situ gel and preparation method thereof
CN102600210B (en) A kind of compound DM Cough agent and preparation method thereof
CN107056959A (en) Jerusalem artichoke moderate resistance HSV 1, the composition of RSV, EV 71 and preparation
CN103301074B (en) Diammonium glycyrrhizinate enteric-coated pellet as well as preparation method and preparation thereof
WO2017157922A1 (en) Prolonged release pharmaceutical composition comprising cysteamine or salt thereof
CN106265684A (en) The application of Lupenyl acetate

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20170531

RJ01 Rejection of invention patent application after publication