CN1879845A - A pharmaceutical composition for preventing or treating acute and chronic liver disease - Google Patents
A pharmaceutical composition for preventing or treating acute and chronic liver disease Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating or preventing acute and chronic hepatic disease, which is prepared from Chinese medicinal herbs including Bupleurum root, licorice root, root of red rooted saliva, notoginseng, schisandra fruit, curcuma longa, picrorhiza rhizome, cow-bezoar, Chinese angelica root, herba patriniae, astragalus root and alisol. The invention also provides the method for preparation and use of the pharmaceutical composition.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of prevention or treatment acute and chronic hepatitis, specifically, relating to a kind of is the pharmaceutical composition that is used for the treatment of acute and chronic hepatitis of active ingredient with the natural medicinal ingredients mainly.
Background technology
According to investigations, the chronic hepatitis patient that China now suffers from is 1,200 ten thousand examples, dies from about 300,000 examples of hepatopathy every year, and wherein 50% is primary hepatoma, most and B-mode relevant with infection with hepatitis C virus.Viral hepatitis is the infectious disease of serious harm China people ' s health, in the infectious disease of statutory report, the M ﹠ M of viral hepatitis all accounts for the first place, and the average year sickness rate is about 1,00/,100,000, i.e. annual about 1,200,000 examples of acute viral hepatitis that take place in the whole nation.But according to the investigation of failing to report of viral hepatitis, the actual morbidity number of primary disease than the high 5-8 of number of reports doubly.In acute viral hepatitis, 50% is the first type, and 25% is B-mode, and 5% is third type, and 10% is penta type, and all the other 10% are prepattern.
According to Epidemiological study, the infection rate of population of China hepatitis B virus is 57.6%; The hepatitis B virus carrier rate is 9.8%, wherein 1.2% carries B-mode simultaneously and virus hepatitis D.Calculate that in view of the above China's about 6.9 hundred million people (wherein 1.2 hundred million people carry hepatitis B virus) had infected or just at hepatitis b virus infection, 1,400,000 people carry B-mode and hepatitis D virus simultaneously.
China women of child-bearing age hbs antigen carrying rate is 8%, and mother-to-baby transmission takes place the positive neonate that mother gives birth to about 40% of hepatitis B antigen, and the two positive mothers of hbs antigen and e antigen the mother-to-baby transmission rate take place up to more than 90%.Calculate that in view of the above if neonate is not carried out the hepatitis B vaccine prophylactic immunization, annual about 800,000 neonates of China will become the HBsAg carrier, wherein 1/4 develop into chronic hepatopathy the most at last, comprise liver cirrhosis and primary hepatoma.
In China, annual nearly 2,000,000 acute hepatitis cases, wherein hepatitis A accounts for half (50%), hepatitis B accounts for 20-25%, hepatitis C accounts for 5-10%, hepatitis E accounts for 10%, the total prevalence rate of the antibody of hepatitis A virus is 81%, wherein rural area crowd's prevalence rate (84%) is higher than city crowd (72%), the specificity difference at age is present in less than among 15 years old the child crowd, the anti-HAV positive rate of the province of China's Mainland 60% (city, autonomous region) is decided to be high popular district greater than 80%.The age less than 10 years old crowd in, the anti-HAV prevalence rate increases with the age and improves, hepatitis A may mainly be popular in the child group.Total prevalence rate of China's hepatitis B virus is 59.17%.The rural area is higher than the city, and south is more than the north.China also is the relative district occurred frequently of hepatitis C and hepatitis E, total the prevalence rate of hepatitis C virus is 3.2% (0.9～5.0%), total prevalence rate of hepatitis E virus is 17.2% (7～46%), and infecting number increased with the age.
Hepatitis monitoring report in 1991 shows that China's viral hepatitis sickness rate is 175.94/10 ten thousand people, and rate of failing to report is 23.64%, and sickness rate is 230.41/10 ten thousand people; The age distribution of HbsAg positive rate has two peaks district, before promptly 10 years old and 30～40 years old.
Fatty liver (Fatty Liver, FL) morbidity is continuous ascendant trend, its sickness rate accounts for 10% of population according to statistics, 50% of overweight people and diabetics, 57.5% of alcoholic, no matter be ethanol or non-alcoholic fatty liver disease, the hepatic fibrosis incidence rate is up to 25%, and 1.5%～8% patient can develop into liver cirrhosis.
The harm one of chronic hepatitis is hepatitis B to be infected to other people by blood, the 2nd, can excite hepatic fibrosis.According to observations, slight chronic hepatitis about 65% has fibrosis, in, severe chronic hepatitis then 100% has fibrosis.
At present the medicine of acute, chronic hepatitis is a lot, for example interferons, nucleoside medicine such as acyclovir, lamivudine, adefovir ester etc., and thymosin class medicine, also have hundreds of to protect the Chinese medicine liver and fall the enzyme medicine, yet, the not enough standard of clinical treatment, the Drug abuse phenomenon is more serious.Some medical workers and patient think that the high medication of price imitates one and reserve, and are to misread in fact, and any medicine all has adaptability.The for example application of interferon preferably finds that through liver puncture the activeness focus is arranged, and transaminase's height, hepatitis virus usefulness when titre is low in serum, answers that dosage is big, the course of disease short the time spent.When if patient has jaundice, cirrhotic ascites, then can not use interferon.
Find that in actual therapeutic with in using the curative effect of these medicines that used at present is not satisfactory, act on singlely that side effect is more, treatment back relapse rate is higher, easily rebounds.Interferon is internationally recognized treatment hepatitis B, hepatitis c virus infection medicine, hepatitis B surface antigen there is certain turning out cloudy (30～40%) effect, but the comprehensive restitution to liver function is not strong, late result is undesirable, and drug administration by injection is very inconvenient, and most of patients has similar drug anaphylaxis.Lamivudine is more definite to the curative effect of hepatitis B virus, but knock-on is very serious after the drug withdrawal of this medicine, and increasing drug resistance phenomenon occurs, find that there is the problem of patient compliance difference in long-term prescription, drug susceptibility descends, medication after 1 year the virus variation rate reach 16-32%, acyclovir is cut the uncertain therapeutic efficacy of hepatitis, side effect is more.These medicines are invalid to fatty liver, liver cirrhosis.And these medicine majorities that use at present are the product of synthetic, the product of gene recombinaton, because hepatopathy usually needs the treatment of long period, therefore how to find that from natural drug hepatopathy is had better curative effect, safe and reliable again and comprehensive recovery liver function prevents that the Fibrotic medicine of hepatic steatosis (fatty liver) regulating liver-QI from being the direction of giving priority in liver disease field.
The Chinese medicine of existing treatment acute and chronic liver injury is more, reach sheet, JIANGANLING JIAONANG, GANFUKANG etc. as hepatitis B detoxifying capsule, hepatitis B strengthening capsule, Chaoyang ball, QINGGAN TANGJIANG, silymarin, glycyrrhizic acid monoammonium, glycyrrhizic acid diamidogen, chronic hepatitis yin-nourishing capsule, oleanolic acid tablet, liver, these Chinese medicine preparation have certain auxiliary treatment effect to the recovery of the liver protecting and ALT lowering and liver function, but its mechanism is unclear, the clinical observation on the therapeutic effect that lacks the system of sending out flies other also seldom use outside silibin and the glycyrrhizic acid diamidogen so these medicines dewater in clinical practice.
Phospholipid is the fundamental component of human body cell and system of tissue film, plays an important role in film dependency metabolism and detoxification processes, also plays an important role in the cell regeneration process.Essential phospholipid generally is meant, Main Ingredients and Appearance is a polyene phosphatidylcholine (natural polyene phosphatidylcholine, have a large amount of unsaturated fatty acids acidic groups, be mainly linoleic acid [accounting for 70%], linolenic acid and oleic acid) a class phospholipid, in human body, can not synthesize separately, the product of listing is Essentiale N/Essentiale Forte N (a polyene phosphatidylcholine capsule) at present, can carry out auxiliary therapy to hepatic injury.In hepatic disease, no matter the infringement of hepatic parenchymal cells and organelle how, all will take place in its cause of disease inevitably, while losing with phospholipid.
Salviamiltiorrhizabung, Radix Bupleuri, Radix Glycyrrhizae, the Radix Astragali, Rhizoma Picrorhizae, Fructus Schisandrae Chinensis; can obviously suppress and alleviate hepatocellular degeneration, necrosis and inflammatory reaction; promote liver cell regeneration; and effect of anti hepatic fibrosis arranged; Calculus Bovis, Herba Patriniae have significant Detoxication to liver; hepar damnification is had significant protective effect, and Rhizoma Alismatis has significant lipotropy, and Rhizoma Curcumae Longae, Radix Angelicae Sinensis, Radix Notoginseng have the effect of blood circulation promoting and blood stasis dispelling, microcirculation improvement, antioxidation, protection liver plasma membrane stability.
Vitamin B complex involved in sugar, protein and lipid metabolism, essential to keeping the normal function of human body.Vitamin E is the important substance of oxidative phosphorylation in the liver metabolism, and vitamin C has the effect of anti-liver plasma membrane oxidation, can cause the hepatocellular degeneration necrosis as lacking.
The treatment acute and chronic hepatitis can not only unilaterally be started with from a certain, must carry out Comprehensive Treatment.Promote hepatic tissue regeneration, recover liver function comprehensively, prevent that the Fibrotic medicine of hepatic steatosis (fatty liver) regulating liver-QI from being the direction of giving priority in liver disease field, have not yet to see the new drug report of this respect.
Summary of the invention:
At above-mentioned defective, the invention provides a kind of pharmaceutical composition for the treatment of acute and chronic hepatitis, extremely the health food of health care behind preparation treatment acute, chronic hepatitis, abnormal liver function, liver cirrhosis, hepatic coma, fatty liver, hyperlipemia, liver poisoning, cholestasis, radiotherapy syndrome, hepatobiliary surgery and the recurrence of prevention cholelithiasis etc. or the purposes in the medicine.
The invention provides the pharmaceutical composition of a kind of prevention and treatment acute and chronic hepatitis; it be by contain must phospholipid (EPL) and one or more Chinese medicine with hepatoprotective effect be the preparation that raw material is made, the described Chinese medicine that protects the liver is one or more mixing in Radix Bupleuri, Radix Glycyrrhizae, Radix Salviae Miltiorrhizae, Radix Notoginseng, Fructus Schisandrae Chinensis, Rhizoma Curcumae Longae, Rhizoma Picrorhizae, Calculus Bovis, Radix Angelicae Sinensis, Herba Patriniae, the Radix Astragali, the Rhizoma Alismatis.
Wherein, described essential phospholipid with the weight ratio that protects the liver Chinese medicine is: essential phospholipid 0.2-10 part protects the liver Chinese medicine 3-90 part.
Described essential phospholipid (EPL) Main Ingredients and Appearance is polyene phosphatidylcholine (natural polyene phosphatidylcholine has a large amount of unsaturated fatty acids acidic groups, is mainly linoleic acid [accounting for 70%], linolenic acid and oleic acid).
Further, described Chinese medicine with hepatoprotective effect is Radix Salviae Miltiorrhizae, Radix Glycyrrhizae, Fructus Schisandrae Chinensis, and its weight proportion is Radix Salviae Miltiorrhizae 3-60 part, Radix Glycyrrhizae 3-30 part, Fructus Schisandrae Chinensis 3-30 part.Be mainly used in the hepatic injury of treatment due to liver cirrhosis, hepatic fibrosis and the chronic hepatitis.
Perhaps, described Chinese medicine with hepatoprotective effect is Rhizoma Alismatis 3-60 part, Radix Notoginseng 3-60 part, Rhizoma Curcumae Longae 3-60 part, Radix Salviae Miltiorrhizae 3-60 part.It is used to prepare the medicine of treatment fatty liver, hyperlipemia.
Perhaps, the Chinese medicine with hepatoprotective effect is Radix Notoginseng 3-60 part, Radix Astragali 3-60 part, Radix Angelicae Sinensis 3-60 part Calculus Bovis 3-60 part.It is used to prepare the health medicine behind treatment liver poisoning, the hepatobiliary surgery.
The above-mentioned Chinese medicine that protects the liver, every 3-90 part protect the liver and add 0.006-0.12 part B2, B6 in the Chinese medicine, 0.000006-0.00012B12, and the vitamin E of 0.01-0.3 part, one or more in the vitamin C of the nicotiamide of 0.03-0.3 part, 0.1-0.5 part.
Pharmaceutical composition of the present invention is by essential phospholipid and one or more protect the liver Chinese medicine and vitamin is an active ingredient, adds that acceptable accessories or complementary composition are prepared into oral or ejection preparation pharmaceutically.
Concrete, described pharmaceutical composition, be to be active ingredient by following various materials of weight proportions, add that acceptable accessories or complementary composition are prepared into oral or ejection preparation pharmaceutically: essential phospholipid 0.2-10 part, Radix Salviae Miltiorrhizae 3-30 part, Radix Glycyrrhizae 3-15 part, Fructus Schisandrae Chinensis 3-15 part, vitamin C 0.1-0.5 part, vitamin B
120.000006-0.000072 part.
Preferably, be to be active ingredient by following various materials of weight proportions, add that acceptable accessories or complementary composition are prepared into oral or ejection preparation pharmaceutically: 1.2 parts of essential phospholipids, 15 parts of Radix Salviae Miltiorrhizaes, 5 parts in Radix Glycyrrhizae, 5 parts of Fructus Schisandrae Chinensis, 0.18 part of vitamin C, vitamin B
120.000036 part.
Described preparation is: tablet, hard capsule, soft capsule, oral liquid, drop pill, injection, injectable powder, lyophilized injectable powder.
Pharmaceutical composition of the present invention can be used for preparing the health food or the medicine of health care behind treatment acute, chronic hepatitis, abnormal liver function, liver cirrhosis, hepatic coma, fatty liver, hyperlipemia, liver poisoning, cholestasis, radiotherapy syndrome, the hepatobiliary surgery and the recurrence of prevention cholelithiasis etc.
Medicine of the present invention is by replenishing the exogenous phospholipid composition of human body, make polyunsaturated phosphatidyl choline be attached in the liver plasma membrane structure, hepatocellular regeneration and reconstruct had important effect, and can obviously improve nutrient substance and the electrolytical membrane process of striding, increase the activity of phospholipid dependency enzyme.Simultaneously, high-octane " essential " phospholipid molecule combines with liver plasma membrane or organelle, can provide lot of energy for ill liver, and these energy are that biofilm structure forms and function is brought into play necessary.In addition, medicine of the present invention still can be secreted into bile, improves the ratio of bile cholesterol and phospholipid, increases the water solublity of bile components, reduces cholelithiasis and forms index.Medicine of the present invention also can reduce hepatocellular fatty infiltration, reduces inflammatory reaction, prevents hepatic necrosis.By suppressing collagenation, reduce collagen/DNA ratio and liver hydroxyproline and generate and the formation of minimizing connective tissue.
Prove that by pharmacodynamics test the compositions of essential phospholipid and above-mentioned Chinese medicine and vitamin has good synergism aspect the treatment acute and chronic liver injury.The each side such as stable of having illustrated from hepatocyte recovers necessary raw material, hepatocyte metabolism, impaired hepatocellular regeneration, hepatocellular detoxifcation, liver plasma membrane from mechanism is regulated the recovery of liver function comprehensively, makes this compositions have above-mentioned Chinese medicine, chemical medicine and the inaccessiable effect of genetic engineering medicine.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment:
Below prove beneficial effect of the present invention by concrete preparation embodiment and pharmacodynamics test.Chinese medicine wherein directly adopts conventional method to be prepared into the mode medication of water extract or ethanol extract.
Embodiment 1
Essential phospholipid 1.2g Radix Salviae Miltiorrhizae 15g or Fructus Schisandrae Chinensis 15g or Radix Glycyrrhizae 15g directly adopt the water extract of described medical material in the effect of treatment in the hepatic injury.
Method:
At random phospholipid Radix Salviae Miltiorrhizae group, phospholipid Fructus Schisandrae Chinensis group, phospholipid Radix Glycyrrhizae group and essential phospholipid group, Radix Salviae Miltiorrhizae group, Fructus Schisandrae Chinensis group, Radix Glycyrrhizae group and positive drug (diammonium glycyrrhizinate capsule), negative group (blank group), model group are divided into ten groups, use the wistar rat, body weight 180～220g, male and female half and half are tested for 10 every group.Negative control group: 1%CMC irritates stomach, dosage 1ml/100g; Model group: 1%CMC irritates stomach, dosage 1ml/100g; The full side of trial drug group dosage group 140mg/kg, essential phospholipid group 160mg/kg, Radix Salviae Miltiorrhizae group 120mg/kg, positive group 40mg/kg irritates stomach every day 1 time, successive administration 7 days, 1h behind the 8th day gastric infusion, except that negative control group, the D-Gal of equal lumbar injection 400mg/kg body weight.Continue gastric infusion, femoral artery is got hematometry ALT (alanine aminotransferase), AST (the amino transaminase of aspartic acid) behind the lumbar injection D-Gal 48h.The results are shown in Table 1
Table 1 compound recipe essential phospholipid is to D-Gal poisoning rat blood serum ALT, the active influence of AST
| Group | Number of animals | Dosage | ALT(u/L) | AST(u/L) |
| Negative group | 10 | —— | 58.12±12.99 ** | 149.65±13.96 ** |
| Model group | 10 | —— | 253.50±155.52 | 501.95±294.21 |
| Phospholipid+Radix Salviae Miltiorrhizae | 10 | 140mg/kg | 92.79±28.67 ** | 206.58±56.54 ** |
| Phospholipid+Fructus Schisandrae Chinensis | 10 | 140mg/kg | 93.15±26.48 ** | 207.41±55.63 ** |
| Phospholipid+Radix Glycyrrhizae | 10 | 140mg/kg | 92.85±25.96 ** | 208.15±59.33 ** |
| The phospholipid group | 10 | 160mg/kg | 102.59±55.88 * | 258.64±142.24 * |
| The Radix Salviae Miltiorrhizae group | 10 | 120mg/kg | 114.34±88.47 * | 296.97±187.97 |
| The Fructus Schisandrae Chinensis group | 10 | 120mg/kg | 110.26±87.38 * | 292.38±186.52 |
| The Radix Glycyrrhizae group | 10 | 120mg/kg | 106.55±84.93 * | 294.59±155.65 |
| Positive group | 10 | 40mg/kg | 105.44±49.51 * | 298.53±179.17 |
Annotate: and model group is relatively,
*P＜0.01,
*P＜0.05
By last table 1 as can be known, model group and negative group relatively, rat blood serum ALT (alanine aminotransferase), AST (the amino transaminase of aspartic acid) activity significantly increase (
*P＜0.01), shows the success of modeling type.
With model group relatively, phospholipid Radix Salviae Miltiorrhizae group, phospholipid Fructus Schisandrae Chinensis group, phospholipid Radix Glycyrrhizae group and phospholipid group all can significantly reduce ALT, AST level of activity (
*P＜0.01,
*P＜0.05), wherein the curative effect of the compound recipe of phosphine fat and Radix Salviae Miltiorrhizae or Fructus Schisandrae Chinensis or Radix Glycyrrhizae is the most outstanding; The level of activity that essential phospholipid, Radix Salviae Miltiorrhizae group, Fructus Schisandrae Chinensis group, Radix Glycyrrhizae are organized, though positive group can obviously reduce ALT (
*P＜0.05), but its effect all not as the compound recipe group.Experimental results show that:
1. this prescription has the effect of ALT, AST due to remarkable reduction hepatic injury and the abnormal liver function.
2. this prescription compound recipe obviously is better than the effect of folk prescription.
3. the compound recipe of essential phospholipid and above-mentioned any Chinese medicine all has the effect of treatment hepatic injury.
Embodiment 2
The use of essential phospholipid 1.2g Radix Bupleuri 5-30g Radix Glycyrrhizae 5-30g in the treatment chronic hepatitis b cirrhosis.
Method:
With modeling and the medication of embodiment 1, but establish two dosage groups
Full side group 1: essential phospholipid 1.2g Radix Bupleuri 15g Radix Glycyrrhizae 15g;
Full side group 2: essential phospholipid 1.2g Radix Bupleuri 30g Radix Glycyrrhizae 30g.
Directly adopt medical material to be prepared into water extract, add essential phospholipid.
After observation index mainly is lumbar injection D-Gal 48h, put to death animal, get rat liver, measure liver coefficient and pathological change.
Hepatic tissue pathology damage criterion, see the following form:
Table 1 hepatic tissue pathology damage criterion
| The pathological change classification | Pathological characters is described | |
| Hydropic degeneration | ||
| Do not have (0 minute) | - | No hepatocellular degeneration, |
| Minor injury (1 minute) | + | Swelling of liver cell, volume increases, and iuntercellular still has boundary, and endochylema is light to be dyed. |
| Moderate lesion (2 minutes) | ++ | The obvious swelling of cell, the iuntercellular boundary is unclear, and endochylema is light to be dyed. |
| Severe injury (3 minutes) | +++ | The balloon sample becomes, and cell expands as balloon, and it is comparatively transparent that endochylema becomes. |
| Steatosis | ||
| Do not have (0 minute) | - | Expression is normal |
| Minor injury (1 minute) | + | Fat vacuole in the hepatocyte is less, and is dispersed in. |
| Moderate lesion (2 minutes) | ++ | It is big that fat vacuole in the hepatocyte becomes, wider range. |
| Severe injury (3 minutes) | +++ | Fat vacuole is fused to big cavity, and nucleus is pressed under the after birth, and shape is like adipose cell. |
| Downright bad | ||
| Do not have (0 minute) | - | Expression does not have necrosis |
| Minor injury (1 minute) | + | Spotty necrosis can have the hepatic necrosis that is dispersed in the lobules of liver, and each necrosis region only involves single or several hepatocyte. |
| Moderate lesion (2 minutes) | ++ | Broken strip necrosis, hepatocyte are the necrosis of kitchen range shape, disintegrate. |
| Severe injury (3 minutes) | +++ | Large stretch of lytic necrosis is arranged. |
| Proliferation of fibrous tissue | ||
| Do not have (0 minute) | - | There is not hypertrophy. |
| Minor injury (1 minute) | + | Fibrocyte and a few fibres hamartoplasia are only arranged, and the normal hepatocytes leaflet structure mays be seen indistinctly. |
| Moderate lesion (2 minutes) | ++ | Tangible proliferation of fibrous tissue is arranged, and the normal hepatocytes leaflet structure is not obvious, but does not form obvious pseudolobuli as yet. |
| Severe injury (3 minutes) | +++ | A large amount of proliferations of fibrous tissue are arranged, hepatocyte is surrounded fritter be little island, obviously pseudolobuli forms. |
The result:
Table 2 compound recipe essential phospholipid is to the influence of D-Gal poisoning liver tissues of rats pathological change
| Group | Number of animals | The hydropic degeneration mean scores | The steatosis mean scores | Downright bad mean scores | Fibrosis hypertrophy mean scores |
| Blank group **△△ | 10 | 0.42 | 0 | 0 | 0 |
| Model group | 10 | 2.62 | 2.24 | 2.18 | 0.90 |
| Full side group 1 **△ | 10 | 1.08 | 1.30 | 1.16 | 0 |
| Full side group 2 **△ | 10 | 1.06 | 1.28 | 1.18 | 0 |
| The essential phospholipid group | 10 | 1.68 | 1.40 | 1.42 | 0.35 |
| Radix Bupleuri Radix Glycyrrhizae group | 10 | 2.59 | 2.08 | 1.91 | 0.58 |
| Positive group * | 10 | 2.42 | 2.20 | 1.40 | 0.32 |
Annotate: Kruskal-Wallis check and model group compare,
*P＜0.01,
*P＜0.05;
Compare △ P＜0.05, △ △ P＜0.01 with Radix Bupleuri Radix Glycyrrhizae group.
From last table 2 as can be known, model group and blank group relatively, the hepatic injury degree obviously increase weight (
*P＜0.01), shows the modeling success.
With model group relatively, full side group, essential phospholipid group, Radix Bupleuri Radix Glycyrrhizae group and positive group, all have significant difference (
*P＜0.01,
*P＜0.05), the hepatic injury degree obviously alleviates, and wherein the curative effect with full side's group is the most outstanding, illustrate that this compound recipe has the effect of remarkable anti-liver cirrhosis, hepatic fibrosis, and compound recipe obviously is better than the effect of folk prescription.The effect there was no significant difference of full side group 1 and full side group 2 illustrates in the above-mentioned dosage range and can select arbitrarily.
Embodiment 3:
Essential phospholipid 1.2g Rhizoma Alismatis 5-30g Radix Notoginseng 5-30g Rhizoma Curcumae Longae 5-30g Radix Salviae Miltiorrhizae 5-30g
Effect in treatment diet fatty liver, and the effect of the triglyceride and the cholesterol of obvious reduction hyperlipidemia is arranged.Method:
Side's group, essential phospholipid group, Chinese drug-treated group (except that essential phospholipid), positive group (XUEZHIKANG JIAONANG), blank group, model group are divided into 7 groups entirely at random, and wherein full side's component is:
Full side group 1: essential phospholipid 1.2g Rhizoma Alismatis 10g Radix Notoginseng 5g Rhizoma Curcumae Longae 5g Radix Salviae Miltiorrhizae 5g
Full side group 1: essential phospholipid 1.2g Rhizoma Alismatis 20g Radix Notoginseng 10g Rhizoma Curcumae Longae 10g Radix Salviae Miltiorrhizae 10g.Medicine directly adopts medical material to be prepared into water extract, adds essential phospholipid.
Healthy male SD rat is used in experiment, and 10 every group, about body weight 120g.Rat is divided into normal diet group and high fat modeling group, give normal diet and high lipid food (cholesterol 2%, cholate 1%, Adeps Sus domestica 5%, normal diet 92%) respectively and raise, continuously around.The 28th late fasting, cut tail and get blood morning next day, and separation of serum is measured TC (cholesterol) in the liver, TG (triglyceride), HDL-C (high density lipoprotein-cholesterol), LDL-C (low density lipoprotein, LDL-cholesterol).The test medication is for irritating stomach, 1m/100g, 1 time/day.During administration, except that the blank group, continue to give high lipid food, the 7th week was got the hematometry These parameters after administration.Next day after the last administration, the execution animal is got liver and weighs, and calculates the liver coefficient.Get the fritter liver and shred and add normal saline and grind homogenate, measure TC, TG, HDL-C, LDL-C value in the hepatic tissue, get fritter liver formaldehyde fixed again and do histopathologic examination in the ratio of 1g: 4ml.The result:
Table 3 compound recipe essential phospholipid is to the influence of diet fatty liver rat liver blood lipids index
| Group | Number of animals (only) | TC (mmol/L) | TG (mmol/L) | HDL-C (mmol/L) | LDL-C (mmol/L) |
| Matched group | 10 | 1.50±0.33△ | 0.73±0.24 | 0.46±0.11△△ | 1.06±0.23 |
| Model group | 10 | 5.63±3.02 ** | 0.69±0.23 | 1.72±0.93 ** | 3.49±1.83 ** |
| Full side group 1 | 10 | 3.01±0.76 *△△ | 0.54±0.14△△ | 0.99±0.25△△ | 1.66±0.45 *△△ |
| Full side group 2 | 10 | 3.12±0.56 *△△ | 0.51±0.23△△ | 0.92±0.45△△ | 1.59±0.20 *△△ |
| The essential phospholipid group | 10 | 3.34±1.31△△ | 0.66±0.11△△ | 0.90±0.23 *△△ | 2.13±0.77△△ |
| Chinese drug-treated group | 10 | 3.19±0.85△△ | 0.62±0.18△△ | 0.93±0.24△△ | 2.02±0.5△△ |
| Positive group | 10 | 3.64±0.80 *△△ | 0.64±0.23△△ | 0.95±0.53△△ | 1.89±0.85 *△△ |
Annotate:
*Expression is compared P＜0.05 with the concurrent control group;
*Expression is compared P＜0.01 with the concurrent control group
△ represents and the model group comparison same period, P＜0.05; △ △ represents and the model group comparison same period, P＜0.01
Experimental result shows:
Full side's group can significantly reduce the effect of TC, TG, LDL-C and rising HDL-C in the diet fat liver, and full side group obviously is better than the Chinese drug-treated group of the essential phospholipid and the folk prescription of folk prescription, proves that both have synergism at (essential phospholipid and Chinese medicine).Do not have significant difference between two dosage groups of full side, illustrate phospholipid and above-mentioned Chinese medicine can be in any dosage range proportioning.Pathologic finding consistent with experimental result (seeing Table 4)
Table 4 compound recipe essential phospholipid is to the influence of diet fatty liver rat liver
| Group | Number of animals (only) | Liver coefficient (g/100g body weight) | Liver scoring (n=5) |
| Matched group | 10 | 2.27±0.16 | 0、0、0、0、0/0 |
| Model group | 10 | 2.75±0.26 ** | 1、1、1、1、1/5 |
| Full side group 1 | 10 | 2.51±0.19 **△ | 0、0、0、0、0/0 |
| Full side group 2 | 10 | 2.55±0.12 **△ | 0、0、0、0、0/0 |
| The essential phospholipid group | 10 | 2.65±0.26 ** | 0、0、0、1、0/1 |
| Chinese drug-treated group | 10 | 2.64±0.27 ** | 0、1、0、0、0/1 |
| Positive group | 10 | 2.73±0.60 | 0、1、0、0、0/1 |
Annotate:
*Expression is compared P＜0.05 with the concurrent control group;
*Expression is compared P＜0.01 with the concurrent control group
△ represents and the model group comparison same period, P＜0.05; △ △ represents and the model group comparison same period, P＜0.01
Embodiment 4:
Essential phospholipid 1.2g Radix Salviae Miltiorrhizae 10g Fructus Schisandrae Chinensis 5g Radix Glycyrrhizae 5g vitamin B
1236ug vitamin C 180mg directly adopts medical material to be prepared into water extract, adds essential phospholipid, vitamin.To the comprehensive restitution of abnormal liver function, has the use that stops the fatty effect that becomes of hepatocyte, the particularly fat that causes by ethanol to become simultaneously.
Method:
At random with full side group, essential phospholipid group, Chinese drug-treated group (prescription except that essential phospholipid), vitamin group (B
12Add V
c), blank group, model group be divided into 6 groups, divides blank group and alcoholic liver modeling group with the SD rat, wherein the blank group is normally raised, the modeling group gavages the ethanol of variable concentrations and dosage.All animals of fasting at the 6th weekend after modeling, cut tail and get blood morning next day, measures the content of GSH in the serum.Put to death animal and get liver, get the fritter liver and shred and add normal saline and grind homogenate, survey LTC, LTG and MDA content in the hepatic tissue in the ratio of 1g: 4ml.Get fritter liver formaldehyde fixed again and do histopathologic examination.The result:
Table 5 compound recipe essential phospholipid is to the influence of GSH in rat liver LTC, LTG and MDA and the blood
| Group | Number of animals (only) | LTC mg/g | LTG mg/g | MDA nmol/mg albumen | GSH mg/L |
| Matched group | 10 | 2.21±0.41 | 14.12±2.32 | 1.09±0.25 | 212.11±41.40 |
| Model group | 10 | 4.90±1.00 | 16.72±2.51 | 1.45±0.39 | 202.81±40.76 |
| Full side group | 10 | 3.39±1.60△ | 13.18±3.04△ | 1.29±0.36△△ | 263.61±37.40△△ |
| The essential phospholipid group | 10 | 4.99±0.69 | 14.42±2.47 | 1.33±0.36△ | 242.51±34.71△ |
| Chinese drug-treated group | 10 | 5.11±0.88 | 13.98±3.44△ | 1.36±0.34△ | 251.50±49.38△ |
| The vitamin group | 10 | 4.84±1.31 | 14.23±2.78 | 1.54±0.51 | 239.50±49.38△ |
△ represents and the model group comparison same period, P＜0.05; △ △, P＜0.01
LTC-liver cholesterol GSH-glutathion
LTG-liver tg MDA-malonaldehyde
Experimental result shows:
The effect that full side group, independent essential phospholipid group and the equal tool of the Chinese drug-treated group except that essential phospholipid significantly reduce TC in the alcoholic fatty liver, TG and MDA.The vitamin group does not have the effect that reduces liver tg and cholesterol; but liver there is significant protective effect; the content of glutathion obviously improves in the blood, and is the strongest with the effect of full side's group in each group, proves that essential phospholipid and other Chinese medicine and vitamin have synergism.
The pathologic finding of liver
Each group hepatic tissue is liquid-solid fixed with 15% neutral formalin, paraffin embedding, section, H-E dyeing, microscopy, observed result is as follows under the mirror:
The normal control group: the hepatic tissue structure is normal, does not see that work becomes.
Model group: liver tissue lesions is obvious, and to the vacuolar degeneration (steatosis) of severe, pathological changes was extensively serious on every side with lobules of liver central authorities venule, accidental point, the necrosis of kitchen range shape during hepatocyte was.
Full side group, essential phospholipid group, Chinese drug-treated group and vitamin group: it is light than model group that each organizes vacuolar degeneration of hepatic cell, has 2 hepatic tissue structures roughly normal in the full side group, and hepatocyte does not see that work becomes, most liver pathological changes be confined to central little quiet forever around.
For the ease of differentiating the drug effect of this prescription, main liver cell lesion is quantized, do rank test with model group.
Grade scale:
-hepatic tissue structure is normal, hepatocyte does not see that work becomes.
The accidental vacuolar degeneration of+hepatocyte.
++ vacuolar degeneration of hepatic cell scope (in doubly) and pathological changes below 1/4 visual field are confined to around the central venule more.
+++vacuolar degeneration of hepatic cell scope (in doubly) pathological changes below 1/4～1/2 visual field is confined to around the central venule more.
++ ++ the vacuolar degeneration of hepatic cell scope is more than 1/2, and (in doubly) and extent of disease are more extensive, and part of hepatocytes is big cavity shape or with point, the necrosis of kitchen range shape.Specifically see Table 6.
Table 6 compound recipe essential phospholipid group is to the influence of rat fat liver cell lesion
| Group | Number of animals (only) | Lesion degree | The P value * | ||||
| - | + | ++ | +++ | ++++ | |||
| Matched group | 10 | 0 | 0 | 0 | 0 | 0 | |
| Model group | 10 | 0 | 0 | 3 | 4 | 5 | |
| Full side group | 10 | 2 | 4 | 4 | 1 | 0 | ＜0.01 |
| The essential phospholipid group | 10 | 0 | 1 | 3 | 6 | 0 | ＞0.05 |
| Chinese drug-treated group | 10 | 1 | 2 | 3 | 6 | 0 | ＞0.05 |
| The vitamin group | 10 | 0 | 1 | 5 | 3 | 1 | ＞0.05 |
Annotate:
*Compare rank test, P＜0.05, P＜0.01 with model group
As seen no matter the vitamin group still is each group of compound recipe by table 6, and the hepatic lesions degree is light than model group all, but then shows the best results (P＜0.01) of this full side group after rank test.Experimental results show that essential phospholipid and Chinese medicine and support one's family and have synergism.
Conclusion:
Result of the test is represented, medicine of the present invention has curative effect preferably to the rat fat liver that alcohol factor causes, can obviously reduce the effect of triglyceride and malonaldehyde in the liver, also can obviously reduce the amount of cholesterol in the liver, the pathomorphology inspection shows that medicine of the present invention is to the pathological changes of the liver effect that improves significantly, the hepatic cell fattydegeneration degree is light, and scope is little, points out medicine of the present invention to provide experimental basis for treating fatty liver clinically.Glutathion (GSH) is an indication of hepatocellular damage and recovery in the variation of blood level; comprehensive paathogenic factor can make sulfhydryl compound content reduction in the serum; and medicine of the present invention can make the recovery of GSH index and surpass normal level; point out it that effect of hepatoprotective is arranged; medicine of the present invention can make mda content reduction in the liver again, and showing has the certain protection effect to the liver lipid peroxidation.In sum, medicine of the present invention has the use that protects the liver comprehensively and treat fatty liver.
Below, in limited range of the present invention, all can be prepared into the medicine of different size by concrete preparation example explanation.
The preparation of embodiment 5 medicines of the present invention
Take by weighing materials of weight proportions: essential phospholipid 2kg, Radix Salviae Miltiorrhizae 10kg, Radix Glycyrrhizae 10kg, Fructus Schisandrae Chinensis 10kg decocts with water Chinese crude drug Radix Salviae Miltiorrhizae, Radix Glycyrrhizae, Fructus Schisandrae Chinensis, concentrates, and adds essential phospholipid, granulation, granulate, is prepared into granule.
The preparation of embodiment 6 medicines of the present invention
Essential phospholipid 10kg, Radix Salviae Miltiorrhizae 40kg, Radix Glycyrrhizae 30kg, Fructus Schisandrae Chinensis 20kg decocts with water, and adds antiseptic, directly is prepared into oral liquid.
The preparation of embodiment 7 medicines of the present invention
Get raw material: Rhizoma Alismatis 30kg, Radix Notoginseng 30kg, Rhizoma Curcumae Longae 30kg, Radix Salviae Miltiorrhizae 30kg, add decocting and boil, concentrate, add essential phospholipid 10kg, be prepared into granule.
The preparation of embodiment 8 medicines of the present invention
Rhizoma Alismatis 15kg, Radix Notoginseng 60kg, Rhizoma Curcumae Longae 30kg, Radix Salviae Miltiorrhizae 40kg add decocting and boil, and concentrate, and add essential phospholipid 10kg, and granulation, granulate are encapsulated, promptly.
The preparation of embodiment 9 medicines of the present invention
Radix Notoginseng 15kg, Radix Astragali 60kg, Radix Angelicae Sinensis 30kg, Calculus Bovis 30kg add decocting and boil, and concentrate, and add essential phospholipid 10kg, granulation, granulate, encapsulated, promptly.
The preparation of embodiment 10 medicines of the present invention
Radix Notoginseng 60kg, Radix Astragali 60kg, Radix Angelicae Sinensis 60kg, Calculus Bovis 60kg add decocting and boil, and concentrate, and add essential phospholipid 10kg, and granulation, granulate get granule.
The preparation of embodiment 11 medicines of the present invention
Get the medical material Radix Salviae Miltiorrhizae 10kg of embodiment 5, Radix Glycyrrhizae 10kg, Fructus Schisandrae Chinensis 10kg, add decocting and boil, concentrate, add essential phospholipid 2kg, each 0.006kg of B2, B6, B12 0.000006kg, vitamin E 0.01kg, nicotiamide 0.03kg, vitamin C 0.1kg, granulation, granulate get granule.
The preparation of embodiment 12 medicines of the present invention
Get the medical material Radix Salviae Miltiorrhizae 10kg of embodiment 5, Radix Glycyrrhizae 10kg, Fructus Schisandrae Chinensis 10kg adds decocting and boils, concentrate, add essential phospholipid 2kg, each 0.12kg of B2, B6,0.00012kgB12, and the 0.3kg vitamin E, 0.3kg nicotiamide, 0.5kg vitamin C, granulation, granulate, add magnesium stearate, tabletting, promptly.
The preparation of embodiment 13 medicines of the present invention
Get Radix Salviae Miltiorrhizae 3kg, Radix Glycyrrhizae 3kg, Fructus Schisandrae Chinensis 3kg adds decocting and boils, and concentrates, and adds essential phospholipid 0.2kg, vitamin C 0.1kg, vitamin B
120.000006kg, adding starch, granulation, granulate add magnesium stearate, tabletting, promptly.
The preparation of embodiment 14 medicines of the present invention
Get Radix Salviae Miltiorrhizae 30kg, Radix Glycyrrhizae 15kg, Fructus Schisandrae Chinensis 15kg adds decocting and boils, and concentrates, and adds essential phospholipid 10kg, vitamin C 0.5kg, vitamin B
120.000072kg, adding water for injection, pH value regulator, osmotic pressure regulator are prepared into injection.
The preparation of embodiment 15 medicines of the present invention
Get Rhizoma Picrorhizae 20kg, Herba Patriniae 15kg adding decocting and boil, concentrate, add essential phospholipid 2kg, each 0.12kg of B2, B6,0.00012kgB12, and the 0.3kg vitamin E, 0.3kg nicotiamide, 0.5kg vitamin C, granulation, granulate, add magnesium stearate, tabletting, promptly.
Claims (15)
1, the pharmaceutical composition of a kind of prevention or treatment acute and chronic hepatitis; it is characterized in that: it is to be the preparation that raw material is made by containing essential phospholipid EPL and one or more Chinese medicines with hepatoprotective effect, and the described Chinese medicine that protects the liver is one or more mixing in Radix Bupleuri, Radix Glycyrrhizae, Radix Salviae Miltiorrhizae, Radix Notoginseng, Fructus Schisandrae Chinensis, Rhizoma Curcumae Longae, Rhizoma Picrorhizae, Calculus Bovis, Radix Angelicae Sinensis, Herba Patriniae, the Radix Astragali, the Rhizoma Alismatis.
2, the pharmaceutical composition of prevention according to claim 1 or treatment acute and chronic hepatitis, it is characterized in that: described essential phospholipid with the weight proportion that protects the liver Chinese medicine is: essential phospholipid 0.2-10 part protects the liver Chinese medicine 3-90 part.
3, the pharmaceutical composition of prevention according to claim 1 and 2 or treatment acute and chronic hepatitis, it is characterized in that: the Main Ingredients and Appearance of essential phospholipid EPL is a polyene phosphatidylcholine, wherein contain the unsaturated fatty acids acidic group in the polyene phosphatidylcholine, mainly contain linoleic acid in the polyene phosphatidylcholine, percentage by weight is 70%.
4, the pharmaceutical composition of prevention according to claim 1 or treatment acute and chronic hepatitis, it is characterized in that: the Chinese medicine with hepatoprotective effect is Radix Salviae Miltiorrhizae, Radix Glycyrrhizae, Fructus Schisandrae Chinensis, and its weight proportion is:
Radix Salviae Miltiorrhizae 3-60 part, Radix Glycyrrhizae 3-30 part, Fructus Schisandrae Chinensis 3-30 part.
5, the pharmaceutical composition of prevention according to claim 1 or treatment acute and chronic hepatitis, it is characterized in that: the Chinese medicine with hepatoprotective effect is Rhizoma Alismatis, Radix Notoginseng, Rhizoma Curcumae Longae, Radix Salviae Miltiorrhizae, and its weight proportion is:
Rhizoma Alismatis 3-60 part, Radix Notoginseng 3-60 part, Rhizoma Curcumae Longae 3-60 part, Radix Salviae Miltiorrhizae 3-60 part.
6, the pharmaceutical composition of prevention according to claim 1 or treatment acute and chronic hepatitis, it is characterized in that: the Chinese medicine with hepatoprotective effect is Radix Notoginseng, the Radix Astragali, Radix Angelicae Sinensis, Calculus Bovis, and its weight proportion is:
Radix Notoginseng 3-60 part, Radix Astragali 3-60 part, Radix Angelicae Sinensis 3-60 part, Calculus Bovis 3-60 part.
7, according to the pharmaceutical composition of any described prevention of claim 1-6 or treatment acute and chronic hepatitis, it is characterized in that: every 3-90 part protects the liver and also can add in the Chinese medicine by in the vitamin of following weight proportion one or more:
0.006-0.12 part B2, B6,0.000006-0.00012 B12, and the vitamin E of 0.01-0.3 part, the vitamin C of the nicotiamide of 0.03-0.3 part, 0.1-0.5 part.
8, according to any described prevention of claim 1-7 or the treatment acute and chronic hepatitis pharmaceutical composition, it is characterized in that: it be by essential phospholipid and one or more protect the liver Chinese medicine, vitamin is an active ingredient, adds that acceptable accessories or complementary composition are prepared into oral or ejection preparation pharmaceutically.
9, the pharmaceutical composition of prevention according to claim 8 or treatment acute and chronic hepatitis, it is characterized in that: it is to be prepared into pharmaceutically oral or ejection preparation by following various materials of weight proportions:
Essential phospholipid 0.2-10 part, Radix Salviae Miltiorrhizae 3-30 part, Radix Glycyrrhizae 3-15 part, Fructus Schisandrae Chinensis 3-15 part, vitamin C 0.1-0.5 part, vitamin B
120.000006-0.000072 part.
10, the pharmaceutical composition of prevention according to claim 9 or treatment acute and chronic hepatitis, it is characterized in that: it is to be prepared into pharmaceutically oral or ejection preparation by following various materials of weight proportions:
1.2 parts of essential phospholipids, 15 parts of Radix Salviae Miltiorrhizaes, 5 parts in Radix Glycyrrhizae, 5 parts of Fructus Schisandrae Chinensis, 0.18 part of vitamin C, vitamin B
120.000036 part.
The pharmaceutical composition of any 11, according to Claim 8-10 described prevention or treatment acute and chronic hepatitis, it is characterized in that: described preparation is: tablet, hard capsule, soft capsule, oral liquid, drop pill, injection, injectable powder or lyophilized injectable powder.
12, health care and the health food of prevention cholelithiasis recurrence etc. or the purposes in medicine of the described pharmaceutical composition of claim 1 behind preparation treatment acute, chronic hepatitis, abnormal liver function, liver cirrhosis, hepatic coma, fatty liver, hyperlipemia, liver poisoning, cholestasis, radiotherapy syndrome, hepatobiliary surgery.
13, the purposes of the pharmaceutical composition of the described treatment acute and chronic hepatitis of claim 4 in the liver injury medicament due to preparation treatment liver cirrhosis, hepatic fibrosis and the chronic hepatitis.
14, the purposes of the pharmaceutical composition of the described treatment acute and chronic hepatitis of claim 5 in preparation treatment fatty liver, hyperlipidemia.
15, the purposes in the health medicine of the pharmaceutical composition of the described treatment acute and chronic hepatitis of claim 6 behind preparation treatment liver poisoning, hepatobiliary surgery.
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Cited By (6)
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| CN102716378A (en) * | 2012-06-28 | 2012-10-10 | 陈慧婷 | Common peony root Chinese materia medica preparation for treating tympanites and preparation method thereof |
| CN104623048A (en) * | 2014-12-23 | 2015-05-20 | 河南省帝一方生物制药有限公司 | Chinese medicinal compound preparation for protecting liver and removing mildew and preparation method of Chinese medicinal compound preparation |
| CN105560550A (en) * | 2016-01-16 | 2016-05-11 | 山东畜牧兽医职业学院 | Medicine composition for preventing and treating laying hen fatty liver syndrome and preparation method thereof |
| CN105795247A (en) * | 2014-12-29 | 2016-07-27 | 伊启棒（天津）科技发展有限公司 | Health food for improving fatty liver |
| CN105853806A (en) * | 2016-05-27 | 2016-08-17 | 王德欣 | Traditional Chinese medicine for treating cholestatic hepatitis and preparation method thereof |
| WO2020224649A1 (en) * | 2019-05-08 | 2020-11-12 | 中南大学湘雅二医院 | Formulation containing cornus wilsoniana extract and use thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102716378A (en) * | 2012-06-28 | 2012-10-10 | 陈慧婷 | Common peony root Chinese materia medica preparation for treating tympanites and preparation method thereof |
| CN104623048A (en) * | 2014-12-23 | 2015-05-20 | 河南省帝一方生物制药有限公司 | Chinese medicinal compound preparation for protecting liver and removing mildew and preparation method of Chinese medicinal compound preparation |
| CN104623048B (en) * | 2014-12-23 | 2017-05-24 | 河南省帝一方生物制药有限公司 | Chinese medicinal compound preparation for protecting liver and removing mildew and preparation method of Chinese medicinal compound preparation |
| CN105795247A (en) * | 2014-12-29 | 2016-07-27 | 伊启棒（天津）科技发展有限公司 | Health food for improving fatty liver |
| CN105560550A (en) * | 2016-01-16 | 2016-05-11 | 山东畜牧兽医职业学院 | Medicine composition for preventing and treating laying hen fatty liver syndrome and preparation method thereof |
| CN105853806A (en) * | 2016-05-27 | 2016-08-17 | 王德欣 | Traditional Chinese medicine for treating cholestatic hepatitis and preparation method thereof |
| WO2020224649A1 (en) * | 2019-05-08 | 2020-11-12 | 中南大学湘雅二医院 | Formulation containing cornus wilsoniana extract and use thereof |
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| CN100423768C (en) | 2008-10-08 |
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