CN106109873A

CN106109873A - Liver-protecting combination is used for the application preventing or treating in the medicine of fatty liver in preparation

Info

Publication number: CN106109873A
Application number: CN201610667874.1A
Authority: CN
Inventors: 不公告发明人
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-07-22
Filing date: 2016-07-22
Publication date: 2016-11-16
Also published as: CN106138653A; CN106038951A; CN105998578A

Abstract

nullThe invention discloses a kind of liver-protecting combination in preparation for preventing or treating the application in the medicine of fatty liver，Belong to medicines and health protection field，This is combined as being made up of following components in parts by weight: puerarin 20 45 parts、Bulbus Allii extract 50 70 parts、Soybean isoflavone 5 10 parts，Also include the adjuvant for preparing tablet，The HUAGAN JIAONANG of the present invention reaches 100% for the effective percentage of alcoholic fatty liver，Effective percentage for obese fatty liver reaches more than 95%，Simultaneously，Notable for the II phase fatty liver effect with inflammation，Effective percentage can reach more than 92%，Simultaneously，Gastrointestinal zest is reduced，Pay a return visit after taking 2 months，There is the ratio near less than 5% of gastrointestinal side effect，Also other side effect are had no，Can be as liver-protecting medicine or health product long-term taking，And can effectively assist the treatment of the most serious II type even III type fatty liver.

Description

Liver-protecting combination is used for the application preventing or treating in the medicine of fatty liver in preparation

The application is Chinese patent: application number 2016105784565；Denomination of invention: a kind of compositions for hepatoprotective；Shen Please the divisional application of day: 2016.07.22.

Technical field

The present invention relates to medicines and health protection field, particularly relate to a kind of compositions for hepatoprotective.

Background technology

In the disease of hepar damnification, fatty liver is the second largest disease being only second to viral hepatitis, along with sending out of society Exhibition and growth in the living standard, the sickness rate of fatty liver is more and more higher.For the classification of fatty liver, the most multiple most common master If obese fatty liver, alcoholic fatty liver and diabetic fatty liver.

In order to prevent or treat above-mentioned fatty liver, those skilled in the art have carried out a lot of effort, and achieve certain Progress.Such as liver-protecting tablet, glucuronolatone etc. are widely applied for a long time.The most such as, publication No. is the Chinese special of 102106876A Profit application, discloses a kind of antialcoholism capsule containing Fructose Diphosphate sodium, puerarin and Ganoderma spore powder with cellular wall broken, this glue that relieves the effect of alcohol There is cost of material height, complicated process of preparation and the problem of less effective in capsule.During the most such as publication No. is CN101874857A State's patent application, discloses a kind of liver-protecting white spirit containing Radix Puerariae, Fructus Lycii, Fructus Crataegi and Fructus Chaenomelis, and this liver-protecting white spirit exists raw material The more more complicated and problem of less effective.In addition, also has a lot of combination using Radix Puerariae or puerarin to carry out compatibility The report of thing, they also tend to exist, and raw material is more, be difficult to acquisition, the asking of complex manufacturing technology, relatively costly, less effective Topic.Owing to all of medicine is as ethanol, it is typically necessary and carries out metabolism through liver, if composition is the most complicated, on the contrary The burden of liver can be increased so that the effect of relieving alcoholism and protecting the liver is had a greatly reduced quality, and the most multicomponent pharmacology is the clearest, especially Interacting after compatibility is the most indefinite for healthy impact, there is potential danger.

The Chinese Patent Application No. 201310157072.2 of present inventor, patent name one relieving alcoholism and protecting the liver combine Thing and application thereof, disclose the compositions using puerarin and Bulbus Allii as relieving alcoholism and protecting the liver, and said composition is only for Alcoholic fat Fat liver effect is notable, and the effect for obese fatty liver is the most notable；And, said composition is not for accompanying I phase fat of inflammation Fat liver effect is notable, but for the II phase fatty liver with inflammation, effect is not notable, it addition, long-term taking, to gastrointestinal tract also Producing certain zest, after taking 1 month, the patient feedback that there are about 20% has gastrointestinal side effect.

Summary of the invention

One of goal of the invention of the present invention, is to provide the compositions for hepatoprotective of a kind of improvement, to solve above-mentioned depositing Problem.

The technical solution used in the present invention is such that a kind of compositions for hepatoprotective, by following components in parts by weight Composition:

Puerarin 20-45 part

Bulbus Allii extract 50-70 part

Soybean isoflavone 5-10 part.

Above-mentioned weight ratio is dry weight, and in each component, biodiversity content is below 1%.

Radix Puerariae (Radix Puerariae) is legume pueraria lobata, for the plant of a kind of common medicine-food two-purpose.Modern medicine Pharmacological research shows, Radix Puerariae has the hepatocellular regeneration capacity of raising, recovers normal liver function, promotes bile secretion, prevents Fat is piled up at liver, and can enhance metabolism, and strengthens liver detoxification function, prevents the ethanol effect to the damage of liver, Flavones ingredient puerarin (puerarin) therein has played Main Function especially, and then people are applied to relieving alcoholism and protecting the liver Medicine or health product, but its less effective, particularly with fatty liver；

Bulbus Allii (Allium sativum L) is Liliaceae allium, its underground bulb conventional.Garlicin therein has had Report can be used for relieving the effect of alcohol, but its effect needs to be improved further, and similarly for the less effective of fatty liver；

Soybean isoflavone (CatheRine Genistein), is the class secondary metabolite formed in Semen sojae atricolor growth, delays female Property old and feeble, improve menopause syndrome, osteoporosis, blood fat rising, breast carcinoma, carcinoma of prostate, heart disease, osteoporosis, cardiovascular Disease etc..Person horizontal for high estrogen, shows as antihormonal activity, can prevent and treat mammary gland, endometrium, colon, prostate, The growth of the cancerous cell such as lung, skin and leukemia, and other cardiovascular disease.The preferred Semen sojae atricolor of soybean isoflavone of the present invention (Glycinemax(L.) merr) in soybean isoflavone, from Semen sojae atricolor extract soybean isoflavone be known in the art technology；

Inventor is found by great many of experiments: on the basis of puerarin and Bulbus Allii, adds appropriate soybean isoflavone, can improve Only contain only the compositions of puerarin and Bulbus Allii for obese fatty liver and with the II phase fatty liver less effective of inflammation Situation, three constituents are mutually coordinated, create beyond thought effect.

As preferred technical scheme, it is made up of following components in parts by weight

Puerarin 20-45 part

Bulbus Allii extract 50-70 part

Soybean isoflavone 5-10 part

Vitamin C 2-5 part.

Vitamin C, is also called ascorbic acid, is formed for antibody and collagen, and tissue repairing (includes that some oxidoreduction is made With), phenylalanine, tyrosine, the metabolism of folic acid, ferrum, the utilization of carbohydrate, fat, the synthesis of protein, maintain immunity Function, hydroxylation and hydroxytryptamine, keep the complete of blood vessel, promote that the institutes such as nonheme iron absorption are required, vitamin C is also equipped with simultaneously There are antioxidation, free radical resisting, the formation of suppression tryrosinase, thus reach whitening, effect of light speckle.

Adding appropriate vitamin C on the basis of aforementioned three constituents, its effect further enhances, and side effect simultaneously is entered One step reduces.

As preferred technical scheme, described Bulbus Allii extract is Bulbus Allii ethanol-water solution extract.

Further study showed that: raw material Bulbus Allii is extracted by ethanol-water solution, other useless one-tenth in removing Bulbus Allii Point, refined effective ingredient therein so that hepatoprotective effect more precisely, also further mitigates the metabolism burden of liver, enhances The metabolic function of liver.

Extracting method is: after being smashed to pieces by Bulbus Allii, adds aquiferous ethanol and soaks, and can be aided with ultrasonic acceleration and extract, simultaneously Can be aided with heating, but heating-up temperature should not be higher than 60 DEG C, in order to improve extraction efficiency, extraction time can control at 2 hours, Then filter, concentrate, be dried, to obtain final product.

As preferred technical scheme: described ethanol-water solution is percent by volume ethanol: water=60%-65%:35%- 40%。

The application, on the basis of patent before, further improves and extracts the concentration of alcohol of effective ingredient in Bulbus Allii, make While hepatoprotective effect further enhances, reduce further side effect.

The two of the purpose of the present invention, are to provide a kind of combinations of the above thing to cause for preventing or treating ethanol in preparation Hepatic injury medicine in application.

The three of the purpose of the present invention, are to provide a kind of combinations of the above thing in preparation for preventing or treating fatty liver Application in medicine.

As preferred technical scheme: add pharmaceutically acceptable adjuvant and make capsule.

As preferred technical scheme: add pharmaceutically acceptable adjuvant and make tablet.

In sum, owing to have employed technique scheme, the invention has the beneficial effects as follows: the compositions of the present invention for The effective percentage of alcoholic fatty liver reaches 100%, and the effective percentage for obese fatty liver reaches more than 95%, simultaneously for companion The II phase fatty liver effect having inflammation is notable, and effective percentage can reach more than 92%, reduces simultaneously for gastrointestinal zest, Pay a return visit after taking 2 months, the ratio near less than 5% of gastrointestinal side effect occurs, also has no other side effect, can conduct Liver-protecting medicine or health product long-term taking, it is possible to controlling of the II type even III type fatty liver that effectively auxiliary is the most serious Treat.

Detailed description of the invention

Below in conjunction with embodiment, the present invention is described in detail.

In order to make the purpose of the present invention, technical scheme and advantage clearer, below in conjunction with embodiment, to the present invention It is further elaborated.Should be appreciated that specific embodiment described herein, only in order to explain the present invention, is not used to Limit the present invention.

Embodiment 1:

A kind of compositions for hepatoprotective, is made up of the component of following weight:

Puerarin 20g

Bulbus Allii extracts 70g

Soybean isoflavone 10g

After above-mentioned composition mix homogeneously, make capsule 100.

Wherein, the preparation method of Bulbus Allii extract is: after being smashed to pieces by Bulbus Allii, adds aquiferous ethanol (ethanol and the volume of water Ratio is 65:35) soak, and it is aided with ultrasonic acceleration extraction, and it is aided with 50 DEG C of heating, extraction time controls at 2 hours, then Filter, concentrate, vacuum drying, to obtain final product.

Vitamin C 2-5 part.

Embodiment 2:

Puerarin 45g

Bulbus Allii extracts 50g

Soybean isoflavone 5g

After above-mentioned composition mix homogeneously, make capsule 100.

Wherein, the preparation method of Bulbus Allii extract is: after being smashed to pieces by Bulbus Allii, adds aquiferous ethanol (ethanol and the volume of water Ratio is 60:40) soak, and it is aided with ultrasonic acceleration extraction, and it is aided with 50 DEG C of heating, extraction time controls at 2 hours, then Filter, concentrate, vacuum drying, to obtain final product.

Embodiment 3:

Puerarin 30g

Bulbus Allii extracts 62g

Soybean isoflavone 8g

After above-mentioned composition mix homogeneously, make capsule 100.

Embodiment 4:

Puerarin 30g

Bulbus Allii extracts 62g

Soybean isoflavone 8g

Vitamin C 3g

After above-mentioned composition mix homogeneously, make capsule 100.

Embodiment 5 mice relieving alcoholic intoxication is tested

This test still uses the embodiment 1 of the embodiment part of the Chinese patent application of Publication No. 102727571A to record Test method, wherein

Test specimen includes: experimental group 1-4(is respectively the relieving alcoholism and protecting the liver compositions obtained by the embodiment of the present application 1-4)；Test (wherein " matched group 1 " is the combination obtained by Chinese patent embodiment 6 of Chinese Patent Application No. 201310157072.2 in comparison Thing, " matched group 2 " is the Medicament for Alcoholism comprising only soybean isoflavone, and " matched group 3 " is for comprising only vitamin C)；

Subjects: the Red Star strong, colourless liquor distilled from sorghum of 56 °, Hongxing Co., Ltd. Beijing；SPF level male mice 210, body weight 20 ± 2g；

Test method: (1-4 group difference compositions obtained by gavage the embodiment of the present application 1-4, the 5th group is to be randomly divided into 7 groups Aforesaid " matched group 1 ", the 6th group is aforesaid " matched group 2 ", and the 7th group is aforesaid " matched group 3 ") often organize 30, every is little The groundwater increment of Mus test specimen is 0.2mg/10g body weight by dry weight, and remaining is special with the China of Publication No. 102727571A The test method that the embodiment 1 of the embodiment part of profit application is recorded is the same, the tolerance time that obtains and holding time as in table 1 Shown in:

Table 1 mice relieving alcoholic intoxication result of the test: (unit of time is min)

Group	Tolerance time	Hold time	Group	Tolerance time	Hold time
						1	72.9±21.2	162.0±22.0	5	71.1±19.1	165.9±22.3
2	73.4±21.5	161.5±21.9	6	21.3±9.3	339.2±60.7
						3	79.2±22.9	159.3±23.2	7	16.9±9.1	351.5±69.7
4	79.3±22.9	159.7±23.1

As it can be seen from table 1 the compositions that the application prepares, there is excellent dispelling effects of alcohol.

The loss test of embodiment 6 anti-acute alcohol liver

Test specimen is as the above embodiments 5, and subjects is SPF level male alcoholic hepatic injury mice 210, body weight 20 ± 2g, is randomly divided into 7 groups, and wherein 1-4 group is administered the compositions of the embodiment of the present application 1-4 respectively, and the 5th group is aforesaid " right According to group 1 ", the 6th group is aforesaid " matched group 2 ", and the 7th group is aforesaid " matched group 3 ") often organize 30, every mouse test sample The groundwater increment of product is 0.2mg/10g body weight by dry weight, and remaining test method is special with the China of Publication No. 102727571A The test method that the embodiment 3 of the embodiment part of profit application is recorded is consistent, and testing program difference therein is: every little The dosage of Mus test specimen every day all by the standard of 600mg/kg bw, mice serum ALT, the AST finally recorded activity, CHOL and TG content is as shown in table 2, and in the murine liver tissue recorded, SOD, GSH activity and MDA content are as shown in table 3；

Table 2 mice serum ALT, AST activity, CHOL and TG content, wherein CHOL unit is (mg/dL), and TG unit is (mmol/ L)

Group

AST/ALT

CHOL

TG

Group

AST/ALT

CHOL

TG

1

2.70±0.32

1.82±0.27

0.692±0.12

5

2.71±0.33

1.85±0.27

0.62±0.15

2

2.69±0.35

1.81±0.26

0.61±0.12

6

3.51±0.45

2.61±0.39

0.99±0.65

3

2.63±0.25

1.79±0.26

0.60±0.11

7

3.65±0.55

2.79±0.47

1.23±0.72

4

2.63±0.24

1.79±0.25

0.59±0.11

SOD, GSH activity and MDA content in table 3 murine liver tissue, wherein SOD unit is (U/mg pro), and GSH unit is (mg/g pro), MDA unit is (n mol/mg pro)

Group

SOD

GSH

MDA

Group

SOD

GSH

MDA

1

170.8±18.3

313.3±45.7

9.2±2.1

5

176.8±16.5

308.2±45.9

9.8±1.9

2

175.6±17.1

311.5±45.9

9.1±2.1

6

136.2±25.3

232.2±47.2

17.3±2.5

3

185.9±18.1

327.8±45.9

8.7±1.8

7

132.5±24.3

229.6±68.7

19.1±6.5

4

186.8±17.1

329.2±46.6

8.9±1.8

From table 2, table 3 it can be seen that the compositions for preparing of the application, the effect in terms of hepatoprotective, it is markedly improved.

Embodiment 7 is for the clinical trial of obese type fatty liver

Choose 150 volunteers, these 150 through clinical examination, intrahepatic fat weight is between the 8%-10% of liver weight, and body Weight average exceeds standard about 20%, is randomly divided into 3 groups, often organizes 50 people and take the embodiment of the present invention 3, embodiment 4 and Chinese patent Shen respectively Please numbers 201310157072.2 the compositions (" contrast groups ") of Chinese patent embodiment 6, Time of Administration is 2 months, then examines Looking into, intrahepatic fat content reduces by more than 1% for " effective ", intrahepatic fat content but be higher than 5% within being down to 5% is " effectively ", its system Meter the results are shown in Table 4

Table 4 is for the clinical test results (unit: people) of obese type fatty liver

Group	Effective	Effectively
			Embodiment 3	32	18
Embodiment 4	35	15
			Contrast groups	9	23

Embodiment 8 is for the clinical trial of the II phase fatty liver with inflammation

Choose 150 volunteers, these 150 through clinical examination, with II phase fatty liver of inflammation, all different journey of its transaminase Degree raises, and intrahepatic fat weight is between the 8%-10% of liver weight, is randomly divided into 3 groups, often organizes 50 people and takes the present invention respectively in fact Execute the compositions (" contrast of the Chinese patent embodiment 6 of example 3, embodiment 4 and Chinese Patent Application No. 201310157072.2 Group "), Time of Administration is 2 months, then checks, within intrahepatic fat content near 5% and transaminase becomes normal for " aobvious Effect ", intrahepatic fat content reduce by more than 1% but higher than 5% and transaminase be reduced to " effectively " in various degree, its statistical result is shown in Table 4

Group	Effective	Effectively
			Embodiment 3	27	23
Embodiment 4	29	21
			Contrast groups	6	21

The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all essences in the present invention Any amendment, equivalent and the improvement etc. made within god and principle, should be included within the scope of the present invention.

Claims

1. a liver-protecting combination is preparing the application being used for preventing or treat in the medicine of fatty liver, it is characterised in that described Compositions is made up of following components in parts by weight:

Puerarin 20-45 part

Bulbus Allii extract 50-70 part

Soybean isoflavone 5-10 part.

Application the most according to claim 1, it is characterised in that also include

Vitamin C 2-5 part.