CN103446577B - A kind of arthritic pharmaceutical composition of prevention and therapy and application thereof - Google Patents

A kind of arthritic pharmaceutical composition of prevention and therapy and application thereof Download PDF

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CN103446577B
CN103446577B CN201310395291.4A CN201310395291A CN103446577B CN 103446577 B CN103446577 B CN 103446577B CN 201310395291 A CN201310395291 A CN 201310395291A CN 103446577 B CN103446577 B CN 103446577B
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庞会心
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Abstract

The invention provides the arthritic pharmaceutical composition of a kind of prevention and therapy, it is made up of the component of following percentage by weight: glucosamine hydrochloride 15% ~ 35%, biological calcium carbonate 20% ~ 40%, Rhizoma Drynariae extract 5% ~ 20%, phosphopeptide caseinate 1% ~ 5%, chondroitin sulfate 10% ~ 20%, Herba Epimedii extract 10% ~ 30%.Pharmaceutical composition of the present invention obviously can suppress the inflammatory cytokine in arthritic's serum and joint fluid, alleviate the sings and symptoms of patient, and the immunologic function of patient can be regulated, can the effective disease such as prevention and therapy rheumatism, rheumatoid arthritis, osteoarthritis, gouty arthritis.Present invention also offers the application of described pharmaceutical composition in the medicine preparing the diseases such as prevention and therapy rheumatism, rheumatoid arthritis, osteoarthritis, gouty arthritis.

Description

A kind of arthritic pharmaceutical composition of prevention and therapy and application thereof
Technical field
The present invention relates to a kind of pharmaceutical composition, being specifically related to one can the arthritic pharmaceutical composition of prevention and therapy, and is preparing the application in the arthritic medicine of prevention and therapy or health product.
Background technology
Arthritis refers to the arthritis pathological changes caused by inflammation, infection, wound or other factors, and belonging to autoimmune disease, is common ailment of middle-aged and old.Its characteristics of lesion is the synovitis that persistence is carried out, and shows as synovial membrane and thickens, and synovial fluid increases, blood vessel hyperplasia, inflammatory cell infiltration, and then attacks soft Bone and bones, causes joint injury.Wherein, a large amount of oxygen-derived free radicals that phagocyte produces play an important role in arthritis develops.
At present, doctor trained in Western medicine there is no specific medicament to arthritic treatment, and routine administration is based on hormone medicine, and its therapeutic purposes are temporarily pain relieving normally.In addition, Long-term Hormone class medicine can produce central obesity (buffalo hump, moon face), osteoporosis, the side effect such as hypoimmunity.
Pure treatment by Chinese herbs arthritis curative effect is single, and effect is slow, and the course for the treatment of is long.The Chinese physical therapy such as acupuncture, massage treatment of arthritis can only be a kind of auxiliary effect, alleviates arthralgia, does not have the effect of essence.
The object of the invention is for above-mentioned phenomenon, aiming to provide can the effective arthritic pharmaceutical composition of prevention and therapy, by the efficient combination of chemicals and Chinese medicine, with the clinical symptoms of effective releasing arthritis patient fast, and non-evident effect.
Summary of the invention
The object of the invention is to: provide a kind of prevention and therapy arthritic pharmaceutical composition, to improve the Prevention and Curation effect sick to rheumatism, rheumatoid arthritis, osteoarthritis, gouty arthritis etc.
Object of the present invention is achieved through the following technical solutions:
There is provided a kind of prevention and therapy arthritic pharmaceutical composition, it is made up of the component of following percentage by weight:
Glucosamine hydrochloride 15% ~ 35%, biological calcium carbonate 20% ~ 40%, Rhizoma Drynariae extract 5% ~ 20%, phosphopeptide caseinate 1% ~ 5%, chondroitin sulfate 10% ~ 20%, Herba Epimedii extract 10% ~ 30%.
Described pharmaceutical composition is preferably made up of the component of following percentage by weight:
Glucosamine hydrochloride 20% ~ 30%, biological calcium carbonate 30% ~ 35%, Rhizoma Drynariae extract 5% ~ 10%, phosphopeptide caseinate 1% ~ 2%, chondroitin sulfate 15% ~ 20%, Herba Epimedii extract 10% ~ 20%.
Described pharmaceutical composition is most preferably made up of the component of following percentage by weight:
Glucosamine hydrochloride 25%, biological calcium carbonate 34%, Rhizoma Drynariae extract 7.5%, phosphopeptide caseinate 2%, chondroitin sulfate 17.5%, Herba Epimedii extract 14%.
In pharmaceutical composition of the present invention, Rhizoma Drynariae extract derives from Plants of Polypodiaceae Mongolian oak Herba pteridii latiusculi Drynariafortunei(Kunze) the dry rhizome extract of J.Sm., being the commercially available prod with unified mass standard, is brown color powder; Herba Epimedii extract derives from as Berberidaceae plant Epimedium brevicornum (EpimediumbrevicornumMaxim.), Epimedium sagittatum (Epimediumsagittatum(Sieb.etZucc.) Maxim.), the dry aerial parts of E. Pubescens (EpimediumpubescensMaxim.), Epimedium wushanense (EpimediumwushanenseT.S.Ying) or Herba Epimedii (EpimediumkoreanumNakai), being the commercially available prod with unified mass standard, is brown powder product.
Other components in pharmaceutical composition of the present invention are all commercially available acquisition also, and the preparation method of described pharmaceutical composition is simply mixed by described several drugs.
The present invention also provides described pharmaceutical composition preparing the application in the arthritic medicine of prevention and therapy or health product.
Described application is prepared in conjunction with customary adjuvant by described pharmaceutical composition to make various preparation process acceptable dosage form, and wherein said adjuvant accounts for medicine or health product gross weight 0.5% ~ 25%.
Described adjuvant can be one or more in disintegrating agent, filler, lubricant, correctives or excipient.Wherein said disintegrating agent can be starch; Described filler can be starch or dextrin; Described lubricant can be magnesium stearate; Described correctives can be lactose; Described excipient can be microcrystalline Cellulose.
Described preparation process acceptable dosage form can be hard capsule, tablet or granule.
Such as can realize pharmaceutical composition of the present invention in accordance with the following methods and prepare the application in the arthritic hard capsule of prevention and therapy:
(1) take the glucosamine hydrochloride, biological calcium carbonate, Rhizoma Drynariae extract, phosphopeptide caseinate, chondroitin sulfate, the Herba Epimedii extract that are up to the standards by formula proportion, cross 80 mesh sieves, mixing;
(2) disintegrating agent and filler is added, mix homogeneously according to described adjuvant part by weight again;
(3) capsule is filled to Autocapsulefillingmachine;
(4) by above-mentioned capsule granulate, polishing, packaging.
The wherein common medicinal supplementary material that specifies for meeting 2010 editions " Chinese Pharmacopoeia " pharmaceutic adjuvant standards of filler described in step (2), disintegrating agent, as magnesium stearate etc.
In pharmaceutical composition of the present invention, glucosamine hydrochloride has the function improving immunity, suppression, prevention inflammation process, has obvious anti-inflammatory analgesic action.Glucosamine hydrochloride can also promote the synthesis of human body mucopolysaccharide, improves the viscosity of knuckle synovia, can improve the metabolism of articular cartilage, be conducive to the reparation of articular cartilage.Chondroitin sulfate to improving Senile degenerative arthritis, rheumatic arthritis has good effect.Rhizoma Drynariae extract has stimulates bone articular cartilage compensatory cellular proliferative effect, and can partly improve because mechanical stress line changes the degeneration causing articular cartilage, thus reduces osteoarthritis variability.Herba Epimedii extract has the anabolic effect promoting medullary cell DNA, has the effects such as good bone and muscle strengthening, wind-damp dispelling, anti-inflammation.Phosphopeptide caseinate can suppress the formation of calcium phosphate precipitation, makes the concentration that free calcium keeps higher, promotes Passive intake and the utilization of calcium, and weakens osteoclast effect and suppress absorbing again of bone.Biological calcium carbonate is the good calcium source being better than the calcium preparation such as calcium carbonate, calcium lactate.
The present invention, by by above-mentioned several drugs organically compatibility in specific proportions, obtains one and has the arthritic pharmaceutical composition of remarkable prevention and therapy.
The concrete effect of pharmaceutical composition of the present invention can be passed through to test proof as follows:
1 materials and methods
1.1 animal Wistar rats, female, body weight 180-200g, the 2-3 monthly age; C57 inbred mice 18-20g, by Changsha Kaifu District, Dong Chuan Animal Science service department provides.
1.2 main agents
BCG, LPS, ConA, BSA, actinomycin D, TNF α standard substance, IL-1 standard substance, IL-6, IL-8 detection kit, MTT, L929 cell strain.
By test product: the sample prepared by embodiment of the present invention method.
1.3 method
1.3.1 rat assist agent arthritis animal model foundation and experiment grouping
By same lot number BCG80 DEG C deactivation 1h, be made into 10g/L with the liquid paraffin of sterilizing, vibration mixing, causes inflammation in rat left hind foot pad intradermal injection 0.1ml.Normal group injection 0.1ml normal saline.
Experiment grouping and dosage: (1) Normal group; (2) model control group; (3) low dose group; (4) high dose group, often organizes 8 rats.Low dose group dosage is equivalent to 5 times of human body recommended dose (0.06g/kgbw), is 0.3g/kgbw, and high dose group is equivalent to 10 times of human body recommended dose (0.06g/kgbw), is 0.6g/kgbw.In cause high dose group on scorching same day, low dose group respectively gavage give by test product: 0.3g/kgbw, 0.6g/kgbw, continuous 14d.Normal group and model control group give isopyknic distilled water.After Yu Zhiyan 0,5,10,15, the different times such as 19d, carry out disease observation and add up arthritis index.In experiment 19d, rat broken end is got blood, separation of serum, and 0.45 μm of membrane filtration is degerming ,-20 DEG C of preservations, cytokine to be measured.
1.3.2 the acquisition of joint immersion
Cause scorching 19d, put to death rat, above ankle joint, 0.5cm place cuts non-injection adjuvant side swelling foot pawl, and peel skin, with shears by sufficient pawl rip cutting, put into 5ml normal saline, in 4 DEG C of soaked overnight, centrifuging and taking supernatant, filtration sterilization ,-20 DEG C of preservations are to be measured.
1.3.3 the preparation of rat peritoneal macrophages (M Φ) and inducing of cytokine
The preparation method of rat abdominal cavity M Φ is for add LPS at M Φ monolayer, and every hole 1ml, final concentration is 30 μ g/ml, at 37 DEG C of 5%CO 2under condition, it is to be measured that supernatant subpackage is gathered in the crops in cultivation 48h (TNF α cultivates 24h).
1.3.4 the preparation of rat spleen lymphocytes and inducing of cytokine
Get Rats Spleen under aseptic condition and prepare single cell suspension, be separated lymphocyte, wash twice with 5%FCS-RPMI1640,10%FCS-RPMI1640 adjusts cell concentration to be 5 × 10 9individual/L adds 24 orifice plates, and 1ml/ hole adds 5mg/LConA, 37 DEG C of 5%CO 2hatch 48h under condition, centrifugal, results supernatant subpackage ,-20 DEG C of preservations are to be measured.
1.3.5 the assay method of cytokine
Thymocyte cell method is adopted to measure IL-1 active.IL-6 content detection adopts ELISA sandwich assay.IL-8 content detection adopts ELISA sandwich assay.L929 cell method is adopted to measure TNF-alpha active.
2 results
2.1 are subject to test product to the observation of rat model therapeutical effect
After Wistar rat injection adjuvant, 1 ~ 4d has acute inflammatory reaction in injection site, shows as erythema and swelling; 7 ~ 12d acute inflammatory reaction disappears; 12 ~ 28d produces systemic inflammatorome change, all occurs erythema, swelling, periangiitis etc. at the hind leg of ear, afterbody, forelimb and non-injection adjuvant.After treatment 19d, by test product high and low dose group rat AI compared with the obvious reduction of model control group rat.
2.2 treat the change of rear model rat blood serum cytokine by test product
From table 1, compared with Normal group, in model control group rat blood serum, IL-1, IL-6, IL-8, TNF-alpha levels significantly improves, and after standing test product treatment 19d, in serum, IL-1, IL-6, IL-8, TNF-alpha levels obviously reduces.
Table 1: sample is on the impact of rheumatoid rat blood serum cytokine
Note: compare with Normal group ##p<0.01, p>0.05; Compare with model control group △ △p<0.01.2.3 by the impact of test product treatment on rat model joint fluid inflammatory cytokine
By test product treatment 19d, put to death animal, have detected the level of inflammatory cytokine in the immersion of joint.Result shows that in rat articular liquid, IL-1, IL-6, IL-8, TNF-alpha levels obviously reduces (see table 2) by after test product treatment.
Table 2: given the test agent is on the impact of rheumatoid rat articular liquid inflammatory cytokine
Note: compare with Normal group ##p<0.01, p>0.05; Compare with model control group △ △p<0.01.2.4 by the impact on rat model secretion by peritoneal macrophages cytokine after test product treatment
As seen from Table 3, the ability of rat model secretion by peritoneal macrophages cytokine (IL-1, TNF-α, IL-6, IL-8) is significantly inhibited.
Table 3: given the test agent is on the impact of rheumatoid rat peritoneal macrophages secrete cytokines
Note: compare with Normal group ##p<0.01; Compare with model control group △ △p<0.01.
2.5 by the impact after test product treatment, rat model splenocyte being induced to IL-6 and IL-8
From table 4, the ability of rat model splenocyte secretion IL-6 and IL-8 is significantly higher than normal rat, and stand after test product respectively organizes treatment, the ability that splenocyte induces IL-6 and IL-8 is obviously suppressed.
Table 4: given the test agent is on the impact of rheumatoid rat peritoneal macrophages secrete cytokines
Note: compare with Normal group ##p<0.01, p>0.05; Compare with model control group △ △p<0.01.
3 conclusions
Through the embodiment of the present invention four prepare by after test product treatment, in rat blood serum and joint fluid, the level of inflammatory cytokine obviously reduces, and the ability of abdominal cavity M Φ and splenocyte secretion inflammatory cytokine is significantly suppressed.Show that pharmaceutical composition of the present invention has immunosuppressive action widely, the level of inflammatory cytokine inflammatory mediator can be reduced, thus stop the generation of bone destruction and development, thus there is good antiinflammatory action, can effective prevention and therapy arthritis.
Detailed description of the invention
Below technical scheme of the present invention is further described by way of example.
Medicine used in each embodiment is commercially available prod.Such as, glucosamine hydrochloride, biological calcium carbonate, Rhizoma Drynariae extract, phosphopeptide caseinate, chondroitin sulfate, Herba Epimedii extract all can purchased from Changsha Kang Long biological product company limiteies.
Embodiment one
1. take glucosamine hydrochloride 110g, biological calcium carbonate 135g, Rhizoma Drynariae extract 30g, phosphopeptide caseinate 4.5g, chondroitin sulfate 70g, Herba Epimedii extract 46.5g bacterium inspection respectively, cross 80 mesh sieves, qualified for subsequent use.
2., by material mix homogeneously each described in step 1, namely obtain pharmaceutical composition of the present invention.
Embodiment two
1. take glucosamine hydrochloride 85g, biological calcium carbonate 100g, Rhizoma Drynariae extract 60g, phosphopeptide caseinate 5g, chondroitin sulfate 45g, Herba Epimedii extract 100g bacterium inspection respectively, cross 80 mesh sieves, qualified for subsequent use.
2., by material mix homogeneously each described in step 1, namely obtain pharmaceutical composition of the present invention.
Embodiment three
1., by glucosamine hydrochloride 90g, biological calcium carbonate 115g, Rhizoma Drynariae extract 50g, phosphopeptide caseinate 6g, chondroitin sulfate 54g, Herba Epimedii extract 80g bacterium inspection respectively, cross 80 mesh sieves, qualified for subsequent use.
2., by material mix homogeneously each described in step 1, namely obtain pharmaceutical composition of the present invention.
Embodiment four
1. add 4g magnesium stearate again by the compositions of preparation in embodiment one.
2. be filled to capsule with the mixture that step 1 obtains by fully-automatic capsule machine, every capsules content is 400mg, obtained 1000 altogether.
3. by gained capsule granulate, polishing, inspection, packaging in step 2.
Embodiment five
1. the compositions prepared by embodiment two and 120g starch, 30g microcrystalline Cellulose and 5g magnesium stearate, for subsequent use after bacterium inspection respectively;
2. by material (except magnesium stearate) mix homogeneously each described in step 1, with 60% ~ 80% alcohol granulation, dry, add magnesium stearate, mixing, is pressed into 1000, tablet.

Claims (7)

1. the application of the arthritic pharmaceutical composition of prevention and therapy in the medicine preparing prevention and therapy rheumatism, rheumatoid arthritis, osteoarthritis, gouty arthritis, it is characterized in that, described pharmaceutical composition is made up of the component of following weight: glucosamine hydrochloride 110g, biological calcium carbonate 135g, Rhizoma Drynariae extract 30g, phosphopeptide caseinate 4.5g, chondroitin sulfate 70g, Herba Epimedii extract 46.5g.
2. application according to claim 1, is characterized in that: described application is prepared in conjunction with customary adjuvant by described pharmaceutical composition to make various preparation process acceptable dosage form, and wherein said adjuvant accounts for 0.5% ~ 25% of medicine gross weight.
3. application according to claim 2, is characterized in that: described adjuvant is excipient.
4. application according to claim 3, is characterized in that: described excipient is microcrystalline Cellulose.
5. application according to claim 2, is characterized in that: described adjuvant is one or more in disintegrating agent, filler, lubricant or correctives.
6. application according to claim 5, is characterized in that: described disintegrating agent is starch; Described filler is starch or dextrin; Described lubricant is magnesium stearate; Described correctives is lactose.
7. application according to claim 2, is characterized in that: described preparation process acceptable dosage form is hard capsule, tablet or granule.
CN201310395291.4A 2013-09-03 2013-09-03 A kind of arthritic pharmaceutical composition of prevention and therapy and application thereof Active CN103446577B (en)

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CN103721242A (en) * 2014-01-20 2014-04-16 庞会心 New application of pharmaceutical composition in prevention or treatment of osteoporosis
JP6243777B2 (en) * 2014-03-28 2017-12-06 森永乳業株式会社 Hyaluronic acid synthesis accelerator
CN104042893A (en) * 2014-06-30 2014-09-17 邹金林 Traditional Chinese medicine preparation for treating gout and preparation method of traditional Chinese medicine preparation
CN110833547A (en) * 2018-08-15 2020-02-25 广西梧州制药(集团)股份有限公司 Use of pyrazolopyrimidine derivatives for the treatment of rheumatoid arthritis
CN109432388B (en) * 2018-12-25 2021-12-31 上海交大昂立股份有限公司 Composition of probiotics and glucosamine hydrochloride and application of composition in bone joint health

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CN102318794A (en) * 2011-10-19 2012-01-18 郭景龙 Health-care food having calcium supplementing function
CN103083650A (en) * 2013-03-04 2013-05-08 中哈福生物医药科技(上海)有限公司 Composition with bone mineral density addition function, and preparation method as well as application of composition
CN103082297A (en) * 2013-02-05 2013-05-08 山西振东五和健康食品股份有限公司 Bone mineral density increase and joint healthcare food and its preparation method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102318794A (en) * 2011-10-19 2012-01-18 郭景龙 Health-care food having calcium supplementing function
CN103082297A (en) * 2013-02-05 2013-05-08 山西振东五和健康食品股份有限公司 Bone mineral density increase and joint healthcare food and its preparation method
CN103083650A (en) * 2013-03-04 2013-05-08 中哈福生物医药科技(上海)有限公司 Composition with bone mineral density addition function, and preparation method as well as application of composition

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