CN102836138A - Paracetamol vitamin C effervescent tablet and preparation process thereof - Google Patents
Paracetamol vitamin C effervescent tablet and preparation process thereof Download PDFInfo
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- CN102836138A CN102836138A CN2012103447268A CN201210344726A CN102836138A CN 102836138 A CN102836138 A CN 102836138A CN 2012103447268 A CN2012103447268 A CN 2012103447268A CN 201210344726 A CN201210344726 A CN 201210344726A CN 102836138 A CN102836138 A CN 102836138A
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Abstract
The invention provides a paracetamol vitamin C effervescent tablet and a preparation process thereof, belongs to the technical field of pharmaceutic preparations, and particularly relates to the paracetamol vitamin C effervescent tablet and the preparation process thereof. The invention provides the paracetamol vitamin C effervescent tablet which is rapidly disintegrated, can be effectively dissolved, is not sticky during the tabletting and has a good tablet shape, and the preparation process thereof. Tablet cores of 50, 000 paracetamol vitamin C effervescent tablets provided by the invention comprise following components by weight ratio: 15.675kg to 17.325kg of paracetamol, 9.5kg to 10.5kg of vitamin C, 2.375kg to 2.625kg of glycine, 9.5kg to 10.5kg of mannitol, 42.75kg to 47.25kg of citric acid, 61.75kg to 68.25kg of sodium bicarbonate and 2.375kg to 2.625kg of sodium dodecyl sulfate.
Description
Technical field
the invention belongs to technical field of medicine, relate in particular to a kind of acetaminophen vitamin C effervescent tablet and preparation technology thereof.
Background technology
acetaminophen is generally white crystalline powder, and through being reduced into p-aminophenol, acidylate makes again by paranitrophenol sodium salt.It is the most frequently used non-steroidal anti-inflammatory antipyretic analgesic, and refrigeration function is similar with aspirin, is best kind in the acetophenone amine medicine, the patient who is particularly suitable for using the carboxylic acids medicine.In addition, be used for arthralgia, neuralgia, migraine, cancer pain and operation back pain relieving etc.
vitamin C is the L-ascorbic acid again, is a kind of water soluble vitamins.It plays important regulatory role in the oxidoreduction metabolism, lack 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 drainage of cholesterol; The treatment anemia improves functions such as body immunity, so vitamin C and people's daily life are closely bound up.
effervescent tablet is a kind of novel tablet of external in recent years Application and Development.Can be divided into effervescent tablet for oral administration and external effervescent tablet by route of administration.It contains gas-producing disintegrant effervescent tablet for oral administration, after effervescent tablet is put into drinking-water, under the effect of gas-producing disintegrant; At once produce great amount of bubbles (carbon dioxide) and make rapid disintegrate of tablet and thawing; Sometimes the bubble that disintegrate produces also can make tablet in water, roll up and down, quickens its disintegrate and thawing, helps improving drug bioavailability; Quality is the beverage of one glass of sweet and sour taste, the patient who is highly suitable for child, old man and can not swallows after oral administration effervescing sheet effervescent finishes preferably.External effervescent tablet mainly contains vagina effervescence and oral cavity effervescent tablet etc., and this type effervescent tablet is easy to use, can effectively increase the contact area of medicine and human body, reduces to the patient and brings uncomfortable shortcoming, improves curative effect simultaneously.
are although the effervescent technology all has broad research and application at quick releasing formulation, slow releasing preparation etc.; But really ability large-scale industrial production effervescent tablet preparation seldom; The industrialization process that mainly is effervescent formulation of tracing it to its cause has some difficult difficult problems of capturing, and FAQs is following.
poor stability: owing to contain soda acid in the effervescent formulation,, be easy to cause acid-base reaction, cause dosage form stability poor, defective such as the sheet type is bad as long as the existence of minor amount of water is arranged.
disintegration time delays: most of oral Chinese medicine effervescent tablet often exists disintegrate time-delay, the not even phenomenon of disintegrate.The factor that influences the effervescent tablet disintegrate is a lot, and is big like stickiness, is unfavorable for that moisture infiltrates label inside etc.
are poorly soluble: the effervescent tablet solute effect on the market is undesirable, and solution do not clarify, transparent, and mouthfeel is not good.
are glutinous to be dashed: maximum problem sticks exactly and dashes in the effervescent tablet production, and this shortcoming is particularly outstanding when especially preparing the extractum effervescent tablet, has seriously reduced the production efficiency of effervescent tablet.
Summary of the invention
the present invention is exactly to the problems referred to above, provide a kind of disintegrate rapidly, medicine can dissolve effectively, and tabletting glutinously dashes, sheet shape is good acetaminophen vitamin C effervescent tablet and preparation technology thereof.
for realizing above-mentioned purpose, the present invention adopts following technical scheme, and the label composition of acetaminophen vitamin C effervescent tablet of the present invention is by weight ratio: in 50,000, and acetaminophen 15.675kg～17.325kg; Vitamin C 9.5kg～10.5kg; Glycine 2.375kg～2.625kg; Mannitol 9.5kg～10.5kg; Citric acid 42.75kg～47.25kg; Sodium bicarbonate 61.75kg～68.25kg; Dodecyl sodium sulfate 2.375kg～2.625kg.
as a kind of preferred version, acetaminophen 16.5kg according to the invention; Vitamin C 10kg; Glycine 2.5kg; Mannitol 10kg; Citric acid 45kg; Sodium bicarbonate 65kg; Dodecyl sodium sulfate 2.5kg.
acetaminophen Preparation of vitamin C effervescent tablets technology of the present invention does.
(1) is pulverized, is sieved: use pulverizer, screening machine, get mannitol, glycine, citric acid and under screen cloth, pulverize, sieve.
Mix
(2): use mixer earlier vitamin C, glycine, acetaminophen, mannitol, citric acid, sodium bicarbonate to be carried out premixing, mixed material is used the tablet machine tabletting, again through waving the granulator granulation of sieving; At last dried granule and sodium lauryl sulphate are mixed through mixer.
(3) tabletting: the material that will obtain after will mixing carries out tabletting through tablet machine.
as a kind of preferred version, step according to the invention (1) pulverizer adopts turbine self-cooled pulverizer, and screening machine adopts whirlpool vibration type screening machine, and screen cloth is 80 eye mesh screens.
secondly, step according to the invention (2) mixer adopts three-dimensional motion mixer, the premixing rotating speed is 900r/min, incorporation time is 30min; Dried granule and sodium lauryl sulphate mixing rotating speed are 600r/min, and the time is 10min; The screen cloth that the said granulation of sieving is adopted is 16 eye mesh screens.
in addition, step according to the invention (3) tablet machine adopts rotary tablet machine, puts down punching press system, Fang Jianwendu < with Φ 23mm; 19 ℃, Shi Du< 30%RH; Tabletting begins, disintegration ≯ 5 minute, and 10 heavy scopes of sheets are by ± 4% control, and formal tabletting detected once in per 30 minutes, and the heavy scope of sheet, is observed in the tabletting process by ± 3% control at any time, rejects if any dirty sheet, relic at once.
beneficial effect of the present invention: the one-tenth of acetyl aminophenol vitamin C effervescent tablet of the present invention is grouped into, each constituent content and preparation technology are the technical schemes that the inventor obtains through long-time and a large amount 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 and dashes, sheet shape is good, production efficiency is high.
The specific embodiment
The label of
acetaminophen vitamin C effervescent tablet of the present invention is formed: in 50,000, and acetaminophen 15.675kg～17.325kg; Vitamin C 9.5kg～10.5kg; Glycine 2.375kg～2.625kg; Mannitol 9.5kg～10.5kg; Citric acid 42.75kg～47.25kg; Sodium bicarbonate 61.75kg～68.25kg; Dodecyl sodium sulfate 2.375kg～2.625kg.
said acetaminophen 16.5kg; Vitamin C 10kg; Glycine 2.5kg; Mannitol 10kg; Citric acid 45kg; Sodium bicarbonate 65kg; Dodecyl sodium sulfate 2.5kg.
acetaminophen Preparation of vitamin C effervescent tablets technology of the present invention does.
(1) is pulverized, is sieved: use pulverizer, screening machine, get mannitol, glycine, citric acid and under screen cloth, pulverize, sieve.
Mix
(2): use mixer earlier vitamin C, glycine, acetaminophen, mannitol, citric acid, sodium bicarbonate to be carried out premixing, mixed material is used the tablet machine tabletting, again through waving the granulator granulation of sieving; At last dried granule and sodium lauryl sulphate are mixed through mixer; The said granulator that waves can adopt YK-160A to wave granulator.
(3) tabletting: the material that will obtain after will mixing carries out tabletting through tablet machine.
said step (1) pulverizer adopts turbine self-cooled pulverizer, and screening machine adopts whirlpool vibration type screening machine, and screen cloth is 80 eye mesh screens, material balance: 99.95-100.00%.Said turbine self-cooled pulverizer can adopt TF-260 turbine self-cooled pulverizer, and whirlpool vibration type screening machine can adopt XZS-400 whirlpool vibration type screening machine.
said step (2) mixer adopts three-dimensional motion mixer, and the premixing rotating speed is 900r/min, and incorporation time is 30min; Dried granule and sodium lauryl sulphate mixing rotating speed are 600r/min, and the time is 10min; The screen cloth that the said granulation of sieving is adopted is 16 eye mesh screens, yield: ≮ 99.00% material balance: 99.80-100.00%.Said three-dimensional motion mixer can adopt the GH-500 three-dimensional motion mixer.
said step (3) tablet machine adopts rotary tablet machine, with the flat punching press system of Φ 23mm, Fang Jianwendu< 19 ℃, Shi Du< 30%RH; Tabletting begins, disintegration ≯ 5 minute, and 10 heavy scopes of sheets are by ± 4% control, and formal tabletting detected once in per 30 minutes, and the heavy scope of sheet, is observed in the tabletting process by ± 3% control at any time, rejects if any dirty sheet, relic at once.Detect by middle control person, detected once in per 2 hours.After the tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in the material balance list.Material metage is write down and be transferred to plain sheet transporting room to be stored.Yield ≮ 98.00% material balance: 99.90-100.00%.Said rotary tablet machine can adopt the ZPY-27B rotary tablet machine.
embodiment 1.
(1) is pulverized, is sieved: use TF-260 turbine self-cooled pulverizer, XZS-400 whirlpool vibration type screening machine, get mannitol 9.5kg, glycine 2.375kg, citric acid 42.75kg and under 80 eye mesh screens, pulverize, sieve.Material balance: 99.95-100.00%.
Mix
(2): use the GH-500 three-dimensional motion mixer; Earlier vitamin C 9.5kg, glycine, acetaminophen 15.675kg, mannitol, citric acid, sodium bicarbonate 61.75kg are carried out premixing; Rotating speed 900r/min mixes 30min.Mixed material is pressed into sheet, YK-160A with tablet machine and waves granulator and cross 16 mesh sieves and granulate.At last with dried granule and sodium lauryl sulphate 2.375kg through mixing in the three-dimensional motion mixer, rotating speed 600r/min mixes 10min.Yield: ≮ 99.00% material balance: 99.80-100.00%.
(3) tabletting: the material that will obtain after will mixing is through the ZPY-27B rotary tablet machine, with the flat stamping of Φ 23mm, Fang Jianwendu< 19 ℃, Shi Du< 30%RH.Tabletting begins, and by QA inspection disintegration ≯ 5 minute, 10 heavy scopes of sheets are by ± 4% control.After each index is qualified, begin formal tabletting, detected by the operator, detected once in per 30 minutes, the heavy scope of sheet, is observed in the tabletting process by ± 3% control at any time, rejects if any dirty sheet, relic at once.Detect by middle control person, detected once in per 2 hours.After the tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in the material balance list.Material metage is write down and be transferred to plain sheet transporting room to be stored.Yield ≮ 98.00% material balance: 99.90-100.00%.
embodiment 2.
(1) is pulverized, is sieved: use TF-260 turbine self-cooled pulverizer, XZS-400 whirlpool vibration type screening machine, get mannitol 10kg, glycine 2.5kg, citric acid 45kg and under 80 eye mesh screens, pulverize, sieve.Material balance: 99.95-100.00%.
Mix
(2): use the GH-500 three-dimensional motion mixer; Earlier vitamin C 10kg, glycine, acetaminophen 16.5kg, mannitol, citric acid, sodium bicarbonate 65kg are carried out premixing; Rotating speed 900r/min mixes 30min.Mixed material is pressed into sheet, YK-160A with tablet machine and waves granulator and cross 16 mesh sieves and granulate.At last with dried granule and sodium lauryl sulphate 2.5kg through mixing in the three-dimensional motion mixer, rotating speed 600r/min mixes 10min.Yield: ≮ 99.00% material balance: 99.80-100.00%.
(3) tabletting: the material that will obtain after will mixing is through the ZPY-27B rotary tablet machine, with the flat stamping of Φ 23mm, Fang Jianwendu< 19 ℃, Shi Du< 30%RH.Tabletting begins, and by QA inspection disintegration ≯ 5 minute, 10 heavy scopes of sheets are by ± 4% control.After each index is qualified, begin formal tabletting, detected by the operator, detected once in per 30 minutes, the heavy scope of sheet, is observed in the tabletting process by ± 3% control at any time, rejects if any dirty sheet, relic at once.Detect by middle control person, detected once in per 2 hours.After the tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in the material balance list.Material metage is write down and be transferred to plain sheet transporting room to be stored.Yield ≮ 98.00% material balance: 99.90-100.00%.
embodiment 3.
(1) is pulverized, is sieved: use TF-260 turbine self-cooled pulverizer, XZS-400 whirlpool vibration type screening machine, get mannitol 10.5kg, glycine 2.625kg, citric acid 47.25kg and under 80 eye mesh screens, pulverize, sieve.Material balance: 99.95-100.00%.
Mix
(2): use the GH-500 three-dimensional motion mixer; Earlier vitamin C 10.5kg, glycine, acetaminophen 17.325kg, mannitol, citric acid, sodium bicarbonate 68.25kg are carried out premixing; Rotating speed 900r/min mixes 30min.Mixed material is pressed into sheet, YK-160A with tablet machine and waves granulator and cross 16 mesh sieves and granulate.At last with dried granule and sodium lauryl sulphate 2.625kg through mixing in the three-dimensional motion mixer, rotating speed 600r/min mixes 10min.Yield: ≮ 99.00% material balance: 99.80-100.00%.
(3) tabletting: the material that will obtain after will mixing is through the ZPY-27B rotary tablet machine, with the flat stamping of Φ 23mm, Fang Jianwendu< 19 ℃, Shi Du< 30%RH.Tabletting begins, and by QA inspection disintegration ≯ 5 minute, 10 heavy scopes of sheets are by ± 4% control.After each index is qualified, begin formal tabletting, detected by the operator, detected once in per 30 minutes, the heavy scope of sheet, is observed in the tabletting process by ± 3% control at any time, rejects if any dirty sheet, relic at once.Detect by middle control person, detected once in per 2 hours.After the tabletting post operation finishes, by QA sampling censorship, and record sample time and sampling weight.Calculate load, yield and fill in the material balance list.Material metage is write down and be transferred to plain sheet transporting room to be stored.Yield ≮ 98.00% material balance: 99.90-100.00%.
are measured the sample disintegration time, lamellar etc. of 10 batches of acetaminophen vitamin C effervescent tablets using the preparation of this prescription and production technology, and it is as shown in the table.
result show: sheet shape is good in process of production for acetaminophen vitamin C effervescent tablet of the present invention, does not have significantly wearing and tearing; Avoided glutinous generation effectively towards phenomenon; Reduced production cost greatly; The effervescent tablet disintegrate is rapid, helps improving drug bioavailability, and the liquid clarification, and medicine dissolves fully.
it is understandable that; More than about specific descriptions of the present invention; Only be used to the present invention is described and be not to be subject to the described technical scheme of the embodiment of the invention; Those of ordinary skill in the art should be appreciated that still and can make amendment or be equal to replacement the present invention, to reach identical technique effect; As long as satisfy the use needs, all within protection scope of the present invention.
Claims (6)
1. acetaminophen vitamin C effervescent tablet is characterized in that label is formed and is by weight ratio: in 50,000, and acetaminophen 15.675kg～17.325kg; Vitamin C 9.5kg～10.5kg; Glycine 2.375kg～2.625kg; Mannitol 9.5kg～10.5kg; Citric acid 42.75kg～47.25kg; Sodium bicarbonate 61.75kg～68.25kg; Dodecyl sodium sulfate 2.375kg～2.625kg.
2. according to the said a kind of acetaminophen vitamin C effervescent tablet of claim 1, it is characterized in that said acetaminophen 16.5kg; Vitamin C 10kg; Glycine 2.5kg; Mannitol 10kg; Citric acid 45kg; Sodium bicarbonate 65kg; Dodecyl sodium sulfate 2.5kg.
3. according to claim 1 or 2 said a kind of acetaminophen Preparation of vitamin C effervescent tablets technologies, it is characterized in that:
(1) pulverizes, sieves: use pulverizer, screening machine, get mannitol, glycine, citric acid and under screen cloth, pulverize, sieve;
(2) mix: use mixer earlier vitamin C, glycine, acetaminophen, mannitol, citric acid, sodium bicarbonate to be carried out premixing, mixed material is used the tablet machine tabletting, again through waving the granulator granulation of sieving; At last dried granule and sodium lauryl sulphate are mixed through mixer;
(3) tabletting: the material that will obtain after will mixing carries out tabletting through tablet machine.
4. according to the said a kind of acetaminophen Preparation of vitamin C effervescent tablets technology of claim 3, it is characterized in that said step (1) pulverizer adopts turbine self-cooled pulverizer, screening machine adopts whirlpool vibration type screening machine, and screen cloth is 80 eye mesh screens.
5. according to the said a kind of acetaminophen Preparation of vitamin C effervescent tablets technology of claim 3, it is characterized in that said step (2) mixer adopts three-dimensional motion mixer, the premixing rotating speed is 900r/min, and incorporation time is 30min; Dried granule and sodium lauryl sulphate mixing rotating speed are 600r/min, and the time is 10min; The screen cloth that the said granulation of sieving is adopted is 16 eye mesh screens.
6. according to the said a kind of acetaminophen Preparation of vitamin C effervescent tablets technology of claim 3, it is characterized in that said step (3) tablet machine adopts rotary tablet machine, with the flat punching press system of Φ 23mm, room temperature < 19 ℃, humidity < 30%RH; Tabletting begins, disintegration ≯ 5 minute, and 10 heavy scopes of sheets are by ± 4% control, and formal tabletting detected once in per 30 minutes, and the heavy scope of sheet, is observed in the tabletting process by ± 3% control at any time, rejects if any dirty sheet, relic at once.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103705581A (en) * | 2013-12-30 | 2014-04-09 | 长沙理工大学 | Compound Huodan dispersible tablet and preparation method and application thereof |
| CN106490164A (en) * | 2016-10-20 | 2017-03-15 | 光明乳业股份有限公司 | A kind of milk powder high protein effervescent tablet and preparation method thereof |
| CN113384549A (en) * | 2021-07-21 | 2021-09-14 | 海南涛生医药科技研究院有限公司 | Acetaminophen vitamin C effervescent tablet and preparation method thereof |
| CN114533693A (en) * | 2022-03-08 | 2022-05-27 | 沈阳奥吉娜药业有限公司 | Paracetamol effervescent tablet for children and preparation process thereof |
| WO2024153959A1 (en) | 2023-01-17 | 2024-07-25 | Ioulia Tseti | Pharmaceutical composotion of paracetamol in a water-soluble form in a hermetically sealed container for preparing a hot beverage |
-
2012
- 2012-09-18 CN CN201210344726.8A patent/CN102836138B/en active Active
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| SY110024: "对乙酰氨基酚维生素C泡腾片", 《HTTP://BAIKE.BAIDU.COM/LINK?URL=YDHKKTUQGKW14B306ZDXGLAGG1FRU0O5EBA-J4OZE8N4X4TOBMQCQP2UPYUQAO50F3XSQYMUIUBQMA2BLVTWG_》, 26 October 2011 (2011-10-26) * |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103705581A (en) * | 2013-12-30 | 2014-04-09 | 长沙理工大学 | Compound Huodan dispersible tablet and preparation method and application thereof |
| CN103705581B (en) * | 2013-12-30 | 2016-01-13 | 长沙理工大学 | Compound Huodan dispersible tablet and its preparation method and application |
| CN106490164A (en) * | 2016-10-20 | 2017-03-15 | 光明乳业股份有限公司 | A kind of milk powder high protein effervescent tablet and preparation method thereof |
| CN106490164B (en) * | 2016-10-20 | 2019-11-05 | 光明乳业股份有限公司 | A kind of milk powder high protein effervescent tablet and preparation method thereof |
| CN113384549A (en) * | 2021-07-21 | 2021-09-14 | 海南涛生医药科技研究院有限公司 | Acetaminophen vitamin C effervescent tablet and preparation method thereof |
| CN114533693A (en) * | 2022-03-08 | 2022-05-27 | 沈阳奥吉娜药业有限公司 | Paracetamol effervescent tablet for children and preparation process thereof |
| CN114533693B (en) * | 2022-03-08 | 2023-09-08 | 沈阳奥吉娜药业有限公司 | Paracetamol effervescent tablet for children and preparation process thereof |
| WO2024153959A1 (en) | 2023-01-17 | 2024-07-25 | Ioulia Tseti | Pharmaceutical composotion of paracetamol in a water-soluble form in a hermetically sealed container for preparing a hot beverage |
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