CN108567843A - A kind of Chinese medicine composition and its preparation and application - Google Patents
A kind of Chinese medicine composition and its preparation and application Download PDFInfo
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- CN108567843A CN108567843A CN201810748766.6A CN201810748766A CN108567843A CN 108567843 A CN108567843 A CN 108567843A CN 201810748766 A CN201810748766 A CN 201810748766A CN 108567843 A CN108567843 A CN 108567843A
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- chinese medicine
- medicine composition
- extract
- hawthorn
- giant knotweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
-
- 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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/708—Rheum (rhubarb)
-
- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
-
- 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)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- 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
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- 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
Abstract
The invention belongs to tcm fields, and in particular to one kind being capable of hepatic cholagogic Chinese medicine composition and its preparation and application.The Chinese medicine composition of the present invention, effective component raw material include：Giant knotweed, green peel, hawthorn and rheum officinale.Chinese medicine composition and Chinese medical extract provided by the present invention, Serum ALT, AST, ALP, T Bil, D Bil and TBA can be significantly reduced, significantly reduce necrosis of liver cells, the case where enlargement of improvement liver cell, cytoplasm loose, in the change of balloon sample and the change of feather sample, mitigate inflammatory cell infiltration, and then prevents or treat cholestasis.
Description
Technical field
The invention belongs to tcm fields, and in particular to one kind can hepatic cholagogic Chinese medicine composition and its prepare and answer
With.
Background technology
Cholestasis clinically often shows as raising of the jaundice with the level such as serum bilirubin, cholate, alkaline phosphatase,
Bile component is often shown as in histology in liver to assemble.Cholestasis usually causes the variation of related hepatic parenchymal cells, especially
Liver cell feathery degeneration can be caused by being bile acid detergent action.
Choleresis is one of liver most important functions, and mesobilirubin and bile acid are bile main component, the two generation
The state of thanking can reflect liver to organic anion turn-over capacity.T-Bil increases companion's D-Bil apparent increases prompt, and there are cholestasis
Property jaundice.When cholestasis occurs, choleresis declines, and rapidly changes the distribution of bile acid storage capacity so that serum and urine
Bile acid concentration in liquid significantly increases.A variety of organs contain ALT and AST, and liver ALT contents are highest, most of to be present in
In cytoplasm；And liver AST contents are only second to heart, are primarily present in liver cell mitochondria.Both enzymes are in cholestasis
It does not increase generally, only when siltation causes necrosis of liver cells or permeability changes, ALT and AST enter blood, make enzyme activity in blood
Property increase.ALP is the enzyme of one group of alkaline environment hydrolysis phosphate monoester compound, and serum levels of ALP is essentially from liver and bone.Bile
When the pathological conditions such as siltation, hepatocellular injury and Space occupation in liver make bile capillaries pressure rise, ALP generations can be induced and increased, blood
Clear ALP activity increases.Serum levels of ALP raising is the most characteristic early stage performance of cholestasis.
The drug that there is good therapeutic effect for cholestasis is researched and developed, is had very important significance.
Invention content
In order to overcome the problems of in the prior art, the purpose of the present invention is to provide one kind can be in hepatic cholagogic
Drug composition and its preparation and application.
To achieve the goals above and other related purposes, the present invention adopt the following technical scheme that：
The first aspect of the present invention, provides a kind of Chinese medicine composition, and effective component raw material includes：Giant knotweed, green peel, hawthorn
And rheum officinale.
In a kind of embodiment, the effective component raw material of the Chinese medicine composition is by giant knotweed, green peel, hawthorn and rheum officinale group
At.
In a kind of embodiment, the weight ratio range between giant knotweed, green peel, hawthorn and rheum officinale is：Giant knotweed 1-30
0.1-10 parts of part, 1-12 parts of green peel, 1-30 parts of hawthorn and rheum officinale.
In a kind of embodiment, giant knotweed is 1-15 parts by weight.
In a kind of embodiment, giant knotweed is 15-30 parts by weight.
In a kind of embodiment, giant knotweed is 15 parts by weight.
In a kind of embodiment, green peel is 1-6 parts by weight.
In a kind of embodiment, green peel is 6-12 parts by weight.
In a kind of embodiment, green peel is 6 parts by weight.
In a kind of embodiment, hawthorn is 1-15 parts by weight.
In a kind of embodiment, hawthorn is 15-30 parts by weight.
In a kind of embodiment, hawthorn is 15 parts by weight.
In a kind of embodiment, rheum officinale is 0.1-1 parts by weight.
In a kind of embodiment, rheum officinale is 1-10 parts by weight.
In a kind of embodiment, rheum officinale is 1 parts by weight.
In a kind of embodiment, the weight ratio range between giant knotweed, green peel, hawthorn and rheum officinale is：15 parts of giant knotweed,
1 part of 6 parts of green peel, 15 parts of hawthorn and rheum officinale.
Further, the second aspect of the present invention provides a kind of Chinese medical extract, to be former with above-mentioned Chinese medicine composition
Expect that effective component extracting is made.
In the present invention, each raw material and its formula are the most key in Chinese medicine composition, after knowing Chinese medicine preparation, this technology neck
Various conventional traditional Chinese medicine extyaction methods can be used to extract its active ingredient in the technical staff in domain, and such as conventional decocts
It boils, alcohol extracting method, water extraction and alcohol precipitation method, ethanol extract from water precipitation, salting out method etc., since said extracted method can obtain aforementioned Chinese medicine preparation
In main pharmacodynamics ingredient, therefore can to cholestasis have certain prevention curative effect.
Wherein, water extraction and alcohol precipitation method is：First using water as solvent extraction medicinal material active ingredient, then the ethanol precipitation with various concentration
The method for removing impurity in extracting solution.When generally reaching 50~60% (w/v i.e. g/100mL) containing amount of alcohol, it can remove
The impurity such as starch, when alcohol content is up to 70% or more, in addition to a small number of invalid components such as tannin, water colo(u)r, remaining is most of miscellaneous
The precipitable removal of matter.
Ethanol extract from water precipitation is：Medicinal ingredient is first extracted with the ethyl alcohol of suitable concentration, then impurity in extracting solution is removed with water
Method.
It can be carried again through conventional step concentration, purifying or the dry Chinese medicine that obtains after the Chinese medicine composition effective component extracting
Take object.The method wherein concentrated includes but not limited to：Atmospheric evaporation, reduction vaporization, thin film evaporation, multiple-effect evaporation, the side of purifying
Method includes but not limited to：Saltout purifying, macroporous resin adsorption purifying, ethanol precipitation purifying, ion-exchange resin purification, flocculation is heavy
Form sediment purifying, membrane separating and purifying, polycaprolactam purifying, silica gel absorption chromatographic purifying etc., and dry method includes but not limited to：It dries
Dry method, drum-type seasoning, belt drying method, hygroscopic desiccation method, fluid-bed drying, spray drying process, hypobaric drying method, freezing are dry
Dry method, infrared drying, micro-wave drying method etc..
In a kind of embodiment, the extraction uses ethanol extraction method.For example, 60%~80% ethyl alcohol (weight can be used
Volume ratio, that is, g/100mL) extraction.
In a kind of embodiment, the extraction uses water extraction method.
The third aspect of the present invention provides the preparation method of aforementioned Chinese medical extract, includes the following steps：Take aforementioned Chinese medicine
Composition is raw material effective component extracting.
In a kind of embodiment, the preparation method includes step：Giant knotweed, green peel and hawthorn are taken according to the ratio, are carried with ethyl alcohol
It takes, Rhubarb Powder, mixing is added after obtaining dry extract in extracting solution concentration, drying, you can.
In a kind of embodiment, the ethyl alcohol is selected from 60%~80% ethyl alcohol.It is preferred that 70% ethyl alcohol.
The Rhubarb Powder is crushed by rheum officinale and is obtained.
In a kind of embodiment, the preparation method includes step：Giant knotweed, green peel, hawthorn and rheum officinale are taken according to the ratio, use second
Alcohol extracting, extracting solution concentration, drying, obtains dry extract.
In a kind of embodiment, the ethyl alcohol is selected from 60%~80% ethyl alcohol.It is preferred that 70% ethyl alcohol.
In a kind of embodiment, the preparation method includes step：Giant knotweed, green peel, hawthorn and rheum officinale are taken according to the ratio, use water
Extraction is filtered, and is concentrated, dry.
The fourth aspect of the present invention, aforementioned Chinese medicine composition is provided or Chinese medical extract be used to prepare hepatic injury prevent and/
Or the purposes of medicine.
The fifth aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare cholestasis prevention
And/or the purposes of medicine.
In a kind of embodiment, aforementioned Chinese medicine composition or Chinese medical extract can prevent and/or treat intrahepatic cholestasis.
In a kind of embodiment, aforementioned Chinese medicine composition or Chinese medical extract can prevent and/or treat acute hepatic bile
Siltation.
The sixth aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare the use of ALT depressants
On the way.
In a kind of embodiment, aforementioned Chinese medicine composition or Chinese medical extract can be used for reducing serum alt horizontal.
The seventh aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare the use of AST depressants
On the way.
In a kind of embodiment, it is horizontal that aforementioned Chinese medicine composition or Chinese medical extract can be used for reducing AST in serum.
The eighth aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare the use of ALP depressants
On the way.
In a kind of embodiment, it is horizontal that aforementioned Chinese medicine composition or Chinese medical extract can be used for reducing ALP in serum.
The ninth aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare T-Bil depressants
Purposes.
In a kind of embodiment, aforementioned Chinese medicine composition or Chinese medical extract can be used for reducing T-Bil horizontal.
The tenth aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare D-Bil depressants
Purposes.
In a kind of embodiment, aforementioned Chinese medicine composition or Chinese medical extract can be used for reducing D-Bil horizontal.
The eleventh aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare TBA depressants
Purposes.
In a kind of embodiment, aforementioned Chinese medicine composition or Chinese medical extract can be used for reducing TBA horizontal.
The twelveth aspect of the present invention, provides aforementioned Chinese medicine composition or Chinese medical extract is used to prepare and appoints with following
The purposes of the drug of one effect：(1) necrosis of liver cells is reduced；(2) improve liver cell enlargement, cytoplasm is loose, become in balloon sample and
The case where feather sample becomes；(3) mitigate inflammatory cell infiltration.
The thirteenth aspect of the present invention provides a kind of Chinese medicine preparation, includes the aforementioned Chinese medical extract of therapeutically effective amount.
The Chinese medicine preparation includes one or more conventional pharmaceutically acceptable auxiliary materials well.
Pharmaceutically acceptable auxiliary material includes (but being not limited to)：Pharmaceutically acceptable carrier, diluent, filler, knot
Mixture and other excipient.Treating inert inorganic or organic carrier known to the branch art personnel of this field includes but is not limited to
Lactose, cornstarch or derivatives thereof, talcum, vegetable oil, wax, fat, more antelope based compounds for example polyethylene glycol, water, sucrose,
Ethyl alcohol, glycerine, such, various preservatives, lubricant, dispersant, corrigent.Moisturizer, sweetener, antioxidant
Toner, stabilizer, salt, buffer solution are such can be also added thereto, these substances are used to help the stabilization of formula as needed
Property or help to improve activity or it biological effectiveness or acceptable mouthfeel or smell are generated in the case of oral.Such as
The Chinese medicine preparation of granule and paste etc, can be prepared by conventional method.The pharmaceutical composition of the present invention can also be with it
He is used together therapeutic agent.
Preferably, the Chinese medicine preparation be oral preparation, including but not limited to granule, pill, tablet, capsule,
Syrup, spray etc..
After the active ingredient in extracting Chinese medicine composition, can be used conventional pharmaceutic adjuvant and additive prepare it is aforementioned
Pharmaceutical composition.
The dose therapeutically effective of the pharmaceutical composition of the present invention is, with the total weight of raw medicinal material, to take orally safe and effective
Amount is usually 1.00-2.65g/kg weight.Certainly, specific dosage is also contemplated that the factors such as administration route, patient health situation, this
It is a little be all skilled practitioners technical ability within the scope of.
Compared with prior art, the present invention has the advantages that：
Chinese medicine composition and Chinese medical extract provided by the present invention, can significantly reduce Serum ALT, AST, ALP, T-
Bil, D-Bil and TBA, hence it is evident that reduce necrosis of liver cells, the enlargement of improvement liver cell, cytoplasm is loose, is in the change of balloon sample and feather sample
The case where change, mitigates inflammatory cell infiltration, and then prevents or treat cholestasis.
Description of the drawings
Fig. 1：Extract A, extract B, extract C and UDCA to cholestasis mice serum ALT, AST caused by ANIT,
The influence of ALP, T-Bil, D-Bil and TBA；Compared with Vehicle groups,*P ＜ 0.05；Compared with ANIT model groups,#P ＜ 0.05.
Fig. 2：Each group hepatic pathology section analyzes (H＆E, × 400), A：Normal group；B：ANIT model groups；C：Extraction
Object A medicament protection groups；D：Extract B medicament protection group；E：Extract C medicament protection group；F：Positive drug UDCA protection groups.
Specific implementation mode
Before further describing the specific embodiments of the present invention, it should be appreciated that protection scope of the present invention is not limited to down
State specific specific embodiment；It is also understood that the term used in the embodiment of the present invention is specific specific in order to describe
Embodiment, the protection domain being not intended to be limiting of the invention.The test method of actual conditions is not specified in the following example,
Usually according to normal condition, or according to the condition proposed by each manufacturer.
When embodiment provides numberical range, it should be appreciated that except non-present invention is otherwise noted, two ends of each numberical range
Any one numerical value can be selected between point and two endpoints.Unless otherwise defined, in the present invention all technologies for using and
Scientific terminology is identical as the normally understood meaning of those skilled in the art of the present technique.Except used in embodiment specific method, equipment,
Outside material, the record according to those skilled in the art to the grasp of the prior art and the present invention can also use and this
Any method, equipment and the material of the similar or equivalent prior art of method, equipment described in inventive embodiments, material come real
The existing present invention.
Unless otherwise stated, disclosed in this invention experimental method, detection method, preparation method be all made of this technology neck
Domain routine techniques.
Embodiment 1
One, experiment material
1.1, drug
α-naphthalene isothiocyanate (α-naphthyl isothiocyanate, ANIT；Sigma,MO,USA)；Ursodeoxycholic
Acid (UDCA；TCI Japan,Japan)；Rhubarb Powder (is crushed by rheum officinale and is obtained, sieved with 100 mesh sieve wherein 95% medicinal powder is logical, Yu Fenbi
Must be sieved by 80 mesh), rheum officinale, giant knotweed, green peel, hawthorn provide by Hehuang Pharmaceutical Co., Ltd., Shanghai.
1.2, reagent
ALT kits, AST kits, ALP kits, T-Bil kits, D-Bil kits, TBA kits (Nanjing
It builds up, Shanghai, China)；Olive oil (Chinese medicines group, Shanghai, China)；Sodium carboxymethylcellulose (CMC-Na；Chinese medicines group, on
Sea, China)；Physiological saline, neutral tissue fixative solution.
1.3, key instrument
Automatic clinical chemistry analyzer；Light microscope；Thermo Scientific Varioskan Flash all-wave lengths are swept
Retouch multi-functional readout instrument (ThermoFisher Scientific, Germany)；Eppendorf 5424R low-temperature and high-speed centrifuges
(Eppendorf,Germany)；SANYO ice machines (SANYO Electric Co., Ltd., Japan)；Millipore pure water
Instrument (Millipore, Bedford, MA, USA).
1.4, experimental animal：C57BL/6 mouse, weight (20 ± 2) g, male, cleaning grade, are purchased from Shanghai Si Laike by 60
Zoopery Co., Ltd.Animal feeding in temperature (22 ± 1) DEG C, relative humidity (65 ± 10) %, 12h hours round the clock more
In the animal housing replaced, adaptable fed 3d before testing.
Two, experimental method
2.1 drugs are prepared
ANIT：Appropriate powder is taken, is configured to 10mg/mL with olive oil dissolving, ultrasound to powder is completely dissolved.
UDCA：It is dissolved to 9mg/mL with 0.5% sodium carboxymethylcellulose (CMC-Na), is mixed well before gavage.
Extract A：Giant knotweed 360g, green peel 144g and hawthorn 360g are taken, is extracted using 70% ethyl alcohol, extracting solution is recovered under reduced pressure
Solvent sets 100 DEG C, dry 5h under -0.1MPa, cools, Rhubarb Powder 24g, mixing, as extraction is added after obtaining dry extract to thick paste
Object A.
Extract B：Rheum officinale 24g, giant knotweed 360g, green peel 144g and hawthorn 360g are taken, is extracted using 70% ethyl alcohol, extracting solution
Solvent is recovered under reduced pressure to thick paste, sets 100 DEG C, dry 5h under -0.1MPa, cools, obtain dry extract, as extract B.
Extract C：Rheum officinale 24g, giant knotweed 360g, green peel 144g and hawthorn 360g are taken, water boiling and extraction, extracting solution warp are used
Solvent is recovered under reduced pressure to thick paste, sets 100 DEG C, dry 5h under -0.1MPa, cools, obtain dry extract, as extract C.
2.2 animal experiment method
C57BL/6 mouse 60, are randomly divided into Normal group, ANIT model groups, three kinds of extract medicament protection groups, and
Positive drug UDCA control groups, every group 10.All drugs are dissolved to 0.5% sodium carboxymethylcellulose (CMC-Na) required dense
Degree.Normal group gives corresponding CMC-Na solution with model group.Remaining daily same reagent of each group mouse presses 10mL/kg agent
It measures gavage (i.g.) to be administered, qd, continuous 5 days.Specifically, every time, the dosage of extract A medicament protection group is 2.69g/
Kg, extract B medicament protection group dosage be 2.34g/kg, the dosage of extract C medicament protection group is 2.13g/
Kg, positive drug UDCA control groups dosage be 0.09g/kg.After 12h is administered in the 5th, except Normal group gavage gives olive
Outside olive oil 10mL/kg, remaining each group mouse gives ANIT olive oil solution modelings according to 10mL/kg dosage gavages.Modeling 12h,
Continue to be administered twice after 36h.Experiment terminates preceding 12h, and animal is deprived of food but not water.
All animals 48h (i.e. after last dose 12h) after giving ANIT plucks eyeball and takes blood, blood supply after etherization
Clear Biochemical Indexes.It cuts same area (left lobe of liver) hepatic tissue and carries out pathological examination, it is solid with 10% neutral formalin
It is fixed spare.
2.3 Biochemical Indices In Serums measure
Mouse plucks eyeball after etherization and blood, whole blood is taken to be stored at room temperature 3h, 3500rpm/min, centrifuges 15min, takes
Layer serum, automatic clinical chemistry analyzer measure serum alanine aminotransferase (ALT), aspartate amino transferase
(AST) serum alkaline phosphatase (ALP) vigor, serum total bilirubin (T-Bil), bilirubin direct (D-Bil) content.By reagent
Box the method measures and calculates total bile acid (TBA) content.
2.4, hepatic tissue pathology is observed
Tissue trimming is carried out after tissue is fixed, paraffin embedding is cut into 4 μm of thin slices, dimethylbenzene dewaxing, and graded ethanol is dehydrated,
Hematoxylin eosin staining (H＆E dyeing), ethanol dehydration, dimethylbenzene permeabilization, resin encapsulation are observed under an optical microscope.
2.5, statistical analysis
Experimental data measurement data with mean ± standard deviation () indicate, in the comparison statistical software of two means
One-way ANOVA analyses, P ＜ 0.05 indicate that difference is statistically significant.
Three, experimental result
3.1, the Biochemical Indices In Serum of ANIT induced mice cholestasis protective effects is evaluated
Such as table 1, shown in table 2 and Fig. 1,6 serological index of ANIT model groups mouse are significantly increased compared with naive mice
(P ＜ 0.05) shows modeling success.Compared with ANIT model groups, caused by can significantly reduce ANIT after extract A successive administration
Serum indices rising condition, difference have statistical significance (P ＜ 0.05), wherein mice serum AST and ALP with normally it is right
According to group compared to there was no significant difference (P ＞ 0.05).Extract B can significantly reduce in mice serum ALT, AST, T-Bil and
D-Bil levels (P ＜ 0.05), it is horizontal (P ＜ 0.05) that extract C only can significantly reduce ALT and AST.Positive control drug UDCA energy
It is enough to significantly reduce other 5 serological index (P ＜ 0.05) in addition to AST.The above result shows that extract A is to caused by ANIT
The hepatic injury of cholestasis mouse has protective effect, and is better than UDCA from the degree for reducing ALT and AST indexs.
1 extract A of table, extract B, extract C and UDCA to cholestasis mice serum ALT, AST caused by ANIT and
The influence of ALP
Note：Compared with Vehicle groups,*P ＜ 0.05；Compared with model group,#P ＜ 0.05
2 extract A of table, extract B, extract C and UDCA are to cholestasis mice serum T-Bil, D- caused by ANIT
The influence of Bil and TBA
Note：Compared with Vehicle groups,*P ＜ 0.05；Compared with model group,#P ＜ 0.05
3.2, the hepatic pathology of ANIT induced mice cholestasis protective effects is analyzed
As shown in Fig. 2, light is under the microscope as it can be seen that liver cell form is normal in Normal group, arrangement is close, has no liver reality
Cell plastid lesion, lobuli hepatis structure is complete, and hepatic cell cords is arranged radially around by last veinlet eventually, and portal area is without apparent
The changes such as inflammatory cell infiltration and proliferation of fibrous tissue, bile capillaries is without silt courage.ANIT model groups, liver cell enlargement, cytoplasm are dredged
Pine, some becomes in balloon sample or feather sample becomes, it is seen that focal necrosis, lobuli hepatis profile is unclear, and there are a large amount of inflammatory cells in portal area
Infiltration, bile capillaries structure are destroyed or are lost.Extract A protection group, necrosis of liver cells is reduced compared with model group, and liver cell is swollen
Greatly, cytoplasm is loose, improves in the case where change of balloon sample and change of feather sample, inflammatory cell infiltration mitigates, the accidental normal hair of structure
Canals of Hering.Extract B protection group, necrosis of liver cells are reduced, and liver cell enlargement, cytoplasm is loose, become in balloon sample and feather sample becomes
The case where improve, inflammatory cell infiltration mitigate.Extract C protection group, liver cell enlargement, cytoplasm is loose, and balloon sample becomes and feather
Sample becomes situation and does not significantly improve, it is seen that focal necrosis area reduces, and inflammatory cell infiltration mitigates.After UDCA administration protections,
Necrosis of liver cells is reduced, and liver cell enlargement, cytoplasm is loose, is improved in the case where change of balloon sample and change of feather sample, portal area inflammatory
Cellular infiltration mitigates.
Four, it discusses
ANIT induces mouse intrahepatic cholestasis, can also cause hepatocellular injury, matrix of curing the disease hepatotoxic to animal
The very anthropoid drug hepatitis of performance in Pathological Physiology is widely used in replicating intrahepatic cholestasis model.
The intoxicating of ANIT is related with its metabolite, and under liver P450 enzyme effects, the oxidation of sulphur in ANIT structures is on behalf of for toxic product
Stones in intrahepatic bile duct endothelial cell is attacked, the appearance for causing hyperbilirubinemia and choleresis to reduce.Also cause membrane lipid mistake simultaneously
Oxidation reaction causes degeneration of liver cells downright bad, causes acute intraheptic cholestatic.
In the research of the present invention, preparation method is extracted using ANIT induced mice intrahepatic cholestasis model evaluation differences
The drug effect of rheum officinale, giant knotweed, green peel and hawthorn compound hepatic cholagogic.The experimental results showed that extract A, can significantly reduce ANIT
Induced mice Serum ALT, AST, ALP, T-Bil, D-Bil and TBA are increased.Compared with positive drug UDCA, extract A can be more effective
Ground reduces by two serological index of ALT and AST.Hepatic pathology section shows that extract A protection group, liver is thin compared with model group
Born of the same parents' necrosis significantly reduces, and liver cell enlargement, cytoplasm is loose, improves in the case where change of balloon sample and change of feather sample, inflammatory cell leaching
Profit mitigates.
In conclusion extract A has good protection effect to the liver of cholestasis model mice caused by ANIT.
In addition, referring also to the preparation method of extract A, it is prepared for respectively：
Extract M-1：Giant knotweed 24g, green peel 144g and hawthorn 360g are taken, is extracted using 60% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 24g is added after dry extract, mixing, as carrying
Take object M-1.
Extract M-2：Giant knotweed 720g, green peel 144g and hawthorn 360g are taken, is extracted using 80% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 24g is added after dry extract, mixing, as carrying
Take object M-2.
Extract M-3：Giant knotweed 360g, green peel 24g and hawthorn 360g are taken, is extracted using 60% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 24g is added after dry extract, mixing, as carrying
Take object M-3.
Extract M-4：Giant knotweed 360g, green peel 288g and hawthorn 360g are taken, is extracted using 80% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 24g is added after dry extract, mixing, as carrying
Take object M-4.
Extract M-5：Giant knotweed 360g, green peel 144g and hawthorn 24g are taken, is extracted using 60% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 24g is added after dry extract, mixing, as carrying
Take object M-5.
Extract M-6：Giant knotweed 360g, green peel 144g and hawthorn 720g are taken, is extracted using 80% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 24g is added after dry extract, mixing, as carrying
Take object M-6.
Extract M-7：Giant knotweed 360g, green peel 144g and hawthorn 360g are taken, is extracted using 60% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 2.4g is added after dry extract, mixing, as
Extract M-7.
Extract M-8：Giant knotweed 360g, green peel 144g and hawthorn 360g are taken, is extracted using 80% ethyl alcohol, extracting solution depressurizes back
Solvent is received to thick paste, 100 DEG C is set, dry 5h under -0.1MPa, cools, obtains and Rhubarb Powder 240g is added after dry extract, mixing, as
Extract M-8.
And with reference to the animal experiment method of second part 2.2, extract M-1 protection groups, dosage 2.69g/ are set
kg；Extract M-2 protection groups, dosage 2.69g/kg；Extract M-3 protection groups, dosage 2.69g/kg；Extraction
Object M-4 protection groups, dosage 2.69g/kg；Extract M-5 protection groups, dosage 2.69g/kg；Extract M-6 is protected
Shield group, dosage 2.69g/kg；Extract M-7 protection groups, dosage 2.69g/kg；Extract M-8 protection groups, give
Pharmaceutical quantities are 2.69g/kg, animal experiment method of other operations with second part 2.2.
As a result, it has been found that：Extract M-1 protections group, extract M-2 protections group, extract M-3 protections group, extract M-4 are protected
Shield group, extract M-5 protections group, extract M-6 protections group, extract M-7 protections group, extract M-8 protections group can be significantly
Serum indices rising condition caused by reducing ANIT, difference have statistical significance (P ＜ 0.05), wherein mice serum
There was no significant difference compared with Normal group by AST and ALP (P ＞ 0.05), but still the effect of extract A protection group is most
It is good.Hepatic pathology section shows, extract M-1 protections group, extract M-2 protections group, extract M-3 protections group, extract M-4
Protection group, extract M-5 protections group, extract M-6 protections group, extract M-7 protections group, extract M-8 protection groups, with model
Group is reduced compared to necrosis of liver cells, and liver cell enlargement, cytoplasm is loose, is improved in the case where change of balloon sample and change of feather sample, inflammatory
Cellular infiltration mitigates, the accidental normal bile capillaries of structure, but still the effect of extract A protection group is best.
The above, only presently preferred embodiments of the present invention, not to the present invention in any form with substantial limitation,
It should be pointed out that for those skilled in the art, under the premise of not departing from the method for the present invention, can also make
Several improvement and supplement, these are improved and supplement also should be regarded as protection scope of the present invention.All those skilled in the art,
Without departing from the spirit and scope of the present invention, when made using disclosed above technology contents it is a little more
Dynamic, modification and the equivalent variations developed, are the equivalent embodiment of the present invention；Meanwhile all substantial technologicals pair according to the present invention
The variation, modification and evolution of any equivalent variations made by above-described embodiment, still fall within the range of technical scheme of the present invention
It is interior.
Claims (11)
1. a kind of Chinese medicine composition, effective component raw material include：Giant knotweed, green peel, hawthorn and rheum officinale.
2. Chinese medicine composition according to claim 1, which is characterized in that the effective component raw material of the Chinese medicine composition by
Giant knotweed, green peel, hawthorn and rheum officinale composition.
3. Chinese medicine composition according to claim 1, which is characterized in that the weight between giant knotweed, green peel, hawthorn and rheum officinale
Number proportional region is：0.1-10 parts of 1-30 parts of giant knotweed, 1-12 parts of green peel, 1-30 parts of hawthorn and rheum officinale.
4. a kind of Chinese medical extract, for as described in any one such as claims 1 to 3 Chinese medicine composition as raw material extraction effectively at
Divide and is made.
5. a kind of preparation method of Chinese medical extract as claimed in claim 4, includes the following steps：Take as claims 1 to 3 it
Any one Chinese medicine composition is raw material effective component extracting.
6. preparation method according to claim 5, which is characterized in that the preparation method is selected from next any：(1) it presses
Proportioning takes giant knotweed, green peel and hawthorn, is extracted with ethyl alcohol, extracting solution concentration, dry, obtains and Rhubarb Powder is added after dry extract, mixing, i.e.,
It can；(2) giant knotweed, green peel, hawthorn and rheum officinale are taken according to the ratio, is extracted with ethyl alcohol, and extracting solution concentration, drying obtain dry extract；(3) it presses
Proportioning takes giant knotweed, green peel, hawthorn and rheum officinale, is extracted with water, and filters, and concentrates, dry.
7. preparation method according to claim 6, which is characterized in that the ethyl alcohol is selected from 60%~80% ethyl alcohol；It is preferred that
70% ethyl alcohol.
8. Chinese medicine composition or Chinese medical extract as claimed in claim 4 are used to prepare as described in any one of claims 1 to 3
The purposes of hepatic injury prevention and/or medicine.
9. Chinese medicine composition or Chinese medical extract as claimed in claim 4 are used to prepare as described in any one of claims 1 to 3
Cholestasis prevents and/or the purposes of medicine.
10. Chinese medicine composition or Chinese medical extract as claimed in claim 4 are for making as described in any one of claims 1 to 3
The standby purposes with following any drug：(1) it is horizontal to reduce ALT；(2) it is horizontal to reduce AST；(3) ALP water is reduced
It is flat；(4) it is horizontal to reduce T-Bil；(5) it is horizontal to reduce D-Bil；(6) it is horizontal to reduce TBA；(7) necrosis of liver cells is reduced；(8) improve
The case where liver cell enlargement, cytoplasm loose, in the change of balloon sample and the change of feather sample；(9) mitigate inflammatory cell infiltration.
11. a kind of Chinese medicine preparation, including Chinese medicine composition as described in any one such as claims 1 to 3 of therapeutically effective amount or such as
Chinese medical extract described in claim 4.
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| CN201810748766.6A CN108567843B (en) | 2018-07-10 | 2018-07-10 | Traditional Chinese medicine composition and preparation and application thereof |
| CA3050146A CA3050146C (en) | 2018-07-10 | 2018-08-13 | Traditional chinese medicine herb composition, making thereof, and application thereof |
| PCT/CN2018/100211 WO2020010664A1 (en) | 2018-07-10 | 2018-08-13 | Traditional chinese medicine composition, and preparation and use thereof |
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| CN201810748766.6A CN108567843B (en) | 2018-07-10 | 2018-07-10 | Traditional Chinese medicine composition and preparation and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113521225A (en) * | 2020-04-21 | 2021-10-22 | 上海和黄药业有限公司 | Traditional Chinese medicine composition for treating liver injury and application thereof |
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| CN1557415A (en) * | 2004-02-03 | 2004-12-29 | 上海和黄药业有限公司 | Medicine preparation for treating liver and gallbladder disease and its preparing process |
| CN102085330A (en) * | 2009-12-02 | 2011-06-08 | 程兴顺 | Gallbladder-soothing capsules |
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2018
- 2018-07-10 CN CN201810748766.6A patent/CN108567843B/en active Active
- 2018-08-13 WO PCT/CN2018/100211 patent/WO2020010664A1/en active Application Filing
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1557415A (en) * | 2004-02-03 | 2004-12-29 | 上海和黄药业有限公司 | Medicine preparation for treating liver and gallbladder disease and its preparing process |
| CN102085330A (en) * | 2009-12-02 | 2011-06-08 | 程兴顺 | Gallbladder-soothing capsules |
Non-Patent Citations (1)
| Title |
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| 王莉等: "胆宁片对胆汁瘀积小鼠肝脏转运体及代谢酶基因表达的影响", 《中成药》 * |
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| CN113521225A (en) * | 2020-04-21 | 2021-10-22 | 上海和黄药业有限公司 | Traditional Chinese medicine composition for treating liver injury and application thereof |
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| WO2020010664A1 (en) | 2020-01-16 |
| CN108567843B (en) | 2021-08-31 |
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