One is prevented or is treated migrainous pharmaceutical composition and application thereof
Technical field
The invention belongs to medical art, be specifically related to a kind of prevention or treat migrainous pharmaceutical composition and application thereof.
Background technology
Migraine is a kind of headache syndrome repeatedly occurred showed with nervous system and Non nervous system.Along with social development, migraineur's sickness rate is in the trend increased.Epidemiology show, China prevalence be 985.2/10 ten thousand, sickness rate is 79.7/10 ten thousand, women higher than male, age of onset concentrate on 25-55 year.Though migraine can not be suddenly fatal, prolonged and repeated outbreak can affect the quality of life of people.Modern medicine it be unclear that relevant migraine attack mechanism, and various inducement causes morbidity, and can be summarized as blood vessel source theory and the large class of neurogenic theory two substantially, current doctor trained in Western medicine is also without significant specific treatment.
Summary of the invention
Traditional medicine is thought: " attack outside ailment said due to cold or exposure, upper criminal empties, functional activity of QI being not smooth, obstruction of collaterals by blood stasis, hyperactive liver-YANG causing syndrome of liver-wind, the brain network stasis of blood are stagnant " is the Important cause of disease pathogenesis of primary disease, and wherein method for the treatment of is mainly based on " leading to ".The present invention according to Traditional Chinese medical theory, through to a large amount of screenings of drug component, restructuring, trial, made by a large amount of animal experiment study again.Therefore, a kind of migrainous pharmaceutical composition of control and application thereof of side effect evident in efficacy, with low cost, almost non-toxic have been the object of the present invention is to provide.
In order to realize object of the present invention, inventor is studied by lot of experiments, finally obtains following technical scheme:
One is prevented or is treated migrainous pharmaceutical composition, is made up of: Rhizoma Chuanxiong 15-23 part, Radix Saposhnikoviae 15-23 part, Folium Isatidis 20-30 part, Rhizoma Et Radix Notopterygii 12-18 part, Fructus Schisandrae Chinensis 5-10 part, Rhizoma Zingiberis 5-10 part, Radix Codonopsis 12-18 part, Fructus Lycii 12-18 part the traditional Chinese medicinal material raw materials of following weight portion.
Preferably, prevention described above or treat migrainous pharmaceutical composition, it is made up of the traditional Chinese medicinal material raw materials of following weight portion: Rhizoma Chuanxiong 18-20 part, Radix Saposhnikoviae 18-20 part, Folium Isatidis 23-27 part, Rhizoma Et Radix Notopterygii 14-16 part, Fructus Schisandrae Chinensis 7-9 part, Rhizoma Zingiberis 7-9 part, Radix Codonopsis 14-16 part, Fructus Lycii 14-16 part.
Further preferably, prevention described above or treat migrainous pharmaceutical composition, it is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Rhizoma Chuanxiong 18 parts, Radix Saposhnikoviae 18 parts, Folium Isatidis 25 parts, Rhizoma Et Radix Notopterygii 15 parts, Fructus Schisandrae Chinensis 8 parts, Rhizoma Zingiberis 8 parts, Radix Codonopsis 15 parts, Fructus Lycii 15 parts.
Again further preferably, above-mentioned prevention or treat migrainous pharmaceutical composition, it is oral formulations; Described oral formulations comprises oral liquid, tablet, granule and capsule.
According to Chinese medicine Historical Data Data About, above-mentioned traditional Chinese medicinal material raw materials has following pharmacologically active and source:
Rhizoma Chuanxiong: blood-activating and qi-promoting, wind-expelling pain-stopping.For pacifying nerve, positive wind syndrome of head headache, lump in the abdomen is suffered from abdominal pain, the twinge of the breast side of body, tumbling and swelling, headache, rheumatic arthralgia.Select the rhizome of samphire Rhizoma Chuanxiong.
Radix Saposhnikoviae: expelling pathogenic wind from the body surface, removing dampness to relieve pain, relieving convulsion is jerked surely.Cure mainly diseases caused by exogenous pathogenic factor exterior syndrome, rubella pruritus, rheumatic arthralgia, tetanus.For the root of Umbelliferae herbaceos perennial Radix Saposhnikoviae.
Folium Isatidis: heat clearing away, removing toxic substances, removing heat from blood, hemostasis.Control epidemic febrile disease intenseness of heat excessive thirst, influenza, acute infectious hepatitis, bacillary dysentery, acute gastroenteritis, acute pneumonia, erysipelas, spit blood, epistaxis, jaundice, dysentery, sore throat, aphtha, swollen ulcer drug.Select the dried leaves of cruciferae isatis Isatis indigotica Fort..
Rhizoma Et Radix Notopterygii: loose exterior cold, wind-damp dispelling, sharp joint.Cure cold wind and cold, has a headache lossless, anemofrigid-damp arthralgia, stiffness of the nape muscular contracture, joint ache, edema due to wind pathogen edema, skin sore.Select rhizome and the root of samphire Rhizoma Et Radix Notopterygii or Radix et Rhizoma Notopterygii.
Fructus Schisandrae Chinensis: restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, and deficient pulse of losing heart, interior-heat is quenched one's thirst, palpitation and insomnia.
Rhizoma Zingiberis: warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant, warming the lung to resolve fluid-retention.Cure mainly coldness and pain in the epigastrium; Vomiting; Have loose bowels, YANG-depletion is fainted inverse; Cold fluid-retention is breathed with cough; Arthralgia due to cold-dampnes.Select the dry rhizome of zingiber Zingiber officinale Rosc..
Radix Codonopsis: invigorating the spleen and replenishing QI, effect of spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.Select the dry root of Campanulaceae Radix Codonopsis Codonopsis pilosula (Franch.) Nannf..
Fructus Lycii: control hepatic and renal YIN deficiency, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, vertigo and tinnitus, impotence and seminal emission, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.Select the dry mature fruit of plant of Solanaceae lycium barbarum Lycium barbarum L..
By the preparation method that above-mentioned each Chinese medicinal components is prepared into compound preparation of the present invention be: take Rhizoma Chuanxiong 15-23 part, Radix Saposhnikoviae 15-23 part, Folium Isatidis 20-30 part, Rhizoma Et Radix Notopterygii 12-18 part, Fructus Schisandrae Chinensis 5-10 part, Rhizoma Zingiberis 5-10 part, Radix Codonopsis 12-18 part and Fructus Lycii 12-18 part, add the water of 10-12 times amount, soak 12h-16h, then decoct three times, first time decocts 1.5-2h, leaches medicinal liquid stand-by; Second time adds the water of 8-10 times amount, decocts 1-1.5h, leaches medicinal liquid stand-by; Add the water of 6-8 times amount for the third time, decoct 0.8-1h, leach medicinal liquid stand-by; Merge three decocting liquids, filter, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1.25-1.35, low-temperature bake 6-8h, and get dry extract powder; By dried cream powder: dextrin is that the weight ratio of 1:1 adds adjuvant, common process is granulated, and is sub-packed in capsule after granulate, uses
60co irradiation bomb irradiation sterilization, obtains Chinese medicine preparation of the present invention.
In addition, two of object of the present invention is to provide the medical usage of this pharmaceutical composition, specifically, the pharmaceutical composition be prepared from by the traditional Chinese medicinal material raw materials of Rhizoma Chuanxiong 15-23 part, Radix Saposhnikoviae 15-23 part, Folium Isatidis 20-30 part, Rhizoma Et Radix Notopterygii 12-18 part, Fructus Schisandrae Chinensis 5-10 part, Rhizoma Zingiberis 5-10 part, Radix Codonopsis 12-18 part and Fructus Lycii 12-18 part is in preparation prevention or the application for the treatment of in migrainous medicine.
The migrainous foothold of medicine composite for curing of the present invention is the allomeric function state of adjustment patient, and using integral idea is treated, both can pain relieving rapidly, again can consolidate curative effect, and untoward reaction is low, and patient medication interdependence is high.
Detailed description of the invention
Be below specific embodiments of the invention, technical scheme of the present invention is done to describing further, but protection scope of the present invention be not limited to these embodiments.Every do not deviate from the present invention's design change or equivalent substituting include within protection scope of the present invention.
The preparation of embodiment 1 Chinese medicine capsules
Crude drug prescription: Rhizoma Chuanxiong 18kg, Radix Saposhnikoviae 18kg, Folium Isatidis 25kg, Rhizoma Et Radix Notopterygii 15kg, Fructus Schisandrae Chinensis 8kg, Rhizoma Zingiberis 8kg, Radix Codonopsis 15kg, Fructus Lycii 15kg.
Preparation technology: the above-mentioned traditional Chinese medicinal material raw materials taking recipe quantity, adds the water of 12 times amount, soaks 15h, then decocts three times, and first time decocts 1.5h, leaches medicinal liquid stand-by; Second time adds the water of 8 times amount, decocts 1h, leaches medicinal liquid stand-by; Add the water of 8 times amount for the third time, decoct 0.8h, leach medicinal liquid stand-by; Merge three decocting liquids, filter, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1.3, low-temperature bake 7h, and get dry extract powder; By dried cream powder: dextrin is that the weight ratio of 1:1 adds adjuvant, common process is granulated, and is sub-packed in capsule after granulate, and every capsules, by the crude drug amount powder charge of 30 grams, is used
60co irradiation bomb irradiation sterilization, obtains capsule preparations.
The preparation of embodiment 2 Chinese medicine capsules
Crude drug prescription: Rhizoma Chuanxiong 15kg, Radix Saposhnikoviae 22kg, Folium Isatidis 29kg, Rhizoma Et Radix Notopterygii 12kg, Fructus Schisandrae Chinensis 10kg, Rhizoma Zingiberis 5kg, Radix Codonopsis 15kg, Fructus Lycii 18kg.
Preparation technology: the above-mentioned traditional Chinese medicinal material raw materials taking recipe quantity, adds the water of 11 times amount, soaks 16h, then decocts three times, and first time decocts 2h, leaches medicinal liquid stand-by; Second time adds the water of 9 times amount, decocts 1.5h, leaches medicinal liquid stand-by; Add the water of 8 times amount for the third time, decoct 1h, leach medicinal liquid stand-by; Merge three decocting liquids, filter, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1.3, low-temperature bake 8h, and get dry extract powder; By dried cream powder: dextrin is that the weight ratio of 1:1 adds adjuvant, common process is granulated, and is sub-packed in capsule after granulate, and every capsules, by the crude drug amount powder charge of 30 grams, is used
60co irradiation bomb irradiation sterilization, obtains capsule preparations.
The preparation of embodiment 3 Chinese medicine capsules
Crude drug prescription: Rhizoma Chuanxiong 23kg, Radix Saposhnikoviae 20kg, Folium Isatidis 20kg, Rhizoma Et Radix Notopterygii 18kg, Fructus Schisandrae Chinensis 5kg, Rhizoma Zingiberis 10kg, Radix Codonopsis 18kg, Fructus Lycii 12kg.
Preparation technology: the above-mentioned traditional Chinese medicinal material raw materials taking recipe quantity, adds the water of 12 times amount, soaks 14h, then decocts three times, and first time decocts 1.5h, leaches medicinal liquid stand-by; Second time adds the water of 9 times amount, decocts 1.2h, leaches medicinal liquid stand-by; Add the water of 8 times amount for the third time, decoct 0.8h, leach medicinal liquid stand-by; Merge three decocting liquids, filter, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1.3, low-temperature bake 7h, and get dry extract powder; By dried cream powder: dextrin is that the weight ratio of 1:1 adds adjuvant, common process is granulated, and is sub-packed in capsule after granulate, and every capsules, by the crude drug amount powder charge of 30 grams, is used
60co irradiation bomb irradiation sterilization, obtains capsule preparations.
Embodiment 4 Chinese medicine is to the observation of curative effect of migraineur
Selection meets " apoplexy cerebropathy therapeutic pandect " (Wang Xinzhi, Han Qunying, Guo Xuefang. apoplexy disease of FU-organ diagnosis and treatment pandect [M], Beijing; Zhong Kun Medical Science Press, 2000; Patient 51 example of migraine diagnostic criteria 795-797), all through cerebral CT scanning, gets rid of organic disease person, the equal recurrent exerbation of patient or persistent headache; Headache attacks and the persistent period different in size, can several minutes to a few days.Be divided into treatment group and matched group at random.Treatment group 26 example, female 17 example, man 9 example, 22 ~ 57 years old age, average 40.2 ± 12.5 years old; The course of disease 0.5 ~ 9 year, average 5.7 ± 3.4 years.Matched group 25 example, female 16 example, man 9 example, 23 ~ 55 years old age, average 39.8 ± 10.9 years old; The course of disease 0.5 ~ 10 year, average 5.9 ± 4.1 years.Two groups of physical data no significant differences (P>0.05), have comparability.
Test group: patient takes capsule prepared by the embodiment of the present invention 1, each 4, every day sooner or later respectively once.Matched group: oral paracetamol tablets 0.3 ~ 0.6g/ time, every day 3 ~ 4 times, 1 consumption per day is no more than 2g.Two groups of patient's equal medication treatment two weeks.
4 grades are divided into: 1. I level: not bitterly with reference to International Headache association criterion; 2. II grade: mild pain, but do not affect activity; 3. III grade: moderate pain, but do not stop action; 4. IV grade: severe pain, can not activity; Clinical efficacy criterion is drafted as follows according to " Chinese medical disease Standardization of diagnosis and curative effect ":
Recovery from illness: headache and simultaneous phenomenon disappear, and follow up a case by regular visits to half a year without recurrence.
Effective: pain intensity alleviates 2 grades, and simultaneous phenomenon alleviates, or attack times or durante dolors reduce more than 2/3;
Effective: pain intensity alleviates 1 grade, or outbreak interval time extend or headache decreased duration less than 2/3;
Invalid: pain intensity alleviates less than 1 grade, or when headache continues, ask that shortening is less than 1/3, or pain increases the weight of, duration extension.
Medication treatment terminate rear statistical result, test group clinical cure rate 42.3%, total effective rate 96.2% all higher than matched group, in table 1.Treatment group adverse reaction rate 15.4%, matched group 64.0%, two groups there were significant differences, in table 2.
Table 1 liang group Clinical efficacy comparison result (example)
Table 2 liang group untoward reaction comparative result (example)