CN104055921B - A kind of pharmaceutical composition and application thereof for the treatment of oral lichen planus - Google Patents
A kind of pharmaceutical composition and application thereof for the treatment of oral lichen planus Download PDFInfo
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- CN104055921B CN104055921B CN201410252120.0A CN201410252120A CN104055921B CN 104055921 B CN104055921 B CN 104055921B CN 201410252120 A CN201410252120 A CN 201410252120A CN 104055921 B CN104055921 B CN 104055921B
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- 206010030983 oral lichen planus Diseases 0.000 title claims abstract description 25
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 21
- 239000003814 drug Substances 0.000 claims abstract description 25
- 241000628997 Flos Species 0.000 claims abstract description 12
- 239000000463 material Substances 0.000 claims abstract description 11
- 239000002994 raw material Substances 0.000 claims abstract description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 3
- 238000002360 preparation method Methods 0.000 claims description 10
- 230000003902 lesion Effects 0.000 abstract description 9
- 210000004877 mucosa Anatomy 0.000 abstract description 8
- 230000000694 effects Effects 0.000 abstract description 7
- 229940079593 drug Drugs 0.000 abstract description 6
- 239000000203 mixture Substances 0.000 abstract description 3
- 238000011443 conventional therapy Methods 0.000 abstract description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 21
- 239000000865 liniment Substances 0.000 description 16
- 229940040145 liniment Drugs 0.000 description 16
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 15
- 238000003756 stirring Methods 0.000 description 14
- 239000000843 powder Substances 0.000 description 9
- 239000000243 solution Substances 0.000 description 9
- 229960004756 ethanol Drugs 0.000 description 8
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- 239000008213 purified water Substances 0.000 description 7
- 201000010099 disease Diseases 0.000 description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- 229960000935 dehydrated alcohol Drugs 0.000 description 5
- -1 hydroxypropyl Chemical group 0.000 description 5
- JLKDVMWYMMLWTI-UHFFFAOYSA-M potassium iodate Chemical compound [K+].[O-]I(=O)=O JLKDVMWYMMLWTI-UHFFFAOYSA-M 0.000 description 5
- 235000006666 potassium iodate Nutrition 0.000 description 5
- 229940093930 potassium iodate Drugs 0.000 description 5
- 239000001230 potassium iodate Substances 0.000 description 5
- 239000000706 filtrate Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 210000000214 mouth Anatomy 0.000 description 4
- 239000007921 spray Substances 0.000 description 4
- 238000005507 spraying Methods 0.000 description 4
- 239000002674 ointment Substances 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 229920001213 Polysorbate 20 Polymers 0.000 description 2
- 241000207844 Scrophulariaceae Species 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 240000008042 Zea mays Species 0.000 description 2
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 2
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 2
- SHGAZHPCJJPHSC-YCNIQYBTSA-N all-trans-retinoic acid Chemical compound OC(=O)\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C SHGAZHPCJJPHSC-YCNIQYBTSA-N 0.000 description 2
- 239000012984 antibiotic solution Substances 0.000 description 2
- 235000005822 corn Nutrition 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 239000003862 glucocorticoid Substances 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 201000011486 lichen planus Diseases 0.000 description 2
- 210000002200 mouth mucosa Anatomy 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 229960001727 tretinoin Drugs 0.000 description 2
- 206010003694 Atrophy Diseases 0.000 description 1
- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 description 1
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- 206010020565 Hyperaemia Diseases 0.000 description 1
- 208000034493 Mucous membrane disease Diseases 0.000 description 1
- 240000008254 Rosa chinensis Species 0.000 description 1
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- 230000037444 atrophy Effects 0.000 description 1
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- 210000004369 blood Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
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- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a kind of pharmaceutical composition and application thereof for the treatment of oral lichen planus, said composition is prepared from by traditional Chinese medicinal material raw materials and excipient, by weight, described traditional Chinese medicinal material raw materials comprises: Radix Scrophulariae 25-40 part, Flos Rosae Chinensis 25-40 part, Radix Rehmanniae 12-20 part and Radix Salicis Babylonicae 5-12 part.Pharmaceutical composition external curing oral lichen planus of the present invention, during medication 4 weeks, patient's mucosa lesions area obviously reduces, and pain is obviously alleviated, and effective percentage reaches 94.7%, and its curative effect is apparently higher than conventional therapy.
Description
Technical field
The invention belongs to technical field of Chinese medicine, in particular to a kind of pharmaceutical composition and application thereof for the treatment of oral lichen planus.
Background technology
Oral lichen planus (orallichenplanus, OLP) is a kind of inflammatory skin, mucous membrane disease of agnogenic T cell mediation, is one of oral mucosa commonly encountered diseases.Modern medicine is not clear and definite to the oral lichen planus cause of disease yet, and thinking may be relevant with Nervous and Mental Factors, infection, medicine, chronic lesion, systemic disease, enzyme exception, cryptorrhea or qi depression to blood stasis etc.This disease is apt to occur in middle age, and women is more than male.Current local therapeutic approaches comprises injection or external glucocorticoid, 0.1% tretinoin ointment in antibiotic solution rinsing the mouth, infringement.But long-term external glucocorticoid often produces the untoward reaction such as local atrophy, infection, telangiectasis, and the curative effect of antibiotic solution rinsing the mouth and 0.1% tretinoin ointment is all undesirable.
Because oral lichen planus is often with the vesicle of oral mucosa, ulceration, erosion, when the conscious obvious spontaneous pain of patient or feed, excite pain, clinical symptoms weight, treat more difficult, traditional Therapeutic Method weak curative effect, easily recurs, and often increases heavy stress to patient.Meanwhile, because its cause of disease is complicated, unstable condition, normal recurrent exerbation, at present both at home and abroad all without effective especially medicine and method.
Summary of the invention
In view of the deficiencies in the prior art, the object of the present invention is to provide a kind of pharmaceutical composition and application thereof for the treatment of oral lichen planus.
Pharmaceutical composition of the present invention completes on the basis of secret prescription handed down in the family from generation to generation, and its concrete technical scheme is as follows:
Treat a pharmaceutical composition for oral lichen planus, be prepared from by traditional Chinese medicinal material raw materials and excipient, by weight, described Chinese crude drug comprises: Radix Scrophulariae 25-40 part, Flos Rosae Chinensis 25-40 part, Radix Rehmanniae 12-20 part, Radix Salicis Babylonicae 5-12 part.
Preferably, the pharmaceutical composition for the treatment of oral lichen planus as mentioned above, by weight, described traditional Chinese medicinal material raw materials is made up of Radix Scrophulariae 30-35 part, Flos Rosae Chinensis 30-35 part, Radix Rehmanniae 14-18 part and Radix Salicis Babylonicae 6-10 part.
In a most preferred embodiment of the present invention, the pharmaceutical composition for the treatment of oral lichen planus as mentioned above, by weight, described traditional Chinese medicinal material raw materials is made up of Radix Scrophulariae 32 parts, Flos Rosae Chinensis 32 parts, 16 parts, the Radix Rehmanniae and Radix Salicis Babylonicae 8 parts.
Pharmaceutical composition of the present invention is preferably external preparation; As ointment, liniment, liniment etc.
Found by clinical experimental study, the pharmaceutical composition be made up of above-mentioned Chinese crude drug has significant curative effect in treatment oral lichen planus patients.Therefore, second object of the present invention is to provide a kind of new pharmaceutical use, the application of namely above-mentioned pharmaceutical composition in the medicine of preparation treatment oral lichen planus.Especially, the application of above-mentioned pharmaceutical composition in the external used medicine of preparation treatment oral lichen planus.
The present invention adopt the source of Chinese crude drug as follows: Radix Scrophulariae is selected from the dry root of dicotyledon Scrophulariaceae Scrophulariaceae Radix Scrophulariae ScrophularianingpoensisHemsl..Flos Rosae Chinensis selects the dried floral into rosaceous plant Chinese rose.The Radix Rehmanniae is selected from the dried root of Scrophulariaceae herbaceos perennial Radix Rehmanniae RehmanniaglutinosaLibosch., also claims Radix Rehmanniae.Radix Salicis Babylonicae selects root and the root hair of Salicaceous Plants Salix babylonica L..
The preparation method of Chinese medicine liniment of the present invention comprises the steps: to take by recipe quantity the Radix Scrophulariae 25-40 part cleaned up, Flos Rosae Chinensis 25-40 part, Radix Rehmanniae 12-20 part and Radix Salicis Babylonicae 5-12 part, merge, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder; In clear paste powder, add Tween-20, glycerol, partial purification water stirs, make to dissolve completely; Add hydroxypropyl emthylcellulose afterwards, stirring is spent the night, and makes it dissolve completely; Then add dehydrated alcohol, stir; After this purified water that takes a morsel dissolves potassium iodate, and joins in previous step material and mix, and stirs; Add to full dose by the purified water of remainder, stir; Fill, packaging, obtain Chinese medicine liniment.
Chinese medicine liniment of the present invention treatment oral lichen planus, during medication 4 weeks, patient's mucosa lesions area obviously reduces, and pain is obviously alleviated, and effective percentage reaches 94.7%, and its curative effect is apparently higher than conventional therapy.
Detailed description of the invention
Be below specific embodiments of the invention, technical scheme of the present invention is done to describing further, but protection scope of the present invention be not limited to these embodiments.Every do not deviate from the present invention's design change or equivalent substituting include within protection scope of the present invention.
The preparation of embodiment 1 Chinese medicine liniment
Take Radix Scrophulariae 32 parts, Flos Rosae Chinensis 32 parts, 16 parts, the Radix Rehmanniae and Radix Salicis Babylonicae 8 parts, merge, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder, for subsequent use;
Prepare burden according to following formula: clear paste powder 1g, hydroxypropyl emthylcellulose 2g, polysorbas20 2g, glycerol 1g, dehydrated alcohol 20g, potassium iodate 0.02g, purified water adds to 100g.In clear paste powder, add Tween-20, glycerol, partial purification water stirs, make to dissolve completely; Add hydroxypropyl emthylcellulose afterwards, stirring is spent the night, and makes it dissolve completely; Then add dehydrated alcohol, stir; After this purified water that takes a morsel dissolves potassium iodate, and joins in previous step material and mix, and stirs; Add to 100g by the purified water of remainder, stir; Fill, packaging, obtain Chinese medicine liniment.
The preparation of embodiment 2 Chinese medicine liniment
Take Radix Scrophulariae 38 parts, Flos Rosae Chinensis 30 parts, 20 parts, the Radix Rehmanniae, Radix Salicis Babylonicae 10 parts, merge, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder, for subsequent use;
Prepare burden according to following formula: clear paste powder 1g, hydroxypropyl emthylcellulose 2g, polysorbas20 3g, glycerol 1g, dehydrated alcohol 30g, potassium iodate 0.025g, adds to 100g by purified water.Method for making, with embodiment 1, obtains liniment.
The preparation of embodiment 3 Chinese medicine liniment
Take Radix Scrophulariae 25 parts, Flos Rosae Chinensis 28 parts, 12 parts, the Radix Rehmanniae, Radix Salicis Babylonicae 6 parts, merge, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 80 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), pulverize 80 mesh sieves, obtain clear paste powder, for subsequent use;
Prepare burden according to following formula: clear paste powder 5g, hydroxypropyl emthylcellulose 3g, polysorbas20 15g, glycerol 5g, dehydrated alcohol 45g, potassium iodate 0.5g, adds to 100g by purified water.Method for making, with embodiment 1, obtains Chinese medicine liniment.
Embodiment 4 Chinese medicine liniment is to the effectiveness study of oral cavity patients with lichen planus
Oral lichen planus patient 38 example, wherein man 22 example, female 16 example; 24 ~ 78 years old age, average (46.5 ± 5.2) year.All patients all have the typical mucosa lesions of lichen planus, and through definitive pathological diagnosis.Exclusion standard: the oral keritonocytes of affected part other evaluation that significantly may affect the treatment concurrent; 2 Zhou Nei local application persons; Gestation or women breast-feeding their children.By medical order, patient is divided into matched group (19 example) and test group (19 example) at random.Two groups in sex, age and disease degree without significantly lower difference, there is comparability.
Matched group patient uses 2% sodium bicarbonate solution and 0.2% liquor hibitane to replace rinsing the mouth for several times every day.Test group local uses Chinese medicine liniment (being prepared from by the prescription of above-described embodiment 1 and technique), and dipping liniment with cotton swab and be directly applied to affected part, every day 2 times, 4 weeks is 1 course for the treatment of.Treatment terminates rear further consultation.The standard of curative effect evaluation is as follows.
Recovery from illness: mucosa lesions disappears completely, transference cure;
Effective: mucosa lesions disappears more than 70%, the healing of rotten to the corn face, hyperemia disappears or reduces more than 2/3, only has a little white stripes, without obvious subjective symptoms;
Take a turn for the better: mucosa lesions disappears 30% ~ 70%, congested, rotten to the corn reduction of area is little, and white stripes reduces, and subjective symptoms alleviates;
Invalid: mucosa lesions disappear less than 30% or the state of an illness unchanged.
Recovery from illness, effective, take a turn for the better and all count effectively.Two groups of comparitive study, in table 1, can be found out by table 1, and patient adopts liniment of the present invention to carry out topical therapeutic, obtains better curative effect.Drug withdrawal is after 4 weeks, and matched group has 5 example recurrences, and test group all has 2 example recurrences.
Table 1 liang group comparitive study
Can be drawn by research above, Chinese medicine liniment of the present invention treatment oral lichen planus, during medication 4 weeks, patient's mucosa lesions area obviously reduces, and pain is obviously alleviated, and effective percentage reaches 94.7%, apparently higher than matched group.
Claims (6)
1. treat the pharmaceutical composition of oral lichen planus for one kind, it is characterized in that: be prepared from by traditional Chinese medicinal material raw materials and excipient, by weight, described traditional Chinese medicinal material raw materials is made up of Radix Scrophulariae 25-40 part, Flos Rosae Chinensis 25-40 part, Radix Rehmanniae 12-20 part and Radix Salicis Babylonicae 5-12 part.
2. treat the pharmaceutical composition of oral lichen planus according to claim 1, it is characterized in that: by weight, described traditional Chinese medicinal material raw materials is made up of Radix Scrophulariae 30-35 part, Flos Rosae Chinensis 30-35 part, Radix Rehmanniae 14-18 part and Radix Salicis Babylonicae 6-10 part.
3. treat the pharmaceutical composition of oral lichen planus according to claim 1, it is characterized in that: by weight, described traditional Chinese medicinal material raw materials is made up of Radix Scrophulariae 32 parts, Flos Rosae Chinensis 32 parts, 16 parts, the Radix Rehmanniae and Radix Salicis Babylonicae 8 parts.
4. according to claim 1 or 2 or 3, treat the pharmaceutical composition of oral lichen planus, it is characterized in that: described pharmaceutical composition is external preparation.
5. claim 1 or the pharmaceutical composition described in 2 or 3 application in the medicine of preparation treatment oral lichen planus.
6. claim 1 or the pharmaceutical composition described in 2 or 3 application in the external used medicine of preparation treatment oral lichen planus.
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| CN101708278B (en) * | 2009-12-08 | 2011-11-09 | 中国人民解放军第三军医大学第二附属医院 | Medicament for treating oral plane lichen and preparation method thereof |
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Address after: Room 2305, 23rd Floor, Unit 1, Building 1, No. 138 Ruida Road, High tech Industrial Development Zone, Zhengzhou City, Henan Province, 450000 Patentee after: Henan yuaitang Biotechnology Co.,Ltd. Country or region after: China Address before: 450000 room 901, block a, metropolis Plaza, Lianyun Road, South Third Ring Road, Erqi District, Zhengzhou City, Henan Province 002 Patentee before: Henan yuaitang Biotechnology Co.,Ltd. Country or region before: China |