CN104367749A - Pharmaceutical composition for invigorating qi and blood and preparation method of pharmaceutical composition - Google Patents
Pharmaceutical composition for invigorating qi and blood and preparation method of pharmaceutical composition Download PDFInfo
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- CN104367749A CN104367749A CN201410568241.6A CN201410568241A CN104367749A CN 104367749 A CN104367749 A CN 104367749A CN 201410568241 A CN201410568241 A CN 201410568241A CN 104367749 A CN104367749 A CN 104367749A
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- semen
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- pharmaceutical composition
- blood
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Abstract
The invention relates to a pharmaceutical composition for invigorating qi and blood and a preparation method of the pharmaceutical composition. The composition is prepared from the following medicines in parts by weight: 200 to 800 parts of poria cocos, 50 to 400 parts of pinenut kernels, 200 to 800 parts of Chinese yam, 200 to 800 parts of gordon euryale seeds, 200 to 800 parts of semen sesami nigrum, 200 to 800 parts of black beans, 200 to 800 parts of red dates, 50 to 400 parts of walnuts, 200 to 800 parts of Barbary wolfberry fruits and 200 to 800 parts of lotus seeds. The compositions has the functions of treating coldness in hands and feet, appetite loss and torpid stomach, clear abundant urine, night sweat, palpitation, irregular menstruation and dizziness which are caused by qi-blood deficiency. The composition only needs to be taken within short time, has an obvious effect of invigorating qi and blood and is convenient to carry.
Description
Technical field
The present invention relates to field of medicine invention, be specifically related to pharmaceutical composition of a kind of benefiting vital QI and blood and preparation method thereof.
Background technology
The deficiency of vital energy in insufficiency of vital energy and blood and Chinese medicine and blood deficiency.The result of insufficiency of vital energy and blood can cause going down of function, causes the pathological changes of senilism.The deficiency of vital energy: namely function decline resistance against diseases is poor.The deficiency of vital energy is aversion to cold and cold limbs, spontaneous perspiration, dizziness and tinnitus, lethargy, tired unable, shortness of breath and palpitation, hypoevolutism then.Blood deficiency: lusterless complexion is sallow, xerosis cutis, hair are withered, fingernail is dry and cracked, blurring of vision, numb hand and foot, insomnia and dreamful sleep, forgetful cardiopalmus, absentminded.
The medicine of benefiting vital QI and blood is in the market various, but effect is undesirable, or the course for the treatment of is long, and side effect is large, and some carries inconvenience,
Inventor, in order to overcome the above problems, through research and clinical practice for many years, have developed a kind of new product.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition of benefiting vital QI and blood.
Another object of the present invention is to the preparation method of the pharmaceutical composition that a kind of benefiting vital QI and blood is provided.
The present invention also provides the brothers of preparation treatment caused by QI and blood deficiency ice-cold, the application in lack of appetite anorexia, clear urine in large amounts, night sweat, cardiopalmus, menoxenia, rocky medicine.
The object of the invention is to be achieved through the following technical solutions:
The pharmaceutical composition of a kind of benefiting vital QI and blood provided by the invention, is made up of the medicine of following weight portion: Poria 200-800 part, Semen pini koraiensis 50-400 part, Rhizoma Dioscoreae 200-800 part, Semen Euryales 200-800 part, Semen Sesami Nigrum 200-800 part, Semen sojae atricolor 200-800 part, Fructus Jujubae 200-800 part, Semen Juglandis 50-400 part, Fructus Lycii 200-800 part, Semen Nelumbinis 200-800 part.
The pharmaceutical composition of a kind of benefiting vital QI and blood provided by the invention, is preferably made up of the medicine of following weight portion: Poria 260-750 part, Semen pini koraiensis 80-350 part, Rhizoma Dioscoreae 260-750 part, Semen Euryales 260-750 part, Semen Sesami Nigrum 260-750 part, Semen sojae atricolor 260-750 part, Fructus Jujubae 260-750 part, Semen Juglandis 80-350 part, Fructus Lycii 260-750 part, Semen Nelumbinis 260-750 part.
The pharmaceutical composition of a kind of benefiting vital QI and blood provided by the invention, is preferably made up of the medicine of following weight portion: Poria 300-700 part, Semen pini koraiensis 100-320 part, Rhizoma Dioscoreae 300-700 part, Semen Euryales 300-700 part, Semen Sesami Nigrum 300-700 part, Semen sojae atricolor 300-700 part, Fructus Jujubae 300-700 part, Semen Juglandis 100-320 part, Fructus Lycii 300-700 part, Semen Nelumbinis 300-700 part.
The pharmaceutical composition of a kind of benefiting vital QI and blood provided by the invention, is preferably made up of the medicine of following weight portion: Poria 350-650 part, Semen pini koraiensis 150-300 part, Rhizoma Dioscoreae 350-650 part, Semen Euryales 350-650 part, Semen Sesami Nigrum 350-650 part, Semen sojae atricolor 350-650 part, Fructus Jujubae 350-650 part, Semen Juglandis 150-300 part, Fructus Lycii 350-650 part, Semen Nelumbinis 350-650 part.
The pharmaceutical composition of a kind of benefiting vital QI and blood provided by the invention, is preferably made up of the medicine of following weight portion: Poria 400-600 part, Semen pini koraiensis 180-280 part, Rhizoma Dioscoreae 400-600 part, Semen Euryales 400-600 part, Semen Sesami Nigrum 400-600 part, Semen sojae atricolor 400-600 part, Fructus Jujubae 400-600 part, Semen Juglandis 180-280 part, Fructus Lycii 400-600 part, Semen Nelumbinis 400-600 part.
The pharmaceutical composition of a kind of benefiting vital QI and blood provided by the invention, is preferably made up of the medicine of following weight portion: 500 parts, Poria, Semen pini koraiensis 250 parts, Rhizoma Dioscoreae 500 parts, Semen Euryales 500 parts, Semen Sesami Nigrum 500 parts, 500 parts, Semen sojae atricolor, Fructus Jujubae 500 parts, Semen Juglandis 250 parts, Fructus Lycii 500 parts, 500 parts, Semen Nelumbinis.
The preparation method of pharmaceutical composition provided by the invention, the method comprises the following steps:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 80 sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 1-3 time, the 3-10 that at every turn adds water doubly, extracts 0.5-3 hour at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, even with pharmaceutically acceptable carrier or mixing diluents, make preparation.
The brothers caused by preparation treatment QI and blood deficiency are ice-cold for the pharmaceutical composition that the present invention also provides, the application in lack of appetite anorexia, clear urine in large amounts, night sweat, cardiopalmus, menoxenia, rocky medicine.
Described preparation is solid preparation or liquid preparation, and described solid preparation is sheet, capsule, granule or pill; Described liquid preparation is oral liquid or injection.
Described pharmaceutically acceptable carrier or diluent refer to the pharmaceutical carrier of pharmaceutical field routine, are selected from one or more in filler, binding agent, disintegrating agent, lubricant, surfactant or correctives, wherein:
Described filler is selected from starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline Cellulose or glucose etc.
Described binding agent is selected from cellulose derivative, alginate, gelatin or polyvinylpyrrolidone etc.
Described disintegrating agent is selected from microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose or cross-linking sodium carboxymethyl cellulose.
Described lubricant is selected from stearic acid, Polyethylene Glycol, calcium carbonate, sodium bicarbonate, micropowder silica gel, Pulvis Talci or magnesium stearate.
Described surfactant is selected from smooth or Polysorbate (tween) of dodecylbenzene sodium sulfonate, stearic acid, Pluronic F68, fatty acid Pyrusussuriensis etc.
Described correctives is selected from aspartame, Sucralose or saccharin sodium.
The pharmaceutical composition of benefiting vital QI and blood provided by the invention has the following advantages:
Compared with prior art:
1) product Time of Administration of the present invention is short, benefiting vital QI and blood successful;
2) easy to carry.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
Described times amount is weight multiple, as Poria adds water 3 times, for adding the water of Poria weight 3 times amount.
Embodiment 1: capsule
1, prescription:
Poria 200g, Semen pini koraiensis 50g, Rhizoma Dioscoreae 200g, Semen Euryales 200g, Semen Sesami Nigrum 200g, Semen sojae atricolor 200g, Fructus Jujubae 200g, Semen Juglandis 50g, Fructus Lycii 200g, Semen Nelumbinis 200g
2, preparation method:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 80 mesh sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 1 time, add water 3 times at every turn, extracts 0.5 hour at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, adds the dextrin of 3 times, and mixing, makes granule, dry, incapsulates, obtains the capsule of the application.
Embodiment 2: granule
1, prescription:
Poria 800g, Semen pini koraiensis 400g, Rhizoma Dioscoreae 800g, Semen Euryales 800g, Semen Sesami Nigrum 800g, Semen sojae atricolor 800g, Fructus Jujubae 800g, Semen Juglandis 400g, Fructus Lycii 800g, Semen Nelumbinis 800g.
2, preparation method:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 300 mesh sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 3 times, add water 10 times at every turn, extracts 3 hours at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, adds the dextrin of 2 times, mixing, granulates, and dry, granulate, obtains the granule of the application.
Embodiment 3: capsule
1, prescription:
500 parts, Poria, Semen pini koraiensis 250 parts, Rhizoma Dioscoreae 500 parts, Semen Euryales 500 parts, Semen Sesami Nigrum 500 parts, 500 parts, Semen sojae atricolor, Fructus Jujubae 500 parts, Semen Juglandis 250 parts, Fructus Lycii 500 parts, 500 parts, Semen Nelumbinis.
2, preparation method:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 80 sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 2 times, add water 5 times at every turn, extracts 2 hours at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, add the dextrin of 2 times, mixing, incapsulate, obtain capsule.
Embodiment 4: tablet
1, prescription:
Poria 260g, Semen pini koraiensis 80g, Rhizoma Dioscoreae 260g, Semen Euryales 260g, Semen Sesami Nigrum 260g, Semen sojae atricolor 260g, Fructus Jujubae 260g, Semen Juglandis 80g, Fructus Lycii 260g, Semen Nelumbinis 260g
2, preparation method:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 80 mesh sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 3 times, add water 8 times at every turn, extracts 3 hours at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, add the starch of 1.5 times, mixing, tabletting, obtains tablet of the present invention.
Embodiment 5: oral liquid
1, prescription:
Poria 750g, Semen pini koraiensis 350g, Rhizoma Dioscoreae 750g, Semen Euryales 750g, Semen Sesami Nigrum 750g, Semen sojae atricolor 750g, Fructus Jujubae 750g, Semen Juglandis 350g, Fructus Lycii 750g, Semen Nelumbinis 750g
2, preparation method:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 80 mesh sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 3 times, add water 8 times at every turn, extracts 3 hours at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, filter, filtrate adds sweeting agent, perfusion, gland, sterilizing, obtains chewing gum liquid of the present invention.
Experimental example 1 pharmacodynamics test
Experiment material
One, medicine of the present invention is on the impact of blood deficiency rat hemopoietic function
1, experiment material
Laboratory animal: Wistar rat: male and female are facultative, body weight 180-200g, is provided by Guiyang Medical College.
2, experimental drug and reagent: Medications Example 3 capsule of the present invention, is provided by Guizhou Tongjitang Pharmaceutical Co., Ltd.Be mixed with concentration be 45%, 30%, 15% for subsequent use, powder with ass: Guizhou Tongjitang Pharmaceutical Co., Ltd provides, specification: every packed 5g*30 bag, it is 15% for subsequent use for being mixed with concentration.
3, experimental apparatus blood analyser: EK-6318K type (Japanese photoelectricity company), 6 Intelligent blood agglutination meters (upper Cacumen et folium clerodendri mandarinori (Clerodendron mandarinorum Diels) mechanical & electrical technology institute product).
4, experimental technique
Rat 60, is divided into 6 groups at random, often organizes 10, i.e. matched group, model group, positive drug control group (powder with ass), the high, medium and low dosage group of the invention process 3.
Before model, all animals is through socket of the eye arterial blood extracting, Blood cell analyzer detection RBC, HGB, then carries out syndrome of deficiency of blood model copy.Method: except blank group, all the other rats adopt docking (heating) to lose blood method, and once a day, each 1ml/100g body weight, continuous 5 days, carries out blood cell analysis through socket of the eye arterial blood extracting after last blood-letting.Next day starts administration, every day gastric infusion once, successive administration 14 days, dosage is respectively: high dose group of the present invention: 6g.kg
-1(30%X20ml.kg
-1); Dosage group: 4g.kg in the present invention
-1(20%X20ml.kg
-1); Low dose group of the present invention: 2g.kg
-1(10%X20ml.kg
-1); Positive drug control group (Colla Corii Asini): 4g.kg
-1(20%X20ml.kg
-1): matched group, model group: same volume pure water gavage.Respectively at modeling terminate 0 day, administration the 7th day and 14 days (last administration) through socket of the eye arterial blood extracting, carry out cell analysis.Indexs measure: RBC, HGB.
5, experimental result
Result shows, compares with blank group, and after duplicating model, the Erythrocytes of animal, content of hemoglobin all obviously decline.Show, massive blood loss may cause animal blood deficiency.Compare with model group, after animal gives the embodiment of the present invention 3 capsule product continuously, animal erythrocyte sum, content of hemoglobin, the indexs such as whole blood viscosity all have significance to improve, and prompting the present invention has obvious blood tonification effect.The results are shown in Table 1.
Table 1 embodiment of the present invention 3 capsule is on the impact of blood deficiency rat RBC, HGB
Note: compare before and after model: * * * P < 0.01; Compare after medicine with after modeling type: P < 0.05,
###P＜0.01。
Two, the invention process 3 capsule is on the impact of Lost blood anemia model mice hemopoietic function
Experiment material
Laboratory animal: kunming mice: male and female are facultative, body weight 18-22g.
Experimental drug is the same.
Experimental technique
This experiment adopts docking method to copy Lost blood anemia animal model.Get mice 60, male and female half and half, body weight 18-22g.With 75% cotton ball soaked in alcohol wiping mouse tail, distend the blood vessels hyperemia, cuts off Mus tail tip (0.25-0.3cm), take a blood sample immediately, EDTA anticoagulant, measures red blood cell count(RBC) (RBC), hemoglobin (HGB) packed cell volume (HCT).Then Mus tail wound is immersed in the scale test tube of the normal saline that 1 DEG C, 37 soil is housed, the 0.5ml until mice loses blood.Lose blood after 24h, tail end blood sampling is surveyed RBC, HGB, is got model of blood dificiency mice 50, is divided into 5 groups at random, often organizes 10, i.e. matched group, positive drug control group (powder with ass), the high, medium and low dosage group of the embodiment of the present invention 3 capsule.Every day gastric infusion once, dosage is respectively: the embodiment of the present invention 3 capsule high dose group: 9g.kg
-1(40%X20ml.kg
-1); Dosage group: 6g.kg in the embodiment of the present invention 3 capsule
-1(30%X20ml.kg
-1); The embodiment of the present invention 3 capsule low dose group: 3g.kg
-1(15%X20ml.kg
-1); Positive drug control group (Colla Corii Asini) 6g.kg-1 (30%X20mlkg
-1); Matched group, model group: same volume pure water gavage.Successive administration 7 days, after last administration 1h, RBC, HGB, HCT are surveyed in blood sampling.
Experimental result shows: the embodiment of the present invention 3 capsule increases mice Lost blood anemia model RBC, HGB, HCT obvious facilitation.The results are shown in Table 2.
Table 2 the invention process 3 capsule is on the impact of Lost blood anemia mice RBC, HGB, HCT
Compare with model group: P < 0.05, * * P < 0.01, * * * P < 0.001.
Compare with self group: P < 0.05, ##P < 0.01, ###P < 0.001.
Three, the invention process 3 capsule is on the impact of cyclophosphamide model mice hemopoietic function
1, experimental technique
Mice 60, male and female half and half, body weight 18-22g, is divided into 6 groups at random, often organizes 10, i.e. matched group, model group, positive drug control group (powder with ass), the high, medium and low dosage group of the embodiment of the present invention 3 capsule.
Except matched group, each group through intraperitoneal injection of cyclophosphamide once (230mg.kg-1 body weight), matched group injection same volume normal saline.Once, dosage is respectively each treated animal gastric infusion every day: the embodiment of the present invention 3 capsule high dose group: 9g.kg
-1(40%X20ml.kg
-1); Dosage group: 6g.kg in the embodiment of the present invention 3 capsule
-1(30%X20ml.kg
-1); The embodiment of the present invention 3 capsule low dose group 3g.kg
-1(15%X20ml.kg
-1); Positive drug control group (Colla Corii Asini): 6g.kg
-1(30%X20ml.kg
-1); Matched group, model group: same volume pure water gavage.Successive administration 14 days.Respectively at 7 days and tail end blood sampling in 14 days after administration, detect animal WBC, RBC, PLT situation of change.
2, experimental result
Show, after cyclophosphamide modeling, animal WBC, PLT all obviously reduce, and more all have significant difference (P < 0.05, P < 0.01) with blank group.Change not obvious before RB and modeling, show that cyclophosphamide is obvious on animal WBC, PLT impact.Compare with model group, the each administration group of the embodiment of the present invention 3 capsule, during administration 7 days, animal WBC, PLT counting compares there was no significant difference with model group, successive administration detects and shows for 14 days afterwards, and the embodiment of the present invention 3 capsule each administration treated animal WBC, PLT compare with model group and occur significant difference.Numeration of leukocyte (WBC) and the platelet (PLT) of cyclophosphamide model mice obviously can be raised when showing the embodiment of the present invention 3 capsule administration 14 days, the prompting embodiment of the present invention 3 capsule improves significantly to caused by cyclophosphamide mouse peripheral blood leukopenia, the results are shown in Table 3.
Table 3 embodiment of the present invention 3 capsule is on the impact of caused by cyclophosphamide model of blood dificiency
Compare with model group: * P < 0.05, * * P < 0.01, * * * P < 0.001.
Four, the embodiment of the present invention 3 capsule is on the impact of Co-Y roentgenization model mice hemopoietic function and immunologic function
1, experimental technique
Select kunming mice, 60, male and female half and half.Body weight 18-22 gram.Be divided into 6 groups at random, often organize 10.Before experiment, each treated animal tail point gets blood, measures peripheral blood WBC, RBC, PLT quantity.Except Normal group, other are respectively organized and all give subsequently
mco-Y irradiates, and a whole body dose is 550 rads, and irradiation time is 2min36.8s, and irradiation distance is 4m.
24h grouping administration after irradiating, once, successive administration 14 days, dosage is respectively each administration group gastric infusion every day: the embodiment of the present invention 3 high dose group: 9g.kg
-1(45%X20ml.kg
-1); Dosage group: 6g.kg in the embodiment of the present invention 3
-1(30%X20ml.kg
-1); The embodiment of the present invention 3 capsule low dose group: 3g.kg
-1(15%X20ml.kg
-1); Positive drug control group (Colla Corii Asini): 3g.kg
-1(15%X20ml.kg
-1); Matched group, model group: same volume pure water gavage.
24h after not secondary administration, animal gets blood 10 μ l with tail point, blood is put into the beaker filling 10ml diluent in advance, measures peripheral blood WBC, RBC, PLT.After getting blood agglomeration bundle, through tail vein injection india ink 0.05ml/10g.After injection, 1min, 5min suction pipe (use in advance heparin solution moistening) gets blood 20ul from vena orbitalis posterior respectively, is dissolved in the Na of 2ml 0.1%
2cO
3shake up in solution.Measure each sample optical density (OD), put to death animal, get liver spleen and weigh.Calculate phagocytic index K, activate the phagocytic capacity a.
2, experimental result
The embodiment of the present invention 3 capsule pair
60what Co-Y irradiated syndrome of deficiency of blood model mice peripheral hemogram affected administration after 14 days, and peripheral hemogram detects and shows.The embodiment of the present invention 3 capsule high dose group and middle dosage treated animal WBC, RBC, PLT quantity and the obvious rising of model group, show the embodiment of the present invention 3 capsule pair
60the leukocyte that Co-Y causes after irradiating, the minimizing of RBC number are significantly improved.
Table 4 embodiment of the present invention 3 capsule irradiates the impact of mouse peripheral blood elephant to Co y
| Group | Number of cases | WBC | RBC | PLT |
| Matched group | 10 | 12.87±2.86** | 9.81±0.57** | 1012±173* |
| Model group | 10 | 7.53±1.56 | 6.33±0.8l | 799±181 |
| Positive controls | 10 | 11.64±5.30* | 8.77±1.03* | 952±132* |
| High dose group | 10 | 12.66±1.28* | 8.24±1.45* | 994±151* |
| Middle dosage group | 10 | 10.53±2.167* | 8.07±1.47* | 883±175* |
| Low dose group | 10 | 9.86±4.94 | 796±1.02 | 872±165 |
Compare with model group: P < 0.05, * * P < 0.01.
The embodiment of the present invention 3 capsule pair
60co-Y irradiates the impact of syndrome of deficiency of blood model mice mononuclear phagocyte phagocytic function
Result shows, the embodiment of the present invention 3 capsule administration high dose group and middle dosage treated animal phagocytic count and bite active a and compare with model group and have significant difference (P < 0.05, P < 0.01 show that the embodiment of the present invention 3 capsule has certain facilitation to animal mononuclear phagocyte phagocytic function.
Table 5 embodiment of the present invention 3 capsule is on the impact of nonspecific immunity of mice
| Group | Number of cases | Phagocytic index K | Engulf great property a |
| Blank group | 10 | 0.03947±0.0059 | 4.3325±0.5670 |
| Model group | 10 | 0.03041±0.0096 | 4.3325±0.5670 |
| Colla Corii Asini group | 10 | 0.05172±0.0083** | 5.1267±0.8362* |
| High dose group | 10 | 0.05288±0.0087** | 5.4506±0.7178** |
| Middle dosage group | 10 | 0.05096±0.0092** | 5.1428±0.5952* |
| Low dose group | 10 | 0.04879±0.0091 | 4.8793±0.6631 |
Compare with model group: P < 0.05, * * P < 0.01.
Experimental example 2 toxicology test
The embodiment of the present invention 3 capsule animal acute toxicity test data is to understand in the embodiment of the present invention 3 capsule one day heavy dose of administration to the impact of laboratory animal safety, according to the requirement that toxicology test is observed, carry out the experimental observation of being correlated with, according to trial test situation in test, grouping administration, mice high dose group has no dead, therefore cannot calculate the median lethal dose(LD 50) (LD of said preparation
50).Test changes the mensuration of the maximum tolerated dose (MTD) of animal into.The MTD of the result animal subject oral embodiment of the present invention 3 capsule is 72g/kg body weight, 171 times of every consumption per day 0.42g/kg body weight that is equivalent to be grown up, has no toxic reaction and animal dead.According to statistics Wrightization rule, the LD the embodiment of the present invention 3 capsule oral administration can be inferred
5072g/kg must be greater than.Show that this medicine oral administration safety is larger.
1, experiment purpose: observe after heavy dose gives animal in test medicine one day, the toxic reaction situation produced and death condition.
2, materials and methods
(1) animal: 6 ~ 8 week age of kunming mice, body weight 18-20 gram, male and female half and half, are provided by Guiyang Medical College Experimental Animal Center.
(2) medicine: the embodiment of the present invention 3 capsule: provided by Guizhou Tongjitang Pharmaceutical Co., Ltd.
According to Pharmaceutical formulations situation, prompting mice is maximum can gavage concentration be 60%.
(3) test method
Maximum tolerated dose (MTD) measures:
(1) size of animal: get mice 40, male and female half and half.Sub-cage rearing after weighing, fasting 16 hours (can't help water) before test.
(2) route of administration: all animal subjects are through gastric infusion (consistent with clinical administration approach).
(3) dosage: give the embodiment of the present invention 3 capsule (Cmax) of 60% by 40ml/kg body weight (maximum volume) gavage.Test administration on the same day 3 times, 8 hours, interval.Dosage finally for the embodiment of the present invention 3 capsule get thing 72g/kg body weight.
(4) toxic reaction is observed: after test mice administration, observe toxic reaction immediately, and record the outward appearance of animal, behavioral activity, the mental status, appetite, stool, urine and color thereof, by hair, the colour of skin, breathing, secretions etc., examine fortnight continuously, the reaction that after recording administration day by day, animal occurs.
(4) experimental result
After observation shows animals administer, movablely in 4 hours slightly to reduce, after 24 hours, activity recovers normal gradually, and body weight is observed and shown that the weight of animals is not significantly affected, and breathes, movable normal, diet, drinking-water, mouth, eye, nose secretions without exception.Stool shape no abnormality seen, color is connected to medicine color, other no abnormality seen, and Continuous Observation fortnight occurs without animal dead.
Discuss and explanation
According to trial test situation, after grouping administration, high dose group animal has no dead, therefore cannot carry out the quantitative determination of animal median lethal.Change the maximum tolerance determination (MTD) of animal oral administration into.
The embodiment of the present invention 3 clinical administration amount is finished medicines 30g/ day, is equivalent to per kilogram of body weight 0.42g/kg body weight.
Test small mouse gives red granule of enriching blood (Cmax 60%) administration of Cmax ginseng by maximum gavage capacity (40ml/kg body weight), for improving dosage, adopt 3 times on the one dose regimens, because limit by drug level and gavage volume, dosage cannot increase again, therefore dosage reaches maximum tolerated dose, in result animal subject 24 hours, dosage is accumulated as 72g/kg body weight.
The embodiment of the present invention 3 capsule Mouse oral maximum tolerated dose (MTD) is to reach more than 171 times of the every consumption per day of people as calculated.Continuous Observation fortnight after administration, all test mice have been showed no Novel presentation, and none is dead.
According to statistics Wrightization rule, the LD of the embodiment of the present invention 3 capsule oral administration can be inferred
5.72g/kg body weight must be greater than.
Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. a pharmaceutical composition for benefiting vital QI and blood, is characterized in that being made up of the medicine of following weight portion: Poria 200-800 part, Semen pini koraiensis 50-400 part, Rhizoma Dioscoreae 200-800 part, Semen Euryales 200-800 part, Semen Sesami Nigrum 200-800 part, Semen sojae atricolor 200-800 part, Fructus Jujubae 200-800 part, Semen Juglandis 50-400 part, Fructus Lycii 200-800 part, Semen Nelumbinis 200-800 part.
2. pharmaceutical composition according to claim 1, is characterized in that being made up of the medicine of following weight portion: Poria 260-750 part, Semen pini koraiensis 80-350 part, Rhizoma Dioscoreae 260-750 part, Semen Euryales 260-750 part, Semen Sesami Nigrum 260-750 part, Semen sojae atricolor 260-750 part, Fructus Jujubae 260-750 part, Semen Juglandis 80-350 part, Fructus Lycii 260-750 part, Semen Nelumbinis 260-750 part.
3. pharmaceutical composition according to claim 1, is characterized in that being made up of the medicine of following weight portion: Poria 300-700 part, Semen pini koraiensis 100-320 part, Rhizoma Dioscoreae 300-700 part, Semen Euryales 300-700 part, Semen Sesami Nigrum 300-700 part, Semen sojae atricolor 300-700 part, Fructus Jujubae 300-700 part, Semen Juglandis 100-320 part, Fructus Lycii 300-700 part, Semen Nelumbinis 300-700 part.
4. pharmaceutical composition according to claim 1, is characterized in that being made up of the medicine of following weight portion: Poria 350-650 part, Semen pini koraiensis 150-300 part, Rhizoma Dioscoreae 350-650 part, Semen Euryales 350-650 part, Semen Sesami Nigrum 350-650 part, Semen sojae atricolor 350-650 part, Fructus Jujubae 350-650 part, Semen Juglandis 150-300 part, Fructus Lycii 350-650 part, Semen Nelumbinis 350-650 part.
5. pharmaceutical composition according to claim 1, is characterized in that being made up of the medicine of following weight portion: Poria 400-600 part, Semen pini koraiensis 180-280 part, Rhizoma Dioscoreae 400-600 part, Semen Euryales 400-600 part, Semen Sesami Nigrum 400-600 part, Semen sojae atricolor 400-600 part, Fructus Jujubae 400-600 part, Semen Juglandis 180-280 part, Fructus Lycii 400-600 part, Semen Nelumbinis 400-600 part.
6. pharmaceutical composition according to claim 1, is characterized in that being made up of the medicine of following weight portion: 500 parts, Poria, Semen pini koraiensis 250 parts, Rhizoma Dioscoreae 500 parts, Semen Euryales 500 parts, Semen Sesami Nigrum 500 parts, 500 parts, Semen sojae atricolor, Fructus Jujubae 500 parts, Semen Juglandis 250 parts, Fructus Lycii 500 parts, 500 parts, Semen Nelumbinis.
7. the pharmaceutical composition according to any one of claim 1-6, is characterized in that, described pharmaceutical composition is solid preparation or liquid preparation, and described solid preparation is sheet, capsule, granule or pill; Described liquid preparation is oral liquid or injection.
8. prepare a preparation method for pharmaceutical composition described in any one of claim 1-6, it is characterized in that, the method comprises the following steps:
1) take medicine by proportioning, Semen pini koraiensis, Semen Sesami Nigrum, Semen sojae atricolor, Fructus Jujubae, Semen Juglandis, Fructus Lycii, Semen Nelumbinis are pulverized, and cross 80 mesh sieves, make fine powder;
2) Jiang's Poria, Rhizoma Dioscoreae, Semen Euryales extracting in water 1-3 time, the 3-10 that at every turn adds water doubly, extracts 0.5-3 hour at every turn, and filter, collecting decoction, obtains Aqueous extracts;
3) above-mentioned Aqueous extracts is concentrated, dry, pulverize, cross 80 mesh sieves, make fine powder;
4) add step 1) fine powder, mixing, even with pharmaceutically acceptable carrier or mixing diluents, make preparation.
9. preparation method according to claim 8, is characterized in that, described pharmaceutically acceptable carrier or diluent are selected from one or more in filler, binding agent, disintegrating agent, lubricant, surfactant or correctives.
10. the brothers caused by preparation treatment QI and blood deficiency are ice-cold for the pharmaceutical composition according to any one of claim 1-6, the application in lack of appetite anorexia, clear urine in large amounts, night sweat, cardiopalmus, menoxenia, rocky medicine.
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Cited By (7)
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| CN105341912A (en) * | 2015-11-09 | 2016-02-24 | 黄名玉 | Longan health care nutrition powder with functions of calming nerves and tonifying qi |
| CN105918589A (en) * | 2016-04-28 | 2016-09-07 | 山东东美阿胶有限公司 | Donkey-hide gelatin tableted candy and preparation method thereof |
| CN106689582A (en) * | 2016-12-07 | 2017-05-24 | 邱庆森 | Health tea as well as preparation method and application thereof |
| CN107519418A (en) * | 2017-08-25 | 2017-12-29 | 武子翔 | A kind of Chinese medicine composition of physical fitness and preparation method thereof |
| CN108185426A (en) * | 2018-02-07 | 2018-06-22 | 东莞市仙津保健饮料食品有限公司 | Five cereals health food and preparation method |
| CN110169571A (en) * | 2019-05-28 | 2019-08-27 | 沈阳抗风竤生物技术有限公司 | For improving the food therapeutic composition of fecundity |
| CN110403166A (en) * | 2019-09-02 | 2019-11-05 | 重庆工商大学 | A kind of energy food and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105341912A (en) * | 2015-11-09 | 2016-02-24 | 黄名玉 | Longan health care nutrition powder with functions of calming nerves and tonifying qi |
| CN105918589A (en) * | 2016-04-28 | 2016-09-07 | 山东东美阿胶有限公司 | Donkey-hide gelatin tableted candy and preparation method thereof |
| CN106689582A (en) * | 2016-12-07 | 2017-05-24 | 邱庆森 | Health tea as well as preparation method and application thereof |
| CN107519418A (en) * | 2017-08-25 | 2017-12-29 | 武子翔 | A kind of Chinese medicine composition of physical fitness and preparation method thereof |
| CN108185426A (en) * | 2018-02-07 | 2018-06-22 | 东莞市仙津保健饮料食品有限公司 | Five cereals health food and preparation method |
| CN110169571A (en) * | 2019-05-28 | 2019-08-27 | 沈阳抗风竤生物技术有限公司 | For improving the food therapeutic composition of fecundity |
| CN110403166A (en) * | 2019-09-02 | 2019-11-05 | 重庆工商大学 | A kind of energy food and preparation method thereof |
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