CN102688450A - Local use antalgic traditional Chinese medicine composition as well as preparation method and application thereof - Google Patents
Local use antalgic traditional Chinese medicine composition as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a local use antalgic traditional Chinese medicine composition, which is prepared by twelve types of crude drugs including raw sichuan axonite roots, raw wild aconite, raw rhizoma arisaematis, safflower, zedoary, borneol, olibanum, myrrh, curcuma, cloves, asarum, red peony roots. Besides, the invention further discloses a preparation method for the traditional Chinese medicine composition which has the antalgic function after being locally applied.
Description
Technical field
The invention belongs to the Chinese medicine technical field, more particularly, it is local with Chinese medicine composition to relate to a kind of analgesic.
Background technology
Human body is an organic whole, and the interior environment and the external environment of body is unified mutually, and what the physiology of human body and pathology all can be direct and indirect reflects, can be through the red medicated wine oral administration and externally of cream to reach the purpose of regulating negative and positive, strengthening vital QI to eliminate pathogenic factors.
" interior warp " said: " institute of heresy gathers, and its gas must be empty, and in healthy energy was deposited, heresy can not be done " Tang Rongchuan say again " the inclined to one side Sheng of the gas of human body declines partially; then give birth to disease " " if people is sick, is due to the inclined to one side Sheng of negative and positive the four stages in the course of an epidemic febrile disease declines partially, life all kinds of diseases and ailments, the disease inside and outside nothing but; the disease of human five internal organs's six internal organs, the disease of human five internal organs's six internal organs, but also treatment by oral administration of medicines; but also external treatment, Chinese medicine, effect is better ".
Food is gone into stomach, assimilates through gastrointestinal, supports in the essence of water and grain in the vital organs of the human body, outer auxilliary supporting in the anti-hair of muscles and bones, and extremity bones of the body collectively, endo-medicine are also like this, with the through sick institute of the property of medicine.
Prince is flourish through secular medical practice; Be blended in handed down from the older generations of the family reaching on the classical works bases such as " interior warp ", treatise on Febrile Diseases, " Medical Treasures of the Golden Chamber "; Recognize that motherland's medical science is abundant precious deposits, the several generations teaches others by his own example through oral instructions, development and abundant in realizing one by one; From the very long years, progressively sum up the perfect inner disease outer treat of a cover again, the unmatched medicine series of disease in the external treatment.
Unmatched cream, its prescription amount to 58 flavor medical materials Olibanum, Myrrha, Herba Asari etc. and are prepared from; Its function cures mainly and is wind-expelling and dispelling dampness, promoting blood circulation by removing blood stasis, and reducing swelling and alleviating pain, removing the necrotic tissue and promoting granulation, heat clearing away is drawn out pus by applying a plaster to the affected part, numbness relieving and pain relieving; Be used for traumatic injury, rheumatic numbness, waist shoulder skelalgia, furuncle congestion and swelling pain.
The present inventor has further developed a kind of analgesic part that is used for and has used Chinese medicine composition on the basis of existing technology.
Summary of the invention
The present invention further develops and provides a kind of analgesic part to use Chinese medicine composition on the basis of existing technology.
The purpose of this invention is to provide a kind of analgesic part and use Chinese medicine composition.
Second purpose of the present invention provides the method for preparing of above-mentioned Chinese medicine composition.
The 3rd purpose of the present invention provides the purposes of above-mentioned Chinese medicine composition.
The 4th purpose of the present invention provides the detection method of above-mentioned Chinese medicine composition.
Specifically, the invention provides that a kind of analgesic is local uses Chinese medicine composition, is that the medical material following weight portion proportioning is prepared from:
In a kind of embodiment preferred of the present invention, the invention provides that a kind of analgesic is local uses Chinese medicine composition, be that the medical material following weight portion proportioning is prepared from:
In a kind of preferred embodiment of the present invention, the invention provides that a kind of analgesic is local uses Chinese medicine composition, be that the medical material following weight portion proportioning is prepared from:
In a kind of particularly preferred embodiment of the present invention, the invention provides that a kind of analgesic is local uses Chinese medicine composition, be that the medical material following weight portion proportioning is prepared from:
In embodiments of the invention, the local regulation that meets the Pharmacopoeia of the People's Republic of China (version in 2010) with the medical material that relates in the Chinese medicine composition of analgesic of the present invention.
In embodiment provided by the invention; The local preparation that can prepare external preparation for skin with Chinese medicine composition of analgesic of the present invention; Randomly; Can be prepared into liniment, lotion, liniment, ointment, ointment, gel, plaster, aerosol, spray or emplastrum, preferably, process liniment.
In embodiments of the invention, above-mentioned Chinese medicine composition provided by the invention comprises acceptable accessories further.For a person skilled in the art, according to the dosage form requirement of above-mentioned Chinese medicine composition, select acceptable accessories for use.
Pain relieving local topical Chinese medicine composition provided by the invention cures mainly limbs pain, swelling, the congestion that causes because of wound or wind-cold damp pathogen; Movable unfavorable disease such as grade; SHENGCAO in the side and Radix Aconiti, the big hot goods of Rhizoma Arisaematis Da Xin dispel the wind by hygropyrexia through collateral dredging, and dispersing cold for relieving pain is a monarch drug.With the passing of time three medicines are overworked for a very long period to exertin and muscle and tendon injury person has remarkable alleviating pain, numbness, recover the effect of limb activity.Be equipped with the article of blood circulation promoting and blood stasis dispelling such as Flos Carthami, Radix Paeoniae Rubra, Rhizoma Curcumae Longae, Rhizoma Curcumae, Olibanum, Myrrha, promoting blood circulation to remove obstruction in the collateral, the repercussive pain relieving is to be ministerial drug.The kind especially promoting blood circulation to remove blood stasis of Olibanum, Myrrha wherein, subduing swelling and relieving pain is strengthened the merit of our pain relieving.Flos Caryophylli, Herba Asari, Borneolum Syntheticum have the property that Xin Xiang walks to scurry; Both can help blood circulation and stasis-eliminating medicine to strengthen the effect of promoting blood circulation, dredging meridian and relieving pain, and can guide full presciption medicine power to permeate in muscle, muscle arteries and veins, with the pain relieving of curing the wound again by the skin table; So be adjuvant, all medicines share the merit of playing blood circulation promoting and blood stasis dispelling, tonneau passages through which vital energy circulates, reducing swelling and alleviating pain altogether.Be one and put the analgesic efficacious prescriptions outward on the skin.
On the other hand, the invention provides the method for preparing of above-mentioned Chinese medicine composition, comprise the steps:
(1) Radix Aconiti, Radix Aconiti Kusnezoffii, Rhizoma Arisaematis, Flos Carthami, Rhizoma Curcumae, Olibanum, Myrrha, Rhizoma Curcumae Longae, Flos Caryophylli, Herba Asari and Radix Paeoniae Rubra ten are ground into coarse powder simply;
(2) add an amount of (0.1-8 of crude drug gross weight times of 50-95 volume % (being preferably 75 volume %) ethanol water; Or 1000-5000 part) immersion (was preferably 3-100 hour in 1-168 hour; It more preferably is 20-80 hour); (this ethanol water is 0.1-8 a times of crude drug gross weight, or 1000-5000 part with 50-95 volume % ethanol water according to the percolation (appendix IO) under the Pharmacopoeia of the People's Republic of China (version in 2010) fluid extract and the extractum item; Be preferably 3000 parts) for solvent, (flow-control press 1000g medical material per minute and flowed out 1-12ml, preferably 2-10ml percolate calculating) percolation slowly; Collect percolate, leave standstill, filter; Filtrating adds Borneolum Syntheticum and dissolving, and then with mixing acceptable accessories, (used ethanol is 30-99 volume % for example to add ethanol water; 2500ml), process required preparation (for example liniment).
The third aspect, pain relieving of the present invention part has hard masses softening and resolving with Chinese medicine composition, reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, the effect of tonneau passages through which vital energy circulates; Be used for acute and chronicly turning round, dampening, the pain that hyperosteogeny, chilblain and lumbar intervertebral disc are deviate to cause.Chinese medicine composition provided by the invention can be smeared and external or stick through skin, administration every day 3 to 4 times, and external is coated with the affected part.
Fourth aspect the invention provides the detection method of above-mentioned Chinese medicine composition, comprises the character of Chinese medicine composition is done check, and the circumstances in which people get things ready for a trip of going forward side by side spectrum is differentiated.When above-mentioned Chinese medicine composition was liniment, its detection method comprised:
[character] these article are brown xanchromatic liquid, and putting for a long time to have trace muddy; Gas is special;
These article are got in [discriminating] (1), and as need testing solution, other gets Rhizoma Curcumae Longae control medicinal material 1g, adds ethanol 10ml, and jolting was flooded 2 hours, filter, and filtrating is as control medicinal material solution; Test according to the Pharmacopoeia of the People's Republic of China (version in 2010) thin layer chromatography; Drawing need testing solution 5 μ l and control medicinal material solution 2 μ l puts respectively on same silica gel g thin-layer plate; With chloroform-methanol (volume ratio 9.4: 0.6) is developing solvent, launches, and takes out; Dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get these article 30ml, put in the evaporating dish, steam to about 5ml, add dilute hydrochloric acid 2ml, mixing filters, and filtrating transfers to alkalescence with the sodium hydroxide saturated solution, with ethanol jolting picked-up 2 times, and each 10ml.Merge ether solution, volatilize, residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution; Other gets the aconitine reference substance, adds dehydrated alcohol and processes the solution that every 1ml contains 2mg, as reference substance solution, according to the test of the Pharmacopoeia of the People's Republic of China (version in 2010) thin layer chromatography.Draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, smoke about 5 minutes with the ammonia steam after; With ether-petroleum ether (60-90 ℃) (volume ratio 4: 1) is developing solvent, puts in the chromatography cylinder of ammonia saturated with vapor, launches; Take out, dry, spray is with the potassium iodide iodine test solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Chinese medicine composition of the present invention has the effect of hard masses softening and resolving, reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, tonneau passages through which vital energy circulates through the test of pesticide effectiveness and clinical trial proof; Can be used for acute and chronic bruise, hyperosteogeny, chilblain and lumbar intervertebral disc are deviate from pain.
The specific embodiment
In embodiments of the invention, except that special declaration, said alcoholic acid percentage ratio is meant percent by volume.
Embodiment 1
Method for preparing: above 12 flavors, except that Borneolum Syntheticum, all the other ten are ground into coarse powder simply; Add 75% soak with ethanol 24 hours of 1 times of amount of crude drug, (appendix IO) is solvent with 75% ethanol 3000g according to the percolation under fluid extract and the extractum item, and the speed that flows out the 3ml percolate by 1000g medical material per minute is carried out percolation; Collect percolate, leave standstill, filter; Filtrating adds Borneolum Syntheticum and dissolving, processes 2500ml, promptly gets.
Embodiment 2
Method for preparing: above 12 flavors, except that Borneolum Syntheticum, all the other ten are ground into coarse powder simply; Add 72% soak with ethanol 48 hours of 1 times of amount of crude drug, (appendix IO) is solvent with 72% ethanol 30000g according to the percolation under fluid extract and the extractum item, and the speed that flows out the 4ml percolate by 1000g medical material per minute is carried out percolation; Collect percolate, leave standstill, filter; Filtrating adds Borneolum Syntheticum and dissolving, processes 25500ml, promptly gets.
Embodiment 3
Method for preparing: above 12 flavors, except that Borneolum Syntheticum, all the other ten are ground into coarse powder simply; Add 73% soak with ethanol 24 hours of 1 times of amount of crude drug, (appendix IO) is solvent with 73% ethanol 3000g according to the percolation under fluid extract and the extractum item, and the speed that flows out the 8ml percolate by 1000g medical material per minute is carried out percolation; Collect percolate, be concentrated into the thick paste shape, add Borneolum Syntheticum and dissolving; Add lanoline and vaseline then, mixing promptly gets.
Embodiment 4
The detection method of the embodiment of the invention 1 liniment comprises:
[character] these article are brown xanchromatic liquid, and putting for a long time to have trace muddy; Gas is special;
These article are got in [discriminating] (1), and as need testing solution, other gets Rhizoma Curcumae Longae control medicinal material 1g, adds ethanol 10ml, and jolting was flooded 2 hours, filter, and filtrating is as control medicinal material solution; Test according to the Pharmacopoeia of the People's Republic of China (version in 2010) thin layer chromatography; Drawing need testing solution 5 μ l and control medicinal material solution 2 μ l puts respectively on same silica gel g thin-layer plate; With chloroform-methanol (volume ratio 9.4: 0.6) is developing solvent, launches, and takes out; Dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get these article 30ml, put in the evaporating dish, steam to about 5ml, add dilute hydrochloric acid 2ml, mixing filters, and filtrating transfers to alkalescence with the sodium hydroxide saturated solution, with ethanol jolting picked-up 2 times, and each 10ml.Merge ether solution, volatilize, residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution; Other gets the aconitine reference substance, adds dehydrated alcohol and processes the solution that every 1ml contains 2mg, as reference substance solution, according to the test of the Pharmacopoeia of the People's Republic of China (version in 2010) thin layer chromatography.Draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, smoke about 5 minutes with the ammonia steam after; With ether-petroleum ether (60-90 ℃) (volume ratio 4: 1) is developing solvent, puts in the chromatography cylinder of ammonia saturated with vapor, launches; Take out, dry, spray is with the potassium iodide iodine test solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Pharmacodynamics test
The liniment of the embodiment of the invention 1 is to the inhibitory action experiment of rat assist agent arthritis; On Carrageenan property foot is opened up the influence experiment of swelling, and to 2, what the 4-dinitrochlorobenzene caused the Mice Auricle SDH influences experiment and experiment of analgesic.The result shows that the liniment of embodiments of the invention 1 can obviously suppress adjuvant-induced arthritis model toes swelling rate; Suppress chondrus ocellatus Holmes colloidality toes swelling rate; Can obviously suppress mice, 4-dinitrochlorobenzene induced mice auricle delayed hypersensitive reaction because of 2; Tangible analgesic effect is arranged.
One, material
(1) medicine and reagent
The liniment of the embodiment of the invention 1 (hereinafter to be referred as unmatched liniment anodyne), every ml contains raw medicinal herbs 0.27g, and test is put on the skin outward with former preparation.
YUNNAN BAIYAO DING: produce lot number: 980503 by Yunnan Paiyao Group Corp., Ltd.Yunnan Baiyao aerosol is produced lot number: 980806 by Yunnan Paiyao Group Corp., Ltd.
The preparation of Freund ' s Freund's complete adjuvant: with liquid paraffin and lanoline (2: 1) altogether heat shake up to 70 ℃, add bacillus calmette-guerin vaccine (Chengdu Biological Products Inst., Ministry of Public Health produces, lot number 971111) 7.5mg by every ml behind the autoclaving and process.Carrageenin is provided lot number: 127H1227 by U.S. Sigma company.2,4-dinitrochlorobenzene (DNCB): produce lot number by Shanghai reagent one factory: 960503, make solution with acetone, Oleum Sesami (1: 1) mixing, be mixed with 5% sensitization concentration and 1% attack concentration.
(2) animal: the SD rat, male, body weight 176 ± 16g is provided by Inst. of Yunnan Baiyao Group Co., Ltd..The Wistar rat, male, body weight 150～200g is provided by Kunming Institute of Zoology, Chinese Academy of Sciences.The ICR mice, male, body weight 20 ± 2g is provided by Inst. of Yunnan Baiyao Group Co., Ltd..Kunming mouse, male and female half and half are provided by Chinese Academy of Sciences's Kunming zooscopy.
(3) Mus foot container determinator: with reference to Qi Chen " herbal pharmacology research methodology ", Beijing people's health publishing house the 1st edition Mus foot volume determination JIUYUE in 1993 device is made.
(4) electronic balance: the BP310S type, produce by German Sartorius balance company limited; The DT500 type is produced by Changde City, Jiangsu weighing apparatus factory.The hot plate dolorimeter, model GJ-8402, the white stone electronics medicine in Ninghai, Zhejiang instrument plant.
Two, method and result
L, to the treatment of rat assist agent arthritis
50 of healthy male SD rats; Normal breeding observing 3 days; Reference literature method (Qi Chen; Herbal pharmacology research methodology, Beijing people's health publishing house JIUYUE in 1993 the 1st edition), animal is divided into five groups in the right back toes of every Mus at random after subcutaneous injection freshly prepared Freund ' s Freund's complete adjuvant 0.05ml (including bacillus calmette-guerin vaccine 0.375mg) cause inflammation respectively: < 1>moulding matched group; < 2>YUNNAN BAIYAO DING prevention group; < 3>YUNNAN BAIYAO DING treatment group; < 4>unmatched liniment anodyne prevention group; < 5>unmatched liniment anodyne treatment group.Beginning administration behind the injection adjuvant immediately is the prevention group, and beginning administration in the 8th day is the treatment group.Embrocate respectively below the hind leg ankle joint of the rat left and right sides with the disinfecting cotton swab dip in liquid medicine, be administered twice altogether 9 o'clock every mornings and at 4 o'clock in afternoon, successive administration 21 days, matched group is embrocated normal saline.Measure every Mus foot sole of the foot volume 1 time (with picric acid at every Mus hind leg ankle joint marking respectively at before the injection adjuvant and back 3h and every interval 2 days with sufficient sole of the foot volume determination device; Equal with liquid level during measurement) with this line; Is the swelling value with the parapodum sole of the foot in giving adjuvant front and back volume difference; And calculating swelling rate and suppression ratio I, the result sees table 1.
Cause scorching before each treated animal weigh weekly once, subtract with the body weight of the Later Zhou Dynasty, one of the Five Dynasties before Zhou Tichong be each all increasing value, each treated animal through the time weight gain value see table 2.
Table 2 respectively organize rat body weight through the time increasing value
Compare * P＜0.05 * * P＜0.01 with the moulding matched group
Each treated animal is dissected a body extremely and is separated after 24 days, observes each important organ, and takes by weighing thymus, spleen, adrenal gland's value, the result all in range of normal value, difference is not remarkable.
Brief summary
Result of the test showed, behind right back sufficient sole of the foot injection Freund ' the s Freund's complete adjuvant of SD rat, the following serious swelling of ankle joint occurs, and the swelling degree reached peak-peak at 3-6 days, and the swelling rate is up to more than 200 percent, and alleviates gradually later in 18 days.The preventive administration treatment of unmatched liniment anodyne and YUNNAN BAIYAO DING; Can significantly suppress to inject the swelling rate of the right back sufficient sole of the foot; Can significantly suppress other rear flank limb again after 12 days; Because of the left foot swelling rate that delayed hypersensitive reaction causes, two medicine action intensities are close, and each administration group weight gain value weekly is big than the matched group increasing value.Each treated animal cuts open extremely and becomes celestial after 24 days, and each vitals is normal, takes by weighing thymus, spleen, adrenal gland all in normal value.Ear's erythema of each treatment group rat and afterbody brief summary occurrence rate and matched group comparing difference do not have significance, and result of the test shows that unmatched antalgesic liniment is wiped outward, and rat assist agent arthritis is had certain therapeutical effect.
2, the inhibitory action of on Carrageenan property pedal swelling
30 of healthy male Wistar rats are divided into 3 groups at random, (1) moulding matched group; (2) Yunnan Baiyao aerosol group; (3) unmatched liniment anodyne group; Put administration outward on the skin, put on the skin every day 6 times, put on the skin continuously 3 days; After the last administration 30 minutes, cause in the rat hindleg subcutaneous injection with 1% carrageenin swollen, every rat 0.1ml; Cause the swollen preceding volume of measuring the sufficient sole of the foot with the improvement volumetric method; Cause and per hour survey once sufficient sole of the foot volume after swollen, continuous 6 times, it is following to cause the swollen back rat paw rate that expands:
The unmatched liniment anodyne on Carrageenan of table 3 causes the influence
of rat paw edema
Compare * * P＜0.01 * P＜0.05 with the moulding matched group
Brief summary
Experimental result shows that Yunnan Baiyao aerosol, unmatched liniment anodyne all can significantly suppress the rat paw edema rate due to the carrageenin.
3, to 2, the influence of 4-dinitrochlorobenzene induced mice auricle delayed hypersensitive reaction
Buy the ICR mice, male 40, normal breeding observing 2 days is divided into 4 groups with animal, (1) matched group at random; (2) solvent group; (3) YUNNAN BAIYAO DING group; (4) unmatched liniment anodyne group.Under 20 ± 2 ℃ of environment of room temperature, with the animal abdominal part with the about 3x3cm of small-sized operating scissors QUMAO
2, the DNCB 50 μ l with freshly prepared 5% evenly are applied to depilation district sensitization, strengthen once in 2nd again.After sensitization, smear normal saline respectively by different groups to mouse right ear, solvent, the YUNNAN BAIYAO DING medicinal liquid, unmatched liniment anodyne is respectively smeared continuous 7 days by above-mentioned dosage 1 time 9 o'clock every mornings and at 4 o'clock in afternoon.Sensitization evenly is applied to freshly prepared 1%DNCB 20 μ 1 after 7 days and respectively organizes the mouse right ear two sides and attack, and takes off cervical vertebra after 24 hours and puts to death animal, cuts left and right sides auricular concha; Take off two auricles with diameter 7mm card punch; Using scales/electronic balance weighing, get mouse thymus simultaneously, spleen is weighed, is the swelling value with the difference of left and right sides auricle weight; And calculating swelling rate and suppression ratio, the result sees the following form 4.
The unmatched liniment anodyne of table 4 causes the influence of tardy quick reaction of mice to DNCB
Compare * * P＜0.01 with matched group
Brief summary
Result of the test shows, attacks after 7 days with DNCB sensitization again, can make mice delayed hypersensitive reaction occur; The auricle edema rate can reach about 50 percent; The swelling value of solvent group and matched group compare, there was no significant difference, and YUNNAN BAIYAO DING and unmatched liniment anodyne two medicine successive administrations can significantly suppress its swelling degree; The result shows that YUNNAN BAIYAO DING and unmatched liniment anodyne all can significantly suppress because of DNCB induced mice auricle delayed hypersensitive reaction.
4. analgesic experiment: (hot plate method)
Get 30 of female Kunming mouses, body weight 20 ± 2g regulates hot plate dolorimeter temperature in 55 ± 5 ℃, behind the temperature stabilization, puts mice successively on hot plate, and it is pain threshold that metapedes required time (second) appears licking in mensuration.All foots of licking are less than 5 seconds or give it up greater than 30 seconds or leaper.Qualified mice is divided into three groups at random, normal saline group, YUNNAN BAIYAO DING group, unmatched antalgesic liniment group, be coated with two hind legs 3 times every day outside each group, survey the threshold of pain once in last administration after 30 minutes, and continuous three days, statistics was respectively organized pain threshold, and the result sees table 5.
The analgesic activity of the unmatched liniment anodyne of table 5 (hot plate method)
Annotate: Δ with compare P＞0.05, P＜0.05 relatively before * and the administration, before * * and the administration and matched group compare P＜0.01.
Brief summary
Relatively, notable difference is arranged all before BAIYADING group and unmatched liniment anodyne group and the administration; The BAIYADING group removes first beyond the highest heavens, and unmatched liniment anodyne group 1,2,3 days and matched group more all have notable difference; Show that unmatched liniment anodyne has obvious analgesic activity.
Conclusion
Show that through above test unmatched liniment anodyne has remarkable inhibitory action to rat assist agent arthritis, can suppress the mice delayed hypersensitivity, also can suppress chondrus ocellatus Holmes colloidality toes swelling rate, and certain analgesic activity is arranged.
Clinical trial
Clinical trial protocol
1, test method: this test adopts single at random blind method to carry out;
2, cohort and case: testing set matched group is " YUNNAN BAIYAO DING " that Yunnan Paiyao Group Corp., Ltd produces; One group of one medicine; Wherein the liniment of the embodiment of the invention 1 (being designated hereinafter simply as " unmatched liniment anodyne ") is observed 270 examples; YUNNAN BAIYAO DING 90 examples are carried out in Traditional Chinese Medical Hospital, Yunnan Prov., Kunming Traditional Chinese Medicine Hospital, the People's Hospital, Yunnan Province, four tame Grade III Class A hospitals of The Second Affiliated Hospital of Kunming Medical School respectively, do not use similar medicine in the process of the test simultaneously.
3, consumption and usage:
(1) unmatched liniment anodyne: get an amount of outer the wiping affected part, every day 3-4 time.
(2) YUNNAN BAIYAO DING: get an amount of outer the wiping affected part, every day 3-4 time.
4,6 days courses of treatment.
5, toxic and side effects is observed: during the medication as toxic and side effects occurs, should be drug withdrawal and take corresponding measure, simultaneously record in addition strictly according to the facts.
The clinical judgment standard:
1, clinical cure: pain and relevant symptoms all disappear, and it is normal that functional activity recovers.
2, produce effects: pain disappears basically, and relevant symptoms disappears basically or significantly alleviates, and functional activity recovers basically.
3, effective: pain and relevant symptoms etc. alleviates to some extent, and functional activity also makes moderate progress.
4, invalid: with the treatment before compare, symptom and function do not have the improvement or increase the weight of.
Above doing well,improving is effectively for 1 grade, and improving 2 grades is that significantly improving 3 grades is clinical cure.
Three, result
1, total effects
u＝6.69 p＜0.01
2, the drug effect time observes
Sum up:
1, this medicine is compared with control drug through the clinical verification of four units, has the curative effect that significantly is superior to matched group, U=6.69, p＜0.01.
2, for eliminating the clinical symptoms aspect, this medicine also shows the good curing effect, improves the function of joint activity for the elimination pain of joint muscle and all obviously is superior to matched group, and comparatively significantly curative effect is also being arranged aspect elimination ecchymosis and the swelling.
3, this medicine is easy to use, and skin not being produced also stimulates not pollution clothes, is worth in clinical, further promoting the use.
Long term toxicity test
Adult healthy rabbit intact skin and damaged skin are coated with the liniment of the embodiment of the invention 1 15 days continuously, when dosage is respectively 3ml and 9ml, observe local toxic reaction and the recovery extent with the whole body generation to rabbit of this liniment.All animals survival as a result; Not child, main organs weight, internal organs weight/power ratio, hematology, liver function, blood urea nitrogen do not have obvious influence to rabbit; Damaged skin high dose group serum creatinine raises; With matched group (50% ethanol) than significant difference (P＜0.05) is arranged, histopathologic examination, the heart, liver, spleen, lung, kidney, adrenal gland, thymus, thyroid, hypophysis, testis/ovary, prostate are not all seen obviously unusual.
Acute toxicity test
The liniment of the embodiment of the invention 1 is used for the complete or damaged skin of rabbit outside 3ml and 9ml dosage, rabbit is not all caused acute toxic reaction.
The skin irritation test
The outer time spent of the liniment 3ml of the embodiment of the invention 1, rabbit intact skin, damaged skin are not found obvious erythema and edema reaction, SI the local excitation reaction do not occur less than 0.2.
Skin anaphylactic test
The liniment 0.2ml of the embodiment of the invention 1 was respectively at the 1st day, the 7th day, the 14th day in kind outer Guinea Pig Left side skin of back that is used for; In last give tried thing sensitization after the 14th day; To be tried thing (0.2ml) once more and be applied to depilation district, Cavia porcellus right side, observed 6 hours, 24 hours, 48 hours, 72 hours skin allergy.The result shows that this liniment does not cause the anaphylaxiss such as erythema edema of guinea pig skin.
In sum; More than being merely preferred embodiment of the present invention, is not to be used to limit protection scope of the present invention, therefore; All any modifications of within spirit of the present invention and principle, being done, be equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (10)
1. an analgesic is local uses Chinese medicine composition, is that the medical material following weight portion proportioning is prepared from:
2. according to the said Chinese medicine composition of claim 1, be that the medical material following weight portion proportioning is prepared from:
3. Chinese medicine composition according to claim 2 is that the medical material following weight portion proportioning is prepared from:
4. according to each described Chinese medicine composition in the claim 1 to 3, said Chinese medicine composition is an external medicine preparation.
5. Chinese medicine composition according to claim 4, wherein, described external medicine preparation is liniment, lotion, liniment, ointment, ointment, gel, plaster, aerosol, spray or emplastrum.
6. Chinese medicine composition according to claim 5, wherein, described external medicine preparation is a liniment.
7. the method for preparing of each described Chinese medicine composition in the claim 1 to 6 comprises the steps:
(1) Radix Aconiti, Radix Aconiti Kusnezoffii, Rhizoma Arisaematis, Flos Carthami, Rhizoma Curcumae, Olibanum, Myrrha, Rhizoma Curcumae Longae, Flos Caryophylli, Herba Asari and Radix Paeoniae Rubra ten are ground into coarse powder simply;
(2) it is an amount of to add 50-95 volume % ethanol water, soaked 1-168 hour, and be solvent according to percolation with 50-95 volume % ethanol; Slowly percolation is collected percolate, leaves standstill; Filter, filtrating adds Borneolum Syntheticum and dissolving, mixes mutually with acceptable accessories then and processes required preparation.
8. each described Chinese medicine composition is used for the application of analgesic medicine in the claim 1 to 6 in preparation.
In the claim 1 to 6 each described Chinese medicine composition be used for treating in preparation anxious or chronicly turn round, the application of the medicine of pain that contusion, chilblain cause.
10. the detection method of each described Chinese medicine composition in the claim 1 to 6 comprises the character of said Chinese medicine composition is done check, and the circumstances in which people get things ready for a trip of going forward side by side spectrum is differentiated.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111905072A (en) * | 2020-07-17 | 2020-11-10 | 北京枢之道生物科技有限公司 | Clove antibacterial powder and preparation method thereof |
| CN112807410A (en) * | 2021-04-07 | 2021-05-18 | 陈洪彬 | Composition for clearing away heat and toxic materials, preparation method and application |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912572A (en) * | 2010-07-30 | 2010-12-15 | 崔宝海 | Multi-effect external plaster |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912572A (en) * | 2010-07-30 | 2010-12-15 | 崔宝海 | Multi-effect external plaster |
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| 中华人民共和国***药典委员会: "《中药成方制剂19册》", 31 December 1998 * |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111905072A (en) * | 2020-07-17 | 2020-11-10 | 北京枢之道生物科技有限公司 | Clove antibacterial powder and preparation method thereof |
| CN112807410A (en) * | 2021-04-07 | 2021-05-18 | 陈洪彬 | Composition for clearing away heat and toxic materials, preparation method and application |
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Application publication date: 20120926 |