CN101073657B - 'Traditional Chinese-medicinal preparation for treating oral ulcers - Google Patents

Abstract

The invention is concerned with the Chinese medicine for recrudescent oral cavity canker theraphy, includes the pilular to be taken orally, made of corktree, chrysanthemum, Astraolylis lancea formalyrata, codonopsis pilosula, roast liquorice, and the ointment to be applied on the surface of the sore that contents Astragalus root, prickly ash, dragon's blood, pearl, cinnabar. The advantages of the medicine are: safely with no toxic side effect.

Description

The Chinese medicine preparation that is used for the treatment of the recurrent oral ulceration disease

Technical field

Content of the present invention belongs to the fabricating technology field of pharmaceuticals, particularly a kind of Chinese medicine preparation of being made by pure Chinese herbal medicine that is used for the treatment of the recurrent oral ulceration disease.

Background technology

Oral ulcer is called " aphtha " again in Chinese medicine, be the high disease of cari oris mucosa of a kind of sickness rate and relapse rate, occupies first of current all oral diseases.Oral ulcer is a feature with show effect repeatedly one or several isolated circles or oval shallow table ulcer of oral mucosa clinically, and normal companion burns sample pain, especially chew, speak and when contact acid, irritable food such as peppery pain more obvious.Concerning the patient, though oral ulcer does not have fatal risk, bring great misery for their work, life, particularly to some often repeatedly or cureless patient, not only draw worries in spirit, also have carcinogenic danger.How the at present known clinical medicine of recurrent oral ulceration disease that is used for the treatment of is with anti-inflammation, antiallergic, local anesthesia pain relieving class medicine is made, the product type is mainly all kinds of external application or is coated with preparation outward, as KOUQIANG KUIYANG MO, subjectively can paste etc., in recent years, this area has also occurred some successively and has treated this sick traditional Chinese compound medicine according to Chinese medicine clearing stomach purgation of spleen excess principle, as the KOUYANQING capsule, the oral ulcer curing capsule, coptos bolus for clearing the upper heat, three sheets etc., though said medicine is controlled executing of oral ulcer certain curative effect is arranged in some aspects, but generally speaking the clinical cure rate of these medicines is lower, relapse rate is high, can not effect a permanent cure, and some medicine also has toxic and side effects to the patient.

Summary of the invention

The objective of the invention is at the existing in prior technology defective, by excavating the abundant Chinese medicine resource of motherland, so provide a kind of prescription science, easy to prepare, curative effect is high, the Chinese medicine preparation that is exclusively used in treatment recurrent oral ulceration disease that takes stopgap measures and effect a permanent cure and do not recur, have no side effect.

The preparation scheme of Chinese medicine preparation of the present invention comes from the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs thought of motherland's traditional medicine about " treatment must aim at the pathogenesis of disease ", and it is designer of the present invention by medical book at all times being concentrated on studies and summing up development and obtain through concentrated on clinical practice basis for many years.Since the recurrent oral ulceration disease mostly be damp-heat in the spleen and stomach, hyperactivity of hesrt-fire and liver-fire, stagnation of dampness due to deficiency of the spleen, QI and blood deficiency because of due to, in view of the above, designer spy from motherland's medical treasure-house, filter out have expelling wind and removing dampness, natural plant that nourishing the liver and kidney, function of spleen and stomach regulating, reducing the minister-fire, clear long-pending row stagnate effect, by the theory of Chinese medical science side of being prepared into meticulously, comprise in the side that the pill agent for oral administration used simultaneously and external are coated with to put on the skin in the cream of the oral cavity skin ulcer face two groups of pharmaceutical formulations of medicament that loose.Wherein said pill agent is processed by all herbal medicine raw materials that comprise Cortex Phellodendri, Flos Chrysanthemi, the Rhizoma Atractylodis Macrocephalae, Radix Codonopsis, Radix Glycyrrhizae Preparata, Fructus Amomi, Flos Lonicerae, Cortex Cinnamomi, Poria, Radix Platycodonis; Said outer being coated with put the cream medicament that looses on the skin and processed by all herbal medicine raw materials that comprise the Radix Astragali, Radix Zanthoxyli, Sanguis Draxonis, Margarita, Cinnabaris, Borax, Radix Glycyrrhizae.Can give full play to the characteristics of Chinese medicine preparation by above-mentioned two groups of medicines that prescription constituted that use simultaneously in clinical practice, it can correct the pathology obstacle, enhances metabolism and the recovery of function.Pill agent residence for oral administration heat clearing away is among temperature compensation, i.e. asthenic fire medication can not pure cold, and the temperature compensation of must holding concurrently can reach the purpose of mending soil clothes fire.External is coated with puts the cream medicament that looses on the skin and acts on skin ulcer face part, has eliminating inflammation and expelling toxin, convergence analgesic effect, and the tissue of devitalization is tending towards normally, the very fast healing of skin ulcer face and then reach the purpose for the treatment of both the principal and secondary aspects of a disease.

The weight proportion value that constitutes each medicine material component of pill agent among the present invention is: Cortex Phellodendri 6～10, Flos Chrysanthemi 6～10, the Rhizoma Atractylodis Macrocephalae 6～10, Radix Codonopsis 10～14, Radix Glycyrrhizae Preparata 3～7, Fructus Amomi 3～7, Flos Lonicerae 3～7, Cortex Cinnamomi 3～7, Poria 8～12, Radix Platycodonis 4～8.

The weight proportion value that formation the present invention is coated with each medicine material component of putting the diffusing medicament of cream on the skin at home and abroad is: the Radix Astragali 8～12, Radix Zanthoxyli 13～17, Sanguis Draxonis 2～5, Margarita 3～7, Cinnabaris 0.8～1.2, Borax 1.3～1.7, Radix Glycyrrhizae 1～3.

Pill agent among the present invention is as medication for oral administration, and the Cortex Phellodendri hardship in its prescription is trembled with fear, and returns kidney, urinary bladder channel, has heat clearing and damp drying, pathogenic fire purging except that the function of steaming, skin ulcer is treated in detoxifcation; Flos Chrysanthemi is sweet, bitter, is slightly cold, and returns lung, Liver Channel, has the function that diffusing wind heat clearing away, suppressing the hyperactive liver make eye bright; Rhizoma Atractylodis Macrocephalae hardship, puckery, flat, GUIXIN, Liver Channel have the function of astringing to arrest bleeding, preventing the attack (or recurrence) of malaria, dysentery relieving, detoxifcation; Radix Codonopsis is sweet, flat, returns spleen, lung meridian, has the function of invigorating the spleen and replenishing QI, spleen invigorating lung benefiting; Radix Glycyrrhizae Preparata is sweet, and flat, GUIXIN, lung, taste warp have the function of spleen reinforcing stomach function regulating, Yiqi and vein recovery; The Fructus Amomi suffering, temperature is returned spleen, stomach, kidney channel, has removing dampness appetizing, warming spleen and stopping diarrha, the antiabortive function of regulating the flow of vital energy; Flos Lonicerae is sweet, and is cold, returns lung, the heart, stomach warp, has the function of heat-clearing and toxic substances removing, wind-heat dissipating; Cortex Cinnamomi suffering, sweet, big heat is returned kidney, spleen, the heart, Liver Channel, have mend that fire is supporing yang, the function of let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow; Poria is sweet, light, and is flat.GUIXIN, lung, spleen, kidney channel.Has promoting diuresis to eliminate damp pathogen, the function of spleen invigorating mind calming; Radix Platycodonis hardship, suffering, flat, return lung meridian, have lung qi dispersing, sore-throat relieving, eliminate the phlegm, the function of evacuation of pus.Above-mentioned all medicines share, and can play strengthening the spleen and nourishing the stomach, the clear long-pending merit stagnant, that clearing away damp-heat moves back asthenic fire of going in clinical, make ulcer healing and no longer recurrence.

Outer among the present invention is coated with to be put the cream medicament that looses on the skin and uses medicine as adjusting outer being coated with that is used in combination with the pill agent, and Radix Astragali is sweet, warm in its prescription, returns spleen, lung meridian, has the function of invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation; Radix Zanthoxyli hardship, suffering, flat, slightly poisonous are returned liver, stomach warp, have the function of promoting the circulation of QI to relieve pain, activating blood circulation to dissipate blood stasis, dispelling wind and removing obstruction in the collateral; Sanguis Draxonis is sweet, salty, and flat, GUIXIN, Liver Channel have the function of the silt of dispelling analgesic therapy, hemostasia and promoting granulation; Margarita is sweet, salty, and cold, the GUIXIN Liver Channel has the function of the arresting convulsion of calming the nerves, the removing nebula that makes eye bright, removing toxic substances and promoting granulation; Cinnabaris is sweet, is slightly cold, and is slightly poisonous, goes into heart channel, has the function of tranquillization with heavy prescription, detoxifcation; Borax is sweet, salty, cool, goes into lung, stomach warp, has the function anticorrosion, removing heat-phlegm of detoxifying; Radix Glycyrrhizae is sweet, flat, and GUIXIN, lung, taste warp have the function of invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Should outer be coated with and use medicine and combine with pill mass action for oral administration, directly be coated with by it and put the eliminating inflammation and expelling toxin that has at disease sites, the convergence analgesic efficacy of a drug on the skin, make the patient can palliate the agonizing sufferings and make the healing of skin ulcer face soon, thereby reach the purpose that thorough treatment is not recurred, promoted health and cured diseases.

Compare the advantage that Chinese medicine preparation of the present invention has safety, specially good effect, has no side effect with domestic and international existing like product.Show that according to clinical use result this medicine has higher curative effect to the recurrent oral ulceration that the treatment a variety of causes causes.In recent years, development person utilizes it obtaining obvious progress aspect treatment of the recurrent oral ulceration disease that people is considered as always refractory and incurable disease, treatment to behcet's syndrome has obtained breakthrough progress especially, and these all are to have like product at present both at home and abroad now to hardly match.

The preparation method of medicine of the present invention is:

1, ball medicaments preparation for oral administration---will be thin by formula ratio and the Chinese crude drug raw material difference powder of respectively distinguishing the flavor of after cleaning, cross 120 mesh sieves, mixing is mixed thoroughly, and making pellets by mixing medical powder with honey, every ball nearly weigh 11 grams.

2, be coated with outward and put the cream medicaments preparation of loosing on the skin---will transfer Oleum sesami to become paste stand-by by formula ratio and the Chinese crude drug raw material of respectively distinguishing the flavor of after cleaning through grinding sterilization treatment into powder.

The specific embodiment

Embodiment:

Getting Cortex Phellodendri 90g, Flos Chrysanthemi 85g, Rhizoma Atractylodis Macrocephalae 85g, Radix Codonopsis 115g, Radix Glycyrrhizae Preparata 55g, Fructus Amomi 50g, Flos Lonicerae 55g, Cortex Cinnamomi 50g, Poria 115g, Radix Platycodonis 60g cleans the back powder is thin respectively, after crossing 120 mesh sieves, mixing is mixed thoroughly, making pellets by mixing medical powder with honey, make the pill agent of Chinese medicine of the present invention, every ball nearly weighs 11 grams.Other gets Radix Astragali 90g, Radix Zanthoxyli 150g, Sanguis Draxonis 30g, Margarita 50g, Cinnabaris 10g, Borax 15g, Radix Glycyrrhizae 20g grinds to form the end after cleaning, after each medicine material end done sterilization treatment, transfer the Oleum sesami mixing and make it to form to be coated with and put paste on the skin, make outer being coated with of Chinese medicine of the present invention and put the diffusing medicament of cream on the skin.

Clinical case is observed and curative effect

In development process of the present invention, for the clinical efficacy of this pharmaceutical preparation of objective evaluation and to the safety of human body, the applicant is clinical treatment and observe case 286 examples once, existing observed result is summarized as follows.

One, diagnostic criteria

Outpatient service is collected recurrent oral ulceration patient 286 examples (being minor aphtha) altogether as object of study, and diagnostic criteria is as the criterion with national state-compiled textbook " oral medicine " and " practical traditional Chinese medical science stomatology " (front page).Choice criteria is: 1. select minor aphtha; 2. the patient does not have serious whole body illness; 3. the patient does not obey the medicine of any treatment oral ulcer in January, and this is fallen ill without any treatment; 4. this morbidity is no more than three days, and the age is more than 15 years old, male or female.

Two, medication

286 routine recurrent oral ulceration patient double blinding stratified randoms are divided into treatment and contrast two groups, wherein 150 people are organized in treatment, matched group is 136 people, treatment group patient uses pure Chinese medicinal preparation pill of the present invention+outer varnish, matched group uses " KUIYANGLING JIAONANG (Tonghua Dragon Lord Pharmaceutical limited company) "+" KOUQIANG KUIYANG MO (Kang Hua pharmaceutical factory, Xi'an) ", two groups administrated method is basic identical: the treatment group is taken pill of the present invention orally, be coated with outward with Oleum sesami and become reconciled into poultice in the ulcer surface, for oral administration pill every day 2～3 times, each 1 ball (child is cut down according to the circumstance) send down with eliminating cold for resuscitation water on an empty stomach; Outer liniment directly is coated with after meal and puts on the skin in the affected part, contains 5～15 minutes and tells, every day 3～4 times; Matched group takes " KUIYANGLING JIAONANG " orally, and external " KOUQIANG KUIYANG MO " is affixed on ulcer surface (during medication, not re-using any other medicines treatment), oral medicine every day 3 times, each 1, medicine for external use every day 4 times, respectively at three 15 minutes before the meal and sleep before half an hour paste usefulness, five days is a course of treatment.Two groups of all further consultations in the 3rd and five day after medication, observe the curative effect is also looked back slightly to ROU (recurrent oral ulceration) cause of disease simultaneously.

Three, observation index

During recurrent oral ulceration further consultation just, mainly observe following index: 1. ulcer diameter: the record maximum gauge, if any a plurality of ulcer, the record ulcer of being treated only, recording method is: establish D=ulcer diameter (just)-ulcer diameter (5), as: D=0 is 3 minutes; 0＜D≤1mm is 2 minutes; 1＜D≤2mm is 1 minute; 2mm＜D is 0 minute; 2. congested situation: divide heavy, in, light, do not have and be respectively 3,2,1,0 fens; 3. pain situation: divide heavy, in, light, do not have and be respectively 3,2,1,0 fens; 4. the situation of taking food: divide liquid, semi-fluid, soft, general food, be respectively 3,2,1,0 fens.

Four, curative effect is judged

The efficacy evaluation method is: establish F=diameter branch+hyperemia branch+pain branch+feed and divide/4 (were standard with five days).Efficacy assessment standard is: 1. healing: four indices reaches " 0 minute " respectively in five days; 2. produce effects: F≤1; 3. effective: 1＜F≤2; 4. invalid: F＞2.And with the sum of healing+produce effects+effectively as the effective percentage of treatment.

Five, therapeutic outcome

1, the harmony of data

The two groups of patient's sexes and the distribution situation at age are learned check there are no significant difference (P＞0.05) by statistics, illustrate that thus the sex of treatment group and matched group and the formation at age are isostatic, have comparability.

2, efficacy analysis

Treatment group healing rate and effective percentage are respectively 51.33% and 97.92%, and matched group is respectively 30.15% and 68.38%, and accurately probability inspection has significant difference (P＜0.05), sees attached list.

Subordinate list treatment group and matched group curative effect are relatively

Above presentation of results treatment group curative effect is better than matched group.

3, untoward reaction: all cases there is no the untoward reaction of local and whole body in treatment group and the matched group

Six, discuss

The cause of disease of recurrent oral ulceration disease (ROU) is not quite clear, and many hypothesis are arranged at present, as: local wound, immunologic derangement, local T cell function defective, malnutrition such as iron deficiency, folic acid, zinc, copper, VitB12 etc.; In addition aspect whole body: as behcet's syndrome, Crohn syndrome, ulcerative colitis, the decline of periodicity neutrophil and mouth, genital ulcer companion's cartilage inflammation syndrome (MAZC) etc.; HTV infection in addition, heredity, microorganism (as streptococcus, helicobacter pylori, virus) and psychentonia etc. also are considered to cause the inducement of oral ulcer.There are 15 examples that the ulcerative colitis medical history is arranged in this paper 286 examples, 30 examples are susceptible disease behind the work strain, 58 examples suffer from primary disease simultaneously with father and mother or children, and father and mother both sides or a side are ill, its children's sickness rate does not all have children's height of this patient than father and mother both sides, in view of this, the obvious genetic tendency is arranged.The ROU histo pathological change is a nonspecific inflammation disease.The change of microcirculation and hemorheology and the ROU state of an illness are closely related, though ROU has self limiting, but the pain that the existence of ulcer brings to the patient on the feed, language and emotion aspect all cause harmful effect, these people are often come the pain of reduction of patient with topical therapeutic, topical therapeutic can make medicine directly act on the part that disease is decreased, give full play to the effect of medicine, eliminate infection inflammation, promote ulcer healing, play reducing swelling and alleviating pain, the effect of convergence granulation promoting, and square medicine residence for oral administration heat clearing away is among temperature compensation, i.e. asthenic fire medication can not pure cold, the temperature compensation of must holding concurrently can reach the purpose of mending soil clothes fire.The present invention is a pure Chinese medicinal preparation, inside and outside combination, curative effect is obvious, do not have to poison, anaphylaxis, nonirritant, and after the medication patient's multiple symptom such as pain and feed etc. all be improved significantly, the ulcer healing quickening, recurrence rate after healing is extremely low.

Claims (1)

1. the Chinese medicine preparation that is used for the treatment of the recurrent oral ulceration disease is characterized in that by the pill agent of using simultaneously for oral administration and is coated with outward using the diffusing two groups of medicaments of medicament of cream and forming, wherein

(1), said pill agent for oral administration is the oral administration pills of being made by the medicine material of following weight proportioning: Cortex Phellodendri 6～10, Flos Chrysanthemi 6～10, the Rhizoma Atractylodis Macrocephalae 6～10, Radix Codonopsis 10～14, Radix Glycyrrhizae Preparata 3～7, Fructus Amomi 3～7, Flos Lonicerae 3～7, Cortex Cinnamomi 3～7, Poria 8～12, Radix Platycodonis 4～8;

(2), saidly outer be coated with that to use the cream medicament that looses be to use cream powder by outer being coated with that the medicine material of following weight proportioning is made: the Radix Astragali 8～12, Radix Zanthoxyli 13～17, Sanguis Draxonis 2～5, Margarita 3～7, Cinnabaris 0.8～1.2, Borax 1.3～1.7, Radix Glycyrrhizae 1～3.