Golden English lozenge of a kind of clearing heat, relieving sore-throat and preparation method thereof
Technical field
The invention belongs to health product technology field, more particularly to a kind of golden English lozenge of clearing heat, relieving sore-throat and preparation method thereof.
Background technology
With the progress and development of society, people are due to long-term operating pressure, frequently dinner party, dietary structure do not conform to
Reason, smoking and pharyngitis is easily triggered by smoking and environmental pollution etc..And pharyngitis can be because of the excessively use of flu, tired and vocal cords
Aggravate, so as to can cause people's poor appetite and One's spirits are drooping, severe patient also affects phase operating efficiency and quality of life.
Buccal tablet is, containing in the oral cavity, the compressed tablets of slow mechanism dissolved to be capable of in the presence of saliva, effect is the advantage is that
The persistence of the time control and site of action (mainly oral cavity and pharynx) of composition, uses and carries convenient etc..Because its is special
Application method and manufacture craft, the lasting volatility of mouthfeel, stability and buccal tablet effect is that buccal tablet exploitation must be captured
The problem of, relate generally to the collocation of the formula and process attribute of functional component and auxiliary material to buccal tablet dissolution mouthfeel, auxiliary material counterpart
The protection of main component and the holding containing tablet quality in lozenge.
The content of the invention
It is an object of the invention to:It is of the invention for above-mentioned problem there is provided a kind of golden English lozenge of clearing heat, relieving sore-throat
Lozenge has effects that clearing heat and detoxicating, relieving sore-throat eliminating the phlegm, while also having regulation rate of release, makes lozenge slow molten in oral cavity
Solution, the drug effect long period rests on oral cavity and pharyngeal, persistently plays drug effect, improves the function of bioavilability.
In order to realize foregoing invention purpose, the technical solution adopted by the present invention is as follows:
A kind of golden English lozenge of clearing heat, relieving sore-throat, the raw material of the golden English lozenge of the clearing heat, relieving sore-throat includes honeysuckle, dandelion, peppermint
Brain, mulberry leaf, Exocarpium Citri Rubrum and auxiliary material, in parts by weight for:20-50 parts of honeysuckle, 60-100 parts of dandelion, 5-20 parts of menthol,
10-50 parts of 5-10 parts of mulberry leaf, 3-8 parts of Exocarpium Citri Rubrum and auxiliary material;
The auxiliary material is made up of gamma-cyclodextrin, mannitol, sucrose, magnesium stearate and adhesive, the gamma-cyclodextrin, sweet
Dew alcohol, sucrose, the weight ratio of magnesium stearate and adhesive are:30:0.5-2:0.5-1:0.5-1:1-3.
It is preferred that the raw material of the golden English lozenge of the clearing heat, relieving sore-throat include honeysuckle, dandelion, menthol, mulberry leaf, Exocarpium Citri Rubrum and
Auxiliary material is made, in parts by weight for:30 parts of honeysuckle, 70 parts of dandelion, 10 parts of menthol, 6 parts of mulberry leaf, 5 parts of Exocarpium Citri Rubrum and auxiliary
15 parts of material.
It is preferred that the auxiliary material is made up of gamma-cyclodextrin, mannitol, sucrose, magnesium stearate and adhesive, the γ-ring
Dextrin, mannitol, sucrose, the weight ratio of magnesium stearate and adhesive are:30:1:0.8:0.8:2.
It is preferred that described adhesive is one kind in CMC, methylcellulose or ethyl cellulose.
It is preferred that the dandelion is dandelion grass or radix tarxaci or the two mixing.
Present invention also offers a kind of preparation method of the golden English lozenge of clearing heat, relieving sore-throat, the preparation method includes following step
Suddenly:
(1) honeysuckle, dandelion, mulberry leaf and Exocarpium Citri Rubrum are weighed according to the above ratio, and after cleaning up, 1- is soaked in chopping
3h, then decocts soak and soaking water 2-3 times together, and the time of decoction is 2-4h, is then filtered, merging filtrate is obtained
Mixed liquor;
(2) mixed liquor be concentrated under reduced pressure into water content for 10-20%, obtain extract;
(3) extract is carried out after autoclaving, is included, be then spray-dried with gamma-cyclodextrin, cross 12-14 mesh
Screen cloth whole grain, obtain cyclodextrin encapsulated composition granule;
(4) menthol ethanol is dissolved, obtains menthol solution, the menthol solution is then sprayed into cyclodextrin again
Include in composition granule, mix, it is closed to stay overnight, obtain compound particles;
(5) hybrid particles are well mixed with mannitol, sucrose and adhesive, pelletized, dried, add magnesium stearate, mixed
Even rear tabletting is produced.
It is preferred that in step (2), described be concentrated under reduced pressure under conditions of 40-60 DEG C is carried out.
It is preferred that in step (3), the autoclaving is the 5-10min that sterilized in 120 DEG C of high steams.
It is preferred that in step (3), being included using ultrasonic method with gamma-cyclodextrin to extract, the ultrasonic method is specific
For:Take extract to add volume fraction to dissolve for 30-50% ethanol, it is standby;Then gamma-cyclodextrin is put into container, be used in combination
Volume fraction is dissolved for 30-50% ethanol, then container is placed in Ultrasound Instrument, and the extract injection γ after ethanol is dissolved-
In cyclodextrin solution, ultrasound is complete to including.
It is preferred that the ultrasonic time is 20-40min, the ultrasonic power is 200-250w, the temperature of the inclusion
Spend for 45-55 DEG C.
In instant component:
Honeysuckle:Honeysuckle is described as clearing heat and detoxicating good medicine from ancient times.It contains chlorogenic acid, glucoside, flavonoids, volatile oil
Constituents.Glycosides composition includes saponin, iridoid glycoside etc., such as with ivy glucoside member for the triterpenoid saponin of aglucon, with caryophyllin
For the triterpenoid saponin of glucoside member;Flavone compound has the trimethoxy flavone of 5- hydroxyls -3 ', 4,7-, cyanidenon -7-O-a-D- Portugals
Grape glucoside, cyanidenon -7-O-b-D- galactosides, Quercetin -3-O-b-D- glycosides, hyperin etc.;In volatile oil
Containing more than 30 kinds compositions, therefore honeysuckle can dispelling wind-heat, also kind removing summer-heat blood poison, for various febrile diseases, such as body heat, hair
The cards such as rash, hair spot, heat toxin sore carbuncle, abscess of throat, equal effect is notable.
Dandelion:Dandelion has clearing heat and detoxicating, effect of dispersing swelling and dissipating binds.Cure mainly the infection of the upper respiratory tract, eye conjunctivitis, stream
Row parotitis, hyperglycaemia, acute mastitis swells and ache, gastritis, dysentery, hepatitis, cholecystitis, acute appendicitis, urinary infection, pelvic cavity
Inflammation, carbuncle furuncle furunculosis, pharyngitis controls acute mastitis, and adenolymphitis, scrofula, malignant boil carbuncle toxin, acute conjunctivitis, cold, fever is acute
Tonsillitis, acute bronchitis, urinary tract infections.Dandelion Injectable Solution in vitro to staphylococcus aureus resistance bacterial strain,
Hemolytic streptococcus has stronger bactericidal action, to Diplococcus pneumopniae, meningococcus, corynebacterium diphtheriae, Pseudomonas aeruginosa, deformed rod
Bacterium, shigella dysenteriae, typhoid bacillus etc. and dandelion micrococcus catarrhalis also have certain bactericidal action.Dandelion decoction can show in vitro
Write and improve human peripheral lymphocyte blast transformation rate.
Menthol:Peppermint brain-capacity optionally stimulates the frigidoreceptor of human body skin or mucous membrane, produce sense of cold reflection and
Creeping chill, causes skin and mucosa vessel retraction (actually skin keeps normal);Receipts can also be caused to the blood vessel of deep tissue in addition
Contracting, and produce therapeutic action.Menthol is oral to be caught a cold with that can alleviate local inflammation (sphagitis) and treatment in compound preparation, and is had
Stomach invigorating, wind dispelling effect.External application is used for local analgesia, antipruritic, headache, dizziness, bite by mosquitos;Collunarium, which is used to catch cold, has a stuffy nose, suction
Or spray for sphagitis;Taking orally can be as carminative, for headache and nose, pharynx, laryngitis etc..
Mulberry leaf:According to《The grass warp of the legendary god of farming hundred》Record, mulberry leaf are a kind of good medicines, are referred to as " mulberry leaf ", with enriching yin
Enrich blood, wind-dispelling heat-dissipating, clearing away the lungheat and moisturizing, the ventilation of beneficial liver, antihypertensive diuretic the effect of;Modern medicine also demonstrate that mulberry leaf have spasmolysis, antibacterial,
Anti-inflammatory, reducing blood lipid, hypoglycemic, hypotensive effect.1-the DNJ of special composition particularly just contained in mulberry leaf
[DNJ], can hinder intake, the decomposition of starch of sugar in human body, be to suppress blood glucose value after meal to rise distinctive main component,
Cancer generation, dispelling fatigue, anti-aging can also be suppressed simultaneously.
Exocarpium Citri Rubrum:Exocarpium Citri Rubrum is rutaceae orange CitrusreticulataBlanco and its drying outer layer fruit of variety
Skin, warm-natured, pungent, hardship, return lung, the spleen channel, cold dispelling eliminating dampness, regulating qi-flowing for eliminating phlegm, wide middle invigorating the spleen.Cough due to wind-cold evil's abundant expectoration circulation of vital energy in the wrong direction is cured mainly, is disliked
The heart is vomitted, and chest institute swollen ruffian is cloudy.Exocarpium Citri Rubrum contains a variety of flavonoids such as aurantiamarin, neohesperidin, flavone compound
(Flavonoids) it is a kind of polyphenol compound being distributed widely in nature, because the diversity of structure, such chemical combination
Thing has multiple biological activities, and such as anti-oxidant, lowering blood pressure and blood fat, anticancer, modern pharmacological research shows, aurantiamarin tool
There are the effects, the auxiliary treatment available for disease of cardiovascular system such as maintenance osmotic pressure.
In summary, by adopting the above-described technical solution, the beneficial effects of the invention are as follows:
(1) golden extract of the English lozenge containing honeysuckle, dandelion, mulberry leaf and Exocarpium Citri Rubrum of clearing heat, relieving sore-throat of the invention, adds simultaneously
Auxiliary material is added, wherein gamma-cyclodextrin is inclusion compound, and sucrose and mannitol are filler, and magnesium stearate is lubricant, and carboxymethyl is fine
Dimension element is received, methylcellulose and ethyl cellulose are adhesive, each reasonable composition compatibility, with stronger biological effect, peace
Completely without toxic side effect.Honegsukle flower P.E can dispelling wind-heat, also kind removing summer-heat blood poison;Dandelion has clearing heat and detoxicating, Sweeling-eliminating medicine powder
Knot, effect of bactericidal antiphlogistic;Menthol can alleviate local inflammation and treatment flu;Mulberry leaf have wind-dispelling heat-dissipating, clearing away the lungheat and moisturizing, benefit
Effect of liver ventilation;Exocarpium Citri Rubrum has effects that invigorating the spleen in cold dispelling eliminating dampness, regulating qi-flowing for eliminating phlegm, width;Cure mainly cough due to wind-cold evil's abundant expectoration circulation of vital energy in the wrong direction.
(2) the golden English lozenge of clearing heat, relieving sore-throat of the invention employs gamma-cyclodextrin and does inclusion compound, by the beneficial molecular beam of Chinese patent drug
Be tied among the molecular structure of gamma-cyclodextrin, when making to take can in saliva slow mechanism dissolved, adjust release efficiency, with respect to market
On common buccal tablet, can effectively extend lozenge in oral cavity and pharyngeal residence time, persistently play drug effect, greatly improve
Curative effect.
(3) the golden English lozenge of clearing heat, relieving sore-throat of the invention carries out autoclaving in preparation process to the extract after concentration,
While Chinese medicine original local flavor and effect is ensured, it can effectively extend the time of lozenge storage.
Embodiment
For the objects, technical solutions and advantages of the present invention are more clearly understood, preferred embodiment is enumerated below, to this hair
It is bright to be further described.However, it is necessary to which many details listed in explanation, specification are used for the purpose of making reader to this
The one or more aspects of invention have a thorough explanation, can also realize the present invention's even without these specific details
These aspects.
First, embodiment
Embodiment 1
A kind of golden English lozenge of clearing heat, relieving sore-throat, the raw material of the golden English lozenge of the clearing heat, relieving sore-throat is careless, thin including honeysuckle, dandelion
Lotus brain, mulberry leaf, Exocarpium Citri Rubrum and auxiliary material, in parts by weight for:20 parts of honeysuckle, 100 parts of dandelion, 5 parts of menthol, mulberry leaf 10
50 parts of part, 3 parts of Exocarpium Citri Rubrum and auxiliary material;
The auxiliary material is made up of gamma-cyclodextrin, mannitol, sucrose, magnesium stearate and CMC, and the γ-
Cyclodextrin, mannitol, sucrose, the weight ratio of magnesium stearate and CMC are:30:0.5:1:0.5:3.
Present invention also offers a kind of preparation method of the golden English lozenge of clearing heat, relieving sore-throat, the preparation method includes following step
Suddenly:
(1) honeysuckle, dandelion grass, mulberry leaf and Exocarpium Citri Rubrum are weighed according to the above ratio, and after cleaning up, chopping is soaked
1h, then decocts soak and soaking water 3 times together, and the time of decoction is 2h, is then filtered, merging filtrate is mixed
Liquid;
(2) it is 10% to carry out mixed liquor under conditions of 40 DEG C being concentrated under reduced pressure into water content, obtains extract;
(3) extract is sterilized 5min in 120 DEG C of high steams, extract entered using ultrasonic method gamma-cyclodextrin
Row is included, and ultrasonic method is specially:Take extract to add volume fraction to dissolve for 30% ethanol, it is standby;Then by gamma-cyclodextrin
Container is put into, and is dissolved with volume fraction for 30% ethanol, then container is placed in Ultrasound Instrument, the extraction after ethanol is dissolved
In thing injection gamma-cyclodextrin solution, ultrasonic 20min, ultrasonic power is 250w, 55 DEG C of the temperature of inclusion;Then it is spray-dried,
The screen cloth whole grain of 12 mesh is crossed, cyclodextrin encapsulated composition granule is obtained;
(4) menthol ethanol is dissolved, obtains menthol solution, the menthol solution is then sprayed into cyclodextrin again
Include in composition granule, mix, it is closed to stay overnight, obtain compound particles;
(5) hybrid particles are well mixed with mannitol, sucrose and CMC, pelletized, dried, added stearic
Tabletting is produced after sour magnesium, mixing.
Embodiment 2
A kind of golden English lozenge of clearing heat, relieving sore-throat, the raw material of the golden English lozenge of the clearing heat, relieving sore-throat includes honeysuckle, radix tarxaci, thin
Lotus brain, mulberry leaf, Exocarpium Citri Rubrum and auxiliary material, in parts by weight for:50 parts of honeysuckle, 60 parts of dandelion, 20 parts of menthol, 5 parts of mulberry leaf,
40 parts of 8 parts of Exocarpium Citri Rubrum and auxiliary material;
The auxiliary material is made up of gamma-cyclodextrin, mannitol, sucrose, magnesium stearate and methylcellulose, the γ-ring paste
Essence, mannitol, sucrose, the weight ratio of magnesium stearate and methylcellulose are:30:2:0.5:1:1.
Present invention also offers a kind of preparation method of the golden English lozenge of clearing heat, relieving sore-throat, the preparation method includes following step
Suddenly:
(1) honeysuckle, radix tarxaci, mulberry leaf and Exocarpium Citri Rubrum are weighed according to the above ratio, and after cleaning up, chopping is soaked
3h, then decocts soak and soaking water 2 times together, and the time of decoction is 4h, is then filtered, merging filtrate is mixed
Liquid;
(2) it is 10% to carry out mixed liquor under conditions of 60 DEG C being concentrated under reduced pressure into water content, obtains extract;
(3) extract is sterilized 10min in 120 DEG C of high steams, extract entered using ultrasonic method gamma-cyclodextrin
Row is included, and ultrasonic method is specially:Take extract to add volume fraction to dissolve for 50% ethanol, it is standby;Then by gamma-cyclodextrin
Container is put into, and is dissolved with volume fraction for 50% ethanol, then container is placed in Ultrasound Instrument, the extraction after ethanol is dissolved
In thing injection gamma-cyclodextrin solution, ultrasonic 40min, ultrasonic power is 200w, the temperature 45 C of inclusion;Then it is spray-dried,
The screen cloth whole grain of 12 mesh is crossed, cyclodextrin encapsulated composition granule is obtained;
(4) menthol ethanol is dissolved, obtains menthol solution, the menthol solution is then sprayed into cyclodextrin again
Include in composition granule, mix, it is closed to stay overnight, obtain compound particles;
(5) hybrid particles are well mixed with mannitol, sucrose and methylcellulose, pelletized, dried, add stearic acid
Tabletting is produced after magnesium, mixing.
Embodiment 3
A kind of golden English lozenge of clearing heat, relieving sore-throat, the raw material of the golden English lozenge of the clearing heat, relieving sore-throat includes honeysuckle, dandelion, peppermint
Brain, mulberry leaf, Exocarpium Citri Rubrum and auxiliary material, in parts by weight for:30 parts of honeysuckle, 70 parts of dandelion, 10 parts of menthol, 6 parts of mulberry leaf, tangerine
Red 5 parts and 15 parts of auxiliary material;Dandelion is made up of dandelion grass and radix tarxaci;
The auxiliary material is made up of gamma-cyclodextrin, mannitol, sucrose, magnesium stearate and ethyl cellulose, the γ-ring paste
Essence, mannitol, sucrose, the weight ratio of magnesium stearate and ethyl cellulose are:30:1:0.8:0.8:2.
Present invention also offers a kind of preparation method of the golden English lozenge of clearing heat, relieving sore-throat, the preparation method includes following step
Suddenly:
(1) honeysuckle, dandelion, mulberry leaf and Exocarpium Citri Rubrum are weighed according to the above ratio, and after cleaning up, 2h is soaked in chopping,
Then soak and soaking water are decocted 3 times together, the time of decoction is 3h, is then filtered, merging filtrate obtains mixed liquor;
(2) it is 15% to carry out mixed liquor under conditions of 50 DEG C being concentrated under reduced pressure into water content, obtains extract;
(3) extract is sterilized 8min in 120 DEG C of high steams, extract entered using ultrasonic method gamma-cyclodextrin
Row is included, and ultrasonic method is specially:Take extract to add volume fraction to dissolve for 40% ethanol, it is standby;Then by gamma-cyclodextrin
Container is put into, and is dissolved with volume fraction for 40% ethanol, then container is placed in Ultrasound Instrument, the extraction after ethanol is dissolved
In thing injection gamma-cyclodextrin solution, ultrasonic 30min, ultrasonic power is 200w, the temperature 50 C of inclusion;Then it is spray-dried,
The screen cloth whole grain of 12 mesh is crossed, cyclodextrin encapsulated composition granule is obtained;
(4) menthol ethanol is dissolved, obtains menthol solution, the menthol solution is then sprayed into cyclodextrin again
Include in composition granule, mix, it is closed to stay overnight, obtain compound particles;
(5) hybrid particles are well mixed with mannitol, sucrose and ethyl cellulose, pelletized, dried, add stearic acid
Tabletting is produced after magnesium, mixing.
Embodiment 4
A kind of golden English lozenge of clearing heat, relieving sore-throat, the raw material of the golden English lozenge of the clearing heat, relieving sore-throat includes honeysuckle, dandelion, peppermint
Brain, mulberry leaf, Exocarpium Citri Rubrum and auxiliary material, in parts by weight for:40 parts of honeysuckle, 80 parts of dandelion, 15 parts of menthol, 6 parts of mulberry leaf, tangerine
Red 7 parts and 40 parts of auxiliary material;Dandelion is made up of dandelion grass and radix tarxaci;
The auxiliary material is made up of gamma-cyclodextrin, mannitol, sucrose, magnesium stearate and ethyl cellulose, the γ-ring paste
Essence, mannitol, sucrose, the weight ratio of magnesium stearate and ethyl cellulose are:30:1.5:1:0.8:1.5.
Present invention also offers a kind of preparation method of the golden English lozenge of clearing heat, relieving sore-throat, the preparation method includes following step
Suddenly:
(1) honeysuckle, dandelion, mulberry leaf and Exocarpium Citri Rubrum are weighed according to the above ratio, and after cleaning up, 2h is soaked in chopping,
Then soak and soaking water are decocted 3 times together, the time of decoction is 3h, is then filtered, merging filtrate obtains mixed liquor;
(2) it is 15% to carry out mixed liquor under conditions of 50 DEG C being concentrated under reduced pressure into water content, obtains extract;
(3) extract is sterilized 8min in 120 DEG C of high steams, extract entered using ultrasonic method gamma-cyclodextrin
Row is included, and ultrasonic method is specially:Take extract to add volume fraction to dissolve for 40% ethanol, it is standby;Then by gamma-cyclodextrin
Container is put into, and is dissolved with volume fraction for 40% ethanol, then container is placed in Ultrasound Instrument, the extraction after ethanol is dissolved
In thing injection gamma-cyclodextrin solution, ultrasonic 30min, ultrasonic power is 200w, the temperature 50 C of inclusion;Then it is spray-dried,
The screen cloth whole grain of 12 mesh is crossed, cyclodextrin encapsulated composition granule is obtained;
(4) menthol ethanol is dissolved, obtains menthol solution, the menthol solution is then sprayed into cyclodextrin again
Include in composition granule, mix, it is closed to stay overnight, obtain compound particles;
(5) hybrid particles are well mixed with mannitol, sucrose and ethyl cellulose, pelletized, dried, add stearic acid
Tabletting is produced after magnesium, mixing.
2nd, safety testing
The golden English lozenge of the clearing heat, relieving sore-throat of the present invention is pulverized last, be dissolved in water, it is standby;Take Kunming mouse 50
Only, body weight 20-24g, male and female dual-purpose, are divided into two groups, every group 25, one of which is normal amount test group, and another group is extraordinary
Measure test group.The medication of normal amount group is 2mg/10g, and excess group is 4mg/10g, and administering mode is administered for administration by gavage, the daily morning and evening
Respectively once, one week is even served, medication reaction is observed daily.As a result show:Each group mouse behavior is without exception, no poisoning symptom, appetite,
Excrement is without exception, and general signs are good, shows that the golden English lozenge of clearing heat, relieving sore-throat of the present invention is safe and free of toxic and side effects.
3rd, clinical observation is tested
Golden English lozenge of the invention is used to treat pharyngitis by inventor, and acute, chronic pharyngitis patient mouth containing is generally sent out after 3 days
The pharyngitis symptoms such as existing pharyngalgia, sound is mute, expectoration is not well, bottleneck throat foreign body sensation are obviously improved.Taken for chronic pharyngitis after 8 days, base
This recovery from illness.It is case demographics table referring to table 1, table 2 is therapeutic effect.
Efficacy assessment standard:
1. clinical recovery:Pastille symptom mitigation within 3 days, clinical symptoms and sign disappear within 5 days.
2. it is effective:Symptom mitigation within medication 7 days, part sign disappears.
3. it is invalid:Clinical symptoms and sign can not be made to disappear within medication 10.
Table 1
Table 2
To sum up, the golden English lozenge of the present invention verifies that it treats the definite effect of acute/chronic pharyngitis by Long-term clinical, and curative effect shows
Write, can obviously improve the throat symptoms such as pharyngalgia, not well, the bottleneck throat foreign body sensation of silent, expectoration, effective percentage is up to more than 90%, its
Middle acpuei pharyngitis cure rate is up to 90%, and chronic pharyngitis cure rate is up to 96%.
The piece weight of the golden English lozenge of the clearing heat, relieving sore-throat of the present invention is 1-2g, compared with the buccal tablet of equivalent weight on the market, this
The lozenge of invention rests on oral cavity and pharyngeal time lengthening 10-15min, and drug effect plays and extends 0.5-1h;Therefore it is of the invention
The golden English lozenge of clearing heat, relieving sore-throat effectively extend lozenge in oral cavity and pharyngeal residence time, persistently play drug effect, carry significantly
High curative effect.
Described above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, under the premise without departing from the principles of the invention, some improvements and modifications can also be made, these improvements and modifications also should
It is considered as protection scope of the present invention.