CN1507862A - Complex acetaminophen vitamin C dispersion tablet and preparing method thereof - Google Patents
Complex acetaminophen vitamin C dispersion tablet and preparing method thereof Download PDFInfo
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- CN1507862A CN1507862A CNA021566879A CN02156687A CN1507862A CN 1507862 A CN1507862 A CN 1507862A CN A021566879 A CNA021566879 A CN A021566879A CN 02156687 A CN02156687 A CN 02156687A CN 1507862 A CN1507862 A CN 1507862A
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Abstract
The present invention relates to compound paracetamol vitamin C disperser tablet and its preparation method. It is formed from paracetamol, vitamin C, disintegrant, filling agent, correctives, adhesive and lubricating agent according to the ratio of 200-400:200-400:1-60:1-100:1-60:2-50:1-10. The disintegrant is carboxy methyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, calcium cellulose glycollate, cross-linked sodium cellulose glycollate, sodium lauryl sulfate, and the filling agent is lactose, mannitol, sorbyl alcohol, starch, modified starch, beta-dextrin, calcium sulfate dihydrate, microcrystal cellulose, and the corrective is wintergreen oil, peperitol, aspatan, citric acid, cane sugar, sterioside, the adhesive is polyvidone, hydroxypropyl cellulose, gelling starch and ethyl cellulose, and the lubricating agent is magnesium stearate, calcium stearate, polyglycol 6000 and talcum powder.
Description
Technical field
The present invention relates to a kind of medicine and manufacture method thereof, particularly relate to a kind of Aminodyne Compound vitamin C dispersible tablet and manufacture method thereof.
Background technology
Acetaminophen is a kind of phenyl amines antipyretic analgesic commonly used, it is non-stimulated to stomach, after taking, the patient can not produce anaphylaxis and accumulation poisoning, be used for the treatment of headache, fever and alleviation clinically slightly to moderate pain more, as headache, migraine, dysmenorrhea, myalgia, arthralgia, neuralgia etc., also be applicable to treatment by common cold and the caused headache of viral infection, fever and general malaise, the effective analgesic when also can be used as treatment toothache and exodontia, long teeth.And vitamin C has the resistance of enhancing body to infectious disease, and enhancing antibody forms, leukocyte increasing phagocytic function and antiinflammatory anti-allergic effects, and can increase body to the resistance of virus with to the capacity of decomposition of poisonous substance.Generally all use the compound preparation and the vitamin C of acetaminophen at present clinically separately, have only the UPSA company of France these two kinds of medicines are combined and to produce a kind of Aminodyne Compound vitamin C effervescent tablet, though effective in cure good, the advantage such as toxic and side effects is little of this medical instrument, but its complex manufacturing, production environment is had relatively high expectations, product stability is relatively poor, and the at present domestic like product of not seeing as yet comes out.
Summary of the invention
In order to address the above problem, the object of the present invention is to provide a kind of rapid-action, bioavailability is high, determined curative effect, toxic and side effects is little, safe and low-cost Aminodyne Compound vitamin C dispersible tablet.
In order to achieve the above object, Aminodyne Compound vitamin C dispersible tablet provided by the invention is made up of with the ratio of 200-400: 200-400: 1-60: 1-100: 1-60: 2-50: 1-10 acetaminophen, vitamin C, disintegrating agent, filler, correctives, binding agent and lubricant; Described disintegrating agent is any one in carboxymethyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, cross-linking sodium carboxymethyl cellulose and the sodium lauryl sulphate; Filler is any one in lactose, mannitol, sorbitol, starch, modified starch, beta-schardinger dextrin-, calcium sulfate two water things and the microcrystalline Cellulose; Correctives is any one in wintergreen oil, menthol, aspartame, citric acid, sucrose and the steviosin; Binding agent is any one in polyvidone, hydroxypropyl cellulose, gelling starch and the ethyl cellulose; And lubricant is magnesium stearate, calcium stearate, Polyethylene Glycol
6000With in the Pulvis Talci any one; The optimal proportion of acetaminophen, vitamin C, disintegrating agent, filler, correctives, binding agent and lubricant is 330: 200: 45: 40: 30: 30: 5.
The manufacture method of Aminodyne Compound vitamin C dispersible tablet provided by the invention comprises the step of carrying out in the following order:
(1) takes by weighing respectively according to the above ratio and pulverize the back and, take by weighing according to the above ratio simultaneously through super-dry, pulverizing and through filler, correctives and the binding agent of 150 mesh sieves screening through the acetaminophen and the vitamin C of 200 mesh sieves screening;
(2) these supplementary materials are placed the mixer mix homogeneously, and tablet forming focuses on the Φ 15mm thin slice between the 300-400mg, granulate with 20 mesh sieves at oscillating granulator then;
(3) this granule is placed oscillating granulator carry out granulate to remove oversized particles with 16 mesh sieves; add according to the above ratio subsequently through super-dry, pulverizing and through disintegrating agent and the lubricant and the mix homogeneously of 150 mesh sieves screening, the sheet that the granule that is up to the standards is calculated according to the granule content of measuring focuses on and carries out tabletting on the tablet machine and make Aminodyne Compound vitamin C dispersible tablet of the present invention at last.
Aminodyne Compound vitamin C dispersible tablet provided by the invention proves through effect experiment, have rapid-action, determined curative effect, toxic and side effects is little and advantage such as safety height, be applicable to flu, headache, myalgia, arthralgia, toothache, dysmenorrhea, neuralgia and some rest pains and slow down fatigue etc.Particularly this medicine both can be swallowed, and can take after mixing it with water again, thereby be specially adapted to old man and child.
The specific embodiment
Embodiment 1
With 1000 Aminodyne Compound vitamin C dispersible tablets is benchmark, take by weighing 200g acetaminophen and the 400g vitamin C pulverizing the back and screen respectively through 200 mesh sieves, take by weighing simultaneously through super-dry, pulverizing and through 45g microcrystalline Cellulose, 15g steviosin and the 30g gelling starch of 150 mesh sieves screening, these supplementary materials are placed the mixer mix homogeneously, and tablet forming focuses on the Φ 15mm thin slice between the 300-400mg, granulates with 20 mesh sieves at oscillating granulator then; Place oscillating granulator to carry out granulate to remove oversized particles this granule with 16 mesh sieves; add subsequently through super-dry, pulverizing and through 10g carboxymethyl starch sodium and the 5g magnesium stearate and the mix homogeneously of 150 mesh sieves screening, the sheet that the granule that is up to the standards is calculated according to the granule content of measuring focuses on and carries out tabletting on the tablet machine and make 1000 Aminodyne Compound vitamin C dispersible tablets at last.
Embodiment 2
With 1000 Aminodyne Compound vitamin C dispersible tablets is benchmark, take by weighing 400g acetaminophen and the 200g vitamin C pulverizing the back and screen respectively through 200 mesh sieves, take by weighing simultaneously through super-dry, pulverizing and through 50g mannitol, 30g sucrose and the 30g polyvidone of 150 mesh sieves screening, these supplementary materials are placed the mixer mix homogeneously, and tablet forming focuses on the Φ 15mm thin slice between the 300-400mg, granulates with 20 mesh sieves at oscillating granulator then; Place oscillating granulator to carry out granulate to remove oversized particles this granule with 16 mesh sieves; add subsequently through super-dry, pulverizing and through 5g hydroxypropyl starch and the 5g magnesium stearate and the mix homogeneously of 150 mesh sieves screening, the sheet that the granule that is up to the standards is calculated according to the granule content of measuring focuses on and carries out tabletting on the tablet machine and make 1000 Aminodyne Compound vitamin C dispersible tablets at last.
Embodiment 3
With 1000 Aminodyne Compound vitamin C dispersible tablets is benchmark, take by weighing 330g acetaminophen and the 200g vitamin C pulverizing the back and screen respectively through 200 mesh sieves, take by weighing simultaneously through super-dry, pulverizing and through 10g lactose, 10g aspartame and the 30g polyvidone of 150 mesh sieves screening, these supplementary materials are placed the mixer mix homogeneously, and tablet forming focuses on the Φ 15mm thin slice between the 300-400mg, granulates with 20 mesh sieves at oscillating granulator then; Place oscillating granulator to carry out granulate to remove oversized particles this granule with 16 mesh sieves; add subsequently through super-dry, pulverizing and through 45g low-substituted hydroxypropyl cellulose and the 5g magnesium stearate and the mix homogeneously of 150 mesh sieves screening, the sheet that the granule that is up to the standards is calculated according to the granule content of measuring focuses on and carries out tabletting on the tablet machine and make 1000 Aminodyne Compound vitamin C dispersible tablets at last.
Aminodyne Compound vitamin C dispersible tablet provided by the invention is a kind of acetaminophen and ascorbic compound preparation of containing, outward appearance is white in color, it has and absorbs and mouthfeel is good, rapid-action, bioavailability is high, determined curative effect, toxic and side effects is little, safe and characteristics such as low price, and not needing special production equipment, manufacturing process is simple and easy to be controlled.
Dissolution determination method (appendix XC first method) according to paracetamol tablets in the Chinese Pharmacopoeia version in 2000, to add according to the Aminodyne Compound vitamin C dispersible tablet that the present invention makes in the dilute hydrochloric acid solvent of 2.4% concentration, and under 100 rev/mins rotating speed, operate, sampling and measuring stripping curve during respectively at 5,10,20,40 and 60 minutes, testing result see Table 1 and table 2.
The stripping curve measurement result (n-6) of table 1 acetaminophen
| Time (branch) | ????5 | ????10 | ????20 | ????40 | ????60 |
| ????1 | ????60.9 | ????96.2 | ????99.2 | ????99.2 | ????98.3 |
| ????2 | ????68.8 | ????97.2 | ????98.9 | ????98.3 | ????98.8 |
| ????3 | ????81.9 | ????87.4 | ????97.1 | ????98.0 | ????98.4 |
| ????4 | ????45.2 | ????90.2 | ????97.9 | ????98.4 | ????98.3 |
| ????5 | ????61.0 | ????87.0 | ????98.4 | ????98.2 | ????98.0 |
| ????6 | ????46.0 | ????87.7 | ????100.1 | ????101.1 | ????101.2 |
| Meansigma methods | ????60.6 | ????91.0 | ????98.6 | ????98.9 | ????98.8 |
| ????RSD(％) | ????23.0 | ????5.1 | ????1.1 | ????1.2 | ????1.2 |
The ascorbic stripping curve measurement result of table 2 (n=6)
| Time (branch) | ????5 | ????10 | ????20 | ????40 | ????60 |
| ????1 | ????40.4 | ????93.8 | ????97.5 | ????97.6 | ????96.8 |
| ????2 | ????44.8 | ????97.9 | ????99.7 | ????99.3 | ????99.8 |
| ????3 | ????69.9 | ????91.9 | ????99.0 | ????98.9 | ????98.6 |
| ????4 | ????24.3 | ????94.7 | ????100.0 | ????98.2 | ????98.8 |
| ????5 | ????52.2 | ????90.5 | ????100.2 | ????99.9 | ????100.8 |
| ????6 | ????26.4 | ????83.0 | ????98.7 | ????98.8 | ????98.4 |
| Meansigma methods | ????43.0 | ????92.0 | ????99.2 | ????98.8 | ????98.9 |
| ????RSD(％) | ????39.5 | ????5.5 | ????1.0 | ????0.82 | ????1.4 |
To place glass dish according to the Aminodyne Compound vitamin C dispersible tablet that the present invention makes, and place 10 days carrying out the light durability test under the illumination of 4000LX, and detect once in sampling in 0,5,10 day, testing result sees Table 3.
Table 3 light durability result of the test
| Blanking time (greatly) | Appearance luster | Dispersing uniformity | Catabolite | Dissolution | Content | |||
| Vitamin C | Acetaminophen (%) | Vitamin C | Acetaminophen (%) | Vitamin C | Acetaminophen (%) | |||
| ????0 | Complete white tablets | Qualified | ??0.03 | ??0.36 | ??100.0 | ????99.6 | ??100.1 | ??100.3 |
| ????5 | Complete white tablets | Qualified | ??0.04 | ??0.37 | ??100.5 | ????100.2 | ???99.4 | ???100.1 |
| ????10 | Complete white tablets | Qualified | ??0.05 | ??0.38 | ???96.7 | ????100.2 | ???97.4 | ????99.7 |
To place glass dish according to the Aminodyne Compound vitamin C dispersible tablet that the present invention makes, and place 10 days carrying out thimble test in 60 ℃ calorstat, and detect once in sampling in 0,5,10 day, testing result sees Table 4.
60 ℃ of thimble test results of table 4
| Blanking time (my god) | Appearance luster | Dispersing uniformity | Catabolite | Dissolution | Content | |||
| Vitamin C | Acetaminophen (%) | Vitamin C | Acetaminophen (%) | Vitamin C | Acetaminophen (%) | |||
| ????0 | Complete white tablets | Qualified | ????0.03 | ????0.36 | ????100.0 | ????99.6 | ????100.1 | ????100.3 |
| ????5 | Complete white tablets | Qualified | ????0.05 | ????0.36 | ????98.1 | ????98.6 | ????98.5 | ????99.6 |
| ????10 | Complete white tablets | Qualified | ????0.04 | ????0.40 | ????95.2 | ????97.1 | ????97.2 | ????99.1 |
To place glass dish according to the Aminodyne Compound vitamin C dispersible tablet that the present invention makes, in the calorstat of relative humidity 75% (NaCl saturated solution), place 10 days to carry out the high humidity stability test, and in sampling detection in 0,5,10 day once, testing result sees Table 5.
Table 5 75% high humidity stability test result
| Blanking time (my god) | Appearance luster | Dispersing uniformity | Draw moist | Draw moist | Catabolite | Dissolution | Content | ||||
| Preceding (g) | Back (g) | Percentage rate (%) | Vitamin C | Acetaminophen (%) | Vitamin C | Acetaminophen (%) | Vitamin C | Acetaminophen (%) | |||
| ????0 | Complete white tablets | Qualified | ??0.6127 | ??0.6127 | ????0 | ??0.03 | ??0.36 | ??100. ????0 | ????96.6 | ???100.1 | ??100.3 |
| ????5 | Complete little erotic film | Qualified | ??0.6127 | ??0.6292 | ????2.7 | ??0.04 | ??0.41 | ??96.6 | ????98.9 | ????96.6 | ???99.6 |
| ????10 | Complete pale yellow color chips | Qualified | ??0.6127 | ??0.6593 | ????7.6 | ??0.04 | ??0.37 | ??97.6 | ????99.7 | ????97.8 | ???100.1 |
From above-mentioned experimental result as seen, Aminodyne Compound vitamin C dispersible tablet provided by the invention catabolite, dissolution and content under the super-humid conditions of illumination, 60 ℃ of high temperature and 75% relative humidity have no significant change, thereby can stablize preservation.
Claims (4)
1, a kind of Aminodyne Compound vitamin C dispersible tablet is characterized in that: described Aminodyne Compound vitamin C dispersible tablet is made up of with the ratio of 200-400: 200-400: 1-60: 1-100: 1-60: 2-50: 1-10 acetaminophen, vitamin C, disintegrating agent, filler, correctives, binding agent and lubricant.
2, Aminodyne Compound vitamin C dispersible tablet according to claim 1, it is characterized in that: described disintegrating agent is any one in carboxymethyl starch sodium, hydroxypropyl starch, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, cross-linking sodium carboxymethyl cellulose and the sodium lauryl sulphate; Filler is any one in lactose, mannitol, sorbitol, starch, modified starch, beta-schardinger dextrin-, calcium sulfate two water things and the microcrystalline Cellulose; Correctives is any one in wintergreen oil, menthol, aspartame, citric acid, sucrose and the steviosin; Binding agent is any one in polyvidone, hydroxypropyl cellulose, gelling starch and the ethyl cellulose; And lubricant is magnesium stearate, calcium stearate, Polyethylene Glycol
6000With in the Pulvis Talci any one.
3, Aminodyne Compound vitamin C dispersible tablet according to claim 1, it is characterized in that: the optimal proportion of acetaminophen, vitamin C, disintegrating agent, filler, correctives, binding agent and lubricant is 330: 200: 45: 40: 30: 30: 5.
4, a kind of manufacture method of Aminodyne Compound vitamin C dispersible tablet is characterized in that: the manufacture method of described Aminodyne Compound vitamin C dispersible tablet comprises the step of carrying out in the following order:
(1) take by weighing respectively according to the above ratio and pulverize the back and through the acetaminophen and the vitamin C of 200 mesh sieves screening, take by weighing according to the above ratio simultaneously through too dry, pulverize and through filler, correctives and the binding agent of 150 mesh sieves screening;
(2) these supplementary materials are placed the mixer mix homogeneously, and tablet forming focuses on the Φ 15mm thin slice between the 300-400mg, granulate with 20 mesh sieves at oscillating granulator then;
(3) this granule is placed oscillating granulator carry out granulate to remove oversized particles with 16 mesh sieves; add according to the above ratio subsequently through super-dry, pulverizing and through disintegrating agent and the lubricant and the mix homogeneously of 150 mesh sieves screening, the sheet that the granule that is up to the standards is calculated according to the granule content of measuring focuses on and carries out tabletting on the tablet machine and make Aminodyne Compound vitamin C dispersible tablet of the present invention at last.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021566879A CN1507862A (en) | 2002-12-19 | 2002-12-19 | Complex acetaminophen vitamin C dispersion tablet and preparing method thereof |
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|---|---|---|---|
| CNA021566879A CN1507862A (en) | 2002-12-19 | 2002-12-19 | Complex acetaminophen vitamin C dispersion tablet and preparing method thereof |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100364528C (en) * | 2006-03-30 | 2008-01-30 | 胡正岳 | Compound amino acid vitamin dispersion tablet and its preparation method |
| CN100386086C (en) * | 2006-03-09 | 2008-05-07 | 山东山大康诺制药有限公司 | Dispersed compound tablet of glycyrrhizic acid and glycyrrhizinate and its preparing process |
| CN101143138B (en) * | 2006-09-11 | 2010-06-16 | 上海玉安药业有限公司 | Paracetamol and pseudoephedrine hydrochloride tablets made by dry powder direct tabletting |
| CN102266301A (en) * | 2011-07-27 | 2011-12-07 | 蚌埠丰原涂山制药有限公司 | Nonsteroidal anti-inflammatory tablet and preparation method thereof |
| CN102940642A (en) * | 2012-07-02 | 2013-02-27 | 吉林大学 | Aspirin eugenol ester-paracetamol compound sustained-release tablet |
| CN102988993A (en) * | 2011-09-13 | 2013-03-27 | 广东九明制药有限公司 | Screening and composition of main auxiliary materials of compound acetaminophen tablet, and preparation method of compound acetaminophen tablet |
| CN101190206B (en) * | 2006-11-29 | 2013-04-24 | Ss制药株式会社 | Orally-administered solid composition capable of reducing irritation of digestion tube |
| CN103099794A (en) * | 2013-02-19 | 2013-05-15 | 青岛正大海尔制药有限公司 | Vitamin C clathrate dispersible tablet |
| CN103705581A (en) * | 2013-12-30 | 2014-04-09 | 长沙理工大学 | Compound Huodan dispersible tablet and preparation method and application thereof |
| CN110101672A (en) * | 2019-05-07 | 2019-08-09 | 安徽金太阳生化药业有限公司 | A kind of paracetamol tablets and preparation method thereof |
-
2002
- 2002-12-19 CN CNA021566879A patent/CN1507862A/en active Pending
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100386086C (en) * | 2006-03-09 | 2008-05-07 | 山东山大康诺制药有限公司 | Dispersed compound tablet of glycyrrhizic acid and glycyrrhizinate and its preparing process |
| CN100364528C (en) * | 2006-03-30 | 2008-01-30 | 胡正岳 | Compound amino acid vitamin dispersion tablet and its preparation method |
| CN101143138B (en) * | 2006-09-11 | 2010-06-16 | 上海玉安药业有限公司 | Paracetamol and pseudoephedrine hydrochloride tablets made by dry powder direct tabletting |
| CN101190206B (en) * | 2006-11-29 | 2013-04-24 | Ss制药株式会社 | Orally-administered solid composition capable of reducing irritation of digestion tube |
| CN102266301A (en) * | 2011-07-27 | 2011-12-07 | 蚌埠丰原涂山制药有限公司 | Nonsteroidal anti-inflammatory tablet and preparation method thereof |
| CN102988993A (en) * | 2011-09-13 | 2013-03-27 | 广东九明制药有限公司 | Screening and composition of main auxiliary materials of compound acetaminophen tablet, and preparation method of compound acetaminophen tablet |
| CN102988993B (en) * | 2011-09-13 | 2017-03-15 | 广东九明制药有限公司 | The screening of compound paracetamol tablets major auxiliary burden and composition and preparation method thereof |
| CN102940642A (en) * | 2012-07-02 | 2013-02-27 | 吉林大学 | Aspirin eugenol ester-paracetamol compound sustained-release tablet |
| CN103099794A (en) * | 2013-02-19 | 2013-05-15 | 青岛正大海尔制药有限公司 | Vitamin C clathrate dispersible tablet |
| CN103099794B (en) * | 2013-02-19 | 2014-07-30 | 青岛正大海尔制药有限公司 | Vitamin C clathrate dispersible tablet |
| 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 |
| CN110101672A (en) * | 2019-05-07 | 2019-08-09 | 安徽金太阳生化药业有限公司 | A kind of paracetamol tablets and preparation method thereof |
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