CN103007068A - Application of traditional Chinese medicine composition for treating headache to preparing medicine for inhibiting thrombosis - Google Patents
Application of traditional Chinese medicine composition for treating headache to preparing medicine for inhibiting thrombosis Download PDFInfo
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Abstract
The invention relates to an application of a traditional Chinese medicine composition for treating headache to preparing a medicine for inhibiting thrombosis. The traditional Chinese medicine composition is formed by ligusticum wallichii, radix angelicae, notopterygium root, asarum, mint, ledebouriella seseloides wolff, liquorice, tea leaves, red paeony root, rhizoma gastrodiae, chrysanthemum and the like. A medicinal preparation is prepared according to a conventional preparation process and the preparation can be any one clinically acceptable preparation.
Description
The present invention is that application number is: 200910104033.X, the applying date is: the dividing an application of on 06 09th, 2009 " a kind of new purposes for the treatment of the Chinese medicine composition of headache " application for a patent for invention.
Technical field
The present invention relates to a kind of new purposes of known drug, particularly a kind of Chinese Traditional Medicines that become known for treating headache are at preparation protection cerebrovascular, anticoagulant, and suppress new purposes in the medicine of the aspects such as thrombosis.
Background technology
A kind of Chinese patent medicine that is used for the treatment of headache in the prior art, ZL 97 100157.X disclose this pharmaceutical composition and preparation method thereof.This medicine is by Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, and Rhizoma Et Radix Notopterygii, Herba Asari, Herba Menthae, Radix Saposhnikoviae, Radix Glycyrrhizae, Folium Camelliae sinensis, Radix Paeoniae Rubra, Rhizoma Gastrodiae and Flos Chrysanthemi form.Show through clinical verification, this medicine can reduce the cerebral ischemia zone, levels of myelin basic protein in the cerebrospinal fluid due to the reduction cerebral ischemic injury, significantly reduce bloodviscosity, reduce packed cell volume and erythrocyte aggregation index, significantly reduce viscous components, component of elasticity and the storage films amount of blood complex viscosity; And have the antagonism adrenalin hydrochloride to the arteriolar contraction of mesentery, the significant prolongation clotting time and to heat, the chemical stimulation induced pain has significant analgesic activity.Can be used for the treatment of various types of headaches clinically, play the effect of relief of symptoms and healing.Particularly, have a headache serious patient anxious for morbidity takes medicine of the present invention, can reach the purpose of rapid releasing headache.
Ischemia apoplexy is common clinical, with its high incidence, high disability rate, high mortality and call the turn harm humans health.The inventor finds through Long-term clinical and laboratory research; the Chinese medicine composition of this treatment headache of above-mentioned patent ZL97100157.X record also has the protection cerebrovascular; anticoagulant, and suppress the thrombosis effect, can be used for the convalescent treatment of cerebral infarction.
Summary of the invention
The object of the present invention is to provide the Chinese medicine composition of the treatment headache of patent ZL97100157.X record to treat brain ischemia medicament in preparation, preparation reduces the cerebral vascular resistance medicine, preparation reduces internal carotid artery translation arterial pressure, arteriovenous pressure reduction medicine, preparation anticoagulant medicine, and preparation suppresses the new purposes in thrombosis medicine and the preparation cerebral infarction convalescent care medicine.
The described cerebral infarction particularly obstruction of collaterals by blood stasis of differential diagnosis in tcm is held the wind card under the arm, caused by Atherosclerosis and thrombosis and cerebral infarction, or caused by lacunar infarction.
The objective of the invention is to realize by clinical verification and research.
The inventor finds through Long-term clinical and laboratory research, by (by weight) Rhizoma Chuanxiong 50-200 part of patent ZL97100157.X record, Radix Angelicae Dahuricae 20-80 part, Rhizoma Et Radix Notopterygii 20-80 part; Herba Asari 5-20 part, Herba Menthae 50-150 part, Radix Saposhnikoviae 10-50 part, Radix Glycyrrhizae 10-50 part, Folium Camelliae sinensis 40-90 part; Radix Paeoniae Rubra 30-100 part; the compositions that Rhizoma Gastrodiae 10-50 part and Flos Chrysanthemi 20-90 part are made has anti-cerebral ischemia, reduces cerebral vascular resistance, reduces internal carotid artery translation arterial pressure, arteriovenous pressure reduction, anticoagulant; and suppress thrombotic effect; can protect cerebrovascular, be used for the convalescent treatment of cerebral infarction.Wherein optimum ratio is 127 parts of Rhizoma Chuanxiongs, 42 parts of the Radixs Angelicae Dahuricae, Rhizoma Et Radix Notopterygii 42,10 parts of Herba Asaris, 84 parts of Herba Menthaes, 15 parts of Radix Saposhnikoviaes, 21 parts in Radix Glycyrrhizae, 63 parts of Folium Camelliae sinensis, 53 parts of Radix Paeoniae Rubra, 21 parts in Rhizoma Gastrodiae, 53 parts of Flos Chrysanthemis.
According to " all kinds of diagnosis and treatment of cerebrovascular diseases main points " that nineteen ninety-five the 4th the cerebrovascular academic conference in the Chinese Medical Association whole nation revised, the Western medicine diagnose of cerebral infarction comprises Atherosclerosis and thrombosis and cerebral infarction and lacunar infarction.
Chinese medicine composition of the present invention can make by following preparation method: Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, Herba Asari, Herba Menthae, Radix Saposhnikoviae, Flos Chrysanthemi Six-element are added water 8-12 doubly measure, hydrodistillation is collected 800 milliliters of Aromatic water, aqueous solution after the distillation in addition device is collected, medicinal residues and Radix Glycyrrhizae, the Radix Angelicae Dahuricae, Radix Paeoniae Rubra, Rhizoma Gastrodiae four flavors add water 3-10 and doubly measure twice of decoction, each decocting time is 0.5-1 hour, merge decocting liquid, filter; Filtering residue is abandoned, and Folium Camelliae sinensis adds fresh boiling water 10-15 and doubly measures immersion twice, and each soak time is 20-60 minute, merge leachate, filter, the aqueous solution after filtrate and above-mentioned decocting liquid and the distillation merges, relative density is 1.14 when being evaporated to 70 ℃, leave standstill, be chilled to and add 1-3 after the room temperature and doubly measure 95% ethanol, stir evenly, cold preservation, make precipitation, get the supernatant decompression recycling ethanol, leave standstill, getting supernatant filters, filtrate is concentrated into that relative density is 1.18 under the room temperature, and above-mentioned Aromatic water with 0.8% tween 80 solubilising, is added in the above-mentioned concentrated solution, stir evenly, water is adjusted to 980 milliliters, regulates PH to 4.5-6.5 with 10%NaOH again, adds water again and adjusts total amount to 1000 milliliter, stir evenly, leave standstill, filter, sterilization is finished.
Medicine of the present invention is take above-mentioned Chinese medicine composition as composition of raw materials, is prepared into pharmaceutical preparation according to the preparation process of routine.Dosage form can be that acceptable any dosage form comprises clinically: can be liquid preparation: such as oral liquid, suspension, syrup, and injection, medicated wine, tincture etc.; Can be solid and semi-solid preparation: such as tablet, pill, unguentum, sublimed preparation, powder, granule, suppository, powder, masticatory, capsule etc.; Also can be the gas preparation: such as aerosol, inhalant etc.
Following experimental example is by weight by 127 parts of Rhizoma Chuanxiongs with patent ZL97100157.X embodiment 1,42 parts of the Radixs Angelicae Dahuricae, Rhizoma Et Radix Notopterygii 42,10 parts of Herba Asaris, 84 parts of Herba Menthaes, 15 parts of Radix Saposhnikoviaes, 21 parts in Radix Glycyrrhizae, 63 parts of Folium Camelliae sinensis, 53 parts of Radix Paeoniae Rubra, laboratory research and clinical trial that 21 parts in Rhizoma Gastrodiae and 53 parts of oral liquid formulations of making of Flos Chrysanthemi (hereinafter to be referred as oral liquid of the present invention) carry out.
1. on the cerebrovascular impact of dog
25 of hybrid dogs are divided into five groups at random, and 5 every group, namely negative control group, positive controls, the high, medium and low dosage group of oral liquid of the present invention (respectively suitable 10.62,5.31 and 2.66g crude drug kg
-1).Press 1mlkg with 3% pentobarbital sodium solution
-1(30mgkg
-1) lumbar injection, anaesthetize sb. generally.Fixedly dog is on operating-table and expose cervical region, preserved skin, medisection skin of neck.The fascia of isolating right carotid and peeling off clean artery surface continues upwards to be separated to the carotid sinus place and exposes internal carotid artery and external carotid artery, dissociate enough external carotid arterys and ligation intubate in order to placing the effusion meter probe.Isolate enough internal jugular veins again and carry out intubate, adhesion reason record four road instrument are measured external carotid artery and are pressed (being equivalent to internal carotid artery presses) and IJP respectively.It also is right side ICAF amount that electromagnetic flowmeter probe mensuration right carotid artery is installed at the right carotid place; The electricity monitoring (II is led) of connecting with the heart of dog extremity.Then abdominal part preserved skin, median incision is opened abdomen, exposes stomachus pyloricus, through the capable pylorus intubate of coat of the stomach, guarantees that intubate has entered duodenum.The every dog duodenum of negative control group gives normal saline 6mlkg
-1, high dose group, middle dosage group, low dose group duodenum give respectively the oral liquid dry extract suspension 6mlkg of the present invention of 36.67%, 18.33%, 9.17% concentration
-1(difference suitable 10.62,5.31 and 2.66g(crude drug) kg
-1), the every dog duodenum of positive controls gives the nimodipine 6mlkg of 0.283% concentration
-1(suitable 17mgkg
-1).Respectively arteriovenous pressure reduction, internal carotid artery per minute blood flow, heart rate, internal carotid artery whenever fight blood flow and cerebral vascular resistance in the internal carotid artery systolic pressure of 30min, 60min, 90min, 120min, 150min, 180min, internal carotid artery diastolic pressure, internal carotid artery mean arterial pressure, IJP, the neck before the observed and recorded administration and after the administration.Each achievement data is added up with the SPSS.10 statistical software, relatively its significance.
Annotate: internal carotid artery mean arterial pressure=diastolic pressure+(systolic pressure-diastolic pressure)/3; Arteriovenous pressure reduction in the neck=internal carotid artery mean arterial pressure-IJP; Arteriovenous pressure differential in cerebral vascular resistance=neck/ICAF amount.
Experimental result sees Table 1-9:
Table 1 oral liquid of the present invention on the impact of dog cerebral vascular resistance (
MmHg/ml/min)
Annotate: * represent with the feminine gender group of time period P＜0.05 relatively, * * represent with the feminine gender group of time period P＜0.01 relatively;
ΔP＜0.05 relatively before expression and the medication on the same group,
The Δ ΔP＜0.01 relatively before expression and the medication on the same group.
Table 2 oral liquid of the present invention on the impact of dog internal carotid artery systolic pressure (
MmHg)
Annotate: with table 1
Table 3 oral liquid of the present invention on the impact of dog internal carotid artery diastolic pressure (
MmHg)
Annotate: with table 1
Table 4 oral liquid of the present invention on the impact of dog internal carotid artery mean arterial pressure (
MmHg)
Annotate: with table 1
Table 5 oral liquid of the present invention on the impact of dog IJP (
MmHg)
Annotate: with table 1
Table 6 oral liquid of the present invention on the impact of dog arteriovenous pressure reduction (
MmHg)
Annotate: with table 1
Table .7 oral liquid of the present invention on the impact of dog internal carotid artery per minute blood flow (
Ml/min)
Annotate: with table 1
Table 8 oral liquid of the present invention on the impact of dog heart rate (
Inferior/min)
Annotate: with table 1
Table 9 oral liquid of the present invention on the dog internal carotid artery whenever fight blood flow impact (
Ml/ time)
Annotate: with table 1
Conclusion: show that by table 1 ~ table 9 result oral liquid of the present invention can obviously reduce cerebral vascular resistance, and demonstrates obvious medication amount effect relationship.After the high dose group medication 30-180 minute, cerebral vascular resistance all reduced (P＜0.01) before than negative control group and this group medication, and minimum point after medication 60 minutes reduces by 30% approximately.Middle dosage group after medication 90-180 minute, cerebral vascular resistance obviously reduces (P＜0.01), and minimum point after medication 90 minutes reduces by 32% than negative control group, than reducing by 16% before this group medication.Low dose group after medication 120-180 minute, cerebral vascular resistance obviously reduces (P＜0.01), and minimum point after medication 120 minutes reduces by 27% than negative control group, than reducing by 20% before this group medication.Oral liquid of the present invention can obviously reduce internal carotid artery mean arterial pressure, arteriovenous pressure reduction.Oral liquid high dose group internal carotid artery per minute blood flow of the present invention is obviously increase (P＜0.05) in 60,90 minutes after medication, but the blood flow of whenever fighting is affected without significant difference.
2 oral liquids of the present invention are on the impact of dog cerebral ischemia
30 of hybrid dogs are divided into five groups at random, and 6 every group, namely negative control group, positive controls, the high, medium and low dosage group of oral liquid of the present invention (respectively suitable 10.62,5.31 and 2.66g crude drug kg
-1).Dog is pressed 1mlkg
-1(25mgkg
-1) intravenous injection 2.5% pentobarbital sodium solution, after the anesthesia dog being fixed on the operating-table, preserved skin cuts off the tempori dextro field of operation by hair, " L " type otch is done in sterilization, is about 10cm, blunt separation muscle, the ligation superficial temporal artery exposes zygomatic arch, stings with rongeur from its root and removes, cut temporalis, turn over to the calvarium side, sphenotresia is windowed, expose temporal lobe fully, cut off arachnoidea, lift temporal lobe, expose right half arterial ring of basis cranii and send tremulous pulse, find out brain right side medium-sized artery, threading, the standby bundle.After art finishes, forelimb venous blood collection 5ml, 2000 rev/mins centrifugal 10 minutes, ALP, CK detection (method is undertaken by the test kit operating instruction) before getting serum (-18 ℃ of lower airtight stored frozen) and doing medicine.Abdominal part unhairing sterilization opening is found out duodenum, avoiding the rich blood vessel place does to open an osculum after bundling type is sewed up, inject tested oral liquid of the present invention from osculum to distal end, namely the dog duodenum gives the oral liquid dry extract suspension 5mlkg of the present invention of 44%, 22% and 11% concentration
-1, positive group gives 0.4% concentration nimodipine suspension 5mlkg
-1(0.02gkg
-1), negative control group gives normal saline 5mlkg
-1Administration is complete, immediately the ligation middle cerebral artery.After the administration ligation 6 hours, again get the forelimb vein by front method and do above-mentioned zymetology detection.The skin of neck opening separates bilateral common carotid arteries and folder closes, and closes to centrifugal end from the right carotid folder immediately and injects 1mlkg
-1The Gentian Violet saturated solution dyes to cerebral tissue, see and cut off immediately bilateral carotid when dog tongue, Ya Gingival place purple occurred, sacrificed by exsanguination, skull saw cuts skull, take out full brain, claim full brain heavy, then downcut undyed cerebral tissue (being the ischemic region cerebral tissue) and weigh, and obtain the percentage rate that it accounts for full brain weight.Compare its significance difference.
Experimental result sees Table 10-12.
Table 10 oral liquid of the present invention is on the impact of dog ischemic rat brain weight
Compare * P＜0.05, * * P＜0.01 with the feminine gender group.
The impact of table 11 Oral Liquid On Experimental dog of the present invention cerebral ischemia blood ALP activity (
N=6)
Annotate: be worth before the value-administration after the rate of change %=(administration) the front value * 100% of ÷ administration
Compare after the administration with before the administration
Δ Δ ΔP＜0.001
Compare * P＜0.05**P＜0.01 with negative control group
The impact of table 12 Oral Liquid On Experimental dog of the present invention cerebral ischemia blood CK activity (
N=6)
Annotate: be worth before the value-administration after the rate of change %=(administration) the front value * 100% of ÷ administration
Compare after the administration with before the administration
Δ Δ ΔP＜0.001
Compare * P＜0.05**P＜0.01 with negative control group
Conclusion: the Cerebral Region of dosage group is heavy in the oral liquid of the present invention, ischemic region/full brain weighs percentage rate and negative control group relatively has significant difference, P＜0.01, the Cerebral Region of small dose group weighs and negative control group compares P＜0.05, and positive controls (nimodipine) Cerebral Region is heavy, ischemic region/full brain weighs percentage rate and negative control group compares P＜0.05.Shown by table 6.1.11 ~ 6.1.12 result: big or middle dosage group ALP value and negative control group compare P＜0.05 after the oral liquid administration of the present invention; Heavy dose of group CK value and negative control group be P＜0.01 relatively.Results suggest: oral liquid extractum of the present invention has protective effect to dog middle cerebral artery caused by ligature cerebral tissue ischemia.
3 oral liquids of the present invention are on the impact (intracorporal method) of rat platelet aggregation
Rat is divided into the large, medium and small dosage group of oral liquid of the present invention (respectively suitable 10.62,5.31,2.66g(crude drug) kg at random
-1), positive controls and negative control group, 10 every group.Press table 13 with the continuous gastric infusion of 1.0ml/100g body weight 5 days, administration every day 1 time, behind the 5th day administration 30min, femoral artery blood sampling 4.5ml, put in the centrifuge tube that is placed with in advance 3.8% liquor sodii citratis (0.5ml), with blood and anticoagulant mixing gently, 500rpm/ divides centrifugal 5min, and the sucking-off upper strata about 1ml of ecru suspension is the PRP(platelet count greater than 800,000/mm
3), then 1000rpm/ divides centrifugal 10min, draws supernatant, makes PPP(platelet count 20～220,000/mm
3).
Then namely connect platelet aggregation instrument and monitor power supply, make it preheating 15～30min, regulate simultaneously and assemble instrument constant temperature knob, make its constant temperature at 37 ± 0.1 ℃.Get 2 cuvettes, 1 adds PRP200ul, and another adds PPP200ul, puts preheating 3～5min in the platelet aggregation instrument.Start instrument, transfer light transmittance with PPP, in the PRP cup, put into stirring rod and derivant ADP20ul, observe and the changes in aggregation of record PRP in 10min, calculate and assemble percentage rate.Adopt t inspection statistics experimental result.
Table 13 grouping and dosage
Result of the test sees Table 14
Table 14 oral liquid of the present invention affects rat platelet aggregation
Annotate: 1. do not require to abandon it because getting blood plasma meets to measure, number of animals is to obtain to measure blood plasma example number with reality in the table.
2. compare * P＜0.05 and * * P＜0.01 with negative control group.
Conclusion oral liquid of the present invention has reducing effect to the rat platelet aggregation rate, and heavy dose of group compares P＜0.01 with negative control group.Prompting, oral liquid of the present invention has inhibitory action to rat platelet aggregation.
The impact that 4 oral liquids of the present invention form rat suppository
Rat is divided into the large, medium and small dosage group of oral liquid of the present invention (be respectively 10.62,5.31 and 2.66g(crude drug) kg at random
-1), positive controls (glad recovery capsule) and five groups of negative control group, 16 every group, male and female half and half.Each group gives corresponding tested material by table 20.17 gavage respectively, and (the administration volume is 1ml100g
-1Body weight), successive administration five days, 20min lumbar injection pentobarbital sodium 0.05gkg after the administration in the 5th day
-1(2.5g100ml
-1, 0.2ml100g
-1Body weight) anesthesia separates right common carotid artery and left external jugular vein.One end of the polyethylene tube got ready is inserted left external jugular vein, in polyethylene tube, inject heparin 50ukg
-1, clamp tube wall, with the other end insertion right common carotid artery of pipe, open blood flow behind administration 30min, middle Herba Clinopodii takes out rapidly silk thread and weighs behind the 15min, and it heavily is wet weight of thrombus that gross weight deducts silk thread.Calculate suppression ratio by following formula.
Suppression ratio=(matched group thrombosis weight-administration group thrombosis is heavy)/matched group thrombosis is heavy
-1* 100%
The preparation of polyethylene tube: 4 trumpeter's art silk threads (weighing) of a long 5cm are put in the stage casing of three sections polyethylene tubes (always being about 15cm).With heparin sodium normal saline solution (50uml
-1) be full of the polyethylene tube chamber.
Table 15 dosage and grouping
The impact that table 16 oral liquid of the present invention forms rat suppository (
Mg)
Compare P＜0.05* with negative control group
Conclusion: the large, medium and small dosage group of oral liquid extractum of the present invention (10.62,5.31 and 2.66g(crude drug) kg
-1) light than negative control to the wet weight of thrombus of rat, but there was no significant difference shows that it has the inhibiting trend of thrombosis.
5. clinical trial
(authentication code: the accurate word Z20043755 of traditional Chinese medicines), metal and stone pharmacy head factory in Shantou is produced, a 10ml, 3 times on the one, the course for the treatment of: 4 weeks in contrast with TONGMAI KOUFUYE.Oral liquid of the present invention is as investigational agent, a 20ml, 3 times on the one, the course for the treatment of: 4 weeks.
Investigational agent, contrast medicine are not only similar aspect function and indication, also very approximate on prescription: the prescription of contrast medicine adds on the basis of blood-activating stasis-removing kind medicine Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong has used the medicine Radix Puerariae that dispels the wind, and the large usage quantity of Radix Puerariae, can learn from contrast medicine composition aspect, this medicine has adopted the prescription principle of the double medicine that dispels the wind of blood circulation promoting and blood stasis dispelling, compare with similar medicine, contrast medicine TONGMAI KOUFUYE is the most similar to investigational agent in principle at prescription, has comparability.By multicenter, at random, double blinding, parallel check experiment, objective evaluation Chinese patent medicine of the present invention is to effectiveness and the safety for the treatment of cerebral infarction convalescent period (obstruction of collaterals by blood stasis is held the wind card under the arm).
Western medicine diagnose standard and Chinese medical discrimination that test crowd selection meets Atherosclerosis and thrombosis and cerebral infarction or lacunar infarction are that obstruction of collaterals by blood stasis is held the wind card under the arm, 2 thoughtful 6 months convalescent patients of cerebral infarction that fall ill, and meet following condition: 35 years old to 75 years old age, nerve function deficit score 〉=6 minute and≤the last week is not used Chinese patent medicine and the professional rehabilitation of blood circulation promoting and blood stasis dispelling in 36 minutes, medication.
This test test group is finished case load 309 examples, and matched group is finished case load 105 examples.
Clinical trial is take Syndrome in TCM marquis curative effect, Clinical Nerve Function Deficiency and disability degree curative effect as the curative effect index, with coagulation function as the secondary efficacy index.Safety indexes comprises general physical examination, blood, routine urinalysis, stool routine examination+occult blood, liver function (glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT), renal function (serum creatinine, blood urea nitrogen), coagulation indexes (PT, APTT, FIB), electrocardiogram and untoward reaction.
This clinical test results shows:
The leading indicator aspect:
(1) test group and matched group tcm syndrome curative effect comparing difference not statistically significant (P value＞0.05), therapeutic equivalence: test group 3 examples of fully recovering, produce effects 34 examples, effective 179 examples, total effective rate 68.14%; Matched group 3 examples of fully recovering, produce effects 9 examples, effective 54 examples, total effective rate 62.26%.PP analytic set, test group 3 examples of fully recovering, produce effects 34 examples, effective 175 examples, total effective rate 68.61%; Matched group 3 examples of fully recovering, produce effects 9 examples, effective percentage 53 examples, total effective rate 61.90%.
(2) comparison in 2 weeks, 4 weeks after each single index of tcm syndrome is treated: stuttering puckery, the numb limbs and tense tendons of test group and matched group hemiplegia, crooked mouth and tongue, speech, have a headache, have a dizzy spell, limbs tremble, the score value of the vibration of order pearl, limbs contracture relatively, difference not statistically significant (the P value of indices equal＞0.05).The score value difference not statistically significant in 2 weeks, 4 weeks after two groups of each single indexs of tcm syndrome are treated, therapeutic equivalence.
Improve the comparison of grade, disappearance rate after each single index of tcm syndrome is treated 4 weeks: stuttering puckery, the numb limbs and tense tendons of test group and matched group hemiplegia, crooked mouth and tongue, speech, have a headache, have a dizzy spell, limbs tremble, the vibration of order pearl, limbs contracture improve grade relatively, difference not statistically significant (the P value of indices equal＞0.05).Two groups of therapeutic equivalences that improve grade and disappearance rate to each single index of tcm syndrome.
(3) test group and the score value of matched group tcm syndrome total mark and the comparison of difference, difference not statistically significant (P value＞0.05), two groups of therapeutic equivalences.
Compare in the group of tcm syndrome total mark before and after the test group treatment, P＜0.001, difference has statistical significance, and total mark has obvious minimizing after treating; Compare in the group before and after the treatment of matched group tcm syndrome total mark, P＜0.001, difference has statistical significance, and total mark has obvious minimizing after treating.
Test group and the total mark classification of matched group tcm syndrome and improve the comparison of grade, difference not statistically significant (P value＞0.05), two groups of therapeutic equivalences.
(4) comparison of test group and matched group Clinical Nerve Function Deficiency and disability degree curative effect, difference not statistically significant (P value＞0.05), therapeutic equivalence.
(5) comparison in 2 weeks, 4 weeks after each single index of Clinical Nerve Function Deficiency is treated: the score value constituent ratio of test group and matched group consciousness, horizontal gaze function, facial paralysis, speech, upper limb muscular strength, hand muscle power, lower-limb muscular strength, walking ability, difference not statistically significant (the P value of indices is all＞0.05), two groups of therapeutic equivalences.
After treating, improves each single index of Clinical Nerve Function Deficiency the comparison of grade and disappearance rate 4 weeks: the comparison that improves grade of test group and matched group consciousness, horizontal gaze function, facial paralysis, speech, upper limb muscular strength, hand muscle power, lower-limb muscular strength, walking ability, difference not statistically significant (the P value of indices is all＞0.05), two groups of therapeutic equivalences.
(6) comparison of test group and matched group Clinical Nerve Function Deficiency integration score value, difference, difference not statistically significant (P value＞0.05), two groups of therapeutic equivalences.
Compare in the group of Clinical Nerve Function Deficiency integration before and after the test group treatment, P＜0.001, difference has statistical significance, and score value has remarkable minimizing after treating; Compare in the group of Clinical Nerve Function Deficiency integration before and after the treatment of control group, P＜0.001, difference has statistical significance, and score value has remarkable minimizing after treating.
Test group and the integration classification of matched group Clinical Nerve Function Deficiency and improve the comparison of grade, difference not statistically significant (P value＞0.05), two groups of therapeutic equivalences.
(7) test group and the classification of matched group disability degree and improve grade and the comparison of normalization rate, difference not statistically significant (P value＞0.05), two groups of therapeutic equivalences.
Less important index aspect, test group and matched group medicine all have no significant effect coagulation function.
This clinical test results shows that Chinese medicine composition of the present invention is for treatment cerebral infarction convalescent period (obstruction of collaterals by blood stasis is held the wind card under the arm) safety, effective.
Embodiment 1:
127 parts of Rhizoma Chuanxiongs, 42 parts of the Radixs Angelicae Dahuricae, Rhizoma Et Radix Notopterygii 42,10 parts of Herba Asaris, 84 parts of Herba Menthaes, 15 parts of Radix Saposhnikoviaes, 21 parts in Radix Glycyrrhizae, 63 parts of Folium Camelliae sinensis, 53 parts of Radix Paeoniae Rubra, 21 parts in Rhizoma Gastrodiae, 53 parts of Flos Chrysanthemis.The Six-elements such as Rhizoma Chuanxiong, Rhizoma Et Radix Notopterygii, Herba Asari, Herba Menthae, Radix Saposhnikoviae, Flos Chrysanthemi are added 10 times of amounts of water, hydrodistillation is collected 800 milliliters of Aromatic water, aqueous solution after the distillation in addition device is collected, medicinal residues and Radix Glycyrrhizae, the Radix Angelicae Dahuricae, Radix Paeoniae Rubra, Rhizoma Gastrodiae four flavors add 8 times of amounts of water and decoct twice, each decocting time is 1 hour, merge decocting liquid, filter; Filtering residue is abandoned.Folium Camelliae sinensis adds 12 times of amounts of fresh boiling water and soaks twice, each soak time is 20 minutes, merge leachate, filter, the aqueous solution after filtrate and above-mentioned decocting liquid and the distillation merges, be evaporated to relative density 1.14 (70 ℃), leave standstill, be chilled to the ethanol that adds 2 times of amounts 95% after the room temperature, stir evenly, cold preservation 24 hours makes precipitation.Get the supernatant decompression recycling ethanol, leave standstill, get supernatant and filter, filtrate is concentrated into relative density 1.18 (room temperature).Above-mentioned Aromatic water with 0.8% tween 80 solubilising, is added in the above-mentioned concentrated solution, stir evenly, water is adjusted to 980 milliliters, is regulating PH to 4.5-6.5 with 10%NaOH, adds water again and adjusts total amount to 1000 milliliter, stirs evenly, and leaves standstill, filter, and fill, sterilization, and get final product.
Embodiment 2:
Rhizoma Chuanxiong 50 grams, the Radix Angelicae Dahuricae 20 grams, Rhizoma Et Radix Notopterygii 20 grams, Herba Asari 5 grams, Herba Menthae 50 grams, Radix Saposhnikoviae 10 grams, Radix Glycyrrhizae 10 grams, Folium Camelliae sinensis 40 grams, Radix Paeoniae Rubra 30 grams, Rhizoma Gastrodiae 10 grams, Flos Chrysanthemi 20 grams.Said medicine is pulverized, crossed 100 mesh sieves, add refined honey, make honeyed pill.
Embodiment 3
Rhizoma Chuanxiong 200 grams, the Radix Angelicae Dahuricae 20 grams, Rhizoma Et Radix Notopterygii 80 grams, Herba Asari 5 grams, Herba Menthae 50 grams, Radix Saposhnikoviae 50 grams, Radix Glycyrrhizae 10 grams, Folium Camelliae sinensis 90 grams, Radix Paeoniae Rubra 30 grams, Rhizoma Gastrodiae 10 grams, Flos Chrysanthemi 20 grams.With Rhizoma Chuanxiong, the Six-elements such as Rhizoma Et Radix Notopterygii, Herba Asari, Herba Menthae, Radix Saposhnikoviae, Flos Chrysanthemi add 10 times of amounts of water, hydrodistillation is collected 800 milliliters of Aromatic water, aqueous solution after the distillation in addition device is collected, medicinal residues and Radix Glycyrrhizae, the Radix Angelicae Dahuricae, Radix Paeoniae Rubra, Rhizoma Gastrodiae four flavors add 8 times of amounts of water and decoct twice, each decocting time is 1 hour, merges decocting liquid, filters; Filtering residue is abandoned.Folium Camelliae sinensis adds 12 times of amounts of fresh boiling water and soaks twice, each soak time is 20 minutes, merge leachate, filter, the aqueous solution after filtrate and above-mentioned decocting liquid and the distillation merges, be evaporated to relative density 1.14 (70 ℃), leave standstill, be chilled to the ethanol that adds 2 times of amounts 95% after the room temperature, stir evenly, cold preservation 24 hours makes precipitation.Get the supernatant decompression recycling ethanol, leave standstill, get supernatant and filter, filtrate is concentrated into the extractum shape, adds above-mentioned Aromatic water, and mixing adds excipient starch, pelletize, and then granulate enters the tablet machine tabletting, makes tablet.
Claims (2)
1. be Rhizoma Chuanxiong 50-200 part by weight ratio, Radix Angelicae Dahuricae 20-80 part, Rhizoma Et Radix Notopterygii 20-80 part, Herba Asari 5-20 part, Herba Menthae 50-150 part, Radix Saposhnikoviae 10-50 part, Radix Glycyrrhizae 10-50 part, Folium Camelliae sinensis 40-50 part, Radix Paeoniae Rubra 30-100 part, the application of the Chinese medicine composition that Rhizoma Gastrodiae 10-50 part and Flos Chrysanthemi 20-90 part are made in preparation inhibition thrombosis medicine.
2. application according to claim 1 is characterized in that described Chinese medicine composition is by weight by 127 parts of Rhizoma Chuanxiongs, 42 parts of the Radixs Angelicae Dahuricae, Rhizoma Et Radix Notopterygii 42,10 parts of Herba Asaris, 84 parts of Herba Menthaes, 15 parts of Radix Saposhnikoviaes, 21 parts in Radix Glycyrrhizae, 63 parts of Folium Camelliae sinensis, 53 parts of Radix Paeoniae Rubra, 53 parts of 21 parts in Rhizoma Gastrodiae and Flos Chrysanthemis are made.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656239A (en) * | 2013-12-16 | 2014-03-26 | 青岛百瑞吉生物工程有限公司 | Traditional Chinese medicine agentia for treating recurrent headache and preparation method thereof |
| CN106109717A (en) * | 2016-08-31 | 2016-11-16 | 天津中新药业研究中心 | A kind of compositions treating headache and preparation method thereof |
| CN109288972A (en) * | 2018-10-16 | 2019-02-01 | 李文本 | A kind of Chinese medicine composition |
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2009
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656239A (en) * | 2013-12-16 | 2014-03-26 | 青岛百瑞吉生物工程有限公司 | Traditional Chinese medicine agentia for treating recurrent headache and preparation method thereof |
| CN103656239B (en) * | 2013-12-16 | 2016-04-06 | 卞佳林 | A kind of Chinese drugs agentia for the treatment of wind syndrome of head and preparation method thereof |
| CN106109717A (en) * | 2016-08-31 | 2016-11-16 | 天津中新药业研究中心 | A kind of compositions treating headache and preparation method thereof |
| CN109288972A (en) * | 2018-10-16 | 2019-02-01 | 李文本 | A kind of Chinese medicine composition |
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Application publication date: 20130403 |