CN105616590A - Composition capable of clearing heat from throat, and preparation method thereof - Google Patents

Composition capable of clearing heat from throat, and preparation method thereof Download PDF

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Publication number
CN105616590A
CN105616590A CN201410621539.9A CN201410621539A CN105616590A CN 105616590 A CN105616590 A CN 105616590A CN 201410621539 A CN201410621539 A CN 201410621539A CN 105616590 A CN105616590 A CN 105616590A
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extract
fructus
radix glycyrrhizae
radix platycodonis
phyllanthi
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张保献
张卫华
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BEIJING BAODE RUNSHENG PHARMACEUTICAL MEDICAL TECHNOLOGY DEVELOPMENT Co Ltd
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BEIJING BAODE RUNSHENG PHARMACEUTICAL MEDICAL TECHNOLOGY DEVELOPMENT Co Ltd
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Abstract

The invention discloses a composition capable of clearing heat from the throat, and a preparation method thereof. The composition is prepared from licorice extract, balloonflower root extract, phyllanthus emblica extract, grosvenor momordica fruit extract and dark plum extract according to a certain weight ratio; and any preparation can be prepared from the composition, preferably, an oral preparation. The composition disclosed in the invention is capable of clearing heat from the throat.

Description

A kind of composition and method of making the same with function of moistening and cleaning throat
Technical field
The present invention relates to a kind of composition and method of making the same with function of moistening and cleaning throat, belong to the technical field of health food.
Background technology
Pharyngolaryngitis is by bacterial a kind of disease, can be divided into acute pharyngolaryngitis and chronic pharyngolaryngitis two kinds.
Acute pharyngitis: often cause for virus, secondly caused by antibacterial, winter-spring season is the most common. It is secondary to acute rhinitis, acute sinusitis, acute tonsillitis more, and is often the complication of the infectious disease such as measles, influenza, scarlet fever. Suffer from cold, tired, long-term by chemical gas or the stimulation of dust, smoking heavily etc., all can reduce resistance of human body, it is easy to its morbidity short. Adult based on pharyngeal symptom, sick just pharyngeal have dry itch, scorching hot, gradually have pain, increase the weight of when swallowing, excessive saliva, lateral pharyngeal band is got involved, and has obvious otalgia. Weak adult or children's, then General Symptoms is notable, has fever to be afraid of cold, has a headache, inappetence, extremities aching pain etc.
Chronic pharyngitis: mainly due to acute pharyngitis treatment thorough recurrent exerbation, transfer to chronic, or because suffering from various cacorhinias, nose key blocks, long-term mouth breathing, and physics, chemical factor, neck radiotherapy etc. often stimulate pharyngeal caused by. Chronic pharyngitis is more common in adult, and child also may occur in which. General Symptoms is all inconspicuous, based on local symptom, as pharyngeal sense of discomfort, foreign body sensation, pharyngeal secretions not easily bring up, pharyngeal gargalesthesia, burn feeling, dry sensation or excitement, also can have hypodynia sense. Due to pharynx rear wall generally because pharyngeal chronic inflammatory disease causes relatively thick secretions to adhere to, and owing to nose, nasal sinuses, nasopharynx pathological changes cause mouth breathing at night, irritable cough occurs when rising morning of being everlasting and feels sick. Frequently swallow owing to foreign body in pharynx sense can behave as, pharyngeal secretions few and not easily expectoration person often show as habitually dry cough and action of coughing up phlegm of clearing one's throat, pharyngeal mucosa hemorrhage can be caused if firmly coughing or clear one's throat, cause band blood in secretions.
Summary of the invention
It is an object of the present invention to provide a kind of compositions with function of moistening and cleaning throat.
The preparation method that another object of the present invention there is provided said composition.
The present invention is achieved by the following technical solutions:
The present invention is made up of the raw material of following weight parts:
Radix Glycyrrhizae extract 10-80 part, Radix Platycodonis extract 10-80 part, Fructus Phyllanthi extract 10-60 part, Fructus Momordicae extract 10-60 part, Fructus Mume extract 5-50 part.
It is preferably:
Radix Glycyrrhizae extract 30-50 part, Radix Platycodonis extract 30-50 part, Fructus Phyllanthi extract 20-40 part, Fructus Momordicae extract 20-40 part, Fructus Mume extract 10-30 part.
More preferably:
Radix Glycyrrhizae extract 40 parts, Radix Platycodonis extract 44 parts, Fructus Phyllanthi extract 30 parts, Fructus Momordicae extract 36 parts, Fructus Mume extract 20 parts.
Fructus Momordicae extract in the present invention can substitute with Fructus chebulae immaturus extract.
In the present invention, the mechanism of action of each component is as follows:
Radix Glycyrrhizae: for dicotyledon pulse family Leguminosae Radix Glycyrrhizae GlycyrrhizauralensisFisch., the root and rhizome of Glycyrrhiza inflata Bat. G.inflataBat. or Glycyrrhiza glabra L. G.glabraL.. Sweet, flat. Enter spleen, stomach, lung meridian. There is effect of QI invigorating invigorating middle warmer, relieving spasm to stop pain, nourishing the lung to arrest cough, eliminating fire and detoxication, coordinating the actions of various ingredients in a prescription, can be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, extremity contraction urgency pain, carbuncle sore tumefacting virus, cushion toxicity, strong. Modern pharmacological research find, Radix Glycyrrhizae have antiinflammatory and resistance state reflection function, clinically mainly as demulcent, can relieving cough, eliminate the phlegm, treat pharyngalgia laryngitis.
Radix Platycodonis: the root of dicotyledon campanulaceae Campanulacea Radix Platycodonis Platycodongrandiflorum (Jacq.) A.DC.. Bitter in the mouth, pungent, slightly warm in nature. Enter lung meridian. Open lung qi dispersing gas, evacuation of pus of eliminating the phlegm. Controlling exogenous cough, laryngopharynx swelling and pain, lung abscess vomiting pus, fullness in the chest and hypochondriac pain, dysentery is suffered from abdominal pain. Modern pharmacological research shows, kikyosaponin crude product has calmness, analgesia and the central inhibitory action such as antipyretic, and has antiinflammatory and relieving cough and expelling phlegm, expansion blood vessel, blood pressure lowering, antiulcer action.
Fructus Phyllanthi: for the fruit of Euphorbiaceae phyllanthus plant Fructus Phyllanthi (PhyllanthusemblicaL) is sweet, sour, puckery, cool. Return lung meridian, stomach warp. Clearing away heat and cooling blood, promoting digestion and invigorating the stomach, cough-relieving of promoting the production of body fluid. For heat in blood blood stasis, dyspepsia, abdominal distention, cough, laryngalgia, xerostomia. Modern pharmacological research, Fructus Phyllanthi can significantly inhibit rat agar pedal swelling and dimethylbenzene induced mice ear edge swelling, significantly inhibit the capillary permeability caused by histamine to strengthen and leukocytoplania, show that Fructus Phyllanthi has significant antiinflammatory and exudation effect, antiinflammatory action increases with dosage and strengthens, Fructus Phyllanthi can significantly inhibit acutely inflamed development, improves and alleviates inflammatory symptoms.
Fructus Momordicae: for the dry fruit of cucurbitaceous plant Fructus Momordicae Siraitiagrosvenorii (Swingle) C.JeffreyexLuetZ.Y.Zhang. Sweet, sour, cool in nature, there is clearing away heat and cooling blood, cough-relieving of promoting the production of body fluid, laxation toxin expelling, skin care benefit face, the effect such as moistening the lung and resolving phlegm, can be used for life prolonging, preserve youthful looks Yue Se and treatment phlegm-heat cough, laryngopharynx swelling and pain, constipation, irritated all cards of quenching one's thirst. Pharmacological research shows, Fructus Momordicae has good curative effect for treatment acute tracheitis, acute tonsillitis, throat fire, acute gastritis.
Fructus Mume: for the dry almost ripe fruit of rose department plant plum Prunusmume (sieb.) Sieb.etZucc.. Sour, puckery, flat. Return liver, spleen, lung, large intestine channel. Astringe the lung, astringing intestine to stop diarrhea, promote the production of body fluid, relieving colic caused by ascaris. For chronic cough of deficiency lung; Deficiency-heat excessive thirst; Chronic malaria; Chronic diarrhea; Dysentery; Have blood in stool; Hematuria; Metrorrhagia; The ascariasis of biliary tract is suffered from abdominal pain; Vomiting; Ancylostomiasis. Research shows, Fructus Mume can be used for dry cough without phlegm, acute and chronic pharyngolaryngitis.
Fructus chebulae immaturus: for the young fruit of Combretum Racemosum plant Fructus Chebulae. Bitter in the mouth, micro-sweet, puckery, cold nature. Heat clearing away, sore-throat relieving, promotes the production of body fluid, can be used for treating deficiency syndrome diphtheria, laryngitis, tonsillitis, bacillary dysentery etc., be mainly used in chronic pharyngitis, chronic laryngitis, chronic tonsillitis.
In order to make each raw material of this medicine better play drug effect, it is preferable that the raw material of proportioning of the present invention is carried out water and carries, but cannot be used for limiting the scope of the invention.
The preparation method of the present composition is as follows:
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, mixing, it is not added with or adds appropriate amount of auxiliary materials, technique makes acceptable preparation on pharmaceutics routinely.
As the oral drugs of the solid dosage form such as conventional tablet (dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet), capsule (hard capsule, soft capsule), granule, pill (drop pill), powder can be made, it is also possible to make the oral liquid of the form such as syrup, oral liquid. Therefore, in said composition except effective ingredient, it is also possible to containing pharmaceutically acceptable adjuvant.
Adjuvant described here, it is possible to different according to different preparations, such as diluent conventional in the solid preparations such as tablet, capsule, granule, disintegrating agent, excipient, binding agent, lubricant, surfactant, filler etc.; Surfactant conventional in the liquid forms such as syrup, oral liquid, diluent, preservative, stabilizer, correctives, thickening agent, fluidizer etc.
Its conventional adjuvant such as starch, lactose, dextrin, Icing Sugar, microcrystalline Cellulose, mannitol, xylitol, Polyethylene Glycol, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, modified starch, sorbitol, polyvidon, Heavy Magnesium Carbonate, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, methylcellulose, ethyl cellulose, carboxymethylstach sodium, hydroxypropyl cellulose, PVP K30, kaolin, pregelatinized Starch, magnesium stearate, Pulvis Talci, micropowder silica gel, sucrose, stevioside, glycine betaine, aspartame, glycyrrhizin, saccharin sodium etc.
The preparation method of present composition tablet is:
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate filler, correctives, be sufficiently mixed, alcohol granulation, dry, granulate, add moderate lubrication agent, mixing, tabletting, coating or not coating, obtain tablet.
Wherein, filler refers to one or more in starch, mannitol, pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose; Correctives refers to one or more in aspartame, stevioside, glycine betaine, glycyrrhizin, sucrose, saccharin sodium; Lubricant refers to one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
The preparation method of present composition tablet is preferably:
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, lactose, dextrin, aspartame, it is sufficiently mixed, alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, coating or not coating, obtain tablet.
Wherein, the consisting of of coating materials: hypromellose, titanium dioxide, Brilliant blue aluminum lake, tartrazine aluminum lake, polyethylene glycol 6000, Pulvis Talci.
Radix Glycyrrhizae extract in the present invention, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract can be obtained by buying commercially available product or take following preparation method to obtain:
Extracting liquorice, Radix Platycodonis, Fructus Phyllanthi, Fructus Momordicae, Fructus Mume add water or the ethanol extraction of variable concentrations respectively, and extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Adoptable concrete operations and/or using method when above-mentioned effective medicinal ingredient is extracted, both can be with the ingredient of described each proportional quantities for raw material, extract decomposite mode after its effective medicinal ingredient respectively, it would however also be possible to employ the common mode extracted again after mixing by each medicine material of described proportional quantities. The actual conditionses such as ideal required when adopting different extraction means, equipment and extract or the Extracting temperature of the best, solvent load, extraction time, extraction time, then can according to practical situation by testing screened and finding.
The present invention relates to a kind of compositions, it is on the basis of existing theory of Chinese medical science, filter out can effectively moistening and cleaning throat, antiinflammatory prescription, carry out scientific compatibility, play its mutual synergism, thus obtaining a kind of formula with function of moistening and cleaning throat.
The detailed description of the invention of form by the following examples, is described in further detail the foregoing of the present invention. But this should not being interpreted as, the scope of the above-mentioned theme of the present invention is only limitted to below example. All technology realized based on foregoing of the present invention belong to the scope of the present invention.
Detailed description of the invention
Embodiment 1
Radix Glycyrrhizae extract 40g, Radix Platycodonis extract 44g, Fructus Phyllanthi extract 30g, Fructus Momordicae extract 36g, Fructus Mume extract 20g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, lactose, dextrin, aspartame, it is sufficiently mixed, 75% alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, film coating, obtains tablet.
Embodiment 2
Radix Glycyrrhizae extract 80g, Radix Platycodonis extract 10g, Fructus Phyllanthi extract 60g, Fructus Momordicae extract 10g, Fructus Mume extract 50g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, lactose, dextrin, aspartame, it is sufficiently mixed, 75% alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, film coating, obtains tablet.
Embodiment 3
Radix Glycyrrhizae extract 10g, Radix Platycodonis extract 80g, Fructus Phyllanthi extract 10g, Fructus Momordicae extract 60g, Fructus Mume extract 5g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, lactose, dextrin, aspartame, it is sufficiently mixed, 75% alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, film coating, obtains tablet.
Embodiment 4
Radix Glycyrrhizae extract 50g, Radix Platycodonis extract 30g, Fructus Phyllanthi extract 40g, Fructus Momordicae extract 20g, Fructus Mume extract 30g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, lactose, dextrin, aspartame, it is sufficiently mixed, 75% alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, obtain tablet.
Embodiment 5
Radix Glycyrrhizae extract 30g, Radix Platycodonis extract 50g, Fructus Phyllanthi extract 20g, Fructus Momordicae extract 40g, Fructus Mume extract 10g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, lactose, dextrin, aspartame, it is sufficiently mixed, 75% alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, obtain tablet.
Embodiment 6
Radix Glycyrrhizae extract 70g, Radix Platycodonis extract 20g, Fructus Phyllanthi extract 50g, Fructus Momordicae extract 30g, Fructus Mume extract 20g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, mixing, granulate, dry, encapsulated, obtain capsule.
Embodiment 7
Radix Glycyrrhizae extract 20g, Radix Platycodonis extract 70g, Fructus Phyllanthi extract 30g, Fructus Momordicae extract 50g, Fructus Mume extract 40g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate amount of auxiliary materials, mixing, make pill according to a conventional method.
Embodiment 8
Radix Glycyrrhizae extract 15g, Radix Platycodonis extract 75g, Fructus Phyllanthi extract 15g, Fructus Momordicae extract 55g, Fructus Mume extract 15g
Taking the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate suspensoid, flavoring agent, preservative, mixing, add water constant volume, filters, subpackage, obtains oral liquid.
Embodiment 9
Radix Glycyrrhizae extract 75g, Radix Platycodonis extract 15g, Fructus Phyllanthi extract 55g, Fructus Momordicae extract 15g, Fructus Mume extract 45g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, sieve respectively, mixing, make powder according to a conventional method.
Embodiment 10
Radix Glycyrrhizae extract 35g, Radix Platycodonis extract 45g, Fructus Phyllanthi extract 25g, Fructus Momordicae extract 35g, Fructus Mume extract 15g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, microcrystalline Cellulose, sucrose, mixing, alcohol granulation, dry, granulate, obtain granule.
Embodiment 11
Radix Glycyrrhizae extract 45g, Radix Platycodonis extract 35g, Fructus Phyllanthi extract 35g, Fructus Momordicae extract 25g, Fructus Mume extract 25g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate mannitol, pregelatinized Starch, dextrin, stevioside, it is sufficiently mixed, alcohol granulation, dry, granulate, add appropriate micropowder silica gel, Pulvis Talci, mixing, tabletting, coating, obtains tablet.
Embodiment 12
Radix Glycyrrhizae extract 60g, Radix Platycodonis extract 60g, Fructus Phyllanthi extract 20g, Fructus Momordicae extract 30g, Fructus Mume extract 8g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate starch, dextrin, sucrose, saccharin sodium, it is sufficiently mixed, alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, coating, obtains tablet.
Embodiment 13
Radix Glycyrrhizae extract 50g, Radix Platycodonis extract 50g, Fructus Phyllanthi extract 60g, Fructus Momordicae extract 20g, Fructus Mume extract 10g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate microcrystalline Cellulose, dextrin, glycyrrhizin, it is sufficiently mixed, alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, coating, obtains tablet.
Embodiment 14
Radix Glycyrrhizae extract 15g, Radix Platycodonis extract 20g, Fructus Phyllanthi extract 60g, Fructus Momordicae extract 25g, Fructus Mume extract 40g
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate lactose, dextrin, glycine betaine, aspartame, it is sufficiently mixed, alcohol granulation, dry, granulate, add appropriate magnesium stearate, mixing, tabletting, obtain tablet.
In above example, the coating materials of coated tablet consists of: hypromellose, titanium dioxide, Brilliant blue aluminum lake, tartrazine aluminum lake, polyethylene glycol 6000, Pulvis Talci.
Fructus Momordicae extract in above example 1-14 all can substitute with Fructus chebulae immaturus extract.
Radix Glycyrrhizae extract in above example 1-14, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract may each be takes following methods to obtain:
Radix Glycyrrhizae extract: extracting liquorice adds water or the ethanol extraction of variable concentrations, and extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Above-mentioned crude extract or extract are Radix Glycyrrhizae extract.
Radix Platycodonis extract: taking Radix Platycodonis and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Above-mentioned crude extract or extract are Radix Platycodonis extract.
Fructus Phyllanthi extract: taking Fructus Phyllanthi and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Above-mentioned crude extract or extract are Fructus Phyllanthi extract.
Fructus Momordicae extract: taking Fructus Momordicae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Above-mentioned crude extract or extract are Fructus Momordicae extract.
Fructus Mume extract: taking Fructus Mume and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Above-mentioned crude extract or extract are Fructus Mume extract.
Or, Radix Glycyrrhizae extract, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract obtain by buying commercially available product.
According to foregoing, without departing under basic fundamental thought premise of the present invention, according to ordinary technical knowledge and the customary means of this area, it is clear that the amendment of other various ways, replacement and change can also be made.
The beneficial effect of of the present invention compositions is expanded on further by following experiment:
One, animal experiment
1, material and method
1.1 samples: sample sets 1,2, make according to the method for the embodiment of the present invention 1,2 respectively.
1.2 experimental animals: cleaning grade BALB/C healthy male mice 36, body weight 18-22g; Cleaning grade SD health male rat 60, body weight 173-190g.
1.3 instruments and reagent: electronic balance, rat toes capacity measurer, bextran 45 ten thousand, dimethylbenzene, thermostatic drying chamber.
1.6 test methods:
1.6.1 rat cotton balls Implantation Test
Choose cleaning grade SD health male rat 30, be randomly divided into 3 groups by body weight, often group 10. Sample sets is made into suitable concn with distilled water respectively, and each group rat, all by 10ml/kgBW gavage, separately sets blank group and gives equivalent distilled water, continuous 30 days. In off-test first 8 days, slough groin place, rat both sides hair with depilator, rat is used ether light anaesthesia, iodophor disinfection, aseptically cuts rat both sides skin of groin, implant standby cotton balls, sew up the incision, continue gavage. The same day was given a given the test agent in off-test again, and after 1 hour, disconnected neck puts to death rat, cuts off skin at former suture, peels off and take out cotton balls granulation tissue, is placed in clean plate, and thermostatic drying chamber 60 DEG C is weighed after uncapping dry 1 hour, calculates granuloma net weight.
Granuloma net weight=dried granuloma induced by implantation of cotton pellets weight-raw cotton ball weight.
1.6.2 rat toes swelling test
Choose cleaning grade SD and cut off male rat 30, be randomly divided into 3 groups by body weight, often group 10. Sample sets is made into suitable concn with distilled water respectively, and each group rat, all by 10ml/kgBW gavage, separately sets blank group and gives equivalent distilled water, continuous 30 days. The same day was given a given the test agent in off-test again, and after 1 hour, with the volume of toes after toes capacity measurer each group of Rat Right of measurement, same position is measured 3 times, as 0h toes volume. Then after Rat Right, toes are only subcutaneously injected into 1% bextran 45 ten thousand 0.1ml/, the volume that 1,2,4,6 hours measure each Mus toes after causing inflammation respectively, and the same position of same time point is measured 3 times, averages. With the difference of the toes volume before the surveyed toes volume of different time and proinflammatory agent effect for swelling value, calculate the toes swelling rate of each time period.
Toes volume * 100% before toes swelling rate (%)=swelling value/cause inflammation.
1.6.3 mouse ear swelling test
Choose BALB/C healthy male mice 36, be randomly divided into 3 groups by body weight, often group 12. Sample group distilled water is made into suitable concn, and each group rat, all by 20ml/kgBW gavage, separately sets blank group and gives equivalent distilled water, after continuous 30 days, draw dimethylbenzene 20ul, drip the central authorities at mouse right ear lateral surface auricle, allow its free diffusing, after 30min, de-for mice cervical vertebra is put to death, cuts ears, lay auricle with 9mm diameter card punch in two ear same area and weigh, with the difference of two ear weight for auricle edema value, calculate auricle edema rate.
Auricle edema rate (%)=auricle edema value/comparison auricle weight * 100%.
1.7 test data statistical method: test data is added up with SPSS software, each sample group compares with blank group uses one factor analysis of variance. Through homogeneity test of variance, the neat test data of variance adopts LSD method to carry out statistical analysis, heterogeneity of variance or nonnormal test data first carries out variable conversion and adds up.
2, result
2.1 rat cotton balls Implantation Tests
The impact on rat body weight, granuloma net weight of table 1 sample
Group Number of animals (only) Initial weight (g) End weight (g) P Granuloma net weight (g) P
Matched group 10 181��5 398��11 / 0.269��0.033 /
Sample sets 1 10 181��5 396��8 0.671 0.205��0.034 0.001
Sample sets 2 10 181��5 404��11 0.178 0.209��0.045 0.001
From table 1, sample sets 1,2 rat granuloma net weight less than blank group, difference statistically significant (P < 0.05).
2.2 rat toes swelling tests
The impact on rat body weight of table 2 sample
Group Number of animals (only) Initial weight (g) End weight (g) P
Matched group 10 185��7 404��9 /
Sample sets 1 10 185��7 408��20 0.848
Sample sets 2 10 185��7 404��21 0.924
The impact on rat toes swelling rate of table 3 sample
Group Number of animals (only) 1 hour P 2 hours P 4 hours P 6 hours P
Matched group 10 24.2��7.2 / 31.0��13.2 / 21.2��9.9 / 17.2��8.6 /
Sample sets 1 10 20.2��11.0 0.298 22.1��11.0 0.109 7.8��4.7 0.001 6.4��5.6 0.003
Sample sets 2 10 23.0��11.1 0.699 23.0��11.1 0.068 11.8��7.3 0.042 8.7��9.1 0.020
From table 3, sample sets 1,2 at 4,6 hours rat toes volume swelling rates lower than blank group, difference statistically significant (P < 0.05).
2.3 mouse ear swelling test
The impact on Mouse Weight, auricle edema rate of table 4 sample
Group Number of animals (only) Initial weight (g) End weight (g) P Auricle edema rate (%) P
Matched group 12 20��1 24��1 / 34.4��7.4 /
Sample sets 1 12 20��1 23��1 0.718 26.1��11.1 0.198
Sample sets 2 12 20��1 24��1 0.589 27.7��7.2 0.193
From table 4, sample sets 1,2 mice auricle swelling rate compares with blank group, the equal not statistically significant of difference (P > 0.05).
Embodiment of the present invention 3-14 has carried out similar test all according to the method described above, and result is identical with the above results.
3, conclusion
Inventive samples rat granuloma net weight is less than blank group, and difference is statistically significant; After injecting 1% bextran 45 ten thousand, within 4,6 hours, rat toes volume swelling rate is lower than blank group, and difference is statistically significant; Mice auricle swelling rate compares with blank group, no significant difference. According to result above, can determine that the present composition has function of moistening and cleaning throat.
Two, human trial
1, case selection standard
1.1 diagnostic criterias
Symptom: even dry laryngopharynx, pain, hoarseness aphonia, or the few expectorant of itching of the throat, dry cough, dysphagia, bottleneck throat has foreign body sensation etc.
1.2 inclusive criterias
(1) above-mentioned diagnostic criteria person is met;
(2) age is 18-65 year person.
1.3 exclusion standards
(1) above-mentioned tcm diagnosis standard person is not met;
(2) though meeting above-mentioned tcm diagnosis standard, but there is the one of following situation simultaneously:
1. the age is at under-18s, or over-65s person;
2. pregnant and lying-in women or women breast-feeding their children;
3. the severe primary diseases such as cardiovascular, liver, kidney and hemopoietic system, psychotic it are associated with;
4. all inclusive criteria is not met, not by regulation medication, it is impossible to judge that curative effect or data are not congruent and affect the treatment and safety judgement person.
2, efficacy determination
Recovery from illness: within medication 3 days, symptom alleviates, within 1 week, clinical symptoms, sign disappear or substantially disappear.
Effective: within medication 1 week, symptom alleviates, within 2 weeks, clinical symptoms, sign disappear or substantially disappear.
Effective: within medication 1 week, symptom alleviates, clinical symptom relief within 2 weeks, major part sign disappears.
Invalid: after medication, symptom slightly alleviates or without alleviating, and sign is not improved.
3, Therapeutic Method
Medicine group: choose the embodiment of the present invention 1 preparation tablet, every day 2 times, each 3, buccal.
Matched group: choose watermelon crystal buccal tablet, every day 5 times, each 2, buccal.
4, clinical efficacy
Sum Recovery from illness Effective Effectively Invalid
Medicine group 195 152(77.9%) 24(12.3%) 13(6.7%) 6(3.1%)
Matched group 190 144(75.8%) 15(7.9%) 22(11.6%) 10(4.7%)
Embodiment of the present invention 2-14 has carried out similar test all according to the method described above, and result is identical with the above results.
5, conclusion
To sum up, the present composition has function of moistening and cleaning throat.

Claims (10)

1. a compositions with function of moistening and cleaning throat, it is characterized in that, it is made up of the component of following weight portion: Radix Glycyrrhizae extract 10-80 part, Radix Platycodonis extract 10-80 part, Fructus Phyllanthi extract 10-60 part, Fructus Momordicae extract 10-60 part, Fructus Mume extract 5-50 part.
2. compositions according to claim 1, it is characterized in that, it is made up of the component of following weight portion: Radix Glycyrrhizae extract 30-50 part, Radix Platycodonis extract 30-50 part, Fructus Phyllanthi extract 20-40 part, Fructus Momordicae extract 20-40 part, Fructus Mume extract 10-30 part.
3. the preparation method of compositions described in claim 1 or 2, it is characterised in that it is prepared:
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, mixing, it is not added with or adds appropriate amount of auxiliary materials, technique makes acceptable preparation on pharmaceutics routinely.
4. preparation method according to claim 3, it is characterised in that described preparation refers to tablet, granule, capsule, pill, powder, oral liquid.
5. preparation method according to claim 4, it is characterised in that tablet is prepared:
Take the Radix Glycyrrhizae extract of described weight portion, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract, add appropriate filler, correctives, be sufficiently mixed, alcohol granulation, dry, granulate, add moderate lubrication agent, mixing, tabletting, coating or not coating, obtain tablet.
6. preparation method according to claim 5, it is characterised in that described filler refers to one or more in starch, mannitol, pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose; Correctives refers to one or more in aspartame, stevioside, glycine betaine, glycyrrhizin, sucrose, saccharin sodium; Lubricant refers to one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
7. compositions according to claim 1 and 2, it is characterised in that described Radix Glycyrrhizae extract, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract are prepared obtaining:
Extracting liquorice, Radix Platycodonis, Fructus Phyllanthi, Fructus Momordicae, Fructus Mume add water or the ethanol extraction of variable concentrations respectively, and extracting solution concentrate drying obtains crude extract; Or adopt further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract; Above-mentioned crude extract or extract namely respectively Radix Glycyrrhizae extract, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract.
8. compositions according to claim 1 and 2, it is characterised in that described Radix Glycyrrhizae extract, Radix Platycodonis extract, Fructus Phyllanthi extract, Fructus Momordicae extract, Fructus Mume extract obtain by buying commercially available product.
9. compositions according to claim 1 and 2, it is characterised in that substitute Fructus Momordicae extract with Fructus chebulae immaturus extract.
10. compositions described in claim 1 or 2 is for preparing the application in the health food with function of moistening and cleaning throat.
CN201410621539.9A 2014-11-07 2014-11-07 Composition capable of clearing heat from throat, and preparation method thereof Pending CN105616590A (en)

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CN105832993A (en) * 2016-06-03 2016-08-10 云南天美天康生物科技有限公司 Composition with function of clearing heat from throats, method for preparing composition and application thereof
CN105998832A (en) * 2016-07-08 2016-10-12 惠州市九惠制药股份有限公司 Traditional Chinese medicine composition and preparation method and application thereof
CN106820125A (en) * 2017-02-28 2017-06-13 深圳市中康福药业有限公司 A kind of mulberry leaf balloonflower root particle and preparation method thereof
CN107616501A (en) * 2016-07-15 2018-01-23 珠海宝德润生健康科技有限公司 A kind of composition with clearing lung-heat function and preparation method thereof
CN108523130A (en) * 2018-07-20 2018-09-14 河南姜生堂生物科技有限公司 A kind of antifatigue buccal tablet and preparation method thereof containing ginger oil
CN109511982A (en) * 2018-12-26 2019-03-26 江苏朸健生命科技发展有限公司 Composition and its preparation method and application with throat-clearing lung-moistening effect
CN110301635A (en) * 2019-08-07 2019-10-08 厦门市养真保健食品有限公司 A kind of emblic oral instant particle and preparation method
CN111514235A (en) * 2019-12-12 2020-08-11 上海市浦东新区周浦医院 Traditional Chinese medicine composition and throat-moistening candy with effects of clearing heat from throat and benefiting throat

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105832993A (en) * 2016-06-03 2016-08-10 云南天美天康生物科技有限公司 Composition with function of clearing heat from throats, method for preparing composition and application thereof
CN105832993B (en) * 2016-06-03 2020-04-07 云南天美天康生物科技有限公司 Composition with throat clearing function and preparation method and application thereof
CN105998832A (en) * 2016-07-08 2016-10-12 惠州市九惠制药股份有限公司 Traditional Chinese medicine composition and preparation method and application thereof
CN105998832B (en) * 2016-07-08 2019-11-22 惠州市九惠制药股份有限公司 A kind of Chinese medicine composition and its preparation method and application
CN107616501A (en) * 2016-07-15 2018-01-23 珠海宝德润生健康科技有限公司 A kind of composition with clearing lung-heat function and preparation method thereof
CN106820125A (en) * 2017-02-28 2017-06-13 深圳市中康福药业有限公司 A kind of mulberry leaf balloonflower root particle and preparation method thereof
CN108523130A (en) * 2018-07-20 2018-09-14 河南姜生堂生物科技有限公司 A kind of antifatigue buccal tablet and preparation method thereof containing ginger oil
CN109511982A (en) * 2018-12-26 2019-03-26 江苏朸健生命科技发展有限公司 Composition and its preparation method and application with throat-clearing lung-moistening effect
CN110301635A (en) * 2019-08-07 2019-10-08 厦门市养真保健食品有限公司 A kind of emblic oral instant particle and preparation method
CN111514235A (en) * 2019-12-12 2020-08-11 上海市浦东新区周浦医院 Traditional Chinese medicine composition and throat-moistening candy with effects of clearing heat from throat and benefiting throat

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Application publication date: 20160601