CN1244333C - Rhodiola root powdery injection and its preparation - Google Patents
Rhodiola root powdery injection and its preparation Download PDFInfo
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- CN1244333C CN1244333C CN 03126742 CN03126742A CN1244333C CN 1244333 C CN1244333 C CN 1244333C CN 03126742 CN03126742 CN 03126742 CN 03126742 A CN03126742 A CN 03126742A CN 1244333 C CN1244333 C CN 1244333C
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Abstract
The present invention discloses a Dazhu rhodiola powder injection which has the technical scheme that Chinese herbal medicine of Dazhu rhodiola is used as raw material and is added with a proper quantity of pharmaceutic adjuvant for allocation through extraction and purification, and the Dazhu rhodiola powder injection is prepared by a freezing and drying method. The present invention mainly comprises active components of 1.2 to 30 wt % of rhodiola medicine, 0.08 to 6 wt % of tyrosol and 7.5 to 64 wt % of total flavonoids. The present invention has the advantages of high stability and long validity period and has the obvious effect on myocardial ischemia and cerebral ischemia prevention by pharmacodynamics testes; the present invention has curative effect on cardio-cerebrovascular diseases of coronary heart diseases, ischemic stroke, etc.
Description
Affiliated technical field
The present invention relates to a kind of rhodiola kirilowii Regel injectable powder, the invention still further relates to the preparation method of this rhodiola kirilowii Regel injectable powder simultaneously.
Background technology
Rhodiola kirilowii Regel has another name called Rhodiola kirilowii (Regel) Maxim., dry root and rhizome for Crassulaceae Rhodida plant Rhodiola kirilowii (Regel.) Maxim., it is an essentialspecies of medicinal Radix Rhodiolae, recorded in one one of Pharmacopoeia of the People's Republic of China version in 1977 and " Tibetan medicine standard ", had the effect of promoting blood circulation and hemostasis, blood stasis dispersing and deswelling.Among the peoplely be used for the treatment of diseases such as traumatic injury, haematemesis, hemoptysis, menorrhagia.Pharmacological research in recent years shows, rhodiola kirilowii Regel has that antithrombotic plainly forms, resists myocardial ischemia, antiviral, radioprotective, resisting fatigue, defying age, the aerobic metabolism that improves the anoxia animal, enhancing be to many-sided pharmacological actions such as tolerance of low-oxygen environment.Fitochemical studies result shows that the main active chemical components of rhodiola kirilowii Regel has rhodioloside, butyl alcohol, flavone compound etc.The rhodiola kirilowii Regel preparation that uses clinically mostly is oral formulations at present, onset is slow, the medication cycle is long, but the injectable powder that still no stability is good, rapid-action, the high injection for intravenous of bioavailability uses has limited rhodiola kirilowii Regel further application clinically.
Summary of the invention
The object of the present invention is to provide a kind of determined curative effect, onset rapid, steady quality, effect duration long rhodiola kirilowii Regel injectable powder, this injectable powder can be used for intravenous injection, the curative effect height.
Another object of the present invention is to provide the preparation method of this rhodiola kirilowii Regel injectable powder.
A kind of rhodiola kirilowii Regel injectable powder provided by the invention is to be the medicament that feedstock production obtains by the Chinese herbal medicine rhodiola kirilowii Regel, and the composition of its main active and weight content are:
Rhodioloside 1.2～30%, butyl alcohol 0.08～6%, total flavones 7.5～64%.
Raw material-rhodiola kirilowii Regel used in the present invention " relevant every regulation, is pressed dry product and is calculated under Radix Rhodiolae item of Chinese pharmacopoeia version in 1977, also require its rhodioloside (C except that meeting
14H
20O
7) content must not be less than 0.3%, and butyl alcohol (C
8H
14O
2) content must not be less than 0.02%.
The preparation method of a kind of rhodiola kirilowii Regel injectable powder provided by the invention comprises following three steps:
(1) extracts: get the rhodiola kirilowii Regel medical material, section, each measure 10～95% alcohol reflux 2～5 times with 4～12 times, each 0.5～3 hour, merge extractive liquid,, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.08 concentrated solution adds the water of 2～5 times of amounts, stirs, cold preservation 12～72 hours, filter, it is 1.05～1.18 that filtrate decompression is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 80～85%, stir evenly, adjust pH to 8.0, cold preservation 12～48 hours filters, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.18 concentrated solution, extracting solution;
(2) purification: get said extracted liquid, adopt any method in organic solvent extractionprocess, macroporous resin column chromatography method, silica gel or three kinds of methods of alumina column chromatography method to make the purification thing;
(3) preparation: get above-mentioned purification thing, add the injection water, cold preservation, filter, filtrate adjust pH to 7.0～7.5 are left standstill, are filtered, filtrate adds pharmaceutic adjuvant and adds the injection water, and stirring and dissolving is filtered, with the filtrate fill in sterilized cillin bottle, lyophilization, lyophilizing finishes back tamponade, gland, quality inspection, packing promptly makes injectable powder of the present invention.
Organic solvent extractionprocess of the present invention is: get extracting solution, and at every turn with isopyknic n-butyl alcohol or ethyl acetate extraction, coextraction 3～6 times, combining extraction liquid, reclaim under reduced pressure, drying promptly get the purification thing; Described macroporous resin column chromatography method is: get extracting solution, the macroporous adsorption resin chromatography post of flowing through, use the water elution of 10～50 times of concentrated solution weight earlier, discard eluent, 20～95% ethanol elutions that reuse concentrated solution weight is 10～50 times, collect this eluent, reclaim under reduced pressure, drying promptly get the purification thing; Described silica gel or alumina column chromatography method are: get extracting solution, drying is used dissolve with ethanol, adds proper silica gel or aluminium oxide and mixes thoroughly, drying, last aluminium oxide or silica gel column chromatography, ethanol elution with 90～100%, collect eluent, reclaim under reduced pressure, drying promptly get the purification thing; Described pharmaceutic adjuvant is one or more in mannitol, 30 POVIDONE K 30 BP/USP 30, glucose, the lactose.
The content detection of active component rhodioloside of the present invention and butyl alcohol has adopted high-efficient liquid phase technique, and spectrophotography is adopted in the detection of total flavones, but content of total flavone is criterion calculation with the rutin.
The rhodiola kirilowii Regel injectable powder of the present invention's preparation has good stability, studies show that through stability test to be valid up to 2.9 years, indexs such as clarity, dissolubility, color and luster, pH value, thermal source, zest all meet " the regulation of the relevant injection of Chinese pharmacopoeia.Facing with before being mixed with solution, can be used in intramuscular injection or adding injection normal saline or the glucose for injection solution, with the administration of intravenous drip mode.Medicine of the present invention has advantages such as onset is rapid, bioavailability is high, definite effect, shows to have to resist myocardial ischemia significantly and treating cerebral ischemia that cardiovascular and cerebrovascular diseases such as coronary heart disease, cerebral infarction are had excellent curative through pharmacodynamics test.
The present invention is further illustrated below in conjunction with embodiment and Pharmacodynamic test of active extract.
Embodiment 1
(1) gets rhodiola kirilowii Regel medical material 1000g, section is measured 45% alcohol reflux 3 times, each 1 hour with 12 times at every turn, merge extractive liquid,, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.05 (60 ℃), adds the water of 3 times of amounts, stir, cold preservation 72 hours filters, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.08 (60 ℃), adding ethanol makes and contains alcohol amount and reach 80%, stir evenly the sodium hydroxide solution adjust pH to 8.0 with 20%, cold preservation 48 hours, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.12 (60 ℃), gets extracting solution, and is standby;
(2) get said extracted liquid, the macroporous adsorption resin chromatography post of flowing through, elder generation's water elution of 40 times of concentrated solution weight, discard eluent, 50% ethanol elution that reuse concentrated solution weight is 40 times is collected this eluent, and decompression recycling ethanol also is concentrated into the concentrated solution that relative density is 1.10 (60 ℃), add injection water 300ml, cold preservation filters, and filtrate is with 10% sodium hydroxide solution adjust pH to 7.0～7.5, leave standstill, filter, filtrate for later use;
(3) getting above-mentioned filtrate adds mannitol 80g and glucose 20g and adds the injection water to 1000ml, use 0.65 μ m and 0.22 μ m filtering with microporous membrane respectively, with the filtrate fill in sterilized cillin bottle, lyophilization, lyophilizing finishes back tamponade, gland, quality inspection, packing promptly makes rhodiola kirilowii Regel injectable powder of the present invention.
Embodiment 2
(1) gets rhodiola kirilowii Regel medical material 1000g, section is measured 65% alcohol reflux 3 times, each 1 hour with 10 times at every turn, merge extractive liquid,, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.08 (60 ℃), adds the water of 4 times of amounts, stir, cold preservation 66 hours filters, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.06 (60 ℃), adding ethanol makes and contains alcohol amount and reach 85%, stir evenly the sodium hydroxide solution adjust pH to 8.5 with 30%, cold preservation 38 hours, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.13 (60 ℃), gets extracting solution, and is standby;
(2) get said extracted liquid, use isopyknic n-butanol extraction at every turn, coextraction 5 times, combining extraction liquid, reclaim under reduced pressure, drying add injection water 600ml, stirring and dissolving, cold preservation, filter, filtrate is left standstill, is filtered, filtrate for later use with 10% sodium hydroxide solution adjust pH to 7.5:
(3) get above-mentioned filtrate and add mannitol 100g and add the injection water, use 0.65 μ m and 0.22 μ m filtering with microporous membrane respectively to 1000ml, with the filtrate fill in sterilized cillin bottle, lyophilization, lyophilizing finishes back tamponade, gland, quality inspection, packing promptly makes injectable powder of the present invention.
Embodiment 3
(1) gets rhodiola kirilowii Regel medical material 1000g, section is measured 60% alcohol reflux 2 times, each 1.5 hours with 12 times at every turn, merge extractive liquid,, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.06 (60 ℃), adds the water of 5 times of amounts, stir, cold preservation 56 hours filters, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.07 (60 ℃), adding ethanol makes and contains alcohol amount and reach 85%, stir evenly the sodium hydroxide solution adjust pH to 8.5 with 30%, cold preservation 48 hours, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.18 (60 ℃), gets extracting solution, and is standby:
(2) get said extracted liquid, behind the vacuum drying, be ground into fine powder, use the 250ml dissolve with ethanol, add 150g silica gel and mix vacuum drying thoroughly, pulverize, last silica gel column chromatography is with the ethanol elution of 5000ml95%, collect eluent, reclaim under reduced pressure, drying add injection water 700ml, stirring and dissolving, cold preservation filters, filtrate is left standstill, is filtered, filtrate for later use with 10% sodium hydroxide solution adjust pH to 7.5;
(3) getting above-mentioned filtrate adds mannitol 85g, 30 POVIDONE K 30 BP/USP 305g, glucose 5g, lactose 5g and adds the injection water to 1000ml, use 0.65 μ m and 0.22 μ m filtering with microporous membrane respectively, with the filtrate fill in sterilized cillin bottle, lyophilization, lyophilizing finishes back tamponade, gland, quality inspection, packing promptly makes injectable powder of the present invention.
Pharmacodynamic test of active extract
By two kinds of experimental animal models of myocardial ischemia due to cerebral ischemia reperfusion and the heart coronary ligation, observe resist myocardial ischemia effect with cerebral ischemia of rhodiola kirilowii Regel powder pin of the present invention; Observed of the influence of rhodiola kirilowii Regel powder simultaneously at anesthesiaing dog heart blood flowing dynamics and cerebral blood flow aspect.For clinical application provides the pharmacology foundation.Result of the test is as follows:
One, to the influence of middle cerebral artery thrombus model rat
Test has adopted ferric chloride to cause middle cerebral artery thrombosis rat model, MCAT rat nervous symptoms evaluation results shows after the modeling: rhodiola kirilowii Regel powder pin 40,20, the treatment of 10mg/kg group are administered three times, to 6h after the modeling, the nervous symptoms of the rat of 24h all has improve (P＜0.01, P＜0.05) in various degree.MCAT rat cerebral infarction range measurements shows, postoperative 24h, and the rat infraction degree of three dosage groups of rhodiola kirilowii Regel powder pin obviously alleviates, and compares with model group to have significant difference (P＜0.01, P＜0.05).The moisture determination result of MCAT rat cerebral tissue shows, 24h after the modeling, and the rat operation side brain water content of rhodiola kirilowii Regel powder pin 20,10mg/kg group is starkly lower than model group, compares with model group to have significant difference (P＜0.01, P＜0.05).MCAT rat cerebral tissue PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM is shown, the visible a large amount of degeneration neurons of MCAT model group rat damage side cortex, and lose the level distribution.As seen rhodiola kirilowii Regel powder pin 40mg/kg group rat damage side cortex be dispersed in normal neurocyte, visible a large amount of degenerative atrophy neurons in rhodiola kirilowii Regel powder pin 20mg/kg, the 10mg/kg group brain cortex ischemic focus, and the neuron number reduces.Graphical analysis shows that administration group sun cell surface density increases (P＜0.01), and binding of pathological photo explanation administration group can make the neurocyte loss reduce, and survivaling cell quantity is many with respect to model group, points out this medical instrument to have to alleviate the nerve injury effect due to the cerebral ischemia.
Two, the protective effect that rat myocardial ischemia and reperfusion is damaged
This laboratory observation the influence of rhodiola kirilowii Regel powder pin drug administration by injection to myocardial damage due to the SD Ischemia and Reperfusion in vivo in Rats, and compare with Radix Salviae Miltiorrhizae Injection.Behind 3% pentobarbital sodium intraperitoneal anesthesia SD rat, left side 4-5 intercostal is opened breast, and the ligation left anterior descending coronary artery is made the acute ischemia re-perfusion model.Ischemia is injected simultaneously and is given rhodiola kirilowii Regel powder pin, and ischemia 30min measures creatine kinase (CK), lactic acid dehydrogenase (LDH) activity and myocardial infarct size in the serum after pouring into 30min again.The basic, normal, high dosage group of rhodiola kirilowii Regel powder pin (10,20,40mg/kg) and Radix Salviae Miltiorrhizae Injection group serum CK, LDH activity, myocardial infarction area weight are starkly lower than model group (P＜0.05); The result shows that rhodiola kirilowii Regel powder pin drug administration by injection has protective effect to rat myocardial ischemia and reperfusion damage, and LDH, CK overflow in the time of can obviously suppressing due to the ischemia-reperfusion rat myocardium from injury, reduce Serum LDH, CK activity, can obviously dwindle myocardial infarct size.
Three, to the influence of anesthetized dog hemodynamics, myocardial oxygen consumption and cerebral blood flow
1. this experiment adopts cardiac catheter method direct observation injection rhodiola kirilowii Regel powder pin (5,10,20mg/kg) to anesthetized dog heart rate (HR), systolic pressure (BPs), diastolic pressure (BPd), mean arterial pressure (MAP), left ventricular systolic pressure (LVSP), left ventricular diastolic pressure LVDP, maximum the rate of change (± dp/dt of left ventricular systolic pressure
Max), ventricular end diastolic pressure hemodynamic influences such as (LVEDP).The result shows: normal saline group, each dosage group of rhodiola kirilowii Regel powder pin and Radix Salviae Miltiorrhizae Injection group are at 5min to 180min, hemodynamic indexs such as the maximum rate of change of anesthetized dog heart rate, blood pressure, left ventricular systolic pressure, left ventricular diastolic pressure, left ventricular systolic pressure, ventricular end diastolic pressure all have fluctuation, but with administration before comparing difference all not remarkable.
2. observe of the influence of rhodiola kirilowii Regel powder pin drug administration by injection to anesthetized dog myocardial oxygen consumption, coronary flow and cerebral blood flow.The result shows: rhodiola kirilowii Regel powder pin 5,10,20mg/kg injection back myocardial oxygen consumption change and compare remarkable decline with time point normal saline group; Also can obviously reduce myocardium oxygen uptake rate, increase coronary flow, reduce coronary resistance, increase the internal carotid artery flow, action intensity and dosage have certain relation.Each dosage group of rhodiola kirilowii Regel powder pin does not all have obvious influence to dog cardiac output, total peripheral resistance.Experimental result shows that rhodiola kirilowii Regel powder pin can obviously increase anesthetized dog coronary flow and cerebral blood flow, obviously reduces myocardium oxygen uptake rate, significantly reduces myocardial oxygen consumption; Cardiac output, total peripheral resistance all there is not obvious influence.
Claims (2)
1, a kind of rhodiola kirilowii Regel injectable powder is characterized in that by the Chinese herbal medicine rhodiola kirilowii Regel being that feedstock production forms, and the composition of its main active and weight content are: rhodioloside 1.2～30%, butyl alcohol 0.08～6%, total flavones 7.5～64%; Its preparation method is made up of following three steps:
(1) extracts: get the rhodiola kirilowii Regel medical material, section, each measure 10～95% alcohol reflux 2～5 times with 4～12 times, each 0.5～3 hour, merge extractive liquid,, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.08 concentrated solution adds the water of 2～5 times of amounts, stirs, cold preservation 12～72 hours, filter, it is 1.05～1.18 that filtrate decompression is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 80～85%, stir evenly, adjust pH to 8.0, cold preservation 12～48 hours filters, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.18 concentrated solution, extracting solution;
(2) purification: get said extracted liquid, adopt any method in n-butyl alcohol or ethyl acetate extraction, macroporous resin column chromatography method, silica gel or three kinds of methods of alumina column chromatography method to make the purification thing, wherein
N-butyl alcohol or ethyl acetate extraction are: get extracting solution, and at every turn with isopyknic n-butyl alcohol or ethyl acetate extraction, coextraction 3～6 times, combining extraction liquid, reclaim under reduced pressure, drying promptly get the purification thing;
The macroporous resin column chromatography method is: get extracting solution, the macroporous adsorption resin chromatography post of flowing through, elder generation's water elution of 10～50 times of concentrated solution weight, discard eluent, 20～95% ethanol elutions that reuse concentrated solution weight is 10～50 times are collected this eluent, reclaim under reduced pressure, drying promptly get the purification thing;
Silica gel or alumina column chromatography method are: get extracting solution, drying is used dissolve with ethanol, adds proper silica gel or aluminium oxide and mixes thoroughly, drying, last aluminium oxide or silica gel column chromatography, ethanol elution with 90～100%, collect eluent, reclaim under reduced pressure, drying promptly get the purification thing;
(3) preparation: get above-mentioned purification thing, add the injection water, cold preservation, filter, filtrate adjust pH to 7.0～7.5 are left standstill, are filtered, filtrate adds pharmaceutic adjuvant and adds the injection water, and stirring and dissolving is filtered, with the filtrate fill in sterilized cillin bottle, lyophilization, lyophilizing finishes back tamponade, gland, quality inspection, packing promptly makes injectable powder.
2, rhodiola kirilowii Regel injectable powder according to claim 1 is characterized in that described pharmaceutic adjuvant is one or more in mannitol, 30 POVIDONE K 30 BP/USP 30, glucose, the lactose.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03126742 CN1244333C (en) | 2003-06-02 | 2003-06-02 | Rhodiola root powdery injection and its preparation |
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| CN 03126742 CN1244333C (en) | 2003-06-02 | 2003-06-02 | Rhodiola root powdery injection and its preparation |
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| CN1244333C true CN1244333C (en) | 2006-03-08 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10034333B2 (en) | 2012-04-11 | 2018-07-24 | Primetals Technologies Germany Gmbh | Method for operating an arc furnace and smelting system having an arc furnace operated according to the method |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1969930B (en) * | 2005-11-04 | 2010-08-11 | 四川宇妥藏药药业有限责任公司 | Method for preparing rhodiola root extract transformed by microbe |
| CN102692464A (en) * | 2012-06-15 | 2012-09-26 | 通化玉圣药业股份有限公司 | Rhodiola rosea injection fingerprint spectrum check method |
| CN104987952B (en) * | 2015-05-31 | 2021-03-02 | 陕西理工大学 | Method for extracting volatile oil and salidroside from rhodiola rosea whole plant |
| CN104983775A (en) * | 2015-07-08 | 2015-10-21 | 成都易创思生物科技有限公司 | Method for preparing medicine for treating coronary heart disease angina through plateau rhodiola |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10034333B2 (en) | 2012-04-11 | 2018-07-24 | Primetals Technologies Germany Gmbh | Method for operating an arc furnace and smelting system having an arc furnace operated according to the method |
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