CN102416095A - Chinese medicine composition for treating amygdalitis and pharyngitis - Google Patents
Chinese medicine composition for treating amygdalitis and pharyngitis Download PDFInfo
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Abstract
The invention belongs to the field of Chinese medicine preparation, and particularly discloses a Chinese medicine composition for treating amygdalitis and pharyngitis. The Chinese medicine composition comprises the following main materials in parts by weight: 100-500 parts of malan grass, 100-500 parts of achyranthes aspera, 100-500 parts of radix ranunculi ternate, 100-500 parts of carpesium abrotanoides, 50-200 parts of oroxylum indicum and 50-100 parts of radix ophiopogonis, and can comprise 50-300 parts of one or more of adjuvants and/or conductant drugs selectively. The Chinese medicine composition has the functions of clearing away heat and toxic materials, benefiting the pharynx and stopping pain, is used for clinically treating the amygdalitis and the pharyngitis and has a good effect on the symptoms such as swelling and pain of the pharyngeal, fever, thirst, constipation and the like caused by excessive heat. The result of the clinical study shows that the total marked efficiency of the Chinese medicine composition for treating the amygdalitis is 78.29% and the total efficiency is 94.08%; the total marked efficiency of the Chinese medicine composition for treating the pharyngitis is 79.47%, and the total efficiency is 93.38%; and compared with the control group, the Chinese medicine composition has obvious difference, is safe in use and has no toxic and side effects.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine composition of treating tonsillitis, pharyngitis.
Background technology
Tonsillitis belongs to the traditional Chinese medical science " tonsillitis " category.Be divided into acute tonsillitis and chronic tonsillitis, severe patient is suppurative tonsillitis.Invade from mouth and nose mainly due to wind-heat evil toxin, violate lung stomach two warps, evil poison is fumigated in throat and is satisfied into primary disease.Or the lung stomach have long-pending heat, or pyretic toxicity is more very, the moon of scorching hot lung stomach, and deficiency of body fluid, hyperactivity of deficient fire forms, the Chang Fanfu outbreak.The clinical rising with heating, pharyngalgia, submandibular lymph nodes enlargement, hemogram of acute tonsillitis is principal character, and visible tonsil is red and swollen, and there is faint yellow or white pus point on the surface.Chronic tonsillitis shows as pharyngeal and tonsil flushing, visible yellow color secretions, and it is not obvious to have sore throat, and low grade fever is arranged once in a while and is off one's feed etc.Primary disease is the rule of treatment of treatment with " disappear, mend clearly, ".Mostly the hurried person that falls ill is excess syndrome, heat syndrome, suitable wind and heat dispersing, relieving sore throat and diminishing swelling, the detoxifcation of purging heat.The course of disease is delayed or is sent out the author repeatedly, is mostly deficiency syndrome or syndrome of intermingled deficiency and excess, suitable nourishing the lung and kidney, clearing throat; Invigorating the spleen and regulating the stomach, the damp eliminating sore-throat relieving; Blood circulation promoting and blood stasis dispelling, dispelling phlegm and relieving sore-throat.
Pharyngitis belongs to the traditional Chinese medical science " sore throat " category.Different according to the length of the course of disease and pathological change character are divided into acute pharyngitis, two big types of chronic pharyngitiss.Theory of Chinese medical science thinks, its cause of disease comprises wind (wind heat, wind and cold are main with wind heat again), fiery, dry, expectorant, internal injury etc.Acute pharyngitis is equivalent to the acute inflammation of the throat of the traditional Chinese medical science, is to be the acute pathological changes of primary symptom with red swelling of the pharynx pain, has another name called acute pharyngitis due to wind-heat, and how because of due to the wind-heat evil toxin invasion and attack, tcm clinical practice mainly is divided into wind heat invasion and attack, wind and cold bundle table, three kinds of pattern of syndrome of exuberant lung-stomach heat.Chronic pharyngitis is equivalent to the chronic throat obstruction, chronic pharyngitis of the traditional Chinese medical science, is the chronic pathological changes that is principal character with pharyngeal little red discomfort, has another name called hypopyretic laryngalgia; How show effect repeatedly because of acute sore throat; So that due to the zang-fu disharmony, hyperactivity of deficient fire, tcm clinical practice is divided into lung-stomach yin deficiency and two kinds of pattern of syndrome of deficiency of kidney-YIN.Primary disease is the rule of treatment of treatment with " clear, rush down, mend, disappear ", i.e. wind and heat dispersing, eliminating fire and detoxication, relieving sore throat and diminishing swelling, invigorating spleen and kidney, the blood stasis dispelling of eliminating the phlegm.
Existing treatment pharyngitis, tonsillitic Chinese medicine preparation have following relevant report:
Disclose a kind of novel therapeutic pharyngitis, tonsillitic Chinese medicine like application number 201110082650.1, comprised Fructus Arctii 90 grams, Rhizoma Belamcandae 60 grams, the Radix Astragali 100 grams, Radix Scutellariae 100 grams, Flos Lonicerae 100 grams, Radix Isatidis 150 grams, Herba Dendrobii 100 grams, Rhizoma Polygonati Odorati 80 grams, Fructus Canarii albi 100 grams.This kind treatment pharyngitis, tonsillitic Chinese medicine reducing swelling and alleviating pain, heat-clearing and toxic substances removing, sore-throat relieving eliminating stagnation, removing heat from blood relieving sore throat and diminishing swelling, treatment pharyngitis, tonsillitis are evident in efficacy, the drug effect safety and stability, cure rate is high, and is without any side effects.
A kind of oral or lozenge medicine of treating acute pharyngitis and acute tonsillitis is disclosed like application number 200410073075; Comprise (consumption is a weight portion): Flos Chrysanthemi Indici 5-30 part, Radix Scutellariae 2-15 part, Rhizoma Belamcandae 2-15 part, Calyx Seu Fructus Physalis 1-10 part, Radix Scrophulariae 1-10 part, press the medicament of conventional formulation method preparation.Medicine of the present invention proves through the test of pesticide effectiveness, and it has the effect of antibacterial, antiinflammatory, analgesia, analgesic, antitussive.
A kind of Chinese medicine preparation of treating pharyngolaryngitis is disclosed like application number 200710034658.4, by Radix Achyranthis 40-60 part, Herba Kalimeridis grass 20-35 part, Herba Plantaginis 10-20 part, Radix Carpesii 5-15 part decocting in water is prepared from.
Along with environmental pollution, pharyngitis, tonsillitis case are in rising trend, and are prone to outbreak repeatedly; It is empty to cause patient's spleen, lung qi to lose, and stasis of blood poison is tied mutually, pyretic toxicity stagnates, and network is serious, adopts conventional YIN nourishing, clearing away heat method treatment; But the respite state of an illness, but often can not effect a radical cure or DeGrain.And doctor trained in Western medicine adopts antibiotic therapy to be prone to make the patient to produce drug resistance in a large number, can not tackle the problem at its root.The present invention continues research on 200710034658.4 basis, draw a kind of Chinese medicine composition of treating tonsillitis, pharyngitis, does not see the report identical or relevant with composition of the present invention as yet.
Summary of the invention
Deficiency to prior art; The purpose of this invention is to provide a kind of new treatment tonsillitis, the Chinese medicine composition of pharyngitis, the tonsillitis that it causes Different types of etiopathogenises, pharyngitis are all effective, and can alleviate symptoms such as redness, pain, scorching hot, thirsty and constipation; Good effect, instant effect.
A kind of Chinese medicine composition of treating tonsillitis, pharyngitis comprises raw material and one or more adjuvant drug and/or messenger drug, and the weight portion proportioning of said raw material is:
100 parts-500g of Herba Kalimeridis grass part, 100 parts-500 parts of Radix Achyranthis,
100 parts-500 parts of Radix Ranunculi Ternatis, 100 parts-500 parts of Radix Carpesiis,
50 parts-200 parts of Semen Oroxylis, 50 parts-100 parts of Radix Ophiopogonis;
The weight portion of said adjuvant drug and/or messenger drug is 50 parts-300 parts; Adjuvant drug and/or messenger drug are selected from Radix Platycodonis, Herba Solani Nigri, Herba Plantaginis, Radix Sophorae Tonkinensis, Herba Dendrobii, Rhizoma Belamcandae and the Radix Glycyrrhizae.
Said adjuvant drug and/or messenger drug preferably are made up of for 10 parts-50 parts 50 parts-200 parts of Radix Platycodoniss, Herba Solani Nigri.
Said adjuvant drug and/or messenger drug preferably are made up of for 10 parts-50 parts 50 parts-200 parts of Radix Sophorae Tonkinensiss, Herba Dendrobii.
Said adjuvant drug and/or messenger drug preferably are made up of for 10 parts-50 parts 50 parts-200 parts of Rhizoma Belamcandae, Radix Glycyrrhizae.
Said adjuvant drug and/or messenger drug preferably are made up of for 10 parts-50 parts 50 parts-200 parts of Radix Platycodoniss, Herba Plantaginis.
Said Chinese medicine composition adds adjuvant by common process and processes tablet, capsule, granule, drop pill, micropill, dispersible tablet, oral cavity disintegration tablet, pill, oral liquid; Said adjuvant comprises one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and the substrate.
Another object of the present invention is to provide a kind of method for preparing above-mentioned Chinese medicine composition.This method is: the decocting that adds with respect to 10-12 times of weight portion of raw material gross weight boils 2-3 time, each 1-2 hour, gets final product.
Preferred manufacturing procedure is: with decocte with water secondary in the raw material, add the water with respect to 12 times of weight of above-mentioned raw materials for the first time, decocted 1.5 hours; Add water for the second time, decocted 1.5 hours with respect to 10 times of weight of above-mentioned raw materials; Merge decocting liquid twice, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.15-1.20, and vacuum drying gets dry extract; Get above-mentioned dry extract, be ground into fine powder, add medicinal adjuvant preparation, get final product.
Chinese medicine composition provided by the invention can add adjuvant by common process and process tablet, capsule, granule, drop pill, micropill, dispersible tablet, oral cavity disintegration tablet, pill or oral liquid (comprising oral liquid, syrup, soft extract, mixture); Said adjuvant comprises one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and the substrate.
The present invention also provides the application of said Chinese medicine composition in preparation treatment tonsillitis, pharyngitis medicine.
The present invention also provides said Chinese medicine composition to cause antipyretic-antalgic, the cold cough of heating in preparation treatment upper respiratory tract infection; The constipation that excess-heat causes; The pharyngodynia with dryness that the smoking insobriety causes, the application in the hoarseness medicine that excessively causes with throat.
Chinese medicine preparation prescription provided by the invention is that the inventor screens from classic treatment pharyngolaryngitis name side, refines prescription, clinical verification through the clinical well-known doctor of modern multidigit authority.Effect with heat-clearing and toxic substances removing, relieving sore throat and pain; Can be used for treating clinically heating, pharyngalgia, the cough that tonsillitis, pharyngitis and treatment upper respiratory tract infection cause; The constipation that excess-heat causes, the pharyngalgia that the smoking insobriety causes, dried itching, hoarseness that excessively causes with throat etc.
Do further explanation and explanation in the face of the present invention down:
Chinese medicine composition provided by the invention is that the inventor screens from classic treatment pharyngolaryngitis name side, refines prescription, clinical verification through the clinical well-known doctor of modern multidigit authority.With " clear, mend, disappear " be principle of treatment, and with heat-clearing and toxic substances removing, relieving sore throat and pain be mainly to treat mechanism, on composition of raw materials, follows the property of medicine through genus, and its efficacy of a drug synergism is laid particular stress on heat-clearing and toxic substances removing, and relieving sore throat and diminishing swelling is taken into account whole machine balancing again.Can be used for treating tonsillitis, pharyngitis and treatment clinically and go up heating, pharyngalgia, the cough that sense causes; The constipation that excess-heat causes, the pharyngalgia that the smoking insobriety causes, dried itching, the diseases such as hoarseness that excessively cause with throat; Get twice the result with half the effort treating both the principal and secondary aspects of a disease.
Chinese medicine composition
The primary raw material of treatment tonsillitis provided by the invention, pharyngitis Chinese medicine composition is Herba Kalimeridis grass, Radix Achyranthis, Radix Ranunculi Ternati, Radix Carpesii, Semen Oroxyli, Radix Ophiopogonis.
Used Herba Kalimeridis grass in the side: sweet in the mouth, suffering, warm in nature, eliminating stagnation, detumescence; Radix Achyranthis: sweet, bitter, salty, be slightly cold removing heat from blood YIN nourishing, eliminating fire and detoxication; Radix Ranunculi Ternati: be minister, sweet, little hardship, warm in nature, dissipating blood stasis hemostasis, subduing swelling and relieving pain, principal drug assistance blood stasis dispelling, eliminating stagnation, detoxifcation; Radix Carpesii: nourishing qi to stop; Semen Oroxyli: promoting the production of body fluid wets one's whistle, and makes spleen, insufficiency of lung-QI be able to training and mends; Radix Ophiopogonis: YIN nourishing and the production of body fluid promoting, lung moistening clear away heart-fire.With temperature, the medicine of a cold nature and usefulness, detoxifcation, heat clearing away combine, and are principal agent with mass dissipating and swelling eliminating, YIN nourishing antidotal Herba Kalimeridis grass, Radix Achyranthis, take hardship, tremble with fear, rush down and impairment of YIN not; Be equipped with Semen Oroxyli, Radix Ophiopogonis in heat clearing away, pathogenic fire purging, removing heat from blood, make spleen, insufficiency of lung-QI be able to training and mend, should treat pharyngitis due to tonsillitis, the pharyngitis, dry pharynx, itching throat, xerostomia, heating and irritable cough, diseases such as hoarseness, curative effect is preferable.
Can be on the basis of this prescription through increasing other adjuvant drugs and/or messenger drug to improve curative effect further.
Preferably, said composition can also comprise one or more adjuvant drug and/or messenger drug: Radix Platycodonis, Radix Sophorae Tonkinensis, Rhizoma Belamcandae, Herba Solani Nigri, Herba Dendrobii, Radix Glycyrrhizae, Herba Plantaginis.Wherein, the weight portion of each component is: Radix Platycodonis 50-200 weight portion, Radix Sophorae Tonkinensis 50-200 weight portion, Rhizoma Belamcandae 50-200 weight portion, Herba Solani Nigri 10-50 weight portion, Herba Dendrobii 10-50 weight portion, Radix Glycyrrhizae 10-50 weight portion, Herba Plantaginis 10-50 weight portion.
Wherein, Radix Platycodonis can lung qi dispersing, sore-throat relieving, eliminate the phlegm; Radix Sophorae Tonkinensis relieves inflammation or internal heat, pain relieving, detumescence; Rhizoma Belamcandae ability clearing away lung-heat, expectorant saliva; Herba Solani Nigri has heat-clearing and toxic substances removing, the effect of inducing diuresis to remove edema; Herba Dendrobii ability nourishing the stomach to promote the production of body fluid, nourishing YIN and clearing away heat; But lung moistening is coughed in Radix Glycyrrhizae invigorating the spleen and replenishing QI, taste; Herba Plantaginis can diuresis, eliminate the phlegm, removing heat from blood and detoxifcation.
Make up through above-mentioned any one or more than one adjuvant drug and/or messenger drug and aforementioned prescription; Make Chinese medicine composition provided by the invention in temperature, cool and usefulness; Heat clearing away, detoxifcation are when combining; Can also play supplementing QI for promoting the production of body fluid, lung moistening repercussive effect, on the basis of original prescription, improve curative effect of medication further.
As a kind of preferred embodiment of the present invention; This Chinese medicine composition is made up of for 10 parts-50 parts 100 parts-500 parts of Herba Kalimeridis grasss, 100 parts-500 parts of Radix Achyranthis, 100 parts-500 parts of Radix Ranunculi Ternatis, 100 parts-500 parts of Radix Carpesiis, 50 parts-200 parts of Semen Oroxylis, 50 parts-100 parts of Radix Ophiopogonis, 50 parts-200 parts of Radix Platycodoniss, Herba Plantaginis, wherein, and the Radix Platycodonis slightly warm in nature; Ability expelling phlegm for arresting cough, lung qi dispersing evacuation of pus; Herba Plantaginis property is sweet, and clearing away heat and promoting diuresis is messenger drug altogether.
As another preferred implementation; This Chinese medicine composition is made up of for 10 parts-50 parts 100 parts-500 parts of Herba Kalimeridis grasss, 100 parts-500 parts of Radix Achyranthis, 100 parts-500 parts of Radix Ranunculi Ternatis, 100 parts-500 parts of Radix Carpesiis, 50 parts-200 parts of Semen Oroxylis, 50 parts-100 parts of Radix Ophiopogonis, 50 parts-200 parts of Radix Platycodoniss, Herba Solani Nigri; Wherein, The Radix Platycodonis slightly warm in nature, ability expelling phlegm for arresting cough, lung qi dispersing evacuation of pus are adjuvant drug.The Herba Solani Nigri heat-clearing and toxic substances removing, inducing diuresis to remove edema is messenger drug.
As another preferred implementation; This Chinese medicine composition is made up of for 10 parts-50 parts 100 parts-500 parts of Herba Kalimeridis grasss, 100 parts-500 parts of Radix Achyranthis, 100 parts-500 parts of Radix Ranunculi Ternatis, 100 parts-500 parts of Radix Carpesiis, 50 parts-200 parts of Semen Oroxylis, 50 parts-100 parts of Radix Ophiopogonis, 50 parts-200 parts of Radix Sophorae Tonkinensiss, Herba Dendrobii, wherein, Radix Sophorae Tonkinensis can relieve inflammation or internal heat detoxifcation, the detumescence sore-throat relieving; Herba Dendrobii is slightly cold; Reinforcing stomach reg fluid, nourishing YIN and clearing away heat is adjuvant drug altogether.
As another preferred implementation; This Chinese medicine composition is made up of for 10 parts-50 parts 100 parts-500 parts of Herba Kalimeridis grasss, 100 parts-500 parts of Radix Achyranthis, 100 parts-500 parts of Radix Ranunculi Ternatis, 100 parts-500 parts of Radix Carpesiis, 50 parts-200 parts of Semen Oroxylis, 50 parts-100 parts of Radix Ophiopogonis, 50 parts-200 parts of Rhizoma Belamcandae, Radix Glycyrrhizae; Wherein Rhizoma Belamcandae ability heat clearing away poison, detumescence pain, throat are adjuvant drug.The Radix Glycyrrhizae heat-clearing and toxic substances removing, nourishing the lung to arrest cough, coordinating the actions of various ingredients in a prescription property is messenger drug.
Compared with prior art; Advantage of the present invention is the treatment tonsillitis that provides in Chinese medicine composition provided by the invention and the prior art, the more remarkable treatment effect of pharyngitis; Visible by the clinical testing data of embodiment, the preparation of said composition to tonsillitic total obvious effective rate be 78.29%, total effective rate 94.06%; Treatment pharyngitis total obvious effective rate is 79.47%, total effective rate 93.38%; Effect obviously is superior to existing product, and master, inferior disease are all had tangible healing or improvement effect.
The specific embodiment:
Following examples and Test Example are used to further specify but are not limited to the present invention.
Embodiment 1:
The Chinese medicine composition that is used to treat tonsillitis, pharyngitis provided by the invention, form according to the weight portion proportioning by following raw material: Herba Kalimeridis grass 100g, Radix Achyranthis 250g, Radix Ranunculi Ternati 100g, Radix Carpesii 250g, Semen Oroxyli 100g, Radix Ophiopogonis 50g.
With above-mentioned raw materials decocte with water secondary, add water for the first time with respect to 12 times of weight of raw material, decocted 1 hour; Add the water with respect to 10 times of weight of raw material for the second time, decocted 1 hour, extracting solution carries out preparation after being condensed into dry extract.
Embodiment 2:
The Chinese medicine composition that is used to treat tonsillitis, pharyngitis provided by the invention, form according to the weight portion proportioning by following raw material: Herba Kalimeridis grass 250g, Radix Achyranthis 100g, Radix Ranunculi Ternati 250g, Radix Carpesii 100g, Semen Oroxyli 100g, Radix Ophiopogonis 50g, Radix Platycodonis 100g, Herba Solani Nigri 10g.
With above-mentioned raw materials decocte with water secondary, add water for the first time with respect to 10 times of weight of raw material, decocted 1.5 hours; Add the water with respect to 12 times of weight of raw material for the second time, decocted 1.5 hours, extracting solution carries out preparation after being condensed into dry extract.
Embodiment 3:
The Chinese medicine composition that is used to treat tonsillitis, pharyngitis provided by the invention, form according to the weight portion proportioning by following raw material: Herba Kalimeridis grass 500g, Radix Achyranthis 500g, Radix Ranunculi Ternati 500g, Radix Carpesii 500g, Semen Oroxyli 200g, Radix Ophiopogonis 100g, Radix Sophorae Tonkinensis 200g, Herba Dendrobii 50g.
With above-mentioned raw materials decocte with water secondary, add water for the first time with respect to 11 times of weight of raw material, decocted 1.5 hours; Add the water with respect to 11 times of weight of raw material for the second time, decocted 1.5 hours, extracting solution carries out preparation after being condensed into dry extract.
Embodiment 4:
The Chinese medicine composition that is used to treat tonsillitis, pharyngitis provided by the invention, form according to the weight portion proportioning by following raw material: Herba Kalimeridis grass 500g, Radix Achyranthis 500g, Radix Ranunculi Ternati 500g, Radix Carpesii 500g, Semen Oroxyli 200g, Radix Ophiopogonis 100g, Rhizoma Belamcandae 200g, Radix Glycyrrhizae 50g.
With above-mentioned raw materials decocte with water secondary, add water for the first time with respect to 11 times of weight of raw material, decocted 1.5 hours; Add the water with respect to 11 times of weight of raw material for the second time, decocted 1.5 hours, extracting solution carries out preparation after being condensed into dry extract.
Embodiment 5:
A kind of preparation tablets of treating the compositions of tonsillitis, pharyngitis:
1, prescription be Herba Kalimeridis grass 300g, Radix Achyranthis 250g, Radix Ranunculi Ternati 250g, Radix Carpesii 200g, Semen Oroxyli 180g, Radix Ophiopogonis 100g, Radix Platycodonis 120g, Herba Plantaginis 50g.More than eight flavors, give as one thinks fit cataclasmly, the decocte with water secondary adds for the first time the water with respect to 12 times of weight of raw material, decocts 1.5 hours; Add water for the second time, decocted 1.5 hours with respect to 10 times of weight of raw material.
2, merge twice decocting liquid, filter, it is the clear paste (about 1000g) of 1.15-1.20 (60 ℃ of surveys) that filtrate decompression concentrates (60-70 ℃) to relative density, and vacuum drying gets dry extract (about 300g).
3, get above-mentioned dry extract, be ground into fine powder, add sucrose 600g, starch 100g, mixing, using weight concentration is 70% ethanol system soft material, cross 20 eye mesh screens and granulate, drying, 20 eye mesh screen granulate must be done the about 1000g of granule.Get Mentholum 1.5g, magnesium stearate 8g, grind to form fine powder, add in the above-mentioned dried granule, mixing, tabletting is processed 1000 approximately, promptly gets.
Embodiment 6:
(1), acute toxicity test
The tablet in treatment tonsillitis of embodiment 5 preparations, the animal acute toxicity test of pharyngitis: get 20 mices; The said composition tablet of oral administration gavage maximum (saturation capacity of maximum administration volume) 25.0g/kg; Observed 7 days continuously, itemized record reaction of animals situation calculates total dosage.The result shows: after 20 mices oral (filling stomach) maximum, activity and appetite are all no abnormal, none death.Record its maximum tolerated dose＞25.0g/kg of said preparation, be equivalent to 117 times of clinical adult's consumption, show its no acute toxicity, oral safety.
(2), long term toxicity test:
Adopt 2 weeks of Wistar rat continuous oral (filling stomach) administration to observe its long term toxicity.Three dose groups, an oral liquid group and a blank group are established in test altogether.Experimental animal outward appearance behavioral activity is normal basically; Each group of body weight is all in rising trend; Pathological examination, each treated animal internal organs is not all found substantive primary cellular defect; Hematological indices, hemoglobin (Hb) and numeration of leukocyte value; The blood parameters paddy third Cyklokapren (SGDT; Reitman-frankel method) and blood urea nitrogen value (urease methods) etc.; Each dose groups and blank group no significant difference (P＞0.05), three dose groups and oral liquid group be indifference (P＞0.05) equally also.
In addition, show all that according to successive dynasties Chinese medicine ancient books record and modern pharmacology toxicological study document contained various Chinese medicines all are nontoxic in the Chinese medicine preparation of the present invention under common dose.
Embodiment 7: pilot scale
For verifying and improve the research method for preparing of embodiment 5, reach adaptability so that reach the operability of production to relevant devices, preparation prescription is amplified 10 times feed intake, use the multi-function extractor of pilot plant, vacuum concentration, drying equipment.To the optimum process technology condition that research under laboratory condition obtains, carry out three batches of pilot scale researches, and each key process technology parameter of itemized record.To the thick paste relative density, must measure, emphasis such as dried cream yield investigates, suitably revise technology condition according to the result, and three batches of pilot products carried out quality inspection.
The result shows that with the tablet that the present invention processes, preparation process condition is reasonable, feasible; Extract, concentrate, methods such as drying, preparation adapt with the amplification production equipment; Prepared product quality is qualified, and is stable, can be used for commercial production.
The continuous 3 batches of pilot product quality inspections of table 1.
Embodiment 8: clinical testing data
(1), clinical data
Tonsillitis, the pharyngitis patient that 407 examples meet the diagnostic criteria of traditional Chinese medical science lung excess of the stomach heat syndrome carries out at random through including in, the clinical trial of double blinding, positive drug parallel control.Primary symptom: pharynx or tonsil are red and swollen, scorching hot pain; Inferior disease: dysphagia, thirsty and dry pharynx, heating, cough and expectoration, headache, constipation; Tongue arteries and veins: red tongue, thick, yellow and greasy fur, rapid pulse.
Therapeutic Method: the tablet that the oral embodiment of the invention 5 of test group is processed, each 3, every day 3 times; The oral YINHUANG PIAN of matched group, each 3, every day 3 times.Take medicine 7 days courses of treatment, duration of test all stop using other treatment tonsil, pharyngitis in, western drug.
Criterion of therapeutical effect: draft with reference to " new Chinese medicine clinical research guideline ", the branch level Four is carried out the curative effect assessment.Clinical recovery: finish back tcm clinical practice symptom, sign disappearance or basic the disappearance course of treatment; Produce effects: tcm clinical practice symptom, sign are obviously improved after finishing the course of treatment; Effectively: tcm clinical practice symptom, sign all take a favorable turn after finishing the course of treatment; Invalid: tcm clinical practice symptom, sign all do not have obvious improvement after finishing the course of treatment, even increase the weight of.
Result of the test:
1, to the therapeutic evaluation result of lung excess of the stomach heat syndrome: total obvious effective rate of test group treatment lung excess of the stomach heat syndrome patient is 78.88%, total effective rate 93.73%; Matched group is respectively 67.33%, 87.13%; Comparing difference has statistical significance (P=0.0313, P＜0.05) between group.
Table 2. lung excess of the stomach heat syndrome curative effect comprehensive evaluation result (example, %, PP)
| The example number | Clinical recovery | Produce effects | Effectively | Invalid | Total obvious effective rate % | Total effective rate % | |
| Test group | 303 | 132 | 107 | 45 | 19 | 78.88 | 93.73 |
| Matched group | 101 | 36 | 32 | 20 | 13 | 67.33 | 87.13 |
2, to the different sick therapeutic evaluation results that plant: test group to total obvious effective rate of pharyngitis patient be 79.47%, total effective rate 93.38%; To total obvious effective rate of tonsillitis patient be 78.29%, total effective rate is 94.08%; Comparing difference not statistically significant (P=0.5733, P＞0.05) between different sick kinds.
The different sick kind test group therapeutic evaluation results of table 3. (example, %, PP)
| The example number | Clinical recovery | Produce effects | Effectively | Invalid | Total obvious effective rate % | Total effective rate % | |
| Pharyngitis | 151 | 62 | 58 | 21 | 10 | 79.47 | 93.38 |
| Tonsillitis | 152 | 70 | 49 | 24 | 9 | 78.29 | 94.08 |
3, to therapeutic evaluation result before and after the cardinal symptom treatment: two groups of cases are treated the back all has obvious decline at classification before and after the treatment of cardinal symptom, score value on changing; With treat before statistical significance (P＜0.05) is more all arranged; Compare improvement between group in pharynx or symptoms such as tonsil is red and swollen, scorching hot, thirsty, dry pharynx, cough and expectoration; Obviously be superior to matched group, statistical significance (P＜0.05) is relatively arranged between group.
4, safety evaluatio: no bad incident takes place in process of the test, and is safe and reliable.
(2) model case:
Selection meets case 30 examples of pharyngitis, tonsillitis diagnostic criteria, takes by following method, and the tablet that the embodiment of the invention 6 is processed, each 3, one day 3 times, warm boiled water, 7 days courses of treatment, to enumerate some model cases following at present:
Thank * *, the woman, 55 years old, subjective symptoms: dry pharynx, twinge, expectorant was sticking, difficulty is coughed, foreign body in pharynx sense, nauseating uncomfortable.Through multiple Chinese and western drugs treatment, be difficult to alleviate, outbreak is 5 years repeatedly, and in July, 08, I went to a doctor PE: pharyngeal congestion, kermesinus, lymph foilicie hyperplasia, the impaired thickening of mucosa, secretions increase at institute.Take the tablet 7 days that the embodiment of the invention 5 processes, patient's clinical symptom disappearance, PE: pharyngeal nothing is obviously congested, red and swollen, and lymph follicle reduces, and does not have obvious secretions.Followed up a case by regular visits to 1 year, the state of an illness does not have repeatedly.
The week * *, the man, 28 years old, the engineer, subjective symptoms is pharyngeal to be done, itching has foreign body sensation, the pharyngeal pain of the too many sense of speech, outbreak is 2 years repeatedly, and hospital diagnosis is an acute pharyngitis.Take the treatment by Chinese herbs poor effect.In February, 09, I went to a doctor at institute: PE: pharyngeal congestion, be kermesinus, and retropharyneal folliculosis, mucosal hyperplasia is plump.Take the tablet 15 days that the embodiment of the invention 5 processes, patient's clinical symptoms is clearly better, and defence added with a course of treatment; Clinical symptom disappearance, PE: the pharynx rear wall does not have obvious hyperemia, redness, and the pharynx rear wall does not have obvious lymph follicle; The pharyngeal mucous membrane hypertrophy is clearly better, and does not have obvious secretions.Follow up a case by regular visits to half a year, the state of an illness does not have repeatedly.
The week * *, the man, 55 years old, subjective symptoms: the dry pharynx twinge, after coughing, like drinking-water, the sticking difficulty of expectorant alleviates to some extent, and the normal pharyngeal sense of time-out in morning is felt sick uncomfortable.More very, through multiple Chinese and western drugs treatment, be difficult to alleviate after the smoking, showed effect repeatedly nearly 7 years, in JIUYUE, 08, I went to a doctor PE at institute: pharyngeal congestion, kermesinus, pharynx back lymph wall follicle hypertrophy, the enlargement of tonsil I degree, secretions increase.Take the tablet 7 days that the embodiment of the invention 5 processes, patient's clinical symptom disappearance, PE: pharyngeal nothing is obviously congested, red and swollen, and lymph follicle reduces, and does not have obvious secretions.Followed up a case by regular visits to 1 year, the state of an illness does not have repeatedly.
Old * *, the man, 30 years old, subjective symptoms: pharyngeal sense was felt sick, is retched when Chang Chenqi brushed teeth.Foreign body in pharynx sense 2 years, patient's smoking history 10 years, hospital diagnosis is an acute pharyngitis.Take other multiple Chinese and western drugs treatments, be difficult to alleviate, outbreak repeatedly, in JIUYUE, 08, I went to a doctor PE at institute: pharyngeal mild hyperaemia, pharynx back lymph wall follicle hypertrophy, secretions increase.Take the tablet 8 days that the embodiment of the invention 5 processes, patient's clinical symptom disappearance, PE: pharyngeal nothing is obviously congested, and the pharynx rear wall does not have lymph follicle, does not have obvious secretions.Reach the clinical cure standard, followed up a case by regular visits to 1 year, the state of an illness does not have recurrence.
The enforcement data show: treatment pharyngitis, tonsillitic Chinese medicinal tablet have tangible heat-clearing and toxic substances removing, detumescence sore-throat relieving, antiinflammatory bacteriostatic pharmacodynamic action, and toxicity is very little, and oral safety is for treating pharyngitis, tonsillitis Chinese medicine preparation preferably.
Claims (9)
1. a Chinese medicine composition is characterized in that, comprises raw material and one or more adjuvant drug and/or messenger drug, and the weight portion proportioning of said raw material is:
100 parts-500g of Herba Kalimeridis grass part, 100 parts-500 parts of Radix Achyranthis,
100 parts-500 parts of Radix Ranunculi Ternatis, 100 parts-500 parts of Radix Carpesiis,
50 parts-200 parts of Semen Oroxylis, 50 parts-100 parts of Radix Ophiopogonis;
The weight portion of said adjuvant drug and/or messenger drug is 50 parts-300 parts; Adjuvant drug and/or messenger drug are selected from Radix Platycodonis, Herba Solani Nigri, Herba Plantaginis, Radix Sophorae Tonkinensis, Herba Dendrobii, Rhizoma Belamcandae and the Radix Glycyrrhizae.
2. Chinese medicine composition according to claim 1, said adjuvant drug and/or messenger drug are made up of for 10 parts-50 parts 50 parts-200 parts of Radix Platycodoniss, Herba Solani Nigri.
3. Chinese medicine composition according to claim 1 is characterized in that, said adjuvant drug and/or messenger drug are made up of for 10 parts-50 parts 50 parts-200 parts of Radix Sophorae Tonkinensiss, Herba Dendrobii.
4. Chinese medicine composition according to claim 1 is characterized in that, said adjuvant drug and/or messenger drug are made up of for 10 parts-50 parts 50 parts-200 parts of Rhizoma Belamcandae, Radix Glycyrrhizae.
5. Chinese medicine composition according to claim 1 is characterized in that, said adjuvant drug and/or messenger drug are made up of for 10 parts-50 parts 50 parts-200 parts of Radix Platycodoniss, Herba Plantaginis.
6. according to the described Chinese medicine composition of one of claim 1-5, it is characterized in that said Chinese medicine composition adds adjuvant by common process and processes tablet, capsule, granule, drop pill, micropill, dispersible tablet, oral cavity disintegration tablet, pill, oral liquid; Said adjuvant comprises one or more in solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant and the substrate.
7. the method for preparing of the said Chinese medicine composition of one of claim 1 to 6 is characterized in that, may further comprise the steps:
A) with the raw material decocte with water secondary of the said weight portion of one of claim 1 to 6, add water for the first time, decocted 1.5 hours with respect to 12 times of weight of raw material; Add water for the second time, decocted 1.5 hours with respect to 10 times of weight of raw material;
B) merge twice decocting liquid, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.15-1.20, and vacuum drying gets dry extract;
C) get above-mentioned dry extract, be ground into fine powder and adjuvant is processed preparation.
8. the application of the said Chinese medicine composition of one of claim 1 to 6 in preparation treatment tonsillitis, pharyngitis medicine.
9. the said Chinese medicine composition of one of claim 1 to 6 causes antipyretic-antalgic, the cold cough of heating in preparation treatment upper respiratory tract infection; The constipation that excess-heat causes; The pharyngodynia with dryness that the smoking insobriety causes, the application in the cracked medicine that excessively causes with throat.
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| CN106266710A (en) * | 2016-09-20 | 2017-01-04 | 四川兴聚焦医药科技有限责任公司 | One is used for treating pharyngitis and tonsillitic Chinese medicine composition and preparation method thereof |
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