CN105796588B - A kind of medicinal composition for injections in articular cavity containing Glucosamine - Google Patents
A kind of medicinal composition for injections in articular cavity containing Glucosamine Download PDFInfo
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- CN105796588B CN105796588B CN201610208328.1A CN201610208328A CN105796588B CN 105796588 B CN105796588 B CN 105796588B CN 201610208328 A CN201610208328 A CN 201610208328A CN 105796588 B CN105796588 B CN 105796588B
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- injections
- aminoglucose hydrochloride
- sodium hyaluronate
- concentration
- articular cavity
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of medicinal composition for injections in articular cavity containing aminoglucose hydrochloride, the pharmaceutical composition contains aminoglucose hydrochloride and sodium hyaluronate, wherein aminoglucose hydrochloride concentration 5%-20%, sodium hyaluronate molecular weight are ten thousand dalton of 80-200, a concentration of 0.5%-1.5%.The present invention has the advantage that small molecule Glucosamine is quickly absorbed, quickly repaired, and has both the advantage that relatively high molecular weight sodium hyaluronate viscoelasticity is good and resiliency is good and Glucosamine can be made to be sustained, and can be used for intra-articular injection therapy arthritis.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of injections in articular cavity drug containing Glucosamine
Composition.
Background technology
Osteoarthritis（Osteoarthritis, OA）Also known as degenerative joint disease is a kind of by multifactor caused,
Become the joint disease of basic pathological changes with articular cartilage degeneration, it is common with middle-older patient.In 60 years old or more crowds
Illness rate is up to 50%, and 75 years old crowd is then up to 80%.The disability rate of the disease may be up to 53%.
With population in the world aging, the incidence cumulative year after year of osteoarthritis.China is that osteoarthropathy is " super big
State ".Now there are about the torments that 1.3 hundred million people are undergo osteoarthritis.Osteoarthritis is in addition to influencing locomitivity and life matter
Amount, and then generate other than depression and anxiety, it also will produce huge financial burden.In the U.S., the medical treatment about OA in 2008
It has been more than 185,000,000,000 yuan that expense is total.Arthritis brings prodigious economy and stress to patient and family, it has also become
Serious public health problem.
Currently, we can not also accomplish to early diagnose Osteoarthritis, and late period, Osteoarthritis was in addition to taking
Other than analgesic drug product or joint replacement, other better therapies are also can not find.Therefore, Osteoarthritis in addition to preventing ahead of time
Outside, also effective treatment is given in the phase in the morning, afternoon and evening or acute stage for finding Osteoarthritis, it is expected that can not only alleviate joint
Pain delays progression of the disease and can repair cartilage, radical curing of disease.Therefore, it is very urgent to research and develop this new drug.
Glucosamine（C6H13NO5）Also known as gucosamine is a kind of natural amino monosaccharide, it is synthesis cartilage base
The main component of poly glucosamine in matter and synovia.Human body can by amination glucose synthesizing amino glucose, have with
The entirely different physiological function of glucose.Ammonia sugared content will gradually decrease in human body with advancing age after 30 years old, 70 years old
It almost no longer synthesizes in vivo afterwards.Research finds that exogenous Glucosamine can stimulate cartilage cell's synthetic proteins polysaccharide, mends
The missing element for filling cartilage matrix improves the repair ability of cartilage cell, inhibits the water such as lysosomal enzyme, clostridiopetidase A and phospholipase A2
The release of enzyme is solved, the hydrolysis to articular cartilage matrix is reduced and destroys, and the generation of the super oxyradical of damaging cells can be prevented,
Promote the repair and reconstruction of cartilage matrix, mitigate arthralgia, improve function of joint, is considered in treating osteoarthritis being peace
Complete effective cartilage protection.Ammonia sugar product is based on oral preparation on the market at present, although according to clinical verification in a part of bone
It is effective in cure in arthritic, but it works slowly, bioavilability is relatively low, only treats the Osteoarthritis of early stage,
Centering patients with terminal function and effect unobvious, and part population takes orally the drug and has nausea, constipation, abdominal distension and diarrheal disease
Shape；It takes for a long time to liver kidney toxic side effect etc..Therefore, developing new ammonia sugar product becomes a weight for the treatment of Osteoarthritis
Want direction.
Sodium hyaluronate is the chain polymer for repeating to be formed by connecting by β-n acetylglucosamine n and D- glucuronic acid monosaccharide, is
Important component part in knuckle synovia has the effect of the mechanical protections such as damping, lubrication to articular cartilage, maintains the normal work(of synovia
It can be extremely important.In the knuckle synovia of arthritic, the molecular weight of sodium hyaluronate, concentration and viscoelasticity are equal
It is substantially reduced, by directly giving the sodium hyaluronate of high molecular weight in articular cavity, natural cover can be re-formed, prevent cartilage
Matrix further destroys disappearance；Joint friction and pain is mitigated or eliminated in the biological function for improving pathological state inferior synovial membrane, but
Reparation speed is slower, and the course for the treatment of is longer.
Invention content
The object of the present invention is to provide a kind of absorptions quickly, repairs in the quickly articular cavity containing Glucosamine and notes
Penetrate pharmaceutical composition.
To achieve the above object, solution of the invention is：
A kind of medicinal composition for injections in articular cavity containing aminoglucose hydrochloride, the wherein pharmaceutical composition contain
Aminoglucose hydrochloride and sodium hyaluronate, wherein aminoglucose hydrochloride concentration 5%-20%, sodium hyaluronate molecular weight are 80-200
Ten thousand dalton, a concentration of 0.5%-1.5%.
The concentration 8%-15% of the Glucosamine.
The concentration 10% of the Glucosamine.
The concentration 0.8%-1.2% of the sodium hyaluronate.
The concentration 1% of the sodium hyaluronate.
The composition is liquid preparation or gelling agent.
The PH of the composition ranging from 5.5-7.4.
After adopting the above scheme, according to the pathogenesis of osteoarthritis and clinical manifestation, and the numerous studies of the present invention
It was found that the effect of drug treatment is than independent joint cavity injection Hyaluronic Acid in sodium hyaluronate and Glucosamine use in conjunction articular cavity
Sodium or Glucosamine are better.Because on the one hand the sodium hyaluronate of macromolecule has the machines such as damping, lubrication to articular cartilage
Tool protective effect prevents impaired cartilage from continuing to aggravate, and is on the one hand used as sustained release preparation, slowly long-term release Glucosamine,
And ingredient one of of the Glucosamine as synthesis cartilage, the structure of cartilage can be directly participated in, the regeneration and reparation of cartilage are accelerated,
, can be in rapid osmotic to cartilage since molecular weight is relatively small, this has the damaging cartilage of not blood supply good
Repair.The two acts synergistically, and on the one hand atraumatic cartilage continues to deteriorate, on the one hand long-term, accelerates to repair cartilage.
Specific implementation mode
Present invention is disclosed a kind of medicinal composition for injections in articular cavity containing aminoglucose hydrochloride, the wherein medicine
Compositions contain aminoglucose hydrochloride and sodium hyaluronate, wherein aminoglucose hydrochloride concentration 5%-20%, sodium hyaluronate point
Son amount is ten thousand dalton of 80-200, a concentration of 0.5%-1.5%.The composition is liquid preparation or gelling agent.The composition
PH ranging from 5.5-7.4.
Embodiment 1
Prescription：
Embodiment 2
Prescription：
Embodiment 3
Prescription：
Test data：
The embodiment of the present invention 1 studies the effect of osteoarthritis
The preparation of 1 laboratory sample
1. test group：The embodiment of the present invention 1.
2. compareing 1 group：Aminoglucose hydrochloride 10g is taken, sodium hyaluronate is added without, remaining is the same as the embodiment of the present invention 1.
3. compareing 2 groups：Take sodium hyaluronate 1g（1,800,000 dalton of relatively high molecular weight）, it is added without aminoguanidine hydrochloride grape
Sugar, remaining is the same as the embodiment of the present invention 1
4. negative control group：Physiological saline
2 experimental animals are grouped
Healthy new zealand white rabbit 40 is taken, weight 2-2.5KG, male and female are unlimited, are randomly divided into 4 groups：1. 2. test group compares
3. 1 group compares 2 groups and 4. compares 3 groups of 5. negative control groups.
The preparation and administration of osteoarthritis
Osteoarthropathy varying model is caused by injecting papain in articular cavity, to distinguishing in 5 groups of right knee joint cavities of rabbit
Inject 0.3 ml of papain solution.It after 3 days, then injects the 2nd time, injects the 3rd time within the 7th day, co-injection 3 times.In modeling
The 14th day afterwards, above-mentioned sample 0.3ml, 1 times a week, totally 5 weeks are injected in the same area of articular cavity respectively to 5 groups of experimental rabbits.
The acquisition and detection of sample
The 7th day after final injection, rabbit is put to death.Hair around rabbit knee is scraped, articular cavity row gross examination of skeletal muscle is opened,
Then it completely takes out cartilage and joint fluid, articular cartilage tissue is fixed, be routinely dehydrated, paraffin embedding is then cut into 5-6nm's
Slice does HE, the dyeing of Ali Xinlan, slice om observation respectively.
As a result
According to Mankin osteoarthropathy histologic classification methods, scores cartilage, the results are shown in Table 1
Statistical analysis is carried out to each test results to show：Each administration group has pole conspicuousness poor with negative control group
Different, wherein the integral of test group is substantially less than a control group, illustrates that the therapeutic effect of the embodiment of the present invention 1 is best.
Claims (4)
1. a kind of medicinal composition for injections in articular cavity containing aminoglucose hydrochloride, it is characterised in that：The pharmaceutical composition
The effective component of object is made of aminoglucose hydrochloride and sodium hyaluronate, wherein aminoglucose hydrochloride concentration 8%-15%, glass
Sour sodium molecule amount is ten thousand dalton of 80-200, a concentration of 0.8%-1.2%；The PH of the composition ranging from 6.5-7.3.
2. a kind of medicinal composition for injections in articular cavity containing aminoglucose hydrochloride as described in claim 1, special
Sign is：The concentration 10% of the aminoglucose hydrochloride.
3. a kind of medicinal composition for injections in articular cavity containing aminoglucose hydrochloride as described in claim 1, special
Sign is：The concentration 1% of the sodium hyaluronate.
4. a kind of injections in articular cavity pharmaceutical composition containing aminoglucose hydrochloride any one of as described in claim 1-3
Object, it is characterised in that：The composition is liquid preparation or gelling agent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610208328.1A CN105796588B (en) | 2016-04-06 | 2016-04-06 | A kind of medicinal composition for injections in articular cavity containing Glucosamine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610208328.1A CN105796588B (en) | 2016-04-06 | 2016-04-06 | A kind of medicinal composition for injections in articular cavity containing Glucosamine |
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| Publication Number | Publication Date |
|---|---|
| CN105796588A CN105796588A (en) | 2016-07-27 |
| CN105796588B true CN105796588B (en) | 2018-10-23 |
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| CN201610208328.1A Active CN105796588B (en) | 2016-04-06 | 2016-04-06 | A kind of medicinal composition for injections in articular cavity containing Glucosamine |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110193006B (en) * | 2019-05-22 | 2022-11-25 | 四川农业大学 | Glucosamine hydrochloride bone joint intelligent hydrogel and preparation method and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1714799A (en) * | 2004-06-30 | 2006-01-04 | 上海科宝生物技术有限公司 | Medicinal composition and its use in treating osteoarthritis |
| CN101112378A (en) * | 2006-07-24 | 2008-01-30 | 凌沛学 | Articular cavity inner injecting and administering reparations containing trehalose |
| CN101810855A (en) * | 2010-05-20 | 2010-08-25 | 佟刚 | II-type collagen joint cartilage fluid and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080139500A1 (en) * | 2006-12-11 | 2008-06-12 | Isadore Elliott Goldberg | Use of composite monomer or monomers, catalyst, sodium hyaluronate or hyaluronic acid, glucosamide sulfate, chondroiten sulfate or chlorides, for the treatment of osteoarthritis by intraarticular application to a hip or knee joint |
-
2016
- 2016-04-06 CN CN201610208328.1A patent/CN105796588B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1714799A (en) * | 2004-06-30 | 2006-01-04 | 上海科宝生物技术有限公司 | Medicinal composition and its use in treating osteoarthritis |
| CN101112378A (en) * | 2006-07-24 | 2008-01-30 | 凌沛学 | Articular cavity inner injecting and administering reparations containing trehalose |
| CN101810855A (en) * | 2010-05-20 | 2010-08-25 | 佟刚 | II-type collagen joint cartilage fluid and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| "盐酸氨基葡萄糖协同关节腔内注射玻璃酸钠治疗膝关节骨关节炎疗效观察";陈永龙等;《中国骨肿瘤病》;20100430;第9卷(第2期);摘要 * |
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| CN105796588A (en) | 2016-07-27 |
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