CN106727791A - It is a kind of to treat pharmaceutical composition of tonsillitis and preparation method thereof - Google Patents

It is a kind of to treat pharmaceutical composition of tonsillitis and preparation method thereof Download PDF

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CN106727791A
CN106727791A CN201611133066.3A CN201611133066A CN106727791A CN 106727791 A CN106727791 A CN 106727791A CN 201611133066 A CN201611133066 A CN 201611133066A CN 106727791 A CN106727791 A CN 106727791A
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • 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)
    • A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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    • 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
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    • A61K2236/30—Extraction of the material
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    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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    • 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
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    • A61K2236/55—Liquid-liquid separation; Phase separation

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Abstract

Pharmaceutical composition of tonsillitis and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, corynoline as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment tonsillitis is evident in efficacy.

Description

It is a kind of to treat pharmaceutical composition of tonsillitis and preparation method thereof
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating tonsillitis and its preparation side Method.
Background technology
Children's suppurative tonsillitis is a kind of common disease of children, belongs to the upper respiratory disease caused by bacterium infection. In the middle of the respiratory tract infection case of children, children's suppurative tonsillitis accounts for 10%-15% or so.Children's suppurative tonsillitis Treatment gets up also to have certain difficulty, and more early discovery receives therapeutic effect will be better.Acute tonsillitis recurrent exerbation, can send out It is chronic tonsillitis to open up, and its reason lowly has certain relation with immunity in children.Stored in chronic tonsillitis tonsillotome Malignant bacteria, the toxin of bacterial secretory is not only swallowed stimulating gastrointestinal road into blood and rheuminess thing, and children can be caused long Phase low-heat, indigestion, anorexia, or even can influence to grow, when immunity of organisms declines again can acute attack, together When bacterium and toxin can cause body occur allergy, cause rheumatic fever (rheumatic arthritis and rheumatic heart disease), kidney The diseases such as inflammation.Due to the infection of bacterium and virus, wherein bacterium is more common.Pathogen be generally hemolytic streptococcus, staphylococcus, Pneumococcus.These bacteriums are typically found in the throat of people and tonsil crypts, under normal circumstances, due to tonsillotome gland table Complete and muccus gland the continuous secretion of face epithelium, bacterium can be discharged with the epithelium bacterium that comes off, therefore remain machine from crypts mouthful The health of body.When body because fatigue, suffer from cold, it is local be subject to the physically or chemically influence of factor after, it is flat when resistance declines The blood fortune of peach gland is reduced, glandular secretion function declines, the reduction of epithelium defence capability, and bacterium is to take advantage of a weak point, and grows breeding, is caused Almond inflammation.
Acute suppurative tonsillitis is the acute non-specific inflammation of tonsilla palatina, is the common disease of pharynx of children, With recurrent exerbation, the features such as easily cause part and systemic complications.Children's acute suppurative tonsillitis belongs to traditional Chinese medical science larynx Section's disease.The clinical usually unexpected hyperpyrexia of this disease, agitation, are presented a kind of performance of acute fever, and diseased region is not limited to pharynx Larynx part, this disease is closer to warm disease.This sick developing stage is in qi leel, and diseased region is two burnt in upper, internal organs be positioned at lung, Stomach, the interpretation of the cause, onset and process of an illness malicious heresy for lung stomach qi leel intrinsic heat has concurrently.Throat is the door of lung stomach, and the circulation of lung meridian and the stomach channel of foot-Yang-ming is equal By throat, therefore lung stomach is closely connected with throat.
Guangxi dog tartar：It is Apocynaceae Ervatamia plant Guangxi dog tartar Ervatamia kwangsiensis The root skin of Tsiang, leaf.Root skin whole year can adopt, and clean, using fresh herb；Leaf using fresh herb.【Nature and flavor】It is bitter；It is pungent；It is mild-natured.【Indication】Promoting blood circulation Analgesic.Main traumatic injury；Fracture swells and ache.【Former phytomorph】Shrub, up to 5m.Without hair in addition to spending；Branch and sprig have hole skin, Internode reaches 2-3cm.Expand and symphysis, oval, up to 2mm on the pretext of leaf base.Leaf opposite；Petiole 5-12mm long；Blade heavily fortified point paper Matter, ellipticity oval, 5-15cm long, 3-6.5cm wide, tip is short tapering, base portion wedge shape, surface bottle green, back side light green； Middle arteries are recessed on blade face, overleaf raised；Lateral vein 12-14 pairs, arc rises.Cyme axillary, usual two discrimination, is born in sprig Top, there is colored 6-7；Total bennet 3-4cm long；Bract and squamella oval；Spend 5 numbers：Bud cylindrical shape；Calyx is wide bell, Base portion inner face Non-gland body, sepal has echinid；Corolla white, it is caducous；Tube top covers to the left to right rotation, sliver base portion, There is micro- pubescence on two sides；Stamen is born in nearly gorge portion；The nearly arrow-shaped of flower pesticide；Column cap 2 splits.Follicle radish is twin, 150 ° of forks, round shape long Lanceolar, has short beak；Carpopodium is about 1cm, fruit 5-6cm long.There is 5-6 in seed Mei Ge Follicle radish.The month at florescence 5-9, fruiting period 9- November.Record in dictionary of medicinal plant.
Plagiogyria distinctissima ching：It is Plagiogyriaceae knurl foot Cyclosorus plant Plagiogyria distinctissima ching Plagiogyria rankanensis Hayata[P.distinctissima Ching;P.adnata Bedd.] herb or rhizome.Summer, autumn harvesting, clean, and shine It is dry.【Nature and flavor】It is pungent；It is cool.【Return through】Enter bladder, lung, the warp of liver three.【Indication】Deliver heat-clearing；Dispelling wind and arresting itching；Promoting eruption.Main flow row Sexuality emits；Measles；Pruitus；Metrorrhagia；Sprain.【Former phytomorph】Plant 30-45cm high.Has the rhizome of upright or oblique ascension. Leafage gives birth to, two types；Nutrition petiole 14-18cm long, base portion prismatic has 1-2 to pneumatophore, is slightly in upwards prismatic or semicircle Shape；Blade long-narrow triangular mesh or ovum shape lanceolar, 17-25cm long, base portion 8-11cm wide, a pinnation；Accessory pinna papery, 15-20 pairs, alternate, 4-6cm long, 8-13mm wide, top and bottom are green, and acumen is micro-bend in falciform lanceolar, base portion upwards Asymmetric, upside is prolonged along rachis, and downside is circular, edge nearly full edge or with teeth；Vein pinniform, lateral vein is single or two forked.Spore Cotyledon petioles 30-40cm long；Time pinniform of blade, 14-22cm long, 4-6cm wide；Accessory pinna 15-25 pairs, it is in linear extremely to shrink, 5-7cm long, 2-3mm wide；The usual y-bend of lateral vein, extends at limb 1/2.Sporangium is born in scun top, and accessory pinna is covered with when ripe Below.Record in dictionary of medicinal plant.
Protocevine（Protocevine）：CAS 5876-23-3, molecular formula C27H43NO8, molecular weight 509.64.【Composition Source】Black false hellebore Veratrum nigrum.
Inulicin（Inulicin）：CAS 33627-41-7, molecular formula C17H24O5, molecular weight 308.37.【Medicine Reason is acted on】Antiulcer, central nervous excitation agent.【Ingredient origin】Feverfew Inula britannica chinensis, inula lineariifolia, inula Britannica Capitulum.
Homoplantaginin（Homoplantaginin）：CAS 17680-84-1, molecular formula C22H22O11, molecular weight 462.40. 【Pharmacological action】Tracheitis is controlled, antibechic, eliminating the phlegm is relievingd asthma, antibechic, eliminating the phlegm.【Ingredient origin】Labiate Common Sage Herb herb.
Corynoline (Corynoline):CAS 18797-79-0, molecular formula C21H21NO5, molecular weight 367.39. 【Physical property】Colourless granules shape is crystallized, 218-219 DEG C of fusing point.UVλMeOH maxnm(logε):238 (3.97), 289 (3.93)；IR γKBrmax cm-1:3240 (OH), 922；MS m/e:367(M+), 349,334,318,202,190,176,162.【Pharmacology is made With】Its sulfate proves through pharmacological testing, gives mouse peritoneal injection 10mg/kg, there is significant sedation.1/8000 is dense Degree this product plays the role of anti-Leptospira.【Purposes】Calmness, anti-Leptospira.【Ingredient origin】Bloodroot point away from Corydalis corydalis sheareri S. Moore root tubers, C. incisa Corydalis incisa (Thunb.) Pers.
4 chemical constitutions of bulk drug：
Homoplantaginin（Homoplantaginin）Protocevine（Protocevine）
Inulicin（Inulicin）Corynoline (Corynoline).
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 tonsillitis 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 tonsillitis be：
Protocevine 5-15 weight portions Guangxi dog tartar 262-268 weight portion Plagiogyria distinctissima ching 222-226 weight portion Inula britannica chinensis Secondary lactone 13-16 weight portions Homoplantaginin 7-9 weight portion corynoline 3-5 weight portions.
The pharmaceutical composition for the treatment of tonsillitis is preferably used in, is made up of the bulk drug of following weight portion：
The weight of 10 224 weight portion inulicin of weight portion Guangxi dog 264 weight portion Plagiogyria distinctissima ching of tartar of protocevine 15 The weight portion of 8 weight portion corynoline of amount part Homoplantaginin 4.
A kind of pharmaceutical composition for treating tonsillitis, 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 tonsillitis, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine Treatment tonsillitis medicine.
A kind of preparation method of the pharmaceutical composition for treating tonsillitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Protocevine 5-15 weight portions Guangxi dog tartar 262-268 weight portion sickleleaf knurls Sufficient fern 222-226 weight portions inulicin 13-16 weight portions Homoplantaginin 7-9 weight portion corynoline 3-5 weight Part；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 tonsillitis, it is characterised in that make as follows It is standby：
The composition and weight portion of bulk drug be：The weight portion Plagiogyria distinctissima ching 224 of 10 weight portion Guangxi dog tartar of protocevine 264 The parts by weight of 15 weight portion Homoplantaginin of weight portion inulicin, 8 weight portion corynoline 4；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 tonsillitis, 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 tonsillitis, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment tonsillitis medicine.
Medicine composite for curing tonsillitis is evident in efficacy.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of tonsillitis and preparation method thereof
Treat tonsillitis pharmaceutical composition bulk drug composition and weight portion be：Protocevine 10g Guangxi dog tartar 264g Plagiogyria distinctissima ching 224g inulicin 15g Homoplantaginin 8g corynolines 4g；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 tonsillitis and preparation method thereof
Treat tonsillitis pharmaceutical composition bulk drug composition and weight portion be：Protocevine 5g Guangxi dog tartar 268g Plagiogyria distinctissima ching 222g inulicin 16g Homoplantaginin 7g corynolines 5g；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 tonsillitis and preparation method thereof
Treat tonsillitis pharmaceutical composition bulk drug composition and weight portion be：Protocevine 15g Guangxi dog tartar 262g Plagiogyria distinctissima ching 226g inulicin 13g Homoplantaginin 9g corynolines 3g；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 1380g of Example 1, adds starch 1280g, mixes, and granulation is dried, plus microcrystalline cellulose 720g, firmly Fatty acid magnesium 30g, mixes, and is pressed into 15000, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 1580g of Example 2, adds starch 2701g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid Magnesium, mixes, and encapsulated 10000, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 137g water-baths and boil molten, add the pharmaceutical composition 7g of embodiment 3, be sufficiently stirred for Uniformly, with atoleine as cooling agent, glass tube is put（4*80cm）In, chilling temperature is -7 DEG C, and drip internal-and external diameter is 7.0/2.0 (mm/mm), drip is 2.0cm away from liquid level, and drop speed is optimum condition with every point 49 drop, and the condensation on dripping pill surface is blotted with cotton Agent, obtains final product medicament composition dropping pills.
Embodiment 7：Treat the pharmaceutical composition of tonsillitis
Treat tonsillitis pharmaceutical composition bulk drug composition and weight portion be：
The weight portion of 35 weight portion corynoline of protocevine 22 weight portion inulicin, 25 weight portion Homoplantaginin 1.
Embodiment 8：Treat the pharmaceutical composition of tonsillitis
Treat tonsillitis pharmaceutical composition bulk drug composition and weight portion be：
The weight portion of 20 weight portion corynoline of protocevine 35 weight portion inulicin, 15 weight portion Homoplantaginin 2.
Embodiment 9：Treat the pharmaceutical composition of tonsillitis
Treat tonsillitis pharmaceutical composition bulk drug composition and weight portion be：
The weight portion of 5 weight portion corynoline of protocevine 26 weight portion inulicin, 10 weight portion Homoplantaginin 4.
Experimental example 1：Treat the experimental study of tonsillitis
1 clinical data
1.1 physical data
This 39 infant of observation comes from community medical service center of city of Jinan City door during being in May, 2009 in March, 2011 Diagnose a disease example, wherein man 20, female 19；2~14 years old age, average 6.2 years old；The course of disease 1~3 day.
1.2 diagnostic criteria
With reference to State Administration of Traditional Chinese Medicine《Chinese medical disease Standardization of diagnosis and curative effect》Exuberance of stomach fire type.Show as pharyngalgia more very, swallows Difficulty, body heat, thirsty, constipation.Tongue is red, yellow tongue fur, slippery and rapid pulse.Inclusion criteria:Meet traditional Chinese medical science acute tonsillitis diagnostic criteria.In meeting Doctor's acute tonsillitis exuberance of stomach fire type CM syndrome differentiation criterion.Age is more than 2 years old, the infant of less than 14 years old.Exclusion standard:Inclusive criteria is not met And have substantially and press from both sides card or have circumtonsillar abscess complication person.Or angiocarpy, liver, kidney and disease of hematopoietic system are suffered from simultaneously Infant.
2 treatments and observational technique
2.1 treatment methods
All cases give pharmaceutical composition（The pharmaceutical composition of embodiment 1）Orally, each 1.3g, 3 times a day.Take 7 days It is 1 course for the treatment of.All cases unused antibiotic therapy during observing.
2.2 observational techniques
(1) symptom and sign integration before and after observation and treatment.Symptom and sign ranking criterion:Pharyngalgia, pharyngeal sign, by it is normal, light, in, Weight, respectively 0,2,4,6 points of score；Thirsty, constipation, by it is normal, light, in, weight, respectively score 0,1,2,3 points；The red, red tongue body of urine, Yellow tongue fur, arteries and veins number or sliding number respectively count 1 point, and normal person counts 0 point.(2) infant body temperature, white blood cell count(WBC) before and after observation and treatment.(3) observe Fever time after infant medication.
2.3 statistical methods
Data statistics is carried out using SPSS statistics softwares.Data compare using paired t inspections before and after treatment.
3 observation of curative effect
3.1 the standard of curative effect evaluation
With reference to the promulgation of Department of Medical Administration of State Administration of Traditional Chinese Medicine in June, 1994《Chinese medical disease Standardization of diagnosis and curative effect》Perform.Cure: Body temperature is normal, and blood picture is normal, and pharyngeal symptom disappears, and tonsillotome is not congested, without pus point.Take a turn for the better:Still there is low-heat；Blood picture is close to just Often, pharyngeal symptom mitigation, tonsillotome pus point is eliminated.Do not heal:Sings and symptoms is not improved.
3.2 observation results
(1) clinical efficacy:39 equal pharmaceutical composition treatments of infant.Treatment 7 days, cures 36, accounts for 92.31%；Take a turn for the better 2, Account for 5.13%:Invalid 1；Total effective rate is 97.44%.
(2) clinical symptoms and somatic feature score situation of change compare before and after infant treatment, it can be seen that with integration ratio before treatment Compared with every symptom, heating, pharyngalgia, pharyngeal sign, constipation, tongue are red, arteries and veins scalar product point significantly reduces (P<0.001)；Yellow tongue fur is integrated Significantly reduce (P<0.05)；Total mark significantly reduces (P<0.01).
(3) body temperature situation of change compares before and after:Treatment is first 38.6 DEG C, and 36.4 DEG C after treatment, patient's body temperature is notable after treatment Decline (P<0.001).
(4) white blood cell count(WBC) compares before and after treating:Treatment preceding 10.576 × 109/ L, 7.566 × 10 after treatment9/ L, patient White blood cell count(WBC) is remarkably decreased (P after treatment<0.001).

Claims (8)

1. a kind of pharmaceutical composition for treating tonsillitis, it is characterised in that be made the bulk drug of the pharmaceutical composition composition and Weight portion is：
Protocevine 5-15 weight portions Guangxi dog tartar 262-268 weight portion Plagiogyria distinctissima ching 222-226 weight portion Inula britannica chinensis Secondary lactone 13-16 weight portions Homoplantaginin 7-9 weight portion corynoline 3-5 weight portions.
2. a kind of pharmaceutical composition for treating tonsillitis 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 of 10 224 weight portion inulicin of weight portion Guangxi dog 264 weight portion Plagiogyria distinctissima ching of tartar of protocevine 15 The weight portion of 8 weight portion corynoline of amount part Homoplantaginin 4.
3. a kind of pharmaceutical composition for treating tonsillitis 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 tonsillitis according to claim 1, it is characterised in that pharmaceutical composition with change Learn the treatment tonsillitis medicine of medicine or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating tonsillitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Protocevine 5-15 weight portions Guangxi dog tartar 262-268 weight portion sickleleaf knurls Sufficient fern 222-226 weight portions inulicin 13-16 weight portions Homoplantaginin 7-9 weight portion corynoline 3-5 weight Part；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 tonsillitis 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 Plagiogyria distinctissima ching 224 of 10 weight portion Guangxi dog tartar of protocevine 264 The weight portion of 15 weight portion Homoplantaginin of weight portion inulicin, 8 weight portion corynoline 4；
Preparation method：
（1）Protocevine, Guangxi dog tartar, Plagiogyria distinctissima ching, inulicin, Homoplantaginin, purple are taken by bulk drug proportioning Violet alcohol spirit alkali, mixes, and with the ethanol of weight percent concentration 20% as solvent, is taken in 30 DEG C of temperature extractions, and extraction time is 10 times, Each extraction time is 46 hours, and each solvent load is 31 times of bulk drug gross weight, is filtered, and obtains dregs of a decoction A and extract solution A, Extract solution A reclaims ethanol, is concentrated into relative density 1.02, filters, and liquid is first washed with water by LK07 large pore resin absorption columns It is de-, then LK07 large pore resin absorption columns are eluted with the ethanol solution of weight percent concentration 32%, collect weight percent concentration 32% Ethanol eluate, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 64% as solvent, heating and refluxing extraction 11 times is carried every time The time is taken for 0.8 hour, each solvent load is 78 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, then use weight by DM11 large pore resin absorption columns The ethanol solution of percent concentration 79% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 79%, Ethanol is reclaimed, 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 tonsillitis 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 tonsillitis according to claim 5, it is characterised in that medicine Composition and chemical drugs or Chinese medicine composition treatment tonsillitis medicine.
CN201611133066.3A 2016-12-10 2016-12-10 It is a kind of to treat pharmaceutical composition of tonsillitis and preparation method thereof Withdrawn CN106727791A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106109721A (en) * 2016-06-30 2016-11-16 济南星懿医药技术有限公司 The pharmaceutical composition for the treatment of cervical cancer
CN106138174A (en) * 2016-06-30 2016-11-23 济南星懿医药技术有限公司 Prevent and treat the pharmaceutical composition of bladder cancer

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106109721A (en) * 2016-06-30 2016-11-16 济南星懿医药技术有限公司 The pharmaceutical composition for the treatment of cervical cancer
CN106138174A (en) * 2016-06-30 2016-11-23 济南星懿医药技术有限公司 Prevent and treat the pharmaceutical composition of bladder cancer

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