CN1481882A - Red peony root injection and its preparation method - Google Patents
Red peony root injection and its preparation method Download PDFInfo
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Abstract
The present invention is one kind of red peony injection prepared with red peony root as material and through alcohol extraction, n-butanol extraction or macroporous resin purification, and adding proper amount of medicinal supplementary material and injection water. It is stable and may be used in intramuscular injection, intravenous injection and intravenous instillation. Pharmacodynamic experiment shows that the medicine of the present invention can improve the behavior disorder of rat with cerebral infarction obviously, reduce the area of cerebral infarction, decrease water content in infracted brain tissue, reduce the peroxidation damage of lipoid in brain tissue and raise the acute oxygen lack tolerance of mouse and thus has excellent treat effect on cerebral infarction.
Description
Affiliated technical field
The present invention relates to a kind of Radix Paeoniae Rubra injection, the invention still further relates to the preparation method of this Radix Paeoniae Rubra injection simultaneously.
Background technology
Radix Paeoniae Rubra is traditional conventional Chinese medicine, derives from the dry root of ranunculaceae plant Radix Paeoniae Paeonia Lactiflora Pall. or river Radix Paeoniae Rubra Paeonia veilchii Lyncn.Record in one one of Pharmacopoeia of the People's Republic of China version in 2000, have the effect of clearing away heat and cooling blood, eliminating stasis to stop pain, clinically be used for diseases such as maculae caused by violent heat pathogen, hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI, amenorrhea are stimulated the menstrual flow, injury from falling down.Pharmacological research in recent years shows that Radix Paeoniae Rubra has many-sided pharmacological actions such as protection heart, coronary blood flow increasing, antithrombotic formation and atherosclerosis, sedation and analgesia, anti-inflammatory, antibacterial, antioxidation.Fitochemical studies result shows that the main effective ingredient of Radix Paeoniae Rubra is monoterpenes chemical compounds such as peoniflorin, lactone glucoside of Radix Paeoniae, Hydroxy peoniflorin.The Radix Paeoniae Rubra injection that uses clinically at present is the little liquid drugs injection of water alcohol method preparation, and active constituent content is low, and quality is stable inadequately, has influenced therapeutic effect.Press for active constituent content height, steady quality, effect duration is long, curative effect is high Radix Paeoniae Rubra injection clinically.
Summary of the invention
The object of the present invention is to provide the long Radix Paeoniae Rubra injection of a kind of active constituent content height, curative effect height, steady quality, effect duration, comprise little liquid drugs injection and infusion solutions, this injection can be used for intramuscular injection, intravenous injection or intravenous drip.
Another object of the present invention is to provide the preparation method of this Radix Paeoniae Rubra injection.
A kind of Radix Paeoniae Rubra injection provided by the invention, it basic composition is in every liter of injection and contains: 100～2500 gram Radix Paeoniae Rubra, 0.3～50 gram injection pharmaceutic adjuvant, all the other are water for injection.
Raw material-Radix Paeoniae Rubra used in the present invention meets " relevant every regulation under Radix Paeoniae Rubra item of Chinese pharmacopoeia version in 2000.Injection pharmaceutic adjuvant of the present invention is one or more in mannitol, sodium chloride, sorbitol, glucose, fructose, the sodium sulfite.
The preparation method of Radix Paeoniae Rubra injection provided by the invention comprises following three steps:
(1) extracts: get the Radix Paeoniae Rubra medical material, section is measured 60～80% alcohol reflux 2～4 times, each 0.5～3 hour with 4～12 times at every turn, merge extractive liquid,, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.15～1.25 concentrated solution adds the water of 2～5 times of amounts, stir, cold preservation 12～72 hours, high speed centrifugation, supernatant are evaporated to the clear paste of relative density 1.25～1.30, adding ethanol makes and contains alcohol amount to 80～85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant adds ammonia and transfers pH to 8.0, cold preservation 12～48 hours, filter, 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 n-butanol extraction or macroporous resin column chromatography legal system to get the purification thing;
(3) preparation: get above-mentioned purification thing, add the dissolving of injection water, transfer pH to 5.0～5.5, heated and boiled 5～10 minutes, cold preservation filters, and filtrate is used the ultrafilter membrane ultrafiltration of molecular cut off 3000, get filtrate and add injection water and injection pharmaceutic adjuvant, stirring and dissolving is transferred pH to 6.0～7.0, with the microporous filter membrane filtration of 0.22um, filtrate embedding, sterilization, quality inspection promptly make injection of the present invention.
N-butanol extraction described in the above-mentioned preparation method is: gets extracting solution, uses isopyknic n-butanol extraction at every turn, and 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, be added on the macroporous adsorption resin chromatography post, use the water elution of 10～50 times of extracting solution weight earlier, discard eluent, 10～30% ethanol elutions that reuse extracting solution weight is 10～50 times, collect this eluent, reclaim under reduced pressure, concentrated, dry promptly gets the purification thing.Described injection pharmaceutic adjuvant is one or more in mannitol, sodium chloride, sorbitol, glucose, fructose, the sodium sulfite.
The Radix Paeoniae Rubra injection of the present invention preparation has good stability, studies show that through stability test to be valid up to 2.1 years, substantially exceeds the effect duration in 1.5 years of present Radix Paeoniae Rubra injection; Indexs such as clarity, color and luster, pH value, thermal source, zest all meet " the regulation of the relevant injection of Chinese pharmacopoeia.Can be used for intramuscular injection, intravenous drip or intravenous administration.Easy to use, advantages such as onset is rapid, bioavailability is high, definite effect that medicine of the present invention has, show through pharmacodynamics test: the present invention can obviously improve the behavior disorder of cerebral infarction rat, reduce cerebral infarct size, significantly reduce the infraction brain water content, alleviate the lipid peroxidation injury of cerebral tissue, improve the ability of the anti-acute anoxia of mouse brain, cerebral infarction is had the good curing effect.
Embodiment 1
Get Radix Paeoniae Rubra medical material 400g, be cut into decoction pieces, measure 70% alcohol reflux 2 times with 6 times, 2 hours for the first time, 1 hour for the second time, merge extractive liquid,, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.18 (50 ℃), and the water that adds 4 times of amounts stirs evenly, cold preservation 24 hours, high speed centrifugation (20000r/min), supernatant is evaporated to the clear paste of relative density 1.25 (50 ℃), add ethanol and make and contain alcohol amount to 85%, cold preservation 24 hours, the leaching supernatant adds ammonia and transfers pH to 8.0, cold preservation 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.08 (50 ℃), uses the water saturated n-butanol extraction of equal-volume 4 times at every turn, combining extraction liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the thick paste that relative density is 1.25 (50 ℃), and vacuum drying gets Radix Paeoniae Rubra extract.Get Radix Paeoniae Rubra extract, add injection water 600ml dissolving, transfer pH to 5.0～5.5 with 40% sodium hydroxide solution, heated and boiled 5 minutes, put cold, cold preservation 24 hours, filter, filtrate is got filtrate and is added the injection water to 1000ml with the ultrafilter membrane ultrafiltration of molecular cut off 3000, add 0.05% sodium sulfite and 0.8% sodium chloride again, transfer pH to 6.0～7.0 with 40% sodium hydroxide solution, with the microporous filter membrane filtration of 0.22um, the filtrate embedding is in the infusion bottle of 100ml, sterilization, quality inspection promptly make injection of the present invention---infusion solutions.
Embodiment 2
Get Radix Paeoniae Rubra medical material 300g, be cut into decoction pieces, with 8 times of amount 60% alcohol reflux 3 times, each 1.5 hours, merge extractive liquid,, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.23 (50 ℃), and the water that adds 3 times of amounts stirs evenly, cold preservation 36 hours, high speed centrifugation (20000r/min), supernatant is evaporated to the clear paste of relative density 1.27 (50 ℃), add ethanol and make and contain alcohol amount to 80%, cold preservation 48 hours, the leaching supernatant adds ammonia and transfers pH to 8.0, cold preservation 28 hours, filter, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.14 (50 ℃), is added on the macroporous adsorption resin chromatography post, use the water elution of 30 times of concentrated solution weight earlier, discard eluent, 20% ethanol elution that reuse concentrated solution weight is 30 times is collected this eluent, reclaim under reduced pressure, concentrate, drying promptly gets the purification thing.Get this purification thing, add injection water 800ml dissolving, transfer pH to 5.0～5.5 with 40% sodium hydroxide solution, heated and boiled 6 minutes, put cold, cold preservation 24 hours, filter, filtrate is got filtrate and is added the injection water to 1000ml with the ultrafilter membrane ultrafiltration of molecular cut off 3000, the mannitol that adds 0.04% sodium sulfite, 0.2% sodium chloride 4.8% again, transfer pH to 6.0～7.0 with 40% sodium hydroxide solution, with the microporous filter membrane filtration of 0.22um, the filtrate embedding is in the infusion bottle of 250ml, sterilization, quality inspection promptly make injection of the present invention---infusion solutions.
Embodiment 3
Get Radix Paeoniae Rubra medical material 1000g, be cut into decoction pieces, measure 70% alcohol reflux 3 times with 8 times, each 1 hour, merge extractive liquid, filters, and decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.16 (50 ℃), the water that adds 5 times of amounts stirs evenly, cold preservation 36 hours, high speed centrifugation (20000r/min), supernatant are evaporated to the clear paste of relative density 1.26 (50 ℃), add ethanol and make and contain alcohol amount to 85%, cold preservation 24 hours, the leaching supernatant adds ammonia and transfers pH to 8.0, and cold preservation 30 hours filters, decompression filtrate recycling ethanol also is concentrated into the concentrated solution that relative density is 1.10 (50 ℃), use the water saturated n-butanol extraction of equal-volume 5 times at every turn, combining extraction liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the thick paste that relative density is 1.25 (50 ℃), vacuum drying gets Radix Paeoniae Rubra extract.Get Radix Paeoniae Rubra extract, add injection water 800ml dissolving, transfer pH to 5.0～5.5 with 40% sodium hydroxide solution, heated and boiled 5 minutes, put cold, cold preservation 24 hours, filter, filtrate is got filtrate and is added the injection water to 1000ml with the ultrafilter membrane ultrafiltration of molecular cut off 3000, add 0.05% sodium sulfite and 0.2% sodium chloride again, transfer pH to 6.0～7.0 with 40% sodium hydroxide solution, with the microporous filter membrane filtration of 0.22um, the filtrate embedding is in the ampoule of 2～10ml, sterilization, quality inspection promptly make injection of the present invention---little liquid drugs injection.Therapeutical effect 1.1 experimental techniques of 1 pair of intraluminal middle cerebral artery occlusion in rats bolt of Pharmacodynamic test of active extract collimation method focal cerebral ischemia model (MACO)
Modeling method: the 280-300g male SD rat is anaesthetized neck median incision, separation, ligation right carotid, external carotid artery and bifurcated artery thereof with 10% chloral hydrate 3ml/kg lumbar injection (ip).Separate the right side internal carotid artery, separate wing jaw tremulous pulse downwards along internal carotid artery, this branch of root ligation.Be equipped with line, far-end placement bulldog clamp at the internal carotid artery near-end, common carotid artery crotch otch inserts the 4-0 nylon wire, and its degree of depth is 17～20mm, and the bolt line enters internal carotid artery, goes into cranium to anterior cerebral artery, all blood flows sources of blocking-up middle cerebral artery.Remove bulldog clamp, tighten line fully, stay the long the end of a thread of 1cm outward, skin suture.1 hour posterior vein of ischemia is injected (iv) administration or iv normal saline.Skin need not anaesthetized and cut to perfusion more once more behind the ischemia 2h, lift gently institute's the end of a thread that stays to resistance is arranged time prompting nylon wire head end to the common carotid artery incision, blood flow is logical again.Sham operated rats is except that plug wire not, and all the other steps are the same.
Experiment grouping and administration: (1) sham operated rats; (2) model (solvent treatment) group; (3) injection iv small dose group of the present invention; (4) the heavy dose of group of dosage group (5) injection iv of the present invention among the injection iv of the present invention; (6) Radix Salviae Miltiorrhizae Injection iv treatment group.
30min and 12h are respectively by each dosed administration once after modeling.
Observation index:
(1) neurological's scoring
After the survival Mus is poured into 24h again, observe rat behavior and learn variation, carry out neurological's scoring.
5 fens system standards of grading with reference to Zea Longa:
0 minute, impassivity damage symptom;
1 minute, can not full extension offside fore paw;
2 minutes, turn-take laterally;
3 minutes, topple over to offside;
4 minutes, can not spontaneously walk loss of consciousness.
(2) mensuration of cerebral infarction scope: carry out behind above-mentioned two index determinings the rat broken end and get brain, be cut into 5 after removing olfactory bulb, cerebellum and low brain stem, dye with red tetrazolium (TTC).Take on a red color after normal structure is dyed, blocking tissue is white in color.Calculate blocking tissue's weight and account for the heavy percentage ratio of total brain as infarction size.
(3) brain water content is measured: after neurological's scoring, broken end is got the Mus brain fast.A part is divided another name left and right sides brain hemisphere weight in wet base, puts 100 ℃ of baking boxs and dries to constant weight, calculates brain water content as follows, brain water content (%)=(weight in wet base-dry weight)/weight in wet base * 100%.
(4) mensuration of cerebral tissue biochemical indicator: the part animal is got cerebral tissue carry out SOD, LPO content in the homogenate mensuration cerebral tissue.
(5) pathologic finding: fixing in another part 10% formalin, prepare tissue slice through steps such as dehydration, embedding, section, dyeing, carry out histopathologic examination.1.2 1.2.1 overview as a result
Promptly there is hemiplegia sample symptom to occur after the rat anesthesia of process cerebral infarction is clear-headed.Mainly show as in various degree the operation offside forelimb and receive, the shoulder inward turning, muscular tension reduces, and pushes away right shoulder to side shifting, and resistance reduces, even some animal also occurs ceaselessly to the side phenomenon of turn-taking.Table 1 shows, compares with model group (normal saline treatment), and each dosage treatment group of behavior scoring the present invention of postoperative 24h and Treated with Radix Salviae Miltiorrhizae group all have obviously low behavioristics's scoring, and there were significant differences for statistical analysis (P＜0.01).The general state of postoperative model group animal is relatively poor, the movable minimizing, and most of the weight of animals descend to some extent, all improve significantly and respectively treat the general situation of treated animal.
Choose preceding 8 rats of each experimental group and carry out neurological scoring, iv injection height of the present invention, middle group of rat and model group comparison, the behavior disorder of rat improves (P＜0.01) significantly, and it is normal that some animal almost completely recovers.Sham operated rats animal behavior no abnormal (seeing Table 1).
Table 1 injection of the present invention is to the influence (x ± s) that marks of the neurological after the intraluminal middle cerebral artery occlusion in rats infraction
Group dosage n neurological scoring
(g/kg)
Sham-operation-10 0
Model-9 1.6 ± 0.77
Radix Salviae Miltiorrhizae 10ml/kg 8 0.8 ± 0.75*
The present invention 88 0.5 ± 0.32**
4 9 0.6±0.57**
2 9 0.9±0.83*
Compare with model group
*P＜0.05,
*P＜0.01,
* *The observation of P＜0.0011.2.2 rat cerebral infarction scope and injection of the present invention are to the influence of infarction size
As can be seen from Table 2, cerebral tissue infraction degree is obvious behind the cerebral ischemia re-pouring 24h, and infarct size accounts for 36.68 ± 10.51% of total brain area.After injection of the present invention and the Radix Salviae Miltiorrhizae Injection administration, cerebral infarct size percentage ratio is obviously descended.The sham operated rats animal does not see that cerebral infarction takes place.
Table 2 injection of the present invention is to the protective effect of focal brain ischemia-reperfusion injury in rats (x ± s)
Group n dosage (g/kg) infarct size (%)
Model group 90 36.68 ± 10.51
Radix Salviae Miltiorrhizae group 8 10ml/kg 13.32 ± 4.77
* *
The present invention 82 19.96 ± 7.28
*
The present invention 84 12.13 ± 7.45
* *
The present invention 98 8.05 ± 2.51
* *
Compare with model group,
*P＜0.01,
* *P＜0.001.1.2.3 brain water content
As can be seen from Table 3, each organizes the weight in wet base of the left side brain that rat do not block, and dry weight does not all have tangible difference; And for the right side cerebral tissue that blocks, the model group brain water content is significantly higher than sham operated rats; Heavy dose of group of injection of the present invention and middle dosage group then significantly are lower than model control group, and it is approaching with sham operated rats, though the brain water content of injection small dose group of the present invention has reduction trend, but compare not statistically significant with model control group, Radix Salviae Miltiorrhizae Injection treatment group also has the effect that reduces brain water content.
The comparison of table 3 cerebral infarction rat brain water content (x ± s, n=8) the right brain of group dosage left side brain
(g/kg) weight in wet base (mg) dry weight (mg) water content (%) weight in wet base (mg) dry weight (mg) water content (%) sham-operation 784.6 ± 34.2 180.1 ± 10.9 77.0 ± 0.93 793.1 ± 55.2 182.8 ± 17.9 77.0 ± 0.93 model group 813.1 ± 20.6 187.1 ± 11.8 77.0 ± 1.32 838.1 ± 64.2 171.6 ± 12.1 79.5 ± 0.73
*Radix Salviae Miltiorrhizae 10ml/kg 813.6 ± 41.5 186.9 ± 14.8 77.0 ± 1.01 862.6 ± 29.6 181.8 ± 10.3 78.3 ± 1.37
#The present invention 2 814.9 ± 39.9 188.1 ± 18.1 76.9 ± 1.43 847.1 ± 42.8 179.0 ± 5.51 78.7 ± 0.29 the present invention 4 826.0 ± 37.9 189.8 ± 10.7 77.0 ± 1.14 833.0 ± 53.7 179.5 ± 11.9 78.4 ± 1.05
#The present invention 8 835.1 ± 38.8 190.8 ± 18.9 77.2 ± 1.35 865.8 ± 45.9 193.0 ± 15.0 77.7 ± 0.88
##Compare with sham operated rats,
*P＜0.01; Compare with model group:
#P＜0.05,
##＜0.01.1.2.4 the variation of cerebral tissue superoxide dismutase, lipid peroxide level
24h observes after the modeling, and the LPO of model group rat cerebral tissue content all significantly increases than normal group, and SOD content significantly reduces.Big or middle dosage group of Radix Salviae Miltiorrhizae group and injection of the present invention and model group compare, and LPO content all reduces; Injection group SOD content of the present invention all increases.Point out the injection of the present invention tissue SOD's content that can raise, reduce the LPO level, thereby alleviate the lipid peroxidation injury of cerebral tissue.See Table 4.
The impact of table 4 Injection in Rats brain homogenate of the present invention SOD, LPO content (among the heavy dose of group of group LPO (nmol/100mg.Pro) SOD (U/mg.Pro) Normal group 256.11 ± 88.21 17.36 ± 2.31* model group 378.88 of x ± s) ± 105.78 13.12 ± 3.98 red sage root groups, 292.23 ± 85.87*, 20.61 ± 3.83** the present invention 249.11 ± 96.28** 25.43 ± 4.25** the present invention behind dosage group 293.09 ± 48.39** 20.31 ± 3.61** small dose group 311.26 of the present invention ± 144.39 19.25 ± 3.57*1.2.5 rat cerebral infarction tectology change and the impact of parenteral solution of the present invention
Rat is through cerebral infarction postoperative 24h, and focus side brain surface is pale, unglazed, and the brain vascular surface is than offside hyperemia, and number of blood vessel also increases to some extent, one section middle cerebral artery colour-darkening between tractus olfactorius and inferior cerebral vein.Postoperative 48h focus side cerebral tissue edema is obvious, and prolongation in time engenders softening.Observe brain tissue slice under light microscopic, in the visible middle cerebral artery thrombosis is arranged, the thrombosis composition mainly is platelet, erythrocyte and fibrin, shows as the feature of mixed thrombus.Cerebral tissue mainly is ischemic change, prolongs in time, and the softening kitchen range scope of ischemia and the degree of depth increase to some extent.Sham operated rats does not have obvious pathological change.
Animal after the present invention's treatment, naked eyes are that visible middle cerebral artery is ruddy than control animals, tissue slice shows that thrombosis obviously alleviates even dissolving fully.The cerebral tissue degree of ischemia alleviates, and has only small pieces to soften kitchen range.And the animal of Radix Salviae Miltiorrhizae group, thrombosis also obviously alleviates.Each experimental group cerebral tissue pathological change is as follows:
Sham operated rats: neuron and brain parenchymal cell structure are normal substantially, and nucleus is not seen swelling, and kernel is clear, and tiger spot is high-visible, and the cell peripheral gap slightly enlarges, and slight hyperemia is arranged in the blood capillary, are slight degeneration edema and change.
Model (normal saline treatment) group: left side cerebral hemisphere structure is normal substantially, is Mild edema and changes; The right side sees that neuron and brain parenchymal cell peripheral clearance obviously enlarge, and nucleus swelling is obvious, and kernel is fuzzy, has hemorrhagely in the brain essence, and blood capillary peripheral clearance enlarges, and becomes degeneration, necrosis, hemorrhage change.
The Radix Salviae Miltiorrhizae Injection group: left side brain cell structure no abnormality seen, rarely seen cell peripheral gap slightly increases, and is slight distortion, the edema performance.Right side neuron and nucleus mild swelling, kernel is unclear, and brain parenchymal cell peripheral clearance increases, and around the blood capillary a small amount of exudative hemorrhage is arranged, and is degeneration, edema and hemorrhage change.
The big dose of amount of being group of injection of the present invention: left side brain cell structure no abnormality seen, the slightly broadening of cell peripheral gap is slight distortion and changes.Right side neuron and brain parenchymal cell, blood capillary peripheral clearance slightly increase, neuronal cell nuclear mild swelling, and kernel is clear, visible more kytoplasm hyperplasia phenomenon.Be degeneration, edema changes.
The agent amount of being group in the injection of the present invention: left side brain cell structure no abnormality seen, the cell peripheral gap slightly increases, and is slight distortion and changes.Right side neuron and brain parenchymal cell, blood capillary peripheral clearance slightly increase, neuronal cell nuclear mild swelling, and kernel loses, and visible more glial cells hyperplasia is degeneration, and edema changes.
Injection small dose group of the present invention: left side brain cell structure no abnormality seen, the cell peripheral gap slightly increases.Neuron and brain parenchymal cell, blood capillary peripheral clearance slightly increase, the cell Mild edema, and kernel is unclear, and hyperemia is arranged in the blood capillary, and peripheral clearance increases, and is degeneration, and edema changes.2. to the influence of chmice acute cerebral hemorrhage
50 of Kunming mouses, body weight 18-22g is divided into 5 groups at random, and 10 every group, medication group iv respectively gives injection 4g/kg of the present invention, 8g/kg, 16g/kg; Positive controls Radix Salviae Miltiorrhizae Injection 20ml/kg, 5% glucose injection of capacity such as normal saline group iv.Successive administration 3d, after the last administration 30min with mice by broken end only, immediately by breathe to dehiscing behind the stopwatch record mice broken end dwell time, dehisce number of times and clotting time.The results are shown in Table 5.
The result shows, all can obviously prolong mice broken end dehisce number of times and breathing time after each dosage group administration of injection of the present invention, and clotting time also prolongs, and is the most remarkable with low dose group of the present invention.Show that the present invention can improve the ability of the anti-acute anoxia of mouse brain, improve brain energy metabolism, and have the effect of blood circulation promoting and blood stasis dispelling.
Table 5 injection of the present invention is to the influence (n=10) of chmice acute cerebral ischemia and clotting time
Dosage mouth breathing continuous time
The group number of times clotting time (s) of dehiscing
(g/kg) (s) dosage group 8 13.9 ± 2.6 among 5% glucose injection-11.8 ± 2.0 14.2 ± 2.3 49.6 ± 16.5 low dose group 4 16.1 ± 3.3** of the present invention, 17.9 ± 2.7**, 86.1 ± 61.2** the present invention
*19.1 ± 2.2** 75.1 ± 19.1* high dose group 16 14.8 ± 3.4 of the present invention
*19.2 ± 1.8** 76.2 ± 16.3*
Radix Salviae Miltiorrhizae group 20ml/kg 14.8 ± 3.4
*19.7 ± 3.0** 60.1 ± 21.2*
Compare with 5% glucose injection group,
*P＜0.05,
*P＜0.01
Above experimental result shows, the present invention has good therapeutical effect to cerebral infarction.
Claims (5)
1, a kind of Radix Paeoniae Rubra injection, it basic composition is in every liter of injection and contains: 100～2500 gram Radix Paeoniae Rubra, 0.3～50 gram injection pharmaceutic adjuvant, all the other are water for injection.
2, Radix Paeoniae Rubra injection according to claim 1 is characterized in that described injection pharmaceutic adjuvant is one or more in mannitol, sodium chloride, sorbitol, glucose, fructose, the sodium sulfite.
3, the preparation method of the described Radix Paeoniae Rubra injection of claim 1, this method comprise following three steps:
(1) extracts: get the Radix Paeoniae Rubra medical material, section is measured 60～80% alcohol reflux 2～4 times, each 0.5～3 hour with 4～12 times at every turn, merge extractive liquid,, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.15～1.25 concentrated solution adds the water of 2～5 times of amounts, stir, cold preservation 12～72 hours, high speed centrifugation, supernatant are evaporated to the clear paste of relative density 1.25～1.30, adding ethanol makes and contains alcohol amount to 80～85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant adds ammonia and transfers pH to 8.0, cold preservation 12～48 hours, filter, 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 n-butanol extraction or macroporous resin column chromatography legal system to get the purification thing;
(3) preparation: get above-mentioned purification thing, add the dissolving of injection water, transfer pH to 5.0～5.5, heated and boiled 5～10 minutes, cold preservation filters, and filtrate is used the ultrafilter membrane ultrafiltration of molecular cut off 3000, get filtrate and add injection water and injection pharmaceutic adjuvant, stirring and dissolving is transferred pH to 6.0～7.0, with the microporous filter membrane filtration of 0.22um, filtrate embedding, sterilization, quality inspection promptly make injection of the present invention.
4, the preparation method of Radix Paeoniae Rubra injection according to claim 3 is characterized in that the described n-butanol extraction of step (2) is: get extracting solution, use isopyknic n-butanol extraction at every turn, coextraction 3～6 times, combining extraction liquid, reclaim under reduced pressure, drying promptly get the purification thing.
5, the preparation method of Radix Paeoniae Rubra injection according to claim 3, it is characterized in that the described macroporous resin column chromatography method of step (2) is: get extracting solution, be added on the macroporous adsorption resin chromatography post, use the water elution of 10～50 times of extracting solution weight earlier, discard eluent, 10～30% ethanol elutions that reuse extracting solution weight is 10～50 times are collected this eluent, reclaim under reduced pressure, concentrated, dry promptly gets the purification thing.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106237065A (en) * | 2016-08-25 | 2016-12-21 | 神威药业集团有限公司 | A kind of pharmaceutical composition and preparation method thereof |
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| CN106237065A (en) * | 2016-08-25 | 2016-12-21 | 神威药业集团有限公司 | A kind of pharmaceutical composition and preparation method thereof |
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