CN102552206B - Medicinal composition with anti-inflammatory and analgesic effects - Google Patents
Medicinal composition with anti-inflammatory and analgesic effects Download PDFInfo
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- CN102552206B CN102552206B CN201210022939.9A CN201210022939A CN102552206B CN 102552206 B CN102552206 B CN 102552206B CN 201210022939 A CN201210022939 A CN 201210022939A CN 102552206 B CN102552206 B CN 102552206B
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Abstract
The invention which belongs to the technical field of medicines discloses a medicinal composition with anti-inflammatory and analgesic effects. The medicinal composition is characterized in that the medicinal composition comprises aceclofenac, a microcrystalline cellulose, pregelatinized starch, a hydroxypropyl cellulose, a lubricant and polyvinyl acetate phthalate; or the medicinal composition comprises aceclofenac, the microcrystalline cellulose, the pregelatinized starch, the hydroxypropyl cellulose, the lubricant, polyvinyl acetate phthalate and a polyacrylic resin III. The medicinal composition of the invention is determined through a disintegration test, a release degree test and the like, and medicinal preparations prepared from the medicinal composition of the invention have the excellent quality characteristics.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of pharmaceutical composition that contains active component aceclofenac.
Background technology
Aceclofenac uses in state's listings such as Sweden, Britain, Belgium in Spain's Initial Public Offering for 1992 afterwards successively.Zoopery shows: the antiinflammatory action of this product is similar to diclofenac, stronger than naproxen; New and the low 4-7 of diclofenac is doubly than indole first to cause ulcer function.This product still can increase the synthetic of chondrocyte, and this is that ability of most NSAIDs is unexistent.In clinical research, 1788 routine patients take aceclofenac, and the routine patient of matched group 1786 takes diclofenac sodium, indomethacin (indometacin), naproxen, piroxicam tablet etc.Result shows: this product on the whole with gastrointestinal safety on, be all better than other common NSAIDs, be a good effect, safe medicine.Adult's usual amounts 2 times on the one, each 100mg, each 1 time sooner or later, can absorb quickly and safely after oral, within 1.25-3 hour, reach the highest blood drug level, 57% is distributed in blood plasma, mainly through renal excretion.Untoward reaction has gastrointestinal upset, dizziness, pruritus etc.Pharmacodynamics: this product is anti-inflammatory agent is orally active phenylacetic acid antiinflammatory drugs.There is antiinflammatory, analgesia, the effect such as antipyretic, can suppress the generation of endogenous pain medium, have the analgesic activity of tip; Also can suppress the synthetic of prostaglandin and discharge and suppress hypothalamic effect, and thering is higher antipyretic activity.Its usefulness and indomethacin, diclofenac are similar, stronger than naproxen and Phenylbutazone.Toxic and side effects: acute toxicity is than the low twice of diclofenac, lower six times than indomethacin, and can reduce the damage to stomach.Clinical indication: the inflammation and the pain that cause for alleviating rheumatic arthritis and rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
The aceclofenac preparation that gone on the market mainly contains ordinary tablet, dispersible tablet, slow releasing tablet, and cause enteric coatel tablets, the enteric coated capsule etc. of gastrointestinal side effect in order to reduce aceclofenac, research shows, the main cause of NSAID (non-steroidal anti-inflammatory drug) gastrointestinal side effect is that the mechanism of action of such medicine causes, also having a major reason is exactly that this class medicine can directly stimulate the epithelial lipoprotein layer on gastric mucosa, cause mucosa injury, thereby have side effects; In process of clinical application, the enteric coated preparation of aceclofenac exist gastrointestinal side effect, research is found, particularly commercially available enteric coatel tablets of existing enteric coated preparation, the certain release existing at gastric, therefore, the enteric-coated medicament combination that the aceclofenac that research makes new advances is raw material, reduce its burst size at gastric, to improving the quality of products, reduce untoward reaction, increase patient's compliance, significant.
Summary of the invention
For these reasons, on the basis that the scientific research personnel of our company furthers investigate aceclofenac physicochemical properties, a kind of new pharmaceutical composition of unexpected discovery, in this combination, use enteric solubility raw material polyvinyl acetate phthalate, or enteric material polyvinyl acetate phthalate and polyacrylic resin III, test shows, enteric coated tablet prepared by pharmaceutical composition of the present invention, the release that can significantly be reduced in gastric, has better release at enteral.
The present invention is achieved through the following technical solutions.
A kind of pharmaceutical composition with anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100 weight portions, microcrystalline Cellulose 35-45 weight portion, pregelatinized Starch 35-45 weight portion, hyprolose 8-12 weight portion, lubricant 1.5-2.5 weight portion, polyvinyl acetate phthalate 30-35 weight portion; Or pharmaceutical composition comprises aceclofenac 100 weight portions, microcrystalline Cellulose 35-45 weight portion, pregelatinized Starch 35-45 weight portion, hyprolose 8-12 weight portion, lubricant 1.5-2.5 weight portion, polyvinyl acetate phthalate 30-35 weight portion, polyacrylic resin III 1-3 weight portion.
Lubricant described above includes but not limited to magnesium stearate, micropowder silica gel, Pulvis Talci.
Pharmaceutical preparation prepared by the pharmaceutical composition with anti-inflammatory and antalgic described above.
Pharmaceutical preparation described above comprises enteric coatel tablets.
The preparation method of enteric coatel tablets described above includes but not limited to:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get the polyvinyl acetate phthalate that weight percentage is 11%-14%, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is put into and carried out coating with coating solution, obtain enteric coatel tablets.
Coating solution described above includes but not limited to:
Get the polyvinyl acetate phthalate of the 86%-89% of weight percentage, add the triethyl citrate of 2.5-3.2 weight portion, the stearic acid of 5-7 weight portion, be mixed with solution with the methanol of 200-300 weight portion.
The preparation method of enteric coatel tablets described above includes but not limited to:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get the polyvinyl acetate phthalate that weight percentage is 11%-14%, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution described above includes but not limited to:
Get the polyvinyl acetate phthalate of the 86%-89% of weight percentage, add the triethyl citrate of 2.5-3.2 weight portion, the stearic acid of 5-7 weight portion, be mixed with solution with the methanol of 200-300 weight portion, add the polyacrylic resin III of 1-3 weight portion, mix completely.
Following test is on test of many times basis, the test of carrying out for technical solution of the present invention.
Pharmaceutical composition screening test
1, slaking test
Element sheet preparation: get aceclofenac 100g and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose 40g, the pregelatinized Starch 40g and the hyprolose 10g that cross 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the magnesium stearate 2g of 100 mesh sieves, mixed completely, tabletting, obtains 1000 of plain sheets;
Above-mentioned plain sheet is used and disused to coating material and be prepared into enteric coatel tablets, concrete test group is as follows:
Test 1 group: 100 of plain sheets are used Lac coating, Lac used is 2.6g;
Test 2 groups: 100 of plain sheets acrylic resin I coating, acrylic resin I used is 2.6g;
Test 3 groups: 100 of plain sheets are used zein coating, zein used is 2.6g;
Test 5 groups: 100 of plain sheets hypromellose titanate esters coating, hypromellose titanate esters used is 2.6g;
Test 6 groups: 100 of plain sheets cellulose acetate peptide acid esters coating, cellulose acetate peptide acid esters used is 2.6g;
Test 7 groups: 100 of plain sheets polyacrylic resin II and polyacrylic resin III coating, acrylic resin II1.3g used and acrylic resin III1.3g.
Test 8 groups: 100 of plain sheets, adding ethanol compound concentration with 0.4g polyvinyl acetate phthalate is 6% solution bag sealing coat, use again 2.9g polyvinyl acetate phthalate, 0.28g triethyl citrate, 0.6g stearic acid, be mixed with solution coating with 25g methanol (31.6ml).
Test 9 groups: 100 of plain sheets, adding ethanol compound concentration with 0.4g polyvinyl acetate phthalate is 6% solution bag sealing coat, use again 2.9g polyvinyl acetate phthalate, 0.28g triethyl citrate, 0.6g stearic acid, be mixed with solution with 25g methanol (31.6ml), 0.2g polyacrylic resin III, carry out coating.
Test 1
Test method: according to 2010 editions two appendix XA inspection techniques disintegration of Chinese Pharmacopoeia, get respectively 6 tablets of enteric coatel tablets of above-mentioned different tests group, be placed in simulated gastric fluid after 2 hours, observation has or not the situation such as breakage, sliver, after a small amount of water rinses, put into immediately simulated intestinal fluid, record the time of the complete disintegrate of enteric coatel tablets.Result of the test is in table 1.
The mass ratio of the different enteric coatel tablets of table 1
Test 2
Hot test
Getting the calorstat that 20 tablets of enteric coatel tablets of different tests group are placed in 60 ℃ placed after 30 days, according to 2010 editions appendix XA inspection techniques disintegration of Chinese Pharmacopoeia, be placed in simulated gastric fluid after 2 hours, observation has or not the situation such as breakage, sliver, after a small amount of water rinses, put into immediately simulated intestinal fluid, record the time of the complete disintegrate of enteric coatel tablets.Result of the test is in table 2.
The mass ratio of the different enteric coatel tablets of table 2
Test 3
Highlight test
Get 20 tablets of enteric coatel tablets of different tests group placed after 30 days under 4500Lx light intensity, according to 2010 editions appendix XA inspection techniques disintegration of Chinese Pharmacopoeia, be placed in simulated gastric fluid after 2 hours, observation has or not the situation such as breakage, sliver, after a small amount of water rinses, put into immediately simulated intestinal fluid, record the time of the complete disintegrate of enteric coatel tablets.Result of the test is in table 3.
The mass ratio of the different enteric coatel tablets of table 3
Test 4
Exposure experiments to light
Get 20 tablets of enteric coatel tablets of different tests group and be placed in temperature (25 ± 2) ℃, relative humidity is under 90% ± 5% condition, to test after 30 days, according to 2010 editions appendix XA inspection techniques disintegration of Chinese Pharmacopoeia, be placed in simulated gastric fluid after 2 hours, observation has or not the situation such as breakage, sliver, after a small amount of water rinses, put into immediately simulated intestinal fluid, record the time of the complete disintegrate of enteric coatel tablets.Result of the test is in table 4.
The mass ratio of the different enteric coatel tablets of table 4
Conclusion (of pressure testing): above-mentioned test shows, under high temperature, high humidity, high light condition, adopt the enteric coatel tablets of Lac, acrylic resin I, zein, hypromellose titanate esters, cellulose acetate peptide acid esters coating, all do not meet prescription (not meeting the quality standard of pharmacopeia), and employing polyacrylic resin II and polyacrylic resin III, polyvinyl acetate phthalate, the enteric coatel tablets of polyvinyl acetate phthalate and polyacrylic resin III coating conform to quality requirements.
2, dissolution test
Element sheet preparation: get aceclofenac 100g and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose 40g, the pregelatinized Starch 40g and the hyprolose 10g that cross 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the magnesium stearate 2g of 100 mesh sieves, mixed completely, tabletting, obtains 1000 of plain sheets;
Test 1 group: 100 of plain sheets polyacrylic resin II and polyacrylic resin III coating, acrylic resin II 1.3g used and acrylic resin III1.3g.
Test 2 groups: 100 of plain sheets, adding ethanol compound concentration with 0.4g polyvinyl acetate phthalate is 6% solution bag sealing coat, use again 2.9g polyvinyl acetate phthalate, 0.28g triethyl citrate, 0.6g stearic acid, be mixed with solution coating with 25g methanol (31.6ml).
Test 3 groups: 100 of plain sheets, adding ethanol compound concentration with 0.4g polyvinyl acetate phthalate is 6% solution bag sealing coat, use again 2.9g polyvinyl acetate phthalate, 0.28g triethyl citrate, 0.6g stearic acid, be mixed with solution with 25g methanol (31.6ml), 0.2g polyacrylic resin III, carry out coating.
Drug release determination method:
Measure according to Chinese Pharmacopoeia (two of versions in 2010) appendix XD the second method method 1, take 0.1mol/L hydrochloric acid solution 750ml as solvent, rotating speed is per minute 150 to turn, operation in accordance with the law, through 120 minutes, getting solution 10ml filters, get in subsequent filtrate 5ml to 25ml measuring bottle, add 0.2ml/L sodium radio-phosphate,P-32 solution 1.7ml, shake up, add phosphate buffer (pH value approximately 6.8) and [get hydrochloric acid solution (9 → 1000) 750ml, add 0.2ml/L sodium radio-phosphate,P-32 solution 250ml, mix, regulate pH to 6.8 ± 0.5 with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution] be diluted to scale, as need testing solution (A liquid).Then to the sodium radio-phosphate,P-32 solution 250ml that discharges solution under quantifier in acid and add 37 ℃ of 0.2mol/L, mix, with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution adjusting pH to 6.8 ± 0.5, continue stripping 45 minutes, get solution 10ml and filter, get subsequent filtrate 5ml and put in 25ml measuring bottle, add above-mentioned pH value and be 6.8 ± 0.5 sodium phosphate buffer and be diluted to scale, shake up, as need testing solution (B liquid); It is appropriate that another precision takes aceclofenac reference substance, add phosphate buffer (pH value 6.8 ± 0.5) appropriate, solution is dissolved, and be quantitatively diluted in every 1ml the approximately solution containing 20 μ g, product solution in contrast, get above-mentioned three kinds of solution, measure trap according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2010) at the wavelength of 273nm, calculate every burst size.
Hot test
Get the calorstat that 50 tablets of enteric coatel tablets of different tests group are placed in 60 ℃ and place after 30 days, measure the release of 0 day and 30 days according to above-mentioned release method.Result of the test is in table 5.
The mass ratio of the different enteric coatel tablets of table 5
Highlight test
Get 50 tablets of enteric coatel tablets of different tests group and under 4500Lx light intensity, place after 30 days, measure the release of 0 day and 30 days according to above-mentioned release method.Result of the test is in table 6.
The mass ratio of the different enteric coatel tablets of table 6
High wet test
Get 50 tablets of enteric coatel tablets of different tests group and be placed in temperature (25 ± 2) ℃, relative humidity is under 90% ± 5% condition, to test after 30 days,, measure the release of 0 day and 30 days according to above-mentioned release method.Result of the test is in table 7.
The mass ratio of the different enteric coatel tablets of table 7
Conclusion (of pressure testing): above-mentioned dissolution test shows, under high temperature, high humidity, high light condition, adopt polyacrylic resin II and polyacrylic resin III to carry out the enteric coatel tablets of coating, under pH1.0 condition after 30 days, release is all greater than 10%, do not meet prescription, and 45 minutes releases are less than 80% under pH6.8 condition; And employing polyvinyl acetate phthalate, or the enteric coatel tablets that polyvinyl acetate phthalate, polyacrylic resin III carry out coating all met the requirements through 30 days, particularly adopt polyvinyl acetate phthalate, polyacrylic resin III to carry out the enteric coatel tablets of coating, its 2 hours release under 0 day, 30 days condition pH1.0 is all less than 1, absolutely proves that said preparation has very outstanding quality.
Above-mentioned evidence, the enteric coatel tablets that pharmaceutical composition of the present invention is prepared into were at 0 day and 30 days, all there are lower 2 hours releases of pH1.0 to be all less than 5%, absolutely prove, said preparation is very little in the burst size of gastric, thereby it is very little to the epithelial lipoprotein layer damage on gastric gastric mucosa to reduce aceclofenac, therefore, pharmaceutical composition of the present invention can further reduce the generation of side effect, increases the compliance of patient's medication.Preparation Example
Embodiment 1
Have a pharmaceutical composition for anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100g, microcrystalline Cellulose 35g, pregelatinized Starch 35g part, hyprolose 8g, lubricant micropowder silica gel 1.5g, polyvinyl acetate phthalate 30g.
Aforementioned pharmaceutical compositions is prepared into enteric coated tablet, and its preparation method is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get 3.3g polyvinyl acetate phthalate, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution is:
Get 26.7g polyvinyl acetate phthalate, add triethyl citrate, the 5g stearic acid of 2.5g, be mixed with solution with the methanol (253.2ml) of 200g.
Embodiment 2
Have a pharmaceutical composition for anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100g, microcrystalline Cellulose 35g, pregelatinized Starch 35g part, hyprolose 8g, lubricant micropowder silica gel 1.5g, polyvinyl acetate phthalate 30g, polyacrylic resin III 1g.
Aforementioned pharmaceutical compositions is prepared into enteric coated tablet, and its preparation method is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get 3.3g polyvinyl acetate phthalate, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution is:
Get 26.7g polyvinyl acetate phthalate, add triethyl citrate, the 5g stearic acid of 2.5g, be mixed with solution with the methanol (253.2ml) of 200g, add polyacrylic resin III 1g, mix completely.
Embodiment 3
Have a pharmaceutical composition for anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100g, microcrystalline Cellulose 45g, pregelatinized Starch 45g part, hyprolose 12g, magnesium stearate lubricant 3g, polyvinyl acetate phthalate 35g.
Aforementioned pharmaceutical compositions is prepared into enteric coated tablet, and its preparation method is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get 4.9g polyvinyl acetate phthalate, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution is:
Get 30.1g polyvinyl acetate phthalate, add triethyl citrate, the 7g stearic acid of 3.2g, be mixed with solution with the methanol (379.7ml) of 300g.
Embodiment 4
Have a pharmaceutical composition for anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100g, microcrystalline Cellulose 35g, pregelatinized Starch 35g part, hyprolose 8g, lubricant micropowder silica gel 1.5g, polyvinyl acetate phthalate 30g, polyacrylic resin III 3g.
Aforementioned pharmaceutical compositions is prepared into enteric coated tablet, and its preparation method is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get 3.3g polyvinyl acetate phthalate, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution is:
Get 26.7g polyvinyl acetate phthalate, add triethyl citrate, the 5g stearic acid of 2.5g, be mixed with solution with the methanol (253.2ml) of 200g, add polyacrylic resin III 3g, mix completely.
Embodiment 5
Have a pharmaceutical composition for anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100g, microcrystalline Cellulose 40g, pregelatinized Starch 40g part, hyprolose 11g, lubricant Pulvis Talci 2.2g, polyvinyl acetate phthalate 34g.
Aforementioned pharmaceutical compositions is prepared into enteric coated tablet, and its preparation method is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get 4g polyvinyl acetate phthalate, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution is:
Get 30g polyvinyl acetate phthalate, add triethyl citrate, the 6g stearic acid of 2.9g, be mixed with solution with the methanol (315.2ml) of 249g.
Embodiment 6
Have a pharmaceutical composition for anti-inflammatory and analgesic effect, pharmaceutical composition comprises aceclofenac 100g, microcrystalline Cellulose 35g, pregelatinized Starch 35g part, hyprolose 8g, lubricant micropowder silica gel 1.5g, polyvinyl acetate phthalate 30g, polyacrylic resin III 2.5g.
Aforementioned pharmaceutical compositions is prepared into enteric coated tablet, and its preparation method is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, the starch slurry with 5% is made soft material in right amount, and 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get 3.3g polyvinyl acetate phthalate, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets.
Coating solution is:
Get 26.7g polyvinyl acetate phthalate, add triethyl citrate, the 5g stearic acid of 2.5g, be mixed with solution with the methanol (253.2ml) of 200g, add polyacrylic resin III 2.5g, mix completely.
Described embodiment includes but not limited to above-mentioned.
Claims (1)
1. one kind has the pharmaceutical composition of anti-inflammatory and analgesic effect, it is characterized in that pharmaceutical composition comprises aceclofenac 100 weight portions, microcrystalline Cellulose 35-45 weight portion, pregelatinized Starch 35-45 weight portion, hyprolose 8-12 weight portion, lubricant 1.5-2.5 weight portion, polyvinyl acetate phthalate 30-35 weight portion, polyacrylic resin III1-3 weight portion; Wherein lubricant is magnesium stearate, micropowder silica gel or Pulvis Talci; Pharmaceutical composition is prepared into enteric coatel tablets, and wherein the preparation method of enteric coatel tablets is:
The preparation of element sheet: get aceclofenac and pulverize, cross 100 mesh sieves, mix completely with microcrystalline Cellulose, pregelatinized Starch and the hyprolose of crossing 100 mesh sieves, make soft material with 5% starch slurry, 20 mesh sieves are granulated, dry, granulate, added the lubricant of 100 mesh sieves, mixed completely, tabletting, obtains plain sheet;
Coating: get the polyvinyl acetate phthalate that weight percentage is 11%-14%, add ethanol, be mixed with concentration and be 6% solution and carry out coating, obtain wrapping the tablet of sealing coat; The tablet of bag sealing coat is carried out to coating with coating solution, obtain enteric coatel tablets; Wherein coating solution is: the polyvinyl acetate phthalate of getting the 86%-89% of weight percentage, add the triethyl citrate of 2.5-3.2 weight portion, the stearic acid of 5-7 weight portion, be mixed with solution with the methanol of 200-300 weight portion, add the polyacrylic resin III of 1-3 weight portion, mix completely.
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