CN1292765C - Pharmaceutical composition, its preparation process and usage - Google Patents
Pharmaceutical composition, its preparation process and usage Download PDFInfo
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- CN1292765C CN1292765C CNB2003101041424A CN200310104142A CN1292765C CN 1292765 C CN1292765 C CN 1292765C CN B2003101041424 A CNB2003101041424 A CN B2003101041424A CN 200310104142 A CN200310104142 A CN 200310104142A CN 1292765 C CN1292765 C CN 1292765C
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention provides a medical composition for treating rheumatoid diseases and rheumatic arthritis, which is a medicinal preparation made from Pterocephalus hookeri Hook, doubleteeth pubesscent angelica root, medicine terminalia fruit, benzoin, prepared kusnezoff monkshood root and common vladimiria root according to proportion by weight. The present invention also provides a method for preparing the medical composition, which comprises: A. weighing raw medicinal materials according to the proportion by weight of each medicine; B. grinding the doubleteeth pubesscent angelica root and the common vladimiria root into powder; C. freezing and grinding the benzoin, mixing and grinding with the ground powder obtained from the step B, and then sieving; D. extracting the medicine terminalia fruit and the prepared kusnezoff monkshood root by water, and then concentrating the filtering liquid into thick paste; E. extracting the Pterocephalus hookeri Hook by ethanol through refluxing, and then concentrating the filtering liquid into thick paste; F. uniformly mixing the thick paste obtained from the step D and the step E with the fine powder obtained from the step C, drying into dry paste through decompression, and then mixing with medically acceptable auxiliary materials for preparing commonly used preparation forms medically. The raw medicinal materials of the present invention are made from tibetan medicines, and have the effects of dispelling cold, removing dampness, dispersing swellings and removing pain for treating rheumatic arthritis and rheumatoid arthritis with the advantages of high efficiency, less side effect, etc.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and its production and use, particularly a kind of pharmaceutical composition for the treatment of rheumatoid arthritis, rheumatic arthritis.
Technical background
Rheumatic arthritis is a kind of allergic disease relevant with hemolytic streptococcal infection.It is one of main performance of rheumatic fever, and for seeing, the joint of getting involved is based on big joint more with the adult.Begin to invade and the joint of the lower extremity person accounts for 85%, knee joint and ankle joint are the most common, be shoulder, elbow and wrist secondly, and hands and sufficient little joint are rarely found.Rheumatoid arthritis (Rheumatiod Arthritis RA) be a kind of common serve as the general immune disease of main performance with the chronic arthritis pathological changes, its clinical manifestation is extremities joint limitation of activity, swelling, pain etc.Primary disease morbidity spreads all over each race all over the world, between twenty and fifty in the majority with 25～55 years old, and women's sickness rate is higher than the male.According to statistics, the external prevalence of RA is 1～2%, and indivedual areas are up to 5%, and China's sickness rate is about 0.74%, and 10,000,000 patients are now arranged approximately.Rheumatoid arthritis is outbreak repeatedly easily, the disability rate height, and 2 years disability rates of patient of diagnosis and treatment in time are not that 50%, three year disability rate reaches 70%.And patient that should disease, average life shortens 10～15 years.The medicine of treatment rheumatoid, rheumatic arthritis is more at present, as antipyretic-antalgic anti-inflammatory agent bigcatkin willow acids, symptom to control rheumatic and rheumatoid arthritis has sure curative effect, but can not effect a radical cure, the generation of development and the complication of can not warding off disease, and side effect is big, easily produces gastrointestinal reaction, blood coagulation disorders, anaphylaxis, salicylism reaction etc.Other NSAID (non-steroidal anti-inflammatory drug), antimalarial, penicillamine, Radix Tripterygii Wilfordii preparation, golden preparation and glucocorticoid, life-time service produces untoward reaction, as hemo-hyperadrenocorticism syndrome, digestive system complication, and withdrawal reaction etc., so effect is all undesirable.
Summary of the invention
Technical problem to be solved by this invention provides a kind of pharmaceutical composition for the treatment of rheumatoid, rheumatic arthritis, and the present invention also provides this preparation of drug combination method.
The invention provides a kind of medicine compositions, it is the medicament of being made by following materials of weight proportions: Herba pterocephali 100-150 part, Radix Angelicae Pubescentis 100-150 part, Fructus Chebulae 220-280 part, Benzoinum 40-100 part, Radix Aconiti Kusnezoffii Preparata 40-100 part, Radix Vladimiriae 40-100 part.
Wherein, Herba pterocephali is the dry herb of Dipsacaceae plant Herba pterocephali Pterocephalushookeri (C.B.Clarke) Hoeck.Radix Angelicae Pubescentis is the root and rhizome of Umbelliferae Heracleum moellendorffii Heracleum moellendorffii Hance or gradually sharp Radix Angelicae Pubescentis H.acuminatumFranch.The Fructus Chebulae is the dry mature fruit of Combretum Racemosum plant Fructus Chebulae Terminalia chebulaRetz. or fine hair Fructus Chebulae Terminalia chebula Retz.var.tomentella Kurt..Benzoinum is the dry resin of Styracaceae plant styrax tonkinensis Craib ex Hart Styrax tonkinensis (Pierre) Ctaib ex Hart..Radix Aconiti Kusnezoffii Preparata is the dry root of Mao Liangke plant Aconitum kusnezoffii Reichb Aconitum kusnezoffii Reichb..Radix Vladimiriae is the dry root of feverfew Radix Vladimiriae Vladimiria souliei (Franch) Ling. or gray wool Radix Vladimiriae Vladimiriasouliei (Franch) Ling.Var.cinerea Ling..
Further, it is the medicament of being made by following materials of weight proportions: Herba pterocephali 130-140 part, Radix Angelicae Pubescentis 130-140 part, Fructus Chebulae 260-270 part, Benzoinum 60-70 part, Radix Aconiti Kusnezoffii Preparata 60-70 part, Radix Vladimiriae 60-70 part.
Further, it is the medicament of being made by following materials of weight proportions: 134 parts of Herba pterocephali, 134 parts of Radix Angelicae Pubescentiss, 268 parts of Fructus Chebulaes, 67 parts of Benzoinumes, 66 parts of Radix Aconiti Kusnezoffii Preparatas, 67 parts of Radix Vladimiriaes.
Described medicament is pill, powder, tablet, capsule, oral liquid.
The present invention also provides this preparation of drug combination method, and it comprises the following steps:
A, by each weight proportion weighting raw materials: Herba pterocephali 100-150 part, Radix Angelicae Pubescentis 100-150 part, Fructus Chebulae 220-280 part, Benzoinum 40-100 part, Radix Aconiti Kusnezoffii Preparata 40-100 part, Radix Vladimiriae 40-100 part;
B, get Radix Angelicae Pubescentis, Radix Vladimiriae is ground into powder;
C, get Benzoinum, freezing smashing, the powder facing-up with the B step is pulverized sieves;
D, get Fructus Chebulae and Radix Aconiti Kusnezoffii Preparata extracting in water, filtrate is condensed into thick paste;
E, get the Herba pterocephali alcohol reflux, filtrate is condensed into thick paste;
F, with the thick paste of D, E step gained and the fine powder mixing of c step gained, drying under reduced pressure becomes dried cream, with mixing acceptable accessories, is prepared into dosage form pharmaceutically commonly used.
The present invention also provides the purposes of each raw material in the medicine of preparation treatment rheumatoid arthritis of described weight proportion.
The present invention also provides the purposes of each raw material in the medicine of preparation treatment rheumatic arthritis of described weight proportion.
The raw material of pharmaceutical composition of the present invention is under the Tibetan medicine and pharmacology theoretical direction, the prescription science, under the Tibetan medicine and pharmacology theory, monarch drug is a Herba pterocephali, the energy removing damp and stopping pain, there is detoxifcation to remove pestilence, the dispel the wind merit of blood stasis dispelling, Radix Angelicae Pubescentis bitter in the mouth suffering, slightly warm in nature has expelling wind and removing dampness, the merit of numbness relieving and pain relieving, fill a prescription in this, both avoided the property of Herba pterocephali bitter cold, the merit that having property of Herba pterocephali is taken, similar because of its therapeutical effect again with Herba pterocephali, can further strengthen the effect of principal agent numbness relieving and pain relieving, its nature and flavor suffering of Radix Aconiti Kusnezoffii Preparata, bitter, temperature, poisonous, stronger wind-damp dispelling is arranged, the merit of dispersing cold for relieving pain is used for diseases such as arthralgia due to cold-dampnes, is Tibetan medicine's common drug, system is to alleviate toxicity, and the Tibetan medicine uses Fructus Chebulae and its compatibility, Fructus Chebulae's bitter in the mouth, acid, puckery, temperature is controlled wind, gallbladder, expectorant, blood sick simple, intercurrent disease and mixing are sick, the energy clearing away heat from blood, astringing intestine to stop diarrhea, astringe the lung, sending down the abnormal ascending QI, more " red crust " and " dragon ".Treatment " Baconic's disease ", " dragon " disease, grasserie, " Baconic " are comprehensive sick, and with coordination " three categories of etiologic factors ", for the king in the medicine and can coordinate all medicines, so compatibility can be prevented the toxicity of Radix Aconiti Kusnezoffii, make its medication safer gentle.Comprehensively above-mentioned, Radix Aconiti Kusnezoffii Preparata had both strengthened the drug effect of Herba pterocephali, Radix Angelicae Pubescentis, strengthened the wet power of Radix Angelicae Pubescentis temperature cold expelling again, also reduced the property of the bitter cold of Herba pterocephali, killing three birds with one stone.Radix Vladimiriae sweet in the mouth, hardship, suffering, property is flat, clear " Baconic " heat of energy, dysphoria with smothery sensation, broken painful abdominal mass tumor, blood-activating analgetic, removing food stagnancy is good for the stomach.The paathogenic factor that can not contain at gastric qi is protected stomach and is good for the stomach, and can strengthen full side's pain relieving strength again.Benzoinum energy heat-clearing and toxic substances removing removes epidemic disease, and treatment " dragon poison ", epidemic disease cellulitis, furuncle, grasserie have detoxifcation, inflammation-diminishing function, help the expeling of the heresy of wind and cold, and warm in nature with its bitter in the mouth, can increase the power of dehumidifying, is less important medicine in writing out a prescription.
Medicine material of the present invention is made up of Tibetan medicine entirely, has dispelling cold and removing dampness, the reducing swelling and alleviating pain effect.Be used for the treatment of cold dampness accumulation pattern rheumatoid arthritis, arthralgia, activity is unfavorable, the joint is cold, weather conversion or disease such as arthralgia aggravation when cold.Efficient, quick-acting and long lasting characteristics that this medicine has, and consumption is little, side effect is little and toxicity is little, preparation is simple, and is easy to use, provides a kind of new selection for clinical.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment 1: the capsule of preparation pharmaceutical composition of the present invention
1) takes by weighing Radix Angelicae Pubescentis 134kg, Radix Vladimiriae 67kg respectively and be ground into 20 order coarse powder;
2) take by weighing Benzoinum 67kg and freezing smashing,, be ground into 80 order fine powders with above-mentioned coarse powder facing-up;
3) take by weighing Fructus Chebulae 268kg and Radix Aconiti Kusnezoffii Preparata 66kg extracting in water, filtrate is condensed into thick paste;
4) take by weighing Herba pterocephali 134kg alcohol reflux, filtrate is condensed into thick paste;
5) with two kinds of thick pastes and above-mentioned fine powder mixing, drying under reduced pressure becomes dried cream, pulverizes 80 mesh sieves, granulate, and drying, granulate is crossed 40 mesh sieves, and filled capsules is made 1000.
Embodiment 2: the tablet of preparation pharmaceutical composition of the present invention
1) takes by weighing Radix Angelicae Pubescentis 134kg, Radix Vladimiriae 67kg respectively and be ground into 20 order coarse powder;
2) take by weighing Benzoinum 67kg and freezing smashing,, be ground into 80 order fine powders with above-mentioned coarse powder facing-up;
3) take by weighing Fructus Chebulae 268kg and Radix Aconiti Kusnezoffii Preparata 66kg extracting in water, filtrate is condensed into thick paste;
4) take by weighing Herba pterocephali 134kg alcohol reflux, filtrate is condensed into thick paste;
5) with two kinds of thick pastes and above-mentioned fine powder mixing, drying under reduced pressure becomes dried cream, pulverizes 80 mesh sieves, granulate, and drying, granulate is crossed 40 mesh sieves, adds 1% magnesium stearate, and tabletting is made tablet.
Embodiment 3: the oral liquid of preparation pharmaceutical composition of the present invention
1) takes by weighing Radix Angelicae Pubescentis 134kg, Radix Vladimiriae 67kg respectively and be ground into 20 order coarse powder;
2) take by weighing Benzoinum 67kg and freezing smashing,, be ground into 80 order fine powders with above-mentioned coarse powder facing-up;
3) take by weighing Fructus Chebulae 268kg and Radix Aconiti Kusnezoffii Preparata 66kg extracting in water, filtrate is condensed into thick paste;
4) take by weighing Herba pterocephali 134kg alcohol reflux, filtrate is condensed into thick paste;
5) with two kinds of thick pastes and above-mentioned fine powder mixing, drying under reduced pressure becomes dried cream, pulverizes 80 mesh sieves, granulate, and drying, granulate is crossed 40 mesh sieves, in the water-soluble solution, adds antibacterial, suspending agent, makes oral liquid.
Below prove beneficial effect of the present invention by toxicity test, clinical trial.
Experimental example 1: toxicity test
Acute toxicity test: medicament capsule content mice of the present invention is once irritated stomach maximum tolerated dose MTD＞20g (crude drug in whole)/kg (be equivalent to clinical every day of recommended dose 800 times).The outward appearance of animal, behavioral activity, the mental status, body weight, defecation and color thereof, quilt hair, the colour of skin, breathing, nose, eye, oral secretion etc. there is no unusually after the administration, and eye anatomy is not seen obvious pathological change during off-test.Performance judges that this product belongs to no overt toxicity medicine after acute toxicity institute's amount of reagent of this product and the administration.
Long term toxicity test: medicine 0.4,0.8 of the present invention, 1.6g (crude drug in whole)/kg (be equivalent to respectively clinical every day of recommended dose 16,32,64 times) irritate stomach 1 time for rat every day, continuous 12 weeks, the ANOMALOUS VARIATIONS of not seeing drug-induced general signs, outward appearance, behavior, feces, food-intake and body weight gain.Blood cell is learned and is detected 14 of numeration of leukocyte, red blood cell count(RBC), hemoglobin concentration, hematocrit, mean corpuscular volume, the average hemoglobin of erythrocyte, mean corpuscular hemoglobin, platelet count, lymphocyte percentage ratio, granulocyte percentage ratio, lymphocyte count, granulocyte count, red cell distribution width, MPW, mean platelet volumes etc.; Blood biochemical is learned and is checked 10 of serum alanine aminotransferase, aspartate amino transferase, alkali phosphatase, blood urea nitrogen, creatinine, total protein, albumin, glucose, total bilirubin, T-CHOLs etc., all sees ANOMALOUS VARIATIONS future.Every animal is carried out careful system's obduction, calculate the organ coefficient of 9 main substantial visceras such as the heart, liver, spleen, lung, kidney, brain, adrenal gland, thymus, uterus, testis, and under light microscopic, histopathologic examination is carried out in liver, kidney, lungs, heart, spleen, stomach, adrenal gland, thymus, testis, uterus, do not see drug-induced naked eyes pathological changes and tissue pathologies change.Did in 2 weeks restorative after the drug withdrawal and the delayed toxicity observation, do not see that medicine of the present invention capsule 's content of science causes the abnormal change of These parameters.So can think that this rat long term toxicity test result shows that medicine of the present invention does not have the overt toxicity effect.
Above-mentioned toxicity test explanation, medicine material of the present invention is Tibetan medicine entirely, derives from the high altitude localities, has no side effect, and is safe in utilization.
Experimental example 2: clinical observation
1, physical data
Clinical relevant case 156 examples through strict screening, determine that 126 people are as the clinical observation object.Rheumatic arthritis case 46 examples wherein, rheumatoid arthritis example 80 examples, men and women's ratio is 1: 1.38.
2, diagnostic criteria
Rheumatic arthritis: anti-" o " index is higher than normal value, the rheumatoid factor reaction that is negative, and the joint does not have degeneration, no hypertrophy.
Rheumatoid arthritis: anti-" o " index is normal, and rheumatoid factor is positive, and there are degeneration, hypertrophy in the joint; Anti-" o " index is higher than normal value, but rheumatoid factor is positive, and there are degeneration, hypertrophy in the joint.
3, Therapeutic Method
Oral 2 times of every day, each 2 (every heavy 0.34g), continuous 4 weeks.
4, therapeutic outcome
The healing number of medicament composition capsule agent treatment rheumatic arthritis of the present invention is 21 people, and cure rate reaches 45.6%, and effectively number is 44 people, and effective percentage reaches 95.6%; The healing number of treatment rheumatoid arthritis is 38 people, and cure rate reaches 47.5%, and effectively number is 77 people, and effective percentage reaches 96.2%; Clinical total cure rate reaches 46.8%, and total effective rate reaches 96%.
Show fully that by above-mentioned toxicity test and clinical trial drug regimen raw material prescription of the present invention is scientific and reasonable, has dispelling cold and removing dampness, the reducing swelling and alleviating pain effect.Be used for the treatment of cold dampness accumulation pattern rheumatoid arthritis, arthralgia, activity is unfavorable, the joint is cold, weather conversion or disease such as arthralgia aggravation when cold, have efficient, quick-acting and long lasting characteristics, and consumption is little, side effect is little and toxicity is little, preparation is simple, easy to use, provide a kind of new selection for clinical.
Claims (7)
1, a kind of pharmaceutical composition for the treatment of rheumatoid, rheumatic arthritis is characterized in that: make its active component raw material and be made up of following components in weight percentage: Herba pterocephali 100-150 part; Radix Angelicae Pubescentis 100-150 part; Fructus Chebulae 220-280 part; Benzoinum 40-100 part; Radix Aconiti Kusnezoffii Preparata 40-100 part; Radix Vladimiriae 40-100 part.
2, according to the pharmaceutical composition of the described treatment rheumatoid of claim 1, rheumatic arthritis, it is characterized in that: make its active component raw material and form: Herba pterocephali 130-140 part by following components in weight percentage; Radix Angelicae Pubescentis 130-140 part; Fructus Chebulae 260-270 part; Benzoinum 60-70 part; Radix Aconiti Kusnezoffii Preparata 60-70 part; Radix Vladimiriae 60-70 part.
3, according to the pharmaceutical composition of the described treatment rheumatoid of claim 2, rheumatic arthritis, it is characterized in that: make its active component raw material and form: 134 parts of Herba pterocephali by following components in weight percentage; 134 parts of Radix Angelicae Pubescentiss; 268 parts of Fructus Chebulaes; 67 parts of Benzoinumes; 66 parts of Radix Aconiti Kusnezoffii Preparatas; 67 parts of Radix Vladimiriaes.
4, according to the pharmaceutical composition of claim 1 or 2 or 3 described treatment rheumatoids, rheumatic arthritis, it is characterized in that: the medicament that described preparation of pharmaceutical compositions forms is pill, powder, tablet, capsule or oral liquid.
5, the described preparation of drug combination method of claim 1, it comprises the following steps:
A, by each weight proportion weighting raw materials: Herba pterocephali 100-150 part; Radix Angelicae Pubescentis 100-150 part; Fructus Chebulae 220-280 part; Benzoinum 40-100 part; Radix Aconiti Kusnezoffii Preparata 40-100 part; Radix Vladimiriae 40-100 part;
B, get Radix Angelicae Pubescentis, Radix Vladimiriae is ground into powder;
C, get Benzoinum, freezing smashing, the powder facing-up with the B step is pulverized sieves;
D, get Fructus Chebulae and Radix Aconiti Kusnezoffii Preparata extracting in water, filtrate is condensed into thick paste;
E, get the Herba pterocephali alcohol reflux, filtrate is condensed into thick paste;
F, with the thick paste of D, E step gained and the fine powder mixing of C step gained, drying under reduced pressure becomes dried cream, with mixing acceptable accessories, is prepared into dosage form pharmaceutically commonly used.
6, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment rheumatoid arthritis.
7, the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment rheumatic arthritis.
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| CNB2003101041424A CN1292765C (en) | 2003-12-26 | 2003-12-26 | Pharmaceutical composition, its preparation process and usage |
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| CN1076117A (en) * | 1993-01-06 | 1993-09-15 | 张良华 | The production method of tablets for eliminating blood stasis and promoting blood circulation |
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| CN1076117A (en) * | 1993-01-06 | 1993-09-15 | 张良华 | The production method of tablets for eliminating blood stasis and promoting blood circulation |
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