CN106729031A - A kind of pharmaceutical composition for treating cold in children - Google Patents

A kind of pharmaceutical composition for treating cold in children Download PDF

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CN106729031A
CN106729031A CN201611132976.XA CN201611132976A CN106729031A CN 106729031 A CN106729031 A CN 106729031A CN 201611132976 A CN201611132976 A CN 201611132976A CN 106729031 A CN106729031 A CN 106729031A
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ethanol
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pharmaceutical composition
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extract
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不公告发明人
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/421—1,3-Oxazoles, e.g. pemoline, trimethadione
    • 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)
    • 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)
    • A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

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Abstract

Pharmaceutical composition of cold in children and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is to dislike alkali, lady's-grass, liana cuneate lespedeza herb with root as bulk drug with bright and beautiful vanilla, willowweed, Chinese ephedra, proportioning is formed, routinely various formulations can be made by preparation process, treatment cold in children is evident in efficacy.

Description

A kind of pharmaceutical composition for treating cold in children
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating cold in children and its preparation side Method.
Background technology
Flu is one of Pediatric Clinic common disease, and tcm theory thinks children for pure-yang constituent, sun have a surplus and the moon not Foot, is susceptible to suffer from heat symptom-complex, therefore paediatrics flu is relatively conventional with anemopyretic cold.Infantile fever weight is mainly shown as, but it is cold afraid of the wind not clear Aobvious, the turbid tears of nasal obstruction stream are coughed low voice speaking, or have sticky yellow phlegm, are had a headache, and thirst and liking drink swallows red, dry throat or sufferings, and stool is dry, urine Huang, checks that visible tonsillotome is red and swollen, congestion of throat, and thin lingual fur is yellow or yellow thick, red tongue body.Children's wind-heat cold is apt to occur in winter-spring season Section, with diseases caused by external factors ailment said due to cold or exposure or when row epidemic disease poison it is relevant.Children's skin space between skin and muscles a surname dredge, weakened defensive QI, easily for exopathogen is attacked.The heresy beam of wind-heat Defend the moon in flesh, checking, cause lung defend become estranged, hot strongly fragrant flesh table, the rules for the treatment of are with relieving the exterior syndrome with drugs pungent in flavor and cool in property, clearing heat and detoxicating as method.
Lady's-grass：It is grass family knotgrass plant Digitaria sanguinalis Digitaria sanguinalis (L.) Scop. [Panicum Sangui-nale L.] herb.Summer, autumn tap herb, dry.【Nature and flavor】It is sweet；It is cold.【Indication】Improving eyesight moistening lung.It is main Mesh is secretly failed to understand；Cough with lung heat.【Proterties】Dry herb 40-100cm long.Stalk branch, takes root on the section of bottom.Intact leaf strip is draped over one's shoulders Aciculiform, 8-17cm long, 5-15mm wide, tip is tapering or short point.Base portion blunt circle, two sides is without hair or sparsely grow pubescence, loose armful of leaf sheath Stem, without hair or sparsely grow pubescence.【Former phytomorph】Lady's-grass, annual herb, culm base is often inclined, and is easily taken root after soil, high 40-100cm.Footpath 2-3mm.Leaf sheath Chang Shusheng has the fur of wart base, dilute without hair；Tip of a leaf 1-3mm long；Blade wire lanceolar is long 8-17cm, 5-15mm wide, two sides are dredged by fur or without hair, and edge is thickening and coarse.Raceme is thin and delicate, 3-10 pieces, 5- long 15cm, is generally arranged in stalk top into finger-like, and cob about 1mm wide, middle rib white accounts for the 1/3 of width；Small spike length 3-3.5mm, drapes over one's shoulders Aciculiform, twin cob is respectively saved, and one has long handle, and one has extremely short handle or a few stockless；1st clever obtuse triangle, is about 0.2mm, acrotism, The 1/2-3/4 of the 2nd clever a length of small ear, it is narrow, have between very unconspicuous 3 arteries and veins, arteries and veins and edge has short cilium mostly；1st lemma with Small ear is isometric, there is a 5-7 arteries and veins, and central 3 veinclearing shows, between arteries and veins distance it is wider and without hair, side form is very approached, sometimes not substantially, without hair or The adhesion pubescence between arteries and veins, the 2nd lemma nearly keratin, celadon is waited and is longer than the 1st lemma；Flower pesticide is about 1mm.Flower, the fruiting period 6-9 months.Receive It is loaded in dictionary of medicinal plant.
Bright and beautiful vanilla：This product is Melastomataceae brocade vanilla platymiscium brocade vanilla Phyllagathis caualeriei The herb or root of (Levl.et van.) Guill. [Allomorphia caualerieiLevl. Et van.].Spring, summer adopt Grass is received, root whole year can be adopted, clean, and chopping is dried.【Nature and flavor】Bitter；It is pungent；It is cold in nature.【Indication】Clearing heat and cooling blood；Profit It is wet.Main toxic-heat and blood stasis；Under humid tropics；Irregular menstruation；Metrorrhagia due to blood-heat；The hot hemorrhoid blood of intestines；Children's scrotum enlargement.【Former phytomorph】Grass This, 10-15cm high.Stem is upright or crawls, and raw section by section very nearly meat is close by coarse wool long, four prismatics, generally not branch.Leaf pair It is raw；Petiole 1.5-9cm long, it is close by coarse wool long；Blade papery, wide avette, oval or circle, the wide anxious point of tip to nearly circle Shape, base portion is heart-shaped, 6-16cm long, 4.5-14cm wide, and two sides green or sometimes back side aubergine, surface are long thick by thin strigose shape Hair, the back side only base goes out the coarse wool long that arteries and veins and lateral vein are flattened into；Base goes out arteries and veins 7-9, and surface arteries and veins is smooth, back side arteries and veins protuberance.Umbel, Basidixed, total bennet 4-17cm long is dilute several without hair by coarse wool long；Bract obovate or nearside lanceolar, by coarse wool, generally only 4 Piece, 1cm is about, or it is longer；Bennet is with calyx by chaff；The prismatic of calyx funnel-form four, sliver is extensively avette；Petal pink is extremely Purple, top is slightly biased tiltedly, the anxious point of tip；Stamen 4, near isometric, flower pesticide base portion tool tubercle or unobvious, connective is downward in short distance； Ovary is cup-shaped, tip tool hat.Capsule, tip hat 4 splits, and stretches out persistent calyx, and persistent calyx has 8 longitudinal ribs, carpopodium elongation, by chaff.Flower Month phase 6-8, the fruiting period 7-9 months.Record in dictionary of medicinal plant.
Willowweed：The herb of Oenotheraceae Epilobium plant willowweed Epilobium hirsutum L..It is annual Adopt, dry.【Nature and flavor】Bitter；It is light；It is cold in nature.【Indication】It is clearing heat and detoxicating；Dampness removing antidiarrheal；Help digestion qi-regulating；Promoting blood circulation synthetism.Master is wet Hot rush down dysentery；Dyspepsia；Abdominal distention；Toothache；Irregular menstruation；Amenorrhea；Under band；Injury and bone fracture；Sore swells；Burn and scald；Scabies.【Chemistry Composition】Willowweed aerial part (gallic acid) containing gallic acid, 3- methoxyl group gallic acids (3-methoxygallic Acid), protocatechuic acid (Protocatechuic acid) and hyperin (hyperoside).Other this product also contains Kaempferol (kaemp ferol), Quercetin (quercetin), myricetin (myricetin), Quercetin -3-O- β-D- glucopyras Glucoside (quercetin-3-O- β-D-glucopyranoside), myricetin rutinoside (myricetin ) and different valonie acid (isovalonic acid) rubinoside.Additionally, leaf and flower also contain palmitic acid (palmitic Acid), stearic acid (stearic acid), linoleic acid (linoleic acid), oleanolic acid (oleanolic acid), mountain Short, bristly hair or beard acid (crategolic acid), tormentic acid (tormentic acid), arjunolic acid (arjunolic acid) and 23- hydroxyls tormentic acid (23-hydroxytormentic acid).【Pharmacological action】Leaf, in vitro to staphylococcus aureus There is inhibitory action, poisoning can occur epileptiform convulsion with stupor.Record in dictionary of medicinal plant.
Liana cuneate lespedeza herb with root：It is Convolvulaceae white crane Calamus plant gray wool white crane rattan Argyreia osyrensis (Roth) The leaf of Choisy var.cinerea Hand.-Mazz. [lettsomia bella auct. Non C. B.Clarke] or Root.Ye Xia, autumn harvesting, dry；Root whole year can adopt, clean, section, dry.【Nature and flavor】It is puckery；Temperature.【Indication】Inducing astrigency is consolidated It is de-；Astringe the lung；Hemostasis.Main rush down prolapse of the anus for a long time；The prolapse of uterus；Deficiency syndrome of the lung cough and asthma；Menorrhalgia；Traumatism and bleeding.【Proterties】The many shrinkages of leaf are broken It is broken.It is in avette or wealthy avette, 6-12cm long, 3.5-11cm wide after complete leaf flattening, the sharp point of tip, base portion is heart-shaped, and upper surface is close By the pubescence grey long of tool warty base portion, the grey pubescence that lower surface is curled；Petiole 3-3.5cm long, close that pubescence is crimped by grey, tool Groove, gas is micro-, mildly bitter flavor.【Former phytomorph】Gray wool white crane rattan climbing shrub.Stem cylinder, it is close by white or with grey or light Brown fine hair.Single leaf alternate；Petiole 3-7.5cm long, it is close that pubescence is crimped by grey, have groove；Blade width egg shape to subcircular, 6- long 12cm, 3.5-11cm wide, the sharp point of tip, base portion are heart-shaped, above the close grey pubescence long of lying prostrate for being had a warty base portion, the back side is close by pole It is close and crimp grey pubescence.Inflorescence is gathered into head, flower stockless or nearly stockless；Total bennet, bract and sepal outside are by fine hair； Corolla tubulose is bell, pink, and limb deep 5 splits, and sliver is narrow avette, with close by white pubescence in valve；Stamen and style stretch out；Flower Silk base portion expands, by hair；Ovary without hair, Room 2.It is really spherical, it is red, the sepal to increase is wrapped, sepal inner face is red.2, seed Or 1, it is bordering on without hair.Autumn at florescence, winter.Record in dictionary of medicinal plant.
Chinese ephedra dislikes alkali（Ephedroxane ）：CAS 16251-46-0, molecular formula C11H13NO2, molecular weight 191.23.【Medicine Reason is acted on】With antiinflammatory action.【Ingredient origin】Ephedraceae ephedra root.
1 bulk drug chemical constitution：
Chinese ephedra dislikes alkali（Ephedroxane ）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of pharmaceutical composition of effective treatment cold in children And preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the pharmaceutical composition of the treatment cold in children be：
Bright and beautiful vanilla 922-928 weight portions willowweed 582-590 weight portions Chinese ephedra dislikes alkali 15-17 weight portion lady's-grass 162-168 weights Amount part liana cuneate lespedeza herb with root 65-70 weight portions.
The pharmaceutical composition for the treatment of cold in children is preferably used in, is made up of the bulk drug of following weight portion：
The weight portion Chinese ephedra of 925 weight portion willowweed of bright and beautiful vanilla 586 dislikes the weight portion liana cuneate lespedeza herb with root of 16 weight portion lady's-grass of alkali 165 68 weight portions.
A kind of pharmaceutical composition for treating cold in children, it is characterised in that pharmaceutical composition can be using the routine of galenic pharmacy Method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating cold in children, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine Treatment cold in children medicine.
A kind of preparation method of the pharmaceutical composition for treating cold in children, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Bright and beautiful vanilla 922-928 weight portions willowweed 582-590 weight portions Chinese ephedra dislikes alkali 15-17 weight portion lady's-grass 162-168 weight portion liana cuneate lespedeza herb with root 65-70 weight portions；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating cold in children, it is characterised in that make as follows It is standby：
The composition and weight portion of bulk drug be：The weight portion Chinese ephedra of 925 weight portion willowweed of bright and beautiful vanilla 586 dislikes the weight portion of alkali 16 The weight portion of 165 weight portion liana cuneate lespedeza herb with root of lady's-grass 68；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating cold in children, it is characterised in that pharmaceutical composition can be using system The conventional method of agent prepares piece agent or capsule or dripping pill.
A kind of preparation method of the pharmaceutical composition for treating cold in children, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment cold in children medicine.
Medicine composite for curing cold in children is evident in efficacy.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of cold in children and preparation method thereof
Treat cold in children pharmaceutical composition bulk drug composition and weight portion be：Bright and beautiful vanilla 925g willowweeds 586g fiber crops Huang dislikes alkali 16g lady's-grass 165g liana cuneate lespedeza herb with root 68g；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of cold in children and preparation method thereof
Treat cold in children pharmaceutical composition bulk drug composition and weight portion be：Bright and beautiful vanilla 922g willowweeds 590g fiber crops Huang dislikes alkali 15g lady's-grass 168g liana cuneate lespedeza herb with root 65g；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of cold in children and preparation method thereof
Treat cold in children pharmaceutical composition bulk drug composition and weight portion be：Bright and beautiful vanilla 928g willowweeds 582g fiber crops Huang dislikes alkali 17g lady's-grass 162g liana cuneate lespedeza herb with root 70g；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4：The preparation of tablet
The pharmaceutical composition 343g of Example 1, adds starch 412g, mixes, and granulation is dried, plus microcrystalline cellulose 102g, stearic Sour magnesium 13g, mixes, and is pressed into 3500, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 332g of Example 2, adds starch 518g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid Magnesium, mixes, and encapsulated 2500, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 830g water-baths and boil molten, add the pharmaceutical composition 36g of embodiment 3, fully stir Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 5 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.3cm away from liquid level, and drop speed is optimum condition with every point 43 drop, and the cold of dripping pill surface is blotted with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Experimental example 1：Treat the experimental study of cold in children
1 data and method
1.1 physical data
In the anemopyretic cold infant 45 of this city hospital for treatment it is research object with September, 2012 in October, -2013, has The clinical manifestations such as heating, headache, nasal obstruction, body temperature is above 38.5 DEG C, meets the Western medicine diagnostic criteria of acute upper respiratory infection. Symptoms include fever and aversion to wind, the yellow tears of stream, the thin yellow, superficial and rapid pulse of yellow phlegm, hypohidrosis, dry mouth and throat, red tongue body, tongue is coughed up, meet anemopyretic cold Tcm diagnosis standard.All infants are grouped at random.Control group 23, wherein man 12, female 11；2 ~ 10 years old age, Average (5.25 ± 1.79) year；10 ~ 33kg of body weight, average (16.42 ± 4.27) kg；1 ~ 4d of the course of disease, average (1.66 ± 0.65) d.Observation group 22, man 11, female 11；1 ~ 10 years old age, average (5.42 ± 1.67) year；9 ~ 33kg of body weight, averagely (16.87±4.41)kg；1 ~ 4d of the course of disease, average (1.62 ± 0.62) d.Contrast two groups of infant sexes, age, body weight, courses of disease etc. Not statistically significant (the P of aspect comparing difference>0.05), with comparativity.
1.2 treatment methods
Control group infant gives oral ribavirin particle, and (Hunan Qianjin Xiangjiang Pharmaceutical Co., Inc. produces, Chinese medicines quasi-word H20044779), dosage is 25mg/ (kg/d)；(Chengdu Hengrui Pharmaceutical Co., Ltd produces roxithromycin dispersing tablet, and traditional Chinese medicines are accurate Word H20059984), dosage is 5 mg/ (kg/d).
Observation group's infant gives combination of oral medication（The pharmaceutical composition of embodiment 1）, orally, each 1.0g, daily 3 It is secondary.Avoided eating anything raw or cold during medication, acid food, strong tea etc..
1.3 curative effect judging standards
It is effective：Temperature recovery is normal in the d of medication 3, nasal obstruction, runny nose, cough up phlegm, the symptom such as pharyngalgia is relieved or disappears.
Effectively：Temperature recovery is normal in the d of medication 3 or is decreased obviously, nasal obstruction, runny nose, cough up phlegm, the symptom mitigation such as pharyngalgia, Pharyngeal visible mild hyperaemia.
It is invalid：Clinical symptoms and sign do not take a turn for the better and even deteriorate after the d of medication 3.
Total effective rate=(effective+effectively) number of cases/total number of cases × 100%.During treatment, such as same example infant occurs many simultaneously Adverse reaction is planted, during data statistics in terms of the adverse reaction of symptom most serious once.
1.4 statistical procedures
All data are entered into the softwares of SPSS 17.0 carries out statistical procedures, and enumeration data uses Chi-square Test, P< 0.05 represents that difference is statistically significant.
2 results
2.1 two groups of infant comparitive studies
Specific data refer to table 1.
1 two groups of infant Clinical efficacy comparisons of table
Group It is effective Effectively It is invalid Total effectively %
Control group (n=23) 11 10 2 91.30
Observation group (n=22) 10 11 1 95.45
Two groups of infant total effective rates compare after treatment, no significant difference (P>0.05).
2.2 two groups of securities compare
Compared with control group, observation group's infant adverse reaction rate is significant lower, the statistically significant (P of difference<0.05). Specific data refer to table 2.
2 two groups of infant adverse reactions of table are compared
Group N and V Abdominal pain diarrhea It is allergic Adverse reaction %
Control group (n=23) 3 2 1 26.09
Observation group (n=22) 1 1 0 9.09*
Note：Compare with control group, * P<0.05.

Claims (8)

1. a kind of pharmaceutical composition for treating cold in children, it is characterised in that be made the bulk drug of the pharmaceutical composition composition and Weight portion is：
Bright and beautiful vanilla 922-928 weight portions willowweed 582-590 weight portions Chinese ephedra dislikes alkali 15-17 weight portion lady's-grass 162-168 weights Amount part liana cuneate lespedeza herb with root 65-70 weight portions.
2. a kind of pharmaceutical composition for treating cold in children according to claim 1, it is characterised in that be made the drug regimen The composition and weight portion of the bulk drug of thing be：
The weight portion Chinese ephedra of 925 weight portion willowweed of bright and beautiful vanilla 586 dislikes the weight portion liana cuneate lespedeza herb with root of 16 weight portion lady's-grass of alkali 165 68 weight portions.
3. a kind of pharmaceutical composition for treating cold in children according to claim 1, it is characterised in that pharmaceutical composition can be with Piece agent or capsule or dripping pill are prepared using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating cold in children according to claim 1, it is characterised in that pharmaceutical composition with change Learn the treatment cold in children medicine of medicine or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating cold in children, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Bright and beautiful vanilla 922-928 weight portions willowweed 582-590 weight portions Chinese ephedra dislikes alkali 15-17 weight portion lady's-grass 162-168 weight portion liana cuneate lespedeza herb with root 65-70 weight portions；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating cold in children according to claim 5, it is characterised in that by such as It is prepared by lower step：
The composition and weight portion of bulk drug be：The weight portion Chinese ephedra of 925 weight portion willowweed of bright and beautiful vanilla 586 dislikes the weight portion of alkali 16 The weight portion of 165 weight portion liana cuneate lespedeza herb with root of lady's-grass 68；
Preparation method：
（1）Bright and beautiful vanilla, willowweed, Chinese ephedra are taken by bulk drug proportioning and dislike alkali, lady's-grass, liana cuneate lespedeza herb with root, mixed, use percentage by weight The ethanol of concentration 33.5% takes as solvent in 35 DEG C of temperature extractions, and extraction time is 24 times, and each extraction time is 44 hours, every time Solvent load is 37 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative Density 1.04, filtration, liquid is first washed with water by H103 large pore resin absorption columns, then with the ethanol of weight percent concentration 27% Eluant solution H103 large pore resin absorption columns, the collection ethanol eluate of weight percent concentration 27%, recovery ethanol, concentrate drying, Obtain final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 55% as solvent, heating and refluxing extraction 35 times is carried every time The time is taken for 0.3 hour, each solvent load is 20 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.12 is concentrated into, filtered, liquid is first washed with water by SP825 large pore resin absorption columns, then with again Amount percent concentration 73% ethanol solution wash-out SP825 large pore resin absorption columns, collect the ethanol elution of weight percent concentration 73% Liquid, reclaims ethanol, and concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating cold in children according to claim 5, it is characterised in that medicine Composition can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method of the pharmaceutical composition for treating cold in children according to claim 5, it is characterised in that medicine Composition and chemical drugs or Chinese medicine composition treatment cold in children medicine.
CN201611132976.XA 2016-12-10 2016-12-10 A kind of pharmaceutical composition for treating cold in children Withdrawn CN106729031A (en)

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Application publication date: 20170531