CN106309554B - It is a kind of for preventing and/or treating the Baical Skullcap root P.E and its pharmaceutical composition of canker sore - Google Patents
It is a kind of for preventing and/or treating the Baical Skullcap root P.E and its pharmaceutical composition of canker sore Download PDFInfo
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Abstract
The invention discloses a kind of for preventing and/or treating the Baical Skullcap root P.E of canker sore, the Baical Skullcap root P.E is extracted from radix scutellariae and is obtained, the Baical Skullcap root P.E contains scutelloside, baicalein, wogonoside, wogonin and qroxylin A, the content of the scutelloside is 85%~91%, the content of the baicalein is 3%~7%, the content of the wogonoside is 1%~2%, and the content of the wogonin is 0.5%~1%, and the content of the qroxylin A is less than 0.5%.The invention further relates to a kind of pharmaceutical composition, described pharmaceutical composition includes above-mentioned Baical Skullcap root P.E and Honegsukle flower P.E.Preferably, described pharmaceutical composition is Lonicera and scutellaria drip pill and dispersant tablets of honeysuckle flower and coptis.Baical Skullcap root P.E content of baicalin provided by the invention is high, and other definite ingredients, pharmaceutical composition drug effect is excellent, and preparation method is simple, is convenient for mass production.Verified discovery, silver yellow pharmaceutical composition of the invention have good curative effect to canker sore.
Description
Technical field
The invention belongs to pharmaceutical fields, mention specifically, being related to a kind of radix scutellariae for preventing and/or treating canker sore
Take object and its pharmaceutical composition.
Background technique
Radix scutellariae is lamiaceae labiatae scutellaria herbaceos perennial, and in China, distributed pole is wide, Heilungkiang, Jilin, Liaoning, river
The provinces such as south, Hebei, Shandong, Sichuan, Yunnan, Shanxi, Shaanxi, Gansu and the Inner Mongol are the place of production, wherein with Shanxi yield highest,
Chengde is best in quality.The root of radix scutellariae is used as medicine, bitter, cold in nature, there is heat-clearing and damp-drying drug, purging fire for removing toxin, hemostasis, miscarriage prevention and other effects.
Cure mainly warm heat disease, the infection of the upper respiratory tract, cough with lung heat, neonatal jaundice caused by dampness-heat, pneumonia, dysentery, hemoptysis, hot eyes, threatened abortion, high blood
The diseases such as pressure, carbuncle swells furuncle sore.Radix scutellariae has anti-inflammatory antiallergic action, anti-microbial effect, refrigeration function, decompression, diuresis, right
The effect of blood lipid and blood glucose, cholagogue, spasmolysis, sedation etc..The clinical antibiotic property of radix scutellariae is better than the coptis, and does not generate
Drug resistance.
Radix scutellariae pharmacological action multiplicity, complex chemical composition, containing a large amount of flavone compound, alcohol glycosides and phenolic glycoside class, terpene
Class, alkaloid, phytosterol, polysaccharide, amino acid etc..At present mostly use greatly the methods of HPLC, UPLC detection radix scutellariae at
Point.Such as Liu Jinxin is proposed with UPLC while being measured baicalin in Scutellaria baicalensis Georgi, baicalein, wogonoside, wogonin, thousand layers of matter
The method of plain A.Containing a large amount of known or non-principal components in Baical Skullcap root P.E, the Baical Skullcap root P.E that distinct methods are prepared is not
Together, when being prepared into pharmaceutical composition, drug effect may not also be identical.And while illustrating product main active, illustrate it
Its ingredient, can not only be used for Quality Control Technology, can also increase the indication of drug.
The preparation method of Baical Skullcap root P.E is more at present, has water to decoct, ethyl alcohol extraction, sour water extraction, heavy in conjunction with quadratic acid,
Alcohol precipitation, recrystallization etc..Application No. is 201410503469.7 Chinese patents to disclose a kind of preparation method of Baical Skullcap root P.E,
Radix scutellariae medicinal materials are taken, are added water to cook 2 times, are filtered, merging filtrate, filtrate is concentrated into right amount, with hydrochloric acid tune pH in the case where heat preservation
Value, is cooled to room temperature, and stands, and filtration after precipitating is rinsed with ethyl alcohol, adds water to stir evenly, with sodium hydroxide tune pH value to neutrality, adds water
After dissolution, add ethyl alcohol, stand, filtration, hydrochloric acid tune pH value is cooling after heat preservation, and filtration, precipitating is rinsed with ethyl alcohol, is dried under reduced pressure, i.e.,
Obtain radix scutellariae crude extract.Radix scutellariae crude extract is suspended in suitable water, with sodium hydroxide tune pH to neutrality, active carbon is added, protects
Ethyl alcohol is added in Wen Hou, filters, filtrate hydrochloric acid tune pH value, heats, and filters, and precipitating rinsed with ethyl alcohol, drying to get.Gained is yellow
Weight percentage in a kind of reed mentioned in ancient books extract containing scutelloside is 88%~95%.
Application No. is 201510492619.3 Chinese patents to disclose a kind of Baical Skullcap root P.E containing high-purity baicalin
Preparation method, this method extracts using radix scutellariae as raw material through faintly acid alcohol reflux, and a step acid is heavy, and to combine macroreticular resin to separate pure
Baical Skullcap root P.E is prepared in change, scutelloside purity >=95% in final product.
Above-mentioned patent and in the prior art, although obtaining the Baical Skullcap root P.E of scutelloside containing higher degree, other impurity
Ingredient is simultaneously indefinite, and the influence for drug effect is also indefinite, and in view of this present invention is specifically proposed.
Summary of the invention
The first object of the present invention is to overcome the deficiencies of the prior art and provide a kind of Baical Skullcap root P.E, and the radix scutellariae mentions
Object is taken to contain scutelloside, baicalein, wogonoside, wogonin and qroxylin A, the content of each ingredient is through high pressure liquid chromatography
It is determined after detection.Baical Skullcap root P.E content of baicalin provided by the invention is high, other stable components, and content is clear.
To achieve the purpose of the present invention, spy adopts the following technical scheme that
It is a kind of for preventing and/or treating the Baical Skullcap root P.E of canker sore, wherein the Baical Skullcap root P.E is from radix scutellariae
It extracts and obtains, the Baical Skullcap root P.E contains scutelloside, baicalein, wogonoside, wogonin and qroxylin A, the Huang
The content of a kind of reed mentioned in ancient books glycosides is 85%~91%, and the content of the baicalein is 3%~7%, the content of the wogonoside is 1%~
2%, the content of the wogonin is 0.5%~1%, and the content of the oroxylin is less than 0.5%.
Radix scutellariae platymiscium generally contains flavone compound, and the flavonoids in radix scutellariae is its basis for playing pharmacological activity,
Wherein scutelloside, baicalein, wogonoside, wogonin are most important active constituents.Scutelloside has antibacterial, diuresis, resists
Scorching, resistance state and spasmolysis, and there are the physiological potencies such as stronger antitumor response.Baicalein can remove free radical, can be pre-
Fibroblastic damage caused by the oxygen radicals such as anti-hydroperoxidase, superoxide anion.In these four masters
It wants in Flavonoid substances, baicalein is strongest antioxidant.Wogonoside, wogonin, qroxylin A also have anti-inflammatory, suppression
Bacterium effect.And compound Chinese medicinal preparation complicated component, it can also happen that interaction between different component, when constituent content difference, can also
Different effects can be generated.The present invention surprisingly has found that Baical Skullcap root P.E each component prepared by the present invention produces good association
Same effect, drug effect are significantly better than the Baical Skullcap root P.E of prior art preparation.The medicine group prepared using Baical Skullcap root P.E of the present invention
Closing object also has more excellent drug effect.
Preferably, the content of the scutelloside is 86%~90%, and the content of the baicalein is 4%~6%.
Preferably, the content of the wogonin is 1.4%~1.9%, the content of the wogonoside is 0.6%~
0.8%.
Preferably, in the Baical Skullcap root P.E content of qroxylin A less than 0.4%.
By test of many times, it is an unexpected discovery of the invention that when each component content of Baical Skullcap root P.E of preparation is where appropriate, collaboration
Effect enhancing, drug effect significantly increase；When inappropriate, drug effect changes unobvious.Preferably, when each component content of Baical Skullcap root P.E
When in above range, drug effect is best.
The second object of the present invention is to provide a kind of pharmaceutical composition of above-mentioned Baical Skullcap root P.E and the Baical Skullcap root P.E
Preparation method, described pharmaceutical composition drug effect is excellent, and preparation method is simple, be suitable for production.
It is a kind of for preventing and/or treating the pharmaceutical composition of canker sore, described pharmaceutical composition is mentioned comprising honeysuckle
Take object and above-mentioned Baical Skullcap root P.E.
Baical Skullcap root P.E is the bulk pharmaceutical chemicals of a variety of Chinese patent drugs.Baical Skullcap root P.E prepared by the present invention can be with Honegsukle flower P.E
Silver yellow drug is made, has effects that heat-clearing, removing toxic substances, anti-inflammatory, relieving sore-throat.It is a discovery of the invention that using Baical Skullcap root P.E of the invention
It is preferred that the Lonicera and scutellaria drip pill and dispersant tablets of honeysuckle flower and coptis that prepare, the effect of heat-clearing, anti-inflammatory, enhances.
Preferably, the pharmaceutical composition is to be prepared by Baical Skullcap root P.E, Honegsukle flower P.E and Macrogol 4000
Made of Lonicera and scutellaria drip pill, wherein the weight ratio of Baical Skullcap root P.E and Honegsukle flower P.E is 1:3~1:5, Baical Skullcap root P.E and poly-
The weight ratio of ethylene glycol is 1:6~1:12.
Preferably, the pharmaceutical composition is dispersant tablets of honeysuckle flower and coptis, and the dispersant tablets of honeysuckle flower and coptis by weight, contains gold
80-120 parts of honeysuckle flower extract, 30-60 parts of Baical Skullcap root P.E, 15-25 parts of low-substituted hydroxypropyl cellulose, microcrystalline cellulose 180-
220 parts, 30-50 parts of crosslinked polyvinylpyrrolidone.
The dispersant tablets of honeysuckle flower and coptis by weight, containing 110 parts of Honegsukle flower P.E, 40 parts of Baical Skullcap root P.E, low takes
For 20 parts of hydroxypropyl cellulose, 200 parts of microcrystalline cellulose, 40 parts of crosslinked polyvinylpyrrolidone.
In the present invention, the preparation of Honegsukle flower P.E can be prepared with reference to the prior art, such as application No. is
201210236695.4 patent described in method；The preparation of Lonicera and scutellaria drip pill and dispersant tablets of honeysuckle flower and coptis can refer to the phase of the prior art
It is prepared with dosage form, pays more creative works without those skilled in the art.
The Baical Skullcap root P.E is prepared with the following method:
(1) it takes radix scutellariae medicinal materials to shred, adds water to cook three times, boiling water feeds intake, and decocts 1~2 hour every time, and filtration merges filter
It crosses, decocting liquid is concentrated into right amount；
(2) decocting liquid hydrochloric acid solution tune pH value to 1.0~2.0,80 DEG C keep the temperature 30 minutes, stand 5~20 hours, filtration,
Sediment adds suitable quantity of water to stir evenly, and with sodium hydroxide solution tune pH value to 7.0, adds equivalent ethyl alcohol, stirs evenly dissolution, filtration；
(3) filtrate sulfuric acid solution adjusting pH value to 1.0~2.0,30min is kept the temperature in 60 DEG C, stands 4~12 hours,
Filtration, precipitating ethanol washing to pH value 5.0~6.0 are waved most ethyl alcohol, are dried under reduced pressure to get Baical Skullcap root P.E crude product；
(4) crude product is soluble in water, active carbon is added, 40 DEG C~60 DEG C are heated 30 minutes, and equivalent ethyl alcohol is added, it filters,
Precipitating ethanol washing is to pH value 7.0, and precipitating drying is to get Baical Skullcap root P.E finished product.
It is described to add water to cook three times, add 10 times of amount water, second plus 8 times of amount water, third time plus 6 times of amount water, institute for the first time
Stating concentration of hydrochloric acid solution is 2mol/L, and the sodium hydroxide solution mass concentration is 45%, and the sulfuric acid solution mass concentration is
10%.
The Baical Skullcap root P.E or pharmaceutical composition that the present invention also provides described for preventing and/or treating canker sore exist
Application in the drug of preparation prevention or treatment canker sore.
Baical Skullcap root P.E of the present invention or pharmaceutical composition can be used for preventing or treating canker sore.
Canker sore is common mouth disease, and the incidence is higher, is a kind of common oral mucosa affection disease, mouth
Although chamber ulcer will not cause great threat to the health of patient, canker sore, the diseased region of patient once occurs
Apparent cusalgia sense is had, the feed of patient is will affect, speaks and sleep, affect to the quality of life of patient.
Chinese medicine thinks the pathogenesis of canker sore, mainly by accumulation of heart and spleen, fire excess from yin deficiency initiation, and Baical Skullcap root P.E has and removes
The effect of hot eliminating dampness, fire of dispelling detoxify, shares with Honegsukle flower P.E collocation, has both enhanced clearing heat and detoxicating effect, also increase and dispel
Damp and hot effect.Verified discovery, silver yellow pharmaceutical composition of the invention also have good curative effect to canker sore.
The amount that the active carbon is added is the 3%~4% of extract.The ethyl alcohol of various concentration described in embodiment is each body
The ethyl alcohol of product concentration.
After adopting the above technical scheme, compared with the prior art, the invention has the following beneficial effects:
(1) Baical Skullcap root P.E provided by the invention, content of baicalin is high, and other definite ingredients can not only be used for needing high-purity
The raw material of scutellaria glycosides drug can also develop new medicinal usage according to other compositions.
(2) pharmaceutical composition provided by the invention containing above-mentioned Baical Skullcap root P.E, drug effect is excellent, and definite ingredients improve
The drug safety of patient.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below to the technical side in embodiment
Case is clearly and completely described, and the following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention..
Chromatographic separation condition: the measuring method of Baical Skullcap root P.E ingredient uses high performance liquid chromatography, utilizes
Agilentl100 high performance liquid chromatograph, using octadecylsilane chemically bonded silica as filler, chromatographic column (Yi Teli C18,
4.6mm × 250mm × 5 μm) scutelloside standard items and prepared Baical Skullcap root P.E are analyzed.It is water-soluble with phosphoric acid with methanol
Liquid (adjusting pH value is 2.6) volume ratio is that 55:45 is mobile phase, Detection wavelength 280nm, flow velocity 1.0ml/min, column temperature 25
℃.Standard items and Baical Skullcap root P.E distinguish automatic sampling.
The preparation of standard solution: accurately weighing scutelloside standard items 0.0063mg, with methanol constant volume 100mL volumetric flask
In.Solution obtains the reference substance solution that mass concentration is 0.063mg/mL in faint yellow.Pipette respectively above-mentioned standard solution 1mL,
2mL, 4mL, 6mL, 8mL, 10mL are in 10mL volumetric flask, with methanol constant volume, obtain standard series mass concentration be 0.0063,
0.0126, the scutelloside standard items of 0.0252,0.0378,0.0504,0.063mg/mL.In the same way, by respective sample introduction
Concentration range produces the titer of other standard items, draws standard curve.
The preparation of extract solution accurately weighs Baical Skullcap root P.E 0.0100g constant volume in the volumetric flask of 50mL.Solution is in
It is faint yellow.Supernatant liquor is taken, is used after 0.45 μm of filtering with microporous membrane as extract solution.
Embodiment 1
The preparation of Baical Skullcap root P.E:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, first time plus 10 times of amount water, second plus 8 times of amount water add for the third time
6 times of amount water, boiling water feed intake, and decoct 1 hour every time, and non-woven fabrics filtration merges filtration, and decocting liquid is concentrated into right amount；Decocting liquid 2mol/
The hydrochloric acid solution tune pH value of L to 1.0,80 DEG C keep the temperature 30 minutes, stand 5h, filtration, sediment adds water to stir evenly, with 45% hydroxide
Sodium solution tune pH value adds equivalent ethyl alcohol, stirs evenly dissolution, filter to 7.0；Filtrate 10% sulfuric acid solution adjusting pH value to 1.0, in
It keeping the temperature 30min in 60 DEG C, stands 4h, filtration, precipitating to pH value 5.0, is waved most ethyl alcohol, is dried under reduced pressure with 75% ethanol washing,
Up to Baical Skullcap root P.E crude product；Crude product is soluble in water, 3% active carbon is added, 40 DEG C are heated 30 minutes, equivalent ethyl alcohol is added,
It filters, precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.It is each to detect Baical Skullcap root P.E
Component content the results are shown in Table 1.
Embodiment 2
The preparation of Baical Skullcap root P.E:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, add 12 times of amount water, second plus 10 times of amount water, third time for the first time
Add 6 times of amount water, boiling water feeds intake, and decocts 1.5 hours every time, and non-woven fabrics filtration merges filtration, and decocting liquid is concentrated into right amount；Decocting liquid is used
The hydrochloric acid solution tune pH value of 2mol/L to 2.0,70 DEG C keep the temperature 30 minutes, stand 12h, filtration, sediment adds water to stir evenly, with 45%
Sodium hydroxide solution tune pH value adds equivalent ethyl alcohol, stirs evenly dissolution, filter to 7.0；Filtrate with 10% sulfuric acid solution adjust pH value to
2.0,30min is kept the temperature in 50 DEG C, stands 6h, filtration, and precipitating, to pH value 5.0, is waved most ethyl alcohol, depressurized with 75% ethanol washing
Drying is to get Baical Skullcap root P.E crude product；Crude product is soluble in water, 3% active carbon is added, 50 DEG C are heated 30 minutes, and equivalent is added
Ethyl alcohol filters, and precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.Detection radix scutellariae mentions
Each component content of object is taken, the results are shown in Table 1.
Embodiment 3
The preparation of Baical Skullcap root P.E:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, first time plus 10 times of amount water, second plus 8 times of amount water add for the third time
6 times of amount water, boiling water feed intake, and decoct 2 hours every time, and non-woven fabrics filtration merges filtration, and decocting liquid is concentrated into right amount；Decocting liquid 2mol/
The hydrochloric acid solution tune pH value of L to 1.0,60 DEG C keep the temperature 30 minutes, stand 20h, filtration, sediment adds water to stir evenly, with 45% hydrogen-oxygen
Change sodium solution tune pH value to 7.0, adds equivalent ethyl alcohol, stir evenly dissolution, filter；Filtrate 10% sulfuric acid solution adjusting pH value to 1.0,
30min is kept the temperature in 40 DEG C, stands 12h, filtration, and precipitating, to pH value 5.0, waves most ethyl alcohol, decompression is dry with 75% ethanol washing
It is dry to get Baical Skullcap root P.E crude product；Crude product is soluble in water, 4% active carbon is added, 60 DEG C are heated 30 minutes, and equivalent second is added
Alcohol filters, and precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.Radix scutellariae is detected to extract
Each component content of object, the results are shown in Table 1.
Embodiment 4
The preparation of Baical Skullcap root P.E:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, add 8 times of amount water, second plus 6 times of amount water, third time plus 6 for the first time
Amount water, boiling water feed intake again, decoct 1 hour every time, non-woven fabrics filtration, merging filtration, and decocting liquid is concentrated into right amount；Decocting liquid 2mol/L
Hydrochloric acid solution tune pH value to 1.0,80 DEG C keep the temperature 30 minutes, stand 10h, filtration, sediment adds water to stir evenly, with 45% hydroxide
Sodium solution tune pH value adds equivalent ethyl alcohol, stirs evenly dissolution, filter to 7.0；Filtrate 10% sulfuric acid solution adjusting pH value to 1.0, in
It keeping the temperature 30min in 60 DEG C, stands 8h, filtration, precipitating to pH value 5.0, is waved most ethyl alcohol, is dried under reduced pressure with 75% ethanol washing,
Up to Baical Skullcap root P.E crude product；Crude product is soluble in water, 3% active carbon is added, 60 DEG C are heated 30 minutes, equivalent ethyl alcohol is added,
It filters, precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.It is each to detect Baical Skullcap root P.E
Component content the results are shown in Table 1.
Embodiment 5
The preparation of Baical Skullcap root P.E:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, first time plus 10 times of amount water, second plus 8 times of amount water add for the third time
6 times of amount water, boiling water feed intake, and decoct 1.5 hours every time, and non-woven fabrics filtration merges filtration, and decocting liquid is concentrated into right amount；Decocting liquid is used
The hydrochloric acid solution tune pH value of 2mol/L to 1.0,80 DEG C keep the temperature 30 minutes, stand 16h, filtration, sediment adds water to stir evenly, with 45%
Sodium hydroxide solution tune pH value adds equivalent ethyl alcohol, stirs evenly dissolution, filter to 7.0；Filtrate with 10% sulfuric acid solution adjust pH value to
1.0,30min is kept the temperature in 60 DEG C, stands 10h, filtration, and precipitating, to pH value 5.0, is waved most ethyl alcohol, subtracted with 75% ethanol washing
It press dry dry to get Baical Skullcap root P.E crude product；Crude product is soluble in water, 4% active carbon is added, 50 DEG C are heated 30 minutes, be added etc.
Ethyl alcohol is measured, is filtered, precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.Detect radix scutellariae
Each component content of extract, the results are shown in Table 1.
Embodiment 6
The preparation of Baical Skullcap root P.E:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, first time plus 10 times of amount water, second plus 8 times of amount water add for the third time
6 times of amount water, boiling water feed intake, and decoct 1 hour every time, and non-woven fabrics filtration merges filtration, and decocting liquid is concentrated into right amount；Decocting liquid 2mol/
The hydrochloric acid solution tune pH value of L to 1.0,80 DEG C keep the temperature 30 minutes, stand 8h, filtration, sediment adds 100ml water to stir evenly, with 45%
Sodium hydroxide solution tune pH value adds equivalent ethyl alcohol, stirs evenly dissolution, filter to 7.0；Filtrate with 10% sulfuric acid solution adjust pH value to
1.0,30min is kept the temperature in 60 DEG C, stands 4h, filtration, and precipitating, to pH value 5.0, is waved most ethyl alcohol, depressurized with 75% ethanol washing
Drying is to get Baical Skullcap root P.E crude product；Crude product is soluble in water, 4% active carbon is added, 60 DEG C are heated 30 minutes, and equivalent is added
Ethyl alcohol filters, and precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.Detection radix scutellariae mentions
Each component content of object is taken, the results are shown in Table 1.
Embodiment 7
The preparation of Lonicera and scutellaria drip pill:
Take the embodiment of the present invention 1 prepare Baical Skullcap root P.E be 40g, Honegsukle flower P.E 200g, Macrogol 4000
For 480g, Macrogol 4000 is heated to molten condition, the mixture of Honegsukle flower P.E and Baical Skullcap root P.E is added, stirs
It is even, keep the temperature 1 hour at 85 DEG C, instill in 0 DEG C of dimethicone, take out, absorb condensate liquid, packing to get.
Embodiment 8
The preparation of Lonicera and scutellaria drip pill:
Take the embodiment of the present invention 2 prepare Baical Skullcap root P.E be 80g, Honegsukle flower P.E 240g, Macrogol 4000
For 480g, Macrogol 4000 is heated to molten condition, the mixture of Honegsukle flower P.E and Baical Skullcap root P.E is added, stirs
It is even, keep the temperature 1 hour at 85 DEG C, instill in 0 DEG C of dimethicone, take out, absorb condensate liquid, packing to get.
Embodiment 9
The preparation of Lonicera and scutellaria drip pill:
Take the embodiment of the present invention 3 prepare Baical Skullcap root P.E be 60g, Honegsukle flower P.E 240g, Macrogol 4000
For 600g, Macrogol 4000 is heated to molten condition, the mixture of Honegsukle flower P.E and Baical Skullcap root P.E is added, stirs
It is even, keep the temperature 1 hour at 85 DEG C, instill in 0 DEG C of dimethicone, take out, absorb condensate liquid, packing to get.
Embodiment 10
The preparation of dispersant tablets of honeysuckle flower and coptis
Baical Skullcap root P.E 30g, the Honegsukle flower P.E 80g, low-substituted hydroxypropyl cellulose for taking the embodiment of the present invention 4 to prepare
15g, microcrystalline cellulose 180g, crosslinked polyvinylpyrrolidone 30g are mixed, and are wetting agent granulation with 95% ethyl alcohol, and 60 DEG C dry
It is dry, whole grain；After passed examination, 1000 are pressed into, packing.
Embodiment 11
The preparation of dispersant tablets of honeysuckle flower and coptis
Baical Skullcap root P.E 60g, the Honegsukle flower P.E 120g, low substituted hydroxy-propyl fiber for taking the embodiment of the present invention 5 to prepare
Plain 25g, microcrystalline cellulose 220g, crosslinked polyvinylpyrrolidone 50g are mixed, and are wetting agent granulation with 95% ethyl alcohol, and 60 DEG C dry
It is dry, whole grain；After passed examination, 1000 are pressed into, packing.
Embodiment 12
The preparation of dispersant tablets of honeysuckle flower and coptis
Baical Skullcap root P.E 40g, the Honegsukle flower P.E 100g, low substituted hydroxy-propyl fiber for taking the embodiment of the present invention 6 to prepare
Plain 20g, microcrystalline cellulose 200g, crosslinked polyvinylpyrrolidone 40g are mixed, and are wetting agent granulation with 95% ethyl alcohol, and 60 DEG C dry
It is dry, whole grain；After passed examination, 1000 are pressed into, packing.
Comparative example 1
This comparative example is prepared for Baical Skullcap root P.E referring to the method for following documents, and uses detection side of the invention
Method determines the content of baicalein in Baical Skullcap root P.E, scutelloside, wogonin, wogonoside and qroxylin A, as a result sees
Table 1.
Sample 1 is the Baical Skullcap root P.E of the method preparation of the embodiment 1 referring to patent application CN102266386B；
Sample 2 is the Baical Skullcap root P.E of the method preparation of the embodiment 1 referring to patent application CN105497131A；
Sample 3 is the Baical Skullcap root P.E of the method preparation of the embodiment 1 referring to patent application CN105131062A；
Sample 4 is the Baical Skullcap root P.E of the method preparation of the embodiment 1 referring to patent application CN1102148C；
Sample 5 is the Baical Skullcap root P.E of the method preparation of the embodiment 1 referring to patent application CN104530161A.
1 sample composition testing result of 1 embodiment 1-6 of table and comparative example
The measurement result of table 1 shows the existing skill of each component content of Baical Skullcap root P.E prepared by the present invention Yu above-mentioned patent
The Baical Skullcap root P.E of art preparation compares significant difference, and each component content of sample of various embodiments of the present invention preparation is stablized.
Comparative example 2
By the Baical Skullcap root P.E sample 1-5 in comparative example 1 according to prior art preparation, according to the side of the embodiment of the present invention 7
Method is prepared into Lonicera and scutellaria drip pill, is respectively labeled as sample 6-10, while being prepared into dispersant tablets of honeysuckle flower and coptis, is labeled as sample 11-15.
Experimental example 1
Effect experiment is carried out to the Baical Skullcap root P.E and 1 sample 1-5 of comparative example of embodiment 1-6 preparation, detects anti-inflammatory effect.
1.1 animal packet
SD rat, male, 180-220g, 112, be randomly divided into 14 groups, every group 8: blank group, model group, the positive are right
According to group, test group 1-6, control group 1-5.
1.2 test method
Rat Fast 12h, blank group and every stomach-filling 0.9%NaCl of model group rats before testing；Positive controls every
Rat oral gavage 10mg/kg Indomethacin；Test group 1-6 rat distinguishes the Baical Skullcap root P.E suspension of stomach-filling embodiment 1-6 preparation, agent
Amount is 4g/kg, and control group 1-5 rat distinguishes the suspension of 1 sample 1-5 of stomach-filling comparative example, dosage 4g/kg.Each group is continuously given
After medicine 5 days, administration in the 5th day 1 hour, the 1% carrageenan 0.1mL that fresh configuration is injected under Yu Youhou toes aponeurosis (aponeuroses) causes scorching (sky
Except white group).
1.2.1 to the influence of rat paw edema volume
The swelling foot volume for measuring 1,2,3,4,5h after causing scorching preceding and cause scorching respectively with rat paw edema analyzer, is pressed
Formula calculates swelling inhibiting rate (%), the results are shown in Table 2 and table 3.
Fs=[1- (V2- V1)/V1] × 100%
Wherein, Fs is swelling inhibiting rate (%)；V1For swelling front foot volume (mL)；V2For swelling metapedes volume (mL).
The influence for the rat paw edema volume that 2 Baical Skullcap root P.E Carrageenan of table induces
The inhibiting rate for the rat paw edema that 3 Baical Skullcap root P.E Carrageenan of table induces
By table 2 and table 3 it is found that Indomethacin and each Baical Skullcap root P.E sample start to show after rat causes inflammation 1 hour
It out to the inhibiting effect of swelling, but is not in time dependence.From to the volume of swelling influence and inhibiting rate from the point of view of, the present invention is real
A Baical Skullcap root P.E for 1-6 preparation is applied, i.e. test group 1-6 shows the inhibitory effect being closer to positive controls, significantly high
In the inhibitory effect of control group 1-5.Therefore, compared with prior art, Baical Skullcap root P.E antiphlogistic effects of the invention significantly improve.
Experimental example 2
Effect experiment is carried out to the silver yellow pharmaceutical composition and 2 sample 6-10 of comparative example of embodiment 7-12 preparation, detects medicine
The anti-inflammatory effect of product.
2.1 animal packet
Experimental animal is Japan large ear rabbit, regular grade, half male and half female, and 2.0~2.5kg of weight, is randomly divided into 14 by 78
Group, every group 6: blank group, model group, test group 1-6, control group 1-5.
2.2 test method
Animal model: in addition to blank control group, each group rabbit daily respectively sprayed its pharyngeal 1 time with 2.5% ammonium hydroxide by the upper and lower noon,
It is pressed with sprayer spray 3 every time and (is often pressed about 0.08ml)；Physiological saline (0.9%NaCl) is pressed in blank control group spray 3, and each group is continuous
Spray 13 days.Modeling the 8th day, in addition to blank control group, turpentine oil was injected in rabbit pharynx with tonsil needle by remaining each group rat
Under portion's mucous membrane, every animal injects 0.5ml.Modeling the 14th day, rabbit pharyngeal was in chronic congestion state, kermesinus, mucus
Secretion increases, hence it is evident that swelling is modeling success.
Administration: modeling the 14th day, test group 1-6 group give 0.026g/ml embodiment 7-12 preparation Lonicera and scutellaria drip pill or
Dispersant tablets of honeysuckle flower and coptis suspension 10ml/kg stomach-filling；Control group 1-5 group gives Lonicera and scutellaria drip pill sample prepared by the comparative example 2 of 0.026g/ml
Product 6-10 suspension 10ml/kg stomach-filling；Blank control group and model group give isometric physiological saline.The daily stomach-filling 1 of each group
It is secondary, continuous 8 days.
2.3 observation index and method
1. the 1h after perfusion in the 8th day visually observes and grading evaluation pharyngeal mucous membrane, according to pharyngeal color, whether there is or not
Gloss, secretion are how many, redness degree, swelling degree are divided into level Four: "-" grade, pharyngeal pale red, wet, surface light
It is sliding, have no the pathological phenomenons such as hyperemia, swelling；"+" grade, animal pharyngeal have Some Animals can substantially close to "-" grade
Degree of taking a favourable turn chronic congestion, mucous membrane glossiness is not good enough, pharyngeal to have a small amount of secretion；" ++ " grade, animal pharyngeal in chronic congestion,
Kermesinus has mild swelling, there is a small amount of secretion；" +++ " grade, pharyngeal are in chronic congestion state, kermesinus, mucus point
Secretions, hence it is evident that swelling.2. auricular vein takes blood to do whole blood viscosity detection.3. being put to death after taking blood with air embolism method, pharynx is taken
Portion's mucous membrane tissue is immediately placed in 10% formalin and fixes, slice, HE dyeing, row histopathologic examination.Pharyngeal mucous membrane and group
Knit quantifying for form and be divided into level Four: "-" mucosal epithelium, sub-mucosal tissues and body of gland are normal；"+" mucosal epithelium,
Hyperplasia that sub-mucosal tissues are slight, sub-mucosal tissues and body of gland are without cell infiltration；In " ++ " mucosal epithelium, sub-mucosal tissues
Hyperplasia is spent, sub-mucosal tissues and body of gland have a small amount of cell infiltration；" +++ " mucosal epithelium, sub-mucosal tissues obviously increase
Raw, sub-mucosal tissues and body of gland have a large amount of cell infiltration.
Statistical method uses SPSS13.0 statistical software, and measurement data indicates that comparison among groups are adopted with mean ± standard deviation
Use one-way analysis of variance.
2.4 result
The pharyngeal mucous membrane naked eyes classification comparison result of each group rabbit is shown in Table 4, compared with blank control group, the pharyngeal mucous membrane meat of model group
Eye changed in stages is significant (P < 0.01), illustrates the success of rabbit chronic pharyngitis model；Compared with model group, test group and control group rabbit
Pharyngeal mucous membrane naked eyes changed in stages difference is statistically significant (P < 0.01).
The pharyngeal mucous membrane naked eyes classification of 4 each group rabbit of table is compared (only)
Each group rabbit whole blood viscosity relatively the results are shown in Table 5, and each shear rate of model group rabbit whole blood viscosity is significantly higher than blank pair
According to group (P < 0.01).The whole blood viscosity value of test group 1-6 and control group 1-5 is substantially less than model group (P < 0.01).Test group
The whole blood viscosity of 1-6 is lower than control group 1-5 (P < 0.01).
Note: shear rate refers to the flowing velocity between two layers of liquid of flowing in per unit distance, with liquid viscosity at anti-
Than, i.e., low shear rate when viscosity increase, viscosity reduces when high shear rate.
5 each group rabbit whole blood viscosity of table compares (mPas, x ± s)
By table 4 and table 5 it is found that test group 1-6 is better than control group to the significant in efficacy of chronic pharyngitis, and there is conspicuousness poor
It is different.Illustrate that the silver yellow drug antiphlogistic effects prepared using Baical Skullcap root P.E of the invention are significantly increased, each ingredient of Baical Skullcap root P.E
Its good synergistic effect, significantly increases its antiphlogistic effects in OK range.
Test example 3
Dispersant tablets of honeysuckle flower and coptis and 2 sample 11-15 of comparative example to embodiment 10-12 preparation carry out the drug effect for the treatment of canker sore
Experiment.
Clinical data
3.1 case selection
160 through clinical diagnosis be canker sore patient as research object, lip, cheek, soft palate or the tooth in patient oral cavity
The mucous membrane of gum etc. has multiple ulcer points, and ulcer surface is yellow, and surrounding's large area of ulcer takes on a red color.Some patientss are also adjoint
There are the symptoms such as dry, halitosis, dysphoria.It is randomly assigned test group 1, test group 2, test group 3 and control group 1-5, every group of trouble
20 people of person, comparison of each group patient in terms of gender, age, the course of disease, ulcer quantity, ulcer is without statistics sex differernce (P
> 0.05), it is comparable.3.2 treatment method
The dispersant tablets of honeysuckle flower and coptis treatment of embodiment 10-12 preparation is respectively adopted in experimental group 1-3 patient, by dispersant tablets of honeysuckle flower and coptis 2
(0.26g/ piece) is dissolved in 20ml water, is taken orally, and the 1min time is kept in oral cavity, while instructing patient when containing medical fluid,
Tongue body cooperates carry out activity, and cooperates repetition drum the cheek 15 times, allows medical fluid fully to be contacted with mucous membrane of mouth, then gulps down
Clothes.According to the above dosage usage, three times a day, the continuous 5d time is treated.After the same method, control group 1-5 patient
The dispersant tablets of honeysuckle flower and coptis sample 11-15 that the preparation of comparative example 2 is respectively adopted is treated.
3.3 criterion of therapeutical effect
The clinical therapeutic efficacy of each group patient judges according to " canker sore evaluation of clinical curative effect standard ", cures: suffering from
Person is after clinical treatment, canker sore all healed, and does not have local discomfort symptom, and after treatment, half a year, the above canker sore did not had
Occur recurrence；Improve: patient is after clinical treatment, and canker sore has 2/3 or more to heal or patient is through treating later six months
The above canker sore does not recur；Invalid: for patient after clinical treatment, the reduction quantity of canker sore is lower than 2/3.
3.4 statistical method
It observes obtained data to be handled with 17.0 software of SPSS, measurement data is indicated with (x ± s), is examined with t, is counted
Number data χ2It examines, P < 0.05, there is statistical significance.
3.5 treatment results
3.5.1 each group Clinical efficacy comparison is shown in Table 6, by table it is found that compared to each control group, test group treatment it is total
Effective percentage is significantly higher than control group, and P < 0.05, there is significant difference.
6 each group Clinical efficacy comparison of table
Note: compared with the control group, P < 0.05.
3.5.2 each group patient pain extenuates, healing compares, and is shown in Table 7, by table it is found that compared to each control
Group, test group patient pain extenuates the time and healing is obviously shortened.
7 each group patient pain of table extenuates, healing compares (x ± s)
By table 6 and table 7 it is found that test group 1-3 is better than control group to the significant in efficacy of canker sore, and there is conspicuousness poor
It is different.Illustrate the silver yellow drug therapy canker sore significant effect enhancing prepared using Baical Skullcap root P.E of the invention, improves patient
Cure rate, shorten the pain time and healing of patient, also illustrate each ingredient of Baical Skullcap root P.E in OK range
Its good synergistic effect makes it treat the enhancing of canker sore significant effect.
The above is only presently preferred embodiments of the present invention, is not intended to limit the present invention in any form, though
So the present invention has been disclosed as a preferred embodiment, and however, it is not intended to limit the invention, any technology people for being familiar with this patent
Member without departing from the scope of the present invention, when the technology contents using above-mentioned prompt make it is a little change or be modified to
The equivalent embodiment of equivalent variations, but anything that does not depart from the technical scheme of the invention content, it is right according to the technical essence of the invention
Any simple modification, equivalent change and modification made by above embodiments, in the range of still falling within the present invention program.
Claims (6)
1. a kind of for preventing and/or treating the Baical Skullcap root P.E of canker sore, which is characterized in that the Baical Skullcap root P.E is from Huang
It extracts and obtains in a kind of reed mentioned in ancient books, the Baical Skullcap root P.E contains scutelloside, baicalein, wogonoside, wogonin and qroxylin A, institute
The content for stating scutelloside is 85.05%, and the content of the baicalein is 7.04%, and the content of the wogonoside is 1.14%,
The content of the wogonin is 1.04%, and the content of the qroxylin A is 0.42%；
The Baical Skullcap root P.E is prepared with the following method:
It takes radix scutellariae medicinal materials to shred, adds water to cook three times, first time plus 12 times of amount water, second plus 10 times of amount water add 6 times for the third time
Water is measured, boiling water feeds intake, and decocts 1.5 hours every time, and non-woven fabrics filtration merges filtration, and decocting liquid is concentrated into right amount；Decocting liquid 2mol/L
Hydrochloric acid solution tune pH value to 2.0,70 DEG C keep the temperature 30 minutes, stand 12h, filtration, sediment adds water to stir evenly, with 45% hydroxide
Sodium solution tune pH value adds equivalent ethyl alcohol, stirs evenly dissolution, filter to 7.0；Filtrate 10% sulfuric acid solution adjusting pH value to 2.0, in
It keeping the temperature 30min in 50 DEG C, stands 6h, filtration, precipitating to pH value 5.0, is waved most ethyl alcohol, is dried under reduced pressure with 75% ethanol washing,
Up to Baical Skullcap root P.E crude product；Crude product is soluble in water, 3% active carbon is added, 50 DEG C are heated 30 minutes, equivalent ethyl alcohol is added,
It filters, precipitates 50% ethanol washing to pH value 7.0, precipitating drying is to get Baical Skullcap root P.E finished product.
2. a kind of for preventing and/or treating the pharmaceutical composition of canker sore, which is characterized in that described pharmaceutical composition includes
Baical Skullcap root P.E and Honegsukle flower P.E, the Baical Skullcap root P.E are Baical Skullcap root P.E described in claim 1.
3. according to claim 2 for preventing and/or treating the pharmaceutical composition of canker sore, which is characterized in that institute
The pharmaceutical composition stated is the Lonicera and scutellaria drip pill being prepared by Baical Skullcap root P.E, Honegsukle flower P.E and Macrogol 4000,
The weight ratio of middle Baical Skullcap root P.E and Honegsukle flower P.E is 1:3~1:5, the weight ratio of Baical Skullcap root P.E and Macrogol 4000
For 1:6~1:12.
4. according to claim 2 for preventing and/or treating the pharmaceutical composition of canker sore, which is characterized in that institute
The pharmaceutical composition stated is dispersant tablets of honeysuckle flower and coptis, and the dispersant tablets of honeysuckle flower and coptis by weight, contains Honegsukle flower P.E 80-120
Part, 30-60 parts of Baical Skullcap root P.E, 15-25 parts of low-substituted hydroxypropyl cellulose, 180-220 parts of microcrystalline cellulose, crosslinked polyethylene
30-50 parts of pyrrolidones.
5. according to claim 4 for preventing and/or treating the pharmaceutical composition of canker sore, which is characterized in that institute
The dispersant tablets of honeysuckle flower and coptis stated is by weight, fine containing 110 parts of Honegsukle flower P.E, 40 parts of Baical Skullcap root P.E, low substituted hydroxy-propyl
20 parts of dimension element, 200 parts of microcrystalline cellulose, 40 parts of crosslinked polyvinylpyrrolidone.
6. a kind of Baical Skullcap root P.E or claim 2-5 described in claim 1 for preventing and/or treating canker sore is appointed
For preventing and/or treating the pharmaceutical composition of canker sore in preparation prevention or the medicine for the treatment of canker sore described in meaning one
Application in object.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1511540A (en) * | 2002-12-24 | 2004-07-14 | 山东绿叶天然药物研究开发有限公司 | Use of scutellarin in preparing medicine for treating or preventing stomatocace |
| CN103830222A (en) * | 2012-11-23 | 2014-06-04 | 青岛百草汇中草药研究所 | Application of baicalein in preparation of oral ulcer treatment medicines |
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| CN105497131A (en) * | 2014-09-26 | 2016-04-20 | 天津中敖生物科技有限公司 | Preparation method for large-flowered skullcap root extract |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1511540A (en) * | 2002-12-24 | 2004-07-14 | 山东绿叶天然药物研究开发有限公司 | Use of scutellarin in preparing medicine for treating or preventing stomatocace |
| CN103830222A (en) * | 2012-11-23 | 2014-06-04 | 青岛百草汇中草药研究所 | Application of baicalein in preparation of oral ulcer treatment medicines |
Non-Patent Citations (2)
| Title |
|---|
| 银黄制剂的研究进展;周淑芳等;《中国实验方剂学杂志》;20150731;第21卷(第14期);第222-225页 |
| 黄芩胶囊治疗复发性口疮90例;周峰等;《中国民间疗法》;20110731;第19卷(第7期);第45页 |
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Denomination of invention: A kind of Scutellaria baicalensis extract and its pharmaceutical composition for preventing and/or treating oral ulcer Effective date of registration: 20220916 Granted publication date: 20190528 Pledgee: Industrial and Commercial Bank of China Limited Lishui Economic Development Zone sub branch Pledgor: ZHEJIANG WECOME PHARMACEUTICAL CO.,LTD. Registration number: Y2022330002256 |