CN102114164A - Application of traditional Chinese medicine preparation in treating oral leukoplakia and preventing diseases caused by oral leukoplakia canceration - Google Patents
Application of traditional Chinese medicine preparation in treating oral leukoplakia and preventing diseases caused by oral leukoplakia canceration Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine externally-applied preparation for treating oral leukoplakia and preventing diseases caused by oral leukoplakia canceration, specifically, a Chinese patent drug prepared from traditional Chinese medicinal herbs. The traditional Chinese medicine externally-applied preparation is prepared from the following traditional Chinese medicine raw materials according to the parts by weight: 18-24 parts of subprostrate soplhor root, 17-21 parts of bistort rhizome, 17-23 parts of dahurian patrinia herb, 8-12 parts of Cortex Dictamni, 18-25 parts of common selfheal spike, and 3-6 parts of airpotato yam.
Description
Technical field
The present invention relates to a kind of new purposes of Chinese medicine preparation, be specifically related to a kind of Chinese medicine for external application for the treatment of oral leukoplakia and prevention buccal cavity white spot.
Background technology
The anticancer second ball of hypertrophy plain film original name, the pure Chinese medicinal preparation of forming by Radix Sophorae Tonkinensis, Rhizoma Bistortae, Sonchus brachyotus DC., Cortex Dictamni, Spica Prunellae and Rhizoma Dioscoreae Bulbiferae Six-element Chinese medicine.With Radix Sophorae Tonkinensis relieve inflammation or internal heat the detumescence sore-throat relieving be monarch drug.The detumescence of Rhizoma Bistortae removing heat from blood and promoting blood circulation, the clear hot and suffocating hard masses softening and resolving of Spica Prunellae, two medicines are minister.Sonchus brachyotus DC. heat clearing away addiction eliminating stagnation, the Cortex Dictamni heat clearing away, the Rhizoma Dioscoreae Bulbiferae eliminating stagnation is reduced phlegm detumescence and is that assistant makes.All medicines are heat and toxic materials clearing away medicine, and nature and flavor are cold partially, cool, and the fraud that helpless transconversion into heat is dry all has certain antitumaous effect and is used for the control of cancer.The hypertrophy plain film is country's " six or five ", " the Seventh Five-Year Plan " and " eight or five " tackling of key scientific and technical problems achievement.Be chosen as the whole nation ten big technological achievements by country in 1991, and be cited as national new product in 1997.
The hypertrophy plain film is applicable to: treat the preceding illness of upper gastrointestinal precancerous lesion and cancer, as oral leukoplakia and lichen planus, the epithelial proliferation of esophagus and cardia, atrophic gastritis, superficial gastritis and mucosa atypical hyperplasia etc., curative effect is obvious, can prevent that its canceration from being treatment gastropathy good medicine.The esophageal carcinoma, carcinoma of gastric cardia, gastric cancer, colon cancer, pulmonary carcinoma, the nasopharyngeal carcinoma of treatment middle and advanced stage, bladder cancer etc. have good mitigation, share with chemotherapy and can improve curative effect, alleviate put, the toxic and side effects of chemotherapy.Be used for patient after cancer operation and the radiotherapy, carry out prophylactic treatment.Prevent recurrence and transfer, improve cure rate, as the esophageal carcinoma, carcinoma of gastric cardia, gastric cancer, colon cancer, pulmonary carcinoma, bladder cancer etc.
The zengshengping tablet function cures mainly: heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating.Be applicable to esophagus and cardia epithelial proliferation, have singultus, feed dysphagia, xerostomia, bitter taste, pharyngalgia, dark, the interior knot of the hot stasis of blood of the people with thready and slippery pulse shower of dry stool tongue.Usage and dosage: oral.One time 4～8,2 times on the one, 6 months courses of treatment.Or follow the doctor's advice.
Oral leukoplakia (oral leukoplakia, OLK) latest definition is decreased in the meeting at the international oral cavity of Sweden Uppsala leukoplakia in 1996 and is made, be defined as " betiding on the oral mucosa infringement; do not have the feature of other any definable infringements, a part of oral leukoplakia can be converted into cancer " based on white.This definition conforms to the precancerous lesion notion that WHO1972 announces, therefore be acknowledged as precancerous lesion, its canceration rate is 7%～15%, and the anisotropism white macula can reach 15%～40%, is one of focus of domestic and international medical circle of oral cavity concern to its treatment and the control of canceration.After white macula usually occurred in 30 years old, studies show that white macula generally occurs in the women of 40 years old later male and 50 years old.Generation that there are some researches show white macula and smoking, drink and local physicochemical irritation such as edible irritable food relevant.
OLK cause of disease complexity, pathogenesis is not clear, can there be any symptom clinically, therefore treat emphasis and should be and prevent or reduce its pernicious transformation, Therapeutic Method comprises Drug therapy and non-drug therapy (operation, laser, freezing), but the latter has the restriction and the higher recurrent rate of indication, and it can not prevent the generation once more of other position white maculas of oral cavity what is more important.Common drug has tretinoin, bleomycin, propolis, fluorouracil, Cycloxygenase-2 depressant, beta-carotene, lycopene etc. clinically at present, the side effect of these medicines such as chemical medicine such as bleomycin and fluorouracil is more, tretinoin treatment relapse rate height, the price of propolis is relatively costly, all can not be as the optimal treatment medicine of oral leukoplakia.
Ideal cancer chemoprevention medicine should possess low toxicity, condition such as safe, effective, inexpensive, the Chinese medicine of China exactly has these ideal conditionss potentially, in " can attempt exploration controls " of malignant tumor and precancerous lesion, shown the advantage of infusive curative effect and low toxicity, low side effect.To the exploitation of Chinese medicine chemoprophylactic drug, become the new research focus of chemoprevention of cancer in recent years.See and the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs principle according to the traditional Chinese medical science is whole, modern Chinese medicine thinks that OLK is a kind of topical manifestations of systemic disease, and external ailment said due to cold or exposure poison is evil, comprised cold superheated thermal stimulus, cigarette, wine, mycete and local chronic stimulation effect, or the seven emotions depression blood trouble of getting angry all can cause the stagnation of QI stagnation of QI.Gas loses unobstructed, and then blood is not all right, and is qi-blood disharmony, accumulates to amass and looses, and cause white macula; Moreover, spleen governing muscles, The spleen has the function to transport and transform nutrients, and water is wet, and The mouth is the body opening or window of the spleen, and if spleen loses fortuneization, the wet poison that stops is strongly fragrant, sends out in oral mucosa, and mucosa is corroded by damp, and speckle then turns white.In addition, deficiency of vital QI, exopathogen poison heresy is taken advantage of a weak point and also can be fallen ill.So can take vital energy regualting and blood circulation-promoting, heat-clearing and toxic substances removing, invigorating the spleen for eliminating dampness, strengthening vital QI to eliminate pathogenic factors to the treatment of primary disease is the main rule of treatment or with the Chinese medicine of promoting flow of QI and blood, heat-clearing and toxic substances removing, benefiting QI and nourishing blood.
Zengshengping tablet is a pure Chinese medicinal preparation, has the effect of heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating.We are through the evidence of science, and zengshengping tablet treatment white macula has been proved has effect, with hypertrophy plain film treatment oral leukoplakia patient, oral zengshengping tablet every day 3 times, each 4, treatment 8-12 month, patient's leukoderma of 67.8% is decreased and is dwindled, and matched group only is 16.8%.Zoopery shows: number of tumors, tumor load, canceration rate, cell micronucleus incidence rate, AgNOR number and the PCNA labelling number average of treatment treated animal significantly are lower than matched group, and the prompting zengshengping tablet can reduce the incidence rate of oral cancer.
Oral cavity mucous membrane white spot is the topical manifestations of disease, and therefore zengshengping tablet is developed as oral local administration will more help the performance of its advantage, and in addition, its preparation technology of preparation of the present invention is simple, cheap, is fit to large-scale production.
Summary of the invention:
The object of the present invention is to provide the application of a kind of Chinese medicine preparation in the medicine of preparation treatment oral cavity mucous membrane white spot.
Preparation of the present invention is processed into by following raw material of Chinese medicine medicine: Radix Sophorae Tonkinensis, Rhizoma Bistortae, Sonchus brachyotus DC., Cortex Dictamni, Spica Prunellae and Rhizoma Dioscoreae Bulbiferae.
Concrete, Chinese medicine preparation of the present invention is prepared from by following Chinese medicine raw materials by weight proportion medicine:
Radix Sophorae Tonkinensis 18-24 part, Rhizoma Bistortae 17-21 part, Sonchus brachyotus DC. 17-23 part,
Cortex Dictamni 8-12 part, Spica Prunellae 18-25 part, Rhizoma Dioscoreae Bulbiferae 3-6 part.
In more than forming, weight is calculated with crude drug, by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or is unit with the ton, and small-scale production can be a unit with gram or milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Chinese medicine preparation of the present invention can be prepared into any pharmaceutical dosage form, comprises oral formulations and external preparation.
Preferably, Chinese medicine preparation of the present invention is prepared into external preparation, is specially any exterior-applied formulation that can be used for the oral cavity, and these dosage forms comprise: gel, ointment, ointment, cream, spray, tincture, paste, suppository, patch etc.
Further preferred, preparation of the present invention is a paste, patch and gel.Wherein, patch comprises: membranous patch and paster agent.
Chinese medicine for external application of the present invention can contain excipient commonly used, such as adhesive, filler, diluent, lubricant, diluent, coloring agent, flavoring agent and lytic agent etc.
Chinese medicine for external application of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but every day three times, each 1-20 agent etc.
Another object of the present invention is to provide the preparation method of pharmaceutical formulation of the present invention.
Preparation of the present invention can be according to existing routine techniques preparation.
Preferably, the preparation method of Chinese medicine for external application of the present invention is as follows:
Above Six-element is got Cortex Dictamni 105g and is ground into fine powder, and is standby, gets Radix Sophorae Tonkinensis and decocts with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35, and drying under reduced pressure becomes dried cream, pulverizes, and is standby; Four flavor crude drug and remaining Cortex Dictamni 105g such as all the other Rhizoma Bistortaes, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35, add Cortex Dictamni fine powder and Radix Sophorae Tonkinensis dried cream powder, be dissolved in behind the mixing in 95% ethanol, get mixed liquor; Precision takes by weighing sodium carboxymethyl cellulose 10g and is dissolved in the 500ml distilled water, leaves standstill 24 hours, obtains 2% sodium carboxymethyl cellulose; Mixed liquor is poured in 2% sodium carboxymethyl cellulose, and adding distil water is to 100ml, and stirs, treat bubble collapse after, smear bed board and dry and get final product.
Other preferred manufacturing procedure of the present invention in an embodiment.
Oral film of the present invention can become colloidal sol after water logging; stick to mucous membrane surface; drug release is lasting in the film; keep topical remedy's valid density; and make disease damage position obtain the mechanicalness protection; more can palliate the agonizing sufferings than its oral formulations such as tablet, improve curative effect, thereby get the optimal treatment pharmaceutical dosage form that may become oral cavity mucous membrane white spot.
Chinese medicine preparation of the present invention is at preparation treatment oral cavity mucous membrane white spot, and the application in the medicine of prevention buccal cavity white spot.Chinese medicine preparation of the present invention has protective effect to oral mucosa, can suppress the generation of oral cancer, effectively blocks the generation of precancerous lesion.
Preparation of the present invention is complete pure Chinese prescription, has avoided fully owing to the various untoward reaction of using antibacterials and other chemical medicine to cause, and the present invention also has evident in efficacy in addition, dosage is few, and is easy to use, and side effect is little, good stability, cheap, treating both the principal and secondary aspects of a disease etc. plurality of advantages.
Description of drawings
The supreme skin hypertrophy of oral mucosa (right figure) behind the light moderate hypertrophy of oral mucous epithelia (left figure)/zengshengping tablet topical therapeutic before Fig. 1, the treatment
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1, zengshengping tablet oral film preparation
Get Cortex Dictamni 210g, it is standby to be ground into fine powder.Get each 420g of Rhizoma Dioscoreae Bulbiferae 100g, Radix Sophorae Tonkinensis, Herba Patriniae, Rhizoma Bistortae and Spica Prunellae again, put in the container, it is an amount of to add water, decocts 2 hours, and leaching medicinal liquid, medicinal residues add an amount of water again, decocts leaching medicinal liquid waste 1.5 hours.Twice filtrate is merged, be evaporated to the extractum of relative density 1.30 to 1.35 (50 ℃ of heat are surveyed).Add the Cortex Dictamni fine powder, be dissolved in behind the mixing in 95% ethanol, get mixed liquor.Precision takes by weighing sodium carboxymethyl cellulose 10g and is dissolved in the 500ml distilled water, leaves standstill 24 hours, obtains 2% sodium carboxymethyl cellulose.Mixed liquor is poured in 2% sodium carboxymethyl cellulose, and adding distil water is to 100ml, and stirs, treat bubble collapse after, smear bed board and dry and get final product, obtain zengshengping tablet oral film preparation.
Embodiment 2, paste
Get Cortex Dictamni 230g, it is standby to be ground into fine powder.Get Rhizoma Dioscoreae Bulbiferae 120g, Radix Sophorae Tonkinensis 480g, Herba Patriniae 420g, Rhizoma Bistortae and each 420g of Spica Prunellae again, put in the container, it is an amount of to add water, decocts 2 hours, and leaching medicinal liquid, medicinal residues add an amount of water again, decocts leaching medicinal liquid waste 1.5 hours.Twice filtrate is merged, be evaporated to the extractum of relative density 1.20 to 1.45 (50 ℃ of heat are surveyed).With standby Cortex Dictamni fine powder and spissated extractum uniform mixing, add an amount of excipient and make paste at last.
Embodiment 3, patch
Prescription:
Radix Sophorae Tonkinensis 420g, Rhizoma Bistortae 420g, Sonchus brachyotus DC. 420g, Cortex Dictamni 210g, Spica Prunellae 420g, Rhizoma Dioscoreae Bulbiferae 100g preparation:
Above Six-element is got Cortex Dictamni 105g and is ground into fine powder, and is standby, gets Radix Sophorae Tonkinensis and decocts with water secondary, each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), drying under reduced pressure (below 60 ℃) becomes dried cream, pulverizes, and is standby.Four flavor and remaining Cortex Dictamni 105g such as all the other Rhizoma Bistortaes, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), add Cortex Dictamni fine powder and Radix Sophorae Tonkinensis dried cream powder, be dissolved in behind the mixing in 95% ethanol, get mixed liquor.Precision takes by weighing sodium carboxymethyl cellulose 10g and is dissolved in the 500ml distilled water, leaves standstill 24 hours, obtains 2% sodium carboxymethyl cellulose.Mixed liquor is poured in 2% sodium carboxymethyl cellulose, and adding distil water is to 100ml, and stirs, treat bubble collapse after, smear bed board and dry and get final product.
Embodiment 4, the test of pesticide effectiveness of the present invention
Further specify beneficial effect of the present invention by following experimental data:
Test one, zengshengping tablet topical therapeutic are to the inhibitory action of Golden Hamster buccal cavity white spot
1. material
Zengshengping tablet paste (see the embodiment of the invention 2: the zengshengping tablet powder adds water and grinds to form pasty state), 0.5% dimethyl phenylpropyl alcohol anthracene (DMBA) acetone soln, TRAP-ELISA test kit, hypertrophy plain film (market purchase)
2. animal model and experimental technique
By randomization 40 Golden Hamster are divided into following 4 groups:
Blank group (A group): 10, the cheek pouch applied with acetone 3 times weekly, was coated with for 6 weeks altogether;
Model control group (B group): 10, cheek pouch coating 0.5%DMBA acetone soln 3 times weekly, was coated with for 6 weeks altogether;
Oral group of zengshengping tablet (C group): 10, make film and irritate stomach zengshengping tablet 6.0g/kg at twice every day simultaneously, treated for 10 weeks;
Zengshengping tablet topical therapeutic group (D group): 10, make film cheek pouch coating every day zengshengping tablet paste twice simultaneously, treated for 10 weeks.
Duration of test, perusal cheek pouch mucosa changes.Put to death animal after the off-test, counting mouth neoplasm number.Pathological changes oral mucosas tissue is got in off-test, 10% formalin fixed, paraffin embedding, conventional section, HE dyeing.Carrying out histopathology, micronucleus cell rate, AgNOR, PCNA and EGFR analyzes.
2.1 a situation arises for mouth neoplasm
During off-test, put to death animal, count the number of every suslik tumor, measure the length diameter of each tumor, with the radius (r) of its meansigma methods as tumor.Calculate and respectively organize average tumor number, average tumor volume and average tumor load, average tumor load=average tumor is counted the average tumor volume of *.
2.2 histopathology is observed
Two paraffin sections are after conventional HE dyeing, and 12 standards of assisting the center to announce in 1978 by the WHO oral precancerous lesion pathological change under light microscopic are judged, it is divided into simple hypertrophy, paraplasm (slightly, moderate and severe) and cancer.
2.3 micronucleus assay
Organize micronucleus detection method to carry out according to the method that proposes.Two paraffin sections dye through Feuglen, carry out the mouth epithelial cells micronucleus and observe under 100 times of oily mirrors of *.500 epithelial cells of every section counting amount to the micronucleus cell number in 1000 cells, and microkernel incidence is represented with permillage.
2.4AgNOR analyze
With two paraffin sections, according to Ploton improvement argentation preparation collargol dye liquor, dye, AgNOR analyzes and carry out the AgNOR counting on MPIAS-500 type multifunctional image analyser, measures each nuclear average A gNOR numbers of particles.
2.5PCNA analyze
PCNA assay method immunohistochemical ABC method.The PCNA positive cell is that nucleus is dyed pale brown color as a result,
The PCNA label index is represented with the PCNA positive cell number in per 100 cells.
2.6EGFR protein expression analysis
EGFR measures with the PCNA detection method.It is that EGFR expresses positive cell that cell membrane and cytoplasm are dyed pale brown color.EGFR expresses according to the expression of the EGFR in per 100 cells positive cell number and divides positive I level (0～25%), II level (26～50%), III level (51～75%) and IV level (76～100%) with it.
3. result
This research is irritated simultaneously and is fed zengshengping tablet being coated with DMBA for suslik oral cavity cheek pouch, after 6 weeks, model group has 100% suslik to develop into tumor, and average tumor number of medication group and average tumor load obviously reduce, illustrate that zengshengping tablet has preventive effect to oral cancer, and from table 1,2 indexs as can be seen, zengshengping tablet oral cavity external group and oral group of comparison more can suppress the generation (p＜0.01) of oral cancer.
The influence that the animal mouth neoplasm that table 1, zengshengping tablet bring out DMBA takes place
Annotate: ▲: p＜0.01 compared with model group; *: compare p＜0.0 with the C group
Table 2, zengshengping tablet are to the influence of suslik oral cavity mucous membrane tissue pathological change
Annotate: ▲: p＜0.01 compared with model group; *: compare p＜0.01 with the C group
Table 3, zengshengping tablet are to suslik oral mucosa micronucleus cell rate, AgNOR number and the exponential influence of PCNA
Annotate: ▲: p＜0.01 compared with model group; *: compare p＜0.01 with the C group
The influence that table 4, zengshengping tablet are expressed suslik oral mucosa EGFR
Annotate: ▲: p＜0.01 compared with model group
The influence that zengshengping tablet is expressed oral mucosas tissue's microkernel incidence, AgNOR, PCNA and EGFR is by shown in the table 3,4, its medication group microkernel incidence, every nuclear AgNOR numbers of particles, PCNA label index and EGFR The positive expression rate, all be starkly lower than model control group, two groups of significant differences of having compared; Zengshengping tablet oral cavity partial treatment group and oral group of comparison also are starkly lower than oral group, and difference has significance.
4. conclusion
Zengshengping tablet has protective effect to the oral mucosa of Golden Hamster, can suppress the generation of oral cancer.The curative effect that the zengshengping tablet oral cavity partial is smeared is better than oral zengshengping tablet.
Test two, zengshengping tablet topical therapeutic are to the effect of suslik oral leukoplakia
1. material
48 of Golden Hamster are at first smeared suslik cheek pouch mucosa with the DMBA acetone solution, are coated with for 6 weeks altogether 3 times weekly.The 7th week the time was got 19 of biopsies at random, saw that it is slight atypical hyperplasia that 57.9% pathological development is arranged.
2. experimental technique
Above-mentioned 62 precancerous lesion animal models are divided into 3 groups at random: A organizes (oral drugs group) 17 animals, and the bilateral cheek pouch is totally 34 place's pathological changes, oral zengshengping tablet 6.0g/kg, perfusion every day 2 times, 1 week of medication; B group (topical therapeutic group) 19 animals are totally 40 place's pathological changes, in the inboard coating of suslik bilateral cheek pouch zengshengping tablet paste; C organizes matched group) refuse to obey any medicine, routine observation, 26 animals are totally 52 place's pathological changes.
Perusal: time of occurrence, number and the size of observing the time, particularly tumor of pathological changes appearance.The sick damage is divided into 4 types:: homogeneous pattern, white macula granular pattern white macula, tuberosity mamillary white macula and tumor.
Observation by light microscope: cut the most obvious place of pathological changes mucosa after the drug withdrawal and do histopathological examination.Mirror is observed the official portrait method evaluation of adopting Smith-Pindbor g down.Cancerating comprises cancer and severe paraplasm person, and suppression ratio is estimated the barrier effect of this medicine to precancerous lesion with cancerating
Suppression ratio=(the matched group rate of cancerating-treatment group cancerate the rate)/matched group that cancerates rate * 100% that cancerates
3. result:
The pathological changes performance and the inhibition situation that cancerates under table 5, the light microscopic
Annotate: A compares p＜0.01 with the B group respectively at the C matched group
(1) perusal: the incidence rate of each experimental group animal tumor is starkly lower than matched group, and the time of generation also is later than matched group.
(2) om observation: its pathological change has been carried out observing relatively, and zengshengping tablet sees Table 5 to the barrier effect of precancerous lesion.Processing treatment group is compared difference with matched group by statistics all has significance (through x
2Check, P＜0.01), illustrate that this medicine truly has blocking effect to precancerous lesion.And the effect of zengshengping tablet oral local administration is better than oral medication, and the two has significant difference (p＜0.05).
Test three. the zengshengping tablet topical therapeutic is to the research of hamster buccal cavity white spot influence
1. material and method
80,6～8 ages in week, 75～90g, the Syria hamster of male and female half and half.Be divided into 4 groups at random, 20 every group, the I group is the blank group, and the II group is model group, and the III group is oral group of zengshengping tablet (filling stomach), and the IV group is zengshengping tablet topical therapeutic group (paste is the same).
Carcinogen is smeared animal is fixed on the homemade mousetrap, retract cheek pouch, dip in DMBA solution with No. four oil painting brushes, squeeze out unnecessary medicinal liquid at bottleneck, at predetermined II, III, IV treated animal right side cheek pouch central authorities move in a circle near smearing in the scope of preceding vein place, about 4～5 times, air blow drying, 3 times weekly.
Administration is coated with the beginning in second day of DMBA, and the III treated animal is irritated hello device with self-control morning every day, and every animal is irritated and feeds compound recipe hypertrophy plain film suspension 6.0g/kg, and 2h fasting before and after the administration is until the experiment end; The IV treated animal is coated with the beginning in second day of DMBA, and in the inboard coating of suslik bilateral cheek pouch zengshengping tablet paste, 2h fasting before and after the administration finishes until experiment.
2. observation index
The activity of daily check animal, hair color, feed and coating district cheek pouch color shape matter change.Weigh record tumor time of occurrence weekly 1 time.Every group of 9 weekend put to death 10 animals at random, all put to death remaining animal 12 weekends, record tumor sizes (length calculates with mm).Cutting right side pathological changes cheek pouch mucosa and lymphonodi cervicales, liver, lung, spleen, kidney carries out conventional organization and learns and estimate.With the rate that the time cancerated in 9 weeks, gross tumor volume V=4/3m during 12 weeks
3, r=(length+wide+height) * 1/6mm3 carries out statistical analysis.
3. result
12 all observed result IIIIIIV organize carcinogenic district and are high differentiated squamous-cell carcinomas, and the inflammatory cell infiltration degree difference is little around three groups of cancer.Lymphonodi cervicales, liver, lung, spleen, kidney are not seen histology's ANOMALOUS VARIATIONS.Compare with model group, oral group of average tumor volume and total gross tumor volume with the topical therapeutic group of zengshengping tablet is little, and difference has significance (p＜0.01); Compare p＜0.05 with the topical therapeutic group for oral group.Four group of 12 all gross tumor volume relatively sees the following form.
Respectively organize relatively (mm of gross tumor volume when table 6,12 weeks
2)
Annotate:
#Expression is compared p＜0.01 with model group;
*Expression is compared p＜0.05. with hypertrophy plain film group
4. conclusion
Under the hamster cheek pouch cancer model system naturalness, neoplasm metastasis is very rare, utilizes this system, not only can carry out the observation whether food or medicine have short cancer or cancer suppressing action, and can observe the transfer that whether can promote cancer.The experimental system that this research takes place with simulation human body oral cancer, the coating treatment of tentative confirmation Chinese medicine zengshengping tablet oral cavity is better than oral medication to the effect that suppresses buccal cavity white spot.
Test four, zengshengping tablet topical therapeutic are to oral leukoplakia patient's observation of curative effect
1. clinical material money
Oral leukoplakia patient 55 examples, male 38 examples, women 17 examples; Lay respectively at buccal 25 examples, tongue 14 examples, lip 9 examples, gum portion 7 examples; Homogeneous pattern 42 examples, wadding type 13 examples; Clinical xerostomia, rough, the sense of discomfort of all showing as.
2. method
The patient who is diagnosed as white macula checks liver function and five indexes of hepatitis b before treatment, unusual person does not list object of study in.Remove local paathogenic factor before the object of study treatment, comprise smoking cessation, alleviating alcohol addiction, avoid pungent, cross and scald diet and remove undesirable root, residual crown and bad dummy etc.Be divided into A group (25 example) and B group (30 example) at random.A organizes oral hypertrophy plain film, each 1.2g, every day 2 times.The each 1.2g of zengshengping tablet paste (the zengshengping tablet powder adds water and grinds to form pasty state), every day 2 times are smeared in B group affected part, oral cavity.2 groups all in further consultation in every month 1 time, observes change of illness state, the itemized record state of an illness.3 months is a course of treatment, the evaluation curative effect.Check liver function and routine urinalysis during further consultation in every month, unusual person's drug withdrawal.Abnormal liver function the person give liver protecting therapy, the periodic review liver function; The unusual person of routine urinalysis checks renal function, unusual person's internal medicine consultation of doctors treatment.
3 results
3.1 efficacy assessment standard
Recovery from illness: disease undermines symptom and all disappears; Produce effects: the sick area that decreases disappears more than 2/3, and symptom obviously alleviates; Take a turn for the better: the sick area that decreases disappears 1/2～2/3, and symptom slightly alleviates; Invalid: as sick to decrease the area less than 1/2 that disappears, or no change, or enlarge, symptom no change or increase the weight of.
3.2 efficacy result
Compare for oral group with zengshengping tablet, the total effective rate that treatment is smeared in the zengshengping tablet oral cavity is higher than oral group, and p＜0.01 difference has significance.
Table 7, two groups of curative effects compare (%)
Annotate: compare with A group effective percentage,
*P＜0.01
4. conclusion
Test confirms that zengshengping tablet oral cavity local medication is better than the zengshengping tablet oral administration to the effect of oral leukoplakia, and is comparatively desirable to the therapeutic effect of oral leukoplakia.
The clinical research of test five, zengshengping tablet local control buccal cavity white spot
1. case grouping
Oral leukoplakia patient 42 examples are made a definite diagnosis through pathologic finding and to be had light, the moderate paraplasm of mucous epithelium, also do not do physical therapy or operative treatment persons such as laser-microwave without the other drug treatment in nearly 3 months.Press the randomly assigne grouping, the patient is divided into oral group of zengshengping tablet (22 example), be called for short oral group; Affected part, zengshengping tablet oral cavity topical group (20 example) is called for short and smears group.
2. clinical observation
Perusal damage range (dwindle, expansion, constant); Congested rotten to the corn (dwindle, constant, increase the weight of); Patient's subjective symptoms (pain, tractive, coarse sense of discomfort improves, constant, increase the weight of).Be decided to be 2w, 4w, 6w, 8w, 10w, 12w after taking medicine observing time.Follow up a case by regular visits to further consultation at every turn and all describe record with sketch map; The each patient takes the same sick position data as a comparison of decreasing with digital camera when the 1st time and last go to a doctor for 1 time.Clinical data adopts specially card special messenger record.When pathological observation each patient the 1st time goes to a doctor and get the most typical sick position of decreasing 1 time and make the living tissue pathological section at last.HE dyeing back light microscopic is observed down, makes medical diagnosis on disease, and makes pathological grading by 12 standards of epithelial dysplasia of WHO.Pathological observation person and clinical observation person adopt blind method in order to avoid subjectivity.
3. result
Comparison notable differences before and after two groups of clinical observation projects are treated as seen from Table 7 are through X
2Check p＞0.05.The patient feels.As seen from Table 8, zengshengping tablet is smeared group 40) patient has improvement in various degree through treatment pain, tractive, harsh feeling, and its effect is better than oral group, through X2 check p＜0.05.Patient's epithelial dysplasia (Fig. 1).Pathological change trend comparison before and after each group treatment sees Table 9.
Table 8, respectively organize contrast (routine number (%) before and after the clinical observation project
Table 9, respectively organize subjective symptoms and improve situation (example (%))
Pathological grading variation tendency before and after table 10, each group treatment is (routine number (%)) relatively
*Severe → slight → slight or slight → no abnormal hypertrophy
*The paraplasm pathological grading remains unchanged
* *Slightly → in, severe, moderate → severe
4. conclusion: zengshengping tablet has the clinical efficacy of blocking-up canceration to oral leukoplakia, and scribble effect is better than oral.
The present invention tests example and selects for use paste as the test medication, need to prove, selects for use the patch of the embodiment of the invention 1 oral film preparation and embodiment 3 to have above-mentioned excellent curative equally.
Claims (10)
1. the application of Chinese medicine preparation in the medicine of preparation treatment oral cavity mucous membrane white spot, described preparation is processed into by following raw material of Chinese medicine medicine: Radix Sophorae Tonkinensis, Rhizoma Bistortae, Sonchus brachyotus DC., Cortex Dictamni, Spica Prunellae and Rhizoma Dioscoreae Bulbiferae.
2. application according to claim 1 is characterized in that described Chinese medicine preparation has protective effect to oral mucosa, can suppress the generation of oral cancer.
3. application according to claim 1 is characterized in that described Chinese medicine preparation can prevent buccal cavity white spot, the generation of blocking-up precancerous lesion.
4. application according to claim 1 is characterized in that, described Chinese medicine preparation is an external preparation.
5. application according to claim 4 is characterized in that, described external preparation is any exterior-applied formulation that is used for the oral cavity, comprising: gel, ointment, ointment, cream, spray, tincture, paste, suppository, patch.
6. application according to claim 5 is characterized in that, the exterior-applied formulation in described oral cavity is a paste, membranous patch and paster agent.
7. application according to claim 1 is characterized in that, described Chinese medicine preparation is prepared from by following Chinese medicine raw materials by weight proportion medicine:
Radix Sophorae Tonkinensis 18-24 part, Rhizoma Bistortae 17-21 part, Sonchus brachyotus DC. 17-23 part,
Cortex Dictamni 8-12 part, Spica Prunellae 18-25 part, Rhizoma Dioscoreae Bulbiferae 3-6 part.
8. application according to claim 1 is characterized in that, described Chinese medicine preparation is prepared from by following Chinese medicine raw materials by weight proportion medicine:
Radix Sophorae Tonkinensis 420g, Rhizoma Bistortae 420g, Sonchus brachyotus DC. 420g,
Cortex Dictamni 210g, Spica Prunellae 420g, Rhizoma Dioscoreae Bulbiferae 100g.
9. the described application of claim 1 is characterized in that, the preparation method of described Chinese medicine preparation is as follows:
Get Cortex Dictamni 210g, it is standby to be ground into fine powder, gets Rhizoma Dioscoreae Bulbiferae 100g again, Radix Sophorae Tonkinensis, Herba Patriniae, each 420g of Rhizoma Bistortae and Spica Prunellae puts in the container, it is an amount of to add water, decocted 2 hours, leaching medicinal liquid, medicinal residues add an amount of water again, decocted 1.5 hours, leaching medicinal liquid waste merges twice filtrate, is evaporated to the extractum of relative density 1.30 to 1.35, add the Cortex Dictamni fine powder, be dissolved in behind the mixing in 95% ethanol, get mixed liquor, precision takes by weighing sodium carboxymethyl cellulose 10g and is dissolved in the 500ml distilled water, left standstill 24 hours, obtain 2% sodium carboxymethyl cellulose, mixed liquor is poured in 2% sodium carboxymethyl cellulose, adding distil water is to 100ml, and stir, after treating bubble collapse, smear bed board and dry and get final product, obtain zengshengping tablet oral film preparation.
10. the described application of claim 1 is characterized in that, the preparation method of described Chinese medicine preparation is as follows:
Get Cortex Dictamni 105g and be ground into fine powder, standby, get Radix Sophorae Tonkinensis and decoct with water secondary, each 1.5 hours, collecting decoction filtered, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35, and drying under reduced pressure becomes dried cream, pulverizes, standby, all the other Rhizoma Bistortae four flavor and remaining Cortex Dictamni 105g decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35, add Cortex Dictamni fine powder and Radix Sophorae Tonkinensis dried cream powder, be dissolved in behind the mixing in 95% ethanol, get mixed liquor, precision takes by weighing sodium carboxymethyl cellulose 10g and is dissolved in the 500ml distilled water, left standstill 24 hours, and obtained 2% sodium carboxymethyl cellulose, mixed liquor is poured in 2% sodium carboxymethyl cellulose, adding distil water is to 100ml, and stir, treat bubble collapse after, smear bed board and dry and get final product.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505656A (en) * | 2013-10-04 | 2014-01-15 | 张成娟 | Chinese medicine preparation for treating stomatitis |
| CN104367831A (en) * | 2014-11-05 | 2015-02-25 | 四川金堂海纳生物医药技术研究所 | Decoction medicine for treating oral leukoplakia and preparation method thereof |
| CN110638919A (en) * | 2018-06-26 | 2020-01-03 | 中国医学科学院药物研究所 | Improved low-toxicity zengshengping composition and preparation method and application thereof |
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| CN101670034A (en) * | 2009-10-21 | 2010-03-17 | 天津普瑞森医药贸易有限公司 | Application of traditional Chinese drug Zengshengping to treating mammary gland tumor |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103505656A (en) * | 2013-10-04 | 2014-01-15 | 张成娟 | Chinese medicine preparation for treating stomatitis |
| CN103505656B (en) * | 2013-10-04 | 2015-02-25 | 张成娟 | Chinese medicine preparation for treating stomatitis |
| CN104367831A (en) * | 2014-11-05 | 2015-02-25 | 四川金堂海纳生物医药技术研究所 | Decoction medicine for treating oral leukoplakia and preparation method thereof |
| CN110638919A (en) * | 2018-06-26 | 2020-01-03 | 中国医学科学院药物研究所 | Improved low-toxicity zengshengping composition and preparation method and application thereof |
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Application publication date: 20110706 |