CN106727958A - It is a kind of to treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof - Google Patents
It is a kind of to treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof Download PDFInfo
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- CN106727958A CN106727958A CN201611134475.5A CN201611134475A CN106727958A CN 106727958 A CN106727958 A CN 106727958A CN 201611134475 A CN201611134475 A CN 201611134475A CN 106727958 A CN106727958 A CN 106727958A
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- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
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Abstract
Pharmaceutical composition of alcoholic hepatitis and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L aspartic acids as bulk drug, proportioning is formed, routinely various formulations can be made by preparation process, treatment alcoholic hepatitis is evident in efficacy.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating alcoholic hepatitis and its preparation
Method.
Background technology
Alcoholic hepatitis is due to liver damage caused by long-term heavy drinking.With carrying for our people's living standard
The change of high and habits and customs, the drink illness rate of crowd's quantity and AML of China has ascendant trend year by year, it has also become
People's health in one of common liver diseases, serious harm.
The treatment method of alcoholic hepatitis mainly has：Including abstinence from alcohol, improve nutrition, treatment hepatic injury, preventing and treating merging presence
Other hepatopathys, prevent or reverse liver fibrosis progress, promote liver regeneration, reduce complication, improve the quality of living, whole latter stage
Hepatopathy will then carry out liver transfer operation.In the selection for the treatment of liver disease drug, the small natural plants of some toxic and side effects are selected to protect as far as possible
Liver medicine carrys out protect liver, because the poisonous side effect of medicine of some treatment liver diseases is larger, can cause the secondary injury to liver.Arrive
So far, a kind of medicine of more efficient treatment alcoholic hepatitis is not yet found.
Silk tree：It is the flower of Magnoliacea plant silk tree.5~June plucks, and dries.【Proterties】Proterties differentiates that flower is slightly in
Umbrella shape, projecting bell or irregular spherical, 2-3cm long, diameter 1-2cm, outside kermesinus to brown purple.Sepal 3, length is fallen
It is avette, 1.5cm, about 8mm wide are about, there is graininess projection on two sides.
6, petal, obovate is crispaturaed, and outer row 3 are larger, is about 2cm, and about 1.2cm wide, outer surface base portion shows graininess
Projection, inner surface is smooth.Matter is thick, hard crisp.Stamen is most, helical arrangement, in rosette-stape.Gynoecium carpel 7-8, from life, the heart
The long and narrow prismatic of skin, puce or sepia, there is small nodules.The anthocaulus dark brown of retention.Air exhaustion, fragrance is lightly seasoned.It is complete with flower
Whole, aroma dense person be preferred.【Chemical composition】The oxygen-containing micheline A of stem（oxoushinsunine）, salicifoline
（salicifoline）, magnoflorine（magnoflorine）, stephanine（stepha-nine）, magnococline
（magnococline）, light interest rattan alkali（), stepharine 10- hydroxyls anonaine（anolobine).Leaf contains volatile oil
（25 kinds）.【Nature and flavor】It is pungent；It is warm in nature.【Indication】Promoting the circulation of qi dissolving stasis；Cough-relieving stop-band.The main distending pain in hypochondrium；Swollen breasts；Hernia pain；
Abdominal mass；Traumatic injury；Insomnia；Cough and asthma；Leukorrhea.【Take passages】《Chinese book on Chinese herbal medicine》.
Chrysanthemum root：It is the root of feverfew chrysanthemum.Autumn, winter excavation root, clean, and using fresh herb or dry.【Original shape state】Chrysanthemum is for many years
Sward sheet, 60-150cm high.Stem is upright, branch or not branch, by pubescence.Leaf alternate；There is short handle；Blade is avette to lanceolar,
5-15cm long, pinniform is shallow to be split or partly splits, base portion wedge shape, below by white pubescence.Flower head diameter 2.5-20cm, size is not
One, single or several collection are born in stem branch top；Phyllary multilayer, outer layer green, bar shaped, edge film quality, outside is by pubescence；Ligule
Floral white, red, purple or yellow.Achene agensis.Florescence 9-11.【Chemical composition】Root kassinin kinin containing cell
(cytokinins)。
【Nature and flavor】Bitter；It is sweet；It is cold in nature.【Indication】Diuresis；It is clearing heat and detoxicating.The main retention of urine；Abscess of throat；Carbuncle swells malignant boil
Poison.【Take passages】《Chinese book on Chinese herbal medicine》.
Toad skin：The hirudo leech of internal organ are removed for Bufonidae animal bufo gargarizans Cantor or Bufo melanostictus.Summer, autumn catch, first
The dried venom of toads is adopted, it is then dirty except boning, body cavity is strutted and is dried.【Proterties】Proterties differentiate, this product be in flat, thickness about 0.5mm,
Head is slightly in obtuse triangle.Four limbs flexing is protruding.Outer surface is coarse, back taupe, is furnished with the excipuliform for differing in size and dashes forward
Rise, color is deeper；Belly yellow-white, wart point is relatively fine.Head is smoother, and substantially, in oval long, eight shape are arranged ear rear gland.
Inner surface canescence, has with product size Yi County with scrobicula point with wart point corresponding section.After more complete person's four limbs flattening, between forelimb toe
Without web；Hind leg is long and sturdy, there is web between toe, and matter is tough, is not easily broken.The micro- raw meat of gas.The micro- fiber crops of taste.【Chemical composition】Skin it is special into
Point, it is typically similar to the dried venom of toads, referring to dried venom of toads bar.The skin of another toad B.vulgaris formosus contains bufothionine
(Bufothionine), bufotenine (Bufotenine), bufotenidine (Bufotenidine)；Gamabufotalin (or
Gammabufogenin, Gamabufotalin), invite this bufolin (Besibufogenin), cinobufotalin
(Cinobufotalin), bufalin (Bufalin), bufotalidin (Bufotalidin or Hellobrigenin), remote China
Bufagin (Teloeiuobufagin), desacetylcinobufagin (Desacetyleinobufagin), desacetylbufotalin
(Desacetylbufotalin)；Gammabufotalininol (Gamabufotalininol) and a kind of reddish black color substance, toad
Pigment (Bufochrome), i.e. three hydroxypropyl butterflies day rope (Trihydroxypropylpterisin).【Pharmacological action】1. pair exempt from
The effect of epidemic disease function, cinobufagin, the depth of water preparation extracted from the full skin of bufo gargarizans Cantor.Cinobufagin can dramatically rising normally with
Immunosupress and the content of sensitized mice serum IgG, have facilitation to body fluid cell and Nonspecific immunity function.
0.1ml/ cinobufagin injection of intraperitoneal injection, can significantly improve total white blood cells after continuous 14 days, the IgG for increasing mouse contains
The price raising of anti-" H " agglutination titer that amount and family exempt from, but percentage to T lymphocytes only increases by 19%.Intraperitoneal injection gives
Then cinobufagin does not influence 10ml/ (kdd) × 7d on Normal Mouse Serum IgG content, can significantly improve mouse peritoneal macrophage
Cell phagocytic percentage and phagocytic index.Also found simultaneously, the leucocyte that magnificent ten days element causes to endoxan declines, reduces lymph
The percentage of cell enters IgG reductions slow angle and antagonism, can also improve the body serum IgG antibody water under antigenic stimulus
It is flat.2. the inhibitory action of pair hepatitis B, cinobufagin can substantially press down the duplication of DHBV and have stronger antivirus action.With
1ml/kg and 3ml/kg cinobufagin intramuscular injections give has infected hepatitis type B virus（DHBV）Sheldrake, 3ml/kg cinobufagins pair
Duck liver pathology has clear improvement, but has 3 sheldrake serum DHBV DNA contents slightly to go up after drug withdrawal, points out work thing to fail
Full suppression DHBV is up to the viral superhelix of destruction, while clinical observation and the discovery using the experiment of 2215 cells in vitro, magnificent
The anti-DHBV curative effects of toad element increase and improve with dosage.3. antitumaous effect, orally gives the significant system of changing of 20g/kg cinobufagins small
Mouse knurl（S180）, rat liver cancer solid type（Heps）, mouse net pass through a cytoma（L2）Etc. tumour growth, inhibiting rate up to 30% with
On；And 8g/kg and 3g/kg cinobufagins have certain inhibitory action but not significant to the strain of 3 kinds of knurls, while the soft and moist gloss of mouse dorsal body setae,
Than blank group, endoxan group substantially, show that suppression tumour growth effect is strong and weak has a certain amount to imitate pass with dosage for increased weight
System, also points out it when tumor suppression is given birth to, and does not injure normal cell.It is another to have been reported that compound cutis bufonis capsule has radiation synergy and certain journey
The radioactive side effect of defence of degree.The μ g of A Ruina bufagins 10 raised from new fresh toad skin are thin to mouse P388 leukaemia
The inhibiting rate of intracellular growth is 52%.4. raising blood pressure effect, 300 μ g A Ruina bufagins can make rat blood pressure raise 5.33kPa
(40mmHg), maintains 40min；Blood pressure raises 3.33kPa (25mmHg) when with 100 μ g, maintains 12min.5. toxicity, abdominal cavity
Injection cinobufagin injection 20.4mg/kg（Equivalent to 500,100 times of quantity）, the next day be administered once, interval weighs 1 for 6 days
It is secondary, 20 days altogether, do not it is found that electrocardiogram and histology have substantially change, but during blood examination, it is found that heavy dose of group is omited in platelet count
Raise and leukocyte count is decreased slightly as low phenomenon, two dosage increase to the average weight of rat in development certain inhibitory action.
Still need on dosage and course for the treatment of length give certain attention when illustrating cinobufagin application and continue observational study.【Nature and flavor】Taste
It is bitter；It is cool in nature；It is poisonous.【Return through】The heart；Lung；Spleen；Large intestine channel.【Indication】It is clearing heat and detoxicating；Inducing diuresis for removing edema.Main ulcer；Pyogenic infections；Scrofula
Scrofula；Swollen scrofula；Infantile malnutrition due to digestive disturbances or intestinalparasites abdominal distension；Chronic bronchitis.【Take passages】《Chinese book on Chinese herbal medicine》.
Zlatostema involucratum Franch. Et savat：It is the herb of contrayerva Zlatostema involucratum Franch. Et savat.Spring, summer, autumn are tapped, and clean, and chopping or is dried at using fresh herb.
【Proterties】Proterties differentiates stem length about 40cm.Leaf shrinkage, flattens oblong of retreading, and tip is sharp, and band shape of tail, base portion is oblique, semicircle
Shape, more than marginal center there is rough sawn tooth.Cyme Chang Jicheng heads；1-10 fasciation of male flower, inflorescence has handle；Female flower 8-12
Fasciation, stockless.Achene is avette, tiny.Gas is micro-, mildly bitter flavor.【Nature and flavor】Slight bitter；Cold nature.【Return through】Large intestine；Liver；The spleen channel.【Work(
Can cure mainly】It is clearing heat and detoxicating；Dispelling wind and eliminating dampness；Inducing diuresis for removing edema；Promoting blood circulation and stopping pain.Main dysentery；Hyperpyrexia and infantile convulsion；Yellow subcutaneous ulcer；Arthralgia pain due to rheumatism；
Oedema；Stranguria；Amenorrhea；Sore swells；Mumps；Herpes zoster；Venomous snake bite；Traumatic injury；Fracture.【Take passages】《Chinese book on Chinese herbal medicine》.
Lombricine（Lombricine）：Molecular formula：C6H15N4O6P,Molecular weight：270.18, CAS accession number：625-20-7
(18416-85-8).Density：1.839g/cm3（Calculated value）.Boiling point：540.924°C at 760 mmHg（Calculated value）.Flash-point：
280.941°C（Calculated value）.
L-Aspartic acid（L-Aspartic Acid）：Molecular formula：C4H7NO4,Molecular weight：133.10, CAS accession number：
6899-03-2 (27881-03-4).Density：1.5±0.1g/cm3（Calculated value）, 1.66（Experiment value）.Boiling point：264.1±
30.0°C at 760 mmHg（Calculated value）.Flash-point：113.5±24.6°C（Calculated value）.Solubility：Soluble to 100
mM in 1eq. NaOH.Fusing point：300°C（Experiment value）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of drug regimen of effective treatment alcoholic hepatitis
Thing and preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the pharmaceutical composition of the treatment alcoholic hepatitis be：
The weight portion stair of 3655-3755 weight portion toad skin of the weight portion chrysanthemum of silk tree 850-950 root 3055-3155
The weight portion of 102-112 weight portion L-Aspartic acid of careless 7655-7755 weight portion lombricine 55-65.
The pharmaceutical composition for the treatment of alcoholic hepatitis is preferably used in, is made up of the bulk drug of following weight portion：
The weight portion earthworm of 900 weight portion chrysanthemum root of silk tree, 3,705 3105 weight portion Zlatostema involucratum Franch. Et savat of weight portion toad skin 7705
The weight portion of 07 weight portion L-Aspartic acid of phosphatidase 1 60.
A kind of pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that pharmaceutical composition can be using the normal of galenic pharmacy
Rule method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine
Treatment alcoholic hepatitis medicine.
A kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：The weight portion toad skin of the weight portion chrysanthemum of silk tree 850-950 root 3655-3755
The weight portion L-Aspartic acid of 3055-3155 weight portion Zlatostema involucratum Franch. Et savat, 7655-7755 weight portion lombricine 102-112
55-65 weight portions；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that make as follows
It is standby：
The composition and weight portion of bulk drug be：The weight portion of 900 weight portion chrysanthemum root of silk tree, 3705 weight portion toad skin 3105
The weight portion of 7705 weight portion lombricine of Zlatostema involucratum Franch. Et savat, 107 weight portion L-Aspartic acid 60；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that pharmaceutical composition can be used
The conventional method of galenic pharmacy prepares piece agent or capsule or dripping pill.
A kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that pharmaceutical composition and chemical drugs
Or Chinese medicine composition treatment alcoholic hepatitis medicine.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof
Treat alcoholic hepatitis pharmaceutical composition bulk drug composition and weight portion be：The weight portion chrysanthemum of silk tree 900
The weight portion L-Aspartic acid of 3,705 7705 weight portion lombricine of weight portion toad 3105 weight portion Zlatostema involucratum Franch. Et savat of skin of root 107
60 weight portions；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof
Treat alcoholic hepatitis pharmaceutical composition bulk drug composition and weight portion be：The weight portion chrysanthemum of silk tree 850
The weight portion L-Aspartic acid of 3,755 7755 weight portion lombricine of weight portion toad 3055 weight portion Zlatostema involucratum Franch. Et savat of skin of root 102
65 weight portions；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof
Treat alcoholic hepatitis pharmaceutical composition bulk drug composition and weight portion be：The weight portion chrysanthemum of silk tree 950
The weight portion L-Aspartic acid of 3,655 7655 weight portion lombricine of weight portion toad 3155 weight portion Zlatostema involucratum Franch. Et savat of skin of root 112
55 weight portions；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
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 310g of Example 1, adds starch 100g, mixes, and granulation is dried, plus microcrystalline cellulose 35g, stearic
Sour magnesium 3g, mixes, and is pressed into 1000, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 308g of Example 2, adds starch 84g, mixes, and granulation is dried, whole grain, adds appropriate magnesium stearate,
Mix, encapsulated 1000, obtain final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 193g water-baths and boil molten, add the pharmaceutical composition 14g of embodiment 3, fully stir
Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 5 DEG C, and drip internal-and external diameter is 7.0/
2.0 (mm/mm), drip is 2.5cm away from liquid level, and drop speed is optimum condition with every point 61 drop, and the cold of dripping pill surface is blotted with cotton
Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7：Treat the pharmaceutical composition of alcoholic hepatitis
Treat alcoholic hepatitis pharmaceutical composition bulk drug composition and weight portion be：
250 weight portion chrysanthemum root of silk tree, 4,500 42 weight portion of weight portion toad 2105 weight portion lombricine of skin L- days
The weight portion of winter propylhomoserin 50.
Embodiment 8：Treat the pharmaceutical composition of alcoholic hepatitis
Treat alcoholic hepatitis pharmaceutical composition bulk drug composition and weight portion be：
200 weight portion chrysanthemum root of silk tree, 4,550 47 weight portion of weight portion toad 2055 weight portion lombricine of skin L- days
The weight portion of winter propylhomoserin 45.
Embodiment 9：Treat the pharmaceutical composition of alcoholic hepatitis
Treat alcoholic hepatitis pharmaceutical composition bulk drug composition and weight portion be：
300 weight portion chrysanthemum root of silk tree, 4,450 37 weight portion of weight portion toad 2155 weight portion lombricine of skin L- days
The weight portion of winter propylhomoserin 55.
Experimental example 1：Treat the experimental study of alcoholic hepatitis
1 data and method
It is special that whole 85 of 1.1 physical data are the 2 months Shandong ProvinceQianfoshan Hospital GI Medicines in March, 2014-2015 year
Family's outpatient service (51) and GI Medicine are in hospital (34) patient, are randomly divided into 2 groups.Treatment group 43, man 36, female 7；Age
25~71 years old, average (40.3 ± 1.6) year；The course of disease 1.8~6.6 years, average (4.3 ± 0.7) year.Control group 42, man 35,
Female 7；26~70 years old age, average (4 1.2 ± 2.1) year；The course of disease 1.6~6 years, average (4.4 ± 0.8) year.2 groups general
Not statistically significant (the P of data comparing difference>0.05), with comparativity.
1.2 case selections
1.2.1 " the alcohol that diagnostic criteria is revised with reference to Chinese Medical Association's hepatopathy branch fatty liver and AML group
Property hepatopathy practice guidelines " (revised edition in 2010) are made a definite diagnosis.
1.2.2 1. inclusive criteria has a long-term alcohol history, generally more than 5 years, converts into amount of alcohol male >=40g/d, and women >=
There is heavy drinking history in 20g/d, or 2 weeks, convert into amount of alcohol>80d；2. clinical symptoms, sign：Upper right abdominal distention and pain, poor appetite,
Weak, weight mitigates, jaundice etc., and some patientss have heating, leukocytosis (mainly neutrophilic leukocytosis), exactly like
Bacterial infection, state of an illness severe one can have neuropsychic symptom and spider angioma, liver palms etc. to show.3. serum aspartat amino turns
Move enzyme (AST), ALT (ALT), the glutamyl transferases of r mono- (r-GT), total bilirubin (TBiL), fibrin ferment
The index such as former time (PT) and mean corpuscular volume (MCV) is raised；4. liver ultrasound, CT have looked into typical performance.
1.2.3 exclusion standard has Hepadna Virus to infect and medicine, toxic liver injury and autoimmune liver disease.According to
It is poor from property, the self termination course for the treatment of or do not make whole observer.
1.3 treatment methods
1.3.1 control group reduced glutathione (Kunming Jida Pharmaceutical Co., Ltd., Chinese medicines quasi-word H20030427)
2.4g, adds 5% glucose injection 250mL, drip-feed that one time a day；Polyene Phosphatidylcholine capsule [essentiale, Sai Nuo
Luxuriant and rich with fragrance (Beijing) pharmaceutical Co. Ltd, Chinese medicines quasi-word H20059010] 456mg, it is oral that 3 times a day；Metadoxine (Shandong all medicine together
Industry Co., Ltd, Chinese medicines quasi-word H 20060280) 0.5g, daily 2 times are oral.2.5 months are taken medicine continuously, and is equipped with support to the ill and treated
Method.Drug therapy will advise patient's abstinence from alcohol simultaneously, and psychological counseling, attention control abstinence syndrome are carried out during abstinence from alcohol.Plus
Strong nutritional support, there is provided high protein, low fat diet.
1.3 .2 treatment groups give the oral pharmaceutical composition on the basis of control group treatment（The drug regimen of embodiment 1
Thing lot number 20140113）, each 1.5g, 2 times a day.Divide and take for 2 times sooner or later.
12 groups of the .3.3 courses for the treatment of carry out statistics efficacy analysis after treating 2.5 months.
1.4 observation index and method observe ALT, AST, r-GT, PT, hyaluronic acid (HA), m types before and after 2 groups of treatments
Precollagen (PC III) and Laminin lens (LN), B ultrasonic, CT situations of change.
1.5 criterion of therapeutical effect clinical recoveries：Clinical symptoms, sign are disappeared, and Hepatic enzyme index, blood fat are down to normally, color
Super or CT examination liver morphology and essence recover normal；It is effective：Clinical symptoms, sign significantly take a turn for the better, and Hepatic enzyme index declines
>=50%, blood fat is significantly improved, and color ultrasound or CT examination are reduced more than 2 ranks, are reverted to slightly from severe；Effectively：Clinical condition
Shape, sign take a turn for the better, and Hepatic enzyme index declines >=30%, and blood fat makes moderate progress, and color ultrasound or CT examination reduce by 1 rank；It is invalid：
Above-mentioned standard person is not reached.
1.6 statistical method application SPSS11.0 statistical packages carry out statistical analysis, and data are first through normal state point
Cloth and homogeneity test of variance, do not meet the data frequency disribution statistical analysis of normal distribution, are examined with nonparametric during heterogeneity of variance
Test, with mean ± represent, two sample datas compare using t inspections continuous data, and the comparing of enumeration data rate is checked using x,
With P<0.05 is that difference is statistically significant.
2 results
2.1 2 groups of comparitive studies are shown in Table 1.
12 groups of comparitive studies of table
| Group | Number of cases (n) | Recovery from illness | It is effective | Effectively | It is invalid | Total effective rate (%) |
| Treatment group | 43 | 21 | 11 | 6 | 5 | 88.37* |
| Control group | 42 | 10 | 7 | 15 | 10 | 76.20 |
From 1,2 groups of statistically significant (P of total effective rate comparing difference of table<0 .0 1), treatment group's curative effect is better than right
According to group.
The GT of ALT, AST, r mono- and PT is relatively shown in Table 2 before and after 2.2 2 groups of treatments.
Table 2
With this group before treatment, * P<0.05；Compare with after control group treatment, △ P<0.05
(P is reduced from ALT, AST, r-GT and PT after 2,2 groups of treatments of table<0.05), and treatment group reduce better than control
Group (P<0.05).
HA, PC1II and LN are relatively shown in Table 3 before and after 22 groups of .3 treatments.
HA, PC III and LN compares before and after 32 groups of treatments of table
With this group before treatment, * P< 0.05；Compare with after control group treatment, △ P<0.05.
(P is reduced from HA, PC111 and LN after 3,2 groups of treatments of table<0.05), and treatment group reduce be better than control group
(P <0.05 )。
Experimental example 2：Model case
By XX, man, 40 years old, the patient in feeling malaise occur without clear and definite inducement before 2 months, be with double lower limb especially it is notable,
With abdominal distension after meal and anorexia, without Nausea and vomiting, without spitting blood, melena, liver pain is in continuation.Once at home voluntarily
The medicine of oral some treatment hepatopathys, but taking a turn for the better does not occur in the state of an illness, later to hospital for treatment.Hospital diagnosis are Alcoholic
Hepatitis, on March 20th, 2015 starts the oral pharmaceutical composition（The pharmaceutical composition lot number 20140113 of embodiment 1）, every time
1.5g, 2 times a day.Divide and take for 2 times sooner or later.Above-mentioned symptom is relieved after one week of continuous treatment.Continuous medication 2 weeks
Afterwards, above-mentioned symptom is all eliminated.In addition to r--GT drops to 225u/L by 1150u/L, other are in normal range (NR) for check liver function
It is interior.Continuous medication is checked after 4 weeks, and liver function recovers normal completely.Continuous medication is checked after 4 months：Liver function is completely normal.
XX high, man 38 years old, suffers from alcoholic liver with the concurrent cholecystitis of drug hepatitis, liver function test：Glutamic-pyruvic transaminase ALT
Increase, glutamic-oxalacetic transaminease AST also hates height, total bilirubin and globulin also all increase, bitter taste halitosis, do not feel like eating, blurred vision,
Hair loss, waist-leg are powerless, chest and abdomen shouting pain, urine are yellow less, hard stool on Mays 21st, 2015 start the orally pharmaceutical composition（It is real
Apply the pharmaceutical composition lot number 20140113 of example 1）, each 1.5g, 2 times a day.Divide and take for 2 times sooner or later.The medicine of 40 days is taken
Symptom is taken a turn for the better, and liver function test is taken 60 days, drug hepatitis, cholecystitis, alcoholic liver full recovery, liver again afterwards close to normal
Function normal table.
Lee XX, male, 45 years old, because " liver pain 6 months " goes to see a doctor.Patient mental, appetite can.Without hepatopathy man
Race's history, mother is diabetic.Patient drinks 20 years, about 150-200g/d;B ultrasonic of having a medical check-up prompting fatty liver 5 years.Have a medical check-up：Blood
Pressure 150/90mmHg, body weight 78kg, height 170cm, waistline 102cm, body mass index is about 27.The traditional Chinese medical science is had a medical check-up：Dark tongue quality, tongue body
It is fat, there is indentation, tongue is greasy in vain, wiry and rolling pulse.Laboratory examination：Liver function mile abnormality (ALT:121U/L, TBil：21.9mmol/L, it is remaining
It is normal), fasting blood-glucose：6.42mmol/L, after the meal hours blood glucose 11mmol/L, TG：11.19mmol/L, insulin assay：
23.18, color ultrasound prompting：Fatty liver (moderate), anti-HCV is negative, and HbsAg is negative.It is diagnosed as：Alcoholic fatty liver hepatitis, height
1 grade of blood pressure diseases, hypertriglyceridemia, impaired glucose tolerance.There is stagnation of liver-QI with deficiency of the spleen from the aspect of the traditional Chinese medical science.August 10 in 2015
Start the oral pharmaceutical composition day（The pharmaceutical composition lot number 20140113 of embodiment 1）, each 1.5g, 2 times a day.Divide sooner or later
Take for 2 times.After oral 30 days of patient, blood pressure 120/80mmHg or so, Body weight loss 2kg, waistline reach 98cm, and liver function is gradually
Recover (ALT:62U/L, TBIL:15.1umol/L), blood fat (TG：2.88mmol/L), insulin assay：17.62, fasting blood-glucose
5.53mmol/L, after the meal 2 hours blood glucose 7.8mmol/L.When continuing oral 2 first quarter moons, blood pressure stabilization in 120/80mmHg or so,
Body weight declines 2.5kg again, and waistline reaches 92cm, and tongue nature is light red, thin white fur of tongue, and indentation is reduced, veins string.Liver function is normal
(ALT:31U/L, TBIL:15.4umol/L), blood fat (TG：1.71mmol/L), insulin assay：14.31, fasting blood-glucose
5.34mmol/L, after the meal 2 hours blood glucose 7.3mmol/L.Patient continues the oral medicine to June, and body weight gradually decreases down 70kg,
Waistline drops to 90cm, and check color ultrasound still points out liver and gall pancreas spleen no abnormality seen, and liver function continues normally, blood fat (TG：
1.31mmol/L)。
Claims (8)
1. a kind of pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that be made the composition of the bulk drug of the pharmaceutical composition
It is with weight portion：
The weight portion stair of 3655-3755 weight portion toad skin of the weight portion chrysanthemum of silk tree 850-950 root 3055-3155
The weight portion of 102-112 weight portion L-Aspartic acid of careless 7655-7755 weight portion lombricine 55-65.
2. a kind of pharmaceutical composition for treating alcoholic hepatitis according to claim 1, it is characterised in that be made the medicine group
The composition and weight portion of the bulk drug of compound be：
The weight portion earthworm of 900 weight portion chrysanthemum root of silk tree, 3,705 3105 weight portion Zlatostema involucratum Franch. Et savat of weight portion toad skin 7705
The weight portion of 07 weight portion L-Aspartic acid of phosphatidase 1 60.
3. a kind of pharmaceutical composition for treating alcoholic hepatitis according to claim 1, it is characterised in that pharmaceutical composition can
Piece agent or capsule or dripping pill are prepared with using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating alcoholic hepatitis according to claim 1, it is characterised in that pharmaceutical composition with
The treatment alcoholic hepatitis medicine of chemical drugs or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：The weight portion toad skin of the weight portion chrysanthemum of silk tree 850-950 root 3655-3755
The weight portion L-Aspartic acid of 3055-3155 weight portion Zlatostema involucratum Franch. Et savat, 7655-7755 weight portion lombricine 102-112
55-65 weight portions；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis according to claim 5, it is characterised in that press
It is prepared by following steps：
The composition and weight portion of bulk drug be：The weight portion of 900 weight portion chrysanthemum root of silk tree, 3705 weight portion toad skin 3105
The weight portion of 7705 weight portion lombricine of Zlatostema involucratum Franch. Et savat, 107 weight portion L-Aspartic acid 60；
Preparation method：
（1）Silk tree, chrysanthemum root, toad skin, Zlatostema involucratum Franch. Et savat, lombricine, L-Aspartic acid are taken by bulk drug proportioning, is mixed, with weight
The amount ethanol of percent concentration 30% takes as solvent in 63 DEG C of temperature extractions, and extraction time is 12 times, and each extraction time is 14 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 1.16 is reduced to, is filtered, liquid is first washed with water, then use percentage by weight by LSA-40 large pore resin absorption columns
The ethanol solution of concentration 46% elutes LSA-40 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 46%, 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 51% as solvent, heating and refluxing extraction 6 times is carried every time
The time is taken for 6.6 hours, each solvent load is 11 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 1.16 is concentrated into, filtered, liquid is first washed with water, then use weight by DM11 large pore resin absorption columns
The ethanol solution of percent concentration 69% elutes DM11 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 69%,
Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis according to claim 5, it is characterised in that medicine
Compositions can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method of the pharmaceutical composition for treating alcoholic hepatitis according to claim 5, it is characterised in that medicine
Compositions and chemical drugs or Chinese medicine composition treatment alcoholic hepatitis medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611134475.5A CN106727958A (en) | 2016-12-10 | 2016-12-10 | It is a kind of to treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611134475.5A CN106727958A (en) | 2016-12-10 | 2016-12-10 | It is a kind of to treat pharmaceutical composition of alcoholic hepatitis and preparation method thereof |
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| Publication Number | Publication Date |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115778957A (en) * | 2022-11-04 | 2023-03-14 | 天津中医药大学 | Application of cepharanthine and composition containing cepharanthine in preventing or treating alcoholic liver disease |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105535095A (en) * | 2016-01-25 | 2016-05-04 | 济南星懿医药技术有限公司 | Medicine composition for treating liver ascites |
| CN105535263A (en) * | 2016-01-25 | 2016-05-04 | 济南星懿医药技术有限公司 | Medicine composition for treating ascites due to cirrhosis and preparation method thereof |
-
2016
- 2016-12-10 CN CN201611134475.5A patent/CN106727958A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105535095A (en) * | 2016-01-25 | 2016-05-04 | 济南星懿医药技术有限公司 | Medicine composition for treating liver ascites |
| CN105535263A (en) * | 2016-01-25 | 2016-05-04 | 济南星懿医药技术有限公司 | Medicine composition for treating ascites due to cirrhosis and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115778957A (en) * | 2022-11-04 | 2023-03-14 | 天津中医药大学 | Application of cepharanthine and composition containing cepharanthine in preventing or treating alcoholic liver disease |
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Application publication date: 20170531 |