CN101468099B - Chinese medicinal composition for dispersing wind, relieving exterior syndrome, clearing heat and detoxicating, and method for preparing the same - Google Patents

Chinese medicinal composition for dispersing wind, relieving exterior syndrome, clearing heat and detoxicating, and method for preparing the same Download PDF

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CN101468099B
CN101468099B CN2007100601906A CN200710060190A CN101468099B CN 101468099 B CN101468099 B CN 101468099B CN 2007100601906 A CN2007100601906 A CN 2007100601906A CN 200710060190 A CN200710060190 A CN 200710060190A CN 101468099 B CN101468099 B CN 101468099B
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radix
chinese medicine
medicine composition
exterior syndrome
relieving
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CN101468099A (en
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李燕钰
金兆祥
罗辉
宋立平
张彤云
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Jinyao Darentang Group Co ltd Darentang Pharmaceutical Factory
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Tianjin Darentang Pharmaceutical Factory Zhongxin Pharmaceutical Group Co Ltd
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Abstract

The invention relates to a traditional Chinese medicine composition capable of expelling wind, relieving exterior syndrome, clearing away the heat-evil and expelling superficial evils, composed of fermented soybean, figwort, mulberrt leaf, tangerine peel, weeping forsythia, mint, red peony root, honeysuckle, cicada skin, cogongrass rhizome, kudzuvine root, iastis root, hogfennel root, scullcap, schizonepeta spike, isatis leaf, cape jasmine, radix trichosanthis, Chinese tamarisk, concentrated powder of buffalo horn and an amount of pharmacueutic adjuvsnt. The traditional Chinese medicine composition mainly treats upper respiratory tract infection, influenza, measles, rubella. The traditional Chinese medicine composition is capable of expelling wind, relieving exterior syndrome, relieving the muscles and skin, promoting eruption, clearing away the heat-evil and expelling superficial evils. The traditional Chinese medicine composition has features of quick effect on upper respiratory tract infection, influenza, throat congestion, measles, rubella; convenient administration, small dosage, no side-effect and easier child acceptability.

Description

Chinese medicine composition of a kind of dispersing wind, relieving exterior syndrome heat-clearing and toxic substances removing and preparation method thereof
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate to a kind of Chinese medicine composition of dispersing wind, relieving exterior syndrome heat-clearing and toxic substances removing, a kind of sick Chinese medicine composition such as upper respiratory tract infection, influenza, measles, rubella and preparation method thereof that is used to treat of saying so more specifically.
Background technology
Influenza is called for short influenza, is the acute respiratory infectious disease that is caused by popular virus.Children's is the Susceptible population of influenza, and 6 months to 3 years old infant is the high-risk group of influenza, and 5 years old to 18 years old child and teenager are the age group occurred frequently of influenza, and infection rate can be more than 50%, and is higher 1.5~3 times than the adult.Bigger child suffers from that the influenza clinical symptoms is close with the adult, and onset is hurried, and General Symptoms is obvious, and performance has lasting hyperpyrexia, headache fear of cold, limb muscle ache, weak, occurs pharyngalgia, watery nasal discharge subsequently, sheds tears, respiratory tract mucositis symptom such as cough.The clinical symptoms of infant influenza often is not true to type, the unexpected hyperpyrexia companion of part infant whole body poisoning symptom, or with symptoms of digestive tract such as vomiting and diarrhoea, visible hyperpyrexia convulsion; The part infant can show as acute laryngitis, and tracheobronchitis hoarseness, barking cough occur, pants, gurgling with sputum, and airway obstruction sign appears in severe patient.Children's's influenza causes multiple complications easily, and influenza virus is invaded upper respiratory tract can cause otitis media, sinusitis, parotitis etc., invades lower respiratory tract and can cause pneumonia.In addition, influenza can concurrent encephalitis, or encephalopathy and fatty degeneration of the viscera, also can bring out bronchial asthma, myocarditis or the like.At present, the medicine of treatment infantile common cold is also more, like medicines such as " capsule for cold ", " GANMAOTONG ", " antondins ", contains compositions such as acetaminophen, phenacetin, aminophenazone, caffeine.These compositions can produce inhibitory action to medulla hematopoietic system, influence the generation and the growth of children's's hemocyte, cause leukopenia and agranulocytosis, reduce children's's immunity, and the caused toxic that has liver damages.
Summary of the invention
Technical problem to be solved by this invention is, provides that a kind of quality of the pharmaceutical preparations is stable, determined curative effect, treats (children's's relieving the exterior syndrome ball) Chinese medicine preparation of respiratory tract infection safely and effectively according to Chinese medical theory.
Chinese medicine preparation prescription of the present invention derives from the Chinese medicine ministry standard: Z19-21 standard numbering: WS3-B-3542-98.
[prescription]
Tasteless preserved soybean, Radix Scrophulariae, Folium Mori, Pericarpium Citri Reticulatae, Fructus Forsythiae, Herba Menthae, Radix Paeoniae Rubra, Flos Lonicerae, Periostracum Cicadae, Rhizoma Imperatae, Radix Puerariae, Radix Isatidis, Radix Peucedani, Radix Scutellariae, Herba Schizonepetae, Folium Isatidis, Fructus Gardeniae, Radix Trichosanthis, Cacumen Tamaricis, Pulvis Cornus Bubali Concentratus are formed.Its method for making is with above 20 flavors, is ground into fine powder, and mixing sieves, and every 100g powder adds refined honey 140~150g, processes big honeyed pills, promptly gets.But ministry standard only discloses composition, and the compatibility dosage between unexposed component.The inventor follows traditional Chinese medical science traditional theory, through the compatibility of monarch, make every medicine addition after, produced the effect that is superior to single medicinal material.And the weight proportion of prescription Chinese crude drug consumption carried out secular, a large amount of pharmacological evaluation screenings, and carried out the animal safety pharmacological testing simultaneously, finally confirmed prescription proportioning of the present invention and consumption.Evidence, prescription composition of the present invention and amount ranges compatibility are reasonable, determined curative effect.Upper respiratory tract infection, influenza, measles, rubella for the treatment child have unique curative effect.
Technical scheme of the present invention thes contents are as follows:
A kind of Chinese medicine composition of dispersing wind, relieving exterior syndrome heat-clearing and toxic substances removing is characterized in that it is processed by the Chinese medicine of following component:
Semen Sojae Preparatum 100-400 part Radix Scrophulariae 100-300 part Folium Mori 50-200 part
Pericarpium Citri Reticulatae 100-300 part Fructus Forsythiae 100-300 part Herba Menthae 50-120 part
Radix Paeoniae Rubra 100-300 part Flos Lonicerae 100-300 part Periostracum Cicadae 50-120 part
Rhizoma Imperatae 100-300 part Radix Puerariae 50-120 part Radix Isatidis 100-300 part
Radix Peucedani 50-120 part Radix Scutellariae 100-300 part Herba Schizonepetae 50-120 part
Folium Isatidis 100-300 part Fructus Gardeniae 50-120 part Radix Trichosanthis 100-300 part
Cacumen Tamaricis 50-120 part Pulvis Cornus Bubali Concentratus 5-20 part.
The preferred Chinese medicine composition of the present invention is characterized in that it is processed by the Chinese medicine of following component:
Semen Sojae Preparatum 200-300 part Radix Scrophulariae 150-200 part Folium Mori 100-150 part
Pericarpium Citri Reticulatae 150-200 part Fructus Forsythiae 150-200 part Herba Menthae 50-100 part
Radix Paeoniae Rubra 150-200 part Flos Lonicerae 150-200 part Periostracum Cicadae 50-100 part
Rhizoma Imperatae 150-200 part Radix Puerariae 50-100 part Radix Isatidis 150-200 part
Radix Peucedani 50-100 part Radix Scutellariae 150-200 part Herba Schizonepetae 50-100 part
Folium Isatidis 150-200 part Fructus Gardeniae 50-100 part Radix Trichosanthis 150-200 part
Cacumen Tamaricis 50-100 part Pulvis Cornus Bubali Concentratus 10-15 part.
The Chinese medicine composition that the present invention is more preferably is characterized in that it is processed by the Chinese medicine of following component:
120 parts on 180 parts of Folium Mori of 240 portions of Radix Scrophulariaes of Semen Sojae Preparatum
90 parts of 180 portions of Herba Menthaes of 180 parts of Fructus Forsythiaes of Pericarpium Citri Reticulatae
90 parts of 180 portions of Periostracum Cicadaes of 180 portions of Flos Loniceraes of Radix Paeoniae Rubra
180 parts of 90 parts of Radix Isatidis of 180 parts of Radix Puerariaes of Rhizoma Imperatae
90 parts of 180 parts of Herba Schizonepetaes of 90 parts of Radix Scutellariaes of Radix Peucedani
180 parts of 90 parts of Radix Trichosanthis of 180 portions of Fructus Gardeniaes of Folium Isatidis
12 parts of 90 parts of Pulvis Cornus Bubali Concentratuss of Cacumen Tamaricis.
More than form to be by weight as proportioning unit; When producing, can increase or reduce according to corresponding proportion; Like large-scale production can kilogram be unit for unit or with the ton, and small-scale production can restrain and be unit, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The upper respiratory tract infection cause of disease, motherland's medical science think that lung loses the machine of logical accent, and metabolism is abundant inadequately; Violate event on the human body inner product heat, must ask its principle according to curing the disease, we wherein Radix Puerariae nature and flavor are sweet, hot, cool; Has relieving muscles diaphoresis, invigorating YANG QI to promote eruption, the analgesic effect of promoting the production of body fluid.Be used for fever caused by exogenous pathogens, headache, lossless, join Radix Scutellariae with expelling pathogenic factors from muscles for clearing heat.Herba Schizonepetae and Fructus Forsythiae, Herba Menthae, Semen Sojae Preparatum are equal to usefulness, the treatment wind-heat syndrome.Add Flos Lonicerae, Radix Isatidis, Radix Trichosanthis, Fructus Gardeniae, Folium Mori, Periostracum Cicadae, Radix Scrophulariae, Folium Isatidis, Cornu Bubali, strengthen the power of heat-clearing and toxic substances removing, treatment fever and headache, laryngopharynx swelling and pain.Radix paeoniae rubrathe for treating epidemic febrile disease heat is at blood system, fever of the body, sends out card such as macule.Pericarpium Citri Reticulatae, Radix Peucedani are regulated the flow of vital energy, are eliminated the phlegm.It is appropriate to make a general survey of the shared 20 flavor medicine compatibilities of full side, has brought into play dispelling wind to relieve the exterior syndrome jointly, expelling pathogenic factors from muscles rash, the effect of heat-clearing and toxic substances removing.
The inventor follows traditional Chinese medical science traditional theory, through the compatibility of monarch, make every medicine addition after, produced the effect that is superior to single medicinal material.And the weight proportion of prescription Chinese crude drug consumption carried out secular, a large amount of pharmacodynamics test screenings, finally confirmed prescription proportioning of the present invention and consumption.Evidence, prescription composition of the present invention and amount ranges compatibility are reasonable, determined curative effect.For the child of special case, can adjust the proportioning of the amount of composition accordingly, increase or reduce being no more than 30%, drug effect is constant.
Chinese medicine composition of the present invention can be common oral formulations such as tablet, granule, capsule, oral liquid, buccal tablet, pill, powder or drop pill or the like.Preferably granule, capsule, drop pill, more preferably pill or granule.
The method for preparing of Chinese medicine composition according to the invention, can adopt following two kinds arbitrary method preparation:
The 1st kind of method for preparing:
A. weigh following bulk drugs by weight:
Semen Sojae Preparatum 100-400 part Radix Scrophulariae 100-300 part Folium Mori 50-200 part
Pericarpium Citri Reticulatae 100-300 part Fructus Forsythiae 100-300 part Herba Menthae 50-120 part
Radix Paeoniae Rubra 100-300 part Flos Lonicerae 100-300 part Periostracum Cicadae 50-120 part
Rhizoma Imperatae 100-300 part Radix Puerariae 50-120 part Radix Isatidis 100-300 part
Radix Peucedani 50-120 part Radix Scutellariae 100-300 part Herba Schizonepetae 50-120 part
Folium Isatidis 100-300 part Fructus Gardeniae 50-120 part Radix Trichosanthis 100-300 part
Cacumen Tamaricis 50-120 part Pulvis Cornus Bubali Concentratus 5-20 part;
B. get above-mentioned 20 flavor medical materials, pulverize, mixing is crossed 100 mesh sieves; With the Mel heating, refine to water content 16-21% sweet temperature 50-100 ℃; In 1: the 1-1.8 ratio adds medicated powder in the good Mel of refining, stirs, and closes to stick together; It is cool to pill below 40 ℃ that medicine is sticked together.
The 2nd kind of method for preparing:
A. weigh following bulk drugs by weight:
Semen Sojae Preparatum 100-400 part Radix Scrophulariae 100-300 part Folium Mori 50-200 part
Pericarpium Citri Reticulatae 100-300 part Fructus Forsythiae 100-300 part Herba Menthae 50-120 part
Radix Paeoniae Rubra 100-300 part Flos Lonicerae 100-300 part Periostracum Cicadae 50-120 part
Rhizoma Imperatae 100-300 part Radix Puerariae 50-120 part Radix Isatidis 100-300 part
Radix Peucedani 50-120 part Radix Scutellariae 100-300 part Herba Schizonepetae 50-120 part
Folium Isatidis 100-300 part Fructus Gardeniae 50-120 part Radix Trichosanthis 100-300 part
Cacumen Tamaricis 50-120 part Pulvis Cornus Bubali Concentratus 5-20 part;
B. the Radix Scrophulariae pulverized, Folium Mori, Pericarpium Citri Reticulatae, Fructus Forsythiae, Herba Menthae, Radix Paeoniae Rubra, Flos Lonicerae, Radix Peucedani, Herba Schizonepetae, Fructus Gardeniae, Cacumen Tamaricis ten medical material simply of learning from else's experience; Extract volatile oil with steam distillation, volatile oil is with an amount of cyclodextrin inclusion compound or subsequent use with an amount of anhydrous alcohol solution; C. through B gained medicinal residues with through Periostracum Cicadae, Rhizoma Imperatae, Radix Puerariae, Radix Isatidis, Radix Scutellariae, Folium Isatidis, the decocte with water of Radix Trichosanthis seven flavor medicine material of pulverizing three times, collecting decoction filters, and is concentrated into thick paste, and is subsequent use; D. get Semen Sojae Preparatum, pulverize, cross 100 mesh sieves, subsequent use; E. with said extracted gained thick paste and cyclodextrin of volatile oil clathrate, medicinal powder and suitable adjuvant mix homogeneously, process required Chinese medicine preparation; Or thick paste and medicinal powder and suitable adjuvant mix homogeneously, process required Chinese medicine preparation, drying, spray adds the volatile oil ethanol solution, promptly gets.
Chinese medicine composition of the present invention; When being prepared into medicament, can add acceptable accessories; Comprise diluent, filler (like mannitol, lactose, Polyethylene Glycol) conventional in the preparation; Binding agent (starch, microcrystalline Cellulose), disintegrating agent (like carboxymethyl cellulose, low substituted hydroxypropyl cellulose), lubricant (like Pulvis Talci, magnesium stearate); Wetting agent (like propylene glycol, ethanol), stabilizing agent (EDTA-2Na, sodium thiosulfate, sodium pyrosulfite, sodium sulfite, ethanolamine, sodium bicarbonate, nicotiamide) or the like.
Above-mentioned adjuvant can be a common dose, mixes with the main constituent extract with proportioning commonly used, and after main constituent extract consumption was confirmed, the proportioning between each pharmaceutic adjuvant can suitably be regulated as required.
It is with 20 flavors for Chinese medicine composition of the present invention, particularly children's's relieving the exterior syndrome ball, is ground into fine powder, and mixing sieves, and every 100g powder adds refined honey 140~150g, processes big honeyed pills.
The Chinese medicine composition of dispersing wind, relieving exterior syndrome heat-clearing and toxic substances removing of the present invention, through the pharmacodynamics test explanation, children's's relieving the exterior syndrome ball has antiviral, antiinflammatory, anti-allergic effects, and experimental technique is following:
1. antivirus action
One, test and medication
Children's's relieving the exterior syndrome ball (seeing embodiment 1): 1 gram crude drug/gram powder, produce by Tianjin Zhongxin Pharmaceutical Group Co, get 10 and restrain dry powder adding distil waters to 50 milliliter; Water-bath was boiled 10 minutes; Centrifugal 2000 rev/mins, 10 minutes, every milliliter of crude drug concentration of clear liquid was 0.32 gram; It is subsequent use to put 4 ℃ of refrigerators, with preceding accent PH=7.4.
SHUANGHUANGLIAN KOUFUYE: positive control drug, 10 milliliters/, 1.5 gram crude drug/milliliters, effluent mao bamboo woods all living creatures pharmaceutcal corporation, Ltd produces, authentication code: the accurate word Z41020565 of traditional Chinese medicines, product batch number: 03351611, with preceding accent PH=7.4.
Two, test is with virus
Influenza first 3 types: the 95-359 chick embryo allantoic liquid prevented in the Chinese.
Influenza B: the 93-184 chick embryo allantoic liquid is prevented in the capital.
Three, Embryo Gallus domesticus
9-10 day instar chicken embryo is provided by last village Ji Chang.
Four, experimental technique
Medicine is to the toxicity test of Embryo Gallus domesticus: will dilute the capable chick embryo allantoic cavity inoculation of good medicinal liquid 0.1-0.4ml, and cultivate 72 hours in 33 ℃ of incubators, and observe Embryo Gallus domesticus anyway.
Medicine and viral equivalent neutralisation: will dilute good medicinal liquid and mix at the test tube moderate with virus, put in 33 ℃ of incubators 1 hour, the row chick embryo allantoic cavity is inoculated 0.2ml, in 33 ℃ of incubators cultivations.
Dose regimen behind elder generation's virus inoculation: the 0.1ml virus inoculation was put in 33 ℃ of incubators 1 hour in chick embryo allantoic cavity, adopted with the good medicinal liquid 0.1ml of approach injection dilution again, cultivated in 33 ℃ of incubators.
More than virus control is done in experiment simultaneously, observes Embryo Gallus domesticus every day, meets extremely then and removes.First 3 types were cultivated 48 hours, B-mode cultivation 72 hours, put 4 ℃ of refrigerator overnight after, get allantoic fluid and survey hemagglutinative titer (HA), the difference of comparative experiments group and virus control group.
The result
One, medicine is seen table 1 to the toxicity test result of Embryo Gallus domesticus
Table 1 medicine is to the toxicity test result of Embryo Gallus domesticus
The medicine name Drug level The Embryo Gallus domesticus number Embryo alive The dead germ number Maximal non-toxic concentration (mg/ml)
Children's's relieving the exterior syndrome ball SHUANGHUANGLIAN KOUFUYE 16 32 64 96 128 150 5 5 5 5 5 5 5 5 5 5 5 5 0 0 0 0 0 0 128
As shown in table 1, the maximal non-toxic concentration of children's's relieving the exterior syndrome ball is 128mg/ml, and SHUANGHUANGLIAN KOUFUYE 150mg/ml is to the Embryo Gallus domesticus avirulence.
Two, medicine and influenza virus A 3 type equivalent neutralization results see table 2.
Table 2 medicine and influenza virus A 3 type equivalent neutralization results
Medicine Concentration (mg/ml) The Embryo Gallus domesticus number HA In the half and concentration
Negative Positive
3 contrasts of children's's relieving the exterior syndrome ball SHUANGHUANGLIAN KOUFUYE first 320 160 80 40 150 8 8 8 8 10 10 6 1 0 0 10 0 2 7 8 8 0 10 241.11
As shown in table 2, children's's relieving the exterior syndrome ball is to being 241.11mg/ml with concentration in the half of first 3 virus, and is viral with influenza virus A 3 types in can be fully during SHUANGHUANGLIAN KOUFUYE 150mg/ml.
Three, the B-mode equivalent neutralization of medicine and influenza virus result sees table 3
The B-mode equivalent neutralization of table 3 medicine and influenza virus result
Medicine Concentration (mg/ml) The Embryo Gallus domesticus number HA In the half and concentration
Negative Positive
The B-mode contrast of children's's relieving the exterior syndrome ball SHUANGHUANGLIAN KOUFUYE 80 40 20 10 150 10 10 10 10 10 10 10 8 0 0 10 0 0 2 10 10 0 10 30.87
As shown in table 3, children's's relieving the exterior syndrome ball is to being 30.87mg/ml with concentration in the half of B virus, can be fully during SHUANGHUANGLIAN KOUFUYE 150mg/ml in and Influenza B virus.
Conclusion:
Direct inactivation of viruses method of medicament and medicine antiviral activity algoscopy are observed this medicine to influenza virus A 3 types, B-mode effect.The result shows, this medicine is to being 241.11mg/ml with concentration in the half of first 3 viruses, to being 30.87mg/ml with concentration in the half of B virus.Results suggest, this medicine has neutralization to influenza virus.
2. antiinflammatory action
One, test material
Experimental animal: the Wistar rat, male, body weight 150-180g.The ICR mice, male, body weight 26-29g.The SPF level provides by Beijing Vital River Experimental Animals Technology Co., Ltd., the laboratory animal quality certification number: SCXK (capital) 2002-0003.
Supply the reagent thing:
(1) children's's relieving the exterior syndrome extract (seeing embodiment 6) is provided by Tianjin Zhongxin Pharmaceutical Group Co.Be made into the suspension that is equivalent to crude drug 0.05,0.1,0.2g/ml with distilled water before the test, face with before shaking up use.
(2) chondrus ocellatus Holmes, U.S. SIGMA company produces, lot number: 59C0328.Test the previous day, be made into 1% chondrus ocellatus Holmes solution with 0.5%CMC solution.
(3) xylene, East China, Tianjin chemical reagent work produces.Lot number: 20040202.
Two, test method and result
(1) children's's relieving the exterior syndrome ball is to the effect of rat paw edema due to the chondrus ocellatus Holmes
50 of extracting male Wistar rats, body weight 150-180g is divided into 5 groups at random, 10 every group.Except that the positive controls indometacin was administered once the same day, other each groups are gastric infusion five days continuously all.The administration volume is the 20ml/kg body weight.Before the administration, measure the normal boll of foot girth value of rat earlier.After the last administration 1 hour, in the left back sufficient aponeurosis (aponeuroses) injected 1% chondrus ocellatus Holmes solution 0.05ml/ of each treated animal only.The boll of foot girth value of rat when measuring behind the injection chondrus ocellatus Holmes solution 1,2,3,4,5 hour then.Calculate its swelling degree and suppression ratio.The result carries out statistical procedures and does test of significance, comparable group differences significance.Result of the test is seen table 1.
The normal boll of foot girth value of swelling degree (cm)=cause scorching back rat boll of foot girth value-rat
Figure S2007100601906D00091
(2) effect of children's's relieving the exterior syndrome ball xylol induced mice ear swelling
Get 50 of male mouses, body weight 26-29g is divided into 5 groups at random, 10 every group.Except that the positive controls indometacin was administered once the same day, other each groups are gastric infusion five days continuously all.The administration volume is the 20ml/kg body weight.Xylene 0.05ml dripped in every mouse right ear in 1 hour after the administration; After 40 minutes the dislocation of mice cervical vertebra is caused death; Cut two ears along the auricle baseline, with the card punch of diameter 9mm respectively in the left and right sides the same position of ear lay round auricle, weigh; Obtain the poor of left and right sides auricle weight, as the swelling degree and calculate its suppression ratio.The result carries out statistical procedures and does test of significance, comparable group differences significance.Result of the test is seen table 2.
Figure S2007100601906D00092
Table 1 children's relieving the exterior syndrome ball is to the effect of rat paw edema due to the chondrus ocellatus Holmes
Group Dosage (the g crude drug/kg) Number of animals (only) Different time rat paw edema meansigma methods after the administration (cm, X ± SD) and suppression ratio (%)
1h 2h 3h 4h 5h
Matched group (distilled water) 20ml/kg 10 2.33±0.22 3.05±0.31 3.03±0.32 3.04±0.41 2.94±0.28
Indometacin 10ml/kg 10 1.51±0.22** 1.49±0.26** 1.22±0.23** 1.30±0.27** 1.52±0.23**
35.2 51.1 59.6 57.2 48.3
Children's's relieving the exterior syndrome ball low dosage 1 10 1.47±0.24** 1.99±0.30** 2.20±0.32** 2.37±0.33** 2.40±0.35**
36.9 34.8 27.4 22.0 18.4
Dosage in children's's relieving the exterior syndrome ball 2 10 1.40±0.35** 1.37±0.36** 1.49±0.24** 1.79±0.28** 1.91±0.28**
39.9 55.1 50.7 41.4 35.2
Children's's relieving the exterior syndrome ball high dose 4 10 1.16±0.33** 1.66±0.21** 1.80±0.21** 1.86±0.32** 1.84±0.33**
50.2 45.6 40.6 38.8 37.4
* and matched group are than P<0.01
Table 2 children's relieving the exterior syndrome ball xylol induced mice ear swelling has tangible exercising result
Group Dosage (the g crude drug/kg) Number of animals (only) Swelling degree (cm) Suppression ratio (%) The P value
Matched group (distilled water) 2ml/kg 10 18.1±3.60
Children's's relieving the exterior syndrome ball low dosage 0.5 10 6.3±3.43** 65.2 0.01
Dosage in children's's relieving the exterior syndrome ball 1 10 8.5±3.37** 53.0 0.01
Children's's relieving the exterior syndrome ball high dose 2 10 7.3±3.27** 59.7 0.01
Indometacin 10mg/kg 10 5.3±1.83** 70.7 0.01
Three, conclusion
Result of the test shows, irritates stomach in continuous five days to give and rat children's relieving the exterior syndrome ball 1,2,4g crude drug/kg, and rat paw edema due to the chondrus ocellatus Holmes is had the obvious suppression effect with xylene induced mice ear swelling, and comparing with matched group all has significant difference.The result of the test prompting, children's's relieving the exterior syndrome ball has antiinflammatory action.
3. anti-allergic effects
One, test material
Receive the reagent thing:
Children's's relieving the exterior syndrome ball (seeing embodiment 1): 1 gram crude drug/gram powder, produce by Tianjin Zhongxin Pharmaceutical Group Co.Be made into the variable concentrations solution for standby with distilled water before the test.
SHUANGHUANGLIAN KOUFUYE: positive control drug, 10 milliliters/, 1.5 gram crude drug/milliliters, effluent mao bamboo woods all living creatures pharmaceutcal corporation, Ltd produces, authentication code: the accurate word Z41020565 of traditional Chinese medicines, product batch number: 03351611.Be made into the desired concn solution for standby with distilled water before the test.
Experimental animal:
Kunming mouse, 18-20g, male and female half and half, the one-level animal is provided by the loosening thing center of Academy of Military Medicine, PLA's experiment.Credit number: the capital is moving is betrothed to 99001.
The Wistar rat, 140-180g, male, the secondary animal provides credit number by laboratory animal research institute of Chinese Academy of Medical Sciences breeding field: SCXK11-00-0006.
The animal feeding environment:
Animal is bought the back and gets into the secondary animal feeding room, and the unified outward numbering of male and female sub-cage rearing, 5 in every cage, cage indicates group and dosage.22 ± 2 ℃ of feeding environment room temperatures, humidity 45-70% regularly ventilates natural lighting.Solid feed is provided by laboratory animal research institute of Chinese Academy of Medical Sciences breeding field, freely absorbs feedstuff and clean water.
Two, test method and result
Mouse resisting anteserum preparation: get fresh albumen 1ml and add normal saline 9ml and be made into 10% egg white solution.Get the mice of 10 25-30g, male and female half and half are injected 10% egg white solution 0.1ml/ foot at mice two hind paw places, and lumbar injection gel aluminum hydroxide 0.1ml/ only simultaneously.After the sensitization 12 days, get blood from eye socket, the low heart that leaves.Get mouse resisting anteserum 0.5ml and add the 2.5ml normal saline, process the antiserum diluent, subsequent use.
Get 50 of mices, male and female half and half, body weight 18.9 ± 0.7g is divided into 5 groups at random, 10 every group.(1) children's's relieving the exterior syndrome ball low dosage: dosage in 2.5g crude drug/Kg (2) children's's relieving the exterior syndrome ball: 5.0g crude drug/Kg (3) children's's relieving the exterior syndrome ball high dose: (4) matched group: give and equivalent distilled water (5) positive controls: SHUANGHUANGLIAN KOUFUYE 5.0g crude drug/Kg.Administration volume 20ml/kg.Each organizes continuous gastric infusion 7 days.Every mice stomach wall intradermal injection antiserum diluent 0.03ml/ point, every injected in mice 2 points.Each only organizes administration posterior vein injection in 30 minutes azovan blue egg white solution 0.3ml/, puts to death mice after 20 minutes, takes off indigo plant with the 6.5cm borer and dyes skin, shreds, and puts in the acetone normal saline solution (7: 3) that fills 4ml and soaks 48 hours.Get indigo plant and dye the skin soak, measure OD value at the 610nm place with spectrophotometer.The result carries out statistical procedures, compares the difference between each administration group and matched group with the t check.The result sees the following form.
Children's's relieving the exterior syndrome ball is to the influence of mice passive cutaneous anaphylaxis, PCA of the same race
Group Dosage (crude drug g/kg) Number of animals (only) Indigo plant is dyed skin OD value (X ± SD) after the administration
Control group children relieving the exterior syndrome ball children's relieving the exterior syndrome ball children's relieving the exterior syndrome ball SHUANGHUANGLIAN KOUFUYE 20 2.5 5.0 10.0 5.0 10 10 10 10 10 0.0386+0.0136 0.0212±0.0056** 0.0205±0.0056** 0.0137+0.0040** 0.0247±0.0072*
With matched group than * P<0.05 * * P<0.01
Result of the test shows that each dose groups of children's's relieving the exterior syndrome ball all can obviously reduce the mice vascular permeability, and mice passive cutaneous anaphylaxis, PCA of the same race is all had the obvious suppression effect, with the matched group ratio significant differences (P<0.01) is arranged.
The specific embodiment
Below in conjunction with preferred embodiment, the present invention is done further description, to specifying as follows according to the specific embodiment provided by the invention; Simultaneously for simple and purpose clearly, the omission that hereinafter is appropriate the description of known technology, in order to avoid those unnecessary details influences are to the description of present technique scheme.
Embodiment 1:
A. get Semen Sojae Preparatum 240g, Radix Scrophulariae 180g, Folium Mori 120g, Pericarpium Citri Reticulatae 180g, Fructus Forsythiae 180g, Herba Menthae 90g, Radix Paeoniae Rubra 180g, Flos Lonicerae 180g, Periostracum Cicadae 90g, Rhizoma Imperatae 180g, Radix Puerariae 90g, Radix Isatidis 180g, Radix Peucedani 90g, Radix Scutellariae 180g, Herba Schizonepetae 90g Folium Isatidis 180g, Fructus Gardeniae 90g, Radix Trichosanthis 180g, Cacumen Tamaricis 90g, Pulvis Cornus Bubali Concentratus 12g; B. with above 20 flavors, be ground into fine powder, mixing sieves, and every 100g powder adds refined honey 140g, processes big honeyed pills.
Embodiment 2:
A. get Semen Sojae Preparatum 200g, Radix Scrophulariae 150g, Folium Mori 100g, Pericarpium Citri Reticulatae 150g, Fructus Forsythiae 150g, Herba Menthae 50g, Radix Paeoniae Rubra 150g, Flos Lonicerae 150g, Periostracum Cicadae 50g, Rhizoma Imperatae 150g, Radix Puerariae 50g, Radix Isatidis 150g, Radix Peucedani 50g, Radix Scutellariae 150g, Herba Schizonepetae 50g, Folium Isatidis 150g, Fructus Gardeniae 50g, Radix Trichosanthis 150g, Cacumen Tamaricis 50g, Pulvis Cornus Bubali Concentratus 10g; B. above 20 flavors are pulverized with starch and be mixed and made into tablet.
Embodiment 3:
A. get Semen Sojae Preparatum 200g, Radix Scrophulariae 180g, Folium Mori 120g, Pericarpium Citri Reticulatae 150g, Fructus Forsythiae 180g, Herba Menthae 90g, Radix Paeoniae Rubra 150g, Flos Lonicerae 180g, Periostracum Cicadae 90g, Rhizoma Imperatae 180g, Radix Puerariae 90g, Radix Isatidis 180g, Radix Peucedani 90g, Radix Scutellariae 170g, Herba Schizonepetae 90g, Folium Isatidis 200g, Fructus Gardeniae 90g, Radix Trichosanthis 180g, Cacumen Tamaricis 90g, Pulvis Cornus Bubali Concentratus 10g; B. above 20 flavors are pulverized and citron sugar mix homogeneously, processed granule.
Embodiment 4:
A. get Semen Sojae Preparatum 200g, Radix Scrophulariae 180g, Folium Mori 120g, Pericarpium Citri Reticulatae 200g, Fructus Forsythiae 200g, Herba Menthae 90g, Radix Paeoniae Rubra 200g, Flos Lonicerae 200g, Periostracum Cicadae 90g, Rhizoma Imperatae 180g, Radix Puerariae 90g, Radix Isatidis 180g, Radix Peucedani 90g, Radix Scutellariae 200g, Herba Schizonepetae 90g, Folium Isatidis 200g, Fructus Gardeniae 90g, Radix Trichosanthis 180g, Cacumen Tamaricis 90g, Pulvis Cornus Bubali Concentratus 12g; B. above 20 flavors are ground into fine powder, mixing sieves, and mix homogeneously is encapsulated, promptly gets.
Embodiment 5:
A. get Semen Sojae Preparatum 220g, Radix Scrophulariae 200g, Folium Mori 120g, Pericarpium Citri Reticulatae 200g, Fructus Forsythiae 200g, Herba Menthae 100g, Radix Paeoniae Rubra 150g, Flos Lonicerae 200g, Periostracum Cicadae 90g, Rhizoma Imperatae 180g, Radix Puerariae 90g, Radix Isatidis 200g, Radix Peucedani 90g, Radix Scutellariae 200g, Herba Schizonepetae 90g, Folium Isatidis 150g, Fructus Gardeniae 90g, Radix Trichosanthis 180g, Cacumen Tamaricis 90g, Pulvis Cornus Bubali Concentratus 10g; B. above 20 flavors are ground into fine powder, mixing sieves, and mix homogeneously adds medicinal starch 100g, dextrin 30g, and mixing is granulated, and drying adds 0.3% magnesium stearate, and compacting is in blocks, or bag film-coat or sugar-coat, promptly gets tablet.
Embodiment 6:
A. get Semen Sojae Preparatum 180g, Radix Scrophulariae 180g, Folium Mori 100g, Pericarpium Citri Reticulatae 200g, Fructus Forsythiae 180g, Herba Menthae 120g, Radix Paeoniae Rubra 160g, Flos Lonicerae 180g, Periostracum Cicadae 90g, Rhizoma Imperatae 150g, Radix Puerariae 90g, Radix Isatidis 200g, Radix Peucedani 90g, Radix Scutellariae 200g, Herba Schizonepetae 100g, Folium Isatidis 150g, Fructus Gardeniae 90g, Radix Trichosanthis 180g, Cacumen Tamaricis 100g, Pulvis Cornus Bubali Concentratus 10g; B. the Radix Scrophulariae pulverized, Folium Mori, Pericarpium Citri Reticulatae, Fructus Forsythiae, Herba Menthae, Radix Paeoniae Rubra, Flos Lonicerae, Radix Peucedani, Herba Schizonepetae, Fructus Gardeniae, Cacumen Tamaricis ten medical material simply of learning from else's experience; Extract volatile oil with steam distillation, volatile oil is with an amount of cyclodextrin inclusion compound or subsequent use with an amount of anhydrous alcohol solution; C. through B gained medicinal residues with through Periostracum Cicadae, Rhizoma Imperatae, Radix Puerariae, Radix Isatidis, Radix Scutellariae, Folium Isatidis, the decocte with water of Radix Trichosanthis seven flavor medicine material of pulverizing three times, collecting decoction filters, and is concentrated into thick paste, and is subsequent use; D. get Semen Sojae Preparatum, pulverize, cross 100 mesh sieves, subsequent use; E. with said extracted gained thick paste and cyclodextrin of volatile oil clathrate, medicinal powder and suitable adjuvant mix homogeneously, process pill or granule or tablet or capsule or the like.
After the preferred embodiment that specifies; Being familiar with this technological personage can be well understood to; Do not break away from above-mentioned claim with spirit under can carry out various variations and modification; All foundations technical spirit of the present invention all belongs to the scope of technical scheme of the present invention to any simple modification, equivalent variations and modification that above embodiment did.And the embodiment that the present invention also is not subject in the description to be given an actual example.

Claims (5)

1. the Chinese medicine composition of a dispersing wind, relieving exterior syndrome heat-clearing and toxic substances removing is characterized in that it is processed by the Chinese medicine of following component:
Figure FSB00000517974600011
2. Chinese medicine composition as claimed in claim 1 is characterized in that it is processed by the Chinese medicine of following component:
Figure FSB00000517974600012
3. Chinese medicine composition as claimed in claim 1 refers to pill, tablet, granule, capsule, oral liquid, buccal tablet, powder or drop pill.
4. Chinese medicine composition as claimed in claim 3 refers to pill or granule.
5. the method for preparing of the said Chinese medicine composition of claim 1 is characterized in that, it comprises following step:
(1) A. weighs following bulk drugs by weight:
Figure FSB00000517974600013
Figure FSB00000517974600021
B. get above-mentioned 20 flavor medical materials, pulverize, mixing is crossed 100 mesh sieves; With the Mel heating, refine to water content 16-21% sweet temperature 50-100 ℃; In 1: the 1-1.8 ratio adds medicated powder in the good Mel of refining, stirs, and closes to stick together; It is cool to pill below 40 ℃ that medicine is sticked together; Or
(2) A. weighs following bulk drugs by weight:
Figure FSB00000517974600022
B. the Radix Scrophulariae pulverized, Folium Mori, Pericarpium Citri Reticulatae, Fructus Forsythiae, Herba Menthae, Radix Paeoniae Rubra, Flos Lonicerae, Radix Peucedani, Herba Schizonepetae, Fructus Gardeniae, Cacumen Tamaricis ten medical material simply of learning from else's experience; Extract volatile oil with steam distillation, volatile oil is with an amount of cyclodextrin inclusion compound or subsequent use with an amount of anhydrous alcohol solution; C. through B gained medicinal residues with through Periostracum Cicadae, Rhizoma Imperatae, Radix Puerariae, Radix Isatidis, Radix Scutellariae, Folium Isatidis, the decocte with water of Radix Trichosanthis seven flavor medicine material of pulverizing three times, collecting decoction filters, and is concentrated into thick paste, and is subsequent use; D. get Semen Sojae Preparatum, pulverize, cross 100 mesh sieves, subsequent use; E. with said extracted gained thick paste and cyclodextrin of volatile oil clathrate, medicinal powder and suitable adjuvant mix homogeneously, process required Chinese medicine preparation; Or thick paste and medicinal powder and suitable adjuvant mix homogeneously, process required Chinese medicine preparation, drying, spray adds the volatile oil ethanol solution, promptly gets.
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CN103655819A (en) * 2013-12-13 2014-03-26 青岛安信医疗器械有限公司 Traditional Chinese medicine liquid for treating viral influenza and preparation method thereof
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CN104998138A (en) * 2015-07-27 2015-10-28 于晓菲 Medicine for preventing and treating infective cold
CN106692595A (en) * 2015-11-13 2017-05-24 赵爱良 Traditional Chinese medicine tea bag for preventing and treating Ebola virus and preparation method of traditional Chinese medicine tea bag
CN105902910A (en) * 2016-06-21 2016-08-31 刘文峰 Respiratory tract infection treating drop for pediatric nursing and preparation method thereof
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CN112121158A (en) * 2020-10-10 2020-12-25 吉林省地方病第一防治研究所 Dry powder based on plague attenuated vaccine and preparation method thereof

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