CN1947724A - Compound amino-glucose hydrochloride, chondroitin sulfate effervescent, tablets prepn. method and use thereof - Google Patents
Compound amino-glucose hydrochloride, chondroitin sulfate effervescent, tablets prepn. method and use thereof Download PDFInfo
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- CN1947724A CN1947724A CNA2006101405509A CN200610140550A CN1947724A CN 1947724 A CN1947724 A CN 1947724A CN A2006101405509 A CNA2006101405509 A CN A2006101405509A CN 200610140550 A CN200610140550 A CN 200610140550A CN 1947724 A CN1947724 A CN 1947724A
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- effervescent
- chondroitin sulfate
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Abstract
An effervescent tablet of compound aminoglucose sulfate/chondroitin sulfate for treating osteoarthritis is prepared from the aminoglucose sulfate, chondroitin sulfate (or its Na salt), and the pharmacologically acceptable additive. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of is effervescent tablet of active component and preparation method thereof, purposes with glucosamine hydrochloride and chondroitin sulfate, belongs to medical technical field.
Background technology
Osteoarthritis is a kind of retrograde chronic joint disease, clinical manifestation is the get involved pain in joint, swelling, limitation of activity, sings and symptomses such as cartilage peels off, bony spur formation, subchondral bone necrosis can appear in end-stage patients, cause the function of joint forfeiture, severe patient must carry out artificial joint conversion operation.
Glucosamine is amino monosaccharide, and chondrocyte utilizes glucose to come the synthesizing amino glucose usually.The glucosamine of supplemented with exogenous, in body is provided the precursor of the disaccharide unit of synthetic glycosaminoglycan, the effect that glucosamine has stimulates chondrocyte synthetic proteins polysaccharide and collagen protein is found in vitro study, help to keep the homergy of cartilage matrix, fundamentally stop the development of OA.In addition, glucosamine is brought into play slight antiphlogistic effect, the infringement that alleviates cartilage by removing free radical.
In the glycosaminoglycan of articular cartilage, the chondroitin sulfate cellulose content is maximum, and the disaccharide unit that it is made up of glucuronic acid and sulphuric acid aminogalactose repeats to be formed by connecting: chondroitin sulfate is connected with collagen fiber, stablizes cartilage matrix.Except that articular cartilage,, bone strong as: flesh at its hetero-organization of health, intervertebral disc, cornea and cardiac valve also are rich in chondroitin sulfate.
Except as the cartilage matrix constituent, chondroitin sulfate mainly by the therapeutic effect of following two mechanism performances to OA: 1} can the competitive inhibition digestive enzyme activity, reduce the formation that the destruction of cartilage matrix and knuckle synovia composition: 2} reduces fibrinous thrombus, improve the blood circulation of synovial membrane and subchondral bone.Under the physiological conditions, secretion of platelet chondroitin sulfate and heparin are with the thrombotic tendency of balance: with the increase at age, the output of chondroitin sulfate reduces, replaced by the less active keratan sulfate of tool, thereby form the thrombus obstruction blood vessel easily, increase the weight of the pathology of OA.Chondroitin sulfate also has antiatherogenic effect according to the study.
Glucosamine and chondroitin sulfate coupling treatment of arthritis, play synergism, then can reach the anabolism that following effect: 1} stimulates chondrocyte and synovial cell, 2} suppresses degraded enzyme activity, 3) formation of minimizing fibrinous thrombus improves the joint microcirculation.Glucosamine stimulates the synthetic of cartilage matrix, and chondroitin sulfate then suppresses its degraded, and therefore the net increase that can bring the cartilage matrix amount during both couplings has delayed the development of OA and alleviated symptom.
Effervescent tablet has the advantage of granule and tablet concurrently.Be to be a kind of tablet of disintegrating agent, in water, can produce a large amount of bubbles, and can make medicine dissolution in the short period of time, conveniently take with the effervescent material.Have rapid-action, bioavailability is high, carrying convenience, the patient who is particularly suitable for old age, child and can not swallows solid preparation.
Principal agent in this compound preparation can both be water-soluble, can obtain clear solutions in the effervescive dissolving simultaneously of tablet; And this compound preparation specification is bigger, is 500mg+400mg, and the principal agent ratio is big, is pressed into conventional tablet and can causes that tablet volume is excessive to be difficult for swallowing or once to take many inconvenience.Therefore, it is developed to effervescent tablet, has science and practicality.
Summary of the invention
It is of the present invention that to provide a kind of be the preparation method and its usage of the effervescent tablet of active component with glucosamine hydrochloride and chondroitin sulfate (and sodium salt).
Effervescent tablet of the present invention, wherein the consumption of glucosamine hydrochloride is 125mg-1500mg for per unit dosage.Be preferably 250-750mg, most preferably be 500mg.
Effervescent tablet of the present invention, the consumption of chondroitin sulfate wherein is 100mg-1200mg for per unit dosage.Be preferably 200-600mg, most preferably be 400mg.
Effervescent tablet of the present invention, wherein the weight ratio of glucosamine hydrochloride and chondroitin sulfate is 10: 1-1: 8.Be preferably 3: 1-1: 2.Most preferably be 5: 4.
In the effervescent tablet of the present invention, except principal agent, contain various adjuvants.These adjuvants are selected from filler, effervescent (acid source and alkali source), correctives, binding agent or lubricant.
Wherein filler is selected from one or more the mixture in lactose, mannitol, pregelatinized Starch, sucrose, dextrin, sorbitol, starch, maltose alcohol, the xylitol.
Acid source is selected from but is not limited only to one or more mixture in citric acid (aqueous or anhydride), tartaric acid, fumaric acid, adipic acid, malic acid, lysine, arginine, acetylcysteine, citric acid potassium dihydrogen, potassium hydrogen tartrate, the fumaric acid sodium etc. in the effervescent, and alkali source is selected from but is not limited only to one or more mixture wherein such as sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, calcium carbonate.
Correctives is selected from but one of is not limited only in Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, stevioside, the acesulfame-K or wherein several mixture.
Lubricant is selected from but is not limited only to one or more mixture in micropowder silica gel, magnesium stearate, PEG6000, Pulvis Talci, sodium chloride, the sodium lauryl sulphate.
In the preparation process of effervescent tablet of the present invention, the adding method of soda acid effervescent is closely related for the quality of control product.The soda acid effervescent can be directly to adopt direct powder compression to carry out behind the form of dry powder and other component mix homogeneously; Also can with behind soda acid effervescent and other component mix homogeneously with the compacting of carrying out tablet behind the dehydrated alcohol system soft material according to the galenic pharmacy method of routine; The soda acid effervescent can also be granulated with the partial supplementary material water respectively, mix after the drying, then carry out the compacting of tablet.Above formulation method is that those skilled in the art is known.
Glucosamine hydrochloride chondroitin sulfate of the present invention (or sodium salt) effervescent tablet can be used for being applicable to the osteoarthritis at each position of whole body, as the treatment of knee joint, hip joint and wrist, spinal column, hands, shoulder joint and ankle joint etc.
The specific embodiment
Come glucosamine hydrochloride of the present invention and chondroitin sulfate preparation done further specifying by following example, but be not limited in following example.
Embodiment 1
Prescription:
| Component | Consumption |
| Aminoglucose hydrochloride sodium chondroitin sulfate sodium acid carbonate citric acid orange flavor PEG6000 makes altogether | An amount of 1000 of 500g 400g 900g 500g 50g |
Preparation method:
Glucosamine hydrochloride, sodium chondroitin sulfate are crossed 100 mesh sieves respectively, behind the mix homogeneously, add sodium bicarbonate, citric acid, orange flavor, the PEG6000 of recipe quantity, abundant mix homogeneously, select suitable punch die, adopt the direct powder compression tabletting, promptly.
Embodiment 2:
Prescription:
| Component | Consumption |
| Glucosamine hydrochloride chondroitin sulfate sucrose | 250g 200g 200g |
| Sodium bicarbonate tartaric acid 1%pvp-k30 aqueous solution grape essence magnesium stearate is made altogether | 1000 of an amount of 30g 20g of 450g 250g |
Preparation method:
Glucosamine hydrochloride, chondroitin sulfate are crossed 80 mesh sieves respectively, get glucosamine hydrochloride and add half amount (100g) sucrose, behind the tartaric acid mix homogeneously, with 1%pvp-k30 aqueous solution system soft material, 18 mesh sieves are granulated, drying, and 16 mesh sieve granulate, standby; Get the sucrose (100g) that chondroitin sulfate adds surplus, behind the sodium bicarbonate mix homogeneously, with 1%pvp-k30 aqueous solution system soft material, 18 mesh sieves are granulated, drying, and 16 mesh sieve granulate, standby; Above-mentioned two kinds of granules are mixed, and adding grape essence, magnesium stearate are fully mixed, tabletting, promptly.
Embodiment 3:
Prescription:
| Component | Consumption |
| Aminoglucose hydrochloride chondroitin sulfate xylitol sodium carbonate sodium acid carbonate citric acid orange flavor | 500g 400g 50g 100g 800g 450g 20g |
| The micropowder silica gel of aspartame ethanol solution is made altogether | 1000 of an amount of 10g of 20g |
Preparation method:
Glucosamine hydrochloride, chondroitin sulfate, xylitol, sodium carbonate, sodium bicarbonate, orange flavor, aspartame are crossed 80 mesh sieves respectively, behind the mix homogeneously, add ethanol solution and make soft material in right amount, 16 mesh sieves are granulated, drying, 12 mesh sieve granulate add micropowder silica gel, tabletting behind the mix homogeneously, promptly.
Embodiment 4:
Below only take compliance and external slaking test investigation, so that the molten release characteristics rapidly of taking convenience medicine of this preparation to be described with regard to the embodiment of the invention 1 prepared effervescent tablet and conventional tablet.
1. taking compliance investigates
Look for 16 volunteers, be divided into two groups at random, give the effervescent tablet of embodiment 1 and the conventional tablet for preparing according to conventional method respectively, advise it to take.And estimate.
The result: test sample group personnel are consistent to be thought: placing bubbly water fully only to rise in tablet needs about three minutes, and the oral liquid that obtains has fragrant taste, no raw meat, and consistent the expression takes like a shot.The matched group personnel then indicate and take very difficulty of so big tablet, need chew and take, and chew the phenomenon that sticks to one's teeth in the process, and special fishy smell is arranged, and easily produce the nausea and vomiting phenomenon, and 80% volunteer ends test.
2. slaking test
Get the effervescent tablet of embodiment 1 and the conventional tablet for preparing according to conventional method respectively, advise respectively and carry out slaking test according to the method under the Chinese Pharmacopoeia appendix item, the result is as follows:
For the examination group: all effervescent tableies in normal-temperature water can effervescent in the about 3.5min fully, solution clarification (showing that dissolving fully), do not have muddy, flavor fragrance.
Matched group: conventional tablet is need be in 30min still can't disintegrate complete, and that touches has a tangible thickness sense, may to form aqueous gel in water relevant with sodium chondroitin sulfate.
More than test shows that effervescent tablet has taking convenience, stripping drug release feature rapidly, reaches the galenic pharmacy imagination of expection.
Claims (7)
1. the present invention is a kind of Pharmaceutical composition, it is characterized in that, it is to be active component with glucosamine hydrochloride and chondroitin sulfate (and sodium salt), the effervescent tablet that forms with mixing acceptable accessories.
2. as claimed in claim 1 a kind of be the effervescent tablet of active component with glucosamine hydrochloride and chondroitin sulfate (and sodium salt), it is characterized in that the consumption of described glucosamine hydrochloride is 125mg-1500mg for per unit dosage.Be preferably 250-750mg; The consumption of chondroitin sulfate (and sodium salt) is 100mg-1200mg for per unit dosage.Be preferably 200-600mg; The weight ratio of glucosamine hydrochloride and chondroitin sulfate (and sodium salt) is 10: 1--1: 8.Be preferably 3: 1-1: 2.
3. glucosamine hydrochloride as claimed in claim 1 and chondroitin sulfate (and sodium salt) effervescent tablet, its single dosage unit active component most preferably is glucosamine hydrochloride 500mg+ chondroitin sulfate (and sodium salt) 400mg.Both weight ratios are 5: 4.
4. effervescent tablet as claimed in claim 1 is characterized in that, described acceptable accessories is selected from filler, effervescent (acid source and alkali source), correctives, binding agent or lubricant.
5. effervescent tablet as claimed in claim 1, described filler are selected from one or more the mixture in lactose, mannitol, pregelatinized Starch, sucrose, dextrin, sorbitol, starch, maltose alcohol, the xylitol; Acid source is selected from but is not limited only to one or more mixture in citric acid (aqueous or anhydride), tartaric acid, fumaric acid, adipic acid, malic acid, lysine, arginine, acetylcysteine, citric acid potassium dihydrogen, potassium hydrogen tartrate, the fumaric acid sodium etc. in the described effervescent, and alkali source is selected from but is not limited only to one or more mixture wherein such as sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, calcium carbonate; Described correctives is selected from but one of is not limited only in Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, stevioside, the acesulfame-K or wherein several mixture; Described lubricant is selected from but is not limited only to one or more mixture in micropowder silica gel, magnesium stearate, PEG6000, Pulvis Talci, sodium chloride, the sodium lauryl sulphate.
6. effervescent tablet as claimed in claim 5 is characterized in that, in preparation process, the soda acid effervescent directly after the form and other component mix homogeneously with dry powder, adopts direct powder compression to carry out; Also can with behind soda acid effervescent and other component mix homogeneously with the compacting of carrying out tablet behind the dehydrated alcohol system soft material according to the galenic pharmacy method of routine; The soda acid effervescent can also be granulated with the partial supplementary material water respectively, mix after the drying, then carry out the compacting of tablet.
Claim 1-6 described a kind of be the Pharmaceutical composition of active component with glucosamine hydrochloride and chondroitin sulfate, can be used for being applicable to the osteoarthritis at each position of whole body, as the treatment of knee joint, hip joint and wrist, spinal column, hands, shoulder joint and ankle joint etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101405509A CN1947724A (en) | 2006-03-10 | 2006-10-17 | Compound amino-glucose hydrochloride, chondroitin sulfate effervescent, tablets prepn. method and use thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610057274 CN1817348A (en) | 2006-03-10 | 2006-03-10 | Medicinal composition with glycosamine hydrochloride and cartilagin sulfate as active components, its preparation and use thereof |
| CN200610057274.X | 2006-03-10 | ||
| CNA2006101405509A CN1947724A (en) | 2006-03-10 | 2006-10-17 | Compound amino-glucose hydrochloride, chondroitin sulfate effervescent, tablets prepn. method and use thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1947724A true CN1947724A (en) | 2007-04-18 |
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|---|---|---|---|
| CNA2006101405509A Pending CN1947724A (en) | 2006-03-10 | 2006-10-17 | Compound amino-glucose hydrochloride, chondroitin sulfate effervescent, tablets prepn. method and use thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101559198B (en) * | 2008-04-15 | 2012-01-04 | 北京康比特体育科技股份有限公司 | Medicament for protecting joints and soft tissues |
| CN102578449A (en) * | 2011-11-01 | 2012-07-18 | 江苏江山制药有限公司 | Preparation technology for three-layer effervescent tablet containing glucosamine |
| CN103622978A (en) * | 2013-12-17 | 2014-03-12 | 吉林省名霖药业有限公司 | Stable glucosamine pharmaceutical composition and preparation method thereof |
| CN104068306A (en) * | 2014-06-18 | 2014-10-01 | 广州市赛健生物科技有限公司 | Health food for improving bone density and preparation method of health food |
| CN106924342A (en) * | 2017-02-24 | 2017-07-07 | 佛山职业技术学院 | A kind of ammonia sugar microcapsules oral liquid and preparation method thereof |
| CN108079012A (en) * | 2017-12-20 | 2018-05-29 | 烟台东诚药业集团股份有限公司 | The pharmaceutical composition of hydrochloric Glucosamine and chondroitin sulfate |
| CN109588604A (en) * | 2017-11-13 | 2019-04-09 | 中国水产科学研究院南海水产研究所 | A kind of pinctada fucata glycosaminoglycan effervescent tablet and preparation method thereof |
| CN110872361A (en) * | 2019-12-06 | 2020-03-10 | 中国科学院烟台海岸带研究所 | Glucosamine chondroitin sulfate, preparation method and application |
| CN110950976A (en) * | 2019-12-06 | 2020-04-03 | 中国科学院烟台海岸带研究所 | Glucosamine hyaluronate and application |
-
2006
- 2006-10-17 CN CNA2006101405509A patent/CN1947724A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101559198B (en) * | 2008-04-15 | 2012-01-04 | 北京康比特体育科技股份有限公司 | Medicament for protecting joints and soft tissues |
| CN102578449A (en) * | 2011-11-01 | 2012-07-18 | 江苏江山制药有限公司 | Preparation technology for three-layer effervescent tablet containing glucosamine |
| CN103622978A (en) * | 2013-12-17 | 2014-03-12 | 吉林省名霖药业有限公司 | Stable glucosamine pharmaceutical composition and preparation method thereof |
| CN104068306A (en) * | 2014-06-18 | 2014-10-01 | 广州市赛健生物科技有限公司 | Health food for improving bone density and preparation method of health food |
| CN104068306B (en) * | 2014-06-18 | 2017-05-17 | 广州市赛健生物科技有限公司 | Health food for improving bone density and preparation method of health food |
| CN106924342A (en) * | 2017-02-24 | 2017-07-07 | 佛山职业技术学院 | A kind of ammonia sugar microcapsules oral liquid and preparation method thereof |
| CN109588604A (en) * | 2017-11-13 | 2019-04-09 | 中国水产科学研究院南海水产研究所 | A kind of pinctada fucata glycosaminoglycan effervescent tablet and preparation method thereof |
| CN108079012A (en) * | 2017-12-20 | 2018-05-29 | 烟台东诚药业集团股份有限公司 | The pharmaceutical composition of hydrochloric Glucosamine and chondroitin sulfate |
| CN110872361A (en) * | 2019-12-06 | 2020-03-10 | 中国科学院烟台海岸带研究所 | Glucosamine chondroitin sulfate, preparation method and application |
| CN110950976A (en) * | 2019-12-06 | 2020-04-03 | 中国科学院烟台海岸带研究所 | Glucosamine hyaluronate and application |
| CN110872361B (en) * | 2019-12-06 | 2022-09-27 | 中国科学院烟台海岸带研究所 | Glucosamine chondroitin sulfate, preparation method and application |
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