CN104524167A - Traditional Chinese medicine preparation for treating liver cirrhosis and liver ascites and preparation method of traditional Chinese medicine preparation - Google Patents

Abstract

The invention discloses a traditional Chinese medicine preparation for treating liver cirrhosis and liver ascites and a preparation method of the traditional Chinese medicine preparation and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine preparation is prepared from the following raw materials: poria cocos, rhizoma alismatis, bighead atractylodes rhizome, radix ophiopogonis, pericarpium arecae, mangnolia officinalis, pericarpium citri reticulatae, rhizoma atractylodis, elecampane, folia perillae acutae, akebiaquinata, ligusticum wallichii, roots of common peony, rush, scutellaria baicalensis, pawpaws, areca-nuts and liquorice. The traditional Chinese medicine preparation for treating liver cirrhosis and liver ascites disclosed by the invention has the technical advantages of good effect, treating both symptoms and root causes and combination of adjustment and treatment. Moreover, the processing process of the preparation has the advantages of low cost, stable efficacy of the preparation and easy popularization and application.

Description

A kind of Chinese medicine preparation and preparation method thereof for the treatment of liver cirrhosis, hepatic ascites

Technical field

The present invention relates to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine preparation and preparation method thereof for the treatment of liver cirrhosis, hepatic ascites.

Technical background

Liver cirrhosis is clinical common chronic progressive external hepatopathy, the diffusivity hepatic injury that long-term or repeated action is formed by one or more causes of disease.In China, great majority are posthepatitic cirrhosis, and small part is alcoholic cirrhosis and Cirrhosis In Schistosomiasis.Histopathology there are hepatic necrosis, the regeneration of remaining liver cell nodules, connective tissue proliferation and fiber widely every formation, cause lobules of liver structural deterioration and pseudolobuli formation, liver is out of shape gradually, hardening and develop into liver cirrhosis.In early days because liver compensation more by force can non-evident sympton, stage with liver function injury and portal hypertension for main manifestations, and have multisystem to get involved, often there is the complication such as upper gastrointestinal hemorrhage, hepatic encephalopathy, secondary infection, hypersplenism, ascites, canceration late period.

Cirrhotic ascites is commonly called as hepatic ascites.Normal person's intraperitoneal has a small amount of free ascites, is generally about 50 milliliters, plays and maintains lubrication between internal organs, when too much free fluid appears in intraperitoneal, be called ascites.Cirrhotic ascites is a kind of chronic hepatopathy.Become by the Hepatocellular of bulk type, nodular type, diffuse type, downright bad, regeneration; Regeneration, necrosis, impel the contraction of tissue fibers hypertrophy and cicatrix, causes liver qualitative change hard, form liver cirrhosis.Cirrhosis, liver hypofunction causes portal hypertension, causes splenomegaly, and the protein liquid leaked out protein and not absorbing of vitamin defines ascites symptoms.

The traditional Chinese medical science is to the differentiation of symptoms and signs for classification of syndrome of liver cirrhosis:

(1) syndrome of stagnation of liver qi (containing incoordination between the liver and stomach, disharmony between the liver and spleen):

Syndrome: distending pain over the hypochondrium or alter pain, being irritable and getting angry easily, poor appetite or food after distension and fullness in the abdomen, feel sick belch, stringy pulse, body of the tongue is light red, white and thin fur or BOHUANG.Syndrome analysis: the liver pulse cloth the side of body rib, stagnation of QI due to depression of the liver, passages through which vital energy circulates is unfavorable, therefore distending pain over the hypochondrium or alter pain.The liver failing to maintain the normal flow of QI, depression and stagnation of QI is not smooth, therefore feelings will being irritable and getting angry easily.The horizontal criminal's taste of irritability, taste lifting imbalance, and have poor appetite, distension and fullness in the abdomen, feel sick, the disease such as belch.

(2) insufficiency of the spleen leading to overabundance of dampness card:

Syndrome: poor appetite or the rear distension and fullness in the abdomen of food, loose stool or viscous are smooth, n or V, and tastelessness is not for drink, and breathe hard, weak, shallow complexion, lower limbs edema, deep-thready pulse or thin and delicate, the fat multiple tooth trace of pale tongue, tongue is greasy in vain.Syndrome analysis: The spleen has the function to transport and transform nutrients, insufficiency of the spleen mistake fortune, there is the disease such as poor appetite, food rear distension and fullness in the abdomen, loose stool, nausea and vomiting, edema of lower limbs, enlarged tongue greasy fur in indigestion.Deficiency-weakness of spleen-QI, no resource of generating and transforming QI and blood, occurs breathing hard, weak, the disease such as shallow complexion, thready and weak pulse.

(3) damp-heat brewing internally:

Syndrome: body order turns to be yellow, the pain over the hypochondriac region, oppression sensation over the epigastrium and anorexia, nausea and vomiting, lassitude, yellowish or reddish urine, constipation or half congealed, stringy and rolling pulse or sliding number, red tongue, yellow and greasy fur.Syndrome analysis: damp and hot heresy is pented up, stifling umbilicus gallbladder, the bile flowing outside the biliary passages and excessive, therefore see that body order turns to be yellow.The liver failing to maintain the normal flow of QI, taste lifting imbalance, and there is incoordination between the liver and stomach or all diseases of disharmony between the liver and spleen.Yellowish or reddish urine, red tongue, yellow and greasy fur, slippery and rapid pulse etc. are damp and hot resembling.

(4) syndrome of yin deficiency of liver and kidney:

Syndrome: side of body rib dull pain, fatigue increases the weight of, two in puckery, waist soreness, feverish sensation in the palms and soles or low grade fever, dry mouth and throat, stringy and thready pulse or count accurately, the few tongue of red tongue.Syndrome analysis: Liver Channel deficiency of YIN-blood, the liver pulse loses supports, and has side of body rib dull pain; Can not on grow in order, then can two dry and astringent.Kidney governing bones, waist is house of kidney, deficiency of kidney yin, can cause waist soreness., the diseases such as feverish sensation in the palms and soles, low grade fever, dry mouth and throat, rapid pulse, red tongue can be there is in heat formation from yin deficiency.

(5) syndrome of yang deficiency of spleen and kidney:

Syndrome: gastral cavity abdominal distention is large, and as capsule wraps up in water, shape is as frog abdomen, and oppression sensation over the epigastrium and anorexia, loose stool or Diarrhoea, dysuria, lassitude loin and legs, sexual impotence, coldness of the body with chills, lower limbs edema, deep-thready pulse, pale tongue is fat, white, slippery and moist fur.Syndrome analysis: gastral cavity is vexed, indigestion and loss of appetite, loose stool is insufficiency of the spleenly see disease.Diarrhoea, lassitude loin and legs, sexual impotence are shown in disease for suffering from a deficiency of the kidney.Deficiency of spleen-YANG and kidneyYANG, can not replenishing vital QI with drugs of warm nature body, and sees coldness of the body with chills; Can not transporting and rising water liquid, so that dysuria, water retention and occur ascites and lower limbs edema.Thready pulse, light red tongue are fat, white, slippery and moist fur is yang deficiency resembling of stopping wetting.

(6) liver blood blood stasis syndrome:

Syndrome: hypochondriac pain as thorn, pain in fixed position, or side of body rib pain of a specified duration, disease block under rib, liver palm or spider angioma color dark, or stomach wall blue veins exposes, and face is dark and gloomy, stringy pulse or puckery, purplish tongue or have ecchymosis.Syndrome analysis: stagnation of blood stasis the liver pulse, or prolonged illness people network, and cause hypochondriac pain as thorn, pain in fixed position.Blood stasis is long-pending forms disease block.Stasis blocking passages through which vital energy circulates, blood obstacle, and see the diseases such as the exposure of liver palm, spider angioma, stomach wall blue veins and purplish tongue.

Summary of the invention

The technical problem to be solved in the present invention has two, and one is will invent a Chinese prescription to make it have good therapeutic effect to liver cirrhosis, hepatic ascites, and another problem is a set of preparation technology of exploitation, above-mentioned Chinese prescription is made the finished product preparation of clinical needs.

In order to solve the problems of the technologies described above, inventor carries out optimization blends again to Chinese prescription on the basis of modern Chinese medicine preparation technique, invent a brand-new Chinese prescription, it not only has very significant therapeutic effect to liver cirrhosis, hepatic ascites, and adapt to modern pharmaceutical technology, when producing in batches, still maintain remarkable, stable curative effect.This Chinese prescription is (with parts by weight): Poria 13-23 part, Rhizoma Alismatis 12-22 part, Rhizoma Atractylodis Macrocephalae 8-22 part, Radix Ophiopogonis 12-28 part, Pericarpium Arecae 9-21 part, Cortex Magnoliae Officinalis 7-17 part, Pericarpium Citri Reticulatae 6-16 part, Rhizoma Atractylodis 8-16 part, Radix Aucklandiae 11-21 part, Folium Perillae 8-18 part, Caulis Akebiae 11-25 part, Rhizoma Chuanxiong 11-29 part, Radix Paeoniae Rubra 12-28 part, Medulla Junci 6-14 part, Radix Scutellariae 7-15 part, Fructus Chaenomelis 7-17 part, Semen Arecae 7-19 part, Radix Glycyrrhizae 8-14 part.

Within the scope of prescription of the present invention, preferred two Chinese prescription proportionings are out (with parts by weight):

1,18 parts, Poria, Rhizoma Alismatis 17 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Ophiopogonis 20 parts, Pericarpium Arecae 15 parts, Cortex Magnoliae Officinalis 12 parts, Pericarpium Citri Reticulatae 11 parts, Rhizoma Atractylodis 12 parts, the Radix Aucklandiae 16 parts, Folium Perillae 13 parts, Caulis Akebiae 18 parts, Rhizoma Chuanxiong 20 parts, Radix Paeoniae Rubra 20 parts, Medulla Junci 10 parts, Radix Scutellariae 11 parts, Fructus Chaenomelis 12 parts, Semen Arecae 13 parts, 11 parts, Radix Glycyrrhizae.

2,21 parts, Poria, Rhizoma Alismatis 16 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, Radix Ophiopogonis 22 parts, Pericarpium Arecae 14 parts, Cortex Magnoliae Officinalis 11 parts, Pericarpium Citri Reticulatae 12 parts, Rhizoma Atractylodis 14 parts, the Radix Aucklandiae 17 parts, Folium Perillae 12 parts, Caulis Akebiae 19 parts, Rhizoma Chuanxiong 22 parts, Radix Paeoniae Rubra 19 parts, Medulla Junci 11 parts, Radix Scutellariae 10 parts, Fructus Chaenomelis 11 parts, Semen Arecae 14 parts, 12 parts, Radix Glycyrrhizae.

The technique above-mentioned Chinese prescription being made finished product preparation is following steps:

(1) ingredientss such as Poria, Rhizoma Alismatis, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Pericarpium Arecae, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Medulla Junci, Radix Scutellariae, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are accurately taken in prescription ratio, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 6-9 times of weight is the ethanol of 65-75%, reflux, extract, 3 times, each 8-15 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 8-11 times of weight, backflow decoction 3 times, each 2-4 hour, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make the finished product preparation of clinical needs, as dosage forms such as capsule, tablet, pill, granule, powder, syrup, oral liquids.

Source, the nature and flavor of the raw materials used medical material of Chinese medicine preparation of the present invention, return through and effect:

Poria: this product is the dry sclerotia of On Polyporaceae Poria.Sweet in the mouth, light, property is put down; GUIXIN, spleen, kidney channel; Eliminating dampness and diuresis, invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming.

Rhizoma Alismatis: this product is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis.Sweet in the mouth, cold in nature; Return kidney, urinary bladder channel; Diuresis, clearing away damp-heat.

The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Bitter in the mouth, sweet, warm in nature; Return spleen, stomach warp; Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.

Radix Ophiopogonis: this product is the dried root of liliaceous plant Radix Ophiopogonis (dwarf lilyturf).Sweet in the mouth, micro-hardship, cold nature; GUIXIN, lung, stomach warp; YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.

Pericarpium Arecae: this product is the dry peel of babassu Semen Arecae.Acrid in the mouth, slightly warm in nature; Return spleen, stomach, large intestine, small intestine meridian; Therapeutic method to keep the adverse QI flowing downwards alleviating distention in middle-JIAO, line water detumescence.

Cortex Magnoliae Officinalis: this product is the dry dried bark of Magnoliacea plant Cortex Magnoliae Officinalis or magnolia officinalis rehd.et wils.var.biloba rehd.et wils., root bark and branch skin.Bitter in the mouth, pungent, warm in nature; Return spleen, stomach, lung, large intestine channel; Dampness expectorant, the therapeutic method to keep the adverse QI flowing downwards is except full.

Pericarpium Citri Reticulatae: be the mature peel of rutaceae orange and variety thereof.Bitter in the mouth, pungent, warm in nature; Return lung, spleen channel; Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.

Rhizoma Atractylodis: this product is the dry rhizome of feverfew Atractylodes lancea (Thunb.) DC. or Atractylis chinensis.Acrid in the mouth, hardship, warm in nature; Return spleen, stomach, Liver Channel; Drying damp and strengthening spleen, expelling wind and cold, improving eyesight.

The Radix Aucklandiae: this product is the dry root of the feverfew Radix Aucklandiae.Acrid in the mouth, hardship, warm in nature; Return spleen, stomach, large intestine, three burnt, gallbladder meridians; Promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion.

Folium Perillae: this product is the dried leaves (or band twig) of labiate Folium Perillae.Acrid in the mouth, warm in nature; Return lung, spleen channel; Induce sweat cold expelling, relieving QI stagnancy in the stomach.

Caulis Akebiae: be the woody stems of plants of Lardizabalaceae Caulis Akebiae or threeleaf akebia, Caulis Akebiae.Bitter in the mouth, cool in nature; Enter the heart, small intestinal, urinary bladder channel; Pathogenic fire purging row water, promoting blood circulation.

Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong.Acrid in the mouth, warm in nature; Return liver, gallbladder, pericardium channel; Blood-activating and qi-promoting, wind-expelling pain-stopping.

Radix Paeoniae Rubra: this product is the dry root of ranunculaceae plant Radix Paeoniae or river Radix Paeoniae Rubra.Bitter in the mouth, cold nature; Return Liver Channel; Clearing away heat and cooling blood, eliminating stasis to stop pain.

Medulla Junci: be the dry stem pith of rush family herbaceos perennial Medulla Junci.Lightly seasoned, property is put down; Enter the heart, small intestine meridian; Clear away heart-fire heat, relieving restlessness diuretic.

Radix Scutellariae: this product is the dry root of labiate Radix Scutellariae.Bitter in the mouth, cold in nature; Return lung, gallbladder, spleen, large intestine, small intestine meridian; Heat clearing and damp drying, eliminating fire and detoxication, hemostasis, antiabortive.

Fructus Chaenomelis: this product is the dry almost ripe fruit of rosaceous plant chaenomeles lagenaria.Sour in the mouth, warm in nature; Return liver, spleen channel; Suppressing the hyperactive liver relaxing muscles and tendons, stomach function regulating removing dampness.

Semen Arecae: this product is the dry mature seed of babassu Semen Arecae.Bitter in the mouth, pungent, warm in nature; Return stomach, large intestine channel; Killing insect and eliminating accumulation, sending down the abnormal ascending QI, row water, preventing the attack (or recurrence) of malaria.

Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.

The prescription analysis of Chinese medicine preparation of the present invention:

Chinese prescription of the present invention is with Poria, Radix Ophiopogonis, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Caulis Akebiae for monarch drug, eliminating dampness and diuresis, YIN nourishing and the production of body fluid promoting, blood-activating and qi-promoting, eliminating stasis to stop pain, pathogenic fire purging row water; With Rhizoma Alismatis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Arecae, the Radix Aucklandiae for ministerial drug, dampness diuretic, line water detumescence, promoting the circulation of QI to relieve pain; With Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Folium Perillae, Semen Arecae for adjuvant drug, dampness expectorant, expelling wind and cold, the cold expelling that induces sweat, the capable water of sending down the abnormal ascending QI; With Pericarpium Citri Reticulatae, Medulla Junci, Radix Scutellariae, Fructus Chaenomelis for making medicine, drying dampness to eliminate phlegm, relieving restlessness diuretic, eliminating fire and detoxication, suppressing the hyperactive liver relaxing muscles and tendons; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, all medicines of monarch are coordinated, complements each other, synergism, thus reach the effects such as eliminating dampness and diuresis, eliminating stasis to stop pain, line water detumescence, drying dampness to eliminate phlegm, to liver cirrhosis, hepatic ascites, there is significant curative effect.

Compared with prior art, Chinese medicine preparation of the present invention at treatment liver cirrhosis, there is in hepatic ascites the technical advantages such as effective, treating both the principal and secondary aspects of a disease, medical treatment combination, and its processing technique has that cost is low, preparation efficacy stability, be easy to advantages such as applying.

Detailed description of the invention

Embodiment 1

Make in the ratio of the maximum magnitude of Chinese prescription of the present invention:

(1) in prescription ratio accurately take Poria 23kg, Rhizoma Alismatis 22kg, Rhizoma Atractylodis Macrocephalae 22kg, Radix Ophiopogonis 28kg, Pericarpium Arecae 21kg, Cortex Magnoliae Officinalis 17kg, Pericarpium Citri Reticulatae 16kg, Rhizoma Atractylodis 16kg, Radix Aucklandiae 21kg, Folium Perillae 18kg, Caulis Akebiae 25kg, Rhizoma Chuanxiong 29kg, Radix Paeoniae Rubra 28kg, Medulla Junci 14kg, Radix Scutellariae 15kg, Fructus Chaenomelis 17kg, Semen Arecae 19kg, Radix Glycyrrhizae 14kg, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 7 times of weight is the ethanol of 75%, reflux, extract, 3 times, each 12 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 10 times of weight, backflow decoction 3 times, each 2 hours, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make granule, amount to crude drug content 0.315g crude drug/g granule.

Embodiment 2

Make in the ratio of the minimum zone of Chinese prescription of the present invention:

(1) in prescription ratio accurately take Poria 13kg, Rhizoma Alismatis 12kg, Rhizoma Atractylodis Macrocephalae 8kg, Radix Ophiopogonis 12kg, Pericarpium Arecae 9kg, Cortex Magnoliae Officinalis 7kg, Pericarpium Citri Reticulatae 6kg, Rhizoma Atractylodis 8kg, Radix Aucklandiae 11kg, Folium Perillae 8kg, Caulis Akebiae 11kg, Rhizoma Chuanxiong 11kg, Radix Paeoniae Rubra 12kg, Medulla Junci 6kg, Radix Scutellariae 7kg, Fructus Chaenomelis 7kg, Semen Arecae 7kg, Radix Glycyrrhizae 8kg, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 7 times of weight is the ethanol of 75%, reflux, extract, 3 times, each 12 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 10 times of weight, backflow decoction 3 times, each 2 hours, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make granule, amount to crude drug content 0.315g crude drug/g granule.

Embodiment 3

Make in the arbitrary ratio in the scope of Chinese prescription of the present invention:

(1) in prescription ratio accurately take Poria 13kg, Rhizoma Alismatis 22kg, Rhizoma Atractylodis Macrocephalae 8kg, Radix Ophiopogonis 28kg, Pericarpium Arecae 9kg, Cortex Magnoliae Officinalis 17kg, Pericarpium Citri Reticulatae 6kg, Rhizoma Atractylodis 16kg, Radix Aucklandiae 11kg, Folium Perillae 18kg, Caulis Akebiae 11kg, Rhizoma Chuanxiong 11kg, Radix Paeoniae Rubra 28kg, Medulla Junci 14kg, Radix Scutellariae 7kg, Fructus Chaenomelis 17kg, Semen Arecae 7kg, Radix Glycyrrhizae 14kg, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 7 times of weight is the ethanol of 75%, reflux, extract, 3 times, each 12 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 10 times of weight, backflow decoction 3 times, each 2 hours, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make granule, amount to crude drug content 0.315g crude drug/g granule.

Embodiment 4

Make in the ratio of the optimum ratio 1 of Chinese prescription of the present invention:

(1) in prescription ratio accurately take Poria 18kg, Rhizoma Alismatis 17kg, Rhizoma Atractylodis Macrocephalae 15kg, Radix Ophiopogonis 20kg, Pericarpium Arecae 15kg, Cortex Magnoliae Officinalis 12kg, Pericarpium Citri Reticulatae 11kg, Rhizoma Atractylodis 12kg, Radix Aucklandiae 16kg, Folium Perillae 13kg, Caulis Akebiae 18kg, Rhizoma Chuanxiong 20kg, Radix Paeoniae Rubra 20kg, Medulla Junci 10kg, Radix Scutellariae 11kg, Fructus Chaenomelis 12kg, Semen Arecae 13kg, Radix Glycyrrhizae 11kg, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 7 times of weight is the ethanol of 75%, reflux, extract, 3 times, each 12 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 10 times of weight, backflow decoction 3 times, each 2 hours, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make granule, amount to crude drug content 0.315g crude drug/g granule.

Embodiment 5

Make in the ratio of the optimum ratio 2 of Chinese prescription of the present invention:

(1) in prescription ratio accurately take Poria 21kg, Rhizoma Alismatis 16kg, Rhizoma Atractylodis Macrocephalae 17kg, Radix Ophiopogonis 22kg, Pericarpium Arecae 14kg, Cortex Magnoliae Officinalis 11kg, Pericarpium Citri Reticulatae 12kg, Rhizoma Atractylodis 14kg, Radix Aucklandiae 17kg, Folium Perillae 12kg, Caulis Akebiae 19kg, Rhizoma Chuanxiong 22kg, Radix Paeoniae Rubra 19kg, Medulla Junci 11kg, Radix Scutellariae 10kg, Fructus Chaenomelis 11kg, Semen Arecae 14kg, Radix Glycyrrhizae 12kg, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 7 times of weight is the ethanol of 75%, reflux, extract, 3 times, each 12 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 10 times of weight, backflow decoction 3 times, each 2 hours, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make granule, amount to crude drug content 0.315g crude drug/g granule.

Embodiment 6

Chinese medicine embodiment 1-5 of the present invention produce granule animal toxicity experiment

1, acute toxicity test

(1) granule produced of tested medicine: embodiment of the present invention 1-5, adds purified water and is modulated into scattered paste shape.

(2) experimental animal: regular grade NIH mice, body weight 22g ± 3g, male and female half and half, female mice is all without pregnant.

(3) to the magma that mouse stomach Chinese medicine granules of the present invention is made, when given low reaches 748.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1.5 hours recover normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.

(4) result of the test shows: the maximum dosage-feeding of the made granule of mouse stomach embodiment 1-5 is 748.5g crude drug/kg/d(LD ₅₀> 748.5g crude drug/kg).Chinese medicine powder clinical application every day total amount of the present invention is 0.21g crude drug/kg/d to the maximum; By weighing machine, the dosis tolerata of the made granule of mouse stomach embodiment 1-5 is 3564.3 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.

2, long term toxicity test

1, test objective: the toxic reaction of viewing test animal after long-term edible Chinese medicine preparation of the present invention, assesses the basic security of Chinese medicine preparation of the present invention.

2, test material:

(1) animal: select adult healthy SD rat 180, original body mass 218 ± 9g, male and female half and half, female rats is all without pregnant.

(2) medicine: Chinese medicine granules obtained by embodiment of the present invention 1-5, adds purified water and makes magma, for subsequent use.Per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount, and dosage is 4.2g crude drug/kg/d, and granule dose is 13.3g granule/kg/d.

3, test method

(1) 210 SD rats are divided into 6 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1250-1450g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (22 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.

(2) medication

With 5 kinds of granules obtained by embodiment 1-5, to wherein 5 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by same method gavage normal saline.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.

(3) test item and the time

General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.

Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).

Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na ⁺), blood potassium (K ⁺), blood calcium (Ca ⁺) and β ₂-microglobulin.

Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β ₂-MG(renal tubular function obstacle sensitive indicator).

System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.

4, result of the test

The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine oral liquid of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this oral liquid for patient.

Embodiment 7

The embodiment of the present invention 4, embodiment 5(two optimum ratio embodiments) made granule clinical effectiveness test

1, basic document is tested

The experimenter of this clinical trial is all from certain the People's Hospital of city, this institute has accepted 561 liver cirrhosis, hepatic ascites patient for medical treatment altogether from year February in February, 2011 to 2014, therefrom select the patient that 312 participate in this test voluntarily, age 31-67 year, wherein man 210, female 102, is divided into 3 groups by all patients by the state of an illness, age, sex etc., is respectively matched group, tests 1 group, tests 2 groups.

Clinical trial is with reference to Hepatic function improvement and Child-Pugh scoring.Child-Pugh grade scale is a kind of grade scale in order to carry out quantitative evaluation to the liver reserve function of liver cirrhosis patient conventional clinically, by patient's 5 indexs: general status, ascites, serum bilirubin, seralbumin concentration and prothrombin time, three levels are divided into according to different conditions, remember with 1 point respectively, 2 points and 3 points, and 5 index score are added, summation is minimum is divided into 5 points, best result is 15 points, thus according to the number of this summation, liver reserve function is divided into A, B, C tri-grades, imply that the liver injury of three kinds of different orders of severity, mark is higher, liver reserve function is poorer.Wherein, A level: 5-6 divides; B level: 7-9 divides; C level: >=10 points.

3 group case in sex, age, the course of disease, liver function scoring etc. through statistical analysis, there is comparability.And all cases all meet Chinese Medical Association's infectious disease and parasitic disease credit meeting, hepatopathy credit can diagnostic criteria.Cardinal symptom: tired, indigestion and loss of appetite, abdominal distention; Two groups all have obvious abnormal liver function and Decompensated stage sign, serum albumin (Alb) < 35g/L, total bilirubin (TBH), alanine aminotransferase (ALT) all raise, Prothrombin activity (PTA) < 60%.

2, test method

Matched group adopts conventional nutrient, supports the conventional therapies such as albumin, aminoacid and diuresis; Test 1 group, test the granule that 2 groups are taken the embodiment of the present invention 4 respectively, embodiment 5 is produced, every day 2 times, each 20g; Within 4 weeks, be a course for the treatment of, treat 4 courses for the treatment of continuously.

3, result of the test

Before and after (1) 3 tested group treatment, changes of liver function compares, and carries out statistical procedures, in table 1 with t inspection.

Table 1 treatment front and back changes of liver function comparison sheet (n=10) ( ± SD)

Note: * P < 0.05, * * P < 0.01 compared with matched group.

Before and after (2) 3 tested group treatment, Child-Pugh situation of marking compares, and carries out statistical procedures, in table 2 with t inspection.

Table 2 treatment front and back Child-Pugh scoring situation comparison sheet (n=10) ( ± SD)

Note: * P < 0.05 compared with matched group.

4, conclusion (of pressure testing)

(1) according to the show, 3 tested group of liver functions are all improved liver function change comparand, but test 1 group, the therapeutic effect of testing 2 groups are significantly better than matched group.

(2) Child-Pugh marks situation comparand according to the show, the Child-Pugh score value of two test group is all remarkable in matched group, point stages of digital that " # " indicates also extremely significantly is better than matched group, illustrates that the therapeutic effect of Chinese medicine preparation of the present invention is significantly better than matched group.

In sum, Chinese medicine preparation of the present invention, in treatment liver cirrhosis, hepatic ascites, compared with prior art, has very significant technical advantage, achieves beat all technological achievement.

Claims (5)

1. treat a Chinese medicine preparation for liver cirrhosis, hepatic ascites, it is characterized in that being made up of the raw material of following weight portion: Poria 13-23 part, Rhizoma Alismatis 12-22 part, Rhizoma Atractylodis Macrocephalae 8-22 part, Radix Ophiopogonis 12-28 part, Pericarpium Arecae 9-21 part, Cortex Magnoliae Officinalis 7-17 part, Pericarpium Citri Reticulatae 6-16 part, Rhizoma Atractylodis 8-16 part, Radix Aucklandiae 11-21 part, Folium Perillae 8-18 part, Caulis Akebiae 11-25 part, Rhizoma Chuanxiong 11-29 part, Radix Paeoniae Rubra 12-28 part, Medulla Junci 6-14 part, Radix Scutellariae 7-15 part, Fructus Chaenomelis 7-17 part, Semen Arecae 7-19 part, Radix Glycyrrhizae 8-14 part.

2. a kind of Chinese medicine preparation for the treatment of liver cirrhosis, hepatic ascites according to claim 1, is characterized in that being made up of the raw material of following weight portion: 18 parts, Poria, Rhizoma Alismatis 17 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Radix Ophiopogonis 20 parts, Pericarpium Arecae 15 parts, Cortex Magnoliae Officinalis 12 parts, Pericarpium Citri Reticulatae 11 parts, Rhizoma Atractylodis 12 parts, the Radix Aucklandiae 16 parts, Folium Perillae 13 parts, Caulis Akebiae 18 parts, Rhizoma Chuanxiong 20 parts, Radix Paeoniae Rubra 20 parts, Medulla Junci 10 parts, Radix Scutellariae 11 parts, Fructus Chaenomelis 12 parts, Semen Arecae 13 parts, 11 parts, Radix Glycyrrhizae.

3. a kind of Chinese medicine preparation for the treatment of liver cirrhosis, hepatic ascites according to claim 1, is characterized in that being made up of the raw material of following weight portion: 21 parts, Poria, Rhizoma Alismatis 16 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, Radix Ophiopogonis 22 parts, Pericarpium Arecae 14 parts, Cortex Magnoliae Officinalis 11 parts, Pericarpium Citri Reticulatae 12 parts, Rhizoma Atractylodis 14 parts, the Radix Aucklandiae 17 parts, Folium Perillae 12 parts, Caulis Akebiae 19 parts, Rhizoma Chuanxiong 22 parts, Radix Paeoniae Rubra 19 parts, Medulla Junci 11 parts, Radix Scutellariae 10 parts, Fructus Chaenomelis 11 parts, Semen Arecae 14 parts, 12 parts, Radix Glycyrrhizae.

4. treat the preparation method of Chinese medicine preparation for liver cirrhosis, hepatic ascites as claimed in claim 1, it is characterized in that comprising following processing step:

(1) ingredientss such as Poria, Rhizoma Alismatis, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Pericarpium Arecae, Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Medulla Junci, Radix Scutellariae, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are accurately taken in prescription ratio, pulverize respectively, for subsequent use;

(2) volumetric concentration Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis, Cortex Magnoliae Officinalis, Radix Paeoniae Rubra, Radix Scutellariae being added 6-9 times of weight is the ethanol of 65-75%, reflux, extract, 3 times, each 8-15 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be 1.15-1.20, be alcohol extraction concentrated solution, for subsequent use;

(3) Poria, Rhizoma Alismatis, Pericarpium Arecae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, the Radix Aucklandiae, Folium Perillae, Caulis Akebiae, Rhizoma Chuanxiong, Medulla Junci, Fructus Chaenomelis, Semen Arecae, Radix Glycyrrhizae are added the purified water of 8-11 times of weight, backflow decoction 3 times, each 2-4 hour, filter, collecting decoction, being concentrated into 60 DEG C of relative densities is 1.15-1.20, is water extracting liquid, for subsequent use;

(4) alcohol extraction concentrated solution and water extracting liquid are merged, continuing to be concentrated into 60 DEG C of relative densities is the thick paste of 1.30-1.40, is Chinese medical concrete, for subsequent use;

(5) Chinese medical concrete is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make the finished product preparation of clinical needs.

5. a kind of Chinese medicine preparation for the treatment of liver cirrhosis, hepatic ascites according to claim 1, it is characterized in that, described Chinese medicine preparation can make capsule, tablet, pill, granule, powder, syrup and oral liquid.