CN106361909A - Drug for treating recurrent oral ulceration and preparation method thereof - Google Patents

Abstract

The invention relates to a drug for treating recurrent oral ulceration. The drug comprises effective components and medically acceptable excipients, wherein the effective components are prepared from the following crude drugs by weight percent: 3.5 to 5.5 percent of uroctea compactilis (baked), 3.5 to 5.5 percent of persimmon frost, 3.5 to 5.5 percent of ampelopsis radix, 0.5 to 1.2 percent of pearl powder, 12 to 21 percent of lonicera japonica, 20 to 30 percent of gypsum fibrosum, 10 to 16 percent of gardenia jasminoides, 10 to 16 percent of dark plum fruit, 10 to 16 percent of radix scrophulariae, and 7 to 11 percent of glycyrrhiza uralensis. The drug has the efficacies of antipyresis, detoxication, removing the necrotic tissue and curing ulceration, and has obvious curative effects for curing recurrent oral ulceration.

Description

A kind of treat medicine of recurrent oral ulceration and preparation method thereof

Technical field:

The present invention relates to medicinal preparation is and in particular to contain the pharmaceutical preparation not determining structure from Uroctea compatilis Koch. section plant.

Background technology:

Recurrent oral ulceration (recurrent oral ulcer, rou) is that repeatedly occur one with oral mucosa or dissipate In multiple aphthas, it is often accompanied by local redness, burns sample pain, numb, excessive saliva is clinical manifestation.Belong to common oral cavity Mucous membrane disease, the prevalence of population may be up to 20%, and the sickness rate in oral keritonocytes be in cumulative year after year it Gesture.This disease has recurrent exerbation, the difficult clinical characters more of delay, and patient feels pain deeply.As with the passing of time do not healed it is possible to develop into As even more serious disease in malignant tumor etc..The cause of disease of rou and mechanism not yet illustrate so far, and some results of study show may be with Local wound, pressure, diet, medicine, hormone and vitamin are relevant with factors such as trace element deficiencies.At present for rou's Treatment there is no specific medicament, although conventional Western medicine is numerous, including external and endo-medicine, also can only reduce the frequency of ulcer generation Rate and the order of severity mitigating ulcer generation, the general curative effect for oral ulcer is still undesirable.Especially hormone medicine, though So certain effect can be obtained at short notice, but because its side effect larger it is easy to recurrence and be difficult to popularization and application.

Chinese medicine shows greater advantage in terms of the last disease for the treatment of.A large amount of Chinese medicine study achievements show: recurrent mouth The main pathological characteristic of chamber ulcer is " burning hot ", and based on excess-fire.Its clinical symptoms is how more with point of bursting, and is notably fused into Piece, scorching hot pain, and how simultaneous see heating, thirsty, the red, constipation of urinating, red tongue, yellow and greasy fur, rapid pulse.Existing treatment recurrent oral is burst The Chinese medicine of infectionss is mainly heat clearing and fire purging medicine, such as coptos bolus for clearing the upper heat, and this medicine cures mainly part of the body cavity above the diaphragm housing the heart and lungs interior-heat, symptoms include dizzy, gingival swelling and pain, Aphtha of the mouth and tongue, pharyngitis, otalgia tinnitus, epidemic hemorrhagic conjunctivitiss, it is hard and dry, yellowish or reddish urine.But coptos bolus for clearing the upper heat clearing away heat-fire Be only capable of improving the symptom of recurrent oral ulceration, can not removing the necrotic tissue and promoting granulation and effect a permanent cure to reduce relapse rate.

Content of the invention

Problem to be solved by this invention is to provide a kind of medicine treating recurrent oral ulceration, and this medical instrument has solution pyrolysis The work(of poison, removing the necrotic tissue more infectionss, treatment recurrent oral ulceration is evident in efficacy.

The technical scheme that the present invention solves the above problems is as described below:

A kind of medicine treating recurrent oral ulceration, this medicine is by active ingredient and medically acceptable excipient group Become, wherein said active ingredient is made up of the crude drug of following percentage by weight:

Uroctea compatilis Koch. (roasting) 3.5～5.5%, Mannosum Kaki 3.5～5.5%, Radix Ampelopsis 3.5～5.5%, Margarita powder 0.5～1.2%, gold Flos Lonicerae 12～21%, Gypsum Fibrosum 20～30%, Fructus Gardeniae 10～16%, Fructus Mume 10～16%, Radix Scrophulariae 10～16%, Radix Glycyrrhizae 7～12%.

In said medicine, the most preferably proportioning of each crude drug is:

Uroctea compatilis Koch. (roasting) 4%, Mannosum Kaki 4%, Radix Ampelopsis 4%, Margarita powder 0.8%, Flos Lonicerae 16.5%, Gypsum Fibrosum 25%, Fructus Gardeniae 12.5% part, Fructus Mume 12.5%, Radix Scrophulariae 12.5%, Radix Glycyrrhizae 8.2%.

Effective ingredient in said medicine can be obtained using various common preparation methoies, and one of which is simple and easy to do Method comprises the steps of:

(1) take Uroctea compatilis Koch., dried with slow fire, be ground into fine powder；

(2) take Radix Ampelopsis, be ground into fine powder；

(3) take Mannosum Kaki and Margarita powder, mix with step (1) and (2) gained fine powder；

(4) extracting honeysuckle, adds the water of 10 times amount to soak 1-2 hour, 6～10 hours vapor distillation extraction times, receives Collection volatile oil, medicinal residues are standby；

(5) Gypsum Fibrosum, Fructus Gardeniae, Fructus Mume, Radix Scrophulariae and Radix Glycyrrhizae and the medicinal residues of step (4) are taken to mix homogeneously, plus 8 each time～10 times Water, decoct 2 times, collecting decoction, standing 12 hours after, take supernatant and be concentrated into thick paste, add volumetric concentration be 40%～ 80% ethanol precipitate with ethanol, stands 24 hours, takes supernatant liquid filtering, decompression recycling ethanol, be then condensed into extractum spray dried Dry, obtain extract powder；

(6) step (3) and step (5) gained extract powder are mixed homogeneously with step (4) gained volatile oil, obtain final product described Effective ingredient.

Medicine of the present invention is oral agents, such as granule, capsule or tablet.

The prescription feature of medicine of the present invention: the present invention, according to tcm prescription theory, is tied using monarch compatibility Structure, makes all medicines work in coordination with compatibility, thus producing overall efficacy, the not simple superposition of drug alone effect, specific as follows:

Uroctea compatilis Koch. salty in the mouth, slight bitter, cool in nature, return lung, liver, large intestine channel, function heat-clearing and toxic substances removing and removing the necrotic tissue；Mannosum Kaki sweet in the mouth, cool in nature, return The heart, lung, stomach, the heat of kind lung heat clearing stomach；Radix Ampelopsis nature and flavor are bitter, sweet, pungent, cool, enter the heart, liver, spleen channel, function heat-clearing and toxic substances removing, SHENGJISAN Knot；Margarita nature and flavor are sweet, salty, cold, GUIXIN, Liver Channel, function removing toxic substances and promoting granulation；Four medicine phases 5, have heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation function It is monarch drug altogether.Flos Lonicerae nature and flavor are sweet, tremble with fear, return lung, the heart, stomach, function heat-clearing and toxic substances removing, the heat of cool scattered lung gold；Gypsum Fibrosum nature and flavor are sweet, Pungent, in Great Cold, attach to the lung and stomach meridians, function clearing away heat-fire, the fire of kind lung heat clearing stomach.Fructus Gardeniae nature and flavor are bitter, tremble with fear, GUIXIN, lung, tri-jiao channel, function Clearing away heat-fire, removing pathogenic heat from blood and toxic substance from the body, the fire of clearing away damp-heat from SANJIAO；Three medicine GUIXIN, lung, stomach, tri-jiao channel, help the removing toxic substances of monarch's clearing away heat-fire to be minister altogether Medicine.Fructus Mume sour in the mouth, puckery, mild-natured, Return liver, spleen, lung, large intestine channel, function YIN nourishing and the production of body fluid promoting；Radix Scrophulariae nature and flavor are sweet, bitter, salty, are slightly cold, and return Spleen, stomach, kidney channel, function clearing away heat and cooling blood, nourishing YIN to lower pathogenic fire, detoxicating and resolving stagnation of pathogens, two medicines are good at yin nourishing pathogenic fire reducing, primary disease exuberant lung-stomach heat, probably There is the change of impairment of YIN, thus Kidney-Yin with the big benefit of this two medicine, altogether for adjuvant drug；Radix Glycyrrhizae property is sweet, flat, enter the heart, lung, spleen, stomach, arrogate to oneself most removing toxic substances, Coordinating the actions of various ingredients in a prescription, therefore for making medicine.Above-mentioned all medicines coordinate, and side plays solution thermal detoxification altogether entirely, the work(of removing the necrotic tissue more infectionss.

The effect of Drug therapy recurrent oral ulceration of the present invention can be obtained into one by the observation of following clinical cases Step confirms.

Clinical research data

1st, data and standard

1.1st, diagnostic criteria:

A: lung and stomach excessive heat type CM syndrome differentiation criterion: with reference to " new Chinese medicine guideline of clinical investigations " dialectical standard formulation of aphtha.

Primary symptom: ulcer surface differs in size, number is many, and edge is red and swollen, locally scorching hot pain；

Secondary disease: dryness in the nasal cavity, xerostomia or thirsty, implication is smelly dirty, big dry stool, yellow fur, rolling pulse or number；

Possessing primary symptom and more than 3 persons of secondary disease is exuberant lung-stomach heat pattern of syndrome recurrent oral ulceration.

B: recurrent oral ulceration diagnostic criteria: reference " oral mucosal disease " (Chen Qianming. oral mucosal disease the scholar people defend The raw publishing house third edition in 2010) formulate.

1. oral ulcer, medical history was more than 2 years；

2. the intermission shown effect is 1～3 month；

3. oral ulcer number is less than 3 every time.

1.2nd, case inclusive criteria: meet the dialectical standard of lung and stomach excessive heat type and recurrent oral ulceration diagnostic criteria simultaneously, Can follow the doctor's advice, and sign Informed Consent Form.

1.3rd, case exclusion standard: do not meet case inclusive criteria；Exclusion behcets disease and oral squamous cell carcinoma patient；Nearly 1 In individual month using antibiotic, glucocorticosteroid hormonal medicaments；It is associated with severe cardiac, brain, lung, kidney or hemopoietic system etc. seriously primary Property disease patient；Uncooperative or therapy discontinued person.

2nd, case packet

Observe 79 patients altogether, according to medical sequencing row number, odd number is treatment group 40, and even numbers is matched group 39 Example.According to case exclusion standard, observe effective patient 72 altogether, treatment group is 38, matched group 34.

3rd, classified data

Treatment group 38, wherein man 22, female 16,45.3 ± 2.5 years old mean age；Matched group 34, wherein man 19 Example, female 15,44.9 ± 1.8 years old mean age.Through statistics x²Inspection, treatment group and 2 groups of cases of matched group are at sex, age Aspect there are no significant difference (p > 0.05), has comparability.

4th, research method

4.1st, observation index

1. clinical symptoms and tongue fur, pulse condition；

2. healing；

4.2nd, safety observation: treatment before and after look Liver and kidney function and blood, routine urinalysis, bad thing during observation and treatment The generation of part.

4.3rd, Therapeutic Method

Treatment group adopts the embodiment of the present invention 1 granule, every time 1 bag, and 2 times a day；Matched group adopts coptos bolus for clearing the upper heat (north Capital limited company of Tongrentang, authentication code: Chinese medicines quasi-word z11020229), 2 ball every time, 2 times a day, warm boiled water.7 At (1 week) day was 1 course for the treatment of.

4.4th, efficacy assessment standard:

With reference to " recurrent aphtha whole body therapeutic therapeutic evaluation tentative standard ", (Chinese stomatology can oral mucosa Sick Professional Committee. recurrent aphtha whole body therapeutic therapeutic evaluation tentative standard. modern practicality medical science, 2003,15 (2): 131.) formulate.

Effective: patient's main clinic symptoms disappear, ulcer surface pain disappears, and the ulcerative stage course of disease substantially shortens；

Effective: patient's main clinic symptoms, ulcer surface pain and ulcer situation are relieved；

Invalid: the state of an illness is no alleviated, even having increased.

Calculate total effective rate using effective with effectively with as virtual value.

4.6th, statistical method:

Statistical analysiss are carried out using statistical software spss17.0.Measurement data adopts x²Inspection, enumeration data adopts t to examine Test, confidence interval is 95%, p < 0.05 is significant difference, has statistical significance.

5th, therapeutic outcome

5.1. 2 groups of Clinical efficacy comparisons

Table 1 treatment group and matched group Clinical efficacy comparison

Note: compare #p ＜ 0.05 with matched group.

Table 1 result shows, two groups of total effectses significant differences, shows Drug therapy lung and stomach excessive heat type recurrent oral of the present invention The total effectses of ulcer are better than matched group coptos bolus for clearing the upper heat.

5.2nd, safety evaluatio:

Before and after 2 groups of patient's treatments, blood, routine urinalysis and hepatic and renal function inspection have no significant change.Do not find obvious adverse reaction Event, shows that medicine of the present invention is a safe and effective preparation.

Specific embodiment:

Embodiment 1 (granule):

1st, prescription: Uroctea compatilis Koch. (roasting) 500g, Mannosum Kaki 500g, Radix Ampelopsis 500g, Margarita powder 100g, Flos Lonicerae 2000g, Gypsum Fibrosum 3000g, Fructus Gardeniae 1500g, Fructus Mume 1500g, Radix Scrophulariae 1500g, Radix Glycyrrhizae 1000g.

2 preparation methoies:

1. take Uroctea compatilis Koch., dried with slow fire, be ground into fine powder；

2. take Radix Ampelopsis, be ground into fine powder；

3. Mannosum Kaki, Margarita powder are taken, with step 1. 2. gained fine powder mixing；

4. extracting honeysuckle, adds the water of 10 times amount to soak 1 hour, 8 hours vapor distillation extraction times, collects volatilization Oil, medicinal residues are standby；

5. 4. remaining medicinal residues are mixed homogeneously to weigh Gypsum Fibrosum, Fructus Gardeniae, Fructus Mume, Radix Scrophulariae, Radix Glycyrrhizae and step according to proportioning, each time Plus 9 times of decocting boils 2 times, collecting decoction, standing, after about 12 hours, takes supernatant and is concentrated into thick paste, and addition volumetric concentration is 60% ethanol precipitate with ethanol, stands 24 hours, takes supernatant liquid filtering, decompression recycling ethanol, be then condensed into extractum spray dried Dry, obtain extract powder；

6. by step 3., step 5. gained fine powder 4. gained volatile oil is mixed homogeneously with step, add appropriate dextrin and shallow lake Powder, then adds water and makes granule, is dried, granulate, and pack is distributed into 10g/ bag.

Embodiment 2 (granule):

1st, prescription: Uroctea compatilis Koch. (roasting) 666g, Mannosum Kaki 605g, Radix Ampelopsis 545g, Margarita powder 82g, Flos Lonicerae 2215g, Gypsum Fibrosum 2723g, Fructus Gardeniae 1573g, Fructus Mume 1210g, Radix Scrophulariae 1392g, Radix Glycyrrhizae 1089g.

2nd, preparation method:

1. take Uroctea compatilis Koch., dried with slow fire, be ground into fine powder；

2. take Radix Ampelopsis, be ground into fine powder；

3. Mannosum Kaki, Margarita powder are taken, with step 1. 2. gained fine powder mixing；

4. extracting honeysuckle, adds the water of 10 times amount to soak 1 hour, 10 hours vapor distillation extraction times, collects volatilization Oil, medicinal residues are standby；

5. 4. remaining medicinal residues are mixed homogeneously to take Gypsum Fibrosum, Fructus Gardeniae, Fructus Mume, Radix Scrophulariae, Radix Glycyrrhizae and step, each time plus 10 times of water Decoct 2 times, collecting decoction, standing, after about 12 hours, takes supernatant and is concentrated into thick paste, add the ethanol that volumetric concentration is 80% Precipitate with ethanol, stands 24 hours, takes supernatant liquid filtering, decompression recycling ethanol, be then condensed into extractum and be spray-dried, obtain extractum Powder；

6. by step 3., step 5. gained fine powder 4. gained volatile oil is mixed homogeneously with step, add appropriate dextrin and shallow lake Powder, then adds water and makes granule, is dried, granulate, and pack is distributed into 10g/ bag.

Embodiment 3 (granule):

1st, prescription: Uroctea compatilis Koch. (roasting) 424g, Mannosum Kaki 462g, Radix Ampelopsis 521g, Margarita powder 118g, Flos Lonicerae 2428g, Gypsum Fibrosum 3179g, Fructus Gardeniae 1503g, Fructus Mume 1330g, Radix Scrophulariae 1210g, Radix Glycyrrhizae 925g.

2nd, preparation method:

1. take Uroctea compatilis Koch., dried with slow fire, be ground into fine powder；

2. take Radix Ampelopsis, be ground into fine powder；

3. Mannosum Kaki, Margarita powder are taken, with step 1. 2. gained fine powder mixing；

4. extracting honeysuckle, adds the water of 10 times amount to soak 2 hours, 8 hours vapor distillation extraction times, collects volatilization Oil, medicinal residues are standby；

5. 4. remaining medicinal residues are mixed homogeneously to take Gypsum Fibrosum, Fructus Gardeniae, Fructus Mume, Radix Scrophulariae, Radix Glycyrrhizae and step, each time plus 8 times of water Decoct 2 times, collecting decoction, standing, after about 12 hours, takes supernatant and is concentrated into thick paste, add the ethanol that volumetric concentration is 50% Precipitate with ethanol, stands 24 hours, takes supernatant liquid filtering, decompression recycling ethanol, be then condensed into extractum and be spray-dried, obtain extractum Powder；

6. by step 3., step 5. gained fine powder 4. gained volatile oil is mixed homogeneously with step, add appropriate dextrin and shallow lake Powder, then adds water and makes granule, is dried, granulate, and pack is distributed into 10g/ bag.

Embodiment 4 (capsule)

By the drug particles of the method preparation according to embodiment 1, load gelatine capsule, make capsule.

Embodiment 5 (tablet):

Embodiment 1 granule is added water moistening, tabletting, is dried and tablet is obtained.

Claims (4)

1. a kind of medicine treating recurrent oral ulceration, this medicine is by active ingredient and medically acceptable excipient group Become, wherein said active ingredient is made up of the crude drug of following percentage by weight:

Uroctea compatilis Koch. (roasting) 3.5～5.5%, Mannosum Kaki 3.5～5.5%, Radix Ampelopsis 3.5～5.5%, Margarita powder 0.5～1.2%, Flos Lonicerae 12～21%, Gypsum Fibrosum 20～30%, Fructus Gardeniae 10～16%, Fructus Mume 10～16%, Radix Scrophulariae 10～16%, Radix Glycyrrhizae 7～11%.

2. a kind of medicine treating recurrent oral ulceration according to claim 1 is it is characterised in that described effective one-tenth Part is made up of the crude drug of following percentage by weight:

Uroctea compatilis Koch. (roasting) 4%, Mannosum Kaki 4%, Radix Ampelopsis 4%, Margarita powder 0.8%, Flos Lonicerae 16.5%, Gypsum Fibrosum 25%, Fructus Gardeniae 12.5% Part, Fructus Mume 12.5%, Radix Scrophulariae 12.5%, Radix Glycyrrhizae 8.2%.

3. a kind of medicine treating recurrent oral ulceration according to claim 1 and 2 is it is characterised in that described has Effect composition is obtained by following methods:

(1) take Uroctea compatilis Koch., dried with slow fire, be ground into fine powder；

(2) take Radix Ampelopsis, be ground into fine powder；

(3) take Mannosum Kaki and Margarita powder, mix with step (1) and (2) gained fine powder；

(4) extracting honeysuckle, adds the water of 10 times amount to soak 1-2 hour, 6～10 hours vapor distillation extraction times, collection is waved Hair oil, medicinal residues are standby；

(5) Gypsum Fibrosum, Fructus Gardeniae, Fructus Mume, Radix Scrophulariae and Radix Glycyrrhizae and the medicinal residues of step (4) are taken to mix homogeneously, plus 8 each time～10 times Water, decoct 2 times, collecting decoction, standing 12 hours after, take supernatant and be concentrated into thick paste, add volumetric concentration be 40%～ 80% ethanol precipitate with ethanol, stands 24 hours, takes supernatant liquid filtering, decompression recycling ethanol, be then condensed into extractum spray dried Dry, obtain extract powder；

(6) step (3), step (5) gained extract powder are mixed homogeneously with step (4) gained volatile oil, obtain final product described effective Composition.

4. a kind of medicine treating recurrent oral ulceration according to claim 3 is it is characterised in that described medicine is Granule, capsule or tablet.