CN100444863C - Chinese medicine composition for diminishing-inflammation and detoxication and its preparing method and use - Google Patents
Chinese medicine composition for diminishing-inflammation and detoxication and its preparing method and use Download PDFInfo
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Abstract
The present invention provides a traditional Chinese medicine composition for relieving inflammation and removing toxicity and a preparation method thereof. Effective components of the traditional Chinese medicine composition comprise baicalin and figwort root. The traditional Chinese medicine composition can be prepared into tablets, capsules, pills, granules or oral medicinal liquid. The traditional Chinese medicine composition has the functions of heat and toxic material clearing, cold expelling, disease dissipation, sore-throat relief and stasis removal, and has obvious effects on upper respiratory tract infections caused by wind-heat comprising viral cold, tonsillitis (catarrh or suppurative tonsillitis) and swelling and pain in throats.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and its production and use, specifically, the present invention relates to Chinese medicine composition of a kind of eliminating inflammation and expelling toxin and its production and use.
Background technology
Radix Scutellariae (Scutellaria baicalensis Georgi) has another name called KONGXINCAO, Chimonanthus salicifolius S.Y.Hu..Scutellariae,radix contains noroxylin, baicalin, wogonin, wogonoside and neobaicalein, also contains compositions such as benzoic acid, cupreol, contains compositions such as scutellarin in the stem and leaf.Radix Scutellariae has the effect of antiinflammatory antiallergic action, its main component baicalin has a wider antimicrobial spectrum external, and Bacillus typhi, dysentery bacterium, bacillus pyocyaneus, bordetella pertussis, staphylococcus, streptococcus, Diplococcus pneumoniae, meningococcus are all had inhibitory action.Influenza virus, leptospira and multiple pathomycete there is inhibitory action.In addition, its effective ingredient baicalin shrinks and the whole animal allergic asthma guinea-pig isolated trachea anaphylaxis, and mitigation is all arranged, and with ephedrine synergism is arranged; Pharmacological actions such as that baicalin has simultaneously is analgesic, blood pressure lowering, diuresis, function of gallbladder promoting spasmolytic and calmness have the removing the relative excess fire clinically, remove damp and hot, hemostasis, antiabortive effect.At present, it is all bigger that the Radix Scutellariae master contains flavonoid polarity, is suitable for methanol, ethanol, the extraction of water equal solvent.People such as Hu Shangda (Hu Shangda, Tang Caiquan, Liu Xia. medical Leader, 2002; 21 (7): 438-439) water is as extracting solvent, and its optimised process is for add 8 times in water at every turn, and decocting time 1.5h decocts 3 times.
Radix Scrophulariae (Scrophularia ningpoensis Hemsl) contains compositions such as alkaloid, saccharide, sterol, aminoacid (being L-asparagine etc.), fatty acid (for oleic acid, linoleic acid, hard ester acid etc.), micro-volatile oil, carotene.Have blood vessel dilating, promote local blood circulation and the effect that diminishes inflammation, can be used for thromboangiitis obliterans.The various skin fungus there is inhibitory action, bacillus pyocyaneus is also had inhibitory action; External have in and the effect of diphtheria toxin, diphtherotoxin, be used for YIN nourishing, pathogenic fire reducing clinically, relieving restlessness, detoxifcation.
Summary of the invention
The object of the present invention is to provide a kind of laryngopharynx swelling and pain, tonsillitic Chinese medicine composition, its preparation method and its purposes that is used for the treatment of due to the wind heat poison heresy.
For achieving the above object, the present invention adopts following technical scheme:
The invention provides a kind of Chinese medicine composition of eliminating inflammation and expelling toxin, it is made up of effective ingredient and/or pharmaceutically acceptable carrier, it is characterized in that, its effective ingredient contains following raw materials according: baicalin 330-350 weight portion, Radix Scrophulariae 90-110 weight portion.
Wherein also contain the heat and toxic materials clearing away medicine except that Radix Scrophulariae in the effective ingredient, described heat and toxic materials clearing away medicine except that Radix Scrophulariae is selected from one or more in the following Chinese medicine: Fructus Arctii 45-55 weight portion, Herba Menthae 45-55 weight portion, Fructus Forsythiae 45-55 weight portion, Radix Platycodonis 95-105 weight portion, Radix Glycyrrhizae 95-105 weight portion, Bombyx Batryticatus 30-35 weight portion, Radix Isatidis 45-55 weight portion, Lasiosphaera Seu Calvatia 45-55 weight portion; Wherein also contain Pericarpium Citri Reticulatae 95-105 weight portion in the effective ingredient; Wherein also contain Rhizoma Cimicifugae 30-35 weight portion, Radix Bupleuri 95-105 weight portion in the effective ingredient.
Furthermore, the Chinese medicine composition of eliminating inflammation and expelling toxin provided by the present invention, it is characterized in that its effective ingredient is made by following raw materials according: baicalin 330-350 weight portion, Radix Scrophulariae 90-110 weight portion, Fructus Arctii 45-55 weight portion, Herba Menthae 45-55 weight portion, Fructus Forsythiae 45-55 weight portion, Radix Platycodonis 95-105 weight portion, Radix Glycyrrhizae 95-105 weight portion, Radix Isatidis 45-55 weight portion, Lasiosphaera Seu Calvatia 45-55 weight portion, Bombyx Batryticatus 30-35 weight portion, Pericarpium Citri Reticulatae 95-105 weight portion, Rhizoma Cimicifugae 30-35 weight portion, Radix Bupleuri 95-105 weight portion.
Chinese medicine composition provided by the present invention can be made into other common dosage forms such as oral liquid, injection, capsule, tablet.
The present invention also provides a kind of preparation method of above-mentioned Chinese medicine composition, it is characterized in that this method may further comprise the steps:
(1) gets Radix Scutellariae, add in 80～90 ℃ of hot water of 8～14 times of amounts by weight, decocted filtration 1～4 hour, in medicinal residues, add the water of 8～14 times of amounts by weight, extract repeatedly 1～5 time, merge medicinal liquid, adjust pH to 1.6～2.0, filter, the filtering residue washing with alcohol gets baicalin; Baicalin obtains except that adopting water to carry the Acid precipitation technology, still can adopt water to put forward the method for organic solvent deposit.
(2) get Radix Platycodonis, Radix Glycyrrhizae, Radix Scrophulariae, Fructus Arctii, Radix Isatidis, Lasiosphaera Seu Calvatia, Bombyx Batryticatus, Rhizoma Cimicifugae, add the water of 8～14 times of amounts by weight, soak, decoct, filter, in medicinal residues, add the water of 8～14 times of amounts by weight, extract repeatedly 1～3 time, it is standby to merge medicinal liquid;
(3) get Pericarpium Citri Reticulatae, Fructus Forsythiae, Radix Bupleuri, Herba Menthae distillation, and distillatory first medicinal liquid medicinal residues are filtered, medicinal liquid is standby; Above-mentioned Chinese medicine extract can extract with the traditional water decoction, also can adopt microwave, technology such as ultrasonic to obtain;
(4) medicinal liquid with step (2) and (3) gained merges, and is evaporated to relative density 1.20～1.22, adds ethanol, leaves standstill, and filters, and surplus liquid adds baicalin, adjusts pH value to 3.5～7.5, adds adjuvant and makes required dosage form.
The present invention also provides the purposes of above-mentioned Chinese medicine composition, it is characterized in that, described Chinese medicine composition is used for the treatment of application in the medicine that upper respiratory tract infection comprises viral influenza, tonsillitis or pharyngitis in preparation.
The Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention is made up of plurality of Chinese such as Radix Scutellariae, Radix Scrophulariaes.Reuse Radix Scutellariae in the side, let out the fire detoxifcation, let out clearly and send out in the pyretic toxicity of the part of the body cavity above the diaphragm housing the heart and lungs, and " fire of the clear part of the body cavity above the diaphragm housing the heart and lungs of withered person, the expectorant promoting the circulation of QI is decided cough with asthma, moves back alternate attack of chill and fever, and wind heat is damp and hot, and headache is separated pestilence, moistening and cleaning throat ... " (" book on Chinese herbal medicine is just "), be monarch drug; Radix Scrophulariae has the effect of heat-clearing and toxic substances removing, and the merit that has yin nourishing to wet one's whistle again simultaneously can be supplied the body fluid that burning hot heresy is hindered, and is ministerial drug.
Modern medicine studies show that, originally can add Fructus Arctii, Herba Menthae, Fructus Forsythiae, Radix Platycodonis, Radix Glycyrrhizae etc. simultaneously as ministerial drug.Fructus Arctii, Herba Menthae, Fructus Forsythiae can be evacuated part of the body cavity above the diaphragm housing the heart and lungs wind heat, resolving toxin and disinhibiting the throat; Radix Platycodonis, Radix Glycyrrhizae pharynx-clearing throat-benefiting, the merit of having share dissipating phlegm and resolving masses with Bombyx Batryticatus is more so; The Radix Isatidis bitter cold, GUIXIN, stomach warp, its merit heat-clearing and toxic substances removing, the removing heat from blood sore-throat relieving, " heating cures cold " the most top grade (" Chinese herbal medicine is used in Shanghai always "), and " controlling laryngopharynx swelling and pain ", Lasiosphaera Seu Calvatia has heat-clearing and toxic substances removing, and the effect of sore-throat relieving eliminating stagnation is the key medicine of treatment pharyngalgia; The effect of the existing heat-clearing and toxic substances removing of Radix Scrophulariae can be strengthened the power of the removing summer-heat of above all medicines, and the merit that has yin nourishing to wet one's whistle again can be supplied the body fluid that burning hot heresy is hindered, more than be ministerial drug altogether.Pericarpium Citri Reticulatae has the merit of regulating qi-flowing for harmonizing stomach, both can help the Radix Platycodonis dissipating phlegm and resolving masses, can prevent again that above all medicines are too cold and cool and sputum is stagnated, and can prevent that its bitter cold upsets one's stomach, as adjuvant drug.Radix Bupleuri, the Rhizoma Cimicifugae yang invigorating fire that looses, i.e. the meaning of " dispersing fire for treating depression of fire " is with the pyretic toxicity of the clear part of the body cavity above the diaphragm housing the heart and lungs; Rhizoma Cimicifugae, Radix Bupleuri are joined Radix Scutellariae and can be prevented again that the former from rising and send out too that the two opposes each other and yet also complement each other, and receives dispelling wind and heat pathogens altogether, the merit of heat-clearing and toxic substances removing.So Rhizoma Cimicifugae, Radix Bupleuri are messenger drug altogether.
More than all medicines share and can play heat-clearing and toxic substances removing, the dispelling wind merit evil, the sore-throat relieving eliminating stagnation of loosing altogether.Rigorous, the specimen of we's compatibility develops simultaneously, and stresses eliminating evilly, closes and is usefulness, and acute tonsillitis, laryngopharynx swelling and pain effect that wind heat is caused are remarkable.
The pharmacodynamic action of the Chinese medicine composition of eliminating inflammation and expelling toxin provided by the present invention:
(1) extracorporeal antivirus effect effect
1, experiment material:
Virus: respiratory syncytial virus (RSV), 1 type adenovirus (Adv1), I herpes simplex virus type (HSV-1), the strange B of Ke Sai family's virus (COXB1-6), 3 type grippe virus.
Cell: Hep-2 cell and HEKC.
2, test method
2.1 be subjected to the preparation of reagent thing: the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention is mixed with every milliliter of concentration that contains crude drug in whole 1g, QINGKAILING KOUFUYE is got stock solution, medicine is behind scalding, it is centrifugal to put centrifuge, centrifugal 15 minutes of elder generation's low speed (3000 rev/mins), get supernatant,, get supernatant and put 4 ℃ of refrigerators and preserve standby again through at a high speed (1.3 ten thousand rev/mins) centrifugal 15 minutes.
2.2 measure the toxic action of medicine pair cell: the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention is pressed 100mg/ml, 50mg/ml, 25mg/ml, 12.5mg/ml, 6.25mg/ml, 3mg/ml, 1.5mg/ml, (wherein respiratory syncytial virus is inoculated in the Hep-2 cell to be inoculated in HEKC and Hep-2 cell after the dilution respectively, all the other are inoculated in HEKC), the result is 12.5mg/ml to the minimum drug toxicity dosage of Hep-2 cell, is 25mg/ml to the minimum drug toxicity dosage of HEKC, virazole is 25mg/ml to HEKC and the minimum drug toxicity dosage of Hep-2 cell, and QINGKAILING KOUFUYE is 1: 10.
2.3 titration virus TCID
50: select 100-200 TCID for use
50Dosage and medicine carry out neutralization, and RSV is 10
-1, Adv1 is 10
-2, HSV-1 is 10
-4, COXB1-6 is 10
-2, first a type influenza is 10
-1
2.4 virus and different dilution factor medicine (20mg/ml; 10mg/ml; 5mg/ml; 2.5mg/ml; 1mg/ml) mix; room temperature effect 1 hour; be inoculated in HEKC and Hep-2 cell respectively; every pipe adds medicine virus mixed liquor 0.2ml, keeps liquid 0.8ml; establish virus, medicine, cell contrast simultaneously, observe the specific cell pathological changes continuously, treat that the virus control pipe occurs ++ judged result after the above cytopathy; if medicine can protect cell the specific cell pathological changes not occur, think that then this dose drug has inhibitory action to certain virus.
2.5 criterion as a result: do not occur cytopathy fully in the-expression cultured cell pipe;
10% following cytopathy appears in ± expression cultured cell the pipe;
25% following cytopathy appears in+expression cultured cell the pipe;
++ 50% following cytopathy appears in the expression cultured cell pipe;
++ 75% following cytopathy appears in+expression cultured cell the pipe;
++ ++ represent that pathological changes almost completely appears in nearly all cell.
The inhibitory action of table 1 pair respiratory syncytial virus
Table 1 results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention and traditional water decocting liquid are 10mg/ml to the minimum inhibitory concentration of respiratory syncytial virus; Virazole is 1mg/ml to the minimum inhibitory concentration of respiratory syncytial virus; QINGKAILING KOUFUYE (1: 10) can partly suppress the effect of respiratory syncytial virus.
Table 2 pair first a type influenza virus inhibitory action
Table 2 results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention and traditional water decocting liquid can suppress first a type influenza virus under the 20mg/ml drug level, can partly suppress under the 10mg/ml drug level; Virazole can suppress first a type influenza virus when 10mg/ml; QINGKAILING KOUFUYE (1: 10) can partly suppress first a type influenza virus.
The inhibitory action of table 3 pair I herpes simplex virus type
Table 3 results suggest, but the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention and traditional water decocting liquid when the 20mg/ml drug level, I herpes simplex virus type major part is suppressed, partly be suppressed during 10mg/ml; Virazole 10mg/ml, QINGKAILING KOUFUYE (1: 10) can partly suppress the I herpes simplex virus type.
Table 4 pair COXB1-6 viral inhibition
Table 4 results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention, traditional water decocting liquid, virazole and QINGKAILING KOUFUYE are to all unrestraint effects of COXB1-6 virus.
The inhibitory action of table 5 pair adenovirus
Table 5 results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention, the traditional water decocting liquid, virazole and QINGKAILING KOUFUYE are to adenovirus unrestraint effect.
(2) interior resisting virus effect
High, medium and low dosage of the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention and traditional water decocting liquid have protective effect to the death of influenza virus infecting mouse, and mouse death rate obviously reduces (P＜0.01), and the survival natural law obviously prolongs.
1, experiment material: the Chinese medicine composition concentrated solution of eliminating inflammation and expelling toxin of the present invention; Every gram contains crude drug in whole 5.64g, is mixed with desired concn with distilled water during use;
Positive control medicine: bright emerging QINGKAILING KOUFUYE, virazole
Strains of influenza viruses: FM1 mice adapted strain.
Virus is propagated: get instar chicken embryo on the 9th, and in every chick embryo allantoic cavity inoculation injection 0.1ml, the inoculation cultivation was got allantoic fluid in 3 days and is put 4 ℃ of preservations, then allantoic fluid sample is made hemagglutination test, survey the blood clotting titre, get and be sub-packed in aseptic small test tube after the identical allantoic fluid of titre merges ,-70 ℃ of preservations are standby, as the test seed culture of viruses.
2, dosage design: be subjected to reagent thing 5 times, 10 times or 20 times by clinical dosage, set up 2-3 dosage group respectively, positive drug dosage is subjected to the maximum multiple of reagent thing by this.
3, experimental technique: choose 230 of healthy mices, body weight is 13-15g, and male and female half and half by the body weight random packet, and shift to an earlier date 3 days gastric infusions, every day 1 time, and during infection, will good (2 LD of dilution
50/ 0.05ml) viral liquid is in the slight collunarium infecting mouse down of anaesthetizing of ether, and every Mus 0.05ml infects the back and continues administration, every day 1 time, continuous 5 days, and write down animal incidence and death toll every day, the observation period is 14 days.
4, the result calculates:
Dead protective rate (%)=(matched group mortality rate-experimental group mortality rate) * 100%
5, statistical method: with X
2Statistical procedures is carried out in check.
6, result of the test
The Chinese medicine composition of table 6 eliminating inflammation and expelling toxin of the present invention is to the dead protective effect of influenza virus infecting mouse
(3) external bacteriostasis
1, strain: select more representational respiratory tract common pathogenic bacteria and conditioned pathogen for use, as 10 kinds of staphylococcus aureus, the first and second type Hemolytic streptococcuss, Bing Xinglianqiujun, streptococcus pneumoniae, micrococcus catarrhalis, diphtheria corynebacterium, bacillus pyocyaneus and Candida albicans etc.
2, test method (test tube method): four kinds of medicinal liquids are all opposed since 1: 25 usefulness meat extract soup and are doubly diluted 1: 320 totally 8 dilution factor, every pipe total amount 1ml, heat sterilization, streptococcic test tube is still needed and add 1% rabbit anteserum in addition in the sterilization medicinal liquid, and Sha Shi culture fluid dilution medicine is then used in the test of Candida albicans.
Each dilution factor of every row's medicinal liquid adds 1: 1000 test organisms liquid (6-8 hour culture) 0.1ml respectively, cultivate observed result after 18 hours for 37 ℃, 24 hours cultures are then used in oidiomycetic test to white, medicinal liquid adds cultivates 48 hours observed results behind the bacterium liquid, is decided to be the inhibitory potency of this medicine with the high dilution of the medicine of complete bacteria growing inhibiting.
3, result of the test
The inhibitory potency of the Chinese medicine composition of table 7 eliminating inflammation and expelling toxin of the present invention
The inhibitory potency of the Chinese medicine composition of table 8 eliminating inflammation and expelling toxin of the present invention
Table 7, table 8 results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention all has in various degree antibacterial action to respiratory tract common pathogen and conditioned pathogen, wherein stronger to staphylococcus aureus and streptococcus pneumoniae effect, its antibacterial efficacy and traditional water decocting liquid do not have evident difference, from this angle of antibacterial action, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention is better than the QINGKAILING KOUFUYE as positive control.
The toxicity test of the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention
(1) acute toxicity test: mouse stomach gives this product maximum tolerated dose and made a living dose 348g/kg/ days, behave 600 times of clinical daily dosage (calculating) by the kg body weight dosage, administration was all survived in 7 days, outward appearance, behavioral activity, the mental status, appetite, defecation, quilt hair, skin, breathing, body weight gain etc. there is no unusual, and the result shows: this kind acute toxicity is lower.
(2) long term toxicity test: rat oral gavage gives this product 11.6,29,58g/kg (the clinical daily dosage of behaving 20,50,100 times), observed for three weeks, rat body weight increases, and ingests, drinks water, drains and reaction and matched group basically identical to external world, shows no obvious abnormalities change.And to each index of hematology, blood biochemical is learned each index, and main organs coefficient and each internal organs mode of appearance all do not have obvious influence.Results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention is safe in utilization, and long term toxicity is lower.
Three, clinical research
1, diagnostic criteria:
1.1 Western medicine diagnose standard acute catarrhal tonsillitis (names of disease of tcm: acute tonsillitis) " diagnosis of acute tonsillitis and curative effect determinate standard " (1991 Hangzhou meeting), " the new Chinese medicine clinical research guideline " 2002 editions of the formulation of department of otorhinolaryngology Professional Committee of the Chinese Chinese medicine of reference association, " Ministry of Public Health planning teaching material-high medical college teaching material-otolaryngology (1995 the 4th editions).
(1) medical history: often suffer from cold, tired, tobacco and wine excessively, the low inferior inducement of malnutrition passive protective physical fitness.
(2) symptom: it is hurried to fall ill, general malaise, and heating, headache, nape and extremities aching pain, inappetence, pharyngeal pain increases the weight of when swallowing.
(3) check: tonsil and the mucous hyperemia swelling of palatoglossal arch surface, the no exudate in surface.
1.2 Chinese medical discrimination standard: " diagnosis of acute tonsillitis and curative effect determinate standard " (1991 Hangzhou meeting) that department of otorhinolaryngology Professional Committee of the Chinese Chinese medicine of reference association formulates, " People's Republic of China's Chinese medicine industry standard traditional Chinese medical science disease diagnosis criterion of therapeutical effect " (1995 State Administration of Traditional Chinese Medicine), " new Chinese medicine clinical research guideline " 2002 editions.
The wind-heat syndrome fever with chills, pharyngeal pain is swallowed then aggravation, can be with dry and astringent, burning sensation, the tonsil redness, headache, body is tired weak, and malasia brings up phlegm when one coughs, and tongue is red partially, white and thin fur or BOHUANG, floating and rapid pulse.
1.3 symptom and sign quantitative criteria
Primary symptom
Pharyngalgia did not have in normal 0 minute
Pharyngalgia was lighter in slight 2 minutes, did not influence and swallowed
4 fens odynophagia of moderate
Severe pain when severe was swallowed in 6 minutes is difficult to swallow diet
Tonsil and normal 0 minute nothing
Pharyngeal congestion is slight, and 2 fens pharyngeal mucous membrane and tonsil are little red
4 fens pharyngeal mucous membrane of moderate and tonsil are obviously congested
Severe pharyngeal and tonsil diffusivity hyperemia in 6 fens, color is scarlet
Inferior disease
Generated heat normal 0 minute
Slight 1 minute 37.3 ℃～38 ℃
38.1 ℃～38.9 ℃ of moderates 2 minutes
Severe 3 minutes is greater than 38.9 ℃
The cough normal 0 minute nothing of coughing up phlegm
Had in 1 minute
Tongue tip side of red, white and thin fur or BOHUANG, floating pulse or floating number: have or other.
1.4 severity extent grade scale
(1) slight: primary symptom is slight or symptom and sign total mark≤5 minute.
(2) moderate: primary symptom has 1 or 2 to be moderate, but does not reach severe or symptom and sign total mark 6～10 minutes.
(3) severe: primary symptom has 1 or 2 to be severe or symptom and sign total mark＞10 minute.
1.5 the standard of including in
1.5.1 meet acute catarrhal tonsillitis diagnostic criteria and the dialectical standard person of traditional Chinese medical science wind-heat syndrome.
1.5.2 the age is between 18～65 years old.
1.5.3 Acute onset, the course of disease is in 48 hours.
1.5.4 informed consent, aspiration is tried.Obtain the Informed Consent Form process and should meet the GCP regulation.
1.6 exclusion standard
1.6.1 suppurative tonsillitis.
1.6.2 body temperature＞38.0 ℃.
Use the Chinese and western drugs of other treatment acute tonsillitis in preceding 1 week 1.6.3 go to a doctor.
1.6.4 the age is under-18s or over-65s person, or is trimester of pregnancy, women breast-feeding their children.
1.6.5 have serious constitutional cardiovascular pathological changes, hepatic lesions, nephropathy, hematology's pathological changes, pneumonopathy or influence the serious disease of its existence, as tumor or acquired immune deficiency syndrome (AIDS).As: 1. albuminuria＞+, or/and erythrocyturia＞+(urine Hb is not as judge index).2. serum creatinine, blood urea nitrogen, ALT surpass the normal value upper limit more than 20%.The arrhythmia that 3. clinical meaning is arranged.
1.5.6 spirit or jural disabled patient.
1.5.7 suspect or truly have ethanol, drug dependence medical history, perhaps according to the judgement of researcher, have to reduce and go into to organize probability or make into other complicated pathological changes of group, as working environment often change etc. easily cause the situation of visiting of losing.
1.5.8 it is known to this medicine composition allergy sufferers.
1.5.9 participating in the patient of other drug clinical trial.
2, test medication: the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention, every 10ml, room temperature preservation.
Contrast medicine: SHUANGHUANGLIAN KOUFUYE.Specification: every 10ml, room temperature preservation.
3, case load: press III clinical trial phase contrast in 3: 1 principle, consider to be no more than 10% release rate, total case load is defined as 440 examples, and each test center is distributed 88 examples, experimental group 330 examples, matched group 110 examples.The layering of employing center, district's group random arrangement.
4, result: with the baseline value is covariant, two groups of treatment back symptom and signs average rank WLS (Weighted Least Squares) covariance analysis relatively of keeping the score.
The traditional Chinese medicine composition for treating catarrhal tonsillitis's of table 9 eliminating inflammation and expelling toxin of the present invention effect assessment
The comparison of table 10 liang group positive symptom sign treatment back disappearance rate
Table 11 liang group treatment proleukocyte or centriole cell rising person treat the back is changeed natural rate of interest relatively
Meet scheme collection test group cure rate 36.98%, total effective rate 73.95%, matched group is respectively 34.65%, 69.31%; Complete analysis collection test group cure rate 36.34%, total effective rate 72.98%, matched group is respectively 34.91%, 68.87%.The equal not statistically significant of difference of two groups of comprehensive therapeutic effects, cure rate, total effective rate.
Table 9～table 11, results suggest, the Chinese medicine composition of eliminating inflammation and expelling toxin of the present invention can effectively improve the symptom and sign of acute catarrhal tonsillitis wind heat disease, and particularly cough is coughed up phlegm, and does not see the heart, liver, renal function and hemopoietic system infringement.
The specific embodiment
Embodiment 1: the preparation of oral liquid:
Take by weighing following raw materials in weight: Radix Scrophulariae 100 grams, Fructus Arctii 50 grams, Herba Menthae 50 grams, Fructus Forsythiae 50 grams, Radix Platycodonis 100 grams, Radix Glycyrrhizae 100 grams, Radix Isatidis 50 grams, Lasiosphaera Seu Calvatia 50 grams, Bombyx Batryticatus 33 grams, Pericarpium Citri Reticulatae 100 grams, Rhizoma Cimicifugae 33 grams and Radix Bupleuri 100 grams.
(1) gets Radix Scutellariae 350 grams, add 85 ℃ of hot water of 12 times of amounts by weight, decocted 3 hours, filter, in medicinal residues, add the water of 8 times of amounts by weight, extract repeatedly 3 times, merge medicinal liquid, in 80 ℃ of adjust pHs to 1.6, filter, filtering residue 85% washing with alcohol gets baicalin 335 grams;
(2) get Radix Platycodonis, Radix Glycyrrhizae, Radix Scrophulariae, Fructus Arctii, Radix Isatidis, Lasiosphaera Seu Calvatia, Bombyx Batryticatus, Rhizoma Cimicifugae, add the water of 14 times of amounts by weight, soaked 2 hours, decocted 1.5 hours, and filtered, in medicinal residues, add the water of 11 times of amounts by weight, extract repeatedly 3 times, it is standby to merge medicinal liquid;
(3) get Pericarpium Citri Reticulatae, Fructus Forsythiae, Radix Bupleuri, Herba Menthae distillation, and distillatory first medicinal liquid medicinal residues are filtered, medicinal liquid is standby;
(4) medicinal liquid with step (2) and (3) gained merges, being evaporated to relative density 1.20 (90 ℃) adding ethanol to concentration is 75%, leave standstill, filter, surplus liquid adds baicalin, adds 0.3% sodium benzoate and 0.266% stevioside, is stirred to whole dissolvings, adjusts pH value to 4.25, supply the water yield to 1000ml, sterilization filling gets final product.
Embodiment 2: the preparation of capsule of the present invention:
Take by weighing following raw materials in weight: baicalin 330 grams, Radix Scrophulariae 90 grams, Herba Menthae 45 grams, Fructus Forsythiae 45 grams, Radix Platycodonis 105 grams, Radix Isatidis 45 grams, Lasiosphaera Seu Calvatia 55 grams, Bombyx Batryticatus 30 grams, Pericarpium Citri Reticulatae 95 grams, Rhizoma Cimicifugae 30 grams and Radix Bupleuri 105 grams.
Said components is mixed, and concentrate drying adds suitable adhesive, forms by capsules preparation technique pelletize, dry packing.
Embodiment 3: the preparation of tablet of the present invention:
Take by weighing following raw materials in weight: Pericarpium Citri Reticulatae 100 grams, Radix Glycyrrhizae 100 grams, Radix Scrophulariae 100 grams, Radix Bupleuri 100 grams, Radix Platycodonis 100 grams, Fructus Forsythiae 50 grams, Lasiosphaera Seu Calvatia 50 grams, Radix Isatidis 50 grams, Herba Menthae 50 grams, Fructus Arctii 50 grams, Bombyx Batryticatus 33 grams, Rhizoma Cimicifugae 33 grams, above-mentioned medical material and 333 gram baicalins mix, and add suitable adhesive, disintegrating agent, magnesium stearate etc. by the tablet producing technology compacting in flakes.
Embodiment 4: the preparation of pill of the present invention:
Take by weighing following raw materials in weight: baicalin 350 grams, Radix Scrophulariae 110 grams, Fructus Arctii 50 grams, Herba Menthae 50 grams, Fructus Forsythiae 50 grams, Radix Platycodonis 100 grams, Radix Glycyrrhizae 100 grams, Radix Isatidis 50 grams, Lasiosphaera Seu Calvatia 50 grams, Bombyx Batryticatus 33 grams, Pericarpium Citri Reticulatae 100 grams, Rhizoma Cimicifugae 33 grams and Radix Bupleuri 100 grams.After pressing embodiment 1 processing, supplementary material mixes, and adds adhesive, pill.
Embodiment 5: the preparation of injection of the present invention:
Take by weighing following raw materials in weight: Pericarpium Citri Reticulatae 100 grams, Radix Glycyrrhizae 100 grams, Radix Scrophulariae 100 grams, Radix Bupleuri 100 grams, Radix Platycodonis 100 grams, Fructus Forsythiae 50 grams, Lasiosphaera Seu Calvatia 50 grams, Radix Isatidis 50 grams, Herba Menthae 50 grams, Fructus Arctii 50 grams, Bombyx Batryticatus 33 grams, Rhizoma Cimicifugae 33 grams.Above-mentioned medical material adds clarifiers precipitations such as ethanol, chitin, remove slag back and 333 gram baicalins mix, and transfers pH to form after making 1000ml.
Embodiment 6: oral liquid of the present invention:
According to embodiment 1 described method, difference is to select following raw materials in weight for use: baicalin 333 grams, Radix Scrophulariae 90 grams, Fructus Arctii 45 grams, Herba Menthae 45 grams, Fructus Forsythiae 55 grams, Radix Platycodonis 105 grams, Radix Glycyrrhizae 95 grams, Radix Isatidis 55 grams, Lasiosphaera Seu Calvatia 45 grams, Bombyx Batryticatus 35 grams, Pericarpium Citri Reticulatae 95 grams, Rhizoma Cimicifugae 30 grams and Radix Bupleuri 105 grams.
Embodiment 7: tablet of the present invention:
According to embodiment 3 described methods, difference is to select following raw materials in weight for use: baicalin 350 grams, Radix Scrophulariae 110 grams.
Claims (4)
1, a kind of Chinese medicine composition of eliminating inflammation and expelling toxin, it is made up of effective ingredient and/or pharmaceutically acceptable carrier, it is characterized in that, its effective ingredient is by baicalin, combine with the water extract of the distillation extraction thing of Pericarpium Citri Reticulatae, Fructus Forsythiae, Radix Bupleuri, Herba Menthae and Radix Platycodonis, Radix Glycyrrhizae, Radix Scrophulariae, Fructus Arctii, Radix Isatidis, Lasiosphaera Seu Calvatia, Bombyx Batryticatus, Rhizoma Cimicifugae; The weight proportion of each raw material is: baicalin 330-350 weight portion, Radix Scrophulariae 90-110 weight portion, Fructus Arctii 45-55 weight portion, Herba Menthae 45-55 weight portion, Fructus Forsythiae 45-55 weight portion, Radix Platycodonis 95-105 weight portion, Radix Glycyrrhizae 95-105 weight portion, Radix Isatidis 45-55 weight portion, Lasiosphaera Seu Calvatia 45-55 weight portion, Bombyx Batryticatus 30-35 weight portion, Pericarpium Citri Reticulatae 95-105 weight portion, Rhizoma Cimicifugae 30-35 weight portion, Radix Bupleuri 95-105 weight portion.
2, Chinese medicine composition as claimed in claim 1 is characterized in that, it is capsule, injection, tablet, pill, granule or oral liquid.
3, the preparation method of Chinese medicine composition as claimed in claim 1 or 2 is characterized in that, this method may further comprise the steps:
(1) gets Radix Scutellariae, add in 80～90 ℃ of hot water of 8～14 times of amounts by weight, decocted filtration 1～4 hour, in medicinal residues, add the water of 8～14 times of amounts by weight, extract repeatedly 1～3 time, merge medicinal liquid, adjust pH to 1.6～2.0, filter, the filtering residue washing with alcohol gets baicalin;
(2) get Radix Platycodonis, Radix Glycyrrhizae, Radix Scrophulariae, Fructus Arctii, Radix Isatidis, Lasiosphaera Seu Calvatia, Bombyx Batryticatus, Rhizoma Cimicifugae, add the water of 8～14 times of amounts by weight, soak, decoct, filter, in medicinal residues, add the water of 8～14 times of amounts by weight, extract repeatedly 1～5 time, it is standby to merge medicinal liquid;
(3) get Pericarpium Citri Reticulatae, Fructus Forsythiae, Radix Bupleuri, Herba Menthae distillation, and distillatory first medicinal liquid medicinal residues are filtered, medicinal liquid is standby;
(4) medicinal liquid with step (2) and (3) gained merges, and is evaporated to relative density 1.20～1.22, adds ethanol, leaves standstill, and filters, and surplus liquid adds baicalin, adjusts pH value to 3.5～7.5, adds adjuvant and makes required dosage form.
4, Chinese medicine composition as claimed in claim 1 or 2 is used for the treatment of application in the medicine of upper respiratory tract infection, viral influenza, tonsillitis or pharyngitis in preparation.
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| CN101152202B (en) * | 2007-09-29 | 2010-11-24 | 中国药科大学 | Pharmaceutical composition for treating apparatus respiratorius disease and method for preparing the same |
| CN102886013A (en) * | 2012-10-26 | 2013-01-23 | 王澜舸 | Shiniu antipyretic oral liquid |
| CN103285179B (en) * | 2013-04-12 | 2014-10-29 | 贵阳中医学院第二附属医院 | Traditional Chinese medicine preparation for treating acute pharyngitis and preparation method thereof |
| WO2014190555A1 (en) * | 2013-05-31 | 2014-12-04 | Qu Jinglai | Traditional chinese medicine composition for resisting influenza a virus infection and relieving cough, and preparation method therefor |
| CN104510998B (en) * | 2013-09-29 | 2017-12-19 | 桂林中族中药股份有限公司 | A kind of Chinese medicine composition for treating flu |
| CN103933128B (en) * | 2014-04-30 | 2015-10-21 | 青岛农业大学 | Pharmaceutical composition of a kind of heat-clearing and toxic substances removing and preparation method thereof |
| CN105288089A (en) * | 2015-11-25 | 2016-02-03 | 严中明 | Throat abscess treating pharmaceutical composition |
| CN116173116A (en) * | 2023-04-04 | 2023-05-30 | 吉林省寰宇济民科技有限公司 | Traditional Chinese medicine composition and traditional Chinese medicine extract for clearing heat and purging fire and preparation method thereof |
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Effective date of registration: 20160321 Address after: Baiyun District of Guangzhou City, Guangdong province 510515 street and with the Cloud Road No. 88 Patentee after: GUANGZHOU BAIYUNSHAN PHARMACEUTICAL HOLDINGS CO., LTD., BAIYUNSHAN PHARMACEUTICAL GENERAL FACTORY Patentee after: Guangzhou Baiyun Mountain Pharmaceutical Group Limited by Share Ltd Address before: Baiyun District of Guangzhou City, Guangdong province 510515 street and with Yunxiang Road No. 88 Guangzhou Baiyun Mountain pharmaceutical Limited by Share Ltd Patentee before: Baiyuanshan Pharmaceutical Co Ltd, Guangzhou |