CN101342280B - Chinese medicine externally used paste for curing bronchial asthma and preparation method thereof - Google Patents

Chinese medicine externally used paste for curing bronchial asthma and preparation method thereof Download PDF

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CN101342280B
CN101342280B CN2008100489934A CN200810048993A CN101342280B CN 101342280 B CN101342280 B CN 101342280B CN 2008100489934 A CN2008100489934 A CN 2008100489934A CN 200810048993 A CN200810048993 A CN 200810048993A CN 101342280 B CN101342280 B CN 101342280B
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fine powder
volatile oil
chinese medicine
bronchial asthma
ointment
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CN101342280A (en
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潘浩宇
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Abstract

The present invention relates to externally applied ointment of Chinese medicine, which is used for treating bronchial asthma, belonging to the externally applied ointment of Chinese medicine. The formula of the ointment consists of the following ingredient: raw radix aconite, raw kusnezoff monkshood, raw Araceae, bark of white mulberry root, balloon-flower root, earthworm, fructus gleditsiae offieinalis, Angelica dahurica, cinnamon, clove, lindera strychnifolium vill and asarum. In the preparation method, the raw radix aconite, the raw kusnezoff monkshood and the Araceae are mixed and crushed to form extra fine powder; the clove, the asarum, the cinnamon and the Angelica dahurica are distilled in vapor to extract volatile oil; the lindera strychnifolium vill, the fructus gleditsiae offieinalis, the earthwor, the bark of white mulberry root and the balloon-flower root are fried and boiled in water; the fried solution and the aqueous solution after the volatile oil is extracted are mixed, filtered, concentrated, decompressed and dried to form dry cream which is then crushed to form fine powder; the two types of fine powder are mixed well; ethyl p-hydroxybenzoate is dissolved in a small amount of ethanol; lanolin, petrolatum and solid paraffin wax are heated and molten; the fine powder, the volatile oil and 10g of azone are added, ground well by colloid mill, and then packaged; thus the ointment is prepared. The ointment can be pasted on Feiyu pointand Fengmen point to treat the bronchial asthma.

Description

A kind of Chinese medicine externally used paste for the treatment of bronchial asthma and preparation method thereof
[technical field]
The present invention designs the field of Chinese medicines and especially designs treatment asthma external form of Chinese drug and preparation method thereof.
[background technology]
Asthma claims again " croup ", is a kind of with ictal dyspnea, and companion's wheezing sound in the throat is sound to be the respiratory system commonly encountered diseases of primary symptom.Western medicine is referred to as " bronchial asthma ", thinks relevant with reactivity of organism and neural factor.Primary disease is a kind of serious frequently-occurring disease, difficult treatment of causing harm.Statistics shows: the prevalence of China's asthma is 0.5~2.0%, and along with the sharp increase of polluter in the living environment, prevalence has the gesture of increase gradually.Primary disease can betide any age, but more than halfly in the asthma infant of onset, 70% onset is arranged approximately before 3 years old before 12 years old.Because the generation of asthma is relevant with reactivity of organism height (allergic constitution), so mainly be control of seizures in this disease treatment, it is very difficult to desire the rooting rule of treatment, be with extensive patients suffer from this after being ill majority show effect repeatedly, touching difficulty heals, and sick one-tenth for a long time is empty, is having a strong impact on production capacity and quality of life.
For the treatment of primary disease, the main oral administration of the traditional Chinese medical science in the past, then oral administration, intramuscular injection or be aided with intravenously administrable of doctor trained in Western medicine.Because this disease course of disease is long, easily recurrence, sending out does not have regularly, long-term Chinese and western drugs treatment not only brings many burdens and inconvenience to patient, and toxic and side effects easily takes place, child patient outstanding difficult acceptance of taking medicine for a long time, therefore be necessary to seek a kind of safe and effective, convenient and swift, be fit to the non-oral medication that the each age group patient uses.The present invention develops for satisfying the clinical needs of this kind.
[summary of the invention]
The objective of the invention is according to the Chinese medicine meridian theory, adopt traditional traditional Chinese medical science interior disease outer treating method of point-application medicine, propose a kind of Chinese medicine externally used paste for the treatment of asthma and preparation method thereof
One, the Chinese medicine externally used paste mainly is made up of following composition among the present invention:
Radix Aconiti 60g, Radix Aconiti Kusnezoffii 60g, Arisaema Cum Bile 60g, Cortex Mori 120g, Radix Platycodonis 60g, Pheretima 90g, Fructus Gleditsiae Abnormalis 20g, Radix Angelicae Dahuricae 60g, Cortex Cinnamomi 60g, Flos Caryophylli 20g, Radix Linderae 60g, Herba Asari 20g.
(1) prescriptions of Chinese medicine of the present invention with Chinese medicine monarch, minister, help, make the theory analysis prescription compatibility of medicines
We's 12 flavor medicines, wherein Radix Aconiti, Radix Aconiti Kusnezoffii are monarch; Rhizoma Arisaematis, Fructus Gleditsiae Abnormalis, Cortex Mori, Radix Platycodonis are minister; The Radix Angelicae Dahuricae, Cortex Cinnamomi, Flos Caryophylli, the Radix Linderae, Pheretima are assistant; Herba Asari is for making.Two monarchs, four ministers, five assistants.So so organize medicine, be because the asthma pathogenesis has latent phlegm (perennial root) in being, seasonal pathogen (inducement) is arranged outward, mechanism of qi is disorderly contrary when outer interior combined pathogens morbidity and asthma attack, and the air flue contraction is anxious, the disadvantageous pathological process of lung qi lifting determines.
In at first being latent phlegm is arranged, lie prostrate deeply on the diaphragm, that sends out does not go out, and that attacks is too late, and that changes is motionless, is the basic reason that asthma is difficult to cure.We select for use Radix Aconiti, Radix Aconiti Kusnezoffii to be monarch.The Radix Aconiti acrid in the mouth is hot in nature, and is poisonous." herbal classic " calls its " removing mass gathers cold and heat for eliminating cold-damp numbness, cough with dyspnea "; " not Lu " says its " expectorant is cold on the breast that disappears, anorexia, the cold disease of trusted subordinate " [6], the jinx of this sincere " phlegm attacking above diaphragm " also.Radix Aconiti Kusnezoffii is identical with the Radix Aconiti nature and flavor, and function is similar, and search wind prevailing over dampness, dispersing cold for relieving pain, open pertinacious phlegm, the power of controlling stupid knot more wins Radix Aconiti, so be monarch with two flavors, can drive straight on to the perennial root nest and brokenly looses it, be " main disease call monarch " also.
Radix Aconiti, Radix Aconiti Kusnezoffii are drived straight on to the latent phlegm nest, disperse its heresy, still probably can not promptly restrain, and are assist it with Rhizoma Arisaematis, Fructus Gleditsiae Abnormalis, Cortex Mori, Radix Platycodonis.Rhizoma Arisaematis bitter in the mouth suffering, warm in nature, poisonous is gone into lung, liver, spleen channel.The function that drying dampness to eliminate phlegm, expelling wind for relieving convulsion, dispersing swelling and dissipating binds are arranged is the key medicine of clinical treatment cold-phlegm, damp-phlegm; Fructus Gleditsiae Abnormalis, acrid in the mouth is salty, and is warm in nature, slightly poisonous.Go into lung and large intestine channel.Xin Wen walks to scurry, and is salty with the softening the hard mass expectorant, goes into nose and then sneezes, and inlet is then told, and intensive clearing away phlegm, sensible effect are arranged.With the two is minister, can increase the power of expectorant powder junction greatly.The Cortex Mori sweet in the mouth is cold in nature, start with lunar lung, spleen meridian." medicine justice " cloud: " Cortex Mori ... the light color of body is white, specially goes into lung meridian, dredges the gas heat radiation, cures mainly the dyspnea with fullness of the chest cough, and the heat-phlegm hemoptysis is all held back by excess pathogen is strongly fragrant, and the lung key must not be unobstructed, and what ooze whereby looses it, in order to lung qi, all card spontaneous recovery.So having a surplus of cloud eliminating the pathogens from the lung, must Cortex Mori ".Two crows, Rhizoma Arisaematis, Fructus Gleditsiae Abnormalis, property be temperature all partially, and Cortex Mori is sweet cold, and the eliminating the pathogens from the lung promoting the circulation of QI is collaborative and supervise its heat with monarch drug.Radix Platycodonis bitter in the mouth suffering, property is flat, goes into lung, stomach warp.Wang Mengying calls its " open the knot of lung qi, declare the strongly fragrant of the motive, part of the body cavity above the diaphragm housing the heart and lungs medicine also ".We use it, assist monarch drug to reduce phlegm with its merit of eliminating the phlegm on the one hand; Use the merit regulating functional activities of qi of its dispersing and elevation lung qi on the other hand,, make lung qi a surname of contrary unrest reach respectful falling and recover normally with Cortex Mori one rise and one drop, thus be ministerial drug.
Reduce phlegm at monarch drug, ministerial drug, on the basis of clearing away phlegm, regulating functional activities of qi, help sensiblely, dismiss pathogenic factor in the exterior with Radix Angelicae Dahuricae dispelling wind; Cortex Cinnamomi complement sun, removing accumulated cold is the product of supporting vital QI to relieve the primary cause of disease, fling the enemy camp as ten thousand armies, and this is the supply of army provisions impedimenta; The Flos Caryophylli warming middle-JIAO, the kidney warming sending down the abnormal ascending QI, the pleasant the chest stuffiness relieving of the Radix Linderae is many-sided replenishing to the effect of monarch drug, ministerial drug, so-called " answering the meaning of minister to make " is also.Lumbricus of Pheretima, salty in the mouth is cold in nature, goes into liver lung two warps.The effect that heat clearing away, arresting convulsion, collateral dredging spasmolytic are arranged, be assistant, the contraction that both can alleviate air flue is anxious, can supervise the warm of monarch-minister drug again, so-called " should cure be assistant " is also.Other has the hot temperature of Herba Asari, goes into lung, kidney two warps, merit specially have one's ideas straightened out dispelling wind, dispersing cold for relieving pain, " medicine justice " claim " if in the cold-evil goes into; and yin channel person, hold out from interior with this ", be for making with Herba Asari, it is warm in nature to get its acrid in the mouth, have one's ideas straightened out, the power of drawing all medicines is gone into interior, reaches in kidney, and multiple cold expelling is gone out, and makes heresy not have institute and escapes also.Monarch is harmonious, and plays the pertinacious phlegm of dispelling altogether, the machine of regulating the flow of vital energy, the effect of the collateral dredging of having one's ideas straightened out, relieving cough and relieving asthma.Make ointment with it and be affixed on air door, Feiyu acupuncture point, but the FENGMEN acupoint dispelling wind pathogens, and regulating functional activities of qi can stimulate governor vessel again, rouses oneself yang-energy, gets rid of evils in order to setting upright.FEIYU acupoint has the accent lung qi, mends strain, clearind deficient heat and nutrient blood effect.Acupuncture clinically, moxibustion air door treatment flu, cough with asthma all have significant curative effect, and gas on the ancient Chinese medicine doctor thorn moxibustion fei shu treatment consumptive lung disease, consumptive disease, fullness in the chest, and it is too numerous to enumerate to breathe heavily serious symptom such as the haematemesis of coughing.Stick on this four cave with we, the efficacy of a drug absorbs by the acupuncture point, in reach internal organs, outer thorough hair key, pathogen is loose outward, healthy energy is mixed well, the asthma self-balancing.
(2) the present invention selects the cave to stick with the Chinese medicine meridian theory analysis
According to the Chinese medicine meridian theory, back of the body cave is the special acupuncture point that the qi of zang-fu viscera infusion is come in and gone out, though belong to bladder meridian, real closely bound up with vital organs of the human body function.So paste medicine in FEIYU acupoint, good conditioning lung qi function is arranged, can make the effect of various medicines in the prescription, in lungs, play a role.The two caves of air door on the two caves of fei shu 1 cun are opened 1.5 cun when the second dorsal vertebra spinous process is other down, are the crossing point of bladder meridian and governor vessel.The kind fever caused by exogenous pathogens of controlling in this cave, diseases such as cough are so have another name called hot mansion; Invade saying of the in close relations and name of lung with itself and exopathogen: " air door ".Ointment is affixed on this cave, on the one hand, drug effect will be very fast in thoroughly in lung; Because of its meridians belong to bladder meridian, TAI YANG being concerned with the exterior act as out, and evacuates pathogenic factor in the exterior preferably so have, evil outer effect of loosing in making; This cave communicates with governor vessel simultaneously, and easily the priming yang-energy plays the effect of getting rid of evils of setting upright.Thereby the present invention will stick the acupuncture point and be selected on fei shu, two four caves of air door, determine under the theoretical direction of the defeated cave of Chinese medicine meridian.
Two, preparation method of the present invention is:
By the present invention prescription, get Radix Aconiti, Radix Aconiti Kusnezoffii, Rhizoma Arisaematis mixed powder and be broken into superfine powder; Flos Caryophylli, Herba Asari, Cortex Cinnamomi, the Radix Angelicae Dahuricae, steam distillation extracted volatile oil 8 hours, and collection volatile oil, aqueous solution are continued to employ; The Radix Linderae, Fructus Gleditsiae Abnormalis, Pheretima, Cortex Mori, Radix Platycodonis decoct with water 3 times, add 8 times in water at every turn, decoct 1 hour, aqueous solution behind collecting decoction and the said extracted volatile oil filters, and being concentrated into relative density is 1.30~1.35 (80 ℃ of surveys), take out, drying under reduced pressure becomes dried cream, is ground into fine powder; With above-mentioned two kinds of fine powder mixings, get ethylparaben 2.5g, be dissolved in the small amount of ethanol, get lanoline 120g, vaseline 580g, hard paraffin an amount of (about 45g), heat fused; The alcoholic solution and the azone 10g that add above-mentioned fine powder, volatile oil, ethylparaben, colloid mill grind evenly, packing, 60Co radiation sterilization (irradiation dose is 10KGY), promptly.Make 1000g ointment altogether.
Three, pharmacodynamic experiment of the present invention is as follows
According to the requirement of country to the Chinese medicine externally used paste, the present invention has finished relevant pharmacodynamics test, and concrete outcome is as follows:
1, to the antitussive action of mice: test causes mouse cough with ammonia, number of times by cough in the incubation period and 3 minutes of measuring mouse cough, observe antitussive action of the present invention, the result shows that the cough that the present invention causes ammonia has the extended period cough latent period and reduces the effect of cough number of times.
2, to the phlegm-dispelling functions of mice: test as the expectorant effect indicator, by measuring the phenol red amount of mice by the respiratory mucosa discharge, is observed phlegm-dispelling functions of the present invention with phenol red.The result shows: the phenol red amount that the present invention discharges respiratory mucosa increases, and points out it that tangible phlegm-dispelling functions is arranged.
3, to the antiasthmatic effect of Cavia porcellus: 1. test with aeroponics and suck histamine, acetylcholine, cause that guinea pig bronchial shrinks, the air flue spasm, cause and pant, suffocate, thereby cause Cavia porcellus to twitch, fall.Utilize this model, observe antiasthmatic effect of the present invention.The result shows, the big or middle dosage of the present invention is breathed heavily guiding drug and played Cavia porcellus and pant significant antiasthmatic effect is arranged causing.2. the atomizing of test utilization 1% egg protein sucks sensitization, and 3% egg protein is attacked and brought out the bronchus model.Utilize this model, observe the present invention to the latent time of anaphylaxis guinea pig bronchial asthma, the time of having a convulsion and the time of falling, the result, the big-and-middle dosage group of the present invention has obvious prolongation latent time, the time of having a convulsion and the time of falling to anaphylaxis guinea pig bronchial asthma, and is remarkable with the model group comparing difference.The heavy dose of group effect of the present invention is better than disappearing and breathes heavily the cream matched group.Show that the present invention has tangible antiasthmatic effect to the Cavia porcellus allergic bronchial asthma.
4, antiinflammatory action: this laboratory observation the influence of the present invention to rat paw edema due to the Ovum Gallus domesticus album and two kinds of inflammatory models of the stupid induced mice ear swelling of diformazan, experimental result shows that the present invention has obvious inflammation-inhibiting swelling and transudation.
5, to Immune Effects: with anti-sheep red blood cell antibody in the serum is index, observes the influence of the present invention to the mouse humoral immune function, and the result shows that the present invention has the effect of remarkable enhancing humoral immune function; The method that employing dinitro fluorine stupid (DNFB) is antigenic delayed allergy, observe the present invention to the mouse cell Immune Effects, the result shows that this medicine has the effect of the tardy paraphilia reaction of obvious enhancing: with carbon clearance index in the serum in the unit interval is index, observe the influence of the present invention to the mice non-specific immunity, the result shows that the present invention does not have obvious influence to the mice non-specific immunity.
6, to the influence of mice chronic bronchial, scorching model: test is a stimulus object with single medicated cigarette, causes mice chronic bronchitis (chronic bronchitis) model.Observed the influence of acupuncture point of the present invention administration to the mice chronic bronchitis.Experimental result shows that the present invention can alleviate the infiltration of mouse bronchial mucosal inflammation, epithelial cell shedding, hemorrhage and minimizing tube chamber secretions, reduces the ratio of the bronchus gross area and cavity area.Lesion degree obviously is lighter than model group.
7, antiallergic test: the method with rat passive anaphylaxis of the same race (PCA) is observed the effect of reagent for the I allergic reaction type that be subjected to.The result shows, among the present invention, heavy dose of group all can dwindle sensitization rat Intradermal locus coeruleus area significantly, compare (P<0.01) with model group, the resistance rate is respectively 48.72~69.23% each administration group of while all can reduce ooze out (P<0.05, P<0.01) of skin to azovan blue, resists and is respectively 40~70%.Proof the present invention has the allergic effect of anti-I type.
8, toxicity test:
8.1 acute toxicity test: large and small dosage group is respectively to rabbit intact skin and once outer 6g/100g of the present invention (being equivalent to crude drug 4.14g/100g), the 3g/100g (being equivalent to crude drug 2.07/100g) of being coated with of damaged skin, secondary for the moment, observed 7 days the result after the administration: do not see that animal any toxic reaction occurred with dead in 7 days after the administration.
8.2 the skin irritation test: the present invention is applied to rabbit complete sum damaged skin respectively, observes the skin irritation reaction after 7 days of single-dose and successive administration.The result: there is no edema and form, individual animal skin is little red or light red reaction, can recover normal after general 72 hours; The skin morphological observation does not have pathology and changes.
8.3 skin anaphylactic test: with 2, the anaphylaxis of the present invention to skin is observed in the stupid positive contrast of 4-dinitro-chlorine, and experimental result shows that the present invention does not have sensitization to skin.
8.4 long term toxicity test: the present invention gives 12 weeks of Cavia porcellus damaged skin coating by 2g/100 (being equivalent to crude drug 1.38g/100g), 1g/100 (being equivalent to crude drug 0.69g/100g), 0.5g/100g (being equivalent to crude drug 0.35/100), drug withdrawal convalescent period observed for 2 weeks, each treated animal general state, body weight gain speed, blood and serum biochemistry inspection, organ coefficient and histopathologic examination there is no significant change, show safety non-toxic of the present invention.
9. transparent absorption test: behind transdermal administration, directly measure hypaconitine content in the blood with the HPLC method.White Rabbit use in test, and after the depilation of back, large tracts of land is coated with the present invention (1.667g/kg.50cm2/kg), through 0,1,4,8,12,24h gets hypaconitine concentration the hematometry blood plasma from ear vein.Tracing analysis during medicine meets one-level absorption and the one-level that arranged lag time and eliminates and one-compartment model.Be 0.99h lag time, and the elimination half-life is 7~12h.The area under curve (AUCO-24) that the statistics moments method obtains is 8.84ug.h/ml, and average residence time (MRT) is 10.8h.
Show by control administration area and dosage and can reach safe and effective medication.
10. the research of medicine stability
By the pertinent regulations of " provisions for new drugs approval ", we also observe, steady quality of the present invention, and room temperature was preserved 2 years down, and effectiveness does not change.
[specific implementation method]
Function of the present invention cures mainly as follows:
Suitable lung promoting the circulation of QI, warming for resolving cold-phlegm.Be applicable to light, two degree (asthma of cold-type card) of acute bronchial asthma.Disease is seen the expiration tachypnea, and wheezing sound is arranged in the larynx, failing to sleep due to dyspnea, die Blausucht, cough with dyspnea, the sticking in vain or clear rare many foams of expectoration, mouthful not thirsty or thirsty desire for hot drinks, white and slippery fur, floating and tense pulse etc.
Using method of the present invention is as follows:
The Chinese medicine unguentum that this prescription is made sticks FEIYU acupoint and the two pairs of acupuncture points of FENGMEN acupoint in the patient, changes dressings once in per two days,, two degree light in order to the treatment acute bronchial asthma.
Clinical experiment result of the present invention is as follows
According to the requirement of China to the Chinese medicine externally used paste, the present invention has implemented medicine I, II, III phase clinical experiment in relevant clinical test unit, and whole clinical experiment meets the relevant regulations of China to medicine, and its concrete conclusion is as follows:
(1) I phase clinical experiment conclusion
Blood pressure, heart rate, breathing, body temperature, body weight all do not occur unusual before and after 30 trial volunteer medications.
30 trial volunteer routine blood test, routine urinalysis, stool routine examination and hepatic and renal function, electrocardiograms all do not occur unusual before and after the medication.
There is after 3 examples (No. 14, No. 16 and No. 17) medication the 6th day local erythra, pruritus to occur in 30 trial volunteers, and continued spontaneous remission in 6~24 hours, consider possible relevant with this medicine or cloth hypersensitivity without medication; Minority experimenter occur rubberized fabric place skin slightly red, itch.
Conclusion: the present invention is safe and reliable, and no obvious toxic-side effects can enter the II clinical trial phase.
(2) II phase clinical experiment conclusion
Two groups of Pass Test schemes are totally 226 examples, test group Pass Test scheme 114 examples wherein, the clinical apparent control rate 65.79% of tcm syndrome (clinic control rate+obvious effective rate); Matched group Pass Test scheme 112 examples show control rate 54.46%, learn by statistics and handle, and two groups of tcm syndrome curative effects compare, and difference has the significance meaning, and test group is better than matched group.Two groups of bronchial asthma curative effects compare: the test group control shows rate 64.91%; Matched group shows control rate 51.79%, learns by statistics and handles two groups of difference not statistically significants.
Before and after two groups of pulmonary function test indexs (the FEV1 measured value accounts for predicted value percentage ratio, the PEFR measured value accounts for predicted value percentage ratio, the FEV1/FVC) treatments relatively, two groups of there are no significant differences.
Safety evaluatio: this clinical trial has 8 examples occur applying ointment or plaster place skin rash, pruritus, test group 6 examples wherein, matched group 2 examples.Have 2 examples and continue, other spontaneous remission and disappearance are considered all relevant with trial drug.Do not observe other untoward reaction, not observing trial drug has anomalous effects to the heart, liver, renal function, blood system.
Conclusion: the present invention treats bronchial asthma acute stage (cold asthma card) determined curative effect, drug safety.The III clinical trial phase is proceeded in suggestion, further observes safety and effectiveness.
(3) III phase clinical experiment conclusion
The present invention's prescription is made up of medicines such as Radix Aconiti, Radix Aconiti Kusnezoffii, Rhizoma Arisaematis, Cortex Cinnamomi, Flos Caryophylli, Herba Asari, the Radixs Angelicae Dahuricae, and this medicine sticks administration by the body surface acupuncture points on the human body, regulates channel system, and the effect of the meridian dredging, sharp lung qi, expelling phlegm and resolving turbidity, relieving cough and asthma is arranged.This test by observe the present invention to bronchial asthma in acute attack stage (cold asthma card) treatment front and back pant, cardinal symptom signs variation such as wheezing sound and pulmonary function test: FEV1 (%), FEV1/FVC (%), PEFR situations of change such as (L/S), objective evaluation the present invention treats the clinical efficacy of bronchial asthma in acute attack stage (cold asthma card).
Two groups of Pass Test schemes are totally 427 examples, test group Pass Test scheme 322 examples wherein, the clinical apparent control rate 55.0% of tcm syndrome (clinic control rate+obvious effective rate); Matched group Pass Test scheme 105 examples show control rate 50.5%, learn by statistics and handle, and two groups of tcm syndrome curative effects compare no difference of science of statistics; Two groups of bronchial asthma curative effects compare: the test group control shows rate 52.2%; Matched group shows control rate 43.8%, learns by statistics and handles two groups of difference not statistically significants.
Relatively, two groups all have significant difference before and after two groups of pulmonary function test indexs (the FEV1 measured value accounts for predicted value percentage ratio, the PEFR measured value accounts for predicted value percentage ratio, FEV1/FVC) treatment; Two groups relatively, no difference of science of statistics.
Two groups of eosinophilic granulocyte's absolute counting treatment back comparative analysiss: relatively, through paired t-test, there is significant difference P<0.05 before and after the test group treatment, no difference of science of statistics before and after the treatment of control group.
Safety evaluatio: adverse events 17 examples take place in this clinical trial altogether, test group 13 examples, adverse events incidence rate 3.94%, matched group 4 examples, adverse events incidence rate 3.67%.16 examples are the place's local skin pruritus of applying ointment or plaster in the adverse events, test group 12 examples, and matched group 4 examples, all spontaneous remission and disappearances behind the medicine of stopping using, consider all to reach with trial drug (or) to stick cloth hypersensitivity relevant.Peritonsillar abscess appears in 1 routine duration of test, and researcher is considered with trial drug irrelevant, does not observe other clinical adverse.Trial drug is not observed in the laboratory safety inspection has anomalous effects to the heart, liver, renal function, blood system.
Conclusion: the present invention treats bronchial asthma (Chinese medical discrimination cold asthma card) determined curative effect, and it is comparatively convenient to use, except that small number of patients occur the part apply ointment or plaster the place skin pruritus, do not see other side effect.Registration is declared in suggestion, and it is clinical that this medicine is served.
The present invention provides a new approach for treatment bronchial asthma, though the present invention asthma walk rapidly stage of attack action effect and speed of action do not have western medicine and medical practitioners treatment fast, but spend stage of attack in acute bronchial asthma early stage or two positive effect is arranged, that is to say, very big patients in remission, palliate the agonizing sufferings, provide the road that to follow for avoiding bronchial asthma further to worsen.In addition, the present invention is an externally applied product, and without crossing human liver's deactivation metabolism, the renal metabolism toxin expelling compares to Western medicine and oral medicine thereof, has quite high safety.If from Chinese medical theory,, believe that the present invention one obtains further curative effect surely according to international advanced modern pharmaceutical technology.

Claims (1)

1. Chinese medicine externally used paste for the treatment of bronchial asthma, it is prepared by following method: get Radix Aconiti 60g, Radix Aconiti Kusnezoffii 60g, Arisaema Cum Bile 60g mixed powder is broken into superfine powder; Get Flos Caryophylli 20g, Herba Asari 20g, Cortex Cinnamomi 60g, Radix Angelicae Dahuricae 60g, steam distillation extracted volatile oil 8 hours, collected volatile oil, and aqueous solution is continued to employ; Radix Linderae 60g, Fructus Gleditsiae Abnormalis 20g, Pheretima 90g, Cortex Mori 120g, Radix Platycodonis 60g, decoct with water 3 times, add 8 times in water at every turn, decocted 1 hour, the aqueous solution behind collecting decoction and the said extracted volatile oil filters, relative density is 1.30~1.35 when being concentrated into 80 ℃ of surveys, take out, drying under reduced pressure becomes dried cream, is ground into fine powder; With above-mentioned two kinds of fine powder mixings, get ethylparaben 2.5g, dissolve in the small amount of ethanol, get lanoline 120g, vaseline 580g, hard paraffin 45g, heat fused; The alcoholic solution and the azone 10g that add above-mentioned fine powder, volatile oil, ethylparaben, colloid mill grind evenly, packing, 60Co radiation sterilization, irradiation dose are 10kGy, promptly.
CN2008100489934A 2008-08-28 2008-08-28 Chinese medicine externally used paste for curing bronchial asthma and preparation method thereof Expired - Fee Related CN101342280B (en)

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