CN102178839A - Pharmaceutical composition for treating blood deficiency and preparation method thereof - Google Patents

Pharmaceutical composition for treating blood deficiency and preparation method thereof Download PDF

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CN102178839A
CN102178839A CN 201110098491 CN201110098491A CN102178839A CN 102178839 A CN102178839 A CN 102178839A CN 201110098491 CN201110098491 CN 201110098491 CN 201110098491 A CN201110098491 A CN 201110098491A CN 102178839 A CN102178839 A CN 102178839A
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blood
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radix
pharmaceutical composition
deficiency
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CN102178839B (en
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黄晓巍
杨海淼
张莲珠
位鸿
李驰坤
陈声武
于秀华
欧喜燕
王明星
王丽娟
刘永强
张永和
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Changchun University of Chinese Medicine
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Abstract

The invention relates to a pharmaceutical composition for treating blood deficiency and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The pharmaceutical composition is prepared from the following bulk pharmaceutical chemicals in parts by weight: 8-10 parts of rhodiola crenulata, 5-7 parts of red ginseng, 5-7 parts of solomonseal, 5-7 parts of rhizoma atractylodis macrocephalae and 5-7 parts of lilyturf root. The pharmaceutical composition has the advantages of clear formula source, exquisite formula and definite curative effect, and particularly the red ginseng and the rhodiola crenulata benefit from each other so as to achieve outstanding curative effect on blood deficiency. By means of organic compatibility of five traditional Chinese medicinal materials, the pharmaceutical composition has functions of benefiting qi for promoting production of blood, nourishing blood for tranquilizing mind, warmly invigorating kidney-yang, invigorating spleen and replenishing qi and activating blood circulation for removing blood stasis.

Description

A kind of pharmaceutical composition for the treatment of syndrome of deficiency of blood and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, in particular for the treatment syndrome of deficiency of blood.
Background technology
Syndrome of deficiency of blood is a common clinical disease, because that blood loses is empty, loses in honor and supports, and with pale white complexion or sallow, lip, first are light white, dizziness and blurred vision, and the cardiopalmus dreaminess, brothers are numb, women's infrequent menstruation amenorrhea, light red tongue, thready pulse etc. are the syndrome of common disease.Many owing to the weary source of hemopoietic, severe loss of blood, deficiency of the kidney, serious disease etc. cause.
Bloodization is born in taste the become thoroughly decomposed essence of water and grain and the kidney essense of fortuneization, and under the promotion and astringency inducing of gas, operation is not stopped, nutrition and moist whole body.If weakness of the spleen and stomach, the decreased food intake of receiving is few, and essence of water and grain is not enough to hemopoietic, or kidney Qi deficiency, and cloudy insufficiency of essence is with change blood, or the consumption of YIN caused by febrile disease hematozemia, or tells chronic diarrhea for a long time and damage cloudy Tianjin, or the overstrain internal injury, and excessive thinking secretly consumes cloudy blood, or severe loss of blood etc., form syndrome of deficiency of blood.
Syndrome of deficiency of blood is similar to the anemia in the modern medicine, adds up according to World Health Organization (WHO): the whole world has 3,000,000,000 people anemia in various degree approximately, and cause that because of suffering from anemia the dead number of all kinds of diseases is up to ten million every year.The population probability of middle national trouble anemia is higher than western countries, and in the crowd who suffers from anemia, the women is apparently higher than the male, and old man and child are higher than the young and the middle aged.Because syndrome of deficiency of blood is clinical frequently-occurring disease, relates to multiple disease, patient group is big, so market demand is bigger.
The chemicals of treatment anemia commonly used has vitamin B12 and folic acid, vitamin B6, chalybeate, corticosteroid, testosterone or the like, these medicines have side effect in various degree, take for a long time human body is produced toxic and side effects, and be merely able to improve symptom, can not fundamentally change anemia body constitution.
Summary of the invention
The invention provides a kind of pharmaceutical composition for the treatment of syndrome of deficiency of blood and preparation method thereof, with what solve that present treatment syndrome of deficiency of blood exists human body is produced toxic and side effects, and be merely able to improve symptom, can not fundamentally change the problem of anemia body constitution.
It is under instruction of Chinese Medicine theory that this medicine is formed, and is monarch with Radix Rhodiolae, Radix Ginseng Rubra, the two compatibility, and strongly invigorating primordial QI, QI invigorating and blood producing, Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae are minister, invigorating the spleen and regulating the stomach, boosting qi and nourishing yin, lung moistening, kidney tonifying is assistant, nourishing YIN and supplementing blood, tranquilizing by nourishing the heart Radix Ophiopogonis.
Each amounts of components of medicine of the present invention also is to grope in a large number to sum up through the inventor to draw, each amounts of components better curative effect of tool all in following weight range:
8~10 parts of Radix Rhodiolaes, 5~7 parts of Radix Ginseng Rubra, 5~7 parts of Rhizoma Polygonatis, 5~7 parts of the Rhizoma Atractylodis Macrocephalaes, 5~7 parts of Radix Ophiopogonis.
Be preferably:
9 parts of Radix Rhodiolaes, 6 parts of Radix Ginseng Rubra, 6 parts of Rhizoma Polygonatis, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 6 parts of Radix Ophiopogonis.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.The preparation method of medicine activity component of the present invention is as follows:
Get 70%~90% alcohol reflux 2 times that Radix Rhodiolae in the prescription, Radix Ginseng Rubra add 5~7 times of amounts, each 1.5 hours, filter, merging filtrate reclaims ethanol, surveys relative density when being evaporated to 80 ℃ and be 1.20~1.25 extractum, and is standby; Medicinal residues decoct 2~4 times with adding Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 5~7 times of water gagings, and each 1~2 hour, decocting liquid filtered, merging filtrate, and the extractum of survey relative density 1.20~1.25 merges with alcohol-extracted extract when being evaporated to 80 ℃.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, as disintegrating agent, lubricant, binding agent etc., method of Chinese medicinal with routine is prepared into any peroral dosage form commonly used, as granule, pill, powder, tablet, capsule, oral liquid etc.
Good effect of the present invention is: according to the theory of Chinese medical science prescription, by the modern pharmacology experimental technique, molecular biology method, immunological method, myeloid element and hematopoieticmicroenviron-ment research, and humoral factor, microcirculation and hemorheology, many-sided experimentatioies such as erythrocyte membrane enzyme, from ergology, morphology, immunology, many-sides such as molecular biology are studied the main pharmacodynamics of preparation, the composition medicine tool that fully proves this medicine promotes bone marrow hematogenesis, anti-hypoxia, defying age, free radical resisting, radioprotective, antioxidation, regulate functions such as immune system and hormonal system, thereby can obtain curative effect preferably clinically.
By theory of Chinese medical science, side of the present invention source is clear, the compatibility exquisiteness, and determined curative effect, particularly Radix Ginseng Rubra and Radix Rhodiolae compatibility bring out the best in each other, and treatment syndrome of deficiency of blood curative effect is particularly outstanding.By organic compatibility of Chinese medicine of the five flavours, this medicine has QI invigorating and blood producing, nourishing blood to tranquillize the mind, warming and recuperating the kidney-YANG, invigorating the spleen and benefiting QI, the function of blood circulation promoting and blood stasis dispelling, for pale white complexion or sallow, lip, first are light white, dizziness and blurred vision, cardiopalmus dreaminess, brothers are numb, women's infrequent menstruation amenorrhea, light red tongue, blood deficiency symptoms such as thready pulse improve significantly.Specification: 10 gram/bags, oral each 1 bag, three times on the one.
The specific embodiment
The preparation of embodiment 1 capsule
Radix Rhodiolae 800g, Radix Ginseng Rubra 500g, Rhizoma Polygonati 500g, Rhizoma Atractylodis Macrocephalae 500g, Radix Ophiopogonis 500g;
Get 70% alcohol reflux 2 times that Radix Rhodiolae in the prescription, Radix Ginseng Rubra add 5 times of amounts, each 1.5 hours, filter, merging filtrate reclaims ethanol, surveys relative density when being evaporated to 80 ℃ and be 1.20 extractum, and is standby; Medicinal residues decoct 2 times with adding Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 5 times of water gagings, and each 1 hour, decocting liquid filtered, merging filtrate, survey the extractum of relative density 1.20 when being evaporated to 80 ℃, merge with alcohol-extracted extract, drying is ground into fine powder, mixing is granulated, and incapsulates, promptly.
Embodiment 2 preparation tablets
Radix Rhodiolae 900g, Radix Ginseng Rubra 600g, Rhizoma Polygonati 600g, Rhizoma Atractylodis Macrocephalae 600g, Radix Ophiopogonis 600g.
Get 80% alcohol reflux 2 times that Radix Rhodiolae in the prescription, Radix Ginseng Rubra add 6 times of amounts, each 1.5 hours, filter, merging filtrate reclaims ethanol, surveys relative density when being evaporated to 80 ℃ and be 1.23 extractum, and is standby; Medicinal residues decoct 3 times with adding Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 6 times of water gagings, and each 1.5 hours, decocting liquid filtered, merging filtrate, the extractum of survey relative density 1.23 merges with alcohol-extracted extract when being evaporated to 80 ℃, drying is ground into fine powder, with ethanol system granule, drying, granulate is crossed 18 mesh sieves, add 0.5% magnesium stearate, beat sheet, every heavy 0.5g, packing, promptly.
The preparation of embodiment 3 watered pill
Radix Rhodiolae 1000g, Radix Ginseng Rubra 700g, Rhizoma Polygonati 700g, Rhizoma Atractylodis Macrocephalae 700g, Radix Ophiopogonis 700g.
Get 90% alcohol reflux 2 times that Radix Rhodiolae in the prescription, Radix Ginseng Rubra add 7 times of amounts, each 1.5 hours, filter, merging filtrate reclaims ethanol, surveys relative density when being evaporated to 80 ℃ and be 1.25 extractum, and is standby; Medicinal residues decoct 4 times with adding Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 7 times of water gagings, and each 2 hours, decocting liquid filtered, merging filtrate, survey the extractum of relative density 1.25 when being evaporated to 80 ℃, merge drying with alcohol-extracted extract, be ground into fine powder, the general ball of the starch slurry of water or debita spissitudo, drying, polishing, packing, promptly.
Below further set forth the beneficial effect of medicine of the present invention by testing example, these test the routine pharmacodynamics test that has comprised medicine of the present invention.
Experiment material
One, medicine of the present invention is to the influence of blood deficiency rat hemopoietic function
1, experiment material
Laboratory animal: the Wistar rat: male and female are facultative, body weight 180-200g.Provide by high-new medical experiment zooscopy center, Changchun.The quality certification number: SCXK (Ji) 2008-0004.
Experimental drug and reagent medicine of the present invention hereinafter to be referred as the red granule of enriching blood of ginseng, is pressed embodiment 2 prescription and methods, is provided by The Affiliated Hospital to Changchun University of Chinese Medicine Chinese medicine experimental center.Be mixed with concentration and be 45%, 30%, 15% standby; The donkey-hide gelatin and Chinese angelica root granule: medicine shrine (Hunan) pharmaceutical Co. Ltd, specification: every packed 5g*30 bag is mixed with concentration and is 15% standby.
Experimental apparatus blood analyser: MEK-6318K type (Japanese photoelectricity company), 96 intelligent blood agglutometers (going up Cacumen et folium clerodendri mandarinori (Clerodendron mandarinorum Diels) mechanical ﹠ electrical technology institute product).
2, experimental technique
60 of rats are divided into 6 groups at random, and 10 every group, i.e. matched group, model group, positive drug control group (donkey-hide gelatin and Chinese angelica root granule), the high, medium and low dosage group of the red granule of enriching blood of ginseng.
All animals is through the socket of the eye arterial blood extracting before the model, and cellanalyzer detects RBC, HGB, carries out the syndrome of deficiency of blood model copy then.Method: except that the blank group, all the other rats are adopted docking (heating) method of losing blood, once a day, each 1ml/100g body weight, continuous 5 days, the last blood-letting was after the socket of the eye arterial blood extracting carries out blood cell analysis.Begin administration next day, every day gastric infusion once, successive administration 14 days, dosage is respectively: join red granule high dose group: the 6gkg that enriches blood -1(30% * 20mlkg -1); Join dosage group: 4gkg in the red granule of enriching blood -1(20% * 20mlkg -1); Join red granule low dose group: the 2gkg that enriches blood -1(10% * 20mlkg -1); Positive drug control group (Colla Corii Asini): 4gkg -1(20% * 20mlkg -1); Matched group, model group: irritate stomach with the volume pure water.Finish 0 day, administration the 7th day and 14 days (last administration) through the socket of the eye arterial blood extracting respectively at modeling, carry out cell analysis.Index detects: RBC, HGB.
3, experimental result
The result shows, compares with the blank group, and the erythrocyte sum of animal, content of hemoglobin all obviously descend behind the duplicating model.Show that massive blood loss may cause the animal blood deficiency.Compare with model group, after animal is joined the red granule of enriching blood continuously, animal erythrocyte sum, content of hemoglobin, indexs such as whole blood viscosity all have significance to improve, and the red granule of enriching blood of prompting ginseng is to having tangible blood tonification effect.The results are shown in Table 1.
Table 1 ginseng is red enrich blood granule to the influence of blood deficiency rat RBC, HGB (
Figure BSA00000476903300051
N=10)
Annotate: compare before and after the model: * * * P<0.01; Compare behind the medicine with behind the modeling type: #P<0.05, ###P<0.01.
Two, the red influence of granule of enriching blood of ginseng to losing blood property model of blood dificiency mice hemopoietic function
1, experiment material
Laboratory animal: kunming mice: male and female are facultative, body weight 18-22g.Provide by high-new medical experiment zooscopy center, Changchun.The quality certification number: SCXK (Ji) 2008-0004.
Experimental drug is the same.
2, experimental technique
This experiment adopts the docking method to duplicate losing blood property blood deficiency animal model.Get 60 of mices, male and female half and half, body weight 18-22g.With 75% cotton ball soaked in alcohol wiping mouse tail, the hyperemia that distends the blood vessels cuts off Mus tail tip (0.25-0.3cm), blood sampling immediately, and the EDTA anticoagulant is measured 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 be equipped with 37 ± 1 ℃, until the mice 0.5ml that loses blood.Lose blood behind the 24h, the tail end blood sampling is surveyed RBC, HGB, is got 50 of model of blood dificiency mices, is divided into 5 groups at random, and 10 every group, i.e. matched group, positive drug control group (donkey-hide gelatin and Chinese angelica root granule), the high, medium and low dosage group of the red granule of enriching blood of ginseng.Every day gastric infusion once, dosage is respectively: join red granule high dose group: the 9gkg that enriches blood -1(40% * 20mlkg -1); Join dosage group: 6gkg in the red granule of enriching blood -1(30% * 20mlkg -1); Join red granule low dose group: the 3gkg that enriches blood -1(15% * 20mlkg -1); Positive drug control group (Colla Corii Asini): 6gkg -1(30% * 20mlkg -1); Matched group, model group: irritate stomach with the volume pure water.Successive administration 7 days, RBC, HGB, HCT are surveyed in blood sampling behind the last administration 1h.
3, the experimental result result shows: joining the red granule of enriching blood has obvious facilitation to losing blood property of mice model of blood dificiency RBC, HGB, HCT increase.The results are shown in Table 2.
Table 2 ginseng is red enrich blood granule to the influence of losing blood property blood deficiency mice RBC, HGB, HCT (
Figure BSA00000476903300061
N=10)
Figure BSA00000476903300062
Compare with model group: * P<0.05, * * P<0.01, * * * P<0.001.
Organize comparison with self: #P<0.05, ##P<0.01, ###P<0.001.
Three, the red influence of granule of enriching blood of ginseng to cyclophosphamide model mice hemopoietic function
1, experimental technique
60 of mices, male and female half and half, body weight 18-22g is divided into 6 groups at random, and 10 every group, i.e. matched group, model group, positive drug control group (donkey-hide gelatin and Chinese angelica root granule), the high, medium and low dosage group of the red granule of enriching blood of ginseng.
Except that matched group, each group is through intraperitoneal injection of cyclophosphamide once (230mgkg-1 body weight), and matched group is injected with the volume normal saline.Each treated animal gastric infusion every day once, dosage is respectively: join red granule high dose group: the 9gkg that enriches blood -1(40% * 20mlkg -1); Join dosage group: 6gkg in the red granule of enriching blood -1(30% * 20mlkg -1); Join red granule low dose group: the 3gkg that enriches blood -1(15% * 20mlkg -1); Positive drug control group (Colla Corii Asini): 6gkg -1(30% * 20mlkg -1); Matched group, model group: irritate stomach with the volume pure water.Successive administration 14 days.Respectively at 7 days and tail end blood sampling in 14 days after the administration, detect animal WBC, RBC, PLT situation of change.
2, experimental result
The result shows that after cyclophosphamide was made, animal WBC, PLT all obviously reduced, and with the blank group significant difference (P<0.05, P<0.01) are arranged more all.The preceding variation of RBC and modeling is not obvious, shows that cyclophosphamide to animal WBC, PLT influence obviously.
Compare with model group, join red each the administration group of granule of enriching blood, administration is in the time of 7 days, and animal WBC, PLT counting compares there was no significant difference with model group, successive administration detects after 14 days and shows, joins red granule each administration treated animal WBC, PLT and the model group of enriching blood and significant difference relatively occurs.Show the red granule administration of enriching blood of ginseng can obviously raise in the time of 14 days numeration of leukocyte (WBC) and the platelet (PLT) of cyclophosphamide model mice, minimizing improves significantly the red granule of enriching blood of prompting ginseng to caused by cyclophosphamide mice peripheral blood leucocyte, the results are shown in Table 3.
Table 3 ginseng is red enrich blood granule to the influence of caused by cyclophosphamide model of blood dificiency (
Figure BSA00000476903300071
N=10)
Figure BSA00000476903300072
Compare with model group: * P<0.05, * * P<0.01, * * * P<0.001.
Four, the red granule of enriching blood of ginseng is right 60Co-radiation gamma model mice hemopoietic function and Immune Effects
1, experimental technique
Select kunming mice for use, 60, male and female half and half.Body weight 18-22 gram.Be divided into 6 groups at random, 10 every group.Each treated animal tail point is got blood before the experiment, measures peripheral blood WBC, RBC, PLT quantity.Except that the normal control group, other each groups all give subsequently 60The Co-gamma-radiation, a whole body dose is 550 rads, and irradiation time is 2min36.8s, and irradiation distance is 4m.
Irradiation back 24h grouping administration, each administration group gastric infusion every day once, successive administration 14 days, dosage is respectively: join red granule high dose group: the 9gkg that enriches blood -1(45% * 20mlkg -1); Join dosage group: 6gkg in the red granule of enriching blood -1(30% * 20mlkg -1); Join red granule low dose group: the 3gkg that enriches blood -1(15% * 20mlkg -1); Positive drug control group (Colla Corii Asini): 3gkg -1(15% * 20mlkg -1); Matched group, model group: irritate stomach with the volume pure water.
24h after the not inferior administration, animal is got blood 10 μ l with the tail point, and blood is put into the beaker that fills the 10ml diluent in advance, measures peripheral blood WBC, RBC, PLT.After getting the blood agglomeration bundle, through tail vein injection india ink 0.05ml/10g.Injection back 1min, 5min get blood 20ul from vena orbitalis posterior respectively with suction pipe (use in advance heparin solution moistening), are dissolved in the Na2CO3 solution of 2ml0.1% shaking up.Measure each sample optical density (OD), put to death animal, get the liver spleen and weigh.Calculate phagocytic index K, activate the phagocytic capacity α.
3, experimental result
(1) the red granule of enriching blood of ginseng is right 60The influence of Co-gamma-radiation syndrome of deficiency of blood model mice peripheral hemogram
After the administration 14 days, peripheral hemogram detects and shows.Join red enrich blood granule high dose group and middle dosage treated animal WBC, RBC, PLT quantity and the apparent in view rising of model group, show that the red granule of enriching blood of ginseng is right 60The leukocyte that causes behind the Co-gamma-radiation, the minimizing of the RBC number effect of having clear improvement.
The red granule of enriching blood of table 4 ginseng is right 60The influence of Co-gamma-radiation mice peripheral hemogram ( N=10)
Figure BSA00000476903300082
Compare with model group: * P<0.05, * * P<0.01.
(2) the red granule of enriching blood of ginseng is right 60The influence of Co-gamma-radiation syndrome of deficiency of blood model mice mononuclear phagocyte phagocytic function
The result shows, joining red enrich blood granule administration high dose group and middle dosage group treated animal phagocyte K phagocytic index and activate the phagocytic capacity α and model group relatively has significant difference (P<0.05, P<0.01 shows that the red granule of enriching blood of ginseng has certain facilitation to animal mononuclear phagocyte phagocytic function.
Table 5 ginseng is red enrich blood granule to the influence of mice non-specific immunity (
Figure BSA00000476903300091
N=10)
Figure BSA00000476903300092
Compare with model group: * P<0.05, * * P<0.01.
The red granule animal acute toxicity test data of enriching blood of toxicologic study-ginseng
For understanding in the red granule one day of enriching blood of ginseng heavy dose of administration to the laboratory animal Influence on security, requirement according to the toxicology test observation, the experimental observation of being correlated with, in the test according to the trial test situation, the grouping administration, the mice high dose group is not seen death, therefore can't 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 red particulate MTD that enriches blood of the oral ginseng of animal subject is the 72g/kg body weight as a result, and 171 times of consumption 0.42g/kg body weight every day that is equivalent to be grown up are not seen toxic reaction and animal dead.According to statistics Wrightization rule, can infer the LD that the red particulate oral administration of enriching blood of ginseng 50Must be greater than 72g/kg.Show that this medicine oral administration safety is bigger.
Experiment purpose: observe to be subjected to after heavy dose gives animal in the reagent thing one day the toxic reaction situation and the death condition that are produced.
Materials and methods
1. animal: 6~8 ages in week of kunming mice, body weight 18-20 gram, male and female half and half are provided by Changchun medical experiment animal center.The quality certification number: SCXK (Ji) 2008-0004.
2. medicine: join the red granule of enriching blood: provide by pharmacy chamber, The Affiliated Hospital to Changchun University of Chinese Medicine Chinese medicine experimentation center.Lot number 090801.
According to medicine preparation situation, it is 60% that prompting mice maximum can be irritated stomach concentration.
3. test method
Maximum tolerated dose (MTD) is measured:
(1) size of animal: get 40 of mices, male and female half and half.Sub-cage rearing after weighing, fasting 16 hours (can't help water) before the test.
(2) route of administration: all animal subjects are through gastric infusion (consistent with the clinical administration approach).
(3) dosage: irritate stomach by 40ml/kg body weight (maximum volume) and give 60% the red granule of enriching blood of ginseng (Cmax).Test administration on the same day 3 times, 8 hours at interval.Dosage finally is: join the red particulate thing 72g/kg body weight of getting of enriching blood.
(4) observe toxic reaction: after being tried the mice administration, observe toxic reaction immediately, and the outward appearance, behavioral activity, the mental status, appetite of record animal, just large and small and color, by hair, the colour of skin, breathing, secretions etc., observe continuously fortnight, write down the reaction that animal occurs after the administration day by day.
Experimental result
After observation shows animals administer, movablely in 4 hours slightly reduce, activity recovers normally gradually after 24 hours, and body weight is observed and shown that the weight of animals is not subjected to obviously to influence, and breathes, normally movable diet, drinking-water, mouth, eye, the no abnormal secretions of nose.Stool shape no abnormality seen, color approaches the medicine color, and other no abnormality seen is observed fortnight continuously, and no animal dead takes place.
Discuss and explanation
Said preparation is the compound granular agent, and according to the trial test situation, the high dose group animal does not see death after the grouping administration, measures so can't carry out the animal median lethal dose(LD 50).Change the maximum tolerance determination (MTD) of animal oral administration into.
Joining the red granule clinical administration amount of enriching blood is finished medicines 30g/ day, is equivalent to per kilogram of body weight 0.42g/kg body weight.
Mice gives the administration of the Cmax ginseng red granule of enriching blood (Cmax 60%) by the maximum gastric capacity (40ml/kg body weight) of irritating in the test, for improving dosage, adopt 3 times on the one dose regimen, because of being subjected to drug level and irritating that body of stomach is long-pending to be limit, dosage can't increase again, so dosage reached maximum tolerated dose, dosage is accumulated as the 72g/kg body weight in the animal subject 24 hours as a result.
Join the red oral maximum tolerated dose of granule mice (MTD) of enriching blood as calculated to reach more than 171 times of people's consumption every day.Observe fortnight after the administration continuously, all are tried mice and there is no unusual performance, none death.
According to statistics Wrightization rule, can infer the LD of the red particulate oral administration of enriching blood of ginseng 50Must be greater than the 72g/kg body weight.

Claims (3)

1. a pharmaceutical composition for the treatment of syndrome of deficiency of blood is characterized in that: be to be made by the crude drug of following ratio of weight and number: 8~10 parts of Radix Rhodiolaes, 5~7 parts of Radix Ginseng Rubra, 5~7 parts of Rhizoma Polygonatis, 5~7 parts of the Rhizoma Atractylodis Macrocephalaes, 5~7 parts of Radix Ophiopogonis.
2. the pharmaceutical composition of treatment syndrome of deficiency of blood according to claim 1 is characterized in that: be to be made by the crude drug of following ratio of weight and number: 9 parts of Radix Rhodiolaes, 6 parts of Radix Ginseng Rubra, 6 parts of Rhizoma Polygonatis, 6 parts of the Rhizoma Atractylodis Macrocephalaes, 6 parts of Radix Ophiopogonis.
3. the preparation of drug combination method of treatment syndrome of deficiency of blood as claimed in claim 1 or 2, it is characterized in that comprising the following steps: to get 70%~90% alcohol reflux 2 times that Radix Rhodiolae in the prescription, Radix Ginseng Rubra add 5~7 times of amounts, each 1.5 hours, filter, merging filtrate, reclaim ethanol, the survey relative density is 1.20~1.25 extractum when being evaporated to 80 ℃, and is standby; Medicinal residues decoct 2~4 times with adding Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Radix Ophiopogonis 5~7 times of water gagings, and each 1~2 hour, decocting liquid filtered, merging filtrate, and the extractum of survey relative density 1.20~1.25 merges with alcohol-extracted extract when being evaporated to 80 ℃.
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* Cited by examiner, † Cited by third party
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CN112244298A (en) * 2020-11-26 2021-01-22 上海市肺科医院 A Ginseng radix Rubri iron folic acid composition for adjuvant chemotherapy of lung tumor and its preparation method
CN113350469A (en) * 2021-06-18 2021-09-07 北京理工亘舒科技有限公司 Traditional Chinese medicine composition with anti-radiation function, preparation method and application thereof, and product containing traditional Chinese medicine composition

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Publication number Priority date Publication date Assignee Title
CN112076228A (en) * 2019-06-13 2020-12-15 新疆维吾尔药业有限责任公司 Medicine and food dual purpose Chinese medicinal product for treating blood deficiency syndrome and its manufacturing method
CN112244298A (en) * 2020-11-26 2021-01-22 上海市肺科医院 A Ginseng radix Rubri iron folic acid composition for adjuvant chemotherapy of lung tumor and its preparation method
CN113350469A (en) * 2021-06-18 2021-09-07 北京理工亘舒科技有限公司 Traditional Chinese medicine composition with anti-radiation function, preparation method and application thereof, and product containing traditional Chinese medicine composition
CN113350469B (en) * 2021-06-18 2022-05-10 北京理工亘舒科技有限公司 Traditional Chinese medicine composition with anti-radiation function, preparation method and application thereof, and product containing traditional Chinese medicine composition

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