CN105434384A - Aceclofenac dispersible tablets and preparation method - Google Patents
Aceclofenac dispersible tablets and preparation method Download PDFInfo
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- CN105434384A CN105434384A CN201610001084.XA CN201610001084A CN105434384A CN 105434384 A CN105434384 A CN 105434384A CN 201610001084 A CN201610001084 A CN 201610001084A CN 105434384 A CN105434384 A CN 105434384A
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- Prior art keywords
- aceclofenac
- polyvinylpolypyrrolidone
- aspartame
- magnesium stearate
- silica gel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention provides aceclofenac dispersible tablets and a preparation method. The aceclofenac dispersible tablets are drugs for relieving pain and inflammation symptoms caused by osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and the like as well as intermittent pain caused by various kinds of inflammation. The aceclofenac dispersible tablets are prepared from components as follows: 20-180 g of aceclofenac, 1-40 g of microcrystalline cellulose, 1-40 g of aerosil, 1-40 g of low-substituted hydroxypropyl cellulose, 1-16 g of aspartame, 1-3 g of magnesium stearate, 10-90 g of polyvinylpolypyrrolidone cross-linked and 6-22 g of carboxymethyl starch sodium.
Description
Technical field: the present invention relates to treatment osteoarthritis, pain that rheumatoid arthritis and ankylosing spondylitis etc. cause and inflammatory symptom, all kinds of inflammation causes the medicine of intermittent pain, especially aceclofenac dispersible tablet and preparation method.
Background technology: non-steroid antiinflammatory drug (NSAID) can the pain of releasing arthritis and inflammation effectively, but the curative effect of NSAID is incomplete same, and some medicine plays neutrality or facilitation to Subchondral drilling, and some medicine even can hinder cartilage tissue regeneration.
Summary of the invention: the object of this invention is to provide formula uniqueness, good dispersion, technological operation is easy, quality controllable, result meets aceclofenac dispersible tablet and the preparation method of national standard, which overcome the shortcoming that absorption is slow, bioavailability is low that other medicines exist, the object of the present invention is achieved like this, and it is made up of aceclofenac 20-180g, microcrystalline Cellulose 1-40g, micropowder silica gel 1-40g, low-substituted hydroxypropyl cellulose 1-40g, aspartame 1-16g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 10-90g, carboxymethylstach sodium 6-22g; Its preparation method is: the first step, aceclofenac crude drug, other adjuvant is pulverized respectively, crosses 100 mesh sieves; Second step, takes recipe quantity microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium puts mix homogeneously in high-speed mixer; 3rd step, takes recipe quantity aceclofenac, aspartame and micropowder silica gel and puts in high-speed mixer and mix; 4th step, adds in the mixed material in second step by the mixed material of third step, soft material processed after mixing; 5th step, granulates with 32 mesh sieves, 60-80 DEG C of dry 3-4 hour after granulating; 24 mesh sieve granulate after dry; 6th step, add magnesium stearate put always be mixed in three-dimensional mixer even; 7th step, chemical examination intermediates content; 8th step, tabletting; 9th step, packaging; Finished product is examined entirely; Finished product is put in storage.
This product is white or the off-white color dispersible tablet of aceclofenac, and every sheet is containing aceclofenac 100mg.This product should be 95.0% ~ 105.0% of labelled amount containing aceclofenac.
Aceclofenac dispersible tablet prescription screening: the selection of adjuvant: be white or off-white color sheet according to aceclofenac dispersible tablet, the good and dissolution feature requirement faster of the performance that is uniformly dispersed, selects microcrystalline Cellulose to be diluent; Low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium are disintegrating agent; Aspartame is correctives; Micropowder silica gel and magnesium stearate are lubricant.
The process of principal agent: aceclofenac is insoluble in water, was pulverized 100 mesh sieves, can reduce granularity, increased the dispersibility of aceclofenac, improved dissolubility, improved bioavailability, absorbed quick acting rapidly in vivo.
Prescription screening: with the outward appearance of tablet and hardness, mouthfeel, dispersing uniformity, dissolution for quality index, on the basis that preliminary formulation and technology is studied, selection has been done to adjuvant each in prescription.
Quality research: the content such as discriminating, inspection, assay 1. specified in this product quality standard is thought and can be controlled its quality preferably.Assay adopts HPLC method, and separating degree is good, easy and simple to handle, highly sensitive, and result is accurate, and recovery test proves, adjuvant on assay without impact.
2. carried out stability test, by influence factor test display this product to light and high temperature all more stable; Accelerated test shows, this product is placed 6 months under constant temperature, constant humidity condition, room temperature reserved sample observing 24 months, indices is without significant change, long term test 36 months, the indices such as character, dispersing uniformity, related substance, dissolution, content of sample, all in acceptability limit, illustrates that this product was stable in 2 years.
Pharmacodynamics is studied: the research of aceclofenac Pharmacodynamics shows: once orally give aceclofenac (Ace) 2.5-10mg/kg dosage, obviously can resist the rat paw edema that carrageenin causes, 2 and 3 hours ED after injection carrageenin
50value is respectively 6.98(5.08-9.57) and 5.07(4.03-6.38) mg/kg; 5.0-20.0mg/kg dosage obviously can improve the little auricle edema that dimethylbenzene causes, its ED
50value is 9.49(7.64-11.79) mg/kg; Its effect is suitable with corresponding diclofenac sodium (Dic), proves that it has antiinflammatory action.After i.g gives 0.625-2.500mg/kg dosage aceclofenac (Ace), obviously can resist the argyric rat articular pain of nitric acid, the ED of 2 and 3 hours
50value is 0.78(0.43-1.42) mg/kg; 1.5-6.0mg/kg dosage aceclofenac, can make the average writhing number of times of mice obviously reduce, incubation period significant prolongation, analgesia ED
50value is for 2.07(1.64-2.62) mg/kg, to ease pain ED with Dic
50value 3.47(2.65-4.54) mg/kg is close; Its effect is suitable with diclofenac sodium (Dic), proves stronger analgesic activity.
Toxicologic study: repeated dose toxicity: the continuous oral administration of rat 1 month, dosage is respectively 15,50 and 100mg/kg/ day, and result rarely seen 100mg/kg/ day treated animal occurs dead, and with fecal occult blood.There is stomach or intestinal mucosa irritative response in histopathological examination this treated animal visible.Similar with other nonsteroidal antiinflammatory drug, the toleration of experimental animal to this product is poor.In addition, the pharmacokinetic difference of animals and human beings causes its genotoxic potential to be difficult to judge, but the toxicological test result display of administration under rat (can be diclofenac by aceclofenac metabolism) and monkey (some is the prototype medicine of non-metabolism) maximum tolerated dose, this product has no other toxicity beyond nonsteroidal antiinflammatory drug Common Toxicity.
Genetoxic: this product genetic toxicity test result is negative.
Genotoxicity: anti-inflammatory agent suppresses the effect of prostaglandin synthesis may cause serious fetal toxicity.This product can suppress uterine contraction, thus causes childbirth to postpone; Narrow or the locking of uterus fetus ductus arteriosus can be caused, cause neonatal pulmonary hypertension and respiratory insufficiency.Anti-inflammatory agent can also suppress fetus platelet function and affect its renal function, causes oligohydramnios and neonatal anuria disease, therefore, within last 3 months, prohibits the use anti-inflammatory agent in gestation.In gestation, in early days, this product can affect fetal development equally.It is not immediately clear whether this product drains through the milk of people, therefore, except non-physician is thought if desired, women breast-feeding their children should not use this product.
Carcinogenecity: having no this product in the carcinogenecity research that Mouse and rat carries out has carcinogenesis.
Pharmacokinetics: (1) absorbs: oral rear aceclofenac can absorb rapidly completely, and its bioavailability almost reaches 100%.Peak reaching time of blood concentration is after medication 1.25 to 3 hours.Extend with taking peak time with food, but absorb the impact of unable to take food thing.
(2) distribute: aceclofenac protein binding rate high (>99.7%).Aceclofenac enters synovial fluid thoroughly, and its concentration reaches 60% of plasma drug level.The nearly 30L of distribution volume.
(3) drain: it is 4 ~ 4.3 hours that average blood plasma eliminates the half-life, and clearance rate is about 5L/h.Nearly 2/3 drug main will with the hydroxylated metabolite of combining form by homaluria, and proto-drug only accounts for 1% of drug dose.
Aceclofenac is 4-OH aceclofenac likely via CYP2C9 metabolism, and its clinical activity is atomic, in many metabolite, diclofenac and 4-OH diclofenac detected.
Partial clinical result of study: multicenter double blind random clinical research, compare this product and diclofenac to the curative effect of knee osteoarthritis, treat 12 weeks, the symptom of two treatment groups all has clear improvement; The patient bending to initial deformity, this product compares with diclofenac, treats 4 weeks, is improving in gonycampsis, and this product is more effective, illustrates that the initiation of this product is faster.By the research of 2 weeks, find that this product group needs to add obviously to be less than diclofenac group with the patient of acetaminophen.Subjective assessment result of study shows, and improvement has an intense pain, and this product effective percentage is 71%, and reference substance is 59%.
The resisting rheumatoid disease arthritis curative effect of another multicenter double-blind study to this product and ketoprofen is evaluated.Two groups all have clear improvement to clinical symptoms.This product, in 15 days that start to treat, is improved symptom and is had clinical statistics meaning.
Two clinical researches also have rated its toleration, this product treatment group occur gastrointestinal side effect compared with other contrasted any one NSAID
sbe few, III clinical trial phase is with regard to this product and other NSAID
s(diclofenac, indomethacin, ketoprofen, naproxen, piroxicam and for promise happiness health) compare, this product is obviously lower to gastrointestinal untoward reaction.
Human bioavailability research conclusion: (1) aceclofenac test preparation and reference preparation main pharmacokinetic parameter T1/2 are respectively 6.063 ± 1.867h and 5.759 ± 2.287h, Tpeak is respectively 2.222 ± 0.521h and 2.306 ± 0.425h, Cmax is respectively 7.143 ± 1.579 μ g/ml and 7.169 ± 1.834 μ g/ml, AUC0 ~ 24 are respectively 20.481 ± 4.943 μ g/mlh and 20.344 ± 4.996 μ g/mlh, AUC0 ~ ∞ is respectively 128.654 ± 61.792 μ g/mlh, and 134.480 ± 61.223 μ g/mlh.Test preparation aceclofenac dispersible tablet relative bioavailability F is 101.848% ± 15.042%.
(2) multifactor analysis of variance display, aceclofenac test preparation and reference preparation single oral dual crossing test main pharmacokinetic parameters (AUC0-∞, AUC0-24) there was no significant difference, between further Doubled haploid population and (1-2 α) Confidence interval analysis individuality, meet bioequivalent hypothesis between mediating recipe type during week.
(3) aceclofenac dispersible tablet single dose administration human bioavailability is 101.848% ± 15.042%.
(4) whole process of the test is smooth, and test preparation and reference preparation are showed no untoward reaction and occur.
Index of the present invention is: appearance character is white tablets; Hardness is 5Kg; Good mouthfeel; Compressibility is good; Disintegration
*for 1.1min; Dispersing uniformity
*conform with the regulations; Dissolution (15min) is 94.8%.
Instructions of taking of the present invention: the present invention's dosage form of going on the market is 100mg tablet, takes for twice on the one, each 100mg.
Meaning of the present invention is:
1, regenerating bone or cartilage can be promoted.
2, no matter acute and repeated application, gastrointestinal side effect and other side effect are all far smaller than other NSAID (non-steroidal anti-inflammatory drug), better tolerance.
3, the present invention is applicable to the symptom treatment that following pain and inflammation cause: degenerative joint disease bring out the stage, chronic arthritis, particularly chronic migration type arthritis, the mandatory spondylitis of chronic joint; Be used for the treatment of the intermittent pain that all kinds of inflammation causes, as lumbago, toothache, scapulohumeral periarthritis, rheumatoid arthritis, also can long-term treatment osteoarthritis, rheumatic arthritis and spondylosis.
4, the present invention has the advantage that absorption is fast, bioavailability is high, untoward reaction is few, and is particularly suitable for patient that is old, young and dysphagia, taking convenience; Existing powder absorbs fast feature, and comparatively powder portably uses conveniently again.
Detailed description of the invention: embodiment 1, the present invention are made up of aceclofenac 20-180g, microcrystalline Cellulose 1-40g, micropowder silica gel 1-40g, low-substituted hydroxypropyl cellulose 1-40g, aspartame 1-16g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 10-90g, carboxymethylstach sodium 6-22g; Its preparation method is: the first step, aceclofenac crude drug, other adjuvant is pulverized respectively, crosses 100 mesh sieves; Second step, takes recipe quantity microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium puts mix homogeneously in high-speed mixer; 3rd step, takes recipe quantity aceclofenac, aspartame and micropowder silica gel and puts in high-speed mixer and mix; 4th step, adds in the mixed material in second step by the mixed material of third step, soft material processed after mixing; 5th step, granulates with 32 mesh sieves, 60-80 DEG C of dry 3-4 hour after granulating; 24 mesh sieve granulate after dry; 6th step, add magnesium stearate put always be mixed in three-dimensional mixer even; 7th step, chemical examination intermediates content; 8th step, tabletting; 9th step, packaging; Finished product is examined entirely; Finished product is put in storage.
Embodiment 2, the present invention are made up of aceclofenac 40-160g, microcrystalline Cellulose 5-35g, micropowder silica gel 5-35g, low-substituted hydroxypropyl cellulose 5-35g, aspartame 2-14g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 20-80g, carboxymethylstach sodium 8-20g.
Embodiment 3, the present invention are made up of aceclofenac 60-140g, microcrystalline Cellulose 10-30g, micropowder silica gel 10-30g, low-substituted hydroxypropyl cellulose 10-30g, aspartame 4-12g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 30-70g, carboxymethylstach sodium 10-18g.
Embodiment 4, the present invention are made up of aceclofenac 80-120g, microcrystalline Cellulose 15-25g, micropowder silica gel 15-25g, low-substituted hydroxypropyl cellulose 15-25g, aspartame 6-10g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 40-60g, carboxymethylstach sodium 12-16g.
Embodiment 5, the present invention are made up of aceclofenac 100g, microcrystalline Cellulose 20g, micropowder silica gel 20g, low-substituted hydroxypropyl cellulose 20g, aspartame 8g, magnesium stearate 2g, polyvinylpolypyrrolidone 50g, carboxymethylstach sodium 14g.
Claims (5)
1. aceclofenac dispersible tablet, is characterized in that: be made up of aceclofenac 20-180g, microcrystalline Cellulose 1-40g, micropowder silica gel 1-40g, low-substituted hydroxypropyl cellulose 1-40g, aspartame 1-16g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 10-90g, carboxymethylstach sodium 6-22g; Its preparation method is: the first step, aceclofenac crude drug, other adjuvant is pulverized respectively, crosses 100 mesh sieves; Polyvinylpolypyrrolidone makes 2% solution for standby; Second step, takes recipe quantity microcrystalline Cellulose, micropowder silica gel, low-substituted hydroxypropyl cellulose mixing; 3rd step, takes the mixing of recipe quantity aceclofenac, aspartame and sodium carboxymethylstarch; 4th step, adds in the mixed material in second step by the mixed material of third step, soft material processed after mixing; 5th step, crosses 18 order nylon wires after granulating; 60-80 DEG C of dryings; Granulate after dry; 6th step, adds magnesium stearate, always mixes; 7th step, chemical examination intermediates content; 8th step, tabletting; 9th step, packaging; Finished product is examined entirely; Finished product is put in storage.
2. aceclofenac dispersible tablet according to claim 1, is characterized in that: be made up of aceclofenac 40-160g, microcrystalline Cellulose 5-35g, micropowder silica gel 5-35g, low-substituted hydroxypropyl cellulose 5-35g, aspartame 2-14g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 20-80g, carboxymethylstach sodium 8-20g.
3. aceclofenac dispersible tablet according to claim 1, is characterized in that: be made up of aceclofenac 60-140g, microcrystalline Cellulose 10-30g, micropowder silica gel 10-30g, low-substituted hydroxypropyl cellulose 10-30g, aspartame 4-12g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 30-70g, sodium carboxymethylstarch 10-18g.
4. aceclofenac dispersible tablet according to claim 1, is characterized in that: be made up of aceclofenac 80-120g, microcrystalline Cellulose 15-25g, micropowder silica gel 15-25g, low-substituted hydroxypropyl cellulose 15-25g, aspartame 6-10g, magnesium stearate 1-3g, polyvinylpolypyrrolidone 40-60g, sodium carboxymethylstarch 12-16g.
5. aceclofenac dispersible tablet according to claim 1, is characterized in that: be made up of aceclofenac 100g, microcrystalline Cellulose 20g, micropowder silica gel 20g, low-substituted hydroxypropyl cellulose 20g, aspartame 8g, magnesium stearate 2g, polyvinylpolypyrrolidone 50g, sodium carboxymethylstarch 14g.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610001084.XA CN105434384A (en) | 2016-01-05 | 2016-01-05 | Aceclofenac dispersible tablets and preparation method |
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| CN201610001084.XA CN105434384A (en) | 2016-01-05 | 2016-01-05 | Aceclofenac dispersible tablets and preparation method |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552206A (en) * | 2012-02-02 | 2012-07-11 | 西藏易明西雅生物医药科技有限公司 | Medicinal composition with anti-inflammatory and analgesic effects |
| CN103396328A (en) * | 2013-08-21 | 2013-11-20 | 湖北美林药业有限公司 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
-
2016
- 2016-01-05 CN CN201610001084.XA patent/CN105434384A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552206A (en) * | 2012-02-02 | 2012-07-11 | 西藏易明西雅生物医药科技有限公司 | Medicinal composition with anti-inflammatory and analgesic effects |
| CN103396328A (en) * | 2013-08-21 | 2013-11-20 | 湖北美林药业有限公司 | Meclofenoxate hydrochloride compound and pharmaceutical composition thereof |
Non-Patent Citations (1)
| Title |
|---|
| SETTY CM,ET AL: "Development of fast dispersible Aceclofenac tablets:effect of functionality of superdisintegrants", 《INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES》 * |
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