CN102225173A - Traditional Chinese preparation for treating headache and preparation method thereof - Google Patents
Traditional Chinese preparation for treating headache and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese preparation for treating headache and a preparation method thereof. The traditional Chinese preparation is a traditional Chinese oral preparation prepared from pharmaceutically acceptable auxiliaries and six medicinal materials namely gastrodia elata, angelica, rhizome smilacis glabrae, radix polygoni multiflori preparata, divaricate saposhnikovia root and scorpio which are used as raw materials. The dosage form of the preparation comprises pill, granule, hard capsule, tablet and the like. The traditional Chinese preparation has the characteristics that preparation process is simple and practicable, and the traditional Chinese preparation is safe and effective and has obvious pharmacological and pharmacodynamic effects.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation for the treatment of headache and preparation method thereof, belong to the pharmaceutical preparations technology field.
Background technology
At present, along with the raising of living standards of the people, the rhythm of life and work is accelerated, pressure strengthens, and the sickness rate of headache raises day by day.Headache belongs to motherland's medical science " wind syndrome of head " category, is one of neural commonly encountered diseases, clinically see so that headache due to internal injury more, during its outbreak pain unbearably, pain very is easy nausea, vomit clear saliva or prolong and facial muscle, the contracture numbness, the course of disease is very long.Numerous at all times families that cure think that the paathogenic factor of having a headache is unsuccessful based on feelings will, six climate exopathogens are attacked, QI and blood is contrary disorderly, pathogenic wind hinders key, stagnation of blood stasis outward.Chinese medicine thinks, head be " confluence of all yang-channels ", " gas of sun all can be in the mountain peak clearly for the blood of the five internal organs elite, six internal organs ".The internal organs Ankang, QI and blood is orderly and clearly, then the clear spirit of brain and the hardship of no headache.If feelings will is unsuccessful, disgruntled anxiety, the liver failing to maintain the normal flow of QI, strongly fragrant and fire-transformation, yang-energy is high moving, and QI and blood is disorderly contrary, and QI-blood circulation is obstructed and is formed stagnation of QI and blood; Six climate exopathogens are attacked outward, wherein " wind being the primary exopathogen ", it can press from both sides cold, folder heat or be mingled with damp invasion and attack human body, top, last criminal mountain peak, also can cause QI-blood circulation not smooth, gradually become stagnation of QI and blood, so pathogenic wind hinders key, stagnation of blood stasis is the pathological factor of migraine phase, internal organs yang blood and qi functional disorder is the pathologic basis of migraine phase, and six climate exopathogens are attacked outward, disorder of emotion then is the most common risk factor.Modern medicine is divided into angioneurotic headache, cluster headache, tension headache etc. with headache, but fully clear and definite as yet to its cause of disease, may be relevant with factors such as heredity, endocrine, nervous, direct stimulation, sleep disorder.Therefore, Chinese medicine has good effect on to the headache treatment of diseases, can reach treating both the principal and secondary aspects of a disease, the absolute advantages that side effect is little.
To this; we have successively applied for two patents of invention and have obtained mandate; application number is respectively 02153456.X and 200410022070.3; in these two patent application documents; mainly be from preparation prescription; aspects such as dosage form preparation technology are protected; but owing to there is defective such as poor stability in its reality; the present invention improves research on this basis; with further improvement medicinal material extract preparation technology; improving medicine stability, bioavailability and curative effect of medication is purpose, and creationary a kind of Chinese medicine preparation for the treatment of headache of succeeding in developing.
Summary of the invention
The object of the present invention is to provide the Chinese medicine preparation of a kind of steady quality, curative effect is reliable, bioavailability is high treatment headache.In present specification, specifically introduce the prescription composition of this Chinese medicine preparation and be suitable for dosage form, and reasonably optimizing gone out feasible extraction and preparation technique route, through corresponding pharmacodynamics test checking, the result show the stable curative effect of this Chinese medicine preparation, effectively, reliable.
Technical solution of the present invention is to be formed by following prepared:
(1) gets and be ground into 270 parts in coarse grained Rhizoma Gastrodiae, 180 parts of Radix Angelicae Sinensis, 270 parts of Radix Polygoni Multiflori Preparatas, 180 parts of Radix Saposhnikoviaes, add for the first time pH value and be 3.0～5.0 water, amount of water and medical material weight ratio are 6～10 times, behind supersound process 10-30min, heating extraction 1.0～2 hours filters; Add for the second time pH value and be 5.5～7.0 water, amount of water and medical material weight ratio are 5～8 times, heating extraction 0.5～1.5 hour, filtration; Add pH value for the third time and be 7.5～9.0 water, amount of water and medical material weight ratio are 5～8 times, heating extraction 0.5～1.5 hour, filter, the merging filtrate concentrating under reduced pressure adds certain density ethanol, and leaves standstill 24 hours, filter, it is that the clear paste of 1.10-1.25 is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get 30 parts of Scorpios, Rhizoma Smilacis Glabrae is ground into fine powder for 360 parts, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant commonly used on the pharmaceutics and is prepared into various oral formulations, promptly.
Preferred manufacturing procedure is as follows in the technical solution of the present invention:
(1) get and be ground into 270 parts in coarse grained Rhizoma Gastrodiae, 180 parts of Radix Angelicae Sinensis, 270 parts of Radix Polygoni Multiflori Preparatas, 180 parts of Radix Saposhnikoviaes, add pH value for the first time and be 4.0 water, amount of water and medical material weight ratio are 8 times, behind supersound process 20min, and heating extraction 1.5 hours, filtration; Add for the second time pH value and be 6.0 water, amount of water and medical material weight ratio are 6 times, heating extraction 1.0 hours, filtration; Add pH value for the third time and be 8.0 water, amount of water is 6 times, heating extraction 0.5 hour, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain the alcohol amount and reach 70%, and left standstill 24 hours, filtering, it is that 1.20 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get 30 parts of Scorpios, Rhizoma Smilacis Glabrae is ground into fine powder for 360 parts, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant commonly used on the pharmaceutics and is prepared into various oral formulations, promptly.
The dosage form that above-mentioned preparation method is suitable for is a hard capsule, granule, and pill or tablet are preferably hard capsule.
Technical solution of the present invention is in the research process of reality, and two the patent 02153456.X and 200410022070.3 with respect in first to file mainly have following creationary useful technique effect:
1. the extraction of medical material and purification aspect:
The present invention's prescription is made up of Rhizoma Smilacis Glabrae, Rhizoma Gastrodiae, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Radix Saposhnikoviae and Scorpio, and its prescription is simplified proper, and effect significantly.Our research is on the basis that prescription is determined, the extraction and purification process of medical material is completely newly groped, and has taken all factors into consideration factors such as medical material physical property, effective ingredient characteristic and production cost, concrete improve be mainly reflected in following some.(1) because the rhizoma smilacis glabrae medicinal material mealiness is bigger, should not decoct, Scorpio belongs to animal drugs, contain a large amount of protide effective ingredient, lost efficacy by thermal lability, so we select for use according to its characteristic and entirely beat powder and be used as medicine, can at utmost keep effective ingredient, play the partial supplementary material filling effect again.(2) other four Chinese medicine material, the effect characteristics of Chinese medicine preparation and according to the present invention in conjunction with modern biopharmaceutical new technique, we adopt semi-bionic extraction alcohol deposition method (being SBAE), creationary it have been carried out the extraction purification, have kept active component effectively.Semi-biomimetic method is a kind of Chinese medicine extraction new technique that the imitation oral drugs propose at the gastrointestinal transport process, and it adopts the acid water of selected pH value and alkaline water to extract continuously successively, its objective is to extract to contain index components high " active mixture ".This method is adhered to the viewpoint of " composition opinion being arranged; not only composition opinion; focus on the reaction of body pharmacodynamics " in the design of extraction process, do index with one or more effective ingredient, total extractives and opposed polarity part or main pharmacological, multifactorial evaluation, the theoretical principle of preferred extraction process can be given full play to the comprehensive function characteristics of mix ingredients like this, help again controlling the quality of the pharmaceutical preparations, finally obtain being fit to the active ingredient of absorption of human body with monomer component.In the present invention, we are through unremitting effort, by a large amount of experimentatioies, final also is to have obtained the technical scheme described in the present invention accidentally: promptly extract 3 pH value and be respectively: 3.0～5.0,5.5～7.0,7.5～9.0, wherein pH value is preferably 4.0,6.0 and 8.0.We adopt the semi-bionic extraction alcohol deposition method to the active substance that extracts gained more then, to remove impurity components such as chlorophyll, polysaccharide, finally reach the purpose of efficient medication.(3) will extract medical material and pass through ultrasonic pretreatment in advance after, its extraction ratio of effective constituents significantly improves, mainly be because by cavitation effect of ultrasonic waves, vibration effect and heating effect, can make the destruction of crude drug cell, thereby quicken the release and the stripping of effective ingredient, to be a very big saving to production cost and production capacity like this, finally be of value to the popularization of industrialization.
2. pharmacodynamics aspect:
Content of the present invention is to improve to get on application number is the basis of 02153456.X and 200410022070.3, through the comparison of corresponding techniques scheme, think that application number is that 02153456.X is immediate prior art, so we have carried out contrast experiment's research with technical solution of the present invention with it.We bring different must the disturbing of curative effect at the dosage form difference of forgoing under study for action, the pharmacodynamics difference of material behind the two medicinal material extract purification relatively only, promptly respectively the two is all made dried cream powder according to optimum extraction purifying process separately, the mode that is mixed with the same concentrations administering medical liquids then compares.In the test of pesticide effectiveness we mainly from the analgesia, sedation, experiment aspects such as hemorheology and meninges microcirculation compare research, in order to illustrate the significant curative effect of product of the present invention, the remarkable useful technique effect that the present invention reaches are described.Concrete experiment is as follows:
2.1 laboratory animal: the Wistar rat, Kunming kind white mice, the male and female dual-purpose, the cleaning level is provided by The Fourth Military Medical University's Experimental Animal Center.
2.2 positive control drug: flunarizine (flunarizine hydrochloride capsules), Xian-Janssen Pharmaceutical Ltd. produces; XUESAITONG JIAONANG, Wenshan Qihua Co., Ltd., Yunnan Baiyao Pharmaceutical Group produces; The Qiyeshen an sheet, Hubei Li Shizhen (1518-1593 A.D.) medicine Group Co.,Ltd produces; Beam balls all, the Beijing TongrenTang Co., Ltd produces.
2.3 the preparation of experiment medicine group:
The preparation of medicine group A. of the present invention: (1) is got Rhizoma Gastrodiae 270g and is ground into coarse granule, Radix Angelicae Sinensis 180g, Radix Polygoni Multiflori Preparata 270g, Radix Saposhnikoviae 180g adds for the first time pH value and is 4.0 water, and amount of water is 8 times of medical material weight ratio, behind supersound process 20min, carried out heating extraction 1.5 hours, filter; Add for the second time pH value and be 6.0 water, amount of water is 6 times of medical material weight ratio, carries out heating extraction 1.0 hours, filters; Add pH value for the third time and be 8.0 water, amount of water is 6 times of medical material weight ratio, carried out heating extraction 0.5 hour, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain alcohol amount and reach 70%, and left standstill 24 hours, filter, it is that 1.20 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get Scorpio 30g, Rhizoma Smilacis Glabrae 360g is ground into fine powder, the clear paste of locating to make with above-mentioned (1) mixes, dry and be ground into dried cream powder after, standby.
B. the preparation of application number 02153456.X medicine group: get Scorpio 30g, Radix Saposhnikoviae 50g, Rhizoma Gastrodiae 150g is ground into fine powder, and is standby.Other gets Radix Saposhnikoviae 130g, Rhizoma Gastrodiae 120g and Rhizoma Smilacis Glabrae 360g, Radix Polygoni Multiflori Preparata 270g, Radix Angelicae Sinensis 180g, be ground into coarse granule, with 70% alcohol reflux secondary, each 1 hour, filter, merging filtrate, decompression recycling ethanol continues to be condensed into thick paste, gained thick paste and Radix Saposhnikoviae, Scorpio, Rhizoma Gastrodiae fine powder mixing, drying under reduced pressure is pulverized, and is standby.
The dried cream powder that above-mentioned A, B are prepared gained faces with preceding and is mixed with the same concentrations administering medical liquids with distilled water.
2.4 analgesic experiment
2.4.1 mice acetic acid is caused the effect of writhing response: 40 of mices, be divided into 4 groups at random, be administered once every day, gastric infusion is 5 days continuously, behind last gastric infusion 1h, lumbar injection 0.6% glacial acetic acid 0.2ml/, observe and write down the number of times of mouse writhing reaction in the 20min (abdominal part indent, stretching, extension hind leg, buttocks are raised), the results are shown in Table 1.
The analgesic activity of table 1 pair mice acetic acid twisting reaction
Annotate: compare with the normal saline group,
* *P＜0.001; Compare with application number 02153456.X medicine group,
△P＜0.05,
△ △ △P＜0.001.
2.4.2 influence: 40 of mices to mice electricity irritation whipping pain threshold, be divided into 4 groups at random, be administered once every day, and gastric infusion is 5 days continuously, behind last gastric infusion 1h, one electrode is put on the mice foot, another electrode stimulating afterbody, after the energising, the pain threshold when observing the mice whipping, and calculate the analgesia suppression ratio, the results are shown in Table 2.
Analgesia suppression ratio=(administration group pain threshold-matched group pain threshold)/matched group pain threshold * 100%
The influence of table 2 pair mice electricity irritation whipping pain threshold
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with application number 02153456.X medicine group,
△P＜0.05,
△ △ △P＜0.001.
2.4.3 the mice hot plate is stimulated the influence of licking the pain in foot threshold value: get female mice and place (55 ℃ of temperature) on the hot-plate instrument, mice is from placing hot-plate instrument to the pain threshold of metapedes required time as this Mus occurring licking, allly lick the metapedes time less than 5 seconds or greater than 30 seconds or leaper, be considered as defective animal, give it up.With 40 of qualified mices, be divided into 4 groups at random, gastric infusion, continuous three days, once a day, and after the last administration 1 hour, begin to measure the mice pain threshold, the results are shown in Table 3.
Table 3 pair mice hot plate stimulates the influence of licking the pain in foot threshold value
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with application number 02153456.X medicine group,
△ △P＜0.01.
Table 1,2,3 experimental result show that the analgesic effect of medicine group of the present invention and application number 02153456.X medicine group more all has significant difference with the normal saline matched group; Medicine group of the present invention and application number 02153456.X medicine group relatively all have significant difference (P＜0.05) at the mice acetic acid twisting with in the experiment of mice electricity irritation whipping pain threshold, and stimulating to lick in the experiment of pain in foot threshold value at the mice hot plate has more excellent analgesia trend.This shows that medicine of the present invention all has good therapeutic effect to various acute and chronic pain.
2.5 blood system contrast experiment
2.5.1 to the thrombotic influence of rats in vitro
Get 40 Wistar rats, be divided into 4 groups at random by body weight, every group 10, continuous irrigation stomach 5 days, every day 1 time, 1h after the administration on the 5th with 3.5% pentobarbital sodium lumbar injection 1ml/100g anesthesia, separates right common carotid artery and left external jugular vein then, tubule (long 10cm) with 2 internal diameter 1mm, be enclosed within on the polyethylene tube of internal diameter 2mm (long 8cm), put 4 trumpeter's art silk threads of a long 5cm in the polyethylene tube, (50u/ml) is full of the polyethylene tube chamber with heparin-saline solution, after an end of pipe inserts left external jugular vein, inject heparin 50u/kg from polyethylene tube, clamp tube wall, with the other end insertion right common carotid artery of pipe, after operation is finished, open blood flow, then blood returns left external jugular vein from the right common carotid artery polyethylene tube of flowing through, open blood flow is middle Herba Clinopodii after 15 minutes, take out silk thread rapidly and weigh, it heavily is wet weight of thrombus that gross weight deducts silk thread, the results are shown in Table 4.
The thrombotic influence of table 4 pair rats in vitro
Annotate: compare with the normal saline group,
*P＜0.01.
The experimental result of table 4 shows that the external anti thrombotic action of medicine group of the present invention and application number 02153456.X medicine group more all has significant difference (P＜0.01) with the normal saline matched group; Medicine group of the present invention and application number 02153456.X medicine group relatively, though in the thrombotic experiment of rats in vitro there was no significant difference, it has more excellent trend.
2.5.2 influence to rat platelet aggregation
Get 40 Wistar rats, be divided into 4 groups at random by body weight, every group 10, continuous irrigation stomach 5 days, every day 1 time, 1h after the administration on the 5th, 3.5% pentobarbital sodium lumbar injection 1ml/100g anesthesia, dorsal position fixing limbs and head, it is total to separate neck, intubate is got blood 1.8ml, puts into " platelet aggregation instrument " special use silication and that added the 0.2ml3.8g/L sodium citrate in advance in vitro.Begin to survey its platelet aggregation degree, the adenosine diphosphate (ADP) double sodium salt is as derivant, and the rule of operation of pressing " QX-200 whole blood platelet aggregation instrument " records the platelet maximum agglutination rate of every part of blood sample, the results are shown in Table 5.
The influence of table 5 pair rat platelet aggregation
Annotate: compare with the normal saline group,
*P＜0.05,
* *P＜0.001.
The experimental result of table 5 shows that medicine group of the present invention and application number 02153456.X medicine group more all have significant difference to the influence of rat platelet aggregation with the normal saline matched group; Medicine group of the present invention and application number 02153456.X medicine group compare, though both there was no significant differences, it has more excellent trend.
2.5.3 influence to cold blood stasis rat hemorheology index
Get 40 Wistar rats, be divided into 4 groups at random, continuous irrigation stomach 7 days by body weight, every day 1 time, behind last administration 1h, fixedly rat extremity and head are used 70% alcohol disinfecting respectively, put ice bag around the experimental rat, freezing 1.5h, rewarming 5min in 45 ℃ of warm water, conventional then the raising after 3 days, blood sampling is also surveyed hemorheology numerical value, the results are shown in Table 6 and 7.
The influence of table 6 pair rat whole blood viscosity
The influence of table 7 pair hemorheology of rat index
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with application number 02153456.X medicine group,
△P＜0.05,
△ △P＜0.01.
Table 6 and 7 experimental result show, the whole blood viscosity of medicine group of the present invention and 02153456.X group in, during low shear rate with the comparison of normal saline matched group, have significant difference, both compare simultaneously, and medicine group of the present invention has better curative effect than the 02153456.X group under high shear rate situation; In addition, compare with application number 02153456.X medicine group, medicine group of the present invention also has significant difference aspect plasma viscosity, have more excellent trend aspect packed cell volume.
By the 2.5.1-2.5.3 experiment as can be known, medicine of the present invention is evident in efficacy aspect anticoagulant and thrombolytic, has better effect than the 02153456.X group, various acute and chronic blood clotting phenomenons had good inhibitory action, especially with strong points to blood stasis due to the cold coagulation, this is because the blood viscosity increase causes easily being deposited on fixed attention blood vessel wall with part headache morbidity, thereby blocks blood circulation, cause brain or whole body blood supply insufficiency, and the mechanism and the treatment means that cause having a headache match.
2.5.4 influence to the normal mouse hypoxia endurance time
Get 40 mices, be divided into 4 groups at random by body weight, continuous irrigation stomach 5 days, after the last administration 60 minutes, is surveyed mice anoxia enduring life span at every day 1 time; Test is with 4 of wide mouthed bottles, and volume 200ml adds sodica calx 70g in every bottle, adds a ground bottle cap above, builds bottle cap and timing, and stopping with mouse breathing is index, and record mice life span (min) the results are shown in Table 8.
The influence of table 8 pair normal mouse hypoxia-bearing capability
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01; Compare with application number 02153456.X medicine group,
△P＜0.05.
The experimental result of table 8 shows, medicine group of the present invention and 02153456.X group be to the influence of normal mouse hypoxia endurance time, with the normal saline matched group relatively, time that all can the existence of significant prolongation normal mouse, and have significant difference; Both compare simultaneously, and medicine group of the present invention is obviously organized mice life span significant prolongation than 02153456.X, and has significant difference.
2.6 sedation
2.6.1 to pentobarbital sodium above threshold dosage cause the influence of mouse sleep time
Select 40 of mices for use, be divided into 4 groups at random, gastric infusion, continuous three days, once a day, 1 hour began to test after the last administration; Mouse peritoneal is injected pentobarbital sodium solution (55mg/kg), with injection pentobarbital sodium solution at once to righting reflex loss be incubation period, be sleep time righting reflex loss to recovery time, notes incubation period and sleep time, the results are shown in Table 9.
Table 9 pair pentobarbital sodium above threshold dosage causes the influence of mouse sleep time
Annotate: compare with the normal saline group,
* *P＜0.001;
The experimental result of table 9 shows that medicine group of the present invention and 02153456.X group compare with the normal saline matched group, does not all have tangible the prolong incubation period of mice sleep and the effect of the length of one's sleep.
2.6.2 the pentobarbital sodium sub-threshold dose is caused the influence of mice sleep rate
Select 48 of mices for use, be divided into 4 groups at random, gastric infusion, continuous three days, once a day, after the last administration 1 hour, mouse peritoneal is injected pentobarbital sodium solution (35mg/kg), observe and note behind the animal injection pentobarbital sodium solution in 15 minutes, the mice righting reflex loss reaches the Mus number more than 1 minute, calculate the sleep rate, the results are shown in Table 10.
Table 10 pair pentobarbital sodium sub-threshold dose causes the influence of mice sleep rate
Annotate: compare with the normal saline group,
*P＜0.05.
As shown in Table 10, medicine group of the present invention and 02153456.X group and normal saline matched group relatively, to the influence of mice sleep rate there are no significant difference; Results suggest: medicine group of the present invention can not be worked in coordination with the sedative-hypnotic effect of pentobarbital sodium.
By the 2.5.4-2.6.2 experiment as can be known, medicine of the present invention can obviously promote the hypoxia-bearing capability of laboratory animal, do not influence the mental status and the activity of laboratory animal during the medication simultaneously, be that the good oxygen lack resistant function of medicine performance is not to realize by the activity that reduces animal, point out medicine of the present invention not have remarkable sedative-hypnotic effect, be applicable to the crowd of duty, and whole curative effect is better than the 02153456.X group.
2.7 to the microcirculatory influence of rat head blood vessel
Select 40 of rats for use, be divided into 4 groups at random, gastric infusion, continuous three days, once a day, after the last administration 1 hour, with 1.00% pentobarbital sodium solution 0.5ml/100g rat abdominal cavity is anaesthetized, after the anesthesia rat ventricumbent position is fixed, cut skin of head, expose parietal bone, puncture with No. 4 pins prior to cerebellum oblongata place, extract cerebrospinal fluid 0.2ml, to reduce intracranial pressure.Then rats with left bone central authorities are windowed with cranial drill, form 0.5cm diameter circular bone hole, with the hemostasis by compression of warm saline cotton balls, cut off cerebral dura mater at last, the pia mater encephali surface is done to be interrupted with 37 ℃ of artificial cerebrospinal fluids and is instiled, with anti-drying.Fixedly rat head is falling to penetrating under the light source, observes with 40 power microscopes, and the top end diameter of maximum blood vessel loop the results are shown in Table 11 near arteriole flow velocity, vein input tap footpath, tremulous pulse output tap footpath, the vein.
The table 11 pair microcirculatory influence of rat head blood vessel
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with application number 02153456.X medicine group,
△P＜0.05,
△ △P＜0.01.
The experimental result of table 11 shows, medicine group of the present invention and 02153456.X group are in the microcirculatory influence experiment of rat head, influence to arteriole flow velocity, input tap footpath, output tap footpath and loop top diameter more all has significant difference with the normal saline matched group; Simultaneously both compare, and the influence of rat arteriole flow velocity is had significant difference, though to the influence no difference of science of statistics of input tap footpath, output tap footpath and loop top diameter, have the trend of microcirculation improvement preferably.This matches with headache part pathogeny and Therapeutic Principle.
Show according to above research contents, though the technology of the present invention content is to carry out on application number 02153456.X basis, but it has the distinguishing feature that drug action obviously is better than application number 02153456.X, and this will bring great potential and development space for the clinical practice of this invention preparation.
The specific embodiment
Embodiment 1
(1) get Rhizoma Gastrodiae 270g and be ground into coarse granule, Radix Angelicae Sinensis 180g, Radix Polygoni Multiflori Preparata 270g, Radix Saposhnikoviae 180g adds for the first time pH value and is 4.0 water, and amount of water is 8 times, behind supersound process 20min, carries out heating extraction 1.5 hours, filters; Add for the second time pH value and be 6.0 water, amount of water is 6 times, carries out heating extraction 1.0 hours, filters; Add pH value for the third time and be 8.0 water, amount of water is 6 times, carries out heating extraction 0.5 hour, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain the alcohol amount and reach 70%, left standstill 24 hours, and filtered, it is that 1.20 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get Scorpio 30g, Rhizoma Smilacis Glabrae 360g is ground into fine powder, the clear paste of locating to make with above-mentioned (1) mixes, and adds an amount of amylum pregelatinisatum, incapsulates after granulating, and promptly gets hard capsule.
Embodiment 2
(1) get Rhizoma Gastrodiae 2700g and be ground into coarse granule, Radix Angelicae Sinensis 1800g, Radix Polygoni Multiflori Preparata 2700g, Radix Saposhnikoviae 1800g adds for the first time pH value and is 3.0 water, and amount of water is 6 times, behind supersound process 10min, carries out heating extraction 1.0 hours, filters; Add for the second time pH value and be 5.5 water, amount of water is 5 times, carries out heating extraction 1.5 hours, filters; Add pH value for the third time and be 7.5 water, amount of water is 5 times, carries out heating extraction 1.0 hours, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain the alcohol amount and reach 60%, left standstill 24 hours, and filtered, it is that 1.10 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get Scorpio 300g, Rhizoma Smilacis Glabrae 3600g is ground into fine powder, the clear paste of locating to make with above-mentioned (1) mixes, and mixes with 100 order amylum pregelatinisatums, it is standby to take out the 15-20% mixed powder; Standby powder adds 5～10% polyvinylpyrrolidone anhydrous alcohol solution mixings, and 20 orders, twice back of granulating forms the ball core, and last pot rolls, and looks wet the situation powder that spreads pesticides and becomes ball, and the drying that takes the dish out of the pot, screening promptly get pill.
Embodiment 3
(1) get Rhizoma Gastrodiae 270g and be ground into coarse granule, Radix Angelicae Sinensis 180g, Radix Polygoni Multiflori Preparata 270g, Radix Saposhnikoviae 180g adds for the first time pH value and is 5.0 water, and amount of water is 10 times, behind supersound process 30min, carries out heating extraction 2 hours, filters; Add for the second time pH value and be 7.0 water, amount of water is 8 times, carries out heating extraction 0.5 hour, filters; Add pH value for the third time and be 9.0 water, amount of water is 8 times, carries out heating extraction 1.5 hours, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain the alcohol amount and reach 50%, left standstill 24 hours, and filtered, it is that 1.25 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get Scorpio 30g, Rhizoma Smilacis Glabrae 360g is ground into fine powder, the clear paste of locating to make with above-mentioned (1) mixes, it is an amount of to add starch, Pulvis Talci and magnesium stearate, granulate, compacting in flakes, coating, promptly.
Embodiment 4
(1) get Rhizoma Gastrodiae 270g and be ground into coarse granule, Radix Angelicae Sinensis 180g, Radix Polygoni Multiflori Preparata 270g, Radix Saposhnikoviae 180g adds for the first time pH value and is 4.0 water, and amount of water is 8 times, behind supersound process 20min, carries out heating extraction 1.5 hours, filters; Add for the second time pH value and be 6.0 water, amount of water is 6 times, carries out heating extraction 1.0 hours, filters; Add pH value for the third time and be 8.0 water, amount of water is 6 times, carries out heating extraction 0.5 hour, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain the alcohol amount and reach 80%, left standstill 24 hours, and filtered, it is that 1.20 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get Scorpio 30g, Rhizoma Smilacis Glabrae 360g is ground into fine powder, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant, mixing is granulated, and is drying to obtain granule.
Claims (6)
1. Chinese medicine preparation for the treatment of headache is characterized in that it is to be prepared from by following method:
(1) gets and be ground into 270 parts in coarse grained Rhizoma Gastrodiae, 180 parts of Radix Angelicae Sinensis, 270 parts of Radix Polygoni Multiflori Preparatas, 180 parts of Radix Saposhnikoviaes, add for the first time pH value and be 3.0～5.0 water, amount of water and medical material weight ratio are 6～10 times, behind supersound process 10-30min, heating extraction 1.0～2 hours filters; Add for the second time pH value and be 5.5～7.0 water, amount of water and medical material weight ratio are 5～8 times, heating extraction 0.5～1.5 hour, filtration; Add pH value for the third time and be 7.5～9.0 water, amount of water and medical material weight ratio are 5～8 times, heating extraction 0.5～1.5 hour, filter, the merging filtrate concentrating under reduced pressure adds certain density ethanol, and leaves standstill 24 hours, filter, it is that the clear paste of 1.10-1.25 is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get 30 parts of Scorpios, Rhizoma Smilacis Glabrae is ground into fine powder for 360 parts, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant commonly used on the pharmaceutics and is prepared into various oral formulations, promptly.
2. a kind of Chinese medicine preparation for the treatment of headache as claimed in claim 1 is characterized in that it is to be prepared from by following method:
(1) get and be ground into 270 parts in coarse grained Rhizoma Gastrodiae, 180 parts of Radix Angelicae Sinensis, 270 parts of Radix Polygoni Multiflori Preparatas, 180 parts of Radix Saposhnikoviaes, add pH value for the first time and be 4.0 water, amount of water and medical material weight ratio are 8 times, behind supersound process 20min, and heating extraction 1.5 hours, filtration; Add for the second time pH value and be 6.0 water, amount of water and medical material weight ratio are 6 times, heating extraction 1.0 hours, filtration; Add pH value for the third time and be 8.0 water, amount of water is 6 times, heating extraction 0.5 hour, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain the alcohol amount and reach 70%, and left standstill 24 hours, filtering, it is that 1.20 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get 30 parts of Scorpios, Rhizoma Smilacis Glabrae is ground into fine powder for 360 parts, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant commonly used on the pharmaceutics and is prepared into various oral formulations, promptly.
3. a kind of Chinese medicine preparation for the treatment of headache as claimed in claim 1 or 2 is characterized in that this Chinese medicine preparation is hard capsule, granule, pill or tablet.
4. a kind of Chinese medicine preparation for the treatment of headache as claimed in claim 3 is characterized in that this Chinese medicine preparation is a hard capsule.
5. a kind of preparation method for the treatment of the Chinese medicine preparation of headache as claimed in claim 1 is characterized in that it may further comprise the steps:
(1) gets and be ground into 270 parts in coarse grained Rhizoma Gastrodiae, 180 parts of Radix Angelicae Sinensis, 270 parts of Radix Polygoni Multiflori Preparatas, 180 parts of Radix Saposhnikoviaes, add for the first time pH value and be 3.0～5.0 water, amount of water and medical material weight ratio are 6～10 times, behind supersound process 10-30min, heating extraction 1.0～2 hours filters; Add for the second time pH value and be 5.5～7.0 water, amount of water and medical material weight ratio are 5～8 times, heating extraction 0.5～1.5 hour, filtration; Add pH value for the third time and be 7.5～9.0 water, amount of water and medical material weight ratio are 5～8 times, heating extraction 0.5～1.5 hour, filter, the merging filtrate concentrating under reduced pressure adds certain density ethanol, and leaves standstill 24 hours, filter, it is that the clear paste of 1.10-1.25 is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get 30 parts of Scorpios, Rhizoma Smilacis Glabrae is ground into fine powder for 360 parts, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant commonly used on the pharmaceutics and is prepared into various oral formulations, promptly.
6. a kind of preparation method for the treatment of the Chinese medicine preparation of headache as claimed in claim 5 is characterized in that it may further comprise the steps:
(1) get and be ground into 270 parts in coarse grained Rhizoma Gastrodiae, 180 parts of Radix Angelicae Sinensis, 270 parts of Radix Polygoni Multiflori Preparatas, 180 parts of Radix Saposhnikoviaes, add pH value for the first time and be 4.0 water, amount of water and medical material weight ratio are 8 times, behind supersound process 20min, and heating extraction 1.5 hours, filtration; Add for the second time pH value and be 6.0 water, amount of water and medical material weight ratio are 6 times, heating extraction 1.0 hours, filtration; Add pH value for the third time and be 8.0 water, amount of water and medical material weight ratio are 6 times, heating extraction 0.5 hour, filter, the merging filtrate concentrating under reduced pressure adds a certain amount of ethanol and makes and contain alcohol amount and reach 70%, and left standstill 24 hours, filter, it is that 1.20 clear paste is standby that filtrate recycling ethanol and 60 ℃ of concentrating under reduced pressure become relative density;
(2) get 30 parts of Scorpios, Rhizoma Smilacis Glabrae is ground into fine powder for 360 parts, the clear paste of locating to make with above-mentioned (1) mixes, and adds pharmaceutic adjuvant commonly used on the pharmaceutics and is prepared into various oral formulations, promptly.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1201781C (en) * | 2002-11-29 | 2005-05-18 | 咸阳步长制药有限公司 | Medicine compositions for treating head-ache, and its prepn. method |
| CN100358492C (en) * | 2004-03-17 | 2008-01-02 | 咸阳步长医药科技发展有限公司 | Preparation of Chinese traditional medicine for curing headache and preparation method |
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| CN1201781C (en) * | 2002-11-29 | 2005-05-18 | 咸阳步长制药有限公司 | Medicine compositions for treating head-ache, and its prepn. method |
| CN100358492C (en) * | 2004-03-17 | 2008-01-02 | 咸阳步长医药科技发展有限公司 | Preparation of Chinese traditional medicine for curing headache and preparation method |
Non-Patent Citations (1)
| Title |
|---|
| 《中国药师》 20100831 杨光义等 半仿生提取法在中药新药研究中的应用 1188-1190 全文 第13卷, 第8期 * |
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