CN1799603A - Chinese traditional medicine composition for treating rheumatic or rheumatoid disease and preparation method thereof - Google Patents
Chinese traditional medicine composition for treating rheumatic or rheumatoid disease and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicinal composition for treating rheumatic diseases, which comprises active constituents and / or pharmaceutically acceptable carriers, wherein the active constituents comprise rehmannia root 10-30 weight parts, prepared rehmannia root 10-30 weight parts, monkshood 5-25 weight parts, dipsacus root 5-25 parts, levisticum 1-20 weight parts, drynaria 5-25 weight parts, cinnamon twig 1-20 weight parts, ledebouriella root 1-20 weight parts, epimedium 5-25 weight parts, Clematis chinensis 5-25 weight parts, white peony root 2-22 weight parts, anemarrhena rhizome weight parts, Cibotium barometz 5-25 weight parts, safflower 1-20 weight parts, and buck grass 1-20 weight parts.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, specifically, the present invention relates to a kind of treatment rheumatism or rheumatoid Chinese medicine composition and preparation method thereof.
Background technology
Rheumatoid arthritis is a kind of disease type more serious in the arthromyodynia." golden your outline apoplexy merit joint piece of writing " said: " pain in the joints of the extremities health rheumatoid arthritis, swollem feet with falling sensation ...." back physicians from a family for generations family is according to the clinical experience in thousands of years, have joint deformity, enlargement, rigid, Jinsuo roulade, can not bend and stretch, the numbness disease of symptom such as bone destruction is called " rheumatoid arthritis ".The performance of the rheumatoid arthritis of modern medicine, ankylosing spondylitis, knee osteoarthritis, Kaschin-Beck disease meets the category of rheumatoid arthritis.At present, the medicine of various these type of diseases of treatment is arranged on the market, but effect and not obvious.
Summary of the invention
The object of the present invention is to provide a kind of treatment rheumatism or rheumatoid Chinese medicine composition, this medicine good effect, taking convenience, side effect is little.
Treatment rheumatism provided by the present invention or rheumatoid Chinese medicine composition, it is made up of effective ingredient and/or pharmaceutically acceptable carrier, it is characterized in that its contained effective ingredient is made by following raw materials according: Radix Rehmanniae 10-30 weight portion, Radix Rehmanniae Preparata 10-30 weight portion, Radix Aconiti Lateralis Preparata 5-25 weight portion, Radix Dipsaci 5-25 weight portion, Radix Angelicae Pubescentis 1-20 weight portion, Rhizoma Drynariae 5-25 weight portion, Ramulus Cinnamomi 1-20 weight portion, Radix Saposhnikoviae 1-20 weight portion, Herba Epimedii 5-25 weight portion, Spina Gleditsiae 1-20 weight portion, Os Caprae seu Ovis 10-30 weight portion, Radix Clematidis 5-25 weight portion, Radix Paeoniae Alba 2-22 weight portion, Rhizoma Anemarrhenae 5-25 weight portion, Rhizoma Cibotii 5-25 weight portion, Flos Carthami 1-20 weight portion, Herba Lycopodii 1-20 weight portion.
Wherein said Radix Aconiti Lateralis Preparata is a Radix Aconiti Lateralis Preparata; Described Rhizoma Cibotii is for processing Rhizoma Cibotii; Described Rhizoma Drynariae is a Rhizoma Drynariae (processed).
Above-mentioned Chinese medicine composition, it is capsule, tablet, granule.
The present invention also provides a kind of preparation method of above-mentioned Chinese medicinal composition granules, it is characterized in that, this method may further comprise the steps:
(1) get described effective ingredient in proportion and put in the extraction pot and decoct with water 2-3 time, merge extractive liquid, filters, and being evaporated to relative density is the clear paste of 1.1-1.4 (50 ℃);
(2) qinghuo reagent adds adjuvant and makes granule, drying, and granulate, promptly.
Further, the invention provides a kind of preparation method of above-mentioned Chinese medicinal composition granules, it is characterized in that, this method may further comprise the steps:
(1) get described effective ingredient in proportion and put in the extraction pot and decoct with water 2-3 time, merge extractive liquid, filters, and being evaporated to relative density is the clear paste of 1.1-1.2 (50 ℃);
(2) qinghuo reagent, spray drying is got spray drying powder and is added adjuvant and make granule, drying, granulate, promptly.
Wherein said adjuvant is selected from one or more in the following material: dextrin, starch, lactose, Icing Sugar.
In addition, the present invention also provides a kind of preparation method of above-mentioned Chinese medicine composition tablet, it is characterized in that, this method may further comprise the steps:
(1) get the 1-11 weight portion Radix Paeoniae Alba in proportion, the 2-12 weight portion Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae, Radix Rehmanniae Preparata, Rhizoma Drynariae, Rhizoma Cibotii, Os Caprae seu Ovis in proportion and decoct with water 2-3 time, collecting decoction filters, and medicinal liquid is standby;
(3) all the other the medical material full doses and the residue Radix Paeoniae Alba, the Rhizoma Anemarrhenae 12 are distinguished the flavor of totally, decoct with water collecting decoction 2-3 time, filter, filtrate decompression is concentrated into crude drug weight, adds 2-3 by weight and doubly measures ethanol, stir evenly, leave standstill, get supernatant, reclaim ethanol, merge, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃) with above-mentioned medicinal liquid, with above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and adjuvant, mixing, drying, tabletting gets final product.
Wherein said adjuvant is selected from one or more in the following material: starch, dextrin, lactose, low going for hydroxypropyl cellulose, carboxymethyl starch sodium, magnesium stearate, micropowder silica gel, Pulvis Talci.
In addition, the present invention also provides a kind of preparation method of above-mentioned Chinese medicinal composition capsules agent, it is characterized in that, this method may further comprise the steps:
(1) get the 1-11 weight portion Radix Paeoniae Alba in proportion, the 2-12 weight portion Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae, Radix Rehmanniae Preparata, Rhizoma Drynariae, Rhizoma Cibotii, Os Caprae seu Ovis in proportion and decoct with water 2-3 time, collecting decoction filters, and medicinal liquid is standby;
(3) all the other the medical material full doses and the residue Radix Paeoniae Alba, the Rhizoma Anemarrhenae 12 are distinguished the flavor of totally, decoct with water collecting decoction 2-3 time, filter, filtrate decompression is concentrated into crude drug weight, adds 2-3 by weight and doubly measures ethanol, stir evenly, leave standstill, get supernatant, reclaim ethanol, merge, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃) with above-mentioned medicinal liquid, with above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and adjuvant, mixed pelletization, drying, granulate, encapsulated;
Wherein said adjuvant is selected from one or more in the following material: starch, dextrin, lactose, low going for hydroxypropyl cellulose, carboxymethyl starch sodium.
Furthermore, the present invention also provides a kind of preparation method of above-mentioned Chinese medicine composition capsule, it is characterized in that, this method may further comprise the steps:
(1) get described effective ingredient in proportion and put in the extraction pot and decoct with water 2-3 time, merge extractive liquid, filters, and being evaporated to relative density is the clear paste of 1.15-1.20 (50 ℃);
(2) qinghuo reagent, spray drying is got spray drying powder and is added adjuvant, and mixing is encapsulated, promptly;
Wherein said adjuvant is selected from one or more in the following material: micropowder silica gel, magnesium stearate, microcrystalline Cellulose, dextrin, lactose, starch.
Part by weight between each adjuvant does not have special requirement.
Chinese medicine composition provided by the present invention has antiinflammatory, analgesic curative effect, and treatment rheumatism or atrophic diseases are had a significant effect.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.
Embodiment 1: the preparation of granule of the present invention
Take by weighing Radix Rehmanniae 176.4g, Radix Rehmanniae Preparata 176.4g, Radix Aconiti Lateralis Preparata 132.3g, Radix Dipsaci 132.3g, Radix Angelicae Pubescentis 88.2g, Rhizoma Drynariae 132.3g, Ramulus Cinnamomi 88.2g, Radix Saposhnikoviae 88.2g, Herba Epimedii 132.3g, Spina Gleditsiae 88.2g, Os Caprae seu Ovis 176.4g, Radix Clematidis 132.3g, Radix Paeoniae Alba 105.9g, Rhizoma Anemarrhenae 132.3g, Rhizoma Cibotii 132.3g, Flos Carthami 88.2g, Herba Lycopodii 88.2g puts and decocts with water 2 times in the extraction pot, merge extractive liquid,, filter, being evaporated to relative density is the clear paste of 1.1-1.4 (50 ℃); Qinghuo reagent adds dextrin and makes granule, drying, and granulate gets final product.
Embodiment 2:
Take by weighing Radix Rehmanniae 88.2g, Radix Rehmanniae Preparata 264.6g, Radix Aconiti Lateralis Preparata 44.1g, Radix Dipsaci 220.5g, Radix Angelicae Pubescentis 8.82g, Rhizoma Drynariae 132.3g, Ramulus Cinnamomi 176.4g, Radix Saposhnikoviae 8.82g, Herba Epimedii 44.1g, Spina Gleditsiae 88.2g, Os Caprae seu Ovis 88.2g, Radix Clematidis 220.5g, Radix Paeoniae Alba 17.64g, Rhizoma Anemarrhenae 44.1g, Rhizoma Cibotii 132.3g, Flos Carthami 176.4g, Herba Lycopodii 8.82g puts and decocts with water 3 times in the extraction pot, merge extractive liquid,, filter, being evaporated to relative density is the clear paste of 1.1-1.2 (50 ℃); Qinghuo reagent, spray drying is got spray drying powder and is added starch and make granule, drying, granulate gets final product.
Embodiment 3:
Take by weighing Radix Rehmanniae 264.6g, Radix Rehmanniae Preparata 88.2g, Radix Aconiti Lateralis Preparata 220.5g, Radix Dipsaci 44.1g, Radix Angelicae Pubescentis 176.4g, Rhizoma Drynariae 44.1g, Ramulus Cinnamomi 176.4g, Radix Saposhnikoviae 176.4g, Herba Epimedii 220.5g, Spina Gleditsiae 8.82g, Os Caprae seu Ovis 264.6g, Radix Clematidis 44.1g, Radix Paeoniae Alba 194.04g, Rhizoma Anemarrhenae 220.5g, Rhizoma Cibotii 44.1g, Flos Carthami 8.82g, Herba Lycopodii 176.4g puts and decocts with water 3 times in the extraction pot, merge extractive liquid,, filter, being evaporated to relative density is the clear paste of 1.1-1.15 (50 ℃); Qinghuo reagent, spray drying gets that spray drying powder adds lactose, Icing Sugar is made granule, drying, granulate gets final product.
Embodiment 4:
(1) the 110g Radix Paeoniae Alba, the 100g Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae 200g, Radix Rehmanniae Preparata 220g, Rhizoma Drynariae 150g, Rhizoma Cibotii 50g, Os Caprae seu Ovis 100g decocts with water 2 times, collecting decoction filters, medicinal liquid is standby;
(3) Radix Dipsaci 150g, Radix Aconiti Lateralis Preparata 150g, Radix Angelicae Pubescentis 10g, Ramulus Cinnamomi 100g, Radix Saposhnikoviae 200g, Herba Epimedii 50g, Spina Gleditsiae 100g, Radix Clematidis 150g, Flos Carthami 100g, Herba Lycopodii 200g and residue Radix Paeoniae Alba 110g, Rhizoma Anemarrhenae 150g is totally ten two flavors, decoct with water 3 times, collecting decoction, filter, filtrate decompression is concentrated into crude drug weight, adds 2 times of amount ethanol by weight, stirs evenly, leave standstill, get supernatant, reclaim ethanol, merge with above-mentioned medicinal liquid, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃), with the above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome reaches to hang down and goes for hydroxypropyl cellulose mixing, drying, tabletting gets final product.
Embodiment 5:
(1) the 10g Radix Paeoniae Alba, the 120g Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae 100g, Radix Rehmanniae Preparata 300g, Rhizoma Drynariae 50g, Rhizoma Cibotii 50g, Os Caprae seu Ovis 100g decocts with water 3 times, collecting decoction filters, medicinal liquid is standby;
(3) Radix Dipsaci 150g, Radix Aconiti Lateralis Preparata 50g, Radix Angelicae Pubescentis 200g, Ramulus Cinnamomi 10g, Radix Saposhnikoviae 10g, Herba Epimedii 250g, Spina Gleditsiae 200g, Radix Clematidis 50g, Flos Carthami 200g, Herba Lycopodii 10g and residue Radix Paeoniae Alba 10g, Rhizoma Anemarrhenae 120g is totally ten two flavors, decoct with water 2 times, collecting decoction, filter, filtrate decompression is concentrated into crude drug weight, adds 3 times of amount ethanol by weight, stir evenly, leave standstill, get supernatant, reclaim ethanol, merge with above-mentioned medicinal liquid, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃), with the above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and carboxymethyl starch sodium, mixed pelletization, dry, granulate, tabletting gets final product.
Embodiment 6:
(1) the 60g Radix Paeoniae Alba, the 75g Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae 200g, Radix Rehmanniae Preparata 200g, Rhizoma Drynariae 150g, Rhizoma Cibotii 150g, Os Caprae seu Ovis 200g decocts with water 2 times, collecting decoction filters, medicinal liquid is standby;
(3) Radix Dipsaci 150g, Radix Aconiti Lateralis Preparata 150g, Radix Angelicae Pubescentis 100g, Ramulus Cinnamomi 100g, Radix Saposhnikoviae 100g, Herba Epimedii 150g, Spina Gleditsiae 100g, Radix Clematidis 150g, Flos Carthami 100g, Herba Lycopodii 100g and residue Radix Paeoniae Alba 60g, Rhizoma Anemarrhenae 75g is totally ten two flavors, decoct with water 3 times, collecting decoction, filter, filtrate decompression is concentrated into crude drug weight, adds 2 times of amount ethanol by weight, stirs evenly, leave standstill, get supernatant, reclaim ethanol, merge with above-mentioned medicinal liquid, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃), with the above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and starch, dextrin, mixing, drying, tabletting gets final product.
Embodiment 7:
(1) the 10g Radix Paeoniae Alba, the 120g Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae 100g, Radix Rehmanniae Preparata 300g, Rhizoma Drynariae 50g, Rhizoma Cibotii 50g, Os Caprae seu Ovis 100g decocts with water 2 times, collecting decoction filters, medicinal liquid is standby;
(3) Radix Dipsaci 150g, Radix Aconiti Lateralis Preparata 50g, Radix Angelicae Pubescentis 200g, Ramulus Cinnamomi 10g, Radix Saposhnikoviae 10g, Herba Epimedii 250g, Spina Gleditsiae 200g, Radix Clematidis 50g, Flos Carthami 200g, Herba Lycopodii 10g and residue Radix Paeoniae Alba 10g, Rhizoma Anemarrhenae 120g is totally ten two flavors, decoct with water 2 times, collecting decoction, filter, filtrate decompression is concentrated into crude drug weight, adds 3 times of amount ethanol by weight, stir evenly, leave standstill, get supernatant, reclaim ethanol, merge with above-mentioned medicinal liquid, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃), with the above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and starch, carboxymethyl starch sodium, mixed pelletization, dry, granulate, encapsulated, get final product.
Embodiment 8:
(1) take by weighing Radix Rehmanniae 264.6g, Radix Rehmanniae Preparata 88.2g, Radix Aconiti Lateralis Preparata 220.5g, Radix Dipsaci 44.1g, Radix Angelicae Pubescentis 8.82g, Rhizoma Drynariae 220.5g, Ramulus Cinnamomi 8.82g, Radix Saposhnikoviae 176.4g, Herba Epimedii 44.1g, Spina Gleditsiae 88.2g, Os Caprae seu Ovis 88.2g, Radix Clematidis 220.5g, Radix Paeoniae Alba 17.64g, Rhizoma Anemarrhenae 44.1g, Rhizoma Cibotii 132.3g, Flos Carthami 176.4g, Herba Lycopodii 8.82g puts and decocts with water 3 times in the extraction pot, merge extractive liquid,, filter, being evaporated to relative density is the clear paste of 1.15-1.20 (50 ℃);
(2) qinghuo reagent, spray drying is got spray drying powder and is added micropowder silica gel, and mixing is encapsulated, gets final product.
Embodiment 9:
(1) take by weighing Radix Rehmanniae 200g, Radix Rehmanniae Preparata 200g, Radix Aconiti Lateralis Preparata 150g, Radix Dipsaci 150g, Radix Angelicae Pubescentis 100g, Rhizoma Drynariae 150g, Ramulus Cinnamomi 100g, Radix Saposhnikoviae 100g, Herba Epimedii 150g, Spina Gleditsiae 100g, Os Caprae seu Ovis 200g, Radix Clematidis 150g, Radix Paeoniae Alba 120g, Rhizoma Anemarrhenae 150g, Rhizoma Cibotii 150g, Flos Carthami 100g, Herba Lycopodii 100g puts and decocts with water 3 times in the extraction pot, merge extractive liquid,, filter, being evaporated to relative density is the clear paste of 1.15-1.20 (50 ℃);
(2) qinghuo reagent, spray drying is got spray drying powder and is added magnesium stearate, microcrystalline Cellulose, and mixing is encapsulated, gets final product.
Experimental example 1:
Material and method
2.1 animal:
Ages in Wistar rat 8 week, body weight 180-200g, in age in Kunming mouse 6-7 week, body weight 18-22g is provided by animal housing of Shenyang Pharmaceutical University, the animal random packet is placed on temperature 24-25 ℃, relative humidity 50-70%, in the sound damping animal housing, fluorescent lamp lighting, 08:00-20:00h is an illumination period, all the other time dark.10 one cage group supports of animal per are freely ingested, are drunk water.Adapt to above-mentioned environment and be used for experiment after one week.
2.2 be subjected to test product and reagent
Tried thing: granule dosage form of the present invention, granule is a brown ceramic powder, faces the time spent to be made into outstanding agent for examination with distilled water.ZHENGQINGFENGTONGNING PIAN: lot number is provided by Baiyunshan Qingzheng Pharmaceutical Co., Ltd: 9903132, glacial acetic acid: Dongxing, Shenyang City chemical reagent work, lot number: 011110.Indomethacin: Linfen, Shanxi Province biochemical-pharmaceutical factory, lot number: 020411302.Sodium sulfide: Tianjin reagent six factories, lot number: 920306.Bacillus calmette-guerin vaccine: Changchun institute of Biological Products, lot number: 010603.Lanoline: Beijing extensive and profound in meaning star biotechnology responsibility company limited, lot number: 000512.Liquid paraffin: Dongxing, Shenyang City chemical reagent work, lot number: 020805.Hydrocortisone: Shenyang No. 1 Pharmaceutical Factory, lot number: 010605.
2.3 instrument
The small-sized volume measuring instrument of MTC-9802: produce by Shenyang Pharmaceutical University.JN-B type precision torsion balance: Shanghai Second Balance Factory, DT-100 balance: Beijing Optical Instrument Factory.JB-2 type constant temperature blender with magnetic force: Shanghai thunder magnetic instrument plant.
2.4 experimental technique
2.4.1 granule of the present invention is to the influence of rat assist agent arthritis
60 of rats, ♀ ♂ half and half divides 6 groups at random by body weight. and first group of 10 rat is the normal control group, in its right back sufficient sole of the foot intradermal injection normal saline 0.1ml/ only; The complete freund adjuvant 0.1ml/ of the right back sufficient sole of the foot intradermal injection of all the other rats only, before the adjuvant injection and the 3h of injection back, 18h measured respectively and respectively to organize sufficient volume below the right ankle of the rat joint in 3,6,9,12,15,18,21 days.And cause the secondary reactions of the 10th day opening entry animal in scorching back in adjuvant, did the sxemiquantitative record (0 minute: do not have red and swollen with 5 grades of point systems; 1 minute: little toe joint was swollen slightly; 2 minutes: toe joint and pedal swelling; 3 minutes: the following foot swelling of ankle joint; 4 minutes: comprise the whole sufficient pawl swelling of ankle joint), per 3 days records are once.The 6th day rat begins administration behind the Yu Zhiyan, wherein, and first and second group rat oral gavage distilled water 10ml/kg, the 3rd to five group of rat oral gavage granule 0.38,0.76 of the present invention and 1.52g/kg, the 6th group of rat oral gavage ZHENGQINGFENGTONGNING PIAN 1.52g/kg.1 time/day, continuous 7 days, inject administration 7 days in the same way again in the 19th day in adjuvant, experimental session is observed the body weight of rat, and the situation of inflammatory reaction is estimated drug effect.
2.4.2 granule of the present invention is to the influence of mice delayed hypersensitive reaction
Get 50 of mices, ♂ ♀ half and half divides 5 groups at random by body weight, is respectively the blank group, positive controls. three dosage groups of granule of the present invention, blank group mouse stomach distilled water 10ml/kg, positive controls mouse stomach hydrocortisone 20mg/kg.Three dosage groups of granule of the present invention are irritated stomach granule 0.5,1.0 of the present invention and 2.0g/kg respectively.Be administered once every day, successive administration 7 days.After the last administration second day, the mouse web portion depilation, and be coated with dinitrochlorobenzene (DNCB) ethanol liquid sensitization (5% in depilation place, 10 μ l/ are only). after the sensitization the 7th day, being coated with the inside and outside auricle of auris dextra with 5%DNCB ethanol liquid (20 μ l/ are only) attacks. attack back 24h, mice is put to death in dislocation, lays left and right sides ear same area auricle with the device that fans the air of diameter 6mm, and weighs. and calculate the swelling degree.
Swelling degree=auris dextra auricle weight-left ear auricle is heavy
2.4.3 granule xylol of the present invention causes the influence of mice ear
Get 50 of mices, ♂ ♀ half and half divides 5 groups at random by body weight, is respectively the blank group, positive controls. three dosage groups of granule of the present invention, blank group mouse stomach distilled water 10ml/kg, positive controls mouse stomach indomethacin 15mg/kg.Three dosage groups of granule of the present invention mice is irritated stomach granule 0.5,1.0 of the present invention and 2.0g/kg respectively.Be administered once every day, successive administration 7 days.Behind last administration 1h, 30 μ l dimethylbenzene are applied to the mouse right ear two sides cause inflammation, cause the 45min dislocation of scorching back and put to death mice, lay left and right sides ear same area auricle with the device that fans the air of diameter 6mm, weigh. and calculate the swelling degree.
Swelling degree=auris dextra auricle weight-left ear auricle is heavy
2.4.4 granule of the present invention causes the influence of pain to the mice chemical stimulation
50 of mices, ♀ ♂ half and half divides 5 groups at random, and first group is the blank group, irritates stomach distilled water 10ml/kg, second group of positive matched group, the oral indomethacin 15mg/kg of mice.The three-five group of mice irritated stomach granule 0.5,1.0 of the present invention and 2.0g/kg respectively.After each organized mice administration 1h, lumbar injection 0.6% acetum 0.2ml/ only respectively.Each Mus is turned round the body number of times in the observed and recorded 15min, carries out statistical procedures.
2.4.5 the preparation of freund adjuvant:
After the anhydrous lanolin heating and melting, cooling is got 5ml in mortar slightly, the dropping liquid paraffin body 10ml dropwise while grinding, and 70 ℃ of water-baths are heat altogether, abundant mixing, autoclaving (8 pounds, 60 minutes).The above-mentioned anhydrous lanolin and the liquid paraffin mixed liquor 6ml that get after the sterilization place mortar, get bacillus calmette-guerin vaccine 60mg/ bottle, use a small amount of physiological saline solution, drip bacillus calmette-guerin vaccine while grinding in mortar, fully grind mixing and get the complete freund adjuvant that concentration is 10mg/ml.
2.5. statistics
Each is organized between the group of data and relatively uses the t inspection statistics.
Three experimental results
3.1 granule of the present invention is to the influence of rat assist agent arthritis
Inject complete freund adjuvant and can cause the direct inflammatory reaction of rat injection site, thereafter also can produce the inflammatory reaction of a series of secondary, comprise the swelling of non-injection acra, the reactions such as arthritis tuberosity that afterbody, ear occur, this series reaction of observed and recorded can be used for evaluate efficacy.
Attack the direct inflammatory reaction that causes the rat injection site for complete freund adjuvant: normal rat is more stable at experimental session foot volume, the just growth of follower body weight, and some becomes big sufficient volume.The rat foot begins swelling after injecting complete freund adjuvant, and with the prolongation of moulding time, the aggravation of the degree of swelling.After granule of the present invention was given rat oral gavage, the swelling that adjuvant is caused had certain inhibitory action.And strengthen with the dosage of medicine, (table 1) strengthened in the effect of adjuvant-induced arthritis.
Complete freund adjuvant is attacked the preventive effect that causes the inflammatory reaction of rat secondary: inject administration in the 6th to the 13 day in adjuvant, and during the administration and detect the secondary inflammatory reaction of rat after the administration, by table 2 data as can be seen: normal rat secondary reactions do not occur at experimental session.After injecting complete freund adjuvant, rat shows left foot swelling, left and right pawl swelling, tuberosity appears in afterbody, ear, injects in adjuvant and can see some secondary reactions signs on the tenth day, to adjuvant injection 13 days, it is fairly obvious that secondary reactions becomes, wherein the secondary reactions of model control group performance is more obvious, and granule of the present invention causes that to adjuvant the generation of secondary reactions has certain inhibitory action (table 2) after giving rat oral gavage.
Table 1 granule of the present invention is to the influence of adjuvant-induced arthritis
| Group | Dosage (g/kg) | Before the moulding | 3h after the moulding | 18h | 3d | 6d (sufficient volume ml) |
| Normal control group arthritis matched group invention group invention group invention group ZHENGQINGFENGTONGNING PIAN | - - 0.38 0.76 1.52 1.52 | 1.44±0.08 1.35±0.07 1.40±0.09 1.40±0.09 1.41±0.11 1.43±0.08 | 1.46±0.09 1.92±0.10 1.89±0.21 1.94±0.12 1.88±0.18 1.89±0.18 | 1.45±0.09 2.22±0.13 # 2.18±0.22 2.34±0.23 2.24±0.20 2.11±0.15 | 1.52±0.09 2.43±0.21 # 2.51±0.23 2.39±0.28 2.31±0.30 2.23±0.20 | 1.55±0.08 2.60±0.29 # 2.25±0.20 2.38±0.35 2.04±0.24 * 1.96±0.19 * |
| Group | Dosage (g/kg) | 9d after the moulding | 12d | 15d | 18d | 21d (sufficient volume ml) |
| Normal control group arthritis matched group invention group invention group invention group ZHENGQINGFENGTONGNING PIAN | - - 0.38 0.76 1.52 1.52 | 1.61±0.07 2.51±0.23 # 2.28±0.32 2.32±0.30 2.13±0.16 * 2.02±0.17 * | 1.67±0.07 2.61±0.38 # 2.43±0.41 2.45±0.43 2.41±0.17 1.96±0.21 * | 1.73±0.08 2.64±0.37 # 2.41±0.48 2.65±0.40 2.39±0.28 * 2.00±0.11 ** | 1.76±0.08 2.90±0.37 # 2.49±0.18 * 2.84±0.38 2.33±0.32 ** 1.93±0.11 ** | 1.80±0.11 3.06±0.30 # 2.55±0.27 * 2.70±0.45 * 2.22±0.21 ** 1.88±0.12 ** |
N=10, with the normal control group than #p＜0.01.With arthritis matched group ratio
*P＜0.05,
*P＜0.01.
Complete freund adjuvant is attacked the therapeutical effect that causes the inflammatory reaction of rat secondary: inject in adjuvant and began medication once more on the 19th day, and during the administration and detect the secondary inflammatory reaction of rat after the administration, by the 3rd to six column data of table 2 as can be seen: normal rat secondary reactions still do not occur at experimental session.Inject rat left side foot swelling behind the complete freund adjuvant, left and right pawl swelling, afterbody, ear secondary reactions such as tuberosity occurs and show more outstandingly.Wherein the secondary reactions of model control group performance is obvious, and after granule of the present invention was given rat oral gavage, the secondary reactions that adjuvant is caused had remarkable inhibitory action (table 2).
Table 2 granule of the present invention is to the influence of adjuvant arthritis rats secondary reactions
| Group | Dosage (g/kg) | 10d after the moulding | 13d | 16d (mark) |
| Normal control group model matched group granule of the present invention granule of the present invention granule ZHENGQINGFENGTONGNING PIAN of the present invention | - - 0.38 0.76 1.52 1.52 | 0 2.5±1.4 1.2±0.6 * 0.7±0.7 * 0.7±0.7 ** 1.2±0.8 * | 0 4.4±1.2 2.3±0.9 * 1.6±0.7 * 0.9±0.7 ** 2.4±1.2 * | 0 5.0±1.1 3.1±1.4 * 2.1±1.0 ** 1.3±0.7 ** 2.9±1.0 ** |
| Group | Dosage (g/kg) | 19d after the moulding | 22d | 25d (mark) |
| Normal control group model matched group granule of the present invention granule of the present invention granule ZHENGQINGFENGTONGNING PIAN of the present invention | - - 0.38 0.76 1.52 1.52 | 0 5.4±1.1 4.0±1.2 * 3.0±0.8 ** 2.0±1.3 ** 3.2±0.6 ** | 0 5.7±0.9 4.7±1.2 * 3.0±0.7 ** 0.7±1.3 ** 3.2±0.8 ** | 0 6.1±1.3 5.0±1.1 * 1.9±1.0 ** 0.5±0.7 ** 2.9±1.1 ** |
N=10 is with the model control group ratio
*P＜0.05.
**p＜0.01。
3.2 granule of the present invention is to the influence to the mice delayed hypersensitive reaction
The formation of rheumatic arthritis and antigen antibody complex are in the deposition of glue unit tissue, and then the reaction that causes inflammation is relevant.Ideal antarthritic should suppress tissue injury, the reaction that reduces inflammation, and therefore experiment adopts dinitrochlorobenzene as immunologic stimulant, estimates the influence of granule of the present invention to delayed hypersensitive reaction.Dinitrochlorobenzene makes animal produce allergy as a kind of immunologic stimulant.Normal mouse ear accepts dinitrochlorobenzene smear after, the auricle of mice is swollen with, under fire the weight difference of ear and the identical auricle of irriate ear not is very remarkable in control group mice.Granule of the present invention significantly reduces the weight difference of the auricle of mice, illustrates that granule of the present invention has certain inhibitory action to delayed hypersensitive reaction, can alleviate the inflammatory reaction degree (table 3) of irriate ear.
Table 3 granule of the present invention is to the influence of mice delayed hypersensitive reaction
| Group | Dosage (g/kg) | Swelling degree (mg) |
| Matched group hydrocortisone granule of the present invention granule of the present invention granule of the present invention | - 0.02 0.5 1.0 2.0 | 1.78±0.31 0.63±0.18 * 1.36±0.28 1.05±0.46 * 0.93±0.25 ** |
N=10 is with the matched group ratio
*P＜0.05.
**p＜0.01。
3.3 granule xylol of the present invention causes the influence of mice ear
After normal mouse was accepted dimethylbenzene and smeared, tangible inflammatory reaction appearred in the remarkable swelling in contact site.Granule xylol of the present invention causes mice ear inhibitory action, and presents certain dose-response relationship (table 4).
Table 4 granule of the present invention is to the influence of mice caused by dimethylbenzene xylene ear swelling
| Group | Dosage (g/kg) | Number of animals | Swelling degree (mg) |
| Matched group indomethacin granule of the present invention granule of the present invention granule of the present invention | - 0.015 0.5 1.0 2.0 | 10 10 10 10 10 | 1.08±0.23 0.64±0.24 ** 0.85±0.30 0.79±0.26 * 0.79±0.24 * |
With the matched group ratio
*P＜0.05,
*P＜0.01.
3.4 granule of the present invention causes the influence of pain to the mice chemical stimulation
The acetic acid lumbar injection makes animal produce pain as a kind of chemical stimulation, and this model class is similar to Encelialgia or arthralgic situation.After normal mouse was accepted acetic acid injection, painful as repeatedly to turn round body, that significantly reduces mice after the administration of positive drug indomethacin turned round the body number of times.Granule of the present invention also makes the body number of times of turning round of mice significantly reduce, and relatively there were significant differences with matched group, and be certain dose-response relationship (table 5).
Table 5 granule of the present invention is to the influence of mouse writhing
| Group | Dosage (g/kg) | Number of animals | Turn round body number of times (inferior) |
| Normal control group indomethacin granule of the present invention granule of the present invention granule of the present invention | - 0.015 0.5 1.0 2.0 | 10 10 10 10 10 | 38.5±6.7 12.0±5.2 ** 24.4±3.5 ** 15.6±3.6 ** 14.7±3.9 ** |
N=10 is with normal control group ratio
*P＜0.01.
Four, brief summary
By the adjuvant arthritis animal model, chemical inflammatory model, chemical substance cause the effects of animal model investigation granule of the present invention aspect antiinflammatory, analgesia and treatment rheumatic or rheumatoid arthritis such as pain.The result shows that granule of the present invention has significant inhibitory effect to adjuvant-induced arthritis.Can reduce the mouse writhing number of times that acetic acid causes, xylol causes the mice inflammatory reaction remarkable inhibitory action, and the delayed hypersensitive reaction that dinitrochlorobenzene is brought out has certain inhibitory action.Point out granule of the present invention to have tangible antiinflammatory and analgesic activity.
Claims (10)
1, a kind of treatment rheumatism or rheumatoid Chinese medicine composition, it is made up of effective ingredient and/or pharmaceutically acceptable carrier, it is characterized in that its contained effective ingredient is made by following raw materials according: Radix Rehmanniae 10-30 weight portion, Radix Rehmanniae Preparata 10-30 weight portion, Radix Aconiti Lateralis Preparata 5-25 weight portion, Radix Dipsaci 5-25 weight portion, Radix Angelicae Pubescentis 1-20 weight portion, Rhizoma Drynariae 5-25 weight portion, Ramulus Cinnamomi 1-20 weight portion, Radix Saposhnikoviae 1-20 weight portion, Herba Epimedii 5-25 weight portion, Spina Gleditsiae 1-20 weight portion, Os Caprae seu Ovis 10-30 weight portion, Radix Clematidis 5-25 weight portion, Radix Paeoniae Alba 2-22 weight portion, Rhizoma Anemarrhenae 5-25 weight portion, Rhizoma Cibotii 5-25 weight portion, Flos Carthami 1-20 weight portion, Herba Lycopodii 1-20 weight portion.
2, Chinese medicine composition as claimed in claim 1 is characterized in that, described Radix Aconiti Lateralis Preparata is a Radix Aconiti Lateralis Preparata; Described Rhizoma Cibotii is for processing Rhizoma Cibotii; Described Rhizoma Drynariae is a Rhizoma Drynariae (processed).
3, Chinese medicine composition as claimed in claim 1 or 2, it is capsule, tablet, granule.
4, the preparation method of Chinese medicinal composition granules as claimed in claim 1 or 2 is characterized in that, this method may further comprise the steps:
(1) get described effective ingredient in proportion and put in the extraction pot and decoct with water 2-3 time, merge extractive liquid, filters, and being concentrated into relative density is the clear paste of 1.1-1.4 (50 ℃);
(2) qinghuo reagent adds adjuvant and makes granule, drying, and granulate, promptly.
5, preparation method as claimed in claim 4 is characterized in that, this method may further comprise the steps:
(1) get described effective ingredient in proportion and put in the extraction pot and decoct with water 2-3 time, merge extractive liquid, filters, and being evaporated to relative density is the clear paste of 1.1-1.2 (50 ℃);
(2) qinghuo reagent, spray drying is got spray drying powder and is added adjuvant and make granule, drying, granulate, promptly.
6, preparation method as claimed in claim 4 is characterized in that, described adjuvant is selected from one or more in the following material: dextrin, starch, Icing Sugar, lactose.
7, the preparation method of Chinese medicine composition tablet as claimed in claim 1 or 2 is characterized in that, this method may further comprise the steps:
(1) get the 1-11 weight portion Radix Paeoniae Alba in proportion, the 2-12 weight portion Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae, Radix Rehmanniae Preparata, Rhizoma Drynariae, Rhizoma Cibotii, Os Caprae seu Ovis in proportion and decoct with water 2-3 time, collecting decoction filters, and medicinal liquid is standby;
(3) all the other the medical material full doses and the residue Radix Paeoniae Alba, the Rhizoma Anemarrhenae 12 are distinguished the flavor of totally, decoct with water collecting decoction 2-3 time, filter, filtrate decompression is concentrated into crude drug weight, adds 2-3 by weight and doubly measures ethanol, stir evenly, leave standstill, get supernatant, reclaim ethanol, merge, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃) with above-mentioned medicinal liquid, with above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and adjuvant, mixing, drying, tabletting gets final product.
8, preparation method as claimed in claim 7 is characterized in that, described adjuvant is selected from one or more in the following material: starch, dextrin, lactose, low going for hydroxypropyl cellulose, carboxymethyl starch sodium, magnesium stearate, micropowder silica gel, Pulvis Talci.
9, the preparation method of Chinese medicinal composition capsules agent as claimed in claim 1 or 2 is characterized in that, this method may further comprise the steps:
(1) get the 1-11 weight portion Radix Paeoniae Alba in proportion, the 2-12 weight portion Rhizoma Anemarrhenae is pulverized, and crosses the 100-200 mesh sieve;
(2) get Radix Rehmanniae, Radix Rehmanniae Preparata, Rhizoma Drynariae, Rhizoma Cibotii, Os Caprae seu Ovis in proportion and decoct with water 2-3 time, collecting decoction filters, and medicinal liquid is standby;
(3) all the other the medical material full doses and the residue Radix Paeoniae Alba, the Rhizoma Anemarrhenae 12 are distinguished the flavor of totally, decoct with water collecting decoction 2-3 time, filter, filtrate decompression is concentrated into crude drug weight, adds 2-3 by weight and doubly measures ethanol, stir evenly, leave standstill, get supernatant, reclaim ethanol, merge, be evaporated to the clear paste of relative density 1.1-1.4 (50 ℃) with above-mentioned medicinal liquid, with above-mentioned clear paste and the Radix Paeoniae Alba, Common Anemarrhena Rhizome and adjuvant, mixing, drying, encapsulated;
Wherein said adjuvant is selected from one or more in the following material: starch, dextrin, lactose, low going for hydroxypropyl cellulose, carboxymethyl starch sodium.
10, the preparation method of Chinese medicine composition capsule as claimed in claim 1 or 2 is characterized in that, this method may further comprise the steps:
(1) get described effective ingredient in proportion and put in the extraction pot and decoct with water 2-3 time, merge extractive liquid, filters, and being evaporated to relative density is the clear paste of 1.10-1.20 (50 ℃);
(2) qinghuo reagent, spray drying is got spray drying powder and is added adjuvant, and mixing is encapsulated, promptly;
Wherein said adjuvant is selected from one or more in the following material: lactose, micropowder silica gel, magnesium stearate, microcrystalline Cellulose, dextrin, starch.
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| CNB200510011140XA CN100363043C (en) | 2005-01-07 | 2005-01-07 | Chinese traditional medicine composition for treating rheumatic or rheumatoid disease and preparation method thereof |
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| CNB200510011140XA CN100363043C (en) | 2005-01-07 | 2005-01-07 | Chinese traditional medicine composition for treating rheumatic or rheumatoid disease and preparation method thereof |
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| CN100363043C CN100363043C (en) | 2008-01-23 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103816382A (en) * | 2012-11-19 | 2014-05-28 | 董根荣 | Medicine for treating headache and preparation method thereof |
| CN113855760A (en) * | 2021-10-15 | 2021-12-31 | 张广才 | Health-preserving health-care preparation |
| CN114209770A (en) * | 2021-12-30 | 2022-03-22 | 辽宁上药好护士药业（集团）有限公司 | Medicinal composition for treating early rheumatoid arthritis and preparation method and application thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1374118A (en) * | 2002-03-22 | 2002-10-16 | 通化利民药业有限责任公司 | Chinese medicine for treating ache tendon and vessel and numb limbs and its prepn process |
| CN1457815A (en) * | 2002-05-17 | 2003-11-26 | 朱桓毅 | Capsule for relaxing muscles and tendons and activating flow of qi and blood channels and collaterals, and expelling wind |
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2005
- 2005-01-07 CN CNB200510011140XA patent/CN100363043C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103816382A (en) * | 2012-11-19 | 2014-05-28 | 董根荣 | Medicine for treating headache and preparation method thereof |
| CN113855760A (en) * | 2021-10-15 | 2021-12-31 | 张广才 | Health-preserving health-care preparation |
| CN114209770A (en) * | 2021-12-30 | 2022-03-22 | 辽宁上药好护士药业（集团）有限公司 | Medicinal composition for treating early rheumatoid arthritis and preparation method and application thereof |
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| CN100363043C (en) | 2008-01-23 |
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