CN102836165B - Aspirin vitamin C effervescent tablet and preparation technology thereof - Google Patents
Aspirin vitamin C effervescent tablet and preparation technology thereof Download PDFInfo
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- CN102836165B CN102836165B CN201210344704.1A CN201210344704A CN102836165B CN 102836165 B CN102836165 B CN 102836165B CN 201210344704 A CN201210344704 A CN 201210344704A CN 102836165 B CN102836165 B CN 102836165B
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- 239000007938 effervescent tablet Substances 0.000 title claims abstract description 37
- BIFOVPVXXCRMNY-XHRAKXRYSA-N 2-acetyloxybenzoic acid;2-[(1s)-1,2-dihydroxyethyl]-3,4-dihydroxy-2h-furan-5-one Chemical compound OC[C@H](O)C1OC(=O)C(O)=C1O.CC(=O)OC1=CC=CC=C1C(O)=O BIFOVPVXXCRMNY-XHRAKXRYSA-N 0.000 title claims abstract description 20
- 238000005516 engineering process Methods 0.000 title claims abstract description 17
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 99
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims abstract description 66
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims abstract description 50
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 48
- 235000017557 sodium bicarbonate Nutrition 0.000 claims abstract description 33
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims abstract description 33
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 claims abstract description 26
- 229960001138 acetylsalicylic acid Drugs 0.000 claims abstract description 26
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims abstract description 25
- 229930003268 Vitamin C Natural products 0.000 claims abstract description 25
- 235000019154 vitamin C Nutrition 0.000 claims abstract description 25
- 239000011718 vitamin C Substances 0.000 claims abstract description 25
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 24
- 239000004471 Glycine Substances 0.000 claims abstract description 24
- 235000010355 mannitol Nutrition 0.000 claims abstract description 24
- 239000003826 tablet Substances 0.000 claims abstract description 15
- 239000000463 material Substances 0.000 claims description 40
- 229930195725 Mannitol Natural products 0.000 claims description 23
- 239000000594 mannitol Substances 0.000 claims description 23
- 239000008187 granular material Substances 0.000 claims description 21
- 239000004677 Nylon Substances 0.000 claims description 15
- 238000007605 air drying Methods 0.000 claims description 15
- 238000009835 boiling Methods 0.000 claims description 15
- 238000007599 discharging Methods 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 15
- 229920001778 nylon Polymers 0.000 claims description 15
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 12
- 238000004080 punching Methods 0.000 claims description 12
- 239000007779 soft material Substances 0.000 claims description 12
- 238000005550 wet granulation Methods 0.000 claims description 12
- 229960002449 glycine Drugs 0.000 claims description 9
- 229960001855 mannitol Drugs 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 9
- 239000004744 fabric Substances 0.000 claims description 6
- 238000005469 granulation Methods 0.000 claims description 6
- 230000003179 granulation Effects 0.000 claims description 6
- 238000010348 incorporation Methods 0.000 claims description 6
- 239000004033 plastic Substances 0.000 claims description 6
- 238000010298 pulverizing process Methods 0.000 claims description 6
- 238000007789 sealing Methods 0.000 claims description 6
- 229960004106 citric acid Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 abstract description 12
- 229940079593 drug Drugs 0.000 abstract description 5
- 238000001035 drying Methods 0.000 abstract 1
- 239000002662 enteric coated tablet Substances 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 238000005453 pelletization Methods 0.000 abstract 1
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- 238000007873 sieving Methods 0.000 abstract 1
- 238000005070 sampling Methods 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000009472 formulation Methods 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 241000167880 Hirundinidae Species 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 208000006770 Ascorbic Acid Deficiency Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 1
- 206010047623 Vitamin C deficiency Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 238000010669 acid-base reaction Methods 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 229940121363 anti-inflammatory agent Drugs 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 230000002785 anti-thrombosis Effects 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
- 239000003907 antipyretic analgesic agent Substances 0.000 description 1
- 235000013361 beverage Nutrition 0.000 description 1
- 150000007516 brønsted-lowry acids Chemical class 0.000 description 1
- 150000007528 brønsted-lowry bases Chemical class 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 238000005352 clarification Methods 0.000 description 1
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- 230000007547 defect Effects 0.000 description 1
- 230000001934 delay Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
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- 238000002474 experimental method Methods 0.000 description 1
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- 238000001727 in vivo Methods 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 208000010233 scurvy Diseases 0.000 description 1
- 235000019614 sour taste Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 235000019605 sweet taste sensations Nutrition 0.000 description 1
- 235000019640 taste Nutrition 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
An aspirin vitamin C effervescent tablet and a preparation technology thereof belong to the technical field of pharmaceutical preparations, in particular to the aspirin vitamin C effervescent tablet and the preparation technology thereof. The aspirin vitamin C effervescent tablet and the preparation technology thereof have the advantages as follows: the effervescent tablet is rapid to disintegrate, drugs can dissolve effectively, the tablet cannot be stuck to each other, and the shape of the tablet is good. A tablet core of the aspirin vitamin C effervescent tablet comprises ingredients by weight ratio as follows: in 50000 tablets, aspirin is 15.675 to 17.325 kg, vitamin C is 9.5 to 10.5 kg, mannite is 9.5 to 10.5 kg, glycine is 2.375 to 2.625 kg, citric acid is 38.95 to 43.05 kg, and sodium bicarbonate is 76 to 84 kg. The technical technology of an aspirin enteric-coated tablet comprises the steps as follows: (1), crushing and sieving are carried out; (2), pelletization and drying are carried out; (3), mixing is carried out; and (4), tabletting is carried out.
Description
Technical field
the invention belongs to technical field of medicine, relate in particular to a kind of aspirin vitamin C effervescent tablet and preparation technology thereof.
Background technology
aspirin is a kind of time-honored antipyretic analgesic, up to the present, it has applied a century, becomes one of three large classical medicines in medical history, so far it is still most widely used antipyretic, analgesia and anti-inflammatory agent in the world, is also the standard preparation of other drug as a comparison.In addition, it has antithrombotic effect in vivo, can suppress hematoblastic release reaction, suppresses hematoblastic gathering, clinically for preventing the outbreak of cardiovascular and cerebrovascular disease.
vitamin C is again L-AA, is a kind of water soluble vitamins.It plays important regulating action in oxidoreduction metabolism, lacks it and can cause vitamin C deficiency; In addition, it can promote the synthetic of collagen protein, is beneficial to the healing of human body wound; Can promote the excretion of cholesterol; Treatment anemia, improves the functions such as body immunity, thus vitamin C and people's daily life closely bound up.
effervescent tablet is to take a kind of tablet that suitable bronsted lowry acids and bases bronsted lowry makes as disintegrating agent.By route of administration, can be divided into effervescent tablet for oral administration and external effervescent tablet.Effervescent tablet for oral administration can produce a large amount of CO after entering water
2
thereby gas dissolves rapidly medicine, disintegrate is rapid, is conducive to improve drug bioavailability, and the color, smell and taste of effervescent tablet can flexible, the patient who is highly suitable for child, old man and can not swallows, is the beverage of one glass of sweet and sour taste after the good oral effervescent tablet effervescent of quality.External effervescent tablet mainly contains vagina effervescence and oral cavity effervescent tablet etc., and this class effervescent tablet is easy to use, can effectively increase the contact area of medicine and human body, improves drug effect, can avoid pollution clothes simultaneously, to patient, brings uncomfortable shortcoming.
although effervescent technology all has broad research and application at quick releasing formulation, slow releasing preparation etc., really energy large-scale industrial production effervescent tablet preparation seldom, with regard to its reason, is mainly that the industrialization process of effervescent formulation has some more difficult difficult problems of capturing.
glutinous punching: it is exactly glutinous punching that effervescent tablet is produced upper maximum problem, and while especially preparing extractum effervescent tablet, this shortcoming is particularly outstanding, has seriously reduced the production efficiency of effervescent tablet.Cause the reason of glutinous punching a lot: ambient humidity is large, the moisture too high or moisture absorption of material and stickness; Ambient temperature is high, and low melting point substance melts and glutinous punching; Lubricant selection is improper etc.
poor stability: owing to containing soda acid in effervescent formulation, as long as there is the existence of minor amount of water, be easy to cause acid-base reaction, cause dosage form stability poor, the defect such as sheet type is bad.
disintegration time delays: most of oral Chinese medicine effervescent tablet often exists disintegrate time delay, not even the phenomenon of disintegrate.The factor that affects effervescent tablet disintegrate is a lot, as stickiness is large, is unfavorable for that moisture infiltrates sheet core inner etc.
Summary of the invention
the present invention is exactly for the problems referred to above, provide a kind of disintegrate rapidly, medicine can dissolve effectively, and the glutinous punching of tabletting, aspirin vitamin C effervescent tablet and preparation technology thereof that sheet shape is good.
for achieving the above object, the present invention adopts following technical scheme, and the label composition of aspirin vitamin C effervescent tablet of the present invention is by weight ratio: in 50,000, and aspirin 15.675kg～17.325kg; Vitamin C 9.5kg～10.5kg; Mannitol 9.5kg～10.5kg; Glycine 2.375kg～2.625kg; Citric acid 38.95kg～43.05kg; Sodium bicarbonate 76kg～84kg.
as a kind of preferred version, aspirin 16.5kg of the present invention, vitamin C 10kg, mannitol 10kg, glycine 2.5kg, citric acid 41kg, sodium bicarbonate 80kg.
the preparation technology of aspirin vitamin C effervescent tablet of the present invention is.
(1) pulverize, sieve: after pulverizing respectively citric acid, aspirin, glycine and mannitol, cross screen cloth, vitamin C and sodium bicarbonate are crossed screen cloth.
(2) granulate and be dried: citric acid is added in wet granulation pot, get dehydrated alcohol soft material processed, with nylon screen, on oscillating granulator, granulate, then dry with boiling drier, cold air drying, discharging; Sodium bicarbonate is added in wet granulation pot, get dehydrated alcohol soft material processed, with nylon screen, on oscillating granulator, granulate, then dry with boiling drier, cold air drying, discharging.
(3) mix: the citric acid after aspirin, glycine, mannitol, vitamin C and granulation, sodium bicarbonate are added in three-dimensional motion mixer and mixed.
(4) tabletting: mixed material is put into tablet machine tabletting.
as a kind of preferred version, step of the present invention (1) citric acid, aspirin, glycine and mannitol are crossed 80 eye mesh screens, and vitamin C and sodium bicarbonate are crossed 60 eye mesh screens.
as another kind of preferred version, step of the present invention (2) citric acid is granulated and sodium bicarbonate is granulated all granulates on oscillating granulator with 18 order nylon screens; Then use boiling drier in dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging.
as another kind of preferred version, step of the present invention (3) is used GH-500 three-dimensional motion mixer, mixes revolution: 600r/min, incorporation time: 20 minutes; Two layers of plastic bag sealing for mixed material, moves to tabletting chamber and deposits.
secondly, the room humidity <30%RH of tabletting of the present invention chamber.
in addition, step of the present invention (4) is used ZPY-27B rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature <19 ℃; Humidity <30%RH; Tabletting starts, and checks disintegration ≯ 5 minute, and 10 heavy scopes of sheet are controlled by ± 4%, and formal tabletting, detects once for every 30 minutes, and the heavy scope of sheet is controlled by ± 3%, in tabletting process, observes at any time, if any dirty sheet, relic, rejects at once.
beneficial effect of the present invention: the one-tenth of aspirin vitamin C effervescent tablet of the present invention is grouped into, each constituent content and preparation technology are the technical scheme that inventor obtains through long-time and great many of experiments, its disintegration of tablet is rapid, medicine can dissolve effectively, the patient who is highly suitable for child, old man and can not swallows; And tabletting does not stick punching, sheet shape is good, production efficiency is high.
The specific embodiment
the label of aspirin vitamin C effervescent tablet of the present invention forms: in 50,000, and aspirin 15.675kg～17.325kg; Vitamin C 9.5kg～10.5kg; Mannitol 9.5kg～10.5kg; Glycine 2.375kg～2.625kg; Citric acid 38.95kg～43.05kg; Sodium bicarbonate 76kg～84kg.
described aspirin 16.5kg, vitamin C 10kg, mannitol 10kg, glycine 2.5kg, citric acid 41kg, sodium bicarbonate 80kg.
the preparation technology of aspirin vitamin C effervescent tablet of the present invention is.
(1) pulverize, sieve: after pulverizing respectively citric acid, aspirin, glycine and mannitol, cross screen cloth, vitamin C and sodium bicarbonate are crossed screen cloth.
(2) granulate and be dried: citric acid is added in wet granulation pot, get dehydrated alcohol soft material processed, with nylon screen, on oscillating granulator, granulate, then dry with boiling drier, cold air drying, discharging; Sodium bicarbonate is added in wet granulation pot, get dehydrated alcohol soft material processed, with nylon screen, on oscillating granulator, granulate, then dry with boiling drier, cold air drying, discharging.
(3) mix: the citric acid after aspirin, glycine, mannitol, vitamin C and granulation, sodium bicarbonate are added in three-dimensional motion mixer and mixed.
(4) tabletting: mixed material is put into tablet machine tabletting.
described step (1) citric acid, aspirin, glycine and mannitol are crossed 80 eye mesh screens, and vitamin C and sodium bicarbonate are crossed 60 eye mesh screens.Material balance: 99.95-100.00%.
described step (2) citric acid is granulated and sodium bicarbonate is granulated all granulates on oscillating granulator with 18 order nylon screens; Then use boiling drier in dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging.Yield: ≮ 92.00%. material balance: 99.00-100.00%.
described step (3) is used GH-500 three-dimensional motion mixer, mixes revolution: 600r/min, incorporation time: 20 minutes; Two layers of plastic bag sealing for mixed material, moves to tabletting chamber and deposits.Yield: ≮ 99.50% material balance: 99.95-100.00%.
the room humidity <30%RH of described tabletting chamber.
described step (4) is used ZPY-27B rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature <19 ℃; Humidity <30%RH; Tabletting starts, and checks disintegration ≯ 5 minute, and 10 heavy scopes of sheet are controlled by ± 4%, and formal tabletting, detects once for every 30 minutes, and the heavy scope of sheet is controlled by ± 3%, in tabletting process, observes at any time, if any dirty sheet, relic, rejects at once.After tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in material balance list.Material metage being recorded and is transferred to plain sheet transporting room stores.Yield ≮ 98.00% material balance: 99.90-100.00%.
embodiment 1.
(1) pulverize, sieve: after pulverizing respectively citric acid, aspirin, glycine and mannitol, cross 80 eye mesh screens, take citric acid 38.95kg, aspirin 15.675kg, glycine 2.375kg and mannitol 9.5kg; Vitamin C, sodium bicarbonate are crossed after 60 eye mesh screens respectively, take vitamin C 9.5kg, sodium bicarbonate 76kg, material balance: 99.95-100.00%.
(2) granulate and be dried: citric acid is added in wet granulation pot, get place's dehydrated alcohol soft material processed, with 18 order nylon screens, on oscillating granulator, granulate, then use boiling drier dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging, yield: ≮ 92.00%. material balance: 99.00-100.00%; Sodium bicarbonate is added in wet granulation pot, get dehydrated alcohol soft material processed, with 18 order nylon screens, on oscillating granulator, granulate, then use boiling drier at dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging, yield: ≮ 92.00%.Material balance: 99.00-100.00%.
(3) mix: the citric acid after aspirin, glycine, mannitol, vitamin C and granulation, sodium bicarbonate are added in GH-500 three-dimensional motion mixer and mixed, mix revolution: 600r/min, incorporation time: 20 minutes; Two layers of plastic bag sealing for mixed material, moves to tabletting chamber (room humidity <30%RH) and deposits.Yield: ≮ 99.50% material balance: 99.95-100.00%.
(4) tabletting: mixed material is put into ZPY-27B rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature <19 ℃; Humidity <30%RH.Tabletting starts, and by QA, checks disintegration ≯ 5 minute, and 10 heavy scopes of sheet are controlled by ± 4%.After each qualified, start formal tabletting, by operator, detected, within every 30 minutes, detect once, the heavy scope of sheet is controlled by ± 3%, in tabletting process, observes at any time, if any dirty sheet, relic, rejects at once.By in control person detect, within every 2 hours, detect once.After tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in material balance list.Material metage being recorded and is transferred to plain sheet transporting room stores.Yield ≮ 98.00% material balance: 99.90-100.00%.
embodiment 2.
(1) pulverize, sieve: after pulverizing respectively citric acid, aspirin, glycine and mannitol, cross 80 eye mesh screens, take citric acid 41kg, aspirin 16.5kg, glycine 2.5kg and mannitol 10kg; Vitamin C, sodium bicarbonate are crossed after 60 eye mesh screens respectively, take vitamin C 10kg, sodium bicarbonate 80kg, material balance: 99.95-100.00%.
(2) granulate and be dried: citric acid is added in wet granulation pot, get place's dehydrated alcohol soft material processed, with 18 order nylon screens, on oscillating granulator, granulate, then use boiling drier dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging, yield: ≮ 92.00%. material balance: 99.00-100.00%; Sodium bicarbonate is added in wet granulation pot, get dehydrated alcohol soft material processed, with 18 order nylon screens, on oscillating granulator, granulate, then use boiling drier at dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging, yield: ≮ 92.00%.Material balance: 99.00-100.00%.
(3) mix: the citric acid after aspirin, glycine, mannitol, vitamin C and granulation, sodium bicarbonate are added in GH-500 three-dimensional motion mixer and mixed, mix revolution: 600r/min, incorporation time: 20 minutes; Two layers of plastic bag sealing for mixed material, moves to tabletting chamber (room humidity <30%RH) and deposits.Yield: ≮ 99.50% material balance: 99.95-100.00%.
(4) tabletting: mixed material is put into ZPY-27B rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature <19 ℃; Humidity <30%RH.Tabletting starts, and by QA, checks disintegration ≯ 5 minute, and 10 heavy scopes of sheet are controlled by ± 4%.After each qualified, start formal tabletting, by operator, detected, within every 30 minutes, detect once, the heavy scope of sheet is controlled by ± 3%, in tabletting process, observes at any time, if any dirty sheet, relic, rejects at once.By in control person detect, within every 2 hours, detect once.After tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in material balance list.Material metage being recorded and is transferred to plain sheet transporting room stores.Yield ≮ 98.00% material balance: 99.90-100.00%.
embodiment 3.
(1) pulverize, sieve: after pulverizing respectively citric acid, aspirin, glycine and mannitol, cross 80 eye mesh screens, take citric acid 43.05kg, aspirin 17.325kg, glycine 2.625kg and mannitol 10.5kg; Vitamin, sodium bicarbonate are crossed after 60 eye mesh screens respectively, take vitamin C 10.5kg, sodium bicarbonate 84kg, material balance: 99.95-100.00%.
(2) granulate and be dried: citric acid is added in wet granulation pot, get place's dehydrated alcohol soft material processed, with 18 order nylon screens, on oscillating granulator, granulate, then use boiling drier dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging, yield: ≮ 92.00%. material balance: 99.00-100.00%; Sodium bicarbonate is added in wet granulation pot, get dehydrated alcohol soft material processed, with 18 order nylon screens, on oscillating granulator, granulate, then use boiling drier at dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging, yield: ≮ 92.00%.Material balance: 99.00-100.00%.
(3) mix: the citric acid after aspirin, glycine, mannitol, vitamin C and granulation, sodium bicarbonate are added in GH-500 three-dimensional motion mixer and mixed, mix revolution: 600r/min, incorporation time: 20 minutes; Two layers of plastic bag sealing for mixed material, moves to tabletting chamber (room humidity <30%RH) and deposits.Yield: ≮ 99.50% material balance: 99.95-100.00%.
(4) tabletting: mixed material is put into ZPY-27B rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature <19 ℃; Humidity <30%RH.Tabletting starts, and by QA, checks disintegration ≯ 5 minute, and 10 heavy scopes of sheet are controlled by ± 4%.After each qualified, start formal tabletting, by operator, detected, within every 30 minutes, detect once, the heavy scope of sheet is controlled by ± 3%, in tabletting process, observes at any time, if any dirty sheet, relic, rejects at once.By in control person detect, within every 2 hours, detect once.After tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in material balance list.Material metage being recorded and is transferred to plain sheet transporting room stores.Yield ≮ 98.00% material balance: 99.90-100.00%.
sheet shape, disintegration time, clarity of solution for 10 batches of aspirin vitamin C effervescent tablets that use composition and engineering of the present invention to prepare are measured, and result as shown in Table 1.
table one: the measurement result such as 10 batches of aspirin vitamin C effervescent tablet sheet shapes, disintegration time.
result shows: sheet shape is good in process of production for the aspirin vitamin C effervescent tablet that uses formula of the present invention and preparation technology to produce, without significantly wearing and tearing; Effectively avoided glutinous generation of rushing phenomenon; Reduced greatly production cost; Effervescent tablet disintegrate is rapid, is conducive to improve drug bioavailability, and liquid clarification, and medicine dissolves completely.
be understandable that, above about specific descriptions of the present invention, only for being described, the present invention is not limited to the described technical scheme of the embodiment of the present invention, those of ordinary skill in the art is to be understood that, still can modify or be equal to replacement the present invention, to reach identical technique effect; As long as meet, use needs, all within protection scope of the present invention.
Claims (4)
1.
an aspirin vitamin C effervescent tablet, is characterized in that label composition is by weight ratio: in 50,000, and aspirin 16.5kg, vitamin C 10kg, mannitol 10kg, glycine 2.5kg, citric acid 41kg, sodium bicarbonate 80kg.
2.
according to claim 1, a preparation technology for aspirin vitamin C effervescent tablet, is characterized in that:
(1) pulverize, sieve: after pulverizing respectively citric acid, aspirin, glycine and mannitol, cross screen cloth, vitamin C and sodium bicarbonate are crossed screen cloth;
(2) granulate and be dried: citric acid is added in wet granulation pot, get dehydrated alcohol soft material processed, with nylon screen, on oscillating granulator, granulate, then dry with boiling drier, cold air drying, discharging; Sodium bicarbonate is added in wet granulation pot, get dehydrated alcohol soft material processed, with nylon screen, on oscillating granulator, granulate, then dry with boiling drier, cold air drying, discharging;
(3) mix: the citric acid after aspirin, glycine, mannitol, vitamin C and granulation, sodium bicarbonate are added in three-dimensional motion mixer and mixed;
(4) tabletting: mixed material is put into tablet machine tabletting;
described step (1) citric acid, aspirin, glycine and mannitol are crossed 80 eye mesh screens, and vitamin C and sodium bicarbonate are crossed 60 eye mesh screens; Described step (2) citric acid is granulated and sodium bicarbonate is granulated all granulates on oscillating granulator with 18 order nylon screens; Then use boiling drier in dry 60 minutes of the temperature of 65 ± 5 ℃, cold air drying 15 minutes, discharging; Described step (4) is used ZPY-27B rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature <19 ℃; Humidity <30%RH; Tabletting starts, and checks disintegration ≯ 5 minute, and 10 heavy scopes of sheet are controlled by ± 4%, and formal tabletting, detects once for every 30 minutes, and the heavy scope of sheet is controlled by ± 3%, in tabletting process, observes at any time, if any dirty sheet, relic, rejects at once.
3.
according to claim 2, a preparation technology for aspirin vitamin C effervescent tablet, is characterized in that described step (3) use GH-500 three-dimensional motion mixer, mixes revolution: 600r/min, incorporation time: 20 minutes; Two layers of plastic bag sealing for mixed material, moves to tabletting chamber and deposits.
4.
according to claim 3, a preparation technology for aspirin vitamin C effervescent tablet, is characterized in that the room humidity <30%RH of described tabletting chamber.
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| CN105106226A (en) * | 2015-09-14 | 2015-12-02 | 泉州市灵源药业有限公司 | Aspirin vitamin c chewable tablet and preparation method thereof |
| CN107441057A (en) * | 2017-09-22 | 2017-12-08 | 安徽世龙生物医药科技有限公司 | A kind of salicylic acid effervescent tablet |
| CN107582528B (en) * | 2017-10-13 | 2019-04-09 | 上海宣泰医药科技有限公司 | Method and products thereof for wet granulation |
| CN111529501A (en) * | 2020-06-30 | 2020-08-14 | 南京白敬宇制药有限责任公司 | Preparation method of aspirin vitamin C dispersible tablet |
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| Title |
|---|
| 徐健等.《阿司匹林维生素Ｃ泡腾片的处方工艺研究》.《药学服务与研究》.2012,第12卷(第2期),129-31页. * |
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