CN107441086A - A kind of pharmaceutical composition and its production and use - Google Patents
A kind of pharmaceutical composition and its production and use Download PDFInfo
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- CN107441086A CN107441086A CN201710621775.4A CN201710621775A CN107441086A CN 107441086 A CN107441086 A CN 107441086A CN 201710621775 A CN201710621775 A CN 201710621775A CN 107441086 A CN107441086 A CN 107441086A
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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
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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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4741—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having oxygen as a ring hetero atom, e.g. tubocuraran derivatives, noscapine, bicuculline
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- 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
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- 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
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- 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
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention provides a kind of pharmaceutical composition and its production and use, belong to field of medicaments.The pharmaceutical composition count in parts by weight including：800~1200 parts of Berberine hydrochloride, 1~3 part of Chelerythrine, pulchinenoside B4300~500 parts.The medicament includes aforementioned pharmaceutical compositions and pharmaceutically acceptable carrier or auxiliary material.The preparation method of the pharmaceutical composition includes：Greater celandine, the Chinese bulbul and the bark of ash are mixed, with 30~70% (vol%) ethanol solution refluxing extraction 1~2 time, 1~5h, merges the filtrate extracted every time, is concentrated to give the first clear cream；The Berberine hydrochloride of 20~30 parts by weight is mixed with the first clear cream.The preparation method can effectively improve Chelerythrine in extract, pulchinenoside B4And the content of aesculin, and then improve the drug effect of the disease such as the pharmaceutical composition and pharmaceutical treatment diarrhea, dysentery.
Description
Technical field
The present invention relates to field of medicaments is related to, in particular to a kind of pharmaceutical composition and its production and use.
Background technology
The traditional Chinese medical science says that diarrhea refers to because of being invaded by exogenous pathogen,invasion of exogenous pathogen, or by injury due to diet, or disorder of emotion, or it is weakness of the spleen and the stomach, or spleen kidney yang
Increased caused by the reasons such as void with defecation frequency, loose and watery stool is half congealed, or even lets out the disease such as water sample for main symptom.Dysentery is with big bowel frequency
Number increases, and suffers from abdominal pain, tenesmus, and red white glutinous freeze is symptom under dysentery.
At present, treatment of the traditional Chinese medical science to such disease is mainly based on clearing heat and detoxicating, dampness-eliminating and dysentery-stopping medicine, but due to its system
There is the defects of certain in standby technique so that the recovery rate of the effective component in medicinal material is low, product unsatisfactory curative effect.
The content of the invention
The first object of the present invention is to provide a kind of pharmaceutical composition and a kind of medicament prepared by said composition, this
Active constituent content in kind medicament or pharmaceutical composition is high, good drug efficacy, can effectively treat diarrhea, dysentery.
The second object of the present invention is to provide a kind of preparation method of aforementioned pharmaceutical compositions, and the pharmaceutical composition is in
The ethanol of isoconcentration is that Extraction solvent extracts to the mixture of greater celandine, the Chinese bulbul and the bark of ash, can effectively improve extraction
Chelerythrine, pulchinenoside B in thing4And the content of aesculin, and then improve drug effect.
The third object of the present invention is to provide a kind of medical usage of aforementioned pharmaceutical compositions, i.e. aforementioned pharmaceutical compositions
Purposes in the medicine for the treatment of diarrhea or dysentery is prepared.
In order to realize the above-mentioned purpose of the present invention, spy uses following technical scheme：
A kind of pharmaceutical composition, the pharmaceutical composition count in parts by weight including：
800~1200 parts of Berberine hydrochloride, 1~3 part of Chelerythrine, pulchinenoside B4300~500 parts.
A kind of medicament, the medicament include aforementioned pharmaceutical compositions and pharmaceutically acceptable carrier or auxiliary material.
A kind of preparation method of aforementioned pharmaceutical compositions, it includes：
By the Qin of the greater celandine of 360~390 parts by weight, the Chinese bulbul of 360~390 parts by weight and 360~390 parts by weight
Skin, mixing, with 30~70% (vol%) ethanol solution refluxing extraction 1~2 time, 1~5h, merges the filtrate extracted every time,
It is concentrated to give the first clear cream；
The Berberine hydrochloride of 20~30 parts by weight is mixed with the first clear cream.
A kind of purposes of aforementioned pharmaceutical compositions in the medicine for the treatment of diarrhea or dysentery is prepared.
Compared with prior art, beneficial effects of the present invention are：
In this medicament of present disclosure offer and this pharmaceutical composition, effective component Chelerythrine, hoary hair
Father-in-law's saponin(e B4Content it is high so that using same weight the preparation-obtained medicament of bulk drug (greater celandine, Chinese bulbul etc.) or
The drug effect of pharmaceutical composition is good, good the effect of clearing heat and detoxicating, dampness-eliminating and dysentery-stopping, can be used in treating diarrhea, dysentery.And due to the medicine
The content of contained effective substance is high in compositions so that good the effect of the medicament, quality is high.
The preparation method for the pharmaceutical composition that present disclosure provides, bends by Extraction solvent dialogue of the ethanol of intermediate concentration
The mixture of dish, the Chinese bulbul and the bark of ash is extracted, and can effectively improve Chelerythrine in extract, pulchinenoside B4、
And the content of aesculin, and then improve drug effect.Simultaneously, additionally it is possible to the content of water-solubility impurity is reduced, so as to improve the medicine
The stability of agent and the controllability of quality.
Embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the present invention.It is unreceipted specific in embodiment
Condition person, the condition suggested according to normal condition or manufacturer are carried out.Agents useful for same or the unreceipted production firm person of instrument, it is
The conventional products that can be obtained by commercially available purchase.
Present embodiment provides a kind of pharmaceutical composition, the pharmaceutical composition count in parts by weight including：
800~1200 parts of Berberine hydrochloride, 1~3 part of Chelerythrine, pulchinenoside B4300~500 parts.
Wherein, Chelerythrine is one of principle active component of traditional natural medicinal plant greater celandine, its have antibacterial,
It is antibacterial, clearing heat and detoxicating, anti-inflammation effect.Chelerythrine can suppress in vitro alpha streptococcus, catarrh, I types how Salmonella,
Mucous membrane how Salmonella, Diplococcus pneumopniae, haemophilus influenzae and other gram-positive bacteriums；Tubercle bacillus can be suppressed in vivo；
The Chelerythrine of low concentration can suppress bacteriophage and Escherichia coli.
Pulchinenoside B4It is one of principle active component of traditional natural medicinal plant Chinese bulbul.It has been investigated that in vain
Head father-in-law alcohol extract can by suppress lipopolysaccharides stimulate cell secreting tumor necrosis factor, interleukin 1 and interleukin 8 and
Antiinflammatory action is played, this inhibitory action and drug concentration are in high-positive correlation.Radix Pulsatillae Alcohol Extract can also be by protecting enteron aisle
Microbial barrier, enteric flora disturbance is corrected, adjust intestinal microecology, reduce proinflammatory cytokine in IBD, rise
Anti-inflammatory cytokines, damage of the inflammatory molecule to enteron aisle chorion barrier is reduced, intestines chorion barrier function is effectively adjusted, so that tightly
The expression of close connection albumen increases, the impaired chance of reduction enterocyte, close between protection enteron aisle chorionic epithelium cell
Albumen is connected, intestinal permeability is reduced, so as to suppress endotoxin by closely connecting into body circulation, reaches the mesh of anti-inflammation
's.
In this pharmaceutical composition, contain Chelerythrine and pulchinenoside B4The content of both components is high, thus
Resulting pharmaceutical composition has the effect of disease such as the effect of preferably clearing heat and detoxicating, dampness-eliminating and dysentery-stopping, treatment diarrhea, dysentery
It is good.
Further, the pharmaceutical composition is counted also include in parts by weight：Aesculin 30-70 parts.
Aesculin, it is one of principle active component in traditional natural medicinal plant bark of ash, there is anti-inflammatory, antibacterial, resist
Blood clotting, analgesia isoreactivity.Aesculetin and aesculin have inhibitory action to a variety of dysentery bacillus in bark of ash ethanol extract, together
Shi Douneng reduces inflammation reaction, its mechanism with its regulate and control microvascular function and suppress inflammatory factor expression it is relevant.
Further, to count in parts by weight, Berberine hydrochloride is 900~1100 parts, and Chelerythrine is 1.5~2.5 parts,
Pulchinenoside B4For 350~450 parts, aesculin is 40-60 parts.
Further, to count in parts by weight, Berberine hydrochloride is 950~1050 parts, and Chelerythrine is 1.8~2.2 parts,
Pulchinenoside B4For 380~420 parts, aesculin is 45-55 parts.
More specifically, count in parts by weight, Berberine hydrochloride is 1000 parts, and Chelerythrine is 2 parts, pulchinenoside
B4For 400 parts, aesculin is 50 parts.
Present embodiment also provides a kind of medicament, and the medicament includes aforementioned pharmaceutical compositions and pharmaceutically acceptable load
Body or auxiliary material.
Herein, it is physiologically acceptable that term " pharmaceutically acceptable ", which refers to the compound when compound is to human administration,
, and the allergic reactions such as gastrointestinal disturbance, dizziness or these similar anaphylactoid systemic anaphylaxis will not occur.
In the present invention, " pharmaceutically acceptable carrier or auxiliary material " includes but is not limited to：Adhesive (such as microcrystalline cellulose
Element, alginates, gelatin and polyvinylpyrrolidone), filler (such as starch, sucrose, glucose and anhydrous lactic acid), disintegrant
(such as cross-linked pvp, crosslinked carboxymethyl fecula sodium, Ac-Di-Sol and low-substituted hydroxypropyl cellulose), lubricant
(magnesium stearate, aluminum stearate, talcum, polyethylene glycol, sodium benzoate), wetting agent (such as glycerine), surfactant (such as hexadecane
Alcohol) and sorbefacient, flavouring, sweetener, diluent, coating agent etc..
Further, pharmaceutical composition is by using obtained by solvent extraction method processing Chinese prescription；Wherein, Chinese prescription
Meter includes in parts by weight：20~30 parts of Berberine hydrochloride, 360~390 parts of greater celandine, 360~390 parts of the Chinese bulbul, the bark of ash 360
~390 parts.
Further, Chinese prescription count in parts by weight including：25 parts of Berberine hydrochloride, 375 parts of greater celandine, the Chinese bulbul
375 parts, 375 parts of the bark of ash.
Further, in order that pharmaceutical composition discharge active component rapidly, continuously and in a very long time, this
The pharmaceutical composition of invention can manufacture according to those conventional methods in the art are disclosed in.The drug regimen of the present invention
The method of administration of thing is oral, nasal inhalation or parenteral.The preparation of the pharmaceutical composition can be powder, granule, piece
Agent, emulsion, syrup, aerosol, soft capsule, hard shell capsules, sterile injectable preparation and sterilized powder etc..
Optionally, the formulation of medicament includes capsule, tablet, granule, pill.Contain in the medicine of one preparation unit
Have：20~30mg of Berberine hydrochloride, 0.025~0.075mg of Chelerythrine, pulchinenoside B47.5~12.5mg.More have
Body, contain in the medicine of a preparation unit：Berberine hydrochloride 25mg, Chelerythrine 0.05mg, pulchinenoside
B410mg。
In this medicament provided in present embodiment and this pharmaceutical composition, effective component Chelerythrine and white
Head father-in-law's saponin(e B4Content it is high so that it is good using the medicament prepared by the raw material of same weight or the drug effect of pharmaceutical composition, from
And improve the quality standard of the medicament, enhance the controllability of the pharmacy quality.
Present embodiment also provides a kind of preparation method of pharmaceutical composition, and it includes：
Step S1:By the greater celandine of 360~390 parts by weight, the Chinese bulbul of 360~390 parts by weight and 360~390 weight
Part the bark of ash, mixing, with 30~70% (vol%) ethanol solution refluxing extraction 1~2 time, 1~5h, merging every time is extracted
Filtrate, be concentrated to give the first clear cream.
The step with the ethanol (30~70% ethanol solutions) of intermediate concentration be Extraction solvent to greater celandine, the Chinese bulbul and
The mixture of the bark of ash is extracted, and can effectively improve Chelerythrine in extract, anemoside B4 and aesculin
Content, and then improve drug effect.Simultaneously, additionally it is possible to reduce the content of water-solubility impurity, so as to improve the stability of the medicament and
The controllability of quality.
Further, using 40~60% (vol%) ethanol solution refluxing extraction 1~2 time, 2~3h every time.
Further, the relative density of the first clear cream is 1.28-1.31 (48~52 DEG C of survey).Or the phase for the first clear cream
It is 1.28-1.31 (50 DEG C of surveys) to density.
Step S2:The Berberine hydrochloride of 20~30 parts by weight is mixed with the first clear cream.
Because Berberine hydrochloride is reactive compound, in order to avoid being lost in operation and structure change, use
Afterwards plus mode, Berberine hydrochloride is mixed with the first clear cream, then carry out preparation.
Present embodiment also provides a kind of purposes of pharmaceutical composition in the medicine for the treatment of diarrhea or dysentery is prepared.Due to
Contained effective substance (such as Chelerythrine, pulchinenoside B in the pharmaceutical composition4) content increase, therefore contain the medicine
The effect of medicine of compositions is stated in disease in the treatment is good.
The feature and performance of the present invention are described in further detail with reference to embodiments：
Embodiment 1
The present embodiment provides a kind of pharmaceutical composition, and it includes：
Berberine hydrochloride 20g, Chelerythrine 0.075g, pulchinenoside B47.5g, aesculin 0.8g.
The preparation method of the pharmaceutical composition includes：
A. it is the bark of ash of 390g greater celandine, the 360g Chinese bulbul and 360g, mixing, the ethanol with 70% (vol%) is molten
Liquid refluxing extraction 1 time, each 2h, merges the filtrate extracted, and is concentrated to give the first clear cream；
B. 20g Berberine hydrochloride is mixed with the first clear cream, dries, produce the pharmaceutical composition.
Embodiment 2
The present embodiment provides a kind of pharmaceutical composition, and it includes：
Berberine hydrochloride 30g, Chelerythrine 0.025g, pulchinenoside B412.5g, aesculin 2.2g.
The preparation method of the pharmaceutical composition includes：
A. it is the bark of ash of 360g greater celandine, the 390g Chinese bulbul and 390g, mixing, the ethanol with 30% (vol%) is molten
Liquid refluxing extraction 2 times, each 1h, merges the filtrate extracted, and is concentrated to give the first clear cream；
B. 30g Berberine hydrochloride is mixed with the first clear cream, dries, produce the pharmaceutical composition.
Embodiment 3
The present embodiment provides a kind of pharmaceutical composition, and it includes：
Berberine hydrochloride 25.3g, Chelerythrine 0.05g, pulchinenoside B410g, aesculin 1.15g.
The preparation method of the pharmaceutical composition includes：
A. by the bark of ash of 375g greater celandine, the 375g Chinese bulbul and 375g, mixing, with 50 (vol%) ethanol solution
Refluxing extraction 2 times, each 5h, merges the filtrate extracted, and is concentrated to give the first clear cream；
B. 25g Berberine hydrochloride is mixed with the first clear cream, dries, produce the pharmaceutical composition.
Embodiment 4
The present embodiment provides a kind of tablet, contains in the tablet in every：
Berberine hydrochloride 25mg, Chelerythrine 0.05mg, pulchinenoside B410mg, aesculin 1.25mg.
The preparation method of the capsule includes：
A. by the bark of ash of 375g greater celandine, the 375g Chinese bulbul and 375g, mixing, with 50 (vol%) ethanol solution
Refluxing extraction 2 times, each 3h, merges the filtrate extracted, and is concentrated under reduced pressure into thick paste of the relative density for 1.30 (50 DEG C of surveys), i.e.,
For the first clear cream；
B. 25g Berberine hydrochloride is mixed with the first clear cream, dries, produce the pharmaceutical composition.
C. pharmaceutical composition is ground into fine powder, adds appropriate amount of starch, dextrin, mixed, particle, tabletting, bag film is made
Clothing, produce 1000 tablets of medicaments.
Embodiment 5
The present embodiment provides a kind of granule, and every bag contains in the granule：
Berberine hydrochloride 23.1mg, Chelerythrine 0.025mg, pulchinenoside B411.5mg, aesculin 1.2mg.
The preparation method of the capsule includes：
A. by the bark of ash of 370g greater celandine, the 375g Chinese bulbul and 380g, mixing, with 50 (vol%) ethanol solution
Refluxing extraction 2 times, each 1.5h, merges the filtrate extracted, and is concentrated under reduced pressure into thick paste of the relative density for 1.28 (52 DEG C of surveys),
As the first clear cream；
B. 23g Berberine hydrochloride is mixed with the first clear cream, dries, produce the pharmaceutical composition.
C. pharmaceutical composition is ground into fine powder, adds appropriate amount of starch, dextrin, mixed, wet granulation, whole grain after drying,
Packaging, produces 1000 bags of granules.
Embodiment 6
The present embodiment provides a kind of capsule, contains in the capsule in every：
Berberine hydrochloride 27.3mg, Chelerythrine 0.065mg, pulchinenoside B48.5mg, aesculin 1.3mg.
The preparation method of the capsule includes：
A. by the bark of ash of 380g greater celandine, the 380g Chinese bulbul and 375g, mixing, with 50 (vol%) ethanol solution
Refluxing extraction 2 times, each 1.5h, merges the filtrate extracted, and is concentrated under reduced pressure into thick paste of the relative density for 1.31 (48 DEG C of surveys),
As the first clear cream；
B. 27g Berberine hydrochloride is mixed with the first clear cream, dries, produce the pharmaceutical composition.
C. pharmaceutical composition is ground into fine powder, adds starch, appropriate dextrin, mixed, particle is made, dried, load glue
Capsule, produce 1000.
Comparative example 1
This comparative example provides a kind of tablet, and its drug prescription is：
Berberine hydrochloride 25g, greater celandine 375g, Chinese bulbul 375g, bark of ash 375g.
The preparation method of the tablet includes：
The taste of the above four, outside demineralizing acid jamaicin, the taste of remaining greater celandine etc. three, add water to cook twice, 2 hours every time, merge
Decocting liquid, filtration, filtrate are concentrated into thick paste of the relative density for 1.31 (50 DEG C of surveys), add Berberine hydrochloride and appropriate starch, mix
It is even, pelletize, dry, tabletting, be made 1000, produce.
Experimental example
Below to the content and pharmaceutical activity of active ingredient in the tablet that is provided in the embodiment of the present invention 4 and comparative example 1
It is measured：
First, assay method：
1st, the assay of Berberine hydrochloride
Determined according to 2015 editions pharmacopeia high performance liquid chromatographies (general rule 0512).
Chromatographic condition and system suitability：Using octadecylsilane chemically bonded silica as filler；Acetonitrile -0.03mol/
L potassium dihydrogen phosphates (40:60) it is mobile phase；Detection wavelength is 265nm.Number of theoretical plate is calculated by Berberine hydrochloride peak should not
Less than 3000.
The preparation of reference substance solution：Precision is weighed in 100 DEG C of dry 5 hours Berberine hydrochloride reference substance 25mg, adds boiling
Water 150ml makes dissolving, slightly cold rear addition watery hydrochloric acid 3ml, stirs evenly, lets cool, be transferred in 250ml measuring bottles, be diluted with water to scale,
Precision measures 2ml, puts in 25ml measuring bottles, adds mobile phase to be diluted to scale, shake up, produces.
The preparation of need testing solution：Take sample appropriate, it is finely ground, 0.4g is taken, it is accurately weighed, add boiling water 150ml to make dissolving, slightly
Watery hydrochloric acid 3ml is added after cold, stirs evenly, lets cool, be transferred in 250ml measuring bottles, be diluted with water to scale, shake up, centrifugation is (per minute
4000 turns), precision measures supernatant 2ml, puts in 25ml measuring bottles, adds mobile phase to be diluted to scale, shakes up, and is filtered with 0.45 μm of micropore
Membrane filtration mistake, takes subsequent filtrate, produces.
Determination method：Accurate absorption reference substance solution and each 10 μ l of need testing solution respectively, injection liquid chromatograph, measure,
Produce.
2nd, the assay of Chelerythrine
Determined according to 2015 editions pharmacopeia high performance liquid chromatographies (general rule 0512).
Chromatographic condition and system suitability：Using octadecylsilane chemically bonded silica as filler；With second eyeball -1% three
Ethylamine solution (phosphorus acid for adjusting pH value to 3.0) (26：74) it is mobile phase；Detection wavelength is 269nm.Number of theoretical plate presses chelerythrine
Alkali peak, which calculates, should be not less than 2000.
The preparation of reference substance solution：Take Chelerythrine reference substance appropriate, it is accurately weighed, add methanol that every 1ml is made and contain 50 μ
G solution, is produced.
The preparation of need testing solution：Take sample appropriate, it is finely ground, about 1g is taken, it is accurately weighed, put in round-bottomed flask, precision adds
The methanol (0.5 of hydrochloric acid one：100) mixed solution 40m1, weighed weight, it is heated to reflux 1.5 hours, lets cool, then weighed weight, use salt
A sour methanol (0.5：100) mixed solution supplies the weight of less loss, shakes up, and filtration, precision measures subsequent filtrate 20m1, is evaporated, residual
Slag adds 50% methanol to make dissolving, is transferred in 10ml measuring bottles, adds 50% methanol to shake up, filtered with 0.45 μm of miillpore filter to scale
Cross, take subsequent filtrate, produce.
Determination method：Accurate absorption reference substance solution and each 10 μ l of need testing solution respectively, injection liquid chromatograph, measure,
Produce.
3rd, pulchinenoside B4Assay
Determined according to 2015 editions pharmacopeia high performance liquid chromatographies (general rule 0512).
Chromatographic condition and system suitability：Using octadecylsilane chemically bonded silica as filler；With the water of methanol one
(64:36) it is mobile phase；Detection wavelength is that 201nm number of theoretical plates press pulchinenoside B4Peak, which calculates, should be not less than 3000.
The preparation of reference substance solution：Take pulchinenoside B4Appropriate reference substance, it is accurately weighed, add methanol that every 1mI is made and contain
0.1mg solution, is produced.
The preparation of need testing solution：Take sample appropriate, it is finely ground, about 200mg is taken, it is accurately weighed, put in conical flask with cover, essence
Close plus methanol 50ml, close plug are ultrasonically treated (power 150W, frequency 40kHz) 25 minutes, let cool, filter, and precision measures subsequent filtrate
10m1 is put in 50ml measuring bottles, adds mobile phase to shake up to scale, filtered with 0.45 μm of miillpore filter, take subsequent filtrate, produce.
Determination method difference is accurate to draw reference substance solution and each 20 μ l of need testing solution, injects liquid chromatograph, determines, i.e.,
.
4th, the assay of aesculin
Determined according to 2015 editions pharmacopeia high performance liquid chromatographies (general rule 0512).
Chromatographic condition and system suitability：Using octadecylsilane chemically bonded silica as filler；With second eyeball -0.1%
Phosphoric acid solution (8：92) it is mobile phase；Detection wavelength is 334nm.Number of theoretical plate is calculated by aesculetin peak should be not less than 5000.
The preparation of reference substance solution：Take aesculin reference substance, aesculetin reference substance appropriate, it is accurately weighed, add methanol
Every lml 0.1mg containing aesculin solution is made, produces.
The preparation of need testing solution：Take sample appropriate, it is finely ground, about 500mg is taken, it is accurately weighed, put in conical flask with cover, essence
Close addition methanol 50m1, close plug, weighed weight, is heated to reflux 1 hour, lets cool, then weighed weight, and the weight of less loss is supplied with methanol
Amount, shakes up, and filters, takes subsequent filtrate, produce.
Determination method：Accurate absorption reference substance solution and each 10 μ l of need testing solution respectively, injection liquid chromatograph, measure,
Produce.
2nd, measurement result
In the tablet provided in embodiment 4 and comparative example 1, the content of each effective component in every, as shown in table 1：
The content of each effective component in the unitary tablet of table 1.
| Effective component | Embodiment 4 (mg) | Comparative example 1 (mg) |
| Chelerythrine | 0.05 | 0.02 |
| Pulchinenoside B4 | 10 | 5.6 |
| Aesculin | 1.25 | 0.39 |
As shown in Table 1, compared to the tablet provided in comparative example 1, each drug effect contained by tablet in the embodiment of the present invention 4
The content of composition is above comparative example 1, thus illustrates, using the medicine obtained by the preparation method provided in the embodiment of the present invention 4
Active constituent content is high in agent, and good drug efficacy, quality are controllable.
In addition, the pharmaceutical composition that other embodiments are provided, tablet or granule are used to carry out above-mentioned experiment, test
As a result it is similar to experimental example 1, therefore do not repeat one by one.
3rd, the quick anti-situation of shigella dysenteriae
10,1 tablet of comparative example is taken respectively, 10,4 tablet of embodiment, respectively plus about 20ml distilled water dissolves, filtered, and
It is settled in 50ml volumetric flasks, as decoction stoste.Appropriate stoste is taken respectively from 1：2 start to dilute, and make test tube inner liquid medicine each dilute
It is interpreted as the experiment decoction of 50%, 25%, 12.5% various concentrations.It is tested thin from 20 plants of shigella dysenteriae strain inclined plane pickings respectively
Bacterium, it is inoculated with extra quality meat soup pipe (often pipe meat soup 10ml), puts 37 DEG C and be incubated 12 hours, bacterium solution is tested for susceptibility.1m1 is taken respectively
Bacterium solution in test tube, be separately added into the decoction of various concentrations, often pipe 0.1ml.Rearmounted 37 DEG C of incubations 24 hours are vibrated, then,
Again from various concentrations susceptibility pipe, the susceptibility liquid through culture is dipped with cotton swab (sterile), EmB agar plates is inoculated with respectively, puts
37 DEG C are incubated 24 hours, take out observation whether there is shigella dysenteriae growth, illustrate the decoction to shigella dysenteriae without bacteriostasis (anti-medicine),
Such as without growth, then illustrate that tested shigella dysenteriae is sensitive (having bacteriostasis) to the decoction.
The quick anti-situation of the shigella dysenteriae of table 2.
As shown in Table 2, compared to comparative example 1, the anti-shigella dysenteriae activity of 4 each concentration liquid of the embodiment of the present invention is above pair
Ratio 1, thus illustrates, using not only active ingredient contains in the medicament obtained by the preparation method provided in the embodiment of the present invention 4
Amount is high, and anti-shigella dysenteriae increased activity.
Although illustrate and describing the present invention with specific embodiment, but will be appreciated that without departing substantially from the present invention's
Many other change and modification can be made in the case of spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (10)
- A kind of 1. pharmaceutical composition, it is characterised in that described pharmaceutical composition count in parts by weight including：800~1200 parts of Berberine hydrochloride, 1~3 part of Chelerythrine, pulchinenoside B4300~500 parts.
- 2. pharmaceutical composition according to claim 1, it is characterised in that described pharmaceutical composition is counted also wrap in parts by weight Include：30~70 parts of aesculin.
- 3. pharmaceutical composition according to claim 2, it is characterised in that count in parts by weight, the Berberine hydrochloride is 900~1100 parts, the Chelerythrine is 1.5~2.5 parts, the pulchinenoside B4For 350~450 parts, the bark of ash A prime is 40-60 parts.
- 4. pharmaceutical composition according to claim 3, it is characterised in that count in parts by weight, the Berberine hydrochloride is 950~1050 parts, the Chelerythrine is 1.8~2.2 parts, the pulchinenoside B4For 380~420 parts, the bark of ash A prime is 45-55 parts.
- 5. a kind of medicament, it is characterised in that the medicament includes the pharmaceutical composition and medicine described in any one of Claims 1 to 4 Acceptable carrier or auxiliary material on.
- 6. medicament according to claim 5, it is characterised in that described pharmaceutical composition is by using at solvent extraction method Manage obtained by Chinese prescription；Wherein, the Chinese prescription count in parts by weight including：20~30 parts of Berberine hydrochloride, 360~390 parts of greater celandine, 360~390 parts of the Chinese bulbul, 360~390 parts of the bark of ash.
- 7. medicament according to claim 6, it is characterised in that the formulation of the medicament includes capsule, tablet, particle Agent, pill.
- 8. the preparation method of a kind of pharmaceutical composition according to any one of Claims 1 to 4, it is characterised in that it includes：By the bark of ash of the greater celandine of 360~390 parts by weight, the Chinese bulbul of 360~390 parts by weight and 360~390 parts by weight, mix Close, with 30~70% (vol%) ethanol solution refluxing extraction 1~2 time, 1~5h, merges the filtrate extracted every time, concentration Obtain the first clear cream；The Berberine hydrochloride of 20~30 parts by weight is mixed with first clear cream.
- 9. the preparation method of pharmaceutical composition according to claim 8, it is characterised in that first clear cream is 48~52 The relative density of geodetic is 1.28-1.31 at DEG C.
- 10. a kind of pharmaceutical composition as described in any one of Claims 1 to 4 is in the medicine for the treatment of diarrhea or dysentery is prepared Purposes.
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Cited By (8)
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| CN109549944A (en) * | 2019-01-30 | 2019-04-02 | 苏州大学 | Application of the anemoside B4 in preparation inflammatory enteropathy drug |
| CN109674870A (en) * | 2019-01-08 | 2019-04-26 | 成都威迪特生物科技有限公司 | A kind of antibacterial growth promotion Chinese medicine composition and preparation method thereof and detection method |
| WO2019149156A1 (en) * | 2018-01-31 | 2019-08-08 | 四川英路维特医药科技有限公司 | Uses of pulsatilla chinensis extract in preparing drug for treating viral and/or bacterial diseases |
| CN110907579A (en) * | 2019-12-04 | 2020-03-24 | 河南牧业经济学院 | HPLC quantitative analysis method for aesculin and aesculetin in pulsatilla chinensis powder |
| CN111084779A (en) * | 2018-10-23 | 2020-05-01 | 广西英路维特药物有限公司 | New application of pulsatilla chinensis saponin B4 |
| CN111249289A (en) * | 2020-02-14 | 2020-06-09 | 广西英路维特药物有限公司 | Oral care product or medicament for anti-inflammation and/or anti-allergy |
| CN111265534A (en) * | 2020-03-19 | 2020-06-12 | 广西馨海药业科技有限公司 | Application of pulsatilla chinensis saponin B4 in preparation of medicines for treating/preventing sepsis |
| RU2799050C2 (en) * | 2018-01-31 | 2023-07-03 | Сычуань Иньлу Вэйтэ Фармасьютикал Текнолоджи Ко., Лтд. | Application of pulsatilla chinensis extract for obtaining a drug for the treatment of viral and/or bacterial diseases |
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| RU2799050C2 (en) * | 2018-01-31 | 2023-07-03 | Сычуань Иньлу Вэйтэ Фармасьютикал Текнолоджи Ко., Лтд. | Application of pulsatilla chinensis extract for obtaining a drug for the treatment of viral and/or bacterial diseases |
| US11793822B2 (en) | 2018-01-31 | 2023-10-24 | Sichuan Inlu Weite Pharmaceutical Technology Co., Ltd. | Uses of Pulsatilla Chinensis extract in preparing drug for treating viral and/or bacterial diseases |
| AU2019214081B2 (en) * | 2018-01-31 | 2023-11-23 | Sichuan Inlu Weite Pharmaceutical Technology Co., Ltd. | Uses of Pulsatilla chinensis extract in preparing drug for treating viral and/or bacterial diseases |
| AU2019214082B2 (en) * | 2018-01-31 | 2023-11-30 | Sichuan Inlu Weite Pharmaceutical Technology Co., Ltd. | Uses of Pulsatilla Chinensis extract in preparing drug for treating viral and/or bacterial diseases |
| CN111084779A (en) * | 2018-10-23 | 2020-05-01 | 广西英路维特药物有限公司 | New application of pulsatilla chinensis saponin B4 |
| CN109674870A (en) * | 2019-01-08 | 2019-04-26 | 成都威迪特生物科技有限公司 | A kind of antibacterial growth promotion Chinese medicine composition and preparation method thereof and detection method |
| CN109549944A (en) * | 2019-01-30 | 2019-04-02 | 苏州大学 | Application of the anemoside B4 in preparation inflammatory enteropathy drug |
| CN110907579A (en) * | 2019-12-04 | 2020-03-24 | 河南牧业经济学院 | HPLC quantitative analysis method for aesculin and aesculetin in pulsatilla chinensis powder |
| CN111249289A (en) * | 2020-02-14 | 2020-06-09 | 广西英路维特药物有限公司 | Oral care product or medicament for anti-inflammation and/or anti-allergy |
| CN111265534A (en) * | 2020-03-19 | 2020-06-12 | 广西馨海药业科技有限公司 | Application of pulsatilla chinensis saponin B4 in preparation of medicines for treating/preventing sepsis |
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Application publication date: 20171208 |