CN101011360A - Recipe composition of dry turbid agent and its preparation process - Google Patents
Recipe composition of dry turbid agent and its preparation process Download PDFInfo
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Abstract
The invention relates to a method for preparing dry mixture suspending agent, comprising 0.1-35.0% active components, 29.0-99.3% shaping agents, and 0.05-36.4% suspending agents. The preparation comprises that selecting the shaping agents, arranging the shaping agents, holing agents, and disintegration agent into the water to obtain suspending medium; adding active component into suspending medium to obtain the mixture suspending solution; arranging the shaping agent into fluid bed, atomizing drug mixed suspending solution, and drying. Compared with present technique, the invention contains suspending agent, without block and tacky contacted with water. The fluid bed can quickly dry material, with high efficiency and low cost.
Description
Technical field
The prescription that the present invention relates to a kind of pharmaceutical preparation is formed and preparation method thereof, and particularly a kind of prescription of dry suspension is formed and preparation method thereof.
Background technology
Dry suspension is a kind ofly to have more the fine particles dosage form of advantage than solid dosage formss such as tablets, and it is big at the gastrointestinal distribution area, absorb fast, bioavailability height, the shortcoming that can avoid the tablet difficulty to swallow simultaneously.It is slow that it has not only changed the conventional tablet oral absorption, is unfavorable for the shortcoming that old man, child and dysphagia person take, and easily obey quick-dissolving characteristics by medicine, and making it in vivo can faster better performance curative effect of medication.Dry suspension stores with solid form, and oral with the confession of suspension form, therefore is particularly suitable for hydrolabil medicine; Applicable child of dry suspension and part have the adult of dysphagia, are a kind of dosage forms that is worth research and development.
The preparation method of prior art dry suspension mainly contains two kinds: a kind of is with packing behind medicine and the adjuvant mix homogeneously, and this method preparation is simple, but powder flowbility difference and easily layering; Another kind is a wet granulation process, and the preparation method of the at present domestic dry suspension that discloses mostly is wet granulation process greatly, and this method is granulated and had easily problems such as the easily crisp broken and powder of long, granule of caking, particle drying time is more.As:
The prescription of dry suspension is formed and is comprised suspending agent and correctives, the at present domestic prescription that discloses several dry suspension is formed: 1. the publication number of Fan Minhua is CN1682739, dry suspension of disclosed a kind of azithromycin and preparation method thereof, prescription comprises azithromycin 0.1～20%, lubricated fluidizer 1～10%, pH value regulator 0.1～10%, polymer binder 10～40%, sweeting agent 50～85% and fragrant correctives 0.5～15%.2. the disclosed cefadroxil dry suspension of publication number CN1682739 and the preparation method of Ouyi Pharmaceutical Industry Co., Ltd., Shijiazhuang Pharmaceutical Group, the content of unit meter in the prescription total amount is as follows by weight for each main materials and auxiliary materials: cefadroxil 80～120%, inclusion agents 16～60%, water-soluble filler 440～520%, disintegrating agent 55～70%, suspending agent 5～10%, binding agent 30～45%.3. Li Jie's publication number is CN1616102, compound dried suspension and the prescription and the preparation method of disclosed treatment flu, every bag contains acetaminophen 0～300mg, best 100～250mg in this suspensoid prescription, pseudoephedrine hydrochloride 5～40mg, best 15～30mg, dextromethorphan hydrobromide 0～20mg, best 5～15mg, diphhydramine hydrochloride 0～30mg, best 5～25mg, chlorphenamine maleate 0～3mg, best 1～2mg, guaifenesin 0～250mg, best 50～200mg.Also contain total consumption and be recipe quantity 0.5～4%, best 1%～3% thickening agent and suspending agent and 60～98%, best 75～95% fragrant correctives.4. the publication number of Zhongshan Baiwen Science ﹠ Technology Co., Ltd is CN1593448, disclosed clarithromycin dry suspension and preparation method thereof comprises the material of following weight portion: 6.25 parts of clarithromycins, carbomer or (with) 3～10 parts of polyvidones, 5～15 parts of hydroxypropyl methylcellulose phthalates, 0.5～1.5 part of xanthan gum, 50～60 parts in mannitol, 10～20 parts of maltodextrins, 1 part of micropowder silica gel, 0.2～1.0 part of citric acid.The dry suspension of above-mentioned patent disclosure prescription all adopts wet granulation technology, the shape of prepared dry suspension and particle diameter heterogeneity, and layering easily, thus the loading amount fluctuation is big when causing packing; Some granule is easily broken, and powder is more; Some granule dissolves slowly, and suspension ability is bad.In addition, easily lump when above-mentioned process is granulated, the particle drying time is longer, and product yield is low, production cost is higher.
Summary of the invention
The prescription that the purpose of this invention is to provide a kind of dry suspension is formed and preparation method thereof, and the technical problem that solve is to avoid caking phenomenon, reduces production costs and enhances productivity.
The present invention is by the following technical solutions: a kind of prescription of dry suspension is formed, and the prescription of described dry suspension is formed the weight ratio component that comprises and is: active constituents of medicine 0.1%～35.0%, excipient 29.0%～99.3%, suspending agent 0.05%～36.4%.
Dry suspension of the present invention contains porogen greater than 0～35.0%.
Dry suspension of the present invention contains disintegrating agent greater than 0～12.0%.
Dry suspension of the present invention contains that defoamer is an amount of, surfactant is an amount of, buffer salt is an amount of, correctives is an amount of, coloring agent is an amount of.
Active constituents of medicine of the present invention is appoint in his magnesium ester of cefaclor, clarithromycin, amoxicillin, clavulanate potassium, cefixime, cefprozil, loratadine, Acetylmidecamycin, Acetylkitasamycin, azithromycin, ibuprofen, Roxithromycin, cefradine, Cefpodoxime Proxetil, hydrochloric acid cephalo, cefalexin, ampicillin, the acetaminophen a kind of or two kinds.
Excipient of the present invention be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds.
Suspending agent of the present invention be in xanthan gum, arabic gum, tragcanth, carbomer, polyvidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropylmethyl cellulose phthalate, polyacrylic resin, polyvinyl alcohol, Polyethylene Glycol or the chitin any or more than two kinds.
Porogen of the present invention be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Disintegrating agent be in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, starch, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose any or more than two kinds; Defoamer is selected any or two kinds in silicone oil, the simethicone for use; Surfactant is selected any or two kinds in sodium lauryl sulphate, the polyoxyethylene sorbitan monoleate for use; Buffer salt adopts acetic acid-sodium acetate buffer salt, citric acid-trisodium citrate buffer salt, Borax-sodium carbonate buffer salt, boric acid-potassium chloride buffer salt, phosphate buffer salt etc.; Correctives is selected pressed powder essence for use: Fructus Fragariae Ananssae powdered flavor, Fructus Pruni pseudocerasi powdered flavor, Fructus Citri tangerinae powdered flavor and Fructus Mangifera Indicae powdered flavor, liquid essence: Fructus Fragariae Ananssae liquid essence, Fructus Mali pumilae liquid essence, Fructus Musae liquid essence, chocolate liquid essence, Rhizoma et radix valerianae liquid essence and Fructus Mangifera Indicae liquid essence, saccharin sodium, aspartame, sucrose, mannitol, stevioside; Coloring agent has pigment or color ingot: red pigments, xanthein, brown pigmentation, sunset yellow aluminum color ingot.
A kind of preparation method of dry suspension may further comprise the steps: one, sieve is got the excipient of 30～65 order particle diameters, oven dry; Two, by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, place suitable quantity of water, stir 1～4 hour, obtain the suspending medium to evenly; Three, active constituents of medicine 0.1%～35.0% is added in the suspending medium, stir, promptly get drug suspension; Four, by weight excipient 29.0%～99.3% is placed in the fluid bed, spray drug suspension thereon, medicine-feeding finishes particle drying.
Method of the present invention adds buffer salt, correctives, the coloring agent of routine dose by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0% when placing water.
Method of the present invention spraying medicine finishes, and correctives, the colourant solution of routine dose evenly is sprayed on particle surface.
Method of the present invention spraying medicine finishes, and the correctives solution of routine dose evenly is sprayed on particle surface.
Method of the present invention adds emulsion by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0% when placing water.
Method emulsion of the present invention is for to make defoamer and surfactant emulsifying in mulser of routine dose.
When method of the present invention adds active constituents of medicine 0.1%～35.0% in the suspending medium, add emulsion.
Method Chinese medicine active component of the present invention is any or two kinds in his magnesium ester of cefaclor, clarithromycin, amoxicillin, clavulanate potassium, cefixime, cefprozil, loratadine, Acetylmidecamycin, Acetylkitasamycin, azithromycin, ibuprofen, Roxithromycin, cefradine, Cefpodoxime Proxetil, hydrochloric acid cephalo, cefalexin, ampicillin, the acetaminophen; Described excipient be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Suspending agent is any or two kinds in xanthan gum, arabic gum, tragcanth, carbomer, polyvidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropylmethyl cellulose phthalate, polyacrylic resin, polyvinyl alcohol, Polyethylene Glycol or the chitin; Porogen be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Disintegrating agent be in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, starch, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose any or more than two kinds; Defoamer is selected any or two kinds in silicone oil, the simethicone for use; Surfactant is selected any or two kinds in sodium lauryl sulphate, the polyoxyethylene sorbitan monoleate for use; Buffer salt adopts acetic acid-sodium acetate buffer salt, citric acid-trisodium citrate buffer salt, Borax-sodium carbonate buffer salt, boric acid-potassium chloride buffer salt, phosphate buffer salt etc.; Correctives is selected pressed powder essence for use: Fructus Fragariae Ananssae powdered flavor, Fructus Pruni pseudocerasi powdered flavor, Fructus Citri tangerinae powdered flavor and Fructus Mangifera Indicae powdered flavor etc., liquid essence: Fructus Fragariae Ananssae liquid essence, Fructus Mali pumilae liquid essence, Fructus Musae liquid essence, chocolate liquid essence, Rhizoma et radix valerianae liquid essence and Fructus Mangifera Indicae liquid essence, saccharin sodium, aspartame, sucrose, mannitol, stevioside; Coloring agent has pigment or color ingot: red pigments, xanthein, brown pigmentation, sunset yellow aluminum color ingot.
The present invention compared with prior art, contain suspending agent in the dry suspension, caking does not appear in the granulation, avoid meeting the sticking phenomenon of waterishlogging, conservation adopts fluid bed dried material apace, shortens preparation process time, solve a series of problems that occur in the wet-granulation process by fluidization simultaneously, for example granulate and easily lump, the granule that makes is frangible, the deficiency that grain shape and particle diameter differ, improved production efficiency, reduce the dry suspension cost, the uniform particles that makes is attractive in appearance, granule is solid, epigranular, dissolve very fast, mobile fine, good mouthfeel is fit to suitability for industrialized production.
The specific embodiment
Below in conjunction with embodiment the present invention is described in further detail.The prescription of dry suspension of the present invention is formed, and by weight component is: active constituents of medicine 0.1%～35.0%, excipient 29.0%～99.3%, suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, defoamer is an amount of, surfactant is an amount of, buffer salt is an amount of, correctives is an amount of, coloring agent is an amount of.
Wherein, described active constituents of medicine is any or two kinds in his magnesium ester of cefaclor, clarithromycin, amoxicillin, clavulanate potassium, cefixime, cefprozil, loratadine, Acetylmidecamycin, Acetylkitasamycin, azithromycin, ibuprofen, Roxithromycin, cefradine, Cefpodoxime Proxetil, hydrochloric acid cephalo, cefalexin, ampicillin, the acetaminophen; Described excipient be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Suspending agent is any or two kinds in xanthan gum, arabic gum, tragcanth, carbomer, polyvidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropylmethyl cellulose phthalate, polyacrylic resin, polyvinyl alcohol, Polyethylene Glycol or the chitin; Porogen be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Disintegrating agent be in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, starch, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose any or more than two kinds; Defoamer is selected any or two kinds in silicone oil, the simethicone for use; Surfactant is selected any or two kinds in sodium lauryl sulphate, the polyoxyethylene sorbitan monoleate for use; Buffer salt adopts acetic acid-sodium acetate buffer salt, citric acid-trisodium citrate buffer salt, Borax-sodium carbonate buffer salt, boric acid-potassium chloride buffer salt, phosphate buffer salt; Correctives is selected pressed powder essence for use: Fructus Fragariae Ananssae powdered flavor, Fructus Pruni pseudocerasi powdered flavor, Fructus Citri tangerinae powdered flavor and Fructus Mangifera Indicae powdered flavor, liquid essence: Fructus Fragariae Ananssae liquid essence, Fructus Mali pumilae liquid essence, Fructus Musae liquid essence, chocolate liquid essence, Rhizoma et radix valerianae liquid essence and Fructus Mangifera Indicae liquid essence, saccharin sodium, aspartame, sucrose, mannitol, stevioside; Coloring agent has pigment or color ingot: red pigments, xanthein, brown pigmentation, sunset yellow aluminum color ingot.
Active constituents of medicine is a therapeutic substance, the composition of performance drug effect.Above-mentioned listed active constituents of medicine is a beta-lactam antibiotic, macrolide antibiotics, antipyretic analgesic.
Excipient is the carrier of medicine, works to support active constituents of medicine.
Suspending agent can increase the sedimentation velocity of the viscosity of disperse medium with the reduction microgranule, or for increasing the hydrophilic additives of microgranule.
Porogen is met water dissolution, forms the duct, and medicine can discharge by passing hole channel, accelerates the stripping of medicine.
Disintegrating agent makes the quick disintegrate of medicine, accelerates the stripping of medicine.
Defoamer reduces surface tension of liquid, eliminates and stirs the foam that fusion process produces.Surfactant has stronger hydrophilic group and lipophilic group, plays stronger emulsification.Buffer salt is regulated the pH value of suspensoid.The bad stink of preparation is covered and corrected to correctives, plays flavoring and rectify smelly effect, makes patient particularly the child is glad to take.Coloring agent can improve appearance color, improves compliance of patients.
The prescription of dry suspension of the present invention is formed, except the suspending agent of routine, also contain excipient, porogen, disintegrating agent etc., wherein excipient plays the granulating central role, porogen plays the promotion solvation, disintegrating agent plays the accelerate dissolution effect, thereby dry suspension better quality, the cost more prepared than prior art are lower.The prepared dry suspension of preparation method of the present invention has grain shape and color and luster, and attractive in appearance evenly medicine dissolves soon, absorbs more fully, and physics and chemical stability are good, and mouthfeel and abnormal smells from the patient are good, taking convenience, characteristics such as patient's compliance is strong.
The preparation method of dry suspension of the present invention may further comprise the steps: one, sieve is got the excipient of 30～65 order particle diameters, in Chongqing immortality experimental apparatus factory, 60 ℃ of oven dry of model C S101-3E electric drying oven with forced convection; Two, with the defoamer of routine dose and surfactant at Fluko, emulsion is made in emulsifying in the model FA25 mulser; Three, by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, the correctives of routine dose, coloring agent, buffer salt place suitable quantity of water, use EYELA, model Z-2100 electric blender stirs 1～4 hour to evenly, obtains the suspending medium; Four, active constituents of medicine 0.1%～35.0% and emulsion are added in the suspending medium, EYELA, model Z-2100 electric blender stirs, and promptly gets drug suspension; Five, by weight excipient 29.0%～99.3% being placed German GLATT company, in the model GPCG1.1 fluid bed, the spraying drug suspension thereon, medicine-feeding finishes granule is continued drying in fluid unit.
Above-mentioned preparation method is simple to operate, but coloring agent large usage quantity, and the chemical property less stable of some coloring agent own, being easy to influences color and luster with other substance reactions, at this kind situation, can also adopt another preparation method, it may further comprise the steps: one, sieve is got the excipient of 30～65 order particle diameters, oven dry; Two, emulsion is made in the emulsifying in mulser with routine dose defoamer and surfactant; Three, by weight suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, the correctives of routine dose, buffer salt are placed water, stir 1～4 hour to evenly, obtain the suspending medium with electric blender; Four, emulsifying agent, active constituents of medicine are added in the suspending medium by weight 0.1%～35.0%, electric blender stirs, and promptly gets drug suspension; Five, by weight excipient 29.0%～99.3% is placed in the fluid bed, the spraying drug suspension thereon; Six, the coloring agent wiring solution-forming with routine dose evenly is sprayed on particle surface, drying; Seven, the correctives, the mix homogeneously that add routine dose, promptly.This method coloring agent consumption is less, and coloring agent concentrates on particle surface, reduced the contact area with other materials, so color is comparatively stable, and is not easy to change.The dry suspension good fluidity that makes thus, epigranular, bright in color is more suitable for big commercial production.Also can when adding in the suspending medium, active constituents of medicine 0.1%～35.0% add emulsion.
Adopt the dry suspension of method of the present invention preparation, be the grain shape of certain particle size, appearance colour and mouthfeel can be adjusted flexibly, and it is good to have physics and chemical stability, and granule dissolves soon, taking convenience, absorb more abundant, the characteristics that patient's compliance is strong.This product places room temperature or shady and cool place to store, and taking after mixing it with water with warm water when taking gets final product.
Embodiment 1, prepares 200 bags of cefaclor dry suspension, specification: cefaclor 125mg/ bag, and component is:
| The composition title | Content | Weight ratio |
| Cefaclor | 28.2g | 4.45％ |
| Sucrose | Excipient 575g, porogen 25g | Excipient 90.71%, porogen 3.94% |
| Xanthan gum | 1.6g | 0.25％ |
| Methylcellulose | 0.5g | 0.08％ |
| Simethicone | 1.2g | 0.19％ |
| Sodium lauryl sulphate | 0.3g | 0.05％ |
| Correctives (Fructus Fragariae Ananssae powdered flavor) | 2.0g | 0.32％ |
| Coloring agent (red No. 3) | 0.11g | 0.017％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | 0.99 | |
| PH value (Chinese Pharmacopoeia cefaclor dry suspension pH value assay method) | 4.18 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 35 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 40～60 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, sodium lauryl sulphate is dissolved with 10 times of purified water to the simethicone amount, add simethicone again, stirred 2 minutes, get the silicon emulsion with blender.Three, xanthan gum, methylcellulose, 25g sucrose are put in the beaker, these three kinds of mixing of materials are evenly added the 200ml purified water in the back, stir with electric blender and made abundant dissolving in 1 hour, add cefaclor active constituents of medicine, silicon emulsion again, stir.Four, 575g sucrose excipient granule is placed in the fluid bed drug suspension spraying medicine-feeding.Five, medicine-feeding finishes, and pigment solution evenly is sprayed on particle surface, drying.Six, the Fructus Fragariae Ananssae powdered flavor is added in the granule, mixing, promptly.
Wherein, fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when temperature of charge is 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 25～30rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 45～48 ℃, finishes until medicine-feeding.
(3) dry (drying):
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3～5min is to 50 ℃ of temperature of charge.
(4) go up pigment (spraying): spray into pigment solution (0.11g pigment 20mL water dissolution), medicine-feeding rotating speed 7rpm.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
(5) dry (drying): parameter is with (3) step, and dry 3～5min is to 50 ℃ of materials.
(6) cooling (cooling):
Air quantity (Air flow) 70m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to material surface temperature near 25 ℃ of room temperatures.
Because the medicine-feeding process temperature is higher, for fear of the loss of medicine-feeding process Fructus Fragariae Ananssae powdered flavor, present embodiment adds essence, and the cefaclor dry suspension color and luster of gained is vivid, gas fragrance, and it is sweet to distinguish the flavor of, and is particularly suitable for the child and partly has the adult of dysphagia to take.Usage: take after mixing it with water with warm water.Consumption: adult, a 0.25g, three times on the one; Children's by body weight 20～40mg/ day on the one, divides to give for 3 times.
Embodiment 2, the preparation clarithromycin dry suspension, and specification: clarithromycin 125mg/ bag, component is:
| The composition title | Content | Weight ratio |
| Clarithromycin | 125g | ?12.55％ |
| Sucrose | 665g | ?66.79％ |
| Amylum pregelatinisatum | 100g | ?10.04％ |
| Carbomer | 5g | ?0.50％ |
| Correctives (saccharin sodium) | 0.108g | ?0.01％ |
| Correctives (stevioside) | 100g | ?10.04％ |
| Correctives (Fructus Citri tangerinae liquid essence) | 0.6g | ?0.06％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?0.95 | |
| Melting (the about allusion quotation soluble particles melting inspection method of China) | Dissolved in 60 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 40～60 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, carbomer, stevioside, amylum pregelatinisatum, saccharin sodium are placed the 300mL purified water, stirred 3 hours, add clarithromycin again, stir with electric blender.Three, the sucrose excipient is placed in the fluid bed, drug suspension spraying medicine-feeding, drying, promptly.Four, spray into the Fructus Citri tangerinae liquid essence at low temperatures.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 25-35rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 45～50 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3～5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 70m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
(5) spray into essence (spraying): spray into the Fructus Citri tangerinae liquid essence, medicine-feeding rotating speed 10rpm.
Air quantity (Air flow) 80m
3/ h
25 ℃ of inlet temperature (Air temp)
The Fructus Citri tangerinae liquid essence sprays at low temperatures, has guaranteed making full use of of liquid essence.The clarithromycin dry suspension color and luster of gained is vivid, and it is sweet to distinguish the flavor of, and is particularly suitable for the child and partly has the adult of dysphagia to take.Usage: take after mixing it with water with warm water.Consumption: adult, 0.25g of usual amounts, twice on the one; 0.5g of severe infection person, twice on the one; The child divided and takes for 2～3 times by body weight 10～15mg/kg administration on the 1st; Or follow the doctor's advice.
Embodiment 3, preparation amoxicillin and clavulanate potassium dry suspension, and amoxicillin: clavulanate potassium=7:1, specification: amoxicillin 0.2g/ bag, clavulanate potassium 28.5mg/ bag, component is:
| The composition title | Content | Weight ratio |
| The amoxicillin | 80.0g | ?13.05％ |
| Clavulanate potassium | 11.4g | ?1.86％ |
| Xanthan gum | 4.5g | ?0.73％ |
| Hypromellose | 15.9g | ?2.59％ |
| Sucrose | 500g | ?81.54％ |
| Correctives (saccharin sodium) | 1.4g | ?0.23％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?0.99 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 80 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 30～65 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, xanthan gum, hypromellose, saccharin sodium are placed the 600mL purified water, stirred 3 hours, add amoxicillin, clavulanate potassium again, stir with electric blender.Three, the sucrose excipient is placed in the fluid bed, drug suspension spraying medicine-feeding, drying, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 30～65 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 25-35rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40～50 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 70m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
This preparation method is simple to operate, the amoxicillin and clavulanate potassium of gained (7: 1) appearance light, and it is sweet to distinguish the flavor of, and is fit to child and adult and takes.Usage: take after mixing it with water with warm water.
Embodiment 4, preparation cefixime dry suspension, and specification: cefixime 50mg/ bag, component is:
| The composition title | Content | Weight ratio |
| Cefixime | 100.0g | ?7.28％ |
| Mannitol | 400g | ?29.12％ |
| Avicel microcrystalline Cellulose sodium carboxymethyl cellulose (RC-591) | 500g | ?36.41％ |
| Anhydrous citric acid | 140g | ?10.19％ |
| Trisodium citrate | 36g | ?2.62％ |
| Disintegrating agent (cross-linking sodium carboxymethyl cellulose) | 160g | ?11.65％ |
| Correctives (aspartame) | 4.0g | ?0.29％ |
| Defoamer (simethicone) | 1.0g | ?0.07％ |
| Surfactant (sodium lauryl sulphate) | 0.09g | ?0.006％ |
| Surfactant (polyoxyethylene sorbitan monoleate) | 0.5g | ?0.04％ |
| Coloring agent (sunset yellow aluminum color ingot) | 1.8g | ?0.13％ |
| Correctives (Fructus Citri tangerinae powdered flavor) | 30g | ?2.18％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?0.95 | |
| PH value (Chinese Pharmacopoeia cefaclor dry suspension pH value assay method) | ?3.5 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 30 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 30～65 purpose mannitol and is made excipient, 60 ℃ of oven dry.Two, sodium lauryl sulphate is dissolved with 10 times of purified water to the simethicone amount, add simethicone and polyoxyethylene sorbitan monoleate again, stirred 2 minutes, get the silicon emulsion with blender.Three, RC-591, anhydrous citric acid, trisodium citrate, cross-linking sodium carboxymethyl cellulose, Aspartane, sunset yellow aluminum color ingot, Fructus Citri tangerinae powdered flavor are placed the 900mL purified water, stirred 3 hours with electric blender, add cefixime active constituents of medicine and silicon emulsion again, stir.Four, the mannitol excipient is placed in the fluid bed, drug suspension spraying medicine-feeding, drying, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 80m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60～90m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 25～45rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40～45 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 90m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 90m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
This preparation method is owing to will add in the Fructus Citri tangerinae powdered flavor, because temperature is higher, the essence loss is very big, so the cefixime dry suspension granule abnormal smells from the patient of gained in the medicine-feeding process, lemon slightly, and sweet and sour is fit to children taking.Each oral 1 bag of child below usage and dosage: the body weight 30kg makes it to take behind the suspendible twice on the one with about 10ml eliminating cold for resuscitation water; Or by 1.5～3.0mg/kg body weight calculating administration, or follow the doctor's advice.
Embodiment 5, preparation cefprozil dry suspension, and specification: cefprozil 125mg/ bag, component is:
| The composition title | Content | Weight ratio |
| Cefprozil | 25g | ?3.92％ |
| Xanthan gum | 2.0g | ?0.31％ |
| Sucrose | 600g | ?94.22％ |
| Defoamer (simethicone) | 1.0g | ?0.16％ |
| Surfactant (polyoxyethylene sorbitan monoleate) | 0.5g | ?0.08％ |
| Surfactant (sodium lauryl sulphate) | 0.09g | ?0.01％ |
| Coloring agent (red No. 3) | 0.2g | ?0.03％ |
| Correctives (Fructus Pruni pseudocerasi powdered flavor) | 8g | ?1.26％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?0.92 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 60 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 30～50 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, sodium lauryl sulphate is dissolved with 10 times of purified water to the simethicone amount, add simethicone and polyoxyethylene sorbitan monoleate again, stirred 2 minutes, get the silicon emulsion with blender.Three, xanthan gum is placed the 200mL purified water, stirred 3 hours, add silicon emulsion and cefprozil active constituents of medicine again, stir with electric blender.Four, the sucrose excipient is placed in the fluid bed drug suspension spraying medicine-feeding, drying.Five, medicine-feeding finishes, and pigment solution evenly is sprayed on particle surface.Six, add the Fructus Pruni pseudocerasi powdered flavor, mixing, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70 m
3/ h
60 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 25～35rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40-45 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) medicine-feeding (spraying): spray into pigment solution (the 0.2g pigment is dissolved in the 20mL water), medicine-feeding rotating speed 7rpm.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
(5) dry (drying): parameter is with 3) step, dry 3～5min is to 50 ℃ of materials.
(6) cooling (cooling)
Air quantity (Air flow) 70m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
The cefprozil dry suspension grain color of gained is bright-coloured, sweet and sour, and lemon is fit to child and adult and takes.Usage: dash usefulness with warm water.Consumption: the adult, upper respiratory tract infection, each 0.5g, once a day; Lower respiratory infection, each 0.5g, twice of every day; Skin or skin soft-tissue infection, every day, 0.5g divided 1 time or 2 times, the serious each 0.5g of case, every day 2 times; 2 to 12 years old childhood upper respiratory tract infection, each 7.5mg/kg body weight, twice of every day; Skin or skin soft-tissue infection, each 20mg/kg body weight, once a day; 6 months babies to 12 year old child's otitis media, each 15mg/kg body weight, twice of every day; Acute sinusitis, general each 7.5mg/kg body weight, twice of every day.
Embodiment 6, preparation loratadine dry suspension, specification: loratadine 10mg/ bag, and component is:
| The composition title | Content | Weight ratio |
| Loratadine | 2g | ?0.16％ |
| Hydroxypropyl emthylcellulose | 6g | ?0.50％ |
| Lactose | 1200g | ?99.30％ |
| Correctives (aspartame) | 0.4g | ?0.03％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?1.0 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 80 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 30～50 purpose lactose and is made excipient, 60 ℃ of oven dry.Two, hydroxypropyl emthylcellulose, Aspartane are placed the 500mL purified water, stirred 3 hours, add the loratadine active constituents of medicine again, stir with electric blender.Three, the lactose excipient is placed in the fluid bed, drug suspension spraying medicine-feeding, drying, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 100m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 90m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 15-30rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40～45 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 90m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 100m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
The loratadine dry suspension grain forming of gained is good, and mouthfeel is good, has good stability.Usage: take after mixing it with water with warm water.Consumption: the adult, once a day, each 1 bag; 2-12 year child, body weight＞30kg, once a day, each 1 bag; Body weight≤30kg, once a day, each half bag.
Embodiment 7, preparation Acetylmidecamycin dry suspension, and specification: Acetylmidecamycin 100mg/ bag, component is:
| The composition title | Content | Weight ratio |
| Acetylmidecamycin | 100g | ?15.13％ |
| 30 POVIDONE K 30 BP/USP 90 | 60g | ?9.08％ |
| Sucrose | 500g | ?75.64％ |
| Coloring agent (yellow No. 6) | 1g | ?0.15％ |
| Correctives (Fructus Mangifera Indicae liquid essence) | 5ml | |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?0.98 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 80 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, good mouthfeel | |
Preparation technology: one, sieve is got 40～60 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, 30 POVIDONE K 30 BP/USP 90, yellow are placed the 1500mL purified water No. 6, stirred 3 hours, add the Acetylmidecamycin active constituents of medicine again, stir with electric blender.Three, the sucrose excipient is placed in the fluid bed, drug suspension spraying medicine-feeding, drying sprays into the Fructus Mangifera Indicae liquid essence, promptly again.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 80m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 20～45rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 45～50 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3～5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 80m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
(5) spray into essence (spraying): spray into the Fructus Mangifera Indicae liquid essence, medicine-feeding rotating speed 7～10rpm.
Air quantity (Air flow) 60m
3/ h
25 ℃ of inlet temperature (Air temp)
Because add in No. 6, the yellow, the Acetylmidecamycin dry suspension color of gained is more shallow.Gained dry suspension grain forming is good, and gas fragrance is sweet, and any surface finish is attractive in appearance.Usage: take after mixing it with water with warm water.Consumption: children's's per kilogram of body weight every day 30～40mg; 0.6～the 1.2g on the one that is grown up divides and takes for 3～4 times.
Embodiment 8, preparation Roxithromycin dry suspension, and specification: Roxithromycin 25mg/ bag, component is:
| The composition title | Content | Weight ratio |
| Roxithromycin | 6.25g | ?0.62％ |
| Microcrystalline Cellulose | 1000g | ?99.27％ |
| Carbomer | 0.5g | ?0.05％ |
| Disintegrating agent (carboxymethyl starch sodium) | 0.15g | ?0.01％ |
| Coloring agent (brown pigmentation A) | 0.225g | ?0.02％ |
| Correctives (aspartame) | 0.2g | ?0.02％ |
| Correctives (Rhizoma et radix valerianae liquid essence) | 10ml | |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | 0.93 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 30 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, little hardship | |
Preparation technology: one, sieve is got 40～60 purpose microcrystalline Cellulose and is made excipient, 60 ℃ of oven dry.Two, carbomer, carboxymethyl starch sodium, Aspartane, brown pigmentation A are placed the 200mL purified water, stirred 2 hours, add the Roxithromycin active constituents of medicine again, stir with electric blender.Three, the microcrystalline Cellulose excipient is placed in the fluid bed drug suspension spraying medicine-feeding, drying.Four, spray into liquid essence again, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 100m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 90m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 10-15rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40～45 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 90m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3～5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 80m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
(5) spray into essence (spraying): spray into the Rhizoma et radix valerianae liquid essence, medicine-feeding rotating speed 7～10rpm.
Air quantity (Air flow) 90m
3/ h
25 ℃ of inlet temperature (Air temp)
The Roxithromycin dry suspension color and luster of gained is fine, imitative iced black tea color, and granule gas fragrance is sweet, is fit to child and adult and takes.Usage: take after mixing it with water with warm water.Consumption: the 0.15g that is grown up a time, one day twice, or follow the doctor's advice; The child of child 6～11kg, early, evening each 25mg, or follow the doctor's advice; The child of 12～23kg, early, evening each 50mg, or follow the doctor's advice; The child of 24～40kg, early, evening each 100mg, or follow the doctor's advice.
Embodiment 9, preparation cefaclor dry suspension, and specification: cefaclor 1.5g/ bag, component is:
| The composition title | Content | Weight ratio |
| Cefaclor | 225.6g | ?33.08％ |
| Sucrose | 400g | ?58.65％ |
| Xanthan gum | 20.0g | ?2.93％ |
| Methylcellulose | 3.6g | ?0.53％ |
| Disintegrating agent (polyvinylpolypyrrolidone) | 9.6g | ?1.41％ |
| Citric acid | 8.0g | ?1.17％ |
| Trisodium citrate | 8.0g | ?1.17％ |
| Coloring agent (brown pigmentation A) | 7.2g | ?1.05％ |
| Correctives (chocolate liquid essence) | 5ml | |
| Preparation method | Fluidization | |
| Settling volume is than (the about allusion quotation oral suspensions settling volume of China is than inspection method) | 0.94 | |
| PH value (Chinese Pharmacopoeia cefaclor dry suspension pH value assay method) | 3.9 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 30 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is fine | |
Preparation technology: one, sieve is got 40～60 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, will go back virgin rubber, methylcellulose, polyvinylpolypyrrolidone, brown pigmentation A, citric acid, trisodium citrate and place the 1200mL purified water, stir 4 hours, add cefaclor again, stir with electric blender.Three, the sucrose excipient is placed in the fluid bed drug suspension spraying medicine-feeding, drying.Four, spray into liquid essence again, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60～80m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 10-25rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40～45 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 80m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 80m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
(5) spray into essence (spraying): spray into the chocolate liquid essence, medicine-feeding rotating speed 7～10rpm.
Air quantity (Air flow) 80m
3/ h
25 ℃ of inlet temperature (Air temp)
The cefaclor dry suspension abnormal smells from the patient of gained and color are like chocolate.Dry suspension granule flavor is sweet, is fit to child and adult and takes.Usage: take after mixing it with water with warm water.Consumption: adult, a 0.25g, 3 times on the one.The severe infections patient dose is multiplicable, but a daily amount is no more than 4g.Or follow the doctor's advice; Children's by body weight 20～40mg/kg on the one, divide to give for 3 times, but a daily amount is no more than 1g.
Embodiment 10, preparation amoxicillin dry suspension, and specification: amoxicillin 125mg/ bag, component is:
| The composition title | Content | Weight ratio |
| The amoxicillin | 25g | ?3.75％ |
| Sucrose | Excipient 375g, porogen 225g | Excipient 56.29%, porogen 33.78% |
| Methylcellulose | 8g | ?1.20％ |
| Disintegrating agent (carboxymethyl starch sodium) | 25g | ?3.75％ |
| Correctives (sunset yellow aluminum color ingot) | 0.14g | ?0.02％ |
| Correctives (orange powder art essence) | 8g | ?1.20％ |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | 0.98 |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 30 seconds |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, little hardship |
Preparation technology: one, sieve is got 40～60 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, methylcellulose, carboxymethyl starch sodium, sunset yellow aluminum color ingot, Fructus Citri tangerinae powdered flavor, 225g sucrose are placed the 1000mL purified water, stirred 2 hours, add the amoxicillin active constituents of medicine again, stir with electric blender.Three, the sucrose excipient is placed in the fluid bed, drug suspension spraying medicine-feeding, drying, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 40～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0bar
Medicine-feeding rotating speed 20-35rpm
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 45～50 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 60m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 80m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
Since add in the Fructus Citri tangerinae powdered flavor, very big in the loss of medicine-feeding process, so the amoxicillin dry suspension and the odorlessness of gained.Dry suspension granule feeble QI fragrance is sweet, is fit to child and adult and takes.Usage: take after mixing it with water with warm water.Consumption: adult, 500mg of nonspecific infection person, 3～4 times on the one; Serious symptom person adds to 1000mg one time, 3～4 times on the one or follow the doctor's advice; The child, by 6.7～13.3mg/kg of body weight, three times on the one or follow the doctor's advice.
Embodiment 11, preparation ibuprofen dry suspension, and specification: ibuprofen 1.2g/ bag, component is:
| The composition title | Content | Weight ratio |
| Ibuprofen | 240g | ?35.46％ |
| Sucrose | 400g | ?59.10％ |
| Carbomer | 20.0g | ?2.96％ |
| Disintegrating agent (polyvinylpolypyrrolidone) | 9.6g | ?1.42％ |
| Coloring agent (brown pigmentation A) | 7.2g | ?1.06％ |
| Correctives (chocolate liquid essence) | 5ml | |
| Preparation method | Fluidization | |
| Settling volume is than (Chinese Pharmacopoeia oral suspensions settling volume is than inspection method) | ?0.94 | |
| Melting (Chinese Pharmacopoeia soluble particles melting inspection method) | Dissolved in 45 seconds | |
| Mouthfeel (according to attempting in healthy volunteer's mouth) | It is sweet to distinguish the flavor of, and mouthfeel is better | |
Preparation technology: one, sieve is got 30～60 purpose sucrose and is made excipient, 60 ℃ of oven dry.Two, with carbomer, polyvinylpolypyrrolidone, brown pigmentation A, place the 1200mL purified water, stirred 4 hours with electric blender, add ibuprofen again, stir.Three, the sucrose excipient is placed in the fluid bed drug suspension spraying medicine-feeding, drying.Four, spray into liquid essence again, promptly.
Fluid bed Glat preparation parameter:
(1) heating (heating): 30～60 order sucrose are put into fluid bed as excipient.
Air quantity (Air flow) 70m
3/ h
70 ℃ of inlet temperature (Air temp)
Be dried to 50 ℃ of temperature of charge (product temp),
(2) medicine-feeding (spraying): when waiting temperature of charge to be 50 ℃, begin to spray medicine.
Air quantity (Air flow) 60～80m
3/ h
60 ℃ of inlet temperature (Air temp)
Atomizing pressure (Atom air press) 2.0
Medicine-feeding rotating speed 10-25rad
The medicine-feeding process is adjusted rotating speed makes temperature of charge be controlled at about 40～45 ℃, finishes until medicine-feeding.
(3) dry (drying)
Air quantity (Air flow) 80m
3/ h
60 ℃ of inlet temperature (Air temp)
Dry 3-5min is to 50 ℃ of temperature of charge
(4) cooling (cooling)
Air quantity (Air flow) 80m
3/ h
10 ℃ of inlet temperature (Air temp)
Be cooled to temperature of charge near 25 ℃ of room temperatures
(5) spray into essence (spraying): spray into the chocolate liquid essence, medicine-feeding rotating speed 7～10rpm.
Air quantity (Air flow) 80m
3/ h
25 ℃ of inlet temperature (Air temp)
The ibuprofen dry suspension abnormal smells from the patient of gained and color are like chocolate.Dry suspension granule flavor is sweet, is fit to child and adult and takes.Usage: take after mixing it with water with warm water.Consumption: the adult and more than 12 years old child's recommended dose be a 0.3～0.4g, 3～4 times on the one, or follow the doctor's advice; Child patient was used for heating in 2 years old～12 years old, and recommended dose is by 20mg/kg of body weight, and 3 times on the one, or follow the doctor's advice; Be used for analgesia, recommended dose is by 30mg/kg of body weight, 3 times on the one, or follow the doctor's advice.
Active constituents of medicine is divided into beta-lactam antibiotic, macrolide antibiotics, antipyretic analgesic.In the above embodiment of the present invention, all there are one or more in example, to occur in the active component of three kinds, and congener active component has similar physicochemical property, so all listed active component all are suitable for dry suspension of the present invention in the active constituents of medicine of the present invention.
The listed suspending agent of the present invention can increase the sedimentation velocity of the viscosity of disperse medium with the reduction microgranule, or for increasing the hydrophilic additives of microgranule.Go up the cited suspending agent in embodiment, owing to all have certain viscosity, the suspending principle is identical, so the listed suspending agent of the present invention all is applicable to dry suspension of the present invention.
Disintegrating agent can make the quick disintegrate of medicine, accelerates the stripping of medicine.Disintegrating agent of the present invention is met all energy rapid expanding of water, so all listed disintegrating agents of the present invention all are applicable to dry suspension of the present invention.
Claims (17)
1. the prescription of a dry suspension is formed, and it is characterized in that: the prescription of described dry suspension is formed the weight ratio component that comprises and is: active constituents of medicine 0.1%～35.0%, excipient 29.0%～99.3%, suspending agent 0.05%～36.4%.
2. the prescription of dry suspension according to claim 1 is formed, and it is characterized in that: described dry suspension contains porogen greater than 0～35.0%.
3. the prescription of dry suspension according to claim 2 is formed, and it is characterized in that: described dry suspension contains disintegrating agent greater than 0～12.0%.
4. the prescription of dry suspension according to claim 3 is formed, and it is characterized in that: described dry suspension contains that defoamer is an amount of, surfactant is an amount of, buffer salt is an amount of, correctives is an amount of, coloring agent is an amount of.
5. the prescription of dry suspension according to claim 4 is formed, and it is characterized in that: described active constituents of medicine is appoint in his magnesium ester of cefaclor, clarithromycin, amoxicillin, clavulanate potassium, cefixime, cefprozil, loratadine, Acetylmidecamycin, Acetylkitasamycin, azithromycin, ibuprofen, Roxithromycin, cefradine, Cefpodoxime Proxetil, hydrochloric acid cephalo, cefalexin, ampicillin, the acetaminophen a kind of or two kinds.
6. the prescription of dry suspension according to claim 5 is formed, and it is characterized in that: described excipient be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds.
7. the prescription of dry suspension according to claim 6 is formed, and it is characterized in that: described suspending agent be in xanthan gum, arabic gum, tragcanth, carbomer, polyvidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropylmethyl cellulose phthalate, polyacrylic resin, polyvinyl alcohol, Polyethylene Glycol or the chitin any or more than two kinds.
8. the prescription of dry suspension according to claim 7 is formed, and it is characterized in that: described porogen be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Disintegrating agent be in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, starch, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose any or more than two kinds; Defoamer is selected any or two kinds in silicone oil, the simethicone for use; Surfactant is selected any or two kinds in sodium lauryl sulphate, the polyoxyethylene sorbitan monoleate for use; Buffer salt adopts acetic acid-sodium acetate buffer salt, citric acid-trisodium citrate buffer salt, Borax-sodium carbonate buffer salt, boric acid-potassium chloride buffer salt, phosphate buffer salt etc.; Correctives is selected pressed powder essence for use: Fructus Fragariae Ananssae powdered flavor, Fructus Pruni pseudocerasi powdered flavor, Fructus Citri tangerinae powdered flavor and Fructus Mangifera Indicae powdered flavor, liquid essence: Fructus Fragariae Ananssae liquid essence, Fructus Mali pumilae liquid essence, Fructus Musae liquid essence, chocolate liquid essence, Rhizoma et radix valerianae liquid essence and Fructus Mangifera Indicae liquid essence, saccharin sodium, aspartame, sucrose, mannitol, stevioside; Coloring agent has pigment or color ingot: red pigments, xanthein, brown pigmentation, sunset yellow aluminum color ingot.
9. the preparation method of a dry suspension may further comprise the steps: one, sieve the excipient of getting 30～65 order particle diameters, oven dry; Two, by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, place suitable quantity of water, stir 1～4 hour, obtain the suspending medium to evenly;
Three, active constituents of medicine 0.1%～35.0% is added in the suspending medium, stir, promptly get drug suspension; Four, by weight excipient 29.0%～99.3% is placed in the fluid bed, spray drug suspension thereon, medicine-feeding finishes particle drying.
10. the preparation method of dry suspension according to claim 9, it is characterized in that: described by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, add buffer salt, correctives, the coloring agent of routine dose when placing water.
11. the preparation method of dry suspension according to claim 9 is characterized in that: described spraying medicine finishes, and correctives, the colourant solution of routine dose evenly is sprayed on particle surface.
12. the preparation method of dry suspension according to claim 9 is characterized in that: described spraying medicine finishes, and the correctives solution of routine dose evenly is sprayed on particle surface.
13. the preparation method according to claim 9,10,11 or 12 described dry suspension is characterized in that: described by weight with suspending agent 0.05%～36.4%, porogen 0～35.0%, disintegrating agent 0～12.0%, add emulsion when placing water.
14. the preparation method of dry suspension according to claim 13 is characterized in that: described emulsion is for to make defoamer and surfactant emulsifying in mulser of routine dose.
15. the preparation method according to claim 9,10,11 or 12 described dry suspension is characterized in that: described when adding active constituents of medicine 0.1%～35.0% in the suspending medium, add emulsion.
16. the preparation method of dry suspension according to claim 15 is characterized in that: described emulsion is for to make defoamer and surfactant emulsifying in mulser of routine dose.
17. the preparation method of dry suspension according to claim 14 is characterized in that: described active constituents of medicine is any or two kinds in his magnesium ester of cefaclor, clarithromycin, amoxicillin, clavulanate potassium, cefixime, cefprozil, loratadine, Acetylmidecamycin, Acetylkitasamycin, azithromycin, ibuprofen, Roxithromycin, cefradine, Cefpodoxime Proxetil, hydrochloric acid cephalo, cefalexin, ampicillin, the acetaminophen; Described excipient be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Suspending agent is any or two kinds in xanthan gum, arabic gum, tragcanth, carbomer, polyvidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropylmethyl cellulose phthalate, polyacrylic resin, polyvinyl alcohol, Polyethylene Glycol or the chitin; Porogen be in sucrose, mannitol, lactose, the microcrystalline Cellulose any or more than two kinds; Disintegrating agent be in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, starch, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose any or more than two kinds; Defoamer is selected any or two kinds in silicone oil, the simethicone for use; Surfactant is selected any or two kinds in sodium lauryl sulphate, the polyoxyethylene sorbitan monoleate for use; Buffer salt adopts acetic acid-sodium acetate buffer salt, citric acid-trisodium citrate buffer salt, Borax-sodium carbonate buffer salt, boric acid-potassium chloride buffer salt, phosphate buffer salt etc.; Correctives is selected pressed powder essence for use: Fructus Fragariae Ananssae powdered flavor, Fructus Pruni pseudocerasi powdered flavor, Fructus Citri tangerinae powdered flavor and Fructus Mangifera Indicae powdered flavor etc., liquid essence: Fructus Fragariae Ananssae liquid essence, Fructus Mali pumilae liquid essence, Fructus Musae liquid essence, chocolate liquid essence, Rhizoma et radix valerianae liquid essence and Fructus Mangifera Indicae liquid essence, saccharin sodium, aspartame, sucrose, mannitol, stevioside; Coloring agent has pigment or color ingot: red pigments, xanthein, brown pigmentation, sunset yellow aluminum color ingot.
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