CN103623046A - Composite playing auxiliary protection role in chemical and alcoholic liver injury, preparation method of composite and application of composite in health-care food - Google Patents
Composite playing auxiliary protection role in chemical and alcoholic liver injury, preparation method of composite and application of composite in health-care food Download PDFInfo
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Abstract
The invention provides a composite which has high bioavailability, is suitable for being applied for a long time and plays an auxiliary protection role in chemical and alcoholic liver injury, a preparation method of the composite and application of the composite in health-care food. The composite comprises the following components in percentage by weight: 5%-45% of silybum marianum extractives-lecithin compounds, 5%-45% of radix puerariae extractives, 10%-50% of pregelatinized starch, 10%-50% of microcrystalline cellulose, 1%-10% of sodium carboxymethyl starch and 1%-5% of magnesium stearate. The production process provided by the invention is an environment-firendly advanced process and is less in environment pollution and high in application value; the obtained product is obviously enhanced in bioavailability, outstanding in liver protection effect, reduced in toxicity and suitable for being applied for a long time.
Description
Technical field
The present invention relates to a kind of compositions and preparation method and application in health food thereof that chemical and alcoholic liver injury is had to auxiliary protection function.
Background technology
In China, become a very important problem because of the hepatic injury (ALD) due to ethanol.Investigation shows, 32%～45% hepatocarcinoma (HCC) is caused by ethanol.ALD is the common cause of one of the whole world hepatopathy cause of disease in topmost whole latter stage ，Ye Shi American-European countries liver transplantation.Along with the fast development of China's economy, the raising of people's living standard, alcohol consumption amount is at obvious rapid growth per capita, and the prevalence of ALD is also rising, and has become the second largest hepatopathy cause of disease that is only second to viral hepatitis at present.Zhejiang Province's Epidemiology of alcoholic liver diseases survey data shows, in Adult group, alcoholic hepatitis prevalence is 4.3%～6.5%, the prevalence of alcoholic cirrhosis is 0.68%, the prevalence of alcoholic fatty liver is 0.94%, the prevalence of alcoholic hepatitis is 1.51%, and other liver injury is 1.21% due to ethanol.The ratio that alcoholic hepatitis accounts for the hepatopathy inpatient same period constantly rises, from 1991 4.2% increase to 1996 21.3%; Alcoholic cirrhosis the constituent ratio of causes of liver cirrhosis from 1999 10.8% rise to 2003 24.0%.Therefore, the health care for liver seems particularly important.
Also have in the market many hepatoprotective, treatment hepatitis Western medicine, but its in vivo metabolic process can produce again the virulent material of liver, cause the secondary injury of liver, be not suitable for long-term taking; And utilize traditional Chinese medicine to come hepatoprotective at the existing long historical tradition of China, but its dosage and difficult quality determine, its use of having carried the effects limit such as inconvenience.
There is at present Chinese invention patent (publication number CN1682749A) to adopt Radix Puerariae flavone and Herba Silybi mariani flavone compositions for alleviating the human body injury due to excessive absorption ethanol.Openly with the passing of time, the corresponding product that still has not yet to see up to now State Food and Drug Administration's approval emerges patent of invention.Trace it to its cause, mainly contain the limitation of following several respects: 1, simple Herba Silybi mariani flavone long-term taking has certain toxic and side effects, do not meet country for the requirement of health food, can not long-term taking; 2, simple Herba Silybi mariani flavone bioavailability, utilization is difficult to be absorbed by the body.Therefore, utilize modern biotechnology, in conjunction with modern preparation technique, improve bioavailability, that researches and develops applicable long-term taking has the health food of auxiliary protection function to have realistic meaning to chemical liver injury and alcoholic liver injury.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of compositions that chemical and alcoholic liver injury is had to auxiliary protection function, to reduce the toxic and side effects of Herba Silybi mariani flavone and to be beneficial to long-term taking and to improve its bioavailability, is beneficial to absorption of human body.
For solving the problems of the technologies described above; the technical solution used in the present invention is: a kind of compositions that chemical and alcoholic liver injury is had to auxiliary protection function; described compositions comprises the component of following percentage by weight: Herba Silybi mariani extract-lecithin 5～45%; Radix Puerariae extract 5～45%; pregelatinized Starch 10～50%; microcrystalline Cellulose 10～50%, carboxymethyl starch sodium 1～10%, magnesium stearate 1～5%.
The bright preparation method that a kind of above-mentioned composition is also provided of we; by Herba Silybi mariani extract and lecithin, carry out the degree of depth compound; alleviate the toxic and side effects of its long-term taking; improve bioavailability; and be aided with Radix Puerariae extract; form a kind of compositions that chemical and alcoholic liver injury is had to auxiliary protection function, its concrete preparation process is as follows:
Get Herba Silybi mariani seed decontamination, squeezing is deoiled, and adds 2～20 times of amount ethanol, 50～80
oc reflux, extract,, each 1～3 hour, extracts 1～3 time.Merge extractive liquid,, concentrates and dries in 40～60 ℃, obtains Herba Silybi mariani extract.
Get Herba Silybi mariani extract, add the lecithin of 0.5～3.0 times of amount, add 2～25 times of amount 60～95% ethanol, reflux, to dissolving, reclaims solvent to thick paste shape.Thick paste shape complex is put in vacuum desiccator and be dry, pulverize and cross 40～80 mesh sieves, obtains Herba Silybi mariani extract-lecithin.
The preparation of preferred Herba Silybi mariani extract-lecithin: get Herba Silybi mariani extract, add the lecithin of 0.8～1.5 times of amount, add 8～15 times of amount 85% ethanol, reflux, to dissolving, reclaims solvent to thick paste shape.Thick paste shape complex is put in vacuum desiccator and be dry, pulverize and cross 60 mesh sieves, obtains Herba Silybi mariani extract-lecithin.
The preparation of preferred Herba Silybi mariani extract-lecithin: get Herba Silybi mariani extract, add the lecithin of 1.2 times of amounts, add 10 times of amount 85% ethanol, reflux, to dissolving, reclaims solvent to thick paste shape.Thick paste shape complex is put in vacuum desiccator and be dry, pulverize and cross 60 mesh sieves, obtains Herba Silybi mariani extract-lecithin.
Get the roguing of Radix Puerariae medical material, pulverize, add 5～15 times of amount 60～95% ethanol, reflux, extract,, each 1～3 hour, extracts 1～3 time.Merge extractive liquid,, in 40～60
oc concentrates and dries, and obtains Radix Puerariae extract.
Get Herba Silybi mariani extract-lecithin, Radix Puerariae extract sieves respectively, by formula ratio by after raw material adjuvant mix homogeneously and get final product.
The present invention also provides the application of above-mentioned composition in health food, a kind of health food, described health food comprises the above-mentioned compositions that chemical and alcoholic liver injury is had to assosting effect, by formula ratio by raw material adjuvant mix homogeneously pelletizing press sheet and get final product, take every day 2 times, each serving with 2 (0.5g/ sheets).
Herba Silybi mariani extract is from the seed of feverfew Herba Silybi mariani, and main component has the Flavonoid substances such as silibinin, Isosilybin, Silychristin and silidianin, wherein the highest with silibinin content.It has multiple pharmacologically active: the liver protecting cell is avoided toxicant infringement, especially ethanol and environmental contaminants (pesticide, heavy metal etc.) invasion infringement liver; There is powerful anti-oxidation function, can avoid free radical destruction by the liver protecting cell; Promote the synthetic of protein, accelerate to manufacture new liver cell, or make liver cell self-healing in damaged condition.Therefore be called as " natural hepatoprotective ", be widely used in treatment acute, chronic hepatitis, early stage liver cirrhosis, fatty liver and toxic hepatitis.
Radix Puerariae is the dry root that pulse family Pueraria lobota belongs to perennial defoliation liana Herba Gelsemii Elegantis or Radix Puerariae rattan, sweet in the mouth, and property is pungent, cool, returns spleen, stomach warp, has expelling pathogenic factors from muscles for reducing heat, rash, promoting the production of body fluid to quench thirst, relieving restlessness, yang invigorating antidiarrheal, the treatment skin ulcer of invigorating blood circulation, the merit of relieving the effect of alcohol.Radix Puerariae extract have suppress large mice ethanol absorbtivity, acceleration of alcohol metabolism, raising to the dosis tolerata of ethanol, reduce mortality rate and reduce effects such as liver injury.
Production technology of the present invention is green advanced technologies, and environmental pollution is little, has larger using value.The product obtaining, bioavailability obviously improves, and hepatoprotective effect is remarkable, the adverse drug taste when overcoming conventional dosage forms simultaneously and taking.
The specific embodiment
Below in conjunction with specific embodiment, technical scheme of the present invention is described further, wherein, related embodiment should not be regarded as the restriction to protection scope of the present invention.
Embodiment 1
Get Herba Silybi mariani seed decontamination, squeezing is deoiled, and adds 10 times of ethanol, 60
oc reflux, extract,, each 2 hours, extracts 2 times.Merge extracted twice liquid, concentrate and dry in 60 ℃, obtain Herba Silybi mariani extract.
Get Herba Silybi mariani extract, add the lecithin of 1.3 times of amounts, add 10 times of amount 85% ethanol, reflux, to dissolving, reclaims solvent to thick paste shape.Thick paste shape complex is put in vacuum desiccator and be dry, pulverize and cross 60 mesh sieves, obtains Herba Silybi mariani extract-lecithin.
Get the roguing of Radix Puerariae medical material, pulverize, add 7～8 times of amount 70% ethanol, reflux, extract,, each 1.5～2 hours, extracts 2 times.Merge extracted twice liquid, concentrate and dry in 60 ℃, obtain Radix Puerariae extract.
Prescription:
Method for making: according to above-mentioned preparation prescription, take main Herba Silybi mariani extract-lecithin and Radix Puerariae extract, add pregelatinized Starch, microcrystalline Cellulose, granulate, dry, granulate; Add tabletting after all the other adjuvant mix homogeneously, make 10000, coating.
Embodiment 2
The health food that chemical and alcoholic liver injury is had to assosting effect, by Herba Silybi mariani extract-lecithin, Radix Puerariae extract, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate, formed, its percentage by weight is Herba Silybi mariani extract-lecithin 25%, Radix Puerariae extract 20%, pregelatinized Starch 22%, microcrystalline Cellulose 27%, carboxymethyl starch sodium 4%, magnesium stearate 2%.Preparation method is with embodiment 1.
Embodiment 3
The health food that chemical and alcoholic liver injury is had to assosting effect, by Herba Silybi mariani extract-lecithin, Radix Puerariae extract, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate, formed, its percentage by weight is Herba Silybi mariani extract-lecithin 22%, Radix Puerariae extract 22%, pregelatinized Starch 25%, microcrystalline Cellulose 25%, carboxymethyl starch sodium 4%, magnesium stearate 2%.Preparation method is with embodiment 1.
Embodiment 4
The health food that chemical and alcoholic liver injury is had to assosting effect, by Herba Silybi mariani extract-lecithin, Radix Puerariae extract, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate, formed, its percentage by weight is Herba Silybi mariani extract-lecithin 22%, Radix Puerariae extract 20%, pregelatinized Starch 25%, microcrystalline Cellulose 25%, carboxymethyl starch sodium 6%, magnesium stearate 2%.Preparation method is with embodiment 1.
Embodiment 5
The health food that chemical and alcoholic liver injury is had to assosting effect, by Herba Silybi mariani extract-lecithin, Radix Puerariae extract, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, magnesium stearate, formed, its percentage by weight is Herba Silybi mariani extract-lecithin 22%, Radix Puerariae extract 22%, pregelatinized Starch 25%, microcrystalline Cellulose 25%, carboxymethyl starch sodium 4%, magnesium stearate 2%.Preparation method is with embodiment 1.
The experimental data of embodiment 6 bioavailability aspects
Using dissolution in vitro as detecting index, investigate the bioavailability of this product.Get this product, according to dissolution method (two appendix XC the second methods of Chinese Pharmacopoeia version in 2010), take 0.54% sodium dodecyl sulfate solution as solvent, rotating speed is per minute 100 to turn, and operation in accordance with the law, in the time of 45 minutes, get solution 10ml, filter, precision measures subsequent filtrate 5ml and is placed in 25ml volumetric flask, with 0.5% polyvinylpyrrolidone liquid to scale; According to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2010), at 288nm wavelength place, measure trap, and make blank with 0.5% polyvinylpyrrolidone liquid, calculate the stripping quantity of every.Get respectively embodiment 1 as the sample of lot number 01, embodiment 2 is as the sample of lot number 02, and embodiment 3 is as the sample of lot number 03, and embodiment 4 is as the sample of lot number 04, and embodiment 5, as the sample of lot number 05, measures its dissolution, and result is as shown in table 1.
Table 1
| Lot number | Stripping (%) in 45 minutes |
| 01 | 87.90 |
| 02 | 85.48 |
| 03 | 85.88 |
| 04 | 88.47 |
| 05 | 89.82 |
According to experimental result, dissolution is 85%, far above the dissolution of common Herba Silybi mariani sheet, has greatly improved bioavailability.
Embodiment 7 Toxicological evaluations
Requirement by the check of Ministry of Public Health < < health food with assessment technique standard > > (version in 2003), carries out Toxicological evaluation test, and method and result are as follows:
acute toxicity test:experiment adopts maximum tolerated dose method, establishes dosage group of sample 20.0g/kg body weight.20 mices, male and female half and half, adopt per os gavage to tested material mode, take sample 20.0g valency distilled water and are made into 0.5g/mL to 40mL, give interval 4h by 20mL/kg body weight secondary gavage.Observation to sample after general status, poisoning symptom and the death condition of animal in two weeks.Result: have no experiment mice in the observation period and occur poisoning symptom and death condition.Female, the male acute oral maximum tolerated dose of this sample mice is all greater than 20.0g/kg.
test:experiment adopts dull and stereotyped infiltration method.Take sample 0.1g and add sterile purified water to 20mL, fully mix, be mixed with 5000 μ g/mL.During test, every culture dish adds 0.1mL and adds 0.1mL, and agent is equivalent to 500 μ g/ wares.As maximum dose level, with sterile purified water, be diluted to 100,20,4,0.8 each dosage of μ g/ ware.Select TA
97, TA
98, TA
100, TA
102test strain is also carried out rats'liver S
9induction and preparation, by < < health food check and the dull and stereotyped infiltration method of assessment technique standard > > (version in 2003), test.Result: feminine gender.
micronucleus test:sample 2.5g, 5.0g and three dosage groups of 10.0g/kg body weight are established in experiment.Separately establish negative control group (distilled water) and positive controls (cyclophosphamide 60mg/kg body weight), every group of 10 mices, female, hero half and half.Three dosage components another name sample thief 2.5g, 5.0g, 10.0g adding distil water to 20mL be mixed with 0.125,0.25,0.50g/mL, by 20mL/kg body weight gavage, employing interval 24h give sample, matched group is same treatment also.Last to sample after 6h put to death animal, get its bone marrow of sternum film-making, methanol is fixed, Giemsa dyeing, microscopy is observed, the micronucleus number of 1000 polychromatic erythrocytes of every Mus counting, calculates microkernel incidence.Result: feminine gender.
sperm malformation test:sample 2.5g, 5.0g and three dosage groups of 10.0g/kg body weight are established in experiment.Separately establish every group of 7 male mices of negative control group (distilled water) and positive controls (ametycin 2.0mg/kg body weight).Three dosage components another name sample thief 2.5g, 5.0g, 10.0g adding distil water to 20mL be mixed with 0.125,0.25,0.50g/mL, by 20mL/kg body weight gavage, continuous five days, matched group is same treatment also.First, to the 35th day of sample, mice was put to death in cervical vertebra dislocation, selects at random 5 mices to get two side epididymises, puts into the plate that fills appropriate normal saline, with eye scissors, epididymis is shredded to four layers of lens paper suction strainer, direct smear, natural drying, methanol is fixed, with 1% Yihong dyeing.Microscopy is observed the lopsided number of 1000 sperms of every Mus, calculates Sperm malformation rate.Result: feminine gender.
it feeding trial:three dosage groups and a negative control group are established in experiment, and basic, normal, high three dosage are respectively 1.25,2.50,5.00g/kg body weight, are equivalent to 25 times, 50 times and 100 times of people's recommended amounts.Test each dosage group and respectively sample is evenly admixed to normal feedstuff by body weight 10% conversion, in forage feed mode, give.Select 80 of SD rats, be divided at random 4 groups, 20 every group, male and female half and half, the single cage of rat is raised, ad lib, drinking-water.Rat Continuous Observation 30 days, record weekly body weight and food-intake and calculate food utilization, experiment finishes rear overnight fasting, broken end is got blood and is carried out hematological examination and blood biochemical analysis, every rat is carried out to internal organs gross examination of skeletal muscle, get liver,kidney,spleen simultaneously, testis (ovary) is weighed and calculate dirty body ratio, and get liver,kidney,spleen, testis (ovary) carries out histopathologic examination.Result: laboratory animal growing state is good, hematological examination, biochemical analysis, when histological examination result of main dirty body are compared with matched group, all no significant difference.
These results suggest that this product is safe and reliable, meet country for the requirement of health food safety, can long-term taking.
The auxiliary protection function of 8 pairs of chemical liver injury of embodiment
With the present composition and by the check of < < health food, carried out chemical liver injury to have the animal function assessment test of auxiliary protection function with assessment technique standard > > (version in 2003).
Given the test agent: the present composition
Dosage design: three dosage groups, a blank group and a model control group are established in experiment.Basic, normal, high three dosage are respectively 0.25,0.50,1.50g/kg body weight, are equivalent to 5 times, 10 times of people's recommended amounts and 30 times (people's recommended amounts is 3.0g/60kg/ day).
Sample treatment: three dosage components another names are got test sample 0.75,1.50,4.50g adding distil water to 60mL, mix, is mixed with concentration and is 0.0125,0.0250 and 0.0750g/mL sample, is test liquid.
Laboratory animal: ICR mice use in experiment, 18-22g, the clean grade of white mice that female ，You Shanghai Slac Experimental Animal Co., Ltd. provides.Receptacle temperature 20-24
oc, relative humidity 40-70%.
Give sample loading mode: gavage, gavage capacity is pressed 0.2mL/10g body weight.
Experimental technique: each dosage group per os every day gavage gives given the test agent, and blank group and model control group give distilled water.Animal weighs weekly twice, to adjust given the test agent dosage.In the 40th day that tests, by each treated animal fasting overnight 16 hours, model control group and each dosage treated animal gave 1%CCl by gavage of 5mL/kg body weight
4, blank treated animal is to vegetable oil, and dosage group continues to give given the test agent to experiment and finishes (with CCl
4gavage interval is more than 4 hours).Give CCl
4after, in 24 hours, put to death animal, get blood separation of serum, measure glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), and get liver and carry out histopathologic examination.
Result:
Sample is as shown in table 2 on the impact of the weight of animals.
Table 2
| Group | Number of animals (only) | Initial body weight (g) | Body weight in mid-term (g) | Final body weight (g) |
| Blank group | 10 | 20.9±0.7 | 28.9±1.5 | 31.1±1.3 |
| CCl 4Model control group | 10 | 21.0±0.8 | 29.7±1.9 | 31.8±1.3 |
| 0.25g/kg | 10 | 20.9±0.8 | 29.1±1.5 | 30.6±1.6 |
| 0.50g/kg | 10 | 20.9±0.9 | 28.6±2.3 | 30.3±3.4 |
| 1.50g/kg | 10 | 20.4±0.7 | 28.6±1.9 | 30.1±1.9 |
As can be seen from the above table, the initial body weight of basic, normal, high three dosage group mice, mid-term body weight, final body weight and blank group, model control group comparison, the equal not statistically significant of difference (variance analysis, P > 0.05).
The biochemistry detection result of sample is as shown in table 3.
Table 3
| Group | Number of animals (only) | ALT（U/L） | AST（U/L） |
| Blank group | 10 | 33.3±6.9 | 116.8±25.5 |
| CCl 4Model control group | 10 | 22950.4±3545.7 a | 30259.2±7481.9 a |
| 0.25g/kg | 10 | 24179.2±3110.3 | 30296.0±4769.6 |
| 0.50g/kg | 10 | 22528.0±4691.0 | 28697.6±8424.4 |
| 1.50g/kg | 10 | 16716.8±5114.4 b | 2044.8±6359.5 b |
Note: a: with the comparison of blank group, t check: P < 0.05; B: with model control group comparison, q check: P < 0.05.
As seen from the above table, the initial data of blank group and model control group adopts t check, with the comparison of blank group, ALT, the AST of model control group mice obviously raise, difference all has statistical significance (t check, P < 0.05), the establishment of carbon tetrachloride hepatic injury model is described.Model control group and three dosage group initial datas are through homogeneity test of variance, meet homogeneity of variance, select variance analysis, respectively with model control group comparison, in high dose group murine liver tissue, ALT and AST all obviously reduce, difference all has statistical significance (q check, P < 0.05).
The pathological examination results of sample is as shown in table 4.
Table 4
Note: a: with the comparison of blank group, t check: P < 0.05; B: with model control group comparison, q check: P < 0.05.
As seen from the above table, blank group and model control group initial data adopt t check, with the comparison of blank group, model control group mouse liver cell hydropic degeneration, the change of balloon sample, steatosis, endochylema cohesion degree increase the weight of, in necrocytosis and pathology, integration difference has statistical significance (t check, P < 0.05), illustrate that liver injury model is successfully established.Model control group and three dosage group initial datas are except the change of balloon sample and steatosis heterogeneity of variance employing rank test, each dosage built-up pattern matched group comparing difference is without significance (H check, P > 0.05) outside, all the other initial datas meet homogeneity of variance, adopt variance analysis, with model control group comparison, high dose group mouse liver cell degree of necrosis alleviates, difference has statistical significance (q check, P < 0.05), and (the variance analysis of other pathological changes types and model control group difference not statistically significant, P > 0.05).
Conclusion: the present composition has auxiliary protection function to mice chemical liver injury.
The auxiliary protection function of 9 pairs of alcoholic liver injuries of embodiment
With the present composition and by the check of < < health food, carried out alcoholic liver injury to have the animal function assessment test of auxiliary protection function with assessment technique standard > > (version in 2003).
Given the test agent: the present composition
Dosage design: three dosage groups, a blank group and a model control group are established in experiment.Basic, normal, high three dosage are respectively 0.25,0.50,1.50g/kg body weight, are equivalent to 5 times, 10 times of people's recommended amounts and 30 times (people's recommended amounts is 3.0g/60kg/ day).
Sample treatment: three dosage components another names are got test sample 0.75,1.50,4.50g adding distil water to 60mL, mix, is mixed with concentration and is 0.0125,0.0250 and 0.0750g/mL sample, is test liquid.
Laboratory animal: ICR mice use in experiment, 18-22g, the clean grade of white mice that female ，You Shanghai Slac Experimental Animal Co., Ltd. provides.Receptacle temperature 20-24
oc, relative humidity 40-70%.
Give sample loading mode: gavage, gavage capacity is pressed 0.2mL/10g body weight.
Experimental technique: each dosage group per os every day gavage gives given the test agent, and blank group and model control group give distilled water.Animal weighs weekly twice, to adjust given the test agent dosage.The 40th day model control group in experiment gives 50% ethanol by 12mL/kg body weight with each dosage treated animal.After fasting 12 hours, each animal is got liver and makes 10% liver homogenate, measures respectively following biochemical indicator: triglyceride (TG), malonaldehyde (MDA), reductive glutathione (GSH); And get liver and carry out histopathologic examination.
Result:
Sample is as shown in table 5 on the impact of the weight of animals.
Table 5
| Group | Number of animals (only) | Initial body weight (g) | Body weight in mid-term (g) | Final body weight (g) |
| Blank group | 10 | 20.8±0.9 | 29.4±1.3 | 31.3±1.1 |
| Ethanol model matched group | 10 | 20.9±1.0 | 29.9±1.7 | 31.5±1.3 |
| 0.25g/kg | 10 | 21.0±0.7 | 28.9±1.3 | 30.5±1.4 |
| 0.50g/kg | 10 | 20.9±0.8 | 28.9±2.1 | 30.1±3.2 |
| 1.50g/kg | 10 | 20.5±0.9 | 29.0±1.9 | 30.8±1.9 |
As can be seen from the above table, the initial body weight of basic, normal, high three dosage group mice, mid-term body weight, final body weight and blank group, model control group comparison, the equal not statistically significant of difference (variance analysis, P > 0.05).
The biochemistry detection result of sample is as shown in table 6.
Table 6
| Group | Number of animals (only) | TG(μ mol/g liver is heavy) | MDA(nmol/g liver is heavy) | GSH(μ mol/g liver is heavy) |
| Blank group | 10 | 16.23±0.36 | 3.24±0.35 | 8.63±0.44 |
| Ethanol model matched group | 10 | 38.01±1.03 a | 11.55±0.17 a | 3.35±0.31 |
| 0.25g/kg | 10 | 36.11±1.33 | 6.34±0.39 | 3.83±0.47 |
| 0.50g/kg | 10 | 31．34±1.07 | 3.97±0.42 b | 5.03±0.23 |
| 1.50g/kg | 10 | 26.35±0.73 b | 2.74±0.55 b | 5.87±0.31 b |
Note: a: with the comparison of blank group, t check: P < 0.05; B: with model control group comparison, q check: P < 0.05.
As seen from the above table, the initial data of blank group and model control group adopts t check, with the comparison of blank group, TG, the MDA of model control group mice obviously raise, GSH obviously reduces, difference all has statistical significance (t check, P < 0.05), and the establishment of alcoholic hepatic injury model is described.Model control group and three dosage group initial datas are through homogeneity test of variance, meet homogeneity of variance, select variance analysis, respectively with model control group comparison, in high dose group murine liver tissue, TG and MDA all obviously reduce, GSH obviously raises, and difference all has statistical significance (q check, P < 0.05).
The pathological examination results of sample is as shown in table 7.
Table 7
Note: a: with the comparison of blank group, t check: P < 0.05; B: with model control group comparison, q check: P < 0.05.
As seen from the above table, apparently higher than blank group, there is significant difference in the pathology integration of ethanol model matched group, and liver injury model establishment is described.High dose group is compared with ethanol model group, and pathology integration obviously declines, and has significant difference.
Conclusion: the present composition has auxiliary protection function to Alcoholic Hepatic Injury.
Embodiment 10 Herba Silybi mariani extract-lecithin clinical effectiveness:
Use Herba Silybi mariani extract-lecithin after one month, in effective example of 80%, liver function is transferred to normally by undesired, and wherein glutamate pyruvate transaminase, alkali phosphatase, gamma glutamyl transpeptidase decline normally, and blood plasma total protein and white/globulin ratio are improved as significantly; 20% hepatitis B three is wherein that middle HBsAg and HBeAg or HBeAg transfer feminine gender to by the positive.
Compositions of the present invention can also adopt other known method to make corresponding dosage form, as granule, tablet, capsule, soft capsule etc.
Claims (10)
1. a compositions that chemical and alcoholic liver injury is had to auxiliary protection function; it is characterized in that described compositions comprises the component of following percentage by weight: Herba Silybi mariani extract-lecithin 5～45%; Radix Puerariae extract 5～45%; pregelatinized Starch 10～50%; microcrystalline Cellulose 10～50%; carboxymethyl starch sodium 1～10%, magnesium stearate 1～5%.
2. the compositions that chemical and alcoholic liver injury is had to auxiliary protection function according to claim 1; it is characterized in that its percentage by weight is Herba Silybi mariani extract-lecithin 19%; Radix Puerariae extract 19%; pregelatinized Starch 28%; microcrystalline Cellulose 28%; carboxymethyl starch sodium 4%, magnesium stearate 2%.
3. the compositions that chemical and alcoholic liver injury is had to auxiliary protection function according to claim 1; it is characterized in that its percentage by weight is Herba Silybi mariani extract-lecithin 25%; Radix Puerariae extract 20%; pregelatinized Starch 22%; microcrystalline Cellulose 27%; carboxymethyl starch sodium 4%, magnesium stearate 2%.
4. the compositions that chemical and alcoholic liver injury is had to auxiliary protection function according to claim 1; it is characterized in that its percentage by weight is Herba Silybi mariani extract-lecithin 22%; Radix Puerariae extract 22%; pregelatinized Starch 25%; microcrystalline Cellulose 25%; carboxymethyl starch sodium 4%, magnesium stearate 2%.
5. the compositions that chemical and alcoholic liver injury is had to auxiliary protection function according to claim 1; it is characterized in that its percentage by weight is Herba Silybi mariani extract-lecithin 22%; Radix Puerariae extract 20%; pregelatinized Starch 25%; microcrystalline Cellulose 25%; carboxymethyl starch sodium 6%, magnesium stearate 2%.
6. the compositions that chemical and alcoholic liver injury is had to auxiliary protection function according to claim 1; it is characterized in that its percentage by weight is Herba Silybi mariani extract-lecithin 22%; Radix Puerariae extract 22%; pregelatinized Starch 25%; microcrystalline Cellulose 25%; carboxymethyl starch sodium 4%, magnesium stearate 2%.
7. described in claim 1～6, chemical and alcoholic liver injury there are is a preparation method for the compositions of auxiliary protection function, it is characterized in that: get Herba Silybi mariani seed decontamination, squeezing is deoiled, add 2～20 times of amount ethanol, 50～80
oc reflux, extract,, each 1～3 hour, extract 1～3 time, merge extractive liquid,, concentrates and dries in 40～60 ℃, obtains Herba Silybi mariani extract; Get Herba Silybi mariani extract, add the lecithin of 0.5～3.0 times of amount, add 2～25 times of amount 60～95% ethanol; reflux, to dissolving, reclaims solvent to thick paste shape, and thick paste shape complex is put in vacuum desiccator dry; pulverize and cross 40～80 mesh sieves, obtain Herba Silybi mariani extract-lecithin; Get the roguing of Radix Puerariae medical material, pulverize, add 5～15 times of amount 60～95% ethanol, reflux, extract,, each 1～3 hour, extract 1～3 time, merge extractive liquid,, in 40～60
oc concentrates and dries, and obtains Radix Puerariae extract; Get Herba Silybi mariani extract-lecithin, Radix Puerariae extract sieves respectively, by formula ratio by after raw material adjuvant mix homogeneously and get final product.
8. according to claim 7 chemical and alcoholic liver injury there is the preparation method of the compositions of auxiliary protection function; it is characterized in that the preparation of Herba Silybi mariani extract-lecithin: get Herba Silybi mariani extract; the lecithin that adds 0.8～1.5 times of amount; add 8～15 times of amount 85% ethanol; reflux, to dissolving, reclaims solvent to thick paste shape, and thick paste shape complex is put in vacuum desiccator dry; pulverize and cross 60 mesh sieves, obtain Herba Silybi mariani extract-lecithin.
9. according to claim 7 chemical and alcoholic liver injury there is the preparation method of the compositions of auxiliary protection function; it is characterized in that the preparation of Herba Silybi mariani extract-lecithin: get Herba Silybi mariani extract; the lecithin that adds 1.2 times of amounts; add 10 times of amount 85% ethanol; reflux, to dissolving, reclaims solvent to thick paste shape, and thick paste shape complex is put in vacuum desiccator dry; pulverize and cross 60 mesh sieves, obtain Herba Silybi mariani extract-lecithin.
10. the application of the compositions that described in claim 1～6, chemical and alcoholic liver injury is had to an auxiliary protection function in health food.
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| CN114557411A (en) * | 2022-03-15 | 2022-05-31 | 山东省农业科学院 | Liver-protecting and alcoholism-relieving compound beverage and preparation method thereof |
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| WO2016150379A1 (en) * | 2015-03-23 | 2016-09-29 | 天士力制药集团股份有限公司 | Pharmaceutical composition containing silibinin and pueraria root extract |
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| CN110237155A (en) * | 2019-07-31 | 2019-09-17 | 王鹏 | One kind sober up patch and preparation method thereof |
| CN111494564A (en) * | 2020-04-30 | 2020-08-07 | 江苏中兴药业有限公司 | Preparation method of compound liver-protecting and alcohol-dispelling tablet |
| CN111494564B (en) * | 2020-04-30 | 2021-07-27 | 江苏中兴药业有限公司 | Preparation method of compound liver-protecting and alcohol-dispelling tablet |
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Application publication date: 20140312 |