CN101088521A - Astragalus medicine prepn and its prepn process - Google Patents
Astragalus medicine prepn and its prepn process Download PDFInfo
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- CN101088521A CN101088521A CN 200610087236 CN200610087236A CN101088521A CN 101088521 A CN101088521 A CN 101088521A CN 200610087236 CN200610087236 CN 200610087236 CN 200610087236 A CN200610087236 A CN 200610087236A CN 101088521 A CN101088521 A CN 101088521A
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Abstract
The present invention relates to medicine preparation, and is especially one kind of medicine preparation containing astragalus polysaccharide and astragaloside A as the effective components and its preparation process. The astragalus preparation of the present invention has functions of treating heart failure and viral myocarditis, protecting liver, strengthening immunity, invigorating qi and antagonizing stress.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, particularly relate to a kind of pharmaceutical preparation that contains astragalus polysaccharides and astragaloside active ingredient and preparation method thereof.
Background technology
Radix Astragali injection (the WS of present listing
3-what B-3335-98) adopt is the decocting in water alcohol deposition method, and one of the effective ingredient in Radix Astragali astragalus polysaccharides is discarded, and only keeps astragaloside, and the glucoside content limit is that every 1ml must not be less than 0.08mg, 2ml (being equivalent to crude drug 4g) should be and is no less than 0.16mg.
Modern study shows, herbal polysaccharide has immunomodulating, antitumor, antiviral, infection, defying age, the anti-width of cloth and penetrates effects such as protection cardiac muscle and blood sugar lowering.Contain polysaccharide (APS) 1.3%～3.3% in the Chinese medicine astragalus, the immunoregulation effect that astragalus polysaccharides has shows the antagonism to immunosuppressant, strengthens humoral immunization and cellular immunization, promotes complement to recover, and promotes the recovery raising of neutrophilic leukocyte phagocytic rate etc.; Astragalus polysaccharides is to the effect of cardiovascular system; the dog heart that shows as acute myocardial infarction has the myocardial contractility of improvement, dwindles myocardial infarction area, alleviates the effect of myocardial damage; the Acute Myocardial Ischemia in Rats that pituitrin is caused has significant protective effect, can obviously resist Bacl
2Rat ventricular that brings out and CHCl
3Quivering in the mice chamber of bringing out, can reduce platelet adhesion rate, decreased heart rate, and microcirculation is had certain improvement effect; Astragalus polysaccharides has obvious antineoplastic: showing as cancer ascites lymphocyte (CTL) activated has potentiation, human peripheral blood single nucleus cell is produced tumor necrosis factor facilitation, improves the regulating action of LAK cell anti-tumor activity and can obviously reduce the general oxygen consumption and hypoxia-bearing capability etc. is organized in increase.In addition, astragalus polysaccharides also has blood sugar lowering and anti-aging effects etc.
More than the explanation astragalus polysaccharides is a kind of important biological material, and the pharmacological action of its pharmacological action and astragaloside is similar, and its immunoregulation effect is stronger.And astragalus polysaccharides occupies bigger ratio in the effective ingredient of the Radix Astragali, therefore presses for a kind of new medicinal preparation that contains astragalus polysaccharides and astragaloside of research and development, makes it bring into play better effect clinically.
Summary of the invention
Purpose of the present invention overcomes the deficiencies in the prior art exactly, and a kind of pharmaceutical preparation that contains astragalus polysaccharides and astragaloside is provided, and makes it more can embody the effect of the Radix Astragali, is fit to clinical practice.
An object of the present invention is to provide a kind of astruganus root medicinal preparation.
Another object of the present invention provides the preparation method of described astruganus root medicinal preparation.
The objective of the invention is to be achieved through the following technical solutions:
A kind of astruganus root medicinal preparation, it is 1mg-10g with the glucose meter that astragalus polysaccharides is contained in every preparation unit, astragaloside 0.04mg-0.5g, randomly right amount of auxiliary materials.
Preferably, a kind of astruganus root medicinal preparation, it is 5mg-3g with the glucose meter that astragalus polysaccharides is contained in every preparation unit, astragaloside 0.08mg-45mg, randomly right amount of auxiliary materials.
More preferably, a kind of astruganus root medicinal preparation, it is 10mg-0.8g with the glucose meter that astragalus polysaccharides is contained in every preparation unit, astragaloside 0.2mg-9mg, randomly right amount of auxiliary materials.
A kind of astruganus root medicinal preparation of the present invention, described adjuvant are selected from one or more mixture in mannitol, lactose, glucose, sodium chloride, sorbitol, the dextran, and content 0-300mg is preferred, content 100-300mg.
The preparation method of a kind of astruganus root medicinal preparation of the present invention, it may further comprise the steps;
1) get the Radix Astragali, decoct with water, filter, filtrate concentrates the back ethanol precipitation, leave standstill, filter, get precipitate A and filtrate, filtrate recycling ethanol also concentrates, with the ethanol precipitation of medical material amount, filter, filtrate recycling ethanol concentrates, add the ethanol precipitation of 1/2 medical material amount, leave standstill, filter filtrate recycling ethanol, concentrate, add the dehydrated alcohol precipitation of 1/4 medical material amount, cold preservation is filtered clear and bright, filtrate recycling ethanol also is concentrated near doing, and vacuum drying gets the astragaloside intermediate;
2) taking precipitate A vacuum drying with the dissolving of distilled water heated and boiled, adds active carbon and stirs evenly, cold preservation then, extract supernatant, filter, filtrate concentrates, and adds ethanol precipitation, leave standstill clarification, leaching precipitation, precipitation washing with alcohol, vacuum drying, dry back is with 1: 50 times distilled water heated and boiled dissolving, and solution cold preservation is filtered clear and brightly, and filtrate is concentrated, add ethanol precipitation, make solution contain the alcohol amount and reach 80%, leave standstill clarification, the leaching precipitation, use washing with alcohol, vacuum drying gets the astragalus polysaccharides intermediate;
3) get the astragaloside intermediate, add injection and blunge after the dissolving, regulate pH7.0～7.5, add active carbon, stir evenly, adsorb, use filtering decarbonization, pump into rare joining in the cylinder with 10% sodium hydroxide solution, standby; Add the injection water and put dense joining in the cylinder, under agitation add astragalus polysaccharides intermediate and adjuvant successively, after the heated and boiled dissolving, add active carbon, stir evenly, 70～80 ℃ of down insulation absorption 15 minutes, during stir filtering decarbonization 2～3 times, pump into rare joining in the cylinder, stir evenly, fine straining is made astruganus root medicinal preparation to clear and bright.
Preferably, the preparation method of a kind of astruganus root medicinal preparation of the present invention, it may further comprise the steps;
1) get the Radix Astragali, adding distil water decocts 2-3 time, decocts 1-2 hour with 8 times of amounts at every turn, merge decoction liquor, filter, filtrate concentrates, use ethanol precipitation, make amount of alcohol reach 70%-80%, standing over night, filter, get precipitate A and filtrate, filtrate recycling ethanol also concentrates, the ethanol precipitation of reuse medical material amount, standing over night is filtered, filtrate recycling ethanol also concentrates, and adds the ethanol precipitation of 1/2 medical material amount then, leaves standstill 3-5 hour, filter, filtrate recycling ethanol, and concentrate, the dehydrated alcohol precipitation that adds 1/4 medical material amount, cold preservation 3-4 hour, filter clear and brightly, filtrate recycling ethanol also is concentrated near doing, at 70～80 ℃ of vacuum dryings, get the astragaloside intermediate;
2) the precipitate A of leaching with 1: 50 times distilled water heated and boiled dissolving, adds active carbon and stirs evenly then at 70～80 ℃ of following vacuum dryings, cold preservation is spent the night, and extracts supernatant, filters, filtrate concentrates, and adds ethanol precipitation, makes solution contain the alcohol amount and reaches 80%, leave standstill clarification, leaching precipitation, precipitate washing with alcohol, in 70～80 ℃ of following vacuum dryings, dissolve with 1: 50 times distilled water heated and boiled dry back, and solution cold preservation 10-14 hour is filtered clear and bright, filtrate concentrates, add ethanol precipitation, make solution contain the alcohol amount and reach 80%, leave standstill clarification, the leaching precipitation, use washing with alcohol,, get the astragalus polysaccharides intermediate at 70～80 ℃ of following vacuum dryings;
3)) get the astragaloside intermediate, add injection and blunge after the dissolving, regulate pH7.0～7.5 with 10% sodium hydroxide solution, the adding active carbon, stir evenly, adsorbed 10～15 minutes, during stir 2～3 times, take off charcoal with 0.85 μ m filtering with microporous membrane, pump into rare joining in the cylinder, standby; Add the injection water and put dense joining in the cylinder, stir and add astragalus polysaccharides intermediate and adjuvant down successively, after the heated and boiled dissolving, add active carbon and stir evenly, be incubated absorption 15 minutes down at 70～80 ℃, stir during this time 2～3 times, take off charcoal with 0.85 μ m filtering with microporous membrane, pump into rare joining in the cylinder, stir evenly, to clear and bright, make astruganus root medicinal preparation with 0.22 μ m microporous filter membrane fine straining.
The Radix Astragali that uses in the preparation method of a kind of astruganus root medicinal preparation of the present invention, preferred Gansu Radix Astragali.
Astruganus root medicinal preparation of the present invention can be made various dosage forms, comprises lyophilized injectable powder, injectable powder, small-volume injection, bulk capacity injection etc., and route of administration is intravenous injection.
A kind of astruganus root medicinal preparation of the present invention adopts new processing step, make it not only contain astragaloside, and contain biological activities such as astragalus polysaccharides, the immunoregulation effect that astragalus polysaccharides has shows the antagonism to immunosuppressant, strengthen humoral immunization and cellular immunization, promote complement to recover, promote the recovery raising of neutrophilic leukocyte phagocytic rate etc.; Astragalus polysaccharides is to the effect of cardiovascular system; the dog heart that shows as acute myocardial infarction has the myocardial contractility of improvement, dwindles myocardial infarction area, alleviates the effect of myocardial damage; the Acute Myocardial Ischemia in Rats that pituitrin is caused has significant protective effect, can obviously resist Bacl
2Rat ventricular that brings out and CHCl
3Quivering in the mice chamber of bringing out, can reduce platelet adhesion rate, decreased heart rate, and microcirculation is had certain improvement effect; Astragalus polysaccharides has obvious antineoplastic: showing as cancer ascites lymphocyte (CTL) activated has potentiation, human peripheral blood single nucleus cell is produced tumor necrosis factor facilitation, improves the regulating action of LAK cell anti-tumor activity and can obviously reduce the general oxygen consumption and hypoxia-bearing capability etc. is organized in increase.In addition, astragalus polysaccharides also has blood sugar lowering and anti-aging effects etc.
Astruganus root medicinal preparation of the present invention has Yiqiyangyuan, and strengthening vital QI to eliminate pathogenic factors nourishes heart and promotes blood circulation, invigorating spleen to remove dampness.Be used for that the motive is deficient, the diseases such as hepatitis of the viral myocarditis of blood-vessel obstructive, cardiac insufficiency and stagnation of dampness due to deficiency of the spleen.
The specific embodiment
Following examples are in order further to describe the present invention for example, rather than limit the present invention by any way.
Embodiment 1: a kind of Radix Astragali medicament freeze-drying powder injection formulation
1) get Gansu Radix Astragali 4kg, adding distil water decocts 3 times, decocts 1.5 hours with 8 times of amounts at every turn, merge decoction liquor, filter, filtrate is concentrated into every 1ml and is equivalent to medical material 2g, use ethanol precipitation, make amount of alcohol reach 75%, standing over night, filter, precipitate A and filtrate, filtrate recycling ethanol also is concentrated into every 1ml and is equivalent to medical material 10g, with the ethanol precipitation of medical material amount, standing over night, filter, filtrate recycling ethanol also is concentrated into every 1ml and is equivalent to medical material 15g, adds the ethanol precipitation of 1/2 medical material amount, left standstill 4 hours, filter, filtrate recycling ethanol is concentrated into every 1ml and is equivalent to medical material 15g, the dehydrated alcohol precipitation that adds 1/4 medical material amount, cold preservation 4 hours is filtered clear and brightly, and filtrate recycling ethanol also is concentrated near doing, at 70～80 ℃ of vacuum dryings, get the astragaloside intermediate;
2) the precipitate A of leaching is at 70～80 ℃ of following vacuum dryings, with 1: 50 times distilled water heated and boiled dissolving, add active carbon and stir evenly then, cold preservation is spent the night, extract supernatant, filter, filtrate is concentrated into every 1ml and is equivalent to crude drug 5g, adds ethanol precipitation, make solution contain the alcohol amount and reach 80%, leave standstill clarification, leaching precipitation, precipitate washing with alcohol 2 times, in 70～80 ℃ of following vacuum dryings, dissolve with 1: 50 times distilled water heated and boiled dry back, and solution cold preservation 12 hours is filtered clear and bright, filtrate is concentrated into every 1ml and is equivalent to crude drug 5g, add ethanol precipitation, make solution contain the alcohol amount and reach 80%, leave standstill clarification, the leaching precipitation, with washing with alcohol 2 times, at 70～80 ℃ of following vacuum dryings, the astragalus polysaccharides intermediate.
3) get the astragaloside intermediate, adding the injection water joins in the cylinder after the stirring and dissolving dense, regulate pH7.0～7.5 with 10% sodium hydroxide solution, add 0.1% (W/V) active carbon, stir evenly, adsorbed 15 minutes, stir during this time 2～3 times, to clear and bright, pump into rare joining in the cylinder with the reinforced filtering with microporous membrane of 0.85 μ m, standby; Add the injection water and put dense joining in the cylinder, under agitation add astragalus polysaccharides intermediate and 250g mannitol successively, after the heated and boiled dissolving, adding 0.2% (W/V) active carbon stirs evenly, be incubated absorption 15 minutes down at 70～80 ℃, stir during this time 2～3 times, filtering decarbonization pumps into rare joining in the cylinder after clear and bright, add injection and wash the dense cylinder of joining with water, washing liquid pumps into rare joining in the cylinder, adds the injection water to 2500ml, regulates about pH value to 6.0, stir evenly,, under aseptic condition, be sub-packed in the sterilized 5ml lyophilizing bottle to clear and bright with mocromembrane inline final filter fine straining ,-40～-50 ℃ of following pre-freezes 2～3 hours by every bottle of 2.5ml, lyophilization then, evacuation is made 1000 bottles of astragalus root freeze-dried powders, promptly.
Usage and consumption;
Intravenous drip: one time 5～10 bottles (dissolving of the glucose injection with 5% or 0.9% sodium chloride injection also is diluted to 1 time on the 200～400ml), one or follows the doctor's advice.
The pharmacodynamics test data
A kind of Radix Astragali medicament freeze-drying injectable powder (developed product) result of the test of the embodiment of the invention 1 is as follows:
One, dog acute heart failure model experiment due to the pentobarbital sodium
1, test method
Healthy careless dog, the male and female dual-purpose, body weight 9～12Kg is divided into 6 groups at random, 6 every group.3% pentobarbital sodium 30mgkg
-1After the intravenous anesthesia, the dog dorsal position is fixed on the dog operating-table, separate trachea, separate common carotid artery, separate root of ascending aorta, measure the maximum climbing speed (LV+dp/dt) of systolic pressure (LVSP), ventricular end diastolic pressure (LVEDP) and left ventricular pressure in the left ventricle, observe the electrocardio variation simultaneously and trace change curve.Art finishes, intravenous injection is injected heparin injection and (after 125 μ/kg) stablize 20 minutes, is write down every normal index, as basic value before the heart failure, import 2% pentobarbital sodium 0.2ml/kg/min with the infusion pump constant speed then, with dp/dtmax decline 45～80% indexs as heart failure.After this with the speed of 0.08ml/kg/min, kept 10 minutes, write down every index, as the basic value before the administration after the moulding.The vein constant speed splashes into medicine (about 30 droplets/minute) then, and measures after the administration 5,10,15,30,60 and the every index of 90min.Each group medicine mediating recipe amount of giving (following data are all by crude drug in whole calculating dosage): 1. developed product dosage 1.67g/kg, 2. developed product dosage 0.83g/kg, 3. developed product dosage 0.42g/kg, 4. Radix Astragali injection (commercially available product) dosage 1.67g/kg, 5. 6. heart failure model control group injection normal saline 10ml/kg of SHENGMAI ZHUSHEYE (commercially available product) 5ml finished product medicinal liquid/kg.
2, result of the test
Dog acute heart failure model test shows due to the sodium pentobarbital, and 1.67～0.83g/kg developed product has obvious rising arteriotony, LVSP, LV ± dp/dtmax, cardiac output, heartbeat output effect (P＜0.05) and reduces LVEDP effect (P＜0.05).To HR and total peripheral resistance influence not obvious (P＞0.05).
Two, viral myocarditis model test
1, test method
With 147 male Balb/c mices, in 5～6 ages in week, body weight 10～20g is divided into 7 groups at random, 21 every group.Except that the normal control group does not contain the Eagle liquid of virus with purgation inoculation 0.2ml, all the other each groups adopt abdominal cavity inoculation 0.2ml coxsackie B
3MWith inducing mouse viral myocarditis model.Vein treatment administration 1h behind virus inoculation begins, and continuous once a day 5 days, model group and normal control group mouse vein were given equivalent substrate liquid.Observe continuously the mice performance, 1h gets blood thought-read creatase from the eye socket venous plexus after administration in the 5th day, get respectively to organize mouse heart and do histological examination, and HE dyeing, mouse cardiac muscle lesion tissue degree and myocarditis incidence rate are respectively organized in observation under the optical microscope.7 groups of following 1. model group are 3. 4. 5. 6. 7. developed product dosage 1.67g/kg of developed product dosage 3.33g/kg of developed product dosage 6.67g/kg of Radix Astragali injection (commercially available product) dosage 6.67g/kg of SHENMAI ZHUSHEYE (commercially available product) dosage 10ml/kg of normal control group 2.
2, result of the test
The viral myocarditis model test shows, 6.67 and the 3.33g/kg developed product can obviously reduce and infect CVB
3mMouse core creatase LDH and CK activity (P＜0.05) significantly and obviously reduce Cardiovirus titer (P＜0.01 and P＜0.05); 6.67 improving ,～1.67g/kg developed product infects CVB
3mThe survival rate of Balb/c mice reduces the cardiomyopathy incidence rate; 6.67g/kg developed product can obviously alleviate myocardial necrosis and cell infiltration pathological lesion degree (P＜0.05).Under Isodose, developed product and Radix Astragali injection (commercially available product) be no significant difference (P＜0.05) relatively.
Three, to the influence of cardiovascular system
1, test method:
Get 16 male and female of careless Canis familiaris L. and be regardless of, divide equally four groups, be respectively three administration group 5g/kg, 10g/kg, 20g/kg developed product and normal saline matched groups.Dog lumbar injection pentobarbital sodium 35mg/kg anesthesia.Separate the total tremulous pulse in side footpath, and insert a cardiac catheter that is full of heparin-saline, the other end of this conduit is connected with MPU-0.5 type pressure transducer measuring blood pressure (BP), the place, nostril put into the respiration energy converting device with survey respiratory frequency (inferior/min) and respiratory depth (mm).By limb lead II record ECG.After tracing the normal voltage electrocardiogram and breathing, through the veins of lower extremity liquid medicine injection, the administration volume is 4ml/kg, approximately constant-speed injection in half a minute.1,5,15,30,45,60,90 minute These parameters before the record administration and after the administration.
2, result of the test
Anesthetized dog intravenous injection 5g/kg, 10g/kg, 20g/kg developed product all do not have obvious influence to systolic pressure, diastolic pressure, heart rate, Electrocardiographic P ripple, T ripple and QRS, Q-T, S-T, P-R interval, and heart rate is also all normal.
Four, traditional Chinese medical science model of qi-asthenia test
1. test method
Get 70 of SD rats, male and female half and half, in Mus 16～18 weeks of age, body weight 180～200g gets each 5 of male and female as the normal control group, raises routinely.All the other animals are put into the thermostatic water bath of 30 ± 1.0 ℃ of water temperatures, the depth of water 40cm every day and swim, and the time that occurs natural subsidence with every rat swims the fatigue proof time for it, and swim the fatigue proof time every animal of the 1st, 8 and 14 day mensuration of swimming.All the other times when natural subsidence appears in complete group 50% rat, all stop swimming, so continuous 14 days.Normal control group in swimming 14 days, the normal control group press 12g feedstuff/100g body weight/day feeding, and each organizes the deficiency of vital energy all by 5g feedstuff/100g body weight/day feeding.Measured every animal swimming endurance on the 8th day after the time in swimming, be divided into totally 7 groups of 6 groups and normal control groups, intravenous administration 1 time/day, continuous 7 days by swimming endurance time random stratified.1. the normal control group 3. 4. 5. 6. 7. developed product dosage 1.67g/kg of developed product dosage 3.33g/kg of developed product dosage 6.67g/kg of Radix Astragali injection (commercially available product) dosage 6.67g/kg of SHENMAI ZHUSHEYE (commercially available product) dosage 0.1ml/10g of strain model group that 2. swims.
2, result of the test
Traditional Chinese medical science model of qi-asthenia test shows, 6.67 and the 3.33g/kg developed product can obviously prolong the deficiency of vital energy rats'swimming endurance time (P＜0.05); 6.67 and the 3.33g/kg developed product can remarkable and obviously increase deficiency of vital energy rat chest gland RNA and liver glycogen content (P＜0.01 and P＜0.05) respectively; 6.67g/kg the developed product group can obviously increase thymic DNA content (P＜0.05); Cut whole blood viscosity and plasma viscosity (P＜0.05) 6.67g/kg developed product can obviously reduce swimming strain rat model height, the 3.33g/kg group can obviously reduce plasma viscosity (P＜0.05).Under Isodose, developed product and Radix Astragali injection (commercially available product) be no significant difference (P＜0.05) relatively.
Five, anti-stress experiment
(1) anti-mice swimming fatigue experiment
1, test method
Get 60 of Kunming mouses, Mus 8 weeks of age, body weight 20～22g, male and female half and half are divided into 6 groups at random.Intravenous administration, every day 1 time, administration 7 days, matched group intravenous injection isometric(al) substrate liquid.30min after the last administration surveys swimming time when respectively organizing mice and bearing a heavy burden (1/10 body weight) (natural subsidence occur with animal till).1. 2. 3. 4. 5. 6. developed product dosage 1.67g/kg of developed product dosage 3.33g/kg of developed product dosage 6.67g/kg of Radix Astragali injection (commercially available product) dosage 6.67g/kg of SHENMAI ZHUSHEYE (commercially available product) dosage 10ml/kg of normal control group.
2, result of the test
Injected in mice 6.67～1.67g/kg developed product all has the effect (p＜0.01) of remarkable increase mice swimming time.Under Isodose, developed product and Radix Astragali injection (commercially available product) be no significant difference (P＜0.05) relatively.
(2) anti-hypoxia experiment
1, test method
Get 60 of Kunming mouses, male and female half and half are divided into 6 groups at random.Intravenous administration, every day 1 time, administration 7 days, matched group intravenous injection isometric(al) substrate liquid, 30min after the last administration, each Mus is put into 200ml wide-mouth frosted bottle, and vaseline sealing bottleneck is surveyed the hypoxia death time, calculates the death time rate elongation.
2, result of the test
Injected in mice 6.67～1.67g/kg developed product significant prolongation mice normobaric hypoxia death time (p＜0.01).Under Isodose, developed product and Radix Astragali injection (commercially available product) be no significant difference (P＜0.05) relatively.
Six, enhance immunity test
(1) macrophage phagocytic function of caused by cyclophosphamide immunocompromised mice experiment
1, test method
Choose 70 of Kunming mouses, male and female half and half are divided into 7 groups at random.Except that the normal control group, all the other 6 groups equal intraperitoneal injection of cyclophosphamide 60mg/kg/d make and touch, for three days on end.Intravenous administration, once a day, continuous 7 days, model group and normal control group intravenous injection isometric(al) normal saline.7 groups of following 1. normal control groups are 3. 4. 5. 6. 7. developed product dosage 1.67g/kg of developed product dosage 3.33g/kg of developed product dosage 6.67g/kg of Radix Astragali injection (commercially available product) dosage 6.67g/kg of SHENMAI ZHUSHEYE (commercially available product) dosage 10ml/kg of model group 2..
2, result of the test
Developed product 6.67 and 3.33g/kg can extremely significantly cause the macrophage phagocytic function (P＜0.001 and p＜0.05) of immunosuppressed mice respectively with obvious enhancing cyclophosphamide.Under Isodose, developed product strengthens macrophage phagocytic function and obviously is better than Radix Astragali injection (commercially available product) (P＜0.05).
(2) cyclophosphamide is caused the influence of immunosuppressed mice immune organ weight
1, test method
Choose 84 body weight 21～23g of Kunming mouse, male and female half and half are divided into 7 groups at random.Except that normal group, all the other 6 groups respectively at the 1st, 3,5 day intraperitoneal injection of cyclophosphamide 60mg/kg modeling.Intravenous administration, once a day, continuous 7 days, normal control group and model group intravenous injection isometric(al) substrate liquid.7 groups of following 1. normal control groups are 3. 4. 5. 6. 7. developed product dosage 1.67g/kg of developed product dosage 3.33g/kg of developed product dosage 6.67g/kg of Radix Astragali injection (commercially available product) dosage 6.67g/kg of SHENMAI ZHUSHEYE (commercially available product) dosage 10ml/kg of model group 2..
2, result of the test
The immune organ weight that cyclophosphamide causes immunosuppressed mice extremely significantly reduces (P＜0.001), and 1.67～6.67g/kg developed product can be significantly or obviously resisted it and suppress the immune organ effect.Under Isodose, the effect of developed product rising thymus index obviously is better than Radix Astragali injection (commercially available product).
(3) leukocyte increasing test
1, test method
Choose 84 body weight 18～21g of Kunming mouse, male and female half and half are divided into 7 groups at random, and 10 every group, except that normal group, all the other respectively organize equal intraperitoneal injection of cyclophosphamide 60mg/kg modeling 3 days.Intravenous administration, once a day, continuous 7 days, normal control group and model group intravenous injection isometric(al) substrate liquid.Each is organized after the last administration 12 hours and gets blood in eye socket, counts leukocyte count under low power microscope.7 groups of following 1. normal control groups are 3. 4. 5. 6. 7. developed product dosage 1.67g/kg of developed product dosage 3.33g/kg of developed product dosage 6.67g/kg of Radix Astragali injection (commercially available product) dosage 6.67g/kg of SHENMAI ZHUSHEYE (commercially available product) dosage 10ml/kg of model group 2..
2, result of the test
6.67 and the 3.33g/kg developed product has extremely remarkable and remarkable function of increasing leukocyte (P＜0.001 and P＜0.01).Relatively, the developed product function of increasing leukocyte obviously is better than Radix Astragali injection (commercially available product) (P＜0.05) under Isodose.
Conclusion: above test shows that the Radix Astragali medicament freeze-drying injectable powder of embodiment 1 has anti-heart failure, the effect of antiviral property myocarditis, function for protecting liver and reducing enzyme activity, enhance immunity, QI invigorating and anti-stress effect.And the enhance immunity effect obviously is better than Radix Astragali injection (commercially available product) (P＜0.05).
Claims (8)
1. astruganus root medicinal preparation, it is 1mg～10g with the glucose meter that astragalus polysaccharides is contained in every preparation unit, astragaloside 0.04mg～0.5g, randomly right amount of auxiliary materials.
2. a kind of astruganus root medicinal preparation according to claim 1, it is 5mg～3g with the glucose meter that astragalus polysaccharides is contained in every preparation unit, astragaloside 0.08mg～45mg, randomly right amount of auxiliary materials.
3. a kind of astruganus root medicinal preparation according to claim 2, it is 10mg～0.8g with the glucose meter that astragalus polysaccharides is contained in every preparation unit, astragaloside 0.2mg～9mg, randomly right amount of auxiliary materials.
4. according to the described a kind of astruganus root medicinal preparation of claim 1～3, wherein said adjuvant is selected from one or more mixture in mannitol, lactose, glucose, sodium chloride, sorbitol, the dextran, content 0～300mg.
5. a kind of astruganus root medicinal preparation according to claim 4, it is made into various dosage forms, comprises lyophilized injectable powder, injectable powder, small-volume injection, bulk capacity injection.
6. according to the preparation method of the described a kind of astruganus root medicinal preparation of claim 4, it may further comprise the steps;
1) get the Radix Astragali, decoct with water, filter, filtrate concentrates the back ethanol precipitation, leave standstill, filter, get precipitate A and filtrate, filtrate recycling ethanol also concentrates, with the ethanol precipitation of medical material amount, filter, filtrate recycling ethanol concentrates, add the ethanol precipitation of 1/2 medical material amount, leave standstill, filter filtrate recycling ethanol, concentrate, add the dehydrated alcohol precipitation of 1/4 medical material amount, cold preservation is filtered clear and bright, filtrate recycling ethanol also is concentrated near doing, and vacuum drying gets the astragaloside intermediate;
2) taking precipitate A vacuum drying with the dissolving of distilled water heated and boiled, adds active carbon and stirs evenly, cold preservation then, extract supernatant, filter, filtrate concentrates, and adds ethanol precipitation, leave standstill clarification, leaching precipitation, precipitation washing with alcohol, vacuum drying, dry back is with 1: 50 times distilled water heated and boiled dissolving, and solution cold preservation is filtered clear and brightly, and filtrate is concentrated, add ethanol precipitation, make solution contain the alcohol amount and reach 80%, leave standstill clarification, the leaching precipitation, use washing with alcohol, vacuum drying gets the astragalus polysaccharides intermediate;
3) get the astragaloside intermediate, add injection and blunge after the dissolving, regulate pH7.0～7.5 with 10% sodium hydroxide solution, the adding active carbon, stir evenly, filtering decarbonization is used in absorption, pumps into rare joining in the cylinder, standby: as to add the injection water and put dense joining in the cylinder, under agitation add astragalus polysaccharides intermediate and adjuvant successively, after the heated and boiled dissolving, add active carbon, stir evenly, 70～80 ℃ of down insulation absorption 15 minutes, during stir filtering decarbonization 2～3 times, pump into rare joining in the cylinder, stir evenly, fine straining is made astruganus root medicinal preparation to clear and bright.
7. the preparation method of a kind of astruganus root medicinal preparation according to claim 6, it may further comprise the steps;
1) get the Radix Astragali, adding distil water decocts 2-3 time, decocts 1-2 hour with 8 times of amounts at every turn, merge decoction liquor, filter, filtrate concentrates, use ethanol precipitation, make amount of alcohol reach 70%～80%, standing over night, filter, get precipitate A and filtrate, filtrate recycling ethanol also concentrates, the ethanol precipitation of reuse medical material amount, standing over night is filtered, filtrate recycling ethanol also concentrates, and adds the ethanol precipitation of 1/2 medical material amount then, leaves standstill 3～5 hours, filter, filtrate recycling ethanol, and concentrate, the dehydrated alcohol precipitation that adds 1/4 medical material amount, cold preservation 3～4 hours is filtered clear and brightly, and filtrate recycling ethanol also is concentrated near doing, at 70～80 ℃ of vacuum dryings, get the astragaloside intermediate;
2) the precipitate A of leaching with 1: 50 times distilled water heated and boiled dissolving, adds active carbon and stirs evenly then at 70～80 ℃ of following vacuum dryings, cold preservation is spent the night, and extracts supernatant, filters, filtrate concentrates, and adds ethanol precipitation, makes solution contain the alcohol amount and reaches 80%, leave standstill clarification, leaching precipitation, precipitate washing with alcohol, in 70～80 ℃ of following vacuum dryings, dissolve with 1: 50 times distilled water heated and boiled dry back, and solution cold preservation 10～14 hours is filtered clear and bright, filtrate concentrates, add ethanol precipitation, make solution contain the alcohol amount and reach 80%, leave standstill clarification, the leaching precipitation, use washing with alcohol,, get the astragalus polysaccharides intermediate at 70～80 ℃ of following vacuum dryings;
3) get the astragaloside intermediate, add injection and blunge after the dissolving, regulate pH7.0～7.5 with 10% sodium hydroxide solution, the adding active carbon, stir evenly, adsorbed 10～15 minutes, during stir 2～3 times, take off charcoal with 0.85 μ m filtering with microporous membrane, pump into rare joining in the cylinder, standby; Add the injection water and put dense joining in the cylinder, stir and add astragalus polysaccharides intermediate and adjuvant down successively, after the heated and boiled dissolving, add active carbon and stir evenly, be incubated absorption 15 minutes down at 70～80 ℃, stir during this time 2～3 times, take off charcoal with 0.85 μ m filtering with microporous membrane, pump into rare joining in the cylinder, stir evenly, to clear and bright, make astruganus root medicinal preparation with 0.22 μ m microporous filter membrane fine straining.
8. according to the preparation method of the described a kind of astruganus root medicinal preparation of claim 6-7, the wherein said Radix Astragali is the Gansu Radix Astragali.
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