CN1868502A - Medicine composition used for treating rheumatoid arthritis, and its prepn. method - Google Patents
Medicine composition used for treating rheumatoid arthritis, and its prepn. method Download PDFInfo
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- CN1868502A CN1868502A CN 200510200292 CN200510200292A CN1868502A CN 1868502 A CN1868502 A CN 1868502A CN 200510200292 CN200510200292 CN 200510200292 CN 200510200292 A CN200510200292 A CN 200510200292A CN 1868502 A CN1868502 A CN 1868502A
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Abstract
A Chinese medicine for treating rheumatoid arthritis is prepared from 6 Chinese-medicinal materials including notopterygium root, pubescent angelica root, tetrandra root, red sage root, etc. Its preparing process is also disclosed.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of pharmaceutical composition that is used for the treatment of rheumatic arthralgia and preparation method thereof.
Background technology
Rheumatoid arthritis (being called for short RA) is a kind of chronic autoimmune disease that has a strong impact on health, also be a kind of commonly encountered diseases, be regarded as one of five big diseases (cardiovascular diseases, arthritis, Alzheimer, cancer and AIDS) that influence human health.Millions of patients is forfeiture live and work ability because suffering from this disease.According to the statistical result that World Health Organization (WHO) provides, the whole world has 1% people to suffer from rheumatoid arthritis approximately, and wherein China patient just reaches more than 1,000 ten thousand people.
The treatment means of present rheumatoid arthritis is comparatively limited, and the medicine that is used for the treatment of rheumatoid arthritis clinically comprises chemical medicine and Chinese patent medicine, and wherein chemical medicine mainly comprises three major types: one is NSAID (non-steroidal anti-inflammatory drug); Two is adrenocortical hormone; Three is the antirheumatic that acts on slowly.The above medicine all has side effect in various degree; Though Chinese medicine is also producing effect aspect the rheumatic arthralgia in treatment, be used for the treatment of clinically that majority all contains Semen Strychni in the Chinese patent medicine of rheumatic arthralgia, and Semen Strychni there is bigger toxicity, should not take for a long time.The object of the present invention is to provide a kind of side effect little and the Chinese medicine composition of better curative effect arranged aspect the rheumatoid arthritis in treatment.Clinical research checking by pharmacological effect and new drug proves that Chinese medicine composition of the present invention has clinical efficacy preferably to the rheumatic arthralgia of cold dampness accumulation pattern.The capsule of Chinese medicine composition of the present invention by the clinical verification of new drug, has been a new Chinese medicine by state approval, by examining of relevant hygiene department of country.Because of this product determined curative effect clinically,, favorable economic benefit and social benefit have been obtained so market is better on the market.Up to the present, pharmaceutical composition of the present invention and preparation thereof do not have disclosed relevant report.
Summary of the invention
The object of the present invention is to provide a kind of side effect little, can take for a long time, the eutherapeutic particularly Chinese medicine composition of cold dampness accumulation pattern rheumatoid arthritis of rheumatic arthralgia that is used for the treatment of.
The inventor is through research repeatedly, and the checking repeatedly by animal and clinical trial, draws the ratio range and the best proportioning of each crude drug finally, thereby has finished the present invention.
Drug main of the present invention will be made up of following a few flavor medicines: Caulis Erycibes 5-7 part, Rhizoma Et Radix Notopterygii 3-5 part, Radix Angelicae Pubescentis 5-7 part, Radix Stephaniae Tetrandrae 3-5 part, Rhizoma Corydalis 3-5 part, Radix Salviae Miltiorrhizae 3-5 part.
Medicine preferred group of the present invention is proportional to be: 311 parts of Caulis Erycibess, 222 parts of Rhizoma Et Radix Notopterygiis, 311 parts of Radix Angelicae Pubescentiss, 222 parts of 222 parts of Rhizoma Corydalis of Radix Stephaniae Tetrandrae, 222 parts of Radix Salviae Miltiorrhizaes.
The present invention also aims to provide a kind of preparation method of aforementioned pharmaceutical compositions.
Pharmaceutical composition of the present invention can adopt on the pharmaceutics conventional method to make various oral formulations, and as capsule, tablet, granule, drop pill, concentrated pill, oral liquid, preferred dosage form is a capsule.
Capsule preparation method thereof of the present invention is as follows:
Crude drug adds 50%-90% ethanol heating extraction 2-3 time, and merge extractive liquid, filters, filtrate recycling ethanol, and concentrating under reduced pressure becomes thick paste, cold drying becomes dry extract, pulverizes, and obtains medicated powder, then medicated powder is inserted softgel shell, makes capsule.
Through step screening, obtaining optimum pre-treating technology is: crude drug adds 70% ethanol heating extraction 3 times, and the 1st, 2 time each 1.5 hours, the 3rd time 1 hour, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is the 1.30-1.35 thick paste when being evaporated to 60 ℃, cold drying becomes dry extract, pulverize, obtain medicated powder, and medicated powder is inserted softgel shell make capsule.
The inventor also once attempted adding carboxymethyl starch sodium and an amount of magnesium stearate and micropowder silica gel in medicated powder, behind the mix homogeneously, compacting in flakes; Also can add an amount of dextrin and sucrose, be pressed into granule.From realizing that the result can judge, use above medicated powder, select adjuvant commonly used in the pharmaceutics, just can make various oral formulations commonly used; And the adjuvant that uses also is not limited to carboxymethyl starch sodium, magnesium stearate, micropowder silica gel, dextrin and sucrose, as long as can reach same effect, all in protection domain of the present invention.
The specific embodiment:
Medicine of the present invention has expelling wind and removing dampness, antalgic, and promoting blood circulation to remove obstruction in the collateral, immunoregulation effect are used for the treatment of diseases such as rheumatic arthritis, rheumatoid arthritis clinically and have better curative effect.Below by concrete experimental example and clinical case curative effect of the present invention is described.Used medicine rattan network rather is to make by optimal proportion of the present invention and best preparation method in the experiment.
The expelling wind and removing dampness effect
The rattan network is rather to the antiinflammatory action of rat assist agent arthritis
Trial drug
Aspirin: commercially available, as positive control drug, be made into suspension with Sal water during experiment and use in this experiment.Producer: Sigma company;
Bacillus calmette-guerin vaccine: Shanghai Vaccine and Serum Institute, 50 μ g/ prop up, and are made into suspension with paraffin oil during experiment and use.Lot number 930501;
Saxol: medical, autoclaving during use, Da Chang chemical plant, Shanghai, lot number 830510.
Be subjected to the reagent thing
Title and character rattan network are peaceful, brown ceramic powder
This school plant teaching and research room of the unit of providing
Lot number 930423
Content 1 gram powder is equivalent to 5 gram crude drugs
Solvent and compound method are made into the suspension of variable concentrations with normal saline
Animal
The SD rat is provided by Shanghai Family Planning Science and Research Institute.'s animal center.Quality certification No.0000189.
Body weight 200～280g
Sex is male
Several 10 of each treated animal
Test method is selected the adjuvant-induced arthritis method
40 of test key step rats are divided into 4 groups, the right back foot pad of every Mus id Fu Shi Freund's complete adjuvant (the bacillus calmette-guerin vaccine 10mg/ml of deactivation) 0.5ml.Each organizes sensitization gastric infusion immediately simultaneously, successive administration 7 days, every day 1 time.With drainage before sensitization and after the sensitization (after the sensitization every 1 day) to measure rat left and right sides metapedes pad long-pending, measure to the sensitization 21 days.
The animals administer afterreaction
Observation index, calculates also and respectively organizes the swelling rate as the arthroncus degree with the variation of left and right sufficient displacement before and after the administration, simultaneously, notices whether rat tails the ring-type tuberosity takes place.
After the observing time sensitization 21 days
2 dosage groups are established in the dosage setting, and dosage is respectively 504 (50.4%) and 1008 (10.08%) mg/kg.
Medication
Approach ig, 1ml/100g
Administration number of times administration 7 days, every day 1 time
Experimental control
The blank normal saline
Positive control aspirin 100mg/Kg
Ring-type tuberosity situation takes place and sees Table 1 in each group of result of the test.From experimental result as seen, the swelling that rat causes scorching back 48 hours right foots is peaking, and the back took a turn for the better in 9 days gradually, swelling once again again in the 11st day.It was to parapodum (promptly the left side of injection adjuvant is insufficient) beginning swelling since the 7th day.Outstanding " arthritis " lesser tubercle appears in indivedual rat tailses about the 13rd day.In the administration group, low dose of (540mg/Kg/ day), be equivalent to 9 times of the clinical consumption of people) the rat assist agent arthritis primary affection there is inhibitory action, polyarthritis also there is inhibitory action; Heavy dose of (1008mg/Kg/ day is equivalent to 18 times of people's clinical dosage) is the most obvious, promptly the primary affection and the polyarthritis person of rat assist agent arthritis is had very obvious suppression effect from the beginning medication.Show that the increase inhibitory action along with the peaceful dosage of rattan network shows more obviously.Compare with aspirin, the effect of the aspirin of 100mg/Kg/ day is similar to the peaceful effect of the rattan network of 1008mg/Kg/ day.
Table 1 rattan network is rather to the nodular influence of rat assist agent arthritis ring-type
| Group | Dosage (mg/Kg) | Number of animals | Tuberosity generation number of animals | Tuberosity incidence rate (%) |
| The peaceful rattan network of normal saline aspirin rattan network is peaceful | 10ml/Kg 100 504 1008 | 10 10 10 10 | 6 0 2 2 | 60 0 20 20 |
Conclusion (of pressure testing): promptly there is certain inhibitory action peaceful 504mg/Kg/ day of rattan network (be equivalent to the clinical consumption of people 9 times) to primary affection in the rat assist agent arthritis model and the performance of Secondary cases chronic arthritis, and increase and inhibitory action is obvious with dosage, optimal dose is 1008mg/Kg/ day (is equivalent to the clinical consumption of people 18 times).
Two, wet meridian and relieving pain effect
1. survey the rattan network rather to the analgesic activity of mice with hot plate method
Investigational agent physics aspirin: commercially available, as positive control drug, be made into suspension with normal saline during experiment and use in this experiment.Producer: Sigma company;
Be subjected to the reagent thing
Title and character rattan network are peaceful, brown ceramic powder
This school plant teaching and research room of the unit of providing
Lot number 930423
Content 1 gram powder is equivalent to 5 gram crude drugs
Solvent and compound method are made into the suspension of variable concentrations with normal saline
Animal
Kunming mouse is provided by the The 2nd Army Medical College animal center.Animal quality certification 28-49 number.
Body weight 18-25g
Several 10 of each treated animal
Test method is selected hot plate method
Is the test key step pursued more than 100 mices and is only put to 55? .5 on ℃ the hot plate, the licking metapedes reaction to occur is observation index, measure and write down the threshold of pain of every mice, occurring threshold of pain responder in 30 seconds selects standby, after 3 minutes, survey again once, average as the normal threshold of pain with the numerical value that records for the first time with similarity condition. select 50 qualified mices, divide 5 groups at random, the threshold of pain is surveyed in administration.
If put into behind the hot plate nonresponder still in 30 seconds, calculated by 60 seconds the threshold of pain; If pain threshold is lower than normal value after the administration, then raising percentage rate in the threshold of pain is 0.Significance with t check inspection group differences.
The animals administer reaction
The time point of foot reaction appears licking in the quantitative observation index
Observe after the time point administration 30 ', 60 ', 90 ', 120 ' and 150 '
The dosage setting is divided into 2 dosage groups, 10 every group, gavages rattan network peaceful 1232 (12.32%) and 848 (18.48%) mg/Kg respectively.
Medication
Approach ig, 0.1ml/10g
Administration number of times 1 time
Experimental control
The blank normal saline
Positive control aspirin 200mg/Kg
Result of the test the results are shown in Table 2.The result shows that the rattan network rather at 22～33 times of analgesic activities that have in various degree of the clinical consumption of people, compares with aspirin, and is peaceful suitable with the aspirin analgesic effect that gavages 200mg/Kg at the rattan network of mouse gavaging 1232mg/Kg.
Table 2 rattan network is rather to the analgesic activity of mice hot plate method (hot plate method improves percentage rate with the threshold of pain and represents) (X ± S)
| Group | Dosage mg/Kg | Body weight g | Percentage rate (%) is improved in the threshold of pain | ||||
| ? ? 30′ | ? ? 60′ | ? ? 90′ | ? ? 120′ | ? ? 150′ | |||
| The peaceful rattan network of normal saline aspirin rattan network is peaceful | ? 10ml/Kg 200 1232 1848 | ? 20±3 20±2 20±2 20±2 | ? 19±11 148±102 ** 77±51 ** 117±109 ** | ? 19±10 132±118 * 67±27 ** 99±39 ** | ? 16±10 148±105 ** 95±44 ** 147±107 ** | ? 13±8 180±113 136±106 ** 122±106 ** | ? 22±14 159±115 ** 109±80 ** 176±105 ** |
Compare * P＜0.05 * * P＜0.01 with matched group
Survey the rattan network rather to the analgesic activity of mice with the acetic acid twisting method
Trial drug
Glacial acetic acid: analytical pure, Shanghai reagent one factory, lot number 920723.
Aspirin: commercially available, as positive control drug, be made into suspension with normal saline during experiment and use in this experiment.Producer: Sigma company;
Be subjected to the reagent thing
Title and character rattan network are peaceful, brown ceramic powder
This school plant teaching and research room of the unit of providing
Lot number 930423
Content 1 gram powder is equivalent to 5 gram crude drugs
Solvent and compound method are made into the suspension of variable concentrations with normal saline
Animal
Kunming mouse is provided by the The 2nd Army Medical College animal center.Quality certification 28-49.
Body weight 18-25g
The sex male and female have concurrently
Several 12 of each treated animal, male and female half and half
The selection acetic acid twisting method of test method
60 of test key step healthy mices are divided into 5 groups at random, and 12 every group, male and female half and half.Each organizes after the administration 45 minutes, the acetic acid 10ml/kg of lumbar injection 0.7%, after 5 minutes in the opening entry 10 minutes each Mus turn round the body number of times.Significance with t check inspection group differences.
Reaction behind the animals administer,
The quantitative observation index is turned round the body number of times.The standard of writhing response is the abdominal part indent, and back leg is upheld, hips up.
10 minutes observing times
2 dosage groups are established in the dosage setting, and dosage is respectively 1232 (12.32%) and 2464 (24.64%) mg/Kg.
Medication
Approach ig, 0.1ml/10g
Administration number of times 1 time
Experimental control
The blank normal saline
A positive control Ah phase woods 200mg/Kg
Result of the test: the results are shown in Table 3.The result shows that the peaceful 1232mg/Kg of mouse gavaging rattan network (be equivalent to the clinical consumption of people 22 times) can suppress the writhing response that mouse peritoneal injection acetic acid produces, compare with aspirin, the effect that the peaceful consumption of rattan network of about 2464mg/Kg and 100mg/Kg aspirin produce is suitable.
Table 3 rattan network is rather injected the inhibitory action (X ± S) that 0.7% acetic acid produces writhing response to mouse peritoneal
| Group | Dosage (mg/Kg) | Body weight (g) | Turn round body number of times (inferior/only/10 minutes) |
| The peaceful rattan network of normal saline aspirin rattan network is peaceful | 10ml/Kg 100 1232 2464 | 22.2±1.1 22.1±0.9 22.4±1.2 22.7±1.6 | 27.75±7.96 16.17±7.53 ** 21.42±5.26 * 18.08±5.82 ** |
Compare * P＜0.05 * * P＜0.01 with matched group
Conclusion (of pressure testing) rattan network rather all has significant analgesia role to the pain that mice hot plate method and chemical substance cause, but it is then much bigger that the peaceful required analgesic dose of rattan network is compared with aspirin, and significant analgesia role can take place aspirin 200mg/Kg (be equivalent to the clinical antipyretic-antalgic dosage of people 8.9 times); And the peaceful 1232mg/Kg of rattan network (be equivalent to the clinical consumption of people 22 times) has an analgesic activity to hot plate is pain caused, chemical stimulation is had significant analgesic activity, and be dose dependent.
Three, promoting blood circulation to remove obstruction in the collateral effect
1. the influence of the Mus ear swelling that causes of the peaceful xylol of rattan network
Trial drug
Aspirin: commercially available, as positive control drug, be made into suspension with normal saline during experiment and use in this experiment.Producer: Sigma company;
Dimethylbenzene: analytical pure, last Pumex bridge chemical plant, lot number: 910301.
Be subjected to the reagent thing
Title and character rattan network are peaceful, brown ceramic powder
This school plant teaching and research room of the unit of providing
Lot number 930423
Content 1 gram powder is equivalent to 5 gram crude drugs
Solvent and compound method are made into the suspension of variable concentrations with normal saline
Animal
Kunming mouse is provided by the The 2nd Army Medical College animal center.Quality certification 28-49.
Body weight 18-25g
Sex is male
Several 12 of each treated animal
Test method is selected the dimethylbenzene method
48 of test key step healthy mices are divided into 5 groups, 12 every group at random.Each organized administration after 30 minutes, was applied to both sides, mouse right ear front and back, the about 0.02ml/ ear of every Mus with 100% dimethylbenzene.Every 3.5 hours, the dislocation of white mice cervical vertebra is caused death, cut two ears from the auricle baseline, lay round auricle at same position respectively with 8mm diameter card punch, torsion balance is weighed.
The animals administer afterreaction
The every Mus auris dextra of observation index sheet weight deducts left auricle and heavily is the swelling degree.
3.5 hours observing times
2 dosage groups are established in the dosage setting, and the peaceful dosage of rattan network is respectively 1232 (12.32%) and 2464 (24.64%) mg/Kg.
Medication
Approach ig, 0.1ml/10g
Administration number of times 1 time
Experimental control
The blank normal saline
A positive control Ah phase woods 200mg/Kg
Result of the test the results are shown in Table 4.The result shows that the rattan network rather has anti-acute inflammation effect to mice when being equivalent to 22 times of the clinical consumption of people, and along with the increase of dosage, effect strengthens.The rattan network of mouse gavaging 1232mg/Kg is peaceful with to gavage 200mg/Kg aspirin generation effect suitable.
Table 4 rattan network is rather to the effect of the scorching ear swelling of mice caused by dimethylbenzene xylene (X ± S)
| Group | Dosage (mg/Kg) | Body weight (g) | Swelling degree (mg) |
| The peaceful rattan network of normal saline aspirin rattan network is peaceful | 10ml/Kg 200 1232 2464 | 25.4±2.8 25.6±3.2 23.5±2.6 24.9±2.3 | 9.28±2.81 6.58±3.18 * 7.25±1.82 * 5.50±3.03 ** |
Compare * P＜0.05 * * P＜0.01 with matched group
Conclusion (of pressure testing): the acute inflammation that the peaceful 1232mg/Kg of rattan network (be equivalent to the clinical consumption of people 22 times) is caused by dimethylbenzene mice has tangible antiinflammatory action, and increases along with the increase of dosage.
2. the rattan network is rather tied the granulomatous inhibitory action of rat
Trial drug
Aspirin: commercially available, as positive control drug, be made into suspension with normal saline during experiment and use in this experiment.Producer: Sigma company;
Diazepam: 10mg/2ml, general pharmaceutical factory, sea, Shanghai, lot number: 920806.
Ketaject injection: 0.1g/2ml, Shanghai first pharmaceutical factory, lot number: 901201.
Be subjected to the reagent thing
Title and character rattan network are peaceful, brown ceramic powder
This school plant teaching and research room of the unit of providing
Lot number 930423
Content 1 gram powder is equivalent to 5 gram crude drugs
Solvent and compound method are made into the suspension of variable concentrations with normal saline
Animal
The SD rat is provided by Shanghai Family Planning Science and Research Institute.'s animal center.Quality certification No.0000189.
Body weight 150～250g
Sex is male
Several 10 of each treated animal
Test method is selected the granuloma method
40 of test key step healthy rats are divided into 4 groups, 10 every group at random.After stable (10mg/2ml) 0.1ml adds ketamine (100mg/2ml) intraperitoneal injection of anesthesia, under the sterile working, the next 20mg cotton balls (autoclaving of sterilization and drying is respectively buried in oxter, the left and right sides, add ampicillin 1mg/0.1ml/, 50 ℃ of stove-dryings), intramuscular injection penicillin 100,000 units.Promptly begin respectively to organize administration after the same day, rat revived, continuous 7 days, rat was put to death in cervical vertebra dislocation in the 8th day, strips granulation tissue, and isolated adipose tissue is placed on 60 ℃ of baking oven inner dryings to constant weight, weighs after the cooling, deducts the raw cotton ball weight, and basis is a granuloma weight.
The animals administer afterreaction
Observation index granuloma weight mg/100g body weight value
7 days observing times
2 dosage groups are established in the dosage setting, and the peaceful dosage of rattan network is respectively 1008 (10.08%) and 1344 (13.44%) mg/Kg.
Medication
Approach ig, 1ml/100g
Administration number of times every day 1 time, give 7 days altogether
Experimental control
The blank normal saline
A positive control Ah phase woods 100mg/Kg
Result of the test: the results are shown in Table 5.The result shows that the rat granuloma that the rattan network rather causes cotton balls from dosage 1344mg/Kg/ day (be equivalent to the clinical consumption of people 24 times) has the obvious suppression effect, and along with the increase of dosage, resistancing action strengthens.The Ah phase of a 100mg/Kg/ day woods effect is similar with the peaceful effect that produces of the rattan network of 1200mg/Kg/ day approximately.
Table 5 rattan network is rather to the bullate effect of rat granuloma (X ± S)
| Group | Dosage (mg/Kg) | Body weight (g) | Granuloma weight (mg): 100g body weight (g) |
| The peaceful rattan network of normal saline aspirin rattan network is peaceful | 10ml/Kg 100 1008 1344 | 174.6±38.3 204.3±29.0 192.3±21.0 272.9±20.0 | 101.8±40.9 68.3±21.7 * 70.5±20.4 * 55.4±13.0 ** |
Compare * P＜0.05 * * P＜0.01 with matched group
Conclusion (of pressure testing): the chronic inflammatory disease that the rattan network is rather caused by cotton balls rat from dosage 1008mg/Kg/ day (be equivalent to the clinical consumption of people 22 times) has tangible antiinflammatory action, and increases along with the increase of dosage.
Four. immunoregulation effect
1. the rattan network rather produces the influence of IL-1 to mice
Trial drug
Aspirin is commercially available, as positive control drug, is made into suspension with normal saline during experiment and uses in this experiment.Producer: Sigma company;
Propylene glycol: analytical pure, Shanghai chemical reagent factory, lot number: 870711;
Culture medium: RPMI-1640, GIBCO, 14072USA includes 15% calf serum, mercaptoethanol, Hepes etc.:
Lactoalbumin hydrolysate: Shanghai pharmaceuticals, lot number: 921203;
Lipopolysaccharide (LPS): escherichia coli 111-B4, Sigma product, lot number: 17F-4019;
Canavaline: Sigma product
The MTT:Fluka product
Be subjected to the reagent thing
Title and character rattan network are peaceful, brown ceramic powder
This school plant teaching and research room of the unit of providing
Lot number 930423
Content 1 gram powder is equivalent to 5 gram crude drugs
Solvent and compound method are made into the suspension of variable concentrations with normal saline
Animal
Kunming mouse is provided by the The 2nd Army Medical College animal center.Quality certification 28-49.
Body weight 18-21g
The sex male and female have concurrently
Several 10 of each treated animal
Test method is selected thymocyte proliferation reaction assay method
40 of test key step healthy mices, male and female are regardless of, and are divided into 4 groups at random, 10 every group.Each organized successive administration 7 days, last administration intraperitoneal injection simultaneously 0.5% hydrolyzed protein 1.5ml.Put to death animal after 24 hours, wash out abdominal cavity cell with Hanks liquid under aseptic condition, adjusting cell concentration is 2 * 10
6/ ml, every hole adds the 2ml cell on 24 porocyte culture plates, 37 ℃ of CO
2Cultivated 2 hours in the incubator, the sucking-off supernatant discards not adherent cell, and sticking parietal cell is the macrophage monolayer, and every hole adds the 1mlRPMI-1640 culture medium, and LPS10mg/ml cultivates sucking-off supernatant after 24 hours, with 0.22 μ m filtering with microporous membrane.Putting-20 ℃ of refrigerators preserves.Get 3 of homology mices, take off cervical vertebra and put to death, get thymus and shred the back and filter the preparation thymocyte cell with stainless (steel) wire the sterile working, and transferring cell concentration is 2 * 10
7/ ml whenever adds 100 μ l cells, ConA3 μ g/ml in 96 well culture plates, every MTT 20 μ l/ holes, 37 ℃ of CO
2Following 5 hours of condition is inhaled and is gone supernatant, every hole to add acidify isopropyl alcohol 100 μ l.After 1 hour, measure with full-automatic microplate reader, and get the result.
The animals administer afterreaction
Observation index OD value
2 dosage groups are established in the dosage setting, and the peaceful dosage of rattan network was respectively for 1232 (12.32%) and 2464 (24.64%) mg/Kg/ days.
Medication
Approach ig, 0.1ml/10g
Administration number of times administration 7 days, every day 1 time,
Experimental control
The blank normal saline
A positive control Ah phase woods 100mg/Kg
Result of the test the results are shown in Table 6.The result shows that the rattan network rather reaches the effect that an Ah phase woods all has promotion IL-1 in various degree to generate in the range of doses.
Table 6 ig rattan network rather produces the influence of IL-1 to mice
| Group | Dosage (mg/Kg) | Number of animals | The OD value (X ± S) |
| The peaceful rattan network of normal saline aspirin rattan network is peaceful | 10ml/Kg 100 1232 2464 | 10 10 10 10 | 0.230±0.027 0.449±0.065 ** 0.324±0.044 ** 0.366±0.056 ** |
* * P＜0.01 compared with the control
Conclusion (of pressure testing): the rattan network rather reaches aspirin all has IL-1 in various degree to induce effect, and IL-1 is the cytokine in a kind of mononuclear phagocyte source, plays an important role in the molecular regulation network of immunne response and inflammation.Therefore for rather being used for the treatment of rheumatoid arthrosis, the rattan network provides experimental basis.
Rattan network Yiganning capsule treatment rheumatoid arthritis clinical summary
Requirement by " new Chinese medicine clinical research guideline ", rattan network Yiganning capsule is by Hospital Attached to Shandong Chinese Medical Univ., Nanjing Traditional Chinese Medicine Univ. affiliated hospital, the Zong Yuan of Nanjing Military Command, Changhai hospital of The 2nd Army Medical College, 4 tame hospitals of Shanghai brilliance hospital have carried out the clinical verification of cold dampness accumulation pattern rheumatoid arthritis with the form of matched group, observe clinical case 450 examples altogether, the result shows, the total effective rate of this product treatment rheumatoid arthritis is 86.67%, prompting rattan network Yiganning capsule to rheumatoid arthritis particularly the cold dampness accumulation pattern rheumatoid arthritis clinical efficacy is preferably arranged.The safety testing result shows, blood before and after the treatment, just routine and the heart, liver, kidney function test all do not point out this product that the heart, liver, renal function are had infringement, prompting this product be safe and effective reliably.
Describe technical scheme of the present invention in detail with embodiment below.
Embodiment 1: capsule
Get raw material: Caulis Erycibes 311g Rhizoma Et Radix Notopterygii 222g Radix Angelicae Pubescentis 311g Radix Stephaniae Tetrandrae 222g Rhizoma Corydalis 222g Radix Salviae Miltiorrhizae 222g
Raw material extracts three times with 70% alcohol heating reflux, first and second time each 1.5 hours, 1 hour for the third time, merge extractive liquid,, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.30-1.35 (60 ℃), cold drying, pulverize, mixing incapsulates, promptly.
Embodiment 2: tablet
Get raw material: Caulis Erycibes 500g Rhizoma Et Radix Notopterygii 300g Radix Angelicae Pubescentis 500g Radix Stephaniae Tetrandrae 300g Rhizoma Corydalis 300g Radix Salviae Miltiorrhizae 300g
Raw material extracts secondary with 60% alcohol heating reflux, and each each 1.5 hours, merge extractive liquid,, filter, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.30-1.35 (60 ℃), low-temperature reduced-pressure is dried to dry extract, add starch, dextrin granulation, drying adds carboxymethyl starch sodium and an amount of magnesium stearate and micropowder silica gel again, mixing, tabletting, coating, promptly.
Embodiment 3: granule
Get raw material: Caulis Erycibes 700g Rhizoma Et Radix Notopterygii 500g Radix Angelicae Pubescentis 700g Radix Stephaniae Tetrandrae 500g Rhizoma Corydalis 500g Radix Salviae Miltiorrhizae 500g
Raw material extracts three times with 90% alcohol heating reflux, and each each 1 hour, merge extractive liquid, filtered, filtrate recycling ethanol, being evaporated to relative density is the clear paste of 1.25-1.30 (60 ℃), adds 1 part of cane sugar powder, 0.7 part in dextrin, stirs evenly, granulate, drying, promptly.
Claims (10)
1. a medicine for the treatment of rheumatic arthralgia is characterized in that it mainly is to be made by following bulk drugs: Caulis Erycibes 5-7 part, Rhizoma Et Radix Notopterygii 3-5 part, Radix Angelicae Pubescentis 5-7 part, Radix Stephaniae Tetrandrae 3-5 part, Rhizoma Corydalis 3-5 part, Radix Salviae Miltiorrhizae 3-5 part.
2. medicine according to claim 1 is characterized in that the consumption of each crude drug is: 311 parts of Caulis Erycibess, 222 parts of Rhizoma Et Radix Notopterygiis, 311 parts of Radix Angelicae Pubescentiss, 222 parts of 222 parts of Rhizoma Corydalis of Radix Stephaniae Tetrandrae, 222 parts of Radix Salviae Miltiorrhizaes.
3. medicine according to claim 1 and 2 is characterized in that the Rhizoma Corydalis in its crude drug is the Rhizoma Corydalis of vinegar system.
4. medicine according to claim 3 is characterized in that adopting the conventional method on the galenic pharmacy to make regular dosage form.
5. medicine according to claim 4, its dosage form are capsule, tablet, concentrated pill, granule, oral liquid or drop pill.
6. medicine according to claim 5, its dosage form are capsule.
7. according to the preparation method of claim 1,2 or 3 described medicines, it is characterized in that comprising following steps: crude drug adds 50%-90% ethanol heating extraction 2-3 time, merge extractive liquid,, filter, filtrate recycling ethanol, and concentrating under reduced pressure becomes thick paste, cold drying becomes dry extract, pulverizes, and obtains medicated powder.
8. the preparation method of medicine according to claim 7, it is characterized in that comprising following steps: crude drug adds 70% ethanol heating extraction 3 times, 1st, 2 times each 1.5 hours, the 3rd time 1 hour, merge extractive liquid,, filter, filtrate recycling ethanol, and concentrating under reduced pressure becomes thick paste, cold drying becomes dry extract, pulverize, obtain medicated powder.
9. according to the preparation method of claim 7 or 8 described medicines, it is characterized in that the medicated powder that will obtain at last, add on the pharmaceutics available adjuvant or do not add adjuvant, make to such an extent that need dosage form.
10. claim 1,2 or 3 described medicines are used for the treatment of purposes in the rheumatic arthralgia disease medicament in preparation, mainly treat the cold dampness accumulation pattern rheumatoid arthritis.
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| CN 200510200292 CN1868502A (en) | 2005-05-23 | 2005-05-23 | Medicine composition used for treating rheumatoid arthritis, and its prepn. method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102406872A (en) * | 2011-11-29 | 2012-04-11 | 宋爱民 | Traditional Chinese preparation for treating rheumatoid arthritis |
| CN104523872A (en) * | 2015-01-06 | 2015-04-22 | 李丹智 | Traditional Chinese medicine combination for treating rheumatic arthritis and preparation method thereof |
| CN105311501A (en) * | 2015-04-27 | 2016-02-10 | 孙喜范 | Traditional Chinese medicine for treating rheumatic arthritis |
| CN110297046A (en) * | 2019-07-01 | 2019-10-01 | 中国药科大学 | Baseline etc. is than method joint mathematical model screening medicine to the method for active constituent and its ratio optimization |
-
2005
- 2005-05-23 CN CN 200510200292 patent/CN1868502A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102406872A (en) * | 2011-11-29 | 2012-04-11 | 宋爱民 | Traditional Chinese preparation for treating rheumatoid arthritis |
| CN102406872B (en) * | 2011-11-29 | 2014-03-05 | 宋爱民 | Traditional Chinese preparation for treating rheumatoid arthritis |
| CN104523872A (en) * | 2015-01-06 | 2015-04-22 | 李丹智 | Traditional Chinese medicine combination for treating rheumatic arthritis and preparation method thereof |
| CN105311501A (en) * | 2015-04-27 | 2016-02-10 | 孙喜范 | Traditional Chinese medicine for treating rheumatic arthritis |
| CN110297046A (en) * | 2019-07-01 | 2019-10-01 | 中国药科大学 | Baseline etc. is than method joint mathematical model screening medicine to the method for active constituent and its ratio optimization |
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