CN1709445A - Tibetan medicine for major functions of acute-chronic sprain-contusion, rheumatism, rheumatoid diseases, and its preparing method - Google Patents
Tibetan medicine for major functions of acute-chronic sprain-contusion, rheumatism, rheumatoid diseases, and its preparing method Download PDFInfo
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Abstract
The present invention relates to a Chinese Tibet medicine for mainly curing the diseases of acute and chronic sprain and contusion, rheumatism and rheumatoid disease and its preparation method. It is characterized by that said preparation method includes the following steps: utilizing the Chinese Tibet medicinal materials of lamiophlomis rotate, Jidou, turmeric, zanthoxylum husk, water buffalo horn and myricaria germanica as raw material, making them undergo the processes of decocting, vacuum freeze-drying, pulverizing and making them into any pharmaceutically-acceptable dosage form, including oral preparation or preparation for external application, in particular, it can be made into the adhesive plaster, ointment preparation, spray, gel preparation, film preparation and resin plaster, etc.
Description
Technical field
The present invention relates to a kind of blood circulation promoting and blood stasis dispelling, the medicine of reducing swelling and alleviating pain or rather, is a kind for the treatment of acute and chronic bruise that is used for, Tibetan medicine of rheumatism, rheumatoid disease and preparation method thereof.
Background technology
Rheumatism, rheumatoid are a kind of common chronic, struvite, carrying out property, destructive arthrosis, and the traditional Chinese medical science claims " arthromyodynia ", belongs to one of world's persistent ailment.
Rheumatism is one group of common acute or chronic disease of outbreak repeatedly based on the whole body connective tissue, it can invade heart, joint, skin, serous coat, blood vessel, brain, lung, kidney, the most remarkable with heart and joint damage, many secondary of rheumatism rheumatic heart disease.
Rheumatoid arthritis (Rheumatoid arthritis) claim rheumatoid (RA) again, it is the extensive and obstinate chronic systemic inflammatory disease that a kind of cause of disease is not understood as yet, with pathological changes outside chronic, symmetry, many synovial jointss inflammation and the joint is main clinical manifestation, belongs to the autoimmune inflammatory diseases.Rheumatoid has that many patient history are long bone destruction, joint deformity just to occur, just dysfunction occurs slightly for a long time, deformity disables.Be a kind of abnormality, glue unit property disease.This disease is mainly in little joints such as hands, wrist, foot.Joint red and swollen heat pain and dysfunction are arranged in early days, late period, stiff deformity in various degree can appear in the joint, and with bone and skeletal muscle atrophy, local ankylosis pain was only arranged when the patient's condition is slight, then can cause the joint swelling and pain and the damage of whole body when serious, even cause deformity.
Add up according to World Health Organization (WHO), whole world rheumatism, annual about 8,000 ten thousand people of rheumatoid patient, prevalence is more than 1%, with the U.S. is example, general North America crowd's rheumatoid arthritis prevalence is about 1%, the American Indian is then up to 5%～6%, part U.S. area more than 60 years old crowd's sickness rate reach 10%.Because of suffering from the patient that this type of disease disables nearly 1,000 ten thousand people just there is every year.
According to Ministry of Public Health statistics, China's rheumatism, rheumatoid patient be up to 2,000 ten thousand people, and have 1st/10th, the patient with severe symptoms.At present, this type of disease is the 4th of suffering from chronic diseases of Lie Ju China urban and rural residents, and also about 1%, 80% patient's age of onset is in 20-45 year for sickness rate, and men and women's ratio is 1: 2.4.Be mainly in North China, the Northeast of China, sickness rate is more than l%, and the women is more than the male.
Along with the quickening of aged tendency of population, also can present the trend that increases year by year in rheumatism, the rheumatoid patient's number world wide, therefore, market potential is huge.
At present, treat this type of disease both at home and abroad and also do not have medicine or preparation preferably.
The Western medicine medicine of treatment rheumatism, rheumatoid disease mainly contains three classes:
The first kind: the non-steroidal anti-inflammatory drug thing has faster analgesic antiphlogistic effect.Comprise various anti-inflammatory drugs, domestic Indocid commonly used, Feldene, Voltaren, Relifex, Naproxen, Sulindac, Surgem, Tilcotil etc. respectively have its characteristic and pluses and minuses.But above medicine generally has the side effect that causes " gastric ulcer and gastropathy ".
Second class: comprise numerous disease modification antirheumatic, be regarded as to improve the medicine of the state of an illness at all.Just brought test as far back as the twentieth century initial stage, be to use the historical famous medicine of the longest and tool clinical experience of experience.It can slow down or suppress proceeding of the course of disease, and is effective for serious progressive rheumatoid arthritis, if result of use is better in early days.But its side effect is quite a few, common as flushing, scratch where it itches, the golden lung disease of oral ulcer, headache, dizziness, leukopenia, thrombocytopenia, nephrotoxicity and less generation.The main medicine of representing has two kinds of Thiomalate (trade name Shiosol) and Aurathioglucose (trade name Solganol).
Anabolic agent: can merge first line or the second line drug use, can be oral, injection or intraarticular injection.This class medicine can alleviate extremely serious arthritic symptom effectively, be most commonly used to treat the carrying out property arthritis that traditional treatment is invalid or be difficult to cure, but often bring many side effect such as liquid and electrolyte imbalance, the intestines and stomach, endocrine, eyes and metabolic damage, and typical moon face.Short-term uses then rare side effect to take place, but can not reach the purpose of treatment fully.
This type of disease of Chinese patent drugs for treatment, though kind of medicine surplus having 120, dosage form mostly is traditional medicated wine, pill etc., the course of treatment is longer, can alleviate, improve symptom.But drug toxicity is big, and effective dose and toxic dose are comparatively approaching, and the drug safety scope is narrower, along with dosage increases, though curative effect has raising, and the also corresponding increase of toxicity.
Both at home and abroad to the primary disease Drug therapy, run into following thorny problem at present:
1, the medicine for treatment thing is common has for oral administration and two kinds of externals, for oral administration based on pain relieving, and as hormone, somedon, indometacin, piroxicam sheet etc., its shortcoming is slow and side effect is bigger to the onset of acute and chronic bruise, easily causes the first pass effect of intestines and stomach.
2, all there is certain shortcoming in traditional external Tibetan medicinal preparation (comprising varnish, patch, unguentum), numerous and diverse as production technology, every batch of production cycle is long, not easy to store, carry inconvenience, flavour of a drug are heavier, and abnormal flavour is denseer, part drug osmotic ability, be difficult for the performance drug effect, the modern people's of part medicine incompatibility life style etc.
Summary of the invention
The purpose of this invention is to provide a kind of blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain is used for the treating acute and chronic bruise, the Tibetan medicine prescription of rheumatism, rheumatoid disease.
Another object of the present invention provides the preparation method of this Tibetan medicine prescription therapeutic agent.
Medicine of the present invention is to make medicament by the raw material of following parts by weight:
Radix Lamiophlomidis Rotatae 5-15 part, Herba Oxytropis Kansuensis 2-10 part, Rhizoma Curcumae Longae 15-40 part, Pericarpium Zanthoxyli 7-20 part, Cornu Bubali 5-15 part and Cacumen Myricariae Germanicae 15-40 part.
The raw material of the formula optimization parts by weight of medicine of the present invention is:
Radix Lamiophlomidis Rotatae 8-13 part, Herba Oxytropis Kansuensis 3-8 part, Rhizoma Curcumae Longae 20-35 part, Pericarpium Zanthoxyli 10-20 part, Cornu Bubali 8-13 part, Cacumen Myricariae Germanicae 20-35 part.
The raw material of the optimum weight umber of medicine of the present invention is:
22.7 parts of 9.1 parts of Radix Lamiophlomidis Rotataes, 4.5 parts of Herba Oxytropis Kansuensiss, 40.9 parts in Rhizoma Curcumae Longae, 13.6 parts in Pericarpium Zanthoxyli, 9.1 parts of Cornu Bubalis and Cacumen Myricariae Germanicaes.
The preparation method of medicine of the present invention is:
Pericarpium Zanthoxyli, Cornu Bubali powder are broken into 0.01-200 μ m fine powder, all the other Radix Lamiophlomidis Rotataes, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae and Cacumen Myricariae Germanicae four flavor choppings, add water, ethanol or vinegar and decocted 0.5-3 hour, add above-mentioned fine powder again, stir evenly, be placed to room temperature, drying is taken out, and is ground into fine powder, according to conventional method, make any preparation.
Pericarpium Zanthoxyli, Cornu Bubali powder can also be broken into 0.01-200 μ m fine powder, all the other Radix Lamiophlomidis Rotataes, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae and Cacumen Myricariae Germanicae four flavor choppings, adding water, ethanol or vinegar decocted 0.5-3 hour, add above-mentioned fine powder again, stir evenly, put into the aluminum dish after reducing to room temperature, go into the vacuum freezing storehouse, be cooled to-15 ℃--40 ℃.The beginning evacuation, the taking-up that opens a position after 10-24 hour is pulverized, according to a conventional method [" pharmacy of Chinese materia medica " (using) for Chinese medicine class specialty, the Shanghai science and technology is published in December, 1997 front page; " pharmaceutical preparation research and development and production new technique technology use complete works of ", contemporary China audio ﹠ video press] make said dosage form on any pharmaceutics.
The said dosage form of the present invention comprises oral formulations and external preparation, and preferably external preparation comprises that emplastrum, ointment, cataplasma, spray, gel, liniment or resin paste.The each dosage of described oral formulations is 0.1-1.5g, and external preparation is 1-5g.
Advantage of the present invention and effect:
Major advantage of the present invention is as follows:
1, make the preparation medicine process stabilizing with method of the present invention, quality is high and quality controllable, helps guaranteeing curative effect, can set examination criteria in quality testing, can measure and the detection of effective ingredient medicament contg, to guarantee the quality of Tibetan medicinal preparation.
2, because method of the present invention has adopted modern Freeze Drying Technique, not only keep the active substance in the natural plant crude drugs and the active ingredient of medical material effectively, improved the ratio of crude drug composition again greatly, make curative effect better; Solved the problem of Transdermal absorption simultaneously, onset is rapider, and prolongs the medicine resting period greatly, is convenient to take and carry.
3, the external preparation made from method of the present invention need not add the stabilizing agent of any chemosynthesis, and is safe in utilization, only need cleaning skin during use after, get final product in right amount; The present invention makes the production of Tibetan medicine realize industrialization by the reform of dosage form, and product also can be transported for long-distance and enter the international market towards huge numbers of families' patient.
4, compare with the preparation for the treatment of rheumatism, rheumatoid disease at present both at home and abroad, characteristics of the present invention are crude drug source uniquenesses, do not contain toxic component in the medical material, can not damage to human body.
5, the medicine of the present invention exterior-applied formulation that can be processed into is more, and transdermal effect is strong, can avoid the first pass effect that is directly produced by the oral intestines and stomach that causes.
The test example
For the safety that shows medicine of the present invention reaches the acute and chronic bruise, the therapeutic effect of rheumatism, rheumatoid disease has carried out the dependency experiment of this medicine, and is specific as follows.
Medicine is used in test: 22.7 parts of 9.1 parts of Radix Lamiophlomidis Rotataes, 4.5 parts of Herba Oxytropis Kansuensiss, 40.9 parts in Rhizoma Curcumae Longae, 13.6 parts in Pericarpium Zanthoxyli, 9.1 parts of Cornu Bubalis and Cacumen Myricariae Germanicaes.Above Six-element except that Pericarpium Zanthoxyli, Cornu Bubali are pulverized in addition, all the other four flavor cuttings, adds water 3000ml, decocts 1 hour, adds Pericarpium Zanthoxyli again, the Cornu Bubali fine powder stirs, and the lyophilization of reducing pressure is ground into fine powder, as medicated powder I; After water-soluble expand of polyacrylate 10g, gelatin 20g heating, the polyacrylate solution II that is mixed into homogeneous is standby; Medicated powder I1.2g or 2.4g are added glycerol 30ml mix homogeneously, add again among the polyacrylate solution II and stir, promptly make ointment.With the ointment softening non-woven fabrics backing of coating of heating, cover polyethylene film; Cut into 7cm * 9.5cm/ sheet, packing gets product.
Safety experiment:
One, skin acute toxicity test
Rabbit skin is shaved hair back grouping, and one group is the normal skin group, and another group is the damaged skin group, and normal skin and damaged skin group are pasted 1.2g and the 2.4g/ patch 2 that invention makes that loses money in a business respectively and pasted (about 150cm
2), fix 24 hours.Do not observe toxic reaction.
1. purpose: the rabbit acute toxicity of understanding the patch that external medicine of the present invention makes.
2. material:
Medicine: the patch that medicine of the present invention is made, concentration are that 1.2g and 2.4g/ paste;
Excipient, no pharmaceutical excipient pastes,
Animal: new zealand rabbit, male female half and half, body weight 2.0～2.8kg, available from Nat'l Pharmaceutical ﹠ Biological Products Control Institute's Experimental Animal Center, No. the 017th, the animal quality certification (2000).
3. method:
Send out animal skin studies on acute toxicity method execution in " study of tcm new drug guide " (pharmacy, pharmacology, toxicology) according to Ministry of Public Health new drug evaluation office.
Rabbit, the about 150cm of hair is shaved at test back the previous day
2Random packet, male and female half and half, totally 5 groups, 1: the lose money in a business patch group made of medicine of invention of normal skin 1.2g/, 2: the normal skin 2.4g/ patch group that the medicine of invention is made that loses money in a business, 3: the damaged skin 1.2g/ patch group that the medicine of invention is made that loses money in a business, 4: the lose money in a business patch group made of medicine of invention of damaged skin 2.4g/, 5: excipient group (normally reaching each 2 of damaged skin rabbit).
Damaged skin group: behind the rabbit skin of back ethanol disinfection, scratch before the experiment, be the checked spun antung shape, with cut oozing of blood, sepage degree of being with the sterilization syringe needle.
The medicines of each concentration more than 2 subsides are attached to other rabbit back of respective sets respectively shave the hair-fields, cover 2 layers of husky cloth on patch, the reuse layer of plastic film covers, the back immobilization with adhesive tape of breathing freely.Remove the external application medicine after 24 hours, observe animal local circumstance and general toxic reaction, observed continuously 7 days at duration of test.
4. result:
Rabbit is normal skin group or damaged skin group no matter, and tangible whole body abnormal response does not appear in part not show, swollen phenomenon yet after external application 1.2 and 2.4g/ lose money in a business the patch that the medicine of invention makes.
5. conclusion: the overt toxicity reaction does not appear in rabbit external application 1.2 and the 2.4g/ patch that the medicine of invention is made that loses money in a business.
Two, rabbit skin irritant test
Rabbit skin is shaved hair back grouping, and one group is the normal skin group, and another group is the damaged skin group, and normal skin and damaged skin group back side are pasted the 1.2g/ patch 1/2 that the medicine of invention makes that loses money in a business and pasted (about 40cm
2) and excipient, opposite side is contrast.Fix 6 hours.As a result, the patch made of medicine of the present invention is to rabbit skin nonirritant.
1. purpose: the skin irritation situation of understanding the patch that medicine of the present invention makes.
2. material:
Medicine: the patch that medicine of the present invention is made, concentration are that 1.2g/ pastes;
Excipient, no pharmaceutical excipient pastes.
Animal: new zealand rabbit, male female half and half, body weight 2.2～2.8kg, available from Nat'l Pharmaceutical ﹠ Biological Products Control Institute's Experimental Animal Center, No. the 017th, the animal quality certification (2000).
3. method:
Rabbit skin irritant test is carried out by skin irritation test determination in " study of tcm new drug guide " (pharmacy, pharmacology, toxicology).
Method: get 8 of rabbit, male and female half and half.Paste spinal column both sides, preceding 24 hours backs of medicine and lose hair or feathers about 150 square centimeters, be divided into normal skin group and damaged skin group, 4 every group, male and female half and half.With scratching epidermis with syringe needle behind the ethanol disinfection, become " well " shape before the experiment of damaged skin group.The upper left side is distinguished in contrast, pastes excipient and pastes half and paste, and the lower-left side is as being subjected to the examination district, pastes the 1.2g/ patch half that the medicine of invention makes that loses money in a business and pastes, and the right side is the own control district.Each district after pasting medicine above covering 2 floor gauze and 1 floor plastic sheeting, the reuse immobilization with adhesive tape of breathing freely.Paste behind the medicine to remove with warm water in 6 hours and tried thing, observe to remove and tried behind the thing respectively to be subjected to examination district skin to have or not situations such as erythema and edema in 1,24,48,72 hour.
4. the result judges that reacting standards of grading by the skin irritation of regulation in " research guide " marks.See Table 1 and table 2:
Table 1 skin irritation reaction scoring
| Irritant reaction | Score value |
| Erythema: | |
| No erythema | ??0 |
| Reluctantly as seen | ??1 |
| Obviously as seen | ??2 |
| Moderate is to serious erythema | ??3 |
| The aubergine erythema also forms with eschar | ??4 |
| Edema | |
| No edema | ??0 |
| Reluctantly as seen | ??1 |
| As seen (edge exceeds surrounding skin) | ??2 |
| Cutaneous protuberance 1mm, profile is clear | ??3 |
| Above and the expanded range of edema protuberance 1mm | ??4 |
| The highest point total value | ??8 |
Table 2 skin irritation intensity evaluation
| Mean scores | Estimate |
| ??0～0.49 | Nonirritant |
| ??0.5～2.99 | Slight zest |
| ??3.0～5.99 | The moderate zest |
| ??6.0～8.0 | Strong and stimulating |
5. result:
Paste the 1.2g/ patch that the medicine of invention makes that loses money in a business, the same with the excipient contrast, no matter be intact skin or damaged skin, irritant reaction does not all appear, and skin irritation reaction scoring is 0 minute, the genus nonirritant.Detailed results sees Table 3.
The lose money in a business patch skin irritation response situation (n=4) made of medicine of invention of table 3 rabbit external application 1.2g/
| Group | 1 hour | 24 hours | 48 hours | 72 hours |
| The normal skin group | ??0 | ??0 | ??0 | ??0 |
| The damaged skin group | ??0 | ??0 | ??0 | ??0 |
6. conclusion: the patch that medicine of the present invention is made is to rabbit skin nonirritant.
Three. skin anaphylactic test
Guinea pig back weekly external application 1.2g/ lose money in a business invention the patch made of medicine once, sensitization 3 times, last sensitization is after 14 days, the external application 1.2g/ patch that the medicine of invention makes that loses money in a business in back excites.The patch that result's medicine of the present invention is made does not have sensitization.
1. purpose: understand the patch that medicine of the present invention makes and have or not the sensitization of skin effect
2. material:
Medicine: the patch that medicine of the present invention is made, concentration are that 1.2g/ pastes;
2.4 dinitrofluorobenzene: as positive control drug, sensitization concentration is 1%, and exciting concentration is 0.1%.Be made into dehydrated alcohol.
Animal: 30 of albino guinea-pigs, average weight 210g, male and female half and half.Animal quality certification scxkc capital 2002-0005 is provided by Beijing section space animal cultivation center.
3. method:
The guinea pig skin hypersensitive test is carried out by skin anaphylactic test regulation in " study of tcm new drug guide " (pharmacy, pharmacology, toxicology).
Cavia porcellus is divided into 3 groups, and 10 every group, male and female half and half are established blank group (normal saline), positive controls (2.4 dinitrofluorobenzene) and the test group patch made of medicine of invention (1.2g/ lose money in a business).Preceding 24 hours of administration is shaved the about 3x3 square centimeter of hair in guinea pig back.
Sensitization contact: get and tried thing 1% fluorobenzene 0.2ml (positive controls) or normal saline 0.2ml and be applied to the left side and shave the hair-fields, volatilize naturally; The patch 20mm that the medicine of invention is made 1.2g/ lose money in a business
2, be attached to the left side and shave the hair-fields, ventilative immobilization with adhesive tape.Tried thing with the warm water flush away after 6 hours, the 7th, 14 day in kind repeats once.
Excite contact: after last sensitization 14 days, 0.1% fluorobenzene 0.2ml (positive controls) or normal saline 0.2ml are applied to depilation district, right side, volatilize naturally; The patch 20mm that the medicine of invention is made 1.2g/ lose money in a business
2, being affixed on depilation district, Cavia porcellus right side, surplus same sensitization test (STT) was tried thing with the warm water removal after last excites 6 hours, observed skin allergy then in 1,24,48,72 hour.The result judges by " research guide " and decides the execution of skin allergy standards of grading, sees Table 3 and table 4.
Table 3 skin allergy standards of grading
| The skin allergy situation | Score value |
| Erythema: | |
| No erythema | ??0 |
| Slight erythema, reluctantly as seen | ??1 |
| Moderate erythema, obviously as seen | ??2 |
| The severe erythema | ??3 |
| Aubergine erythema and eschar formation again | ??4 |
| Edema forms | |
| No edema | ??0 |
| Mild edema, reluctantly as seen | ??1 |
| Intermediate edema, obviously visible (edge exceeds skin) | ??2 |
| The severe edema, cutaneous protuberance 1mm, profile is clear | ??3 |
| Serious edema, cutaneous protuberance 1mm is above and expansion arranged | ??4 |
| The highest point total value | ??8 |
The classification of table 4 sensitization rate
| Sensitization rate (%) | Response strength |
| ??0～10 | No sensitization |
| ??11～30 | Weak sensitization |
| ??31～60 | Slight sensitization |
| ??61～80 | The moderate sensitization |
| ??81～100 | The height sensitization |
4. result:
Positive control treated animal sensitization rate is 100% as a result, and the severe erythema appears in skin, is the height sensitizer; Lose money in a business the not anaphylaxis such as show speckle of the patch group guinea pig skin made of medicine of invention of blank group group and 1.2g/, no sensitization.Detailed results sees Table 5.
The patch guinea pig skin hypersensitive test (n=10) that table 5 medicine of the present invention is made
| Group | Irritated number of animals | The sensitization classification |
| Blank | ??0 | No sensitization |
| The patch that medicine of the present invention is made | ??0 | No sensitization |
| Fluorobenzene | ??10 | High sensitization |
Conclusion: under this experimental condition, the lose money in a business patch made of medicine of invention of 1.2g/ does not have sensitization.
Clinical experiment and report:
The clinical efficacy of this medicine treatment scapulohumeral periarthritis has carried out the comparative study observation, now is summarized as follows:
One, materials and methods
1.1 it is tame hospitals in year July two in January, 2004 to 2004 (The 6th Hospital of Shanghai Jiao Tong University, the attached middle mountain hospital of Fudan University in Shanghai) outpatient service and inpatients that case is selected whole cases, amount to 198 routine patients, clinical employing simple randomization digital watch method is divided into groups, and the patient that will meet diagnostic criteria is divided into treatment group and matched group at random.Wherein treatment group patient 99 examples (six institutes, 52 examples, middle mountain 47 examples.Comprise male's 51 examples, women's 48 examples; Age distribution is under-21 person 2 examples, 21-30 8 examples between year, 31-40 13 examples between year, 41-50 22 examples between year, 51-60 27 examples between year, 61-70 16 examples between year, person's 11 examples more than 70 years old, minimal ages 16 years old, maximum 84 years old age, 46.75 ± 15.38 years old mean age), matched group patient 99 examples (six institutes, 48 examples, middle mountain 51 examples.Comprise male's 57 examples, women's 42 examples, age distribution is: under-21 person 0 example, 21-30 8 examples between year, 31-40 16 examples between year, 41-50 23 examples between year, 51-60 26 examples between year, 61-70 20 examples between year, person's 6 examples more than 70 years old, minimal ages 21 years old, maximum 78 years old age, 44.05 ± 13.62 years old mean age).
1.1.1 two groups of case sexes, age distribution situations see Table 6 and table 7
Table 6 liang group sex distribution situation relatively
| Group | The example number | The man | The woman |
| Treatment group matched group adds up to | ????99 ????99 ????198 | ????51 ????57 ????108 | ????48 ????42 ????90 |
Two groups of sex ratios, x is analysed in credit by statistics
2=0.5, p＞0.05, difference does not have significance.
Table 7 liang group age distribution situation relatively
| Group | ＜21 years old | 21～30 years old | 31～40 years old | ????41～50 | 51～60 years old | 61～70 years old | ??＞70 |
| Treatment group matched group adds up to | 2 0 2 | ??8 ??8 ??16 | ??13 ??16 ??29 | ????22 ????23 ????45 | ??27 ??26 ??53 | ??16 ??20 ??36 | ??11 ??6 ??17 |
Two groups of age ratios, x is analysed in credit by statistics
2=4.26, p＞0.05, difference does not have significance.
1.2 method
The treatment group: liniment is the patch that the medicine of the invention described above is made.
After the illing skin cleaning, be affixed on the affected part, whenever sticked 24 hours, once a day, continuous five days is a course of treatment, finishes the back observe the curative effect course of treatment.
Matched group: medicine for external application is diclofenac (Novartis Pharma AG's product).With after the illing skin cleaning, latex cream is extruded as forefinger length, then evenly be applied in the affected part about 3 minutes, up to drug osmotic till subcutaneous.Every day 3 times, continuous five days is a course of treatment, finishes the back observe the curative effect course of treatment.
1.3 the standard of including in
According to observing requirement, the patient of all treatment groups and matched group is inactive all other pain relieving class Chinese and western drugses during using observation medicine and control drug.The following principle of including in exclusion standard is all followed in this clinical observation research:
1) meet the diagnostic criteria of scapulohumeral periarthritis, the course of disease at one month with interior person;
2) age-sex does not limit;
3) inactive other therapies during accepting this demonstration test.
Exclusion standard:
1) viewing duration uses other externally-used pain-relieving class medicines simultaneously;
2) tangible skin allergy person is arranged;
3) anemia of pregnant woman or allergic constitution person;
4) disease sites has skin injury or inflammation person;
5) medication according to the rules, judgement person affects the treatment.
1.4 criterion of therapeutical effect
With reference to Shanghai Health Bureau's writing it " Shanghai City traditional Chinese medical science disease conventional treatment " (2003 the 2nd edition, the publication of publishing house of Shanghai Univ. of Traditional Chinese Medicine) the curative effect judgment criteria of relevant scapulohumeral periarthritis is divided into healing and (contains produce effects, be that shoulder pain disappears, shoulder joint function recovers fully or substantially; VAS 〉=80% or tenderness is arranged slightly); Taking a turn for the better, (shoulder pain alleviates, and movable function improves; 80%＞VAS＞40% or tenderness is arranged slightly) and invalid (VAS≤40%, symptom and sign do not have change).
Pain is observed and is adopted VAS vision analogy scale, divides between being divided by 100-0 successively without any pain from extremely violent pain.
Tenderness, joint function disturbance are observed respectively with 3 (no tenderness, the shoulder joint activity does not have the manifest function obstacle), 2 (mild tenderness, the shoulder joint activity has dysfunction slightly), 1 (moderate tenderness, the shoulder joint activity is than the manifest function obstacle) and 0 (severe tenderness, shoulder joint activity manifest function obstacle) keep the score, estimate once every day.
Two groups of all data all utilize SASS mathematical statistics software to carry out Data Management Analysis, relatively between two groups zero difference to be arranged.
Two, therapeutic outcome
Two groups of therapeutic outcomes see Table 8.
Table 8 liang group therapeutic outcome relatively
| Group (example) | Cure (example; %) | Produce effects (example; %) | (example takes a turn for the better; %) | Invalid (example; %) | Total effective rate (%) | Cure-remarkable-effectiveness rate (%) |
| Treatment group (99) matched group (99) | ??12(12.12) ??7(7.07) | ??60(60.61) ??30(30.31) | ??19(19.19) ??41(41.41) | ??8(8.08) ??21(21.21) | ??91.92 ??78.79 | ??72.73 ??37.38 |
Two groups of total effective rates are respectively treatment group 91.92%, matched group 78.79%; Obvious effective rate is respectively treatment group 72.73%, matched group 37.37%.Analyze through Ri dit, U=4.93P＜0.01, treatment group curative effect obviously is better than matched group.
[discussion]
1, scapulohumeral periarthritis is the common clinical frequently-occurring disease, and Therapeutic Method is a lot of, and curative effect is different.During The 6th Hospital of Shanghai Jiao Tong University and Fudan University in Shanghai are attached mountain hospital use respectively the patch of making by medicine of the present invention treat 99 routine scapulohumeral periarthritis patients and with 99 routine matched groups relatively, obtained satisfied curative effect.
2, the effect of the patch made of medicine of the present invention with blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain and dredging the meridian.
3, as can be seen from clinical observation result, the patch that medicine of the present invention is made is respectively 91.92% and 72.73% to the total effective rate and the obvious effective rate of scapulohumeral periarthritis treatment, illustrate that its treatment to this disease has good effect, treatment group and matched group compare, and credit is analysed by statistics, P＜0.05, treatment group comparative control group, the onset of treatment group rapidly and analgesic effect more obvious, the good clinical using value is arranged, be fit to clinically extensively promote the use of.
The clinical efficacy of the patch treatment osteoarthritis that medicine of the present invention is made has carried out the comparative study observation, now is summarized as follows:
One, material and method
1, case is selected
From in May, 2004～2004 year August, select outpatient service or osteoarthritis patient's 200 examples of being in hospital are carried out the clinical contrast observation, all patients all conform to the osteoarthritis diagnostic criteria that U.S. rheumatoid association works out.Get rid of following situation: external used medicine allergies person; The digestive tract ulcer person; Gestation or nursing women; Serious viscera illness; The local skin condition is poor; The similar analgesic drug product person of recent application; Noncooperationist etc.200 routine patients are divided into 2 groups at random, i.e. treatment group (patch that medicine of the present invention is made) and matched group (diclofenac emulsion), every group of each 100 routine patient.Wherein male 47 examples are organized in treatment, women 53 examples, 36～97 years old age, average 62.5 ± 4.83 years old.Male 48 examples are organized in treatment, women 52 examples, 38～90 years old age, average 60.8 ± 5.12 years old.
2, Therapeutic Method
Clean the knee joint local skin before all patient's medications, the treatment group is used patch that medicine of the present invention makes and is affixed on and suffers from the knee joint part, and paste every day 1, and 5 days is a course of treatment.The control group diclofenac emulsion (Novartis Pharma AG's product) is applied in suffers from the knee joint part, each 2～3g, and every day 2 times, 5 days is a course of treatment.
3, observation index and efficacy determination
The outpatient adopts phone to follow up a case by regular visits to and outpatient service reservation follow-up method, and the inpatient observes pain every day and changes.Pain variation before and after the recording medicine, articular pain and mobility are improved situation respectively.With Huskission pain range estimation integration method (VAS); Tenderness integration 4 degree, 1 is painless, and 2 is tenderness, and 3 are the pain of frowning, and 4 for escaping; Calculate with integration X100% before formula (medication before integration-medication after integration)/medication, judge the improvement degree after trying to achieve average.Produce effects: improvement degree 〉=75%; Effectively: 50%≤improvement degree≤75%; Invalid :≤50%, total effective rate=(produce effects+effectively)/total routine number.
4, check
Adopt the t check.Get α=0.05.
If H
0: μ
1=μ
2(the treatment group is identical with the population mean of matched group curative effect)
H
1: μ
1≠ μ
2(the treatment group is different with the population mean of matched group curative effect)
According to t check formula, calculate t=4, t dividing value=3.34 of tabling look-up, as seen, and t＜3.34, α=0.05 level is pressed in P＞0.05, refusal H
0, accept H
1, the difference of promptly comparing has statistical significance, and matched group＜treatment group.
Two, result
Efficacy evaluation
1, pain all has clear improvement after treatment group and the treatment of control group.Articular pain and joint motion also have improvement.Concrete condition sees attached list 9.
Table 9 treatment group and matched group doing well,improving are relatively
| Group | Pain (VAS scoring) is improved | Tenderness and joint motion improve scoring |
| Treatment group matched group | ??60.8％ ??50.1％ | ??39.8％ ??30.5％ |
Treatment group pain, tenderness and joint motion improve significantly better than matched group.T checks P＜0.05, presses α=0.05 level, refusal H
0, accept H
1, the difference of comparing has statistical significance.
2, treatment group and matched group curative effect relatively the results are shown in Table 10.
Table 10 treatment group and matched group curative effect are relatively
| Group | Produce effects (%) | Effectively (%) | Invalid (%) | Total effective rate |
| Treatment group matched group | ??17(17％) ??13(13％) | ??65(65％) ??44(44％) | ??18(18％) ??43(43％) | ??82％ ??57％ |
Through the Ridit check, U=4.86 P＜0.01, two group curative effect compares, and the treatment group obviously is better than matched group
Three, untoward reaction
Treatment group and matched group are during treating, and obvious adverse reaction does not all take place all patients
Four, discuss
This group patient is the osteoarthritis patient, uses patch and diclofenac emulsion contrast carrying out clinical observation on the therapeutic effect that medicine of the present invention is made.The result shows that two kinds of external used medicines all have certain therapeutic effect to the osteoarthritis patient, and treatment group and matched group are to patient and joint motion improvement situation is marked and comprehensive therapeutic effect compares, and result's credit by statistics analyses, and the treatment group is better than matched group, P＜0.05.Clinical value is preferably arranged.
Treatment group and matched group are during treating, and the patch pain relieving clinical experiment report that obvious adverse reaction medicine of the present invention is made does not all take place all patients:
The experimenter is outpatient service and inpatient, and clear and definite clinical diagnosis is arranged, and observes 229 routine patients altogether, adopts random packet, selects 160 examples to organize as treatment, and 69 examples are organized in contrast.Two groups of harmonious inspections are as follows:
One, sex: see Table 11.
Table 11 experimenter sex distribution situation (example)
| Group | The example number | The man | The woman | ??X2 |
| Treatment group matched group | ??160 ??69 | ??103 ??47 | ??57 ??22 | ??0.30 |
Two groups of experimenter's sex distributional difference nonsignificance P＞0.05.
Two, the age: see Table 12.
Table 12 subject age distribution situation (year)
| Group | ??20 | ??21-35 | ??36-50 | ??51 | ??X2 | |
| The treatment group | ??31 | ??53 | ??58 | ??18 | ??1.53 | |
| Matched group | ??12 | ??19 | ??27 | ??11 |
Two groups of subject age distributional difference nonsignificance P＞0.05.
[case selection]
One, selection of clinical is because of acute and chronic soft tissue injury, hyperosteogeny, and arthritis, diseases such as scapulohumeral periarthritis are planted local joint, the myalgia case that causes.
Two, pain degree standard: branch 1,2,3, level.
I level: pain symptom is arranged, but do not influence operate as normal, can be engaged in normal activity.
The II level: pain symptom is obvious, influences work.
The III level: pain symptom is heavier, and local joint motion is fallen into, and influences work and life.
[Therapeutic Method]
The random packet counter point is adopted in clinical research
One, treatment group
Get the clear and definite case of above-mentioned diagnosis 160 examples at random, used medicine is the patch that medicine of the present invention is made.Directly be attached to affected part, 24 hours is a course of treatment.Two days observing times.
Two, matched group
Get the clear and definite case of above-mentioned diagnosis 69 examples at random, used medicine is commercially available Musk Analgesic Plaster (Jing Zhou, Hubei medical material factory, a specification 7 * 10CM).
Two days observing times.
Three, observation item
1, comprehensive therapeutic effect is observed.
2, pain intensity of variation, pain palliation efficacy behind onset time, duration of efficacy, the medicine behind the medicine.
3, other reactions after the medication.
Four, the criterion of onset time, duration of efficacy behind the medicine:
To begin medication to the conscious pain degree of experimenter begins to change and is decided to be onset time behind the medicine during this period of time; To begin in the onset to two day once more pain begins outbreak and is duration of efficacy during this period of time; The pain person of not reaccessing after the medication, duration of efficacy is decided to be 36 hours.
Five, curative effect determinate standard:
Produce effects: in the medication 48 hours, mainly state transference cure and show as: agents area is swollen to disappear, pain is ended, functional rehabilitation.
Effectively: in the medication 48 hours, mainly state sx and show as: pain and swelling alleviate, and function is recovered substantially.
Invalid: in the medication 48 hours, the main symptom no change of stating, swollen, pain does not have and takes a turn for the better, and function is not seen recovery.
[therapeutic outcome]
One, total effects analysis: see Table 13.
Table 13 total effects is (example) relatively
| Group | Total routine number | Produce effects | Effectively | Invalid | Total effective rate | The u value |
| Treatment group matched group | ??160 ??69 | ??92 ??12 | ??61 ??31 | ??7 ??27 | ??95.6％ ??62.3％ | ??6.265 |
As seen from the above table, two groups of comparing results are analyzed through Ridit, treatment group curative effect highly significant be better than matched group P＜0.01.
Two, onset time, the relative analysis of holding time behind two groups of medicines: see Table 14.
Onset time behind the table 14 liang group medicine, the relative analysis of holding time (X ± SD)
| Group | Onset time behind the medicine (minute) | Duration of efficacy (hour) |
| Treatment group matched group | ??25.17±7.46 ??47.45±11.63 | ??29.23±5.52 ??10.55±3.97 |
| T value | ??17.45 | ??25.42 |
As seen from the above table, behind the treatment group medicine onset time highly significant be shorter than matched group P＜0.01.The duration of efficacy highly significant be longer than matched group P＜0.01.
[discussing and conclusion]
1, treats acute and chronic soft tissue injury, hyperosteogeny, arthritis by the above patch that medicine of the present invention is made, curative effect of disease results of study such as scapulohumeral periarthritis show, this medicine has good combined therapy effect, and obvious effective rate reaches 57.5%, far above 17.39% of matched group.The patch total effective rate that medicine of the present invention is made is 95.6%, and matched group is 62.3%.By statistics credit analyse the treatment group the curative effect highly significant be better than matched group P＜0.01.
2, the patch made of medicine of the present invention is a principle of utilizing the modern medicine Transdermal absorption, during local the use medicine stripping fast, penetration is strong, therefore reaches the effect of quickly alleviating pain.Treatment organizes that onset time is 25.17 ± 7.46 minutes behind the average medicine, and what the highly significant of onset time behind the medicine of treatment group was analysed in credit by statistics is shorter than matched group P＜0.01.Illustrate that this medicine onset is rapid.
3, the patch made of medicine of the present invention has tangible blood circulation promoting and blood stasis dispelling, the channels sootheing and network vessel quickening effect, and the pain that a variety of causes is caused all has the effect of effecting a permanent cure, and meets the treatment principle of " general rule is not bitterly ".Treatment group duration of efficacy is compared obvious prolongation with matched group, by statistics credit analyse the treatment group the duration of efficacy highly significant be longer than matched group P＜0.01.Illustrate that this medicine analgesic effect is lasting.
4, through our clinical research, the patch that medicine of the present invention is made has very excellent curative, and is rapid-action, and effect is lasting, and is easy to use, and advantage such as have no adverse reaction is suitable for clinical expansion and uses.
The specific embodiment
Further specify characteristics of the present invention below by specific embodiment.
Example 1
This example is the preparation emplastrum.Proportioning raw materials is as follows:
Radix Lamiophlomidis Rotatae 9.1 weight portions, Herba Oxytropis Kansuensis 4.5 weight portions, Rhizoma Curcumae Longae 40.9 weight portions, Pericarpium Zanthoxyli
13.6Weight portion, Cornu Bubali
9.1Weight portion, Cacumen Myricariae Germanicae 22.7 weight portions
Preparation method is as follows:
Pericarpium Zanthoxyli, Cornu Bubali powder are broken into the fine powder of 50 μ m.Four flavor choppings such as all the other Radix Lamiophlomidis Rotataes decoct with water 0.5 hour, add above-mentioned fine powder again, stir evenly, and are placed to room temperature, and drying is taken out, and is ground into fine powder.Fine powder is packed in the non-woven bag, seal, stick at and make emplastrum on the adhesive plaster, packing promptly.
Example 2
This example is that preparation is that the ointment proportioning raw materials is as follows:
Radix Lamiophlomidis Rotatae 9.1 weight portions, Herba Oxytropis Kansuensis 4.5 weight portions, Rhizoma Curcumae Longae 40.9 weight portions, Pericarpium Zanthoxyli 13.6 weight portions, Cornu Bubali 9.1 weight portions and Cacumen Myricariae Germanicae 22.7 weight portions.
Preparation process is as follows:
Pericarpium Zanthoxyli, Cornu Bubali powder are broken into the fine powder of 0.1 μ m.Four flavor choppings such as all the other Radix Lamiophlomidis Rotataes decocted 3 hours with vinegar, added above-mentioned fine powder again, stirred evenly, and were placed to room temperature, and drying is taken out, and is ground into fine powder.With fine powder and ointment base mixing and emulsifying, stirring, make ointment, packing is promptly.
Described ointment base is the mixture of Tween 80 5g, liquid paraffin 12g, glycerol 12g, antiseptic 0.2g etc., and itself and medicament mixed are made ointment.
Example 3
This example is the preparation cataplasma, and proportioning raw materials is as follows:
Radix Lamiophlomidis Rotatae 11 weight portions, Herba Oxytropis Kansuensis 5.5 weight portions, Rhizoma Curcumae Longae 28 weight portions, Pericarpium Zanthoxyli 16.5 weight portions, Cornu Bubali 11 weight portions, Cacumen Myricariae Germanicae 28 weight portions.
Preparation process is as follows:
Pericarpium Zanthoxyli, Cornu Bubali powder are broken into 200 μ m fine powders.Four flavor choppings such as all the other Radix Lamiophlomidis Rotataes add ethanol and decocted 1 hour, add above-mentioned fine powder again, stir evenly, and are placed to room temperature, and drying is taken out, and is ground into fine powder.With fine powder and ground substance of plaster ointment mixing and emulsifying, stirring, be coated with, cut, packing promptly gets cataplasma.
Described ground substance of plaster ointment has:
Gelatin 12g, polyacrylate 6g, glycerol 25g, BASF glue 40g, tragcanth 8g mix, and make catablasm base material through stirring,
Ratio: medicated powder: substrate weight ratio 1: 4
Claims (8)
1, the Tibetan medicine of a kind for the treatment of acute and chronic bruise, rheumatism, rheumatoid disease is characterized in that it is the medicament of being made by following materials based on weight:
Radix Lamiophlomidis Rotatae 5-15 part, Herba Oxytropis Kansuensis 2-10 part, Rhizoma Curcumae Longae 15-60 part, Pericarpium Zanthoxyli 7-20 part, Cornu Bubali 5-15 part and Cacumen Myricariae Germanicae 15-40 part.
2, Tibetan medicine according to claim 1 is characterized in that described raw material weight umber is:
Radix Lamiophlomidis Rotatae 8-13 part, Herba Oxytropis Kansuensis 3-8 part, Rhizoma Curcumae Longae 20-50 part, Pericarpium Zanthoxyli 10-20 part, Cornu Bubali 8-13 part and Cacumen Myricariae Germanicae 20-35 part.
3, Tibetan medicine according to claim 1 is characterized in that described raw material weight umber is:
22.7 parts of 9.1 parts of Radix Lamiophlomidis Rotataes, 4.5 parts of Herba Oxytropis Kansuensiss, 40.9 parts in Rhizoma Curcumae Longae, 13.6 parts in Pericarpium Zanthoxyli, 9.1 parts of Cornu Bubalis and Cacumen Myricariae Germanicaes.
4,, it is characterized in that said medicament is a said dosage form on any pharmaceutics according to claim 1,2 or 3 described Tibetan medicines.
5, Tibetan medicine according to claim 4 is characterized in that said medicament is external preparation or oral formulations.
6, Tibetan medicine according to claim 4 is characterized in that making and comprises ointment, cataplasma, spray, gel, liniment or resin external preparation and the oral formulations in being attached to.
7, the preparation method of the described Tibetan medicine of claim 4, it is characterized in that Pericarpium Zanthoxyli, Cornu Bubali powder are broken into 0.01-200 μ m fine powder, all the other Radix Lamiophlomidis Rotataes, Herba Oxytropis Kansuensis, Rhizoma Curcumae Longae and Cacumen Myricariae Germanicae four flavor choppings add water, ethanol or vinegar and decocted 0.5-3 hour, add above-mentioned fine powder again, stir evenly, be placed to room temperature, drying, take out, be ground into fine powder,, make said dosage form on the pharmaceutics according to conventional method.
8, method according to claim 7, it is characterized in that Pericarpium Zanthoxyli, Cornu Bubali powder are broken into 0.01-200 μ m fine powder, all the other Radix Lamiophlomidis Rotatae Herba Oxytropis Kansuensiss, Rhizoma Curcumae Longae and Cacumen Myricariae Germanicae four flavor choppings, adding water, ethanol or vinegar decocted 0.5-3 hour, add above-mentioned fine powder again, stir evenly, put into the aluminum dish after reducing to room temperature, go into the vacuum freezing storehouse, be cooled to-15 ℃--40 ℃.The beginning evacuation, the taking-up that opens a position after 10-24 hour is pulverized, and according to a conventional method medicated powder is made said dosage form on any pharmaceutics.
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