CN101375854A - Medicinal preparation for treating osteoarthritis - Google Patents
Medicinal preparation for treating osteoarthritis Download PDFInfo
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- CN101375854A CN101375854A CNA2007101207663A CN200710120766A CN101375854A CN 101375854 A CN101375854 A CN 101375854A CN A2007101207663 A CNA2007101207663 A CN A2007101207663A CN 200710120766 A CN200710120766 A CN 200710120766A CN 101375854 A CN101375854 A CN 101375854A
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- 238000002360 preparation method Methods 0.000 title claims abstract description 28
- 201000008482 osteoarthritis Diseases 0.000 title claims abstract description 23
- 229960002442 glucosamine Drugs 0.000 claims abstract description 39
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- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 claims abstract description 38
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 20
- 150000003839 salts Chemical class 0.000 claims abstract description 4
- 239000000203 mixture Substances 0.000 claims description 25
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Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to a pharmaceutical preparation for the treatment of osteoarthritis. The active ingredients of the preparation are composed of cextrogire brufen and glucosamine or the medicinal composite salt according to the proportion of 1: 3. The combination is prepared into the pharmaceutical preparation which has stable quality and convenient administration through the preparation forming mode, and the pharmaceutical preparation comprises orally disintegrating tablets.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation for the treatment of osteoarthritis, the active component of said preparation is the compositions that (S)-ibuprofen and glucosamine or the compound 1:3 in proportion of its pharmaceutical salts combine, by the preparations shaping mode, be prepared into the pharmaceutical dosage form that steady quality is convenient to take, comprising oral cavity disintegration tablet.
Technical background
(Osteoarthritis OA) claims osteoarthritis, osteoarthritis, senile arthritis, proliferative arthritis, hypertrophiarthritis again to osteoarthritis, is divided into constitutional arthritis and Secondary cases arthritis.The characteristics of osteoarthritis are that pain, inflammation, stiff, enlargement, deformity and dysfunction appear in hands, wrist, ankle, knee joint, hip, shoulder, spinal joint etc.The articular cartilage of human body inevitably takes place to degenerate and wearing and tearing with advancing age, the regression of cartilage promptly began from 20 years old later stage, in crowd more than 50 years old, big multipotency shows the performance of osteoarthritis on the X sheet, the old man of over-65s nearly all suffers from tangible osteoarthritis, so osteoarthritis is the commonly encountered diseases and the frequently-occurring disease of middle-aged and elderly people.
Because the definite cause of disease and the pathogenesis of osteoarthritis are still very not clear and definite, therefore, both at home and abroad its treatment emphasis is mainly concentrated at present and suit the medicine to the illness, the purpose of treatment is alleviating pain, reduces inflammation, and delays cartilage degradation, improves function, avoids or reduces deformity.
The medicine that to treat osteoarthritis in the world is divided into and improves symptom and improve the state of an illness two classes.If improve the drug main anti-inflammatory analgesic medicine of symptom, comprise acetaminophen, NSAID (non-steroidal anti-inflammatory drug), opiates medicine.NSAID (non-steroidal anti-inflammatory drug) is the active drug commonly used of treatment osteoarthritis, by suppressing the effect of Cycloxygenase performance antalgic and inflammation relieving.The medicine that improves the state of an illness comprise glucosamine and two auspicious vinegar because of etc.Wherein, glucosamine is that first changes the medicine of the OA state of an illness, can anti-inflammatory analgesic, the effect that delays knee joint OA development is arranged again.
Osteoarthritis belongs to chronic pain, and relapse rate height, administration time are longer relatively, need give special concern for safety, effectiveness and the price of medicine.Therefore, as the osteoarthritis curative that need are taken for a long time, still should select for use through long-term clinical practice proof curative effect certainly, untoward reaction is little, and is safe, and traditional NSAID (non-steroidal anti-inflammatory drug) of relative low price.Wherein, (S)-ibuprofen is that drug effect is remarkable, one of NSAID (non-steroidal anti-inflammatory drug) that safety is best, be characterized in safe, oral easy absorption has predictable pharmacokinetics, can in body, discharge in 24 hours 100%, and the genotoxic potential that does not produce because of metabolite, to compare with other NSAID (non-steroidal anti-inflammatory drug), the half-life of ibuprofen is short, dosage is little, mechanism is more reasonable, only when antiinflammatory dosage, relatively low gastrointestinal side effect is arranged.NSAID (non-steroidal anti-inflammatory drug) commonly used clinically at present is an ibuprofen, and ibuprofen is racemic mixture, is made up of the laevoisomer and the dextroisomer of equivalent, and wherein (S)-ibuprofen is its active component.After the ibuprofen administration, wherein inactive laevoisomer 50%～60% becomes dextrorotation structure performance pharmacological action through biotransformation, but the biotransformation from the levo form to the d-isomer is not can finish moment.
Show that with the comparative study of ibuprofen (S)-ibuprofen group total effective rate is 80%, and the ibuprofen group is 58%; Indexs such as (S)-ibuprofen group pain relief degree, articular pain, arthroncus and function of joint illustrate that also apparently higher than the ibuprofen group (S)-ibuprofen has stronger pain relieving, antiinflammatory, detumescence effect, relief of symptoms more effectively, and curative effect is better than ibuprofen.Simultaneously, with the contrast experiment of ibuprofen in, (S)-ibuprofen group adverse reaction rate does not increase, no serious adverse reaction takes place, blood, routine urinalysis before and after the treatment, hepatic and renal function does not have significant change, illustrates that the (S)-ibuprofen safety is good.Recent result of study also shows, when the dosage of (S)-ibuprofen be ibuprofen 1/2 the time, can bring into play identical curative effect, and onset is faster.Because NSAID (non-steroidal anti-inflammatory drug) has dose dependent, so (S)-ibuprofen is littler than the toxic and side effects of ibuprofen.Therefore, use (S)-ibuprofen can obviously reduce dosage, further reduce adverse effect.
(Glucosamine is a naturally occurring amino monosaccharide in the human body GS) to glucosamine, is that chondrocyte carries out biosynthesis and the requisite substrate of metabolism.Under normal circumstances, glucosamine is next synthetic by the amination of glucose in the body, have and the diverse physiologically active of glucose, can stimulate chondrocyte to produce the proteoglycan of normal polymer structure, improve the repair ability of chondrocyte, the enzyme such as collagenase and the phospholipase A2 that suppress the damage cartilage, and can prevent the generation of the super oxyradical of damaging cells, can impel the repair and reconstruction of cartilage matrix, thereby can delay the pathological process of bone joint pain and the process of disease, improve joint motion, alleviating pain.The oral easy absorption of glucosamine, but onset is slower, the back just meeting onset in 1～3 month of taking medicine usually.As unique biosynthetic medicine that can recover the glycoprotein of destroyed in the osteoarthritis, be easy to after such medicine oral administration by the passive absorption of small intestinal, its final metabolism result is exactly the synthetic proteins polysaccharide, perhaps do not rely on the cytochrome enzyme and degrade, finally stop the outbreak of osteoarthritis.
The glucosamine clinical research shows that generally speaking, glucosamine treatment OA is safe and effective.In 16 randomized controlled trials (RCT), among the RCT that wherein 13 compare with placebo, glucosamine all is better than matched group.And among 4 RCT that compare with nonsteroidal anti inflammatory analgesic (NSAID), 2 RCT think that GS is better than NSAID, think that GS and NSAID do not have difference for 2 in addition.Another studies show that the RCT in 3 years by a definite date that 202 routine knee joint OA patients carry out, and uses glucosamine and placebo,, glucosamine not only can improve patient's OA symptom, and can delay the progress of OA on radiology.The placebo group joint space is average narrow 0.2mm in 3 years, apparently higher than the glucosamine group.In sum, the result of clinical research shows, glucosamine is safe, effective, with strong points but osteoarthritis treatment medicine that onset is slow, so the patient answers active adoption other treatment method control arthralgia and stiff before onset.
Up-to-date result of the test shows, the determined curative effect of (S)-ibuprofen and glucosamine, safe, but (S)-ibuprofen can only relief of symptoms when using separately, and the glucosamine onset is slow, all there is defective, when (S)-ibuprofen and glucosamine share, have obvious synergism at ease pain, glucosamine and other analgesic such as acetaminophen, diclofenac, indomethacin, piroxicam, naproxen etc. share then have only addition, inferior addition even do not have effect.This explanation is compared with other analgesic, when ibuprofen and glucosamine share, can reduce dosage, strengthens analgesic effect.
We prove by pharmacological experiment, have determined (S)-ibuprofen and glucosamine optimum amount and have been used optimal proportion 1:3, and particular content is referring to the patent 200710119684.7 of my company's application.
In order to convert it into clinical operable medicine, we have carried out galenic pharmacy research to the compositions of (S)-ibuprofen and glucosamine (1:3), because of its various preparation types, comprise various oral formulations and external preparation, all osteoarthritis is had therapeutical effect, we have carried out dividing other research to its preparation process again.By using different types of pharmaceutic adjuvant, obtained various pharmaceutical preparation.
Oral cavity disintegration tablet is emerging in recent years novel form, compares with conventional tablet, and this dosage form need not water and also need not to chew, medicine places mouth, after the rapid disintegrate of chance saliva, borrows swallowing act to go into the stomach onset, also can place the Sublingual, medicine absorbs onset by mucosa after the disintegrate rapidly.We have determined the prescription of this medicine oral cavity disintegration tablet also by research.
Summary of the invention
The objective of the invention is in order to overcome the deficiency of above-mentioned existing medicine, a kind of pharmaceutical preparation for the treatment of osteoarthritis is provided, its active component is (S)-ibuprofen and glucosamine (1:3), study by galenic pharmacy, it is simple to have determined to reach a kind of preparation technology, and taking convenience is rapid-action, (S)-ibuprofen and glucosamine compound preparation comprise oral disintegrating tablet formulation and prescription safely and effectively.Pharmaceutical composition of the present invention is by after the preparations shaping, and the stability of product has strengthened, and facilitates patients.
The invention provides a kind of pharmaceutical preparation, is that 1:3 combines by (S)-ibuprofen and glucosamine or its pharmaceutical salts according to weight ratio, wherein adds pharmaceutic adjuvant, to form steady quality, pharmaceutical dosage form easy to use.
The invention provides a kind of pharmaceutical preparation, its pharmaceutic adjuvant comprises disintegrating agent, filler, lubricant, correctives, diluent, binding agent.
In the prescription that the present invention proposes, disintegrating agent can be selected the pharmacy acceptable auxiliary, as low-substituted hydroxypropyl methylcellulose (L-HPC), polyvinylpolypyrrolidone (PVPP), sodium carboxymethyl cellulose (CCNa), carboxymethyl starch sodium (CMS-Na), gas-producing disintegrant etc. and composition thereof.
In the prescription that the present invention proposes, filler can be selected the pharmacy acceptable auxiliary, as microcrystalline Cellulose (MCC), dextrin, lactose, Icing Sugar, glucose, calcium sulfate, mannitol, starch etc. and composition thereof.
In the prescription that the present invention proposes, binding agent is to select the pharmacy acceptable auxiliary, as hydroxypropyl emthylcellulose (HPMC), and polyvidone (PVP), starch slurry, dextrin, syrup, rubber cement, cellulose and derivant thereof, sodium alginate etc. and composition thereof.
In the prescription that the present invention proposes, lubricant can be selected the pharmacy acceptable auxiliary, as Pulvis Talci, and stearic acid and its esters, hydrogenated vegetable oil, Polyethylene Glycol, sodium lauryl sulphate (magnesium), micropowder silica gel etc. and composition thereof.
In the prescription that the present invention proposes, correctives can be selected the pharmacy acceptable auxiliary, as mannitol, and natural or artificial sweetening agent such as stevioside.
The invention provides a kind of pharmaceutical preparation, it can be an oral formulations, also can be external preparation.
Pharmaceutical preparation of the present invention comprises following dosage form: conventional tablet, oral cavity disintegration tablet, chewable tablet, buccal tablet, capsule, spray, gel, gel inhalant, oral liquid, suspensoid, granule, patch, pill, powder, injection, infusion solution, suppository, slow releasing preparation, controlled release preparation etc.
The invention provides a kind of pharmaceutical preparation, its dosage form is an oral cavity disintegration tablet, and its prescription consists of:
100 parts of (S)-ibuprofens
300 parts of glucosamine
Disintegrating agent 3-90 part
Filler 10-100 part
Lubricant 0.2-10 part
Correctives 0.2-10 part
Binding agent is an amount of
(S)-ibuprofen of the present invention-glucosamine compound preparation can utilize the (S)-ibuprofen quick acting on the one hand, the characteristics that analgesic activity is strong, relief of symptoms rapidly; On the other hand, glucosamine can delay the cartilage degradation process, repairs cartilage lesion, stops even the reverse disease process.Simultaneously, the two makes the dosage that compound preparation can reduce single medicine, further reduces toxic and side effects, and has obvious synergism at ease pain, overcome ordinary preparation and can not reach the limitation of improving symptom and improving the state of an illness simultaneously, had characteristics such as safe, effective.
Technical characterstic of the present invention is that filler and disintegrating agent are mixed into main adjuvant formation oral cavity disintegration tablet skeleton with proper proportion, make tablet rapidly even disintegrate in the oral cavity become fine powder, help the medicine stripping and absorb, thereby make the oral back onset rapidly of (S)-ibuprofen-glucosamine.And the said preparation taking convenience, especially be fit to patient such as old man and coma patient medication under part dysphagia or the special environment.
The specific embodiment
The invention will be further described below in conjunction with specific embodiment, and following specific embodiments should be understood that only to illustrate, but not limits the scope of the invention by any way.
Embodiment 1:
Prescription one
100 parts of (S)-ibuprofens
300 parts of glucosamine
20 parts of polyvinylpolypyrrolidone
50 parts of microcrystalline Cellulose
3 parts of stearic acid
1 part of cyclamate
Hydroxypropyl emthylcellulose is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds magnesium stearate, direct powder compression.
Be 20 seconds disintegration.
Embodiment 2
Take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel, direct powder compression.
100 parts of (S)-ibuprofens
300 parts of glucosamine
20 parts of polyvinylpolypyrrolidone
20 parts of sodium carboxymethyl cellulose
50 parts of microcrystalline Cellulose
2 parts of magnesium stearate
2 parts of steviosides
Hydroxypropyl emthylcellulose is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel, direct powder compression.
Be 30 seconds disintegration.
Embodiment 3
100 parts of (S)-ibuprofens
300 parts of glucosamine
30 parts of sodium carboxymethyl cellulose
60 parts of lactose
2 parts of Macrogol 4000s
0.5 part of stevioside
Water is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds magnesium stearate, direct powder compression.
Be 25 seconds disintegration.
Embodiment 4
100 parts of (S)-ibuprofens
300 parts of glucosamine
90 parts of sodium carboxymethyl cellulose
70 parts of lactose
1 part of Pulvis Talci
0.2 part of sweetener
Hydroxypropyl emthylcellulose is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel, direct powder compression.
Be 50 seconds disintegration.
Embodiment 5
100 parts of (S)-ibuprofens
300 parts of glucosamine
90 parts of carboxymethyl starch sodium
10 parts of starch
10 parts of micropowder silica gels
0.2 part of stevioside
Polyvidone is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds magnesium stearate and micropowder silica gel, direct powder compression.
Be 35 seconds disintegration.
Embodiment 6
100 parts of (S)-ibuprofens
300 parts of glucosamine
60 parts of low-substituted hydroxypropyl methylcellulose
70 parts of starch
2 parts of Pulvis Talci
2 parts of micropowder silica gels
10 parts in mannitol
Polyvidone is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel and Pulvis Talci, direct powder compression.
Be 90 seconds disintegration.
Embodiment 7
100 parts of (S)-ibuprofens
300 parts of glucosamine
20 parts of polyvinylpolypyrrolidone
20 parts of low-substituted hydroxypropyl methylcellulose
100 parts in mannitol
3 parts of polyethylene glycol 6000s
0.2 part of stevioside
Dextrin is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel and Pulvis Talci, direct powder compression.
Be 33 seconds disintegration.
Embodiment 8
100 parts of (S)-ibuprofens
300 parts of glucosamine
60 parts of low-substituted hydroxypropyl methylcellulose
100 parts in mannitol
5 parts of sodium lauryl sulphates
0.2 part of sweetener
Sodium alginate is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds magnesium stearate and Pulvis Talci, direct powder compression.
Be 55 seconds disintegration.
Embodiment 9
100 parts of (S)-ibuprofens
300 parts of glucosamine
50 parts of polyvinylpolypyrrolidone
50 parts in dextrin
0.5 part of hydrogenated vegetable medicine
0.3 part of stevioside
Syrup is an amount of
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel and Pulvis Talci, direct powder compression.
Be 45 seconds disintegration.
Embodiment 10
100 parts of (S)-ibuprofens
300 parts of glucosamine
100 parts of starch
10 parts of low replacement-hydroxypropyl celluloses
20 parts of crospolyvinylpyrrolidone
20 parts of 5%PVPK30 aqueous solutions
2 parts of magnesium stearate
Preparation: take by weighing each composition, cross 100 mesh sieves, stirring and evenly mixing adds micropowder silica gel and Pulvis Talci, direct powder compression.
Claims (10)
1 one kinds of pharmaceutical preparatioies for the treatment of osteoarthritis, its active component are (S)-ibuprofen and glucosamine or its pharmaceutical salts, and both weight ratios are 1:3, it is characterized in that wherein adding pharmaceutic adjuvant, to form steady quality, pharmaceutical dosage form easy to use.
2 pharmaceutical preparatioies as claimed in claim 1 is characterized in that the pharmaceutic adjuvant that wherein adds comprises disintegrating agent, filler, lubricant, correctives, diluent, binding agent.
3 pharmaceutical preparatioies as claimed in claim 2, the disintegrating agent that it is characterized in that this pharmaceutical preparation is for can select the pharmacy acceptable auxiliary, as low-substituted hydroxypropyl methylcellulose (L-HPC), polyvinylpolypyrrolidone (PVPP), sodium carboxymethyl cellulose (CCNa), carboxymethyl starch sodium (CMS-Na), gas-producing disintegrant etc. and composition thereof.
4 pharmaceutical preparatioies as claimed in claim 2, the filler that it is characterized in that this pharmaceutical preparation are for can select the pharmacy acceptable auxiliary, as microcrystalline Cellulose (MCC), dextrin, lactose, Icing Sugar, glucose, calcium sulfate, mannitol, starch etc. and composition thereof.
5 pharmaceutical preparatioies as claimed in claim 2, the binding agent that it is characterized in that this pharmaceutical preparation is for can select the pharmacy acceptable auxiliary, as hydroxypropyl emthylcellulose (HPMC), polyvidone (PVP), starch slurry, dextrin, syrup, water, rubber cement, cellulose and derivant thereof, sodium alginate etc. and composition thereof.
6 pharmaceutical preparatioies as claimed in claim 2, the lubricant that it is characterized in that this pharmaceutical preparation is for can select the pharmacy acceptable auxiliary, as Pulvis Talci, stearic acid and its esters, hydrogenated vegetable oil, Polyethylene Glycol, sodium lauryl sulphate (magnesium), micropowder silica gel etc. and composition thereof.
7 pharmaceutical preparatioies as claimed in claim 2, the correctives that it is characterized in that this pharmaceutical preparation be for can select the pharmacy acceptable auxiliary, as mannitol, and natural or artificial sweetening agent such as stevioside.
8 pharmaceutical preparatioies as claimed in claim 2 is characterized in that this pharmaceutical preparation is oral formulations.
9 pharmaceutical preparatioies as claimed in claim 2 is characterized in that this pharmaceutical preparation is external preparation.
10 pharmaceutical preparatioies as claimed in claim 8, the dosage form that it is characterized in that this pharmaceutical preparation is an oral cavity disintegration tablet, its prescription consists of:
100 parts of (S)-ibuprofens
300 parts of glucosamine
Disintegrating agent 3-90 part
Filler 10-100 part
Lubricant 0.2-10 part
Correctives 0.2-10 part
Binding agent is an amount of
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101207663A CN101375854A (en) | 2007-08-27 | 2007-08-27 | Medicinal preparation for treating osteoarthritis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101207663A CN101375854A (en) | 2007-08-27 | 2007-08-27 | Medicinal preparation for treating osteoarthritis |
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| CN101375854A true CN101375854A (en) | 2009-03-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2007101207663A Pending CN101375854A (en) | 2007-08-27 | 2007-08-27 | Medicinal preparation for treating osteoarthritis |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105853446A (en) * | 2016-04-07 | 2016-08-17 | 梁海东 | Medicine preparation for treating osteoarthritis and preparation method thereof |
| CN105935445A (en) * | 2016-03-28 | 2016-09-14 | 赤峰赛林泰药业有限公司 | 2-(-4-isobutylphenyl)propionic acid dextrogyre-containing pharmaceutical composition and preparation method thereof |
-
2007
- 2007-08-27 CN CNA2007101207663A patent/CN101375854A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105935445A (en) * | 2016-03-28 | 2016-09-14 | 赤峰赛林泰药业有限公司 | 2-(-4-isobutylphenyl)propionic acid dextrogyre-containing pharmaceutical composition and preparation method thereof |
| CN105935445B (en) * | 2016-03-28 | 2019-02-01 | 赤峰赛林泰药业有限公司 | Pharmaceutical composition and preparation method thereof containing 2- (- 4- isobutyl phenenyl) propionic acid dextrogyre |
| CN105853446A (en) * | 2016-04-07 | 2016-08-17 | 梁海东 | Medicine preparation for treating osteoarthritis and preparation method thereof |
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