KR20140135106A - Lipid lowering and liver protecting chinese medical composition and the method thereof - Google Patents

Abstract

The present invention relates to a combination therapy agent composed of a Chinese medical component and medicinal adjurvants. Disclosed are a Chinese medical composition to lower lipid and protect liver, a method to prepare the same, and an application thereof; wherein the composition is characterized by comprising: calculated by weight ratio, 60-120 parts by weight of Panax notoginsengs (Burk), 50-110 parts by weight of Puerariae Radix, and 20-60 parts by weight of Paeonia lactiflora Pallas as a compound of the Chinese medical composition. The advantageous effects of the present invention are as follow: it is possible to prepare an effective pharmaceutical capable of lowering lipids and protecting liver based on traditional Chinese medical theory; and efficacy of the agent of the present invention becomes more significant and the administration is more convenient because it is possible to prepare as an up-to-date formulation such as a capsule through recent pharmaceutical means. Since the present invention shows the lipids lowering and the actions of the liver being protected, the present invention can be used to prevent and treat hyperlipidemia, obesity, viral hepatitis, chemical liver damage, alcoholic liver damage and so forth.

Description

[0001] LIPID LOWERING AND LIVER PROTECTING CHINESE MEDICAL COMPOSITION AND THE METHOD THEREOF [0002]

The present invention relates to a Chinese medicine composition, and more particularly, to a Chinese medicine composition having a function of lowering lipid and protecting liver, a method for producing the same, and an application thereof.

Liver injury can be divided into viral liver damage and chemical liver injury. The former is hepatic inflammation caused by a pathogenic microorganism such as a viral infection, for example, hepatitis A and hepatitis B. The latter includes various toxic substances, For example, alcohol in food, toxic chemicals in the environment, and drugs in seedlings cause damage to the liver. Among them, viral hepatitis is a worldwide epidemic, with the number of patients suffering from hepatitis every year, of which about 200,000 die. The major types of impairment of chemical liver damage (including alcoholic liver damage) include: (1) fatty degeneration. ② Lipid peroxidation, a specific expression pattern of toxic liver injury. ③ Cholestatic reaction is mainly related to excretion disorder of bile acid due to damage of hepatocytes and microvilli. The liver damage caused by both types is one of the diseases that seriously affects the physical and mental health of mankind.

As the national standard of living has improved, the dietary life structure and lifestyle have changed greatly. Experts predict that the obesity population in Korea will exceed 200 million in the next 10 years, and the resulting hyperlipidemia and fatty liver incidence Showing a marked upward trend. Currently, the number of patients with hyperlipidemia in Korea is 90 million.

It is important to research and develop health foods that utilize traditional Chinese medicine resources and use modern biotechnology and pharmaceutical technology to prevent and treat hepatitis and hyperlipidemia suitable for long-term use.

It is an object of the present invention to provide a medicinal herbal composition for preventing hepatitis and hyperlipidemia and having a lipid-lowering soy sauces protection effect.

It is still another object of the present invention to provide a method for preparing the above-described low fat-reducing soy sauce herbal composition.

It is still another object of the present invention to provide an application of the above-described lipid-lowering soy sauce herbal composition for the manufacture of medicines or health foods for the prevention and treatment of hyperlipidemia, obesity, viral hepatitis, chemical liver damage and alcoholic liver damage.

The object of the present invention is embodied as follows: A lipid-lowering soy sauce herbal composition is a combination prescription preparation consisting of a herbal medicine ingredient and a pharmaceutical adjuvant, calculated as a weight fraction, and the combination of the herbal medicine composition is one hundred thirty- (7) 60 to 120 parts, 50 to 110 parts of Puerariae radix, and 20 to 60 parts of a marigold.

Preferably 80 to 100 parts, 70 to 90 parts, and 30 to 50 parts, respectively.

The one hundred and thirty-second is the outpost of white porcelain.

The Puerariae are dry roots of Eagle.

The count is dried roots of peony.

The above-mentioned combination prescription preparation is a capsule, a tablet, a granule, or a solution of the underpants.

The pharmaceutical adjuvant is selected from a mixture of at least one of dextrin, sucrose, lactose, starch, sodium carboxymethyl starch, polyvinyl pyrrolidone, magnesium stearate.

The process for preparing the herbal composition comprises the following steps:

(1) 8 to 12 times of water is added in a hundredths of a second for 1 to 1.5 hours, and then the solution is added to the residue for 5 to 8 hours. After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, the filtrate is concentrated, and the filtrate is concentrated to obtain a one-hundred-thirty-second extract.

(2) 8 to 12 times of water was added to the brow roots calculated as parts by weight, and the mixture was allowed to stand for 1.5 to 2 hours. Then, water was added again to the residue for 5 to 8 times, After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, filtration is performed, and the filtrate is concentrated and dried to obtain Puerariae Radix Extract;

(3) Water is added 8-12 times in water to the counted water, and the water is added again to the residue for 5 to 8 times, and the solution is added for 1 to 1.5 hours before the addition After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, filtration is performed, and the filtrate is concentrated and dried to obtain an extract of the beetle;

(4) combining the above extracts with the above-mentioned three hundred milligrams of extract, Puerariae Radix extract and Marigold extract, mixing the extracts thoroughly to prepare a total extract, adding a medicinal adjuvant to the total extract, and preparing various formulations using a suitable process.

After adding the medicinal supplements to the total extract, they are uniformly mixed to prepare granules, dried and compressed to prepare tablets, or capsules to prepare capsules or granules, respectively, to prepare granules.

It can also be manufactured as an internal solution, and its manufacturing process is as follows:

(1) 8 to 12 times of water is added in a hundredths of a second for 1 to 1.5 hours, and then the solution is added to the residue for 5 to 8 hours. After filtration and concentration, ethanol is added until the alcohol content reaches 70% ~ 90%, and after filtration, the filtrate is concentrated to obtain an extract of 100 times three days.

(2) 8 to 12 times of water was added to the brow roots calculated as parts by weight, and the mixture was allowed to stand for 1.5 to 2 hours. Then, water was added again to the residue for 5 to 8 times, After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, the filtrate is concentrated, and then the filtrate is concentrated to obtain a clarified extract;

(3) Water is added 8-12 times in water to the counted water, and the water is added again to the residue for 5 to 8 times, and the solution is added for 1 to 1.5 hours before the addition After filtration and concentration, ethanol is added until the alcohol content reaches from 70% to 90%, filtration is performed, and the filtrate is concentrated to obtain an extract.

(4) combining the above-mentioned one hundredths of a third of the extract, the Puerariae root extract and the marigold extract, mixing them evenly, and adding the mating agent to obtain the inner solution.

The dosage form of the present invention can be administered clinically in an infertile manner. The dosage varies depending on the formulation. The granules are 12-20 g per day, the tablets are 10-25 tablets per day, the capsules 10-25 times daily, 30 to 50 ml.

The beneficial effect of the present invention is that it can constitute an effective prescription agent capable of lowering lipids and protecting the liver according to the traditional Chinese medicine theory and can also be manufactured in modern formulations such as capsules through modern pharmaceutical means , The effect of the preparation of the present invention is more pronounced and it is more convenient to take. The present invention has lipid lowering and liver protecting action and can be used for prevention and treatment of hyperlipemia, obesity, viral hepatitis, chemical liver damage, alcoholic liver injury and the like.

The present invention relates to a medicinal composition for the prevention of lipid lowering soy sauce, which is a combination prescription preparation made of a medicinal herb ingredient and a medicinal supplement, and the medicinal composition is 60 to 120 parts per 100 parts by weight, , And 20 to 60 parts by weight of the composition.

Preferably, 80 to 100 parts per hundred of milliseconds, 70 to 90 parts of granules, and 30 to 50 parts of marigolds.

)과 식물인 작약 Paeonia lactiflora Pall . 의 건조 뿌리이다.Among them, one hundred and thirteen days is a white flower which is asteraceae, Gynura divaricata (L.) DC. [ G. oualis DC .; G. pseudo -china (L.) DC.], And Pueraria is the dried root of the leguminous Pueraria lobata ( Willd .) Ohwi ,

) And the plant Paeonia lactiflora Pall . Of dry roots.

The pharmaceutical adjuvant is selected from a mixture of at least one of dextrin, sucrose, lactose, starch, sodium carboxymethylstarch, polyvinylpyrrolidone, magnesium stearate. The above-mentioned combination prescription preparation is a capsule, a tablet, a granule, or a solution of the underpants.

The process for preparing the herbal composition comprises the following steps:

(1) 8 to 12 times of water is added in a hundredths of a second for 1 to 1.5 hours, and then the solution is added to the residue for 5 to 8 hours. After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, the filtrate is concentrated, and the filtrate is concentrated to obtain a one-hundred-thirty-second extract.

(2) 8 to 12 times of water was added to the brow roots calculated as parts by weight, and the mixture was allowed to stand for 1.5 to 2 hours. Then, water was added again to the residue for 5 to 8 times, After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, filtration is performed, and the filtrate is concentrated and dried to obtain Puerariae Radix Extract;

(3) Water is added 8-12 times in water to the counted water, and the water is added again to the residue for 5 to 8 times, and the solution is added for 1 to 1.5 hours before the addition After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, filtration is performed, and the filtrate is concentrated and dried to obtain an extract of the beetle;

(4) combining the above extracts with the above-mentioned three hundred milligrams of extract, Puerariae Radix extract and Marigold extract, mixing the extracts thoroughly to prepare a total extract, adding a medicinal adjuvant to the total extract, and preparing various formulations using a suitable process. For example, the medicinal supplements may be added to the total extracts, and they may be uniformly mixed to prepare granules, dried and compressed to prepare tablets, or capsules to prepare capsules or granules, respectively, to prepare granules.

Hereinafter, the production method of the present invention will be described in more detail with reference to Examples, but the practice should not be construed as limiting the scope of the present invention.

Example 1

90 g of pearl beads and 90 g of pearl were added, and 10 times of water was added to the residue for 2 hours, 6 times of water was added to the residue, and the solution was poured for 1.5 hours. Then the extract was combined and filtered to obtain a relative density of 1.10 to 1.12 After concentration, ethanol was added to reach an alcohol content of 85%, and the filtrate was concentrated and dried to obtain a one-third-three-thirds extract. 80 g of crab curd was taken, 10 times of water was added, and 2 hours of bath water was added. Six times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtrated, and concentrated to have a relative density of 1.20 to 1.30 After that, ethanol was added to reach an alcohol content of 90%, and the filtrate was concentrated and dried to obtain a Puerariae Radix extract. 40 g of the extract was taken, 10 times of water was added thereto, and 2 hours of bath water was added. Six times as much water was added to the residue and the solution was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.15 to 1.25 After that, ethanol was added so that the alcohol content reached 80%, and the filtrate was concentrated and dried to obtain an ear-extract. The total extract is prepared by mixing the extracts of 100, 300 and 200 mg, and then adding the appropriate amount of magnesium stearate to the total extract.

Example 2

120 g of the pellet is taken, and 8 times the amount of water is added to the residue for 1 hour, and 8 times of water is added to the residue. After 1.5 hours of bathing, the extract is combined and filtered to obtain a relative density of 1.10 to 1.12 After concentration, ethanol was added to reach an alcohol content of 90%, the mixture was filtered, and the filtrate was concentrated and dried to obtain a one hundredth of a third of the extract. 600 g of crab curd were taken and 12 times of water was added thereto and the mixture was allowed to pass for 1 hour. 8 times as much water was added to the residue, and the mixture was stirred for 1.5 hours. The extract was combined and filtered. Thereafter, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered. The filtrate was concentrated and dried to obtain a Puerariae Radix extract. 20 g of water was added, 12 times of water was added, and 1.5 hours of bath water was added, and 8 times of water was added to the residue. After 1.5 hours of bathing, the extract was combined and then filtered to concentrate the solution to a relative density of 1.10 to 1.20 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated and dried to obtain an ear-extract. The total extract is prepared by mixing the extracts of 100, 300 and 200 mg, and then adding the appropriate amount of magnesium stearate to the total extract.

Example 3

The filtration was performed after adding the extract to the filtrate, and the relative density reached 1.10 to 1.12. The filtrate was then filtered, After concentration, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered, and the filtrate was concentrated and dried to obtain a one hundredth of a third of an extract. 50 g of granular persimmon was taken, 12 times of water was added thereto, and the mixture was transferred for 2 hours. Ten times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.10 to 1.15 Thereafter, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered. The filtrate was concentrated and dried to obtain a Puerariae Radix extract. 60 g of water was added, and 8 times of water was added thereto, and 2 hours of bath water was added, and 6-fold amount of water was added to the residue. After 1.5 hours of bathing, the extract solution was combined and filtered to concentrate the solution to a relative density of 1.10-1.18 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated and dried to obtain an ear-extract. The total extract is prepared by mixing the extracts of 100, 300 and 200 mg, and then adding the appropriate amount of magnesium stearate to the total extract.

Example 4

90 g of pearl beads and 90 g of pearl were added, and 10 times of water was added to the residue for 2 hours, 6 times of water was added to the residue, and the solution was poured for 1.5 hours. Then the extract was combined and filtered to obtain a relative density of 1.10 to 1.12 After concentration, ethanol was added to reach an alcohol content of 85%, and the filtrate was concentrated and dried to obtain a one-third-three-thirds extract. 80 g of crab curd was taken, 10 times of water was added, and 2 hours of bath water was added. Six times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtrated, and concentrated to have a relative density of 1.20 to 1.30 After that, ethanol was added to reach an alcohol content of 90%, and the filtrate was concentrated and dried to obtain a Puerariae Radix extract. 40 g of the extract was taken, 10 times of water was added thereto, and 2 hours of bath water was added. Six times as much water was added to the residue and the solution was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.15 to 1.25 After that, ethanol was added so that the alcohol content reached 80%, and the filtrate was concentrated and dried to obtain an ear-extract. Total extracts were prepared by adding 100% extracts, Puerariae radix extracts, and marigold extracts. The total extracts were mixed with the appropriate amount of magnesium stearate and dextrin and compressed into tablets.

Example 5

120 g of the pellet is taken, and 8 times the amount of water is added to the residue for 1 hour, and 8 times of water is added to the residue. After 1.5 hours of bathing, the extract is combined and filtered to obtain a relative density of 1.10 to 1.12 After concentration, ethanol was added to reach an alcohol content of 90%, the mixture was filtered, and the filtrate was concentrated and dried to obtain a one hundredth of a third of the extract. 600 g of crab curd were taken and 12 times of water was added thereto and the mixture was allowed to pass for 1 hour. 8 times as much water was added to the residue, and the mixture was stirred for 1.5 hours. The extract was combined and filtered. Thereafter, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered. The filtrate was concentrated and dried to obtain a Puerariae Radix extract. 20 g of water was added, 12 times of water was added, and 1.5 hours of bath water was added, and 8 times of water was added to the residue. After 1.5 hours of bathing, the extract was combined and then filtered to concentrate the solution to a relative density of 1.10 to 1.20 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated and dried to obtain an ear-extract. Total extracts were prepared by adding 100% extracts, Puerariae radix extracts, and marigold extracts. The total extracts were mixed with the appropriate amount of magnesium stearate and dextrin and compressed into tablets.

Example 6

The filtration was performed after adding the extract to the filtrate, and the relative density reached 1.10 to 1.12. The filtrate was then filtered, After concentration, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered, and the filtrate was concentrated and dried to obtain a one hundredth of a third of an extract. 50 g of granular persimmon was taken, 12 times of water was added thereto, and the mixture was transferred for 2 hours. Ten times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.10 to 1.15 Thereafter, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered. The filtrate was concentrated and dried to obtain a Puerariae Radix extract. 60 g of water was added, and 8 times of water was added thereto, and 2 hours of bath water was added, and 6-fold amount of water was added to the residue. After 1.5 hours of bathing, the extract solution was combined and filtered to concentrate the solution to a relative density of 1.10-1.18 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated and dried to obtain an ear-extract. Total extracts were prepared by adding 100% extracts, Puerariae radix extracts, and marigold extracts. The total extracts were mixed with the appropriate amount of magnesium stearate and dextrin and compressed into tablets.

Example 7

90 g of pearl beads and 90 g of pearl were added, and 10 times of water was added to the residue for 2 hours, 6 times of water was added to the residue, and the solution was poured for 1.5 hours. Then the extract was combined and filtered to obtain a relative density of 1.10 to 1.12 After concentration, ethanol was added to reach an alcohol content of 85%, and the filtrate was concentrated and dried to obtain a one-third-three-thirds extract. 80 g of crab curd was taken, 10 times of water was added, and 2 hours of bath water was added. Six times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtrated, and concentrated to have a relative density of 1.20 to 1.30 After that, ethanol was added to reach an alcohol content of 90%, and the filtrate was concentrated and dried to obtain a Puerariae Radix extract. 40 g of the extract was taken, 10 times of water was added thereto, and 2 hours of bath water was added. Six times as much water was added to the residue and the solution was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.15 to 1.25 After that, ethanol was added so that the alcohol content reached 80%, and the filtrate was concentrated and dried to obtain an ear-extract. Total extracts were prepared by mixing 100, 300, and 100 g of extracts, and then added with the appropriate amount of dextrin and sucrose. The extracts were dried and compressed to prepare granules.

Example 8

120 g of the pellet is taken, and 8 times the amount of water is added to the residue for 1 hour, and 8 times of water is added to the residue. After 1.5 hours of bathing, the extract is combined and filtered to obtain a relative density of 1.10 to 1.12 After concentration, ethanol was added to reach an alcohol content of 90%, the mixture was filtered, and the filtrate was concentrated and dried to obtain a one hundredth of a third of the extract. 600 g of crab curd were taken and 12 times of water was added thereto and the mixture was allowed to pass for 1 hour. 8 times as much water was added to the residue, and the mixture was stirred for 1.5 hours. The extract was combined and filtered. Thereafter, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered. The filtrate was concentrated and dried to obtain a Puerariae Radix extract. 20 g of water was added, 12 times of water was added, and 1.5 hours of bath water was added, and 8 times of water was added to the residue. After 1.5 hours of bathing, the extract was combined and then filtered to concentrate the solution to a relative density of 1.10 to 1.20 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated and dried to obtain an ear-extract. Total extracts were prepared by mixing 100, 300, and 100 g of extracts, and then added with the appropriate amount of dextrin and sucrose. The extracts were dried and compressed to prepare granules.

Example 9

The filtration was performed after adding the extract to the filtrate, and the relative density reached 1.10 to 1.12. The filtrate was then filtered, After concentration, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered, and the filtrate was concentrated and dried to obtain a one hundredth of a third of an extract. 50 g of granular persimmon was taken, 12 times of water was added thereto, and the mixture was transferred for 2 hours. Ten times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.10 to 1.15 Thereafter, ethanol was added to reach an alcohol content of 80%, and the mixture was filtered. The filtrate was concentrated and dried to obtain a Puerariae Radix extract. 60 g of water was added, and 8 times of water was added thereto, and 2 hours of bath water was added, and 6-fold amount of water was added to the residue. After 1.5 hours of bathing, the extract solution was combined and filtered to concentrate the solution to a relative density of 1.10-1.18 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated and dried to obtain an ear-extract. Total extracts were prepared by mixing 100, 300, and 100 g of extracts, and then added with the appropriate amount of dextrin and sucrose. The extracts were dried and compressed to prepare granules.

Example 10

The filtration was performed after adding the extract to the filtrate, and the relative density reached 1.10 to 1.12. The filtrate was then filtered, After concentration, ethanol was added so that the alcohol content reached 80%, the mixture was filtered, and the filtrate was concentrated to obtain a one-third-three-third extract. 50 g of granular persimmon was taken, 12 times of water was added thereto, and the mixture was transferred for 2 hours. Ten times as much water was added to the residue and the mixture was stirred for 1.5 hours. Then, the extract was combined and filtered to obtain a concentrate having a relative density of 1.10 to 1.15 Thereafter, ethanol was added thereto so that the alcohol content reached 80%, the mixture was filtered, and the filtrate was concentrated to obtain a crude extract. 60 g of water was added, and 8 times of water was added thereto, and 2 hours of bath water was added, and 6-fold amount of water was added to the residue. After 1.5 hours of bathing, the extract solution was combined and filtered to concentrate the solution to a relative density of 1.10-1.18 After that, ethanol was added to reach an alcohol content of 70%, and the filtrate was concentrated to obtain an extract. One hundred milliliters of the extract, the Puerariae root extract and the marigold extract are mixed together and mixed thoroughly to prepare a total extract. The appropriate amount of stevioside is added to make a final solution.

Example 11 < RTI ID = 0.0 >

1. Materials and Methods

Experimental drug: Capsule contents prepared according to Example 1.

Simvastatin Chung, Hangzhou MSD (默沙東) Pharmaceutical Co., Ltd., Lot Number: 110689.

) 2011-0015. 동물은 남방의과대학 동물실험센터에서 제공.Animals: SD rat, SPF, 70, male, body weight 170 ~ 200g. Laboratory animal quality certificate number: 2006A051. SPF class laboratory animal environmental condition certificate number: 2006B023. SPF class laboratory animal production license number: SCXK month (

) 2011-0015. Animals are provided by the Animal Experiment Center of the Southern Medical University.

High fat fat diet: 12% of lard (self-manufactured), 2% of cholesterol (Aladdin Industrial Corporation, Lot No. 1216021), propylthiouracil 0.2% (Guangdong Huannam Pharmaceutical Group Co., Lot No. 120601) % (Guangdong Fangkai Microorganism Industry Co., Ltd., lot number: 3201077), and 85.3% of ordinary mixed feed powder (provided by Southern Animal Medical Center). Each of the above materials is mixed thoroughly by hand, and then agitated using a device and compressed to form circular strip-shaped granules, which are then frozen in a freezer. High fat diets were produced at the experimental animal center of the Southern Medical University.

Major Chemical Reagents and Detectors: Formaldehyde Solution, Analytical Reagent, Lot No. 20111007, Guangdong Guanghua Chemical Co., Ltd.; OLYMPUS BH-2 fluorescence microscope, OLYMPUS production in Japan; BECKMAN ™ 30-type freezing centrifuge manufactured by BACKMAN, USA; LEICA RM2135 type microtome, Germany LEICA production; ECHO LCD Biochemical Analyzer, produced by Elchena, Italy.

급 등급/빈도수 표 자료로 나타내고, spss 8.0 통계 소프트웨어 One-Way ANOVA LSD 또는 DunnettT3 법 및 Nonparametric Test 2 Independent Samples Tests법으로 데이터를 처리하였다.The animals were divided into two groups: normal group, model group, simvastatin group (10mg / kg), high dose group (1.12g / kg), intermediate dose group (0.56g / kg) And low dose group (0.14 g / kg). Ten animals were placed in each group. In addition to the normal control group, the animals in each of the remaining groups were fed with about 20 g per day, on average, by replacing the feed with the above-mentioned high-fat diets. The control group and the control group administered tap water to the gastrointestinal tract, while each other group was administered the gastrointestinal tract once a day in the afternoon, and the gastrointestinal volume was 1 ml / 100 g in the mice. The above animals were administered to the gastrointestinal tract for 21 days continuously from the time of model construction. At the end of the experiment, the last dose was given one time and the food was forbidden for 12 hours, but the water was not forbidden. After the anesthesia the next day, blood was collected from the main artery of the abdomen and sent to the medical examination center of the Southern Medical University. The items were measured. Hepatic tissues were streaked at 1.5 cm from the left lobe of the liver, fixed with neutral formalin, dehydrated by conventional methods, and stained with HE. The experimental data

Data were analyzed using the SPSS 8.0 statistical software One-Way ANOVA LSD or the DunnettT3 method and the Nonparametric Test 2 Independent Samples Tests.

2. Detection result

(1) weight change of a large mouse

See table 1 for changes in body weight of the larger rats.

, N=6)Table 1: Large rat weight change status of each experimental group (

, N = 6)

Note: Compared to the 1. * model control group, P <0.05, ** Compared with the model control group, P <0.01

2. Percentage of weight gain = (22 days weight - first day weight) ÷ first day weight × 100.

As can be seen in Table 1, the weight and weight gain percentage at day 15 and 22 of the larger rats was significantly lower (P <0.05, P <0.01, P <0.01) There was no significant difference between the other experimental groups and the model group.

(2) Feed consumption

See table 2 for feed consumption of large rats.

Table 2: Large rat feed consumption in each experimental group

As can be seen in Table 2, the average consumption of feed per average rat is relatively similar. In the normal group, the amount of feed consumed in 1 g of body weight was the lowest. There was no significant difference in each of the other experimental groups compared to the model group.

(3) blood lipid detection results

See Table 3 for results of blood lipid detection in large rats.

)Table 3: Results of detection of large rat blood lipids in each experimental group (

)

Note: Compared to the 1. * model control group, P <0.05, ** Compared with the model control group, P <0.01

2. H / T ratio = high density lipoprotein cholesterol / total cholesterol × 100%

3. Total cholesterol = high density lipoprotein (cholesterol) + low density lipoprotein + extremely low density lipoprotein

As shown in Table 3, serum total cholesterol and low density lipoprotein cholesterol were significantly elevated (P <0.01) and the H / T ratio was significantly decreased (P <0.01) in the model group as compared with the normal group. Compared with the model group, in the case of serum triglyceride, the simvastatin group significantly decreased (P <0.05, P <0.05, P <0.05, P <0.01) Serum total cholesterol of each dosage group was lowered to a certain extent, but there was no significant difference.

(4) Hepatic pathologic examination

Refer to Table 4 for results of hepatic pathology.

Table 4: Results of large mouse hepatopathological examination of each experimental group

Note: Liver change (1): + indicates that the liver lobular structure is still present, the liver tissue structure is normal, some hepatocyte color arrangement is disordered, the capillary blood vessels of the liver are narrowed, , With mild vacuole denaturation and balloon metaplasia; ++ has an unusual lobular structure, a loss of some hepatocyte color structures, a disorder in the arrangement of the hepatocytes, edema in most of the hepatocytes, balloon metamorphosis and panic metamorphosis, and in some animals hepatocellular pigmentation and localized necrosis , Indicating that there is a small amount of inflammatory cell infiltration in the portal area; +++ indicates that the outline of the hepatic lobule is lost, the shape of the hepatocytes is irregular, the hepatocytes of the absolute part are swollen, the balloon is denatured, some of the hepatocytes are denudated with fear, and some animals have hepatocyte spot or necrosis And the presence of inflammatory cell infiltration in the context area.

As can be seen in Table 4, compared with the normal group, liver fat degeneration in the model mice was very severe (P <0.01), and compared to the model group, (P = 0.075), which was consistent with the observation of liver in general.

3. Experimental Conclusion:

In the model group, the body weight was clearly decreased, the serum total cholesterol and low density lipoprotein cholesterol were significantly increased, the H / T ratio was significantly lowered, and the hepatocyte expanded remarkably (fat degeneration).

Compared with the model group, the high-dose, medium-dose, and low-dose groups significantly lowered the serum triglycerides of the large rats, and each dose group had a function to lower the serum total cholesterol of the mice to a certain extent, There was no significant difference.

Compared with the model group, each dose group alleviated liver fat degeneration in a somewhat larger rat, and the effect of the low dose group was most pronounced.

Example 12 Study of Liver Protection &lt; RTI ID = 0.0 &gt;

1. Materials and Methods

(1) Experimental drug: Capsule contents prepared in accordance with Example 1, Bifendate Pills, Gwangju Singhong (Pharmaceutical) Co., Ltd., Lot No .: JF40021.

) 2011-0015. 동물은 남방의과대학 동물실험센터에서 제공.(2) Animals NIH small rat, SPF, 110 rats, male, body weight 18-22 g. Laboratory animal quality certificate number: 2006A051. SPF class laboratory animal environmental condition certificate number: 2006B023. SPF class laboratory animal production license number: SCXK month (

) 2011-0015. Animals are provided by the Animal Experiment Center of the Southern Medical University.

(3) Major chemical reagents and measuring instrument: ALT assay reagent kit, Zhongshan Bean Bean Co., Ltd., lot number: 121881; Aspartic acid amino acid transport enzyme (AST) assay reagent kit, Zhongshan Bean Bean (Zhongshan Northwest) Qingdao Co., Ltd., Lot number: 120921; Carbon tetrachloride solution, analytical reagent, Tianjin Pining refinement, Lot No.: 111010; Formaldehyde solution, Analytical reagent, Lot No. 20111007, Guangdong Guanghua Chemical Co., Ltd.; Anhydrous ethanol, analytical reagent, lot number 20110416, Tianjin Xinfeng Chemical Co., Ltd.; Dimethylbenzene, Analytical Reagent, Lot No 20101224, Guangdong Guanghua Chemical Industry Co., Ltd.; Hematoxylin, biotite, lot No. 060408, Beijing Dingguo Biological Technology Co., Ltd. Fluka import separation packaging; eosin-Y, biotite, lot No. 20050912, China East China Normal University chemical window; ECHO LCD Biochemical Analyzer is produced in Elchena, Italy. OLYMPUS AU5421 type automatic biochemical analyzer, OLYMPUS production in Japan; OLYMPUS BH-2 fluorescence microscope, OLYMPUS production in Japan; BECKMAN ™ 30-type freezing centrifuge manufactured by BACKMAN, USA; LEICA RM2135 type microtome, Germany LEICA production; SARTORIUS electronic balance, produced by SARTORIUS Germany.

(4) Experimental Method and Drug Quantity: Animals were divided into two groups: normal control group, model group, biphenate group (0.2 g / kg), high dose group (1.56 g / (0.39 g / kg), and 12 animals were placed per group. Gastrointestinal tract was administered once daily for 7 consecutive days. Normal control group and model group received the same volume of tap water in the gastrointestinal tract. The gastrointestinal administration volume was 0.25 ml / 10 g in a small mouse and fed freely. One hour after administration of the last gastrointestinal tract, 0.2 ml / mouse of 0.12% (by volume) carbon tetrachloride (prepared with purified peanut oil) was intraperitoneally injected. Food was banned but water was not forbidden. After 16 hours, eyeballs were extracted and blood was collected. Serum was centrifuged to detect alanine amino transferase and aspartate amino transferase.

(5) Pathological examination

Left hepatic lobes were fixed with neutral formalin, dehydrated by conventional methods, stained with paraffin embedded sections (4 microns) with HE, and pathological changes in liver tissues were observed under an optical microscope. Levels of hepatic tissue damage were classified as grade (1): grade 0 (-) in the absence of significant denaturation, necrosis and inflammatory cell infiltration with normal liver tissue structure; Ⅰ (+) indicates that the hepatic lobular structure is still normal, some hepatocytes show cloudy edema, balloon metamorphosis or fat metamorphosis, and sporadic necrosis; Class Ⅱ (++) is characterized by ambiguous liver lobular structure, distinct localized necrosis, accompanied by inflammatory cell infiltration; Class Ⅲ (+++) was classified as a state in which hepatic lobular structure was ambiguous, distinct necrosis was seen, and inflammatory cell infiltration was involved.

및 등급/빈도수 표 자료로 나타내고, spss 8.0 통계 소프트웨어 One-Way ANOVA LSD 또는 DunnettT3 법 및 Nonparametric Test 2 Independent Samples Tests법으로 데이터를 처리하였다.(6) The experimental data

Data were analyzed using the SPSS 8.0 statistical software One-Way ANOVA LSD or the DunnettT3 method and the Nonparametric Test 2 Independent Samples Tests.

2. Detection result

(1) weight change of small rats

See table 5 for changes in weight in small rats. As shown in Table 5, there was no significant difference in the weight of the small rats in each group.

, N=12)Table 5: Weight change events of small rats in each experimental group (

, N = 12)

(2) Liver function detection result

The results of the detection of serum alanine amino transferase and aspartate amino transferase in small rats are shown in Table 6.

, N=12)Table 6: Results of detection of alanine aminotransferase and aspartic acid amino group transferase in each experimental group (

, N = 12)

Note: Compared to the 1. * model control group, P <0.05, ** Compared with the model control group, P <0.01

As shown in Table 6, serum alanine and aspartic acid amino acid transport enzymes were significantly elevated in the model group (P <0.01) compared with the normal group, and the serum alanine amino group transferase of the biphenate group was clearly decreased (P <0.01). All of the serum alanine and aspartic acid amino acid transporter enzymes in the high dose group were significantly lowered (P <0.05), and the intermediate and low dose groups had a certain enzyme degrading action but no statistical significance due to the heterogeneity of the dispersion. There was no significant difference between the dosing groups compared to the model group.

(3) Effects of acute liver injury on liver histopathologic damage in small rats

Pathological sections showed normal hepatocyte structure in the normal control group, hepatocytes were radially arranged around the central vein, hepatocyte color, hepatic capillary arrangement, and hepatic lobular structure were complete , Mild swelling in hepatocytes of some animals, and necrosis of the stomach. The small rats of the CC14 model group showed that most of the hepatocytes showed swollen edema with ring central vein distribution, cytoplasmic swelling, and some showed balloon metaplasia. Hepatic cells distributed in the hepatic lobule central vein and hepatic capsule showed parenchyma, localized or necrotic necrosis, and accompanied by pathologic changes such as inflammatory cell infiltration. The biphenate group and the high dose group showed a significant reduction in hepatocyte necrosis (P <0.05). This indicates that the high dose group has a protective effect against liver injury due to CC14 intraperitoneal injection, and the results of the pathological examination are shown in Table 7.

Table 7: Effects of CC14 on acute liver injury histopathology in small mice in each experimental group

Note: P is the result of comparing each group to the model group.

3. Experimental Conclusion:

In this experiment, it was found that in the case of acute liver injury caused by CCl4 in small rats, the high dose group had a remarkable inhibitory action. Serum alanine, and aspartic acid amino group transferase, hepatocyte denaturation and necrosis. In the intermediate and low dose groups, there was a certain enzymatic degradation liver protection function.

Claims (10)

A medicinal herbal composition for lowering hepatic degrade as a combined prescription preparation comprising a medicinal ingredient and a medicinal adjuvant,
Wherein the composition of the Chinese herbal composition comprises 60 to 120 parts of Baekdongsan-7, 50 to 110 parts of Puerariae radix, and 20 to 60 parts of the herbal composition. The method according to claim 1,
Wherein the composition of the Chinese medicine composition is 80-100 parts per hundreds of days, 70-90 parts of Puerariae radix, and 30-50 parts of a marigold. 3. The method according to claim 1 or 2,
Wherein said one hundred and thirty-second is the outpour of white porcelain. 3. The method according to claim 1 or 2,
Wherein the granulocyte is a dry root of an eggplant. 3. The method according to claim 1 or 2,
The herbal composition as claimed in claim 1, wherein the extract is a dry root of peony root. 3. The method according to claim 1 or 2,
Wherein the combined prescription preparation is a capsule, a tablet, a granule, or a liquid preparation. 3. The method according to claim 1 or 2,
Wherein the pharmaceutical adjuvant is selected from a mixture of at least one of dextrin, sucrose, lactose, starch, sodium carboxymethyl starch, polyvinyl pyrrolidone, and magnesium stearate. The method for producing a low fat liver protective cold medicine composition according to claim 1 or 2,
(1) 8 to 12 times of water is added in a hundredths of a second for 1 to 1.5 hours, and then the solution is added to the residue for 5 to 8 hours. After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, the filtrate is concentrated, and the filtrate is concentrated to obtain a one-hundred-thirty-second extract.
(2) 8 to 12 times of water was added to the brow roots calculated as parts by weight, and the mixture was allowed to stand for 1.5 to 2 hours. Then, water was added again to the residue for 5 to 8 times, After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, filtration is performed, and the filtrate is concentrated and dried to obtain Puerariae Radix Extract;
(3) Water is added 8-12 times in water to the counted water, and the water is added again to the residue for 5 to 8 times, and the solution is added for 1 to 1.5 hours before the addition After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, filtration is performed, and the filtrate is concentrated and dried to obtain an extract of the beetle;
(4) preparing a total extract by mixing the above-mentioned one hundred milliliters of the extract, the Puerariae Radix extract and the marigold extract, adding the medicinal adjuvant to the total extract, and preparing the various extracts by a suitable process Wherein said lipid-lowering soy sauce herbal composition is a soy sauce. The method for producing a low fat liver protective cold medicine composition according to claim 1 or 2,
(1) 8 to 12 times of water is added in a hundredths of a second for 1 to 1.5 hours, and then the solution is added to the residue for 5 to 8 hours. After filtration and concentration, ethanol is added until the alcohol content reaches 70% ~ 90%, and after filtration, the filtrate is concentrated to obtain an extract of 100 times three days.
(2) 8 to 12 times of water was added to the brow roots calculated as parts by weight, and the mixture was allowed to stand for 1.5 to 2 hours. Then, water was added again to the residue for 5 to 8 times, After filtration and concentration, ethanol is added until the alcohol content reaches 70% to 90%, the filtrate is concentrated, and then the filtrate is concentrated to obtain a clarified extract;
(3) Water is added 8-12 times in water to the counted water, and the water is added again to the residue for 5 to 8 times, and the solution is added for 1 to 1.5 hours before the addition After filtration and concentration, ethanol is added until the alcohol content reaches from 70% to 90%, filtration is performed, and the filtrate is concentrated to obtain an extract.
(4) A method for producing a liver oil-reduced soy sauce herbal composition, which comprises combining the above-mentioned one hundred milliliters of the extract, the extract of Puerariae radix, and the extract of the marigold, and then mixing the mixture well and adding a mating agent to obtain a solution. An application of the pharmaceutical composition of claim 1 or 2 in the manufacture of a health food for the prevention and treatment of hyperlipidemia, obesity, viral hepatitis, chemical liver damage, alcoholic liver damage, and the like.