CN108888686A - It is a kind of to treat stomachache, hypochondriac pain, gastroenteritic ulcer, the Chinese medical extract of depression and its preparation method and application - Google Patents
It is a kind of to treat stomachache, hypochondriac pain, gastroenteritic ulcer, the Chinese medical extract of depression and its preparation method and application Download PDFInfo
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Abstract
Stomachache, hypochondriac pain, gastroenteritic ulcer, the Chinese medical extract and preparation method thereof of depression and its application are treated the present invention provides a kind of.Using green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae as raw material, weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：3：3：3：6.Providing 6 kinds of preparation methods is respectively：1) water extraction method；2) alcohol extracting is followed the example of；3) water extraction and alcohol precipitation method；4) water, which extracts, combines macroporous resin purification method；5) alcohol extracting combination macroporous resin purification method；6) classical decoction preparation method (classics recipe matter basis).The present invention extracts the process optimization of object to the party, is prepared into all kinds of preparations of Chinese medicine, and carries out defining for active part main component." Liver-Comforting Decoction side " traditional Chinese medicine extraction composition oral preparation provided, and the product of preparation is detected, the Active regenerator clear and definite of " Liver-Comforting Decoction side " Chinese medical extract is embodied, content is higher.
Description
Technical field
The present invention relates to a kind of stomachache, hypochondriac pain, gastroenteritic ulcer, Chinese medical extract of depression for the treatment of is (following also referred to as to change liver
Decoct formula extraction) and its preparation method and applications, belong to technical field of Chinese medicine.
Background technique
Traditional Chinese medicine is that the quintessence of Chinese culture of China is especially derived from the applicating history that China has thousands of years《Jing Yue's complete work》,《Wound
Cold opinion》,《The formulary of peaceful benevolent dispensary》,《Synopsis Golden Chamber》The classics recipe of equal monumental works, by the clinical trial of nearly one thousand years,
It is proved to be scientific and effective thus flourishing long time by succession extensively.Compared to modern Chinese herbal medicine preparation, conventional formulation is commonly deposited
The disadvantages of technique falls behind, and unstable quality, technical level are low, prouctiveness is insufficient.
Liver-qi attacking stomach also known as syndrome of incoordination between liver and stomach, stagnation of liver-QI and stomach-QI card.It is liver dysfunction, perverse and unreasonable manner violates stomach, stomach Qi rising to be showed
Syndrome.It is mostly unsuccessful by feelings will, qi depression transforming into fire or cold-evil's enemy intrusion or invasion liver stomach and fall ill.Clinic is based on chest side of body gastral cavilty turgor pain
It shows.It is common in chronic gastritis, gastroduodenal ulcer, the stomach mind of epigastric pain, vomiting, hiccup, hypochondriac pain and modern medicine
Through diseases such as functional disease, chronic hepatitis, cirrhosis.Under physiological conditions, the catharsis function of liver can promote the transporting of taste, taste
Transportation capabilities facilitate the catharsis of liver again, the two interdepends, mutually coordinated.Under disease event, the two also influences each other, such as
The depressed impariment of the liver, liver dysfunction, perverse and unreasonable manner violates stomach, stomach Qi rising, and liver-qi attacking stomach is caused to be demonstrate,proved；If stomach Qi is first empty, irritability is contained partially relatively, is multiplied
In taste, liver-qi attacking stomach can also be caused to demonstrate,prove.The former is excessive wood over-restricting earth, and the latter is deficient earth being subjugated by wood.Mainly there is chest side of body gastral cavilty turgor
Pain, hiccup belch are vomitted, or see noisy acid regurgitation, irritable, thin white fur of tongue or thin Huang, veins string or chord number etc..Hepatic depression
Knot, catharsis dereliction of duty, then be shown in that feelings will is gloomy, is apt to sigh or irritable, distending pain in the chest and hypochondrium；Liver-qi perversion, the stagnation of the circulation of vital energy is on stomach, stomach Qi
It is inverse, then show as epigastric distending pain, hiccup belch；Heat in obstruction of the circulation of vital energy stomach, it is seen that water brass.Difference whether because of qi depression transforming into fire
Not, tongue fur can be thin white or thin Huang, veins string or chord number.If liver depression is with the passing of time, qi depression transforming into fire, then it is acute to can behave as chest side of body gastral cavity pain
It is strong, dysphoria, dry mouth with bitter taste, red tongue with yellowish fur, wiry and frequent pulse.The liver-yin if internal heat is burnt consumes the saliva that injures one's stomach, then often has side of body rib indistinctly to make
Bitterly, epigastric distending pain, anorexia, dry, stool is dry, the red less fur of tongue or in have the performance of the deficiency of Yin such as crackle.If liver-qi attacking stomach, the stagnation of the circulation of vital energy
It is not all right, it with the passing of time influences blood operation and causes blood stasis, then showing as side of body rib gastral cavity pain fixes, and stabbing opthalmalgia very then damages train of thought,
And see spitting blood melena.
Currently, western medical treatment chronic gastritis is mainly the infection for removing helicobacter pylori, promotes WeiDongLi Capsule, protection stomach viscous
Film.Traditional Chinese medicine has its unique advantage in treatment chronic gastritis, dispels the cause of disease with Chinese medicine classical prescription to care for shield stomach Qi as this
For mark, notice that irritability tune reaches, acupuncture and drugs flexibly carry out dialectical treatment, can obtain satisfied curative effect.Treatment chronic gastritis at present
Chinese medicine there are many, but the Chinese patent drug for being directed to liver-fire invading the stomach type chronic gastritis there is no report.
Currently, whole world mental disease has become social concern outstanding, depression as a kind of serious phrenoblabia,
Its disease incidence has leapt to the 4th of the big common disease in the world ten.From the point of view of the burden of disease, depression has accounted for entire disease
The 6.2% of disease burden will will become the second that most expensive disease is paid in world wide up to 10.0% to the year two thousand twenty, only secondary
In coronary heart disease.Depression is also that other diseases are incomparable to pain caused by personal and family and loss.So energetically plus
The exploitation of strong medicament for treatment of depression has important social effect.
Modern medicine thinks that this disease cause of disease is very complicated, not yet illustrates completely so far.Its cause of disease can be summarized as biology and society
It can physiological mechanism.Biological reasons research shows that mainly with heredity, neuroendocrine, the biochemical (monoamine neurotransmitter of nerve
Theory etc.) mechanism is related.Treatment to this disease, commonly using traditional antidepressants in the past is mainly chemical synthetic drug, there is tricyclic
There is many not though can be relieved symptom to varying degrees in class antidepressant (TCA), monoamine oxidase inhibitors (MAOI)
Foot and disadvantage.First, these antidepressants do not prove effective to a part of refractory depression；Second, original conventional anti-depressant disease
Adverse reaction is more in treatment, is resistant to some people not.For example, cholinolytic side effect and cardiovascular secondary work in tricyclic antidepressants
With influence and cheese reaction etc. of the MAOI drug to liver function for another example can be such that treatment interrupts；Third, conventional antidepressant agents work
Low, on the whole need for when could generate antidepressant effect within 2-3 weeks.Action, which slowly will affect severe patients with depression, effectively to be controlled
Treatment opportunity, it is difficult to control symptom, be allowed to lose the confidence for the treatment of.
Since the nineties, there are some novel antidepressants, agent inhibitor is mainly absorbed with highly selective serotonin
For first choice, Clovoxamine, horse Clofibride, Prozac, venlafaxine new, Sertraline (Zoloft) etc. are commonly used, but there are different journeys
The side effect of degree, prolonged application easily cause serious complication.As it can be seen that in relation to the synthetic drug and biological agent kind for the treatment of this disease
Class is various, but because effect is limited and inaccurate, toxic side effect and adverse reaction more than or it is expensive be difficult to the problems such as universal, arrive
So far, Western medicine circle not yet finds the ideal medicament of anti-disease of effecting a permanent cure.Therefore, the hot spot of Recent study is turned to integrally-regulated
For the traditional Chinese medicine of characteristic, motherland's medicine is rich and have advantageous natural resources of Chinese medicinal materials to the disease cause of disease, the interpretation of the cause, onset and process of an illness and the understanding for the treatment of,
Clinical verification is significant in efficacy.Chinese medicine with its good effect, few side effects or advantage without side-effects increasingly by the concern of common people,
The new Chinese medicine of high effect nontoxic side effect is developed, will be benefited the society and vast family.
Theory of traditional Chinese medical science thinks, the generation of depression, be hurt by feelings will, stagnation of liver qi gradually causes the five internal organs mechanism of qi to be got along well
It is caused.Be mainly shown as feel depressed, the kind various complexity symptoms such as cry, have a sleepless night of irritable emotion, the distending pain in hypochondrium or irritability.Strongly fragrant disease
Generation, because it is disgruntled, ponder over, the institute of grieved, worried seven feelings hurts, lead to that liver dysfunction, spleen weakness, the mind are not normal, liver is negative
Positive disorder of qi and blood forms.Therefore strongly fragrant disease from the beginning of, be often hurt with feelings will cause the liver losing its smoothly moving state, catharsis mistake department, the obstruction of the circulation of vital energy stagnation of the circulation of vital energy is main
The interpretation of the cause, onset and process of an illness.It is disgruntled unsmooth, make the liver losing its smoothly moving state, air humidity catharsis, and cause stagnation of liver qi, then, it is seen that feel depressed, irritable emotion, it is depressed not
Happy, suspicious kind worry；Irritability circulation is distributed in two sides of body, and liver dysfunction is stagnant through the obstruction of the circulation of vital energy, sees fullness in chest and hypochondrium；The visible abdominal distension of liver depression suppression spleen is received
It is slow-witted, the main house mind of the heart, liver controlling conveyance and dispersion, the easily sad mind of seven feelings, therefore visible palpitation and insomnia, dreaminess, so, the main pathogenesis of strongly fragrant disease is gas
Machine stasis, treatment is when to dredge based on mechanism of qi.As《The strongly fragrant disease of Zhengzi Huibu》It is sayed：" though strongly fragrant disease is more, all because gas is not circulated,
Method is when pleasant for first." according to by sick internal organs actual situation, it or with reality of dispelling, or with qi-restoratives, or to reconcile lifting mechanism of qi etc. is all dredging gas
The method of machine.For the etiology and pathogenesis of this disease, we are from disgruntled unsmooth, liver dysfunction, stagnation of liver qi, liver depression suppression spleen, confused and worried
Start with, draft based on dispersing stagnated hepatoqi relieve stagnation relieving restlessness, and using blood-nourishing clearing away the heart fire and tranquillizing sedate as principle of reatment.
Treatment for strongly fragrant disease, ancient Chinese medicine doctor respectively have speciality, and clinical experience accumulation is very rich.Its comprehensive big method, head is when conditioning gas
Machine, while paying attention to three burnt tonneaus and the invisible strongly fragrant identification with tangible stagnant (such as dyspepsia phlegm wet water stops).Lee is said with essence：
Though " strongly fragrant disease is more, all because gas is not circulated.Method is when pleasant entitled secondary first, to open."(《The strongly fragrant disease of Zhengzi Huibu internal cause door》) Ye Tian
Scholar control it is strongly fragrant, it is wonderful in dexterity.Its side's of sending medication has run through the logical principle of a surname, has attacked benefit without focusing on.
YE Tian shi proposes that strongly fragrant disease treats big method and treatment compatibility and incompatibility of drugs, especially to do not focus on it is dialectical and absurd attack to stay mend to obtain harmful trend
It is criticized.He says：" the Yu Ze stagnation of the circulation of vital energy, it is stagnant or in shape body, or in internal organs, must there is not easypro existing disease.Lid gas sheet is invisible, strongly fragrant
Then gas is poly-, and poly- then seemingly tangible and real without matter, such as septum pectorale is like hindering, and empty ruffian under the heart, the side of body is swollen, and back is swollen, and gastral cavity is bored not to be eaten, and gas lump in the abdomen attacks punching, tendon and vessel
It does not relax.Doctor does not examine, and tangible stagnant of misidentification uses relieving stagnant Qi tapping boldly and with confidence, fits acute to more curing, and turns side and belong to slow-witted again to mend, this is not died of
Disease, and die of medicine."(《Linzheng Zhinan Yi, it is strongly fragrant》).
From in discussed above as can be seen that motherland's medicine to strongly fragrant disease from the cause of disease, the interpretation of the cause, onset and process of an illness, sick position to the rules for the treatment of, medication, compatibility and incompatibility of drugs,
It has been formed than more complete theoretical system, has had accumulated clinical experience abundant.
Liver-Comforting Decoction side derives from《Jing Yue's complete work》(written by Ming Dynasty's Zhang Jingyue, volume 50 is one).Control the anger impariment of the liver, thus the circulation of vital energy in the wrong direction
Get angry, causes as dysphoria with smothery sensation hypochondriac pain, the card such as dynamic blood of turgor.One cup of water half, decocts seven, eight points.Food far warmly takes.Main component is green peel, old
Each two money of skin, two money of Chinese herbaceous peony, the root bark of tree peony, cape jasmine (stir-fry), each money of rhizoma alismatis half, the rhizoma bolbostemmae two, three money.It cures mainly：The anger impariment of the liver, the circulation of vital energy in the wrong direction
Get angry, hypochondriac pain turgor, dysphoria with smothery sensation moves blood.Primary efficacy is for controlling the anger impariment of the liver, thus the circulation of vital energy in the wrong direction is got angry, and is caused as dysphoria with smothery sensation hypochondriac pain, turgor
The cards such as dynamic blood.Green peel dispersing stagnated hepatoqi in we, Chinese herbaceous peony nourishing blood and liver, dried orange peel regulating qi-flowing for harmonizing stomach, relieving spasm to stop pain, the root bark of tree peony, mountain Cape jasmine clear liver
It purges heat, rhizoma alismatis dampness elimination is purged heat, rhizoma bolbostemmae heat-clearing dissipating bind.All medicine compatibilities play clearing away heat to ease the stomach, the function of dispersing stagnated hepatoqi altogether.It is mainly used for
Liver depression forming fire is treated, gastral cavity caused by heat invading the stomach coerces distending pain.Liver, tree peony are held back in side green peel, dried orange peel regulating qi-flowing for harmonizing stomach, Chinese herbaceous peony blood-nourishing
Skin, mountain Cape jasmine purging liver-heat；Liver stomach is simultaneously controlled, and is its compatible experiments.Clinical application is with burning pain in the epigastrium, pain gesture is urgent, hypochondriac pain turgor, tired
Hot irritability is its dialectical main points.
Traditionally, the preparation process of the prescription and instructions of taking are mainly decocted in water for oral dose, and (one cup of water half, decocts seven, eight points.Food is remote
Warmly take), and only decoct primary, traditional extraction process by water parameter does not have, it is seen then that traditionally its technique is coarse, active constituent content compared with
It is low, and take, is inconvenient to carry, dose is big, is also not suitable for being processed into other dosage forms.Modern preparation work in relation to Liver-Comforting Decoction side
Skill, extract are studied, and there is no report, its novel formulation, new drug, new product development and nothing on document.Its main active exists
The embodiment of compound is also blank in research.And dried orange peel, green peel main component are the flavones ingredients such as aurantiamarin in compound；Chinese herbaceous peony
Middle main component is the flavones ingredients such as Paeoniflorin；Main component is Paeonol in cortex moutan；Main component is cape jasmine in cape jasmine
Glycosides；Main component is Alisol B monoacetate in rhizoma alismatis；Main component is the composition of alkaloids such as Bolbostemma paniculatum glucoside A in the rhizoma bolbostemmae,
Present invention process carries out system optimization and confirmation to its main component, while having carried out galenic pharmacy research.
Summary of the invention
Stomachache, hypochondriac pain, gastroenteritic ulcer, the Chinese medical extract of depression and its system are treated the object of the present invention is to provide a kind of
Preparation Method and application.System optimization and confirmation are carried out to its main component, solving conventional formulation, there are unstable quality, techniques to fall
Afterwards, the problems such as efficiency is insufficient.
The present invention includes following technical solution：
In the present invention, green peel used, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, rhizoma bolbostemmae raw material are them
The prepared slices of Chinese crude drugs.The centival % of related ethyl alcohol is concentration expressed in percentage by volume %v/v.Following methods of the invention
In " Liver-Comforting Decoction side " Chinese medical extract being prepared, by weight, aurantiamarin is not less than 4.1%, Paeoniflorin for amount
Lower than 0.80%, Paeonol not less than 0.67%, Gardenoside not less than 0.10%, Alisol B monoacetate not less than 0.03%,
Bolbostemma paniculatum glucoside A is not less than 0.70%.
Technical solution 1：It is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract water extract preparation side
Method, using green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae as raw material, each raw material relative weight ratio is green peel：
Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；Preparation method includes the following steps：It will
Above-mentioned ingredients cleans, and weighs raw material in proportion, and 7~12 times of waters is added to impregnate 20-30min, and heating extraction 3 times, for the first time
Extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time one
Cause), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extracting liq in combined extract
Product is 3~5 times of the raw material weight, obtains initial concentration extracting solution；Being further dried to relative density is 1.0~1.2g/
" Liver-Comforting Decoction side " Chinese medical extract of cm3.
Technical solution 2：It is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract alcohol extracting preparation side
Method, using green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae as raw material, each raw material relative weight ratio is green peel：
Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；Preparation method includes the following steps：It will
Above-mentioned ingredients cleans, and weighs raw material in proportion, and 7~12 times of 65%~85% ethyl alcohol is added to impregnate 20-30min, heating extraction 3
It is secondary, extract 2.5h for the first time, second extracts 1h (alcohol adding amount and consistent for the first time), and third time extracts 30min (alcohol adding amount and the
It is primary consistent), each extraction time after boiling calculate, combined extract, the extracting solution that acquisition is concentrated is mentioned to described
Taking the volume of liquid is 3~5 times of the raw material weight, obtains initial concentration extracting solution；Being further dried to relative density is 1.0
~1.2g/cm3 " Liver-Comforting Decoction side " Chinese medical extract.
Technical solution 3：It is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract water extract-alcohol precipitation preparation
Method, using green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae as raw material, each raw material relative weight ratio is blueness
Skin：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；Preparation method includes following step
Suddenly：
1) concentrate is prepared：Above-mentioned ingredients is cleaned, weighs raw material in proportion, 7~12 times of waters is added to impregnate 20-
30min, heating extraction 3 times, first time extracts 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction
30min (amount of water and for the first time consistent), each extraction time after boiling calculate, combined extract, concentration obtains
Extracting solution to the extracting liquid volume be 3~5 times of the raw material weight, obtain initial concentration extracting solution；
2) add ethanol precipitation：Add ethanol in proper amount into the initial concentration extracting solution of above-mentioned preparation, makes extracting solution alcohol content
65~75%, 24 hours are stood, filtration, filtrate recycling ethanol obtains refined liquid, is concentrated, is drying to obtain " Liver-Comforting Decoction side " Chinese medicine
Extract.
Technical solution 4：It is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract macroporous resin purification
Preparation method, using green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae as raw material, each raw material relative weight ratio
For green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；Preparation method includes as follows
Step：
1) concentrate is prepared：Above-mentioned ingredients is cleaned, weighs raw material in proportion, 7~12 times of waters is added to impregnate 20-
30min, heating extraction 3 times, first time extracts 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction
30min (amount of water and for the first time consistent), each extraction time after boiling calculate, combined extract, concentration obtains
Extracting solution to the extracting liquid volume be 3~5 times of the raw material weight, obtain initial concentration extracting solution；
2) macroporous resin purification：Respectively plus 3~5 times of volume hot water are into initial concentration extracting solution, take supernatant；By supernatant
Liquid crosses macroporous resin column absorption, abandons efflux；Then the suction was washed with 0.5~2.5BV/ hours flow velocitys with the water of 1~5BV
Attached column abandons water lotion；50~70% ethyl alcohol is used later, and 3~5BV of elution volume was washed with 0.5~2.5BV/ hours flow velocitys
Desorption attached column, collects the ethanol eluate, and concentration, the dry ethanol eluate obtain " Liver-Comforting Decoction side " Chinese medical extract.
Technical solution 5：It is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract macroporous resin purification
Preparation method is made using green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae by raw material, and each raw material is relatively heavy
Amount is than being green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：
1) concentrate is prepared：Each taste prepared slices of Chinese crude drugs are taken, weigh raw material in proportion, add 7~12 times of 65%~85% concentration
Ethyl alcohol impregnates 20-30min, and heating extraction 3 times, first time extracts 2.5h, extracts 1h (alcohol adding amount and first time are consistent) for the second time,
Third time is extracted 30min (alcohol adding amount and for the first time consistent), each extraction time after boiling calculate, merge and extract
Liquid, the volume that extracting solution to the extracting solution of acquisition is concentrated is 3~5 times of the raw material weight, obtains initial concentration and extracts
Liquid；
2) macroporous resin purification：Respectively plus in the initial concentration extracting solution that is obtained to upper step of 3~5 times of volume hot water, take
Clear liquid；Supernatant is crossed into macroporous resin column absorption, abandons efflux；First the adsorption column described in the water washing of 5BV, abandoning are washed after loading
Liquid；Then the adsorption column was washed with 0.5~2.5BV/ hours flow velocitys with the water of 1~5BV, abandons water lotion；50 are used later
~70% ethyl alcohol, 3~5BV of elution volume elute adsorption column with 0.5~2.5BV/ hours flow velocitys, collect the ethanol elution
Liquid, concentration, the dry ethanol eluate, obtains " Liver-Comforting Decoction side " Chinese medical extract.
Technical solution 6：A kind of " Liver-Comforting Decoction side " decoction preparation method, which is characterized in that with green peel, dried orange peel, Chinese herbaceous peony, tree peony
Skin, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine
Sub (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：Each taste prepared slices of Chinese crude drugs are taken, weigh raw material in proportion, add 7 times of waters, heating mentions
2.5h is taken, the extracting solution that extracting solution concentration obtains obtains initial concentration to 5 times that the extracting liquid volume is the raw material weight
Extracting solution；Being further dried to relative density is 1.0g/cm3" Liver-Comforting Decoction " matter basis.Obtained material benchmark it is effective
Ingredient aurantiamarin is not less than not less than 0.56%, Paeonol not less than 0.42%, Gardenoside not less than 3.6%, Paeoniflorin
0.05%, Alisol B monoacetate is not less than 0.43% not less than 0.01%, Bolbostemma paniculatum glucoside A.
Technical solution 7：Provide the oral administration solid of " Liver-Comforting Decoction side " Chinese medical extract being prepared containing the above method
Preparation, wherein oral solid formulation include：Tablet, hard capsule, soft capsule, granule, oral solution；Granule, hard capsule and
Additive of tablet be selected from starch, Icing Sugar, lactose, dextrin, stevioside, pregelatinized starch, microcrystalline cellulose, calcium bicarbonate, mannitol,
The common auxiliary material such as hydroxypropyl methyl cellulose, magnesium stearate, superfine silica gel powder, talcum powder, polyethylene glycols；The choosing of soft capsule auxiliary material
From polyethylene glycol (polyethylene glycol 2000-6000), beeswax, atoleine, vegetable oil, glycerol, gelatin etc..Oral solution auxiliary material is selected
Beta-cyclodextrin, sorbierite etc., wherein tablet refers specifically to common compressed tablets, coating tablet, sugar coated tablet, Film coated tablets.
Technical solution 8：Provide " Liver-Comforting Decoction side " Chinese medical extract that the above method is prepared preparation treatment stomachache,
Application in hypochondriac pain, gastroenteritic ulcer and medicament for treatment of depression or health care product.
The present invention has following advantages：
1, Chinese medical extract of the invention is original with green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae
Material preparation.Wherein green peel is the drying young fruit of rutaceae orange (Citrus reticulata Blanco) and its variety
Or the pericarp of immature fruit；Dried orange peel is rutaceae orange (Citrus reticulata Blanco) and its variety
Dry mature skin；Chinese herbaceous peony is the dry root of ranunculaceae plant Chinese herbaceous peony (Paeonia tacti lora Pall.)；Cortex moutan
For the dry root skin for Ranunculaceae perennial deciduous shrub plant tree peony (Paeonia suffruticosa Andr.)；Cape jasmine
For the dry mature fruit of madder wort cape jasmine (Gardenia jasminoides Ellis)；Rhizoma alismatis is Notes On Alism At Aceae pool
Rush down the dry tuber of (Alisma orientalis (Sam.) Juzep.)；The rhizoma bolbostemmae is the cucurbitaceous plant rhizoma bolbostemmae
The dry tuber of (Bolbostemma paniculatum (Maxim.) Franquet).The Chinese medical extract of acquisition is contained each
The mixture that the collaboration of kind of active ingredients of medicinal materials works, it is different from activated monomer, drug effect also different from various activity of drug ingredients at
The simple adduction of drug dispensing effect.
2, " Liver-Comforting Decoction " of the invention square Chinese medical extract is with green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), pool
It rushes down, the rhizoma bolbostemmae is raw material, prescription ratio clear and definite.Ming Dynasty Zhang Jing is derived from through " Liver-Comforting Decoction " prescription known to examination pertinent literature
What high mountain was write《Jing Yue's complete work》, specific formula and ratio are as follows：
In " the Chinese dynasties weights and measures unit magnitude table and explanation " text write according to Qiu Long it is found that in the Ming Dynasty 1 liang be equal to
37.3g is equivalent to 1 money equal to 3.73g, and can obtain daily prescription dosage by this metering conversion is two money of green peel [7.5g], dried orange peel two
Money [7.5g], two money of Chinese herbaceous peony [7.5g], one money of cortex moutan half [5.6g], cape jasmine (stir-fry) money half [5.6g], one money of rhizoma alismatis half
[5.6g], three money of the rhizoma bolbostemmae [11.2g], each raw material relative weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Pool
It rushes down：The rhizoma bolbostemmae=4：4：4：：3：3：3：6.
3, a variety of methods such as present invention employs water to mention, alcohol extracting, water extract-alcohol precipitation, macroporous resin purification, fundamentally guarantee
The superiority of " Liver-Comforting Decoction side " traditional Chinese herbal decoction provides safeguard to be prepared into the different dosage forms product of high quality.It is provided by the invention
The preparation process of extract can effectively be enriched with main active such as：Aurantiamarin, Paeoniflorin, Paeonol, Gardenoside, 23- second
Acyl alisol B and Bolbostemma paniculatum glucoside A etc..
4, quality control carries out assay using high efficient liquid phase analysis method, simple and easy to control.Extract of the invention
Material base is a certain proportion of multiple active component content compositions, still clear to be put forward for the first time active constituent for the formula
Material base.Embody the novelty of patent of invention.
5, the various preparation processes extract component obtained and ancient prescription preparation process of extract according to the present invention
Compared to (classics recipe matter basis), have effective component high, at low cost, process preparation of being more convenient for convenient for marketing and is answered
With.
6, use purifying resin method in macroporous resin purification preparation method provided by the invention, this method is easy, it is quick,
Favorable reproducibility；Selected macroporous resin adsorption amount is big, and desorption efficiency is big, can Reusability, reduce process costs；Solvent used
Ethyl alcohol is inexpensive nontoxic.The extract that preparation method through macroporous resin purification obtains is compared with the decocting object of former prescription, volume
Small, Chinese medicine inherent quality height, product moisture absorption is reduced, stability increases, and is easily formed the various dosage forms of appearance looks elegant.
7, the tool of " Liver-Comforting Decoction side " Chinese medical extract prepared by preparation method of the invention treatment stomachache, hypochondriac pain, stomach and intestine are burst
Ulcer and treatment depression function.And toxicity is low, has good drug safety, and this has sufficiently prompted mentioning for this technique preparation
Take the safety of the clinical application of object.
Therefore, heretofore described " Liver-Comforting Decoction " square Chinese medical extract is suitble to industrialized production, has very strong practical
Property.
Specific embodiment
Essence of the invention, but do not limit the invention in any way can be better understood by the following examples.
Material source：Green peel is the dry of rutaceae orange (Citrus reticulata Blanco) and its variety
The pericarp of dry young fruit or immature fruit；Dried orange peel is rutaceae orange (Citrus reticulata Blanco) and its plants
Train the dry mature skin of mutation；Chinese herbaceous peony is the dry root of ranunculaceae plant Chinese herbaceous peony (Paeonia tacti lora Pall.)；
Cortex moutan is the dry root of Ranunculaceae perennial deciduous shrub plant tree peony (Paeonia suffruticosa Andr.)
Skin；Cape jasmine is the dry mature fruit of madder wort cape jasmine (Gardenia jasminoides Ellis)；Rhizoma alismatis is rhizoma alismatis
The dry tuber of section plant rhizoma alismatis (Alisma orientalis (Sam.) Juzep.)；The rhizoma bolbostemmae is the cucurbitaceous plant rhizoma bolbostemmae
The dry tuber of (Bolbostemma paniculatum (Maxim.) Franquet).Wherein material is purchased by commercial sources
It buys.
1 water extracting method of embodiment prepares " Liver-Comforting Decoction " square Chinese medical extract
Method 1：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 28 kilograms of green peel, 28 kilograms of dried orange peel, 28 kilograms of Chinese herbaceous peony, cortex moutan in proportion
21 kilograms, 21 kilograms of cape jasmine, 21 kilograms of rhizoma alismatis, 42 kilograms of the rhizoma bolbostemmae, 1.89 tons of waters impregnate 20min, and heating extraction 3 times, the
Once extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time
Unanimously), each extraction time after boiling calculate.The extracting solution of acquisition is concentrated to the extracting solution in combined extract
Volume is 3 times of the raw material weight, obtains initial concentration extracting solution；Being further dried to relative density is 1.0g/cm3's
" Liver-Comforting Decoction " side's Chinese medical extract (lot number 18010106).
Method 2：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 48 kilograms of green peel, 48 kilograms of dried orange peel, 48 kilograms of Chinese herbaceous peony, cortex moutan in proportion
36 kilograms, 36 kilograms of cape jasmine, 36 kilograms of rhizoma alismatis, 72 kilograms of the rhizoma bolbostemmae, 3.24 tons of waters impregnate 30min, and heating extraction 3 times, the
Once extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time
Unanimously), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extracting solution in combined extract
Volume is 5 times of the raw material weight, obtains initial concentration extracting solution；Being further dried to relative density is 1.2g/cm3's
" Liver-Comforting Decoction " side's Chinese medical extract (lot number 18010208).
Method 3：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 40 kilograms of green peel, 40 kilograms of dried orange peel, 40 kilograms of Chinese herbaceous peony, cortex moutan in proportion
30 kilograms, 30 kilograms of cape jasmine, 30 kilograms of rhizoma alismatis, 60 kilograms of the rhizoma bolbostemmae, 2.70 tons of waters impregnate 25min, and heating extraction 3 times, the
Once extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time
Unanimously), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extracting solution in combined extract
Volume is 4 times of the raw material weight, obtains initial concentration extracting solution；Being further dried to relative density is 1.1g/cm3's
" Liver-Comforting Decoction " side's Chinese medical extract (lot number 18010309).
2 alcohol extracting method of embodiment prepares " Liver-Comforting Decoction " square Chinese medical extract
Method 1：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is with 65% ethyl alcohol
Raw material described in solvent extraction, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：
4：4：：3：3：3：6；Above-mentioned ingredients is cleaned, weighs 28 kilograms of green peel, 28 kilograms of dried orange peel, 28 kilograms of Chinese herbaceous peony, male in proportion
21 kilograms of the root bark of tree peony, 21 kilograms of cape jasmine, 21 kilograms of rhizoma alismatis, 42 kilograms of the rhizoma bolbostemmae, 1.89 ton of 65% ethyl alcohol impregnate 20min, and heating mentions
It takes 3 times, first time extracts 2.5h, second of extraction 1h (alcohol adding amount and first time are consistent), third time extraction 30min (alcohol adding amount
Unanimously with first time), it is calculated each reflux extracting time is after boiling, extracting solution merges, and stands 24 hours, filters to take
Supernatant is concentrated to 3 times of crude drug, obtains initial concentration extracting solution by supernatant；It is further dried to relative density and is
1.0g/cm3" Liver-Comforting Decoction " square Chinese medical extract (lot number 18020423).
Method 2：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is with 85% ethyl alcohol
Raw material described in solvent extraction, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：
4：4：：3：3：3：6；Above-mentioned ingredients is cleaned, weighs 48 kilograms of green peel, 48 kilograms of dried orange peel, 48 kilograms of Chinese herbaceous peony, male in proportion
36 kilograms of the root bark of tree peony, 36 kilograms of cape jasmine, 36 kilograms of rhizoma alismatis, 72 kilograms of the rhizoma bolbostemmae, 3.24 ton of 85% ethyl alcohol impregnate 30min, and heating mentions
It takes 3 times, first time extracts 2.5h, second of extraction 1h (alcohol adding amount and first time are consistent), third time extraction 30min (alcohol adding amount
Unanimously with first time), it is calculated each reflux extracting time is after boiling, extracting solution merges, and stands 24 hours, filters to take
Supernatant is concentrated to 5 times of crude drug, obtains initial concentration extracting solution by supernatant；It is further dried to relative density and is
1.2g/cm3" Liver-Comforting Decoction " Chinese medicine alcohol extracting thing (lot number 18020524).
Method 3：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is with 75% ethyl alcohol
Raw material described in solvent extraction, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：
4：4：：3：3：3：6；Above-mentioned ingredients is cleaned, weighs 40 kilograms of green peel, 40 kilograms of dried orange peel, 40 kilograms of Chinese herbaceous peony, male in proportion
30 kilograms of the root bark of tree peony, 30 kilograms of cape jasmine, 30 kilograms of rhizoma alismatis, 60 kilograms of the rhizoma bolbostemmae, 2.70 ton of 75% ethyl alcohol impregnate 25min, and heating mentions
It takes 3 times, first time extracts 2.5h, second of extraction 1h (alcohol adding amount and first time are consistent), third time extraction 30min (alcohol adding amount
Unanimously with first time), it is calculated each reflux extracting time is after boiling, extracting solution merges, and stands 24 hours, filters to take
Supernatant is concentrated to 4 times of crude drug, obtains initial concentration extracting solution by supernatant；It is further dried to relative density and is
1.1g/cm3" Liver-Comforting Decoction " Chinese medicine alcohol extracting thing (lot number 18020625).
3 water extract-alcohol precipitation method of embodiment prepares " Liver-Comforting Decoction " square Chinese medical extract
Method 1：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 28 kilograms of green peel, 28 kilograms of dried orange peel, 28 kilograms of Chinese herbaceous peony, cortex moutan in proportion
21 kilograms, 21 kilograms of cape jasmine, 21 kilograms of rhizoma alismatis, 42 kilograms of the rhizoma bolbostemmae, add 1.89 tons：Ton water impregnates 20min, heating extraction 3
It is secondary, extract 2.5h for the first time, second extracts 1h (amount of water and consistent for the first time), and third time extracts 30min (amount of water and the
It is primary consistent), each extraction time after boiling calculate, combined extract, the extracting solution that acquisition is concentrated is mentioned to described
Taking liquid product is 3 times of the raw material weight, obtains initial concentration extracting solution；It is slowly added to ethanol in proper amount while stirring, makes molten
Agent alcohol content is 65%, stands 24 hours, and filtration, filtrate recycling ethanol obtains refined liquid, is concentrated, dry to obtain " Liver-Comforting Decoction "
Square Chinese medical extract (lot number 18030518).
Method 2：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 48 kilograms of green peel, 48 kilograms of dried orange peel, 48 kilograms of Chinese herbaceous peony, cortex moutan in proportion
36 kilograms, 36 kilograms of cape jasmine, 36 kilograms of rhizoma alismatis, 72 kilograms of the rhizoma bolbostemmae add 3.24 tons of waters to impregnate 30min, and heating extraction 3 times,
First time extracts 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first
It is secondary consistent), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extraction in combined extract
Liquid product is 5 times of the raw material weight, obtains initial concentration extracting solution；It is slowly added to ethanol in proper amount while stirring, makes solvent
Alcohol content is 75%, stands 24 hours, and filtration, filtrate recycling ethanol obtains refined liquid, is concentrated, dry to obtain " Liver-Comforting Decoction " side
Chinese medical extract (lot number 18030620).
Method 3：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 40 kilograms of green peel, 40 kilograms of dried orange peel, 40 kilograms of Chinese herbaceous peony, cortex moutan in proportion
30 kilograms, 30 kilograms of cape jasmine, 30 kilograms of rhizoma alismatis, 60 kilograms of the rhizoma bolbostemmae add 2.70 tons of waters to impregnate 25min, and heating extraction 3 times,
First time extracts 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first
It is secondary consistent), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extraction in combined extract
Liquid product is 4 times of the raw material weight, obtains initial concentration extracting solution；It is slowly added to ethanol in proper amount while stirring, makes solvent
Alcohol content is 70%, stands 24 hours, and filtration, filtrate recycling ethanol obtains refined liquid, is concentrated, dry to obtain " Liver-Comforting Decoction " side
Chinese medical extract (lot number 18030722).
4 macroporous resin method one of embodiment prepares " Liver-Comforting Decoction " square Chinese medical extract
Method 1：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 28 kilograms of green peel, 28 kilograms of dried orange peel, 28 kilograms of Chinese herbaceous peony, cortex moutan in proportion
21 kilograms, 21 kilograms of cape jasmine, 21 kilograms of rhizoma alismatis, 42 kilograms of the rhizoma bolbostemmae, 1.89 tons of waters impregnate 20min, and heating extraction 3 times, the
Once extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time
Unanimously), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extracting solution in combined extract
Volume is 3 times of the raw material weight, obtains initial concentration extracting solution；Initial concentration extracting solution is added into 3 times of hot water dilutions, is added
Appropriate Chinese medicine clarifying agent chitosan, centrifugation go to precipitate, take supernatant, be splined on D101 macroporous resin column and (use respectively before loading
Acid, alkali, water, alcohol carry out pre-treatment to resin column), 1BV pure water rinsing is first used after loading, aqueous solution reject uses the 50% of 3BV instead
Ethanol elution, eluent flow rate 0.5BV/h collect the ethanol eluate.Continue that solvent is recovered under reduced pressure, collects medicinal extract, it is dry
Obtain " Liver-Comforting Decoction " square Chinese medical extract (lot number 18040817).
Method 2：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 48 kilograms of green peel, 48 kilograms of dried orange peel, 48 kilograms of Chinese herbaceous peony, cortex moutan in proportion
36 kilograms, 36 kilograms of cape jasmine, 36 kilograms of rhizoma alismatis, 72 kilograms of the rhizoma bolbostemmae, 3.24 tons of waters impregnate 30min, and heating extraction 3 times, the
Once extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time
Unanimously), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extracting solution in combined extract
Volume is 5 times of the raw material weight, obtains initial concentration extracting solution；Initial concentration extracting solution is added into 5 times of hot water dilutions, is added
Appropriate Chinese medicine clarifying agent chitosan, centrifugation go to precipitate, take supernatant, be splined on D101 macroporous resin column and (use respectively before loading
Acid, alkali, water, alcohol carry out pre-treatment to resin column), 5BV pure water rinsing is first used after loading, aqueous solution reject uses the 70% of 5BV instead
Ethanol elution, eluent flow rate 2.5BV/h collect the ethanol eluate.Continue that solvent is recovered under reduced pressure, collects medicinal extract, it is dry
Obtain " Liver-Comforting Decoction " square Chinese medical extract (lot number 18040927).
Method 3：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, takes water as a solvent and mentions
The raw material is taken, each raw material weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：
3：3：3：6；Above-mentioned ingredients is cleaned, weighs 40 kilograms of green peel, 40 kilograms of dried orange peel, 40 kilograms of Chinese herbaceous peony, cortex moutan in proportion
30 kilograms, 30 kilograms of cape jasmine, 30 kilograms of rhizoma alismatis, 60 kilograms of the rhizoma bolbostemmae, 2.70 tons of waters impregnate 25min, and heating extraction 3 times, the
Once extract 2.5h, second of extraction 1h (amount of water and first time are consistent), third time extraction 30min (amount of water and first time
Unanimously), each extraction time after boiling calculate, the extracting solution of acquisition is concentrated to the extracting solution in combined extract
Volume is 4 times of the raw material weight, obtains initial concentration extracting solution；Initial concentration extracting solution is added into 4 times of hot water dilutions, is added
Appropriate Chinese medicine clarifying agent chitosan, centrifugation go to precipitate, take supernatant, be splined on D101 macroporous resin column and (use respectively before loading
Acid, alkali, water, alcohol carry out pre-treatment to resin column), 2.5BV pure water rinsing is first used after loading, aqueous solution reject uses 4BV's instead
60% ethanol elution, eluent flow rate 1.5BV/h collect the ethanol eluate.Continue that solvent is recovered under reduced pressure, collect medicinal extract,
It is dry to obtain " Liver-Comforting Decoction " square Chinese medical extract (lot number 18041021).
5 macroporous resin method two of embodiment prepares " Liver-Comforting Decoction " square Chinese medical extract
Method 1：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is with 65% ethyl alcohol
Raw material described in solvent extraction, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：
4：4：：3：3：3：6；Above-mentioned ingredients is cleaned, weighs 28 kilograms of green peel, 28 kilograms of dried orange peel, 28 kilograms of Chinese herbaceous peony, male in proportion
21 kilograms of the root bark of tree peony, 21 kilograms of cape jasmine, 21 kilograms of rhizoma alismatis, 42 kilograms of the rhizoma bolbostemmae, 1.89 ton of 65% ethyl alcohol impregnate 20min, and heating mentions
It takes 3 times, first time extracts 2.5h, second of extraction 1h (alcohol adding amount and first time are consistent), third time extraction 30min (alcohol adding amount
Unanimously with first time), it is calculated each reflux extracting time is after boiling, extracting solution merges, and stands 24 hours, filters to take
Supernatant is concentrated to 3 times of crude drug, obtains initial concentration extracting solution by supernatant；Concentrated extracting solution plus 3 times of hot water is dilute
It releases, appropriate Chinese medicine clarifying agent chitosan is added, be centrifuged, go to precipitate, take supernatant, be splined on D101 macroporous resin column (in loading
It is preceding respectively with acid, alkali, water, alcohol carries out pre-treatment to resin column), first washed with 5BV water (being 5 with 1% hydrochloric acid adjusting PH) after loading
The adsorption column is washed, water lotion is abandoned；It being eluted again with neutrality 1BV aqueous solution, aqueous solution reject uses 50% ethanol elution of 3BV instead,
Elution flow rate is 0.5BV/h, collects the ethanol eluate.Continue that solvent is recovered under reduced pressure, collects medicinal extract, it is dry to obtain " Liver-Comforting Decoction "
Square Chinese medical extract (lot number 18051103).
Method 2：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is with 85% ethyl alcohol
Raw material described in solvent extraction, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：
4：4：：3：3：3：6；Above-mentioned ingredients is cleaned, weighs 48 kilograms of green peel, 48 kilograms of dried orange peel, 48 kilograms of Chinese herbaceous peony, male in proportion
36 kilograms of the root bark of tree peony, 36 kilograms of cape jasmine, 36 kilograms of rhizoma alismatis, 72 kilograms of the rhizoma bolbostemmae, 3.24 ton of 85% ethyl alcohol impregnate 30min, and heating mentions
It takes 3 times, first time extracts 2.5h, second of extraction 1h (alcohol adding amount and first time are consistent), third time extraction 30min (alcohol adding amount
Unanimously with first time), it is calculated each reflux extracting time is after boiling, extracting solution merges, and stands 24 hours, filters to take
Supernatant is concentrated to 5 times of crude drug, obtains initial concentration extracting solution by supernatant；Concentrated extracting solution plus 5 times of hot water is dilute
It releases, appropriate Chinese medicine clarifying agent chitosan is added, be centrifuged, go to precipitate, take supernatant, be splined on D101 macroporous resin column (in loading
It is preceding respectively with acid, alkali, water, alcohol carries out pre-treatment to resin column), first washed with 5BV water (being 6 with 1% hydrochloric acid adjusting PH) after loading
The adsorption column is washed, water lotion is abandoned；Again with the elution of neutrality 5BV aqueous solution, aqueous solution reject is used instead and washes 70% ethyl alcohol of 5BV and wash
De-, elution flow rate 2.5BV/h collects the ethanol eluate.Continue that solvent is recovered under reduced pressure, collect medicinal extract, dry obtain " changes liver
Decoct " side's Chinese medical extract (lot number 18051205).
Method 3：Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is with 75% ethyl alcohol
Raw material described in solvent extraction, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：
4：4：：3：3：3：6；Above-mentioned ingredients is cleaned, weighs 40 kilograms of green peel, 40 kilograms of dried orange peel, 40 kilograms of Chinese herbaceous peony, male in proportion
30 kilograms of the root bark of tree peony, 30 kilograms of cape jasmine, 30 kilograms of rhizoma alismatis, 60 kilograms of the rhizoma bolbostemmae, 2.70 ton of 75% ethyl alcohol impregnate 25min, and heating mentions
It takes 3 times, first time extracts 2.5h, second of extraction 1h (alcohol adding amount and first time are consistent), third time extraction 30min (alcohol adding amount
Unanimously with first time), it is calculated each reflux extracting time is after boiling, extracting solution merges, and stands 24 hours, filters to take
Supernatant is concentrated to 4 times of crude drug, obtains initial concentration extracting solution by supernatant；Concentrated extracting solution plus 5 times of hot water is dilute
It releases, appropriate Chinese medicine clarifying agent chitosan is added, be centrifuged, go to precipitate, take supernatant, be splined on D101 macroporous resin column (in loading
It is preceding respectively with acid, alkali, water, alcohol carries out pre-treatment to resin column), first with 5BV water after loading (adjusting PH with 1% hydrochloric acid is 5.5)
The adsorption column is washed, water lotion is abandoned；It is eluted again with neutrality 3BV aqueous solution, aqueous solution reject uses 60% ethyl alcohol for washing 4BV instead
Elution, elution flow rate 1.5BV/h collect the ethanol eluate.Continue that solvent is recovered under reduced pressure, collect medicinal extract, dry obtain " is changed
Liver is decocted " side's Chinese medical extract (lot number 18051228).
6 water extracting method of embodiment prepares " Liver-Comforting Decoction " square Chinese medicine soup (classics recipe matter basis)
Taking green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae is raw material, is taken water as a solvent described in extraction
Raw material, each raw material weight ratio are green peel：Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：
6；Above-mentioned ingredients is cleaned, weighs 28 kilograms of green peel, 28 jin of dried orange peel, 28 kilograms of Chinese herbaceous peony, 21 kilograms of cortex moutan, Cape jasmine in proportion
Sub 21 kilograms, 21 kilograms of rhizoma alismatis, 42 kilograms of the rhizoma bolbostemmae, 1.89 tons of water heating extraction 2.5h, the extraction that extracting solution concentration obtains
Liquid obtains initial concentration extracting solution to 5 times that the extracting liquid volume is the raw material weight；It is further dried to relative density
For 1.0g/cm3" Liver-Comforting Decoction " matter basis (lot number 18011118).
The oral preparation preparation method of embodiment 7 " Liver-Comforting Decoction " side Chinese medical extract
1) preparation of " Liver-Comforting Decoction " square Chinese medical extract granule
Prescription：(Liver-Comforting Decoction extract be taken respectively from embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5,
The square Chinese medical extract of " Liver-Comforting Decoction " of embodiment 6)
Liver-Comforting Decoction extract：500.0g
Starch：200.0g
Calcium monohydrogen phosphate：150.0g
Dextrin：100.0g
Lactose：50.0g
Recipe quantity Liver-Comforting Decoction extract is weighed, the auxiliary material of recipe quantity is added, adds 60% ethyl alcohol softwood, crosses the granulation of 20 mesh,
50~60 DEG C of forced air dryings (moisture control is 5%~8%) cross 16 mesh sieves to get Liver-Comforting Decoction particle.
2) preparation of " Liver-Comforting Decoction " square Chinese medical extract coating tablet
Prescription：(Liver-Comforting Decoction extract be taken respectively from embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5,
The square Chinese medical extract of " Liver-Comforting Decoction " of embodiment 6)
Liver-Comforting Decoction extract：500.0g
Pregelatinized starch：200.0g
Microcrystalline cellulose：230.0g
Stevioside：25.0g
Sucrose：25.0g
Magnesium stearate：10.0g
Superfine silica gel powder：10.0g
Coating agent：Promise coloured silk TM coating agent soluble in the stomach (appropriate)
The Liver-Comforting Decoction extract for weighing recipe quantity is added the auxiliary material (magnesium stearate, superfine silica gel powder are additional) of recipe quantity, adds
60% ethyl alcohol softwood crosses the granulation of 20 mesh, and 50~60 DEG C of forced air dryings (moisture control is 5%~8%) cross 16 mesh sieves,
It is uniformly mixed, tabletting, is coated to get Liver-Comforting Decoction coating tablet with additional auxiliary material magnesium stearate, superfine silica gel powder.
3) preparation of " Liver-Comforting Decoction " square Chinese medical extract capsule
Prescription：(Liver-Comforting Decoction extract be taken respectively from embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5,
The square Chinese medical extract of " Liver-Comforting Decoction " of embodiment 6)
Liver-Comforting Decoction extract：500.0g
Hydroxypropyl methylcellulose：40.0g (the additional half Inner of half adds)
Pregelatinized starch：190.0g
Microcrystalline cellulose：200.0g
Lactose：25.0g
Icing Sugar：25.0g
Magnesium stearate：10.0g
Talcum powder：10.0g
Recipe quantity Liver-Comforting Decoction extract is weighed, the auxiliary material (magnesium stearate, talcum powder are additional) of recipe quantity is added, adds 60% second
Alcohol softwood crosses the granulation of 20 mesh, and 50~60 DEG C of forced air dryings (moisture control is 5%~8%) cross 16 mesh sieves, and additional
Auxiliary material magnesium stearate, superfine silica gel powder are uniformly mixed, and are filled with filling machine to get Liver-Comforting Decoction capsule.
4) preparation of " Liver-Comforting Decoction " square Chinese medical extract soft capsule
Prescription：(Liver-Comforting Decoction extract be taken respectively from embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5,
The square Chinese medical extract of " Liver-Comforting Decoction " of embodiment 6)
Liver-Comforting Decoction extract：500.0g
Vegetable oil：140.0g
Sorbierite：100.0g
Glycerol：50.0g
Atoleine：60.0g
Gelatin：150.0g
It weighs recipe quantity Liver-Comforting Decoction extract to be uniformly mixed with the vegetable oil of recipe quantity, sorbierite, by gelatin and glycerol point
It is not contained in hopper, two liquid are sprayed by the double-deck spray head of concentric tube-shaped with friction speed, make a certain amount of glue by one
It after quantitative medical fluid package, instills in another coolant liquid (atoleine) that do not dissolve each other mutually, because of table after glue contact coolant liquid
Face tension force effect becomes spherical, and gradually solidification forms soft capsule.
5) preparation of " Liver-Comforting Decoction " square Chinese medical extract oral solution
Prescription：(Liver-Comforting Decoction extract be taken respectively from embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5,
The square Chinese medical extract of " Liver-Comforting Decoction " of embodiment 6)
Liver-Comforting Decoction extract：500.0g
Beta-cyclodextrin：140.0g
Sucrose：100.0g
Distilled water 260.0g
Recipe quantity Liver-Comforting Decoction extract is weighed, the auxiliary material of recipe quantity is added, distilled water is added to dissolve, stirs evenly to get change
Liver decocts extract oral liquid.
The determination of bioactive constituent of embodiment 8 " Liver-Comforting Decoction " formula extraction
1. chromatographic condition
Agilent1260 high performance liquid chromatograph, UV detector (DAD) are to fill out with octadecylsilane chemically bonded silica
Fill agent, C18 chromatographic column (4.6mm × 250mm, 5 μm)；Aurantiamarin (National Institute for Food and Drugs Control, lot number：110773-
20101) Detection wavelength：283nm, mobile phase：Methanol acetic acid water (35：4：51)；Paeoniflorin (Chinese food drug assay research
Institute, lot number：Detection wavelength 110663-20201)：230nm, mobile phase：Methanol -005mol/L potassium dihydrogen phosphate (40：
65)；Paeonol (National Institute for Food and Drugs Control, lot number：Detection wavelength 110887-20101)：274nm, mobile phase：
Methanol-water (40：55)；Gardenoside (National Institute for Food and Drugs Control, lot number：Detection wavelength 110457-20012)：
238nm, mobile phase：Acetonitrile-water (15：85)；Alisol B monoacetate (National Institute for Food and Drugs Control, lot number：
Detection wavelength 110468-20162)：208nm, mobile phase：Acetonitrile-water (73：27)；Bolbostemma paniculatum glucoside A (Chinese food drug inspection
Determine research institute, lot number：Detection wavelength 110763-20201)：214nm, mobile phase：Methanol-water (65：35)；Flow velocity：1.0ml/
min；Column temperature：30℃；Sample volume：10μl.
The preparation of " 2. Liver-Comforting Decoction " side Chinese medical extract sample
1) extract of the present invention
Each 1 lot number of above-mentioned Chinese medical extract is made respectively by method described in present example 1,2,3,4,5,6.
3. the preparation of standard solution
Take aurantiamarin reference substance appropriate, it is accurately weighed, add methanol be made every solution of the 1m l containing 0.4mg to get；Learn from else's experience five
It is appropriate to aoxidize dry 36 hours in two phosphorus vacuum drying apparatus Paeoniflorin reference substances, it is accurately weighed, add methanol that every 1mL is made and contains
The solution of 0.5mg to get；Take Paeonol reference substance appropriate, it is accurately weighed, add methanol that the solution that every 1m l contains 20 μ g is made, i.e.,
?；Take Gardenoside reference substance appropriate, it is accurately weighed, add methanol be made every 1m l containing 30 μ g solution to get；Take 23- acetyl damp
It is appropriate to rush down alcohol B reference substance, it is accurately weighed, add acetonitrile be made every 1m l containing 20 μ g solution to get；Take Bolbostemma paniculatum glucoside A reference substance
In right amount, accurately weighed, add mobile phase be made solution of every 1mL containing 0.1mg to get.
4. measuring method
Take the above-mentioned Chinese medical extract sample of each lot number appropriate respectively, accurately weighed about 10-25mg is transferred to 50ml capacity
In bottle, add methanol 40ml, ultrasound 30min under room temperature, taking-up is cooled to room temperature, adds methanol to scale, shakes up, draw in right amount, determine
Hold to 50ml, shakes up, can measure.Each component content is calculated according to one point external standard method.It the results are shown in Table 1：
1 Liver-Comforting Decoction extract each component assay result of table
Therefore " Liver-Comforting Decoction " square Chinese medical extract, contain by weight, aurantiamarin is not less than not less than 4.1%, Paeoniflorin
0.80%, Paeonol is not less than 0.03%, native shellfish not less than 0.10%, Alisol B monoacetate not less than 0.67%, Gardenoside
Female glycosides first is not less than 0.70%.
The antidepression experimental study of embodiment 9 " Liver-Comforting Decoction " side Chinese medical extract
Kunming mice 180, divide blank group, model group, negative control group, sample 1-1 (lot number：18010106), sample
1-2 (lot number：18010208), sample 1-3 (lot number：18010309), sample 2-1 (lot number：18020423), sample 2-2 (is criticized
Number：18020524), sample 2-3 (lot number：18020625), sample 3-1 (lot number：18030518), sample 3-2 (lot number：
18030620), sample 3-3 (lot number：18030722), sample 4-1 (lot number：18040817), sample 4-2 (lot number：
18040927), sample 4-3 (lot number：18041021), sample 5-1 (lot number：18051103), sample 5-2 (lot number：
18051205), sample 5-3 (lot number：18051228), sample 6-1 (lot number：18011118) totally ten nine groups.Every group of animal each 10
Only, each group mouse continuous gavage is administered 24 days.
Depression model is established：Model mice receives following processing, cuts off the water supply for 24 hours, with hemostasis clamp tail portion 1min, 40 DEG C of environment
5min, mouse cage tilt 45 degree, 4 DEG C of ice water swimming 3min, jejunitas for 24 hours, horizontal concussion (160 times/min) 45min, vola of shocking by electricity
10min (current strength 1mA, voltage 30V stimulate 1 time every 1min, every time lasting 10s, costimulation 10 times), moist padding
For 24 hours, mouse receives often and only a kind of processing, the processing that animal is received in continuous two days during receiving depression model processing
It is all different, so that animal cannot predict the generation of stimulation.
Mouse performance testing
1) tail-suspention test：Mouse tail is hung with adhesive tape.Tail portion point is hung away from tail point 2cm, hangs 6min, after record
The 4min mouse completely motionless time.
2) swimming test：Animal is put into sizeable cylindrical glass cylinder, one animal of every cylinder, the depth of water is suitble to swim
Swimming, 25 DEG C of water temperature.Swimming instruction is carried out to animal for 24 hours before experiment.When experiment, animal 4min after cylinder went swimming 6mig, record
The complete dead time of interior mouse.
MDA content and SOD determination of activity in brain tissue：Mouse is quickly put to death after experiment, on ice quick separating
Brain tissue.It is put into after brain tissue is weighed in tissue homogenizer, homogenate is homogenized at 10% tissue.After the completion, homogenate is taken
It is placed in centrifuge tube, is freezed under the conditions of 4 DEG C out, 3000r/min is centrifuged 10min.Supernatant is taken after standing, is distinguished using kit
Measure Mice brain tissues MDA content and the activity of SOD.
To outstanding influence, it the results are shown in Table 2.
In 2 tail-suspention test of table and forced swim test the mouse dead time comparison (N=10)
Compared to the blank group, * p<0.01；Compared with model group, * * p<0.05；***p<0.001
As can be seen from Table 2, compared with blank group, mouse is motionless in model group Tail suspension test and forced swim test
Time is obviously prolonged (p<0.01), show to model successfully.After drug therapy, each administration group Tail suspension test and forced trip
The mouse dead time significantly reduces in swimming experiment.
On MDA content in Mice brain tissues and the active influence of SOD, it the results are shown in Table 3
3 Mice brain tissues of table, 10% homogenate MDA content and SOD activity (N=10)
Compared to the blank group, * p<0.01；Compared with model group, * * p<0.05；***p<0.001
As can be seen from Table 3, compared with blank group, model group Mice brain tissues MDA content increases, and SOD activity reduces, table
It is bright to model successfully.Compared with model group mouse, SOD activity is increased in each administration group Mice brain tissues, and MDA content is decreased obviously.
The treatment gastric ulcer experimental study of embodiment 10 " Liver-Comforting Decoction " side Chinese medical extract
1 materials and methods
1.1 material
1.1.1 it is dynamic up to experiment to be purchased from Hunan Si Laike scape by rat health male SD rat 190,180~200g of weight
Object Co., Ltd, credit number：SCXK (Hunan) 2017-0006.
1.1.2 feed is provided by Hunan University of Traditional Chinese Medicine's Experimental Animal Center.
1.1.3 barrier environment Experimental Establishment Hunan University of Traditional Chinese Medicine Experimental Animal Center.
1.1.4 drug case study on implementation 1-6 prepares sample.Distilled water (is mentioned by Hunan University of Traditional Chinese Medicine's Experimental Animal Center
For)；10% chloraldurate, physiological saline (being provided by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine).
1.1.5 reagent and instrument PGE2 Elisa kit (being purchased from Bio-Swamp Life Science company)；Electronics
Balance, constant water bath box, low temperature refrigerator, microplate reader, high-pressure steam sterilizing pan, supercentrifuge etc. are (big by Hunan traditional Chinese medicine
Study medicine the offer of fundamental education and experimental centerl biochemistry and molecular biology laboratory).
1.2 method
1.2.1 animal is raised into 3d under 22~26 DEG C of quiet environments of room temperature before animal packet experiment, to allow it to adapt to ring
Border and observing determines each experimental rat without starting to test after obvious illness.190 rats are divided into 19 groups by random digits table：
Blank control group, model control group, positive controls, sample 1-1 (lot number：18010106), sample 1-2 (lot number：
18010208), sample 1-3 (lot number：18010309), sample 2-1 (lot number：18020423), sample 2-2 (lot number：
18020524), sample 2-3 (lot number：18020625), sample 3-1 (lot number：18030518), sample 3-2 (lot number：
18030620), sample 3-3 (lot number：18030722), sample 4-1 (lot number：18040817), sample 4-2 (lot number：
18040927), sample 4-3 (lot number：18041021), sample 5-1 (lot number：18051103), sample 5-2 (lot number：
18051205), sample 5-3 (lot number：18051228), sample 6-1 (lot number：18011118), every group of each 10 rat.
1.2.2 animal model blank control group rat not modeling.Other each group rats are deprived of food but not water after the last administration
It for 24 hours, stress (WRS) modeling method production stress in rats gastric ulcer model using water-immersion restraint.With 10% chloral hydrate anesthesia
It after rat, is lain on the back and is fixed on mouse plate, mouse plate is uprightly dipped in 20 DEG C after rat is awake by the elastic appropriateness of cotton rope used
Constant water bath box in, the water surface is maintained at rat ensiform process of sternum position, takes out after water logging 15h.
1.2.3 the sample of 16 sample sets difference stomach-filling embodiment 1-6 preparations of medication；Positive controls stomach-filling is existing
The Omeprazole aqueous suspensions of the 3g/kg matched；Blank control group and model control group press 1mL/100g stomach-filling physiological saline, and each group is pre-
Anti- property administration, 1 time a day, continuous gavage 5d, after administration in the 5th day, modeling after being deprived of food but not water for 24 hours.
1.2.4 after collection of specimens modeling, 10% chloraldurate of each group rats by intraperitoneal injection (300mg/kg) carries out deep
Degree anesthesia, opens abdomen after anesthesia, is rapidly separated abdominal aorta, and abdominal aorta blood sampling is placed in no anti-coagulants heparin tube and stands 4h, and 3
000r/min, centrifugation 10min, isolate serum and are placed in EP pipe, save backup in -20 DEG C of refrigerators.After blood sampling, ligature rapidly
Pylorus takes out mouse stomach, takes a small amount of gastric juice in pH test paper (measurement range by cardia drop：0.5~5.0, it is cured by Hunan University of Traditional Chinese Medicine
Fundamental education and experimental centerl biochemistry and molecular biology laboratory is learned to provide), measure pH value.By mouse stomach from pylorus to cardia along stomach
Big curved scissors appetizing wall, makes mucous membrane face turn up, is gently rinsed with physiological saline, writing brush gently brushes away mucosa surface mucus, in hand
It is flattened in art kidney basin, visually observes the mucosal lesion situation of rat, calculate ulcer index.Then gastric tissue is stored in
Fixed in 4% paraformaldehyde solution, gastric mucosa tissue pathomorphology change is observed in HE dyeing.
1.2.5 index detection method gastric juice pH measures：Mouse stomach pylorus is ligatured, takes a small amount of gastric juice to try in pH by cardia drop
On paper, pH value is measured.The calculating of ulcer index (UI)：Referring to Guth standard, i.e. mucosal lesion length is calculated with mm, spot
1 point of erosion meter；Rotten to the corn length < 1mm counts 2 points；Rotten to the corn 1~2mm of length counts 3 points；Rotten to the corn 2~3mm of length counts 4 points；Rotten to the corn length
> 4mm counts 5 points；Score value × 2 when width G T.GT.GT 1mm, the summation that full stomach must divide are ulcer index.Enzyme-linked immunization detects serum
The content of middle PGE2 illustrates to be operated according to Elisa kit.
1.2.6 statistical method carries out statistical analysis using 16.0 software of SPSS, as a result with mean ± standard deviation (x
± s) it indicates, mean compares using one-way analysis of variance between group, and is compared two-by-two with LSD method, correlation test, P <
0.05 indicates that difference is statistically significant.
2 results
The observation of 2.1 gross specimens
Blank control group：Gastric mucosa is smooth complete, no ulcer surface and blutpunkte；Model control group：Rat stomach surface
There is coffee sample substance, it is seen that mucosa surface congestion and edema, erosion have a large amount of dotted or streak-like hemorrhage points and ulcer；It is positive right
According to group：Mucosa surface smoother, have it is few be dispersed in blutpunkte, without apparent ulcer surface；16 sample sets：Stomach lining table
There are the blutpunkte being dispersed in, ulcer point in face.
The comparison of 2.2 each group gastric mucosa Pathologic changes
Blank control group：Gastric mucosa layer is smooth complete, epithelial cell and body of gland marshalling, has no that hair and blood enlargement of pipe is congested
And inflammatory cell infiltration.Model control group：Gastric epithelial is obviously damaged, continuity interruption occurs, forms ulcer.Have obvious thin
Born of the same parents fall off, histolysis, hemorrhagic tendency, visible inflammatory cell infiltration under mucous membrane.Positive controls：Mucosal lesion is compared with model pair
Substantially reduced according to organizing, body of gland arrangement is more neat, and accidental surface layer strip falls off epithelium.16 sample sets：Stomach lining Mild edema,
Mucosal integrity is preferable, and body of gland arrangement is more neat, is damaged mucous membrane table shallowly and limits to.
The measurement result of 2.3 each group rat gastric ulcer indexes is as shown in table 4：Compared with blank control group, model control group
Rat UI value is significantly raised, and difference is statistically significant (P < 0.01)；Compared with model control group, positive controls and various kinds
Product group rat UI value is substantially reduced (P < 0.01)；Compared with positive controls, the different no system of Zuojin Wan high dose group rat UI value difference
Meter learns meaning (P=0.429).The above prompt：(1) gastric mucosa is obviously damaged after modeling success；(2) each sample group can drop
Low stress gastric ulcer rat UI value protects stomach lining, and is in apparent dose-effect positive correlation.
4 each group gastric mucosa damage index of table compares
Note：Compared with blank control group,aP < 0.01；Compared with model control group,bP < 0.01.With positive controls ratio
Compared with,cP < 0.01.
2.4 each group rat gastric juice pHs, the measurement result of serum PG E2 are as shown in table 5：Compared with blank control group, model
Control rats gastric juice pH and serum PG E2 content are substantially reduced (P < 0.01)；Compared with model control group, positive control
Group, sample sets rat gastric juice pH and serum PG E2 content are significantly raised, and difference is statistically significant (P < 0.01).Prompt：
(1) " Liver-Comforting Decoction side " can increase the gastric juice pH of stress gastric ulcer rat, the damage of attack factor gastric acid be reduced, to protect
Stomach lining；(2) " Liver-Comforting Decoction side " can promote the synthesis and secretion of stress gastric ulcer P of Rats GE2, play the work of protection stomach lining
With.
5 each group rat gastric juice pH of table, serum PG E2 comparision contents
Note：Compared with blank control group,aP < 0.01；Compared with model control group,bP < 0.01.With positive controls ratio
Compared with,cP < 0.01,dP > 0.05.
The treatment stomachache experimental study of embodiment 11 " Liver-Comforting Decoction " side Chinese medical extract
1 material
1.1 drug case study on implementation 1-6 prepare sample：Sample 1-1 (lot number：18010106), sample 1-2 (lot number：
18010208), sample 1-3 (lot number：18010309), sample 2-1 (lot number：18020423), sample 2-2 (lot number：
18020524), sample 2-3 (lot number：18020625), sample 3-1 (lot number：18030518), sample 3-2 (lot number：
18030620), sample 3-3 (lot number：18030722), sample 4-1 (lot number：18040817), sample 4-2 (lot number：
18040927), sample 4-3 (lot number：18041021), sample 5-1 (lot number：18051103), sample 5-2 (lot number：
18051205), sample 5-3 (lot number：18051228), sample 6-1 (lot number：18011118).External application ethanol extract 3g/
Ml, facing the used time is made into required concentration.Second phthalein choline 100ug/ml (three factory of Shanghai reagent, lot number 860920), histamine 1 00ug/ml
(Shanghai biochemical research institute of the Chinese Academy of Sciences).Barium chloride 10mg/ml and aspirin 12.5mg/ml, it is commercially available.
1.2 animal rabbit 2kg/ only, are provided by animal housing of our hospital；18~22g of Kun Ming mice, by Hubei Province's epidemic prevention station
It provides.
1.3 equipment ultra thermostats, tonotransducer, physiograph, water bath with thermostatic control etc..
2 methods and result
The 2.1 stomachaches only effect to rabbit intestinal smooth muscle
2.1.1 prepare to put to death rabbit, cut open the belly, take one section of jejunum to set and fill oxygenation (containing 5%CO2) tyrode's solution in, PH
Value is 7 or so.Mesenterium is separated along intestinal wall, is rinsed well intestinal contents with tyrode's solution.One section of 2~2.5cm sample is chosen,
Both ends threading, one end lie on ventilation hook, are gently put into 37.5 DEG C of constant temperature Magnus' bath, and the other end is lain on energy converter,
Myenteron contraction movement is traced with the LMS-2A type physiograph that Chengdu Instruement Factory produces.
2.1.2 the stomachache only effect to the in vitro intestinal smooth muscle of rabbit
The in vitro intestines sample of rabbit shows shrink tension reduction to embodiment 1-6 sample.It the results are shown in Table 6.
The stomachache of the table 6 only influence to the in vitro intestines spontaneous activity of rabbit
2.1.3 stomachache stops the effect of anti-second phthalein choline, histamine and barium chloride
Sample of the present invention has apparent spasmolysis to rabbit intestinal smooth muscle spasm caused by second phthalein choline, histamine, barium chloride
Effect.It the results are shown in Table 7.
The stomachache of table 7 stops the effect of anti-Ach, histamine and barium chloride
Only then the influence mouse to mouse enterocinesia is given by oral administration containing ink fasting 24 hours before testing for 2.2 stomachaches
The drug (in every 5ml drug plus prepared Chinese ink 1ml) of juice, puts to death through dislocation of cervical vertebra method after 30 minutes, cuts open the belly, extremely from cardia by alimentary canal
Rectum end completely extracts, and traction is not added, is laid on experimental bench, surveys its length, and cardia is arrived in the forward position for recording prepared Chinese ink
Distance calculates the percentage of itself and gastrointestinal tract overall length, and the t carried out between each cell mean is examined.
Experimental result shows that this sample can obviously inhibit mouse enterocinesia.It the results are shown in Table 8.
Table 8 stomachache only to mouse body intestinal smooth muscle influence
2.3 stomachaches, will only to analgesic activity (hot plate method) the regulating thermostatic water-bath water temperature of small white mouse at 55 ± 0.5 DEG C
500ml copper pot is put into wherein, and the bottom of a pan is made to contact the water surface.Female small white mouse 1 is taken every time, is put into pot, and record is put into copper pot certainly
To there is licking (second) the time required to the rear foot, the pain threshold as the mouse.Do not occur licking metapedes person in all 30 seconds, gives it up.It takes
Mouse 65 of pre-selection qualification, are randomly divided into 8 groups, gastric infusion.It is tested after forty minutes by hot plate method, measures each mouse threshold of pain
Value, is compared with control group.
As a result it prompts, sample of the present invention, aspirin have apparent analgesic activity.It is shown in Table 4.
The stomachache of table 4 is only to the analgesic activity (hot plate method) of small white mouse
The acute toxicological experiment of 12 extract of embodiment
Preliminary experiment：By acute toxicological experiment method, kunming mice 20 are selected, water 12h is can't help in fasting.In embodiment 1
Extract is configured to the suspension of maximum concentration.The each stomach-filling of every mouse is about 0.8mL/20g (weight), for 24 hours interior stomach-filling 3
It is secondary, it is spaced 4h.Then routinely raise, and observe mouse toxic reaction situation (appearance, activity, breathing, secretion, defecation,
Death etc.), and continuous weighting 7 days.Because not measuring median lethal dose (LD50) with maximum administration concentration, maximum administration capacity,
Therefore do maximum dosage-feeding experiment.
1) general performance
After administration in 14 days, the equal diet of experimental mice is normal, and fur is smooth, and freely, stool and urine is normal, without exception for activity
Secretion, respiratory system, cardiovascular system, nervous system, digestive system and urinary system are showed no exception, and mouse is all deposited
It is living.Its daily maximum dosage-feeding is that per kilogram is greater than 250g.
2) changes of weight situation
After administration in 14 days, weight variation without exception.
3) main organs are observed
2 groups of mouse are through gross anatomy and observe by the naked eye, and have no the abnormal phenomenon such as internal organs enlargement, atrophy, necrosis, mainly
Internal organs are close with blank control group without any bad lesion.In conclusion prompting this medicine nontoxic, clinical dosage is one
A safe dosage, clinical application safety.
Claims (9)
1. it is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract, which is characterized in that with green peel, dried orange peel, Chinese herbaceous peony
Medicine, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：It is male
The root bark of tree peony：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：Each taste prepared slices of Chinese crude drugs are taken, weigh raw material in proportion, 7~12 times of waters is added to impregnate 20-
30min, heating extraction 3 times, each amount of water is identical, extraction time after boiling calculate, be 2.5h for the first time, second
It is 1h, is 30min for the third time；Merge extracting solution three times, extracting solution to the extracting liquid volume that acquisition is concentrated is the raw material
3~5 times of weight obtain initial concentration extracting solution；Being further dried to relative density is 1.0~1.2g/cm3Traditional Chinese medicine extraction
Object.
2. it is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract, which is characterized in that with green peel, dried orange peel, Chinese herbaceous peony
Medicine, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：It is male
The root bark of tree peony：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：Each taste prepared slices of Chinese crude drugs are taken, weigh raw material in proportion, add 7~12 times 65%~85%
Concentration ethanol impregnates 20-30min, and heating extraction 3 times, every time plus amount of alcohol is identical, extraction time after boiling calculate, the
It is once 2.5h, second of 1h, third time 30min, the extracting solution of acquisition is concentrated to the volume of the extracting solution in combined extract
It is 3~5 times of the raw material weight, obtains initial concentration extracting solution；Being further dried to relative density is 1.0~1.2g/cm3
Chinese medical extract.
3. it is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract, which is characterized in that with green peel, dried orange peel, Chinese herbaceous peony
Medicine, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：It is male
The root bark of tree peony：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：
1) concentrate is prepared：Above-mentioned ingredients is cleaned, weighs raw material in proportion, 7~12 times of waters is added to impregnate 20-30min,
Heating extraction 3 times, each amount of water is identical, extraction time after boiling calculate, be 2.5h for the first time, be 1h for the second time,
Third time is 30min, combined extract, and the extracting solution of acquisition is concentrated to 3~5 that the extracting liquid volume is the raw material weight
Times, obtain initial concentration extracting solution；
2) add ethanol precipitation：Add ethanol in proper amount into the initial concentration extracting solution of above-mentioned preparation, make solvent alcohol content 65~
75%, 24 hours are stood, filtration, filtrate recycling ethanol obtains refined liquid, is concentrated, is drying to obtain Chinese medical extract.
4. it is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract, which is characterized in that with green peel, dried orange peel, Chinese herbaceous peony
Medicine, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：It is male
The root bark of tree peony：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：
1) concentrate is prepared：Above-mentioned ingredients is cleaned, weighs raw material in proportion, 7~12 times of waters is added to impregnate 20-30min,
Heating extraction 3 times, each amount of water is identical, extraction time after boiling calculate, be 2.5h for the first time, be 1h for the second time,
Third time is 30min, combined extract, and the extracting solution of acquisition is concentrated to 3~5 that the extracting liquid volume is the raw material weight
Times, obtain initial concentration extracting solution；
2) macroporous resin purification：Respectively plus in the initial concentration extracting solution that obtains to step 1) of 3~5 times of volume hot water, supernatant is taken
Liquid；Supernatant is crossed into macroporous resin column absorption, abandons efflux；Then with the water of 1~5BV with 0.5~2.5BV/ hours flow velocitys
The adsorption column is washed, water lotion is abandoned；50~70% ethyl alcohol is used later, and elution volume 3~5BV is small with 0.5~2.5BV/
When flow velocity elute adsorption column, collect the ethanol eluate, concentration, the dry ethanol eluate obtain Chinese medical extract.
5. it is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract, which is characterized in that with green peel, dried orange peel, Chinese herbaceous peony
Medicine, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：Dried orange peel：Chinese herbaceous peony：It is male
The root bark of tree peony：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：
1) concentrate is prepared：Each taste prepared slices of Chinese crude drugs are taken, weigh raw material in proportion, add 7~12 times of 65%~85% concentration ethanol
Impregnate 20-30min, heating extraction 3 times, every time plus amount of alcohol it is identical, extraction time after boiling calculate for the first time be
2.5h is 1h for the second time, is 30min for the third time, combined extract, and the volume that extracting solution to the extracting solution of acquisition is concentrated is
3~5 times of the raw material weight obtain initial concentration extracting solution；
2) macroporous resin purification：Respectively plus in the initial concentration extracting solution that obtains to step 1) of 3~5 times of volume hot water, supernatant is taken
Liquid；Supernatant is crossed into macroporous resin column absorption, abandons efflux；First the adsorption column described in the water washing of 5BV, abandoning are washed after loading
Liquid；Then the adsorption column was washed with 0.5~2.5BV/ hours flow velocitys with the water of 1~5BV, abandons water lotion；50 are used later
~70% ethyl alcohol, 3~5BV of elution volume elute adsorption column with 0.5~2.5BV/ hours flow velocitys, collect the ethanol elution
Liquid, concentration, the dry ethanol eluate, obtains Chinese medical extract.
6. such as the Chinese medical extract that any one method is prepared in claim 1-5, which is characterized in that in the extract
It is not less than not less than 0.80%, Paeonol not less than 0.67%, Gardenoside containing aurantiamarin not less than 4.1%, Paeoniflorin
0.10%, Alisol B monoacetate is not less than 0.70% not less than 0.03%, Bolbostemma paniculatum glucoside A.
7. it is a kind of treat stomachache, hypochondriac pain, gastroenteritic ulcer, depression Chinese medical extract decoction preparation method, which is characterized in that with
Green peel, dried orange peel, Chinese herbaceous peony, cortex moutan, cape jasmine (stir-fry), rhizoma alismatis, the rhizoma bolbostemmae are made of raw material, and each raw material relative weight ratio is green peel：
Dried orange peel：Chinese herbaceous peony：Cortex moutan：Cape jasmine (stir-fry)：Rhizoma alismatis：The rhizoma bolbostemmae=4：4：4：：3：3：3：6；
Preparation method includes the following steps：Each taste prepared slices of Chinese crude drugs are taken, weigh raw material in proportion, add 7 times of waters, heating extraction
2.5h, the extracting solution that extracting solution concentration obtains to 5 times that the extracting liquid volume is the raw material weight, obtains initial concentration and mentions
Take liquid；Being further dried to relative density is 1.0g/cm3" Liver-Comforting Decoction " matter basis；Obtained material benchmark it is effective at
Point aurantiamarin not less than 3.6%, Paeoniflorin not less than 0.56%, Paeonol not less than 0.42%, Gardenoside not less than 0.05%,
Alisol B monoacetate is not less than 0.43% not less than 0.01%, Bolbostemma paniculatum glucoside A.
8. containing the pharmaceutical composition such as the Chinese medical extract that any one method is prepared in claim 1-5 or right 7,
It is characterized in that, the composition is oral preparation, such as oral solution, capsule, soft capsule, pill, granule, the mouth
It include pharmaceutically acceptable carrier and (or) excipient in formulation.
9. the Chinese medical extract as any one method is prepared in claim 1-5 treats stomachache, hypochondriac pain, stomach and intestine in preparation
Application in ulcer and medicament for treatment of depression or health care product.
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| CN110559373A (en) * | 2019-09-12 | 2019-12-13 | 河北万岁药业有限公司 | Preparation method of classic famous prescription liver-clearing decoction granules |
| CN110579539A (en) * | 2019-07-11 | 2019-12-17 | 神威药业集团有限公司 | Establishing method of fingerprint of Huaganjian tea |
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Address after: 430000 Yongan East Road, Xianning hi tech Industrial Development Zone, Xianning, Hubei, 63 Applicant after: Hubei Yiren General Institute of traditional Chinese Medicine Co., Ltd Address before: 430000 Yongan East Road, Xianning hi tech Industrial Development Zone, Xianning, Hubei, 63 Applicant before: HAIWANG (HUBEI) CHINESE MEDICINE RESEARCH INSTITUTE Co.,Ltd. |
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