CN104547486A

CN104547486A - Traditional Chinese medicine preparation for treating anemia and qi-deficiency weakness and preparation process for traditional Chinese medicine preparation

Info

Publication number: CN104547486A
Application number: CN201410827838.8A
Authority: CN
Inventors: 邓凤桂
Original assignee: GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
Current assignee: GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
Priority date: 2014-12-29
Filing date: 2014-12-29
Publication date: 2015-04-29

Abstract

The invention relates to a traditional Chinese medicine preparation for treating anemia and qi-deficiency weakness and a preparation process for the traditional Chinese medicine preparation. The traditional Chinese medicine prepration is prepared from the following 19 main medicinal raw materials: astragalus membranaceus, white atractylodes rhizome, ginseng, Chinese yam, prepared rehmannia root, fructus schizandrae, white paeony root, ligusticum wallichii, rhizoma cyperi, fritillaria cirrhosa, dried tangerine or orange peel, cassia twig, Chinese angelica, poria cocos, moutan bark, fruit of Chinese wolfberry, jujube, rhizoma alismatis, radix glycyrrhizae and the like. The traditional Chinese medicine preparation has technical advantages of being good in effect in treating anemia and qi-deficiency weakness, treating both manifestation and root cause of disease, placing emphasis on nursing and nourishing, and the like; the preparation process for the traditional Chinese medicine preparation is simple and easy to perform, stable in pharmacological function of the preparation, wide in application range, free of any toxic or side effect, and easy to popularize and apply.

Description

A kind ofly be used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy and preparation technology thereof

Technical field

The present invention relates to and be a kind ofly used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy and preparation technology thereof, belong to the field of Chinese medicines.

Background technology

The traditional Chinese medical science will have a delicate constitution and claim body empty, claim deficiency syndrome, and weakness is divided into the deficiency of vital energy, blood deficiency, the deficiency of YIN, yang deficiency Four types the weakness of chronic disease, in conjunction with the heart, liver, spleen, lung, kidney the five internal organs, then each dirty type having again gas, blood, yin, yang weakness, as insufficiency of lung-QI, deficiency of spleen-YANG etc., theory of Chinese medical science says balance, as long as energy and blood of human body equilibrium between yin and yang, is exactly healthy, unfortunately weak, need take a tonic or nourishing food to build up one's health, unnecessary is pathogenic factor, dispel, reach new balance with it, recover healthy.

The traditional Chinese medical science is thought, " all blood all belongs to the heart ", " middle Jiao is bullied extracting juice, change and red be meaning blood ", " source of blood is kidney ... vital essence is sufficient, and hundred normal pulse are smooth ".As can be seen here, the generating resource of blood is in essence-QI from water and grain, and people absorbs water paddy nutrient substance, absorbs the precise and tiny of ingesta, by gasification, become ying-qi by middle Jiao (taste).Spleen obtain heart-fire a surname fall help, be converted into essence, body fluid, a part for essence is stored in kidney, and to treat the use of biochemistry, another part obtains helping of heart-fire and is converted into blood, with the flourish buffings vital organs of the human body.In kidney, congenital essence obtains the essence-QI from water and grain day after tomorrow, absorbs the transpiration of life fire, is converted into marrow.Marrow obtains that the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels is burning hot ly to swash, and is divided into the seminal fluid of marrow, and seminal fluid is converted into blood for a surname of life fire steams again, defeated in body, thinks the use of physiology.

The generation of blood and regulate with the Zang-Fu relationship such as the heart, liver,spleen,kidney close, therefore the traditional Chinese medical science calls " the main blood of the heart, blood stored in the liver, the spleen governs the blood." and giving full play to of these functions, depend on again the fiery Wen Zhao of life of kidney.Therefore, the heart, liver,spleen,kidney function are weak, all can cause blood deficiency.And the formation of blood deficiency is nothing more than internal and external factor.Exopathogen six climate exopathogens and warm intrusion body, dive and irregularly go out, and deeply changes the machine of blood, cause fresh blood without life, this paathogenic factor and modern medicine said " bacteriological infection, protozoon, toxin generation haemolysis are disease " perfectly in harmony.In endogenous cause of ill, or forfeit one's integrity for seven emotions, or be improper diet, or form for losing blood, or be that natural endowment is not enough, or exaggerate for exhaustion due to sexual indulgence after being ill, or be pregnant imbalance, and cause the machine of hemopoietic to be obstructed; Or the machine of digestion is disorderly, indigestion, does not precise and tinyly become, and the disease of blood deficiency occurs.Visible in endogenous cause of ill with modern medicine said " lack hemopoietic raw material or hemopoietic organ's dysfunction, or chronic blood loss forming anemia " be consistent substantially.

Blood is tangible thing, and gas belongs to invisible use.The operation of blood depends on gas, thus have " qi being the governor of blood, the capable then blood of gas, blood being the material foundation of QI, blood to gas also to " theory.Blood is given birth to by gas, and gas also must have blood for depending on, its effect that is biochemical, motion of competence exertion.The two interdepends, and promotes mutually again, keeps relative equilibrium.If qi-blood disharmony, will cause a disease."Nei Jing" is said: " be therefore excess of QI leading to insufficiency of blood that the institute of blood is also the deficiency of vital energy." therefore, blood deficiency patient generally all has the deficiency of vital energy, this on Diagnosis and Treat all tool have very important significance.

Summary of the invention

To be that exploitation is a kind of treat the weak Chinese medicine of anemia, the deficiency of vital energy to the technical problem to be solved in the present invention, and this Chinese medicine can utilize modern pharmaceutical technology to make facilitates easy-to-use finished product preparation.

For solving this technical problem, inventor is according to self experience of practising medicine for many years, treat on the basis of the weak experience of anemia, the deficiency of vital energy summing up ancients, in conjunction with modern industry pharmaceutical technology feature, again composition of prescription, Clinical Practice replication and adjustment, invented one finally to anemia, weak brand-new Chinese prescription and its preparation technology having remarkable therapeutic effect of the deficiency of vital energy.This Chinese prescription is (with parts by weight):

Radix Astragali 14-36 part, Rhizoma Atractylodis Macrocephalae 18-30 part, Radix Ginseng 19-31 part, RHIIZOMA DIOSCOREAE fr0m Henan of China 18-32 part, Radix Rehmanniae Preparata 11-25 part, Fructus Schisandrae Chinensis 7-23 part, Radix Paeoniae Alba 8-20 part, Rhizoma Chuanxiong 7-17 part, Rhizoma Cyperi 6-16 part, Bulbus Fritillariae Cirrhosae 7-17 part, Pericarpium Citri Reticulatae 12-24 part, Ramulus Cinnamomi 9-23 part, Radix Angelicae Sinensis 11-23 part, Poria 7-17 part, Cortex Moutan 7-17 part, Fructus Lycii 6-16 part, Fructus Jujubae 8-22 part, Rhizoma Alismatis 6-14 part, Radix Glycyrrhizae 9-17 part.

Three proportionings optimized are respectively:

1, the Radix Astragali 30 parts, the Rhizoma Atractylodis Macrocephalae 24 parts, Radix Ginseng 25 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 25 parts, 18 parts, Radix Rehmanniae Preparata, Fructus Schisandrae Chinensis 15 parts, the Radix Paeoniae Alba 14 parts, Rhizoma Chuanxiong 12 parts, Rhizoma Cyperi 11 parts, Bulbus Fritillariae Cirrhosae 12 parts, Pericarpium Citri Reticulatae 18 parts, Ramulus Cinnamomi 16 parts, Radix Angelicae Sinensis 17 parts, 12 parts, Poria, Cortex Moutan 12 parts, Fructus Lycii 11 parts, 15 parts, Fructus Jujubae, Rhizoma Alismatis 10 parts, 13 parts, Radix Glycyrrhizae.

2, the Radix Astragali 32 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, Radix Ginseng 23 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 24 parts, 19 parts, Radix Rehmanniae Preparata, Fructus Schisandrae Chinensis 16 parts, the Radix Paeoniae Alba 13 parts, Rhizoma Chuanxiong 13 parts, Rhizoma Cyperi 10 parts, Bulbus Fritillariae Cirrhosae 13 parts, Pericarpium Citri Reticulatae 19 parts, Ramulus Cinnamomi 15 parts, Radix Angelicae Sinensis 18 parts, 11 parts, Poria, Cortex Moutan 14 parts, Fructus Lycii 10 parts, 16 parts, Fructus Jujubae, Rhizoma Alismatis 11 parts, 14 parts, Radix Glycyrrhizae.

3, the Radix Astragali 31 parts, the Rhizoma Atractylodis Macrocephalae 23 parts, Radix Ginseng 24 parts, RHIIZOMA DIOSCOREAE fr0m Henan of China 26 parts, 19 parts, Radix Rehmanniae Preparata, Fructus Schisandrae Chinensis 17 parts, the Radix Paeoniae Alba 15 parts, Rhizoma Chuanxiong 11 parts, Rhizoma Cyperi 12 parts, Bulbus Fritillariae Cirrhosae 14 parts, Pericarpium Citri Reticulatae 16 parts, Ramulus Cinnamomi 18 parts, Radix Angelicae Sinensis 18 parts, 11 parts, Poria, Cortex Moutan 14 parts, Fructus Lycii 12 parts, 14 parts, Fructus Jujubae, Rhizoma Alismatis 11 parts, 14 parts, Radix Glycyrrhizae.

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

(1), the ingredientss such as the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Ginseng, RHIIZOMA DIOSCOREAE fr0m Henan of China, Radix Rehmanniae Preparata, Fructus Schisandrae Chinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Rhizoma Cyperi, Bulbus Fritillariae Cirrhosae, Pericarpium Citri Reticulatae, Ramulus Cinnamomi, Radix Angelicae Sinensis, Poria, Cortex Moutan, Fructus Lycii, Fructus Jujubae, Rhizoma Alismatis, Radix Glycyrrhizae are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2), all medical materials are added the purified water of initial medical material 8-12 times weight, soak 12-24 hour, backflow decocts 1-3 hour, filter, add the purified water of initial weight 5-9 times weight again, backflow decocts 1-3 hour, filters and retains filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;

(3), the filtering residue of step (2) is added the ethanol of the concentration 65-80% of 5-7 times of weight, reflux, extract, 2 times, each 2-5 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4), by the concentrated solution of step (2) and (3) gained merge, continuing to be concentrated into 55 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.33-1.38, for subsequent use;

(5), by the Chinese medical concrete of step (4) add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make the finished product preparation of clinical needs, as dosage forms such as capsule, granule, tablet, pill, powder, syrup, oral liquids.

Source, the nature and flavor of Chinese medicine preparation of the present invention Chinese crude drug used, return through and effect:

The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.

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 Ginseng: this product is the dry root of Araliaceae Radix Ginseng.Sweet in the mouth, micro-hardship, property is put down; Return spleen, lung, heart channel; Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid, and calms the nerves.

RHIIZOMA DIOSCOREAE fr0m Henan of China: this product is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae.Sweet in the mouth, property is put down; Return spleen, lung, kidney channel; Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.

Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae.Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.

Fructus Schisandrae Chinensis: this product is the dry mature fruit of magnoliaceae schisandra or schisandra chinensis.Sour in the mouth, sweet, warm in nature; Return lung, the heart, kidney channel; Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.

The Radix Paeoniae Alba: this product is the dry root of ranunculaceae plant Radix Paeoniae.Bitter in the mouth, acid, cold nature; Return liver, spleen channel; Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.

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.

Rhizoma Cyperi: this product is the dry rhizome of sedge dried tuber.Acrid in the mouth, micro-hardship, micro-sweet, property is put down; Return liver, spleen, tri-jiao channel; Promoting QI circulation for relieving depression, menstruction regulating and pain relieving.

Bulbus Fritillariae Cirrhosae: this product is the dry bulb of liliaceous plant Bulbus Fritillariae Cirrhosae, Fritillaria unibracteata, Gansu Bulbus Fritillariae Uninbracteatae or Bulbus Fritillariae cirrhosae.Bitter in the mouth, sweet, cold nature; Return lung, heart channel; Clearing heat and moistening lung, preventing phlegm from forming and stopping coughing.

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.

Ramulus Cinnamomi: this product is the dry twig of canella Cortex Cinnamomi.Acrid in the mouth, sweet, warm in nature; GUIXIN, lung, urinary bladder channel; Diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.

Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica.Sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.

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.

Cortex Moutan: this product is the dry root bark of ranunculaceae peony.Bitter in the mouth, pungent, cold nature; GUIXIN, liver, kidney channel; Clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.

Fructus Lycii: this product is the dry mature fruit of plant of Solanaceae lycium barbarum.Sweet in the mouth, property is put down; Return liver, kidney channel; Nourishing the liver and kidney, replenishing vital essence to improve eyesight.

Fructus Jujubae: this product is the dry mature fruit of Rhamnaceae jujube Fructus Jujubae.Sweet in the mouth, warm in nature; Return spleen, stomach warp; Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.

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.

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 prescription of the present invention:

Chinese prescription of the present invention is with the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Ginseng, RHIIZOMA DIOSCOREAE fr0m Henan of China, Radix Rehmanniae Preparata for monarch drug, invigorating QI to consolidate the body surface resistance, invigorating the spleen and benefiting QI, invigorating the spleen to benefit the lung, nourishing YIN and supplementing blood; With Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, Ramulus Cinnamomi, Radix Angelicae Sinensis, Fructus Jujubae for ministerial drug, supplementing QI for promoting the production of body fluid, regulating qi-flowing for strengthening spleen, promoting the flow of QI-blood by warming the meridian, enrich blood invigorate blood circulation, nourishing blood to tranquillize the mind; With the Radix Paeoniae Alba, Poria, Bulbus Fritillariae Cirrhosae, Cortex Moutan for adjuvant drug, nourishing blood for regulating menstruation, eliminating dampness and diuresis, clearing heat and moistening lung, blood circulation promoting and blood stasis dispelling; With Rhizoma Chuanxiong, Rhizoma Cyperi, Fructus Lycii, Rhizoma Alismatis for making medicine, blood-activating and qi-promoting, promoting QI circulation for relieving depression, nourishing the liver and kidney, clearing away heat and promoting diuresis; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, make all medicine coordinated, complement each other, jointly reach the effects such as invigorating QI to consolidate the body surface resistance, nourishing YIN and supplementing blood, regulating qi-flowing for strengthening spleen, nourishing blood for regulating menstruation, to anemia, the deficiency of vital energy be weak etc., disease has very significant therapeutic effect.

Compared with prior art, Chinese medicine preparation of the present invention has effective, treating both the principal and secondary aspects of a disease, stresses the technical advantages such as conditioning nourishing in treatment anemia, the deficiency of vital energy are weak, and its preparation process is simple and easy to do, preparation efficacy stability, applied widely, without any side effects, be easy to apply.

Detailed description of the invention

Embodiment 1

Capsule preparations is produced by the numerical value of the optimum ratio 1 of Chinese prescription of the present invention:

(1), Radix Astragali 3000g, Rhizoma Atractylodis Macrocephalae 2400g, Radix Ginseng 2500g, RHIIZOMA DIOSCOREAE fr0m Henan of China 2500g, Radix Rehmanniae Preparata 1800g, Fructus Schisandrae Chinensis 1500g, Radix Paeoniae Alba 1400g, Rhizoma Chuanxiong 1200g, Rhizoma Cyperi 1100g, Bulbus Fritillariae Cirrhosae 1200g, Pericarpium Citri Reticulatae 1800g, Ramulus Cinnamomi 1600g, Radix Angelicae Sinensis 1700g, Poria 1200g, Cortex Moutan 1200g, Fructus Lycii 1100g, Fructus Jujubae 1500g, Rhizoma Alismatis 1000g, Radix Glycyrrhizae 1300g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2), all medical materials are added the purified water of initial medical material 11 times of weight, soak 16 hours, backflow decoction 2 hours, filter, add the purified water of initial weight 7 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;

(3), the filtering residue of step (2) is added the ethanol of the concentration 75% of 6 times of weight, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(5), by the Chinese medical concrete of step (4) add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make capsule, amounting to crude drug content is 0.96g crude drug/capsules.

Embodiment 2

Capsule preparations is produced by the numerical value of the optimum ratio 2 of Chinese prescription of the present invention:

(1), Radix Astragali 3200g, Rhizoma Atractylodis Macrocephalae 2500g, Radix Ginseng 2300g, RHIIZOMA DIOSCOREAE fr0m Henan of China 2400g, Radix Rehmanniae Preparata 1900g, Fructus Schisandrae Chinensis 1600g, Radix Paeoniae Alba 1300g, Rhizoma Chuanxiong 1300g, Rhizoma Cyperi 1000g, Bulbus Fritillariae Cirrhosae 1300g, Pericarpium Citri Reticulatae 1900g, Ramulus Cinnamomi 1500g, Radix Angelicae Sinensis 1800g, Poria 1100g, Cortex Moutan 1400g, Fructus Lycii 1000g, Fructus Jujubae 1600g, Rhizoma Alismatis 1100g, Radix Glycyrrhizae 1400g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 3

Capsule preparations is produced by the numerical value of the optimum ratio 3 of Chinese prescription of the present invention:

(1), Radix Astragali 3100g, Rhizoma Atractylodis Macrocephalae 2300g, Radix Ginseng 2400g, RHIIZOMA DIOSCOREAE fr0m Henan of China 2600g, Radix Rehmanniae Preparata 1900g, Fructus Schisandrae Chinensis 1700g, Radix Paeoniae Alba 1500g, Rhizoma Chuanxiong 1100g, Rhizoma Cyperi 1200g, Bulbus Fritillariae Cirrhosae 1400g, Pericarpium Citri Reticulatae 1600g, Ramulus Cinnamomi 1800g, Radix Angelicae Sinensis 1800g, Poria 1100g, Cortex Moutan 1400g, Fructus Lycii 1200g, Fructus Jujubae 1400g, Rhizoma Alismatis 1100g, Radix Glycyrrhizae 1400g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 4

Capsule preparations is produced by the minimum value of Chinese prescription scope of the present invention:

(1), Radix Astragali 1400g, Rhizoma Atractylodis Macrocephalae 1800g, Radix Ginseng 1900g, RHIIZOMA DIOSCOREAE fr0m Henan of China 1800g, Radix Rehmanniae Preparata 1100g, Fructus Schisandrae Chinensis 700g, Radix Paeoniae Alba 800g, Rhizoma Chuanxiong 700g, Rhizoma Cyperi 600g, Bulbus Fritillariae Cirrhosae 700g, Pericarpium Citri Reticulatae 1200g, Ramulus Cinnamomi 900g, Radix Angelicae Sinensis 1100g, Poria 700g, Cortex Moutan 700g, Fructus Lycii 600g, Fructus Jujubae 800g, Rhizoma Alismatis 600g, Radix Glycyrrhizae 900g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 5

Capsule preparations is produced by the greatest measure of Chinese prescription scope of the present invention:

(1), Radix Astragali 3600g, Rhizoma Atractylodis Macrocephalae 3000g, Radix Ginseng 3100g, RHIIZOMA DIOSCOREAE fr0m Henan of China 3200g, Radix Rehmanniae Preparata 2500g, Fructus Schisandrae Chinensis 2300g, Radix Paeoniae Alba 2000g, Rhizoma Chuanxiong 1700g, Rhizoma Cyperi 1600g, Bulbus Fritillariae Cirrhosae 1700g, Pericarpium Citri Reticulatae 2400g, Ramulus Cinnamomi 2300g, Radix Angelicae Sinensis 2300g, Poria 1700g, Cortex Moutan 1700g, Fructus Lycii 1600g, Fructus Jujubae 2200g, Rhizoma Alismatis 1400g, Radix Glycyrrhizae 1700g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 6

Capsule preparations is produced by the arbitrary numerical value within the scope of Chinese prescription of the present invention:

(1), Radix Astragali 1400g, Rhizoma Atractylodis Macrocephalae 3000g, Radix Ginseng 1900g, RHIIZOMA DIOSCOREAE fr0m Henan of China 3200g, Radix Rehmanniae Preparata 1100g, Fructus Schisandrae Chinensis 2300g, Radix Paeoniae Alba 800g, Rhizoma Chuanxiong 1700g, Rhizoma Cyperi 600g, Bulbus Fritillariae Cirrhosae 1700g, Pericarpium Citri Reticulatae 1200g, Ramulus Cinnamomi 2300g, Radix Angelicae Sinensis 1100g, Poria 1700g, Cortex Moutan 700g, Fructus Lycii 1600g, Fructus Jujubae 800g, Rhizoma Alismatis 1400g, Radix Glycyrrhizae 900g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(5), by the Chinese medical concrete of step (4) add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make capsule, amounting to crude drug content is 1.02g crude drug/capsules.

Embodiment 7

The animal toxicity test of Chinese medicine preparation of the present invention

1, test drug: Chinese medicine capsules obtained by embodiment of the present invention 1-6, abolishes capsule shells, adds purified water and is modulated into magma.

Test animal used: regular grade NIH mice, body weight 20g ± 3g, male and female half and half, female mice is all without pregnant; SD rat, original body mass 220 ± 12g, male and female half and half, female rats is all without pregnant.

2, acute toxicity test

Application mice carries out acute toxicity testing and shows: mouse stomach Chinese medicine oral liquid of the present invention, under 782.6g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none dead mouse, and overall health of patients, diet, take the photograph water, urine and body weight increase all normal.Experimental result shows: the maximum dosage-feeding of mouse stomach Chinese medicine capsules of the present invention is 782.6g crude drug/kg/d(LD ₅₀> 782.6g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.17g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 4603.5 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.

3, long term toxicity test

Select SD rat, give the Chinese medicine capsules of the present invention of Three doses: 30.6g crude drug/kg, 10.2g crude drug/kg, 3.4g crude drug/kg(per weight dosage is by 20 times of calculating of clinical application amount, and clinical application amount is according to Pharmacopoeia of the People's Republic of China version in 2010).Every day gavage once, continuous 90 days, after last administration 24 hours respectively group live and kill 1/2 animal (male and female half and half), all the other 1/2 animals continue that observations are alive after 2 weeks kills.Duration of test observes outward appearance, general behavior, food ration, the body weight change of animal; Within after administration 90 days, within 2 weeks, carry out the index checking such as hematology's (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology with drug withdrawal.

Result of the test shows: Chinese medicine preparation of the present invention is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavioral activity, food-intake and body weight increase change all without exception; Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis all in normal range, without significant difference between group; Each group of main organs histopathological examination shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage is respectively 180,60,20 times of clinical medicine dose, according to result of the test: Chinese medicine preparation of the present invention has no significant effect rat in high, medium and low three dosage (30.6g crude drug/kg, 10.2g crude drug/kg, 3.4g crude drug/kg) administration in continuous 90 days, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no retardance toxic reaction, points out the dose safety of Chinese medicine preparation clinical practice of the present invention very high.

Embodiment 8

The pharmacodynamic experiment of Chinese medicine preparation of the present invention

1, Experimental agents and dosage

The capsule that the embodiment of the present invention 1 is produced, amounting to crude drug content is 1.02g crude drug/capsules, abolish capsule shells, add purified water, 0.85,0.425, the crude drug of 0.213g/kg/d be modulated into the magmas of high, normal, basic three kinds of meterings:, be equivalent to respectively and 5,2.5,1.25 of its clinical medicine dose times.Ferrous sulfate is 0.27g/kg/d, is equivalent to 2 times of clinical amounts; FUFANG EJIAO JIANG is 22ml/kg/d, is equivalent to 2.5 times of clinical amount; GUIPI WAN is 7 g/kg/d, is equivalent to 2.5 times of clinical amount; Above dosage all converts by body surface area.

2, laboratory animal and structure model

Kunming mouse, body weight 20 ± 2g, male and female half and half, female mice is all without pregnant.By animal effect experiment conventional method, build Lost blood anemia mouse model, hemolytic hydracetin-induced anemia mice model, hemopoietic deficiency hydracetin-induced anemia mice model.

3, kind is tested

(1), this preparation is on the impact of the Lost blood anemia mice with insufficiency of the spleen factor

Get Lost blood anemia model mice 60, be divided into 6 groups at random, often organize 10, the Chinese medicine magma of 3 high, normal, basic three dosage of test group difference gavage, ferrous sulfate group is gavage ferrous sulfate according to dosage, the isometric normal saline of blank group gavage.

As a result, blank group hemoglobin is tested and is significantly reduced (P ﹤ 0.01) than before experiment on the 8th day, tests and recovers to some extent for the 10th day, but still significantly lower than before experiment (P ﹤ 0.01); Test the 8th day, Chinese medicine preparation high dose group hemoglobin pole of the present invention is significantly higher than blank group (P ﹤ 0.01), and suitable with ferrous sulfate; In, low dose group hemoglobin is also significantly higher than blank (P ﹤ 0.05); Test the 10th day, high, medium and low 3 dosage group hemoglobin are all significantly higher than blank (P ﹤ 0.01), and are better than ferrous sulfate (P ﹥ 0.05).

(2), on the impact of hemolytic blood deficiency mice

Get hemolytic model of blood dificiency mice 60, be divided into 6 groups at random, often organize 10, the Chinese medicine magma of 3 high, normal, basic three dosage of test group difference gavage, GUIPI WAN group is gavage GUIPI WAN according to dosage, the isometric normal saline of blank group gavage.

As a result, after S.C APH, each treated animal Hemoglobin Value declines all gradually, after second time S.C APH hemoglobin highly significant lower than level before experiment; Along with the prolongation of administration time, each group Hemoglobin Value demonstrates difference gradually, tests the 7th day, and the experimental group hemoglobin of 3 dosage very significantly (P ﹤ 0.01) is higher than blank group, and suitable with GUIPI WAN group; Test the 9th, 10 day each administration group Hemoglobin Value all very significantly higher than blank group, compare with the clinical dosage of identical multiple, low dose group of the present invention has significantly been better than GUIPI WAN (P ﹤ 0.05).

(3), on the impact of hemopoietic deficiency blood deficiency mice

Get hemopoietic deficiency model of blood dificiency mice 60, be divided into 6 groups at random, often organize 10, the Chinese medicine magma of 3 high, normal, basic three dosage of test group difference gavage, FUFANG EJIAO JIANG group is gavage FUFANG EJIAO JIANG according to dosage, the isometric normal saline of blank group gavage.

As a result, through CO ⁶⁰the blank group mice of irradiating is compared with intact animal, test the 7th and 10 days leukocyte counts reduce very significantly (P ﹤ 0.01), test the 10th day, medullary cell mitotic index and spleen weight reduce (P ﹤ 0.01) all very significantly, and Spleen nodes is high-visible; Test the 7th day, the height of experimental group, middle dosage group leukocyte count very significantly (P ﹤ 0.01) higher than blank group, test the 10th day, high, medium and low dosage group leukocyte higher than blank group (P ﹤ 0.01), shows that the effect of Chinese medicine preparation of the present invention strengthens along with the prolongation of administration time all very significantly; High, middle dosage group bone marrow mitotic index is very significantly higher than blank group (P ﹤ 0.01), and high dose group is also very significantly higher than intact animal (P ﹤ 0.01), each dosage group increases with dosage and effect strengthens, compare with the clinical dosage of identical multiple, middle dosage group a little more than FUFANG EJIAO JIANG, but without statistical significant difference (P ﹥ 0.05).

High, medium and low dosage group Spleen nodes number all very significantly (P ﹤ 0.01) or significantly (P ﹤ 0.05) higher than blank group, and increase with dosage, effect strengthens, show that Chinese medicine preparation of the present invention can obviously promote that pluripotential hemopoietic stem cell is bred, compare with the clinical dosage of identical multiple, middle dosage group a little more than FUFANG EJIAO JIANG, but without statistical significant difference (P ﹥ 0.05).

4, experiment conclusion: on Lost blood anemia mouse model, Chinese medicine preparation of the present invention demonstrates the effect significantly increasing hemoglobin, and its intensity is better than ferrous sulfate.

On hemolytic hydracetin-induced anemia mice model, Chinese medicine preparation of the present invention demonstrates the effect significantly increasing hemoglobin, and its intensity is significantly better than GUIPI WAN.

On hemopoietic deficiency hydracetin-induced anemia mice model, Chinese medicine preparation of the present invention demonstrates significantly increases leukocyte count and medullary cell mitotic index, promote the effect of pluripotential hemopoietic stem cell propagation, its effect increasing leukocyte count is a little more than FUFANG EJIAO JIANG, and it increases medullary cell mitotic index and promotes that the effect of pluripotential hemopoietic stem cell propagation is also a little more than FUFANG EJIAO JIANG.

In a word, shown by the pharmacodynamics test of 3 kinds of models: the effect that Chinese medicine preparation of the present invention has obvious spleen invigorating and enriches blood.

Embodiment 9

The clinical trial of the clinical Chinese medicine preparation of the present invention

1, physical data

240 experimenters are collected in this clinical trial altogether, from certain the People's Hospital of city, certain the People's Hospital of city second, certain institute of traditional Chinese medicine of city, wherein man 60, age 29-66 year, female 180, age 21-68 year, all experimenters are divided into 3 groups, often organize 80,3 group case in sex, age, the course of disease etc. through statistical analysis, there is comparability.

2, test drug

The made capsule of embodiment of the present invention 1-3 (making by 3 optimum ratios), amounting to crude drug content is 0.96g crude drug/capsules.

3, test method

3 test group made capsule of oral embodiment of the present invention 1-3 respectively, every day 2 times, each 53 weeks is a course for the treatment of, treats 3 courses for the treatment of continuously.Record recurrent cases.

4, therapeutic evaluation

Cure: the weak all transference cures of anemia, the deficiency of vital energy, and make a definite diagnosis through doctor and fully recover;

Effective: the weak partial symptoms of anemia, the deficiency of vital energy disappears or takes a turn for the better;

Invalid: the weak all symptoms of anemia, the deficiency of vital energy are without any improvement, even more serious;

Recurrence: healing person again suffers from original disease in 6 months after drug withdrawal.

5, test data statistical analysis

After test all terminates, by as shown in table 1 for test data statistical analysis.

Table 1 test data statistical analysis table

Group	Number of cases	Cure (rate)	Effectively	Invalid	Total effective rate	Recurrence (rate)
							Embodiment 1 group	80	41（51.3%）	39	0	100%	1（2.4%）
Embodiment 2 groups	80	46（57.5%）	33	1	98.8%	0
							Embodiment 3 groups	80	43（53.8%）	36	1	98.8%	2（4.7%）

6, conclusion (of pressure testing)

Test data shows, and the average cure rate of Chinese medicine preparation of the present invention is 54.2%, and average total effective rate is up to 99.2%, average relapse rate is only 2.4%, therefore, Chinese medicine preparation of the present invention has very significant technical advantage in treatment anemia, the deficiency of vital energy are weak, obtains beat all technological achievement.

Claims

1. be used for the treatment of the Chinese medicine preparation that anemia, the deficiency of vital energy are weak, it is characterized in that, the Chinese prescription of described Chinese medicine preparation is (with parts by weight):

Radix Astragali 14-36 part Rhizoma Atractylodis Macrocephalae 18-30 part Radix Ginseng 19-31 part RHIIZOMA DIOSCOREAE fr0m Henan of China 18-32 part

Radix Rehmanniae Preparata 11-25 part Fructus Schisandrae Chinensis 7-23 part Radix Paeoniae Alba 8-20 part Rhizoma Chuanxiong 7-17 part

Rhizoma Cyperi 6-16 part Bulbus Fritillariae Cirrhosae 7-17 part Pericarpium Citri Reticulatae 12-24 part Ramulus Cinnamomi 9-23 part

Radix Angelicae Sinensis 11-23 part Poria 7-17 part Cortex Moutan 7-17 part Fructus Lycii 6-16 part

Fructus Jujubae 8-22 part Rhizoma Alismatis 6-14 part Radix Glycyrrhizae 9-17 part.

2. be according to claim 1ly a kind ofly used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy, it is characterized in that, the Chinese prescription of described Chinese medicine preparation can be preferably (with parts by weight):

The Radix Astragali 30 parts of Rhizoma Atractylodis Macrocephalaes 24 parts of Radix Ginsengs 25 parts of RHIIZOMA DIOSCOREAE fr0m Henan of China 25 parts

Radix Rehmanniae Preparata 18 parts of Fructus Schisandrae Chinensis 15 portions of Radix Paeoniae Albas 14 parts of Rhizoma Chuanxiongs 12 parts

Rhizoma Cyperi 11 parts of Bulbus Fritillariae Cirrhosaes 12 parts of Pericarpium Citri Reticulataes 18 parts of Ramulus Cinnamomi 16 parts

Radix Angelicae Sinensis 17 parts of Poria 12 parts of Cortex Moutans 12 parts of Fructus Lycii 11 parts

13 parts, Fructus Jujubae 15 portions of Rhizoma Alismatis 10 portions of Radix Glycyrrhizaes.

3. be according to claim 1ly a kind ofly used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy, it is characterized in that, the Chinese prescription of described Chinese medicine preparation can be preferably (with parts by weight):

The Radix Astragali 32 parts of Rhizoma Atractylodis Macrocephalaes 25 parts of Radix Ginsengs 23 parts of RHIIZOMA DIOSCOREAE fr0m Henan of China 24 parts

Radix Rehmanniae Preparata 19 parts of Fructus Schisandrae Chinensis 16 portions of Radix Paeoniae Albas 13 parts of Rhizoma Chuanxiongs 13 parts

Rhizoma Cyperi 10 parts of Bulbus Fritillariae Cirrhosaes 13 parts of Pericarpium Citri Reticulataes 19 parts of Ramulus Cinnamomi 15 parts

Radix Angelicae Sinensis 18 parts of Poria 11 parts of Cortex Moutans 14 parts of Fructus Lycii 10 parts

14 parts, Fructus Jujubae 16 portions of Rhizoma Alismatis 11 portions of Radix Glycyrrhizaes.

4. be according to claim 1ly a kind ofly used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy, it is characterized in that, the Chinese prescription of described Chinese medicine preparation can be preferably (with parts by weight):

The Radix Astragali 31 parts of Rhizoma Atractylodis Macrocephalaes 23 parts of Radix Ginsengs 24 parts of RHIIZOMA DIOSCOREAE fr0m Henan of China 26 parts

Radix Rehmanniae Preparata 19 parts of Fructus Schisandrae Chinensis 17 portions of Radix Paeoniae Albas 15 parts of Rhizoma Chuanxiongs 11 parts

Rhizoma Cyperi 12 parts of Bulbus Fritillariae Cirrhosaes 14 parts of Pericarpium Citri Reticulataes 16 parts of Ramulus Cinnamomi 18 parts

Radix Angelicae Sinensis 18 parts of Poria 11 parts of Cortex Moutans 14 parts of Fructus Lycii 12 parts

14 parts, Fructus Jujubae 14 portions of Rhizoma Alismatis 11 portions of Radix Glycyrrhizaes.

5. described be a kind ofly used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy according to claim 1-4 is arbitrary, it is characterized in that, the preparation technology of described Chinese medicine preparation is following steps:

Step (1), take the ingredientss such as the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Ginseng, RHIIZOMA DIOSCOREAE fr0m Henan of China, Radix Rehmanniae Preparata, Fructus Schisandrae Chinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Rhizoma Cyperi, Bulbus Fritillariae Cirrhosae, Pericarpium Citri Reticulatae, Ramulus Cinnamomi, Radix Angelicae Sinensis, Poria, Cortex Moutan, Fructus Lycii, Fructus Jujubae, Rhizoma Alismatis, Radix Glycyrrhizae respectively by Chinese prescription, pulverize respectively, for subsequent use;

Step (2), all medical materials are added the purified water of initial medical material 8-12 times weight, soak 12-24 hour, backflow decocts 1-3 hour, filter, add the purified water of initial weight 5-9 times weight again, backflow decocts 1-3 hour, filters and retains filtering residue, merging filtrate, being concentrated into 55 DEG C of-60 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;

Step (3), the filtering residue of step (2) is added the ethanol of the concentration 65-80% of 5-7 times of weight, reflux, extract, 2 times, each 2-5 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 55 DEG C of-60 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

Step (4), merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 55 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.33-1.38, for subsequent use;

Step (5), the Chinese medical concrete of step (4) is added suitable adjuvant, utilize modern general Chinese medicine preparation technology to make the finished product preparation of clinical needs.

6. described be a kind ofly used for the treatment of the weak Chinese medicine preparation of anemia, the deficiency of vital energy according to claim 1-4 is arbitrary, it is characterized in that, described Chinese medicine preparation can make capsule, granule, tablet, pill, powder, syrup and oral liquid.