CN105396039A - Pharmaceutical composition preventing children from repeated cold and preparation method therefor - Google Patents

Pharmaceutical composition preventing children from repeated cold and preparation method therefor Download PDF

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CN105396039A
CN105396039A CN201510928298.7A CN201510928298A CN105396039A CN 105396039 A CN105396039 A CN 105396039A CN 201510928298 A CN201510928298 A CN 201510928298A CN 105396039 A CN105396039 A CN 105396039A
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pharmaceutical composition
parts
extractum
common cold
coarse powder
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叶宗耀
邹锦新
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605—Morus (mulberry)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233—Bupleurum
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/287—Chrysanthemum, e.g. daisy
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535—Perilla (beefsteak plant)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract

The invention belongs to the traditional Chinese medicine field, and relates to a pharmaceutical composition preventing children from repeated cold and a preparation method therefor. The pharmaceutical composition is composed of the following medicinal materials, by weight, 10-22 parts of mulberry leaf, 10-18 parts of lilium brownii, 12-22 parts of radix bupleuri, 12-22 parts of fructus amomi, 12-18 parts of flos farfarae, 8-14 parts of chrysanthemum, 8-12 parts of semen brassicae, 6-12 parts of white perilla leaf, 6-10 parts of tendril-leaved fritillary bulb, 4-8 parts of dried orange peel and 4-12 parts of licorice. The pharmaceutical composition has functions of dispelling wind and heat, relieving cough, resolving phlegm, rectifying qi, invigorating spleen, clearing heart, calming nerves, transforming dampness and promoting appetite. The pharmaceutical composition has outstanding curative effects on symptoms of fever, cough, nasal discharge, nasal obstruction, vomit, diarrhoea and the like caused by child cold. The medicinal materials selected for the pharmaceutical composition have reasonable compatibility, are low in cost and have no toxic or side effects. The pharmaceutical composition is suitable for children, and worth of wide popularization in clinic.

Description

Pharmaceutical composition of control infantile recurrent common cold and preparation method thereof
Technical field
The invention belongs to the field of Chinese medicines, particularly relate to pharmaceutical composition of control infantile recurrent common cold and preparation method thereof.
Background technology
Acute upper respiratory tract infection claim flu, the four seasons all can occur, with weather cataclysm and winter-spring season sickness rate high.Infantile common cold is common holds expectorant under the arm, it is stagnant to hold under the arm, hold the accompanied symptoms such as frightened under the arm.Primary disease sickness rate accounts for pediatric disease first place, except the less morbidity of children's within 4-5 month, can betide the children's at any age.Primary disease all can be fallen ill throughout the year, common with Winter-Spring, and when seasonal variations, weather cataclysm, sickness rate is high.Children's catches a cold, and because of its physiological and pathological feature, is easy to occur folder expectorant, presss from both sides stagnant, that folder is frightened double folder card.
Flu onset is comparatively anxious, suddenly falls ill, without incubation period (or incubation period is extremely short).The course of disease is short, few person 3-5 days, many persons 7-8 days.Symptom is defended for primary symptom, as nasal obstruction, watery nasal discharge, sneeze, cough, aversion to cold, heating, general malaise etc. with lung.Symptoms, in variation, is itched with nasopharynx part, dry, discomfort is early symptom, and continue then sneeze, nasal obstruction, nasal mucus or tired, general malaise etc., gently the then criminal's of going up lung key, and symptom does not weigh, and is easy to fully recover; Heavy then high heat, cough, chest pain, there is coma delirium in some patients, children's can faint from fear, and occurs the change of disease.
The base therapy principle of flu is dispelling wind to relieve the exterior syndrome.Because children's is the body of immature yin and yang, diaphoresis should not too, in order to avoid consume body fluid.Infantile common cold is easily cold from transconversion into heat, or heat is constipation due to cold pathogen, forms the card of intermingling cold and heat, and alone pungent cool sweating is not saturating, and alone pungent temperature probably helps transconversion into heat fire, often gets the pungent Wen Bingyong of Xin Liang.The re-heat after the easy sweating of alone diaphoretic therapy if catch a cold, heat-clearing and toxic substances removing, clearing away summer-heat and eliminating dampness should be share according to card feelings, reduce phlegm help digestion, the relieving convulsion method for the treatment of such as to relieve dizziness, high fever, infantile convulsions, epilepsy, etc.The person of having a delicate constitution should not too deliver, or adopts method of strengthening body resistance and relieveing exterior syndrome.Children with repeated respiratory tract infections should be nursed one's health in time after flu, improves body constitution, enhancing immunity.
Treatment at present for infantile common cold is mainly divided into western medical treatment and Chinese traditional treatment.Western medical treatment is mainly based on antibiotic, NSAID (non-steroidal anti-inflammatory drug), antihistaminic etc., and these drug side effectes are many, and what have even can cause serious untoward reaction, totally unfavorable to the Health restoration of child; The traditional Chinese medical science is in treatment infantile common cold, and mainly based on Chinese patent medicine, not only dosage is large, drug absorption slow, and patient compliance is poor, does not feel any better for a long time, and often delay treatment, aggravates disease.
Chinese patent application 201310634057 discloses a kind of oral liquid for the treatment of infantile common cold, this oral liquid is prepared from by the raw material of following weight portion: Herba Rostellulariae, Herba Arthraxonis Hispidi, the Plantula cucurbitae moschatae, Concretio Silicea Bambusae, Folium et Caulis Indigoferae Tinctoriae, Stigma Maydis, Radix Platycodonis, Periostracum Cicadae, Radix Asteris, carambola, Bulbus Lilii, Cortex Phellodendri, Radix Dauci Sativae, Radix Puerariae, Radix Cynanchi Atrati and Caulis Sacchari sinensis, this invention oral liquid has effect of heat-clearing and toxic substances removing, expelling phlegm for arresting cough, lung moistening sending down the abnormal ascending QI, but this oral liquid component is complicated, treatment infantile common cold is cured the symptoms, not the disease, easily recurrence more.
Summary of the invention
The technical problem to be solved in the present invention is to provide the pharmaceutical composition of control infantile recurrent common cold, and this pharmaceutical composition has dispelling wind and heat pathogens, relieving cough and resolving phlegm, regulating qi-flowing for strengthening spleen, effect of clearing away heart-fire for tranquillization and removing dampness appetizing, also has good effect, side effect is low, the advantage such as treating both the principal and secondary aspects of a disease and taking convenience.In addition, the present invention also provides corresponding preparation method to be made and facilitate easy-to-use preparation under the prerequisite ensureing curative effect by this pharmaceutical composition.
Pharmaceutical composition of the present invention is made up of the medical material of following formulation by weight:
Folium Mori 10-22, Bulbus Lilii 10-18, Radix Bupleuri 12-22, Fructus Amomi 12-22, Flos Farfarae 12-18, Flos Chrysanthemi 8-14, Semen Sinapis Albae 8-12, Folium Perillae Frutescentis 6-12, Bulbus Fritillariae Cirrhosae 6-10, Pericarpium Citri Reticulatae 4-8 and Radix Glycyrrhizae 4-12.
In the scope of this formulation by weight, the comparatively significant formula of preferred 3 curative effects:
Formula 1: Folium Mori 10, Bulbus Lilii 10, Radix Bupleuri 12, Fructus Amomi 12, Flos Farfarae 12, Flos Chrysanthemi 8, Semen Sinapis Albae 8, Folium Perillae Frutescentis 6, Bulbus Fritillariae Cirrhosae 6, Pericarpium Citri Reticulatae 4 and Radix Glycyrrhizae 4.
Formula 2: Folium Mori 22, Bulbus Lilii 18, Radix Bupleuri 22, Fructus Amomi 22, Flos Farfarae 18, Flos Chrysanthemi 14, Semen Sinapis Albae 12, Folium Perillae Frutescentis 12, Bulbus Fritillariae Cirrhosae 10, Pericarpium Citri Reticulatae 8 and Radix Glycyrrhizae 12.
Formula 3: Folium Mori 16, Bulbus Lilii 14, Radix Bupleuri 17, Fructus Amomi 17, Flos Farfarae 15, Flos Chrysanthemi 10, Semen Sinapis Albae 10, Folium Perillae Frutescentis 9, Bulbus Fritillariae Cirrhosae 8, Pericarpium Citri Reticulatae 6 and Radix Glycyrrhizae 8.
Further, described pharmaceutical composition is made into capsule, tablet, powder, oral liquid, granule or pill.
Correspondingly, the present invention also provides the preparation method of described pharmaceutical composition, comprises following step:
Step 1: get Folium Mori, washes away impurity, 50 DEG C of hot air dryings 5 hours, and control moisture is 3-8%, pulverizes, and crosses 40-60 mesh sieve, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
Step 2: get Bulbus Lilii, Radix Bupleuri, Fructus Amomi, Flos Farfarae, Flos Chrysanthemi, Semen Sinapis Albae, Folium Perillae Frutescentis, Bulbus Fritillariae Cirrhosae, Pericarpium Citri Reticulatae and Radix Glycyrrhizae respectively, clean, crushed after being dried, merge coarse powder, add the water soaking 2-3 hour of coarse powder total amount 8-12 times amount, then decoct 2-3 time, each 2-4 hour, filter and retain residue, merging filtrate, filtrate surveys the extractum A that relative density is 1.05-1.15 under vacuum-concentrcted to 60 DEG C condition;
Step 3: it is the ethanol of 40-60% that the filtering residue that past step 2 obtains slowly adds its weight 4-6 times amount volume fraction while stirring, 4 DEG C of standing 3-5 hour filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture, and cleaning mixture is surveyed the extractum B that relative density is 1.05-1.15 under vacuum-concentrcted to 60 DEG C condition;
Step 4: extractum A and extractum B are merged, drying under reduced pressure, pulverizes, and crosses 100-200 mesh sieve, mixes, to obtain final product with Ultra-fine Powder of Mulberry Leaves.
Source, the nature and flavor of the present invention's component used, return through and effect:
Folium Mori: this product is the dried leaves of moraceae plants Mulberry; Sweet in the mouth, hardship, cold in nature; Return lung, Liver Channel; Dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, liver heat removing and eyesight improving.
Bulbus Lilii: this product is the dry meat scale leaf of liliaceous plant tiger lily, Bulbus Lilii or Lilium tenuifolium; Sweet in the mouth, cold in nature; GUIXIN, lung meridian; Nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization.
Radix Bupleuri: this product is the dry root of umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii.; Bitter in the mouth, cold nature; Return liver, gallbladder meridian; Reconciling superficies and interior, soothing the liver, yang invigorating.
Fructus Amomi: this product is the dry mature fruit of zingiberaceous plant Fructus Amomi, green shell sand or SEMEN AMOMI LONGILIGULA; Acrid in the mouth, warm in nature; Return spleen, stomach, kidney channel; Removing dampness is whetted the appetite, warming spleen and stopping diarrha, regulates the flow of vital energy antiabortive.
Flos Farfarae: this product is the dry flower of feverfew coltsfoot; Acrid in the mouth, micro-hardship, warm in nature; Return lung meridian; Nourishing the lung to keep the adverse QI downward, relieving cough and resolving phlegm.
Flos Chrysanthemi: this product is the dry capitulum of feverfew chrysanthemum ;sweet in the mouth, hardship, cold nature; Return lung, Liver Channel; Loose wind heat clearing away, suppressing the hyperactive liver improving eyesight.
Semen Sinapis Albae: this product is the seed of crucifer Caulis et Folium Sinapis albee; Acrid in the mouth, warm in nature; Return lung, liver, spleen, stomach, pericardium channel; Reduce phlegm by drink, mass dissipating and swelling eliminating.
Folium Perillae Frutescentis: this product is the blade of labiate common perilla; Acrid in the mouth, warm in nature; Start with, meridian of Foot-TAI YIN; Induce sweat, cold expelling, regulates the flow of vital energy, and helps digestion.
Bulbus Fritillariae Cirrhosae: this product is the dry bulb of liliaceous plant Bulbus Fritillariae Cirrhosae; Bitter in the mouth, sweet, cold nature; Return lung, heart channel; Clearing heat and moistening lung, preventing phlegm from forming and stopping coughing.
Pericarpium Citri Reticulatae: this product is the dry peel of rutaceae orange; Bitter in the mouth, pungent, warm in nature; Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.; Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of Chinese medicine of the present invention:
According to the compatibility theory of the dialectical and Chinese crude drug of traditional Chinese medicine on children ' flu, in conjunction with the body constitution of modern and the feature of modern pharmaceutical technology, the collocation ingredients of reasonable science, forms Chinese prescription of the present invention.The prescription of pharmaceutical composition of the present invention is with Folium Mori and Radix Bupleuri for monarch drug, dispelling wind and heat pathogens ,reconciling superficies and interior; With Bulbus Lilii, Fructus Amomi, Flos Farfarae and Bulbus Fritillariae Cirrhosae for ministerial drug, nourishing YIN and moistening the lung, clearing away heart-fire for tranquillization, removing dampness is whetted the appetite, relieving cough and resolving phlegm; With Flos Chrysanthemi, Semen Sinapis Albae, Folium Perillae Frutescentis and Pericarpium Citri Reticulatae for adjuvant drug, loose wind heat clearing away, reduces phlegm by drink, regulating qi-flowing for strengthening spleen, helps digestion; With Radix Glycyrrhizae for making medicine, invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, coordinating the actions of various ingredients in a prescription; The all medicines of monarch coordinate, and collaborative promotion, complements each other, finally reach dispelling wind and heat pathogens, relieving cough and resolving phlegm, regulating qi-flowing for strengthening spleen, and effect of clearing away heart-fire for tranquillization and removing dampness appetizing, is used for the treatment of infantile common cold evident in efficacy.
Compared with prior art, the present invention has following technical advantage:
1, the prescription element of pharmaceutical composition of the present invention is pure natural medical material, untoward reaction and side effect significantly reduce, and in prescription, each medical material effect is comprehensive, and medication effect is better, efficiently solve the morbidity root of infantile recurrent common cold, and improve the quality of life of patient.
2, Pharmacodynamic Data shows, pharmaceutical composition of the present invention significantly can reduce the rat temperature that dry yeast causes rat fever, has obvious cooling effect to heating; Clinical data shows that the cure rate of medicine composite for curing infantile common cold of the present invention is high, and without recurrent cases, therapeutic effect is remarkable.
Detailed description of the invention
It will be understood by those skilled in the art that technology disclosed in following examples represents the technology playing good action in the practice of the invention of the present inventor's discovery.But, many changes can be made in disclosed specific embodiments, and still obtain same or analogous result, and not depart from the spirit and scope of the present invention.
embodiment 1:
The embodiment of the present invention 1 pharmaceutical composition is made up of the medical material of following formulation by weight: Folium Mori 10, Bulbus Lilii 10, Radix Bupleuri 12, Fructus Amomi 12, Flos Farfarae 12, Flos Chrysanthemi 8, Semen Sinapis Albae 8, Folium Perillae Frutescentis 6, Bulbus Fritillariae Cirrhosae 6, Pericarpium Citri Reticulatae 4 and Radix Glycyrrhizae 4.
Preparation method is as follows:
Step 1: get Folium Mori, washes away impurity, 50 DEG C of hot air dryings 5 hours, and controlling moisture is 4%, pulverizes, and crosses 50 mesh sieves, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
Step 2: get Bulbus Lilii, Radix Bupleuri, Fructus Amomi, Flos Farfarae, Flos Chrysanthemi, Semen Sinapis Albae, Folium Perillae Frutescentis, Bulbus Fritillariae Cirrhosae, Pericarpium Citri Reticulatae and Radix Glycyrrhizae respectively, clean, crushed after being dried, merge coarse powder, add the water soaking 2 hours of coarse powder total amount 10 times amount, then decoct 3 times, each 3 hours, filter and retain residue, merging filtrate, filtrate surveys the extractum A that relative density is 1.05 under vacuum-concentrcted to 60 DEG C condition;
Step 3: it is the ethanol of 50% that the filtering residue that past step 2 obtains slowly adds its weight 5 times amount volume fraction while stirring, 4 DEG C leave standstill 4 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 3 times of 50% again, collects and merges cleaning mixture, cleaning mixture is surveyed the extractum B that relative density is 1.05 under vacuum-concentrcted to 60 DEG C condition;
Step 4: extractum A and extractum B are merged, drying under reduced pressure, pulverizes, and crosses 100 mesh sieves, mixes, obtain fine drug powder with Ultra-fine Powder of Mulberry Leaves;
Step 5: get described fine drug powder, adds suitable adjuvant, utilizes Modern preparations technology to make capsule.
embodiment 2:
The embodiment of the present invention 2 pharmaceutical composition is made up of the medical material of following formulation by weight: Folium Mori 22, Bulbus Lilii 18, Radix Bupleuri 22, Fructus Amomi 22, Flos Farfarae 18, Flos Chrysanthemi 14, Semen Sinapis Albae 12, Folium Perillae Frutescentis 12, Bulbus Fritillariae Cirrhosae 10, Pericarpium Citri Reticulatae 8 and Radix Glycyrrhizae 12.
Preparation method is with embodiment 1.
embodiment 3:
The embodiment of the present invention 3 pharmaceutical composition is made up of the medical material of following formulation by weight: Folium Mori 16, Bulbus Lilii 14, Radix Bupleuri 17, Fructus Amomi 17, Flos Farfarae 15, Flos Chrysanthemi 10, Semen Sinapis Albae 10, Folium Perillae Frutescentis 9, Bulbus Fritillariae Cirrhosae 8, Pericarpium Citri Reticulatae 6 and Radix Glycyrrhizae 8.
Preparation method is with embodiment 1.
pharmacodynamic experiment
test example 1: pharmaceutical composition of the present invention causes the research experiment of rat fever impact to dry yeast
1, laboratory animal: SPF level Wistar rat 72, male and female half and half, weight 220-260g, 22-24 week age.
2, Experimental agents: the capsule that the embodiment of the present invention 1 prepares; Positive control drug is XIAOER GANMAO KOUFUYE (Beijing Tongrentang Technology Development Co.ltd. Pharmaceutical Factory).
3, dry yeast causes rat fever: choose the comparatively constant rat of body temperature 72,6 groups are divided at random by weight, often organize 12, be respectively the obtained capsule of Normal group, model group, positive controls and the embodiment of the present invention 1 basic, normal, high (1.2,2.4,4.8g/kg) dosage group.First 1 day of administration, shaves hair by Wistar rat abdomen, and the same day was surveyed rat anus temperature 3 times in administration, got anus temperature based on its meansigma methods.Positive controls dosage is 4.8g/kg, normal group and model group gavage are to equal-volume normal saline, after each group of gastric infusion 30min, every rat is with 10ml/kg dorsal sc note 15% dry yeast suspension, Normal group is left intact, respectively at 2,4,6,8h measures anus temperature, records anus temperature changing value.
4, experimental result: in table 1.
Table 1 pharmaceutical composition of the present invention causes the impact of rat fever on yeast
Note: compare with Normal group, △ △ p< 0.01, △ △ △ p< 0.001; Compare with model control group, * p< 0.05, * p< 0.01, * * p< 0.001; Compare with positive controls, # p< 0.05.
From upper table 1, after subcutaneous injection dry yeast suspension, the anus temperature of rat raises gradually.Compare with Normal group, the anus temperature of model group rats extremely significantly increases ( p< 0.01 or p< 0.001), show modeling success; Compare with model group, pharmaceutical composition of the present invention basic, normal, high dosage group and positive controls to heating rat all have significant refrigeration function ( p< 0.05), and sustainable 8h, wherein, pharmaceutical composition of the present invention presents good dose relationship; In addition, the high dose group of pharmaceutical composition of the present invention is significantly better than positive controls at the refrigeration function of 8h to heating rat.Above result shows, pharmaceutical composition of the present invention has obvious cooling effect to heating.
test example 2: pharmaceutical composition of the present invention is to the observation of curative effect of infantile recurrent common cold disease clinical volunteers patient
One, diagnostic criteria
Diagnostic criteria with reference to infantile common cold in Ministry of Health of the People's Republic of China's " influenza diagnosis and treatment standard and treatment guidelines (2011 editions) ":
1, heating, cough, watery nasal discharge, nasal obstruction and pharyngalgia, headache, there is myalgia, vomiting, diarrhoea in small part;
2, heating is light, moderate heat, without shivering;
3, without obvious General Symptoms.
Two, criterion of therapeutical effect
Efficacy assessment standard with reference to infantile common cold in Ministry of Health of the People's Republic of China's " influenza diagnosis and treatment standard and treatment guidelines (2011 editions) ":
Cure: the transference cures such as heating, cough, watery nasal discharge, nasal obstruction and pharyngalgia, feel comfortable;
Effective: the symptoms such as heating, cough, watery nasal discharge, nasal obstruction and pharyngalgia alleviate;
Invalid: after taking medicine, the state of an illness is without significant change.
Three, clinical trial
1, physical data
600 selected infantile common cold clinical volunteers patients are divided into 4 groups at random, often organize 150 people, be respectively treatment A group, treatment B group, treatment C group and matched group, the each group of influence factor such as age, symptom, through statistical procedures, there was no significant difference, meets a point set condition.
2, Therapeutic Method
Treatment A, B and C group: take capsule prepared by embodiment 1-3 respectively, every day 3 times, each 2, serve on 3 weeks;
Matched group: take XIAOER GANMAO KOUFUYE (Beijing Tongrentang Technology Development Co.ltd. Pharmaceutical Factory), a 10ml, 3 times on the one, serve on 3 weeks.
3, therapeutic outcome
Table 2 therapeutic effect
From upper table 2, the capsule cure rate that patient takes embodiment 1-3 obtained reaches more than 85%, and total effective rate reaches more than 94, higher than cure rate and the total effective rate of matched group, wherein best with the effect for the treatment of group A group and embodiment 1, cure rate reaches 88%, and total effective rate reaches 96.7%.3 months by a definite date following up a case by regular visits to is carried out, without recurrent cases to the patient of medicine composite for curing group clinical cure of the present invention.Visible, pharmaceutical composition good effect of the present invention, cure rate is high, and relapse rate is low, can as the drug use for the treatment of infantile common cold.
Owing to describing the present invention by above preferred embodiment, in spirit of the present invention and/or scope, any for replacement/of the present invention or combination implement the present invention, be all apparent for a person skilled in the art, and be included among the present invention.

Claims (7)

1. prevent and treat the pharmaceutical composition of infantile recurrent common cold, it is characterized in that, described pharmaceutical composition is made up of the medical material of following formulation by weight:
Folium Mori 10-22, Bulbus Lilii 10-18, Radix Bupleuri 12-22, Fructus Amomi 12-22, Flos Farfarae 12-18, Flos Chrysanthemi 8-14, Semen Sinapis Albae 8-12, Folium Perillae Frutescentis 6-12, Bulbus Fritillariae Cirrhosae 6-10, Pericarpium Citri Reticulatae 4-8 and Radix Glycyrrhizae 4-12.
2. the pharmaceutical composition of control infantile recurrent common cold as claimed in claim 1, it is characterized in that, described pharmaceutical composition is made up of the medical material of following formulation by weight:
Folium Mori 10, Bulbus Lilii 10, Radix Bupleuri 12, Fructus Amomi 12, Flos Farfarae 12, Flos Chrysanthemi 8, Semen Sinapis Albae 8, Folium Perillae Frutescentis 6, Bulbus Fritillariae Cirrhosae 6, Pericarpium Citri Reticulatae 4 and Radix Glycyrrhizae 4.
3. the pharmaceutical composition of control infantile recurrent common cold as claimed in claim 1, it is characterized in that, described pharmaceutical composition is made up of the medical material of following formulation by weight:
Folium Mori 22, Bulbus Lilii 18, Radix Bupleuri 22, Fructus Amomi 22, Flos Farfarae 18, Flos Chrysanthemi 14, Semen Sinapis Albae 12, Folium Perillae Frutescentis 12, Bulbus Fritillariae Cirrhosae 10, Pericarpium Citri Reticulatae 8 and Radix Glycyrrhizae 12.
4. the pharmaceutical composition of control infantile recurrent common cold as claimed in claim 1, it is characterized in that, described pharmaceutical composition is made up of the medical material of following formulation by weight:
Folium Mori 16, Bulbus Lilii 14, Radix Bupleuri 17, Fructus Amomi 17, Flos Farfarae 15, Flos Chrysanthemi 10, Semen Sinapis Albae 10, Folium Perillae Frutescentis 9, Bulbus Fritillariae Cirrhosae 8, Pericarpium Citri Reticulatae 6 and Radix Glycyrrhizae 8.
5. the pharmaceutical composition of the control infantile recurrent common cold as described in as arbitrary in claim 1-4, it is characterized in that, the preparation method of described pharmaceutical composition comprises following step:
Step 1: get Folium Mori, washes away impurity, 50 DEG C of hot air dryings 5 hours, and control moisture is 3-8%, pulverizes, and crosses 40-60 mesh sieve, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
Step 2: get Bulbus Lilii, Radix Bupleuri, Fructus Amomi, Flos Farfarae, Flos Chrysanthemi, Semen Sinapis Albae, Folium Perillae Frutescentis, Bulbus Fritillariae Cirrhosae, Pericarpium Citri Reticulatae and Radix Glycyrrhizae respectively, clean, crushed after being dried, merge coarse powder, add the water soaking 2-3 hour of coarse powder total amount 8-12 times amount, then decoct 2-3 time, each 2-4 hour, filter and retain residue, merging filtrate, filtrate surveys the extractum A that relative density is 1.05-1.15 under vacuum-concentrcted to 60 DEG C condition;
Step 3: it is the ethanol of 40-60% that the filtering residue that past step 2 obtains slowly adds its weight 4-6 times amount volume fraction while stirring, 4 DEG C of standing 3-5 hour filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture, and cleaning mixture is surveyed the extractum B that relative density is 1.05-1.15 under vacuum-concentrcted to 60 DEG C condition;
Step 4: extractum A and extractum B are merged, drying under reduced pressure, pulverizes, and crosses 100-200 mesh sieve, mixes, to obtain final product with Ultra-fine Powder of Mulberry Leaves.
6. the pharmaceutical composition of the control infantile recurrent common cold as described in as arbitrary in claim 1-4, it is characterized in that, described pharmaceutical composition is made into capsule, tablet, powder, oral liquid, granule or pill.
7. the preparation method of the pharmaceutical composition of the control infantile recurrent common cold as described in as arbitrary in claim 1-6, is characterized in that, comprise following step:
Step 1: get Folium Mori, washes away impurity, 50 DEG C of hot air dryings 5 hours, and control moisture is 3-8%, pulverizes, and crosses 40-60 mesh sieve, obtains coarse powder; Coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, carries out micronizing respectively after drying, crosses 800 mesh sieves, obtains Ultra-fine Powder of Mulberry Leaves, for subsequent use;
Step 2: get Bulbus Lilii, Radix Bupleuri, Fructus Amomi, Flos Farfarae, Flos Chrysanthemi, Semen Sinapis Albae, Folium Perillae Frutescentis, Bulbus Fritillariae Cirrhosae, Pericarpium Citri Reticulatae and Radix Glycyrrhizae respectively, clean, crushed after being dried, merge coarse powder, add the water soaking 2-3 hour of coarse powder total amount 8-12 times amount, then decoct 2-3 time, each 2-4 hour, filter and retain residue, merging filtrate, filtrate surveys the extractum A that relative density is 1.05-1.15 under vacuum-concentrcted to 60 DEG C condition;
Step 3: it is the ethanol of 40-60% that the filtering residue that past step 2 obtains slowly adds its weight 4-6 times amount volume fraction while stirring, 4 DEG C of standing 3-5 hour filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture, and cleaning mixture is surveyed the extractum B that relative density is 1.05-1.15 under vacuum-concentrcted to 60 DEG C condition;
Step 4: extractum A and extractum B are merged, drying under reduced pressure, pulverizes, and crosses 100-200 mesh sieve, mixes, to obtain final product with Ultra-fine Powder of Mulberry Leaves.
CN201510928298.7A 2015-12-15 2015-12-15 Pharmaceutical composition preventing children from repeated cold and preparation method therefor Pending CN105396039A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105770532A (en) * 2016-03-31 2016-07-20 杨登新 Medicine for treating exogenous cold and endogenous heat type cold and preparation method thereof
CN108186868A (en) * 2018-03-07 2018-06-22 韩坤 A kind of children join shellfish cough relief traditional Chinese medicine and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
赖玲等: "中药汤剂在治疗小儿感冒中的体会", 《当代医学》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105770532A (en) * 2016-03-31 2016-07-20 杨登新 Medicine for treating exogenous cold and endogenous heat type cold and preparation method thereof
CN108186868A (en) * 2018-03-07 2018-06-22 韩坤 A kind of children join shellfish cough relief traditional Chinese medicine and preparation method thereof

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Application publication date: 20160316