CN102139081B - Chinese medicinal composition and preparation for treating recurrent oral ulcer and preparation method thereof - Google Patents
Chinese medicinal composition and preparation for treating recurrent oral ulcer and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition for treating recurrent oral ulcer. The Chinese medicinal composition is prepared from the following Chinese herbal medicines in part by weight: 10 to 50 parts of spreading hedyotis herb, 5 to 30 parts of barbed skullcap herb, 5 to 25 parts of pinellia tuber, 10 to 50 parts of job stears, 5 to 30 parts of zedoary and 5 to 20 parts of herba rabdosiae rubescentis. The Chinese medicinal composition has an effect of treating the recurrent oral ulcer and an obvious curative effect, is safe, and does not have toxic or side effects. Meanwhile, animal experiments prove that the Chinese medicinal composition also has an effect of preventing and treating radioactive esophagitis. The Chinese medicinal composition has readily available raw materials, can be prepared into different formulations, has a convenient preparation method, can be easily accepted by a large number of consumers, and has good application and market prospects.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, the specifically a kind of Chinese medicine composition that can effectively treat recurrent oral ulceration, and by oral formulations of said composition preparation and preparation method thereof.
Background technology
Recurrent oral ulceration is a ulcer property infringement disease common in the disease of cari oris mucosa, sharp ache during outbreak, and causalgia is unbearably.Chinese medicine thinks that primary disease is because feelings will is unsuccessful; Plain body is weak; The heresy of diseases caused by exogenous pathogenic factor six climate exopathogens causes that liver loses that bar reaches, dysfunction of the spleen in transportation, stagnation of QI due to depression of the liver, and hot and suffocating fire-transformation, hyperactivity of deficient fire are fumigated in mouth and ill, and secular outbreak repeatedly will directly influence the immunologic function of patient's whole machine body; Cause metabolism disorder; Halitosis, chronic pharyngitis, constipation, headache, dizziness, nauseating, weak, General Symptomies such as energy is concentrated, insomnia, agitation, heating, lymphadenectasis occur, have a strong impact on patient's work, life, even cause and cancerate or canceration.
At present, the method and the medicine of treatment recurrent oral ulceration are a lot, generally have following several kinds:
1, local naturopathy: comprise laser, low frequency ultrasound, chemical erosion (like silver nitrate), physical barriers (like cyanoacrylate adhesive).The defective of the method is, cures the symptoms, not the disease, and it can alleviate the symptom of oral ulcer, but uncontrollable its recurrence.
2, local analgesia agent and antibacterials: benzydamine gargarism or spray, local anesthesia gel, chlorhexidine gargarism, chlortetracycline ointment.This Therapeutic Method defective is the same.
4, other local anti-inflammatory preparations: amlexanox, sodium cromoglicate cough syrup, PGE2 glue, local granulocyte one macrophage stimulation factor, aspirin gargarism, diclofenac, ulcerlmin.
5, Chinese traditional treatment: existing Chinese medicine preparation does not have special medicine to recurrent oral ulceration, is mostly to remove the symptom of " hyperactivity of deficient fire ", does not cause fundamentally playing therapeutical effect but do not suit the remedy to the case.
In sum, can treat recurrent oral ulceration and the medicine that has no side effect is the focus that those skilled in the art study.
Summary of the invention
The purpose of this invention is to provide a kind of heat-clearing and toxic substances removing, supplementing QI and nourishing YIN, the removing heat from blood dampness removing is used to treat recurrent oral ulceration, to the also medicable Chinese medicine composition of prevention radiation esophagitis.
Another object of the present invention is to propose a kind of method for preparing of above-mentioned Chinese medicine composition.
A purpose more of the present invention is to propose to utilize the preparation of above-mentioned Chinese medicine composition preparation.
The present invention selects Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, the Rhizoma Pinelliae, Semen Coicis, Rhizoma Curcumae and the combination of Rabdosia rubescens six medicaments for use, thereby effectively plays the treatment recurrent oral ulceration.The brief introduction of six medicaments medical material effect is following:
Herba Hedyotidis Diffusae: property bitter but sweet flavor; Cold; Nontoxic.GUIXIN; Liver; Spleen; Large intestine channel.Function cures mainly: heat-clearing and toxic substances removing; Dampness removing.Main dyspnea and cough due to lung-heat; Laryngopharynx swelling and pain; The intestinal carbuncle; The furuncle and phyma skin infection; Venom; The puckery pain of pyretic stranguria; Edema; Dysentery; Intestinal is scorching; Jaundice due to damp-heat; Cancerous protuberance.
Herba Scutellariae Barbatae: nature and flavor are hot, bitter, and are cold.Return lung, liver, kidney channel.Function with cure mainly: heat-clearing and toxic substances removing, blood stasis dispelling diuresis.Be used for furuncle swelling toxin, venom falls and pounces on the pain of injury, edema, jaundice.
The Rhizoma Pinelliae: nature and flavor are hot, and temperature is poisonous.Be included into spleen, stomach warp.It is poisonous to have the hot warm-dryness syndrome that looses, and mainly goes into that taste are double goes into lung, and the water of manage it wets, lowering the adverse flow of QI, and the effect of the taste damp-phlegm of being apt to dispel.
Semen Coicis: cool in nature, sweet in the mouth, light.Function cures mainly: spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal.Can be used for treating edema, beriberi, dysuria, arthralgia chiefly caused by damp pathogen contracture, diarrhea due to hypofunction of the spleen.
Rhizoma Curcumae: nature and flavor are hot, bitter, temperature.Return liver, spleen channel.Function with cure mainly: the removing blood stasis promoting the circulation of QI to relieve pain, can treat amenorrhea due to stagnation of blood stomachache, abdominal mass, gather.
Rabdosia rubescens: nature and flavor are bitter, sweet, be slightly cold.Good heat clearing away poison, promoting blood circulation and stopping pain, antibacterial, antitumor action are arranged, cure mainly laryngopharynx swelling and pain, tonsillitis, headache due to common cold, tracheitis, chronic hepatitis, joint rheumatalgia, snake bite and insect sting etc.
Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae heat-clearing and toxic substances removing; Semen Coicis, Rhizoma Curcumae, the Rhizoma Pinelliae, Rabdosia rubescens eliminating damp, detoxifying phlegm reduction of blood circulation promoting; The present invention is aided with Rhizoma Paridis, Folium Bambusae, Gypsum Fibrosum, Radix Scrophulariae, Radix Ginseng, Radix Glehniae, Radix Ophiopogonis and Radix Glycyrrhizae on the basis of above-mentioned six medicaments compositions; The supplementing QI and nourishing YIN removing pathogenic heat from blood and toxic substance from the body, the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.
Its effect brief introduction is following:
Rhizoma Paridis: another name, Rhizoma Paridis, Rhizoma Paridis, Typhonium divaricatum (L.) Decne.Cold nature, bitter in the mouth; Slightly poisonous.Function cures mainly: heat-clearing and toxic substances removing, reducing swelling and alleviating pain, cool liver arresting convulsion.Make in furuncle swollen carbuncle, laryngopharynx swelling and pain, venom, fall and pounce on the pain of injury, convulsion with spasms.
Folium Bambusae: the property slightly sweet flavor, cold.Has clearing heat and relieving fidgetness, the diuretic effect of promoting the production of body fluid.
Gypsum Fibrosum: the Gypsum Fibrosum main component is a hydrous calcium sulfate.Ferrum, magnesium etc. that a small amount of silicic acid, aluminium hydroxide, sulfide and trace are still arranged in addition.For oral administration through the gastric acid effect, a part becomes soluble calcium salt, the concentration to increasing calcium ion in the serum after blood is gone in intestinal absorption, can suppress thermotaxic centre, alleviate skeletal muscle irritability, reduce vascular permeability, so effects such as analgesic, spasmolytic, antiinflammatory are arranged.
Radix Scrophulariae: removing heat from blood YIN nourishing, eliminating fire and detoxication, fever excessive thirst, spontaneous sweating, haematemesis nose bleeding, pharyngolaryngitis, pulmonary tuberculosis.Be used for consumption of YIN caused by febrile disease, crimson tongue excessive thirst, maculae caused by violent heat pathogen, Tianjin and hinder constipation, hectic fever due to YIN-deficiency chronic cough, conjunctival congestion, pharyngalgia, scrofula, diphtheria, carbuncle sore tumefacting virus etc.
Radix Ginseng: property is flat, sweet in the mouth, little hardship, tepor.Return spleen, lung meridian.Have strongly invigorating primordial QI, multiple arteries and veins takes off invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst, the effect of the Fructus Alpiniae Oxyphyllae of calming the nerves admittedly.
Radix Glehniae: cold nature, sweet in the mouth, little hardship.Function cures mainly: nourishing YIN and clearing away lung-heat, reinforcing stomach reg fluid.It is thirsty to be used for lung-heat type cough, chronic cough expectorant blood, calentura Tianjin wound.
Radix Ophiopogonis: have the sick impairment of body fluid of replenishing YIN and removing heat treatment interior-heat caused by deficiency of YIN or calentura, restlessness and thirst.Cough, expectorant due to the nourishing the lung to arrest cough treatment dryness-heat impairing the lung is thick, the effect of the QI rising in reverse order.
Radix Glycyrrhizae: Radix Glycyrrhizae property is flat, and sweet in the mouth is returned 12 warps.Detoxifcation arranged, eliminate the phlegm, pain relieving, spasmolytic be so that pharmacological action such as anticancer.On the traditional Chinese medical science, the Radix Glycyrrhizae invigorating the spleen and replenishing QI is grown and to be coughed lung moistening, and the emergency detoxifcation is in harmonious proportion hundred medicines.The clinical practice branch " is given birth to and uses " with " processed with honey " not.Give birth to curing mainly laryngopharynx swelling and pain cellulitis skin infection, gastrointestinal ulceration and separate poison of drug, alimentary toxicosis etc.; Processed with honey cures mainly spleen and stomach function and goes down, and big loose stool is thin, weak heating and cough, cardiopalmus etc.
Concrete technical scheme of the present invention is following:
A kind of treatment recurrent oral ulceration Chinese medicine composition, said compositions is processed by following raw materials in weight portion medicine:
Herba Hedyotidis Diffusae 10～50 weight portions, Herba Scutellariae Barbatae 5～30 weight portions, the Rhizoma Pinelliae 5～25 weight portions, Semen Coicis 10～50 weight portions, Rhizoma Curcumae 5～30 weight portions, Rabdosia rubescens 5～20 weight portions.
Said compositions optimum weight part proportioning is:
Herba Hedyotidis Diffusae 30 weight portions, Herba Scutellariae Barbatae 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Semen Coicis 30 weight portions, Rhizoma Curcumae 10 weight portions, Rabdosia rubescens 10 weight portions.
Said compositions also comprises by following raw materials in weight portion medicine:
Rhizoma Paridis 3～20 weight portions, Folium Bambusae 5～20 weight portions, Gypsum Fibrosum 5～25 weight portions, Radix Scrophulariae 5～20 weight portions, Radix Ginseng 2～8 weight portions, Radix Glehniae 3～15 weight portions, Radix Ophiopogonis 10～30 weight portion, Radix Glycyrrhizae 5～10 weight portions.
Above-mentioned composition optimum weight part proportioning is:
Rhizoma Paridis 10 weight portions, Folium Bambusae 10 weight portions, Gypsum Fibrosum 15 weight portions, Radix Scrophulariae 10 weight portions, Radix Ginseng 6 weight portions, Radix Glehniae 10 weight portions, Radix Ophiopogonis 30 weight portion, Radix Glycyrrhizae 6 weight portions.
A kind of treatment recurrent oral ulceration Chinese medicine preparation, said preparation is processed by acceptable auxiliary on above-mentioned Chinese medicine composition and the pharmaceutics.
Said preparation the best is an oral formulations.Said oral formulations is pill, powder, granule, tablet, capsule, soft extract, drop pill, syrup or medicinal tea.According to the difference of route of administration, the present composition also can be made into general external preparation, like oral spray or unguentum etc.But be not limited to above-mentioned dosage form, can be according to known method in the field of traditional Chinese, process various different dosage forms after aforementioned pharmaceutical compositions extracted by known method.
A kind of method for preparing above-mentioned Chinese medicine composition, concrete steps are following:
(1) takes by weighing each crude drug according to said components and consumption;
(2) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four were distinguished the flavor of herbal medicine immersions more than 30 minutes; Crude drug after the immersion adds water and mixes agitating heating, and boil water is carried 2 times, extracts 1～3 hour at every turn, adds 10 times of amounts of water; Merge extracted twice liquid;
(3) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1～3 hour, add 10 times of amounts of water; Merge extracted twice liquid;
(4) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
A kind of treatment treatment recurrent oral ulceration Chinese medicine granules, the active component that step (4) is prepared is condensed into extractum, density 1.2kg/m for 60～65 ℃
3, drying and granulating, packing.
The application of the activity extract of step (4) preparation in preparation treatment recurrent oral ulceration Chinese medicine preparation.
The granular preparation that the present invention processes.Its usage and consumption are following:
Method: granule of the present invention three times on the one, warm water is taken after mixing it with water; 7 days one courses of treatment.
Consumption: each 12g.
Advantage of the present invention and benefit:
The present invention has the effect of treatment recurrent oral ulceration, and evident in efficacy, safe without toxic side effect.Simultaneously, confirm that through zoopery the present invention also has the effect of the radiation esophagitis of preventing and treating.Raw material of the present invention obtains simply, can be prepared into different dosage form, and method for preparing is convenient, is easy to accepted by consumers in general, has good application and market prospect.
Foregoing invention content part of the present invention has been done detailed description to technical scheme of the present invention, and those skilled in the art get final product repetition the present invention and obtain technique effect of the present invention according to foregoing.Through the specific embodiment technology contents of the present invention being done further explanation below, understand content of the present invention so that those skilled in the art are clearer, is not limitation of the present invention, anyly is equal to replacement or known change all belongs to protection domain of the present invention.
Description of drawings
Describe embodiment of the present invention in detail below in conjunction with accompanying drawing:
Fig. 1 changes for the histopathology of each group rat esophagus mucosa;
Fig. 2 is each group rat average weight every day change curve;
Fig. 32 days was the initial average daily food-intake broken line graph of rat of respectively organizing for pre-irradiation.
The specific embodiment
The used medical material of present embodiment all can enough can buy from China Medicament Group Corp., meets 2005 editions standards of Pharmacopoeia of People's Republic of China.Other compositions are the conventional adjuvant of the field of Chinese medicines, also all can obtain through commercially available purchase.
The preparation of embodiment 1 granule of the present invention
(1) take by weighing each crude drug according to following component and consumption:
Herba Hedyotidis Diffusae 1000g, Herba Scutellariae Barbatae 3000g, Rhizoma Pinelliae 2500g, Semen Coicis 5000g, Rhizoma Curcumae 500g, Rabdosia rubescens 500g.
(2) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked in water 30 minutes; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 1 hour.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 200 orders filter, boil and carried out second extraction in 1 hour.Merge extracted twice liquid.
(3) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1 hour, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(4) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(5) get step (4) extracting solution, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, reuse spray-drying pelleting machine spray-drying process is used the particles packing machine packing at last, every bag of 12g.
The preparation of embodiment 2 granules of the present invention
(1) take by weighing each crude drug according to following component and consumption:
Herba Hedyotidis Diffusae 5000g, Herba Scutellariae Barbatae 1000g, Rhizoma Pinelliae 500g, Semen Coicis 1000g, Rhizoma Curcumae 3000g, Rabdosia rubescens 2000g.
(2) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked 1 hour in water; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 2 hours.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 200 orders filter, boil and carried out second extraction in 2 hours.Merge extracted twice liquid.
(3) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 2 hours, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(4) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(5) get step (4) extracting solution, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, reuse spray-drying pelleting machine spray-drying process is used the particles packing machine packing at last, every bag of 12g.
The preparation of embodiment 3 granules of the present invention
(1) take by weighing each crude drug according to following component and consumption:
Herba Hedyotidis Diffusae 3000g, Herba Scutellariae Barbatae 1500g, Rhizoma Pinelliae 1500g, Semen Coicis 3000g, Rhizoma Curcumae 1000g, Rabdosia rubescens 1000g.
(2) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked in water 90 minutes; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 1 hour.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 100 orders filter, boil and carried out second extraction in 1 hour.Merge extracted twice liquid.
(3) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1 hour, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(4) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(5) get step (4) extracting solution, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, reuse spray-drying pelleting machine spray-drying process is used the particles packing machine packing at last, every bag of 12g.
The preparation of embodiment 4 granules of the present invention
(1) take by weighing each crude drug according to following component and consumption:
Herba Hedyotidis Diffusae 3000g, Herba Scutellariae Barbatae 1500g, Rhizoma Pinelliae 1500g, Semen Coicis 3000g, Rhizoma Curcumae 1000g, Rabdosia rubescens 1000g, Rhizoma Paridis 1000g, Folium Bambusae 1000g, Gypsum Fibrosum 1500g, Radix Scrophulariae 1000g, Radix Ginseng 600g, Radix Glehniae 1000g, Radix Ophiopogonis 3000g, Radix Glycyrrhizae 600g.
(2) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked 1 hour in water; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 1 hour.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 200 orders filter, boil and carried out second extraction in 1 hour.Merge extracted twice liquid.
(3) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1 hour, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(4) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(5) get step (4) extracting solution, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, reuse spray-drying pelleting machine spray-drying process is used the particles packing machine packing at last, every bag of 12g.
The preparation of embodiment 5 capsules of the present invention
Crude drug and consumption:
Herba Hedyotidis Diffusae 3000g, Herba Scutellariae Barbatae 1500g, Rhizoma Pinelliae 1500g, Semen Coicis 3000g, Rhizoma Curcumae 1000g, Rabdosia rubescens 1000g, Rhizoma Paridis 300g, Folium Bambusae 2000g, Gypsum Fibrosum 2500g, Radix Scrophulariae 500g, Radix Ginseng 800g, Radix Glehniae 300g, Radix Ophiopogonis 1000g, Radix Glycyrrhizae 500g.
Method for preparing:
(1) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked 1 hour in water; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 1 hour.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 200 orders filter, boil and carried out second extraction in 1 hour.Merge extracted twice liquid.
(2) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1 hour, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(3) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(4) get step (3) extracting solution, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, drying: in vacuum is that 0.01～0.02Mpa, temperature are 40～60 ℃ of dryings down, makes dried medicated powder.
(5) divide in the soft capsule of packing into and promptly make capsule, the 0.5g/ grain.
The preparation of embodiment 6 pills of the present invention
Main active component in this prescription is processed ball shape preparation, be divided into common (large and small) ball shape preparation and little dropping pill formulation.The binding agent that uses is different, can be made into honeyed pill, the watered pill, paste pill, wax pill and concentrated pill etc.
Crude drug and consumption:
Herba Hedyotidis Diffusae 5000g, Herba Scutellariae Barbatae 1000g, Rhizoma Pinelliae 500g, Semen Coicis 1000g, Rhizoma Curcumae 3000g, Rabdosia rubescens 2000g, Rhizoma Paridis 2000g, Folium Bambusae 500g, Gypsum Fibrosum 500g, Radix Scrophulariae 2000g, Radix Ginseng 200g, Radix Glehniae 1500g, Radix Ophiopogonis 2000g, Radix Glycyrrhizae 1000g.
Method for preparing:
(1) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked 1 hour in water; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 1 hour.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 200 orders filter, boil and carried out second extraction in 1 hour.Merge extracted twice liquid.
(2) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1 hour, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(3) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(4) get step (3) extracting solution---active component, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, add suitable binding agent and adjuvant and process spherical preparation.
The preparation of embodiment 7 soft extracts of the present invention
Main active component in this prescription is processed ball shape preparation, be divided into common (large and small) ball shape preparation and little dropping pill formulation.The binding agent that uses is different, can be made into honeyed pill, the watered pill, paste pill, wax pill and concentrated pill etc.
Crude drug and consumption:
Herba Hedyotidis Diffusae 1000g, Herba Scutellariae Barbatae 3000g, Rhizoma Pinelliae 2500g, Semen Coicis 5000g, Rhizoma Curcumae 500g, Rabdosia rubescens 500g, Rhizoma Paridis 2000g, Folium Bambusae 500g, Gypsum Fibrosum 500g, Radix Scrophulariae 2000g, Radix Ginseng 200g, Radix Glehniae 1500g, Radix Ophiopogonis 2000g, Radix Glycyrrhizae 1000g.
Method for preparing:
(1) Agkistrodon house grass, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four flavor Chinese medicines were soaked 1 hour in water; Crude drug after the immersion adds 10 times of water gagings and mixes agitating heating, boils from liquid constantly to pick up counting, and boils 1 hour.Stop heating, be cooled to room temperature, add the water of 10 times of amounts of dose after 200 orders filter, boil and carried out second extraction in 1 hour.Merge extracted twice liquid.
(2) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1 hour, add 10 times of amounts of water; Merge extracted twice liquid; The same step of concrete steps (2).
(3) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
(4) get step (3) extracting solution---active component, become extractum, density 1.2kg/m with vacuum external circulation evaporator cryoconcentration (60～65 ℃)
3, adding refined honey and receive cream, the refined honey addition is as the criterion to be no more than 3 times of extractum.Packing is finished product.
The present invention treats recurrent oral ulceration clinical experiment and interpretation of result
1 data and method
1.1 physical data
80 routine recurrent oral ulceration patients are the outpatient of Chinese People's Liberation Army General Hospital, carry out randomized controlled trial in proper order by prescription on individual diagnosis, and 60 examples are organized in treatment, matched group 20 examples; Age 26-56 year, 37 years old mean age, course of disease person's 4 examples within 3 years, person's 35 examples more than 3 years, person's 41 examples more than 5 years, male patient's 45 examples, female patient 35 examples.
1.2 inclusion criteria
(l) stomatocace show effect repeatedly (annual outbreak more than 10 times); Showing effect continuously, person (2) occurs in the pain of the ulcer of lip, oral mucosa, gingiva, tongue body, scorching hot, xerostomia halitosis more than 1 year; Ulcer number 1-5 visiblely oozes out, hyperemia, edema etc. show as the master.
1.3 Therapeutic Method
The granule that the treatment group prepares with embodiment four, 12g, 3 times/day, warm water is taken after mixing it with water; Matched group is used kouyanqing granules 20g, and 2 times/day, warm water is taken after mixing it with water; All treated 7 days for two groups, judge curative effect.
1.4 observation index
Local disease is decreased evaluation criteria and is as the criterion with ulcer variation healing degree and the scorching hot degree of pain.
Clinical cure: medication is transference cure after 7 days, and sign disappears basically, and Peptic Ulcers is decreased all healings, and the leading indicator integration is 0 or 1.
Produce effects: medication is transference cure after 7 days, and sign all has clear improvement, and ulcer healing reaches 2/3, or ulcer shoals and dwindle, and integration leading indicator integration is l, and two is 2.
Effectively: medication is transference cure after 7 days, and sign all take a favorable turn, ulcer healing reach 1/3 or ulcer shoal and dwindle, it is 3 that integration leading indicator integration is 2, two.
Invalid: medication cardinal symptom after 7 days, sign are improved not obvious, the basic no change of ulcer, and main integration index is 3 or 4.
1.5 statistical method
Adopt the t check to carry out statistical procedures.
2 results
2.1 the recurrent oral ulceration curative effect relatively
Through clinical observation, can improve the cardinal symptom of recurrent oral ulceration in 7 days: ulcer area, ulcer number, edema, ulcer pain, burning sensation, xerostomia and syndrome classification; To recurrent oral ulceration recovery from illness case Follow-up results relatively, the comparison of 1 month two groups of relapse rate, the treatment group is superior to matched group; Self-appraisal pain is improved situation, the comparison of pain self-appraisal total points situation before and after the comparison of marking, treatment, the evaluation and the comparison of curative effect through two groups of experimenters, statistical significance is all arranged.
For the comparison of two groups of relapse rates after 1 month of treatment recurrent oral ulceration (light-duty, stomatitis type), difference has statistical significance, and < 0.05, the overall merit of observing after adding up is that the curative effect that the reduction of treatment group is recurred is superior to matched group to p.See table 1.
Table 1 liang group recurrent oral ulceration curative effect relatively
2.2 untoward reaction
All do not find obvious adverse reaction before and after two groups of treatments.
3 conclusions
The present invention is evident in efficacy to recurrent oral ulceration, safe without toxic side effect, and relapse rate is low.
The present invention is directed to the experimentation of control rat radiation esophagitis
1 material and method
1.1 laboratory animal
56 of healthy Wistar rats, male, body weight 160～200g.Provided by Military Medical Science Institute's Experimental Animal Center, the quality certification number is SCXK (army) 2007-004.
1.2 main agents and instrument
60Co irradiation unit (Military Medical Science Institute's radiological medicine and radiation protection Institute for Medical Research); Pathological section machine (Shanghai-German joint Lycra DM9000); OLYMPUS BX40 microscope (Japan); Motic IMAQ and processing system (China-Canada is joint), electronic balance (China).
3% pentobarbital sodium, H.E dye liquor, 10% formalin.
1.4 divide into groups and medication
Group technology: laboratory animal is divided into 5 groups at random:
A group: 8 of normal control groups;
B group: 12 of simple irradiation group;
C group: 12 of small dose group of the present invention;
The D group: dose groups is 12 among the present invention;
E group: 12 of high dose group of the present invention.
Medication: A group: be left intact; B group: give the 1ml/100g normal saline 1 time every day and irritate stomach; C, D, E group are irritated stomach by the granule 1ml/100g that gives little, middle and high dosage every day embodiment 4 preparations for 1 time respectively; Successive administration 14～21 days, i.e. pre-irradiation beginning in 7 days administration, irradiation continued administration 7～14 days.Granule dosage of the present invention 5 times, 10 times, calculates that the animal dose is low dose of 1.15g/Kg, middle dosage 2.3g/Kg, high dose 4.6g/Kg by 2.5 times of adult's (70Kg) normal dose.
1.5 illuminating method
Discover that through preliminary experiment use the irradiation of this institute cobalt source, exposure dose rate is at 490cGy/min, exposure dose can cause the rat radiation esophagitis more than 30Gy, and exposure dose excessive (35Gy/min) then is difficult for the effect of performance medicine.So illuminating method is decided to be: 3% pentobarbital anesthetized rat extremity are fixed on the special irradiation frame, place on the irradiation table apart from the high 1m of cobalt source center 3m, the tooth hanging wire is regulated irradiation field, and irradiation field is rat esophagus epimere to thyroid hypomere 3mm place.To 30cm * 20cm * 5cm lead brick irradiation hole, all the other positions shield with double-deck lead brick with the rat esophagus epimere outside of belly, and exposure dose rate is 490.25Gy/min, and exposure dose is 30Gy.
1.6 the making of esophagus Pathologic specimen and observation
With experimental rat in each experimental point, promptly shine back 7 days every group get 4 rats, shine to get in back 14 days and respectively organize survival rats, get total length esophageal tissue down in 3% pentobarbital anesthesia and carry out 10% formalin and fix, the back dewaters, transparent, waxdip, FFPE.Section, after H.E dyeing in the pathological change of microscopically tissues observed.
1.7 the rat ordinary circumstance detects
To shining back 14 days, take by weighing the variation of surviving animals food ration and body weight pre-irradiation 7 days every day, and observe the animal mental status, behavior variation and feces situation.
1.8 radiation esophagitis pathological diagnosis and standards of grading
Set up the pathological change marking system, respectively according to esophageal tissue's degree of injury and the cell infiltration degree of depth and degree observation score:
Be divided into 0 (remembering 0 fen) according to esophageal tissue's degree of injury: mucous layer, Submucosa, flesh layer and theca externa all do not have the pathology damage; + (remembering 1 fen): the slight necrosis of mucosal epithelium come off (the base intercellular substance has minute crack for the attenuation that comes off of squamous epithelial cancer layer, prickle cell layer, basal layer slight damage, basal layer cell Mild edema or indivedual kitchen range shape nuclear boat cavity); ++ (remembering 2 fens): mucosal epithelium moderate necrosis come off (squamous epithelial cancer layer, prickle cell layer, basal cell layer segment or focal necrosis come off, basal layer cell intermediate edema or a plurality of kitchen range shape nuclear boat cavity); +++(note 3 minutes): mucosal epithelium severe necrosis come off (squamous epithelial cancer layer, prickle cell layer, basal cell layer major part or completeness necrosis come off, and the scope of coming off accounts for more than 60%, visible a plurality of kitchen range shapes nuclear boat cavitys of basal layer cell, and see indivedual ulcer kitchen ranges).
Be divided into 0 (remembering 0 fen) according to the cell infiltration degree of depth and degree: mucous layer, Submucosa, flesh layer and skin all do not have cell infiltration; + (remembering 1 fen): lamina propria and Submucosa have a small amount of cell infiltration (n < 5 neutrophil/HP), do not invade flesh layer and theca externa; ++ (remembering 2 fens): amount cell infiltration (5>n < 10 neutrophil/HP) during lamina propria and Submucosa have; +++(note 3 minutes): lamina propria and Submucosa have a large amount of cell infiltration (n>510neutrophil/HP), and flesh layer and theca externa all have cell infiltration.
The pathological change integration is tissue injury and cell infiltration integration sum.
1.9 the statistical procedures of data
Each organizes pathological score The data method of analysis of variance, and rat body weight and food ration The data match repeated merasurements model carry out data analysis.Data analysis adopts SAS9.1 software to carry out analyzing and processing.
2 results
2.1 respectively organizing the histopathology of rat esophagus mucosa changes
The rat esophagus tissue is divided into horny layer, mucous layer, tela submucosa, flesh layer and theca externa.The normal esophageal mucous layer is intact, and mucosa is no cell infiltration down, shown in Fig. 1 a.Simple irradiation back the 7th day rat mucous membrane of esophagus is rotten to the corn, rough, and the microscopically visible vessels is congested; Epithelium of esophagus comes off on a large scale, and lamina propria, tela submucosa have a large amount of cell infiltration, and inflammatory cell is main with neutrophilic granulocyte; The 14th day esophageal disease check result of science in simple irradiation back is similar with the 7th day; The visible exuviation of microscopically is downright bad, and lamina propria, tela submucosa, flesh layer, theca externa all have a large amount of cell infiltration, and inflammation is destroyed heavy zone; Inflammatory cell is main with neutrophilic granulocyte, and the peripheral region has the eosinophilic granulocyte to be dispersed in.Shown in Fig. 1 b.
Granule intervention group rat esophagus mucous epithelium of the present invention has reparation in various degree, and pathological manifestations is similar, visible horny layer, mucous layer, tela submucosa, flesh layer and theca externa structural integrity, and mucous epithelium is continuous; Prickle cell layer, basal cell layer hyperplasia; Inflammatory cell quantity reduces or disappears.Small dose group is shone inspection in back 7 days and is seen that mucosal epithelium is slight or moderate is downright bad and come off that lamina propria and tela submucosa do not have or have a small amount of cell infiltration.Shine inspection in back 14 days and see mucosal epithelium nipple hypertrophy, cuticular layer thickening, lamina propria and theca externa hypertrophy, mucosal epithelium variation, a small amount of cell infiltration.In dose groups shine that inspection in back 7 days sees that mucosal epithelium does not have or slight necrosis comes off, lamina propria and tela submucosa do not have or have a small amount of cell infiltration.Shine inspection in back 14 days and see that mucosal epithelium nipple hypertrophy, cuticular layer thickening, lamina propria and theca externa hypertrophy, mucosal epithelium do not have and come off that lamina propria and tela submucosa NIP cellular infiltration are like Fig. 1 c; Heavy dose of group irradiation inspection in back 7 days sees that mucosal epithelium does not have or slight necrosis comes off, and lamina propria and tela submucosa do not have or a small amount of cell infiltration is arranged, and it is identical basically with the 7th day to shine back 14 days check results, like Fig. 1 d.Respectively organize rat esophagus histopathology score and carry out statistical analysis, result such as table 2 according to the marking system evaluation:
Damage of table 2 esophageal tissue and the scoring of cell infiltration degree
Because matched group is complete 0, can't calculate, so do not do analysis.Remain four groups, do dependent variable with scoring, divide into groups and time point as independent variable, use the GLM model of fit, the result shows, dose groups and heavy dose of group and model group all have significant difference (P < 0.05) among the present invention, other each organize between indifference.
2.2 respectively organize the variation of body weight behind the rat pre-irradiation
Each group rat body weight every day is carried out record, and result of calculation is seen table 3.
Table 3 is respectively organized rat body weight every day record
* BI: before the radiation; .# after the AI radiation; & DI: radiate the same day.
This group data are repeated measurement data, are covariant with body weight before the medicine, with the GLM process of SAS to each time point weight increase match repeated merasurements model.Four point of observation operational analyses in 14 days behind 7 days, radiotherapy before drawing medicine, after radiotherapy same day, radiotherapy; The result is: respectively organizing body weight before the administration does not have statistical significance to each time point weight increase; The 7th day is no statistics difference (F=0.18 between each group of radiotherapy weight increase on the same day after the administration; P=0.9473) the 7th day weight increase has difference (F=19.32, P < 0.0001) after the radiotherapy between different grouping, and the Tukey The result of multiple comparisons is: between matched group and each processed group significant difference is arranged; Significant difference (P < 0.05) is arranged between model group and the heavy dose of group group of compound recipe SHELIAN granule in addition, other each organize between indifference.After the radiotherapy the 7th day with administration after the 6th day weight increase compare significant difference between processed group (F=13.68, P < 0.0001).After the radiotherapy the 14th day weight increase between different grouping indifference (F=1.44, P=0.2457), but after the radiotherapy 14 days with radiotherapy after the 7th day weight increase compare, significant difference between processed group (F=5.99, P=0.0012).
Rat average weight every day change curve is respectively organized in drafting according to data, can find out intuitively that also respectively organizing rat body weight changes difference.
See Fig. 2.Pre-irradiation 7 days is promptly respectively organized the average original body weight no significant difference of rat, rises to same slope straight line basically and shines the same day.Back matched group continues to rise with same slope straight line; The model group body weight obviously drops to gos up after irradiation reached minimum in back 8 days; Treatment group irradiation back body weight maintains an equal level or slightly drops to the beginning in the 7th day of irradiation back to go up with the slope identical with matched group basically.Shone back 14 days, the treatment group is respectively organized body weight and is all obviously organized dose groups ﹥ small dose group among the ﹥ greater than model group less than matched group and heavy dose.
2.3 respectively organize the variation of average daily food-intake behind the rat pre-irradiation
Rat every food-intake every day, result such as table 4 respectively organized in record.
Table 4 is respectively organized the average daily food-intake record of rat
This group data are repeated measurement data, and it is carried out covariance analysis.Ingesting the same day with radiotherapy in the 7th day behind the medicine is covariant;, pick and place and treat after the same day, the radiotherapy 7 days each time point food ration match repeated merasurements model with the GLM process of SAS, carried out operational analysis for point of observation in 14 days after the radiotherapy; The result is following: radiotherapy was ingested the same day does not have significant difference (F=1.05 between group; P=0.3930), ingested in the 7th day after the radiotherapy difference is arranged between different grouping (F=212.00, P .0001); Tukey The result of multiple comparisons:, the two indifference of middle dose groups high, statistics difference (P < 0.05) is arranged all between other wantonly 2 groups except that the present invention.Compared with radiotherapy weight increase on the same day in the 7th day after the radiotherapy, significant difference between processed group (F=70.64, P .0001).Ingested in 14 days after the radiotherapy difference is arranged between different grouping (F=7.86, P=0.0002).After the radiotherapy 14 days with radiotherapy after ingested in 7 days and to compare, significant difference between processed group (F=18.90, P < .0001).
Respectively organized the average daily food-intake broken line graph of rat for initial drafting in 2 days according to the record data pre-irradiation, see Fig. 3, found out by Fig. 3, normal control group visible curve is more steady, does not have obviously fluctuation; Simple irradiation group sees that irradiation appetite on the same day obviously descends, shine to continue to be dropped rapidly to irradiation back the 7th day after ging up in back 1 day, after begin progressively to go up, return original food-intake basically to shining back 12 days.Treatment group food-intake variation tendency and model group are roughly the same, but the curve fluctuating margin obviously reduces, and are outstanding with the heavy dose group especially.
3 conclusions
Granule of the present invention can obviously alleviate the pathology damage degree of rat radiation esophagitis, reduces inflammatory cell and invades profit; Increase the food-intake of rat, prevent to lose weight, improve ordinary circumstance; And it is more remarkable to increase effect with dosage.Explain that compound recipe SHELIAN granule has tangible protective action to the rat radiation esophagitis.
Claims (10)
1. treat the recurrent oral ulceration Chinese medicine composition for one kind, it is characterized in that said compositions is processed by following raw materials in weight portion medicine:
Herba Hedyotidis Diffusae 10～50 weight portions, Herba Scutellariae Barbatae 5～30 weight portions, the Rhizoma Pinelliae 5～25 weight portions, Semen Coicis 10～50 weight portions, Rhizoma Curcumae 5～30 weight portions, Rabdosia rubescens 5～20 weight portions.
2. Chinese medicine composition according to claim 1 is characterized in that, said compositions is processed by following raw materials in weight portion medicine:
Herba Hedyotidis Diffusae 30 weight portions, Herba Scutellariae Barbatae 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Semen Coicis 30 weight portions, Rhizoma Curcumae 10 weight portions, Rabdosia rubescens 10 weight portions.
3. treat the recurrent oral ulceration Chinese medicine composition for one kind, it is characterized in that said compositions is processed by following raw materials in weight portion medicine:
Herba Hedyotidis Diffusae 30 weight portions, Herba Scutellariae Barbatae 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Semen Coicis 30 weight portions, Rhizoma Curcumae 10 weight portions, Rabdosia rubescens 10 weight portions;
Rhizoma Paridis 3～20 weight portions, Folium Bambusae 5～20 weight portions, Gypsum Fibrosum 5～25 weight portions, Radix Scrophulariae 5～20 weight portions, Radix Ginseng 2～8 weight portions, Radix Glehniae 3～15 weight portions, Radix Ophiopogonis 10～30 weight portion, Radix Glycyrrhizae 5～10 weight portions.
4. Chinese medicine composition according to claim 3 is characterized in that, said compositions is processed by following raw materials in weight portion medicine:
Herba Hedyotidis Diffusae 30 weight portions, Herba Scutellariae Barbatae 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Semen Coicis 30 weight portions, Rhizoma Curcumae 10 weight portions, Rabdosia rubescens 10 weight portions;
Rhizoma Paridis 10 weight portions, Folium Bambusae 10 weight portions, Gypsum Fibrosum 15 weight portions, Radix Scrophulariae 10 weight portions, Radix Ginseng 6 weight portions, Radix Glehniae 10 weight portions, Radix Ophiopogonis 30 weight portion, Radix Glycyrrhizae 6 weight portions.
5. a treatment recurrent oral ulceration Chinese medicine preparation is characterized in that said preparation is processed by acceptable auxiliary on any said Chinese medicine composition and the pharmaceutics in the claim 1 to 4.
6. treatment recurrent oral ulceration Chinese medicine preparation according to claim 5 is characterized in that said preparation is an oral formulations.
7. treatment recurrent oral ulceration Chinese medicine preparation according to claim 6 is characterized in that said oral formulations is pill, powder, granule, tablet, capsule, soft extract, drop pill, syrup or medicinal tea.
8. method for preparing any said Chinese medicine composition in the claim 1 to 4 is characterized in that concrete steps are following:
(1) takes by weighing each crude drug according to any said component and consumption in the claim 1 to 4;
(2) Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Rabdosia rubescens, Folium Bambusae four were distinguished the flavor of herbal medicine immersions more than 30 minutes; Crude drug after the immersion adds water and mixes agitating heating, and boil water is carried 2 times, extracts 1～3 hour at every turn, adds 10 times of amounts of water; Merge extracted twice liquid;
(3) all the other the crude drug boil water except that the said crude drug of step (2) are carried 2 times, each 1～3 hour, add 10 times of amounts of water; Merge extracted twice liquid;
(4) extracting solution with step (2) and step (3) mixes, and is prepared into active component.
9. a treatment treatment recurrent oral ulceration Chinese medicine granules is characterized in that the active component that claim 8 is prepared is condensed into extractum, density 1.2kg/m for 60～65 ℃
3, drying and granulating, packing.
10. the application of the activity extract of claim 8 preparation in preparation treatment recurrent oral ulceration Chinese medicine preparation.
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