Summary of the invention
The purpose of this invention is to provide a kind of new Chinese medicine composition, said composition has the effect of wind and heat dispersing, resolving toxin and disinhibiting the throat, be used for the treatment of on the wind heat attack, the red and swollen pain of pharynx, itching throat, hoarseness due to the exuberant lung-stomach heat, acute pharyngitis, acute episode of chronic pharyngitis phase are seen above-mentioned patient.
Another object of the present invention provides the preparation method of above-mentioned Chinese medicine composition.
The 3rd purpose of the present invention provides the application of above-mentioned Chinese medicine composition in throat, respiratory tract disease medicines such as preparation treatment cough, laryngopharynx swelling and pain, acute/chronic pharyngitis, tracheitis.
The present invention is achieved by the following technical solutions:
Chinese medicine composition of the present invention is to be made by the raw material of following weight parts:
Rabdosia rubescens 1-18 part, Radix Platycodonis 1-9 part, Radix Glycyrrhizae 0.1-3 part, Mentholum 0.01-0.2 part and Oleum Eucalypti 0.01-0.2 part
Chinese medicine composition of the present invention is preferably made by the raw material of following weight parts:
Rabdosia rubescens 3-10 part, Radix Platycodonis 1-6 part, Radix Glycyrrhizae 0.5-2 part, Mentholum 0.01-0.09 part and Oleum Eucalypti 0.01-0.09 part
The preparation method of Chinese medicine composition of the present invention is as follows:
Rabdosia rubescens, Radix Platycodonis, the Radix Glycyrrhizae of described weight proportion added the water or the ethanol extraction of variable concentrations, filters, reclaim ethanol and do not get supernatant to having the alcohol flavor, filtering or leave standstill, extracting solution; Also can be further refining with macroporous resin column, method is to be loaded on the macroporous resin column of having handled well, and the water eluting discards eluent, and the reuse ethanol elution is collected ethanol elution, reclaims ethanol; Extracting solution is concentrated, and drying under reduced pressure is pulverized, and promptly gets medical material extractum powder; Medical material extractum powder, Mentholum, Oleum Eucalypti, appropriate amount of auxiliary materials are mixed, make any medicament on the pharmaceutics.
Chinese medicine composition preferred manufacturing procedure of the present invention is as follows:
Rabdosia rubescens is ground into coarse powder, adds 90% ethanol percolate extraction, 60 ℃ of concentrating under reduced pressure, regulating determining alcohol is 50%, stand at low temperature is centrifugal, gets supernatant, decompression recycling ethanol, drying under reduced pressure; Radix Glycyrrhizae and Radix Platycodonis are added 70% ethanol extraction 3 times, each 1 hour, add 8,6,6 times of amounts of alcohol, filter, merging filtrate, being evaporated to does not have the alcohol flavor, dilute with water, centrifugal, discard precipitation, supernatant by handle well macroporous adsorptive resins, water and Different concentrations of alcohol eluting discard eluent, collect 70% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; With the PEG4000 heating and melting, add extract, Oleum Eucalypti, Mentholum mixing in the prescription ratio earlier, be incubated 60 ℃~80 ℃, splash in the refrigerative simethicone, treat drop pill cooling back taking-up, drop is clean and wipe simethicone, promptly gets drop pill.
The instructions of taking of drop pill: suck or oral, preferably suck.
Chinese medicine composition prescription of the present invention and compatibility:
Rabdosia rubescens: bitter, sweet, be slightly cold, have heat-clearing and toxic substances removing, anti-inflammatory analgetic, be good for the stomach invigorate blood circulation, antitumor, antibiotic, to separate heat drop dry, is used for laryngopharynx swelling and pain, tonsillitis, snake bite and insect sting, rheumatic ostalgia etc.Main component has volatile oil and Diterpenes, winter Ling Xia grass first element, second element, third element, fourth element, penta element, hot element and α one Amyrin, also has 5 unknown structure compositions, also contains inorganic elements ferrum, zinc, selenium etc.
Radix Platycodonis: bitter in the mouth, suffering, property is flat, attaches to the lung and stomach meridians the Materia Medica of Decoction lunar lung meridian of starting with.Lung qi dispersing arranged, eliminate the phlegm, the effect of sore-throat relieving, evacuation of pus, cure mainly diseases such as cough with copious phlegm, laryngopharynx swelling and pain, fullness in the chest and hypochondriac pain, lung abscess vomiting pus." book on Chinese herbal medicine converges and says ": " alleviating distention in middle-JIAO is regulated the flow of vital energy for main sharp lung qi, logical throat, and the key medicine of the capable expectorant of dissipating depression of QI also." modern pharmacological research shows: the effective ingredient of Radix Platycodonis is a Radix Platycodi total saponins, and the phlegm-dispelling functions of highly significant and tangible antitussive effect are arranged.Radix Platycodonis also has certain antiphlogistic antibacterial effect in addition.
Radix Glycyrrhizae: sweet in the mouth is flat, " not record ": " nontoxic ", " herbal through separating ": " start with lunar lung meridian, spleen meridian " has the effect of smoothing lung, relieving cough, eliminating phlegm, eliminating fire and detoxication sore-throat relieving.Cure mainly diseases such as cough and asthma, laryngopharynx swelling and pain, no matter have expectorant, no expectorant all to use it always.Assistant Radix Platycodonis is strengthened the effect of dispelling phlegm and relieving sore-throat, " Medical Treasures of the Golden Chamber " Radix Platycodonis decoction: " the cough with sensation of fullness in chest cold with shivering, rapid pulse, dry pharynx, not thirsty, the time go out fetid and sticky sputum, chronically spitting purulent sputum as porridge is lung abscess, the Radix Platycodonis decoction master it." main component licoflavone, enoxolone and the derivant thereof of Radix Glycyrrhizae, have the effect of relieving cough and expelling phlegm.
Mentholum: aromatic drug, remedium corrigens and carminative can be used for skin or mucosa and produce that refrigerant sense is not suitable for to alleviate, pain.The Herba Menthae brain-capacity optionally stimulates the Cold receptor of human body skin or mucosa, produces sense of cold reflection and creeping chill, causes the skin mucosa vasoconstriction, also can cause the blood vessel of deep tissue and shrink and produce therapeutical effect.External can antiinflammatory, pain relieving, and antipruritic, blood circulation promoting alleviates edema etc.; For oral administration can alleviating local inflammation (pharyngolaryngitis) and treatment flu in the compound preparation, and have and be good for the stomach the wind dispelling effect.
Oleum Eucalypti: antibiotic, antiinflammatory, dispel the wind, pain relieving.
In the present invention in the drug composition, Rabdosia rubescens has the effect of heat-clearing and toxic substances removing as monarch drug, Radix Platycodonis has the effect of sore-throat relieving, evacuation of pus as ministerial drug, Radix Glycyrrhizae, Mentholum, Oleum Eucalypti have antibiotic, antiinflammatory for assistant makes altogether, the effect of pain relieving, relieving cough and expelling phlegm, Mentholum also has the function of fragrant seasoning, and all medicines merge the effect of playing resolving toxin and disinhibiting the throat altogether.
Chinese medicine composition of the present invention has the effect of antiinflammatory, antibacterial, detumescence, wind and heat dispersing, resolving toxin and disinhibiting the throat, be used for the treatment of on the wind heat attack, the red and swollen pain of pharynx, itching throat, hoarseness due to the exuberant lung-stomach heat, acute pharyngitis, acute episode of chronic pharyngitis phase are seen above-mentioned patient.
Below, foregoing of the present invention is described in further detail by the specific embodiment:
The specific embodiment
Embodiment 1:
Rabdosia rubescens 6g, Radix Platycodonis 3g, Radix Glycyrrhizae 1g, Mentholum 0.05g, Oleum Eucalypti 0.05g.
The Rabdosia rubescens pulverizing medicinal materials is become coarse powder, add ethanol percolate extraction, reclaim ethanol, drying under reduced pressure; With Radix Glycyrrhizae and Radix Platycodonis, add 60% ethanol extraction, filter, merging filtrate, being evaporated to does not have alcohol flavor, dilute with water, centrifugal, discard precipitation, the macroporous adsorptive resins of supernatant by having handled well, the water eluting, discard eluent, continue and use the Different concentrations of alcohol eluting, collect 70% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; Above extract and Oleum Eucalypti, Mentholum mixing add dextrin, Icing Sugar, mannitol, protein sugar mixing, add 75% ethanol and granulate as wetting agent, granulate; Again at 60 ℃ of following drying under reduced pressure, 16 mesh sieve granulate; Evenly the magnesium stearate that adds grain amount 1% with semi-finished product tablet machine tabletting, gets buccal tablet as lubricant.
Embodiment 2:
Rabdosia rubescens 1g, Radix Platycodonis 1g, Radix Glycyrrhizae 0.5g, Mentholum 0.01g, Oleum Eucalypti 0.01g.
With Rabdosia rubescens, Radix Glycyrrhizae and Radix Platycodonis, add 70% alcohol reflux, filter, merging filtrate, concentrating under reduced pressure, drying under reduced pressure, pulverize, cross 80 mesh sieves, add hyprolose, calcium hydrogen phosphate, Heavy Magnesium Carbonate, polyvinylpolypyrrolidone, aspartame, mixing, granulate in right amount with 95% ethanol, drying, tabletting promptly gets dispersible tablet.
Embodiment 3:
Rabdosia rubescens 18g, Radix Platycodonis 9g, Radix Glycyrrhizae 3g, Mentholum 0.2g, Oleum Eucalypti 0.2g.
The Rabdosia rubescens pulverizing medicinal materials is become coarse powder, add ethanol percolate extraction, reclaim ethanol, drying under reduced pressure; With Radix Glycyrrhizae and Radix Platycodonis, add 80% ethanol extraction, filter, merging filtrate, being evaporated to does not have alcohol flavor, dilute with water, centrifugal, discard precipitation, the macroporous adsorptive resins of supernatant by having handled well, the water eluting, discard eluent, continue and use the Different concentrations of alcohol eluting, collect 70% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; Above extract and Oleum Eucalypti, Mentholum mixing are pulverized, and cross 80 mesh sieves, add tartaric acid, sodium bicarbonate, Aspartane, xylitol, and dehydrated alcohol is granulated, and drying adds PEG4000, mix homogeneously, and the system granule, drying, compacting promptly gets effervescent tablet in flakes.
Embodiment 4:
Rabdosia rubescens 3g, Radix Platycodonis 2g, Radix Glycyrrhizae 1g, Mentholum 0.05g, Oleum Eucalypti 0.05g.
Rabdosia rubescens is ground into coarse powder, adds 90% ethanol percolate extraction, 60 ℃ of concentrating under reduced pressure, regulating determining alcohol is 50%, stand at low temperature is centrifugal, gets supernatant, decompression recycling ethanol, drying under reduced pressure; Radix Glycyrrhizae and Radix Platycodonis are added 70% ethanol extraction 3 times, each 1 hour, add 8,6,6 times of amounts of alcohol, filter, merging filtrate, being evaporated to does not have the alcohol flavor, dilute with water, centrifugal, discard precipitation, supernatant by handle well macroporous adsorptive resins, water and Different concentrations of alcohol eluting discard eluent, collect 70% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; With the PEG4000 heating and melting, add extract, Oleum Eucalypti, Mentholum mixing in the prescription ratio earlier, be incubated 60 ℃~80 ℃, splash in the refrigerative simethicone, treat drop pill cooling back taking-up, drop is clean and wipe simethicone, promptly gets drop pill.
Embodiment 5:
Rabdosia rubescens 3g, Radix Platycodonis 1g, Radix Glycyrrhizae 0.5g, Mentholum 0.01g, Oleum Eucalypti 0.01g.
The Rabdosia rubescens pulverizing medicinal materials is become coarse powder, add ethanol percolate extraction, reclaim ethanol, drying under reduced pressure; With Radix Glycyrrhizae and Radix Platycodonis, add 80% ethanol extraction, filter, merging filtrate, being evaporated to does not have alcohol flavor, dilute with water, centrifugal, discard precipitation, the macroporous adsorptive resins of supernatant by having handled well, the water eluting, discard eluent, continue and use the Different concentrations of alcohol eluting, collect 70% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; Above extract and Oleum Eucalypti, Mentholum mixing, the cane sugar powder of adding 80%, mixing, add 75% ethanol and stir evenly in right amount and make into the thick paste shape, add the cane sugar powder of calcium carbonate, glucosamine hydrochloride, chondroitin sulfate, phosphopeptide caseinate, dextrin, sucralose, orange flavor, magnesium stearate and residue 20%, 75% alcohol granulation, dry, granulate, compacting promptly gets chewable tablet in flakes.
Embodiment 6:
Rabdosia rubescens 9g, Radix Platycodonis 6g, Radix Glycyrrhizae 2g, Mentholum 0.09g, Oleum Eucalypti 0.09g.
The Rabdosia rubescens pulverizing medicinal materials is become coarse powder, add ethanol percolate extraction, reclaim ethanol, drying under reduced pressure; With Radix Glycyrrhizae and Radix Platycodonis, add 80% ethanol extraction, filter, merging filtrate, being evaporated to does not have alcohol flavor, dilute with water, centrifugal, discard precipitation, the macroporous adsorptive resins of supernatant by having handled well, the water eluting, discard eluent, continue and use the Different concentrations of alcohol eluting, collect 80% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; Above extract and Oleum Eucalypti, Mentholum mixing add dextrin, Icing Sugar, and evenly mixed, adding ethanol is wetting agent, granulate, and drying, granulate is made granule.
Embodiment 7:
Rabdosia rubescens 5g, Radix Platycodonis 2g, Radix Glycyrrhizae 2g, Mentholum 0.05g, Oleum Eucalypti 0.03g.
With Rabdosia rubescens medicine, Radix Glycyrrhizae and Radix Platycodonis, extracting in water filters, and merging filtrate adds ethanol to 40%, and standing over night is got supernatant, decompression recycling ethanol, drying under reduced pressure; Above extract and Oleum Eucalypti, Mentholum mixing earlier with the Macrogol 4000 heating and melting, add extract, Oleum Eucalypti, Mentholum mixing in the prescription ratio, insulation splashes in the refrigerative liquid Paraffin, treats drop pill cooling back taking-up, drop is clean and wipe simethicone, promptly gets drop pill.
Embodiment 8:
Rabdosia rubescens 10g, Radix Platycodonis 5g, Radix Glycyrrhizae 3g, Mentholum 0.05g, Oleum Eucalypti 0.05g.
Rabdosia rubescens is ground into coarse powder, adds 90% ethanol percolate extraction, 60 ℃ of concentrating under reduced pressure, regulating determining alcohol is 50%, stand at low temperature is centrifugal, gets supernatant, decompression recycling ethanol, drying under reduced pressure; Radix Glycyrrhizae and Radix Platycodonis are added 70% ethanol extraction 3 times, each 1 hour, add 8,6,6 times of amounts of alcohol, filter, merging filtrate, being evaporated to does not have the alcohol flavor, dilute with water, centrifugal, discard precipitation, supernatant by handle well macroporous adsorptive resins, water and Different concentrations of alcohol eluting discard eluent, collect 70% ethanol elution part, decompression recycling ethanol, drying under reduced pressure; With the PEG4000 heating and melting, add extract, Oleum Eucalypti, Mentholum mixing in the prescription ratio earlier, be incubated 60 ℃~80 ℃, splash in the refrigerative simethicone, treat drop pill cooling back taking-up, drop is clean and wipe simethicone, promptly gets drop pill.
Further set forth the beneficial effect of Chinese medicine composition of the present invention by following experiment:
Chinese medicine composition of the present invention is to the influence of rat acute pharyngitis model
Materials and methods
Animal: Wistar rat
Medicine and reagent: Chinese medicine composition of the present invention: every gram finished product contains crude drug (crude drug) 3g.Compound concentration is respectively 30%, 20%, 10% during experiment.Ammonia: 500ml is bottled, concentration 25%~28%.Compound Japanese polygala granule: every packed 10g (quite crude drug in whole 14g).
Instrument: handle type laryngeal spray: L56-03 type, microscope: Olympus BX-51.Medical image analysis system: B I-2000, medical frontal mirror, spatula.Pathologic finding equipment.
Experimental technique: 1. animal grouping: select 60 of Wister rats for use, body weight 160~200g, male and female half and half.6 groups of random packet, i.e. blank group, model group, positive drug control group (compound Japanese polygala granule), the high, medium and low dosage group of Chinese medicine composition of the present invention.Every group 10.2. acute pharyngitis replication of Model: except that the blank group, all the other 5 treated animal at 8 o'clock in mornings and at 4 o'clock in afternoon, each sprayed its pharyngeal 1 time with 25% ammonia, sprayed continuously 3 days.The pharyngeal situation of every day observed and recorded animal appearance state and animal.3. dosage: rose in the 4th day after the modeling, each treated animal begins gastric infusion by following dosage, every day 1 time, successive administration 5 days.Dosage is respectively: positive drug group (compound Japanese polygala granule): 8g/kg body weight (80% * 10ml/kg body weight), Chinese medicine composition high dose group of the present invention: 3g/kg body weight (30% * 10ml/kg body weight), middle dosage group: 2g/kg body weight (20% * 10ml/kg body weight), low dose group: 1g/kg body weight (10% * 10ml/kg body weight), blank group and model group: distilled water 10ml/kg body weight.4. draw materials: the last administration is after 45 minutes, and animal is put to death in vertebral pulling, wins pharyngeal mucosa of each treated animal and undertissue thereof and fixes with 10% formalin solution, and histopathologic examination is carried out in section.5. observation index and criterion: the pathological score of rat pharynx tissue mucosa epithelial proliferation degree and cell infiltration degree.
Experimental result: the pharyngeal pathological examination results, the mucosal epithelium of blank group rat pharyngeal is the squamous epithelial cancer structure, clear layer.Mucosa undertissue, body of gland are normal.The mucosal epithelium lamellar necrosis of model group rat pharyngeal, come off a large amount of inflammatory cell diffuse infiltratings of mucosal epithelium and mucosa undertissue, the obvious vasodilation hyperemia of mucosa undertissue, hemorrhage, the atrophy of part body of gland.Show the success of acute pharyngitis model copy.The mucosal epithelium hyperplasia degree integration of positive drug control group, Chinese medicine composition object height of the present invention, middle dosage group rat pharyngeal and cell infiltration degree integration and model group more obviously reduce.Point out Chinese medicine composition of the present invention that pharyngeal mucosal epithelium hyperplasia degree of acute pharyngitis model due to the ammonia and cell infiltration degree are had certain mitigation (seeing Table 1,2,3).
Table 1 mucosal epithelium hyperplasia degree
Table 2 cell infiltration degree integration
The comparison of each treated animal acute pharyngitis pathological change of table 3 experiment (X ± s, N=10)
Compare * P<0.05, * * P<0.01 with matched group
Experiment conclusion: pathological examination results shows that the mucosal epithelium hyperplasia degree integration of positive drug control group, Chinese medicine composition object height of the present invention, middle dosage group rat pharyngeal and cell infiltration degree integration and model group more obviously reduce.Chinese medicine composition of the present invention has certain alleviation and therapeutical effect to pharyngeal mucosal epithelium hyperplasia degree of the acute pharyngitis model due to the ammonia and cell infiltration degree.