CN106692503A - Pharmaceutical composition for prevention and treatment of tuberculosis and preparing method thereof - Google Patents

Pharmaceutical composition for prevention and treatment of tuberculosis and preparing method thereof Download PDF

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Publication number
CN106692503A
CN106692503A CN201611133248.0A CN201611133248A CN106692503A CN 106692503 A CN106692503 A CN 106692503A CN 201611133248 A CN201611133248 A CN 201611133248A CN 106692503 A CN106692503 A CN 106692503A
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weight
ethanol
pharmaceutical composition
weight portion
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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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
    • A61K31/435—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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
    • 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)
    • A61K36/37—Celastraceae (Staff-tree or Bittersweet family), e.g. tripterygium or spindletree
    • 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)
    • A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • 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
    • A61K2236/33—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
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • 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

Abstract

The invention discloses a pharmaceutical composition for prevention and treatment of tuberculosis and a preparing method thereof. The pharmaceutical composition is prepared by proportioning euodia suaveolens, euonymus myrianthus, acrifoline, bergia ammannioides and pilea mongolica as raw material medicines, can be made into various dosage forms according to a conventional preparation process, and has the significant curative effect of prevention and treatment of tuberculosis.

Description

Phthisical pharmaceutical composition of one kind preventing and treating and preparation method thereof
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of phthisical pharmaceutical composition of preventing and treating and its preparation side Method.
Background technology
Over 50 years, amic therapy method is played a great role on prevalence lungy is controlled, and more than 90% first is controlled pulmonary tuberculosis Patient is cured.Yet with increasing for irrational drug combination, mismanagement, irregular medication and immune impairment host Deng, cause resistance person's proportion in China's tuberculosis patient to be up to 28%~41%, appearance largely controls patient again.There is MSDS Bright, recurrent tuberculosis are accounted for and newly register the 15%~20% of tuberculosis patient every year, retreat tuberculosis is turned into Tubercufosis control In subject matter, be also resistant tuberculosis, especially multi-drug resistance tuberculosis produce root, global Tubercufosis control is caused It is serious to threaten.Manpower, financial resources needed for the Case management of retreat tuberculosis patient are just control patient 2~3 times.While resistive connection Infringement of the nuclear pharmaceuticals on liver, kidney is always the major obstacles that influence chemotherapy is smoothly completed.Some patients are on the one hand due to sharp good fortune The adverse reaction of equality conventional anti-tubercular medicine is extremely sensitive and force drug withdrawal, on the other hand again be can not afford due to financial difficulties Anti-tubercular drug of new generation, just for economical, effective traditional Chinese medicine leaves wide space for this.It is well known that immunity of organisms is low Under be not only the main cause of pulmonary tuberculosis recurrence, be also key point that can relapsing pulmonary tuberculosis cure；Additionally, due to lung knot Core lesion center blood circulation is obstructed, causes chemicals to be fully infiltrated into, and focus can not be restored, so as to cause lung group Damage is knitted, respiratory dysfunction has a strong impact on patient health and life.Therefore, patient's immunity of organisms is improved, tuberculosis bar is killed Bacterium, promotes perilesional blood circulation, improves chemotherapeutics concentration in focus, softens and reduce focus, recovers lung group in focus It is the cardinal principle for thoroughly curing retreat tuberculosis to knit normal configuration.
Root of Denseflower Euonymus：It is root, the stem of Celastraceae burning buss root of Denseflower Euonymus Euonymus myrianthus Hemsl.. Root, is harvested after autumn, cleans, and section is dried；Stem, summer, autumn harvesting, segment is dried.【Nature and flavor】It is sweet；Slight bitter；It is flat.【Return through】 Liver；Spleen；Kidney channel.【Indication】Kidney-nourishing strengthens waist；Stagnation resolvation dampness removing.Main lumbago due to the kidney deficiency；Fetal irritability；Chronic nephritis；Lochia Not to the utmost；Injury and bone fracture；Arthralgia pain due to rheumatism；Under band.【Former phytomorph】Big fruit lance defends shrub, up to 6m.Leaf opposite；Petiole 5- long 8mm；Keratin, ovum shape lanceolar is to oblong, and 5-13cm long, 3-4.5cm wide, tip is tapering, edge pure circle serration.Flower The nearly basidixed of sequence, many times branch shape spends more thyrse；Flower yellow, diameter 7-10mm, 4 numbers, stamen has extremely short filigree.Capsule Golden yellow, obovate or the cone of falling ovate, are about 1.5cm, diameter about 1cm.Seed has orange-yellow aril.Record in Chinese medicine Voluminous dictionary.
Three-jaw gold dragon：It is Vitaceae Parthenocissus plant parthenocissus himalayana Plancs Parthenocissus himalayana （Royle）Planch. the complete stool of ［ Ampelopsis himalayana Royle ］.Autumn, winter harvesting root and stem, cut after cleaning Piece or segment, dry.Summer, autumn picking leaves, dry.【Nature and flavor】It is pungent；Temperature.【Indication】Dispelling wind and eliminating dampness；Dissipate blood stasis and smoothing collaterals.Main wind Arthritis with fixed pain caused by dampness is bitterly；Traumatic injury；Fracture.【Former phytomorph】Parthenocissus himalayana Plancs fallen leaves woody climber.Multi-branched, branch is sturdy, drabon Color；Tendril is short and branch, and there is sucker on top.The leaflet alternate of palmate 3；Common petiole 5-12cm long, without hair or hairiness；Blade papery, Middle leaflet is avette or width drape over one's shoulders needle-like avette, 6-12cm long, 2-7cm wide, and tip is tapering or nearly shape of tail, and base portion wedge shape, side life is small Leaf is asymmetric, tiltedly avette, compared with the middle of leaflet it is smaller, edge have substantially and the sawtooth with tip, above without hair, below or along vein There is thin pubescence；Petiolule 5-6mm long.Flower both sexes, cyme be often born in brachyplast top or with leaf opposite；Bennet is compared with petiole It is short；Flower light green, 5 numbers 4 are counted sometimes；Calyx shallow disc shape, full edge；Petal Long Circle；Stamen and petal opposite；Floral disc is not obvious； Style short cylindrical shape, tip often expands discoid after petal comes off.Berry is spherical, ripe time-varying dark brown, has white powder, seed 1-2 .Record in dictionary of medicinal plant.
Close flowers and plants：This product is Elatinaceae field chickweed platymiscium field chickweed Bergia ammannioides Roxb. Ex The herb of Roth.Whole year can adopt；Clean；Dry.【Nature and flavor】It is sweet；It is cool in nature.【Indication】It is clearing heat and detoxicating.Main urinary tract infections； Carbuncle furuncle；Stomatitis.【Original shape state】Annual herb, 7-30cm high.Near upright or edge up, branch is more, pale red, has open and flat Glandular hairs.Leaf opposite, several stockless；Slotting leaf is about 2mm, and 2 drastic cracks, sliver lanceolar has the tear small tooth of shape；Blade is narrow oval or falls There is sharp small sawtooth at lanceolar, 0.4-2cm long, 2-8mm wide, edge, there is undercoat below.Spend small, majority is fasciating in axil；Flower Obstruct 1-2mm long；Sepal 5, it is narrow avette, 1.2mm is about, tip is tapering；Petal 5, pale red is narrow avette, about isometric with sepal；It is male Stamen 5；Style 5, it is short.Capsule is subsphaeroidal, 1.2-2mm long, and it is 5 valves to split.I counts seed, minimum.Florescence is almost annual.Record in Medicine voluminous dictionary.
Pilea mongolica：This product be Urticaceae Pilea plant pilea mongolica Pilea pumila (L.) A.Cray Ur-tica pumila L.；P.mongolica Wedd. ］ herb or rhizome.Summer, autumn harvesting, clean, and dry.【Nature and flavor】 It is sweet；It is cold in nature.【Indication】Heat-clearing；Diuresis；Removing toxic substances.Main urinary tract infections；Acute nephritis；Endometritis；The prolapse of uterus；It is red white Under band；Traumatic injury；Carbuncle swells from the beginning of；Worm snake bite.【Original shape state】Annual herb, 40-100cm high.Stem is upright, normal branch, Light green, without hair, meat, sometimes transparent shape.Leaf opposite；Petiole 1-4cm long, with respect to petiole Length discrepancy；Stipule is small, caducous； Blade water chestnut shape is avette or width egg shape, and 2-10cm long, 1-7cm wide, tip is tapering, and there is wire cystolith on base portion wide wedge shape, two sides, There is rough sawn tooth at edge more than base portion；Base goes out 3, arteries and veins.Flower monoecism, same to sequence, sometimes different strain；Cyme scorpion shape of tail, sometimes In fasciation shape, male tapel 2, boat-shaped, the nearly tip in the back side has short angle, stamen 2, with perianth opposite；Female tapel 3, narrow lanceolar, Gynoecium 1.Achene is flat avette, and brown is smooth.The month at florescence 8-10, the fruiting period 9-11 months.Record in dictionary of medicinal plant.
Acrifoline（Acrifoline）：CAS 664-24-4, molecular formula C16H23NO2, molecular weight 261.36.【Composition Source】Selago-like climbing fern herb Huperzia selago [Syn. Lycopodium selago], 2 years lycopod Lycopodium annotinum var. acrifolium。
1 chemical constitution of bulk drug：
Acrifoline（Acrifoline）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided one kind effectively prevent and treat phthisical pharmaceutical composition and Its preparation method.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the phthisical pharmaceutical composition of the preventing and treating be：
The three-jaw gold dragon 480-490 weight portion root of Denseflower Euonymus 450-460 weight portion acrifoline close flowers and plants of 5-7 weight portions 380-390 weight portion pilea mongolica 346-348 weight portions.
The phthisical pharmaceutical composition of preventing and treating is preferably used in, is made up of the bulk drug of following weight portion：
Three-jaw gold imperial 485 weight portion root of Denseflower Euonymus 455 weight portion acrifoline, the 6 close weight portions of flowers and plants 385 of weight portion are saturating The weight portion of stem Pilea notata 347.
The phthisical pharmaceutical composition of one kind preventing and treating, it is characterised in that pharmaceutical composition can be using the routine side of galenic pharmacy Method prepares piece agent or capsule or dripping pill.
The phthisical pharmaceutical composition of one kind preventing and treating, it is characterised in that pharmaceutical composition is anti-with what chemical drugs or Chinese medicine were constituted Control tuberculosis drugs.
A kind of preparation method for preventing and treating phthisical pharmaceutical composition, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Three-jaw gold dragon 480-490 weight portion root of Denseflower Euonymus 450-460 weight portions point leaf stone The loose close flowers and plants 380-390 weight portions pilea mongolica 346-348 weight portions of alkali 5-7 weight portions；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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 for preventing and treating phthisical pharmaceutical composition, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：The weight of 455 weight portion acrifoline of the three-jaw imperial 485 weight portion root of Denseflower Euonymus of gold 6 The amount close weight portion of 385 weight portion pilea mongolica of flowers and plants 347 of part；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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 for preventing and treating phthisical pharmaceutical composition, it is characterised in that pharmaceutical composition can use preparation Conventional method prepares piece agent or capsule or dripping pill.
A kind of preparation method for preventing and treating phthisical pharmaceutical composition, it is characterised in that pharmaceutical composition and chemical drugs or in Medicine composition preventing and treating tuberculosis drugs.
It is evident in efficacy that pharmaceutical composition prevents and treats pulmonary tuberculosis.
Specific embodiment
Embodiment 1：Prevent and treat phthisical pharmaceutical composition and preparation method thereof
The composition and weight portion for preventing and treating the bulk drug of phthisical pharmaceutical composition be：Three-jaw gold dragon 485g root of Denseflower Euonymus 455g The close flowers and plants 385g pilea mongolicas 347g of acrifoline 6g；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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：Prevent and treat phthisical pharmaceutical composition and preparation method thereof
The composition and weight portion for preventing and treating the bulk drug of phthisical pharmaceutical composition be：Three-jaw gold dragon 480g root of Denseflower Euonymus 460g The close flowers and plants 390g pilea mongolicas 346g of acrifoline 5g；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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：Prevent and treat phthisical pharmaceutical composition and preparation method thereof
The composition and weight portion for preventing and treating the bulk drug of phthisical pharmaceutical composition be：Three-jaw gold dragon 490g root of Denseflower Euonymus 450g The close flowers and plants 380g pilea mongolicas 348g of acrifoline 7g；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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 63g of Example 1, adds starch 152g, mixes, and granulation is dried, plus microcrystalline cellulose 36g, stearic acid Magnesium 3g, mixes, and is pressed into 700, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 247g of Example 2, adds starch 147g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid Magnesium, mixes, and encapsulated 1100, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 315g water-baths and boil molten, add the pharmaceutical composition 18g of embodiment 3, fully stir Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is -1 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.4cm away from liquid level, and drop speed is optimum condition with every point 53 drop, and the cold of dripping pill surface is blotted with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7：Prevent and treat phthisical pharmaceutical composition
The composition and weight portion for preventing and treating the bulk drug of phthisical pharmaceutical composition be：
The imperial close weight portion of 350 weight portion pilea mongolica of flowers and plants 300 of 489 weight portion of three-jaw gold.
Embodiment 8：Prevent and treat phthisical pharmaceutical composition
The composition and weight portion for preventing and treating the bulk drug of phthisical pharmaceutical composition be：
The close weight portion of 190 weight portion pilea mongolica of flowers and plants 200 of the weight portion of acrifoline 1.
Embodiment 9：Prevent and treat phthisical pharmaceutical composition
The composition and weight portion for preventing and treating the bulk drug of phthisical pharmaceutical composition be：
The close weight portion of 300 weight portion pilea mongolica of flowers and plants 140 of the weight portion of acrifoline 4.
Experimental example 1：Prevent and treat phthisical experimental study
1 data and method
1.1 physical data
Selection Sputum smears acid-fast stain before the court's hospitalization is positive, the retreat tuberculosis patient 50 of resistance, diagnosis Standard reference《Pestology》.Man 28, female 22,26~72 years old age, average (45 ± 3) year.Divided at random Group:Treatment group 25, man 14, female 11, average age (46 ± 2) year；Control group 25, man 14, female 11 Example, average age (44 ± 3) year.Comparing difference is not statistically significant before two groups of ages of patient, state of an illness treatments, with comparable Property.
1.2 treatment methods
Control group is straight based on isoniazid para-aminosalicylate (H), protionamide, three kinds of medicines of lavo-ofloxacin (V) Connect inspection lower chemotherapy regimen, the course for the treatment of 9 months.To there is complication person to give anti symptom treatment, to being in a bad way, the person of having bad physiques to Give supporting treatment.Treatment group on the basis of such scheme, plus with self-control pharmaceutical composition（The pharmaceutical composition of embodiment 1) mouth Clothes, each 1.8g, daily 3 times.
1.3 observation items
Record disease time, types of medicines, dosage, administration time, sputum bacteria, X lines rabat and clinical manifestation in detail.Looked into before treatment Three is big conventional, Liver and kidney function, sputum bacteria smear, culture and drug sensitive test and X line rabats.Monthly looked into during treatment sputum bacteria smear, Culture, Liver and kidney function takes the photograph X line rabats in every 2 months.Record adverse drug reaction in detail month by month.
1.4 curative effect determinate standards
Recovery from illness:Clinical symptom disappearance, sputum bacteria continues feminine gender up to more than 1 year, and X line rabats show inactive focus, follow-up observation More than 1 year still no active.
Take a turn for the better:Possess following persons:Lesion absorbs improvement earlier above, and cavity reduces closure, and sputum bacteria is reduced or turned out cloudy.
It is invalid:Sputum bacteria and X ray examinations, without changer before and after treatment.
1.5 statistical methods
Statistical analysis are carried out using the statistical softwares of SPSS 11. 0, enumeration data uses Chi-square Test.Inspection level α= 0.05。
2 results
Treatment group:Focus cures improvement 23, the unchanged or person of increasing 2, total effective rate 92%；Sputum is looked into turn out cloudy 24, negative conversion rate is 96%, and all cases are taken during kanglaosan, are had no adverse reaction.
Control group:Focus cures improvement 15, unchanged 10, total effective rate 60%；Sputum turns out cloudy 17 Example, negative conversion rate 68%.Two groups of comparing differences are statistically significant (P ＜ 0.01).It is shown in Table 1, table 2.
1 two groups of retreat tuberculosis patient clinical symptoms of table improve situation and compare ［ example (%) ］
Group Number of cases Cure Take a turn for the better It is invalid Total effective rate（%）
Treatment group 25 8 15 2 92.00*
Control group 25 5 10 10 60.00
Note:Compare with control group, * P ＜ 0.01.
2 two groups of retreat tuberculosis patient's sputum conversion situations of table compare ［ example (%) ］
Group Number of cases Effectively It is invalid
Treatment group 25 24* 1
Control group 25 17 8
Note:Compare with control group, * P ＜ 0.01.

Claims (8)

1. it is a kind of to prevent and treat phthisical pharmaceutical composition, it is characterised in that to be made the composition and weight of the bulk drug of the pharmaceutical composition Measuring part is：
The three-jaw gold dragon 480-490 weight portion root of Denseflower Euonymus 450-460 weight portion acrifoline close flowers and plants of 5-7 weight portions 380-390 weight portion pilea mongolica 346-348 weight portions.
2. it is a kind of according to claim 1 to prevent and treat phthisical pharmaceutical composition, it is characterised in that to be made the pharmaceutical composition Bulk drug composition and weight portion be：
Three-jaw gold imperial 485 weight portion root of Denseflower Euonymus 455 weight portion acrifoline, the 6 close weight portions of flowers and plants 385 of weight portion are saturating The weight portion of stem Pilea notata 347.
3. it is a kind of according to claim 1 to prevent and treat phthisical pharmaceutical composition, it is characterised in that pharmaceutical composition can be adopted Piece agent or capsule or dripping pill are prepared with the conventional method of galenic pharmacy.
4. it is a kind of according to claim 1 to prevent and treat phthisical pharmaceutical composition, it is characterised in that pharmaceutical composition and chemistry The preventing and treating tuberculosis drugs of medicine or Chinese medicine composition.
5. a kind of preparation method for preventing and treating phthisical pharmaceutical composition, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Three-jaw gold dragon 480-490 weight portion root of Denseflower Euonymus 450-460 weight portions point leaf stone The loose close flowers and plants 380-390 weight portions pilea mongolica 346-348 weight portions of alkali 5-7 weight portions；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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 for preventing and treating phthisical pharmaceutical composition according to claim 5, it is characterised in that by as follows It is prepared by step：
The composition and weight portion of bulk drug be：The weight of 455 weight portion acrifoline of the three-jaw imperial 485 weight portion root of Denseflower Euonymus of gold 6 The amount close weight portion of 385 weight portion pilea mongolica of flowers and plants 347 of part；
Preparation method：
（1）Three-jaw gold dragon, root of Denseflower Euonymus, acrifoline, close flowers and plants, pilea mongolica are taken by bulk drug proportioning, is mixed, with weight The amount ethanol of percent concentration 16% takes as solvent in 33 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 34 small When, each solvent load is 46 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, dense Relative density 1.09 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by HZ-801 large pore resin absorption columns The ethanol solution of concentration 32% elutes HZ-801 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 32%, reclaims Ethanol, concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 58% as solvent, heating and refluxing extraction 9 times is carried every time The time is taken for 0.2 hour, each solvent load is 70 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 1.05 is concentrated into, filtered, liquid is first washed with water, then use weight by H103 large pore resin absorption columns The ethanol solution of percent concentration 67% elutes H103 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 67%, 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 for preventing and treating phthisical pharmaceutical composition according to claim 5, it is characterised in that medicine group Compound can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method for preventing and treating phthisical pharmaceutical composition according to claim 5, it is characterised in that medicine group Compound and chemical drugs or Chinese medicine composition preventing and treating tuberculosis drugs.
CN201611133248.0A 2016-12-10 2016-12-10 Pharmaceutical composition for prevention and treatment of tuberculosis and preparing method thereof Withdrawn CN106692503A (en)

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