CN100364565C - Chinese medicine composition for treating apoplexy and its preparing method - Google Patents
Chinese medicine composition for treating apoplexy and its preparing method Download PDFInfo
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- CN100364565C CN100364565C CNB2005101049336A CN200510104933A CN100364565C CN 100364565 C CN100364565 C CN 100364565C CN B2005101049336 A CNB2005101049336 A CN B2005101049336A CN 200510104933 A CN200510104933 A CN 200510104933A CN 100364565 C CN100364565 C CN 100364565C
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Abstract
The present invention discloses a Chinese medicine composition for treating apoplexy, which is prepared from an effective component and/or a medically adacceptable excipient vehicle, wherein the effective component is prepared from Chinese medicine raw materials of milkvetch root, red sage root, leech, earthworms and chuanxiong rhizome. The Chinese medicine composition for treating apoplexy has the efficacy of replenishing qi to dredge collaterals and promoting blood circulation by removing blood stasis, can be used for treating apoplexy, and is particularly suitable for persons with the symptoms of qi deficiency and blood stasis apoplexy involving the meridians, hemiplegia, deviation of mouth and tongue, aphasia, hemianesthesia, short breath, weakness, vertigo and cerebral infarction in the recovery stage. The present invention also discloses a method for preparing the Chinese medicine composition, a quality controlling method for the Chinese medicine composition and the application of the Chinese medicine composition.
Description
Technical field
The present invention relates to the field of Chinese medicines, relate to a kind of Chinese medicine composition for the treatment of apoplexy specifically.The invention still further relates to preparation method, method of quality control and the purposes of said composition.
Background technology
Apoplexy is a kind of old common disease, because the deficiency of vital energy can not transport blood, and the gas unable to walk, blood can not be flourish, and QI and blood is retarded by silt, venation numbness resistance and cause primary disease.The Chinese medicine of treatment apoplexy is a lot of at present, but general flavour of a drug are many, and cost is higher, and curative effect neither be very good.For this reason, inventor's developmental research a kind of flavour of a drug concise, the Chinese medicine of treatment apoplexy evident in efficacy.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of apoplexy.
Another object of the present invention provides a kind of preparation method for the treatment of the Chinese medicine composition of apoplexy.
Chinese medicine composition of the present invention is made up of effective ingredient and/or acceptable accessories, wherein prepares raw materials of effective components and consists of:
Radix Astragali 14-17 weight portion, Radix Salviae Miltiorrhizae 10-13 weight portion, Hirudo 1-5 weight portion, Pheretima 8-12 weight portion and Rhizoma Chuanxiong 4-8 weight portion.
In order to obtain better therapeutic, preparation raw materials of effective components composition is preferably:
The Radix Astragali 15 weight portions, Radix Salviae Miltiorrhizae 12 weight portions, Hirudo 3 weight portions, Pheretima 10 weight portions and Rhizoma Chuanxiong 6 weight portions.
In above-mentioned raw materials, the Radix Astragali, sweet, tepor is returned spleen lung two warps, and the function replenishing QI to invigorate the spleen is the key medicine of QI invigorating, makes the capable then blood of gas capable, so be monarch drug.Radix Salviae Miltiorrhizae, bitter, be slightly cold, GUIXIN, pericardium, Liver Channel, the blood vessels that can pass through, merit is arrogated to oneself activating blood circulation to dissipate blood stasis, and promoting tissue regeneration by removing blood stasis is to be ministerial drug.Hirudo, Pheretima, two medicines, salty in the mouth is returned Liver Channel, plays the effect of removing blood stasis by the silt the meridian dredging altogether, is adjuvant drug in the side.Rhizoma Chuanxiong, hot, warm, return liver, gallbladder meridian, merit is the gas medicine in the blood at blood-activating and qi-promoting, the effect of the sensible QI and blood of real tool can strengthen the power of activating blood circulation to dissipate blood stasis, is messenger drug.More than all medicines share, play the benefiting QI for activating blood circulation silt altogether, the merit of dredge the meridian passage.Be applicable to treatment apoplexy blood stasis due to qi deficiency disease.
The present invention treats the method for making of the Chinese medicine composition of apoplexy, can adopt the physical pulverization method that each flavor Chinese crude drug is ground into the powder mixing and make powder, also can adopt decoction and alcohol sedimentation technique or ethanol extract from water precipitation etc. to be extracted, the effective ingredient that extracts is made various oral formulations with acceptable accessories, as oral solid formulation is tablet, hard capsule, soft capsule, granule etc., oral liquid such as oral liquid etc.But preferably adopt following method to be prepared, can reduce dose and do not lessen the curative effect, this preferred manufacturing procedure comprises the following steps: to take by weighing the above five tastes, with Rhizoma Chuanxiong elder generation vapor distillation, collects distillate; The Radix Salviae Miltiorrhizae alcohol reflux, decompression recycling ethanol concentrates, and oven dry is pulverized; Other gets the Radix Astragali, Pheretima, Hirudo and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decocts with water, and filtrate is evaporated to 50 ℃ of relative densities and is 1.20～1.25 clear paste, merges with the Rhizoma Chuanxiong clear paste and puts coldly, adds ethanol and makes that to contain the alcohol amount be 60%, and placement is spent the night, and filters.Decompression filtrate recycling ethanol concentrates, and oven dry is pulverized, and adds above-mentioned Radix Salviae Miltiorrhizae extractum powder and Hirudo fine powder, and mixing is made effective ingredient.
Preferred preparation method comprises the following steps: to take by weighing the above five tastes, and water intaking trematodiasis 50-60% is ground into fine powder; The Rhizoma Chuanxiong vapor distillation is collected distillate, and the distillate redistillation is once collected double distilled liquid, and Rhizoma Chuanxiong clear paste and double distilled liquid is standby; It is 1.20～1.25 clear paste that decocting liquid is concentrated into 50 ℃ of relative densities; Radix Salviae Miltiorrhizae alcohol reflux secondary filters, merging filtrate, and decompression recycling ethanol concentrates, and oven dry is pulverized, and makes the Radix Salviae Miltiorrhizae extractum powder; Other gets the Radix Astragali, Pheretima, residue Hirudo and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decocts with water 2-3 time, and 2 hours for the first time, second or three time respectively was 1 hour, filter, merging filtrate is evaporated to 50 ℃ of relative densities and is 1.20～1.25 clear paste, merge with the Rhizoma Chuanxiong clear paste, put coldly, add ethanol and make that to contain the alcohol amount be 60%, placement is spent the night, and filters decompression filtrate recycling ethanol, concentrate, oven dry is pulverized, add above-mentioned Radix Salviae Miltiorrhizae extractum powder, Hirudo fine powder and Rhizoma Chuanxiong re-distilled liquid, mixing is made effective ingredient.
Treatment apoplexy Chinese medicine composition of the present invention has QI invigorating pain network and blood circulation invigorating efficacies.Orally can be used for treating apoplexy, especially blood stasis due to qi deficiency apoplexy apoplex involving the channels and collaterals, disease is seen hemiplegia, the askew heresy of dispute, and language is held high up puckery, hemianesthesia, shortness of breath and fatigue, dizziness, cerebral infarction at restoration stage is seen above-mentioned patient.
Experiment shows that the Chinese medicine composition that the present invention treats apoplexy can improve brain microcirculation, the cerebral blood flow increasing amount, vascular permeability and edema when alleviating cerebral ischemia, improve the cerebral tissue hypoxia-bearing capability, the Chinese medicine composition energy expansion of cerebral vascular of prompting treatment apoplexy, increase cerebral tissue blood supply, oxygen supply, help the recovery of ischemic cerebrovascular; Simultaneously can also antiplatelet aggregation, reduce platelet adhesion power, suppress the rat thrombus in vivo and form, and anticoagulation, accelerating fibers protein dissolution are arranged, and the hemorheology that improves the blood stasis rat, this helps preventing and treating the formation of thrombosis.Above-mentioned many-sided pharmacological action is the Chinese medicine composition of treatment apoplexy, activating qi and collateral, wind-induced hemiplegia, facial hemiparalysis, the disadvantageous pharmacological basis of speech in the activating blood circulation to dissipate blood stasis treatment.
The present invention treats the Chinese medicine composition energy cerebral blood flow increasing amount of apoplexy, improve cerebral circulation, increase the cerebral tissue blood supply, oxygen-supplying amount, and cerebrovascular permeability and cerebral edema when alleviating rat cerebral ischemia, improve the cerebral tissue hypoxia-bearing capability, suppress the formation of rat thrombus in vivo, reduce the platelet adhesion reaction rate, antiplatelet aggregation, anticoagulant, the accelerating fibers protein dissolution, and the Blood stasis hemorheology of rat had clear improvement.
Apoplexy blood stasis due to qi deficiency disease 409 examples are treated in this clinical trial altogether, are that 304 examples are organized in treatment with treatment apoplexy Chinese medicine composition of the present invention, are matched group 105 examples with the XIAOSHUAN TONGLUO PIAN.Sex, age, course of disease distribution, state of an illness weight and sings and symptoms distribution situation between two groups of cases, difference does not have significance (P＞0.05), has comparability.
Clinical test results, treatment group clinical cure 38 examples (12.5%), total effective and total produce effects is respectively 280 examples (92.11%) and 166 examples (54.61%).Matched group clinical cure 8 examples (7.62%), total effective and total produce effects is respectively 94 examples (89.52%) and 37 examples (35.24%).Two groups of total effective rate contrasts, difference does not have significance P＞0.05, total obvious effective rate contrast, difference has utmost point significance, P＜0.01, the treatment group is better than matched group.Before two groups of case sign treatment back treatments obvious alleviation is arranged all, treat the back contrast between two groups, upper limb articulations digitorum manus and lower limb hip joint obstacle and comprehensive function obstacle are better than matched group (P＜0.05.The two groups of case symptoms in treatment back all have disappearance in various degree, except that tongue arteries and veins contrast difference does not have significantly, and each remission, the treatment group is better than matched group.Two groups of cases contrast with treating preceding integration after treating back integration comparison, treatment group and each autotherapy of matched group, and utmost point significant difference (P＜0.01=is arranged.Compare for two groups, before treating after integral difference similar (P＞0.05) treatment group of contrast and matched group systolic pressure and diastolic pressure are treated before and after the treatment, obvious reduction is all arranged, and (P＜0.01=, to the absorption of focus of infarct, the treatment group is better than matched group (P＜0.05=.Contrast before the every index of hemorheology is treated does not all have dominance difference through t check P＞0.05.The treatment group treat back self contrast whole blood contrast viscosity low cut with reduction ratio viscosity in, low cutting and RPV, Fbg, obviously reduce P＜0.05.Contrast before the every index of matched group is treated the back and treated, one of an IED obviously reduces P＜0.05.Treatment group and matched group are treated the back contrast, cut matched group in the whole blood contrast viscosity and reduce obviously (P＜0.05=, and RPV treatment group reduces than the obvious (P＜0.05=of matched group.From the relation analysis of the state of an illness and curative effect, middle disease group is better than severe group (P＜0.05=.
All observe cases, treatment is organized 13 examples and slight stomachache occurred at drug administration process, not drug withdrawal spontaneous remission, through change into take medicine after the meal after, stomachache appears again, any untoward reaction does not all appear in all the other patients.304 examples are organized in treatment, matched group 105 examples have all been done blood, urine, just routine examination before treatment, 294 examples are organized in treatment, matched group 102 examples have been checked liver (GPT), kidney (BUN, Gr) and electrocardiogram respectively before and after treatment, abnormal change did not all take place all cases after the result showed medication.
The discrimination method of medicine of the present invention is:
(1) get this product porphyrize, add methanol 50ml, reflux 1 hour, extracting solution is concentrated into dried, and residue adds water 30ml makes dissolving, extracts 2 times with the ether jolting, and each 15ml merges ether solution, volatilizes, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Get the tanshinone reference substance, add ethyl acetate and make the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000) test, draw each 3 μ l of above-mentioned two kinds of solution, put in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with petroleum ether (60～90 ℃)-ethyl acetate (8: 2) is developing solvent, launch, take out, dry.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical kermesinus speckle.
(2) get Rhizoma Chuanxiong control medicinal material 2g, add chloroform 10ml, merceration 2 hours filters, and filtrate is concentrated into 1ml, in contrast medical material solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 6 μ l and above-mentioned control medicinal material solution 2 μ l under the item of [discriminating] (1), put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with chloroform-petroleum ether (60～90 ℃) (2: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue-fluorescence speckle.
(3) water intaking trematodiasis control medicinal material 5g adds chloroform 20ml merceration, and placement is spent the night, and filters, and filtrate is concentrated into 1ml, in contrast medical material solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution and each 3 μ l of above-mentioned control medicinal material solution under the item of [discriminating] (1), put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with the chloroform is developing solvent, launch, take out, dry, spray is with 10% phosphomolybdic acid ethanol solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical blue spot.
The method of quality control of medicine of the present invention is:
Get this product porphyrize, get 7g, the accurate title, decide, put in the apparatus,Soxhlet's, add methanol 60ml, reflux 6 hours, extracting solution reclaims methanol to doing, residue adds water 30ml slight fever makes dissolving, with water saturated n-butyl alcohol difference 30,30,30, the 20ml jolting is extracted 4 times, merges n-butanol extracting liquid, the ammonia solution saturated with n-butyl alcohol washs 2 times, each 90ml discards the ammonia washing liquid, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 5ml dissolving, on D101 type macroporous adsorptive resins,, discard water lotion with water 60ml eluting, reuse 40% ethanol 200ml eluting, discard 40% ethanol elution, continue, collect eluent with 70% ethanol 600ml eluting, reclaiming solvent does near, residue adds dissolve with methanol and quantitatively is transferred in the 5ml measuring bottle, add methanol and be diluted to scale, shake up, as need testing solution; Precision is got the astragaloside reference substance in addition, adds methanol and makes the solution that every 1ml contains 1mg, solution in contrast.Test according to an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography, the accurate need testing solution 4 μ l that draw, reference substance solution 1 μ l and 3 μ l, the cross point is on same silica gel g thin-layer plate respectively, placing the lower floor's solution that spends the night below 10 ℃ with the chloroform-methanol-water of 13: 6: 2 ratios is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 100 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan according to an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography scanning, wavelength: λ s=515nm, λ r=700nm measures test sample trap integrated value and reference substance trap integrated value, calculates, this product per unit dosage contains the Radix Astragali in astragaloside, must not be less than 0.14mg.
Embodiment 1
Take by weighing: Radix Astragali 750g, Radix Salviae Miltiorrhizae 600g, Hirudo 150g, Pheretima 500g and Rhizoma Chuanxiong 300g;
Water intaking trematodiasis 80g is ground into fine powder; The Rhizoma Chuanxiong vapor distillation is collected distillate, and the distillate redistillation is once collected double distilled liquid, and is standby.Decocting liquid is concentrated into the clear paste that relative density is 1.20～1.25 (50 ℃); Radix Salviae Miltiorrhizae alcohol reflux secondary filters, merging filtrate, and decompression recycling ethanol concentrates, and oven dry is pulverized; Get the Radix Astragali, Pheretima, residue Hirudo (70g) and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decoct with water three times, 2 hours for the first time, second and third time respectively was 1 hour, filter, merging filtrate, being evaporated to relative density is the clear paste of 1.20～1.25 (50 ℃), merges with the Rhizoma Chuanxiong clear paste, put cold, add ethanol and make that to contain alcohol amount be 60%, placement is spent the night, and filters.Decompression filtrate recycling ethanol concentrates, and oven dry is pulverized, and adds above-mentioned Radix Salviae Miltiorrhizae extractum powder, Hirudo fine powder and appropriate amount of starch, and mixing is granulated with the Rhizoma Chuanxiong re-distilled liquid, cold drying, and tabletting is made 1000, coating, that is, and the red trematodiasis sheet of commodity compound recipe by name.
Oral, one time 5,3 times on the one, 6 weeks of the course of treatment.
Embodiment 2
Take by weighing: Radix Astragali 750g, Radix Salviae Miltiorrhizae 600g, Hirudo 150g, Pheretima 500g and Rhizoma Chuanxiong 300g; Each flavor Chinese crude drug is ground into powder, and mixing is made powder.
Embodiment 3
Take by weighing: Radix Astragali 750g, Radix Salviae Miltiorrhizae 600g, Hirudo 150g, Pheretima 500g and Rhizoma Chuanxiong 300g; Water intaking trematodiasis 80g is ground into fine powder; The Rhizoma Chuanxiong vapor distillation is collected distillate, and the distillate redistillation is once collected double distilled liquid, and is standby.Decocting liquid is concentrated into the clear paste that relative density is 1.20～1.25 (50 ℃); Radix Salviae Miltiorrhizae alcohol reflux secondary filters, merging filtrate, and decompression recycling ethanol concentrates, and oven dry is pulverized; Get the Radix Astragali, Pheretima, residue Hirudo (70g) and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decoct with water three times, 2 hours for the first time, second and third time respectively was 1 hour, filter, merging filtrate, being evaporated to relative density is the clear paste of 1.20～1.25 (50 ℃), merges with the Rhizoma Chuanxiong clear paste, put cold, add ethanol and make that to contain alcohol amount be 60%, placement is spent the night, and filters.Decompression filtrate recycling ethanol concentrates, and oven dry is pulverized, and adds above-mentioned Radix Salviae Miltiorrhizae extractum powder, Hirudo fine powder and appropriate amount of starch, and mixing is granulated with the Rhizoma Chuanxiong re-distilled liquid, cold drying, levigation, the red trematodiasis powder of commodity compound recipe by name.
Experimental example 1
Experiment material
Animal: Kunming kind white mice body weight 18-21g, rat body weight 140-160g, all male and female half and half are provided by the court animal housing.The mice quality certification number 0005, the rat quality certification numbers 9200050.The healthy adult dog, body weight 12-15kg, male and female dual-purpose.
The red trematodiasis powder of the compound recipe that medicine: embodiment 3 makes is provided by Tonghua Bai Shan pharmaceutical factory, makes the desired concn suspension before the experiment, puts 4 ℃ of refrigerators and preserves, and irritates stomach fully and uses.The NIAOXUEKANG KOUFUYE authentication code: (87) defend the accurate word of medicine (z-103), and Jilin Province Gongzhuling City HONGGUANG pharmaceutical factory produces, lot number 921005.FUFANG DANSHEN PIAN Jilin Province Changchun morning twilight pharmaceutical factory produces, lot number 910922.
Instrument: polygraph (RM-6000, Japan), electromagnetic flowmeter (MFV-1100, Japan), XSN-R type external thrombus forms, the platelet adhesion reaction double-purpose instrument, and the experimental thrombus in vivo of BT87-2 type forms analyzer, the SA-SC type is adjustable constant pressure capillary viscosimeter.
Method and result
One, to the influence of anesthetized dog cerebral blood flow and peripheral vascular resistance
24 of dogs are divided into four groups at random: the 1st group is physiology saline control group, and the 2nd group is the heavy dose of group of the red trematodiasis of compound recipe (0.8g powder/kg), the 3rd group of red trematodiasis small dose group (0.7ml/kg) of compound recipe.Give dog intravenous injection sodium pentobarbital (30mg/kg) anesthesia, connect artificial respirator, open breast after separating right carotid and ligature external carotid artery and vertebral artery, separate aortic root, place the electromagnetic flowmeter probe respectively, to measure ICAF amount (CF), as cerebral blood flow and per minute cardiac output (CO) [1].Separate femoral artery, intubate is measured arteriotony (systolic pressure SBP, diastolic pressure DBP), places electrocardiogram limbs crosslinking electrode, and the accurate II of mark leads electrocardiogram to measure the rhythm of the heart (HR); Separate femoral artery, in order to the intravenous injection medicine.With every observation index input polygraph, the variation of 1,2,5,10,15,20,30,45,60 minute each index before the record administration and after the administration, and calculate peripheral vascular resistance (TPVR) [2], the results are shown in Table 1.The result shows that the Chinese medicine composition injection that the present invention treats apoplexy began obvious cerebral blood flow increasing amount in 1 minute, with before the administration or matched group more all there were significant differences, can keep action time 15 minutes.The Chinese medicine composition that the present invention treats apoplexy can make cardiac output increase and the peripheral vascular resistance reduction, and continue 45 minutes its action time.The arteriotony and the rhythm of the heart there is not obvious influence.
Two, to the influence of rats with cerebral ischemia cerebrovascular permeability
6 groups of 60 five equilibriums of rat, 1st, irritate stomach water for 2 groups, irritate stomach NIAOXUEKANG 20ml/kg for the 3rd group, irritating respectively for the 4th, 5,6 group is compound recipe pellet trematodiasis 1.8,3.6,5.4g/kg, every day 1 time, continuous 7 days, with after the last administration 1 hour, each organized equal intravenous injection Ye Wensilan 50mg/kg, after 5 minutes except that the 1st group, other respectively organize the bilateral common carotid arteries that all ligatures, and cause acute imperfection cerebral ischemic model.After ligaturing 3 hours, broken end is got brain and is weighed, and is soaked in respectively in the Methanamide, and incubation is 72 hours in 45 ℃ of calorstats, gets leachate in 620nm place colorimetric, surveys the content of ivens orchid in the brain, the results are shown in Table 2.As seen the blue content of big or middle dosage group ivens all has obvious minimizing.Show that the cerebrovascular permeability increase has the reduction effect after Chinese medicine composition that the present invention treats apoplexy is to cerebral ischemia.
The influence of table 1 pair rat brain vascular permeability (n=10,
)
| Group | The blue content of ivens (μ g/g brain is heavy) |
| The red trematodiasis 1.8g/kg of the red trematodiasis 3.6g/kg of the red trematodiasis 5.4/kg of normal control cerebral ischemic model NIAOXUEKANG 20ml/kg compound recipe compound recipe compound recipe | 8.58±0.72 10.30±1.92 8.43±2.00 7.21±1.48 8.04±2.14 8.42±2.64 |
Compare with model group
*P＜0.05
*P＜0.01
* *P＜0.001
Three, to the influence of rats with cerebral ischemia brain water content
60 of rats, 6 groups of five equilibriums are pressed table 3 gastric infusion, every day 1 time, continuous 7 days, after the last administration 1 hour, the bilateral carotid that ligatures after 3 hours, breaked end rat, get brain and weigh, at 110 ℃ of baking ovens, dry to constant weight, calculate brain water content and cerebral index, result such as table 3.Large, medium and small three and two groups and cerebral ischemic model group relatively, brain water content and cerebral index all obviously reduce, and show that the present invention treats the cerebral edema that the Chinese medicine composition of apoplexy causes the imperfection ischemia obvious protective effect is arranged.
The influence of table 2 pair rat brain water content and cerebral index (n=10,
)
| Group | Cerebral index (the heavy g/100g body weight of brain) | Brain water content (%) |
| The red trematodiasis 1.8g/kg of the red trematodiasis 3.6g/kg of the red trematodiasis 5.4/kg of normal control cerebral ischemic model NIAOXUEKANG 20ml/kg compound recipe compound recipe compound recipe | 0.616±0.051 ** 0.694±0.052 0.629±0.073 * 0.607±0.052 ** 0.638±0.042 * 0.634±0.036 * | 78.57±0.47 ** 79.37±0.74 78.631±0.53 * 78.53±0.41 ** 78.39±0.40 ** 78.63±0.54 * |
Compare with model group
*P＜0.05
*P＜0.01
* *P＜0.001
Four, to the influence of mouse brain ischemia
50 of mices, 5 groups of five equilibriums are pressed table 4 gastric infusion, matched group feedwater, every day 1 time, continuous 7 days, after the last administration 1 hour, break end rapidly at the mouse ear rear portion, cause brain acute ischemia, anoxia, observe broken end back frequency of respiration and hold time, the results are shown in Table 4.As seen, the Chinese medicine composition of treatment apoplexy can increase frequency of respiration, prolongs breathing time.Showing has excitation to the respiratory center under the mouse brain hypoxic-ischemic, and can improve the cerebral tissue hypoxia-bearing capability.
The influence of table 3 pair chmice acute cerebral ischemia (n=10,
)
| Group | Frequency of respiration | Hold time (second) |
| The red trematodiasis 3.6g/kg of the red trematodiasis 5.4/kg of normal control NIAOXUEKANG 20ml/kg compound recipe compound recipe | 6.6±2.5 10.2±4.0 * 11±3.9 ** 12.4±3.4 *** | 22.5±5.2 27.4±4.0 * 32.5±6.2 ** 35.8±10.2 ** |
| The red trematodiasis 1.8g/kg of compound recipe | 10.8±4.1 * | 33.7±6.0 ** |
Compare with matched group
*P＜0.05
*P＜0.01
* *P＜0.001
Five, to the influence of artery thrombosis in the rat body
50 of rats, 5 groups of five equilibriums are pressed table 5 gastric infusion, the matched group feedwater, every day 1 time, continuous 7 days, last administration 1 hour, sodium pentobarbital anesthesia separates a side common carotid artery, and the stimulating electrode and the temperature sensor that the experimental thrombus in vivo of BT87-2 type are formed analyzer are colluded respectively on tremulous pulse, continue to stimulate blood vessel wall 3 minutes with the 2mA unidirectional current, observe variations in temperature, the record blood vessel blockage time (OT), the results are shown in Table 5.Show obvious time of the tentative artery thrombosis of prolong rats of Chinese medicine composition for the treatment of apoplexy, suppress artery thrombosis.
The influence of artery thrombosis in the table 4 pair rat body (n=10,
)
| Group | The blood vessel blockage time (branch) |
| The red trematodiasis 1.8g/kg of the red trematodiasis 3.6g/kg of the red trematodiasis 5.4/kg of normal control NIAOXUEKANG 20ml/kg compound recipe compound recipe compound recipe | 6.09±2.49 8.65±2.05 * 9.52±2.16 ** 10.8±3.13 * 8.10±2.16 |
Compare with matched group
*P＜0.05
*P＜0.01
* *P＜0.001
Six, to the therapeutical effect of " blood stasis " disease rat
The rat blood stasis model is pressed literature method [6].60 rats etc. are divided 6 groups, except that first group of intramuscular injection saline is done the normal control, all the other organize equal intramuscular injection of dexamethasone 1mg/kg, then, press table 10 gastric infusion, normal control group and model control group are irritated stomach equal-volume water, every day 1 time, injection dexamethasone and gastric infusion are 7 continuously, and the 8th day morning is with pentobarbital sodium anesthesia ventral aorta blood sampling 3ml (with the EDTA anticoagulant, anticoagulant is 1: 9 with the blood ratio).With the adjustable constant pressure capillary viscosity of SA-Bc type instrumentation whole blood contrast viscosity and plasma viscosity, adopt warm Qu Shi method to survey packed cell volume, survey Fibrinogen with turbidimetry, result such as table 10, as seen, the rat " Blood stasis " that the Chinese medicine composition of treatment apoplexy can obviously cause hormone antagonist has the whole blood contrast viscosity of reduction, plasma viscosity, packed cell volume and fibrinogenic effect.
Blood stasis rat model lethargy is depressed during treating, and fur is owed gloss, become thin, body weight obviously alleviates, and the general behavior of the heavy dose of group of the Chinese medicine composition of treatment apoplexy and FUFANG DANSHEN PIAN treated animal and fur gloss are near normal rat; The apparent in view increase of body weight and model group shows that the Chinese medicine composition for the treatment of apoplexy has remarkable therapeutical effect to the Blood stasis rat.
Experimental example 2 clinical trials
According to Ministry of Public Health bureau of drug administration (95) ZL-65 file, the function of this medicine cures mainly, " new Chinese medicine treatment apoplexy clinical research guideline " formulated " stroke rehabilitation sheet treatment apoplexy convalescent period (syndrome of blood stasis due to qi deficiency) II clinical trial phase scheme " and carried out clinical trial year February in March, 1996～1998, total experiment case 409 examples, inpatient's 348 examples (85.09%) wherein, clinic case 61 examples (14.91%).Random packet, single blind controlled trial.304 examples are organized in treatment, and clinical basic healing 38 examples (12.50%) are organized in treatment, produce effects 128 examples (42.11%), effective 114 examples (37.50%), total effective 280 examples (92.11%), total produce effects 166 examples (54.61%).Matched group 105 examples, matched group is treated with XIAOSHUAN TONGLUO PIAN, wherein clinical basic healing 8 examples (7.62%), produce effects 29 examples (27.62%), effective 57 examples (54.29%), total effective 94 examples (89.52%), total produce effects 37 examples (35.24%).Two groups of total effective rate contrast P＞0.05, difference does not have significance.
Test method
One, case choice criteria
(1) diagnostic criteria
1. tcm diagnosis standard (with reference to " apoplexy tcm diagnosis, the efficacy assessment standard " of Society of Internal Medicine of All-China Association of Traditional Chinese Medicine in 1986 revision)
(1) primary symptom: hemiplegia, crooked mouth and tongue refreshing is known unconsciousness, and the stiff tongue speech is not smoothgoing or in silence, hemianesthesia;
(2) Acute onset;
(3) sick sending out has inducement more, and premorbid does not often have tendency
(4) how send out the age well more than 40 years old
Have 2 above persons of primary symptom, Acute onset can be determined diagnosis in conjunction with the characteristics of aspects such as tongue, arteries and veins, inducement, tendency, age.
2. Chinese medical discrimination standard (with reference to " apoplexy tcm diagnosis, the efficacy assessment standard " of Society of Internal Medicine of Chinese Medical Association in 1989 revision)
Apoplex involving the channels and collaterals
Syndrome of blood stasis due to qi deficiency: hemiplegia, crooked mouth and tongue, stiff tongue speech is not smoothgoing or in silence, hemianesthesia, pale complexion, shortness of breath and fatigue, slobbering, from sweating, brothers' swelling, dimly pale tongue, or ecchymosis is arranged, or corpulent tongue is big, or indentation is arranged, thin white fur of tongue or white greasy, deep-thready pulse, thin slow or thin string.
3. Western medicine diagnose standard (" all kinds of cerebrovascular disease diagnosis main points " revised for the third time with reference to Chinese Medical Association in 1989 national cerebrovascular academic conference for the second time)
Cerebral thrombosis
(1) often under rest state, falls ill;
(2) great majority do not have obviously headache and vomiting;
(3) morbidity can be slower, progress gradually how, or be stage and carry out, it is how relevant with atherosclerosis,
Also be found in arteritis, hematopathy;
(4) realize clear or slight obstacle after the general morbidity in 1～2 day;
(5) have the internal carotid artery system and or vertebral-basilar artery systemic symptom and sign;
(6) waist is worn cerebrospinal fluid and is not generally contained blood;
(7) CT examination is found cerebral location of lesions.
4. apoplexy standard by stages
(1) acute stage: morbidity is in 2 weeks
(2) convalescent period: 2 thoughtful half a year after the morbidity
(3) sequela stage: fall ill more than later six months
(2) test case standard
1. include the case standard in
(1) tcm diagnosis meets apoplexy apoplex involving the channels and collaterals diagnosis, dialectically is syndrome of blood stasis due to qi deficiency.
(2) Western medicine diagnose meets cerebral thrombosis convalescent period
(3) morbidity two week backs to the patient of half a year based on the inpatient, initial integration＞12 minute.
2. discharge the case standard
(1) transient ischemic attack.
(2) confirm to have the cerebral tumor, cerebral trauma, cerebral parasitosis, rheumatic heart disease, coronary heart disease on inspection, and other heart diseases merge atrial fibrillations, the person that causes the cerebral infarction.
(3) more than 70 years old, gestation or women breast-feeding their children and may be to this medicine allergy sufferers.
(4) be associated with serious primary disease such as liver, kidney, hemopoietic system and hormonal system and psychotic.
3. reject the case standard
(1) do not meet and include standard person in;
(2) belong to the object of observation, but do not affect the treatment and safety judgement person entirely because of observations;
(3) unprovoked recovery from illness, unsatisfactory curative effect and untoward reaction are not finished the course of treatment and drug withdrawal person midway
(4) use instead or add medicine and Therapeutic Method person with other relevant these diseases of treatment
Two, Therapeutic Method
Take the method for the single blind contrast control experiment of random packet, all case all requires hospitalization
(1) treatment group: 104 examples, the red trematodiasis sheet of the compound recipe of embodiment 1 preparation, each 5, three times on the one
(2) matched group: 35 examples, XIAOSHUAN TONGLUO PIAN, each 5 just, three times on the one
(3) course of treatment: two groups of cases were for six weeks the course of treatment
(4) stop using in the therapeutic process that all treat the medicine of this disease
Three, observation index
(1) safety indexes
1. blood, urine, just conventional (comprise, clotting time).
2. general physical examination and the untoward reaction that may occur.
3. electrocardiogram, liver function (SGPT), renal function (BUN, Cr).
(2) observation of curative effect
1. patient's mind, language and motor function
2. nervous system signs
3. head CT inspection (comprising infarct size)
4. hemorheology is learned and is checked
5. tcm symptom, picture of the tongue, pulse condition
Four, efficacy evaluation
(1) apoplexy point system
1. mind state: conscious 0 minute; Staring spells 1 minute; Mind mist 3 minutes; Muddle-headed 4 minutes.
2. language performance: normal 0 minute; The general expression, name can not 1 minute; Form a complete sentence in a minute and expressed incomplete 2 minutes; Not talkative word, phrase 3 minutes; Language can not or substantially can not 4 minutes.
3. upper limb shoulder joint: normal 0 minute; Normal but the muscular strength of last act differed from 1 fen; Last act is put down shoulder or is skipped over shoulder 2 minutes; Last act is less than takeing on 3 fens; The active or forward and backward summary of energy was swung 4 fens.
4. upper limb articulations digitorum manus: normal 0 minute; Finger action respectively is normal and muscular strength differed from 1 fen; Clench fist to stretch and refer to 2 fens; Count on one's fingers, can not hold fist, can not stretch 3 fens; Can not move 4 fens.
5. lower limb hip joint: normal 0 minute; Raised 45 degree above 1 minute; Less than 45 degree persons 2 minutes; Swing energy translation 3 minutes; Inactive 4 minutes.
6. lower limb toe joint: normal 0 minute; Stretch and bend freedom but a little less than the power; Stretch and bent incomplete 2 minutes; Slightly moving 3 minutes; Can not move 4 fens.
7. comprehensive function: life can be taken care of oneself open 0 minute; Live on one's own life incomplete 1 minute of simple work and partial function; Can walk partial self-help, auxiliary 2 minutes of the people that still needs; Can stand and take a step, need the people to take care of at any time 3 fens; Liied in bed 4 fens.
Classification: 1.≤10 minute; 2. in: 11～19 minutes; 3. heavy: 〉=20 minutes.
(2) syndrome of blood stasis due to qi deficiency assessment method
Divide normal, light, in, be designated as 0,1,2,3 fen heavily respectively.
1. hemiplegia: (1) is light 1 minute: take care of oneself, can walk, need the people auxiliary sometimes; (2) in 2 minutes: can stand and take a step, need at any time to take care of; (3) weigh 3 fens: bed
2. speech is not smoothgoing puckery: (1) is light 1 minute: can not form a complete sentence in a minute or form a complete sentence in a minute and express incomplete; (2) in 2 minutes: word or phrase can not be expressed; (3) weigh 3 fens: hemianesthesia influences orthobiosis.
3. hemianesthesia: (1) is light 1 minute: little sense hemianesthesia; (2) in 2 minutes: hemianesthesia did not influence orthobiosis; (3) weigh 3 fens: hemianesthesia influences orthobiosis;
4. crooked mouth and tongue: (1) is light 1 minute: crooked mouth and tongue is arranged during speech; (2) in 2 minutes: obvious crooked mouth and tongue; (3) weigh 3 fens: crooked mouth and tongue has a strong impact on the facial muscle function;
5. shortness of breath and fatigue: (1) is light 1 minute: movable back shortness of breath and fatigue; (2) in 2 minutes: moving slightly was shortness of breath and fatigue; (3) weigh 3 fens: also feel shortness of breath and fatigue usually;
6. complexion: (1) is light 1 minute: lustreless complexion; (2) in 2 minutes: lusterless complexion; (3) weigh 3 fens:; Pale complexion
7. dizzy: (1) is light 1 minute: idol has dizziness; (2) in 2 minutes: often dizziness can be adhered to operate as normal; (3) weigh 3 fens: obviously dizzy, influence operate as normal and life;
8. spontaneous perspiration: (1) is light 1 minute: the little tide of motionless then skin, moving slightly then more very; (2) in 2 minutes: motionless then moist skin, sweating while acting; (3) weigh 3 fens: be sweating usually, moving then antiperspirant removes as water stain shape;
9. brothers' swelling: (1) is light 1 minute: self-induction brothers' swelling; (2) in 2 minutes: brothers' swelling did not influence normal activity; (3) weigh 3 fens: brothers' swelling obviously influences normal activity;
10. picture of the tongue: dimly pale tongue, or ecchymosis is arranged, or corpulent tongue is big, or indentation is arranged, and thin white fur of tongue or white is remembered 1 fen respectively;
11. pulse condition: deep-thready pulse, thin slow or thin string, counted respectively 1 fen.
(3) curative effect determinate standard
The highest only 28 minutes before the treatment, initial integration was not less than 12 fens, and its efficacy determination adopts the nimodipine method: [integration * 100% before (integration before the treatment-treatment back integration) ÷ treatment
1. be almost recovered: 〉=85%.
2. produce effects: 〉=50%
3. effective: 〉=20%
4. invalid :≤20%
5. head CT scans efficacy assessment standard:
Absorb fully: infarct size absorbs 100%
The most of absorption: infarct size absorbs 60～99%
Fraction absorbs: infarct size absorbs 20～59%
No change: infarct size absorbs＜20%.
Therapeutic outcome
One, general curative effect
The contrast of table 5 total effects
| Sum | Total effectively example (%) | Total produce effects example (%) | The basic example (%) of curing | Produce effects example (%) | Effectively routine (%) | Invalid example (%) | |
| The treatment group | 304 | 280(92.11) | 166(54.61) | 38(12.50) | 128(42.11) | 114(37.50) | 24(7.89) |
| Matched group | 105 | 94(89.52) | 37(35.24) | 8(7.62) | 29(27.62) | 57(54.29) | 11(10.48) |
The contrast of two groups of case total effective rates, through the Ridit check analysis, R controls=0.5, and R is right=and 0.428, P＞0.05, difference does not have significance.Total obvious effective rate contrast, U check analysis P＜0.01, difference has utmost point significance, and the treatment group is better than matched group.
Two, two groups of case symptom and signs improve the disappearance situation
Table 6 a liang group case sign is improved disappearance situation contrast table
| The treatment group | Matched group | |||||||
| Before the treatment | After the treatment | Remission rate (%) | Before the treatment | After the treatment | Remission rate (%) | X2 | P | |
| Stiff tongue speech is not smoothgoing or in silence | 244 | 38 | 84.43 | 92 | 23 | 75.00 | 0.058 | ＞ 0.05 |
| Upper limb shoulder joint obstacle | 303 | 29 | 90.43 | 105 | 18 | 82.26 | 3.386 | ＞ 0.05 |
| Upper limb articulations digitorum manus obstacle | 303 | 59 | 80.53 | 104 | 32 | 69.23 | 5.060 | ＜ 0.05 |
| Lower limb hip joint obstacle | 302 | 28 | 90.73 | 104 | 21 | 79.81 | 7.695 | ＜ 0.01 |
| Lower limb toe joint obstacle | 300 | 76 | 74.67 | 104 | 34 | 67.31 | 1.756 | ＞ 0.05 |
| The comprehensive function obstacle | 304 | 38 | 87.50 | 105 | 28 | 73.33 | 10.55 | ＜ 0.01 |
Two groups of cases are treated the back remission rate, and contrast before upper limb articulations digitorum manus and lower limb hip joint obstacle and comprehensive function obstacle are treated the back and treated has remarkable P＜0.05 or utmost point significance P＜0.01 through X2 check difference.After all the other each Signs were treated, X2 checked there was no significant difference, P＞0.05.
Table 7 liang group case transference cure situation contrast table
| The treatment group | Matched group | |||||||
| Before the treatment | After the treatment | Remission rate (%) | Before the treatment | After the treatment | Remission rate (%) | X2 | P | |
| Hemiplegia | 299 | 209 | 30.10 | 105 | 87 | 17.14 | 6.016 | ＜ 0.05 |
| Hemianesthesia | 265 | 135 | 49.06 | 92 | 62 | 32.61 | 6.82 | ＜ 0.01 |
| Crooked mouth and tongue | 210 | 57 | 38.57 | 80 | 61 | 23.75 | 4.99 | ＜ 0.05 |
| Dizzy | 235 | 79 | 66.38 | 88 | 48 | 45.45 | 10.53 | ＜ 0.05 |
| Shortness of breath and fatigue | 272 | 111 | 59.19 | 96 | 61 | 36.46 | 13.83 | ＜ 0.01 |
| Lusterless complexion | 196 | 88 | 55.10 | 61 | 42 | 31.15 | 9.743 | ＜ 0.01 |
| Spontaneous perspiration | 184 | 53 | 71.20 | 61 | 33 | 45.90 | 11.78 | ＜ 0.01 |
| Brothers' swelling | 118 | 44 | 62.71 | 40 | 24 | 40.00 | 5.393 | ＜ 0.05 |
| Dark tongue quality | 240 | 177 | 26.25 | 84 | 66 | 21.43 | 0.536 | ＞ |
| Light | 0.05 | |||||||
| The body of the tongue ecchymosis | 116 | 67 | 42.24 | 31 | 24 | 22.58 | 3.219 | ＞ 0.05 |
| Thin white fur of tongue | 172 | 216 | 61 | 67 | ||||
| Tongue fur is white | 124 | 66 | 46.77 | 43 | 32 | 25.58 | 9.732 | ＜ 0.01 |
| Deep pulse | 153 | 117 | 23.53 | 61 | 53 | 13.11 | 2.294 | ＞ 0.05 |
| Thready pulse | 202 | 170 | 15.84 | 63 | 53 | 15.87 | 0.037 | ＞ 0.05 |
| Weak pulse | 93 | 60 | 35.48 | 33 | 25 | 24.24 | 0.937 | ＞ 0.05 |
| Hesitant pulse | 44 | 27 | 38.64 | 12 | 7 | 41.67 | 0.02 | ＞ 0.05 |
Each the transference cure situations contrast of two groups of cases, difference had significance before white and thin fur was treated in the tongue arteries and veins, all the other there are no significant differences.Each symptom and the preceding contrast of treatment, difference has significance or utmost point significance, and the treatment group is better than matched group.
Three, two groups of case apoplexy score treatment back contrasts
Table 8 liang group case apoplexy score treatment back contrast (X ± S)
| Example | Integration before treating | Treat the back integration | Long-pending before and after the treatment | t | P |
| Number | It is poor to divide | |||||
| The treatment group | 304 | 15.01±2.67 | 7.42±4.27 | 7.39±3.41 | 26.28 | ＜ 0.01 |
| Matched group | 105 | 14.98±3.26 | 8.76±4.32 | 6.99±3.51 | 11.78 | ＜ 0.01 |
| t | 0.094 | 2.764 | 1.028 | |||
| P | ＜0.05 | ＜0.05 | ＜0.05 |
Integration contrast before the treatment group is treated the back and treated, through t check t=26.278, there is the utmost point significant difference P＜0.01.
Integration contrast before matched group is treated the back and treated, through t check t=11.777, there is the utmost point significant difference P＜0.01.
Treatment group and matched group are treated the back contrast, are better than contrast groups with the treatment group.Integral difference before and after the treatment, difference does not have significance.
Claims (10)
1. Chinese medicine composition for the treatment of apoplexy, it is made up of effective ingredient and/or acceptable accessories, wherein prepares raw materials of effective components and consists of:
Radix Astragali 14-17 weight portion, Radix Salviae Miltiorrhizae 10-13 weight portion, Hirudo 1-5 weight portion, Pheretima 8-12 weight portion and Rhizoma Chuanxiong 4-8 weight portion.
2. Chinese medicine composition according to claim 1 wherein prepares raw materials of effective components and consists of: the Radix Astragali 15 weight portions, Radix Salviae Miltiorrhizae 12 weight portions, Hirudo 3 weight portions, Pheretima 10 weight portions and Rhizoma Chuanxiong 6 weight portions.
3. Chinese medicine composition according to claim 1 and 2, it is an oral formulations.
4. Chinese medicine composition according to claim 3, it is powder, tablet, granule, soft capsule or hard capsule.
5. the Chinese medicine composition preparation method of claim 1 or 2 described treatment apoplexy, it comprises the following steps: to take by weighing the above five tastes, with Rhizoma Chuanxiong elder generation vapor distillation, collects distillate; Radix Salviae Miltiorrhizae alcohol reflux decompression recycling ethanol concentrates, and oven dry is pulverized; Other gets the Radix Astragali, Pheretima, Hirudo and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decocts with water, and filtrate is evaporated to 50 ℃ of relative densities and is 1.20～1.25 clear paste, merges with the Rhizoma Chuanxiong clear paste and puts coldly, adds ethanol and makes that to contain the alcohol amount be 60%, and placement is spent the night, and filters.Decompression filtrate recycling ethanol concentrates, and oven dry is pulverized, and adds above-mentioned Radix Salviae Miltiorrhizae extractum powder and Hirudo fine powder, and mixing is made effective ingredient.
6. the Chinese medicine composition preparation method of claim 1 or 2 described treatment apoplexy, it comprises the following steps:
Take by weighing the above five tastes, water intaking trematodiasis 50-60% is ground into fine powder; The Rhizoma Chuanxiong vapor distillation is collected distillate, and the distillate redistillation is once collected double distilled liquid, and Rhizoma Chuanxiong clear paste and double distilled liquid is standby; It is 1.20～1.25 clear paste that decocting liquid is concentrated into 50 ℃ of relative densities; Radix Salviae Miltiorrhizae alcohol reflux secondary filters, merging filtrate, and decompression recycling ethanol concentrates, and oven dry is pulverized, and makes the Radix Salviae Miltiorrhizae extractum powder; Other gets the Radix Astragali, Pheretima, residue Hirudo and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decocts with water 2-3 time, and 2 hours for the first time, second or three time respectively was 1 hour, filter, merging filtrate is evaporated to 50 ℃ of relative densities and is 1.20～1.25 clear paste, merge with the Rhizoma Chuanxiong clear paste, put coldly, add ethanol and make that to contain the alcohol amount be 60%, placement is spent the night, and filters decompression filtrate recycling ethanol, concentrate, oven dry is pulverized, add above-mentioned Radix Salviae Miltiorrhizae extractum powder, Hirudo fine powder and Rhizoma Chuanxiong re-distilled liquid, mixing is made effective ingredient.
7. the Chinese medicine composition preparation method of claim 1 or 2 described treatment apoplexy, it comprises the following steps:
Water intaking trematodiasis 50-60% is ground into fine powder; The Rhizoma Chuanxiong vapor distillation is collected distillate, and the distillate redistillation is once collected double distilled liquid, and is standby; Decocting liquid is concentrated into 50 ℃, and to survey relative densities be 1.20～1.25 clear paste; Radix Salviae Miltiorrhizae alcohol reflux secondary filters, merging filtrate, and decompression recycling ethanol concentrates, and oven dry is pulverized; Other gets the Radix Astragali, Pheretima, residue Hirudo and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decoct with water 2-3 time, 2 hours for the first time, second or three time respectively was 1 hour, filter, merging filtrate, being evaporated to 50 ℃, to survey relative densities be 1.20～1.25 clear paste, merges with the Rhizoma Chuanxiong clear paste, put cold, add ethanol and make that to contain alcohol amount be 60%, placement is spent the night, and filters; Decompression filtrate recycling ethanol concentrates, and oven dry is pulverized, and adds above-mentioned Radix Salviae Miltiorrhizae extractum powder, Hirudo fine powder and Rhizoma Chuanxiong re-distilled liquid, and mixing is made effective ingredient.
8. the Chinese medicine composition preparation method of the described treatment apoplexy of claim 5, its trematodiasis 50-60% that comprises the following steps: to fetch water is ground into fine powder; The Rhizoma Chuanxiong vapor distillation is collected distillate, and the distillate redistillation is once collected double distilled liquid, and is standby; Decocting liquid is concentrated into 50 ℃, and to survey relative densities be 1.20～1.25 clear paste; Radix Salviae Miltiorrhizae alcohol reflux secondary filters, merging filtrate, and decompression recycling ethanol concentrates, and oven dry is pulverized; Other gets the Radix Astragali, Pheretima, residue Hirudo and Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae decoction dregs, decoct with water 2-3 time, 2 hours for the first time, second or three time respectively was 1 hour, filter, merging filtrate, being evaporated to and surveying relative density for 50 ℃ 2 is 1.20～1.25 clear paste, merges with the Rhizoma Chuanxiong clear paste, put cold, add ethanol and make that to contain alcohol amount be 60%, placement is spent the night, and filters; Decompression filtrate recycling ethanol concentrates, and oven dry is pulverized, and adds above-mentioned Radix Salviae Miltiorrhizae extractum powder, Hirudo fine powder and appropriate amount of starch, and mixing is granulated cold drying, tabletting with the Rhizoma Chuanxiong re-distilled liquid.
9. the method for quality control of the Chinese medicine composition of claim 1 or 2 described treatment apoplexy, get the Chinese medicine composition porphyrize, get 7g, the accurate title, decide, and puts in the apparatus,Soxhlet's, add methanol 60ml, reflux 6 hours, extracting solution reclaim methanol to doing, and residue adds water 30ml slight fever makes dissolving, with water saturated n-butyl alcohol difference 30,30,30, the 20ml jolting is extracted 4 times, merge n-butanol extracting liquid, the ammonia solution saturated with n-butyl alcohol washs 2 times, each 90ml, discard the ammonia washing liquid, n-butyl alcohol liquid evaporate to dryness, residue add methanol 5ml dissolving, on D101 type macroporous adsorptive resins, with water 60ml eluting, discard water lotion, reuse 40% ethanol 200ml eluting discards 40% ethanol elution, continue with 70% ethanol 600ml eluting, collect eluent, reclaim solvent and do near, residue adds dissolve with methanol and quantitatively is transferred in the 5ml measuring bottle, adds methanol and is diluted to scale, shake up, as need testing solution; Precision is got the astragaloside reference substance in addition, adds methanol and makes the solution that every 1ml contains 1mg, solution in contrast.Test according to an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography, the accurate need testing solution 4 μ l that draw, reference substance solution 1 μ l and 3 μ l, the cross point is on same silica gel g thin-layer plate respectively, placing the lower floor's solution that spends the night below 10 ℃ with the chloroform-methanol-water of 13: 6: 2 ratios is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 100 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan according to an appendix VIB of Chinese Pharmacopoeia version in 2000 thin layer chromatography scanning, wavelength: λ s=515nm, λ r=700nm measures test sample trap integrated value and reference substance trap integrated value, calculates, this product per unit dosage contains the Radix Astragali in astragaloside, must not be less than 0.14mg.
10. claim 1 or 2 described Chinese medicine compositions are preparing the purposes for the treatment of in the apoplexy medicine.
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| 通络愈瘫胶囊治疗脑血栓形成的临床研究. 马云枝，张运克，杨守峰.实用中西医结合杂志，第11卷第5期. 1998 * |
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