CN1883560A - A compound Chinese medicinal preparation containing Chinese globeflower and method for preparing same - Google Patents
A compound Chinese medicinal preparation containing Chinese globeflower and method for preparing same Download PDFInfo
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Abstract
The invention relates to a Chinese compound preparation for anti-inflammation, heat clearing and detoxicating, and process for preparation, wherein the medicament is prepared from the following Chinese herbal materials (by weight ratio): Chinese globeflower 8-12, baikal skullcap root 2-4, radix isatidis 2-4, honeysuckle flower 1 and capsule of weeping forsythia 1.
Description
Technical field
But the present invention relates to a kind of anti-inflammation, heat-clearing and toxic substances removing, the acute inflammation of the throat, acute tonsillitis, the disease that are used for the treatment of due to the affection due to external wind and heat are seen the pharmaceutical preparation that red swelling of the pharynx, pharyngalgia, pharyngitis, tonsillitis and swelling and aching of gum, acute otitis media, acute conjunctivitis, parotitis etc. catch, especially about a kind of compound Chinese medicinal preparation that contains Flos Trollii and preparation method thereof.
Background technology
What affection due to external wind and heat caused has sore throat, acute pharyngitis, tonsillitis are human modal multiple diseases, not only the influence work is produced, the harm people are healthy, and the human expense that is used for the treatment of flu also is quite high, according to statistics, be used for the treatment of the expense of flu nearly more than 1,000,000,000 dollars in the U.S..In China, the sickness rate of flu and the expense that is used for the treatment of flu also are quite high.Therefore, the generation of control flu alleviates the harm of flu to human body health, is the research topic that medical circle is attached great importance to.
Affection due to external wind and heat can cause acute upper respiratory tract infection.Acute upper respiratory tract infection refers to the acutely inflamed general name of nasal cavity, pharynx or throat, and main pathology is changed into nose, pharyngeal mucous membrane hyperemia, and a small amount of monocyte infiltration has serosity and mucus to ooze out, and behind the secondary bacterial infection, purulent secretion can be arranged.The commonly encountered diseases substance is a virus, and the about 70%-80% of acute upper respiratory tract infection is caused that by virus minority is an antibacterial, and what have begins to be viral infection, secondary bacterial infection.As risk factors such as suffering from cold, drench with rain, be overtired, when the local resistance of whole body or respiratory tract is reduced, former virus or the antibacterial that has been present in respiratory tract or has invaded from the external world can breed rapidly, cause primary disease, especially old germling is weak or more susceptible of chronic respiratory tract disease (as sinusitis, tonsillitis etc.) arranged.The general state of an illness is light, the course of disease short, good prognosis.But the sickness rate height, and have certain infectiousness, not only influence daily life, and also can produce severe complication sometimes, so should actively prevent and treat.All can fall ill the whole year, but with the winter-spring season pilosity.
The different infection sites of upper respiratory tract infection, its nosetiology have with having different, advocate the acute respiratory infection antibiotic and rationally use, and must make clear and definite level diagnosis to acute upward sense.Such as being virus more than the common cold cause of disease 70%-80%, clinical treatment should not be used antibiotic based on anti symptom treatment.The nasal discharge thickness is opaque, variable color, or the heat that occurs together, leukocyte increases, and considers bacterial infection, can add and use antibiotic.
Because acute upper respiratory tract infection is common disease; child particularly; also be to use the disease that the antibiotic frequency is the highest, quantity is maximum for a long time simultaneously; and the phenomenon of abuse of antibiotics is serious, so that antimicrobial resistance has brought existing and potential crisis for treatment acute upper respiratory tract infection disease in recent years.Upper respiratory tract infection is many to be caused by virus, antibacterial or both mixed infection, infection increases local telangiectasis, permeability, trachea and bottleneck throat swelling, secretions increase, bacteriogenic endotoxin also causes fervescence, and therefore the antigen microorganism is one of treatment key in Treatment of Upper Respiratory Tract Infection.Western medical treatment is based on the control infection symptomatic treatment, usually with antibiotics, interferon or antiviral agents treatment.But antibiotics commonly used can not affirm the effect of virus, to antibacterial again regular meeting cause Drug resistance, add antibiotics class medicine toxic and side effects more commonly used or can cause allergy etc., the ideal medicament of the above-mentioned disease of real non-treatment; The interferon price is higher, is difficult for popularizing using; Antiviral Western medicine kind is less, only have virazole etc. a few, effect is also not remarkable.Moreover, often being difficult in time judging that for first morbidity people disease mainly is by virus or bacterial actually clinically, this has just more increased the blindness of using above-mentioned several drugs.Therefore, research and development determined curative effect, safe and reliable new drug seem very urgent, important.
According to theory of Chinese medical science, acute upper respiratory tract infection is mainly due to the diseases caused by exogenous pathogenic factor ailment said due to cold or exposure, and the total Therapeutic Principle of the traditional Chinese medical science is dispelling wind to relieve the exterior syndrome or relieving the exterior syndrome with drugs of pungent in flavor and warm in nature, relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, eliminating summer-heat from the exterior, holds the then respectful lung of expectorant under the arm and reduces phlegm, and holds the then dyspepsia and intestinal stasis relieving that stagnates under the arm, holds frightened then heat clearing away arresting convulsion under the arm.Motherland's medical science utilization traditional Chinese medical herbal treatment viral disease has long history and rich experience, the Chinese patent medicine and the compound preparation of treatment upper respiratory tract infection: antelope sticks up detoxifying pills, YINQIAO JIEDU PIAN, complex {yin huang} liquid, QINGKAILING, SHUANGHUANLIAN, Radix Isatidis granules, Folium Isatidis oral liquid, material for anti parotitis pin etc. have antivirus action preferably through clinical and laboratory observation.
Summary of the invention
Purpose of the present invention provides a kind of compound Chinese medicinal preparation that contains Flos Trollii at above-mentioned weak point, and the acute inflammation of the throat, acute tonsillitis, the disease that are used for the treatment of due to the affection due to external wind and heat are seen the pharmaceutical preparation (tablet, capsule, oral liquid, granule) that red swelling of the pharynx, pharyngalgia, pharyngitis, tonsillitis and swelling and aching of gum, acute otitis media, acute conjunctivitis, parotitis etc. catch.The present invention is with the tangible Chinese medicine of antibacterial effect " Flos Trollii ", with other anti virus herb (Fructus Forsythiae, Radix Scutellariae, Flos Lonicerae, Radix Isatidis) prescription, make Chinese traditional compound medicine energy antibiotic, the antiviral of while that makes, overcome the simple antibiotic or simple antiviral limitation of medicine in the past, clinical therapeutic efficacy is good.
Another object of the present invention is to provide a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii.
A kind of compound Chinese medicinal preparation that contains Flos Trollii and preparation method thereof is to take following scheme to realize:
A kind of compound Chinese medicinal preparation that contains Flos Trollii is characterized in that it is the compound preparation of being made by following Chinese crude drug raw material by weight ratio: Flos Trollii 8～12, Radix Scutellariae 2～4, Radix Isatidis 2～4, Flos Lonicerae 1, Fructus Forsythiae 1.
Described a kind of compound Chinese medicinal preparation that contains Flos Trollii is tablet, capsule, oral liquid, granule.
A kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii: the title Chinese crude drug raw material of pressing following weight ratio: Flos Trollii 8～12, Radix Scutellariae 2～4, Radix Isatidis 2～4, Flos Lonicerae 1, Fructus Forsythiae 1;
After above-mentioned Chinese crude drug selected, cleans, after mixed extraction is handled dry extract or clear paste, add oral drugs and allow the adjuvant that uses or the fine powder of above-mentioned raw material of Chinese medicine, make oral formulations.
The adjuvant that described oral drugs permission is used is selected a kind of or mixture in magnesium stearate, Pulvis Talci, microcrystalline cellulose, starch, cane sugar powder, dextrin, cyclamate, water, saccharin sodium, the flavoring orange essence for use.Wherein Chinese crude drug raw material and adjuvant weight proportion are 1: 0～5.
The fine powder of described raw material of Chinese medicine is selected a kind of or mixture in Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, the Fructus Forsythiae raw material fine powder for use.The raw material fine powder is crossed 80～120 mesh sieves.Wherein the fine powder weight proportion of Chinese crude drug raw material and raw material of Chinese medicine is 1: 0～0.5.
When described a kind of compound Chinese medicinal preparation that contains Flos Trollii prepared, Chinese crude drug mixed extraction method was: above-mentioned Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae mixed extraction are handled and can be adopted decocting in water extraction, alcohol reflux, ethanol percolate extraction; Wherein decocting in water extracts the back extract, and directly concentration or handle the back through precipitate with ethanol and concentrate gets dry extract or clear paste; Alcohol reflux, ethanol percolate extraction, can directly concentrate dry extract or clear paste.
Described a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii is characterized in that taking following steps:
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after handling, mixed extraction gets dry extract or clear paste, add oral drugs and allow the adjuvant of use or the fine powder of above-mentioned raw material of Chinese medicine, make granule, drying, compacting is in blocks, and coating promptly gets tablet.
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after handling, mixed extraction gets dry extract or clear paste, add oral drugs and allow the adjuvant of use or the fine powder of above-mentioned raw material of Chinese medicine, make granule, drying incapsulates, and promptly gets capsule.
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after mixed extraction is handled, get dry extract or clear paste, add the adjuvant that the permission of sucrose or dextrin or granule is used, make granule, drying promptly gets granule.
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after handling, mixed extraction gets dry extract or clear paste, add the adjuvant that the permission of sucrose or steviosin or oral liquid is used, added water boil 15 minutes, treat to regulate when temperature is reduced to below 80 ℃ pH value to 6.0～7.5, filter, fill, sterilization promptly gets oral liquid.
The above-mentioned compound Chinese medicinal preparation that contains Flos Trollii, acute inflammation of the throat, acute tonsillitis due to the treatment affection due to external wind and heat, disease see the application in red swelling of the pharynx, pharyngalgia, pharyngitis, tonsillitis upper respiratory tract infection and treatment swelling and aching of gum, acute otitis media, acute conjunctivitis, the parotitis disease medicament.
Raw material of the present invention is formed and can be amplified according to the production scale equal proportion.
The present invention is five kinds of Chinese medicine altogether, and its nature,taste and action is as follows:
Flos Trollii is used for wind-heat evil toxin and attacks lung, the upper respiratory tract infection that dominance of heat in the interior causes, pharyngitis, tonsillitis, Flos Trollii beginning see supplementary Amplifications of the Compendium of Materia Medica " bitter in the mouth, cold in nature, nontoxic " " control that aphtha, larynx are swollen, superficial heat gingival atrophy, otalgia, ophthalmalgia; Make eye bright, separate the haze miasma ", its light weight liter looses, bitter in the mouth is let out clearly, heat clearing away cold in nature, and treatment wind-heat cold or the appropriate pathogenesis of upper respiratory tract infection (tonsillitis, pharyngitis) so it is quite outstanding to produce effects, are our principal agent.Flos Lonicerae is sweet cold, heat-clearing and toxic substances removing, and the power of the carbuncle detumescence of loosing is quite strong, and for controlling the key medicine of all carbuncle furuncle YANG syndrome, the Fructus Forsythiae bitter cold is mainly gone into heart channel, can clearing away heart-fire, separate sore, the QI and blood of loosing is again condensed, and has the merit of eliminating carbuncle eliminating stagnation concurrently, is accessory drugs altogether.Radix Scutellariae eliminating fire and detoxication dampness, the Radix Isatidis heat-clearing and toxic substances removing, the removing heat from blood sore-throat relieving is adjuvant drug altogether.All medicines share, and play heat-clearing and toxic substances removing altogether, the merit of the diffusing carbuncle of detumescence.
Modern medicine study thinks that Flos Trollii contains materials such as alkaloid, flavonoid, and antimicrobial spectrum is wider.The in vitro tests of Chinese medicine Flos Trollii shows that it belongs to broad-spectrum antibacterial medicine.The antibacterial of Flos Trollii be studies show that, Flos Trollii external to G
+Coccus and G
-Bacillus all has antibacterial action preferably.The aqueous extract of Flos Trollii (every 100ml is equivalent to the 25g medical material) has the stronger bacteriostasis heart to staphylococcus aureus, bacillus pyocyaneus, Staphylococcus albus, Fu Shi bacillus, escherichia coli, Bacillus typhi, Salmonella paratyphi, Bacillus proteus, dysentery bacterium.Someone has tested the sensitivity of 21 kinds of first type haemolysis type streptococcus to Flos Trollii, the result shows that Flos Trollii all has inhibitory action to these 21 kinds of bacterial strains, and especially the inhibitory action to bacterial strains such as dysentery Fu Shi 6 types, bacillus pyocyaneus, first type haemolysis type streptococcus, beta hemolysis type streptococcus, staphylococcus aureus and paratyphoid Bs is obvious.The relatively discovery of the external bacteriostasis of Chinese medicine Flos Trollii extract in to different lyases such as Lin Chen, water and 60% ethanol extraction to the bacteriostasis of gram positive bacteria obviously greater than gram negative bacteria, bigger to staphylococcic inhibitory action especially.And from the fungistatic effect and the effective ingredient content of total flavone of longpetal globeflower flower, the water extract is better than alcohol extract.Research shows that also the Flos Trollii water extract also has certain inhibitory action to virus.
Flos Lonicerae can delay the pathological changes effect of Respirovirus pair cell, is the representative medicine of heat-clearing and toxic substances removing, and pyretic toxicity essence is except that containing multiple pathogenic microorganism, and microbial toxin also accounts for critical positions.Flos Lonicerae preparation lumbar injection can reduce obviously that the leukocyte count of rabbit descends due to the endotoxin of bacillus pyocyaneus, and deviation to the left phenomenon etc. has obvious antagonism.Flos Lonicerae compatibility Radix Scutellariae is prepared into poisoning symptom and the death that preparation can obviously alleviate rabbit due to the bacillus pyocyaneus endotoxin.The YINQIAO mixture is to having deactivation in external PR8 influenzae strain virus.Virus to the present popular SARS in the whole world also has certain preventive and therapeutic effect.
Flos Lonicerae has certain antivirus action, can suppress influenza virus capital 68-1, ECHOII on human embryo kidney (HEK) simple epithelium cell culture of former generation, and remote born of the same parents' pathological changes effect that causes of herpes simplex virus; In the Embryo Gallus domesticus experiment, no matter before infective virus 6h through the yolk sac administration make the simulation prophylactic tria or in viral infection after the simulation therapeutic test is done in the allantois administration, Flos Lonicerae all has obvious inhibitory action to the increment of influenza virus capital 68-1, but it is invalid: as to infect for the influenza virus induced mice to parainfluenza virus, the mice of honeysuckle aqueous extract protection 68 avoids death, and can be dose-effect relationship ground and obviously suppress tiring of viral hemagglutinin in the Mus lung; It is few that immunofluorescence shows when Flos Lonicerae extract can also make behind the viral infection 48h propagation peak that Mus lung bronchioles internal specific fluorescent grain is evident as, and The above results shows that honeysuckle aqueous extract all shows certain antiviral activity in vivo and vitro.
The effective ingredient of Flos Lonicerae is the chlorogenic acid chemical compound, chlorogenic acid has broad-spectrum antiviral, antibacterium effect, but chlorogenic acid is internal energy by the albumen deactivation in body, and the chlorogenic acid antibacterial action is very not strong, and reaching chlorogenic acid in body, to suppress the dosage of Flos Lonicerae that bacterial concentration requires excessive.Once had many reports to show, Flos Lonicerae to multiple pathogenic bacteria, has inhibitory action in various degree external, but the antibacterial least concentration of Flos Lonicerae is big, inaccessible in vivo this concentration.
Flos Lonicerae also has antiinflammatory and refrigeration function: Flos Lonicerae extractive solution can suppress the rat carrageenan swelling of the feet, simultaneously rat Fructus Crotonis oiliness granulation capsule is also had obvious exudation and anti-proliferative effect.The Flos Lonicerae effect of strengthening the defense: gold silver flower pesticide decocting liquid can promote leukocytic phagocytic function.
Fructus Forsythiae has antibiosis and antiviral functions: Fructus Forsythiae extract has the effect of anti-Coxsackie B virus and Echovirus.Coxsackie B myiasis poison is to cause one of myocarditic cause of disease.Relatively the activity of Fructus Forsythiae, Radix Ophiopogonis, Flos Lonicerae, 4 kinds of anti-change of coxsackie b virus of Chinese medicine decoction of Radix Sophorae Tonkinensis is best with the Fructus Forsythiae; Add after the Fructus Forsythiae dosing formerly behind virus group, infective virus dosing simultaneously group, the infective virus in the dosing group, certain antivirus action is all arranged.Embryo Gallus domesticus in vitro tests proof Fructus Forsythiae also has inhibitory action to Asia influenza A virus, rhinovirus .I7 type etc.Fructus Forsythiae also has certain antibacterial action.
Fructus Forsythiae also has antiinflammatory action: rat Fructus Crotonis oiliness granulation capsule experiment showed, that Fructus Forsythiae has tangible exudation effect and reduces the effect of scorching kitchen range wall of micrangium fragility, and to the facilitation that is formed with of inflammatory barrier.3, refrigeration function: Fructus Forsythiae decoct per kilogram 4 gram is irritated stomaches, can make that fever in rabbits significantly descends due to the intravenous injection hay infusion, recovers normal after 1 hour, also can reduce to below the normal body temperature subsequently.
The Main Ingredients and Appearance baicalin of Radix Scutellariae has inhibitory action to multiple virus, and what wherein Recent study was the most popular is the effect of the resisting HIV HIV of baicalin.In vitro culture finds that baicalin can suppress the cell fusion by the tropical mononuclear cell strain R5 of the tropical T cell strain X4 of involucrum egg mediation and infected by HIV-1 virus, and can stop duplicating of DNA at the commitment of HIV-1 viral infection.Baicalin under finite concentration to the T cell strain CEM no cytotoxicity of In vitro culture, then show significant cytotoxicity at the cem cell of carrying HIV, cause that cell DNA ruptures, the CEM.HIV cytological effect that high power capacity is discharged HIV virus is especially obvious, infers that the anti-HIV effect of baicalin may be relevant with the apoptosis of inducing the CEM.HIV cell.Radix Scutellariae also has wider antimicrobial spectrum, and certain antibacterial action is arranged.
Radix Scutellariae has antiallergic action and antiinflammatory action: contained baicalin of Radix Scutellariae and baicalin can obviously suppress sensitized guinea pig rat small intestine in vitro and isolated tracheal to anaphylaxis contractile response that antigen produced, to passive general allergy and the Cavia porcellus passivity skin allergic reaction of Cavia porcellus and mice, baicalin and baicalin also have inhibitory action.Radix Scutellariae has refrigeration function, most evidences, and the active ingredient baicaligenin of Radix Scutellariae has refrigeration function.Radix Scutellariae has Detoxication, and baicalin has tangible Detoxication, and this may be because under the effect of glucuronidase, and baicalin decomposites glucuronic acid, and with due to multiple poisonous substance combines.10 milligrams of LD that can improve strychnine of baicalin
50Reach 2.5 times, and the hepatic glycogen content of carbon tetrachloride poisoning mice is increased.
Radix Isatidis has antibiosis and antiviral functions: Radix Isatidis and activity extract thereof all have inhibitory action to hepatitis B virus, influenza virus, mumps virus, herpes simplex virus, hemorrahgic fever with renal syndrome virus, cytomegalovirus, Coxsackie virus etc.Liu Sheng etc. adopt chick embryo method to do the antiviral experiment with Radix Isatidis water extract-alcohol precipitation liquid, measure direct effect, therapeutical effect and the preventive effect of Radix Isatidis to influenza A virus, and effective percentage is respectively 100%, 60%, and 70%.Zhang Chenhao etc. adopt the histiocyte culture method, are the inhibitory action of evaluation index reflection Radix Isatidis to Coxsackie B virus to suppress the virus replication index, and the result shows that Radix Isatidis has tangible antiviral effect at cellular level.Radix Isatidis all has antibacterial action to multiple Gram-positive and negative bacteria, in addition leptospira is had killing action.
Radix Isatidis has anti-endotoxin effect: in the morbidity and evolution of acute infectious diseases, endotoxin has general influence, and test shows that Radix Isatidis has extremely significant protective effect to endotoxemia mouse macrophage membrane fluidity.Radix Isatidis also has analgesic and antiinflammatory action.
The present invention is according to the pathogeny of upper respiratory tract infection, the characteristics that comprise virus, antibacterial at its infection, in conjunction with motherland's theory of medicine and modern pharmacology and The Chemical Constituents achievement, with the tangible Chinese medicine of antibacterial effect " Flos Trollii ", with other anti virus herb (Fructus Forsythiae, Radix Scutellariae, Flos Lonicerae, Radix Isatidis) prescription, make Chinese traditional compound medicine energy antibiotic, the antiviral of while that makes, overcome the simple antibiotic or simple antiviral limitation of medicine in the past.The present invention comes from Chinese medical theory, use habit and don't sticks to pharmacopeia, is target with the indication, and the treatment disease is clear and definite, belongs to the anxious medicine scope of reusing of the traditional Chinese medical science, and virus is held concurrently with antibacterial and controlled it.And prescription Chinese medicine is conventional Chinese medicine, is easy to hold quality.Development target is for treating by virus or bacterial acute respiratory disease, and dosage form is peroral dosage forms such as tablet, capsule, oral liquid, granule, is convenient to patient's use.Owing to the Chinese medicine that the present invention is used is cheap, the source can be fully guaranteed again, and therefore suitable industrialization and market prospect are arranged.
The present invention compares with the medicine of existing upper respiratory tract infection:
1, reasonable recipe: according to motherland's theory of Chinese medical science, in conjunction with modern pharmacology and The Chemical Constituents achievement, the present invention all has therapeutical effect to the antigen microbial virus and the antibacterial of upper respiratory tract infection
2, evident in efficacy: through clinical trial, medicine of the present invention is obvious to therapeutic effect.
3, taking convenience: medicine of the present invention is cheap, and taking convenience is easy to carry, and has no side effect.
The specific embodiment
By the following examples, in conjunction with results of pharmacodynamic test, further specify the present invention, following embodiment only is used to the present invention is described and to the present invention without limits.
Embodiment 1
Depletion Flos Nelumbinis 300g, Radix Scutellariae 116g, Radix Isatidis 116g cut into chunks, and add the decoction secondary (amount of water is respectively 5L) of entry, and each 1 hour, collecting decoction filtered, and filtrate is condensed into clear paste; Depletion Flos Nelumbinis 164g, Flos Lonicerae 58g, Fructus Forsythiae 58g are ground into fine powder, cross 100 mesh sieves, add the said extracted clear paste, stir well, and 65 ℃ of drying under reduced pressure are made granule, dry 428g, compacting in flakes, sugar coating, about 1400 of tablet.
Embodiment 2
Depletion Flos Nelumbinis 400g, Radix Scutellariae 150g, Radix Isatidis 150g, Flos Lonicerae 50g, Fructus Forsythiae 50g cut into chunks, 80% alcohol heating reflux twice of adding 6L, and each 1 hour, to filter, filtrate decompression concentrates, and reclaims ethanol and gets clear paste; Depletion Flos Nelumbinis 100g is ground into fine powder, crosses 80 mesh sieves, adds above-mentioned concentrated clear paste, stirs well, and 60 ℃ of drying under reduced pressure are made granule, and dry 253g adds Pulvis Talci 1g, compacting in flakes, sugar coating, about 1000 of tablet.
Embodiment 3
Depletion Flos Nelumbinis 400g, Radix Scutellariae 200g, Radix Isatidis 200g, Flos Lonicerae 50g, Fructus Forsythiae 50g are ground into coarse powder, after 24 hours, collect percolate 9L with 90% soak with ethanol, and the percolate concentrating under reduced pressure reclaims ethanol and gets clear paste; Depletion Flos Nelumbinis 200g is ground into fine powder, crosses 120 mesh sieves, adds above-mentioned percolation clear paste, stirs well, and 60 ℃ of drying under reduced pressure are made granule, and the dry 307g that gets adds magnesium stearate 1g, and compacting is in blocks, and the bag film-coat gets about 1200 of tablet.
Embodiment 4
Depletion Flos Nelumbinis 500g, Radix Scutellariae 150g, Radix Isatidis 150g, Flos Lonicerae 50g, Fructus Forsythiae 50g cut into chunks, and add the decoction secondary (amount of water is respectively 10L) of entry, each 2 hours, collecting decoction filters, after filtrate concentrates, slowly add 95% ethanol, make to contain the alcohol amount, leave standstill cold preservation and spend the night, filter to 75%, filtrate decompression concentrates, and reclaims ethanol and gets clear paste; Get microcrystalline cellulose 50g, add in the said extracted clear paste, stir well, 65 ℃ of drying under reduced pressure are made granule, and the dry 210g that gets incapsulates, and gets about 1000 of capsule.
Embodiment 5
Depletion Flos Nelumbinis 364g, Radix Scutellariae 116g, Radix Isatidis 116g cut into chunks, 85% alcohol heating reflux twice of adding 7L, and each 1.5 hours, to filter, filtrate decompression concentrates, and reclaims ethanol and gets clear paste; Depletion Flos Nelumbinis 100g, Flos Lonicerae 58g, Fructus Forsythiae 58g are ground into fine powder, cross 100 mesh sieves, add in the above-mentioned concentrated clear paste, stir well, and 60 ℃ of drying under reduced pressure are made granule, and the dry 307g that gets adds magnesium stearate 1g, incapsulates, and gets about 1200 of capsule.
Embodiment 6
Depletion Flos Nelumbinis 700g, Radix Scutellariae 230g, Radix Isatidis 230g, Flos Lonicerae 58g, Fructus Forsythiae 58g are ground into coarse powder, after 36 hours, collect percolate 10L with 85% soak with ethanol, and the percolate concentrating under reduced pressure reclaims ethanol and gets clear paste; Get starch 200g, add above-mentioned percolation clear paste, stir well, 60 ℃ of drying under reduced pressure are made granule, and the dry 359g that gets adds Pulvis Talci 1g, incapsulates, and gets about 1400 of capsule.
Embodiment 7
Depletion Flos Nelumbinis 600g, Radix Scutellariae 200g, Radix Isatidis 200g, Flos Lonicerae 50g, Fructus Forsythiae 50g cut into chunks, and the decocting that adds 11L respectively boils secondary, and 2 hours for the first time, 1 hour for the second time, merge decoction liquor, filter; After filtrate concentrates, slowly add 95% ethanol and make and contain the alcohol amount to 60%, leave standstill cold preservation and spend the night, filter, filtrate decompression concentrates, reclaim ethanol and concentrated solution; Slowly add 95% ethanol again, make to contain the alcohol amount to 80%, leave standstill cold preservation and spend the night, filter, filtrate decompression concentrates, reclaim ethanol and clear paste, 70 ℃ of oven dry are dry, porphyrize, adding cane sugar powder 710g makes granule, drying, packing promptly gets 175 bags of granules.
Embodiment 8
Depletion Flos Nelumbinis 464g, Radix Scutellariae 116g, Radix Isatidis 116g, Flos Lonicerae 58g, Fructus Forsythiae 58g cut into chunks, twice of 80% alcohol heating reflux of adding 8L, each 2 hours, to filter, filtrate decompression concentrates, reclaim ethanol and get clear paste, 60 ℃ of drying under reduced pressure, porphyrize adds cane sugar powder 640g, dextrin 200g, make granule, drying, packing promptly gets 193 bags of granules.
Embodiment 9
Depletion Flos Nelumbinis 500g, Radix Scutellariae 150g, Radix Isatidis 150g, Flos Lonicerae 50g, Fructus Forsythiae 50g are ground into coarse powder, with 80% soak with ethanol after 24 hours, collect percolate 7L, the percolate concentrating under reduced pressure reclaims ethanol and gets clear paste, 60 ℃ of drying under reduced pressure, porphyrize, add cane sugar powder 674g, make granule, drying, packing promptly gets 160 bags of granules.
Embodiment 10
Depletion Flos Nelumbinis 464g, Radix Scutellariae 116g, Radix Isatidis 116g, Flos Lonicerae 58g, Fructus Forsythiae 58g are ground into coarse powder, with 90% soak with ethanol after 24 hours, collect percolate 6.5L, the percolate concentrating under reduced pressure reclaims ethanol and gets clear paste, add cane sugar powder 400g, add water to 2000g, boiled 15 minutes, treat to regulate when temperature is reduced to below 80 ℃ pH value to 6.0, filter, fill is to the 10ml bottle, and sterilization promptly gets 195 of oral liquids.
Embodiment 11
Depletion Flos Nelumbinis 500g, Radix Scutellariae 150g, Radix Isatidis 150g, Flos Lonicerae 50g, Fructus Forsythiae 50g cut into chunks, and the decocting that adds 9L respectively boils secondary, and 1.5 hours for the first time, 1 hour for the second time, merge decoction liquor, filter; After filtrate concentrates, slowly add 95% ethanol and make and contain the alcohol amount to 65%, leave standstill cold preservation and spend the night, filter, filtrate decompression concentrates, reclaim ethanol and concentrated solution; Slowly add 95% ethanol again and make and contain the alcohol amount, leave standstill cold preservation and spend the night, filter to 85%, filtrate decompression concentrates, reclaim ethanol and get clear paste, add cyclamate 2g, add water to 1700g, boiled 15 minutes, treat to regulate pH value to 7.0 when temperature is reduced to below 80 ℃, filter, fill is to the 10ml bottle, sterilization promptly gets 160 of oral liquids.
Embodiment 12
Depletion Flos Nelumbinis 600g, Radix Scutellariae 200g, Radix Isatidis 200g, Flos Lonicerae 50g, Fructus Forsythiae 50g are ground into coarse powder, twice of 85% alcohol heating reflux of adding 10L, each 1.5 hours, to filter, filtrate decompression concentrates, reclaim ethanol and get clear paste, add cane sugar powder 150g, saccharin sodium 2g, flavoring orange essence 2ml, add water to 1800g, boiled 15 minutes, treat to regulate pH value to 7.5 when temperature is reduced to below 80 ℃, filter, fill is to the 10ml bottle, sterilization promptly gets 170 of oral liquids.
The capsule of gained, tablet among the embodiment 1～6 are grown up each 2～3, every day three times; The granule of gained among the embodiment 7～9, each 5g/ bag of being grown up, every day three times; The oral liquid of gained among the embodiment 10～12, each 10ml/ bottle of being grown up, every day three times.
Use medicine of the present invention (test group), the FUFANG YUXINGCAO PIAN (matched group) of producing with Taiji Group Sichuan Mianyang Pharmaceutical Co., Ltd. contrasts, (patient all has headache, tussiculas treatment upper respiratory tract infection, pharyngalgia, the hyperemia of pharynx mucosa, general malaise, part is coughed up phlegm), the results are shown in Table one, table two, both have significant difference.
Table one is treated relatively with the effect of contrast medicine
| Group | Cure | Produce effects | Effectively | Invalid | Obvious effective rate |
| Test group | 75 | 167 | 73 | 21 | 72％ |
| Matched group | 22 | 86 | 137 | 75 | 34％ |
Table two is disease type and the comparison that contrasts medicine effectively
| Group | Pharyngalgia | The hyperemia of pharynx mucosa | Cough | Cough up phlegm | ||||
| The example number | Ratio | The example number | Ratio | The example number | Ratio | The example number | Ratio | |
| Test group | 203 | 60％ | 188 | 56％ | 154 | 46％ | 129 | 38％ |
| Matched group | 135 | 42％ | 119 | 37％ | 85 | 27％ | 69 | 22％ |
Development purpose of the present invention: according to the pathogeny of upper respiratory tract infection, the characteristics that comprise virus, antibacterial at its infection, in conjunction with motherland's theory of medicine and modern pharmacology and The Chemical Constituents achievement, with the tangible Chinese medicine of antibacterial effect " Flos Trollii ", with other antiviral curative effect is main Chinese medicine (Fructus Forsythiae, Radix Scutellariae, Flos Lonicerae, Radix Isatidis) prescription, make Chinese traditional compound medicine energy antibiotic, the antiviral of while that makes, overcome the simple antibiotic or simple antiviral limitation of medicine in the past.The test of pesticide effectiveness shows that the present invention has antibiotic and antivirus action.Test as follows:
Antibiotic, the antiviral pharmacodynamics test research of compound recipe Flos Trollii Chinese medicine
One, experiment material
1, animal subject
Kunming mouse, 18-22g, male and female half and half; Instar chicken embryo on the 9th.
2, antibacterial and virus
Bacterial isolates is clinical separation strain, totally 97 strains; Influenza virus Mus lung adapted strain FM1 strain.
3, plate: MH culture medium; Streptococcus pneumoniae is adopted blood meida, promptly adds 5% defiber Sanguis caprae seu ovis and make in the MH culture medium; Hemophilus influenza is adopted chocolate culture-medium.
Two, inside and outside antibacterial tests
1, the mensuration of external minimum inhibitory concentration (MIC)
(1) experimental technique:
Be subjected to reagent (herbal mixture that contains Flos Trollii) to extract extractum and be diluted to following Concentraton gradient with sterile saline, i.e. 1600,800,400,200,100,50,25,12.5,6.25,3.13 (mg/ml), draw 1.5 ml respectively to aseptic plate, add the sterilization MH culture medium in 55 ℃ of water-baths of 13.5 ml constant temperature again, the mixing postcooling is standby.The ultimate density of the dull and stereotyped Chinese medicine of each medicine is 160,80,40,20,10,5,2.5,1.25,0.625,0.313 (mg/ml).Establish blank simultaneously.
The test organisms of cultivating 8-12h is diluted to desired concn with sterile saline (is generally 10
7CFU/ml), adopt multiple spot inoculation instrument to be connected to the medicine flat board of variable concentrations, inoculum concentration is about 10
4～10
5CFU.Test organisms is in 24 hours observed results of 37 ℃ of constant temperature culture, and record MIC value.
(2) experimental result
The in-vitro antibacterial result of the test shows (following table), medicine is all inhibited to the Grain-positive and the Grain-negative clinical bacteria of upper respiratory tract infection, wherein to the MIC of staphylococcus aureus, staphylococcus epidermidis, streptococcus pneumoniae, bloodthirsty hemophilus influenza, Klebsiella Pneumoniae, escherichia coli and bacillus pyocyaneus
50Be respectively 10,20,20,2.5,40,20 and 10mg/ml, MIC
90Be respectively 80,40,80,20,160,40 and 160mg/ml.
Vitro antibacterial activity
| Strain | The strain number | MIC(mg/ml) | ||
| MIC 50 | MIC 90 | The MIC scope | ||
| Staphylococcus aureus | 20 | 10 | 80 | 0.313-80 |
| Staphylococcus epidermidis | 12 | 20 | 40 | 1.25-40 |
| Diplococcus pneumoniae | 12 | 20 | 80 | 2.5-80 |
| Hemophilus influenza | 10 | 2.5 | 20 | 0.313-40 |
| Klebsiella Pneumoniae | 15 | 40 | 160 | 20-160 |
| Escherichia coli | 18 | 20 | 40 | 0.625-40 |
| Bacillus pyocyaneus | 10 | 40 | 160 | 10-160 |
2, vivo bacteria corrosion action is measured
(1) experimental technique
Get 70 of 18-22g mices, male and female half and half are divided into 7 groups at random, and 10 every group, the bacteria suspension 0.5ml/ of mouse peritoneal injection 2 * MLD is (bacteria suspension is diluted to desired concn with 5% gastric Mucin) only.Wherein 6 groups of mices respectively every day gastric infusion 3 times, between the agent of each medicine gradient than being 1: 0.75; Surplus one group of negative contrast.Note after the administration observing reaction of animals, observe 7 days (be administered twice every day) continuously, write down the animal dead number, calculate the medicine median effective dose (ED of each infectious bacteria by the Bliss method
50).
(2) experimental result
The antibacterial tests result shows (following table) in the body, the ED that gastric infusion infects the clinical pathogenic strain of staphylococcus aureus
50Be 37.77mg/kg.The result shows that the mouse infection that the above-mentioned Flos Trollii compound preparation of orally give causes staphylococcus aureus has certain curative effect.
The endogenous protective effect
| Group | Dosage mg/kg | Log10 dose | n | The survival number | Survival rate | Return probit | ED 50 mg/kg |
| 1 | 70 | 1.845 | 10 | 9 | 90 | 6.28 | 37.77 |
| 2 | 53 | 1.724 | 10 | 7 | 70 | 5.52 | |
| 3 | 39 | 1.591 | 10 | 6 | 60 | 5.25 | |
| 4 | 30 | 1.477 | 10 | 4 | 40 | 4.75 | |
| 5 | 22 | 1.342 | 10 | 1 | 10 | 3.72 | |
| 6 | 17 | 1.230 | 10 | 0 | 0 | 3.04 | |
| Negative control | 0 | 0 | 100 | ||||
Three, inside and outside antivirus test
1, external resisiting influenza virus research
(1) experimental technique
With the strain of going down to posterity of people's embryo integumentary musculature fibroblast is host cell, the chick embryo allantoic liquid gradient dilution of FM1 virus inoculation is to required titre (effective cell pathological changes titre), being subjected to reagent (herbal mixture that contains Flos Trollii) extraction extractum to be diluted to concentration with physiological saline solution is 1600mg/ml, and by 1: 10,1: 100,1: 200,1: 400,1: 800 ratio adds the cell monolayer culture fluid, the final drug level of cell culture fluid is 160,16,8,4 and 2mg/ml, the lowest concentration of drug that suppresses virus multiplication is measured in microexamination.
(2) experimental result
External resisiting influenza virus Mus lung adapted strain FM1 activity research experimental result shows (following table), had by reagent and suppresses the effect of virus in the host cell internal breeding.
External resisiting influenza virus experimental result
| Experimental technique | Drug level (mg/ml) | Incubation time (h) | Blood cell absorption (Hd) | Hemagglutinative titer (HA) |
| Medicine is anticipated behind the cell infective virus again | 4 | 48 | - | 2 |
| 4 | 72 | + | 8 | |
| 2 | 48 | - | 4 | |
| 2 | 72 | + | 16 | |
| Medicine and virus mix be incorporated in 4 ℃ spend the night after infection host again | 4 | - | 2 | |
| 2 | - | 4 | ||
| Medicine adds behind the host cell culture fluid infective virus at once | 4 | - | 2 | |
| 2 | - | 8 | ||
| The virus control group | +++ | 32 | ||
| Ribavirin (medicine positive control) | - | - | ||
| Blank cell contrast | - | - |
2, resisiting influenza virus research in the body
(1) experimental technique
Be subjected to the reagent oral administration, establish 240,120 and high, medium and low three dosage groups of 60mg/kg, the oral administration dosage of positive drug ribavirin is 10mg/kg.Get 60 mices, male and female half and half are divided into 5 groups at random, 12 every group, wherein are subjected to 3 groups of the high, medium and low dosed administrations of reagent, 1 group of positive drug contrast ribavirin administration, 1 group of virus control.Use 10 * LD respectively
50The influenza virus Mus lung adapted strain FM1 collunarium infecting mouse of titre, 30 μ l/ are only.Infect back 2h and begin gastric infusion, successive administration 7 days, every day 3 times.Observed 15 days continuously after the administration, write down death toll and death time after the mouse infection virus every day, calculate dead protective rate and prolong vital rates.
(2) experimental result
Experimental result shows (following table), and high, medium and low dosage is subjected to reagent all can reduce the animal dead rate, and the natural law of on average surviving prolongs.Medicine negative control group (virus control group) zoogenetic infection virus-4 occurs becoming thin behind the sky, dyspnea, opens and follows death.Experimental result shows, is subjected to reagent (240mg/kg) similar to positive control drug 'Libaweilin ' (10mg/kg) with increase in life span to the dead protective rate of influenza virus Mus lung adapted strain FM1 strain induced mice pneumonia.
Resisiting influenza virus experimental result in the body
| The laboratory animal group | Dosage mg/kg | Death toll | Mortality rate | Dead protective rate | Average survival natural law | Prolong vital rates |
| Be subjected to reagent | 240 | 3 | 25.0％ | 75.0％ | 13.3 | 84.7％ |
| 120 | 5 | 41.7％ | 58.3％ | 11.1 | 54.2％ | |
| 60 | 11 | 91.7％ | 8.3％ | 8.8 | 22.2％ | |
| Ribavirin | 10 | 2 | 16.7％ | 83.3％ | 14.3 | 98.6％ |
| The virus control group | - | 12 | 100％ | 0％ | 7.2 | 0％ |
Claims (8)
1, a kind of compound Chinese medicinal preparation that contains Flos Trollii is characterized in that it is the compound preparation of being made by following Chinese crude drug raw material by weight ratio: Flos Trollii 8～12, Radix Scutellariae 2～4, Radix Isatidis 2～4, Flos Lonicerae 1, Fructus Forsythiae 1.
2, a kind of compound Chinese medicinal preparation that contains Flos Trollii according to claim 1 is characterized in that described preparation is tablet, capsule, oral liquid, granule.
3, the described a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii of claim 1 is characterized in that: the title Chinese crude drug raw material of pressing following weight ratio: Flos Trollii 8～12, Radix Scutellariae 2～4, Radix Isatidis 2～4, Flos Lonicerae 1, Fructus Forsythiae 1; After above-mentioned Chinese crude drug selected, cleans, after mixed extraction is handled dry extract or clear paste, add oral drugs and allow the adjuvant that uses or the fine powder of above-mentioned raw material of Chinese medicine, make oral formulations.
4, a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii according to claim 3, it is characterized in that adjuvant that described oral drugs allow to use selects a kind of or mixture in magnesium stearate, Pulvis Talci, microcrystalline cellulose, starch, cane sugar powder, dextrin, cyclamate, water, saccharin sodium, the flavoring orange essence for use, wherein Chinese crude drug raw material and adjuvant weight proportion are 1: 0～5.
5, a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii according to claim 3, the fine powder that it is characterized in that described raw material of Chinese medicine is selected a kind of or mixture in Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, the Fructus Forsythiae raw material fine powder for use, the raw material fine powder is crossed 80～120 mesh sieves, and wherein the fine powder weight proportion of Chinese crude drug raw material and raw material of Chinese medicine is 1: 0～0.5.
6, a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii according to claim 3 is characterized in that the extraction of described Chinese crude drug mixed extraction processing employing decocting in water, alcohol reflux, ethanol percolate extraction; Wherein decocting in water extracts the back extract, and directly concentration or handle the back through precipitate with ethanol and concentrate gets dry extract or clear paste; Alcohol reflux, ethanol percolate extraction, can directly concentrate dry extract or clear paste.
7, a kind of preparation method that contains the compound Chinese medicinal preparation of Flos Trollii according to claim 3 is characterized in that taking following steps:
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after handling, mixed extraction gets dry extract or clear paste, add oral drugs and allow the adjuvant of use or the fine powder of above-mentioned raw material of Chinese medicine, make granule, drying, compacting is in blocks, and coating promptly gets tablet;
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after handling, mixed extraction gets dry extract or clear paste, add oral drugs and allow the adjuvant of use or the fine powder of above-mentioned raw material of Chinese medicine, make granule, drying incapsulates, and promptly gets capsule;
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after mixed extraction is handled, get dry extract or clear paste, add the adjuvant that the permission of sucrose or dextrin or granule is used, make granule, drying promptly gets granule;
Get Chinese crude drug Flos Trollii, Radix Scutellariae, Radix Isatidis, Flos Lonicerae, Fructus Forsythiae in the said components, after selecting, cleaning, after handling, mixed extraction gets dry extract or clear paste, add the adjuvant that the permission of sucrose or steviosin or oral liquid is used, added water boil 15 minutes, treat to regulate when temperature is reduced to below 80 ℃ pH value to 6.0～7.5, filter, fill, sterilization promptly gets oral liquid.
8, claim 1 or the 3 described compound Chinese medicinal preparation that contain Flos Trollii, acute inflammation of the throat, acute tonsillitis due to the treatment affection due to external wind and heat, disease see the application in red swelling of the pharynx, pharyngalgia, pharyngitis, tonsillitis upper respiratory tract infection and treatment swelling and aching of gum, acute otitis media, acute conjunctivitis, the parotitis disease medicament.
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