CN1562100A - Medicine for treating alcohol liver damage and its preparing method - Google Patents

Abstract

A Chinese medicine for treating alcoholic liver injury is prepared from 8 Chinese-medicinal materials including pueraria flower, bitter pattra fruit, ginseng, tangerine peel, etc through extracting, spray drying, granulating, and loading in capsules.

Description

Medicine of treatment alcoholic liver injury and preparation method thereof

Technical field

The present invention relates to a kind of medicine for the treatment of alcoholic liver injury, belong to the field of Chinese medicines.

The invention still further relates to the preparation method of this medicine.

Background technology

Excessive consumption of alcohol is important social problem in world today's scope, has a strong impact on people's physical and mental health, and very big to social danger, and long-term heavy drinking can cause alcoholic liver disease, even develops into liver cirrhosis.Therefore seek and find that the medicine meaning of treatment alcoholic liver injury is very great.At present alcoholic liver injury be there is no specific drug, some has certain infringement to the effective Western medicine of fatty liver itself to liver, and popular just Antialcoholic liver-protecting class health product can not play effective therapeutical effect on the market.

Summary of the invention

Purpose of the present invention just for the shortcoming of the existence that overcomes above-mentioned prior art with not enough, and provide a kind of and with the Chinese herbal medicine be that raw material has in the fill temperature, the medicine of the treatment alcoholic liver injury of spleen invigorating, dampness removing, thereby can effectively prevent the excessive consumption of alcohol liver injury.

The present invention also provides the preparation method of this medicine.

The objective of the invention is to realize by following technical proposal:

The medicine of treatment alcoholic liver injury is characterized in that it is made by following raw materials by weight proportions:

10～14 parts of 10～14 portions of Herba Pogostemoniss of 10～14 portions of Fructus Amomi Rotunduss of 10～14 parts of Semen Hoveniae (Fructus Hoveniae)s of Flos puerariae lobatae

3～7 parts of 3～7 portions of Polyporus of 3～7 parts of Pericarpium Citri Reticulataes of 3～7 parts of Rhizoma Atractylodis Macrocephalae (parched)s of Radix Ginseng.

The preparation method of medicine of treatment alcoholic liver injury is characterized in that it is undertaken by following step:

A), with respectively 10～14 parts of Flos puerariae lobatae, Fructus Amomi Rotundus, Herba Pogostemoniss, after Radix Ginseng, Rhizoma Atractylodis Macrocephalae (parched), each 3～7 parts of merging of Pericarpium Citri Reticulatae, 55～60% concentration ethanol that add 8～10 times of volumes of said medicine weight are carried out three medicinal liquids of normal reflux extraction, each 1～2 hour, filter and remove residue, merging filtrate, decompression recycling ethanol, filtrate are through the centrifugal 15min of 2500rpm, and supernatant is by D-101 type macroporous resin, be washed to the eluent colorless and odorless and abandon it, the reuse ethanol gradient elution is colourless to eluent, merges eluent, is evaporated to relative density, 60 ℃ is 1.1～1.15g/ml

B) 10～14 parts of Semen Hoveniae (Fructus Hoveniae)s are smashed to pieces the back and mixed for 3～7 parts with Polyporus, added 8～10 times of water logging bubbles of said medicine weight 0.5～1 hour, decoct 3 times, each 1.0～1.5h filters, and merging filtrate is evaporated to relative density, and 60 ℃ is 1.1～1.15g/ml,

C) at last two concentrated solutions of (a) and (b) are merged, spray drying powder process divides encapsulated or packaging bag, is finished product.

Medicine of the present invention is capsule and the electuary on the pharmaceutics.

The Chinese crude drug that is adopted among the present invention all meets the Pharmacopoeia of the People's Republic of China or " provinces and cities' medical material standard ", wherein Flos puerariae lobatae is the flower of leguminous plant Pueraria lobota, Semen Hoveniae (Fructus Hoveniae) is the fruits and seeds that has the meat fruit stem of Rhamnaceae plant Semen Hoveniae (Fructus Hoveniae), Fructus Amomi Rotundus is zingiberaceous plant Fructus Amomi Rotundus or amomum compactum Soland ex Maton dry mature fruit, Herba Pogostemonis is the herb of labiate Herba Pogostemonis or Herba Pogostemonis, Radix Ginseng is the dry root of Araliaceae Radix Ginseng, the Rhizoma Atractylodis Macrocephalae is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae is the dry mature skin of rutaceae orange, and Polyporus is the dry sclerotia of Polyporaceae fungus Polyporus.

In eight flavor medical materials of the present invention, Flos puerariae lobatae goes into sun, and relieving acute alcoholism and recuperating the spleen makes damp go out from the flesh table, is monarch drug; Semen Hoveniae (Fructus Hoveniae) is gone into heart spleen two warps, can strengthen the merit of Flos puerariae lobatae alcoholic intoxication, is minister; Radix Ginseng, Rhizoma Atractylodis Macrocephalae (parched) spleen invigorating food stagnation removing, Fructus Amomi Rotundus, Radix agastachesization are turbid, and hot loosing relieved the effect of alcohol; Pericarpium Citri Reticulatae removes painful abdominal mass and dredges stagnant; The light branch profit of oozing of Polyporus; Back Six-element is an adjuvant drug.All medicines are shared, play altogether and open effect.Curing mainly is addicted to drink excessively or is still drank after a night does not wake up, insufficiency of the spleen wet resistance, dizzy vomiting etc.

Medicine of the present invention has carried out a series of toxicity test and pharmacodynamics test, and the result is as follows:

1. acute toxicity test

With medicine of the present invention kunming mice is carried out acute toxicity test, under the maximum dosage of maximum administration concentration, an orally give mice medicine 9.463g/kg of the present invention, amounting to the crude drug amount is 194.286g/kg, animal does not have death in 7 days of administration, the body weight sustainable growth, no abnormal behavior in 14 days.Think that the maximum tolerated dose of oral medicine of mice is 9.463g/kg.Clinical adult's consumption every day three times, each 1.0g, promptly be 3.0g every day, and quite crude drug amount 68g becomes body weight for humans press 70g and calculates, and then the clinical drug of the invention dosage of being grown up is 0.04286g/kg, and the mice maximum tolerated dose is 220 times of clinical adult's dosage.

2. pharmacodynamics test:

(1) kunming mice is divided into 3 groups at random: blank group, model control group, medicament group of the present invention, 12 every group.Per os filling every day stomach gives given the test agent, and blank group and model control group give distilled water.Weigh every day and adjust given the test agent dosage.Successive administration 20 days is once irritated stomach with model control group and medicament group of the present invention when giving given the test agent and finishing and is given 50% ethanol 12ml/kgBW, and the blank group is given distilled water, 10 hours sacrificed by exsanguination of fasting.Carry out malonaldehyde (MDA), glutathion (GSH) and the detection of triglyceride (TG) index after getting liver homogenate.The result carries out one factor analysis of variance with the SPSS statistical software, carries out the F check respectively, and all data are represented with x ± s.

The results are shown in Table 1.

Table 1 medicament of the present invention is to alcoholic hepatic injury mice MDA, GSH and TG content influence

(x±s)A

Group number of animals MDA (nmol/g) TG (mmol/100g) GSH (mg/g)

Blank group 12 115.692 ± 43.159* 0.521 ± 0.234* 908.099 ± 65.502

Model group 12 188.121 ± 64.186 ^##0.766 ± 0.416 778.870 ± 105.343

Medicament 12 33.146 ± 15.393 of the present invention ^{* ##}0.160 ± 0.054* 939.149 ± 125.433*

Compare * P＜0.05, * * P＜0.01 with model group

Compare #P＜0.05, ##P＜0.01 with the blank group

Model group MDA content is apparently higher than blank group (P＜0.05), and the MDA content of medicament group of the present invention obviously descends, and compares with model group and blank group, and significant difference is all arranged.GSH obviously descends in the model group liver homogenate, relatively has significant difference with the blank group, and GSH rises in the medicament group liver homogenate of the present invention, relatively has significant difference (P＜0.05) with model group.Medicament of the present invention lowers the content of triglyceride of alcohol damaged mice, alleviates the degree of hepatic injury.

Compared with the prior art the technology of the present invention has following advantage:

1. medicine of the present invention does not see that to kunming mice toxicity takes place, and illustrates this drug effect safety under the situation that is higher than 220 times of human dosage.

2. the pharmacodynamics test of animal proves that this medicine can reduce the liver tg rising that ethanol causes; reduce liver MDA content; that is to say and to suppress the hepatocyte lipid peroxidation that ethanol causes; avoid the cell function infringement; this medicine increases the liver glutathione content, has liver-protective effect.More than effect also obtains the support of the micro-pathology of liver.

3. preparation method is removed invalid components such as sugar through multiple working procedure, the active ingredient extraction ratio is improved relatively, the daidzein content that wherein has an antialcoholism action obviously improves before than process optimization, through high-performance liquid chromatogram determination, new technology daidzein content is 2.87mg/g, is 1.054mg/g before making with extra care.Because the removal of invalid components has reduced the drug administration amount, drug effect is clearer and more definite.

The specific embodiment

Embodiment 1

After getting Flos puerariae lobatae 10kg, Fructus Amomi Rotundus 14kg, Radix agastaches 10kg, Radix Ginseng 7kg, Rhizoma Atractylodis Macrocephalae (parched) 3kg, Pericarpium Citri Reticulatae 7kg mixing, 60% ethanol that adds the 408L volume carries out normal reflux and extracts three medicinal liquids, each 1 hour, filter and remove residue, merging filtrate, decompression recycling ethanol, filtrate is through the centrifugal 15min of 2500rpm, supernatant is crossed D-101 type macroporous resin, washes with water to the eluent colorless and odorless and abandons it, and the reuse ethanol gradient elution is colourless to eluent, merge eluent, be evaporated to relative density, 60 ℃ is 1.1g/ml

Smash Semen Hoveniae (Fructus Hoveniae) 10kg to pieces back and mix with Polyporus 7kg, added 170L water logging bubble 0.5 hour, decoct three times, each 1.5h filters, and merging filtrate is evaporated to relative density, and 60 ℃ is 1.15g/ml,

At last above-mentioned two concentrated solutions are merged, spray drying powder process divides encapsulatedly, and each capsule 0.5g is capsule finished product.

Embodiment 2

After getting Flos puerariae lobatae 12kg, Fructus Amomi Rotundus 12kg, Herba Pogostemonis 12kg, Radix Ginseng 5kg, Rhizoma Atractylodis Macrocephalae (parched) 5kg, Pericarpium Citri Reticulatae 5kg mixing, 55% ethanol that adds the 459L volume carries out normal reflux and extracts three medicinal liquids, each 1.5 hours, filter and remove residue, merging filtrate, decompression recycling ethanol, filtrate is through the centrifugal 15min of 2500rpm, supernatant is by D-101 type macroporous resin, washes with water to the eluent colorless and odorless and abandons it, and the reuse ethanol gradient elution is colourless to eluent, merge eluent, be evaporated to relative density, 60 ℃ is 1.12g/ml

Smash Semen Hoveniae (Fructus Hoveniae) 12kg to pieces back and mix, added 153L water logging bubble 0.5 hour, decoct three times with Polyporus 5kg, each 1.5h, filter, merging filtrate is evaporated to relative density, 60 ℃ is 1.12g/ml, at last above-mentioned two concentrated solutions are merged, spray drying powder process divides encapsulated, each capsule 0.5g is capsule finished product.

Embodiment 3

After getting Flos puerariae lobatae 14kg, Fructus Amomi Rotundus 10kg, Herba Pogostemonis 14kg, Radix Ginseng 7kg, Rhizoma Atractylodis Macrocephalae (parched) 5kg, Pericarpium Citri Reticulatae 3kg mixing, 60% ethanol that adds the 510L volume carries out normal reflux and extracts three medicinal liquids, each 2 hours, filter and remove residue, merging filtrate, decompression recycling ethanol, filtrate is through the centrifugal 15min of 2500rpm, supernatant is crossed D-101 type macroporous resin, washes with water to the eluent colorless and odorless and abandons it, and the reuse ethanol gradient elution is colourless to eluent, merge eluent, be evaporated to relative density, 60 ℃ is 1.15g/ml

Smash Semen Hoveniae (Fructus Hoveniae) 14kg to pieces back and mix with Polyporus 3kg, added 136L water logging bubble 0.5 hour, decoct three times again, each 1.5h filters, and merging filtrate is evaporated to relative density, and 60 ℃ is 1.1g/ml,

At last above-mentioned two concentrated solutions are merged, spray drying powder process, the packaging bag of packing into, every bag of 1g is the electuary finished product.

Claims (3)

1, the medicine of treatment alcoholic liver injury is characterized in that it is made by following raw materials by weight proportions,

10～14 parts of 10～14 portions of Herba Pogostemoniss of 10～14 portions of Fructus Amomi Rotunduss of 10～14 parts of Semen Hoveniae (Fructus Hoveniae)s of Flos puerariae lobatae

3～7 parts of 3～7 portions of Polyporus of 3～7 parts of Pericarpium Citri Reticulataes of 3～7 parts of Rhizoma Atractylodis Macrocephalae (parched)s of Radix Ginseng.

2, the medicine of treatment alcoholic liver injury according to claim 1 is characterized in that described medicine is capsule and the electuary on the pharmaceutics.

3, the preparation method of treatment alcoholic liver injury medicine as claimed in claim 1 or 2 is characterized in that it is undertaken by following step:

A) with respectively 10～14 parts of Flos puerariae lobatae, Fructus Amomi Rotundus, Herba Pogostemoniss, after Radix Ginseng, Rhizoma Atractylodis Macrocephalae (parched), each 3～7 parts of mixing of Pericarpium Citri Reticulatae, 55～60% concentration ethanol that add 8～10 times of volumes of said medicine weight are carried out three medicinal liquids of normal reflux extraction, each 1～2 hour, filter and remove residue, merging filtrate, decompression recycling ethanol, filtrate are through the centrifugal 15min of 2500rpm, and supernatant is by D-101 type macroporous resin, be washed to the eluent colorless and odorless and abandon it, the reuse ethanol gradient elution is colourless to eluent, merges eluent, is evaporated to relative density, 60 ℃ is 1.1～1.15g/ml

B) 10～14 parts of Semen Hoveniae (Fructus Hoveniae)s are smashed to pieces the back and mixed for 3～7 parts with Polyporus, added 8～10 times of water logging bubbles of said medicine weight 0.5～1 hour, decoct 3 times, each 1.0～1.5h filters, and merging filtrate is evaporated to relative density, and 60 ℃ is 1.1～1.15g/ml,

C) at last two concentrated solutions of (a) and (b) are merged spray drying powder process, divide encapsulated or packaging bag, be finished product.