CN101199668A - Chinese medicine agent for treating alcohol fatty liver and preparing method thereof - Google Patents
Chinese medicine agent for treating alcohol fatty liver and preparing method thereof Download PDFInfo
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Abstract
The invention relates to a Chinese herbal preparation for treating alcoholic fatty liver and the preparation method. The Chinese herbal preparation contains Astragalus root, Barbary Wolfberry Fruit, Largehead Atractylodes Rhizome, Pericarpium Citri Reticulatae Viride, Lobed Kudzuvine Root, Chicken's Gizzard-membrane (prepared), rose and Radix Rhapontici seu Radix Echinopsis. When the Chinese herbal preparation is prepared, the methods such as vapor distilment, water decoction and ethanol extraction are adopted for different ingredients for reaching the purpose of fully developing the efficacy of the drugs. The invention has the effects of replenishing qi and liver, detoxifying and descending turbid, eliminating blood stasis and freeing channels and applied for treating alcoholic fatty liver, alcoholic hepatitis and alcoholic hepatocirrhosis (liver energy deficiency, alcoholic impairment of liver, haemostasis and turbid lipid blocked in liver collaterals); the symptoms are embodied in flank ribs expansion and smothering, secret anguish, accidie and hypodynamia, intolerant fatigue, lassitude, easy fear and restiness, anorexia, tongue coating darkness, white fur and small and wiry pulse. The invention is a safe and reliable good medicine which has the advantages of prescription basing on the Chinese medical theory, sufficient drug source, simple process and evident effect.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation for the treatment of alcoholic fatty liver and preparation method thereof.Specifically, be to be the Chinese patent medicine that raw material is made with the Chinese herbal medicine, its prescription composition, extraction process, preparation process thereof and function cures mainly and indication.
Background technology:
In western countries, alcoholic liver disease is one of young and middle-aged main causes of death.The U.S. dies from ten thousand people surplus the alcoholic meter 10 every year on average, Sweden's statistics in 1980, and middle age alcoholism mortality rate and cancerous protuberance and coronary heart disease is similar over 6 years.Therefore the America and Europe, alcoholic liver disease is a commonly encountered diseases, and frequently-occurring disease, the reasearch funds that it spent are also very surprising.In China, along with living condition's improvement, the health harm that excessive drinking brings is also comparatively general, has become one of serious health problem.The drink every day people of smart 160g, 40% will have alcoholic hepatitis and fatty liver to take place.Therefore, correctly be familiar with alcoholic liver disease, in time diagnose and prevent and treat, have great importance.
Alcoholic liver disease comprises alcoholic fatty liver, alcoholic hepatitis and alcoholic cirrhosis.Wherein, alcoholic fatty liver is the most common in alcoholic liver disease, is commonly encountered diseases of internal department and frequently-occurring disease, and is especially higher at person in middle and old age's phase sickness rate, but its morbidity in the last few years has the trend of rejuvenation.The primary disease later stage, the part patient can develop into hepatic fibrosis and hepatitis interstitialis chronica, even developed into hepatocarcinoma and death.
Alcoholic fatty liver belongs to categories such as motherland's medical science " hypochondriac pain ", " alcoholophilia ".All plain body deficiency of liver-QI, the multiple impairing the liver gas of alcoholism; Or heavy drinking, alcoholism injures irritability, and causes deficiency of liver-QI, all can cause the liver failing to maintain the normal flow of QI.Liver storing blood loses in catharsis, and then the blood vessels stasis of blood stagnates; Hepatopathy and spleen, spleen fortune is not normal, then gives birth to turbid fat.The turbid fat of day protracted blood stasis hinders in the liver network and forms primary disease.
Doctor trained in Western medicine is not good enough to the therapeutic effect of primary disease at present.And Chinese medicine mainly is by methods such as blood circulation promoting and blood stasis dispelling, soothing the liver dampness removing, expelling phlegm and resolving turbidities by determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs treatment alcoholic fatty liver.And we are by the clinical discovery deficiency of liver-QI, the alcoholism impairing the liver, and the turbid fat of blood stasis, hindering in the liver network is the generation of alcoholic fatty liver and the important pathogenesis in the evolution.Clinical with fullness in the chest and hypochondrium vexed or dull pain, fatigue and weakness, spirit is not smooth, loss of appetite etc. are main performance.This type of patient accounts for about 30% of clinical patient.The appearance of this invention will have comparatively vast market prospect, will bring good social benefit and economic benefit.
Summary of the invention:
One of purpose of the present invention provides a kind of Chinese medicine preparation for the treatment of alcoholic fatty liver, is primarily characterized in that the Chinese crude drug that it includes following weight proportion makes:
The Radix Astragali 200～3000 weight portion Fructus Lycii 100～1200 weight portions
The Rhizoma Atractylodis Macrocephalae 150～1200 weight portion Pericarpium Citri Reticulatae Virides 50～900 weight portions
Radix Puerariae 100～1500 weight portion Endothelium Corneum Gigeriae Galli (system) 50～900 weight portions
Flos Rosae Rugosae 50～600 weight portion Radix Rhapontici 50～900 weight portions
Described a kind of Chinese medicine preparation for the treatment of alcoholic fatty liver, its best raw material weight proportioning is:
The Radix Astragali 300 weight portion Fructus Lycii 200 weight portions
The Rhizoma Atractylodis Macrocephalae 200 weight portion Pericarpium Citri Reticulatae Virides 90 weight portions
Radix Puerariae 150 weight portion Endothelium Corneum Gigeriae Galli (system) 100 weight portions
Flos Rosae Rugosae 90 weight portion Radix Rhapontici 90 weight portions
Two of purpose of the present invention provides the pharmaceutically medicament of acceptable pharmaceutical carrier mixing formation of above-described compositions, and said medicament is an acceptable dosage form on the various pharmaceuticss such as tablet, hard capsule, soft capsule, pill, powder, syrup, soft extract, mixture, drop pill, granule, oral liquid, drop.
Three of purpose of the present invention provides a kind of extraction process for preparing above-mentioned Chinese medicine preparation, it is characterized in that:
A, Endothelium Corneum Gigeriae Galli powder are broken into fine powder, sterilization;
B, the Radix Astragali, Fructus Lycii, Radix Puerariae add 6-12 and doubly measure the 70%-90% alcohol reflux 1-3 time, and each 1-3 hour, gradation filtered, merge extractive liquid,, and decompression recycling ethanol, standby;
C, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae Viride, Flos Rosae Rugosae, Radix Rhapontici etc. four flavor adds 6-12 times of water gaging and soaked 2-5 hour, extracts volatile oil 4-8 hour with the way of distillation, and volatile oil is with 6 times of amount beta-schardinger dextrin-s, 40 ℃ of following enclose 1 hour, the device collection in addition of the aqueous solution after the distillation;
D, the medicinal residues among the B and the medicinal residues among the C are added 6-12 times of water gaging jointly decoct 1-3 time, each 1-3 hour, the gradation filtration, merging filtrate is concentrated into relative density 1.10 (60 ℃ of surveys), adds ethanol and reaches 50% to containing the alcohol amount, left standstill 24 hours, and filtered decompression recycling ethanol;
E, alcohol extract among D and the B is merged, being concentrated into relative density is the thick paste of 1.28～1.30 (60 ℃ of surveys), adds fine powder among the A, mixing, and drying is ground into fine powder, adds volatile oil beta cyclodextrin inclusion complex, and mixing adds suitable adjuvant, preparation, promptly.
The function that four of purpose of the present invention provides above-mentioned Chinese medicine preparation cures mainly and indication.The function of described Chinese medicine preparation cures mainly with indication and it is characterized by: have the QI invigorating tonifying liver, detoxifying and descending turbid, the effect of eliminating blood stasis and smoothing collaterals.Can treat alcoholic fatty liver, alcoholic hepatitis and alcoholic cirrhosis (deficiency of liver-QI, the alcoholism impairing the liver, the turbid fat of blood stasis hinders in liver network card) disease sees: disease sees that side of body rib is full vexed, or dull pain, fatigue and weakness, non-endurance, spirit is not smooth, the susceptible to fear irritability, loss of appetite, and pale tongue is dim, tongue fur is white, a little less than the stringy and thready pulse.
For achieving the above object, prove its therapeutic effect and safety non-toxic, its pharmacology and pharmacodynamics test data following (pharmacodynamics, anxious poison, long term toxication are example with the hard capsule):
One, Pharmacodynamic test of active extract
1. to the influence of alcoholic fatty liver: 90 of Wistar male rats, body weight 150-210g, get 15 and raise as normal control group normal diet and drinking-water, all the other animals give the mixed platform feedstuff that 79.5% Semen Maydis powder, 20% Adeps Sus domestica, 0.5% cholesterol are made, and other 30% ethanol is quantitatively drunk
[1]Raised 1 month, and got the blood sampling of part animal at random and measure CHO, TG, HDL, LDL, live and get Gn level in the interior TG regulating liver-QI of liver detection liver extremely, and do histopathologic examination, determine whether to form the fatty liver model.Test data sees Table 1-1.
The detection of table 1-1. rat alcoholic fatty liver model (X ± s, n=10)
Annotate: with the normal control group than ##P＜0.01, ###P＜0.001
Table 1-1. data show that adding ethanol through continuous high fat diet in 30 days stimulates, and causes metabolism disorder of blood lipid and intrahepatic fat and glycogen to be accumulated, and model group and normal control group more all have significant difference.
General pathology is checked: normal control group and model control group rat liver are respectively 5 and 10 parts.Rats in normal control group liver color is brown red, bright-coloured, and peplos is complete, smooth, clear-cut margin.Model control group rat liver color is slightly yellow, full, the peplos anxiety, greasy sensation is arranged, and it is sharp keen that the edge is owed.
Tissue pathology checking: two groups of rapid low-temperature quick-freezings of specimen, frozen section, fixing after, conventional specimen is all carried out fatty spy and is dyed fatty tissue present crocus under mirror.
Normal control group hepatocyte size is consistent, the hepatic cords marshalling, nuclear does not have deformity, sinus hepaticus as seen, Kupffer is accidental, does not have obvious degeneration, necrosis and fibrosis.The obvious swelling of model control group hepatocyte, the endochylema sky is bright, is lobulated, not of uniform size causing; Thickening of nuclear membrane, sinus hepaticus disappears.The portal area blood vessel is squeezed, and tube chamber diminishes, and the small amount of fibers connective tissue proliferation is arranged.
The pathologic finding conclusion: compare with the normal control group, tangible steatosis appears in model control group.
Determine to have formed the fatty liver model.All the other animals are divided into 6 groups at random: normal control group, model control group, liver-protecting tablet matched group, bifendate matched group, the high, medium and low dosage group of capsule preparations of the present invention.Each medicine group is pressed 1ml/100g ig. administration, once a day, continuous 30 days, normal control group, model control group ig equivalent NS.Experiment finishes respectively to organize rat by only weighing, and fasting is 12 hours behind the last medicine, and the socket of the eye vein is got blood, and 2500rpm low-temperature centrifugation 15min gets serum, measures CHO, TG, HDL, LDL, AST, ALT and MDA level, and the result organizes a t check.
Table 1-2 capsule preparations of the present invention to the metabolic influence of alcoholic fatty liver rat fat (X ± s, n=10)
Annotate: with the normal control group than #P＜0.05, ##P＜0.01, ###P＜0.001 is with the model control group ratio
*P＜0.05,
*P＜0.01,
* *P＜0.001, with high dose group than @P＜0.05
By horizontal table 1-2. result as seen, alcoholic fatty liver rat serum CHO, TG, LDL all significantly raise, and HDL then significantly reduces.
Give behind the capsule preparations of the present invention the CHO of rising is significantly reduced, high, medium and low dosage and model control group have more respectively extremely significantly, highly significant, significant difference; The action intensity of high dose and liver-protecting tablet, bifendate are suitable.
Give behind the capsule preparations of the present invention the TG of rising is significantly reduced, the drug action intensity between the high, medium and low dosage of its medicine has certain dose-dependence, has more respectively extremely significantly and significant differences with model control group.
Give behind the capsule preparations of the present invention the HDL of reduction is significantly raise, high, medium and low dosage of its medicine and model control group more all have utmost point significant difference, and action intensity and liver-protecting tablet are suitable.
Give behind the capsule preparations of the present invention the LDL of rising is significantly reduced, the drug action intensity between the high, medium and low dosage of its medicine has certain dose-dependence, with model control group utmost point significant difference is arranged relatively, and action intensity is better than liver-protecting tablet.
Get behind the blood lumbar injection 10% glucose 20ml/kg immediately, sacrificed by exsanguination is dissected rat after 1 hour, and electronic balance takes by weighing liver weight, calculates liver/body ratio, liver weight, liver/body ratio result organize a t check behind the body weight change of experimental session and the medicine, see horizontal table 1-3.
The influence that table 1-3 capsule preparations of the present invention heavily changes alcoholic fatty liver rat body weight, liver (X ± s, n=10)
By horizontal table 1-3. result as seen, the alcoholic fatty liver rat body weight reduces, liver heavily increases, and liver/body ratio increases, and with rats in normal control group utmost point significance and significant differences is arranged relatively.Give behind the capsule preparations of the present invention of high dose the liver of rising is heavily lowered, body weight also has certain increase.Make liver/body ratio obtain reduction in various degree; Than higher dosage significant differences is arranged with model control group, in, low dosage presents certain effect trend.
Other gets the smart title of part liver, uses tissue grinder, beats liver homogenate, then according to the reagent operating instruction, measures glycogen in the hepatic tissue
]With TGMDA content, the result organizes a t check, sees horizontal table 1-4.
The influence that table 1-4 capsule preparations of the present invention is tested material and antioxidation in the alcoholic fatty liver rats'liver (X ± s, n=10)
By table 1-4 result as seen, TG, Gn, MDA content all significantly raise in the alcoholic fatty liver rats'liver.
Give behind the capsule preparations of the present invention the interior TG of liver of rising is significantly reduced, with model control group comparative drug height, middle dosage highly significant, significant difference are arranged respectively, medicine low dosage and model control group relatively present certain effect trend; The action intensity and the liver-protecting tablet of high dose are suitable, and the action intensity and the bifendate of middle dosage are suitable.
Give behind the capsule preparations of the present invention the interior Gn of liver of rising is significantly reduced, the drug action intensity between the high, medium and low dosage of its medicine has certain dose-dependence, with model control group extremely remarkable, significant difference is arranged more respectively; The action intensity of high dose is better than liver-protecting tablet, and the action intensity and the liver-protecting tablet of middle dosage are suitable.
Give behind the capsule preparations of the present invention the interior MDA of liver of rising is significantly reduced, the drug action intensity between the high, medium and low dosage of its medicine has certain dose-dependence, with model control group extremely remarkable, significant difference is arranged more respectively; The action intensity of high dose is better than liver-protecting tablet, and the action intensity and the liver-protecting tablet of middle dosage are suitable.
Table 1-5. capsule preparations of the present invention to the influence of alcoholic fatty liver rats'liver function (X ± s, n=10)
Annotate: with the normal control group than #P＜0.05, ##P＜0.01, ###P＜0.001 is with the model control group ratio
*P＜0.05,
*P＜0.01,
* *P＜0.001, with the bifendate group than $P＜0.05, with the liver-protecting tablet group than ﹠amp; P＜0.05, with high dose group than @P＜0.05
By table 1-5 result as seen, alcoholic fatty liver rat serum AST, ALT content all significantly raise.
Give behind the capsule preparations of the present invention the blood AST of rising is significantly reduced, drug action intensity between the high, medium and low dosage of its medicine has certain dose-dependence, has respectively extremely significantly with model control group comparative drug height, middle dosage, highly significant, significant difference; The action intensity of high, medium and low dosage is better than liver-protecting tablet, in, the action intensity and the bifendate of low dosage be suitable.
Give behind the capsule preparations of the present invention the blood ALT of rising is significantly reduced, the drug action intensity between the high, medium and low dosage of its medicine presents tangible dose-dependence, with the high, medium and low dosage of model control group comparative drug utmost point significant difference is arranged all; The action intensity of high dose is better than liver-protecting tablet, and is suitable with bifendate.
Other gets the part liver, does histopathology procuratorial work with 10% formalin fixed, and evaluation criterion is as follows, and the result carries out Ridit and analyzes, and sees Table 1-6.
The pathologic finding report: model group internal organs peplos is slightly nervous, and the section light yellow complexion has slight greasy feeling, and all the other respectively organize the equal Non Apparent Abnormality of outward appearance tangent plane.Microscopy: the model group liver has steatosis in various degree, the endochylema ghost, and visible fat drips, and serves as obviously with nearly peplos place, distributes along the lobule central area.Visible little focal necrosis in subregion and cell infiltration.Do not see the fibrosis hypertrophy.It is all not obvious that all the other respectively organize pathological changes.Grade scoring is as follows:
1. no obvious corresponding pathological change in the section is "-".
2. accidental corresponding pathological change in the sheet, pathological changes are dispersed in and distribute or single generation, and extent of disease accounts for below 1/4 of the full visual field, is "+".
3. corresponding pathological change is obvious, and in the form of sheets or the distribution of trooping, the 1/4-1/2 that extent of disease accounts for the full visual field counts " ++ ".
4. corresponding lesion degree is serious, and pathological changes is big lamellar and distributes, and occupies full lobule or reaches more than 1/2 of the full visual field, count " +++"
. table 1-6 capsule preparations of the present invention to the pathology classification of alcoholic fatty liver rat and integral result (X ± s, n=10)
By table 1-6 data as seen, the high, medium and low dosage of capsule preparations of the present invention to alcoholic fatty liver rat liver steatosis, granular degeneration have respectively significantly, the improvement effect of highly significant.Proliferation of fibrous tissue has significant improvement effect to capsule preparations high dose of the present invention to the alcoholic fatty liver rat liver.
The image in any three visuals field of (* 20) collection lesion region under 20 times of object lens is put in section, by taking the photograph in the phase system input computer, use the software that cls video company of Wuhan Tongji Medical Univ. provides: MPI-500 multi-media color pathology picture and text analytical system is measured.Select measurement coefficient---color segmentation (the attenuate average of percentage ratio * 100% of born of the same parents' area occupied/ken district area of fat: be the adipose cell area percentage.), (average of percentage ratio * 100% of normal cell area occupied/ken district area: be the normal liver cell area percentage.)。Unified ken condition: the 4.535e+0.4 that rectifies, the system monoploid is 20 times, the long 0.411 μ m of pixel.Getting image (getting the image of collection) → filtering → company breaks → choosing deletion (removing fine particle and other non-sick cell) → measure (cut into slices for every and measure the images in three visuals field), every group of institute's slice of data of surveying obtained a result after the machine statistics as follows as calculated: the result organizes a t check, sees Table 1-7.
Table 1-7. to the influence of alcoholic fatty liver pathology of livers image analysis (X ± s, n=10)
By table 1-7 data as seen, capsule preparations of the present invention has the fat of the reduction born of the same parents' area percentage that attenuates, the effect that improves the normal liver cell area percentage to rat alcoholic fatty liver model; Fat born of the same parents/hepatocyte area percentage the ratio that attenuates there is the minimizing effect.Point out capsule preparations of the present invention that ethanol rat liver steatosis is had significant improvement effect.
2. to CCl
4Due to the influence of hepatic injury
60 of 18-20g Kunming mouses, male and female half and half are divided into six groups at random by body weight: normal control group, model control group, liver-protecting tablet matched group, the high, medium and low dosage group of capsule preparations of the present invention.Gastric infusion 0.2ml/10g, continuous 7 days.2h behind the last medicine, ip 0.25%CCl except that the normal control group
4-olive oil 10ml/kg
[6], the socket of the eye vein is got blood behind the 24h, and the centrifugal 15min of 2500rpm gets determination of serum ALT, gets to dissect rat behind the blood immediately and get that the part liver is smart to claim, calculate liver/body ratio.TG in the hepatic tissue is measured in homogenate, and the result organizes a t check, sees Table 2-1, table 2-2.
Table 2-1 capsule preparations of the present invention to the influence of hepatic injury mice due to the CCl4 (X ± s, n=10)
Annotate: with the normal control group than #P＜0.05, ###P＜0.001 is with the model control group ratio
*P＜0.05,
*P＜0.01,
* *P＜0.001 and high dose group are than ﹠amp; P＜0.05, with the liver-protecting tablet group than $P＜0.05
By table 2-1 result as seen, ip in mice gives CCl
4TG content all significantly raises in the back Serum ALT content regulating liver-QI.After giving capsule preparations of the present invention, high dose can make the Serum ALT of rising significantly reduce, but action intensity is not as liver-protecting tablet.
The influence that table 2-2 capsule preparations of the present invention heavily changes hepatic injury mice body weight, liver due to the CCl4 (X ± s, n=10)
The high, medium and low dosage of capsule preparations medicine of the present invention can make the interior TG of the liver of rising extremely significantly reduce, and with model control group utmost point significant difference is arranged relatively, and action intensity is better than bifendate.
Other gets the part liver, does histopathology procuratorial work with 10% formalin fixed, and evaluation criterion is as follows, and the result carries out Ridit and analyzes, and sees Table 2-3.
Table 2-3 capsule preparations of the present invention to the influence of hepatic injury mouse liver pathology classification due to the CCl4 and integration (X ± s, n=10)
By table 2-3 data as seen, mice gives CCl
4Back pathology of livers is based on the change of hepatocyte fatty, acidophilia's change and hepatic necrosis, cell infiltration, and giving has significant improvement effect to above-mentioned change behind the capsule preparations of the present invention.
Pathological examination results: 6 groups of specimen outward appearances there is no obvious enlargement, atrophy and obviously downright bad, and tangent plane does not have tangible greasy feeling.Microscopy: compare with the normal control group, the all visible significantly hepatic necrosis of model control group and each medication group, acidophilia's degeneration and cell infiltration mainly are positioned at around the central vein and the portal area, in spite of illness in a disguised form to lighter, each group there is no proliferation of fibrous tissue and steatosis in the middle of the lobule.Compare with the damage matched group, each medication group degeneration necrosis degree is lighter, but the performance of endochylema puffing, it is little that each organizes difference.Liver cytoplasm puffing, hepatocyte acidophilia are become, and the anti-damage performance of sex expression of hepatic necrosis equivalent damage and cell infiltration is marked by following standard:
The various damaging performances of hepatocyte:
(-): represent no obvious pathological change.
(+): represent that corresponding pathological change takes place accidental several cell, distribution is dispersed in.
(++): represent that corresponding pathological change takes place 1/3 left and right sides cell, distributed more widely.
(+++): expression has about half approximately even corresponding pathological change takes place more cell.
Cell infiltration:
(-): inflammatory cell is can not see in expression basically.
(+): the expression inflammatory cell is accidental in most visuals field.
(++): be illustrated in and easily see in most visuals field and be dispersed in distribution.
(+++): more the expression inflammatory cell is seen, and is assembled replacement part and cellularity in the part.
3. lipid metabolism is influenced
3.1 influence to rat hyperlipidemia due to the high fat diet
60 of Wistar male rats, body weight 120-140g is divided into 6 groups: normal control group, model control group, lovastatin matched group, the high, medium and low dosage group of capsule preparations of the present invention, each Mus ig fat milk except that the normal control group
[7]1ml/100g, once a day, continuous 7 days.Normal control group ig equivalent NS.Be carried out to mould and detect, random packet then, beginning administration in the 8th day, 1ml/100g, once a day, and continuous 10 days, normal control group ig equivalent NS.Fasting is 12 hours behind the art time medicine, gets blood and irritates stomach in preceding 1 hour, and the socket of the eye vein is got blood then, and the centrifugal 15min of 2500rpm gets serum, measures CHO, TG, HDL, LDL, and the result organizes a t check.
As a result, rat oral gavage gives all significantly risings of CHO, TG, LDL in the high fat diet bleeding from anus, and HDL then significantly reduces.Give CHO, LDL that the high, medium and low dosage of capsule preparations of the present invention can make rising and reduce extremely significantly, utmost point significant difference is relatively arranged with model control group; Give the high, medium and low dosage of capsule preparations of the present invention the TG of rising is reduced significantly, significant difference is relatively arranged with model control group; Give the high, medium and low dosage of capsule preparations of the present invention the HDL of reduction is raise significantly, highly significant, significant difference are arranged more respectively with model control group.
3.2 influence to egg yolk Emulsion induced mice hyperlipidemia
60 of Male Kunming strain mice, body weight 18-22g is divided into 6 groups: normal control group, model control group, nicotinic acid matched group, the high, medium and low dosage group of capsule preparations of the present invention, administration is in advance pressed 0.25ml/10g volume ig, once a day, continuous 5 days, water gagings such as normal, model control group ig.。Get 1-2 day fresh egg yolk and be made into 75% egg yolk emulsion with normal saline
[8]Standby.Above-mentioned mice in experiment fasting in preceding 14 hours, is only irritated stomach pneumoretroperitoneum injection in 2 hours egg yolk emulsion 0.5ml/ except that the normal control group, the socket of the eye vein is got blood after 20 hours, placed 30 minutes, the centrifugal 15min of 2500rpm gets serum, measure the CHO level, the result organizes a t check, sees Table 3-1.
Table 3-1. capsule preparations of the present invention to egg-nog cause the influence that the mice blood fat changes (X ± s, n=10)
Annotate: with the normal control group than #P＜0.05, ##P＜0.01, ###P＜0.00; With the model control group ratio
*P＜0.05,
*P＜0.01,
* *P＜0.001; With the nicotinic acid matched group than $P＜0.05 ， $$P＜0.01 ， $$$P＜0.001
By table 3-1. result as seen, egg-nog induced mice blood CHO level extremely significantly raises, give behind the capsule preparations of the present invention the CHO of rising is significantly reduced, drug action intensity between the high, medium and low dosage of its medicine has certain dose-dependence, have respectively extremely significantly with the high, medium and low dosage of model control group comparative drug, highly significant, significant difference, but its action intensity is not as nicotinic acid.
Two, acute toxicity test
Anxious poison test shows: be calculated as 192.0g/kg by containing the crude drug amount in one day mouse stomach capsule preparations of the present invention, be equivalent to more than 734.43 times of clinical 70kg people's per kilogram of body weight consumption per day, observed continuously seven days, mice generally in order, none death illustrates this product low toxicity, safety.
Three, long term toxicity test
Long term toxicity test shows: it is 18.3g that the capsule preparations Coming-of-Age Day clothes dosage of the present invention of clinical recommendation is amounted to the crude drug amount, and 2 months is a course of treatment, does not measure the LD of this medicine in the acute toxicity test
50One in a few days maximum tolerated dose is more than the 192.0g/kg, so selecting 70 times of clinical 70kg day for human beings dose for use is that 18.3g/kg is a high dose, 35 times of clinical 70kg day for human beings dose is that 9.2g/kg is middle dosage, 15 times of clinical 70kg day for human beings dose, be that 3.9g/kg is a low dosage, be the principle of 2～4 times of clinical course of treatment according to the long poison time again, determine that the long malicious successive administration time is 180 days, successive administration 90 days, carrying out rat blood after 180 days respectively learns, blood biochemical is learned, histopathologic examination, the administration height, low dose group there is no significant difference with blank group ratio, through 60 days convalescent periods observation, also find that lose tangible back and the toxic and side effects of secondary.In view of overt toxicity is not made in this test, there are not medicines such as eighteen incompatible medicaments, nineteen medicaments of mutual restraint in the side of adding, so exempt to do the long term toxicity test of Canis familiaris L..
Capsule preparations of the present invention is pressed 18.3g/kg, 9.2g/kg, 3.9g/kg dosage to rat every day, continuous irrigation stomach 180 days, general situation such as the activity of rat, behavior, feed, drinking-water, hair color, fecaluria is not seen appreciable impact, and none death, the hematology of rat, blood biochemical learn and important organ pathological tissue index does not all have remarkable change, recovered to observe through 60 days after administration finishes, do not observe other the back something lost and the toxic action of secondary.Point out clinical dosage of drafting of capsule preparations of the present invention and medication cycle safety, low toxicity.
Advantage of the present invention is:
1, scientific formula: promptly according to TCM Document ancient books and distinguished veteran doctors of TCM experience prescription, utilization modern medicine technology screening Chinese medicine preparation has breakthrough on traditional Chinese medical science Shi Zhi is dialectical.
2, medicine source abundance is simple for process, very easily promotes the use of.
3, evident in efficacy, toxic and side effects is little, safety and low toxicity.
The specific embodiment:
For a better understanding of the present invention, further set forth the present invention, but be not understood to that the present invention is had any restriction below by specific embodiment.
Embodiment 1
The preparation of capsule:
Radix Astragali 300g Fructus Lycii 250g Rhizoma Atractylodis Macrocephalae 300g Pericarpium Citri Reticulatae Viride 90g Radix Puerariae 150g Endothelium Corneum Gigeriae Galli (system) 100g Flos Rosae Rugosae 90g Radix Rhapontici 90g
A, Endothelium Corneum Gigeriae Galli powder are broken into fine powder, sterilization;
B, the Radix Astragali, Fructus Lycii, Radix Puerariae add 6 times of amount 70% alcohol reflux secondaries, and each 2 hours, gradation filtered, merge extractive liquid,, and decompression recycling ethanol, standby;
C, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae Viride, Flos Rosae Rugosae, Radix Rhapontici etc. four flavor adds 8 times of water gagings and soaked 3.5 hours, extracts volatile oil 8 hours with the way of distillation, and volatile oil is with 6 times of amount beta-schardinger dextrin-s, 40 ℃ of following enclose 1 hour, the device collection in addition of the aqueous solution after the distillation;
D, the medicinal residues among the B and the medicinal residues among the C are added 10 times of water gagings jointly decoct 2 times, each 3 hours, gradation filtered, and merging filtrate is concentrated into relative density 1.10 (60 ℃ of surveys), adds ethanol and reaches 50% to containing the alcohol amount, leaves standstill 24 hours, filters decompression recycling ethanol;
E, alcohol extract among D and the B is merged, being concentrated into relative density is the thick paste of 1.28～1.30 (60 ℃ of surveys), adds fine powder among the A, mixing, and drying is ground into fine powder, adds volatile oil beta cyclodextrin inclusion complex, and mixing adds suitable adjuvant, preparation, promptly.
Put forced air drying in the baking oven with extracting the extractum that concentrates gained, pulverized 80 mesh sieves and get dry powder.Add 2 times of heavy dextrin of amount of dry powder, 2% steviosin, dextrin and steviosin are all crossed 80 mesh sieves.With 70% ethanol moistening system soft material, cross 14 mesh sieves and granulate, 60 ℃ of oven dry of wet granular, behind the dried granule granulate, packing, promptly.
Embodiment 2
The preparation of tablet:
Prescription: Radix Astragali 250g Fructus Lycii 300g Rhizoma Atractylodis Macrocephalae 200g Pericarpium Citri Reticulatae Viride 100g Radix Puerariae 150g Endothelium Corneum Gigeriae Galli (system) 120g Flos Rosae Rugosae 90g Radix Rhapontici 120g
A, Endothelium Corneum Gigeriae Galli powder are broken into fine powder, sterilization;
B, the Radix Astragali, Fructus Lycii, Radix Puerariae add 12 times of amount 70% alcohol reflux 2 times, and each 1.5 hours, gradation filtered, merge extractive liquid,, and decompression recycling ethanol, standby;
C, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae Viride, Flos Rosae Rugosae, Radix Rhapontici etc. four flavor adds 10 times of water gagings and soaked 3 hours, extracts volatile oil 6 hours with the way of distillation, and volatile oil is with 6 times of amount beta-schardinger dextrin-s, 40 ℃ of following enclose 1 hour, the device collection in addition of the aqueous solution after the distillation;
D, the medicinal residues among the B and the medicinal residues among the C are added 8 times of water gagings jointly decoct three times, each 2 hours, gradation filtered, and merging filtrate is concentrated into relative density 1.10 (60 ℃ of surveys), adds ethanol and reaches 50% to containing the alcohol amount, leaves standstill 24 hours, filters decompression recycling ethanol;
E, alcohol extract among D and the B is merged, being concentrated into relative density is the thick paste of 1.28～1.30 (60 ℃ of surveys), adds fine powder among the A, mixing, and drying is ground into fine powder, adds volatile oil beta cyclodextrin inclusion complex, and mixing adds suitable adjuvant, preparation, promptly.
Extracting solution is concentrated, dries, pulverized 80 mesh sieves, the dry powder that makes is added 5% starch, add 70% suitable ethanol and make granule, drying, dried granule is crossed 20 mesh sieve granulate.Add 0.5% magnesium stearate again, mix homogeneously, tabletting is made plain sheet or Film coated tablets promptly.
Embodiment 3
Preparation of soft capsule:
Radix Astragali 320g Fructus Lycii 250g Rhizoma Atractylodis Macrocephalae 300g Pericarpium Citri Reticulatae Viride 120g Radix Puerariae 100g Endothelium Corneum Gigeriae Galli (system 100g) Flos Rosae Rugosae 100g Radix Rhapontici 100g
A, Endothelium Corneum Gigeriae Galli powder are broken into fine powder, sterilization;
B, the Radix Astragali, Fructus Lycii, Radix Puerariae add 8 times of amount 70% alcohol reflux 3 times, and each 3 hours, gradation filtered, merge extractive liquid,, and decompression recycling ethanol, standby;
C, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae Viride, Flos Rosae Rugosae, Radix Rhapontici etc. four flavor adds 12 times of water gagings and soaked 3 hours, extracts volatile oil 6 hours with the way of distillation, and volatile oil is with 6 times of amount beta-schardinger dextrin-s, 40 ℃ of following enclose 1 hour, the device collection in addition of the aqueous solution after the distillation;
D, the medicinal residues among the B and the medicinal residues among the C are added 10 times of water gagings jointly decoct 2 times, each 2.5 hours, gradation filtered, and merging filtrate is concentrated into relative density 1.10 (60 ℃ of surveys), adds ethanol and reaches 50% to containing the alcohol amount, leaves standstill 24 hours, filters decompression recycling ethanol;
E, alcohol extract among D and the B is merged, being concentrated into relative density is the thick paste of 1.28～1.30 (60 ℃ of surveys), adds fine powder among the A, mixing, and drying is ground into fine powder, adds volatile oil beta cyclodextrin inclusion complex, and mixing adds suitable adjuvant, preparation, promptly.
Extract the extracting solution of gained by said extracted technology and make dry powder, be dissolved in the soybean oil, this solution is made soft capsule, promptly through concentrated, dry, pulverizing.
Claims (6)
1. Chinese medicine preparation for the treatment of alcoholic fatty liver is characterized in that the Chinese medicine preparation that it is made by the Chinese crude drug of following weight proportioning:
The Radix Astragali 200～3000 weight portion Fructus Lycii 100～1200 weight portions
The Rhizoma Atractylodis Macrocephalae 150～1200 weight portion Pericarpium Citri Reticulatae Virides 50～900 weight portions
Radix Puerariae 100～1500 weight portion Endothelium Corneum Gigeriae Galli (system) 50～900 weight portions
Flos Rosae Rugosae 50～600 weight portion Radix Rhapontici 50～900 weight portions
2. a kind of Chinese medicine preparation for the treatment of alcoholic fatty liver according to claim 1, wherein the optimum weight proportioning of each Chinese crude drug is:
The Radix Astragali 300 weight portion Fructus Lycii 200 weight portions
The Rhizoma Atractylodis Macrocephalae 200 weight portion Pericarpium Citri Reticulatae Virides 90 weight portions
Radix Puerariae 150 weight portion Endothelium Corneum Gigeriae Galli (system) 100 weight portions
Flos Rosae Rugosae 90 weight portion Radix Rhapontici 90 weight portions
3. a kind of Chinese medicine preparation for the treatment of alcoholic fatty liver according to claim 1 and 2 is characterized in that described dosage form is the above a dosage form of any pharmaceutics.
4. a kind of Chinese medicine preparation for the treatment of alcoholic fatty liver according to claim 3 is characterized in that described medicament is tablet, hard capsule, soft capsule, pill, powder, syrup, mixture, drop pill, granule, oral liquid, drop or the like.
5. the preparation method of the Chinese medicine preparation of a claim 1,2,3,4 described treatment alcoholic fatty livers is characterized in that:
A, Endothelium Corneum Gigeriae Galli powder are broken into fine powder, sterilization;
B, the Radix Astragali, Fructus Lycii, Radix Puerariae add 6-12 and doubly measure the 70%-90% alcohol reflux 1-3 time, and each 1-3 hour, gradation filtered, merge extractive liquid,, and decompression recycling ethanol, standby;
C, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae Viride, Flos Rosae Rugosae, Radix Rhapontici etc. four flavor adds 6-12 times of water gaging and soaked 2-5 hour, extracts volatile oil 4-8 hour with the way of distillation, and volatile oil is with 6 times of amount beta-schardinger dextrin-s, 40 ℃ of following enclose 1 hour, the device collection in addition of the aqueous solution after the distillation;
D, the medicinal residues among the B and the medicinal residues among the C are added 6-12 times of water gaging jointly decoct 1-3 time, each 1-3 hour, the gradation filtration, merging filtrate is concentrated into relative density 1.10 (60 ℃ of surveys), adds ethanol and reaches 50% to containing the alcohol amount, left standstill 24 hours, and filtered decompression recycling ethanol;
E, alcohol extract among D and the B is merged, being concentrated into relative density is the thick paste of 1.28～1.30 (60 ℃ of surveys), adds fine powder among the A, mixing, and drying is ground into fine powder, adds volatile oil beta cyclodextrin inclusion complex, and mixing adds suitable adjuvant, preparation, promptly.
6. the function according to the Chinese medicine preparation of claim 1,2,3,4,5 described treatment alcoholic fatty livers cures mainly and indication, it is characterized in that: have the QI invigorating tonifying liver, detoxifying and descending turbid, the effect of eliminating blood stasis and smoothing collaterals.Treatment alcoholic fatty liver, alcoholic hepatitis and alcoholic cirrhosis (deficiency of liver-QI, the alcoholism impairing the liver, the turbid fat of blood stasis hinders in liver network card) disease sees: disease sees that side of body rib is full vexed, or dull pain, fatigue and weakness, non-endurance, spirit is not smooth, the susceptible to fear irritability, loss of appetite, and pale tongue is dim, tongue fur is white, a little less than the stringy and thready pulse.
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| CN103083573A (en) * | 2013-01-20 | 2013-05-08 | 崔英坤 | Traditional Chinese medicine used for treating alcoholic fatty liver |
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| CN1660200A (en) * | 2004-12-14 | 2005-08-31 | 彭静涛 | Chinese traditional medicine for treating fatty liver |
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| CN103083573A (en) * | 2013-01-20 | 2013-05-08 | 崔英坤 | Traditional Chinese medicine used for treating alcoholic fatty liver |
| CN103083573B (en) * | 2013-01-20 | 2014-04-02 | 李孝芹 | Traditional Chinese medicine used for treating alcoholic fatty liver |
| CN103285107A (en) * | 2013-06-24 | 2013-09-11 | 阿斯亚·拜山伯 | Alcoholic hepatitis treatment Kazakh traditional drug composition and preparation method thereof |
| CN103611035A (en) * | 2013-11-14 | 2014-03-05 | 张桂洁 | Traditional Chinese medicine composition for treating phlegm-dampness stagnation type fatty liver |
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| CN104189877A (en) * | 2014-09-29 | 2014-12-10 | 洛阳御平国生物科技有限公司 | Traditional Chinese medicine formula for treating alcoholic liver disease |
| CN104547263A (en) * | 2014-12-23 | 2015-04-29 | 尹常健 | Alcoholic liver treating tablet |
| CN113577130A (en) * | 2021-10-08 | 2021-11-02 | 广东海洋大学 | Histidine dipeptide composition for repairing liver injury and application thereof |
| CN113577130B (en) * | 2021-10-08 | 2022-03-15 | 广东海洋大学 | Histidine dipeptide composition for repairing liver injury and application thereof |
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