CN1583100A - Chinese medicinal preparation and preparing method for acute cerebral infarction - Google Patents
Chinese medicinal preparation and preparing method for acute cerebral infarction Download PDFInfo
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Abstract
A Chinese medicine for treating acute cerebral infarction is prepared from ginseng, red sage root and notoginseng.
Description
Technical field: the present invention relates to a kind of Chinese medicine preparation for the treatment of acute cerebral infarction and preparation method thereof, belong to technical field of Chinese medicine.
Technical background: the sickness rate of acute cerebral infarction accounts for brain acute disease people's 43%-65%, case fatality rate 15%-25%, and disability rate and relapse rate are all very high, and be very harmful to people ' s health.Therefore, a kind of effective and safe drug for the treatment of acute cerebral infarction is that the patient is needed.The medicine that some treatment acute cerebral infarctions are also arranged in the market.But some uncertain therapeutic efficacy of existing medicine is cut, and some is cured the symptoms, not the disease, some untoward reaction is bigger; The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.
Summary of the invention: the object of the present invention is to provide a kind of Chinese medicine preparation for the treatment of acute cerebral infarction and preparation method thereof.The main cause of acute cerebral infarction is on atherosclerotic basis, because hyperlipidemia, hyperglycemia, hypercoagulability and hemodynamic change, in hematoblastic presence, thrombosis hyperamization pipe choking, or embolus comes off and causes angiemphraxis; the cerebral tissue generation infarction that lesion vessels is supplied, local edema, surrounding tissue hyperemia and ischemia.The size of ischemic region and degree depend on that to a great extent side props up the circulation Status And Capability.Treatment should be recovering the blood supply in cerebral ischemia district as early as possible, microcirculation improvement, and the pathology process of blocking-up cerebral infarction is main.Motherland's medical science belongs to acute cerebral ischemic infarction " apoplexy " category, what think this disease is because of venation is blocked, diseases such as facial hemiparalysis, hemiplegia or coma are not freely taken place in the QI and blood mediation, belong to apoplex involving the channels and collaterals mostly, part is middle internal organs, its pathological factor is nothing more than wind, fire, expectorant, the stasis of blood, and acute ischemic cerebral apoplexy freely is not a pathological process with stagnation of blood stasis, passages through which vital energy circulates often, thereby the generation of " blood stasis " is relevant with the formation of thrombosis.Control to stimulate the menstrual flow, blood stasis dispelling, to invigorate blood circulation.
Preparation of the present invention constitutes like this: calculate according to components by weight percent: made by following component: Radix Ginseng 10-3000 and 20-8000 Radix Salviae Miltiorrhizae, one or both combinations in the Radix Notoginseng, be equipped with suitable adjuvant again and make acceptable preparation, comprising: injection, freeze-dried powder, capsule, soft capsule, tablet, granule, pill, microcapsule, micropill, concentrated pill, drop pill, slow releasing preparation, controlled release preparation, quick releasing formulation, targeting preparation, oral liquid, syrup, powder, mixture, powder, spray, medicated wine, tincture, lozenge, extractum, fluid extract.Ideal preparation is: according to can components by weight percent calculating, use one or both combinations in Radix Ginseng 10-3000 and 20-8000 Radix Salviae Miltiorrhizae, the Radix Notoginseng, be prepared into injection, freeze-dried powder, tablet, drop pill, capsule, granule, oral liquid.
The present invention is directed to prior art, extract Radix Ginseng and Radix Salviae Miltiorrhizae with ethanol reflux extraction, decoction and alcohol sedimentation technique, percolation respectively, and serve as to detect index with the important effective ingredient danshensu in the important effective ingredient ginsenoside in the Radix Ginseng and panoxadiol, the Radix Salviae Miltiorrhizae, its result is:
1, the comparison of extraction of panax ginseng:
| Extracting method | The ginsenoside | The panoxadiol |
| Ethanol reflux extraction | ????2.16％ | ????1.315％ |
| Decoction and alcohol sedimentation technique | ????0.76％ | ????0.593％ |
| Percolation | ????1.81％ | ????1.039％ |
2, the comparison of Radix Salviae Miltiorrhizae extraction process:
| Extracting method | Danshensu |
| Ethanol reflux extraction | ????2.13％ |
| Decoction and alcohol sedimentation technique | ????2.96％ |
| Percolation | ????1.71％ |
In addition because the Radix Notoginseng total arasaponins water soluble and the ethanol of effective ingredient in the Radix Notoginseng, but consider to contain a large amount of starch in the Radix Notoginseng, should not adopt water or low-concentration ethanol, in order to avoid gelatinizing.For this reason, select 50-95% ethanol as extracting solvent, adopt percolation, Jin Stains method, decoction and alcohol sedimentation technique to extract Radix Notoginseng, its result is:
3, the comparison of Radix Notoginseng extraction process:
| Extracting method | Radix Notoginseng total arasaponins |
| Percolation | ????3.59％ |
| Jin Stains method | ????2.33％ |
| Decoction and alcohol sedimentation technique | ????1.42％ |
According to above experimental result, the present invention adopts ethanol reflux extraction to extract Radix Ginseng, extracts Radix Salviae Miltiorrhizae with decoction and alcohol sedimentation technique, and percolation extracts Radix Notoginseng.In experiment, find in addition, Radix Ginseng, Radix Salviae Miltiorrhizae, Radix Notoginseng are pulverized carefully more, bioavailability in its decoction process is high more, if but the medical material granularity too greatly then easily be difficult in the pasty state leaching in large-scale production process, thereby influence the quality of medicine, find that through experiment contrast back under the existing equipment situation, it is best that Radix Ginseng, Radix Salviae Miltiorrhizae, Radix Notoginseng powder are broken into the drug quality of coarse powder.
Preparation process:
The present invention can participate in the Radix Salviae Miltiorrhizae prescription by the people, and its prescription is: Radix Ginseng 10-3000 part, Radix Salviae Miltiorrhizae 20-8000 part.Its preparation technology is: 1, get the ginseng crude drug and be ground into the above fine powder of 60 orders, promptly get the Radix Ginseng powder.2, get red rooted salvia and be ground into coarse powder, use alcohol reflux, extracting solution reclaims ethanol and is condensed into extractum, and drying promptly gets Radix Salviae Miltiorrhizae extract.3, with Radix Ginseng powder, Radix Salviae Miltiorrhizae extract mix homogeneously, can make different products according to conventional method again.
The present invention also can participate in the Radix Notoginseng prescription by the people, and its prescription is: Radix Ginseng 10-3000 part, Radix Notoginseng 20-8000 part.Its preparation technology is: 1, get the ginseng crude drug and be ground into coarse powder, make solvent with ethanol, soak more than 1 day, carry out percolation, merge percolate, reclaim ethanol and be condensed into extractum, drying promptly gets Radix Ginseng extract.2, get Radix Notoginseng, be ground into the above fine powder of 60 orders, promptly get Radix Notoginseng powder.3, with Radix Ginseng extract, Radix Notoginseng powder mix homogeneously, can make different products according to conventional method again.
The present invention also can be by Radix Ginseng, Radix Salviae Miltiorrhizae and Radix Notoginseng prescription, and its prescription is: Radix Ginseng 10-3000 part, Radix Salviae Miltiorrhizae 10-5000 part, Radix Notoginseng 10-3000 part.Its preparation technology is: 1, get the ginseng crude drug and be ground into coarse powder, extract with ethanol refluxing process, reclaim ethanol and be condensed into extractum, drying promptly gets Radix Ginseng extract.2, get red rooted salvia and be ground into coarse powder, the water decocting method extracts, once reach once with the ethanol precipitate with ethanol more than, contain the alcohol amount and be 50-99%, extracting solution recovery ethanol also is condensed into extractum, drying promptly gets Radix Salviae Miltiorrhizae extract.3, get Radix Notoginseng powder and be broken into coarse powder, more than 1 hour, jolting constantly filters with alcohol dipping, and filtrate is condensed into extractum, and drying promptly gets Radix Notoginseng extract.4, get Radix Ginseng extract, Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract mix homogeneously, can make different products according to a conventional method again.
The technology that the present invention makes injection is:
When the present invention makes injection, because the tanshinone compound in the Radix Salviae Miltiorrhizae is a liposoluble constituent, so we add cosolvent on the basis of former prescription.
| Cosolvent | Consumption | Effect |
| Glycerol | ????8％ | The content of tanshinone is 6.8mg |
| Sodium benzoate | ????8％ | The content of tanshinone is 5.2mg |
| Salicylic acid | ????8％ | The content of tanshinone is 5.7mg |
So the present invention makes the cosolvent of injection as the present invention with glycerol.Its preparation technology is: get the ginseng crude drug and be ground into coarse powder, extract with ethanol refluxing process, reclaim ethanol and be condensed into extractum, promptly get Radix Ginseng extract.Get red rooted salvia and be ground into coarse powder, the water decocting method extracts, once reach once with the ethanol precipitate with ethanol more than, contain the alcohol amount and be 50-99%, extracting solution recovery ethanol also is condensed into extractum, promptly gets Radix Salviae Miltiorrhizae extract.Get Radix Notoginseng powder and be broken into coarse powder, more than 1 hour, jolting constantly filters with alcohol dipping, and filtrate is condensed into extractum, promptly gets Radix Notoginseng extract.Get the glycerol mix homogeneously of Radix Ginseng extract, Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract and total medicinal liquid 1-30%, add to the full amount of water for injection, the adjusting liquid PH value is 2-7, crosses the ultrafiltration post, embedding, sterilization, i.e. ejection preparation.
The technology that the present invention makes freeze-dried powder injection is:
Because the outward appearance after the herb liquid lyophilization of the present invention is bad, so add excipient in medicinal liquid.
| Excipient | Consumption | Appearance character |
| Glucose | ????15％ | Big gun and volumetric expansion phenomenon have been arranged |
| Trehalose | ????15％ | Volume-diminished, irregular colour is even |
| Lactose | ????15％ | Constancy of volume, color even, outward appearance is better |
| Glycine | ????15％ | Irregular colour is even, and lamination is arranged |
So the present invention is with the excipient of lactose as lyophilized formulations.Its preparation technology is: get the ginseng crude drug and be ground into coarse powder, extract with ethanol reflux extraction, reclaim ethanol and be condensed into extractum, promptly get Radix Ginseng extract.Get red rooted salvia and be ground into coarse powder, make solvent, extract, get Radix Salviae Miltiorrhizae extract with ultrasound assisted extraction technique with ethanol.Get Radix Notoginseng powder and be broken into coarse powder, water decocts, and centrifugalize merges supernatant, crosses macroporous adsorptive resins, gets Radix Notoginseng extract.Get the lactose mix homogeneously of Radix Ginseng extract, Radix Notoginseng extract, Radix Salviae Miltiorrhizae extract and 1-30%, add in an amount of water for injection and dissolve, and continue to add and add to the full amount of water for injection, transfer pH value 2-7, ultrafiltration, fill, lyophilization promptly gets lyophilized formulations.
The technology that the present invention makes drop pill is:
| Substrate | Medicine and substrate ratio | Condensing agent | Fusion mode, shaping situation and sedimentation situation | The molten diffusing time |
| Glycerol | 1: 1 | Liquid paraffin | Be difficult for mixing, the toughness material is separated out, and sedimentation velocity is fast, and ball shape is flat, and roundness is bad. | 18min |
| Glycerol | 1: 2 | Oleum Glycines | The energy mixing, sedimentation velocity is moderate, and ball shape rounding is non-caked. | 25min |
| Glycerol | 1: 3 | Dimethicone | The energy mixing, sedimentation velocity is fast slightly, and ball shape is rounding not, not molding. | 19min |
| Gelatin | 1: 1 | Liquid paraffin | The energy mix homogeneously, sedimentation velocity is moderate, and ball shape is better, and bonding keeps up with. | 30min |
| Gelatin | 1: 2 | Oleum Glycines | Easy mix homogeneously, sedimentation velocity is moderate, and ball shape rounding is non-caked. | 29min |
| Gelatin | 1: 3 | Dimethicone | Easy mix homogeneously, formability is good, the smooth surface densification, rounding, non-caked. | ????24min |
By above experimental result as can be known, its molten diffusing time is all up to specification, but is substrate with the gelatin, dimethicone is the fusion mode that condensing agent prepares drop pill, shaping situation and sedimentation situation the best, so be substrate with the gelatin when the present invention prepares drop pill, dimethicone is a condensing agent.Its preparation technology is: get the ginseng crude drug and be ground into coarse powder, make solvent with 45-80% ethanol, soak more than 1 day, add the ethanol that 15-40 doubly measures altogether, carry out percolation, merge percolate, reclaim ethanol and be condensed into extractum, drying promptly gets Radix Ginseng extract.Get Radix Notoginseng, be ground into the above fine powder of 60 orders, promptly get Radix Notoginseng powder.3, with Radix Ginseng extract, Radix Notoginseng powder mix homogeneously, the gelatin that medicated powder 0.1-10 is doubly measured adds mix homogeneously in the above drug powder, splashes in the dimethicone and cools off, and promptly gets drop pill.
The technology that the present invention makes tablet is:
It is bad that the present invention makes the disintegrative of tablet, so can add disintegrating agent, it selects the experimental result of disintegrating agent to be:
| Disintegrating agent | Consumption | Disintegration time | Appearance character |
| Starch | ??2％ | ??21min | Easily moisture absorption, medicine stability is poor slightly |
| Carboxymethyl starch sodium | ??2％ | ??9min | Hardness is good, outward appearance compressibility and flowability all meet the requirements |
| Silicon dioxide | ??2％ | ??25min | Compressibility and flowability are all bad |
| The low substituted hydroxy-propyl fiber | ??2％ | ??14min | Hardness and outward appearance are poor slightly |
So the present invention is with the disintegrating agent of carboxymethyl starch sodium as the preparation tablet.Its preparation technology is: get the ginseng crude drug and be ground into the above fine powder of 60 orders, promptly get the Radix Ginseng powder.Get red rooted salvia and be ground into coarse powder, use alcohol reflux, extracting solution reclaims ethanol and is condensed into extractum, and drying promptly gets Radix Salviae Miltiorrhizae extract.With the carboxymethyl starch sodium mix homogeneously of Radix Ginseng powder, Radix Salviae Miltiorrhizae extract, medicated powder amount 0.5-10%, and use alcohol granulation, with the carboxymethyl starch sodium mix homogeneously of medicated powder amount 0.5-2%, tabletting carries out coating with the 2-8% film coating agent to plain sheet, promptly gets tablet again.
In more than forming, every part of representative be weight portion.Weight is calculated with crude drug, and as if being unit with the gram, more than composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make injection 1000ml, 1000 of soft capsules, 1000 of drop pill, 1000 of capsules, 1000 in tablet, oral liquid 1000ml etc., can make 100-1000 as freeze-dried powder and prop up, can make the 50-500 bag as granule.
More than form,, can be made into the preparation of 50-1000 taking dose if be unit with the gram, but every day 1-5 time, each 1-20 agent, as 1-20 prop up, bottle, bag, or sheet, determine usage and dosage according to patient's situation in use.
The present invention is with Radix Ginseng, Radix Salviae Miltiorrhizae and Radix Notoginseng prescription, and Radix Ginseng strongly invigorating primordial QI, tonifying the lung strengthening the spleen in the side can shock, enhancing body's immunological function; Radix Salviae Miltiorrhizae, Radix Notoginseng are stimulated the menstrual flow, blood stasis dispelling, invigorate blood circulation, conducting blood to flow downwards, all medicines share, and played blood circulation promoting and blood stasis dispelling, microcirculation improvement, improved the confession of ischemic tissue of brain blood, avoid the ischemic tissue of brain necrosis, thereby progressively recover the function of impaired cerebral tissue.
Compared with prior art, prescription of the present invention is simple and clear, and the preparation method science is feasible, is prepared into the preparation that needs and has energy shock, enhancing body's immunological function; Play blood circulation promoting and blood stasis dispelling, microcirculation improvement, avoided the ischemic tissue of brain necrosis, thereby progressively recovered the effect of impaired cerebral tissue; This preparation has blood vessel dilating simultaneously, and the cerebral blood flow increasing amount alleviates or remove the function of hemocyte and platelet aggregation, is the good medicine of treatment acute cerebral infarction.
Pharmacological effect
One, the present invention is to the protective effect of cerebral ischemia
1, materials and methods: SD male rat, body weight 250 ± 30g.With rat with 10% chloral hydrate 3ml/kg intraperitoneal injection of anesthesia, neck median incision, separation, ligation right carotid proximal part, external carotid artery and bifurcated artery thereof.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.Gastric infusion or filling stomach are given the solvent control normal saline behind the ischemia 1h.Continue perfusion again behind the ischemia 1h, need not anaesthetize and cut skin once more, prompting nylon wire head end is to the common carotid artery incision when resistance is arranged to lift institute's the end of a thread that stays gently, and blood flow is logical again.Sham operated rats is except that plug wire not, and all the other steps are the same.After the survival Mus is poured into 24h again, observe rat behavior and change, carry out behavior scoring.Standards of grading: 0 minute, normal, 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.Broken end is got the Mus brain fast then.A part is divided another name left and right sides brain hemisphere weight in wet base, puts in 160 ℃ of baking boxs to claim dry weight behind the 24h, calculates brain water content as follows:
Brain water content (%)=(weight in wet base-dry weight)/weight in wet base * 100%;
A part is downcut the crown brain sheet of thick about 2mm on the anterior commissure plane, place 2%TTC solution at once, hatches 30min for 37 ℃.Infarct presents white, and non-infarct presents redness.Measure with planimeter (C63 image analysis system) and respectively to distinguish area, and calculate the percentage ratio that infarct accounts for full brain.Animal is divided into 5 groups at random, model success back: (1) sham operated rats; (2) solvent control group: normal saline is pressed the 1ml/100g gastric infusion; (3) XINGLING KELI 740mg/kg group; (4) administration group: give capsule 16.5mg/kg group of the present invention; (5) administration group: give capsule 49.5mg/kg of the present invention; (6) administration group: give capsule 148.5mg/kg of the present invention.Before complete ischemia, in the ischemia process and quietly respectively in the refilling process push away administration 1 time.
2, result:
(1) the present invention is to the influence of behavior: all no abnormal symptom of sham operated rats rat, the neuroethology scoring is 0.The solvent control group is that the thromboembolism intraluminal middle cerebral artery occlusion in rats prepares focal cerebral ischemia in rats 2h and pours into 24h damage model group again, cerebral ischemia 1h irritates the gastric solubleness agent, appearance can not full extension offside fore paw or the nerve injury symptom of turn-taking laterally or toppling over to offside, and behavior scoring is 1.7 ± 0.8.Basic, normal, high 3 the dosage groups of stomach medicine of the present invention of promptly irritating cerebral ischemia 1h all can significantly reduce the neuroethology scoring, be respectively 0.8 ± 0.5,0.5 ± 0.5 and 0.3 ± 0.4, with solvent control group comparing difference significance is arranged: P＜0.05, P＜0.01, P＜0.001, the reduction degree has dose-dependence.Positive control XINGLING KELI group behavior scoring is 0.2 ± 0.3, significantly is lower than solvent control group P＜0.05.Show that capsule filling stomach of the present invention can significantly improve the nerve injury symptom of focal brain ischemia-reperfusion injury rat.
(2) the present invention is to the influence of brain water content: the brain water content highly significant of solvent control group ischemia-reperfusion side (right hemisphere) is higher than sham operated rats P＜0.01; The brain water content of low dose group of the present invention is significantly higher than sham operated rats P＜0.05; Be lower than the solvent control group, do not have significance P＞0.05 but compare difference with the solvent control group; The brain water content of middle and high two dosage groups of medicine of the present invention and positive controls significantly is lower than the solvent control group, sees Table 2.Show that dosage and high dose group can significantly reduce the ischemical reperfusion injury brain water content among the present invention, alleviate ischemia side brain hemisphere edema degree.
Table 2 the present invention is to the influence of Ischemia and Reperfusion in vivo in Rats brain water content
| Group | Quantity | Dosage (mg/kg) | Left hemisphere (%) | Right hemisphere (%) |
| Sham operated rats | ????6 | ??77.08±0.86 | ??76.94±1.62 | |
| The solvent control group | ????9 | ??76.99±1.24 | ??79.50±0.68 | |
| The administration group | ????7 | ??16.5 | ??76.92±1.05 | ??78.87±0.73 |
| ????6 | ??49.5 | ??77.01±1.06 | ??77.95±0.91 | |
| ????6 | ??148.5 | ??77.05±0.95 | ??77.72±0.89 | |
| The Fructus Pruni spirit | ????6 | ??740 | ??77.05±0.95 | ??77.39±1.05 |
(3) the present invention is to the influence of cerebral infarct volume: the sham operated rats cerebral tissue does not have infraction, and solvent control group ischemia side cerebral tissue has the infraction phenomenon, and infarct volume accounts for 36.24% of full brain; Basic, normal, high 3 dosage groups of medicine of the present invention and positive control XINGLING KELI group all can significantly be dwindled ischemia side cerebral tissue infarct volume, compare difference with the solvent control group highly significant P＜0.01 is arranged, reduced by 44.92%, 63.25%, 86.07% and 90.59% respectively; And it is suitable with positive control XINGLING KELI group that high dose group is dwindled the infarct volume effect of ischemia side cerebral tissue, sees Table 3.Show that the cerebral infarction that the present invention causes cerebral ischemia is plugged with remarkable protective effect.
Table 3 the present invention is to the cerebral infarction of cerebral ischemic reperfusion in rats
| Group | Dosage (mg/kg) | Infarct volume (%) |
| Sham operated rats | ????0 | |
| The solvent control group | ????36.24±7.10 | |
| Medicine of the present invention | ????16.5 | ????19.96±6.29 |
| ????49.5 | ????13.32±4.38 | |
| ????148.5 | ????5.05±1.43 | |
| The Fructus Pruni spirit | ????740 | ????3.41±2.26 |
3, conclusion: experimental result shows that the present invention can significantly improve the behavior symptom that cerebral ischemia causes, alleviates damage side cerebral edema, dwindles cerebral infarct volume, and action intensity has dose-dependence, dosage during for 148.5mg/kg effect the strongest.Prompting the present invention has protective effect to the rat acute focal brain ischemia-reperfusion injury.
Two, the clinical observation on the therapeutic effect of injection for treating acute cerebral infarction of the present invention
1, data and method
1.1 clinical data: 80 routine patients all meet " all kinds of diagnosis and treatment of cerebrovascular diseases main points " that the 4th national cerebrovascular meeting passed through after diagnosing, and patient is divided into two groups at random, 40 examples are organized in treatment, male's 21 examples wherein, women's 19 examples, in age 41-85 year, give injection of the present invention according to routine dose; Matched group 40 examples, male's 17 examples, women's 23 examples in age 43-82 year, give low molecular dextran according to routine dose and add FUFANG DANSHEN ZHUSHEYE.The course of disease is in morbidity 1h-3d.Get rid of and merge severe cardiac, lung, liver, kidney disease and severe diabetes mellitus.Do not expand blood vessel medicine and thrombolytics with other.Learn to handle by statistics, two groups of ages, sex, equal not statistically significant (P＞0.05) such as consultation time, clinical symptoms, head CT result after being ill have comparability.
1.2 method: each group administration respectively, once a day, 15 days is a course of treatment.Two groups of cases are conventional simultaneously with 20% mannitol 125ml venoclysis, every 8h-12h1 time, do not wait with 3d-7d.And conventional applied energy mixture, depressor etc. support anti symptom treatment, all treat 1-2 courses of treatment.
1.3 criterion of therapeutical effect: estimate according to the neurological deficits score standard that whole nation cerebrovascular academic conference for the second time in 1986 is passed through, curative effect is divided into is almost recovered: the functional impairment scoring reduces 91%-100%, 0 grade of invalid degree; Marked improvement: the functional impairment scoring reduces 46%-90%, and invalid degree is 1 grade-3 grades; Progressive: the functional impairment scoring reduces 18%-45%; No change: the functional impairment scoring reduces or increases in 17%; Worsen: the functional impairment scoring reduces or increases more than 18%; Dead.Above-mentionedly be almost recovered, marked improvement and progressive summation be for effectively.
2, result:
Table 1 liang group curative effect comparative example
| Group | Be almost recovered | Marked improvement | Progressive | No change | Worsen | Dead | Total effective rate |
| The treatment group | ??18 | ??9 | ??7 | ??6 | ??0 | ??0 | ??85.0％ |
| Matched group | ??9 | ??12 | ??5 | ??13 | ??1 | ??0 | ??65.0％ |
Two groups of total effective rates compare P＜0.05
3, discuss: treatment group total effective rate 85.0%, matched group are 65.0%, and visible injection of the present invention is a treatment acute cerebral infarction good medicine, is characterized in safe and reliable, good effect, and instant effect, and without any side effects in the use.
The specific embodiment:
Embodiments of the invention 1:
Radix Ginseng 100g Radix Salviae Miltiorrhizae 150g Radix Notoginseng 120g glycerol 20ml
Get the ginseng crude drug and be ground into coarse powder, the alcohol reflux of usefulness 1000ml 65% three times, each 2 hours, merge extractive liquid, reclaimed ethanol and concentrating under reduced pressure and becomes extractum, and lyophilization promptly gets Radix Ginseng extract.Get red rooted salvia and be ground into coarse powder, boil three times with the 1200ml decocting respectively, decocting time was respectively 3 hours, 2 hours, 1 hour, filtered, merging filtrate and concentrating under reduced pressure become extractum, add the ethanol precipitate with ethanol, containing the alcohol amount is 50%, leaves standstill 12 hours, filter, filtrate adds the ethanol precipitate with ethanol again, and containing the alcohol amount is 99.9%, leaves standstill 12 hours.Filtrate recycling ethanol and concentrating under reduced pressure become extractum, and vacuum drying promptly gets Radix Salviae Miltiorrhizae extract.Get Radix Notoginseng powder and be broken into coarse powder, the alcohol dipping of usefulness 1200ml 75% 24 hours, jolting constantly filters, and filtrate decompression is condensed into extractum, promptly gets Radix Notoginseng extract.Get Radix Ginseng extract, Radix Salviae Miltiorrhizae extract, Radix Notoginseng extract and glycerol mix homogeneously, add the injection water to 1000ml, regulating liquid PH value is 6.5, crosses the ultrafiltration post, embedding, sterilization, i.e. ejection preparation.
Embodiments of the invention 2:
Radix Ginseng 80g Radix Salviae Miltiorrhizae 120g Radix Notoginseng 100g lactose 250g
Get the ginseng crude drug and be ground into coarse powder, the alcohol reflux of usefulness 800ml 95% three times, each 2 hours, merge extractive liquid, reclaimed ethanol and concentrating under reduced pressure and becomes extractum, promptly gets Radix Ginseng extract.Get red rooted salvia and be ground into coarse powder, make solvent with 60% ethanol, 110KHz ultrasonic extraction 40min gets Radix Salviae Miltiorrhizae extract.Get Radix Notoginseng powder and be broken into coarse powder, boil twice with 1000ml, 500ml decocting respectively, decocted 2 hours for the first time, decocted 1 hour for the second time, after the cooling, centrifugalize merges supernatant, cross macroporous adsorptive resins, ethanol gradient elution is collected eluent, reclaims ethanol, be concentrated into the thick paste shape, get Radix Notoginseng extract.Get Radix Ginseng extract, Radix Notoginseng extract, Radix Salviae Miltiorrhizae extract and lactose mix homogeneously, add in the 500ml water for injection and dissolve, and continue to add water for injection, transfer PH7 to 1000ml, ultrafiltration, fill, lyophilization promptly gets lyophilized formulations.
Embodiments of the invention 3:
Radix Ginseng 3000g Radix Notoginseng 8000g gelatin 30000g
Get the ginseng crude drug and be ground into coarse powder, make solvent with 80% ethanol, soaked 3 days, add the ethanol of 75000ml altogether, carry out percolation, merge percolate, reclaim ethanol and be condensed into extractum, drying promptly gets Radix Ginseng extract.Get Radix Notoginseng, be ground into 120 purpose fine powders, promptly get Radix Notoginseng powder.With Radix Ginseng extract, Radix Notoginseng powder mix homogeneously and join mix homogeneously in the gelatin, splash in the dimethicone and cool off, promptly get drop pill.
Embodiments of the invention 4:
Radix Ginseng 10g Radix Salviae Miltiorrhizae 20g carboxymethyl starch sodium 2.5g
Get the ginseng crude drug and be ground into 80 purpose fine powders, promptly get the Radix Ginseng powder.Get red rooted salvia and be ground into coarse powder, use the alcohol reflux three times of 200ml 70% respectively, each 2 hours, merge extractive liquid, reclaimed ethanol and concentrating under reduced pressure and becomes extractum, and lyophilization promptly gets Radix Salviae Miltiorrhizae extract.With Radix Ginseng powder, Radix Salviae Miltiorrhizae extract and 1.25g carboxymethyl starch sodium mix homogeneously, and use alcohol granulation, with 1.25g carboxymethyl starch sodium mix homogeneously, tabletting carries out coating with 4% film coating agent to plain sheet, promptly gets tablet again.
Embodiments of the invention 5:
Radix Ginseng 3000g Radix Salviae Miltiorrhizae 5000g Radix Notoginseng 3000g Pulvis Talci 50g
Get Radix Salviae Miltiorrhizae, the ginseng crude drug is ground into coarse powder, extract with Radix Notoginseng water decocting method, the leaching decocting liquid, filtrate is carried out the gradient isolated by filtration with the ultrafilter membrane of the sub-very much magnitude of 5-10, discards liquid on the film, and the ultrafilter membrane of the sub-very much magnitude of filtrate reuse 0.1-0.3 carries out the gradient isolated by filtration, get liquid on the thick paste shape film, liquid is by macroporous resin column under the film, and ethanol gradient elution is collected eluent, reclaim ethanol, be concentrated into the thick paste shape, drying is ground into 100 purpose granules, with the Pulvis Talci mix homogeneously, use alcohol granulation, filling promptly gets capsule.
Embodiments of the invention 6:
Radix Ginseng 10g Radix Salviae Miltiorrhizae 10g Radix Notoginseng 10g Oleum Glycines 10ml
Get red rooted salvia and be ground into coarse powder, extract with Radix Notoginseng water decocting method, with ethanol precipitate with ethanol twice, containing the alcohol amount for the first time is 65%, and containing the alcohol amount for the second time is 82%.Reclaim ethanol and be condensed into extractum, drying is ground into 100 purpose fine powders, promptly gets Radix Salviae Miltiorrhizae, Radix Notoginseng extract.Get the ginseng crude drug and be ground into coarse powder, use alcohol reflux, reclaim ethanol and be condensed into extractum, drying is ground into 100 purpose fine powders, promptly gets Radix Ginseng extract.Get Radix Salviae Miltiorrhizae, Radix Notoginseng extract, Radix Ginseng extract and Oleum Glycines mix homogeneously, pill promptly gets soft capsule.
Embodiments of the invention 7:
Radix Ginseng 3000g Radix Salviae Miltiorrhizae 8000g sucrose 600g
Get Radix Salviae Miltiorrhizae, ginseng crude drug's pulverizing, water decocts three times, adds the 132000ml decocting for the first time and boils 3 hours, for the second time add the 88000ml decocting and boiled 2 hours, add the 66000ml decocting for the third time and boiled the leaching decocting liquid 1 hour, merge, concentrating under reduced pressure gets extract, and sucrose is dissolved in the hot water that boils, drop into the said extracted thing, filter, fill promptly gets oral liquid.
The embodiment of the invention 8:
Radix Ginseng 10g Radix Notoginseng 20g sucrose 40g
Get Radix Notoginseng, the water decocting method extracts, and adds ethanol and makes that to contain the alcohol amount be 75%, and cold preservation is spent the night, and reclaims ethanol and also is condensed into extractum, promptly gets Radix Notoginseng extractum.Get the ginseng crude drug and be ground into coarse powder, make solvent, soaked 1 day, add the ethanol of 400ml altogether, carry out percolation, merge percolate, reclaim ethanol and be condensed into extractum, promptly get Radix Ginseng extract with 80% ethanol.Other gets cane sugar powder and is broken into 100 purpose fine powders.Get Radix Notoginseng extractum, Radix Ginseng extractum and cane sugar powder mix homogeneously, granulate, promptly get granule.
Claims (9)
1, a kind of Chinese medicine preparation for the treatment of acute cerebral infarction, it is characterized in that: calculate: make: Radix Ginseng 10-3000 and 20-8000 Radix Salviae Miltiorrhizae by following component according to components by weight percent, one or both combinations in the Radix Notoginseng, be equipped with suitable adjuvant again and make acceptable preparation, comprising: injection, freeze-dried powder, capsule, soft capsule, tablet, granule, pill, microcapsule, micropill, concentrated pill, drop pill, slow releasing preparation, controlled release preparation, quick releasing formulation, targeting preparation, oral liquid, syrup, powder, mixture, powder, spray, medicated wine, tincture, lozenge, extractum, fluid extract.
2, according to the Chinese medicine preparation of the described treatment acute cerebral infarction of claim 1, it is characterized in that: calculate according to components by weight percent, one or both combinations with in Radix Ginseng 10-3000 and 20-8000 Radix Salviae Miltiorrhizae, the Radix Notoginseng are prepared into injection, freeze-dried powder, tablet, drop pill, capsule, granule, oral liquid.
3, the preparation method of the Chinese medicine preparation of treatment acute cerebral infarction as claimed in claim 1 or 2, it is characterized in that: calculate: get Radix Ginseng 10-3000 part, Radix Salviae Miltiorrhizae 20-8000 part according to components by weight percent, (1), gets the ginseng crude drug and be ground into the above fine powder of 60 orders, promptly get the Radix Ginseng powder, (2), get red rooted salvia and be ground into coarse powder, use alcohol reflux, extracting solution reclaims ethanol and is condensed into extractum, dry, promptly get Radix Salviae Miltiorrhizae extract, (3), with Radix Ginseng powder, Radix Salviae Miltiorrhizae extract mix homogeneously, can make different products according to conventional method again.
4, preparation method according to the Chinese medicine preparation of the described treatment acute cerebral infarction of claim 3, it is characterized in that: calculate: get Radix Ginseng 10-3000 part according to components by weight percent, Radix Notoginseng 20-8000 part, (1), get the ginseng crude drug and be ground into coarse powder, make solvent with ethanol, soak more than 1 day, carry out percolation, merge percolate, reclaim ethanol and be condensed into extractum, drying, promptly get Radix Ginseng extract, (2), get Radix Notoginseng, be ground into the above fine powder of 60 orders, promptly get Radix Notoginseng powder, (3), with Radix Ginseng extract, the Radix Notoginseng powder mix homogeneously can be made different products according to conventional method again.
5, preparation method according to the Chinese medicine preparation of claim 3 or 4 described treatment acute cerebral infarctions, it is characterized in that: calculate: get Radix Ginseng 10-3000 part according to components by weight percent, Radix Salviae Miltiorrhizae 10-5000 part, Radix Notoginseng 10-3000 part, (1), get the ginseng crude drug and be ground into coarse powder, extract with ethanol refluxing process, reclaim ethanol and be condensed into extractum, dry, promptly get Radix Ginseng extract, (2), get red rooted salvia and be ground into coarse powder, the water decocting method extracts, more than once reaching once with the ethanol precipitate with ethanol, contain the alcohol amount and be 50-99%, extracting solution reclaims ethanol and is condensed into extractum, drying, promptly get Radix Salviae Miltiorrhizae extract, (3), get Radix Notoginseng powder and be broken into coarse powder, use alcohol dipping more than 1 hour, jolting constantly, filter, filtrate is condensed into extractum, and drying promptly gets Radix Notoginseng extract, (4), get Radix Ginseng extract, Radix Salviae Miltiorrhizae extract, the Radix Notoginseng extract mix homogeneously can be made different products more according to a conventional method.
6, according to the preparation method of the Chinese medicine preparation of the described treatment acute cerebral infarction of claim 5, it is characterized in that: the technology that the present invention makes injection is:
Get the ginseng crude drug and be ground into coarse powder, extract with ethanol refluxing process, reclaim ethanol and be condensed into extractum, promptly get Radix Ginseng extract, get red rooted salvia and be ground into coarse powder, the water decocting method extracts, more than once reaching once with the ethanol precipitate with ethanol, contain the alcohol amount and be 50-99%, extracting solution reclaims ethanol and is condensed into extractum, promptly gets Radix Salviae Miltiorrhizae extract, get Radix Notoginseng powder and be broken into coarse powder, more than 1 hour, jolting constantly filters with alcohol dipping, filtrate is condensed into extractum, promptly get Radix Notoginseng extract, get Radix Ginseng extract, Radix Salviae Miltiorrhizae extract, the glycerol mix homogeneously of Radix Notoginseng extract and total medicinal liquid 1-30% adds to the full amount of water for injection, the adjusting liquid PH value is 2-7, cross the ultrafiltration post, embedding, sterilization, i.e. ejection preparation.
7, according to the preparation method of the Chinese medicine preparation of the described treatment acute cerebral infarction of claim 5, it is characterized in that: the technology that the present invention makes freeze-dried powder injection is: get the ginseng crude drug and be ground into coarse powder, extract with ethanol reflux extraction, reclaim ethanol and be condensed into extractum, promptly get Radix Ginseng extract, get red rooted salvia and be ground into coarse powder, make solvent with ethanol, extract, get Radix Salviae Miltiorrhizae extract with ultrasound assisted extraction technique, get Radix Notoginseng powder and be broken into coarse powder, water decocts, and centrifugalize merges supernatant, cross macroporous adsorptive resins, get Radix Notoginseng extract.Get the lactose mix homogeneously of Radix Ginseng extract, Radix Notoginseng extract, Radix Salviae Miltiorrhizae extract and 1-30%, add in an amount of water for injection and dissolve, and continue to add and add to the full amount of water for injection, transfer pH value 2-7, ultrafiltration, fill, lyophilization promptly gets lyophilized formulations.
8, preparation method according to the Chinese medicine preparation of the described treatment acute cerebral infarction of claim 4, it is characterized in that: the technology that the present invention makes drop pill is: get the ginseng crude drug and be ground into coarse powder, make solvent with 45-80% ethanol, soak more than 1 day, add the ethanol that 15-40 doubly measures altogether, carry out percolation, merge percolate, reclaim ethanol and be condensed into extractum, drying promptly gets Radix Ginseng extract, gets Radix Notoginseng, be ground into the above fine powder of 60 orders, promptly get Radix Notoginseng powder, with Radix Ginseng extract, the Radix Notoginseng powder mix homogeneously, the gelatin that medicated powder 0.1-10 is doubly measured adds mix homogeneously in the above drug powder, splash in the dimethicone and cool off, promptly get drop pill.
9, preparation method according to the Chinese medicine preparation of the described treatment acute cerebral infarction of claim 3, it is characterized in that: the technology that the present invention makes tablet is: get the ginseng crude drug and be ground into the above fine powder of 60 orders, promptly get the Radix Ginseng powder, get red rooted salvia and be ground into coarse powder, use alcohol reflux, extracting solution reclaims ethanol and is condensed into extractum, dry, promptly get Radix Salviae Miltiorrhizae extract, with the Radix Ginseng powder, Radix Salviae Miltiorrhizae extract, the carboxymethyl starch sodium mix homogeneously of medicated powder amount 0.5-10%, and use alcohol granulation, again with the carboxymethyl starch sodium mix homogeneously of medicated powder amount 0.5-2%, tabletting carries out coating with the 2-8% film coating agent to plain sheet, promptly gets tablet.
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|---|---|---|---|
| CN 200410040032 CN1284551C (en) | 2004-06-15 | 2004-06-15 | Chinese medicinal preparation and preparing method for acute cerebral infarction |
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| CN 200410040032 CN1284551C (en) | 2004-06-15 | 2004-06-15 | Chinese medicinal preparation and preparing method for acute cerebral infarction |
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| CN1284551C CN1284551C (en) | 2006-11-15 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105012591A (en) * | 2014-04-22 | 2015-11-04 | 上海中医药大学附属龙华医院 | Traditional Chinese medicine compound preparation for treating cerebral infarction as well as preparation method and application of traditional Chinese medicine compound preparation |
| CN108403759A (en) * | 2018-04-16 | 2018-08-17 | 东莞市亚洲制药有限公司 | A kind of health composition and its preparation method and application |
-
2004
- 2004-06-15 CN CN 200410040032 patent/CN1284551C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105012591A (en) * | 2014-04-22 | 2015-11-04 | 上海中医药大学附属龙华医院 | Traditional Chinese medicine compound preparation for treating cerebral infarction as well as preparation method and application of traditional Chinese medicine compound preparation |
| CN108403759A (en) * | 2018-04-16 | 2018-08-17 | 东莞市亚洲制药有限公司 | A kind of health composition and its preparation method and application |
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| Publication number | Publication date |
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| CN1284551C (en) | 2006-11-15 |
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