CN108721539A - The preparation method of Chinese medicine composition and its preparation for treating neurogenic disease - Google Patents

The preparation method of Chinese medicine composition and its preparation for treating neurogenic disease Download PDF

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CN108721539A
CN108721539A CN201810774997.4A CN201810774997A CN108721539A CN 108721539 A CN108721539 A CN 108721539A CN 201810774997 A CN201810774997 A CN 201810774997A CN 108721539 A CN108721539 A CN 108721539A
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parts
volatile oil
chinese medicine
radix
medicine composition
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贾振华
魏聪
高怀林
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Shijiazhuang Yiling Pharmaceutical Co Ltd
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Shijiazhuang Yiling Pharmaceutical Co Ltd
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Abstract

The preparation method of Chinese medicine composition and its preparation for treating neurogenic disease belongs to the field of neurogenic disease Chinese medicine treatment, counts in parts by weight, raw material includes 10-80 parts of Radix Astragali, 5-50 parts of asarum, 5-50 parts of Radix Salviae Miltiorrhizae, 5-50 parts of cassia twig, 4-40 parts of smilax, 2-25 parts of Radix Angelicae Sinensis, 3-30 parts of Rhizoma Chuanxiong, 2-20 parts of Chinese ephedra, 3-40 parts of monkshood, 2-25 parts of radix paeoniae rubra, 5-40 parts of the root of bidentate achyranthes, 5-50 parts of rhizoma anemarrhenae.Chinese medicine composition of the present invention can be used for treating diabetic neuropathy, Guillain Barre syndrome, sciatica, peripheral neuritis.

Description

The preparation method of Chinese medicine composition and its preparation for treating neurogenic disease
Technical field
The invention belongs to the fields of neurogenic disease Chinese medicine treatment, are related to the Chinese medicine composition for treating neurogenic disease And its preparation method of preparation.
Background technology
Peripheral neuritis refers to the clinical upper table since poisoning, infection or allergy etc. cause most peripheral nerves to be fallen ill It is now multiple or monistic peripheral nerve paralysis, far-end of limb sensory disturbance, the flaccid paralysis of symmetry or asymmetry The disease of paralysis and vegetative nerve functional disturbance.Any age can fall ill, more with person between twenty and fifty's morbidity.This disease can acute, sub- urgency Property, chronic onset, just distal limbs are numb or spontaneous pain occur for disease, and pain can also have pain in sample or cut sample is burnt The cacesthesias such as allergy or ant row sense, there is picotement in vola when standing or walking.Also there are weakness of limbs, of flaccid muscles or atrophy etc. Disease.Its main pathogenic is 1. to be poisoned：Such as lead arsenic, mercury, phosphorus, XiLin class, the different cigarette side of body, streptomysin, phenytoin, the Changchun of muttering of barking New alkali etc..2. Nutrition and Metabolism obstacle：Such as the shortage of vitamin B complex, diabetes, hypothyroidism, chronic digestible tract disease Deng.3. infecting：Such as acute and chronic infectious diseases, catarrhal jaundice, tuberculosis are in addition, vasculitis, hypertension, artery sclerosis, mistake Quick allergy etc. is also the reason of causing peripheral neuritis.Peripheral neuritis can involve any part of whole body nervous system, Therefore some patientss can disable.Most scholars think that peripheral neuritis pathogenesis may hinder with organism metabolism obstacle, blood supply Hinder and neural malnutrition etc. have it is closely related.After blood supply, dystrophia occur for organism metabolism, Na can be caused+/K+ATP enzyme is lived Property decline, intracellular calcium accumulation and nerve conduction velocity slow down, to induce peripheral neuropathy.
The peripheral neuritis disease one of relatively conventional as nervous system, clinical symptoms include injured nerve dominate range inner sense Feel, motor function exception, western medical treatment is to improve glycolipid metabolism, improve the means such as microcirculation and trophic nerve, however curative effect Not good enough, clinic there is no ideal treatment means.
Peripheral neuritis similar to the scopes such as Chinese medical ' arthralgia syndrome ', " impotence card ", " vessle-Bi symptom-complex ", " meciless ",《Danxi's experiential therapy》It records： " under heat floats on, kidney deficiency by it, the withered thin joint ache of waist-leg."《Xu Mingyi Lei》Meaning：" sufficient knee withers weak, and tiny step is difficult." point out Peripheral neuritis is similar to four limbs or certain limb adynamia, cacesthesia, the clinical symptoms of numb pain.Its cause of disease mostly with deficiency of yang gas It is weak, pass is accumulated in striae of the skin and muscles being loose or the deficiency of Yin, in addition positive unsaturated vapor, tendon and vessel, which is lost, supports, and wind-cold damp pathogen invades human body retardance train of thought, qi and blood It stagnates obstructed and is formed, asthenia in origin and asthenia in superficiality is common.
Sciatica is the stimulation and compressing being led to due to Different types of etiopathogenises, is caused in sciatic nerve access and its distributed area The pain syndrome occurred in domain, for clinical common peripheral nerve disease, pain is more common in outside arm, thigh or shank Then, it is in burn feeling, acupuncture sense or dull pain.Statistics shows that China's sciatica illness rate is up to 121.8/10 ten thousand, and women is sat Osteoneuralgia annual morbidity is 6.5%, and male's annual morbidity is 3%, and female patient Damage coefficient is significantly higher than male patient. Sciatica can be divided into root and dryness sciatica according to pathological change, and researches show that root incidence to be higher than dryness. Human body sciatic nerve starts from the spinal cord of lumbosacral region, is made of the 4th, fifth lumbar nerve and first to third group nerve, this nerve Pelvis is pierced by buttocks, in gluteus maximus deeply towards downlink, through being dropped on the inside of greater trochanter on rear side of thigh, pipe across infrapiriform foramen It manages the feeling of lower limb and dominates movement.Researches show that no matter any reason makes the upper and lower hole of pyriformis become smaller, or the blood vessel passed through Nerve is thicker, can lead to sciatic nerve Outlet of The Pelvic Cavity stenosis syndrome.In addition, in the out of shape and pelvis bone of buttocks sciatic nerve Property structure have close ties, outlet be located at pelvic cavity on the outside of, it is extremely narrow, it is suitable for reading also extremely narrow, passing through greater sciatic foramen When again and a plurality of nervus vasculairs beam go hand in hand, there are the bone and ligament of many extensibility very littles around it, this just becomes The physiological cause of disease of sciatica.
Cause it is most commonly seen with intervertebral disc disorder in the factor of sciatica, it is special due to sciatic nerve anatomical results Property, pathogenesis has following several 1. mechanical pressure theories：Due to directly generating certain mechanical effect to nerve, lead to simultaneously It crosses the blood supply of neurotrosis and generates brief introduction effect, the artery blood flow in certain pressure, nerve root stops, and occurs The transhipment of venous congestion, capillary blood adverse current, the substances such as neurotransmitter and protein is impaired, to induce local nerve branch It is impaired with area's function.2. nerve root inflammation theory：After root compression, unbalanced blood supply and impaired nerve fiber In locally generation inflammatory reaction, various inflammatory factors and regression production are also will produce in the pathological process of mechanical damage and lumber ertebral disc Object, including nitric oxide, interleukin-11, tumor necrosis factor, proteoglycan etc., above-mentioned inflammatory factor once leak outside to interverbebral disc Except can induce the sacrum innervation region pain.3. theory of autoimmunity：Autoimmunity system caused by exposed disc tissue Nerve root inflammation caused by dysfunction of uniting, causes corresponding region pain.
Sciatica is as a kind of syndrome based on sciatic nerve access and its distributed area pain, western modern medicine treatment Aspect is made slow progress.Generally acute stage, lies up, and should lie in bed for etiological treatment, such as lumbar intervertebral disc protrusion people's acute stage Rest.Common analgesics such as brufen (Fenbid), aspirin, aminopyrine, phenylbutazone etc., while assistance application sedative And vitamin medicaments, also there is the report using cortex hormone of aadrenaline, however since side effect is more, and often recur, it needs Carry out Retreatment.Obvious Modern medical therapy cannot be satisfied the requirement of healthcare givers and patient to disease treatment.
Without this name of disease of sciatica in Chinese medicine, but with " sit stern wind " " leg stock wind " and " pain in waist and lower extremities " etc. in ancient literature Symptom seen in disease is similar or identical.Early in《Interior warp》In just about the record of " painful loins and legs " and " lumbar vertebra pain ", to its disease Shape, the rules for the treatment of and therapy are described.《Ling Shu Miraculous Pivot or Divine Axis passages through which vital energy circulates》Described in the urinary bladder channel of foot-Taiyang after being ill caused by " rachiagia, This disease was classified as urinary bladder channel of foot-Taiyang disease at that time and fell to control by severe lumbago as if the lumbar vertebra would break off ".《Plain Questions thorn pain in the back is fallen》Described in：" sufficient TAI YANG pulse makes us Pain in the back draws person's back wind, the back of the body such as weight shape；Few sun makes us pain in the back, as like in acupuncture its skin, follow so cannot pitching, it is not possible to care for； Positive explicit order people pain in the back, it is not possible to care for, the Gu Ruyou persons of opinion, susceptible to sorrow；Foot lacks the moon and makes us pain in the back, pain referring to the interior of the spinal column；It faints the arteries and veins of the moon, makes us Pain in the back, such as draw a bow in waist crossbow string ", it is similar that symptom described above to sciatica pain connects back symptom.In addition《Plain Questions numbness It falls》Described in:" wet three gas of chill is combined into numbness ", it is indicated that its basic pathogenesis is that chill wet three is evil by outer invasion fur, channels and collaterals, makes gas Blood-arthralgia hinders, and perverse trend is gone along channels and collaterals, not general rule pain, induces patient's waist, DOMS weighs.《Standards of Diagnosis and Treatment pain in the back》Call it The cause of disease " have wind, have it is wet, have it is cold, have heat, have the sudden strain of a muscle, have extravasated blood, have the stagnation of the circulation of vital energy, have phlegm product ".《Medical secrets of official》It carries：" the main waist-leg of kidney, Kidney channel is deficient, air-cooled to multiply it, therefore pain in the back ", it is indicated that this disease etiology and pathogenesis is to be caught cold when the positive deficiency of vital energy declines, or occupy long wet Cold ground.In conclusion sciatica morbidity is that tendon and vessel loses and supports cause " pain in waist and lower extremities ", belong to " not Rong Ze pains ", diseases caused by external factors Fleshy exterior is invaded, caused by QI-blood circulation is unsmooth, for " not general rule pain ".
Invention content
The object of the present invention is to provide a kind of preparation sides for treating the Chinese medicine composition and its preparation of neurogenic disease Method, for treating diabetic neuropathy, Guillain Barre syndrome, sciatica, peripheral neuritis.
The present invention be realize its purpose the technical solution adopted is that：
Chinese medicine composition for treating neurogenic disease, is counted in parts by weight, and raw material includes 10-80 parts of Radix Astragali, asarum 5-50 parts, 5-50 parts of Radix Salviae Miltiorrhizae, 5-50 parts of cassia twig, 4-40 parts of smilax, 2-25 parts of Radix Angelicae Sinensis, 3-30 parts of Rhizoma Chuanxiong, 2-20 parts of Chinese ephedra is attached It is 3-40 parts sub-, 2-25 parts of radix paeoniae rubra, 5-40 parts of the root of bidentate achyranthes, 5-50 parts of rhizoma anemarrhenae.
Oral liquor for the Chinese medicine composition for treating neurogenic disease, includes the following steps：
A, prepare raw material described in claim 1, cleaned, processed, obtain batch；
B, above-mentioned batch is added water to cook twice, every time decoct 1-3 hour, extracting solution is filtered, then through centrifuge or It is concentrated after ultrafiltration removal impurity, obtains concentrate；When decoction, it is added 5-10 times and measures water, preferably 8 times are measured, and decocting time is preferred It is 2 hours；
C, add water that oral solution liquid is made above-mentioned concentrate, after filling, through flowing 100 DEG C of steam 20-30min sterilizing, thus obtaining the products Oral solution.
Process for producing granula for the Chinese medicine composition for treating neurogenic disease, includes the following steps：
A, prepare raw material described in claim 1, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil is wrapped up through beta-cyclodextrin；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added water to cook 1-3 times, filter every time, It is mixed with extracting solution obtained by step b, concentrates, is dried to medicinal powder；It is added 5-10 times when decoction and measures water, preferably 8 times amounts, when decoction Between 1-3 hours, preferably 2 hours, decoct number, preferably 2 times, a shift can produce a batch；
D, the volatile oil after package is mixed with dry medicinal powder, and pharmaceutically acceptable auxiliary material, dry obtained particle is added Agent.Auxiliary material used in the present invention be granule often use auxiliary material, preferably, Icing Sugar, dextrin, the optional Aspartame of corrigent, stevioside Deng.
The volatile oil is through beta-cyclodextrin package, by volatile oil, beta-cyclodextrin, water in mass ratio 1:6:80, in 60 DEG C, 0.5h is stirred, stands overnight, discards supernatant liquid, inclusion compound to the no water droplet for filtering lower sediment is extracted out, and inclusion compound is collected, 40 DEG C of low temperature dryings, the volatile oil after being wrapped up.The low temperature drying time is 3-8 hours, preferably 5 hours.
Process for producing granula for the Chinese medicine composition for treating neurogenic disease, includes the following steps：
A, Radix Astragali, Radix Salviae Miltiorrhizae, 70% alcohol reflux of Rhizoma Chuanxiong are extracted three times, every time plus 6 times are measured ethyl alcohol, are extracted 2 hours, filter It crosses, merging filtrate obtains alcohol extract, spare；
B, asarum adds 12 times of amounts of water, steam distillation 4 hours to extract Herba Asari volatile oil；Cassia twig, Radix Angelicae Sinensis add 8 times of amounts of water, water Volatile oil is extracted in steam distillation 6 hours, and volatile oil is mixed with Herba Asari volatile oil, with beta-cyclodextrin inclusion, obtains inclusion complex, steams The another device of aqueous solution after evaporating is collected, and the dregs of a decoction are spare；
C, cassia twig, Radix Angelicae Sinensis are carried to the dregs of a decoction and the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae after oil add decocting It boils three times, every time plus 8 times of amounts of water, decoction 1 hour, collecting decoction, filtration, filtrate merge with the aqueous solution of step B, are concentrated into phase To the clear cream that density is 1.10-1.15 (60 DEG C), add ethyl alcohol to make alcohol content up to 70%, stand overnight, filters, filtrate and step A Alcohol extract merge, recycling ethyl alcohol simultaneously be concentrated into relative density be 1.10-1.15 (60 DEG C) clear cream, spray drying, dry extract Powder is mixed with the inclusion complex of step B, and aspartame, lactose, mixing is added, and dry-pressing is pelletized to get granule.
The volatile oil is through beta-cyclodextrin inclusion, by volatile oil, beta-cyclodextrin, water in mass ratio 1:6:80, in 60 DEG C, stirring 0.5h carries out inclusion, and 40 DEG C of low temperature dryings obtain inclusion complex.
The Chinese medicine composition is in the application on treatment diabetic neuropathy.
The Chinese medicine composition is in the application on treatment Guillain Barre syndrome.
The Chinese medicine composition is in the application in treatment sciatica.
The Chinese medicine composition is in the application in treatment peripheral neuritis.
Preferred embodiment：
Chinese medicine composition for treating neurogenic disease, is counted in parts by weight, and raw material includes 10 parts of Radix Astragali, asarum 50 Part, 5 parts of Radix Salviae Miltiorrhizae, 50 parts of cassia twig, 4 parts of smilax, 25 parts of Radix Angelicae Sinensis, 3 parts of Rhizoma Chuanxiong, 20 parts of Chinese ephedra, 3 parts of monkshood, 25 parts of radix paeoniae rubra, the root of bidentate achyranthes 5 parts, 50 parts of rhizoma anemarrhenae.
Chinese medicine composition for treating neurogenic disease, is counted in parts by weight, raw material include 80 parts of Radix Astragali, 5 parts of asarum, 50 parts of Radix Salviae Miltiorrhizae, 5 parts of cassia twig, 40 parts of smilax, 2 parts of Radix Angelicae Sinensis, 30 parts of Rhizoma Chuanxiong, 2 parts of Chinese ephedra, 40 parts of monkshood, 2 parts of radix paeoniae rubra, the root of bidentate achyranthes 40 Part, 5 parts of rhizoma anemarrhenae.
Chinese medicine composition for treating neurogenic disease, is counted in parts by weight, and raw material includes 50 parts of Radix Astragali, asarum 25 Part, 25 parts of Radix Salviae Miltiorrhizae, 25 parts of cassia twig, 25 parts of smilax, 12.5 parts of Radix Angelicae Sinensis, 20 parts of Rhizoma Chuanxiong, 15 parts of Chinese ephedra, 25 parts of monkshood, radix paeoniae rubra 12.5 parts, 25 parts of the root of bidentate achyranthes, 35 parts of rhizoma anemarrhenae.
Chinese medicine composition for treating neurogenic disease, is counted in parts by weight, and raw material includes 60 parts of Radix Astragali, asarum 15 Part, 20 parts of Radix Salviae Miltiorrhizae, 20 parts of cassia twig, 15 parts of smilax, 10 parts of Radix Angelicae Sinensis, 10 parts of Rhizoma Chuanxiong, 10 parts of Chinese ephedra, 20 parts of monkshood, 10 parts of radix paeoniae rubra, 20 parts of the root of bidentate achyranthes, 25 parts of rhizoma anemarrhenae.
Chinese medicine composition for treating neurogenic disease, is counted in parts by weight, and raw material includes 42 parts of Radix Astragali, asarum 4.5 Part, 12.5 parts of Radix Salviae Miltiorrhizae, 12.5 parts of cassia twig, 21 parts of smilax, 8.5 parts of Radix Angelicae Sinensis, 12.5 parts of Rhizoma Chuanxiong, 8.5 parts of Chinese ephedra, monkshood 12.5 Part, 8.5 parts of radix paeoniae rubra, 21 parts of the root of bidentate achyranthes, 12.5 parts of rhizoma anemarrhenae.
The beneficial effects of the invention are as follows：
Chinese medicine composition of the present invention can be used for treating diabetic neuropathy, Guillain Barre syndrome, sciatica, week Enclose neuritis.
Specific implementation mode
With reference to specific embodiment, the present invention is further illustrated.
One, specific embodiment
Embodiment 1
Bulk pharmaceutical chemicals：Radix Astragali 10g, asarum 50g, Radix Salviae Miltiorrhizae 5g, cassia twig 50g, smilax 4g, Radix Angelicae Sinensis 25g, Rhizoma Chuanxiong 3g, Chinese ephedra 20g, monkshood 3g, radix paeoniae rubra 25g, root of bidentate achyranthes 5g, rhizoma anemarrhenae 50g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, by above-mentioned batch add 8 times amount water, decoct twice, every time decoct 1 hour, extracting solution is filtered, then through from It is concentrated after the heart or ultrafiltration removal impurity, obtains concentrate；
C, add water that oral solution liquid is made above-mentioned concentrate, after filling, through flowing 100 DEG C of steam 20min sterilizing, thus obtaining the product mouths Take liquid.
Embodiment 2
Bulk pharmaceutical chemicals：Radix Astragali 80g, asarum 5g, Radix Salviae Miltiorrhizae 50g, cassia twig 5g, smilax 40g, Radix Angelicae Sinensis 2g, Rhizoma Chuanxiong 30g, Chinese ephedra 2g, Monkshood 40g, radix paeoniae rubra 2g, root of bidentate achyranthes 40g, rhizoma anemarrhenae 5g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, above-mentioned batch is added into 10 times of water amount, decocts twice, decoct 3 hours every time, extracting solution is filtered, then through from It is concentrated after the heart or ultrafiltration removal impurity, obtains concentrate；
C, add water that oral solution liquid is made above-mentioned concentrate, after filling, through flowing 100 DEG C of steam 30min sterilizing, thus obtaining the product mouths Take liquid.
Embodiment 3
Bulk pharmaceutical chemicals：Radix Astragali 50g, asarum 25g, Radix Salviae Miltiorrhizae 25g, cassia twig 25g, smilax 25g, Radix Angelicae Sinensis 12.5g, Rhizoma Chuanxiong 20g, fiber crops Yellow 15g, monkshood 25g, radix paeoniae rubra 12.5g, root of bidentate achyranthes 25g, rhizoma anemarrhenae 35g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil adds beta-cyclodextrin to wrap up；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 5 times of water amount, decocts 3 times, every time 2 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and Icing Sugar, dry obtained granule is added.
Embodiment 4
Bulk pharmaceutical chemicals：Radix Astragali 60g, asarum 15g, Radix Salviae Miltiorrhizae 20g, cassia twig 20g, smilax 15g, Radix Angelicae Sinensis 10g, Rhizoma Chuanxiong 10g, Chinese ephedra 10g, monkshood 20g, radix paeoniae rubra 10g, root of bidentate achyranthes 20g, rhizoma anemarrhenae 25g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil is wrapped up through beta-cyclodextrin；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 8 times of water amount, decocts 2 times, every time 1 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and dextrin, dry obtained granule is added.
Embodiment 5
Bulk pharmaceutical chemicals：Radix Astragali 42g, asarum 4.5g, Radix Salviae Miltiorrhizae 12.5g, cassia twig 12.5g, smilax 21g, Radix Angelicae Sinensis 8.5g, Rhizoma Chuanxiong 12.5g, Chinese ephedra 8.5g, monkshood 12.5g, radix paeoniae rubra 8.5g, root of bidentate achyranthes 21g, rhizoma anemarrhenae 12.5g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil is wrapped up through beta-cyclodextrin；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 10 times of amounts of water, decocted 1 time, 3 is small When, filtering is mixed with extracting solution obtained by step b, is concentrated, is dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and lactose, dry obtained granule is added.
Embodiment 6
Bulk pharmaceutical chemicals：Radix Astragali 20g, asarum 50g, Radix Salviae Miltiorrhizae 5g, cassia twig 50g, smilax 4g, Radix Angelicae Sinensis 25g, Rhizoma Chuanxiong 3g, Chinese ephedra 20g, monkshood 3g, radix paeoniae rubra 25g, root of bidentate achyranthes 5g, rhizoma anemarrhenae 50g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil is wrapped up through beta-cyclodextrin；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 9 times of water amount, decocts 2 times, every time 1 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and glucose, dry obtained granule is added.
Embodiment 7
Bulk pharmaceutical chemicals：Radix Astragali 30g, asarum 5g, Radix Salviae Miltiorrhizae 50g, cassia twig 5g, smilax 4g, Radix Angelicae Sinensis 2g, Rhizoma Chuanxiong 30g, Chinese ephedra 2g, Monkshood 40g, radix paeoniae rubra 2g, root of bidentate achyranthes 40g, rhizoma anemarrhenae 5g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil is wrapped up through beta-cyclodextrin；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 10 times of amounts of water, decocted 1 time, 3 is small When, filtering is mixed with extracting solution obtained by step b, is concentrated, is dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and lactose, dry obtained granule is added.
Embodiment 8
Bulk pharmaceutical chemicals：Radix Astragali 70g, asarum 25g, Radix Salviae Miltiorrhizae 25g, cassia twig 25g, smilax 25g, Radix Angelicae Sinensis 12.5g, Rhizoma Chuanxiong 20g, fiber crops Yellow 15g, monkshood 25g, radix paeoniae rubra 12.5g, root of bidentate achyranthes 25g, rhizoma anemarrhenae 20g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil adds beta-cyclodextrin to wrap up；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 5 times of water amount, decocts 3 times, every time 2 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and Icing Sugar, dry obtained granule is added.
Embodiment 9
Bulk pharmaceutical chemicals：Radix Astragali 35g, asarum 15g, Radix Salviae Miltiorrhizae 20g, cassia twig 20g, smilax 15g, Radix Angelicae Sinensis 10g, Rhizoma Chuanxiong 10g, Chinese ephedra 10g, monkshood 20g, radix paeoniae rubra 10g, root of bidentate achyranthes 20g, rhizoma anemarrhenae 30g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil adds beta-cyclodextrin to wrap up；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 5 times of water amount, decocts 3 times, every time 2 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and Icing Sugar, dry obtained granule is added.
Comparative example 1：
Bulk pharmaceutical chemicals：Radix Astragali 85g, asarum 3g, Radix Salviae Miltiorrhizae 60g, cassia twig 3g, smilax 45g, Radix Angelicae Sinensis 30g, Rhizoma Chuanxiong 35g, Chinese ephedra 1g, monkshood 1g, radix paeoniae rubra 30g, root of bidentate achyranthes 45g, rhizoma anemarrhenae 5g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil adds beta-cyclodextrin to wrap up；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 5 times of water amount, decocts 3 times, every time 2 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and Icing Sugar, dry obtained granule is added.
Comparative example 2：
Bulk pharmaceutical chemicals：Radix Astragali 80g, asarum 45g, Radix Salviae Miltiorrhizae 20g, cassia twig 40g, smilax 10g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 25g, Chinese ephedra 20g, monkshood 40g, radix paeoniae rubra 25g, root of bidentate achyranthes 8g.
Preparation method：
A, prepare above-mentioned raw materials, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil adds beta-cyclodextrin to wrap up；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added into 5 times of water amount, decocts 3 times, every time 2 Hour, it filters, mixed with extracting solution obtained by step b respectively, concentrate, be dried to medicinal powder；
D, the volatile oil after package is mixed with dry medicinal powder, and Icing Sugar, dry obtained granule is added.
Two, clinical test
I, clinical research of the present invention in terms for the treatment of peripheral neuritis
1. data and method
1.1 are in our hospital (Hebei Yi Ling hospitals) medical peripheral neuritis patient in January, 2016~2017 year December Observe object.60 peripheral neuritis patients are filtered out, test group and control group are randomly divided into according to medical sequence, every group 30 Example.Test group male 20, women 10,24~66 years old age, the course of disease 1 month~12 years；Protopathy is glycosuria patient 17, Protopathy is arteritis person 4, and protopathy is Drug reason person 3, and protopathy is rheumatoid arthritis person 3, and protopathy is Athlete's foot 2, protopathy are pellagra 1.Control group male 25, women 5,24~64 years old age, the course of disease 2 months~11 Year, it is 6 months average.Protopathy is glycosuria patient 16, and protopathy is arteritis person 5, and protopathy is Drug reason person 2 Example, protopathy are rheumatoid arthritis person 4, and protopathy is athlete's foot 2, and protopathy is pellagra 1.2 groups of subjects generally provide Expect that comparing difference is not statistically significant, is comparable (P>0.05).
1.2 therapy
1.2.1 (8g/ bags) treatments of granule that test group is prepared using the prescription and method of embodiment 2,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
1.2.2 control group uses conventional therapy, that is, under the premise of giving protopathy treatment, gives trophic nerve and anti-inflammatory control It treats, treats 60 days.
1.3 curative effect determinate standards are fully recovered：Clinical symptoms and sign (symmetry extremity numbness, pain, the feeling of patient's treatment Exception, burning heat sensation, hyperesthesia (feeling in gloves or ankle socks sample), feels decline, anesthesia, Abdeminal pain, just at myrmeciasis Secret, diarrhea, constipation replaces with diarrhea, incontinence of faces, trouble urinating, urine retention, palpitaition, ephidrosis, hypohidrosis, lossless, brothers Ice-cold equal basic disappearance, Electrophysiology detect nerve conduction and restore normal.It is effective：The clinical symptoms and sign of patient's treatment have It is obviously improved, nerve conduction resume speed has increase than before.Effectively：The clinical symptoms and sign of patient's treatment have improvement.Nothing Effect：Its sings and symptoms is not improved after patient's treatment.
1.4 statistical methods are for statistical analysis using SPSS19.0, P<0.05 thinks that examined difference has statistics Meaning.The comparison of curative effect of disease uses rank sum test, carries out two-sided test.
After 2. result treats 4 courses for the treatment of, test group healing 13, effective 10, effective 5, invalid 2, total effective rate It is 93.33%；Control group is cured 8, effective 7, effective 9, invalid 6, total effective rate 80.00%, two groups of curative effect of disease Compare, the statistically significant (P of difference<0.05), test group curative effect is apparently higher than control group.
12 groups of curative effects of table compare (example/%)
Group Number of cases Recovery from illness It is effective Effectively In vain Z/P
Control group 30 8(26.67) 7(23.33) 9(30.00) 6(20.00) -2.027/0.043
Test group 30 13(43.33) 10(33.33) 5(16.67) 2(6.67)
II, the present invention are in the clinical research for treating Guillain-Barre syndrome
1. data and method
1.1 actue infectious polyradiculoneuritis (GBS) reconvalescents to be gone to a doctor in our hospital in January, 2016~2017 year December To observe object.60 actue infectious polyradiculoneuritis (GBS) reconvalescents are filtered out, experiment is randomly divided into according to medical sequence Group and control group, every group 30.Test group male 27, women 3,23~65 years old age, the course of disease 1 month~1 year are average 5.8 months.Control group male 25, women 5,24~64 years old age, the course of disease 2 months~1 year are 6 months average.2 groups tested Person's general information comparing difference is not statistically significant, is comparable (P>0.05).
1.2 diagnostic criteria are formulated with reference to Barolac diagnostic criteria：1. progressive myasthenia was up to 2 months or more, in symmetry Limb or lower limb myasthenia, tendon reflex weaken or disappear.Polyneuropathy caused by other causes of disease except 2..3. electrophysiologic study: Nerve conduction velocity is slack-off, and at least 2 motorial conduction of velocity are less than normal 70% or less.4. cerebrospinal fluid protein > 0.45g/L。
1.3 therapy
1.3.1 (8g/ bags) treatments of granule that test group is prepared using the prescription and method of embodiment 3,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
1.3.2 control group uses conventional therapy, treats 60 days, and conventional therapy uses trophic nerve, anti-inflammatory and symptomatic treatment.
1.4 curative effect determinate standards are cured：Freely, four limbs tendon reflex is normal by patient activity；Subjective sensation abnormal disappearance, needle thorn Feel that decline disappears or level declines；III grade of muscular strength or more；Electromyogram shows no obvious abnormalities change；Cerebrospinal fluid protein is normal.It is effective： Freely, four limbs tendon reflex is normal by patient activity；Subjective sensation abnormal disappearance, needle thorn feel that decline disappears or level declines；Muscular strength III Grade or more；Electromyogram has partial nerve kinaesthesis delayed conduction to be no more than mean value 20%；Cerebrospinal fluid protein is normal.Effectively：Suffer from Person's four limbs and body thousand, which are slightly got better, to be turned, and for muscular strength generally at 3 grades hereinafter, four limbs tendon reflex is low, electromyogram has partial nerve kinaesthesis Delayed conduction is more than mean value 20%, and cerebrospinal fluid protein is normal.In vain：Patient activity does not improve, and four limbs tendon reflex is low, electromyogram Kinaesthesis nerve conduction velocity does not improve compared with electromyographic data of paying a home visit, and cerebrospinal fluid protein is normal or critical.
1.5 statistical methods are for statistical analysis using SPSS19.0, P<0.05 thinks that examined difference has statistics Meaning.The comparison of curative effect of disease uses rank sum test, carries out two-sided test.
2. as a result, treatment 4 courses for the treatment of after, test group cure 3, effective 12, effective 12, invalid 3, total effective rate It is 90.0%；Control group is cured 1, effective 7, effective 14, invalid 8, total effective rate 73.3%, two groups of curative effect of disease ratios Compared with the statistically significant (P of difference<0.05), test group curative effect is apparently higher than control group.
22 groups of curative effects of table compare (example/%)
Group Number of cases Recovery from illness It is effective Effectively In vain Z/P
Control group 30 3(10.00) 12(40.00) 12(40.00) 3(10.00) -2.150/0.032
Test group 30 1(3.33) 7(23.33) 14(46.67) 8(26.67)
Three, effect of the present invention to rat experimental autoimmune nerve inflammation
Actue infectious polyradiculoneuritis (GBS) is also known as acute inflammatory demyelinating polyneuropathy, be with peripheral nerve and The inflammatory reaction of the demyelinate and thin vessels peripheral lymphocyte and macrophage of nerve root is the autoimmunity disease of pathological characteristic Disease.It is similar to mankind GBS in the clinical manifestation of experimental autoimmune neuritis, pathogenesis, it is the reason of generally acknowledged research GBS Think animal model.This experiment observes Chinese medicine composition of the present invention by making rat experimental autoimmune nerve inflammation model The neuritic effect of granules of rats experimental autoimmune.
1. materials and methods
1.1 animals and grouping：Lewis rats, male, 200-220g, 36, purchased from Beijing dimension tonneau China experimental animal technology Co., Ltd.Rat is randomly divided into：Normal group, model group, tested group of group (are prepared according to the prescription and method of embodiment 5 Granule, metering：12g/kg, QD groups are calculated according to crude drug amount), every group 12.Model group and rats in normal control group are given Equivalent distilled water.
1.2 modelings and administration：The double 200 μ l antigens emulsions of hind leg subplantar injection of rat (contain 200 μ g peripheral nerve myelin sheath antigens P0180-199Polypeptide, 1.5mgH37Ra tubercle bacilluses, 100 μ l 0.1mol/L phosphate buffers and 100 μ l complete Freund's adjuvants, It is mixed into water-in-oil emulsion with pin type homogenizer).Start on the day of modeling to carry out gastric infusion to each group animal, continuous 15 days.
1.3 signs score：0 grade:It is without exception；1 grade:Tail portion tension reduces；2 grades:Tail paralysis, righting reflex excalation；3 Grade:Righting reflex lacks；4 grades:Ataxic gait, posture are abnormal；5 grades:Hind leg paresis；6 grades:Moderate is paralysed；7 grades:Hind leg is serious Paralysis；8 grades:Quadriplegia；9 grades:It is dying；10 grades:It is dead.
1.4HE dyeing:Rat is put to death, sciatic nerve is immediately disconnected, carries out HE dyeing, calculates the average inflammation in 5 visuals field Property cell number.
1.5 flow cytomery INF- γ, Th17：Rat is put to death, inguinal lymph nodes is taken, prepares the single core of lymph node Cell suspension, flow cytomery INF- γ, Th17 are horizontal.
1.6ELISA detects antibody:Rat is put to death, cardiac blood, centrifuging and taking serum, by P0 are left and taken180-199Polypeptide is dissolved in coating Liquid is added the confining liquid containing 10% fetal calf serum and is incubated, the rabbit-anti anti-rat IgG antibody of biotin labeling is added, horseradish is added afterwards The Streptavidin of peroxidase labelling, after terminating reaction, microplate reader measures, and is as a result indicated with OD value.
1.7 statistical method：All data mean ± standard deviationIt indicates.Using SPSS statistical packages, T is carried out It examines.
2 results
The variation of 2.1 signs scoring：Compared with model group, the initial disease time of QD groups is obviously prolonged (P<0.01)；QD groups Peak period scoring is substantially reduced (P<0.01).It is shown in Table 3.
The comparison of 3 each group sign of table scoring
Compared with model group：△△P<0.01
The variation of 2.2 sciatic nerve inflammatory cells：Compared with Normal group, model group number of inflammatory cells apparent increase (P <0.01), compared with model group, QD group number of inflammatory cells is remarkably decreased (P<0.01).
The comparison of 4 each group inflammatory cell of table
Note：Compared with Normal group：**P<0.01；Compared with model group：△△P<0.01。
The variation of 2.3INF- γ, Th17 level：Compared with Normal group, the horizontal apparent liter of model group INF- γ, Th17 Height (P<0.01), compared with model group, QD groups INF- γ, Th17 levels are remarkably decreased (P<0.01).
The comparison of table 5 each group INF- γ, Th17 levels
Note：Compared with Normal group：**P<0.01；Compared with model group：△△P<0.01。
2.4P0180-199The variation of antibody：Compared with Normal group, model group OD value apparent increases (P<0.01), with mould Type group compares, and QD group OD values are remarkably decreased (P<0.01).
The comparison of 6 each group OD values of table
Note：Compared with Normal group：**P<0.01；Compared with model group：△△P<0.01。
3 conclusions
QD particles (being exactly granule medicament group of the present invention) can mitigate experimental autoimmune neuritis clinical symptoms, subtract Few sciatic nerve inflammatory cellular infiltration,
Reduce INF- γ, Th17 and anti-P0180-199The generation of antibody shows that QD particles have treatment Guillain Barre synthesis The potentiality of sign.
Four, the effect of granules of rats sciatica of the present invention
Inflammatory reaction is combined by chronic constriction injury of sciatic nerve (CCI) model with mechanical pain, with clinical nerve Pain symptom is similar, it has also become the classical model of peripheral nerve pain.This experiment is by making rat sciatic nerve CCI modelings Rat sciatic nerve pain, observes the effect of QD granules in rats sciatica.
1. materials and methods
1.1 animals and grouping：SD rats, male, 200-220g, have purchased from Beijing dimension tonneau China experimental animal technology by 48 Limit company.Rat is randomly divided into：Sham-operation group, model group, QD particle groups (prepared according to the prescription and method of embodiment 6 Granula, metering：According to crude drug amount calculate 12g/kg, QD groups), positive drug Fenbid group, every group 12.QD particles by Shijiazhuang with Ridge medicine company limited liability company provides, and positive drug group gives Fenbid, and model group and rats in sham-operated group give equivalent distilled water.
1.2 modelings and administration：Every animal gives 2% yellow Jackets (3m L/kg) anesthesia, cuts off right lower extremity skin Skin successively detaches, and finds out sciatic nerve trunk, carries out 4 ligation to it, per pass ligation be spaced about 1mm (ligation degree with Muscle around notch exposure generates subject to slight, of short duration twitch), it is sutured later.The only exposure of sham-operation group animal is sat Bone is neural but does not ligature.Modeling starts to carry out gastric infusion to each group animal on the 8th day, removes Fenbid group animal successive administration 5d, Interval 2d be administered once it is outer, remaining each group animal 1 time a day, successive administration 28d.
1.3 thermal hyperalgesias measure：Rat is put into the organic glass grid of radiant heat shouting pain instrument, it is big with strong illumination Skin in the middle part of mouse sole, measures the paw withdrawal incubation period of rat, is surveyed 1 time every 10min, takes the average value conduct of 3 measurement results Measurement result.To prevent rat sole from being scalded by heat radiation, preclinical upper limit value is set to 30s.
1.4 pathologic finding：Take sciatic nerve, HE dyeing, light microscopic observation pathological change.
1.5 statistical method
All data are indicated with mean ± standard deviation (x ± s).Using SPSS statistical packages, T inspections are carried out.
2 results
The preclinical variation of 2.1 paw withdrawals：Compared with sham-operation group, model group incubation period is obviously shortened (P<0.01)；It is positive For medicine group compared with model group, incubation period obviously rises (P<0.01)；QD groups incubation period compared with model group obviously rises (P< 0.01).It is shown in Table 7.
The preclinical comparison of 7 each group of table
Note：Compared with sham-operation group：**P<0.01；Compared with model group：△△P<0.01。
2.2 pathological change：Interstitial and nerve fibre structure are complete around sham-operation group animal sciatic nerve, marshalling； Visible majority vacuole in the equal visible cell matter of model group animal, Cell nuclei spreads are irregular, and visible many mast cells, to sit Bone nerve vacuolar degeneration.Compared with model group, administration group sciatic nerve oedema, vacuolar degeneration degree reduce.
3 conclusions
QD granules in rats sciatica has therapeutic effect.
Five, contrast test 1：The clinical drug clinical trial that drug prepared by comparative example 1 is prepared with embodiment 3
Both I compares the clinical efficacy of peripheral neuritis
1. data and method
1.1 are seen in June, 2015~2016 year August in the medical peripheral neuritis patient of our hospital (Hebei Yi Ling hospitals) Examine object.60 peripheral neuritis patients are filtered out, test group and control group are randomly divided into according to medical sequence, every group 30. Test group male 21, women 9,27~68 years old age, the course of disease 1 month~12 years；Protopathy is glycosuria patient 9, primary Disease is arteritis person 2, and protopathy is Drug reason person 15, and protopathy is rheumatoid arthritis person 1, and protopathy is tinea pedis Disease 2, protopathy are pellagra 1.Control group male 24, women 6,24~71 years old age, the course of disease 2 months~11 years.It is former Morbidity is glycosuria patient 8, and protopathy is arteritis person 3, and protopathy is Drug reason person 13, and protopathy is rheumatoid Arthritis person 2, and protopathy is athlete's foot 2, and protopathy is pellagra 2.2 groups of subject's general information comparing differences are without statistics Meaning is comparable (P>0.05).
1.2 therapy
1.2.1 (8g/ bags) treatments of granule that test group is prepared using the prescription and method of embodiment 3,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
1.2.2 (8g/ bags) treatments of granule that control group is prepared using the prescription and method of comparative example 1,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
Under the premise of two groups are given protopathy treatment, trophic nerve and anti-inflammatory treatment are given.
1.3 curative effect determinate standards are fully recovered：Clinical symptoms and sign (symmetry extremity numbness, pain, the feeling of patient's treatment Exception, burning heat sensation, hyperesthesia (feeling in gloves or ankle socks sample), feels decline, anesthesia, Abdeminal pain, just at myrmeciasis Secret, diarrhea, constipation replaces with diarrhea, incontinence of faces, trouble urinating, urine retention, palpitaition, ephidrosis, hypohidrosis, lossless, brothers Ice-cold equal basic disappearance, Electrophysiology detect nerve conduction and restore normal.It is effective：The clinical symptoms and sign of patient's treatment have It is obviously improved, nerve conduction resume speed has increase than before.Effectively：The clinical symptoms and sign of patient's treatment have improvement.Nothing Effect：Its sings and symptoms is not improved after patient's treatment.
1.4 statistical methods are for statistical analysis using SPSS19.0, P<0.05 thinks that examined difference has statistics Meaning.The comparison of curative effect of disease uses rank sum test, carries out two-sided test.
After 2. result treats 4 courses for the treatment of, test group healing 14, effective 11, effective 2, invalid 3, total effective rate It is 90.00%；Control group cures 7, and effective 6, effective 6, invalid 11, total effective rate 63.33%, two groups of diseases are treated Effect compares, the statistically significant (P of difference<0.05), test group curative effect is apparently higher than control group.
82 groups of curative effects of table compare (example/%)
Group Number of cases Recovery from illness It is effective Effectively In vain
Test group 30 14(46.67) 11(36.67) 2(6.67) 3(10.00)
Control group 30 7(23.33) 6(20.00) 6(20.00) 11(36.67)
II, the two are in the Clinical efficacy comparison for treating Guillain-Barre syndrome
1. data and method
1.1 are in medical actue infectious polyradiculoneuritis (GBS) reconvalescent of our hospital in July, 2014~2018 year January Observe object.60 actue infectious polyradiculoneuritis (GBS) reconvalescents are filtered out, test group is randomly divided into according to medical sequence And control group, every group 30.Test group male 25, women 5,24~68 years old age, the course of disease 1 month~1 year, average 5.6 A month.Control group male 27, women 3,24~66 years old age, the course of disease 2 months~1 year are 6.1 months average.2 groups of subjects General information comparing difference is not statistically significant, is comparable (P>0.05).
1.2 diagnostic criteria are formulated with reference to Barolac diagnostic criteria：1. progressive myasthenia was up to 2 months or more, in symmetry Limb or lower limb myasthenia, tendon reflex weaken or disappear.Polyneuropathy caused by other causes of disease except 2..3. electrophysiologic study: Nerve conduction velocity is slack-off, at least 2 motorial conduction of velocity less than normal 70% with.4. cerebrospinal fluid protein > 0.45g/ L。
1.3 therapy
1.3.1 (8g/ bags) treatments of granule that test group is prepared using the prescription and method of embodiment 3,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
1.3.2 (8g/ bags) treatments of granule that control group is prepared using the prescription and method of comparative example 1,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
Two groups are carried out at the same time conventional therapy, using trophic nerve, anti-inflammatory and symptomatic treatment.
1.4 curative effect determinate standards are cured：Freely, four limbs tendon reflex is normal by patient activity；Subjective sensation abnormal disappearance, needle thorn Feel that decline disappears or level declines；III grade of muscular strength or more；Electromyogram shows no obvious abnormalities change；Cerebrospinal fluid protein is normal.It is effective： Freely, four limbs tendon reflex is normal by patient activity；Subjective sensation abnormal disappearance, needle thorn feel that decline disappears or level declines；Muscular strength III Grade or more；Electromyogram has partial nerve kinaesthesis delayed conduction to be no more than mean value 20%；Cerebrospinal fluid protein is normal.Effectively：Suffer from Person's four limbs and body thousand, which are slightly got better, to be turned, and for muscular strength generally at 3 grades hereinafter, four limbs tendon reflex is low, electromyogram has partial nerve kinaesthesis Delayed conduction is more than mean value 20%, and cerebrospinal fluid protein is normal.In vain：Patient activity does not improve, and four limbs tendon reflex is low, electromyogram Kinaesthesis nerve conduction velocity does not improve compared with electromyographic data of paying a home visit, and cerebrospinal fluid protein is normal or critical.
1.5 statistical methods are for statistical analysis using SPSS19.0, P<0.05 thinks that examined difference has statistics Meaning.The comparison of curative effect of disease uses rank sum test, carries out two-sided test.
2. as a result, treatment 4 courses for the treatment of after, test group cure 4, effective 15, effective 9, invalid 2, total effective rate It is 90.0%；Control group healing 2, effective 6, effective 7, invalid 15, total effective rate 50%, two groups of curative effect of disease ratios Compared with the statistically significant (P of difference<0.05), test group curative effect is apparently higher than control group.
92 groups of curative effects of table compare (example/%)
Group Number of cases Recovery from illness It is effective Effectively In vain
Experimental group 30 4(13.33) 15(50.00) 9(30.00) 2(10.00)
Control group 30 2(6.67) 6(20.00) 7(23.33) 15(50.00)
Six, contrast test 2：The clinical drug clinical trial that drug prepared by comparative example 2 is prepared with embodiment 3
Both I compares the clinical efficacy of peripheral neuritis
1. data and method
1.1 are in our hospital (Hebei Yi Ling hospitals) medical peripheral neuritis patient in September, 2014~2015 year October Observe object.60 peripheral neuritis patients are filtered out, test group and control group are randomly divided into according to medical sequence, every group 30 Example.Test group male 22, women 8,27~61 years old age, the course of disease 1 month~11 years；Protopathy is glycosuria patient 13, Protopathy is arteritis person 3, and protopathy is Drug reason person 10, and protopathy is rheumatoid arthritis person 1, and protopathy is Athlete's foot 2, protopathy are pellagra 1.Control group male 23, women 7,26~63 years old age, the course of disease 2 months~12 Year.Protopathy is glycosuria patient 10, and protopathy is arteritis person 2, and protopathy is Drug reason person 11, and protopathy is Rheumatoid arthritis person 2, protopathy are athlete's foot 3, and protopathy is pellagra 2.2 groups of subject's general information comparing differences without Statistical significance is comparable (P>0.05).
1.2 therapy
1.2.1 (8g/ bags) treatments of granule that test group is prepared using the prescription and method of embodiment 3,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
1.2.2 (8g/ bags) treatments of granule that control group is prepared using the prescription and method of comparative example 2,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
Under the premise of two groups are given protopathy treatment, trophic nerve and anti-inflammatory treatment are given.
1.3 curative effect determinate standards are fully recovered：Clinical symptoms and sign (symmetry extremity numbness, pain, the feeling of patient's treatment Exception, burning heat sensation, hyperesthesia (feeling in gloves or ankle socks sample), feels decline, anesthesia, Abdeminal pain, just at myrmeciasis Secret, diarrhea, constipation replaces with diarrhea, incontinence of faces, trouble urinating, urine retention, palpitaition, ephidrosis, hypohidrosis, lossless, brothers Ice-cold equal basic disappearance, Electrophysiology detect nerve conduction and restore normal.It is effective：The clinical symptoms and sign of patient's treatment have It is obviously improved, nerve conduction resume speed has increase than before.Effectively：The clinical symptoms and sign of patient's treatment have improvement.Nothing Effect：Its sings and symptoms is not improved after patient's treatment.
1.4 statistical methods are for statistical analysis using SPSS19.0, P<0.05 thinks that examined difference has statistics Meaning.The comparison of curative effect of disease uses rank sum test, carries out two-sided test.
2. after result treats 4 courses for the treatment of, test group cures 15, and effective 8, effective 3, invalid 4, total effective rate is 86.67%；Control group healing 8, effective 4, effective 6, invalid 12, total effective rate 60.00%, two groups of curative effect of disease Compare, the statistically significant (P of difference<0.05), test group curative effect is apparently higher than control group.
10 2 groups of curative effects of table compare (example/%)
II, the two are in the Clinical efficacy comparison for treating Guillain-Barre syndrome
1. data and method
1.1 actue infectious polyradiculoneuritis (GBS) reconvalescents to be gone to a doctor in our hospital in June, 2014~2017 year December To observe object.60 actue infectious polyradiculoneuritis (GBS) reconvalescents are filtered out, experiment is randomly divided into according to medical sequence Group and control group, every group 30.Test group male 22, women 8,28~71 years old age, the course of disease 1 month~3 years are average 6.7 months.Control group male 25, women 5,26~70 years old age, the course of disease 2 months~3.5 years are 7.0 months average.2 groups Subject's general information comparing difference is not statistically significant, is comparable (P>0.05).
1.2 diagnostic criteria are formulated with reference to Barolac diagnostic criteria：1. progressive myasthenia was up to 2 months or more, in symmetry Limb or lower limb myasthenia, tendon reflex weaken or disappear.Polyneuropathy caused by other causes of disease except 2..3. electrophysiologic study: Nerve conduction velocity is slack-off, at least 2 motorial conduction of velocity less than normal 70% with.4. cerebrospinal fluid protein > 0.45g/ L。
1.3 therapy
1.3.1 (8g/ bags) treatments of granule that test group is prepared using the prescription and method of embodiment 3,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
1.3.2 (8g/ bags) treatments of granule that control group is prepared using the prescription and method of comparative example 2,3 times a day, often Secondary 1 bag, 15 days as a treatment course, treatment cycle is 4 courses for the treatment of.
Two groups are carried out at the same time conventional therapy, using trophic nerve, anti-inflammatory and symptomatic treatment.
1.4 curative effect determinate standards are cured：Freely, four limbs tendon reflex is normal by patient activity；Subjective sensation abnormal disappearance, needle thorn Feel that decline disappears or level declines；III grade of muscular strength or more；Electromyogram shows no obvious abnormalities change；Cerebrospinal fluid protein is normal.It is effective： Freely, four limbs tendon reflex is normal by patient activity；Subjective sensation abnormal disappearance, needle thorn feel that decline disappears or level declines；Muscular strength III Grade or more；Electromyogram has partial nerve kinaesthesis delayed conduction to be no more than mean value 20%；Cerebrospinal fluid protein is normal.Effectively：Suffer from Person's four limbs and body thousand, which are slightly got better, to be turned, and for muscular strength generally at 3 grades hereinafter, four limbs tendon reflex is low, electromyogram has partial nerve kinaesthesis Delayed conduction is more than mean value 20%, and cerebrospinal fluid protein is normal.In vain：Patient activity does not improve, and four limbs tendon reflex is low, electromyogram Kinaesthesis nerve conduction velocity does not improve compared with electromyographic data of paying a home visit, and cerebrospinal fluid protein is normal or critical.
1.5 statistical methods are for statistical analysis using SPSS19.0, P<0.05 thinks that examined difference has statistics Meaning.The comparison of curative effect of disease uses rank sum test, carries out two-sided test.
2. as a result, treatment 4 courses for the treatment of after, test group cure 5, effective 12, effective 10, invalid 3, total effective rate It is 90.0%；Control group cures 2, and effective 8, effective 6, invalid 14, total effective rate 53.33%, two groups of diseases are treated Effect compares, the statistically significant (P of difference<0.05), test group curative effect is apparently higher than control group.
11 2 groups of curative effects of table compare (example/%)
Group Number of cases Recovery from illness It is effective Effectively In vain
Experimental group 30 5(16.67) 12(40.00) 10(33.33) 3(10.00)
Control group 30 2(6.67) 8(26.67) 6(20.00) 14(46.67)

Claims (10)

1. the Chinese medicine composition for treating neurogenic disease, which is characterized in that count in parts by weight, raw material includes Radix Astragali 10- 80 parts, 5-50 parts of asarum, 5-50 parts of Radix Salviae Miltiorrhizae, 5-50 parts of cassia twig, 4-40 parts of smilax, 2-25 parts of Radix Angelicae Sinensis, 3-30 parts of Rhizoma Chuanxiong, Chinese ephedra 2-20 parts, 3-40 parts of monkshood, 2-25 parts of radix paeoniae rubra, 5-40 parts of the root of bidentate achyranthes, 5-50 parts of rhizoma anemarrhenae.
2. the oral liquor as described in claim 1 for treating the Chinese medicine composition of neurogenic disease, feature It is, includes the following steps：
A, prepare raw material described in claim 1, cleaned, processed, obtain batch；
B, above-mentioned batch is added water to cook twice, decocts 1-3 hours every time, extracting solution is filtered, then through centrifugation or ultrafiltration It is concentrated after removal impurity, obtains concentrate；
C, add water that oral solution liquid is made above-mentioned concentrate, it is oral through 100 DEG C of steam 20-30min sterilizing, thus obtaining the products of stream after filling Liquid.
3. the process for producing granula as described in claim 1 for treating the Chinese medicine composition of neurogenic disease, feature It is, includes the following steps：
A, prepare raw material described in claim 1, cleaned, processed, obtain batch；
B, asarum, cassia twig Radix Angelicae Sinensis, Rhizoma Chuanxiong are extracted into volatile oil, extracting solution is spare, and volatile oil is wrapped up through beta-cyclodextrin；
C, Radix Astragali, the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae are added water to cook 1-3 times, every time filtering and step Extracting solution mixing, concentrates, is dried to medicinal powder obtained by rapid b；
D, the volatile oil after package is mixed with dry medicinal powder, and pharmaceutically acceptable auxiliary material, dry obtained granule is added.
4. the process for producing granula according to claim 3 for treating the Chinese medicine composition of neurogenic disease, special Sign is that the volatile oil is through beta-cyclodextrin package, by volatile oil, beta-cyclodextrin, water in mass ratio 1:6:80, in 60 DEG C, 0.5h is stirred, stands overnight, discards supernatant liquid, inclusion compound to the no water droplet for filtering lower sediment is extracted out, and inclusion compound is collected, 40 DEG C of low temperature dryings, the volatile oil after being wrapped up.
5. the process for producing granula as described in claim 1 for treating the Chinese medicine composition of neurogenic disease, feature It is, includes the following steps：
A, Radix Astragali, Radix Salviae Miltiorrhizae, 70% alcohol reflux of Rhizoma Chuanxiong are extracted three times, every time plus 6 times are measured ethyl alcohol, are extracted 2 hours, filtration, Merging filtrate obtains alcohol extract, spare；
B, asarum adds 12 times of amounts of water, steam distillation 4 hours to extract Herba Asari volatile oil；Cassia twig, Radix Angelicae Sinensis add 8 times of amounts of water, vapor Volatile oil is extracted in distillation 6 hours, and volatile oil is mixed with Herba Asari volatile oil, with beta-cyclodextrin inclusion, inclusion complex is obtained, after distillation The another device of aqueous solution collect, the dregs of a decoction are spare；
C, cassia twig, Radix Angelicae Sinensis are carried to the dregs of a decoction and the root of bidentate achyranthes, Radix Salviae Miltiorrhizae, upper Poria cocos, radix paeoniae rubra, Chinese ephedra, monkshood, rhizoma anemarrhenae after oil add water to cook three Secondary, every time plus 8 times of amounts of water, decoction 1 hour, collecting decoction, filtration, filtrate merge with the aqueous solution of step B, are concentrated into relatively close Degree is the clear cream of 1.10-1.15 (60 DEG C), adds ethyl alcohol to make alcohol content up to 70%, stands overnight, and is filtered, the alcohol of filtrate and step A Extract merge, recycling ethyl alcohol simultaneously be concentrated into relative density be 1.10-1.15 (60 DEG C) clear cream, spray drying, dry extract with The inclusion complex of step B mixes, and aspartame, lactose, mixing is added, and dry-pressing is pelletized to get granule.
6. the process for producing granula according to claim 5 for treating the Chinese medicine composition of neurogenic disease, special Sign is that the volatile oil is through beta-cyclodextrin inclusion, by volatile oil, beta-cyclodextrin, water in mass ratio 1:6:80, in 60 DEG C, stirring 0.5h carries out inclusion, and 40 DEG C of low temperature dryings obtain inclusion complex.
7. Chinese medicine composition as described in claim 1 is in the application on treatment diabetic neuropathy.
8. Chinese medicine composition as described in claim 1 is in the application on treatment Guillain Barre syndrome.
9. Chinese medicine composition as described in claim 1 is in the application in treatment sciatica.
10. Chinese medicine composition as described in claim 1 is in the application in treatment peripheral neuritis.
CN201810774997.4A 2018-07-16 2018-07-16 The preparation method of Chinese medicine composition and its preparation for treating neurogenic disease Pending CN108721539A (en)

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CN113813330A (en) * 2021-10-03 2021-12-21 王钢柱 Industrial preparation method of traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy and product thereof

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Application publication date: 20181102