CN104524247B - One treats migrainous medical composition and its use - Google Patents

Abstract

The invention belongs to medical art, be specifically related to one and treat migrainous pharmaceutical composition and purposes.Described pharmaceutical composition comprises following component: Poria, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae, Rhizoma Cyperi, Bulbus Fritillariae Thunbergii, Radix Saposhnikoviae, Semen Sinapis Albae, Flos Magnoliae, Radix Glycyrrhizae.The present invention is pure pharmaceutical composition, reasonable recipe, dialectical administration, and disturbing type migraine on turbid for migraine especially expectorant has good curative effect.

Description

One treats migrainous medical composition and its use

Technical field

The invention belongs to medical art, be specifically related to one and treat migrainous medical composition and its use.

Background technology

Migraine is one of common disease of Neurology Department, and its feature is easily recurrence, and stage of attack is painful large, and even pain is difficult to stand.The traditional Chinese medical science is referred to as " headache " " wind syndrome of head " " headache due to upward adverse flow of channel-QI ".In the traditional Chinese medical science, wind syndrome of head is by excessive rising of liver-YANG, phlegm and blood stasis and cause clear YANG failing to ascend, or turbid pathogen is violated, YANG-orifices failing to be nourished, take cephalic pain as the disease of main manifestations.Modern Western medicine treatment easily produces dependence, and side effect is obvious, mostly can not receive good therapeutic effect clinically.Use Chinese traditional treatment, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, effectively can overcome the untoward reaction that Western medicine causes, have good researching value and practical significance.

Summary of the invention

The invention provides and a kind ofly treat migrainous new pharmaceutical composition, overcome the deficiency of Chinese and western medicine preparation in the past, disturbing type migraine on turbid to expectorant has good curative effect, and has no side effect.Described pharmaceutical composition is obtained by following raw material: Poria, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae, Rhizoma Cyperi, Bulbus Fritillariae Thunbergii, Flos Magnoliae, Radix Glycyrrhizae.

Preferably, described pharmaceutical composition also comprises Radix Saposhnikoviae and Semen Sinapis Albae.

The technical scheme adopted for solving its technical problem is the migrainous pharmaceutical composition of described treatment, be made up of the medicine of following weight: Poria 15-20 part, Rhizoma Pinelliae 10-20 part, Pericarpium Citri Reticulatae 10-20 part, Rhizoma Chuanxiong 5-15 part, Rhizoma Gastrodiae 15-25 part, Radix Angelicae Dahuricae 8-12 part, Rhizoma Cyperi 8-12 part, Bulbus Fritillariae Thunbergii 15-20 part, Flos Magnoliae 5-10 part, Radix Glycyrrhizae 1-6 part.

Preferably, described pharmaceutical composition also comprises the medicine of following weight: Radix Saposhnikoviae 15-20 part and Semen Sinapis Albae 5-15 part.

Most preferred technique scheme of the present invention is, described pharmaceutical composition of the present invention, is obtained by the raw material of following weight portion: 18 parts, Poria, the Rhizoma Pinelliae 15 parts, Pericarpium Citri Reticulatae 15 parts, Rhizoma Chuanxiong 10 parts, 20 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 10 parts, Rhizoma Cyperi 10 parts, Bulbus Fritillariae Thunbergii 18 parts, Radix Saposhnikoviae 18 parts, Semen Sinapis Albae 10 parts, Flos Magnoliae 8 parts, 3 parts, Radix Glycyrrhizae.

Present invention also offers the preparation method of described pharmaceutical composition, after specifically comprising the steps: the raw material Poria of above-mentioned weight portion, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae, Rhizoma Cyperi, Bulbus Fritillariae Thunbergii, Radix Saposhnikoviae, Semen Sinapis Albae, Flos Magnoliae, Radix Glycyrrhizae to pulverize respectively, add the water of 3 times amount of medical material gross weight, filter after decocting 90min, and concentrate filtrate to thick paste, crushed after being dried.

Those skilled in the art directly can be used as medicine on obtained active constituents of medicine basis of the present invention to use or add on pharmaceutics acceptable adjuvant routinely technique be prepared into required preparation.Preferably, pharmaceutical composition of the present invention conveniently preparation technology be prepared into tablet or capsule.Described tablet, is after being pulverized by active component and microcrystalline Cellulose, hydroxypropyl cellulose mix, and add 2% polyvidone alcoholic solution soft material, cross 20 mesh sieves and granulate, dry, add magnesium stearate, 20 mesh sieve granulate, mixing, tabletting, to obtain final product.

The present invention also asks to protect aforementioned pharmaceutical compositions particularly on preparation treatment expectorant is turbid, to disturb purposes in type migraine remedy in preparation treatment migraine.Known by clinical trial, cure 31 examples (68.9%) in the routine clinical patients for the treatment of group 45, effective 9 examples (20%), effective 3 examples (6.67%), invalid 2 examples (4.44%), total effective rate 95.6%; 10 examples (22.2%) are cured, effective 14 examples (31.1%), effective 8 examples (17.8%), invalid 13 examples (28.9%), total effective rate 71.1% in the routine clinical patients of matched group 45.Between two groups, total effective rate compares, and difference has statistical significance (P < 0.05).In treatment group therapeutic process, vital sign steadily and without serious adverse reactions such as allergy, treatment terminates the indexs such as the rear routine blood test to the routine patient for the treatment of group 45, routine urinalysis, stool routine examination, excrement occult blood, Liver and kidney merit and carries out statistical procedures, shows no obvious abnormalities.Result shows that the clinical application of we is safely and effectively, and relapse rate is low, is worth studying and applying further.

Pharmaceutical composition of the present invention, described Poria is sweet, light, flat.GUIXIN, lung, spleen, kidney channel.Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.

The Rhizoma Pinelliae, pungent, temperature; Poisonous.Return spleen, stomach, lung meridian.Drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.For abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, syncope due to accumulation of phlegm is had a headache, vomiting regurgitation, and breast gastral cavity painful abdominal mass is vexed, globus hystericus; Raw with external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is used for stopping nausea and vomiting by lowering the adverse flow of QI.

Pericarpium Citri Reticulatae, bitter, pungent, temperature.Return lung, spleen channel.Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.

Rhizoma Chuanxiong, pungent, temperature.Return liver, gallbladder, pericardium channel.Blood-activating and qi-promoting, wind-expelling pain-stopping.For menoxenia, amenorrhea dysmenorrhea ， mass in the abdomen is suffered from abdominal pain, the twinge of the breast side of body, tumbling and swelling, headache, rheumatic arthralgia.

Rhizoma Gastrodiae, sweet; Pungent; Flat; Nontoxic.Liver; Spleen; Kidney; Gallbladder; The heart; Urinary bladder channel.Endogenous wind stopping relieving convulsion; Suppressing the hyperactive liver sun; Dispelling wind and removing obstruction in the collateral.Main anxious chronic infantile convulsion; Tic contracture; Dizzy; Headache; Hemiplegia; Limb fiber crops; Rheumatic arthralgia.

The Radix Angelicae Dahuricae, pungent, temperature.Return stomach, large intestine, lung meridian.Loose wind dehumidifying, understand things pain-stopping, detumescence and apocenosis.For headache due to common cold, supraorbital bone pain, nasal obstruction, nasal sinusitis, toothache, leucorrhea, skin infection swells and ache.

Rhizoma Cyperi, pungent, micro-hardship, micro-sweet, flat.Return liver, spleen, tri-jiao channel.Promoting QI circulation for relieving depression, menstruction regulating and pain relieving.For stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, dyspepsia, breast gastral cavity painful abdominal mass is vexed, and colic of cold type is suffered from abdominal pain, distending pain of the breast, menoxenia, amenorrhea dysmenorrhea.

Bulbus Fritillariae Thunbergii is bitter, cold.Return lung, heart channel.Heat clearing away eliminating stagnation, preventing phlegm from forming and stopping coughing, for wind-heat invading the lung, phlegm-fire cough, lung abscess, acute mastitis, scrofula, sore.

Flos Magnoliae, pungent, temperature.Attach to the lung and stomach meridians.Dispersing wind and cold, clearing the nasal passage.For headche due to wind-cold, nasal obstruction, nasal sinusitis, turbid nasal discharge.

Radix Glycyrrhizae, sweet, flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.

Radix Saposhnikoviae, acrid, sweet, warm.Return bladder, liver, spleen channel.Inducing diaphoresis to dispel wind, victory is wet, relieving convulsion.For headache due to common cold, rheumatic arthralgia, rubella pruritus, tetanus.

Semen Sinapis Albae, pungent; Temperature.Lung; Liver; Spleen; Stomach; Pericardium channel.Reduce phlegm by drink; Mass dissipating and swelling eliminating.Main cough with asthma abundant expectoration; Fullness in the chest and hypochondriac pain; Numb limbs and tense tendons; Arthralgia; Multiple abscess caused by damp-phlegm; Carbuncle of yin nature toxic swelling.

In side of the present invention, Rhizoma Pinelliae merit is apt to expelling phlegm and resolving turbidity, normalizing the stomach by guiding QI downward; Bulbus Fritillariae Thunbergii removing heat-phlegm, the Radix Angelicae Dahuricae, Pericarpium Citri Reticulatae are regulated the flow of vital energy dampness and reducing phlegm, and help the Rhizoma Pinelliae to eliminate the phlegm altogether; Flos Magnoliae cold expelling is sensible, liter reaches clearing heat in QI system, and Poria invigorating the spleen and benefiting QI eliminating dampness by diuresis, to control the source of producing phlegm; Rhizoma Chuanxiong, Rhizoma Gastrodiae, Radix Saposhnikoviae can and blood suppressing the hyperactive liver, relieving spasm by subduing liver-wind; Rhizoma Cyperi, Semen Sinapis Albae blood circulation promoting and dispersing pathogen accumulation, wind-expelling pain-stopping; Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, for making medicine.Pharmaceutical composition reasonable recipe of the present invention, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, all medicines share, and can make phlegm-damp and have a headache only, thus effectively cure migraine particularly expectorant turbid on disturb type migraine pain disorders.Through clinical practice checking, its determined curative effect, mild in medicine property and, do not occur toxic and side effects and untoward reaction, safety coefficient is high, and relapse rate is low, and clinical observation total effective rate reaches more than 95%.

Detailed description of the invention

Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.

Embodiment 1

The each raw material of the present invention is taken: 18 parts, Poria, the Rhizoma Pinelliae 15 parts, Pericarpium Citri Reticulatae 15 parts, Rhizoma Chuanxiong 10 parts, 20 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 10 parts, Rhizoma Cyperi 10 parts, Bulbus Fritillariae Thunbergii 18 parts, Radix Saposhnikoviae 18 parts, Semen Sinapis Albae 10 parts, Flos Magnoliae 8 parts, 3 parts, Radix Glycyrrhizae by following weight portion.

Preparation technology is as follows:

After the raw material Poria of above-mentioned weight portion, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae, Rhizoma Cyperi, Bulbus Fritillariae Thunbergii, Radix Saposhnikoviae, Semen Sinapis Albae, Flos Magnoliae, Radix Glycyrrhizae are pulverized respectively, add the water of 3 times amount of medical material gross weight, filter after decocting 90minn, and concentrate filtrate to thick paste, crushed after being dried.Those skilled in the art directly can be used as medicine and be used or mix with appropriate microcrystalline Cellulose, hydroxypropyl cellulose on this basis, add 2% polyvidone alcoholic solution soft material, cross 20 mesh sieves and granulate, drying, adds magnesium stearate, 20 mesh sieve granulate, mixing, tabletting, to obtain final product.

When using medicine composite for curing migraine of the present invention, take prepared tablet, every sheet, containing crude drug amount 0.2g, every day 3 times, each 3, is taken after meal half an hour.

Embodiment 2

The each raw material of the present invention is taken: 15 parts, Poria, the Rhizoma Pinelliae 10 parts, Pericarpium Citri Reticulatae 10 parts, Rhizoma Chuanxiong 5 parts, 15 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 8 parts, Rhizoma Cyperi 8 parts, Bulbus Fritillariae Thunbergii 15 parts, Radix Saposhnikoviae 15 parts, Semen Sinapis Albae 5 parts, Flos Magnoliae 5 parts, 1 part, Radix Glycyrrhizae by following weight portion.

Preparation technology is with embodiment 1.

Embodiment 3

The each raw material of the present invention is taken: 20 parts, Poria, the Rhizoma Pinelliae 20 parts, Pericarpium Citri Reticulatae 20 parts, Rhizoma Chuanxiong 15 parts, 25 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 12 parts, Rhizoma Cyperi 12 parts, Bulbus Fritillariae Thunbergii 20 parts, Radix Saposhnikoviae 20 parts, Semen Sinapis Albae 15 parts, Flos Magnoliae 10 parts, 6 parts, Radix Glycyrrhizae by following weight portion.

Preparation technology is with embodiment 1.

Embodiment 4

The each raw material of the present invention is taken: 15 parts, Poria, the Rhizoma Pinelliae 10 parts, Pericarpium Citri Reticulatae 20 parts, Rhizoma Chuanxiong 15 parts, 15 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 8 parts, Rhizoma Cyperi 12 parts, Bulbus Fritillariae Thunbergii 20 parts, Radix Saposhnikoviae 15 parts, Semen Sinapis Albae 5 parts, Flos Magnoliae 10 parts, 6 parts, Radix Glycyrrhizae by following weight portion.

Preparation technology is with embodiment 1.

Embodiment 5

The each raw material of the present invention is taken: 20 parts, Poria, the Rhizoma Pinelliae 20 parts, Pericarpium Citri Reticulatae 10 parts, Rhizoma Chuanxiong 5 parts, 25 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 12 parts, Rhizoma Cyperi 8 parts, Bulbus Fritillariae Thunbergii 15 parts, Radix Saposhnikoviae 20 parts, Semen Sinapis Albae 15 parts, Flos Magnoliae 5 parts, 1 part, Radix Glycyrrhizae by following weight portion.

Preparation technology is with embodiment 1.

The migrainous clinical observation of embodiment 6 medicine composite for curing of the present invention

1, case-data: select hospital ward and outpatient clinic meet expectorant turbid on disturb type migraineur 90 example, be divided into treatment group, matched group at random.

Wherein, treatment group: in 45 routine patients, man 20 example, female 25 example; The oldest 60 years old, minimum 21 years old, 43 years old mean age; Course of disease 6-14 month; II grade of 13 example, III grade of 25 example, IV grade of 7 example.

Matched group: in 45 routine patients, man 19 example, female 26 example; The oldest 60 years old, minimum 20 years old, 42 years old mean age; Course of disease 5-13 month; II grade of 15 example, III grade of 25 example, IV grade of 5 example.

The physical data there was no significant differences such as two groups of Genders, age, courses of disease, have comparability.

2, diagnosis basis:

(1) tcm diagnosis standard:

1) having a headache, position is many pushes up on head side volume temporo, forehead, top, or left or right tosses about in bed outbreak, or in full headache.The character of headache mostly is jumping pain, twinge, distending pain, confused pain, dull pain, or headache is as split.Sustainable several minutes of each outbreak of headache, a few hours, a couple of days, the person that also has continued for several weeks;

2) hiddenly attack onset, increase the weight of gradually or recurrent exerbation;

3) should have a blood test routine, measuring blood pressure, does that waist is worn, bone is worn, electroencephalogram if desired.Do the inspections such as transcranial doppler, CT, magnetic resonance when having ready conditions, with the cause of disease of clearly having a headache, get rid of organic disease.

(2) expectorant turbid on disturb disease CM syndrome differentiation criterion: have a headache swollen heavy, or hold concurrently dizzy.Gastral cavity uncomfortable in chest is swollen, lack of appetite of feeling sick, and abundant expectoration is sticky white.White and greasy fur, stringy and rolling pulse.

(3) Western medicine diagnose standard: with reference to the diagnostic criteria (absence of aura (plain edition) migraine or have (typical case) migraine of tendency) of International Headache association ICHD-II in 2004.

(4) pain intensity classification:

I grade: not bitterly.

II grade: mild pain, normal activity is unaffected.

III grade: moderate pain, affect normal activity, but can activity be proceeded.

IV grade: severe pain, any activity can not be engaged in, even fear activity.

3, case standard is included in:

(1) age 18-60 year, male or female;

(2) Western medicine diagnose standard is met;

(3) tcm diagnosis standard and syndrome CM syndrome differentiation criterion is met;

(4) average monthly >=2 times of medical front Headache attacks;

(5) enter to organize the Chinese medicine not taking pain relieving within the last week or Western medicine and use other Analgesic techniques person;

(6) clinical observation " Informed Consent Form " is signed.

4, Excluded cases standard:

(1) clinical observation " Informed Consent Form " is not signed;

(2) gestation or women breast-feeding their children;

(3) drug allergy or can not resistance to receptor is used to this research;

(4) severe pulmonary insufficiency is merged, the severe primary diseases such as liver, kidney and hemopoietic system, psychotic;

(5) age is under-18s or more than 60 years old person.

5, case standard is rejected:

(1) rear discovery is included in exclusion standard disease patient;

(2) headache that infectivity, toxic, intracranial mass lesion, cerebrovascular malformation and diseases of the five sense organs etc. cause is got rid of;

(3) migraine of specific type, as types such as ocular type migraine, hemiplegia type migraine;

(4) case of medication is not specified by testing program;

(5) drug administration process data logging is incomplete, cannot judge curative effect person.

6, to come off and termination criteria:

(1) observe in patient exit voluntarily, person lost to follow-up;

(2) there is the person that should not continue reception test such as complication or special physiological change in experimenter;

(3) serious adverse reaction occurs person in test, should stop clinical trial in time.

Come off and answer itemized record reason with the case stopped, and the switching of its last curative effect testing result is added up for final result.

7, usage and dosage:

Treatment group: take medicine composite for curing of the present invention, tablet prepared by Example 1, every sheet containing crude drug amount 0.2g, every day 3 times, each 3, after meal half an hour warm water delivery service.

Matched group: YANSUAN FUGUILIQIN JIAONANG (the accurate word H10930003 of traditional Chinese medicines) 5mg, 1 time/d, per os hora somni.

Taking continuously for two groups 7 days is 1 course for the treatment of, observe the curative effect after 2 courses for the treatment of.

8, curative effect determinate standard:

(1) cure: headache and companion's disease disappear;

(2) effective: headache intensity alleviates 2 grades, simultaneous phenomenon alleviates, durante dolors or attack times reduce more than 2/3;

(3) effective: headache intensity alleviates 1 grade, outbreak prolongation interval time or headache decreased duration are less than 2/3;

(4) invalid: headache intensity alleviate less than 1 grade, headache increase the weight of or decreased duration of having a headache less than 1/3, duration extension.

9, therapeutic effect:

In observation process, treatment group comes off 1 routine case, and matched group comes off 2 routine cases, and with invalid statistics curative effect, all the other all complete clinical observation.Treatment group efficacy result is as follows: clinical cure 31 example (68.9%), effective 9 examples (20%), effective 3 examples (6.67%), invalid 2 examples (4.44%), total effective rate 95.6%; Matched group clinical cure 10 example (22.2%), effective 14 examples (31.1%), effective 8 examples (17.8%), invalid 13 examples (28.9%), total effective rate 71.1%.Between two groups, total effective rate compares, and difference has statistical significance (P < 0.05).

In treatment group therapeutic process, vital sign steadily and without serious adverse reactions such as allergy, treatment terminates the indexs such as the rear routine blood test to the routine patient for the treatment of group 45, routine urinalysis, stool routine examination, excrement occult blood, Liver and kidney merit and carries out statistical procedures, shows no obvious abnormalities.Result shows that the clinical application of we is safely and effectively, and relapse rate is low, is worth studying and applying further.

Claims (5)

1. the migrainous pharmaceutical composition for the treatment of, it is characterized in that, it is obtained by the raw material of following weight portion: Poria 15-20 part, Rhizoma Pinelliae 10-20 part, Pericarpium Citri Reticulatae 10-20 part, Rhizoma Chuanxiong 5-15 part, Rhizoma Gastrodiae 15-25 part, Radix Angelicae Dahuricae 8-12 part, Rhizoma Cyperi 8-12 part, Bulbus Fritillariae Thunbergii 15-20 part, Radix Saposhnikoviae 15-20 part, Semen Sinapis Albae 5-15 part, Flos Magnoliae 5-10 part, Radix Glycyrrhizae 1-6 part.

2. pharmaceutical composition as claimed in claim 1, it is characterized in that, it is obtained by the raw material of following weight portion: 18 parts, Poria, the Rhizoma Pinelliae 15 parts, Pericarpium Citri Reticulatae 15 parts, Rhizoma Chuanxiong 10 parts, 20 parts, Rhizoma Gastrodiae, the Radix Angelicae Dahuricae 10 parts, Rhizoma Cyperi 10 parts, Bulbus Fritillariae Thunbergii 18 parts, Radix Saposhnikoviae 18 parts, Semen Sinapis Albae 10 parts, Flos Magnoliae 8 parts, 3 parts, Radix Glycyrrhizae.

3. pharmaceutical composition as claimed in claim 1 or 2, it is characterized in that, described pharmaceutical composition is oral formulations.

4. pharmaceutical composition as claimed in claim 3, it is characterized in that, described oral formulations is tablet or capsule.

5. pharmaceutical composition as claimed in claim 1 or 2 disturbs the purposes in type migraine remedy on preparation treatment expectorant is turbid.