CN100337658C - Chinese medicine composition for treating cold anemopyretic syndrome, and its preparing method - Google Patents
Chinese medicine composition for treating cold anemopyretic syndrome, and its preparing method Download PDFInfo
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- CN100337658C CN100337658C CNB2005100404519A CN200510040451A CN100337658C CN 100337658 C CN100337658 C CN 100337658C CN B2005100404519 A CNB2005100404519 A CN B2005100404519A CN 200510040451 A CN200510040451 A CN 200510040451A CN 100337658 C CN100337658 C CN 100337658C
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Abstract
The present invention relates to a traditional Chinese medicine composition for treating cold anemopyretic syndrome. Per 1000g of medicines comprise 550 to 650g of kudzuvine root, 250 to 350g of great burdock achene, 550 to 650g of isatis root, 550 to 650g of common dayflower herb, 550 to 650g of dandelion, 250 to 350g of perilla leaf, 120 to 190g of dried tangerine peel, 250 to 350g of tuckahoe, 250 to 350g of plantain herb, 350 to 350g of white mulberry root-bark and 250 to 350g of apricot kernel. In the optimized scheme of the present invention, the kudzuvine root uses alcohol liquid immersed paste, the perilla leaf, the dried tangerine peel and the apricot kernel use volatilization oil, and the beta-cyclodextrin inclusion compound of the volatilization oil or the alcohol sedimentation paste of the water decocting liquid of medicine dregs after the volatilization oil is extracted; the dandelion, the common dayflower herb, the great burdock achene, the white mulberry root-bark, the plantain herb and the isatis root respectively use the alcohol sedimentation paste of the water decocting liquid; the tuckahoe uses a water decocting concentrated solution. The present invention in the preparation type of granules has the functions of cold-pungent diaphoresis, clearing away heat and toxic materials, eliminating sputum and relieving asthma, and is used for treating cold anemopyretic syndrome.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of cold anemopyretic syndrome and preparation method thereof.
Background technology
Flu is the diseases caused by exogenous pathogenic factor seasonal disease that caused by ailment said due to cold or exposure, and the four seasons all can take place, and in the majority with spring and autumn, is the most general now, a kind of disease that sickness rate is the highest.The lighter is called cold, and weight person is called myxoidedema or influenza, and stronger infectiousness is arranged, and often can cause to pay attention to widely or many complication, and the work production and the people's health is brought bigger influence.Chinese medicine waits viral infection class treatment of diseases to have good curative effect and clear superiority to flu, and more and more is subjected to patient's attention and use.
The treatment of flu is clinically mainly started with from two approach, and the one, kill, suppress cold virus, because the polytropy of virus, still unmatchful at present all viruses are effective broad-spectrum antiviral coldrex all; The 2nd, alleviate clinical symptoms, most of coldrex is all started with thus, how to form compound recipe by antiallergic and antipyretic analgesic.The medicine of treatment flu in the market is many, with regard to the Chinese medicine for the treatment of anemopyretic cold antitoxic bolus of honeysuckle flower and forsythia (diffusing, granule are arranged, form by YINQIAO etc.), Sang Ju Yin flu diffusing (sheet, ball, granule are made up of Folium Mori, Flos Chrysanthemi etc.), KANGKAN KELI, anemopyretic cold electuary (forming) by Radix Isatidis, Fructus Forsythiae, Herba Menthae, Herba Schizonepetae, Folium Mori, Rhizoma Phragmitis, Fructus Arctii, Flos Chrysanthemi, Semen Armeniacae Amarum, Ramulus Mori etc.Symptoms such as on clinical symptoms, typical single anemopyretic cold is less, usually accompanies wet the elephant, and dominant response is that limbs are miserable, and expectorant sticks and white and thin fur is bored with, this and people's living standard improve, and be how wet relevant in the body.The wet treatment of flu folder is touching, and the types of drugs at this clinical symptoms in the prior art is less.
According to recent statistics, people's group mean outbreak flu of the annual nearly 2-3 hundred million of China once at present, domestic flu market maintains about 3,000,000,000 yuans always, has very much the value of exploitation so press from both sides the characteristic coldrex of wet phenomenon development flu removing summer-heat class at catching a cold.
Summary of the invention
In order to remedy the deficiency of treatment by Chinese herbs cold medicine in the prior art, the present invention is directed to the coldrex prescription that the wet phenomenon of flu folder provides a kind of removing summer-heat class of catching a cold.This product prescription is in conjunction with the modern times characteristics of incidence of catching a cold, and in the method for treatment of relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing, 5 go into damp-resolving medicinal, to improve the hit rate of treatment, has increased the power that the toxin expelling damp eliminating is brought down a fever simultaneously, has also improved the hit rate of treatment.
Technical scheme of the present invention is as follows:
A kind of Chinese medicine composition for the treatment of cold anemopyretic syndrome includes the medical material of following component in the raw material:
Radix Puerariae 550～650g, Fructus Arctii 250～350g, Radix Isatidis 550～650g, Herba Commelinae 550～650g, Herba Taraxaci 550～650g, Folium Perillae 250～350g, Pericarpium Citri Reticulatae 120～190g, Poria 250～350g, Herba Plantaginis 250～350g, Cortex Mori 350～350g and Semen Armeniacae Amarum 250～350g.
Above ratio is the composition of 1000g finished product.Dose is: each 10g, every day 3 times.
The composition that the raw material of this Chinese medicine composition is more optimized is:
Radix Puerariae 600g, Fructus Arctii 300g, Radix Isatidis 600g, Herba Commelinae 600g, Herba Taraxaci 600g, Folium Perillae 300g, Pericarpium Citri Reticulatae 167g, Poria 300g, Herba Plantaginis 300g, Cortex Mori 300g and Semen Armeniacae Amarum 300g/1000g (each 10g, every day 3 times).
This programme can be used for the preparation of medicine directly as the Chinese medicine composition of treatment cold anemopyretic syndrome; But also can adopt following prioritization scheme to be used for the preparation of cold medicine:
Radix Puerariae 600g, Fructus Arctii 300g, Radix Isatidis 600g, Herba Commelinae 600g, Herba Taraxaci 600g, Folium Perillae 300g, Pericarpium Citri Reticulatae 167g, Poria 300g, Herba Plantaginis 300g, Cortex Mori 300g and Semen Armeniacae Amarum 300g/1000g; Radix Puerariae wherein is to adopt ethanol stream extractum; Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors are to adopt its volatile oil respectively; The perhaps clathrate of the beta-cyclodextrin inclusion compound of volatile oil; Perhaps when adopting volatile oil or volatile oil inclusion, also adopt it to extract the ethanol precipitation of the decocting liquid of medicinal residues behind volatile oil, be concentrated into certain density clear paste; Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element adopt the ethanol precipitation of its decocting liquid respectively, are concentrated into certain density clear paste; Poria adopts its water drug-decocting concentrating liquid.
The method for preparing above-mentioned Chinese medicine composition:
Step 1, get Radix Puerariae, Fructus Arctii, Radix Isatidis, Herba Commelinae, Herba Taraxaci, Folium Perillae, Pericarpium Citri Reticulatae, Poria, Herba Plantaginis, Cortex Mori and Semen Armeniacae Amarum 11 flavor medicines by the quality component (or enlarging quantity in proportion) of above-mentioned prescription, standby;
Step 2, Radix Puerariae are made solvent with ethanol, dipping, and percolation, percolate concentrates, and fluid extract is standby;
Step 3, Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors extract volatile oil, and volatile oil is standby;
Step 4, volatile oil beta-cyclodextrin inclusion compound, clathrate is standby;
Medicinal residues, mother solution, Aromatic water behind step 5, the extraction volatile oil decoct with water with Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element, and decocting liquid filters, and concentrates, adding ethanol leaves standstill, filter, filtrate recycling ethanol also concentrates, and clear paste is standby;
Step 6, Poria decoct with water, and decocting liquid filters, and concentrate, and concentrated extract is standby;
Step 7, above-mentioned concentrated extract, precipitate with ethanol clear paste and Radix Puerariae fluid extract, drying, dry powder is standby;
Step 8, dry powder add dextrin, (dry extract: dextrin=1: 1.4), volatile oil beta cyclodextrin inclusion complex, mixing, dry granulation sieves, and makes 1000g, promptly.
More optimize and more particularly, above-mentioned preparation method is:
Step 1, get Radix Puerariae, Fructus Arctii, Radix Isatidis, Herba Commelinae, Herba Taraxaci, Folium Perillae, Pericarpium Citri Reticulatae, Poria, Herba Plantaginis, Cortex Mori and Semen Armeniacae Amarum 11 flavor medicines by the quality component (or enlarging quantity in proportion) of above-mentioned prescription, standby;
Step 2, Radix Puerariae are made solvent according to percolation under fluid extract and the extractum item with 50% ethanol, flooded 24 hours, and percolation slowly, percolate is condensed into about 1.03 (50 ℃) of relative density, and fluid extract is standby.
Step 3, Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors extract volatile oil, and volatile oil is standby.
(volatile oil: beta-schardinger dextrin-: water=1: 4: 24), clathrate is standby with beta-cyclodextrin inclusion compound for step 4, volatile oil.
Medicinal residues, mother solution, Aromatic water behind step 5, the extraction volatile oil decoct with water secondary with Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element, each 1.5 hours, collecting decoction filtered, filtrate is concentrated into about 1.10 (50 ℃) of relative density, be cooled to room temperature, add ethanol and make and contain alcohol amount and reach 50%, stir evenly, leave standstill, filter, filtrate recycling ethanol also is concentrated into about 1.30 (50 ℃) of relative density, and clear paste is standby.
Step 6, Poria decoct with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate is concentrated into about 1.20 (50 ℃) of relative density, and concentrated extract is standby.
Step 7, above-mentioned concentrated extract, precipitate with ethanol clear paste and Radix Puerariae fluid extract, drying, dry powder is standby.
Step 8, dry powder add dextrin, (dry extract: dextrin=1: 1.4), volatile oil beta cyclodextrin inclusion complex, mixing, dry granulation sieves, and makes 1000g, promptly.
Above semi-finished product are packaged into the 10g/ bag respectively and get final product.
Above concrete process chart sees Appendix 1.
The drying of concentrated solution can adopt methods such as drying under reduced pressure, spray drying or vacuum drying in the above preparation method.
The method of granulating of dry powder can be other advanced reasonable method in dry method, wet method and the prior art in the above preparation method.
Clinical studies show:
Chinese medicine composition of the present invention is that Radix Puerariae, Fructus Arctii, Radix Isatidis, Herba Commelinae, Herba Taraxaci, Folium Perillae, Pericarpium Citri Reticulatae, Poria, Herba Plantaginis, Cortex Mori and Semen Armeniacae Amarum 11 flavor medicines are formed, and according to the characteristics of incidence of catching a cold, be made into preparations such as granule, tablet, pill, soft, hard capsule, electuary or oral liquid, bring benefit to the mankind.This medicine reasonable recipe, compatibility is simplified, and determined curative effect reaches treating both the principal and secondary aspects of a disease.
The granular preparation of treatment flu of the present invention is named with " flu removing summer-heat granule " in clinical trial.Below all therapeutic effect of the present invention is described with this title.
This flu removing summer-heat granule has dissolving well, and stripping is fast, special effect, and short treating period, the bioavailability height does not have toxic and side effects, good stability, good looking appearance, easy to carry, advantages such as taking convenience.Granule of the present invention is a natural medicine, has the effect of relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing, resolving phlegm and relieving asthma, is used for cold anemopyretic syndrome.Card sees that heating, micro evil wind, nasal obstruction, watery nasal discharge, sneeze, dizzy headache, limb are miserable, cough, expectorant is glutinous or yellow, laryngopharynx swelling and pain, thirst with desire to drink, tongue tip side of red, greasy or the little Huang of white and thin fur, floating and rapid pulse by pharmacology and clinical verification checking, can reach the purpose for the treatment of both the principal and secondary aspects of a disease.
1. flu removing summer-heat granule is brought down a fever soon: body temperature is obviously descended, but this product temperature fall time is early than KANGKAN KELI, back 1 hour to the 2 hours test group body temperature of taking medicine descends and descends obviously than matched group, and two groups of body temperature drop-out values and rate of descent all have statistical significance.
2. flu removing summer-heat granule verification Hou Gaishan is obvious: two groups of all obviously declines of card Hou Jifen after treating, through carrying out the repeated measure ANOVA showed significant respectively to two groups, before two groups of take medicine each time point of back and treatments statistical significance is arranged more all, card Hou Jifen is obviously descended and test group is better than matched group.
3. flu removing summer-heat granule is obvious to doing well,improving: all obviously descend after all symptoms are taken medicine, before and after statistical significance more all arranged, test group improve heating, cough, nasal obstruction, headache,, general malaise, thirsty and be better than matched group in aspect, the sweating situation symptom.
4. the removing summer-heat particle synthesis curative effect of catching a cold height: the test group total effective rate is 97.59%, and the matched group total effective rate is that 91.15%, two group of curative effect relatively has statistical significance, and flu removing summer-heat granule curative effect is better than KANGKAN KELI.
5. flu removing summer-heat granule drug safety: before and after two groups of treatments all to breathe, heart rate is influential, more all change before and after in each group, but not statistically significant relatively between two groups, before and after two groups of treatments to the not statistically significants that influence of blood pressure.
In the quality standard, with thin layer method Radix Puerariae, Fructus Arctii etc. is differentiated respectively,, selected for use different developing solvents, all obtain satisfied result according to different materials, and with this discriminating project as this product.Select for use puerarin in the Radix Puerariae as quantitative target: (1) adopts the HPLC method, has carried out precision test, repeatability test, solvent stability test and application of sample recovery test respectively, and method of proof is feasible, can be used as the quantitative approach of preparation.By the soft capsule that above preparation technology, moulding process and quality standard are produced, the product that becomes high in technological content, steady quality and be easy to control, (2) have adopted ultraviolet, have also monitored the quality of this product from another kind of method.
The Chinese medicine composition of treatment flu of the present invention, checking proves through the preclinical pharmacology toxicity:
1. flu removing summer-heat granule peroral administration mtd test result shows: 20 mices all do not have tangible toxic reaction after by 399g/Kg dosage gastric infusion, also do not have death in the week.This dosage is 152 times (clinical adult oral 131g/50Kg of being on the one) of clinical adult oral dose on the one.
2. effect experiment research
Cure mainly according to " Chinese medicine preclinical study guideline " according to the particulate function of flu removing summer-heat,, carried out the inside and outside antibacterial tests of body respectively in conjunction with modern means of science and technology; The inside and outside antivirus test of body; Separate heat test; The anti-inflammatory test; Analgesic test etc.
Result of the test shows, that flu removing summer-heat granule has is antibiotic preferably, antiviral, analgesic, analgesia and antiinflammatory action.
2.1 the outer antibacterial tests of flu removing summer-heat granule
2.1.1 dull and stereotyped punch method
Get each bacterial strain nutrient broth culture of cultivating in 6 hours, be diluted in test as 10-3 with nutrient broth.In diameter 9cm sterilization culture dish, add bacterium liquid 1ml.Pour the nutrient agar 20ml that has dissolved to 45 ℃ then into.The rotation mixing, wait to solidify the back and on agar plate, make a call to 3 holes with the sterilization steel pipe of external diameter 6mm, take out culture medium in the hole with aseptic nipper, variable concentrations medicine (0.25g/ml, 0.50g/ml, 1.00g/ml) 0.05ml progressively increases in each hole, in 37 ℃ of cultivations 20 hours, take out and measure the bacterium loop diameter.Each test repeats once, gets the test meansigma methods twice.Test is set up routinely to be had only medicine not plant the negative control of antibacterial and not to have medicine only to plant the positive control of antibacterial, and the result is as follows.
Flu removing summer-heat granule is to the bacteriostasis (dull and stereotyped punch method) of reference culture
| Medicine | Dosage (g/ml) | Antibacterial circle diameter (mm) | |||||
| Staphylococcus aureus | Escherichia coli | Bacillus pyocyaneus | Bacillus pumilus | Bacillus subtilis | Micrococcus luteus | ||
| Flu removing summer-heat granule flu removing summer-heat granule flu removing summer-heat granule SHUANGHUANLIAN (stock solution) | 0.25 0.50 1.00 0.05ml | 0 12.0 22.5 22.0 | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 | 0 15.0 18.0 20.5 |
Flu removing summer-heat granule is to the bacteriostasis (dull and stereotyped punch method) of clinical isolates strain
| Medicine | Dosage (g/ml) | Antibacterial circle diameter (mm) | ||||
| Staphylococcus aureus | Escherichia coli | Bacillus pyocyaneus | Kerekou pneumonia hundred Salmonellas | Acinetobacter calcoaceticus | ||
| Flu removing summer-heat granule flu removing summer-heat granule flu removing summer-heat granule SHUANGHUANLIAN (stock solution) | 0.25 0.50 1.00 0.05ml | 15.0 18.5 20.0 25.0 | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 | 10.5 12.0 18.0 22.0 |
2.1.2 test tube method
Get each bacterial strain nutrient broth culture of cultivating in 6 hours, be diluted in test as 10-3 with nutrient broth.Add culture medium 1.6ml in first test tube, all the other every pipes add 1ml.Get flu removing summer-heat granule medicinal liquid (SHUANGHUANLIAN stock solution is tested with same method) 0.4ml (1g/ml) and add first pipe, take out 1ml to the second pipe behind the mixing, dilution successively, the 11 pipe is set up to be had only medicine (concentration is the flu removing summer-heat granule medicinal liquid 0.1ml of 0.5g/ml) not to plant the negative control of antibacterial and the 12 pipe positive control that removing summer-heat granule medicinal liquid only plants antibacterial of not catching a cold, every pipe adds bacterium liquid 0.1ml (except that the 11 pipe), shake up, cultivated 18 hours for 37 ℃, the result is as follows.
Flu removing summer-heat granule is to the bacteriostasis (test tube method) of reference culture
| Reference culture | Minimum inhibitory concentration (MIC) is (drug dilution degree) (mg/ml) | |
| Flu removing summer-heat granule | SHUANGHUANLIAN stock solution (dilution factor) | |
| Staphylococcus aureus e coli bacillus pyocyaneus Bacillus pumilus millet straw bacillus cereus Resina garciniae microsphere bacillus | 62.5(1∶16) 250.0(1∶4) 125.0(1∶8) 62.5(1∶16) 125.0(1∶8) 62.5(1∶16) | 1∶16 1∶4 1∶8 1∶16 1∶8 1∶16 |
Flu removing summer-heat granule is to the bacteriostasis (test tube method) of clinical isolates strain
| Reference culture | Minimum inhibitory concentration (MIC) is (drug dilution degree) (mg/ml) | |
| Flu removing summer-heat granule | SHUANGHUANLIAN stock solution (dilution factor) | |
| Staphylococcus aureus e coli pyocyanic pneumonia Cray hundred Salmonella acinetobacter calcoaceticus | 62.5(1∶16) 125.0(1∶8) 500.0(1∶2) 500.0(1∶2) 62.5(1∶16) | 1∶16 1∶8 1∶2 1∶2 1∶16 |
2.2 the outer antibacterial tests of flu removing summer-heat granule
2.2.1 flu removing summer-heat granule is to the protective effect of infection of staphylococcus aureus mice
Get 80 of 19-22g kunming mouses, male and female half and half.Be divided into five groups at random.Each group is all used the 20ml/kg gastric infusion, every day 1 time, continuous 3 days.10min after the last administration, lumbar injection staphylococcus aureus culture fluid, this inoculation is in the culture broth culture medium, cultivated 6 hours for 37 ℃, be inoculated on the blood plate and cultivated 18 hours, wash bacterium liquid on the blood plate, only attack with 0.5ml/ then with 5% gastric Mucin 2.5ml, observe dead mouse number in 24 hours, the results are shown in following table.
Flu removing summer-heat granule is to the protective effect (24 hours) of infection of staphylococcus aureus mice
| Group | Dosage (g/kg) | Number of animals (only) | Death toll (only) | Mortality rate (%) |
| The heavy dose of group of dosage group flu removing summer-heat granule in normal saline group SHUANGHUANLIAN (stock solution) the group flu removing summer-heat granule small dose group flu removing summer-heat granule | - 20ml/kg 12.5 25.0 50.0 | 16 16 16 16 16 | 15 9 12 10 8 | 93.8 56.2 * 75.0 62.5 ** 50.0 ** |
*P＜0.05
*Compare with the normal saline group P＜0.01
2.2.2 flu removing summer-heat granule is to the protective effect of coli-infection mice
Get 80 of 19-22g kunming mouses, male and female half and half.Be divided into five groups at random.Each group is all used the 20ml/kg gastric infusion, every day 1 time, continuous 3 days.10min after the last administration, lumbar injection escherichia coli culture fluid, this inoculation is in the culture broth culture medium, cultivated 18 hours for 37 ℃, get 1ml culture fluid+5% gastric Mucin 9ml, only attack with 0.5ml/ as infecting culture fluid, observe dead mouse number in 24 hours, the results are shown in following table.
Flu removing summer-heat granule is to the protective effect (24 hours) of coli-infection mice
| Group | Dosage (g/kg) | Number of animals (only) | Death toll (only) | Mortality rate (%) |
| The heavy dose of group of dosage group flu removing summer-heat granule in normal saline group SHUANGHUANLIAN (stock solution) the group flu removing summer-heat granule small dose group flu removing summer-heat granule | 20ml/kg 12.5 25.0 50.0 | 16 16 16 16 16 | 16 13 15 15 14 | 100.0 81.3 93.8 93.8 87.5 |
2.3 the particulate antivirus action of flu removing summer-heat
2.3.1 influence to the pathological changes caused by virus effect
Get the prosperous Embryo Gallus domesticus of planting of 10 age in days Lays, every piece of allantoic inoculation virus 0.2ml cultivated 36 hours for 37 ℃, and 4 ℃ are spent the night, and enter allantoic cavity with aseptic straw and draw urine, and cryopreservation is also made aseptic culture.
Select well-grown Hep-2 cell culture, press the passage cell culture method, with the cell monolayer washing, digestion, numeration, cell number is about 280,000/ml.Cell suspension is added in the cellular plastic panel, and every hole 0.1ml, microwell plate put 37 ℃ of CO2 incubators 18 hours.
Viral chick embryo allantoic liquid is done continuous 10 times of dilutions with RPMI-1640, abandon culture fluid, the viral liquid that 10-1-10-10 is diluted adds micropore successively, every hole 0.1ml, and the cell contrast does not add virus, and each viral dilution degree adds 4 holes.Place the CO2 incubator, press the Reed-Muench method and calculate TCID50.
The removing summer-heat granule (1g/ml) of will catching a cold is mixed with different dilution factors (1: 20-1: medicinal liquid 160) with 1640 incubators, variable concentrations medicine and 30TCID50 effect 1 hour, add the Hep-2 cell culture then, 37 ℃ of CO2 incubators are cultivated, the observation of cell pathologic changes after 24 hours, and experiment repeats 3 times.Establish cell contrast, virus control, medicine contrast at every turn, treat the contrast of medicine and cell still for normal, and virus control occur ++-++ result of determination during+pathological changes the results are shown in following table.
Flu removing summer-heat granule is to the influence of pathological changes caused by virus effect
| Group | Flu removing summer-heat granule dilution factor | The SHUANGHUANGLIAN KOUFUYE dilution factor | ||||||
| 1∶20 | 1∶40 | 1∶80 | 1∶160 | 1∶20 | 1∶40 | 1∶80 | 1∶160 | |
| Cell control drug contrast adenovirus 3 influenza virus FM1 | - - + - | - - + - | - - ++ - | - - +++ ++ | - - + - | - - ++ - | - - ++ - | - - +++ ++ |
Annotate: cytopathy degree: "-" acellular pathological changes; "+" cytopathy below 25%; The cytopathy of " ++ " 25-50%; The cytopathy of " +++" 50-75%; The cytopathy of " ++ ++ " 75-100%.
2.3.2 flu removing summer-heat granule is to the influence of mice influenza virus property pneumonia
Get 60 of 19-22g kunming mouses, male and female half and half.Each group is all used the 20ml/kg gastric infusion, every day 1 time, successive administration 3 days.After the last administration 1 hour, except that normal group, all the other each group collunarium influenza virus infection Mus lung adapted strain FM1 150LD50 under the ether light anaesthesia infected after 96 hours and dissect, and get lung and weigh, calculating lung exponential quantity, the result is as follows.
Flu removing summer-heat granule is to the influence of mice influenza virus property pneumonia
| Group | Dosage (g/kg) | Number of animals (only) | The lung exponential quantity (X ± S) | Suppression ratio (%) |
| The heavy dose of group of dosage group flu Qingjie Granules in the two coptis (stoste) group of the normal group physiological saline group flu Qingjie Granules small dose group flu Qingjie Granules | - - 20ml/kg 12.5 25.0 50.0 | 10 10 10 10 10 10 | 0.71±0.08 1.19±0.07## 0.94±0.09 ** 1.11±0.07 * 1.06±0.09 ** 0.92±0.10 ** | 21.0 6.7 10.9 22.7 |
The Chinese medicine composition of treatment flu of the present invention proves through clinical verification:
The I phase is clinical finishes common cold due to wind heat 5 routine clinical analysiss altogether:
Alleviate fully (CR): treatment back symptom alleviates fully.Part is alleviated (PR): treatment back symptom obviously alleviates, can normal daily life.Slight alleviate (MR): symptom alleviates before taking medicine, but still the sense significant discomfort, daily life is disturbed.Invalid (NR): alleviate with comparing not have before the treatment.Observe this 5 routine patient in the court, CR accounts for 20%, and PR accounts for 60%, and MR accounts for 20%, and NR accounts for 0%.The CR+PR total effective rate is that 80%, 100% patient is eased.Wherein obvious rising person's 1 example of total white blood cells accounts for 20%.
I phase model case sees Appendix 1.
The II phase is clinical finishes common cold due to wind heat 221 routine clinical analysiss altogether:
1. this test is total to income group case 221 examples, and wherein 111 examples are organized in treatment, matched group 110 examples.According to two groups of basic datas relatively, harmonious good at aspects such as age, sex, height, body weight, the course of disease, the state of an illness, body temperature, breathing, pulse, blood pressure, occupations, its curative effect and safety have comparability.
2. flu removing summer-heat granule and KANGKAN KELI comprehensive therapeutic effect are analyzed, flu removing summer-heat granule test group recovery from illness 21/111, cure rate 18.92%, produce effects 50/111, obvious effective rate 45.05%, effective 31/111, effective percentage 27.93%, invalid 9/111, inefficiency 8.11, total effective rate is 91.89%; Matched group recovery from illness 15/110, cure rate 13.64%, produce effects 33/110, obvious effective rate 30.00%, effective 50/110, effective percentage 45.45%, invalid 12/110, inefficiency 10.91%, total effective rate is 89.09%, the deduction center effect, two groups of curative effects relatively have statistical significance, and flu removing summer-heat granule curative effect is better than KANGKAN KELI.
3. this result of study shows, takes flu removing summer-heat granule and KANGKAN KELI treatment flu (wind heat disease), tangible curative effect is all arranged recovering aspect the body temperature two groups, and body temperature is obviously descended, and flu removing summer-heat granule temperature fall time is early than KANGKAN KELI.
4. this result of study shows, improving aspect the symptom, after taking the treatment of flu removing summer-heat granule and KANGKAN KELI, two groups all have obvious curative effects, flu removing summer-heat granule is better than KANGKAN KELI, especially improve aspect heating, aversion to wind, pharyngalgia, cough, general malaise, 6 symptoms such as thirsty and dried meaningful, and more outstanding with second day, the 4th day.
5. do not find serious adverse events and untoward reaction during flu removing summer-heat granule and the KANGKAN KELI II phase clinical observation and after observing, do not find serious adverse events and untoward reaction, two groups are not all had predicable, tangible influence to hepatic and renal function, hematuria stool routine, electrocardiogram.Do not find the function damage of the sure heart, liver, kidney and other internal organs and system, illustrate that the safety of this medicine is good.
6. this test is followed Declaration of Helsinki and is carried out with relevant new drug standard, rules, all carries out the signature of informed consent.
This result of study shows, takes flu removing summer-heat granule and KANGKAN KELI treatment cold anemopyretic syndrome, and two groups all have tangible curative effect, can obviously reduce flu patient's body temperature and symptom.
Aspect reduction body temperature, body temperature is obviously descended, the test group temperature fall time is more Zao than matched group.
Improving aspect the symptom, symptom is obviously improved, test group is better than matched group effect, is especially improving test group better effects if aspect heating, aversion to wind, pharyngalgia, cough, general malaise, thirsty and dried 6 symptoms.
Comprehensive therapeutic effect, test group cure rate 18.92%, obvious effective rate 45.05%, effective percentage 27.93%, inefficiency 8.11%, total effective rate is 91.89%; Matched group cure rate 13.64%, obvious effective rate 30.00%, effective percentage 45.45%, inefficiency 10.91%, total effective rate is 89.09%, test group curative effect and matched group have statistical significance.
Significantly serious adverse events and untoward reaction are found in the safety aspect during the treatment and after the treatment, do not find sure, the tangible function damage of the heart, liver, kidney and other internal organs and system.
Show by this clinical research, the wet flu of flu removing summer-heat granule therapy wind heat folder is particularly suitable, also more obvious to simple anemopyretic and wind and cold heat-transformation type effect, therefore the removing summer-heat granule of catching a cold is a kind of safe and effective Chinese medicine preparation of treatment cold anemopyretic syndrome, is a kind of Chinese medicine preparation that has broad field of application in the treatment flu.
II phase model case sees Appendix 2.
The III phase is clinical finishes common cold due to wind heat 459 routine clinical analysiss altogether:
1. this test is total to income group case 459 examples, and wherein 345 examples are organized in treatment, matched group 114 examples.According to two groups of basic datas relatively, harmonious good at aspects such as age, sex, height, body weight, the course of disease, the state of an illness, body temperature, breathing, pulse, blood pressure, occupations, its curative effect and safety have comparability.
2. flu removing summer-heat granule and KANGKAN KELI comprehensive therapeutic effect are analyzed, flu removing summer-heat granule recovery from illness 78/333, cure rate 23.42%, produce effects 162/333, obvious effective rate 48.64%, effective 85/333, effective percentage 25.52%, invalid 8/333, inefficiency 2.40%, total effective rate is 97.59%; KANGKAN KELI group recovery from illness 21/113, cure rate 18.58%, produce effects 50/113, obvious effective rate 44.24%, effective 32/113, effective percentage 28.31%, invalid 10/113, inefficiency 8.84%, total effective rate is 91.15%, the deduction center effect, two groups of curative effects relatively have statistical significance, and flu removing summer-heat granule curative effect is better than KANGKAN KELI.
3. this result of study shows, take flu removing summer-heat granule and KANGKAN KELI treatment flu (wind heat disease), tangible curative effect is all arranged recovering aspect the body temperature two groups, body temperature is obviously descended, through carrying out the repeated measure ANOVA showed significant respectively to two groups, test group more all has statistical significance before take medicine each time point of back and treatment, matched group relatively has statistical significance before each time point and treatment after 2 hours taking medicine, and shows that flu removing summer-heat granule temperature fall time is early than KANGKAN KELI; Between two groups, compare, adopt general linear model, the repeated measure variance analysis, with data before treating is covariant, consider center effect, time point effect, carry out the comparison of test group and matched group, the result shows that comparison between covariant effect, two groups, center effect, time point effect all have statistical significance, and the body temperature difference has statistical significance between test group and the matched group.Body temperature changes between difference and body temperature rate of descent group relatively before and after to treatment, and the result shows, treats that body temperature difference has statistical significance between two groups of back 1 hour and 2 hours, At All Other Times two groups of relatively equal no difference of science of statistics.
Comprehensive The above results shows, body temperature is obviously descended, but flu removing summer-heat granule temperature fall time is early than KANGKAN KELI, and back 1 hour to the 2 hours test group body temperature of taking medicine descends and descends obviously than matched group, and two groups of body temperature drop-out values and rate of descent all have statistical significance.
4. card Hou Jifen difference has statistical significance between two groups of treatment back the 2nd day and the 4th days, between two groups of the coughs in the 2nd day of treatment back, thirsty and dried transference cure rate statistical significance is arranged, and between two groups of transference cure rates such as cough in the 4th day, sweating situation statistical significance is arranged.Show flu removing summer-heat granule improve heating, cough, nasal obstruction, headache,, be better than matched group aspect the general malaise, thirsty and dried, sweating situation symptom.
5. do not find serious adverse events and untoward reaction during flu removing summer-heat granule and the KANGKAN KELI III phase clinical observation and after observing, two groups are not all had predicable, tangible influence to hepatic and renal function, hematuria stool routine, electrocardiogram.Do not find the function damage of the sure heart, liver, kidney and other internal organs and system, illustrate that the safety of this medicine is good.
6. this test is followed Declaration of Helsinki and is carried out with relevant new drug standard, rules, all carries out the signature of informed consent.
By the clinical further checking of large sample III phase, affirmed fully particulate curative effect of flu removing summer-heat and safety, flu removing summer-heat granule II, III clinical research be basically identical as a result.
Flu removing summer-heat granule curative effect is than KANGKAN KELI height: comprehensive therapeutic effect, and flu removing summer-heat granule cure rate 23.42%, obvious effective rate 48.64%, effective percentage 25.52%, inefficiency 2.40%, total effective rate is 97.59%; KANGKAN KELI cure rate 18.58%, obvious effective rate 44.24%, effective percentage 28.31%, inefficiency 8.84%, total effective rate is 91.15%, test group curative effect and matched group have clear meaning; Aspect reduction body temperature, body temperature is obviously descended, the test group temperature fall time is more Zao than matched group; Improving aspect the symptom, symptom is obviously improved, test group is better than matched group effect, is especially improving test group better effects if aspect heating, cough, nasal obstruction, headache, general malaise, thirsty and dried, 7 symptoms of sweating situation.
The safety of flu removing summer-heat granule is than KANGKAN KELI height, and toxicity is lower than KANGKAN KELI, and two groups of adverse events incidence rates are respectively flu removing summer-heat granule 0.90%, KANGKAN KELI 1.77%.
Find by this clinical research, the wet flu of the removing summer-heat of checking flu again granule therapy wind heat folder is particularly suitable, also more obvious to simple anemopyretic and wind and cold heat-transformation type effect, therefore the removing summer-heat granule of catching a cold is a kind of safe and effective Chinese medicine preparation of treatment cold anemopyretic syndrome, is a kind of Chinese medicine preparation that has broad field of application in the treatment flu.
III phase model case sees Appendix 3.
So, compare with similar drug, of high quality and at a reasonable price being easy to get of medicine raw material of the present invention, preclinical pharmacology and clinical research proof determined curative effect reaches the effect of " effecting a permanent cure " that the traditional Chinese medical science is referred to as.The granular preparation of the treatment flu that the present invention makes has dissolving well, and stripping is fast, special effect, and short treating period, the bioavailability height does not have toxic and side effects, good stability, good looking appearance, easy to carry, advantages such as taking convenience.Granule of the present invention is a natural medicine, has the effect of relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing, resolving phlegm and relieving asthma, is used for cold anemopyretic syndrome.Card sees that heating, micro evil wind, nasal obstruction, watery nasal discharge, sneeze, dizzy headache, limb are miserable, cough, expectorant is glutinous or yellow, laryngopharynx swelling and pain, thirst with desire to drink, tongue tip side of red, greasy or the little Huang of white and thin fur, floating and rapid pulse by pharmacology and clinical verification checking, can reach the purpose for the treatment of both the principal and secondary aspects of a disease.The pharmaceutical preparation of the present invention of above preparation technology, moulding process and quality standard production has efficiently, the good product of safe without toxic side effect.
Adnexa 1:I phase model case
The king *, 27 years old, the male, the workman, examine February 27 nineteen ninety.Fear of cold hyperpyrexia body temperature 39.40C, half a day, headache, lossless, nasal obstruction, snivel, the itching throat pharynx is painful, little coughing, podomere ache, white and thin fur, floating and rapid pulse.Have a medical check-up: refreshing clear, spirit is fair, and neck is soft, and the rhythm of the heart is neat, fast 108 times/minute of heart rate.The pulmonary respiration sound is thick, and abdomen does not have to press and aches, and extremity are movable normal.Blood count: leukocyte 4300 neutrality 64%, lymph 35%, acidity 1%, Chest X-rays: cardiopulmonary are normal, and disease belongs to anemopyretic cold, controls and intends relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing.To two doses of removing summer-heat flu soup, slowly sweating behind the potion of taking medicine, conscious body temperature descends, and headache alleviates, and can fall asleep night, and survey body temperature inferior morning and reduce to normally, mental restoration, syndrome disappears, and it is normal that physical and chemical index recovers, blood count: leukocyte 5600 neutral 72% lymphs 28%.
Horse * *, the women, 48 years old, accounting, JIUYUE was examined on the 24th in 1991.Began fear of cold heating 38.70C last night, headache, stuffy nose with watery discharge, the painful general malaise of pharynx, little coughing, the few color of expectorant is white, white and thin fur, floating and rapid pulse, have a medical check-up: refreshing clear, spirit is poor, and BITONG gas is not good enough.The pharyngeal hyperemia moderate, retropharyneal folliculosis, the rhythm of the heart is neat, heart rate 102 times/minute, lung is normal, and the soft nothing of abdomen is pressed painful, and extremity are movable normal.Blood count: leukocyte 4800 neutrality 68%, lymph 32%, the Chest X-rays cardiopulmonary are normal, and disease belongs to anemopyretic cold, controls and intends relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing.To two doses of removing summer-heat flu soup, the only potion of taking medicine, headache is alleviated, and perspires, and spirit takes a turn for the better, the before measurement body temperature 37.90C that sleeps, the temperature recovery of taking medicine after two doses is normal, and disease disappears, and physical and chemical index also recovers normally, checks leukocyte 6200 neutral 70% lymphs 30%.
Adnexa 2:II phase model case
1. case: Lee so-and-so, the women, 55 years old, heating, aversion to wind 8 hours, with the dry pharynx pain, cough, feeling of fullness in the head, sweating, general malaise, sweating, 38.5 ℃ of body temperature are in 9 the court's emergency treatments of coming in morning August 14 calendar year 2001.The syndrome integration is 18 minutes during prescription on individual diagnosis.Yellow and thin fur, red tongue, floating and rapid pulse.Health check-up: heart rate 72 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.Routine blood test, stool routine, liver function, renal function, electrocardiogram are all normal.Chinese medical discrimination: flu (wind heat disease).Western medicine diagnose: common cold.No. 44, medicine numbering, 3 times/day, 1 bag/time, oral.
The back 1 hour body temperature of taking medicine begins to descend, and body temperature is reduced to 37.1 ℃ after 24 hours, heating, aversion to wind, cough, feeling of fullness in the head, sweating, general malaise transference cure.Continued to take medicine 72 hours, 36.80 ℃ of body temperature, symptom all disappears.Yellow and thin fur, tongue just, normal pulse.Health check-up: heart rate 65 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.Check routine blood test, stool routine, liver function, renal function, electrocardiogram are all normal.Treatment back syndrome integration 0 minute.Clinical efficacy is judged to be recovery from illness, has no adverse reaction during the medication.
2. case: Chen, the male, 38 years old, heating micro evil wind 1 hour, with the dry pharynx pain, cough, feeling of fullness in the head, sneeze, sweating, general malaise, 37.50 ℃ of body temperature are in 4 the court's emergency treatments of coming in afternoon July 11 calendar year 2001.Go to a doctor number: 47994.The syndrome integration is 17 minutes during prescription on individual diagnosis.Yellow and thin fur, red tongue, floating and rapid pulse.Health check-up: heart rate 80 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.Routine blood test, routine urinalysis, stool routine, liver function, renal function, electrocardiogram are all normal.Chinese medical discrimination: flu (wind heat disease).Western medicine diagnose: common cold.No. 055, medicine numbering, 3 times/day, 1 bag/time, oral.
The back 2 hours body temperature of taking medicine begins to descend, and body temperature is reduced to 37.20 ℃ after 24 hours, and sneeze and general malaise disappear.Continuing to take medicine 72 disappears, 36.70 ℃ of body temperature, and except thirsty slightly, it all disappears in symptom.Yellow and thin fur, tongue just, normal pulse.Health check-up: heart rate 76 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.Check routine blood test, routine urinalysis, stool routine, liver function, renal function, electrocardiogram are all normal.Treatment back syndrome integration 1 minute.Clinical efficacy is judged to be produce effects, has no adverse reaction during the medication.
Adnexa 3:III phase model case
1. case: cover so-and-so, the male, 22 years old, heating, aversion to wind 3 hours, with symptoms such as pharyngalgia, cough, nasal obstruction, watery nasal discharge, sneeze, distending pain in the head, sweating, general malaises, 38.5 ℃ of body temperature are in 9 the court's emergency treatments of coming in the morning on March 9th, 2002.The syndrome integration is 20 minutes during prescription on individual diagnosis.Yellow and thin fur, red tongue, floating and rapid pulse.Health check-up: heart rate 70 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.Routine blood test, stool routine, liver function, renal function, electrocardiogram are all normal.Chinese medical discrimination: flu (wind heat disease).Western medicine diagnose: common cold.No. 31, medicine numbering, 3 times/day, 1 bag/time, oral.
The back 2 hours body temperature of taking medicine begins to descend, and body temperature is reduced to 37.6 ℃ after 24 hours, and all diseases obviously alleviate.Continued to take medicine 72 hours, 36.5 ℃ of body temperature, except that nasal obstruction, other symptoms all disappear.Yellow and thin fur, tongue just, normal pulse.Health check-up: heart rate 60 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.Check routine blood test, stool routine, liver function, renal function, electrocardiogram are all normal.Treatment back syndrome integration 1 minute.Clinical efficacy is judged to be recovery from illness, has no adverse reaction during the medication.
2. king XX, the women, 44 years old, generate heat and accompanied little stomach disorder due to wind pathogen in 8 hours, pharyngalgia, feeling of fullness in the head, slight perspiration, general malaise, T38.1 ℃, in the 9:30 the court's emergency treatment of coming in the morning on the 15th October in 20014.Go to a doctor number: 25611.Total mark is 14 minutes during prescription on individual diagnosis.White and thin fur, the red tongue floating and rapid pulse.Health check-up: heart rate per minute 96 times, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.The routine of having a blood test, routine urinalysis, stool routine, liver function, renal function, electrocardiogram are all normal.Differential diagnosis in tcm: flu (wind heat disease).Western medicine diagnose: common cold.Medicine numbering 129 is obeyed one bag at every turn.
The back 24 hours body temperature of taking medicine is reduced to normally, still feels xerostomia, and miserable from head to foot, surplus disease all subtracts, total mark 5 minutes.Took medicine back 72 hours, T36.8 ℃, all diseases all disappear.Health check-up: heart rate per minute 68 times/minute, the rhythm of the heart is neat, and two pulmonary respiration sounds are clear.White and thin fur, light red tongue, rolling pulse.The check routine blood test, routine urinalysis, stool routine, liver function, renal function, electrocardiogram are all normal.Treated each total mark 0 minute.Clinical efficacy is judged to be recovery from illness, has no adverse reaction during the medication.
Description of drawings
Fig. 1 is the process chart of the embodiment of the invention 1.
The specific embodiment
Embodiment 1, the treatment Chinese medicine composition of cold anemopyretic syndrome and the preparation of preparation thereof, with reference to Fig. 1:
Radix Puerariae 600g, Fructus Arctii 300g, Radix Isatidis 600g, Herba Commelinae 600g, Herba Taraxaci 600g, Folium Perillae 300g, Pericarpium Citri Reticulatae 167g, Poria 300g, Herba Plantaginis 300g, Cortex Mori 300g and Semen Armeniacae Amarum 300g/1000g (each 10g, every day 3 times)
Step 1, get Radix Puerariae, Fructus Arctii, Radix Isatidis, Herba Commelinae, Herba Taraxaci, Folium Perillae, Pericarpium Citri Reticulatae, Poria, Herba Plantaginis, Cortex Mori and Semen Armeniacae Amarum 11 flavor medicines by the quality component (or enlarging quantity in proportion) of prescription, standby;
Step 2, Radix Puerariae are made solvent according to percolation under fluid extract and the extractum item with 50% ethanol, flooded 24 hours, and percolation slowly, percolate is condensed into about 1.03 (50 ℃) of relative density, and fluid extract is standby.
Step 3, Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors extract volatile oil, and volatile oil is standby.
(volatile oil: beta-schardinger dextrin-: water=1: 4: 24), inclusion complex is standby with beta-cyclodextrin inclusion compound for step 4, volatile oil.
Medicinal residues, mother solution, Aromatic water behind step 5, the extraction volatile oil decoct with water secondary with Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element, each 1.5 hours, collecting decoction filtered, filtrate is concentrated into about 1.10 (50 ℃) of relative density, be cooled to room temperature, add ethanol and make and contain alcohol amount and reach 50%, stir evenly, leave standstill, filter, filtrate recycling ethanol also is concentrated into about 1.30 (50 ℃) of relative density, and clear paste is standby.
Step 6, Poria decoct with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate is concentrated into about 1.20 (50 ℃) of relative density, and concentrated extract is standby.
Step 7, above-mentioned concentrated extract, precipitate with ethanol clear paste and Radix Puerariae fluid extract, drying, dry powder is standby.
Step 8, dry powder add dextrin, (dry extract: dextrin=1: 1.4), volatile oil beta cyclodextrin inclusion complex, mixing, dry granulation sieves, and makes 1000g, promptly.
Above semi-finished product are packaged into the 10g/ bag respectively and get final product.
In the quality standard, with thin layer method Radix Puerariae, Fructus Arctii etc. is differentiated respectively,, selected for use different developing solvents, all obtain satisfied result according to different materials, and with this discriminating project as this product.Select for use puerarin in the Radix Puerariae as quantitative target: (1) adopts the HPLC method, has carried out precision test, repeatability test, solvent stability test and application of sample recovery test respectively, and method of proof is feasible, can be used as the quantitative approach of preparation.By the soft capsule that above preparation technology, moulding process and quality standard are produced, the product that becomes high in technological content, steady quality and be easy to control, (2) have adopted ultraviolet, have also monitored the quality of this product from another kind of method.
Embodiment 2, and is substantially the same manner as Example 1, but following change is arranged:
The ratio of each medical material is in the compositions:
Radix Puerariae 550g, Fructus Arctii 250g, Radix Isatidis 550g, Herba Commelinae 550g, Herba Taraxaci 550g, Folium Perillae 250g, Pericarpium Citri Reticulatae 120g, Poria 250g, Herba Plantaginis 250g, Cortex Mori 350g and Semen Armeniacae Amarum 250g.
Embodiment 3, and is substantially the same manner as Example 1, but following change is arranged:
The ratio of each medical material is in the compositions:
Radix Puerariae 650g, Fructus Arctii 350g, Radix Isatidis 650g, Herba Commelinae 650g, Herba Taraxaci 650g, Folium Perillae 350g, Pericarpium Citri Reticulatae 190g, Poria 350g, Herba Plantaginis 350g, Cortex Mori 350g and Semen Armeniacae Amarum 350g.
Embodiment 4, and is substantially the same manner as Example 1, but following change is arranged:
The ratio of each medical material is in the compositions:
Radix Puerariae 650g, Fructus Arctii 350g, Radix Isatidis 650g, Herba Commelinae 550g, Herba Taraxaci 550g, Folium Perillae 250g, Pericarpium Citri Reticulatae 120g, Poria 250g, Herba Plantaginis 250g, Cortex Mori 350g and Semen Armeniacae Amarum 250g.
Embodiment 5, and is substantially the same manner as Example 1, but following change is arranged:
The ratio of each medical material is in the compositions:
Radix Puerariae 550g, Fructus Arctii 250g, Radix Isatidis 550g, Herba Commelinae 550g, Herba Taraxaci 650g, Folium Perillae 350g, Pericarpium Citri Reticulatae 190g, Poria 350g, Herba Plantaginis 350g, Cortex Mori 350g and Semen Armeniacae Amarum 350g.
Embodiment 6,
Treat Chinese medicine composition of cold anemopyretic syndrome and preparation method thereof, include the medical material of following component in the compositions:
Radix Puerariae 550～650g, Fructus Arctii 250～350g, Radix Isatidis 550～650g, Herba Commelinae 550～650g, Herba Taraxaci 550～650g, Folium Perillae 250～350g, Pericarpium Citri Reticulatae 120～190g, Poria 250～350g, Herba Plantaginis 250～350g, Cortex Mori 350～350g and Semen Armeniacae Amarum 250～350g.
More than each component directly decoct with water secondary, each 1.5 hours, collecting decoction filtered, filtrate is concentrated into about 1.20 (50 ℃) of relative density, concentrated extract, drying, dry powder is standby.
Dry powder adds dextrin, (dry extract: dextrin=1: 1.4), mixing, dry granulation sieves, and makes 1000g, promptly.
Embodiment 7～11, and is basic identical with embodiment 1～5 respectively, but dosage form is respectively tablet, pill, soft, hard capsule, electuary or oral liquid.
Embodiment 12～16, and the ratio of each medical material is basic identical with embodiment 1～5 respectively in the compositions, but each component is directly medicinal, does not adopt its extract.Dosage form is respectively tablet, pill, soft, hard capsule, electuary or oral liquid.
Claims (4)
1, a kind of Chinese medicine composition for the treatment of cold anemopyretic syndrome comprises in the raw material of every 1000g medicine:
Radix Puerariae 550～650g, Fructus Arctii 250～350g, Radix Isatidis 550～650g, Herba Commelinae 550～650g, Herba Taraxaci 550～650g, Folium Perillae 250～350g, Pericarpium Citri Reticulatae 120～190g, Poria 250～350g, Herba Plantaginis 250～350g, Cortex Mori 350～350g and Semen Armeniacae Amarum 250～350g
Described Radix Puerariae is to adopt its ethanol stream extractum;
Described Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors are to adopt its volatile oil respectively; The perhaps inclusion complex of the beta-cyclodextrin inclusion compound of volatile oil; Perhaps when adopting volatile oil or volatile oil inclusion complex, also adopt it to extract the ethanol precipitation clear paste of the decocting liquid of medicinal residues behind volatile oil;
Described Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element adopt the ethanol precipitation clear paste of its decocting liquid respectively;
Described Poria adopts its water drug-decocting concentrating liquid.
2, the Chinese medicine composition of treatment cold anemopyretic syndrome according to claim 1 is characterized in that, each component ratio of described raw material is:
Radix Puerariae 600g, Fructus Arctii 300g, Radix Isatidis 600g, Herba Commelinae 600g, Herba Taraxaci 600g, Folium Perillae 300g, Pericarpium Citri Reticulatae 167g, Poria 300g, Herba Plantaginis 300g, Cortex Mori 300g and Semen Armeniacae Amarum 300g;
Described Chinese medicine composition also includes acceptable carrier and adjuvant on the pharmaceutics, and dosage form is granule, tablet, pill, soft, hard capsule, electuary or oral liquid.
3, the preparation method of the Chinese medicine composition of the described treatment cold anemopyretic syndrome of a kind of claim 1 may further comprise the steps:
Radix Puerariae 550～650g, Fructus Arctii 250～350g, Radix Isatidis 550～650g, Herba Commelinae 550～650g, Herba Taraxaci 550～650g, Folium Perillae 250～350g, Pericarpium Citri Reticulatae 120～190g, Poria 250～350g, Herba Plantaginis 250～350g, Cortex Mori 350～350g and Semen Armeniacae Amarum 250～350g, standby;
Radix Puerariae is made solvent with ethanol, dipping, and percolation, percolate concentrates, and fluid extract is standby;
Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors extract volatile oil, and volatile oil is standby;
The volatile oil beta-cyclodextrin inclusion compound, inclusion complex is standby;
Medicinal residues, mother solution, Aromatic water behind the extraction volatile oil decoct with water with Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element, and decocting liquid filters, and concentrate, and add ethanol and leave standstill, and filter, and filtrate recycling ethanol is also concentrated, and clear paste is standby;
Poria decocts with water, and decocting liquid filters, and concentrates, and concentrated extract is standby;
Above-mentioned concentrated extract, precipitate with ethanol clear paste and Radix Puerariae fluid extract, drying, dry powder is standby;
Dry powder adds dextrin, dry extract: dextrin=1: 1.4, volatile oil beta cyclodextrin inclusion complex, and mixing, dry granulation sieves, and makes 1000g, promptly.
4, according to the preparation method of the Chinese medicine composition of the described treatment cold anemopyretic syndrome of claim 3, the steps include:
Radix Puerariae 600g, Fructus Arctii 300g, Radix Isatidis 600g, Herba Commelinae 600g, Herba Taraxaci 600g, Folium Perillae 300g, Pericarpium Citri Reticulatae 167g, Poria 300g, Herba Plantaginis 300g, Cortex Mori 300g and Semen Armeniacae Amarum 300g, standby;
Radix Puerariae is made solvent according to percolation under fluid extract and the extractum item with 50% ethanol, floods 24 hours, and it is about 1.03 that percolation slowly, percolate are condensed into relative density, and fluid extract is standby;
Folium Perillae, Pericarpium Citri Reticulatae, Semen Armeniacae Amarum three flavors extract volatile oil, and volatile oil is standby;
Volatile oil beta-cyclodextrin inclusion compound: volatile oil: beta-schardinger dextrin-: water=1: 4: 24, inclusion complex is standby;
Medicinal residues, mother solution, Aromatic water behind the extraction volatile oil decoct with water secondary with Herba Taraxaci, Herba Commelinae, Fructus Arctii, Cortex Mori, Herba Plantaginis, Radix Isatidis Six-element, each 1.5 hours, collecting decoction filtered, filtrate is concentrated into relative density about 1.10, be cooled to room temperature, add ethanol and make and contain alcohol amount and reach 50%, stir evenly, leave standstill, filter, filtrate recycling ethanol and to be concentrated into relative density about 1.30, clear paste is standby;
Poria decocts with water secondary, and each 1.5 hours, collecting decoction filtered, and it is about 1.20 that filtrate is concentrated into relative density, and concentrated extract is standby;
Above-mentioned concentrated extract, precipitate with ethanol clear paste and Radix Puerariae fluid extract, drying, dry powder is standby;
In dry extract: the ratio of dextrin=1: 1.4 adds dextrin in dry powder; Volatile oil beta cyclodextrin inclusion complex, mixing, dry granulation sieves, and makes 1000g, that is,
The drying of the above concentrated solution is to adopt drying under reduced pressure, spray drying or vacuum drying;
The method of granulating of the above dry powder is dry method or wet method.
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