CN102106993B - Chinese medicinal composition for treating fatty liver and preparation method thereof - Google Patents
Chinese medicinal composition for treating fatty liver and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the field of traditional Chinese medicines, and discloses a Chinese medicinal composition for treating symptoms such as transaminase elevation, intrahepatic fatty infiltration, hyperlipemia, adiposity and the like which are caused by fatty liver. In the invention, a formula is made according to the conventional principle of treatment based on syndrome differentiation in traditional Chinese medical science, Chinese medicinal composition tablets for treating the fatty liver are prepared by mixing bupleurum, curcuma aromatica, giant knotweed rhizome, notoginseng root, dahurian patrinia herb, largehead atractylodes rhizome, immature bitter orange, glossy privet fruit and lycium bark according to a certain weight ratio, and by process steps of decocting, filtering, concentrating, alcohol depositing, drying, tabletting and the like. The Chinese medicinal composition has the effects of soothing liver-qi stagnation, promoting qi circulation, eliminating damp, eliminating blood stasis and removing stagnation, and has the effects of reducing enzymes and blood fat and eliminating intrahepatic fatty accumulation.
Description
Technical field
The present invention relates to a kind of treatment and raise by the transaminase that fatty liver causes, intrahepatic fatty infiltration, hyperlipidemia, Chinese medicine composition of diseases such as obesity and preparation method thereof belongs to the field of Chinese medicines.
Background technology
Along with living standard improves, dietary structure changes, and the sickness rate of fatty liver is in rising trend, and the crowd of not agnate, all ages and classes and different sexes all fatty liver can take place.Epidemiological study, various countries report that the non-alcoholic fatty liver disease prevalence rate is 10%-24% among the general crowd, have become one of modal diffusivity hepatic lesions; And it possibly be the major reason of cryptogenic cirrhosis; Also be the unusual common cause of health examination crowd liver zymetology, further developing to become fat hepatitis, and final progress is hepatopathy in whole latter stage such as liver cirrhosis; Bring harm for broad masses of the people's health, so more and more come into one's own.
At present clinically to the treatment of the fatty liver complete method of none cover still.Doctor trained in Western medicine often adopts simple fat-reducing medicament to handle, and the pathology of fatty liver not merely is the blood fat reducing problem, also comprises behind the intrahepatic fatty infiltration infringement to liver function, and uses the Western medicine blood fat reducing merely, tends to have side effects the infringement liver function.And do not have the Chinese patent medicine of treating fat hepatitis on the market, have only some health foods to declare that fatty liver is had some health-care effects, but do not have obvious curative effects.
Summary of the invention
The purpose of this invention is to provide a kind of prescription of treating the Chinese medicine composition (soothing the liver fat sheet) of fatty liver, this prescription has the soothing the liver fat that disappears, heat clearing away eliminate indigestion, the function of promoting flow of QI and blood.The transaminase that mainly treating fatty liver causes raises, intrahepatic fatty infiltration, hyperlipidemia, diseases such as obesity.This project product is compared (Chinese patent medicine that does not have the special for treating non-alcoholic fatty liver disease in the market) short treating period with existing Chinese medicine health-care medicine, required expense is low and drug effect is obvious.Compare with import Western medicine (lipid lowerers), unit medication course of treatment economy, wholistic therapy are effective, have no side effect.
Radix Bupleuri has dispersing the stagnated live-QI to relieve the stagnation of QI, the heat clearing away effect; Fructus Aurantii Immaturus has promoting the circulation of QI to alleviate the stagnation in middle-JIAO, and removing food stagnancy removes long effect; Radix Curcumae has promoting QI circulation for relieving depression, the stasis-dispelling and pain-killing effect.Three medicines share, and then stagnation of liver-QI is able to evacuate, and QI and blood is able to unobstructed.Rhizoma Polygoni Cuspidati, Herba Patriniae two medicines fall the important medication of enzyme for the treatment fatty liver fat that disappears.Radix Notoginseng has the promoting blood circulation to disperse blood clots and relieves pain effect, uses in a small amount, to strengthen the face of Radix Curcumae stasis-dispelling and pain-killing effect.Rhizoma Atractylodis Macrocephalae spleen invigorating, the Fructus Ligustri Lucidi nourishing the liver, two medicines are the article that tonification is set upright.Though fatty liver is an excess syndrome, disease for a long time then healthy energy gradually consume, patient has the insufficient another side of healthy energy.Though the fatty liver patient should not mend high benefit greatly, the spleen invigorating nourishing the liver, protection gastrointestinal function and the liver protecting function still are necessary.Cortex Lycii has the clearing away heat and cooling blood effect.Be the principal agent that summer-heat removing beverage Cortex Lycii among the people reveals, long-term drink finds to have lowering blood-fat and reducing weight and the effect of eliminating fatty liver.
In sum, Patients with Fatty Liver liver-fire person is many, and stagnation of QI person is many, and heat in blood person is many; Long-pending person is many for the stasis of blood, and food stagnation person is many, and the person is many from constipation, therefore; Treatment is taken in and is gone out to get rid of evils is main, strengthens relieving inflammation or internal heat, resolving depression, removing heat from blood, blood stasis dispelling, dampness, relieving constipation, removing food stagnancy, so that five kinds of masses in the chest and abdomen six kinds of stagnation-syndromes and fat can be dissolved drainage from liver, from intestinal, excretes; Thereby intrahepatic fat is eliminated, and rate and blood-lipid decreased loses weight.We have dispersing the stagnated live-QI to relieve the stagnation of QI, circulation of qi promoting removing dampness, blood stasis dispelling removing food stagnancy effect both according to traditional determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs principle prescription.From the experience of clinical practice, innovate again, form a novel prescription, have the enzyme of falling blood fat reducing, eliminate the effect that intrahepatic fat gathers.
Another object of the present invention provides the method for preparing of this Chinese medicine composition.
The invention provides following prescription forms: Chinese medicine composition of the present invention is characterized in that it is to be processed by the raw material of following weight portion: 200～400 parts of Radix Bupleuri, 200～400 parts of Radix Curcumaes, 300～500 parts of Rhizoma Polygoni Cuspidati; 50～200 parts of Radix Notoginseng, 200～400 parts of Herba Patriniae, 100～300 parts of the Rhizoma Atractylodis Macrocephalaes; 100～300 parts of Fructus Aurantii Immaturuss, 100～300 parts of Fructus Ligustri Lucidi, 200～400 parts of Cortex Lycii; 20～80 parts of microcrystalline Cellulose, polyvinylpolypyrrolidone XL10～80 part, 4～12 parts of silicon dioxide; 10～150 parts of lactose, 10～200 parts of 8% copolyvidone S-630-95% alcoholic solution, 1～10 part of magnesium stearate.
Described Chinese medicine composition is processed by the raw material of following weight portion: 250～350 parts of Radix Bupleuri, 250～350 parts of Radix Curcumaes, 350～450 parts of Rhizoma Polygoni Cuspidati; 50～150 parts of Radix Notoginseng, 250～350 parts of Herba Patriniae, 150～250 parts of the Rhizoma Atractylodis Macrocephalaes; 150～250 parts of Fructus Aurantii Immaturuss, 150～250 parts of Fructus Ligustri Lucidi, 250～350 parts of Cortex Lycii; 40～60 parts of microcrystalline Cellulose, polyvinylpolypyrrolidone XL30～50 part, 6～10 parts of silicon dioxide; 50～100 parts of lactose, 50～150 parts of 8% copolyvidone S-630-95% alcoholic solution, 1～5 part of magnesium stearate.
Described Chinese medicine composition is processed by the raw material of following preferred weight part: 300 parts of Radix Bupleuri, 300 parts of Radix Curcumaes, 400 parts of Rhizoma Polygoni Cuspidati; 100 parts of Radix Notoginseng, 300 parts of Herba Patriniae, 200 parts of the Rhizoma Atractylodis Macrocephalaes, 200 parts of Fructus Aurantii Immaturuss; 200 parts of Fructus Ligustri Lucidi, 300 parts of Cortex Lycii, 50 parts of microcrystalline Cellulose, polyvinylpolypyrrolidone XL40 part; 8 parts of silicon dioxide, 75 parts of lactose, 115 parts of 8% copolyvidone S-630-95% alcoholic solution, 2 parts of magnesium stearate.
The method for preparing of Chinese medicine composition of the present invention may further comprise the steps:
Get 9 flavor medical materials such as above-mentioned Radix Bupleuri and add 12 times of water gagings and boil and carry 1 hour, filter; 8 times of water gagings of filtering residue adding boil carries 1 hour, filters; 8 times of water gagings of filtering residue adding boil carries 1 hour, filter, and merging filtrate, reclaim under reduced pressure to solution density ratio is 1.1～1.2; Put and be chilled to room temperature, slowly adding 95% ethanol to determining alcohol is 70%, leaves standstill 16 hours, gets supernatant; Reclaim under reduced pressure to thick extractum, 60 ℃ of vacuum drying oven dryings get dry extract; Beat powder, add adjuvant, tabletting, coating promptly gets.
According to drug use " five just " principle, our selected pharmaceutical dosage form is changed the inconvenience of Chinese medicine, makes medicine be convenient to the patient and uses and accept.For a change the disagreeable taste of Chinese patent medicine can make medicine better store, so that make full use of limited Chinese material medicine resource; And the effective ingredient that makes medicine makes full use of and the prerequisite that can be effectively absorbed by body under, we are according to the effective ingredient character of medicine, selected tablet is the industrialized great production dosage form of medicine.
The present invention is except that amount of water, and the proportioning that other relate to or its percentage composition are all by weight.
The specific embodiment
Below through specific embodiment technical scheme of the present invention is described further.In these embodiment, unless otherwise indicated, all proportionings or percentage composition and limit weight portion with kg or g all by weight.
Embodiment 1:
Chinese medicine composition, it is to be processed by the raw material of following weight portion: Radix Bupleuri 200g, Radix Curcumae 200g, Rhizoma Polygoni Cuspidati 300g; Radix Notoginseng 50g, Herba Patriniae 200g, Rhizoma Atractylodis Macrocephalae 100g, Fructus Aurantii Immaturus 100g; Fructus Ligustri Lucidi 100g, Cortex Lycii 200g, microcrystalline Cellulose 20g, polyvinylpolypyrrolidone XL 10g; Silicon dioxide 4g, lactose 10g, 8% copolyvidone S-630-95% alcoholic solution 10g, magnesium stearate 1g.
The method for preparing of Chinese medicine composition may further comprise the steps:
Get 9 flavor medical materials and add 12 times of water gagings (17.4L) and boil and carry 1 hour, filter; Filtering residue 8 times of water gagings of adding (11.6L) boil carries 1 hour, filters; Filtering residue 8 times of water gagings of adding (11.6L) boil carries 1 hour, filters merging filtrate; Reclaim under reduced pressure to solution density ratio is 1.1～1.2, puts and is chilled to room temperature, and slowly adding 95% ethanol to determining alcohol is 70%; Left standstill 16 hours, and got supernatant, reclaim under reduced pressure to thick extractum; 60 ℃ of vacuum drying oven dryings get dry extract 203g; Beat powder, add adjuvant, tabletting, coating promptly gets.
Embodiment 2:
Chinese medicine composition, it is to be processed by the raw material of following weight portion: Radix Bupleuri 400g, Radix Curcumae 400g, Rhizoma Polygoni Cuspidati 500g; Radix Notoginseng 200g, Herba Patriniae 400g, Rhizoma Atractylodis Macrocephalae 300g, Fructus Aurantii Immaturus 300g; Fructus Ligustri Lucidi 300g, Cortex Lycii 400g, microcrystalline Cellulose 80g, polyvinylpolypyrrolidone XL 80g; Silica 1 2g, lactose 150g, 8% copolyvidone S-630-95% alcoholic solution 200g, magnesium stearate 10g.
The method for preparing of Chinese medicine composition may further comprise the steps:
Get 9 flavor medical materials and add 12 times of water gagings (38.4L) and boil and carry 1 hour, filter; Filtering residue 8 times of water gagings of adding (25.6L) boil carries 1 hour, filters; Filtering residue 8 times of water gagings of adding (25.6L) boil carries 1 hour, filters merging filtrate; Reclaim under reduced pressure to solution density ratio is 1.1～1.2, puts and is chilled to room temperature, and slowly adding 95% ethanol to determining alcohol is 70%; Left standstill 16 hours, and got supernatant, reclaim under reduced pressure to thick extractum; 60 ℃ of vacuum drying oven dryings get dry extract 480g; Beat powder, add adjuvant, tabletting, coating promptly gets.
Embodiment 3:
Chinese medicine composition, it is to be processed by the raw material of following weight portion: Radix Bupleuri 250g, Radix Curcumae 250g, Rhizoma Polygoni Cuspidati 350g; Radix Notoginseng 50g, Herba Patriniae 250g, Rhizoma Atractylodis Macrocephalae 150g, Fructus Aurantii Immaturus 150g; Fructus Ligustri Lucidi 150g, Cortex Lycii 250g, microcrystalline Cellulose 40g, polyvinylpolypyrrolidone XL30g; Silicon dioxide 6g, lactose 50g, 8% copolyvidone S-630-95% alcoholic solution 50g, magnesium stearate 1g.
The method for preparing of Chinese medicine composition may further comprise the steps:
Get 9 flavor medical materials and add 12 times of water gagings (22.2L) and boil and carry 1 hour, filter; Filtering residue 8 times of water gagings of adding (14.8L) boil carries 1 hour, filters; Filtering residue 8 times of water gagings of adding (14.8L) boil carries 1 hour, filters merging filtrate; Reclaim under reduced pressure to solution density ratio is 1.1～1.2, puts and is chilled to room temperature, and slowly adding 95% ethanol to determining alcohol is 70%; Left standstill 16 hours, and got supernatant, reclaim under reduced pressure to thick extractum; 60 ℃ of vacuum drying oven dryings get dry extract 268.5g; Beat powder, add adjuvant, tabletting, coating promptly gets.
Embodiment 4:
Chinese medicine composition, it is to be processed by the raw material of following weight portion: Radix Bupleuri 350g, Radix Curcumae 350g, Rhizoma Polygoni Cuspidati 450g; Radix Notoginseng 150g, Herba Patriniae 350g, Rhizoma Atractylodis Macrocephalae 250g, Fructus Aurantii Immaturus 250g; Fructus Ligustri Lucidi 250g, Cortex Lycii 350g, microcrystalline Cellulose 60g, polyvinylpolypyrrolidone XL 50g; Silica 1 0g, lactose 100g, 8% copolyvidone S-630-95% alcoholic solution 150g, magnesium stearate 5g.
The method for preparing of Chinese medicine composition may further comprise the steps:
Get 9 flavor medical materials and add 12 times of water gagings (33L) and boil and carry 1 hour, filter; Filtering residue 8 times of water gagings of adding (22L) boil carries 1 hour, filters; Filtering residue 8 times of water gagings of adding (22L) boil carries 1 hour, filters merging filtrate; Reclaim under reduced pressure to solution density ratio is 1.1～1.2, puts and is chilled to room temperature, and slowly adding 95% ethanol to determining alcohol is 70%; Left standstill 16 hours, and got supernatant, reclaim under reduced pressure to thick extractum; 60 ℃ of vacuum drying oven dryings get dry extract 426.3g; Beat powder, add adjuvant, tabletting, coating promptly gets.
Embodiment 5:
Chinese medicine composition, it is to be processed by the raw material of following weight portion: Radix Bupleuri 30kg, Radix Curcumae 30kg, Rhizoma Polygoni Cuspidati 40kg; Radix Notoginseng 10kg, Herba Patriniae 30kg, Rhizoma Atractylodis Macrocephalae 20kg, Fructus Aurantii Immaturus 20kg; Fructus Ligustri Lucidi 20kg, Cortex Lycii 30kg, microcrystalline Cellulose 5kg, polyvinylpolypyrrolidone XL 4kg; Silicon dioxide 0.8kg, lactose 7.5kg, 8% copolyvidone S-630-95% alcoholic solution 11.5kg, magnesium stearate 0.2kg.
The method for preparing of Chinese medicine composition may further comprise the steps:
Get 9 flavor medical materials and add 12 times of water gagings (2760L) and boil and carry 1 hour, filter; Filtering residue 8 times of water gagings of adding (1840L) boil carries 1 hour, filters; Filtering residue 8 times of water gagings of adding (1840L) boil carries 1 hour, filters merging filtrate; Reclaim under reduced pressure to solution density ratio is 1.1～1.2, puts and is chilled to room temperature, and slowly adding 95% ethanol to determining alcohol is 70%; Left standstill 16 hours, and got supernatant, reclaim under reduced pressure to thick extractum; 60 ℃ of vacuum drying oven dryings get dry extract 36.34kg; Beat powder, be soothing the liver fat extract powder.Get wherein 1kg dry extract, add adjuvant, tabletting, coating promptly gets.
As the zooperal reagent thing that receives, through concrete experimental data, the effect of the Chinese medicine composition (soothing the liver fat sheet) that the present invention is prepared is described further with soothing the liver fat extract powder prepared among the embodiment 5.
(1) pharmacodynamic action research
1 soothing the liver fat sheet is studied the effect of hyperlipidemia Carnis Coturnicis japonicae antilipemic
1.1 receiving the reagent name claims: soothing the liver fat extract powder
1.2 test dose design
Design high, medium and low three the drug effect dose groups of soothing the liver fat, dosage is: 100mg extractum/kg, 300mg extractum/kg, 900mg extractum/kg.
1.3 positive drug title: gemfibrozil (tieing up deep red knowledge)
1.4 experimental technique
Divide cage at random with commercially available Carnis Coturnicis japonicae, 5 in every cage, two cages are one group.Soothing the liver fat extract powder is divided into high, medium and low three dose groups, positive drug gemfibrozil group, model control group, blank group, 6 groups altogether.Freely drink water, eat, adaptability is raised a week, begins the high lipid food of except that the blank group, feeding and preparing second week; Irritate the various medicines of clothes simultaneously, once a day, continuous 3 weeks; Finish fasting the previous day in experiment and can't help water; Experiment finishes the carotid artery blood sampling, centrifuging and taking serum, and automatic biochemical analyzer is measured cholesterol in serum (CHO), triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein, LDL (LDL).
1.5 experimental result
Can know through biochemistry detection statistics: the model control group Carnis Coturnicis japonicae shows that because of serum cholesterol (CHO), triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein, LDL (LDL) index due to the high lipid food significantly raise (P＜0.01) than normal group this experiment modeling successfully.The hyperlipidemia Carnis Coturnicis japonicae after three weeks were irritated the soothing the liver fat of clothes each dose groups Carnis Coturnicis japonicae serum cholesterol (CHO), triglyceride (TG), high density lipoprotein (HDL) is compared with model control group has tangible reduction, and is particularly particularly evident for serum cholesterol (CHO) and low density lipoprotein, LDL (LDL) reduction effect.Middle and high dosage effect of soothing the liver fat and positive drug effect are similar.With low dosage certain dose-effect relationship is arranged relatively.
1.6 experiment conclusion
Can be known by experimental result: three dosage of soothing the liver fat have effect for reducing blood fat preferably for the hyperlipidemia Carnis Coturnicis japonicae more, and wherein middle and high dose groups effect is close with the positive drug group, sees table 1.
Table 1: soothing the liver fat is to the influence of hyperlipidemia Carnis Coturnicis japonicae CHO, TG, HDL, LDL
Compare with model control group:
*P＜0.05;
*P＜0.01.
Compare with the blank group: #P＜0.05; ##P＜0.01.
2. soothing the liver fat sheet is studied the serum lipids in rats effect
2.1 receiving the reagent name claims: soothing the liver fat extract powder
2.2 test dose design
Design high, medium and low three the drug effect dose groups of soothing the liver fat, dosage is: 100mg extractum/kg, 300mg extractum/kg, 900mg extractum/kg.
2.3 positive drug title: gemfibrozil (tieing up deep red knowledge)
2.4 experimental technique
Divide cage at random with rat, 5 in every cage, 10 is one group.Be divided into high, medium and low three dose groups of soothing the liver fat, positive drug gemfibrozil group, model control group and blank group.The blank group normal feedstuff of feeding; All the other dose groups high lipid food of feeding, according to dosage group is irritated the thing of taking medicine simultaneously, and continuous irrigation obeyed for 4 weeks; Weigh weekly once; According to body weight adjustment dosage, experiment finishes fasting the previous day and can't help water, the last time carotid artery blood sampling in a hour, centrifuging and taking serum after the administration.Measure serum cholesterol (CHO), triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein, LDL (LDL) in the serum.
2.5 experimental result
Can know that by table 24 indexs of model control group are explained rat modeling success apparently higher than the blank group.Soothing the liver fat has certain effect for reducing blood fat to hyperlipemia rat, between three dose groups certain dosage correlation is arranged, and the effect for reducing blood fat of high dose group is particularly evident in this experiment.Can be known that by table 3 the hyperlipidemia feedstuff has certain influence to the body weight of rat, with the apparent in view reduction of blank group, and medication group decrease speed when the 4th week is starkly lower than model group.
2.6 experiment conclusion
Can know that by this experimentation soothing the liver fat has certain effect for reducing blood fat to the hyperlipemia rat that is caused by high lipid food, particularly evident in high dose group, the weight loss that causes because of high lipid food there is certain effect that slows down.
Table 2: soothing the liver fat is to the influence of hyperlipemia rat CHO, TG, HDL, LDL
Compare with model control group:
*P＜0.05;
*P＜0.01.
Compare with the blank group: #P＜0.05; ##P＜0.01.
Table 3: soothing the liver fat changes (X ± SD) to rat body weight
Compare with model group:
*P＜0.05;
*P＜0.01.
Compare with the blank group: #P＜0.05; ##P＜0.01.
3. soothing the liver fat sheet is studied the protective effect of chemical acute liver damage
3.1 receiving the reagent name claims: soothing the liver fat extract powder
3.2 test dose design
Design high, medium and low three the drug effect dose groups of soothing the liver fat, dosage is: 100mg extractum/kg, 300mg extractum/kg, 900mg extractum/kg.
3.3 positive drug title: bifendate
3.4 experimental technique
Divide 6 groups at random with mice, 10 every group, be respectively three dose groups of soothing the liver fat, positive drug bifendate group, model control group, blank group.Raised one day after dividing into groups, second day begins by each dosed administration, continuous seven days; Preceding 18-20 hour of last administration; All the other only respectively organize the equal lumbar injection 0.1%CCL40.2ml/ of mice except that the normal control group, and the last administration is the blood sampling from the mice canthus after 1 hour, separation of serum; The biochemical measurement appearance is measured ALT, AST, gets right lobe of the liver 10% formaldehyde fixed of part and does the pathology detection.
3.5 experimental result
Can know that through the serum biochemistry detection statistics soothing the liver fat raises to ALT, AST due to the chmice acute chemical liver injury and has tangible reduction effect, compares ALT (P＜0.01) with model control group >, AST (P＜0.01) has certain dosage correlation.Pathologic finding shows that the model control group mouse liver cell is bad focal necrosis, hepatocyte arrangement disorder, swelling, and be mixed with inflammatory cell infiltration.All obviously alleviate the mouse liver injury degree with each dose groups of the more soothing the liver fat of model control group and positive drug bifendate group.
3.6 experiment conclusion
Three dose groups of soothing the liver fat all have the ALT due to certain reduction CCL4, the rising of AST; Alleviate degree of liver; Acute liver damage due to the chemical substance CCL4 is had the certain protection effect, tangible dosage correlation is arranged, wherein the high dose group effect is superior to positive drug bifendate group.
Table 4: soothing the liver fat is caused the protective effect (X ± SD) of acute liver damage by CCL4 to mice
Compare with model control group:
*P＜0.05;
*P＜0.01.
Compare with the blank group:
#P＜0.05;
##P＜0.01.
4. soothing the liver fat sheet is to fatty liver rat preventive effect research due to the high lipid food
4.1 receiving the reagent name claims: soothing the liver fat extract powder
4.2 test dose design
Design high, medium and low three the drug effect dose groups of soothing the liver fat, dosage is: 100mg extractum/kg, 300mg extractum/kg, 900mg extractum/kg.
4.3 positive drug title: DONGBAO GANTAI
4.4 experimental technique
With the rat random packet, 10 every group, totally 6 groups.Be soothing the liver fat three dose groups, positive drug group, model control group and blank group.All the other respectively organize the high lipid food (containing Adeps Sus domestica 10%, cholesterol 2%, thiouracil 0.25%, edible oil 5%) of feeding except that the blank group; Simultaneously by divide into groups irritating the thing of taking medicine, totally 4 weeks, finishing fasting the previous day around the and can't help water; After the administration on the same day 1 hour; With rat with 3% secobarbital anaesthetize, ventral aorta blood sampling, separation of serum is surveyed AST, ALT, TG, CHO, HDL, LDL.Get liver and weigh, calculate liver coefficient (heavy (gram)/body weight (gram) * 100 of liver); The liver main lobe is used 10% formaldehyde fixed, makes pathology and detects; Other gets the 200mg hepatic tissue and adds 10% normal saline 1.8ml, processes homogenate with homogenizer, presses the test kit operating instruction and surveys TG, CHO in the liver.
4.5 experimental result
4.5.1 biochemical indicator detects
Model control group AST, ALT, CHO, LDL significantly raise than normal group.Respectively organize AST, ALT, CHO after the soothing the liver fat administration and obviously descend, three dose groups of wherein soothing the liver fat to ALT and in high dose group CHO and model group are more all had significant difference; High dose group also has the significance effect to AST, and the high dose group effect is close with the positive drug effect.Hepatic tissue CHO, TG are measured each dose groups and the liver coefficient calculations shows that also soothing the liver fat causes that to high lipid food rat fat liver preventive administration has remarkable effect (P＜0.01).The result sees table 5,6.
4.5.2 pathology detection
Pathologic finding shows, model group rat hepatocytes arrangement disorder, the cellular swelling is obvious, the accumulation scope between whole liver section 2/3 and 3/3 between, steatosis almost all takes place in the hepatic tissue that has.Each dose groups of soothing the liver fat and the pathological change of positive drug group: hepatic tissue endite structure is unclear, the hepatocyte arrangement disorder, and cord structures disappears, the hepatocyte enlargement, sinus hepaticus is narrow.The low dose group hepatocyte is kitchen range property steatosis, and middle dose groups hepatocyte is gently, moderate or severe steatosis.High dose group and positive drug group hepatocyte are gently, the moderate steatosis, and the soothing the liver fat of various dose and positive drug DONGBAO GANTAI can make the rat liver fat lesion obviously alleviate, and high dose group pathological change and positive drug group are similar, and the result sees table 7.
4.6 experiment conclusion
In this experiment, the liver T-CHOL of model control group and the T-CHOL in the serum, each item liver function index all obviously raise, and serious widely steatosis takes place hepatocyte, and the liver index significantly increases, and can cause serious fatty liver after showing high fat diet.And serum AST, ALT and other liver function indexs of animal are obviously descended; Pathology detection shows that also soothing the liver fat has the effect of tangible prevention of liver infringement; Liver tg, T-CHOL and the liver coefficient of liver significantly descend simultaneously; The hepatic tissue fat lesion significantly alleviates, and shows that soothing the liver fat has tangible preventive effect to the rat experimental fatty liver.
Table 7: soothing the liver fat changes treatment rat fat liver preventive administration hepatopathy reason
5. soothing the liver fat sheet is to fatty liver rat therapeutical effect research due to the high lipid food
5.1 receiving the reagent name claims: soothing the liver fat extract powder
5.2 test dose design
Design high, medium and low three the drug effect dose groups of soothing the liver fat, dosage is: 100mg extractum/kg, 300mg extractum/kg, 900mg extractum/kg.
5.3 positive drug title: DONGBAO GANTAI
5.4 experimental technique
With the rat random packet, 10 every group, totally 6 groups.Be soothing the liver fat three dose groups, DONGBAO GANTAI group, model control group and blank group.All the other respectively organize the high lipid food (containing Adeps Sus domestica 10%, cholesterol 2%, thiouracil 0.25%, edible oil 5%) of feeding except that the blank group; In beginning to irritate the thing of taking medicine the 4th week by grouping dosage; Finish fasting the previous day in the 8th week and can't help water, after the administration on the same day 1 hour, with rat with 3% secobarbital anaesthetize, ventral aorta takes a blood sample; Separation of serum is surveyed AST, ALT, TG, CHO, HDL, LDL.Get liver and weigh, calculate liver coefficient (liver heavy/body weight * 100); The liver main lobe is used 10% formaldehyde fixed, makes pathology and detects; Other gets the 200mg hepatic tissue and adds 10% normal saline 1.8ml, processes homogenate with homogenizer, presses the test kit operating instruction and surveys TG, CHO in the liver.
5.5 experimental result
5.5.1 biochemical indicator detects
Model control group AST, ALT, CHO, HDL, LDL significantly raise than normal group.Respectively organize TG, HDL, LDL decline after the soothing the liver fat administration, relatively there were significant differences with model control group.Hepatic tissue CHO, TG measure and the liver Index for Calculation shows that also soothing the liver fat has the effect of good curing fatty liver.Three dose groups of soothing the liver fat have certain dose-effect relationship, see table 8.
5.5.2 pathology detection
Pathologic finding shows, model group rat hepatocytes arrangement disorder, the cellular swelling is obvious, is the severe steatosis, the accumulation scope between whole liver section 2/3 and 3/3 between, steatosis almost all takes place in the hepatic tissue that has.Basic, normal, high and positive drug group pathological change: hepatic tissue endite structure is unclear, the hepatocyte arrangement disorder, and cord structures disappears, the hepatocyte enlargement, sinus hepaticus is narrow, is steatosis in various degree.Can know that according to pathologic finding the soothing the liver fat of various dose and positive drug DONGBAO GANTAI can make the rat liver fat lesion obviously alleviate, the high dose group pathological change is close with the positive drug group, and the result sees table 10.
5.6 experiment conclusion
This experimental studies results shows that soothing the liver fat extract powder can obviously reduce triglyceride, high density, low density lipoprotein, LDL in the fatty liver model, and pathological examination shows that also soothing the liver fat sheet can reduce the degree of rat fat liver degeneration.
Table 10: soothing the liver fat changes rat fat liver therapeutic studies hepatopathy reason
Through to soothing the liver fat extract powder antilipemic, liver injury protection and fatty liver is preventative, therapeutic effect research, show that soothing the liver fat extract powder has unique curative effect above aspect several.Aspect lipidemia, suitable effect is arranged with the positive drug gemfibrozil; Chemical liver injury protection aspect is similar with bifendate; Preventative to fatty liver, therapeutic treatment is similar with DONGBAO GANTAI.
(2) acute toxicity test in mice
1. experiment purpose: observe behind the soothing the liver fat extract powder of disposable filling clothes maximal dose death condition and toxic reaction to mice produced.
2. claimed by the reagent name: soothing the liver fat extract powder
3. experimental technique:
Get healthy mice and be divided into medication group, matched group at random.Each 20 of male and female.The medication group is by the disposable filling of the 0.8ml/20g thing of taking medicine, and matched group is irritated the clothes normal saline.Observed mice after the administration movable 4 hours, observe once later every day, 13 days altogether.
4. observation index
4.1 dead: male and female dead mouse number in the record observation period, dead animal is dissected at once, and the variation of the perusal mice main organs heart, liver, spleen, lung, kidney etc. is if perusal has and carries out pathologic finding unusually.
4.2 toxic reaction: the behavioral activity of male and female mice in the record observation period, had or not the abnormal secretion thing by hair, skin, breathing, defecation, appetite, nose, eye, oral cavity, routine weighing finishes all to put to death mice, and dissecting tool inspection animal has no abnormal.
5. experimental result
Soothing the liver fat extract powder is not seen dead mouse and abnormal movement through the test of mice maximum dosage-feeding, dissects mice after 13 days and does not see the main organs pathological change, and all are normal.
6. experiment conclusion
The oral soothing the liver fat extract powder acute toxicity test maximum dosage-feeding of mice is 20g/kg.
(3) soothing the liver fat rat long term toxicity test
1. experiment purpose
Observe the toxic reaction and the order of severity thereof that soothing the liver fat per os successive administration produced the rat body after 6 months, the target organ of prompting toxic reaction and the reversibility of infringement thereof are confirmed non-toxic reaction dosage, for drafting the human safe dose reference are provided.
2. claimed by the reagent name: soothing the liver fat sheet extract powder
3. experimental technique:
3.1 route of administration: irritate the appetite clothes
3.2 dosage, group setting and reason:
When 100mg/kg, show certain curative effect with reference to soothing the liver fat rat pharmacodynamics test, confirm of 3, the 10 and 30 times settings of soothing the liver fat rat long term toxication dosage, be respectively low dose group: 300mg/kg by the drug effect effective dose; Middle dose groups: 1000mg/kg; High dose group: 3000mg/kg.Administration volume: 1ml/100g
3.3 administration frequency: once a day, on every Saturdays day.
3.4 experimental period: six months
3.5 inspection before the administration
Be placed on the quarantine chamber after rat is bought and observe a week, observed content comprises: general activity, diet situation, have or not loose stool, morbid state such as become thin.After one week animal is divided cage marshalling at random and begins to establish the raising of answering property, 7 days observation periods, write down outward appearance sign, behavioral activity, the feces shape of animal weekly and ingest etc.
3.6 during the administration with drug withdrawal after, observation period inspection
3.6.1 general symptom: every day the observed and recorded animal outward appearance sign, behavioral activity, feces shape etc.
3.6.2 body weight: claim once weekly, calculate the average weight of every treated animal, observe the dynamic change that rat body weight increases.
3.6 3 food rations: claim once weekly, calculate the average appetite in every one week of cage animal, observe its dynamic change.
3.7 zootomy
Dissect for the first time: 3 months each groups are dissected 10 rats, male and female half and half, totally 40 after the administration.Carry out gross anatomy, hematology, serum biochemistry inspection.
Dissect for the second time: administration in 6 months finishes, and every treated animal is dissected 10 rats, male and female half and half, totally 40.
Dissect for the third time: drug withdrawal was dissected 40 rats of residue after one month.
When dissecting animal, second and third time carry out hematology, serum biochemistry, gross anatomy and histopathologic examination.
3.8 hematological indices inspection:
Hematological examination is done in the blood sampling of rat anesthesia when dissected; The inspection index comprises: RBC (RBC), numeration of leukocyte (WBC) and classification (NE: neutrophilic granulocyte; LY: lymphocyte; Basophilic leukocyte), hemoglobin (Hb), red cell volume (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) (MCHC), reticulocyte (Ret), platelet (PLT) MO: mononuclear cell, EO: acidophil, BA:.
3.9 blood biochemical is learned the index inspection:
The rat anesthesia when dissected is learned the index inspection through ventral aorta blood sampling carrying out blood biochemical, and project comprises: measure alanine aminotransferase (ALT), aspartate transaminase (AST), alkali phosphatase (ALP), creatine kinase (CK), blood urea nitrogen (BUN), creatinine (CRE), total protein (TP), albumin (ALB), blood glucose (GLU), STB (T-BiL), T-CHOL (T-CHO), triglyceride (TG), inorganic ions K+, Na+, Cl-.Same hematological indices of review time.
3.10 pathological examination
3.10.1 system becomes celestial: visual examination has or not positive pathological changes
3.10.2 organ coefficient:
Comprise the heart, liver, spleen, lung, kidney, adrenal gland, testis, epididymis, ovary, uterus, thymus and brain.Organ coefficient=organ weights/body weight * 100
3.10.3 histological examination:
Content comprises brain (brain, XIAONAO, brain stem), spinal cord (neck, breast, waist section), hypophysis cerebri, thymus, thyroid, parathyroid gland, esophagus, salivary gland, stomach, intestinal (duodenum, ileum, colon), liver, pancreas, kidney, adrenal gland, spleen, the heart, trachea, lung, aorta, uterus, ovary, mammary gland, prostate, bladder, testis (attached testis), lymph node (mesenteric lymph node).10% formalin fixed, conventional dehydration, embedding, section, H.E dyeing, om observation.
4. statistical method: each item quantitative target adopts between two groups of means the t-check to carry out statistical test, and group difference P＜0.05 is judged.
5. experimental result:
5.1 general situation:
Each dose groups rat fur glossiness and general behavior are compared with matched group and are not seen obvious change.Body weight and appetite change sees table, and each dose groups male and female rat is compared with matched group and do not see notable difference.
5.2 hematological examination:
Administration finishes hematological examination and shows that administration group and matched group physiochemical indice do not have outstanding property difference.
5.3 blood biochemical is learned inspection:
Administration finish blood biochemical learn in the inspection low in the ALT of dose groups compared with matched group significant difference (P＜0.01 >; ALP, BUN in low in the high dose group compared with matched group significant difference (P＜0.01 >; Inorganic ions K+, Na+ in ALB in the low middle dose groups and the low middle dose groups, Cl-and matched group in the low middle high dose group relatively have significant difference (P＜0.01).But these differences are all in normal range, no pathology meaning.
5.4 system becomes celestial:
Interim inspection in 4 months, the part rat becomes celestial as system, and each treated animal internal organs form of perusal, color and luster etc. are normal basically, and the pathologic finding main organs is not seen the obviously change relevant with medicine.Administration latter stage and convalescent period main organs do not see the pathological change relevant with medicine yet.
5.5 organ weights and coefficient thereof:
Relatively medication group and matched group organ weights and organ coefficient are except that indivedual organ weights and coefficient there were significant differences.The basic genus normally, further any unusual of these difference tissues do not found in the pathological tissue inspection yet.
5.6 histological examination:
Each histoorgan of this experiment specifically changes, and finding specifically describes as follows under the mirror:
Heart: the heart tissue of each treated animal shows that all the cardiac muscle fiber hierarchical structure is intact, and karyon dyeing is clear, and not seeing in the cardiac muscular tissue has unusual pathological change such as inflammation, congestion, edema.
Aorta: respectively organize the aorta tube wall fiber alignment of animal neat, hierarchical structure is clear, does not see obvious abnormal change.
Liver: the hepatic tissue endite clear in structure of each treated animal, hepatocyte are strand arranges, and does not see pathological changes such as tangible degeneration, necrosis.
Spleen: the splenic capsule and the spleen trabeculae of each treated animal dye, and morphosis is clear, pulpa lienis and splenic cords clear layer, no abnormality seen pathological changes.
Lungs: tunicle and the equal morphosis of bronchus at different levels are intact in each treated animal lung tissue, and the bronchial mucosa epithelium does not have obvious damage, no abnormal pathological changes.
Trachea: the morphology of trachea structure of each treated animal is intact, and the mucosal epithelium cell is not seen obvious pathological change.
Kidney: the kidney skin of each treated animal, the equal boundary clear of medullary substance, the tissue morphology clear in structure of glomerule, renal tubules and renal pelvis is not seen unusual pathological change such as degeneration, necrosis, inflammation, cast.
Brain: the cerebral cortex of each treated animal and medullary substance hierarchical structure are clear, and neurite is obvious, and form is intact, and the neurocyte number of modalities is all normal; XIAONAO and brain stem tissue form clear layer are intact, and no abnormality seen changes.
Spinal cord: white matter and grey matter morphosis are intact in three sections tissues of the spinal cord of each treated animal (neck, breast, waist), clear layer, and no abnormality seen changes.
Hypophysis: the pituitary tissue morphosis of each treated animal is clear, and cell is arranged intact, no abnormal pathological changes.
Neural: the interior all visible structure of the sciatic nerve of each treated animal are clear, the nerve fiber and the neurilemma cell of marshalling, the no abnormality seen pathological change.
Thyroid: the parathyroid tissue morphosis of each treated animal is intact, and follicular cells is cube, and it is clear to dye, folliculus interior visible have a liking for Yihong coloring agent matter, no abnormality seen pathological change.
Parathyroid gland: the parathyroid gland tissue of each treated animal is interior to be main parenchyma marshalling with the chief cell, and form is intact, no abnormal pathological change.
Thymus: the thymic tissue inner cortex and the medullary substance structure of each treated animal are intact, and it is clear to demarcate, and epithelial reticular cell and lymphocyte form and quantity are normal in the thymus essence, no abnormal pathological change.
Salivary gland: all visible various types of acinuses and conduit in the salivary organization of each treated animal, Non Apparent Abnormality changes.
Esophagus: each treated animal esophageal tissue structure is intact, mucosal epithelium cell marshalling, clear layer, no abnormal change.
Stomach: each treated animal gastric epithelial and last subcutaneous each layer tissue structure are not all seen has unusual pathological change such as tangible degeneration, necrosis, inflammation.
Duodenum: all not seeing in the duodenum mucous membrane tissue of each treated animal has unusual pathological change such as tangible degeneration, inflammation, necrosis, ulcer.
Ileum, colon: the ileum of each treated animal, colonic mucosa organize equal form intact, and hierarchical structure is clear, do not see obvious pathological change.
Pancreas: the pancreas essence leaflet of each treated animal is obvious, and acinous cell dyeing is clear, and the islets of langerhans form is intact basically, no abnormal pathological change.
The adrenal gland: adrenal tissue's inner cortex of each treated animal and medullary substance boundary are clear, glomerular zone, the equal marshalling cortex cell of zona fasciculata and reticular zone and the equal no abnormality seen pathological change of medullary epithelium in the cortex.
Lymph node: lymph node tissue endolymph folliculus, diffuse lymphoid tissue and the equal form of lymphoid sinus of each treated animal are intact.
The uterus: each uterine cancer cell morphosis of organizing jenny is intact, endometrium, myometrium and uterus body of gland no abnormality seen pathological change.
Ovary: each interior follicle at different levels of ovary tissue of organizing jenny all physically well develops no abnormal pathological change.
Mammary gland: each organizes the mammary gland tissue endite clear in structure of jenny, glandular tube epithelial cell marshalling, no abnormal pathological change.
Testis: each organizes the convoluted seminiferous tubule clear in structure in the buck testis tissue, and spermatogenic cells at different levels physically well develop, and can see spermatid and sperm in the tube chamber, and interstitial tissue of testis is no abnormal.
Prostate: each organizes the interior glandular tube epithelial cell marshalling of prostata tissue of buck, no abnormality seen pathological change.
Epididymis: each interior epididymis tube wall epithelial cell of epididymis tissue of organizing buck is high column shape arrangement, visible sperm in the tube chamber.
Bladder: the mucosal epithelium clear layer of each treated animal, the interlaced arrangement of longitudinal muscle and circular muscle under the mucosa, structure is intact, the no abnormality seen pathological changes.
Each is organized administration and finishes the pathological tissue form inspection with the convalescent period rat; Not observing obvious pathological tissue form changes; No tangible group difference and sex difference between the observed result can think that soothing the liver fat sheet does not have the overt toxicity effect to the histoorgan that is tried rat under this experiment condition.
6. experiment conclusion:
Through six months to rat blood serum biochemistry, physiochemical indice, histological research, do not see the toxic reaction relevant with medicine, the safe dose of rat is 3000mg/kg.
Claims (5)
1. Chinese medicine composition of treating fatty liver is characterized in that this Chinese medicine composition processed by the raw material of following weight portion: 200～400 parts of Radix Bupleuri, 200～400 parts of Radix Curcumaes, 300～500 parts of Rhizoma Polygoni Cuspidati; 50～200 parts of Radix Notoginseng, 200～400 parts of Herba Patriniae, 100～300 parts of the Rhizoma Atractylodis Macrocephalaes; 100～300 parts of Fructus Aurantii Immaturuss, 100～300 parts of Fructus Ligustri Lucidi, 200～400 parts of Cortex Lycii; 20～80 parts of microcrystalline Cellulose, polyvinylpolypyrrolidone XL10～80 part, 4～12 parts of silicon dioxide; 10～150 parts of lactose, 10～200 parts of 8% copolyvidone S-630-95% alcoholic solution, 1～10 part of magnesium stearate.
2. Chinese medicine composition of treating fatty liver is characterized in that this Chinese medicine composition processed by the raw material of following weight portion: 250～350 parts of Radix Bupleuri, 250～350 parts of Radix Curcumaes, 350～450 parts of Rhizoma Polygoni Cuspidati; 50～150 parts of Radix Notoginseng, 250～350 parts of Herba Patriniae, 150～250 parts of the Rhizoma Atractylodis Macrocephalaes; 150～250 parts of Fructus Aurantii Immaturuss, 150～250 parts of Fructus Ligustri Lucidi, 250～350 parts of Cortex Lycii; 40～60 parts of microcrystalline Cellulose, polyvinylpolypyrrolidone XL30～50 part, 6～10 parts of silicon dioxide; 50～100 parts of lactose, 50～150 parts of 8% copolyvidone S-630-95% alcoholic solution, 1～5 part of magnesium stearate.
3. Chinese medicine composition of treating fatty liver is characterized in that this Chinese medicine composition processed by the raw material of following weight portion: 300 parts of Radix Bupleuri, 300 parts of Radix Curcumaes, 400 parts of Rhizoma Polygoni Cuspidati; 100 parts of Radix Notoginseng, 300 parts of Herba Patriniae, 200 parts of the Rhizoma Atractylodis Macrocephalaes, 200 parts of Fructus Aurantii Immaturuss; 200 parts of Fructus Ligustri Lucidi, 300 parts of Cortex Lycii, 50 parts of microcrystalline Cellulose, polyvinylpolypyrrolidone XL40 part; 8 parts of silicon dioxide, 75 parts of lactose, 115 parts of 8% copolyvidone S-630-95% alcoholic solution, 2 parts of magnesium stearate.
4. the method for preparing of the Chinese medicine composition of claim 1,2,3 arbitrary described treatment fatty livers is characterized in that may further comprise the steps: the 9 flavor medical materials such as Radix Bupleuri of getting said weight proportion add 12 times of water gagings and boil and carries 1 hour, filter; 8 times of water gagings of filtering residue adding boil carries 1 hour, filters; 8 times of water gagings of filtering residue adding boil carries 1 hour, filter, and merging filtrate, reclaim under reduced pressure to solution density ratio is 1.1～1.2; Put and be chilled to room temperature, slowly adding 95% ethanol to determining alcohol is 70%, leaves standstill 16 hours, gets supernatant; Reclaim under reduced pressure to thick extractum, 60 ℃ of vacuum drying oven dryings get dry extract; Beat powder, add adjuvant, tabletting, coating promptly gets.
5. the Chinese medicine composition of claim 1,2,3 arbitrary described treatment fatty livers is characterized in that this Chinese medicine composition is a tablet.
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| CN105434681A (en) * | 2015-12-24 | 2016-03-30 | 兰州古驰生物科技有限公司 | Traditional Chinese medicine health-care preparation for reducing blood lipid |
| CN116549563B (en) * | 2023-07-05 | 2023-09-19 | 北京盛际中医药研究院 | Traditional Chinese medicine composition for soothing liver and promoting bile flow as well as preparation method and application thereof |
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