CN106267209A - Low dosage non-steroidal anti-inflammatory class pharmaceutical composition and preparation technology thereof - Google Patents
Low dosage non-steroidal anti-inflammatory class pharmaceutical composition and preparation technology thereof Download PDFInfo
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- CN106267209A CN106267209A CN201610595605.9A CN201610595605A CN106267209A CN 106267209 A CN106267209 A CN 106267209A CN 201610595605 A CN201610595605 A CN 201610595605A CN 106267209 A CN106267209 A CN 106267209A
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- steroidal anti
- low dosage
- pharmaceutical composition
- inflammatory class
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
Abstract
The invention discloses low dosage non-steroidal anti-inflammatory class pharmaceutical composition and preparation technology thereof, belong to pharmaceutical technology field.Described pharmaceutical composition comprises: the non-steroidal anti-inflammatory class medicine of low dosage and be applicable to this pharmaceutical composition and include other adjuvants of oral administration mixed suspension, granule, tablet and capsule.The present invention is with diclofenac as model drug, high pressure homogenization technique is used to obtain submicron diclofenac, thus increase In Vitro Dissolution, improve bioavailability, use with minimum effective dose, so that medicine has the shortest persistent period in vivo, reduce the risk of major cardiovascular events, and the gastrointestinal problems with high dose nonsteroidal anti-inflammatory class medicine, improve patient's compliance.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to low dosage non-steroidal anti-inflammatory class pharmaceutical composition and system thereof
Standby technique.
Background technology
Non-steroidal anti-inflammatory class medicine (Nonsteroidal Antiinflammatory Drugs, NSAIDs) be a class not
Containing the anti-inflammatory agent of steroidal structure, NSAIDs is after aspirin synthesized first in 1898, over more than 100 year on existing over one hundred kind
Thousand brand listings, this kind of medicine includes that aspirin, acetaminophen, indomethacin, naproxen, Nabumetone, double chlorine are fragrant
Acid, ibuprofen, nimesulide, rofecoxib, celecoxib etc., such medicine has antiinflammatory, rheumatism, pain relieving, brings down a fever and resist
Blood coagulations etc. act on, and are widely used in the slow of osteoarthritis, rheumatoid arthritis, multiple heating and various pain symptom clinically
Solve.NSAIDs is that the whole world uses one of most medicament categories.The whole world has 30,000,000 people using about every day.Along with
NSAIDs use increase, the safe handling problem of this kind of medicine the most increasingly by clinicist, pharmacist, patient, society and
The concern of government.U.S. food Drug Administration (FDA) thinks that NSAIDs exists potential cardiovascular and digestive tract hemorrhage
Risk, it is proposed that nonsteroidal antiinflammatory drug should use with minimum effective dose so that medicine have in vivo the shortest lasting time
Between, this makes the safe medication of NSAIDs become the hot issue of whole world the world of medicine at present.
Diclofenac, belongs to NSAID (non-steroidal anti-inflammatory drug), and main mechanism is suppression prostaglandin synthetase, makes prostaglandin
Biosynthesis is obstructed, and has antiinflammatory, analgesia and refrigeration function.It heals up oral dosage form for rheumatic arthritis, viscous with gastrointestinal tract
The pain that even property spondylitis, non-inflammatory arthralgia, arthritis, nonarticular rheumatism, non-non-articular inflammatory cause, various nerves
Bitterly, heating caused by cancer pain, post-traumatic pain and various inflammation etc..Diclofenac is a kind of novel potent anti-inflammatory analgesic
Medicine, the most orally available but also can inject, its analgesia, antiinflammatory and refrigeration function are stronger 2～2.5 times than indomethacin, stronger by 26 than aspirin
～50 times, oral dosage ranges is 100～200mg/ days, and infusion or the gastrointestinal administration dosage range being interrupted fractionated dose are 75
～150mg/ days (1～2mg/kg/ days).Gastrointestinal tract, blood, kidney, liver, cardiovascular and the anaphylaxis of oral and parenteral road dosage form
Untoward reaction is more notable, but lighter than most of NSAID (non-steroidal anti-inflammatory drug), and better tolerance, dosage is little, and individual variation is little, in the world
More than 120 countries and regions are widely used.
In the dosage form that diclofenac sodium lists at present, the usage and dosage of tablet and capsule is: adult rheumatoid arthritis
150～200mg/ days (3～4 (sheet)/skies), the every day of medication the most frequently brings the biggest inconvenience to patient, and
Blood drug level is unstable, peak valley phenomenon occurs, and the medication of high dose produces the biggest toxic and side effects.
Diclofenac is practically insoluble in water, and body absorbs and dissolves the slowest.In treatment use, in water, indissoluble eases up
The slow material dissolved trends towards being eliminated from gastrointestinal tract before being absorbed into circulation.It addition, the active substance of indissoluble is owing to depositing
In the drug particles blocking blood flow risk by blood capillary, intravenous is used the most disadvantageous or the most dangerous
's.The dissolution of drug particles will increase along with surface area and increase.A kind of method increasing surface area is to reduce granularity.Cause
This, control particle diameter and the particle size range of drug particles, is the key point of insoluble drug application.It is ultra-fine by medicine is converted into
Powder is to improve the dissolubility of medicine, and then increases its dissolution and bioavailability.
The specification of FDA marketed products ZORVOLEX (diclofenac capsule) is 18mg and 35mg, than other commercially available pair of chlorine sweet smell
Acid sodium (or potassium) preparation, such as VOLTAREN (diclofenac sodium sheet, specification 25mg and 50mg) and ZIPSOR (diclofenac potassium glue
Capsule, specification 25mg), dosage reduces 20%, which employs " SoluMatrix Fine Particle Technology "
Obtain the diclofenac of " submicron " particles submicron, thus reach the biological utilisation consistent with high dose medicament
Degree.United States Patent (USP) 8679544 discloses " SoluMatrix Fine Particle Technology " (drymilling).
SoluMatrix microparticle technologies decreases the medicine granularity by granule to superfine powder, and these granules are little 20 times of left sides than initial size
The right side, grain diameter reduction increases specific grain surface and amasss, makes dissolving faster.The exploitation of this novel form is in 2005 as FDA
The response of the healthy bulletin issued in year.FDA suggestion nonsteroidal antiinflammatory drug should use with minimum effective dose, so that medicine
There is the shortest persistent period in vivo, it is intended to reduce the risk of major cardiovascular events, and resist with high dose nonsteroidal
The gastrointestinal problems of scorching medicine.
The present invention uses high pressure homogenization technique to obtain the diclofenac of " submicron " particles submicron, thus
While increasing In Vitro Dissolution, reduction dosage, raising bioavailability, it is possible to improve patient's compliance, reduce untoward reaction and send out
Raw rate.
Summary of the invention
Low dosage non-steroidal anti-inflammatory class pharmaceutical composition, this pharmaceutical composition include oral administration mixed suspension, granule, tablet and
Capsule, pharmaceutical composition comprises:
A) low dosage non-steroidal anti-inflammatory class medicine；
B) it is applicable to this pharmaceutical composition and includes other adjuvants of oral administration mixed suspension, granule, tablet and capsule.
The preparation technology of described low dosage non-steroidal anti-inflammatory class pharmaceutical composition comprises the steps of
A) non-steroidal anti-inflammatory class medicine, is distributed in purified water or other solvents, is prepared as disperseing homogeneous suspension；Mixed
Suspension uses high pressure homogenizer to carry out homogenizing, obtains emulsion；
B) emulsion is spray-dried, and obtains dried powder；
C) by above-mentioned dried powder add be applicable to described pharmaceutical composition include oral administration mixed suspension, granule, tablet and
Other adjuvants of capsule are prepared as oral administration mixed suspension, granule, tablet and capsule.
Non-steroidal anti-inflammatory class medicine includes: aspirin, acetaminophen, diflunisal, salsalate, Bu Luo
Sweet smell, indomethacin, flurbiprofen, fenoprofen, naproxen, nabumetone, piroxicam, Phenylbutazone, venlofen, ketone Lip river
The insoluble drugs such as sweet smell, ketorolac, four clofenamic acides, sulindac, tolmetin, diclofenac, rofecoxib, celecoxib.
Low dosage non-steroidal anti-inflammatory class, its dosage is not more than conventional using dosage.
The adjuvant being applicable to oral suspensions includes that (suspending agent, wetting agent, flocculant and deflocculant, pH adjust stabilizer
Joint agent, antibacterial, correctives, pigment), dispersant etc..
The adjuvant being applicable to granule includes filler, binding agent, correctives, lubricant etc..
The adjuvant being applicable to tablet includes filler, binding agent, disintegrating agent, lubricant etc..
The adjuvant being applicable to capsule includes filler, binding agent, disintegrating agent, lubricant etc..
The particle diameter of emulsion is not more than 0.5 μm.
The particle diameter of dried powder is not more than 0.5 μm.
Suspending agent is glycerol, syrup, sorbitol, arabic gum, tragcanth, sodium alginate, sodium carboxymethyl cellulose, fibre
Dimension element class, silicates, one or more mixture in any proportion of thixotrope apoplexy due to endogenous wind.
Wetting agent is poly yamanashi esters, polyoxyethylene fatty acid ester class, polyoxyethylene castor oil class, phospholipid, Bo Luosha
One or more in nurse, ethanol, glycerol mixture in any proportion.
Flocculant and deflocculant are citron acids, citric acid hydrogen salt, tartrate, biatrate, phosphate and chlorine
One or more in compound mixture in any proportion.
PH adjusting agent is the mixture in any proportion of one or more in citrate, phosphate buffer.
Antibacterial is in parabens, benzoic acid and sodium benzoate, sorbic acid and its esters, benzalkonium bromide
One or more mixture in any proportion.
Dispersant is water.
Filler be starch, amylum pregelatinisatum, dextrin, lactose, microcrystalline Cellulose, sorbitol, mannitol, calcium hydrogen phosphate,
One or more in medicinal calcium carbonate mixture in any proportion.
Correctives is the mixture in any proportion of one or more in sucrose, stevioside, saccharin sodium, Aspartane.
Lubricant be magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol apoplexy due to endogenous wind one or more
Mixture in any proportion.
Binding agent be the one in purified water, starch, sodium carboxymethyl cellulose, cellulose family, polyvinylpyrrolidone or
Multiple mixture in any proportion.
Disintegrating agent is starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, crosslinking
One or more in sodium carboxymethyl cellulose mixture in any proportion.
Accompanying drawing explanation
Accompanying drawing 1 is the grain size distribution of the emulsion that high pressure homogenize obtains.
Accompanying drawing 2 is the grain size distribution being spray-dried gained dried powder.
Detailed description of the invention
ZORVOLEX (diclofenac capsule) is the non-steroidal anti-inflammatory class medicine using the first listing of submicron technology, therefore
This patent carries out embodiment description with diclofenac for model drug.
Embodiment 1
Suspension prescription:
Suspensoid prescription:
The preparation technology of low dose diclofenac pharmaceutical composition comprises the steps of:
A) weigh 10g polyvidone k90, add purified water 1000ml, prepare 1% polyvidone k90 aqueous solution；Weigh double chlorine fragrant
Acid 40g, joins in 1% polyvidone k90 aqueous solution, and 4000rpm stirs 30min, is prepared as disperseing homogeneous suspension；Suspendible
Liquid uses D-6L type high pressure homogenizer to carry out homogenizing, and under 15000psi pressure, pretreatment is once；Homogenizing again under 23000psi pressure
Twice, obtain emulsion；
B) emulsion uses 6000Y type spray dryer to be spray-dried, inlet temperature 55～60 DEG C, leaving air temp 50
～55 DEG C, inlet amount 1000ml/h, nozzle diameter 0.7mm, pressure 0.2Mpa, obtain dried powder；
C) dried powder 43.8g, sodium carboxymethyl cellulose 8g, poloxamer 4g, sorbitol 343.4g, aspartame are weighed
0.8g, puts G6 efficient wet mixer-granulator, rotating speed 3r/s, time 120s, to obtain final product.0.4g/ bag, specification 35mg.
The mean diameter utilizing MALVERN laser particle analyzer to measure emulsion is 145.8nm, is spray-dried gained xeraphium
The mean diameter at end is 187.5nm.The grain size distribution of emulsion and dried powder is shown in accompanying drawing 1～2.
Embodiment 2
Suspension prescription:
Granule prescription:
The preparation technology of low dose diclofenac pharmaceutical composition comprises the steps of:
A) weigh 10g polyvidone k90, add purified water 1000ml, prepare 1% polyvidone k90 aqueous solution；Weigh double chlorine fragrant
Acid 40g, joins in 1% polyvidone k90 aqueous solution, and 4000rpm stirs 30min, is prepared as disperseing homogeneous suspension；Suspendible
Liquid uses D-6L type high pressure homogenizer to carry out homogenizing, and under 15000psi pressure, pretreatment is once；Homogenizing again under 23000psi pressure
Twice, obtain emulsion；
B) emulsion uses 6000Y type spray dryer to be spray-dried, inlet temperature 55～60 DEG C, leaving air temp 50
～55 DEG C, inlet amount 1000ml/h, nozzle diameter 0.7mm, pressure 0.2Mpa, obtain dried powder；
C) weigh dried powder 43.8g, mannitol 354.1g, saccharin sodium 0.12g, Pulvis Talci 2g, put G6 efficient wet and mix
Close granulator, rotating speed 3r/s, time 120s, to obtain final product.0.4g/ bag, specification 35mg.
The mean diameter utilizing MALVERN laser particle analyzer to measure emulsion is 145.8nm, is spray-dried gained xeraphium
The mean diameter at end is 187.5nm.The grain size distribution of emulsion and dried powder is shown in accompanying drawing 1～2.
Embodiment 3
Suspension prescription:
Tablet formulation:
The preparation technology of low dose diclofenac pharmaceutical composition comprises the steps of:
A) weigh 10g polyvidone k90, add purified water 1000ml, prepare 1% polyvidone k90 aqueous solution；Weigh double chlorine fragrant
Acid 40g, joins in 1% polyvidone k90 aqueous solution, and 4000rpm stirs 30min, is prepared as disperseing homogeneous suspension；Suspendible
Liquid uses D-6L type high pressure homogenizer to carry out homogenizing, and under 15000psi pressure, pretreatment is once；Homogenizing again under 23000psi pressure
Twice, obtain emulsion；
B) emulsion uses 6000Y type spray dryer to be spray-dried, inlet temperature 55～60 DEG C, leaving air temp 50
～55 DEG C, inlet amount 1000ml/h, nozzle diameter 0.7mm, pressure 0.2Mpa, obtain dried powder；
C) weigh sodium carboxymethyl cellulose 12g, join in 100ml purified water, be configured to the carboxymethyl cellulose of 12%
Sodium water solution；Weigh dried powder 43.8g, lactose 110g, microcrystalline Cellulose 220g, low-substituted hydroxypropyl methylcellulose 12g, put G6
Efficient wet mixer-granulator, rotating speed 3r/s, time 120s；Cutter rotating velocity 6r/s, adds sodium carboxymethyl cellulose solution, cuts
Cut time 60s, have obvious granule, to obtain final product.Wet granular is put in 201 type air dry ovens, temperature 60 C, it is dried 2h, moisture
1.75%；Take out and be dried granule, add micropowder silica gel 2g, cross 200 mesh sieves, obtain and always mix granule.Total mixed granule ZP-17 rotates
Tabletting machine, tablet weight 0.4g, pressure 8kg, specification 35mg.
The mean diameter utilizing MALVERN laser particle analyzer to measure emulsion is 145.8nm, is spray-dried gained xeraphium
The mean diameter at end is 187.5nm.The grain size distribution of emulsion and dried powder is shown in accompanying drawing 1～2.
Embodiment 4
Suspension prescription:
Capsule prescription:
The preparation technology of low dose diclofenac pharmaceutical composition comprises the steps of:
A) weigh 10g polyvidone k90, add purified water 1000ml, prepare 1% polyvidone k90 aqueous solution；Weigh double chlorine fragrant
Acid 40g, joins in 1% polyvidone k90 aqueous solution, and 4000rpm stirs 30min, is prepared as disperseing homogeneous suspension；Suspendible
Liquid uses D-6L type high pressure homogenizer to carry out homogenizing, and under 15000psi pressure, pretreatment is once；Homogenizing again under 23000psi pressure
Twice, obtain emulsion；
B) emulsion uses 6000Y type spray dryer to be spray-dried, inlet temperature 55～60 DEG C, leaving air temp 50
～55 DEG C, inlet amount 1000ml/h, nozzle diameter 0.7mm, pressure 0.2Mpa, obtain dried powder；
C) weigh sodium carboxymethyl cellulose 12g, join in 100ml purified water, be configured to the carboxymethyl cellulose of 12%
Sodium water solution；Weigh dried powder 43.8g, lactose 110g, microcrystalline Cellulose 220g, low-substituted hydroxypropyl methylcellulose 12g, put G6
Efficient wet mixer-granulator, rotating speed 3r/s, time 120s；Cutter rotating velocity 6r/s, adds sodium carboxymethyl cellulose solution, cuts
Cut time 60s, have obvious granule, to obtain final product.Wet granular is put in 201 type air dry ovens, temperature 60 C, it is dried 2h, moisture
1.75%；Take out and be dried granule, add micropowder silica gel 2g, cross 200 mesh sieves, obtain and always mix granule.To always mix material by hand to fill
0#Capsule, grain weight 0.4g, specification 35mg.
The mean diameter utilizing MALVERN laser particle analyzer to measure emulsion is 145.8nm, is spray-dried gained xeraphium
The mean diameter at end is 187.5nm.The grain size distribution of emulsion and dried powder is shown in accompanying drawing 1～2.
Embodiment 5
The low dose diclofenac suspensoid of above-described embodiment 1～4 gained, granule, tablet and capsule and commercial reference
Preparation VOLTAREN (diclofenac sodium sheet, specification 50mg) and ZIPSOR (Diclofenac Potassium Capsules, specification 25mg) dissolution enter
Row compares.Dissolution method and assay method are as shown in table 1 below, and dissolution determination result is as shown in table 2 below.
Table 1 dissolution method and assay method
Table 2 dissolution determination result
Result shows, low dose diclofenac pharmaceutical composition ratio prepared by high pressure homogenize and drying process with atomizing is commercially available
Reference preparation VOLTAREN (50mg) and ZIPSOR (25mg) dissolution are the most complete.With commercially available high dose diclofenac formulations phase
Low dose diclofenac pharmaceutical composition prepared by ratio, high pressure homogenize and drying process with atomizing can obtain double chlorine sweet smell that equivalent is dissolved
Acid, i.e. can reach the therapeutic effect of the commercially available diclofenac formulations of high dose.
Prescription and technique that above-described embodiment describes are applicable to other slightly solubility non-steroidal anti-inflammatory class medicines.
Claims (20)
1. low dosage non-steroidal anti-inflammatory class pharmaceutical composition, described pharmaceutical composition comprises:
A) low dosage non-steroidal anti-inflammatory class medicine；
B) it is applicable to this pharmaceutical composition and includes other adjuvants of oral administration mixed suspension, granule, tablet and capsule.
The preparation technology of described low dosage non-steroidal anti-inflammatory class pharmaceutical composition comprises the steps of
A) non-steroidal anti-inflammatory class medicine, is distributed in purified water or other solvents, is prepared as disperseing homogeneous suspension；Suspension
Use high pressure homogenizer to carry out homogenizing, obtain emulsion；
B) emulsion is spray-dried, and obtains dried powder；
C) addition of above-mentioned dried powder is applicable to described pharmaceutical composition and includes oral administration mixed suspension, granule, tablet and capsule
Other adjuvants of agent are prepared as oral administration mixed suspension, granule, tablet and capsule.
2. low dosage non-steroidal anti-inflammatory class drug regimen as claimed in claim 1, it is characterised in that: described non-steroidal anti-inflammatory
Class medicine includes: aspirin, acetaminophen, diflunisal, salsalate, ibuprofen, indomethacin, fluorine compare Lip river
Sweet smell, fenoprofen, naproxen, nabumetone, piroxicam, Phenylbutazone, venlofen, ketoprofen, ketorolac, tetrachloro fragrant that
The insoluble drugs such as acid, sulindac, tolmetin, diclofenac, rofecoxib, celecoxib.
3. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 1, it is characterised in that: described low dosage is non-
Steroidal anti-inflammatory class medicine, its dosage is not more than conventional using dosage.
4. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 1, it is characterised in that: described is applicable to mouth
The adjuvant taking suspensoid includes stabilizer (suspending agent, wetting agent, flocculant and deflocculant, pH adjusting agent, antibacterial, taste masking
Agent, pigment), dispersant etc..
5. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 1, it is characterised in that: described it is applicable to
The adjuvant of granule includes filler, binding agent, correctives, lubricant etc..
6. low dosage non-steroidal anti-inflammatory class drug regimen as claimed in claim 1, it is characterised in that: described is applicable to tablet
Adjuvant include filler, binding agent, disintegrating agent, lubricant etc..
7. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 1, it is characterised in that: described is applicable to glue
The adjuvant of wafer includes filler, binding agent, disintegrating agent, lubricant etc..
8. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 1, it is characterised in that: described emulsion
Particle diameter is not more than 0.5 μm.
9. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 1, it is characterised in that: described dried powder
Particle diameter be not more than 0.5 μm.
10. low dosage non-steroidal anti-inflammatory class pharmaceutical composition as claimed in claim 4, it is characterised in that: described suspending agent
For glycerol, syrup, sorbitol, arabic gum, tragcanth, sodium alginate, sodium carboxymethyl cellulose, cellulose family, silicate
Class, one or more mixture in any proportion of thixotrope apoplexy due to endogenous wind.
11. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as claimed in claim 4, it is characterised in that: described wetting agent
For in poly yamanashi esters, polyoxyethylene fatty acid ester class, polyoxyethylene castor oil class, phospholipid, poloxamer, ethanol, glycerol
One or more mixture in any proportion.
12. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as claimed in claim 4, it is characterised in that: described flocculant
With deflocculant be the one in citron acids, citric acid hydrogen salt, tartrate, biatrate, phosphate and chloride or
Multiple mixture in any proportion.
13. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as claimed in claim 4, it is characterised in that: described pH regulator
Agent is the mixture in any proportion of one or more in citrate, phosphate buffer.
14. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as claimed in claim 4, it is characterised in that: described antibacterial
For one or more in parabens, benzoic acid and sodium benzoate, sorbic acid and its esters, benzalkonium bromide by appointing
The mixture of meaning ratio.
15. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as claimed in claim 4, it is characterised in that: described dispersant
For water.
16. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as claimed in claim 5, it is characterised in that: described filler
For in starch, amylum pregelatinisatum, dextrin, lactose, microcrystalline Cellulose, sorbitol, mannitol, calcium hydrogen phosphate, medicinal calcium carbonate
One or more mixture in any proportion.
The 17. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as described in claim 4,5, it is characterised in that: described taste masking
Agent is the mixture in any proportion of one or more in sucrose, stevioside, saccharin sodium, Aspartane.
The 18. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as described in claim 5,6,7, it is characterised in that: described profit
Lubrication prescription be magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol apoplexy due to endogenous wind one or more in any proportion
Mixture.
The 19. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as described in claim 5,6,7, it is characterised in that: described is viscous
Mixture is that one or more in purified water, starch, sodium carboxymethyl cellulose, cellulose family, polyvinylpyrrolidone are by arbitrarily
The mixture of ratio.
The 20. low dosage non-steroidal anti-inflammatory class pharmaceutical compositions as described in claim 6,7, it is characterised in that: described disintegrate
Agent is starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose
One or more in sodium mixture in any proportion.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610595605.9A CN106267209A (en) | 2016-07-18 | 2016-07-18 | Low dosage non-steroidal anti-inflammatory class pharmaceutical composition and preparation technology thereof |
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| CN201610595605.9A CN106267209A (en) | 2016-07-18 | 2016-07-18 | Low dosage non-steroidal anti-inflammatory class pharmaceutical composition and preparation technology thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111035764A (en) * | 2018-10-14 | 2020-04-21 | 深圳市健元医药科技有限公司 | Composition for treating rheumatoid arthritis and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102438610A (en) * | 2009-04-24 | 2012-05-02 | 伊休蒂卡有限公司 | A novel formulation of diclofenac |
-
2016
- 2016-07-18 CN CN201610595605.9A patent/CN106267209A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102438610A (en) * | 2009-04-24 | 2012-05-02 | 伊休蒂卡有限公司 | A novel formulation of diclofenac |
Non-Patent Citations (1)
| Title |
|---|
| （美）塔苏等编著: "《纳米粒药物输送系统》", 30 September 2010, 北京大学医学出版社 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111035764A (en) * | 2018-10-14 | 2020-04-21 | 深圳市健元医药科技有限公司 | Composition for treating rheumatoid arthritis and preparation method thereof |
| CN111035764B (en) * | 2018-10-14 | 2021-09-07 | 深圳市健元医药科技有限公司 | Composition for treating rheumatoid arthritis and preparation method thereof |
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