CN102973519B - Amoxicillin granules and preparation technology of same - Google Patents
Amoxicillin granules and preparation technology of same Download PDFInfo
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- CN102973519B CN102973519B CN201210571394.7A CN201210571394A CN102973519B CN 102973519 B CN102973519 B CN 102973519B CN 201210571394 A CN201210571394 A CN 201210571394A CN 102973519 B CN102973519 B CN 102973519B
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Abstract
The invention discloses amoxicillin granules and a preparation technology of the same. The amoxicillin granules are prepared by taking a pure water solution of povidone as a binding agent solution for granulation, wherein the dosage ratio of the povidone to the amoxicillin is (1:25)-(1:10) by weight percent. With the preparation technology, the production safety is improved, and the solubility and the stability of the amoxicillin granules are improved greatly.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to amoxicillin granules preparation and preparation technology thereof.
Background technology
(Amoxicillin) has another name called amoxicillin in amoxicillin, for semisynthetic penbritin, all there is antibacterial action for Hemolytic streptococcus, Streptococcus viridans, streptococcus pneumoniae, the responsive golden yellow staphylococcus of benzylpenicillin, gonococcus, hemophilus influenza, enterococcus, Salmonella, Bacillus typhi and Bacillus proteus etc.Because acid resistance is strong, has a broad antifungal spectrum, determined curative effect be widely used in clinical.
Due to the unstability of beta-lactam structure in Penicillin antibiotics molecule, very easily there is intermolecular polyreaction in amoxicillin, forms the macromolecule impurity with sensitization, makes the anaphylaxis of its preparation become a problem can not be ignored clinically.For oral amoxicillin, when macromolecule impurity in preparation (high polymer) is less than 0.2%, generally can not produce penicillin allergy.Therefore controlling the macromolecule impurity content in Wymox, is to reduce the anaphylactoid fundamental way of this type of antibiotic.
The macromolecular polymerization reaction of amoxicillin very easily occurs under the high hot state of high temperature, especially in granulation dry run, produces.In patent CN102000033B, adopt 90% above ethanol and syrup to granulate, baking temperature is controlled between 55-65 DEG C, but because quantity of solvent is larger, high concentration ethanol security risk is very big.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of amoxicillin granules, can improve production security, reduce molecular impurity, improves grain dissolution degree and stability.
Described amoxicillin granules adopts the pure water solution of polyvidone to granulate as adhesive solution, and the consumption of described polyvidone and amoxicillin, by weight calculating as 1:25～1:10, is preferably 1:20～1:12.
Described amoxicillin granules, wherein the mass concentration of polyvidone in pure water solution is 5%～15%, is preferably 6～10%, described polyvidone is for being preferably PVP K30
Described amoxicillin granules, uses boiling drier to be dried after preferably granulating, and the temperature of its airpillow-dry is 40～70 DEG C, is preferably 45～65 DEG C, drying time≤40min, preferably≤30min.
Described amoxicillin granules, also contains filler, disintegrating agent, further also can contain correctives, rectify toner and antiseptic.
Described filler is preferably lactose, mannitol, sucrose, and disintegrating agent is preferably sodium carboxymethyl cellulose, and correctives can be selected from stevioside, orange flavor, and strong toner can be selected from lemon yellow, and antiseptic can be selected from ethyl hydroxybenzoate.
In described granule, feeding intake of described lactose, mannitol, sucrose, sodium carboxymethyl cellulose and amoxicillin is 170～130:80～120:1700～1400:3～8:125 by weight, is preferably 170:80:1700:3:125,150:100:1500:5:125,130:120:1400:8:125.
In described granule, feeding intake of described lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside, orange flavor, ethyl hydroxybenzoate, lemon yellow and amoxicillin is 170～130:80～120:1700～1400:3～8:4～6:0.8～1.2:0.1～0.3:0.1～0.3:125 by weight, is preferably 170:80:1700:3:4:0.8:0.1:0.13:125,150:100:1500:5:5:1:0.1:0.12:125,130:120:1400:8:6:1.2:0.12:0.30:125.
The present invention provides a kind of preparation method of above-mentioned amoxicillin granules simultaneously, its step is as follows: after each adjuvant is pulverized and sieved, first prepare adhesive solution, then amoxicillin and other adjuvants except adhesive solution are mixed, then add adhesive solution soft material processed, wet granular processed, by granulate after wet granular airpillow-dry, dry temperature is 40～70 DEG C, is preferably 45～65 DEG C, drying time≤40min, preferably drying time≤20min.
Amoxicillin granules provided by the invention and preparation method thereof, avoids with an organic solvent, as adhesive solution, can improving production security; The prepared granule obtaining has not only reduced macromolecule impurity, has improved dissolubility simultaneously.
Detailed description of the invention
Further explain and describe by the following examples content of the present invention, but invention protection domain is not construed as limiting.
Reference example 1
Embodiment 1 in patent CN102000033B.
Preparation technology:
(1) take amoxicillin.
(2) citric acid, sodium citrate, lemon yellow and sucrose co-grinding are crossed to 80 mesh sieves.
(3) prepare adhesive solution, be mixed with in proportion the 95 % alcoholic solution of sodium carboxymethyl cellulose of 1.0wt % and the syrup of 66.52wt%.
(4) amoxicillin and adjuvant are mixed, add adhesive solution, be placed in efficient wet granulator hopper, sealing hopper, unlatching turns oar and cutting knife low speed and stirs to cut and mix 5 minutes, stop stirring and cut, add 95 % appropriate amount of ethanols, unlatching turns oar and stirs and cutting knife, stir at a slow speed and cut 120 seconds, stop stirring and cut, add 1 % sodium carboxymethyl cellulose slurry, when high-speed stirring is switched to 60 seconds, from observation panel, add syrup, high-speed stirring is switched to 180 seconds～and 240 seconds, with the material barrel reception wet granular through cleaning and sterilizing, crossing 14 eye mesh screens with YK-160 type oscillating granulator again granulates.
(5) particle drying: first add the dried granule of skim in the dry pot of boiling drier, wet granular after granulating is put in boiling drier, inlet temperature is set as to 55 DEG C, inlet temperature is presented at 55 ± 5 DEG C and (exceeds temperature range if inlet temperature was presented in 30 seconds, be considered as in tolerance interval), every pot of approximately 2/3 amount wet granular is poured in pot and opened and stir 55 DEG C of preliminary dryings 3 minutes, granule is slightly poured every pot of surplus wet granular into after molding, start timing, open and stir, dry and (start for 27 minutes, 10min, 20min, when end, respectively record air intake leaving air temp once).The dry taking-up granule that finishes.
(6) granulate after 55 DEG C are dried, adds essence always mixed.
(7) pack.
Reference example 2
Preparation technology
(1) take amoxicillin, lactose, mannitol, stevioside, sucrose, sodium carboxymethyl cellulose are for subsequent use;
(2) configuration of adhesive solution:
By PVP K30, ethyl hydroxybenzoate, lemon yellow, orange flavor, be placed in the purified water stirring and dissolving of 80g, preparation binder solution.
(3) amoxicillin, lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside are dropped in wet granulator, open stirring arm motor, be uniformly mixed 10 minutes time; Open cover, add binder solution, approximately 3 minutes granulation time.
(4) after having granulated, open discharge piston, crawl stirring arm is discharged wet granular.Wet granulator granulation (sieve number is 16 orders) for wet granular.
(5) starting aerator sucks material in boiling drier.Inlet temperature is set in 60 DEG C ± 5 DEG C, and leaving air temp is set in 50 DEG C ± 5 DEG C, temperature of charge≤55 DEG C, approximately 25 minutes drying times.
(6) M-1000 type shaking screen is loaded onto to 16 orders and 40 eye mesh screens, feed intake and sieve.To be greater than 16 object granules drops in crushing and pelletizing machine.The granule that granulate is crossed is put in shaking screen again, and 16 collected orders are to 40 order granules.
(7) always mixed, packed.
Embodiment 1
Preparation technology
(1) take amoxicillin, lactose, mannitol, stevioside, sucrose, sodium carboxymethyl cellulose are for subsequent use;
(2) configuration of adhesive solution:
By PVP K30, ethyl hydroxybenzoate, lemon yellow, orange flavor, be placed in the purified water stirring and dissolving of 80g, preparation binder solution.
(3) amoxicillin, lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside are dropped in wet granulator, open stirring arm motor, be uniformly mixed 10 minutes time; Open cover, add binder solution, approximately 3 minutes granulation time.
(4) after having granulated, open discharge piston, crawl stirring arm is discharged wet granular.Wet granulator granulation (sieve number is 16 orders) for wet granular.
(5) starting aerator sucks material in boiling drier.Inlet temperature is set in 60 DEG C ± 5 DEG C, and leaving air temp is set in 50 DEG C ± 5 DEG C, temperature of charge≤55 DEG C, approximately 25 minutes drying times.
(6) M-1000 type shaking screen is loaded onto to 16 orders and 40 eye mesh screens, feed intake and sieve.To be greater than 16 object granules drops in crushing and pelletizing machine.The granule that granulate is crossed is put in shaking screen again, and 16 collected orders are to 40 order granules.
(7) always mixed, packed.
Embodiment 2
Preparation technology
(1) take amoxicillin, lactose, mannitol, stevioside, sucrose, sodium carboxymethyl cellulose are for subsequent use;
(2) configuration of adhesive solution:
By PVP K30, ethyl hydroxybenzoate, lemon yellow, orange flavor, be placed in the purified water stirring and dissolving of 90g, preparation binder solution.
(3) amoxicillin, lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside are dropped in wet granulator, open stirring arm motor, be uniformly mixed 13 minutes time; Open cover, add binder solution, approximately 4 minutes granulation time.
(4) after having granulated, open discharge piston, crawl stirring arm is discharged wet granular.Wet granulator granulation (sieve number is 16 orders) for wet granular.
(5) starting aerator sucks material in boiling drier.Inlet temperature is set in 60 DEG C ± 5 DEG C, and leaving air temp is set in 50 DEG C ± 5 DEG C, temperature of charge≤55 DEG C, approximately 20 minutes drying times.
(6) M-1000 type shaking screen is loaded onto to 16 orders and 40 eye mesh screens, feed intake and sieve.To be greater than 16 object granules drops in crushing and pelletizing machine.The granule that granulate is crossed is put in shaking screen again, and 16 collected orders are to 40 order granules.
(7) always mixed, packed.
Embodiment 3
Preparation technology
(1) take amoxicillin, lactose, mannitol, stevioside, sucrose, sodium carboxymethyl cellulose are for subsequent use;
(2) configuration of adhesive solution:
By PVP K30, ethyl hydroxybenzoate, lemon yellow, orange flavor, be placed in the purified water stirring and dissolving of 120g, preparation binder solution.
(3) amoxicillin, lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside are dropped in wet granulator, open stirring arm motor, be uniformly mixed 13 minutes time; Open cover, add binder solution, approximately 4 minutes granulation time.
(4) after having granulated, open discharge piston, crawl stirring arm is discharged wet granular.Wet granulator granulation (sieve number is 16 orders) for wet granular.
(5) starting aerator sucks material in boiling drier.Inlet temperature is set in 60 DEG C ± 5 DEG C, and leaving air temp is set in 50 DEG C ± 5 DEG C, temperature of charge≤55 DEG C, approximately 20 minutes drying times.
(6) M-1000 type shaking screen is loaded onto to 16 orders and 40 eye mesh screens, feed intake and sieve.To be greater than 16 object granules drops in crushing and pelletizing machine.The granule that granulate is crossed is put in shaking screen again, and 16 collected orders are to 40 order granules.
(7) always mixed, packed.
Embodiment 4 Stability Determinations
,, under 75% condition, place and within 6 months, carry out accelerated stability investigation, in 0,1,2,3,6 sampling and measuring high polymers in 40 DEG C with reference to the sample of example 1, reference example 2 and embodiment 1, embodiment 2.
In amoxicillin, high polymer is measured, and with reference to 2010 editions amoxicillin standards of Chinese Pharmacopoeia, measures according to molecular exclusion chromatography (annex V H).
Chromatographic condition and system suitability: using sephadex G-10(40～120 μ is m) filler, glass column internal diameter 1.0～1.6cm, post height 30～40cm.Taking the 0.05mol/L phosphate buffer [0.05mol/L disodium phosphate soln-0.05 mol/L sodium dihydrogen phosphate (95:5)] of pH8.0 as mobile phase A, taking water as Mobile phase B, flow velocity is 1.5ml per minute, and detection wavelength is 254nm.Taking mobile phase A, B as mobile phase, get 0.1mg/ml blue dextran 2000 solution 200 μ l injection liquid chromatographies respectively, number of theoretical plate calculates and is all not less than 500 by blue dextran 2000 peaks.Tailing factor all should be less than 2.0.In two kinds of flow phase system, the ratio of blue dextran 2000 peak retention times should be between 0.93～1.07, and in contrast solution main peak and need testing solution, in polymer peak and corresponding chromatographic system, the ratio of the retention time at blue dextran 2000 peaks all should be between 0.93～1.07.Take the about 0.2g in amoxicillin and put in 10ml measuring bottle, add 2% Carbon Dioxide sodium solution 4ml and make after dissolving,, shake up to scale with blue dextran 2000 solution dilutions of 0.3mg/ml.Measure 200 μ l injection liquid chromatographies, measure by mobile phase A, record chromatogram.Paddy between the peak height of high polymer and monomer and high polymer is high than being greater than 2.0.Separately, taking Mobile phase B as mobile phase, precision measures contrast solution 200 μ l, continuous sample introduction 5 times, and the relative standard deviation of peak area should be not more than 5.0%.
The preparation of contrast solution: get penicillin reference substance appropriate, accurately weighed, with water dissolution and quantitatively dilution make in every 1ml the approximately solution containing 0.2mg.
Algoscopy: get the about 0.2g of this product, accurately weighed, put in 10ml measuring bottle, add 2% Carbon Dioxide sodium solution 4ml and make to dissolve, be diluted with water to scale, shake up, precision measures 200 μ l injecting chromatographs immediately, measures as mobile phase taking mobile phase A, records chromatogram.Another precision measures contrast solution 200 μ l injecting chromatographs, taking Mobile phase B as mobile phase, is measured in the same method.
Result is as following table:
The above results shows, the contained macromolecule impurity content of amoxicillin granules that the present invention prepares is less than the impurity content in reference example, also be, amoxicillin granules of the present invention has higher quality, better stability, and in preparation process, avoid with an organic solvent, being more suitable for suitability for industrialized production.
Claims (11)
1. an amoxicillin granules, is characterized in that:
This granule is made up of polyvidone, filler, disintegrating agent, correctives, strong toner and antiseptic;
Described polyvidone is PVP K30, and described filler is lactose, mannitol, sucrose, and disintegrating agent is sodium carboxymethyl cellulose, and correctives is stevioside, orange flavor, and strong toner is lemon yellow, and antiseptic is ethyl hydroxybenzoate;
Feeding intake of described lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside, orange flavor, ethyl hydroxybenzoate, lemon yellow and amoxicillin is 170～130: 80～120 by weight: 1700～1400: 3～8: 4～6: 0.8～1.2: 0.1～0.3: 0.1～0.3: 125;
The consumption of described PVP K30 and amoxicillin is 1: 25～1: 10 by weight calculating;
It adopts the pure water solution of PVP K30, orange flavor, ethyl hydroxybenzoate, lemon yellow to granulate as adhesive solution.
2. amoxicillin granules according to claim 1, is characterized in that feeding intake of described lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside, orange flavor, ethyl hydroxybenzoate, lemon yellow and amoxicillin is 170: 80: 1700 by weight: 3: 4: 0.8: 0.1: 0.13: 125.
3. amoxicillin granules according to claim 1, is characterized in that feeding intake of described lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside, orange flavor, ethyl hydroxybenzoate, lemon yellow and amoxicillin is 150: 100: 1500 by weight: 5: 5: 1: 0.1: 0.12: 125.
4. amoxicillin granules according to claim 1, is characterized in that feeding intake of described lactose, mannitol, sucrose, sodium carboxymethyl cellulose, stevioside, orange flavor, ethyl hydroxybenzoate, lemon yellow and amoxicillin is 130: 120: 1400 by weight: 8: 6: 1.2: 0.12: 0.30: 125.
5. amoxicillin granules according to claim 1, is characterized in that the mass concentration of described PVP K30 in pure water solution is 5%～15%.
6. amoxicillin granules according to claim 5, is characterized in that the mass concentration of described PVP K30 in pure water solution is 6～10%.
7. amoxicillin granules according to claim 1, is characterized in that the consumption of described PVP K30 and amoxicillin is 1: 20～1: 12 by weight calculating.
8. amoxicillin granules according to claim 1, uses boiling drier to be dried after it is characterized in that granulating.
9. amoxicillin granules according to claim 8, the temperature that it is characterized in that described airpillow-dry is 40～70 DEG C, drying time≤40min.
10. amoxicillin granules according to claim 9, the temperature that it is characterized in that described airpillow-dry is 45～65 DEG C, drying time≤30min.
The preparation technology of the amoxicillin granules described in 11. claim 1-10, after it is characterized in that each adjuvant to pulverize and sieve, first prepare adhesive solution, then amoxicillin and other adjuvants except adhesive solution are mixed, add again adhesive solution soft material processed, wet granular processed, by granulate after wet granular airpillow-dry.
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| CN106344522B (en) * | 2016-11-11 | 2019-04-09 | 河北利华药业有限公司 | A kind of amoxicillin granules for animals and preparation method thereof |
| CN107115316A (en) * | 2017-05-18 | 2017-09-01 | 海口市制药厂有限公司 | Amoxicillin granule composition, the preparation method and the usage of a kind of stabilization |
| CN108969488B (en) * | 2018-07-30 | 2021-05-25 | 石药集团中诺药业（石家庄）有限公司 | Amoxicillin granules |
| CN113069418A (en) * | 2021-04-21 | 2021-07-06 | 海南通用三洋药业有限公司 | Preparation method of amoxicillin granules |
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Address after: No. 63 Kexin Road, Jiangbei New District, Nanjing City, Jiangsu Province, 210000 Co-patentee after: Chang'ao Science and Technology of Medical Industry Co., Ltd., Nanjing Patentee after: C & O Pharmaceutical Technology (Holdings) Ltd. Address before: Kexinlu Liuhe District of Nanjing City, Jiangsu Province, No. 63 211500 Co-patentee before: Chang'ao Science and Technology of Medical Industry Co., Ltd., Nanjing Patentee before: C & O Pharmaceutical Technology (Holdings) Ltd. |