The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Flos Chrysanthemi Indici 496.88g Radix Scutellariae 298.13g Rhizoma Belamcandae 298.13g
Calyx Seu Fructus Physalis 248.44g Radix Scrophulariae 248.44g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Starch adds to 750g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.75g, every gram contains raw material of Chinese medicine 2.12g, sucks each 4 every day three times.
With production granule product of the present invention 1000g is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 662.50g Radix Scutellariae 397.50g Rhizoma Belamcandae 397.50g
Calyx Seu Fructus Physalis 331.25g Radix Scrophulariae 331.25g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Dextrin adds 1000g
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 3g, every gram contains raw material of Chinese medicine 2.12g, obeys each 1 bag every day three times.
With 1000 of production capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 496.88g
Radix Scutellariae 298.13g
Rhizoma Belamcandae 298.13g
Calyx Seu Fructus Physalis 248.44g
Radix Scrophulariae 248.44g
Citric acid 9g
Mentholum 1.5g
Starch adds to 300g
Its preparation technology is undertaken by the preparation technology of capsule of the present invention.Every heavy 0.3g, every gram contains raw material of Chinese medicine 5.3g, obeys each 4 every day three times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 198.75g Radix Scutellariae 119.25g Rhizoma Belamcandae 119.25g
Calyx Seu Fructus Physalis 99.38g Radix Scrophulariae 99.38g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Distilled water adds to 1000mL
Its preparation technology is undertaken by the preparation technology of syrup of the present invention.Every milliliter contains raw material of Chinese medicine 0.636g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
10 parts of Flos Chrysanthemi Indicis
6 parts of Radix Scutellariaes
6 parts of Rhizoma Belamcandae
5 parts of Calyx Seu Fructus Physaliss
5 parts of Radix Scrophulariaes
Embodiment 2
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Flos Chrysanthemi Indici 722.73g Radix Scutellariae 289.09g penetrates 289.09g
Calyx Seu Fructus Physalis 144.55g Radix Scrophulariae 144.55g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Starch adds to 750g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.75g, every gram contains raw material of Chinese medicine 2.12g, obeys each 4 every day three times.
With production granule product of the present invention 1000g is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 963.64g Radix Scutellariae 385.45g Rhizoma Belamcandae 385.45g
Calyx Seu Fructus Physalis 192.73g Radix Scrophulariae 192.73g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Starch adds to 1000g
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 3g, every gram contains raw material of Chinese medicine 2.12g, obeys each 1 bag every day three times.
With 1000 of production capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 722.73g
Radix Scutellariae 289.09g
Rhizoma Belamcandae 289.09g
Calyx Seu Fructus Physalis 144.55g
Radix Scrophulariae 144.55g
Citric acid 9g
Mentholum 1.5g
Starch adds to 300g
Its preparation technology is undertaken by the preparation technology of capsule of the present invention.Every heavy 0.3g, every gram contains raw material of Chinese medicine 5.3g, obeys each 4 every day three times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 289.09g Radix Scutellariae 115.64g Rhizoma Belamcandae 115.64g
Calyx Seu Fructus Physalis 57.82g Radix Scrophulariae 57.82g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Distilled water adds to 1000mL
Its preparation technology is undertaken by the preparation technology of syrup of the present invention.Every milliliter contains raw material of Chinese medicine 0.636g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
5 parts of Flos Chrysanthemi Indicis
2 parts of Radix Scutellariaes
2 parts of Rhizoma Belamcandae
1 part of Calyx Seu Fructus Physalis
1 part of Radix Scrophulariae
Embodiment 3
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Flos Chrysanthemi Indici 596.25g Radix Scutellariae 298.13g Rhizoma Belamcandae 298.13g
Calyx Seu Fructus Physalis 198.75g Radix Scrophulariae 198.75g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Starch adds to 750g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.75g, every gram contains raw material of Chinese medicine 2.12g, obeys each 4 every day three times.
With production granule product of the present invention 1000g is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 795g Radix Scutellariae 397.50g Rhizoma Belamcandae 397.50g
Calyx Seu Fructus Physalis 265g Radix Scrophulariae 265g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Starch adds to 1000g
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 3g, every gram contains raw material of Chinese medicine 2.12g, each 1 bag, obeys every day three times.
With 1000 of production capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 596.25g
Radix Scutellariae 298.13g
Rhizoma Belamcandae 298.13g
Calyx Seu Fructus Physalis 198.75g
Radix Scrophulariae 198.75g
Citric acid 9g
Mentholum 1.5g
Starch adds to 300g
Its preparation technology is undertaken by the preparation technology of capsule of the present invention.Every heavy 0.3g, every gram contains raw material of Chinese medicine 5.3g, obeys each 4 every day three times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Flos Chrysanthemi Indici 238.50g Radix Scutellariae 119.25g Rhizoma Belamcandae 119.25g
Calyx Seu Fructus Physalis 79.50g Radix Scrophulariae 79.50g citric acid 9g
Mentholum 1.5g stevioside 11.25g sucrose 550g
Distilled water adds to 1000mL
Its preparation technology is undertaken by the preparation technology of syrup of the present invention.Every milliliter contains raw material of Chinese medicine 0.636g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
30 parts of Flos Chrysanthemi Indicis
15 parts of Radix Scutellariaes
15 parts of Rhizoma Belamcandae
10 parts of Calyx Seu Fructus Physaliss
10 parts of Radix Scrophulariaes
In order to verify the therapeutic effect of medicine of the present invention to acute pharyngitis and acute tonsillitis, the applicant entrusts Xi'an Shang Yikang medical research to adopt the embodiment of the invention 1 proportioning to prepare medicine of the present invention (name is called the compound wild chrysanthemum flower buccal tablet during test) tablet, entrust pharmaceutical college of Xi'an Communications University to carry out pharmacodynamics test by Xi'an Shangyikang Medicine Research Institute, and entrust the hospital of traditional Chinese hospital, Xi'an to carry out treatment acute pharyngitis 40 examples, acute tonsillitis 30 example initial stage clinical observation tests, various test situation are as follows:
One, the test of pesticide effectiveness
1, test objective
Adopt the test of inside and outside antibacterial tests of body and whole animal, observe the body inside and outside antibacterial action of medicine of the present invention acute pharyngitis acute tonsillitis common pathogen and respiratory tract common pathogen; And observe medicine of the present invention to the antiinflammatory of acute inflammation model and antitussive, analgesia, effect such as analgesic, the effect of reflection medicine of the present invention with cure mainly, for clinical trial provides theoretical foundation.
2, experiment material
(1) experiment material
Prednisone acetate tablets: Xi'an grand celebration pharmaceutical factory of limited company of Jinhua Enterprise Co. (group) produces, lot number: 030102, and specification: 5mg/ sheet.
Aspirin tablet: Shaanxi Province white deer pharmaceutical factory produces, lot number: 030117.
Morphine hydrochloride injection: Shenyang No. 1 Pharmaceutical Factory (eastern medicine group) is produced, and specification: 2ml/ props up (1%), lot number: 030803.
YINHUANG HANPIAN: buchu pharmaceutical Co. Ltd in Chengdu produces, lot number: 0307041.
Mirabilitum praeparatum buccal tablets: Sanjin Pharmaceutical Group Co, Guilin produces, 0.5 gram/sheet, lot number 0210055.
Codeine phosphate tablets (codeine phosphate): Qinghai Pharmaceutic Plant produces, every 30mg, lot number: 20030301.
(2) experimental strain and experiment reagent
Reference culture: escherichia coli ATCC25922 strain, staphylococcus aureus ATCC25925 strain, blue pus organism ATCC27853 strain, Jia Xingrongxuexinglianqiujun 32209 strains, beta hemolytic streptococcus 32210 strains, streptococcus pneumoniae 32401 strains, Neisseria meningitidis 29010 strains, hemophilus influenza 58535 strains, Klebsiella Pneumoniae 46104 strains, saccharomyces albicans 85021 strains.
Above reference culture lyophilizing bacterial strain is identified institute Chinese medicine antibacterial preservation center available from Chinese Academy of Medical Sciences's Beijing pharmaceutical biological product, in October, 2003 recovery, and the test forward pass is for standby.
Clinical separation strain: amount to 430 strains
Staphylococcus aureus 150 strains, numbering: SPC001-SPC150; Jia Xingrongxuexinglianqiujun 80 strains, numbering: AST001-AST080; Beta hemolytic streptococcus 80 strains, numbering: BST001-BAT080; Streptococcus pneumoniae 35 strains, numbering: PSS001-PSS035; Klebsiella Pneumoniae 60 strains, numbering: 25 strains of KLB001-KLB060 hemophilus influenza, numbering: FLC001-FLC025.
Above clinical separation strain is provided by Xi'an Communications University's first hospital laboratory, second hospital laboratory, clinical laboratory of The People's Hospital, all identifies through the full-automatic digital Bacteria Identification instrument of Take II.
The preparation of test organisms liquid: escherichia coli, staphylococcus aureus, blue pus organism, Klebsiella Pneumoniae are inoculated in MH meat soup, put 37 ℃ of common incubators, cultivate in 24 hours; Jia Xingrongxuexinglianqiujun, beta hemolytic streptococcus, streptococcus pneumoniae, meningococcus, hemophilus influenza are inoculated in 5% calf serum meat soup, 5%CO
2Incubator was cultivated in 37 ℃, 48 hours; Saccharomyces albicans is inoculated in the husky Ruo Shi of guarantor meat soup, puts 37 ℃ of common incubators, cultivates in 48 hours; Turbidimetry is carried out count of bacteria, and transferred species is measured viable count, i.e. colony-forming units (CFU/ml) in the bacterium liquid in flat board.It is standby to be deployed into 106CFU/ml bacterium liquid with diluent.
Culture medium: MH meat soup, MH culture medium, husky Ruo Shi culture medium, 5% calf serum meat soup, blood plate, the chocolate plating medium protected: by " modern microbiological culture media and the preparation of reagent handbook.
3, experiment reagent and instrument
Normal saline: Jingxi district, Xi'an pharmaceutical factory produces, lot number: 020624123;
2% dimethylbenzene: chemical reagent factory in Xi'an produces, lot number: 031119, and the distilled water preparation;
Ammonia: chemical reagent factory in Xi'an produces, lot number: 021017;
Sodium hydroxide: the Shantou Xilong Chemical Factory, Guangdong produces, lot number: 030820;
Citric acid, Typhoid-Paratyphoid tetravaccine (available from the anti-epidemic prevention station of Shaanxi Province's health), ether, povidone iodine, ethanol, pentobarbital sodium etc.
CO
2Incubator, common incubator, colony count instrument, LD4-2A low speed centrifuge, thermostat water bath, sufficient sole of the foot plethysmometer, constant voltage citric acid are sprayed to draw and are coughed device, analytical balance etc.
4, laboratory animal
ICR strain white mice, body weight 18~22g, the male and female dual-purpose is provided by Xi'an Communications University's medical experiment animal center.The quality certification number: the moving card of Shan doctor word 08-004 number.
CIR closed colony mice, body weight 18 ± 2g, the male and female dual-purpose is provided by Xi'an Communications University's medical experiment animal center.
SD strain rat, body weight 180~220g, the male and female dual-purpose is provided by Xi'an Communications University's medical experiment animal center.The quality certification number: the moving card of Shan doctor word 08-005 number.
Rabbit, body weight 2-2.5kg, the male and female dual-purpose is provided by Xi'an Jiaotong University Medical College's Experimental Animal Center, the quality certification number: the moving card of Shan doctor word 08-018.
Cavia porcellus, body weight 200~250g, the male and female dual-purpose is provided by Xi'an Communications University's medical experiment animal center.The quality certification number is: the moving word 08-019 of Shan doctor.
Laboratory temperature is 22-26 ℃, relative humidity 35%-70%, and lamp, ventilation fan ventilates, the drink tap water, food full price solid feed is provided by Xi'an Communications University's medical experiment animal center, and animal is by the sex sub-cage rearing.
5, be subjected to the reagent thing
Medicinal tablet of the present invention: every heavy 0.75g, every contains raw material of Chinese medicine 1.59g, and the suitable 2.12g crude drug of promptly every gram is provided by Xi'an Shangyikang Medicine Research Institute; Lot number: 031216;
Clinical people's consumption: every day 3 times, each 4, people's consumption per day is about 0.15g/kg (amount to crude drug 0.318g/kg, body weight for humans is by 60kg).
Compound method: medicine of the present invention is made into suitable suspension with tap water, faces with facing and join.
6, antibacterial tests in the body
(1) test method
With reference to " antibacterial tests principle in the body " and " herbal pharmacology research methodology " in " Ministry of Public Health bureau of drug administration new drug preclinical study instructs "; adopt the Sun Shi synthetic method to measure the half protective number of medicine of the present invention, calculate its 95% fiducial limit the Jia Xingrongxuexinglianqiujun infecting mouse.
(2) test organisms minimum lethal dose (MLD) is measured
With CIR mice random packet, 10 every group, the male and female dual-purpose.(the test organisms 24-48 hour culture of colony-forming units/ml) carries out 10 times of continuous gradients dilutions with normal saline, and each dilution factor bacterium drop nose infects one group of mice, infective dose 0.05ml/20g body weight will to have measured viable count.The while normal control.Raise meticulously, observe, write down the dead mouse situation of respectively organizing.Control group mice fully just often, in 7 days, cause in the group mice all the smallest bacteria amounts of death be minimum lethal dose (MLD).
The MLD that the CIR mice is infected in Jia Xingrongxuexinglianqiujun 32209 strains is 8.75 * 10
9CFU/kg.
(3) trial drug is to 0% (ED of infecting mouse
0) and 100% (ED
100) the protection preliminary assay
The mice random packet, 10 every group, the male and female dual-purpose.With MLD amount Jia Xingrongxuexinglianqiujun 32209 strain bacterium drop nose infecting mouses.Infect after 6 hours, 20% medicine medicinal liquid of the present invention is done 5 times of continuous gradient dilutions with normal saline, each dilution factor medicine liquid irrigation stomach gives one group of mice, dosage 0.5ml/20g body weight.Be administered once every day, successive administration 7 days.Set up normal control simultaneously.Raise meticulously, observe, write down dead mouse situation in 7 days.Matched group fully just often, all dead maximum dosage-feedings of mice are 0% protective number; The mice all minimum dosage of survival is 100% protective number.
Medicine of the present invention is to the ED of Jia Xingrongxuexinglianqiujun 32209 strain infecting mouses
100Be 8.33g crude drug/kg, ED
0Be 0.3332g crude drug/kg.
1.4 50% protective number (ED
50) mensuration: mice random packet, 10 every group, male and female dual-purpose.With MLD amount Jia Xingrongxuexinglianqiujun 32209 strain bacterium drop nose infecting mouses, set up positive drug (watermelon crystal) treatment group simultaneously, infect matched group and normal control group earlier, infect back 6 hours beginning gastric infusions.
Is starting point with medicine of the present invention by 1%, does 5 gradients of 1: 0.6 continuous gradient dilution with normal saline, and each dilution gradient medicinal liquid lumbar injection is respectively organized mice, dosage 0.5ml/20g in pneumococcal infection.The positive control drug watermelon crystal is by 5% suspension 0.5ml/20g (1.25g/kg) gastric infusion; Infect matched group and normal control group and give 0.5ml/20g normal saline.Administration every day 1 time, successive administration 7 days.Raise meticulously, observe, write down the dead mouse situation of respectively organizing.Statistics, arrangement experimental data are calculated the ED of medicine of the present invention to alpha streptococcus 32209 strain infecting mouses
50And 95% fiducial limit.
Bacteriostatic test result in the body: medicine of the present invention infects the ED of CIR closed colony mice to Jia Xingrongxuexinglianqiujun 32209 strains
50And 95% fiducial limit see Table 1.
Table 1 medicine of the present invention is to alpha streptococcus 32209 strain infecting mouse endogenous protective result of the tests
Dosage (the g crude drug/kg) | Log10 dose | Number of animals (only) | Death toll (only) | Survival rate (%) |
4.165 2.499 1.4994 0.8996 0.5398 0.3239 | 0.6196 0.3977 0.1759 -0.0460 -0.2678 -0.4896 | 10 10 10 10 10 10 | 1 2 8 9 10 10 | 90 80 20 10 0 0 |
The watermelon crystal matched group infects matched group blank group | | 10 10 10 | 0 10 0 | 100 0 100 |
ED
5095% fiducial limit
| 1.9360 1.5290-2.4513 | G crude drug/kg g crude drug/kg | | |
Conclusion: antibacterial tests has determined medicine of the present invention to median protective dose ED in the body of the CIR closed colony mice of Jia Xingrongxuexinglianqiujun 32209 strains infection in the body under all satisfactory condition of each matched group
50Be 1.9360g crude drug/kg, the 95% credible 1.5290-2.4513g crude drug/kg that is limited to.Result of the test shows that medicine of the present invention has significant protective effect to the Jia Xingrongxuexinglianqiujun mice infected.
7, in-vitro antibacterial test
(1) test method
With reference to " antimicrobial drug in-vitro antibacterial test principle " and " microbiological Test technology " in " Ministry of Public Health bureau of drug administration new drug preclinical study guideline ", adopt doubling dilution to measure MIC, dull and stereotyped infection protocol is measured MBC.
(2) medicine of the present invention is measured MIC, the MBC of escherichia coli, staphylococcus aureus, blue pus organism, Klebsiella Pneumoniae
Medicine of the present invention is carried out continuous two times gradient dilutions by 20% (W/V) for starting point with MH meat soup, be added on the 96 porocyte culture plates 0.4ml/ hole successively.Adding concentration again is 10
6The test organisms liquid 0.01ml/ hole of CFU/ml.Set up the contrast of antibacterial and culture medium simultaneously.Put 4 ℃ of effects 12 hours, in 37 ℃ of common incubators, cultivation in 24 hours, observed result.The contained minimum drug level in no bacterial growth hole is minimal inhibitory concentration (MIC).Culture absorption 0.1ml dibbling that to not see each hole of bacterial growth is more successively put 37 ℃ of common incubators, was cultivated in 48 hours in the MH flat board, and aseptic dibbling area relative medicine Cmin of being born long is minimal bactericidal concentration (MBC).
(3) medicine of the present invention is to first type, beta hemolytic streptococcus, the MIC of streptococcus pneumoniae, meningococcus, hemophilus influenza, the mensuration of MBC
Medicine of the present invention is carried out continuous two times gradient dilutions by 20% (W/V) for starting point with 5% calf serum meat soup, be added on the 96 porocyte culture plates 0.4ml/ hole successively.Adding concentration again is 10
6The test organisms liquid 0.01ml/ hole of CFU/ml.Set up the contrast of antibacterial and culture medium simultaneously.Put 4 ℃ of effects 12 hours, put 5%CO
2Incubator was cultivated observed result in 37 ℃, 48 hours.The contained minimum drug level in no bacterial growth hole is minimal inhibitory concentration (MIC).To not have in the bacterial growth hole culture 0.1ml successively dibbling put 5%CO to nutrition flat board (Jia Xingrongxuexinglianqiujun, hemolytic hammer, streptococcus pneumoniae, hemophilus influenza are inoculated in blood plate, and meningococcus vaccination is in the chocolate flat board)
2Incubator was cultivated in 37 ℃, 48 hours, and aseptic inoculation area relative medicine Cmin of being born long is MBC.
(4) medicine of the present invention is measured MIC, the MBC of saccharomyces albicans
(Sabouraud, SB) meat soup carries out continuous two times of gradient dilutions by 20% (W/V) for starting point, is added on the 96 porocyte culture plates 0.4ml/ hole successively with husky guarantor Ruo Shi with medicine of the present invention.Add 10 successively again
6The bacterium liquid 0.01ml of CFU/ml sets up the contrast of antibacterial and culture medium simultaneously, and 4 ℃ act on 12 hours; Put 37 ℃ of common incubators, cultivated observed result in 48 hours.The contained drug Cmin is MIC in the hole of no bacterial growth.To not have in the bacterial growth hole culture 0.1ml successively transferred species put 37 ℃ of common incubators, cultivated in 48 hours to the husky Ruo Shi of guarantor flat board, aseptic dibbling area relative medicine Cmin of being born long is MBC.
Result of the test: medicine of the present invention sees Table 2 to MIC, the MBC of 10 strain reference cultures.Medicine of the present invention sees Table 3 to MIC, MIC50, MIC90 and the MBC of 430 strain clinical isolates strains.
Table 2 medicine of the present invention is to the MIC and the MBC of reference culture
Bacterial strain | MIC (the g crude drug/ml) | MBC (crude drug g/ml) |
85021 strains of EHEC ATCC25922 strain staphylococcus aureus ATCC25925 strain blue pus organism ATCC27853 strain α-hemolytic streptococcus 32209 strain beta hemolytic streptococcus 32210 strain pneumococcus 31001 strain Neisseria meningitidis 29010 influenzae strain haemophiluses 58535 strain Klebsiella Pneumoniaes 46104 strain saccharomyces albicanses | 0.052 0.0065 0.052 0.026 0.013 0.026 0.0065 0.052 0.026 0.104 | 0.208 0.013 0.208 0.052 0.013 0.104 0.0065 0.104 0.104 0.4165 |
As seen from Table 2, medicine of the present invention all has than obvious suppression and deactivation testing 10 selected strain reference cultures.
Table 3. medicine of the present invention is to MIC, the MIC of 430 strain clinical isolates strains
50, MIC
90And MBC (mg/ml)
Bacterial strain | The strain number | The MIC scope | MIC
50 | MIC
90 | The MBC scope |
The B-mode chain bacterium of golden yellow Portugal fungus beetle type chain bacterium streptococcus pneumoniae klebsiella hemophilus influenza | 150 80 80 35 60 25 | 3.25-26.0 13.0-52.0 6.5-52.0 13.0-104.0 13.0-104.0 13.0-104.0 | 8.537 24.054 21.693 37.886 43.550 45.760 | 9.121 28.415 23.121 40.131 47.188 48.315 | 6.5-26.0 26.0-104.0 13.0-52.0 26.0-208.0 13.0-208.0 26.0-104.0 |
As seen, medicine of the present invention all has certain inhibition and deactivation to testing 430 selected strain clinical isolates strains from table 3.
Conclusion: the in-vitro antibacterial test has selected for use clinical common upper respiratory tract infection antibacterial and fungus as test strain, has measured MIC and the MBC of medicine of the present invention to 10 strain reference cultures and 430 strain clinical isolates strains, has calculated MIC separately
50And MIC
90Result of the test shows that medicine of the present invention all has certain inhibition and deactivation to testing selected test strain, can resist the infection of respiratory tract common bacteria and fungus effectively.
The test of 8 antiinflammatories
(1) xylol causes the influence of mice auricle swelling
60 of ICR strain white mice, body weight 18-22g, male and female half and half are divided into 6 groups at random by body weight, 10 every group.Be respectively: model control group, give the isometric(al) tap water; The prednisolone acetate positive controls is given prednisolone acetate 6mg/kg; The YINHUANG HANPIAN positive controls is given YINHUANG HANPIAN 1.95g/kg; The large, medium and small dosage group of medicine of the present invention is given medicine 5.4g/kg of the present invention, 2.7g/kg, 1.35g/kg (amounting to crude drug in whole 11.448g/kg, 5.724g/kg, 2.862g/kg) respectively.Each is organized all by the 0.2ml/10g gastric infusion, once a day, and for three days on end.After the last administration 1 hour, the outside was coated with dimethylbenzene 0.05ml and causes inflammation in every Mus auris dextra, and left ear compares, and mice is put to death in the cervical vertebra dislocation after 1 hour.Cut two ears along the auricle baseline, lay auricle with card punch (8mm), weigh, be calculated as follows mice auricle swelling degree and swelling rate, analyze the effect of the anti-Mice Auricle dimethylbenzene swelling of medicine of the present invention with analytical balance in left and right sides ear same area.Result of the test sees Table 4.
Swelling degree=auris dextra sheet weight-left auricle is heavy
The influence of table 4 medicine xylol of the present invention induced mice auricle edema (x ± s, n=10)
Group | Dosage | Left side ear heavy (mg) | Auris dextra heavy (mg) | Swelling degree (mg) | Swelling rate (%) |
1 2 3 4 5 6 | - 6mg/kg 2.95g/kg 5.4g/kg 2.7g/kg 1.35g/kg | 7.1±0.74 7.0±0.82 6.9±1.10 7.1±0.88 7.2±0.79 7.1±0.99 | 13.0±1.76 10.1±2.13 10.9±1.20 10.5±2.17 11.6±1.58 12.7±2.11 | 5.9±1.52 3.1±2.08** 4.0±1.15** 3.4±1.78** 4.4±1.07* 5.6±2.01 | 83.75±23.31 45.30±31.32** 60.5±22.79* 47.79±25.69** 61.19±12.82* 81.38±35.03 |
Annotate: group 1 is a model control group, and group 2 is the prednisone group, and group 3 is the YINHUANG HANPIAN group, and group 4,5,6 is medicine group of the present invention.
Compare * P<0.05, * * P<0.01 with model control group.
By table 4 result as seen, prednisone sheet group and YINHUANG HANPIAN group xylol cause mice auricle swelling the obvious suppression effect, compares with model control group, and the difference of auricle swelling degree and swelling rate all has significance (P<0.01 or P<0.05).Medicine xylol of the present invention causes mice auricle swelling the obvious suppression effect, compares with model control group, and the difference of medicine of the present invention big or middle dosage group auricle swelling degree and swelling rate all has significance (P<0.01 or P<0.05).Prove that medicine of the present invention has significant antiinflammatory action.
(2) Ovum Gallus domesticus album is caused the influence of rat paw edema
The preparation of Ovum Gallus domesticus album: get one piece of new fresh hen egg, strike a hole in the top gently, pour out Ovum Gallus domesticus album and in small beaker, (note not egg yolk), make evenly with thin Glass rod stirring, and be mixed with 10% concentration, use at once after preparing with cold distilled water.
50 of SD strain male rats, body weight 180-220g is divided into 5 groups at random by body weight.Every group 10.Be respectively: model control group, give the isometric(al) tap water; Positive controls is given prednisone 5mg/kg; The large, medium and small dosage group of medicine of the present invention is given medicine 2.4g/kg of the present invention, 1.2g/kg, 0.6g/kg (amounting to crude drug in whole 5.088g/kg, 2.544g/kg, 1.272g/kg) respectively.Each is organized all by 2ml/100g body weight gastric infusion, once a day, and continuous 6 days.Around every Mus right hind ankle joint, do a labelling, press pharmacological experimental methodology (third edition, People's Health Publisher) method mensuration and cause scorching preceding right back sufficient sole of the foot volume with marking pen.After the last administration 1 hour,, surveyed right back sufficient sole of the foot volume with sufficient sole of the foot plethysmometer in 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours behind the Yu Zhiyan at right back sufficient plantar subcutaneous injection 10% fresh albumen 0.05ml.So that before and after scorching the volume difference with cause scorching before likening to of normal volume be the pedal swelling rate, judge the influence of medicine to rat paw edema due to the Ovum Gallus domesticus album.Result of the test sees Table 5.
Table 5 medicine of the present invention is to the influence of rat paw edema due to the Ovum Gallus domesticus album (n=10, x ± s)
Group | Dosage g/kg | Cause scorching front volume ml | Cause scorching back different time volume |
0.5h | 1h | 2h | 4h | 6h |
1 2 3 4 5 | - 0.005 2.4 1.2 0.6 | 1.38 ±0.24 1.36 ±0.10 1.39 ±0.10 1.39 ±0.24 1.34 ±0.24 | 1.87 ±0.19 1.57 ±1.42 1.67 ±0.18 1.64 ±0.16 1.66 ±0.13 | 2.01 ±0.21 1.67 ±1.14 1.71 ±0.13 1.79 ±0.20 1.81 ±0.12 | 1.97 ±0.22 1.58 ±0.16 1.64 ±0.09 1.63 ±0.14 1.73 ±0.13 | 1.88 ±0.20 1.50 ±0.16 1.55 ±0.10 1.57 ±0.11 1.66 ±0.09 | 1.85 ±0.21 1.44 ±0.13 1.50 ±0.10 1.48 ±0.20 1.56 ±0.13 |
Continuous table medicine of the present invention is to the influence of rat paw edema due to the Ovum Gallus domesticus album (n=10, x ± s)
Group | Dosage g/kg | Cause scorching front volume ml | Cause scorching back different time pedal swelling rate |
0.5h | 1h | 2h | 4h | 6h |
1 2 3 4 5 | - 0.005 2.4 1.2 0.6 | 1.38 ±0.24 1.36 ±0.10 1.39 ±0.10 1.39 ±0.24 1.34 ±0.24 | 0.38 ±0.16 0.16 ±0.08** 0.20 ±0.08** 0.20 ±0.12* 0.28 ±0.26 | 0.48 ±0.22 0.23 ±0.10** 0.24 ±0.10** 0.31 ±0.17 0.41 ±0.31 | 0.46 ±0.25 0.17 ±0.10** 0.18 ±0.09** 0.20 ±0.22* 0.34 ±0.28 | 0.40 ±0.26 0.14 ±0.13** 0.12 ±0.11** 0.16 ±0.19* 0.28 ±0.26 | 0.37 ±0.27 0.06 ±0.09** 0.08 ±0.09** 0.08 ±0.18* 0.20 ±0.23 |
Annotate: group 1 is a model control group, group 2 positive matched groups, and group 3,4,5 is medicine group of the present invention.
Compare * P<0.05, * * P<0.01 with model control group.
By table 5 result as seen, the prednisone group obviously reduces in the swelling rate that Ovum Gallus domesticus album causes scorching back 0.5 hour, 1 hour, 2 hours, 4 hours, the 6 hours right back sufficient sole of the foots, compares with the swelling rate of identical time of model control group, and significant difference (P<0.01) is arranged.The swelling rate of medicine of the present invention after Ovum Gallus domesticus album causes inflammation obviously reduces, compare with model control group, heavy dose of group all has significant difference (P<0.01) in the swelling rate that causes scorching back 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours each time points, and the dosage group has significant difference (P<0.05) in the swelling rate that causes scorching back 0.5 hour, 2 hours, 4 hours, 6 hours in the medicine of the present invention.Point out medicine of the present invention to have to suppress the pedal swelling effect due to the rat Ovum Gallus domesticus album.
(3) influence of the mouse peritoneal capillary permeability due to the Dichlorodiphenyl Acetate (HAc)
Get 60 of ICR strain mices, body weight 18-22g, male and female half and half are divided into 6 groups at random by body weight, 10 every group.Be respectively: model control group, irritate stomach and give tap water; The prednisolone acetate positive controls is irritated stomach and is given prednisolone acetate 6mg/kg; The YINHUANG HANPIAN positive controls is irritated stomach and is given YINHUANG HANPIAN 1.95g/kg; The large, medium and small dosage group of medicine of the present invention: irritate stomach respectively and give medicine 5.4g/kg of the present invention, 2.7g/kg, 1.35g/kg (amounting to crude drug in whole 11.448g/kg, 5.724g/kg, 2.862g/kg).Each group is all distinguished gastric infusion by 0.2ml/10g, once a day, and continuous 5 days.After the last administration, mouse peritoneal is only injected 0.6% acetic acid 0.25ml/, tail vein injection 0.5% azovan blue normal saline solution 10ml/kg after 30 minutes, take off neck after 30 minutes and put to death, cut the abdominal cavity, stomach wall is mentioned with vascular forceps, with 6ml normal saline washing abdominal cavity, suction pipe sucking-off cleaning mixture 4ml, per minute 3000 changes centrifugal 15 minutes; Get supernatant in the 578nm colorimetric determination, read optical density, analyze the influence of medicine of the present invention the mouse peritoneal capillary permeability.Result of the test sees Table 6.
Table 6 medicine of the present invention is to the influence of mouse peritoneal capillary permeability (x ± s)
Group | Dosage | Number of animals | Optical density | Suppression ratio % |
Model contrast prednisolone acetate YINHUANG HANPIAN medicine of the present invention medicine of the present invention medicine of the present invention | - 6mg/kg 1.95g/kg 5.4g/kg 2.7g/kg 1.35g/kg | 10 10 10 10 10 10 | 0.44±0.15 0.22±0.08** 0.29±0.09* 0.23±0.14** 0.28±0.10* 0.33±0.10 | - 49.2 33.3 46.4 35.9 25.4 |
Compare * P<0.05, * * P<0.01 with model group.
By table 6 result as seen, prednisolone acetate group and YINHUANG HANPIAN group all can suppress the mice capillary permeability, compare with model control group, and significant difference (P<0.01 or P<0.05) is arranged.Medicine of the present invention can reduce the mice capillary permeability, compares with model control group, and the big or middle dosage group of medicine of the present invention all has significant difference (P<0.01 or P<0.05).Point out medicine of the present invention to have the effect that suppresses the mice capillary permeability.
9, hot plate method is caused the influence of the pain mice threshold of pain
ICR strain mice, body weight 18~22g, female, hot plate method is measured the threshold of pain, carries out primary dcreening operation.With the 250ml beaker is hot plate, puts water temperature and is in 55 ± 5 ℃ the water bath with thermostatic control, and preheating 10 minutes is put into beaker to mice to the pain threshold of the time of metapedes for this Mus occurring licking then.Get the threshold of pain and be divided into 5 groups at random by pain threshold, 10 every group less than 30 seconds mice greater than 6 seconds.Be respectively: model control group gives tap water; The morphine positive drug control group is given morphine; The YINHUANG HANPIAN positive controls is given YINHUANG HANPIAN 2.95g/kg; The large, medium and small dosage group of medicine of the present invention is given medicine 5.4g/kg of the present invention, 2.7g/kg, 1.35g/kg gastric infusion (amounting to crude drug in whole 11.448g/kg, 5.724g/kg, 2.862g/kg) respectively.With the dosage gastric infusion of 0.2ml/10g body weight, once a day, for three days on end.The single intraperitoneal injection morphine, 0.2ml/10g.1 hour (behind the injection of morphia 30 minutes) measures pain threshold again after the last administration, the difference that deducts pain threshold (threshold of pain time expand) before the administration with pain threshold after the administration divided by administration before the percentage value of pain threshold as the analgesia percentage rate, data are organized a t check.
Result of the test sees Table 7.
Table 7 medicine of the present invention to hot plate method cause the pain mice influence (x ± s, n=10)
Group | Dosage | The preceding threshold of pain of administration | The threshold of pain after the administration | Threshold of pain difference before and after the administration | Analgesia percentage rate % |
1 2 3 4 5 6 | - 0.2ml/10g 2.95g/kg 5.4g/kg 2.7g/kg 1.35g/kg | 17.63±6.26 17.47±4.76 17.20±3.73 17.39±6.40 17.66±4.98 17.47±5.92 | 20.36±7.49 48.31±15.71
△△ 26.97±10.42
△ 30.42±10.96
△△ 29.12±12.14
△ 21.73±8.03
| 2.74±5.12 30.84±15.58** 9.77±9.31* 13.03±8.74** 11.46±9.56* 4.26±4.36 | 18.39±31.45 193.61±124.62** 58.14±52.41* 83.19±74.35* 64.85±52.26* 24.92±21.87 |
Annotate: group 1 is a model control group, and group 2 is the morphine group, and group 3 is the YINHUANG HANPIAN group, and group 4,5,6 is medicine group of the present invention.
Compare * P<0.05 * * P<0.01 with model control group; With comparison before the administration,
△P<0.05
△ △P<0.01.
Pain threshold takes out animal during greater than 60s immediately, and its pain threshold calculates with 60s.
By table 7 result as seen, the morphine group can improve mice hot plate method pain threshold, compares with model control group, and threshold of pain improvement value all has significant difference (P<0.01) with the analgesia percentage rate.The Chinese medicine YINHUANG HANPIAN also can improve mice hot plate pain threshold, compares with model control group, and threshold of pain improvement value all has significant difference (P<0.05) with the analgesia percentage rate.Medicine of the present invention can improve mice hot plate method pain threshold, compares with model control group, and big or middle dosage group has significant difference (P<0.05).Point out medicine of the present invention that certain analgesic activity is arranged.
10, antitussive test
(1) strong aqua ammonia is caused the influence of coughing the mouse cough number of times
60 of ICR strain mices, body weight 18-22g, male and female half and half are divided 6 groups at random by body weight, 10 every group.Be respectively: model control group, give distilled water; The codeine phosphate positive controls is given codeine phosphate 30mg/kg, lumbar injection; The YINHUANG HANPIAN positive controls is given YINHUANG HANPIAN 2.9g/kg; The large, medium and small dosage group of medicine of the present invention is given medicine 5.4g/kg of the present invention, 2.7g/kg, 1.35g/kg (amounting to crude drug in whole 11.448g/kg, 5.724g/kg, 2.862g/kg) respectively.Each is organized all by 20ml/kg stomach administration administration, once a day, and for three days on end.After the last administration 30 minutes, in the 250ml of back-off beaker, put into mice, and on the cotton balls of equal size and weight, inject 12.5% strong aqua ammonia 1ml, observe cough (the abdominal muscle contraction of mice in 2 minutes with syringe, magnify mouth simultaneously and be as the criterion, cough sound sometimes) number of times.Difference between relatively each is organized.
Result of the test sees Table 8.
Table 8 medicine of the present invention is to the influence of mice strong aqua ammonia antitussive number of times (x ± s)
Group | Dosage | Number of animals | The cough number of times |
Model contrast codeine phosphate YINHUANG HANPIAN medicine of the present invention medicine of the present invention medicine of the present invention | - 30mg/kg 2.9g/kg 5.4g/kg 2.7g/kg 1.35g/kg | 10 10 10 10 10 10 | 13.4±4.03 5.7±1.89** 10.6±3.90 9.3±2.90* 10.2±3.52 11.3±4.35 |
Compare * P<0.05 * * P<0.01 with model control group
By table 8 result as seen, the codeine phosphate group can reduce strong aqua ammonia and cause the mouse cough number of times, compares with model control group, and the cough number of times has significant difference (P<0.01).Medicine of the present invention can reduce strong aqua ammonia and cause the mouse cough number of times, compares with model control group, and heavy dose of group has significant difference (P<0.05).Point out medicine of the present invention that certain antitussive effect is arranged.
11, medicine of the present invention draws the influence of coughing cough latent period and cough number of times to the Cavia porcellus citric acid
Cavia porcellus body weight 200~250g, male and female half and half, press the pharmacological experimental methodology (third edition, the People's Health Publisher) method: Cavia porcellus places in the airtight transparent glass cover of 2L, pressure with 80ka sprays into 17.5% citric acid by the glass shower nozzle, sprays 1 minute, and the record spraying stops cough number of times (the cough fullness of tone of Cavia porcellus in back 5 minutes, be as the criterion with the person of hearing, if less than 10 persons reject need not).Get 50 of the qualified Cavia porcelluss of preliminary election, be divided into 5 groups at random, 10 every group by the cough number of times.Be respectively: model control group gives distilled water; Positive controls, lumbar injection codeine phosphate 5mg/kg; The large, medium and small dosage group of medicine of the present invention is given medicine 2.4g/kg of the present invention, 1.2g/kg, 0.6g/kg (amounting to crude drug in whole 5.088g/kg, 2.544g/kg, 1.272g/kg) respectively.The gastric infusion volume is 2ml/100g.After administration 30 minutes, by preselected conditions, draw with the citric acid spraying and to cough, observe spraying and stops cough number of times and cough latent period in back 5 minutes.Carry out the t check.
Result of the test sees Table 9.
Table 9 medicine of the present invention draws citric acid coughs the preclinical influence of guinea pig cough (x ± s)
Group | N | Dosage g/kg | Cough latent period (S) | The cough number of times (inferior/5min) |
1 2 3 4 5 | 10 10 10 10 10 | - 0.005 2.4 1.2 0.6 | 47.7±16.3 106.4±22.6** 93.7±20.2** 69.2±10.9** 53.7±14.4 | 14.1±2.5 10.0±2.2** 10.3±1.6** 12.4±1.8 13.2±1.4 |
Annotate: group 1 is a model control group, and group 2 is the codeine group, and group 3,4,5 is medicine group of the present invention.
Compare * P<0.05 * * P<0.01 with model control group.
By table 9 result as seen, the codeine phosphate group can prolong citric acid draws and coughs guinea pig cough's incubation period, with model control group relatively, cough latent period has significant difference (P<0.01) after the administration.Medicine of the present invention can prolong citric acid and draw and cough guinea pig cough's incubation period, with model control group relatively, cough latent period has significant difference (P<0.01) after the administration of big or middle dosage group.Point out medicine of the present invention that tangible antitussive effect is arranged.Table 9 is the result be also shown in, and the codeine phosphate group can reduce citric acid draws and cough guinea pig cough's number of times, with model control group relatively, the cough number of times has significant difference (P<0.01) after the administration.Medicine of the present invention can reduce citric acid and draw and cough guinea pig cough's number of times, with model control group relatively, the cough number of times has significant difference (P<0.01) after the administration of heavy dose of group, in, small dose group also has minimizing trend.Point out medicine of the present invention that tangible antitussive effect is arranged.
12, separate heat test
Rabbit body weight 2kg~2.5kg, male and female are regardless of, and measure basal body temperature: surveyed every 15 minutes 1 time (scribble the lubricated anus thermometre of vaseline and insert anus 4cm, continue 1 minute), get the body temperature value continuously 2 times.Get fluctuation less than 48 of 0.2 ℃ rabbit, be divided into 6 groups at random, 8 every group.Be respectively: the normal control group, do not give the heating vaccine, give distilled water; Model control group gives distilled water; Positive controls is given aspirin 0.25g/kg; The large, medium and small dosage group of medicine of the present invention is given medicine 1.5g/kg of the present invention, 0.75g/kg, 0.375g/kg (amounting to crude drug in whole 3.18g/kg, 1.59g/kg, 0.795g/kg) respectively.Each group is pressed the 20ml/kg gastric infusion.0.5 hour every rabbit is pressed the quiet notes Typhoid-Paratyphoid of 1.5ml/kg body weight tetravaccine after the administration, then respectively at 0.5,1,2,3,4,5 hour measurement anus temperature.Average body using warming therapy difference is as the fervescence value before deducting administration by body temperature value after each rabbit administration, and the fervescence value of each observing time is carried out the t check.
Result of the test sees Table 10.
Table 10 medicine of the present invention to the influence of rabbit body temperature (x ± s, n=8)
Group | Dosage g/kg | Basal body temperature | The fervescence value |
0.5h | 1h | 2h |
1 2 3 4 5 6 | - - 0.25 1.5 0.75 0.375 | 39.06±0.23 39.18±0.26 39.08±0.27 39.11±0.17 39.10±0.21 39.09±0.25 | 0.02±0.12 0.62±0.26
△△ 0.29±0.13** 0.50±0.16 0.40±0.21 0.69±0.18
| -0.06±0.17 1.33±0.28
△△ 0.63±0.17** 0.96±0.22* 1.05±0.46 1.46±0.25
| -0.01±0.19 1.68±0.24
△△ 1.1±0.14** 1.16±0.17** 1.38±0.44 1.42±0.38
|
Continuous table medicine of the present invention to the influence of rabbit body temperature (x ± s, n=8)
Group | Dosage g/kg | Basal body temperature | The fervescence value |
3h | 4h | 5h |
1 2 3 4 5 6 | - - 0.25 1.5 0.75 0.375 | 39.06±0.23 39.18±0.26 39.08±0.27 39.11±0.17 39.10±0.21 39.09±0.25 | 0.17±0.13 1.64±0.82
△△ 0.65±0.37** 0.54±0.40** 0.78±0.54* 0.91±0.4*
| -0.04±0.29 1.46±0.75
△△ 0.56±0.21** 0.38±0.19** 0.69±0.46* 0.79±0.39*
| -0.01±0.16 1.29±0.45
△△ 0.35±0.13** 0.23±0.09** 0.55±0.39** 0.77±0.36*
|
Annotate: group 1 is the normal control group, and group 2 is a model control group, and group 3 is the aspirin group, and group 4,5,6 is the large, medium and small dosage group of medicine of the present invention,
Compare * P<0.05, * * P<0.01 with model control group.
Compare with the normal control group,
△P<0.05
△ △P<0.01.
By table 10 result as seen, very obviously cause heating (P<0.01) behind the rabbit injection Typhoid-Paratyphoid tetravaccine.Aspirin group fervescence value of 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours after Typhoid-Paratyphoid tetravaccine pyrogenicity obviously reduces, compare with model control group, the fervescence value in each identical time has significant difference (P<0.01).Medicine of the present invention can make the fervescence value after the Typhoid-Paratyphoid tetravaccine pyrogenicity obviously reduce, compare with model control group, heavy dose of group 1 hour, 2 hours, 3 hours, 4 hours, 5 hours each time after pyrogenicity, in, the fervescence value of small dose group 3 hours, 4 hours, 5 hour each time after pyrogenicity all has significant difference (P<0.01 or P<0.05).Point out medicine of the present invention to have the antipyretic effect.
The pharmacodynamics test conclusion of medicine of the present invention:
By the pharmacodynamics test of medicine of the present invention, the antibacterial tests result shows that medicine of the present invention has significant protective effect to the Jia Xingrongxuexinglianqiujun mice infected in the body; The in-vitro antibacterial result of the test shows that medicine of the present invention all has certain inhibition and deactivation to testing selected test strain, can resist the infection of respiratory tract common bacteria and fungus effectively.Point out medicine of the present invention to have the inside and outside antibacterial action.Antiinflammatory is the result show, medicine xylol of the present invention causes mice auricle swelling the obvious suppression effect; The swelling rate that Ovum Gallus domesticus album is caused scorching rat paw edema has obvious inhibitory action; Can suppress acetic acid induced mice abdominal cavity capillary permeability.Point out medicine of the present invention to have antiinflammatory action.The antitussive result of the test shows that medicine of the present invention can reduce strong aqua ammonia and cause the mouse cough number of times; Medicine of the present invention can prolong citric acid and draw and cough guinea pig cough incubation period, reduce the cough number of times.Point out medicine of the present invention to have antitussive effect.The analgesic test is the result show, medicine of the present invention can improve mice hot plate method pain threshold.Point out medicine of the present invention that analgesic activity is arranged.Analgesic result of the test shows that medicine of the present invention can make Typhoid-Paratyphoid tetravaccine pyrogenicity rabbit body temperature lift-off value obviously reduce.Point out medicine of the present invention to have refrigeration function.Illustrate that medicine of the present invention has in the significant body, vitro antibacterial activity and antiinflammatory, analgesia, antitussive and refrigeration function, provide experimental basis to the therapeutical effect of acute pharyngitis acute tonsillitis.
Two, Drug therapy acute pharyngitis 40 examples of the present invention, acute tonsillitis 30 example initial stage clinical observation tests
1, physical data
40 routine acute pharyngitis patients are the out-patient in year April in August, 2003 to 2004, wherein male 26 examples, women 14 examples, and the oldest 66 years old, minimum 5 years old, 35 years old mean age, the course of disease is the longest 5 days, the shortest 1 day, average 2 days.The diagnostic criteria of " the clinical guidance principle of new Chinese medicine treatment acute pharyngitis " that all cases all meet 2002 in " new Chinese medicine clinical research guideline ".
30 routine acute tonsillitis patients are the out-patient in year April in August, 2003 to 2004, wherein male 12 examples, women 18 examples, and the oldest 56 years old, minimum 7 years old, 26 years old mean age, the course of disease is the longest 7 days, the shortest 2 days, average 3.5 days.The diagnostic criteria of " new Chinese medicine is treated the clinical guidance principle of acute tonsillitis " that all cases all meet 1997 in " new Chinese medicine clinical research guideline ".
2, diagnostic criteria
(1) diagnostic criteria of acute pharyngitis
Diagnostic criteria according to " the clinical research guideline of new Chinese medicine treatment acute pharyngitis " in 2002 " new Chinese medicine clinical research guideline ":
Medical history: virus all can cause primary disease with bacterial infection.Often suffer from cold, be heated, wet, overwork, tobacco and wine be excessive, and various physics or chemical stimulation inducement.
Symptom: primary symptom: pharyngalgia or odynophagia, pharyngeal drying, scorching hot.Inferior disease: general malaise sense, heating, fear heat, extremities aching pain, inappetence.
Check: A, pharyngeal mucosa hyperemia, color is scarlet.B, pharynx rear wall lymph follicle and lateral pharyngeal band redness or mucosa pus point are dispersed in distribution.C, outstanding heap soil or fertilizer over and around the roots are hung down, soft palate is red and swollen.D, throat swab cultivation have pathogenic bacterium or feminine gender.
During diagnosis, acute attack must be arranged, possess above part or all of symptom, and inspection finding positive sign more than 1 or 1 is arranged, promptly diagnosable.
(2) diagnostic criteria of acute tonsillitis
All meet 1997 in " the new Chinese medicine clinical research guideline " diagnostic criteria of " the clinical research guideline of new Chinese medicine treatment acute tonsillitis ":
Medical history: often suffer from cold, tired, tobacco and wine excessively, malnutrition, the low inferior inducement of passive protective physical fitness.
Symptom: it is hurried to fall ill, general malaise, and the shiver with cold heating, fervescence, headache, nape and extremities aching pain, inappetence often has constipation, and pharyngeal pain increases the weight of when swallowing, often with in ear pain.
Check: patient's face of acute ill, the buccal flushing, halitosis, thick fur is white, the tonsil redness, the crypts mouth has yellow-white pus point, can merge in flakes, and shape such as pseudomembrane are easily wiped, mandibular lymph node enlargement and tenderness.Lab testing blood leukocytes sum can increase.
2 Therapeutic Method
Suck 1~2 of medicinal tablet of the present invention, every day 4~6 times, medication 3~7 days at every turn.
3, criterion of therapeutical effect
(1) criterion of therapeutical effect of acute pharyngitis
Work out according to " the clinical research guideline of new Chinese medicine treatment acute pharyngitis " in 2002 " new Chinese medicine clinical research guideline ":
Clinical recovery: integration reduced more than or equal to 95% with interior clinical symptoms and sign disappearance in 5 days with interior sx in 3 days in medication.
Produce effects: medication 5 days obviously improves with interior symptom, sign, and integration reduces more than or equal to 70%.
Effectively: medication 5 days reduces more than or equal to 30% with interior symptom, sign integration.
Invalid: do not have bright improvement with interior symptom and sign in 5 days, integration reduces less than 30%.
(2) acute tonsillitis criterion of therapeutical effect
Work out according to " the clinical research guideline of new Chinese medicine treatment acute tonsillitis " in 1997 " new Chinese medicine clinical research guideline ":
Recovery from illness: treat 7 days with interior clinical symptoms and sign disappearance, body temperature, numeration of leukocyte recover normal.
Produce effects: treat and improved more than 2 grades with interior cardinal symptom, sign in 7 days.
Effectively: treat and improved more than 1 grade with interior symptom, sign in 7 days.
Invalid: as not reach effective standard or deterioration person on the contrary.
4, therapeutic outcome
Treatment acute pharyngitis 40 routine efficacy results: 37 examples of fully recovering, account for 92.5%, produce effects 2 examples, account for 5%, invalid 1 example, account for 2.5%, total effective rate is 97.5%.
Treatment acute tonsillitis 30 routine efficacy results: 27 examples of fully recovering, account for 90%, produce effects 2 examples, account for 6.67%, effective 1 example, account for 3.33%, total effective rate is 100%.
Model case:
Lei Ying, woman, 24 years old, student, the postgraduate of pharmaceutical college of Xi'an Communications University.Go to a doctor the date: on March 2nd, 2004.Main suit: pharyngeal pain companion dysphagia 1 day.History of present illness: heating appears after cause was suffered from cold in 1 day, aversion to cold, pharyngeal pain, aggravation when swallowing, with dry and astringent, headache, body is tired weak, and malasia brings up phlegm when one coughs.Check: pharyngeal little red, antiadoncus II °, crypts has yellow-white pus point, mandibular lymph node enlargement and tenderness, 38.5 ℃ of body temperature.Blood routine examination: leukocyte 12.5 * 10
12, neutral grain leukocyte: 83%, lymphocyte: 17%.Diagnosis: acute tonsillitis.Chinese medical discrimination: wind-heat syndrome.The treatment: suck clothes medicinal tablet of the present invention, one time 4,3 times on the one.Take medicine and promptly felt sxs such as pharyngeal pain, headache, malasia in back second day.Advise it to serve on 5 days, all diseases are all healed.Efficacy determination: recovery from illness.
Zhu Huifang, woman, 35 years old, level road mausoleum, Weinan City Pucheng County township peasant.Go to a doctor the date: on April 11st, 2004.Main suit: uncomfortable 2 days of pharyngeal pain.History of present illness: pharyngeal dryness and heat behind 2 days cause foods of readme chaffy dish, pain, and companion's dysphagia increase the weight of 1 day, and the heat that occurs together, and mouth is little thirsty, slight chill.Check: pharyngeal congestion, the uvula redness, the tongue edge point is red, white and thin fur, floating and rapid pulse.Diagnosis: acute pharyngitis.Dialectical: wind-heat syndrome.The treatment: suck clothes medicinal tablet of the present invention, one time 4,3 times on the one.The patient stated pharyngeal pain, drying in second day, scorching hotly all take a favorable turn, and dysphagia disappears, continues medication one day, and above-mentioned symptom all disappears.Efficacy determination: recovery from illness.
Dang Wenchao, man, 59 years old, the Xi'an Fu Ruide vice general manager of Food Co., Ltd.Go to a doctor the date: on April 10th, 2004.The main suit: pharyngeal pain, aggravation is three days when swallowing.Three days cause skies of readme heat, suffer from cold evening in bed, pharyngeal pain promptly occurred in second day, dryness and heat, drinking-water is difficult to resolve, dry cough without phlegm, it is pharyngeal when swallowing that the pain increased.It is obvious to look into pharyngeal congestion, the uvula redness.Red tongue, yellow and thin fur, floating and rapid pulse.Diagnosis: acute pharyngitis.Chinese medical discrimination: wind-heat syndrome.The treatment: suck clothes medicinal tablet of the present invention, one time 4,3 times on the one.The patient examined readme in three days afterwards and serve on medicinal tablet of the present invention three days, and all symptoms all disappear.Efficacy determination: recovery from illness.
Zhou Lin, man, 38 years old, the Sales Manager of Xi'an drugmaker.Go to a doctor the date: on March 24th, 2004, main suit: pharyngeal pain foreign body sensation three days.History of present illness: suffered from cold after the shower before three days, promptly feel fever with aversion to cold, pharyngeal pain, aggravation when swallowing, with dry and astringent, pharyngeal before one day the pain increased, and headache occurs again, and body is tired weak, malasia, the disease of cough.Check: 38.5 ℃ of body temperature.Pharyngeal congestion, the tonsil redness, III ° of enlargement, crypts has yellow-white pus point, mandibular lymph node enlargement, and not tenderness sense.Lab testing: blood WBC:12.2 * 10
12, neutral grain leukocyte: 85%, lymphocyte: 15%.Diagnosis: acute tonsillitis.Chinese medical discrimination: wind-heat syndrome.The treatment: suck clothes medicinal tablet of the present invention, one time 4,3 times on the one.The patient promptly felt pharyngeal pain relief in second day, and swallowing pain also has and alleviate, and advises the continuation medication, takes medicine all transference cures back five days.Efficacy determination: recovery from illness.
Function of the present invention: wind and heat dispersing, resolving toxin and disinhibiting the throat;
The present invention cures mainly: cure mainly acute pharyngitis, acute tonsillitis.
Specification of the present invention: every heavy 0.75g of medicinal tablet of the present invention, every gram contains raw material of Chinese medicine 2.12g; Every bag heavy 3g of medicinal granule of the present invention, every gram contains raw material of Chinese medicine 2.12g; Every heavy 0.3g of medicine capsule of the present invention, every gram contains raw material of Chinese medicine 5.3g; Every bottle of 10mL of medical syrup agent of the present invention, every milliliter contains raw material of Chinese medicine 0.636g.
Usage and dosage of the present invention: obey each oral or 4 of buccal tablets or 4 of oral capsules or 1 bag of granule or syrup 10mL every day three times.
Storage of the present invention: the shady and cool dry place of sealing storage.
Effect duration of the present invention: 2 years.