CN106727394B - The method for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation - Google Patents
The method for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation Download PDFInfo
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- CN106727394B CN106727394B CN201710030529.1A CN201710030529A CN106727394B CN 106727394 B CN106727394 B CN 106727394B CN 201710030529 A CN201710030529 A CN 201710030529A CN 106727394 B CN106727394 B CN 106727394B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The invention discloses a kind of methods for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, sustained release tablets of the invention are by roxithromycin, the porous tapioca of phosphorylation and other auxiliary materials composition, roxithromycin sustained release tablets preparation process of the present invention uses wet granulation, it is dried by particle, after whole grain, moderate lubrication agent is added to mix, tabletting is up to sustained release tablets, preparation process simple and effective, roxithromycin sustained release tablets of the invention slowly can persistently discharge, administration number of times can be effectively reduced, steady lasting effective blood drug concentration is provided, improve Drug safety and validity.
Description
Technical field
The present invention relates to a kind of process for preparing medicine more particularly to a kind of porous tapioca of application phosphorylation to prepare Luo Hong
The method of mycin sustained release tablets.
Background technique
Roxithromycin is macrolide antibiotics of new generation, mainly acts on gram-positive bacteria, anaerobic bacteria, Chlamydia
With mycoplasma etc., belong to broad-spectrum antibiotic, antibacterial activity in vitro is similar with erythromycin, and vivo bacteria corrosion action is stronger than erythromycin
1-4 times.Roxithromycin has degree of ionization low, fat-soluble height, and distribution is wide in vivo, has acidproof, long half time, oral absorption
The advantages that rapid, side effect is slight, is easy to be resistant to, and adverse reaction is mainly gastrointestinal side effect；Furthermore roxithromycin belongs to
Time-dependent drug, bactericidal effect is directly proportional to drug and bacterium time of contact, and the time, longer effect was better.Luo Hong is mould
Plain sustained release tablets are more longlasting due to discharging than ordinary tablet, can reduce administration frequency, reduce blood concentration fluctuation, reduce drug to stomach and intestine
The stimulation in road, therefore sustained release tablets are made and are conducive to maintain higher bacteriocidal concentration, administration number of times is reduced, blood concentration wave is reduced
It is dynamic, adverse reaction is reduced, patient compliance is improved.
The research of existing roxithromycin sustained release tablets at present.Number of patent application is that 200910082159.1 patents are mould using Luo Hong
Element, lactose, hypromellose, talcum powder, 10% polyvinylpyrrolidone ethanol solution, magnesium stearate are supplementary material
Prepare roxithromycin sustained release tablets；Wherein using hypromellose as roxithromycin sustained release framework material, release is within 8 hours
85%-98%, slow release effect are general.This patent prepares roxithromycin sustained release tablets with the porous tapioca of phosphorylation, can effectively control
Roxithromycin rate of release processed effectively extends its antibacterial time, reduces times for spraying, shortens administration time.
Summary of the invention
The object of the invention is that providing a kind of application phosphorylation porous tapioca system to solve the above-mentioned problems
The method of standby roxithromycin sustained release tablets.
The present invention through the following technical solutions to achieve the above objectives:
It is an object of the invention to: a kind of side preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation is provided
Method.
Roxithromycin sustained release tablets of the present invention are made of the supplementary material medicine of following parts by weight: the phosphorylation for loading roxithromycin is more
400 parts by weight of hole tapioca, 40 parts by weight of microcrystalline cellulose, 130 parts by weight of hydroxypropyl methyl cellulose, 4 weight of talcum powder
Part, 1 parts by weight of magnesium stearate, volume fraction v/v are 50% ethanol water, 40 parts by weight.
The present invention the following steps are included:
(1) 600 parts by weight tapiocas are weighed, sterile water is added, the tapioca lotion of 40%m/v concentration is made into, weighs one
Quantitative alpha-amylase, makes the 0.2% of the quality tapioca quality of alpha-amylase, weighs a certain amount of glucoamylase, make α-
The quality of amylase is the 1% of tapioca quality, and alpha-amylase, glucoamylase are dissolved in pH5.6 disodium hydrogen phosphate-lemon
Enzyme solution is made into lemon acid buffer, alpha-amylase, glucoamylase and disodium hydrogen phosphate-citrate buffer solution press quality: matter
Amount: enzyme solution is transferred in tapioca lotion by volume ratio 3:15:500.After stirring 0.5 h, it is placed in 45 DEG C of shaking table reactions 20
h.The sodium hydroxide solution that mass volume ratio m/v is 4.0%, the matter of tapioca and sodium hydroxide solution are added after reaction
Amount volume ratio m/v is 6:1, terminates reaction, and supernatant is abandoned in centrifugation, and precipitating is taken to be placed in 45 DEG C of drying to constant weight, crushing it is spare to get
Porous tapioca；It is 4% tripolyphosphate sodium water solution by the sodium tripolyphosphate mass volume ratio m/v soluble in water that is made, institute is added
It obtains porous tapioca and is configured to the porous tapioca sodium tripolyphosphate solution that mass volume ratio m/v is 40%, with quality volume
Be that adjust pH value be 9.0 to 8% sodium hydroxide solution than m/v, 30 min of mechanical stirring is filtered, washing, filter cake in 50 DEG C it is dry extremely
Water content 10% is crushed, is again heated in 100 DEG C of reaction 3h, 50 DEG C dry, pulverize to get the porous tapioca of phosphorylation.
(2) 100 parts by weight of roxithromycin bulk pharmaceutical chemicals are accurately weighed, addition v/v is 95% ethanol water, roxithromycin
Bulk pharmaceutical chemicals and v/v are that the mass volume ratio m/v of 95% ethanol water is 1:25, and 45 DEG C of heating water bath stirring and dissolvings obtain Luo Hong
Mycin ethanol solution;The porous tapioca of 300 parts by weight of phosphoric acidization is accurately weighed, sterile water, the porous para arrowroot of phosphorylation is added
The mass volume ratio m/v of powder and sterile water is 1:50, and 95 DEG C of heating water bath dissolutions obtain the porous tapioca solution of phosphorylation;It will
Roxithromycin ethanol solution is slowly added into the porous tapioca solution of phosphorylation, 75 DEG C of heating water baths, stirs 2 h, is stopped
Continue to stir 2 h after heating, be stored at room temperature 12 h, filter, gained filter residue is in 60 DEG C of dry phosphoric acid to get load roxithromycin
Change porous tapioca.
(3) all supplementary materials are accurately weighed in proportion, by weight by the porous tapioca of phosphorylation for loading roxithromycin
Part is uniformly mixed with microcrystalline cellulose, hydroxypropyl methyl cellulose, and the ethanol water that volume fraction v/v is 50% is added, mixing
Suitable softwood is made, particle, 55 DEG C of dryings is made in sieving, and talcum powder and magnesium stearate is added in whole grain, it is uniformly mixed, tabletting,
Up to roxithromycin sustained release tablets.
The beneficial effects of the present invention are:
The present invention is a kind of method for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, with the prior art
It compares, the present invention has the advantage that
1, roxithromycin sustained release tablets wet granulation products obtained therefrom is relatively strong with good appearance, good fluidity, wearability, compresses
The advantages that formability is good；
2, this method increases the absorption to roxithromycin, effectively by the modified porous tapioca of phosphorylation with hydroxypropyl
Methylcellulose takes orally and enters in vivo as auxiliary skeleton slow-release material, wet granule compression tablet, and the porous tapioca of phosphorylation exists
It is hydrolyzed under humoral effect, slow release roxithromycin, to have the function that sustained release；
3, the preparation method is with short production cycle, at low cost, improves the added value of starch, while preparation is sustained, satisfaction is faced
The requirement of bed medication.
Specific embodiment
The invention will be further described below:
Embodiment 1:
(1) 600g tapioca is weighed, sterile water is added, the tapioca lotion that m/v is 40% is made into, weighs 1.2g α-shallow lake
Powder enzyme, 6g glucoamylase are made into enzyme solution with 0.2 mol/L pH5.6 disodium hydrogen phosphate-citrate buffer solution 200mL, will
Enzyme solution is transferred in tapioca lotion；After stirring 0.5h, it is placed in 45 DEG C of shaking table 20 h of reaction.M/v is added after reaction is
4.0% sodium hydroxide solution 100mL terminates reaction, and supernatant is abandoned in centrifugation, takes precipitating to be placed in 45 DEG C of dryings to constant weight, crushes standby
With to get porous tapioca；By sodium tripolyphosphate it is soluble in water be made m/v be 4% tripolyphosphate sodium water solution, take much
Hole tapioca is added tripolyphosphate sodium water solution and the porous tapioca lotion that m/v is 40% is made, with mass volume ratio m/v
Adjusting pH value for 8% sodium hydroxide solution is 9.0, and 30 min of mechanical stirring is filtered, washing, and filter cake is dry to water content in 50 DEG C
10%, it crushes, is again heated in 100 DEG C of reaction 3h, 50 DEG C dry, pulverize to get the porous tapioca of phosphorylation.
(2) 200 g of roxithromycin bulk pharmaceutical chemicals is accurately weighed, addition v/v is 95% ethanol water 5000mL, 45 DEG C of water-baths
Heating stirring dissolution, obtains roxithromycin ethanol solution;The porous tapioca of 600g phosphorylation is accurately weighed, it is sterile that 30L is added
Water, 95 DEG C of heating water bath dissolutions, obtains the porous tapioca solution of phosphorylation;Roxithromycin ethanol solution is slowly added into phosphorus
It is acidified in porous tapioca solution, 75 DEG C of heating water baths, stirs 2 h, continue to stir 2 h after stopping heating, be stored at room temperature 12
H is filtered, and gained filter residue is in 60 DEG C of dry porous tapiocas of phosphorylation to get load roxithromycin.
(3) all supplementary materials are accurately weighed in proportion, by weight by the porous tapioca of phosphorylation for loading roxithromycin
Part is uniformly mixed with microcrystalline cellulose, hydroxypropyl methyl cellulose, and the ethanol water that v/v is 50% is added, is mixed suitable
Particle, 55 DEG C of dryings is made in suitable softwood, sieving, and talcum powder and magnesium stearate is added in whole grain, is uniformly mixed, tabletting is to get sieve
Erythromycin sustained release tablets.
Drug release determination: according to four the first method of general rule (basket method) measurements of " Chinese Pharmacopoeia " version in 2015.
Roxithromycin sustained release tablets extracorporeal releasing experiment result is as follows:
| Time (hour) | 1 | 2 | 4 | 6 | 8 | 10 | 12 |
| Release (%) | 11 | 19 | 32 | 48 | 57 | 66 | 78 |
Embodiment 2:
(1) 300g tapioca is weighed, sterile water is added, the tapioca lotion that m/v is 40% is made into, weighs 0.6g α-shallow lake
Powder enzyme, 3g glucoamylase are made into enzyme solution with 0.2 mol/L pH5.6 disodium hydrogen phosphate-citrate buffer solution 100mL, will
Enzyme solution is transferred in tapioca lotion；After stirring 0.5h, it is placed in 45 DEG C of shaking table 20 h of reaction.M/v is added after reaction is
4.0% sodium hydroxide solution 50mL terminates reaction, and supernatant is abandoned in centrifugation, takes precipitating to be placed in 45 DEG C of dryings to constant weight, crushes standby
With to get porous tapioca；By sodium tripolyphosphate it is soluble in water be made m/v be 4% tripolyphosphate sodium water solution, take much
Hole tapioca is added tripolyphosphate sodium water solution and the porous tapioca lotion that m/v is 40% is made, and is 8% hydroxide with m/v
It is 9.0,30 min of mechanical stirring that sodium solution, which adjusts pH value, is filtered, and washing, filter cake is in 50 degree of oven dryings to water content 10%, powder
It is broken, it is again heated in 100 DEG C of reaction 3h, 50 DEG C dry, pulverize to get the porous tapioca of phosphorylation.
(2) 100 g of roxithromycin bulk pharmaceutical chemicals is accurately weighed, addition v/v is 95% ethanol water 2500mL, 45 DEG C of water-baths
Heating stirring dissolution, obtains roxithromycin ethanol solution;The porous tapioca of 300g phosphorylation is accurately weighed, it is sterile that 15L is added
Water, 95 DEG C of heating water bath dissolutions, obtains the porous tapioca solution of phosphorylation;Roxithromycin ethanol solution is slowly added into phosphorus
It is acidified in porous tapioca solution, 75 DEG C of heating water baths, stirs 2 h, continue to stir 2 h after stopping heating, be stored at room temperature 12
H is filtered, and gained filter residue is in 60 DEG C of dry porous tapiocas of phosphorylation to get load roxithromycin.
(3) all supplementary materials are accurately weighed in proportion, by weight by the porous tapioca of phosphorylation for loading roxithromycin
Part is uniformly mixed with microcrystalline cellulose, hydroxypropyl methyl cellulose, and addition v/v is 50% ethanol water, and it is suitable to be mixed
Particle, 55 DEG C of dryings is made in softwood, sieving, and talcum powder and magnesium stearate is added in whole grain, is uniformly mixed, tabletting is to get Luo Hong
Mycin sustained release tablets.
Drug release determination: four the first method of general rule (basket method) measurements of " Chinese Pharmacopoeia " version in 2015.
Roxithromycin sustained release tablets extracorporeal releasing experiment result is as follows:
| Time (hour) | 1 | 2 | 4 | 6 | 8 | 10 | 12 |
| Release (%) | 12 | 18 | 33 | 46 | 58 | 65 | 77 |
Roxithromycin sustained release tablets extracorporeal releasing experiment method of the present invention is as follows:
By four the first method of general rule (basket method) measurements of " Chinese Pharmacopoeia " version in 2015, takes test sample 7 to put into 7 respectively and do
Dry turns in basket, will turn basket and falls into stripping rotor, using the hydrochloric acid 900mL of 0.1mol/L as solvent, 37 DEG C of temperature, and revolving speed 100r/
Min is operated according to methods, and takes solution 5ml respectively at 1,2,4,6,8,10,12 hour, while adding same volume dissolution medium, sample liquid
With 0.45um filtering with microporous membrane, filtrate is taken, should be completed in 30 seconds from sampling to filtration, clear filtrate is taken, precision measures one
Quantitative filtrate is set in tool plug teat glass, is diluted to 5 mL with dissolution medium, is mixed, as test solution;Ultraviolet point
Light photometry measures absorbance respectively at the wavelength of 482nm, calculates burst size.It is appropriate that another precision weighs roxithromycin, with releasing
It puts medium and solution in every 1 mL containing about 60 ug of roxithromycin is quantitatively made, as reference substance solution.Precision is drawn for examination
Product solution and each 5mL of reference substance solution are respectively placed in tool plug teat glass, add 75% sulfuric acid solution, 5 mL, shake up, place
30 min, are cooled to room temperature, and absorbance is measured at 482 nm wavelength, calculates the accumulative releasing degree of each sampling time point.
Basic principles and main features and advantages of the present invention of the invention have been shown and described above.The technology of the industry
Personnel are it should be appreciated that the present invention is not limited to the above embodiments, and the above embodiments and description only describe this
The principle of invention, without departing from the spirit and scope of the present invention, various changes and improvements may be made to the invention, these changes
Change and improvement all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and its
Equivalent thereof.
Claims (8)
1. a kind of method for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, it is characterised in that: the sustained release tablets
Supplementary material weight ratio are as follows: load porous 400 parts by weight of tapioca of phosphorylation, 40 weight of microcrystalline cellulose of roxithromycin
Amount part, 130 parts by weight of hydroxypropyl methyl cellulose, 4 parts by weight of talcum powder, 1 parts by weight of magnesium stearate, volume fraction v/v are
50% ethanol water, 40 parts by weight；
The preparation method of the porous tapioca of phosphorylation of the load roxithromycin is carried out according to the following steps: accurately weighing sieve
100 parts by weight of erythromycin bulk pharmaceutical chemicals, addition volume fraction v/v are 95% ethanol water, roxithromycin bulk pharmaceutical chemicals and volume point
Number v/v is that the mass volume ratio m/v of 95% ethanol water is 1:25g/mL, and it is mould to obtain Luo Hong for 45 DEG C of heating water bath stirring and dissolvings
Plain ethanol solution；The porous tapioca of 300 parts by weight of phosphoric acidization is accurately weighed, sterile water, the porous tapioca of phosphorylation is added
Mass volume ratio m/v with sterile water is 1:50g/mL, and 95 DEG C of heating water bath dissolutions obtain the porous tapioca solution of phosphorylation；
Roxithromycin ethanol solution is slowly added into the porous tapioca solution of phosphorylation, 75 DEG C of heating water baths, stirs 2h, stopped
Continue to stir 2h after heating, be stored at room temperature 12h, filter, gained filter residue is in 60 DEG C of dry phosphorylations to get load roxithromycin
Porous tapioca；
The preparation method of the porous tapioca of phosphorylation adds sterile the following steps are included: weigh 600 parts by weight tapiocas
Water is made into the tapioca lotion that mass volume ratio m/v is 40%g/mL, weighs a certain amount of alpha-amylase, make alpha-amylase
Quality is the 0.2% of tapioca quality, weighs a certain amount of glucoamylase, makes the quality para arrowroot of glucoamylase
Alpha-amylase, glucoamylase are dissolved in pH5.6 disodium hydrogen phosphate-citrate buffer solution and are made into enzyme by the 1% of silty amount
Liquid, alpha-amylase, glucoamylase and disodium hydrogen phosphate-citrate buffer solution are by quality: quality: volume ratio 3:15:
Enzyme solution is transferred in tapioca lotion by 500g/g/mL, after stirring 0.5h, is placed in 45 DEG C of reaction 20h of shaking table, reaction terminates
The sodium hydroxide solution that mass volume ratio m/v is 4.0%g/mL, the hydroxide that tapioca and m/v are 4.0%g/mL are added afterwards
The mass volume ratio m/v of sodium solution is 6:1g/mL, terminates reaction, and supernatant is abandoned in centrifugation, and precipitating is taken to be placed in 45 DEG C of dryings to constant weight,
It crushes spare to get porous tapioca；It is 4%g/mL trimerization by the sodium tripolyphosphate mass volume ratio m/v soluble in water that is made
Sodium radio-phosphate,P-32 solution is added the porous tapioca of gained and is configured to the porous tapioca three that mass volume ratio m/v is 40%g/mL
It is 9.0 that polyphosphate sodium solution, which is 8%g/mL sodium hydroxide solution adjusting pH value with mass volume ratio m/v, mechanical stirring 30min,
It filters, washing, filter cake is dry to water content 10% in 50 DEG C, crushes, is again heated in 100 DEG C of reaction 3h, 50 DEG C of dryings, powder
It is broken to get the porous tapioca of phosphorylation.
2. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: microcrystalline cellulose, model PH101.
3. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: hydroxypropyl methyl cellulose, and manufacturer is Anhui Shanhe Medicinal Subsidiary Material Co., Ltd., model
SHK10M。
4. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: alpha-amylase, enzyme activity >=50U/mg.
5. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: glucoamylase, enzyme activity 50000u/g.
6. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: sodium tripolyphosphate is food-grade.
7. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: pH5.6 disodium hydrogen phosphate-citrate buffer solution, concentration 0.2mol/L.
8. the method according to claim 1 for preparing roxithromycin sustained release tablets using the porous tapioca of phosphorylation, special
Sign is: the sustained release tablets the preparation method comprises the following steps: accurately weigh all supplementary materials in proportion, the phosphorylation for loading roxithromycin is more
Hole tapioca is uniformly mixed with microcrystalline cellulose, hydroxypropyl methyl cellulose by weight, and it is 50% that volume fraction v/v, which is added,
Ethanol water, be mixed and made into suitable softwood, particle, 55 DEG C of dryings is made in sieving, and talcum powder and stearic acid is added in whole grain
Magnesium is uniformly mixed, and tabletting is to get roxithromycin sustained release tablets.
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| CN102492046A (en) * | 2011-11-11 | 2012-06-13 | 山东龙力生物科技股份有限公司 | Preparation method of high-purity resistant starch |
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| CN102492046A (en) * | 2011-11-11 | 2012-06-13 | 山东龙力生物科技股份有限公司 | Preparation method of high-purity resistant starch |
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