CN103768357B - A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha - Google Patents

A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha Download PDF

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CN103768357B
CN103768357B CN201410061059.1A CN201410061059A CN103768357B CN 103768357 B CN103768357 B CN 103768357B CN 201410061059 A CN201410061059 A CN 201410061059A CN 103768357 B CN103768357 B CN 103768357B
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CN103768357A (en
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何晓瑾
汪悦
周学平
王磊
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Nanjing University of Chinese Medicine
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Abstract

The invention discloses a kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is made up of the raw material of following parts by weight: Rhizoma Coptidis 5 ~ 10 parts, Radix Scutellariae 10 ~ 20 parts, the Rhizoma Pinelliae 10 ~ 20 parts, 15 ~ 25 parts of Poria, Pollen Typhae 15 ~ 25 parts, the Rhizoma Anemarrhenae 15 ~ 25 parts, Rhizoma Cimicifugae 5 ~ 10 parts, 3 ~ 6 parts of Radix Glycyrrhizae. the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention, pathogenesis according to Chinese medical theory and recurrent aphtha chooses material combination prescription, each component proportioning is scientific and reasonable, can be mutually coordinated between each component, mutually promote, play the effect of Synergistic, have and well let out clearly accumulated heat, nourshing Yin and drynsessmoistening prescription, effect of convergence granulation promoting, can substantially alleviate the RAU local pain caused, and ulcer healing can be promoted, extend the intermission, control effect of ulcer recurrence, and Traditional Chinese medicine compound composition provided by the invention, safety is high, have no adverse reaction, it is expected to develop into the new drug of new treatment recurrent aphtha.

Description

A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha
Technical field
The present invention relates to a kind of Chinese medicine compound, be specifically related to a kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, belong to technical field of traditional Chinese medicine preparation.
Background technology
Recurrent aphtha (recurrentaphthousulcer, RAU) also known as recurrent oral ulceration, it it is modal stomatocace class disease, investigation finds that the crowd of at least 10%��25% suffers from this disease, in specific crowd, the prevalence of RAU may be up to 50%, and the prevalence of women is generally greater than male. RAU send out well the age be 10-30 year, canker sores is obvious, and recurrent exerbation, affects patients diet, speech, emotion, causes bigger puzzlement to the live and work of patient. RAU etiology unknown, big quantity research confirms immune factor in recent years, especially cellullar immunologic response plays an important role in the pathogenesis of RAU, and other inducements include heredity, local wound, food, medicine, stress, endocrine, systemic disease, infection, vitamin or trace element deficiency etc.
Due to the cause of disease of RAU and pathogenesis not yet completely clearly, at present both at home and abroad but without the effect method of radical cure RAU, therefore the treatment of RAU is mainly based on symptomatic treatment, and using the ulcer healing that eases the pain, promotes, extend the intermission purpose as treatment.
The treatment of current doctor trained in Western medicine is broadly divided into Drug therapy (local application and systemic administration), naturopathy and psychotherapy. Claims priority selects local treatment, and the glucocorticoid of topical application is classified as the first-line drug treating RAU, including triamcinolone acetonide pastes and Dexamethasone ointment, gargarism etc. But, long-term topical application glucocorticoid is likely to cause oral cavity monilial infection. Promote healing drug and other topical formulations, as recombinant human epidermal growth factor gel, bFGF bovine basic fibroblast growth factor gel, ammonia come cluck promise paste, mouth paster, double; two chlorine sweet smell hyaluronic acid gels etc. and can ease the pain, promote ulcer healing, but without controlling ulcer recurrence effect;And carbenoxolone sodium gargarism, ciclosporin gargarism side effect is more. Systemic administration selects glucocorticoid to be also only that short-term is effective, and Control in recurring is undesirable, and side effect is big, therefore can not use for a long time, more can not rely on, otherwise drug withdrawal knock-on. Immunosuppressant, as RAU is all had certain therapeutical effect by azathioprine, cyclophosphamide, methotrexate, ciclosporin etc., but untoward reaction is more, can occur anorexia, feel sick etc. symptom, long-term taking may result in bone marrow depression,, even there is aplastic anemia, it is possible to cause toxic hepatitis, pancreatitis etc. in granulocytopenia. Immunostimulant, as RAU is had certain curative effect by transfer factor, thymosin etc., and side effect is little, but late result is not still affirmed. Other are such as Thalidomide energy mitigation symptoms rapidly, hence it is evident that shorten stage of attack, the oral ulcer damage of this medicinal medicine of U.S. FDA approved treatment AIDS, but should be noted the side effect such as its teratogenesis, and anemia of pregnant woman's disabling, the women of child-bearing age are cautious use of. RAU belongs to Chinese medicine " erosion of the oral mucosa, aphtha, aphtha " category, the understanding of RAU pathogenic factor is based upon on macro-view cognition basis by Chinese medicine, think that it is a kind of topical manifestations of systemic disease, propose that flaming up of heart-fire, taste are hot and suffocating, excessive heat of liver and gallbladder, stagnation of dampness due to deficiency of the spleen, deficiency of YIN of the spleen and stomach, hyperactivity of fire etc. of suffering from a deficiency of the kidney all may result in the generation of primary disease, giving consideration to both the incidental and fundamental in treatment, obtain certain curative effect, and there is the advantages such as side effect is little, cheap, day by day obtain the accreditation of extensive patients. But do not have yet treatment RAU specific medicament, many have Chinese Medicine promote the production of body fluid effect alternative medicine treatment primary disease curative effect still imprecise.
Summary of the invention
Goal of the invention: the technical problem to be solved is to overcome the deficiencies in the prior art, based on Chinese medical theory, adopt determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, pathogenesis according to recurrent aphtha, science carries out composition of prescription, thering is provided one can effectively treat recurrent aphtha, clear curative effect, side effect is little, the Traditional Chinese medicine compound composition of taking convenience.
Technical scheme: in order to realize object above, the technical solution used in the present invention is:
A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 5��10 parts, Radix Scutellariae 10��20 parts, the Rhizoma Pinelliae 10��20 parts, 15��25 parts of Poria, Pollen Typhae 15��25 parts, the Rhizoma Anemarrhenae 15��25 parts, Rhizoma Cimicifugae 5��10 parts, 3��6 parts of Radix Glycyrrhizae.
Preferably, the above-described Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 5��8 parts, Radix Scutellariae 10��15 parts, the Rhizoma Pinelliae 10��15 parts, 15��20 parts of Poria, Pollen Typhae 15��20 parts, the Rhizoma Anemarrhenae 15��20 parts, Rhizoma Cimicifugae 5��8 parts, 3��4 parts of Radix Glycyrrhizae.
The present invention is under the guidance of Chinese medical theory, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, pathogeny and disease symptom in conjunction with recurrent aphtha, pathogenesis emphasis according to recurrent aphtha (RAU) " accumulation of heat in the heart and spleen ", " insufficiency of the spleen raw heat ", raw material scientific compatibility is chosen according to Chinese medical theory, Chinese medicine compound of the present invention have spleen invigorating purge heat, effect of detumescence and promoting granulation, with treating both the principal and the secondary aspects of a disease at the same time for therapeutic goal, selecting Rhizoma Coptidis, Radix Scutellariae, the Rhizoma Pinelliae, Poria, Pollen Typhae, the Rhizoma Anemarrhenae, Rhizoma Cimicifugae, Radix Glycyrrhizae is that raw material prepares the Chinese medicine compound with treatment RAU effect.
The foundation of raw material selected by the present invention is: in component, Rhizoma Coptidis bitter cold drops clearly, and letting out clearly heart stomach accumulated heat is monarch drug. ?well and raise free and unfettered person of outstanding talent strontium dental caries ? and ram mythical bird like the phoenix error chaste tree extensive ? lid character used in proper names and in rendering some foreign names sword and ram and reap the ? ? sandfly broom polished ? straw a word used for translation ginseng roasting ? �� character used in proper names and in rendering some foreign names sword of ? family ? ? flesh slightly a small tinkling bell and ram Lu mire cooked food boundless and indistinct ? flag verdant Fructus Persicae Yun county free and unfettered rose of Sharon dental caries ? ? Kuo even broom an ancient spear F crow Herba Marsileae Quadrifoliae titanium ? europium an ancient wine vessel made of horn (6) Camphor tree of mounting and adopt ?. ����Ŀ�������?���ɢ�����?����߽�Ƣк���?ף��?߹��?��??ȿɽ�Ƣ��к����?ֿɷ��?���???������?�ɢ��ⶾ�??����У��ʲݵ������??��?��?���������ҽҩ���ݿ�ѧѡȡ�?ϺͿ��?���?ϣ?�����?����໥�?����໥�ٽ??��??��y����ã?��кܺõ���й�?ȣ?�������?����? > Ĺ�Ч�?����Լ��?AU����ľֲ���ʹ�� and ulcer healing can be promoted, extend the intermission, control ulcer recurrence.
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention can be used for preparation treatment recurrent aphtha medicine.
The preparation method of the Traditional Chinese medicine compound composition extract with treatment recurrent aphtha provided by the invention comprises the following steps, and takes Rhizoma Coptidis, Radix Scutellariae, the Rhizoma Pinelliae, Poria, Pollen Typhae, the Rhizoma Anemarrhenae, Rhizoma Cimicifugae and Radix Glycyrrhizae, add the water soaking 20��60min of total medical material weight 8��12 times, then decoct and extract 1 to 3 time, each 1 to 3 hour, united extraction liquid, concentrates to obtain extractum.
The Traditional Chinese medicine compound composition with treatment recurrent aphtha of the present invention treats the application in recurrent aphtha medicine in preparation, the extract of Traditional Chinese medicine compound composition and pharmaceutically acceptable carrier is made the medicine of capsule, microcapsule, tablet, granule or oral liquid formulation.
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention is when making tablet, the extract of Chinese medicine compound and carrier lactose or corn starch, it is necessary to time add magnesium stearate lubricant, mix homogeneously, then tablet made by tabletting.
The extract of Traditional Chinese medicine compound composition and carrier lactose or corn starch mix homogeneously when the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention makes capsule, granulate, then encapsulated make capsule.
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention is when making granule, the extract of Traditional Chinese medicine compound composition and diluent lactose or corn starch mix homogeneously, and granulate, dry, make granule.
When the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention makes oral liquid, the extract of Traditional Chinese medicine compound composition is added water and cosolvent dissolves, add syrup and prepare oral liquid.
Beneficial effect: compared to the prior art the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention has the advantage that
The Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention, pathogenesis according to Chinese medical theory and recurrent aphtha chooses material combination prescription, each component proportioning is scientific and reasonable, can be mutually coordinated between each component, mutually promote, play the effect of Synergistic, have and well let out clearly accumulated heat, nourshing Yin and drynsessmoistening prescription, effect of convergence granulation promoting, can substantially alleviate the RAU local pain caused, and ulcer healing can be promoted, extend the intermission, control ulcer recurrence, there is the effect well treating recurrent aphtha, and test result indicate that, Traditional Chinese medicine compound composition provided by the invention, safety is high, have no adverse reaction.
And the Traditional Chinese medicine compound composition with treatment recurrent aphtha provided by the invention can prepare into the medicine of various dosage form by convenient and pharmaceutically acceptable carrier, facilitates clinic to take.
Detailed description of the invention
According to following embodiment, it is possible to be more fully understood that the present invention. But, as it will be easily appreciated by one skilled in the art that the concrete material proportion described by embodiment, process conditions and result thereof are merely to illustrate the present invention, and should without the present invention described in detail in restriction claims.
Embodiment 1
A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 5 parts, Radix Scutellariae 10 parts, the Rhizoma Pinelliae 10 parts, 15 parts of Poria, Pollen Typhae 15 parts, the Rhizoma Anemarrhenae 15 parts, Rhizoma Cimicifugae 5 parts, 3 parts of Radix Glycyrrhizae.
Embodiment 2
A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 10 parts, Radix Scutellariae 20 parts, the Rhizoma Pinelliae 20 parts, 25 parts of Poria, Pollen Typhae 25 parts, the Rhizoma Anemarrhenae 25 parts, Rhizoma Cimicifugae 10 parts, 6 parts of Radix Glycyrrhizae.
Embodiment 3
A kind of Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 8 parts, Radix Scutellariae 15 parts, the Rhizoma Pinelliae 15 parts, 20 parts of Poria, Pollen Typhae 20 parts, the Rhizoma Anemarrhenae 20 parts, Rhizoma Cimicifugae 8 parts, 4 parts of Radix Glycyrrhizae.
Embodiment 4 clinical research data
1 case selection
1.1 physical data
In JIUYUE, 2011 in August, 2013 rheumatism immunity section of Jiangsu TCM Hospital and general internal clinic go to a doctor meet China's stomatology can oral mucosal disease Professional Committee, China's stomatology can RAU patient 106 example made a definite diagnosis of the CM syndrome differentiation criterion of " RAU practice guidelines (is tried) " the Chinese and western medicine diagnostic criteria formulated of integrated Chinese and Western medicine committee and the traditional Chinese medical science " accumulation of heat in the heart and spleen ", " insufficiency of the spleen accumulated heat " pattern of syndrome, wherein male 46 example, women 60 example; 18��62 years old age, average (38.5 �� 1.2) year; The course of disease 1 to 15 year, average (3.1 �� 1.0) year. Case adopts digits table to randomly choose, treatment group 54 example, matched group 52 example.
1.2 diagnostic criterias
1.2.1 Western medicine diagnose standard
Owing to RAU does not have specific laboratory parameters, therefore the diagnosis of RAU is mainly with medical history feature (recurrent, periodically, self limiting) and Clinical symptoms (yellow, red, recessed, bitterly) for foundation, lab testing that generally need not be special. According to Clinical symptoms, RAU can be divided into light-duty, heavy and 3 kinds of types of herpesvirus type.
1.2.1 Standards of Chinese Medical Syndrome Differentiation (about " guideline of clinical investigations of new Chinese medicine treatment recurrent aphtha " in " new Chinese medicine guideline of clinical investigations (tries) " of reference Zheng Xiao cornel chief editor in 2002)
(1) accumulation of heat in the heart and spleen card
Primary symptom: ulcer differs in size, round or oval, can by small rice grain to Semen phaseoli radiati or Semen Glycines size, ulcer number is more, around can be red and swollen raised, concavity. The scorching hot pain in local, thirst with desire to drink.
Secondary disease: flushing mouth and nose burn and do and heat, dysphoria with smothery sensation, are hard and dry, and yellowish urine is red.
Tongue fur: the tip of the tongue is partially red and dry, yellow fur or greasy.
Pulse condition: stringy,thready and rapid pulse.
(2) insufficiency of the spleen raw heat syndrome
Primary symptom: ulcer is deep greatly and relatively, and the rubescent edema in edge is raised, has greyish white or lark to ooze out, indolence, and easy recurrent exerbation is hard and dry or smooth, and abdominal distention, mouth is viscous or thirsty.
Secondary disease: shallow complexion, lassitude and weak, urine is clear long or yellow red.
Tongue fur: light red tongue tongue is greasy or yellow greasy in vain.
Pulse condition: soft and thready pulse or heavy thin.
1.3 include in and exclusion standard (with reference to " tentative standard of RAU therapeutic evaluation " that stomatology meeting diseases of oral mucosa Professional Committee of China formulates)
1.3.1 inclusive criteria: 1. have at least 2 RAU morbidity histories and medical history more than 1 year; 2. ulcer is shown effect more than 1 time every month.
1.3.2 exclusion standard: 1. heavy RAU, Behcet disease; 2. systemic disease background: anemia, peptic ulcer, crohn, acute infectious diseases, autoimmune disease etc.; 3. using analgesic in 24h, use antibiotic, antibiotic medicine in 1 month, in 3 months, whole body uses corticosteroid, immunosuppressant; 4. tumor patient; 5. gravid woman.
2, Therapeutic Method
Treatment group: adopt what the embodiment of the present invention 1 provided Traditional Chinese medicine compound composition, soak by water, every day, potion, point sooner or later took for twice 1 hour after meal. Matched group: the peace that swells and ache capsule, each 3, every day 2 times, warm water is swallowed.
All taking 1 month for two groups is 1 course for the treatment of, and 1 year observation oral cavity ulcer recurrence situation is followed up a case by regular visits in treatment end.
3 observation index
3.1 cardinal symptoms, sign Index:
3.1.1 total intermittent time (my god) (interval, I): evaluate the period without ulcer temporal summation.
3.1.2 total ulcer number (individual) (number, N): evaluate period ulcer recurrence number summation.
3.1.3 average ulcerative stage (my god) (duration, D): evaluate period each ulcer persistent period summation divided by ulcer sum.
3.1.4 pain index (dividing) (pain, P): adopt Visual analogue scale (visualanalogscale, VAS) to record the pain scores of ulcerative stage every day. VAS is meant that the straight line adopting 10cm, and 0 end of straight line represents " painless ", and 10cm end represents " the most violent pain ", and patient is different according to the level of sensitivity of pain, and the corresponding scale at straight line keeps a record, every day 1 time.
3.2 main hypertensive TCM syndrome indexs:
Including clinical modal local and General Symptoms (ulcer surface pain has congestion and edema to ooze out, and local has burn feeling, thirsty or mouth viscous, and constipation with dry stool or stool are smooth, tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding yellow or light red tongue greasy fur).
With reference to " new Chinese medicine guideline of clinical investigations (tries) " of Zheng Xiao cornel chief editor in 2002, record the score value of each symptom one by one by following scalar quantization standard.
3.2.1 ulcer surface pain has congestion and edema to ooze out
0=without.
2=ulcer diameter is less than 3mm, and skin surface is micro-wet, and color is micro-red, and edema is confined to ulcer place, hypodynia.
4=ulcer diameter is more than 3mm, and less than 5mm, skin surface has greyish white (Huang) to ooze out on a small quantity, and color depth is red, and the light white edge of color, local is micro-raised, and pain is slightly obvious, but does not affect feed.
6=ulcer diameter is at more than 5mm, and skin surface exudate is many and has pseudomembrane, and color is purplish red, and the obvious edema high improvement of whole disease damage is white, and pain substantially and affects feed.
3.2.2 there is burn feeling local
0=without.
2=is micro-burn feeling.
4=scalded sense like hot water
6=need to containing cold water
3.2.3 thirsty or mouth glue
0=without.
The slightly dry nothing of 1=mouth is felt yearningly, or even feel mouth glues.
2=xerostomia thinks drink, or sometimes feels sticky in mouth.
3=xerostomia drink does not quench one's thirst, or continues in mouth sticky.
3.2.4 constipation with dry stool or stool are not smooth
0=without.
1=has but dry stool every day, or it is shapeless to defecate, and every day 1-2 time, slightly feels not well time just.
2=a few days a line, dry stool, or loose stool, every day 3-4 time, not well time just.
3=needs relieving constipation just to solve, or diarrhea with loose stool, every day more than 4 times, not well time just.
3.2.5 lassitude and weak
0=without.
1=random thoughts are tired, and degree is slight, weak to labour, can adhere to light physical labor.
Namely 2=general activity feels weak, and interval occurs, supports daily routines reluctantly.
3=has a rest and also feels fatigue and weak, continues to occur, it is impossible to adhere to daily.
3.2.6 tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding is yellow or light red tongue greasy fur
0=is without exception.
1=tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding yellow or light red tongue greasy fur is inconspicuous.
2=tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding yellow or light red tongue greasy fur is more apparent.
3=tongue is partially red and Enteromorpha clathrata (Roth) Grev. Emend bliding yellow or light red tongue greasy fur is obvious.
4 the standard of curative effect evaluations (about " guideline of clinical investigations of new Chinese medicine treatment recurrent aphtha " in " tentative standard of RAU therapeutic evaluation " and " new Chinese medicine guideline of clinical investigations (tries) " of Zheng Xiao cornel chief editor in 2002 formulated with reference to stomatology meeting diseases of oral mucosa Professional Committee of China)
4.1 short-term evaluation standards: after medicine 7 days, carry out the comparitive study for the treatment of group and matched group.
4.1.1DP staging: effective: average ulcerative stage shortens, pain index reduces (t checks, P < 0.05);
Effective: average ulcerative stage shortening (t checks, P<0.05), pain index reduce (t checks, P<0.05) without changing (t checks, P>0.05) or average ulcerative stage without change (t checks, P>0.05), pain index; Invalid: average ulcerative stage without changing, pain index is without changing (t checks, P>0.05).
4.1.2 Chinese medicine syndrome integral change: clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%; Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%; Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%; Invalid: tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integral reduces less than 30%.
Note: computing formula (nimodipine method) is: [before (before treatment integration after integration-treatment) �� treatment integration] �� 100%.
4.2 Evaluation of long-term standards: recovery from illness: oral ulcer does not recur more than 1 year; Effective: total intermittent time extends, total ulcer number reduces (t checks, P<0.05); Effective: total intermittent time extends (t inspection, P<0.05), total ulcer number unchanged (t check, P>0.05) or total intermittent time unchanged (t checks, P>0.05), total ulcer number minimizing (t checks, P<0.05); Invalid: total intermittent time ulcer number unchanged, total unchanged (t checks, P>0.05).
5 statistical procedures methods
Clinical symptoms, sign and laboratory observation index before and after statistics treatment, adopt SPSSl9.0 software kit to analyze, and measurement data mean adds and subtracts standard deviation, ask that measurement data compares employing t inspection for two groups, enumeration data adopts X2 inspection, and ranked data Ridit analyzes, test level ��=0.05, two-sided test.
6 therapeutic outcomes
6.1 baselines compare
Therapist the basic condition such as position of case load, sex, age, the course of disease and ulcer, size, number, type, pain degree etc. and matched group no significant difference (P > 0.05), illustrate that treatment group and matched group data are balanced, there is comparability.
6.2 liang of group short term effects compare
Treatment group compares with matched group, and average ulcerative stage substantially shortens (P < 0.01), and pain index reduces (P < 0.05), and specific experiment result is such as shown in table l;Treatment group clinical efficacy is notable, and total effective rate is 100%, is significantly better than matched group (P < 0.05), and specific experiment result is as shown in table 2; Treatment group tcm syndrome curative effect clinical recovery rate 18.5%, obvious effective rate 59.3%, total effective rate 100%, it is significantly better than matched group (P < 0.01), specific experiment result is in Table 3.
Two groups of average ulcerative stages of table l and pain index compare
Group Number of cases (n) Average ulcerative stage (my god) Pain index (p)
Treatment group (embodiment 1) 54 3.81��1.22 1.5��0.361
Matched group 52 5.15��1.6 1.9��0.48
Compare with matched group:1P < 0.05,2p<0.01
2 liang of table group Clinical efficacy comparison (n, %)
Group Effective Effectively Invalid Total effective rate
Treatment group (embodiment 1) 46(85.2) 8(14.8) 0(0.0) 54(100.0)1
Matched group 19(36.5) 25(48.1) 8(15.4) 44(84.6)
Compare with matched group:1P<0.05
3 liang of table group tcm syndrome comparitive study (n, %)
Group Clinical recovery Effective Effectively Invalid Total effective rate
Treatment group (embodiment 1) 10(18.5)2 32(59.3)2 12(22.2) 0(0.0) 54(100.0)2
Matched group 0(0.0) 10(19.2) 27(51.9) 15(28.9) 37(71.1)
Compare with matched group:2P < 0.01
6.3 liang of group late results compare
The cure rate that treatment group does not recur after the treatment for 1 year is 51.9%, obvious effective rate 40.7%, and total effective rate is 100%, is significantly better than matched group (P < 0.01), specific experiment result such as table 4.
4 liang of groups of table follow up a case by regular visits to 1 year after comparitive study (n, %)
Group Recovery from illness Effective Effectively Invalid Total effective rate
Treatment group (embodiment 1) 28(51.9)2 22(40.7)2 4(7.4) 0(0.0) 54(100.0)2
Matched group 2(3.8) 7(13.5) 31(59.6) 12(23.1) 40(76.9)
Compare with matched group:2P < 0.01
7 safety observations
In clinical experiment process, treatment group patient has no untoward reaction, and matched group has 1 example the symptoms such as Upper abdominal pain, loss of appetite occur, but adds with transference cure after protection gastric mucosa medicine. Two groups of exceptions that hepatic and renal function and the index such as blood, routine urinalysis all do not occur. Safety testing result shows that Chinese medicine compound safety provided by the invention is good, and long-term taking has no adverse reaction.
Above clinical observation result shows, Traditional Chinese medicine compound composition provided by the invention can substantially alleviate the local pain that recurrent aphtha (RAU) causes, and ulcer healing can be promoted, extend the intermission, control ulcer recurrence, short term effect is all notable with late result, illustrate that RAU is had obvious therapeutic action by Traditional Chinese medicine compound composition provided by the invention, and Traditional Chinese medicine compound composition life-time service provided by the invention is without obvious adverse reaction, can be developed into the new drug treating RAU into a new generation.
Embodiment of above is only for illustrating technology design and the feature of the present invention; its object is to allow person skilled in the art understand present invention and to be carried out; can not limit the scope of the invention with this; all equivalences done according to spirit of the invention change or modify, and all should be encompassed in protection scope of the present invention.

Claims (4)

1. a Traditional Chinese medicine compound composition with treatment recurrent aphtha, it is characterised in that it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 5 ~ 10 parts, Radix Scutellariae 10 ~ 20 parts, the Rhizoma Pinelliae 10 ~ 20 parts, 15 ~ 25 parts of Poria, Pollen Typhae 15 ~ 25 parts, the Rhizoma Anemarrhenae 15 ~ 25 parts, Rhizoma Cimicifugae 5 ~ 10 parts, 3 ~ 6 parts of Radix Glycyrrhizae.
2. the Traditional Chinese medicine compound composition with treatment recurrent aphtha according to claim 1, it is characterised in that it is made up of the raw material of following parts by weight:
Rhizoma Coptidis 5 ~ 8 parts, Radix Scutellariae 10 ~ 15 parts, the Rhizoma Pinelliae 10 ~ 15 parts, 15 ~ 20 parts of Poria, Pollen Typhae 15 ~ 20 parts, the Rhizoma Anemarrhenae 15 ~ 20 parts, Rhizoma Cimicifugae 5 ~ 8 parts, 3 ~ 4 parts of Radix Glycyrrhizae.
3. the application in preparation treatment recurrent aphtha medicine of the Traditional Chinese medicine compound composition with treatment recurrent aphtha described in claim 1 or 2.
4. the Traditional Chinese medicine compound composition with treatment recurrent aphtha according to claim 3 treats the application in recurrent aphtha medicine in preparation, it is characterized in that, the extract of Traditional Chinese medicine compound composition and pharmaceutically acceptable carrier are made the medicine of capsule, microcapsule, tablet, granule or oral liquid formulation.
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CN101167900A (en) * 2007-09-20 2008-04-30 吴月 Traditional Chinese medicine for treating recurrent aphthae
CN102727817A (en) * 2012-07-02 2012-10-17 葛晓云 Oral liquid for treating oral ulcer
CN102772693A (en) * 2012-08-21 2012-11-14 孙凤梅 Medicine for treating recurrent oral ulcer and preparation method thereof
CN103071070A (en) * 2013-01-29 2013-05-01 张永雷 Traditional Chinese medicine formula for treating recurrent aphthous ulcer

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101167900A (en) * 2007-09-20 2008-04-30 吴月 Traditional Chinese medicine for treating recurrent aphthae
CN102727817A (en) * 2012-07-02 2012-10-17 葛晓云 Oral liquid for treating oral ulcer
CN102772693A (en) * 2012-08-21 2012-11-14 孙凤梅 Medicine for treating recurrent oral ulcer and preparation method thereof
CN103071070A (en) * 2013-01-29 2013-05-01 张永雷 Traditional Chinese medicine formula for treating recurrent aphthous ulcer

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