CN100579539C - Chinese medicine preparation for preventing upper respiratory tract infection and preparing method thereof - Google Patents
Chinese medicine preparation for preventing upper respiratory tract infection and preparing method thereof Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine preparation for curing upper respiratory tract infection and its preparation method. It is made up by using (by weight portion) 3-5 portions of inula cappa, 1-2 portions of andrographis and 2-4 portions of gypsum through a certain preparation process.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation for the treatment of upper respiratory tract infection and preparation method thereof, belong to the technical field of herbal pharmaceutical.
Background technology:
Upper respiratory tract infection (flu) disease is clinical common, multiple disease, and the four seasons can be sent out, especially with the winter-spring season pilosity, and the sickness rate height.And in recent years because the variation of common cold strain, and the motion that town and country air pollution, urbanization bring lacks, being busy with one's work causes the influence of factors such as resistance of human body reduction, and sickness rate is high, brings many discomforts to the patient, has a strong impact on work and life.According to statistics, the adult will catch a cold 3～4 every year, and the child is then nearly more than 6 times.Worker's absence from duty 36%, 67% all the causing of student's sick leave by flu, the harm that flu causes anemia of pregnant woman, old man and child is also very big.China has 75% people to suffer from once flu at least every year approximately, and 20～30% of clinic case in 1998 is sought medical advice because of flu, adds and buys Drug therapy person by oneself, and the whole nation is not estimated 1,000,000,000 person-times.According to World Health Organization's statistics, the number of dying from flu every year has a strong impact on human body health at least more than 2,000,000.Therefore, the generation of control flu alleviates the harm of flu to human body health, is the research topic that medical educational circles attaches great importance to.And the medicine of developing the treatment cold disease seems particularly important.According to another Chinese nonprescription drugs association and the big pharmacy of Shanghai Fahrenheit company limited statistics, what China's common disease self-medication ratio was the highest at present is coldrex, is 89.6%, exceeds 30 percentage points of second places.This phenomenon is at global ubiquity.According to estimates, the coldrex sales volume in China every year is about about 10,000,000,000 yuans.
It is modal infectious disease to the infection between the throat that upper respiratory tract infection (flu) means from nasal cavity.Primary disease belongs to traditional Chinese medical science flu category.Modern Chinese medicine is to the understanding basically identical of primary disease etiology and pathogenesis: mainly be to experience due to the ailment said due to cold or exposure, or touch and emit seasonal pathogen, or the heresy of six climate exopathogens such as wind and cold heat-damp in summer is held seasonal pathogen under the arm and invaded human body and fall ill.Be mainly in abrupt change of climate, cold warm not normal in.All can fall ill throughout the year, but with winter-spring season for seeing more.Because of the vasoconstriction of winter-spring season nasal cavity bottleneck throat, the mucosa drying, cell rupture, antibody horizontal descends.Generally occur fever with aversion to cold etc. earlier and defend the disease of table, this is a defensive QI being obstructed, and battalion defends and becomes estranged, due to the struggle between vital QI and pathogen.Exopathogen is violated lung, and lung qi loses in a surname respectful, then sees diseases such as cough, nasal obstruction; The evil then systemic pain of meridians of violating; Disturb then headache on the pathogen.Body constitution is generally only attacked lung and is defended than the powerhouse, based on exterior syndrome, still easily dismisses; If old person, then easy going from the exterior into the interior makes sx, or become sick it.To Treatment of Upper Respiratory Tract Infection, past mainly is to treat by the method for differentiation of symptoms and signs for classification of syndrome, show through nearly 10 years clinical research, only follow traditional differentiation of symptoms and signs for classification of syndrome opinion and control method, the problem complicated and changeable that can't resolve clinically far away to be occurred, only based on differentiation of symptoms and signs for classification of syndrome, differential diagnosis of diseases just can meet clinical needs with dialectical combining.
At present, though the upper respiratory tract infection doctor trained in Western medicine has antiviral drugs, antibiotic and human leukocytes interferon etc., still there is not desirable effect.Chinese medicine is possessed real skills on anti-curing cold, and differential diagnosis of diseases nowadays and the dialectical extensively treating flu that combines have become development trend.In addition, anemopyretic and excessive heat type flu have the trend that increases, this lacks the motion that resistance of human body reduces and urbanization brings with cold virus type, strain variation and town and country air pollution in recent years, it is relevant to be busy with one's work, therefore strengthen research to its control, a kind of safe, effective, inexpensive Chinese medicine is provided, will has important practical significance and extensive market prospects.
Summary of the invention:
The objective of the invention is to: a kind of Chinese medicine preparation for the treatment of upper respiratory tract infection and preparation method thereof is provided.The present invention adopts modern preparation technique, with the pharmacodynamics test is that the basis is studied preparation technology, Herba Inulae cappae, Herba Andrographis are through the macroporous adsorption resin technology separation and purification, effective ingredient obtains abundant enrichment, and total solid matters obviously reduces, and has overcome the easy moisture absorption of finished product, day dose is big, storage inconvenience, quality is wayward, shortcomings such as poor stability.
The present invention constitutes like this: a kind of Chinese medicine preparation for the treatment of upper respiratory tract infection, calculate according to composition by weight, and make for 2～4 parts by 3～5 parts of Herba Inulae cappae, 1～2 part of Herba Andrographis and Gypsum Fibrosum.
Specifically, calculate according to composition by weight, it is made for 3 parts by 4 parts of Herba Inulae cappae, 2 parts of Herba Andrographis and Gypsum Fibrosum.
Described Chinese medicine preparation is granule, tablet or capsule.
The preparation method of the Chinese medicine preparation of treatment upper respiratory tract infection of the present invention is: take by weighing Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum in proportion, decoct with water 3 times, each 1 hour, filter merging filtrate, filtrate is condensed into thick paste, add appropriate amount of starch, mixing is granulated, drying is prepared into various preparation according to a conventional method.
Another kind of preparation method is: take by weighing Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum in proportion, decoct with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into extractum, add ethanol and make that to contain alcohol amount be 50～80%, mixing was placed 24 hours, filter, filtrate recycling ethanol is condensed into thick paste, add appropriate amount of starch, mixing is granulated, drying is prepared into various preparation according to a conventional method.
Another preparation method is: take by weighing three flavor medical materials in proportion, Herba Inulae cappae and Herba Andrographis are decocted with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into extractum, adds ethanol and makes that to contain alcohol amount be 50～80%, mixing, placed 24 hours, and filtered decompression filtrate recycling ethanol, D on the concentrated solution
101Macroporous adsorptive resins with 40～90% ethanol elutions, is collected eluent, reclaims ethanol, concentrates, and vacuum drying or microwave vacuum drying are pulverized, and get extract; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge two kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into various preparation according to a conventional method.
Its preparation method can also for: take by weighing three flavor medical materials in proportion, Herba Inulae cappae, Herba Andrographis decoct with water extraction respectively, concentrate, and handle with ethanol precipitation, reclaim ethanol; Aqueous solution is gone up D respectively
101Macroporous adsorptive resins discards and penetrates liquid, uses ethanol elution, collects eluent, reclaims ethanol, concentrates, and drying is pulverized, and gets Herba Inulae cappae, Herba Andrographis extract respectively; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge three kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into various preparation according to a conventional method.
The detailed process of said method is: take by weighing three flavor medical materials in proportion, Herba Inulae cappae, Herba Andrographis add 10 times of water gagings respectively and decoct extraction 3 times, each 1 hour, filter merging filtrate, filtrate decompression is condensed into extractum, add ethanol and make that to contain alcohol amount be 50～80%, mixing was placed 24 hours, filter decompression filtrate recycling ethanol; Aqueous solution is gone up D respectively
101Macroporous adsorptive resins discards and penetrates liquid, with 40～90% ethanol elutions, collects eluent, reclaims ethanol, concentrates, and reduced vacuum drying or microwave vacuum drying are pulverized, and gets Herba Inulae cappae, Herba Andrographis extract respectively; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge three kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into granule, or is pressed into tablet, or incapsulates and make capsule.
The present invention's prescription is made up of Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum three flavor medicines, wherein: Herba Inulae cappae: property suffering, mildly bitter flavor.Diffusing wind heat clearing away, removing toxic substances and promoting subsidence of swelling.Be used for cold, fever, laryngopharynx swelling and pain, rheumatalgia, carbuncle skin ulcer furunculosis, acute mastitis." Guizhou natural resources of Chinese medicinal materials ": heat clearing away, tonify deficiency, expectorant Dingchuan." Chinese ethnic drug will " record: Miao ethnic group: be used for tonsillitis, bronchitis, gingivitis, mastitis.The Yao nationality: the detumescence of dispeling the wind, promoting the circulation of QI to relieve pain, expelling cold and relieving exterior syndrome.The Yi nationality, distributed over Yunnan, Sichuan and Guizhou: clearing away heat-fire.Be used for toothache, urinary tract infection.Zhuang: heat-clearing and toxic substances removing, the emaciation due to emotional upset that looses is swollen.Be used for cold, fever, laryngopharynx swelling and pain, rheumatalgia, carbuncle skin ulcer furunculosis, acute mastitis.The Dai nationality is used for infantile fever.Decocting liquid all has better action to staphylococcus aureus, escherichia coli, Song Shi dysentery bacterium.Clinical acute tonsillitis, chronic bronchial pharynx, the arthritis etc. of being used for the treatment of.
Herba Andrographis: the nature and flavor hardship, cold.GUIXIN, lung, large intestine, urinary bladder channel.The function heat-clearing and toxic substances removing, removing heat from blood, detumescence.Be used for cold, fever, laryngopharynx swelling and pain, aphtha of the mouth and tongue, pertussis chronic cough, dysentery, carbuncle skin infection, venom." Quanzhou book on Chinese herbal medicine ": heat-clearing and toxic substances removing, antiinflammatory detumescent.Control laryngopharyngitis, dysentery, hyperpyrexia.Modern pharmacological research shows that Herba Andrographis has more antibiotic, antivirus action.
Gypsum Fibrosum: nature and flavor suffering, sweet, Great Cold.Attach to the lung and stomach meridians.The function clearing away heat-fire, relieving restlessness is quenched the thirst, the convergence granulation promoting.Be used for the high fever excessive thirst, dyspnea and cough due to lung-heat, toothache due to stomach-fire, skin infection is not held back." not Lu ": " remove seasonal epidemic pathogens headache fever of the body ... expelling pathogenic factors from muscles by diaphoresis; Only quench one's thirst pharynx heat." " Amplification on Materia Medica addendum ": " and Gypsum Fibrosum, this Yangming Channel medicine, the bright main muscle of sun, it is also sweet, can delay the spleen QI invigorating, quenches the thirst and reduces internal heat, and its suffering also can be perspired by expelling pathogenic factors from muscles, goes upward to head, and it is lunar few positive to start with again, and can be the main person of three warps." " Bencao Jingshu ": " Gypsum Fibrosum is originally separated excess-heat, the gas that drives away summer heat, the pathogenic heat of loosing, the key medicine of the relieving restlessness of quenching the thirst.”
The present invention is according to fever caused by exogenous pathogens, system is by the heresy invasion and attack flesh table of six climate exopathogens, and heresy just disaccords, and battalion defends and becomes estranged, the excess of YANG in outside, defending the etiology and pathogenesis of table from the beginning of heresy, and at the excess syndrome of affection due to external wind and heat, with dispelling wind to relieve the exterior syndrome, heat clearing away is got rid of evils and is the method for prescription, with Herba Inulae cappae pungent in flavor and cool in property is monarch, the wind and heat dispersing of using, resolving toxin and disinhibiting the throat; Herba Andrographis nature and flavor bitter cold, heat-clearing and toxic substances removing is evacuated wind and heat in the lung meridian poison heresy, clearing throat, the wind heat of the part of the body cavity above the diaphragm housing the heart and lungs that looses, principal drug assistance is opened fur and is pursued evil poison, and what use is minister; Gypsum Fibrosum hot sweet Great Cold, but its suffering expelling pathogenic factors from muscles perspire, its sweet spleen QI invigorating of delaying is quenched the thirst and is reduced internal heat, its cold can clearing away lung-heat, and lung is combined into adjuvant drug mutually with fur.All medicines cooperate, and are total to the long memorial wind, relieving exterior syndrome, the effect of heat-clearing and toxic substances removing.
The function of preparation of the present invention cures mainly: dispelling wind to relieve the exterior syndrome, heat-clearing and toxic substances removing.Be used for affection due to external wind and heat, disease sees that heating, micro evil wind are cold, headache, cough, watery nasal discharge, thirsty, pharyngalgia, white and thin fur or little Huang, floating and rapid pulse, and the upper respiratory tract infection person that sees the above-mentioned symptom.
At present, the Chinese medicine preparation that treatment upper respiratory tract infection belongs to affection due to external wind and heat reaches over one hundred kind, dosage form is almost included modern various dosage forms commonly used, as pill, electuary (granule), tablet, capsule, oral liquid, injection, suppository, syrup, medicinal tea etc., how based on compound preparation.Preparation of the present invention with compare with veriety, have following characteristics: (1) similar medicine identical with indication compared, and this preparation is also paid attention to heat-clearing and toxic substances removing heat except the characteristics dispelling wind to relieve the exterior syndrome at upper respiratory tract infection, at the excess syndrome prescription, to reach the purpose for the treatment of both the principal and secondary aspects of a disease.(2) write out a prescription composition from traditional Chinese medical science clinical practice, draw traditional Chinese medical science tradition and medication experience among the people, select the medicine prescription, meet theory of Chinese medical science according to upper respiratory tract infection clinical characters and adaptation syndrome.(3) among the people on probation, evident in efficacy, instant effect has clinical preferably basis.
In order to ensure the effect of preparation of the present invention, the applicant has carried out a series of pharmacodynamics test research, and is specific as follows:
1. to the influence of rat abdominal cavity leukoplania
Get 60 of body weight 200 ± 20gSD rats, be divided into 6 groups at random.The administration group is pressed table 1 dosage gastric infusion, and the normal control group is given the isometric(al) normal saline with method, and positive controls is irritated stomach antiviral granule 8.0g/kg.Be administered once every day, for three days on end.1h after the last administration, every Mus lumbar injection 1% carboxymethylcellulose sodium solution 4ml puts to death behind the 3h, and intraperitoneal injection of saline 5ml washes the abdominal cavity, and the leukocyte count in the counting eluate the results are shown in Table 1.
The influence of table 1 pair rat abdominal cavity leukoplania (n=10, x ± SD)
| Group | Dosage (the g crude drug/kg) | Leukocyte count (* 10 9/L) | Suppression ratio (%) |
| Matched group | - | 12.11±3.51 | |
| Low dose group | 2.0 | 8.04±2.05* | 31.45 |
| Middle dosage group | 4.0 | 7.42±2.57* | 35.61 |
| Office's agent reorganization | 8.0 | 6.21±3.12** | 41.33 |
| Antiviral granule | 8.0 | 7.06±2.87* | 38.41 |
Compare * p＜0.05 * * p＜0.01 with matched group.
The result shows that the leukocyte count of each dosage group of preparation of the present invention and positive controls is starkly lower than matched group, with matched group significant difference (P＜0.05, P＜0.01) is arranged relatively.
2. the influence of rat paw edema due to the on Carrageenan
Get 60 of body weight 200 ± 20g SD rats, be divided into 6 groups at random, 10 every group, the administration group is pressed table 2 dosage gastric infusion, and the normal control group is given the isometric(al) normal saline with method, and positive controls is irritated stomach antiviral granule 8.0g/kg.1h after the administration in the right back sufficient plantar subcutaneous injection 1% carrageenin 0.1ml/ of rat, causes scorching back 1,2,4,6 hour, measures the sufficient sole of the foot volume that causes scorching front and back different time respectively, calculates the swelling value, the results are shown in Table 2.
The influence of rat paw edema due to table 2 on Carrageenan (n=10, x ± SD)
Compare * p＜0.05 * * p＜0.01 with matched group.
Result of the test shows that each dosage group of preparation of the present invention causes 2 and 4 hours the swelling value in scorching back and is starkly lower than matched group, with matched group significant difference (P＜0.05, P＜0.01) is arranged relatively.
3. endotoxin is caused the refrigeration function of fever in rabbits
If get body weight 1.8～2.5kg healthy rabbits in only, laboratory temperature is controlled at about 25 ℃.In preceding 3 days of test, survey normal anus temperature every day 2 times, choose body temperature and change 40 of rabbit not being higher than 0.3 ℃, be divided into 5 groups by the basal body temperature stratified random.Measuring 3 anus temperature (per 30 minutes 1 time) before the administration, is basal body temperature with the body temperature meansigma methods.The administration group is pressed table 3 dosage gastric infusion, and the normal control group is given the isometric(al) normal saline with method, and positive controls is irritated stomach and given aspirin tablet 0.15g/kg.Each treated animal auricular vein is injected endotoxin 5EU/kg simultaneously.Attack the back in endotoxin and measured rabbit anus temperature in 1,2,3,4,5 hour, the results are shown in Table 3.
The result shows, each dosage group can obviously suppress the rising of rabbit body temperature due to the endotoxin, and the action time of wherein middle and high dosage group and intensity obviously are better than low dose group, with matched group significant difference (P＜0.05, P＜0.01) are arranged relatively.
The refrigeration function of fever in rabbits due to the table 3 pair endotoxin (n=8, x ± SD)
Compare * p＜0.05 * * P＜0.01 with matched group.
4. to Immune Effects
4.1 influence to the mouse immune organ weight:
Get 50 of body weight 20 ± 2g Kunming mouses, be divided into 5 groups at random, 10 every group, the administration group is pressed table 4 dosage gastric infusion, and the normal control group is given the isometric(al) normal saline.Administration every day 1 time, continuous 7 days.24h after the last administration, the execution animal is got thymus and spleen is weighed, and calculates thymus and index and spleen index.The results are shown in Table 4.
Result of the test shows that the middle and high dosage group of preparation of the present invention mouse spleen exponential sum high dose group mouse thymus index relatively has significant difference (P＜0.05, P＜0.01) apparently higher than matched group with matched group.
4.2 to mice reticuloendothelial system phagocytic index k and the influence of engulfing factor alpha
Get 50 of body weight 20 ± 2g mices, be divided into 5 groups at random, the administration group is pressed table 4 dosage gastric infusion, and the normal control group is given the isometric(al) normal saline.Administration every day 1 time, continuous 4 days.24h after the last administration in tail vein injection dilution india ink 0.1ml/10g body weight, injects and got blood 25 μ l in 0.1% sodium carbonate 2ml from the mouse orbit rear vein beard respectively in back 30 seconds and 6 minutes, and colorimetric is also calculated phagocytic index k and engulfed factor alpha.The results are shown in Table 4.
Result of the test shows, the phagocytic index k of preparation high dose group of the present invention and engulf factor alpha apparently higher than matched group relatively has significant difference (p＜0.05) with matched group.
4.3 influence to the mouse humoral immune function:
Get 40 of body weight 20 ± 2g mices, be divided into 4 groups at random, the administration group is pressed table 4 dosage gastric infusion, and the normal control group is given the isometric(al) normal saline.Administration every day 1 time, continuous 8 days.After the administration 2 days, lumbar injection sheep red blood cell (SRBC) suspension 0.2ml/ only, in immunity back 6 days, eye socket was got hematometry and is calculated the plain value (HC of HD50
50).The results are shown in Table 4.
Result of the test shows, the HC of the middle and high dosage group of preparation of the present invention
50Apparently higher than matched group, significant difference (p＜0.05) is relatively arranged with matched group.
Table 4 pair Immune Effects (n=10, x ± SD)
| Group dosage (the g crude drug/kg) | Thymus index | Index and spleen index | Phagocytic index k | Engulf factor alpha | HC 50 |
| Matched group- | 3.65±1.03 | 4.91±1.36 | 0.0308±0.0084 | 5.06±0.74 | 283.1±141.0 |
| Low dose group 4.0 | 4.54±1.02 | 5.42±1.36 | 0.0317±0.0130 | 5.26±1.21 | 306.4±138.7 |
| Middle dosage group 8.0 | 4.91±1.56 | 6.45±1.39* | 0.0321±0.0127 | 5.34±0.70 | 431.3±133.5* |
| High dose group 16.0 antiviral granules (granule) 8.0 | 5.24±1.31* 4.81±1.60 | 6.32±1.52* 5.35±1.48* | 0.0489±0.0178* 0.0424±0.0130 | 6.47±1.08* 5.84±0.81* | 421.8±137.6* 429.6±116.5* |
Compare * p＜0.05 with matched group.
5. antivirus action
5.1 to influenza virus FM
1Cause the influence of mice pneumonia
Get 60 of body weight 15.0+0.5gBalb/c mices, be divided into 6 groups at random, 10 every group by table 5; Except that the normal control group, all the other mices are slightly anaesthetized with ether, with 15 times of LD
50Influenza virus FM
1Collunarium, every 0.05ml.The administration group is pressed table 5 dosage, begins gastric infusion the previous day in infecting, and once a day, continuous 5 days, the normal control group was given the isometric(al) normal saline with method.Weighed in the 6th day (prohibiting water 8 hours), put to death animal, dissect and get the lung cleaning, remove tissues such as trachea, hilar lymph node, use the filter paper suck dry moisture, weigh, the perusal pulmonary lesion calculates lung exponential sum suppression ratio as follows one by one, the results are shown in Table 5.
Table 5 couple influenza virus FM1 causes the influence (n=10) of mice pneumonia
Compare ##P＜0.01, compare * p＜0.05, * * p＜0.01 with the normal control group with the virus control group.
Result of the test shows, (4g crude drug/kg) and high dose (8g/kg) group are to influenza virus FM for dosage in the administration group
1Pneumonopathy becomes due to the strain obvious inhibitory action, with the virus control group significant difference (P＜0.05, P＜0.01) is arranged relatively.
5.2 dead protective effect to the influenza virus infecting mouse
Get 240 of Balb/c mices, body weight 14-16g is divided into 12 groups at random by table 6,7, and 20 every group, except that the normal control group, all the other mices are slightly anaesthetized with ether, with 30 times of LD
50The influenza virus collunarium, every 0.05ml.The administration group is pressed table 6 dosage, begins gastric infusion the previous day in infecting, and once a day, continuous 5 days, the normal control group was given the isometric(al) normal saline with method.From infective virus, observed 14 days continuously, write down animal symptom and death toll day by day.Calculate dead protective rate (%) as follows, prolong vital rates (%), the results are shown in Table 6, table 7.
Dead protective rate (%)=(matched group mortality rate-test group mortality rate) * 100%
Table 6 couple mice influenza virus FM
1The dead protective effect of virus strain infection
Compare * p＜0.05 * * p＜0.01 with the virus control group.
The dead protective effect of anti-/ 252/2001 virus strain infection in table 7 pair clinical separation influenza virus B/ Guizhou Province
Compare * p＜0.05 * * p＜0.01 with the virus control group.
Result of the test shows that dosage in the administration group (4.0g/kg) and high dose (8.0g/kg) group are to influenza virus FM
1Infecting mouse has dead protective effect, compares with the virus control group, and middle dosage group has significant difference (P＜0.05), and high dose group has utmost point significant difference (P＜0.01); Each dosage group medicine all has dead protective effect to anti-/ 252/2001 infecting mouse in clinical strain influenza virus B/Guizhou Province, compares with the virus control group, and low dose group has significant difference (P＜0.05), and middle and high dosage group has utmost point significant difference (P＜0.01).
5.3 influence to proliferation of influenza virus in the mice body
Get 50 of body weight 14～16g Balb/c mices, be divided into 5 groups at random, 10 every group, under the slight anesthesia of ether, with 1000 times of LD
50Influenza virus FM
1Infecting mouse infected preceding 1 day, gave mouse stomach be subjected to the reagent thing and the virazole solution of variable concentrations respectively by table 8 dosage.Successive administration 3 days after infecting 48 hours, is dissected and got lung, and is fixing, makes section and dewaxing; Use influenza virus FM
137 ℃ of effects of rabbit immune serum 30 minutes, 0.01M PBS fine laundering 3 times, add 1: 10 37 ℃ of goat anti-rabbit igg fluorescent antibodys 15 minutes again, 0.01M PBS fine laundering 3 times, suck dry moisture, counting is respectively organized the mice bronchioles and is included specificity fluorescent antibody granule under the fluorescence microscope, and carries out statistical procedures.The results are shown in Table 8.
The influence of table 8 pair proliferation of influenza virus
Experimental result shows that dosage in the administration group (4.0g/kg) and high dose (8.0g/kg) group are to influenza virus FM
1In the intravital propagation of mice the obvious suppression effect is arranged, significant difference (P＜0.01) is relatively arranged with the virus control group.
5.4 inhibitory action to the virocyte pathological changes
Hep-2 and Hela cell are seeded in respectively on the 96 hole microtest plates, put in 37 ℃ of incubators, grow up to cell monolayer after, every then hole adds with 100 TCID that keep the liquid preparation
50Various viral 0.1ml, Hep-2 inoculation respiratory syncytial virus, parainfluenza virus, Hela inoculate adenovirus, adsorbs after 2 hours, the venom of preventing or cure a disease that inclines with keeping liquid cleaning 3 times, adds the medicinal liquid of variable concentrations respectively then, the medicinal liquid of every kind of concentration is inoculated 6 holes.Establish virus control, cell contrast, medicine contrast and virazole contrast simultaneously.Put CO
2Hatch for 37 ℃ in the incubator, every day is the observation of cell pathological changes under inverted microscope, and writes down each hole pathological changes situation.Obvious pathological changes occurs with the virus control porocyte, when the cell control well cell did not have obvious regression, judged result the results are shown in Table 9.
The inhibitory action of table 9 pair pathological changes caused by virus
Annotate: the cytopathy degree is pressed following standard recording:
The growth of-cell is normal, and no pathological changes occurs;
± cytopathy is less than 10% of cell monolayer;
+ cytopathy accounts for 25% of cell monolayer;
++ cytopathy accounts for 50% of cell monolayer;
+++cytopathy accounts for 75% of cell monolayer;
++ ++ cytopathy accounts for 100% of cell monolayer.
The result shows, is infecting 100 TCID
50Under the situation of virus, 5mg/ml concentration all has different inhibitory action to various pathological changes caused by virus.
6. antibacterial action
6.1 in-vitro antibacterial test Fructus Jujubae standing grain spouse ∈ head
Get 11 of small test tubes, 1～9 adds above-mentioned each concentration pharmaceutical liquid culture medium 1ml respectively, adds 10 again
-3The fresh bacterium liquid 0.1ml of dilution; Be equipped with reagent contrast (not adding bacterium liquid) and bacterial strain contrast (adding the fluid medium that does not contain medicine) with legal system.Put 37 ℃ of incubators and cultivated 24 hours, observe the bacterial growth situation, not show muddiness, the reagent concentration of integral asepsis growth is the minimum inhibitory concentration (MIC) of medicine to this bacterial strain; Select the cultivation parent tube of asepsis growth in the MIC test, getting a ring with inoculating loop is inoculated on the agar culture medium that does not contain reagent, putting 37 ℃ of incubators cultivated 18 hours, observe the bacterial growth situation, the reagent concentration of integral asepsis growth is the minimum bactericidal concentration (MBC) of medicine to this bacterial strain, the results are shown in Table 10,11.
Result of the test shows, staphylococcus aureus, escherichia coli, Diplococcus pneumoniae, group B streptococcus, meningococcus, hemophilus influenza and the strain of staphylococcus aureus clinical isolates, the strain of alpha streptococcus clinical isolates all there are in various degree inhibitory action and bactericidal action, wherein to a little less than the colibacillary effect.
Table 10 bacteriostatic test (MIC) result
Table 11 bacteriostatic test (MBC) result
6.2 vivo bacteria corrosion action-to the protective effect of bacterial infection induced mice death
Get 150 of body weight 17～19g Balb/c mices, male and female half and half are divided into 10 groups at random, and 15 every group, press the grouping of table 12 dosage, gastric infusion, matched group is given the isometric(al) normal saline.After the administration 3 days, in MLD0.5ml (the staphylococcus aureus 5x10 of the 4th day lumbar injection infecting mouse
7Bacterium/only, staphylococcus aureus clinical strain 7x10
7Bacterium/only), continued administration again 3 days.Observed and recorded infects the death toll of respectively organizing mice in one week of back, calculates mortality rate, presses the Biliss method and calculates median effective dose and 95% fiducial limit, the results are shown in Table 12.
The protective effect of table 12 pair infection of staphylococcus aureus induced mice death
Compare * p＜0.05 * * p＜0.01 with the virus control group.
Result of the test shows that each dosage group is to staphylococcus aureus type strain and the deadly protective effect that all has in various degree of clinical strain infecting mouse.
7. conclusion
Preparation of the present invention can suppress the pedal swelling due to leukocytic migration of rat abdominal cavity and the carrageenin; Fever in rabbits due to the endotoxin there is tangible refrigeration function; Can increase the weight of mouse immune organ, improve the phagocytic index of mice reticuloendothelial system and engulf coefficient, increase the generation of mice hemolytic antibody; To influenza virus FM
1Causing the mouse lung pathological changes has obvious inhibitory action, to influenza virus Mus FM
1And anti-/ 252/2001 infecting mouse death in influenza virus B/Guizhou Province has significant protective effect, can obviously suppress influenza virus FM in the mice body
1Propagation; Staphylococcus aureus (type strain and clinical strain), hemophilus influenza, escherichia coli, Diplococcus pneumoniae, alpha streptococcus (clinical strain), group B streptococcus, meningococcus etc. are had the antibacterial and bactericidal action of obvious in-vitro, the pathogenic infection dead mouse is had in various degree protective effect.The result shows that preparation of the present invention has the effect of antiinflammatory, antibiotic, antiviral, antiallergic, analgesic and raise immunity.
Compared with prior art, preparation dispelling wind to relieve the exterior syndrome of the present invention, heat-clearing and toxic substances removing, evident in efficacy, instant effect can reach the purpose for the treatment of both the principal and secondary aspects of a disease; Adopt advanced technology such as macroporous resin adsorption separation and purification active constituent-enriched, have prescription to simplify, technology advanced person, constant product quality is controlled, clinical characteristics such as safe in utilization, effective.For treatment upper respiratory tract infection provides a kind of effective, safe, inexpensive Chinese patent medicine, have important practical significance and extensive market prospects.
The specific embodiment:
Embodiments of the invention 1: Herba Inulae cappae 20g, Herba Andrographis 10g, Gypsum Fibrosum 15g
Take by weighing Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum, decoct with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into thick paste, adds appropriate amount of starch, and mixing is granulated, and drying is prepared into granule.Said preparation is oral, every day 3 times, a 5g.
Embodiments of the invention 2: Herba Inulae cappae 30g, Herba Andrographis 10g, Gypsum Fibrosum 20g
Take by weighing Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum, decoct with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into extractum, add ethanol and make that to contain alcohol amount be 60%, mixing was placed 24 hours, filter, filtrate recycling ethanol is condensed into thick paste, add appropriate amount of starch, mixing is granulated, drying is pressed into tablet.Said preparation is oral, every day 3 times, one time 3.
Embodiments of the invention 3: Herba Inulae cappae 50g, Herba Andrographis 20g, Gypsum Fibrosum 40g
Take by weighing three flavor medical materials, Herba Inulae cappae and Herba Andrographis are decocted with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into extractum, adds ethanol and makes that to contain the alcohol amount be 70%, and mixing was placed 24 hours, filtration, decompression filtrate recycling ethanol, D on the concentrated solution
101Macroporous adsorptive resins is used 40% ethanol elution, collects eluent, reclaims ethanol, concentrates, and vacuum drying or microwave vacuum drying are pulverized, and get extract; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge two kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying incapsulates and makes capsule.Said preparation is oral, every day 3 times, one time 3.
Embodiments of the invention 4: Herba Inulae cappae 45g, Herba Andrographis 15g, Gypsum Fibrosum 25g
Take by weighing three flavor medical materials, Herba Inulae cappae, Herba Andrographis add 10 times of water gagings respectively and decoct and extract 3 times, and each 1 hour, filter, merging filtrate, filtrate decompression is condensed into extractum, adds ethanol and makes that to contain the alcohol amount be 50%, and mixing was placed 24 hours, filtration, decompression filtrate recycling ethanol; Aqueous solution is gone up D respectively
101Macroporous adsorptive resins discards and penetrates liquid, uses 60% ethanol elution, collects eluent, reclaims ethanol, concentrates, and the reduced vacuum drying is pulverized, and gets Herba Inulae cappae, Herba Andrographis extract respectively; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge three kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into granule, or is pressed into tablet, or incapsulates and make capsule.
Embodiments of the invention 5: Herba Inulae cappae 35g, Herba Andrographis 10g, Gypsum Fibrosum 35g
Take by weighing three flavor medical materials, Herba Inulae cappae, Herba Andrographis add 10 times of water gagings respectively and decoct and extract 3 times, and each 1 hour, filter, merging filtrate, filtrate decompression is condensed into extractum, adds ethanol and makes that to contain the alcohol amount be 80%, and mixing was placed 24 hours, filtration, decompression filtrate recycling ethanol; Aqueous solution is gone up D respectively
101Macroporous adsorptive resins discards and penetrates liquid, uses 90% ethanol elution, collects eluent, reclaims ethanol, concentrates, and microwave vacuum drying is pulverized, and gets Herba Inulae cappae, Herba Andrographis extract respectively; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge three kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into granule, or is pressed into tablet, or incapsulates and make capsule.
Claims (8)
1. Chinese medicine preparation for the treatment of upper respiratory tract infection is characterized in that: calculate according to composition by weight, it is made for 2～4 parts by 3～5 parts of Herba Inulae cappae, 1～2 part of Herba Andrographis and Gypsum Fibrosum.
2. according to the Chinese medicine preparation of the described treatment upper respiratory tract infection of claim 1, it is characterized in that: calculate according to composition by weight, it is made for 3 parts by 4 parts of Herba Inulae cappae, 2 parts of Herba Andrographis and Gypsum Fibrosum.
3. according to the Chinese medicine preparation of claim 1 or 2 described treatment upper respiratory tract infection, it is characterized in that: described Chinese medicine preparation is granule, tablet or capsule.
4. treat the preparation method of the Chinese medicine preparation of upper respiratory tract infection as claimed in claim 1 or 2, it is characterized in that: take by weighing Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum in proportion, decoct with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into thick paste, adds appropriate amount of starch, mixing, granulate, drying is prepared into various preparation according to a conventional method.
5. treat the preparation method of the Chinese medicine preparation of upper respiratory tract infection as claimed in claim 1 or 2, it is characterized in that: take by weighing Herba Inulae cappae, Herba Andrographis and Gypsum Fibrosum in proportion, decoct with water 3 times, each 1 hour, filter merging filtrate, filtrate is condensed into extractum, adds ethanol and makes that to contain alcohol amount be 50～80%, mixing, placed 24 hours, and filtered filtrate recycling ethanol, be condensed into thick paste, add appropriate amount of starch, mixing, granulate, drying is prepared into various preparation according to a conventional method.
6. treat the preparation method of the Chinese medicine preparation of upper respiratory tract infection as claimed in claim 1 or 2, it is characterized in that: take by weighing three flavor medical materials in proportion, Herba Inulae cappae and Herba Andrographis are decocted with water 3 times, each 1 hour, filter, merging filtrate, filtrate is condensed into extractum, add ethanol and make that to contain alcohol amount be 50～80%, mixing was placed 24 hours, filtered, decompression filtrate recycling ethanol, D on the concentrated solution
101Macroporous adsorptive resins with 40～90% ethanol elutions, is collected eluent, reclaims ethanol, concentrates, and vacuum drying is pulverized, and gets extract; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge two kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into various preparation according to a conventional method.
7. treat the preparation method of the Chinese medicine preparation of upper respiratory tract infection as claimed in claim 1 or 2, it is characterized in that: take by weighing three flavor medical materials in proportion, Herba Inulae cappae, Herba Andrographis decoct with water extraction respectively, concentrate, and handle with ethanol precipitation, reclaim ethanol; Aqueous solution is gone up D respectively
101Macroporous adsorptive resins discards and penetrates liquid, with 40～90% ethanol elutions, collects eluent, reclaims ethanol, concentrates, and the reduced vacuum drying is pulverized, and gets Herba Inulae cappae, Herba Andrographis extract respectively; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge three kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into various preparation according to a conventional method.
8. according to the preparation method of the Chinese medicine preparation of the described treatment upper respiratory tract infection of claim 7, it is characterized in that: take by weighing three flavor medical materials in proportion, Herba Inulae cappae, Herba Andrographis add 10 times of water gagings respectively and decoct extraction 3 times, each 1 hour, filter, merging filtrate, filtrate decompression is condensed into extractum, adds ethanol and makes that to contain alcohol amount be 50～80%, mixing, placed 24 hours, and filtered decompression filtrate recycling ethanol; Aqueous solution is gone up D respectively
101Macroporous adsorptive resins discards and penetrates liquid, with 40～90% ethanol elutions, collects eluent, reclaims ethanol, concentrates, and the reduced vacuum drying is pulverized, and gets Herba Inulae cappae, Herba Andrographis extract respectively; Gypsum Fibrosum decocts with water, and concentrates, and drying gets extract; Merge three kinds of extracts, add appropriate amount of starch, mixing is granulated, and drying is prepared into granule, or is pressed into tablet, or incapsulates and make capsule.
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