CN108904656A - The pharmaceutical composition and its preparation method and application for treating cervical spondylosis or lumbar vertebra disease - Google Patents
The pharmaceutical composition and its preparation method and application for treating cervical spondylosis or lumbar vertebra disease Download PDFInfo
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- CN108904656A CN108904656A CN201811181450.XA CN201811181450A CN108904656A CN 108904656 A CN108904656 A CN 108904656A CN 201811181450 A CN201811181450 A CN 201811181450A CN 108904656 A CN108904656 A CN 108904656A
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A61K36/88—Liliopsida (monocotyledons)
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Abstract
The invention discloses a kind of for treating the pharmaceutical composition and its preparation method and application of cervical spondylosis or lumbar vertebra disease.Pharmaceutical composition of the invention is by including that the bulk pharmaceutical chemicals of following component are made：8~15 parts by weight of ramulus mori, 8~15 parts by weight of rhizoma cibotii, 6~10 parts by weight of Fructus Liquidambaris, 3~6 parts by weight of radix achyranthis bidentatae, 3~6 parts by weight of lycopodium calvatum, 2.5~5 parts by weight of Rhizoma Chuanxiong, 2.5~5 parts by weight of the root of Chinese clematis, 2~5 parts by weight of great burdock achene, 2~5 parts by weight of Radix Paeoniae Alba, 2~5 parts by weight of pueraria lobata, 2~5 parts by weight of ramulus cinnamomi, 2~5 parts by weight of Rhizoma Et Radix Notopterygii, 2~5 parts by weight of pawpaw, 2~5 parts by weight of arisaema cum bile, 2~5 parts by weight of safflower, 1.5~3 parts by weight of olibanum, 1~2.5 parts by weight of 1.5~3 parts by weight of myrrh and Radix Glycyrrhizae.Pharmaceutical composition of the invention has the function of good treatment cervical spondylosis or lumbar vertebra disease.
Description
Technical field
The present invention relates to a kind of pharmaceutical compositions for treating cervical spondylosis or lumbar vertebra disease, further relate to the preparation of the pharmaceutical composition
Method and purposes.
Background technique
There are many something in commons in terms of pathogenesis, pathophysiology, clinical manifestation for cervical spondylosis and lumbar vertebra disease.Cervical spondylosis is
Refer to that intervertebral disc of cervical vertebra degenerative change and its secondary adjacent structure pathological change involve structures surrounding (nerve, blood vessel etc.)
And there is the disease of clinical manifestation corresponding with Imageology.Cervical pain, numb limb, inability are mainly facing for cervical spondylosis
Bed symptom.Lumbar vertebra disease refers to because of backbone and backbone surrounding soft tissue acute and chronic injury or Lumbar Intervertebral Disc Degeneration, lumbar vertebrae hyperosteogeny
Etc. caused by reasons, clinically show as using pain in the loins, waist limitation of activity and pain in waist and lower extremities as the disease of cardinal symptom.Lumbar vertebra disease
The concept of a broad sense, clinically cover " waist soft tissue injury, waist myofascitis, lumbar degenerative osteoarthropathy,
The illness such as No.3 vertebral transverse process syndrome, the protrasion of the lumbar intervertebral disci, acute lumbar muscle sprain, piriformis syndrome, tuberculosis of lumbar spine ".
It is disclosed application No. is 201510331716.4 Chinese patent application and a kind of treats qi depression to blood stasis and cold solidifying resistance network
The Chinese medicine of the type protrasion of the lumbar intervertebral disci, with activating microcirculation and removing stasis medicinal dredging collateral and for expelling wind and cold pathogens, promoting qi circulation and relieving pain is that principle treats qi depression to blood stasis
And the Chinese medicine of the cold solidifying resistance network type protrasion of the lumbar intervertebral disci, the raw material composition of effective component：Rhizoma cibotii, teasel root, the root of Chinese clematis, corydalis tuber, solely
It is living, Fructus Liquidambaris, Cortex Eucommiae, Rhizoma Chuanxiong, lycopodium calvatum, ramulus mori, lopseed, gentianae macrophyllae, pawpaw, herba taxilli, radix achyranthis bidentatae, wilsonii, Radix Paeoniae Alba, meat
Osmanthus, Radix Glycyrrhizae.Application No. is the Chinese patent applications of 201110262361.X to disclose a kind of Chinese medicinal pill for treating cervical spondylosis, by
The bulk pharmaceutical chemicals of following weight parts are made：Rhizoma cibotii 10, rhizoma dioscoreae nipponicae 8, Fructus Liquidambaris 8, Caulis Spatholobi 8, cortex cinnamomi 10, ramulus mori 12, radix cyathulae 10,
Luffa 6, lycopodium calvatum 8, Radix Paeoniae Alba 6, peach kernel 8, ginger 5, jujube 12, the root of Chinese clematis 8 and honey 10.These pharmaceutical compositions need long-term
It takes, works relatively slow.
Therefore, one kind is needed safely and effectively, and rapid-action Chinese medicine composition.
Summary of the invention
The first object of the present invention is to provide a kind of pharmaceutical composition, with good treatment cervical spondylosis or lumbar vertebra disease
Effect, and it is rapid-action.
The second object of the present invention is to provide the preparation method of described pharmaceutical composition.
The third object of the present invention is to provide a kind of pharmaceutical preparation for treating cervical spondylosis or lumbar vertebra disease effect.
The fourth object of the present invention is to provide the preparation method of the pharmaceutical preparation.
The fifth object of the present invention is to provide the pharmaceutical applications of described pharmaceutical composition.
The purpose of the present invention is what is be achieved through the following technical solutions.
On the one hand, the present invention provides a kind of for treating the pharmaceutical composition of cervical spondylosis or lumbar vertebra disease, by including as follows
The bulk pharmaceutical chemicals of component are made：
8~15 parts by weight of ramulus mori, 6~10 parts by weight of Fructus Liquidambaris, 3~6 parts by weight of radix achyranthis bidentatae, stretch muscle at 8~15 parts by weight of rhizoma cibotii
Careless 3~6 parts by weight, 2.5~5 parts by weight of Rhizoma Chuanxiong, 2.5~5 parts by weight of the root of Chinese clematis, 2~5 parts by weight of great burdock achene, 2~5 weight of Radix Paeoniae Alba
Measure part, 2~5 parts by weight of pueraria lobata, 2~5 parts by weight of ramulus cinnamomi, 2~5 parts by weight of Rhizoma Et Radix Notopterygii, 2~5 parts by weight of pawpaw, 2~5 weight of arisaema cum bile
Measure part, 2~5 parts by weight of safflower, 1~2.5 parts by weight of 1.5~3 parts by weight of olibanum, 1.5~3 parts by weight of myrrh and Radix Glycyrrhizae.
On the other hand, the present invention also provides the preparation methods of described pharmaceutical composition.
The preferred preparation method of the first of pharmaceutical composition according to the present invention, includes the following steps：
(1) by the ramulus mori, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae, lycopodium calvatum, Rhizoma Chuanxiong, the root of Chinese clematis, great burdock achene, Radix Paeoniae Alba, pueraria lobata, osmanthus
Branch, Rhizoma Et Radix Notopterygii, pawpaw, arisaema cum bile, safflower, olibanum, myrrh and Radix Glycyrrhizae mixing, use water as solvent extraction, obtain extracting solution；
(2) extracting solution is concentrated, is dry, pulverize, obtain described pharmaceutical composition.
The preferred preparation method of second of pharmaceutical composition according to the present invention, includes the following steps：
(1 ') pulverising step：The Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile are crushed, mixed powder is obtained；
(2 ') extraction step：By the olibanum, myrrh, great burdock achene, Radix Paeoniae Alba, ramulus mori, pueraria lobata, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae,
Lycopodium calvatum, the root of Chinese clematis, pawpaw and Radix Glycyrrhizae are mixed to get mixture, and water is added as solvent in the mixture and is extracted, is obtained
To extracting solution；
(3 ') concentration step：The extracting solution is subjected to concentration, obtains concentrate；
(4 ') mixing step：The mixed powder is uniformly mixed with the concentrate, dry, pulverize, obtain the medicine
Compositions.
In described second preferred preparation method, it is preferable that in step (1 '), the partial size of the mixed powder is 65
~100 mesh.
In described second preferred preparation method, it is preferable that in step (2 '), before extraction, the mixture
It is soaked in water 15~60 minutes；The method of extraction is heating and refluxing extraction method, and extraction time is 1~4 time, and each extraction time is
0.5~2 hour, each amount of water was 2~8 times of the mixture weight.
In described second preferred preparation method, it is preferable that in step (3 '), thickening temperature is 90~99 DEG C, dense
The vacuum degree of contracting is -0.05~-0.1MPa.
In another aspect, the present invention provide it is a kind of for treating the pharmaceutical preparation of cervical spondylosis or lumbar vertebra disease comprising it is above-mentioned
Pharmaceutical composition.
Pharmaceutical preparation according to the present invention, it is preferable that the pharmaceutical preparation is granule comprising said medicine combination
Object, further includes glucose, starch and crospovidone, and described pharmaceutical composition, the weight ratio of grape sugar and starch be 0.8~
1.2:0.5~0.7:0.25~0.5；The weight of the crospovidone is described pharmaceutical composition, grape sugar and starch gross weight
2~5wt% of amount.
The present invention also provides a kind of preparation methods of said medicine preparation, include the following steps：
It A. is 0.8~1.2 according to weight ratio by described pharmaceutical composition, glucose and starch:0.5~0.7:0.25~
0.5 is uniformly mixed, and obtains the first mixture；
B. first mixture is uniformly mixed with crospovidone, obtains the second mixture；Wherein, the crosslinking is poly-
The weight for tieing up ketone is 2~5wt% of the mixture weight；
C. the ethanol water that the second mixture concentration is 40~50vol% is pelletized, whole grain is dried, obtained
Particle；Particle dries 48h or more under ventilation state；
D., the particle is dried to water content at 60~70 DEG C lower than 6wt%, obtains dried material, sterilized, packaging,
Obtain the granule.
Another aspect, the present invention provide the use that aforementioned pharmaceutical compositions are used to prepare the drug for the treatment of cervical spondylosis or lumbar vertebra disease
On the way.
Pharmaceutical composition of the invention treatment cervical spondylosis or lumbar vertebra disease in terms of have good effect, drug safety, and
It is rapid-action.
Specific embodiment
The present invention is further illustrated combined with specific embodiments below, but protection scope of the present invention is not limited to
This.
< pharmaceutical composition >
Pharmaceutical composition of the invention is by including that the bulk pharmaceutical chemicals of following component are made：
8~15 parts by weight of ramulus mori, 6~10 parts by weight of Fructus Liquidambaris, 3~6 parts by weight of radix achyranthis bidentatae, stretch muscle at 8~15 parts by weight of rhizoma cibotii
Careless 3~6 parts by weight, 2.5~5 parts by weight of Rhizoma Chuanxiong, 2.5~5 parts by weight of the root of Chinese clematis, 2~5 parts by weight of great burdock achene, 2~5 weight of Radix Paeoniae Alba
Measure part, 2~5 parts by weight of pueraria lobata, 2~5 parts by weight of ramulus cinnamomi, 2~5 parts by weight of Rhizoma Et Radix Notopterygii, 2~5 parts by weight of pawpaw, 2~5 weight of arisaema cum bile
Measure part, 2~5 parts by weight of safflower, 1~2.5 parts by weight of 1.5~3 parts by weight of olibanum, 1.5~3 parts by weight of myrrh and Radix Glycyrrhizae.
In the present invention, it is preferable that described pharmaceutical composition is by including that the bulk pharmaceutical chemicals of following component are made：
9~12 parts by weight of ramulus mori, 7~9 parts by weight of Fructus Liquidambaris, 4.5~5 parts by weight of radix achyranthis bidentatae, are stretched at 9~12 parts by weight of rhizoma cibotii
4.5~5 parts by weight of muscle grass, 3~3.6 parts by weight of Rhizoma Chuanxiong, 3~3.6 parts by weight of the root of Chinese clematis, 3~3.6 parts by weight of great burdock achene, Radix Paeoniae Alba 3
~3.6 parts by weight, 2~3 parts by weight of pueraria lobata, 2~3 parts by weight of ramulus cinnamomi, 2~3 parts by weight of Rhizoma Et Radix Notopterygii, 2~3 parts by weight of pawpaw, gallbladder south
2~3 parts by weight of star, 2~3 parts by weight of safflower, 1.6~2.5 parts by weight of olibanum, 1.6~2.5 parts by weight of myrrh and Radix Glycyrrhizae 1~1.5
Parts by weight.
In the present invention, it is highly preferred that described pharmaceutical composition is by including that the bulk pharmaceutical chemicals of following component are made：
9 parts by weight of ramulus mori, 9 parts by weight of rhizoma cibotii, 7.5 parts by weight of Fructus Liquidambaris, 4.5 parts by weight of radix achyranthis bidentatae, 4.5 weight of lycopodium calvatum
Part, 3.6 parts by weight of Rhizoma Chuanxiong, 3.6 parts by weight of the root of Chinese clematis, 3 parts by weight of great burdock achene, 3 parts by weight of raw Radix Paeoniae Alba, 3 parts by weight of pueraria lobata, ramulus cinnamomi
3 parts by weight, 3 parts by weight of Rhizoma Et Radix Notopterygii, 3 parts by weight of pawpaw, 3 parts by weight of arisaema cum bile, 3 parts by weight of safflower, 2.4 parts by weight of stir-baked OLIBANUM, toast
1.5 parts by weight of 2.4 parts by weight of myrrh and Radix Glycyrrhizae；Or
9 parts by weight of ramulus mori, 9 parts by weight of rhizoma cibotii, 9 parts by weight of Fructus Liquidambaris, 4.5 parts by weight of radix achyranthis bidentatae, 4.5 parts by weight of lycopodium calvatum,
3.6 parts by weight of Rhizoma Chuanxiong, 3.6 parts by weight of the root of Chinese clematis, 3 parts by weight of great burdock achene, 3 parts by weight of raw Radix Paeoniae Alba, 3 parts by weight of pueraria lobata, 3 weight of ramulus cinnamomi
Measure part, 3 parts by weight of Rhizoma Et Radix Notopterygii, 2.7 parts by weight of pawpaw, 2.7 parts by weight of arisaema cum bile, 2.7 parts by weight of safflower, 2.1 parts by weight of stir-baked OLIBANUM,
1.5 parts by weight of 2.1 parts by weight of stir-baked MYRRHA with vinegar and Radix Glycyrrhizae；Or
12 parts by weight of ramulus mori, 9 parts by weight of rhizoma cibotii, 7.5 parts by weight of Fructus Liquidambaris, 4.5 parts by weight of radix achyranthis bidentatae, 4.5 weight of lycopodium calvatum
Part, 3.6 parts by weight of Rhizoma Chuanxiong, 3.6 parts by weight of the root of Chinese clematis, 3 parts by weight of great burdock achene, 3 parts by weight of raw Radix Paeoniae Alba, 3 parts by weight of pueraria lobata, ramulus cinnamomi
3 parts by weight, 3 parts by weight of Rhizoma Et Radix Notopterygii, 3 parts by weight of pawpaw, 3 parts by weight of arisaema cum bile, 3 parts by weight of safflower, 1.8 parts by weight of stir-baked OLIBANUM, toast
1.2 parts by weight of 1.8 parts by weight of myrrh and Radix Glycyrrhizae.
In the present invention, it is preferable that the medicinal active ingredient of described pharmaceutical composition is only made of said components, weight proportion
As described above；The medicinal active ingredient of described pharmaceutical composition and do not include other components.
In the present invention, it is preferable that the olibanum is stir-baked OLIBANUM, and the myrrh is stir-baked MYRRHA with vinegar, and the Radix Paeoniae Alba is made a living Radix Paeoniae Alba.
Ramulus mori：Bitter, micro-pungent, it is mild-natured；Return liver, lung channel；Clearing heat and expelling damp dredging collateral；For beriberoid pyretic arthralgia, extremities joint pain；
Main function is dispelling wind and removing obstruction in the meridians；Rheumatic Bi syndrome is cured mainly, and is suitable for upper limb numbness pain especially.
Rhizoma cibotii：It is bitter, sweet, it is warm-natured；There is the effect of wind-damp dispelling, nourishing liver and kidney, strong waist and knee；For rheumatic arthralgia, waist and knee acid
It is soft, weakness of the lower extremities.
Fructus Liquidambaris：Bitter, it is mild-natured；There are dispelling, collateral-activating, Li Shui, the effect of promoting menstruation；For arthralgia, numb spasm, water
Swelling is full, and cream is few, menostasis.
Radix achyranthis bidentatae：It is bitter, sweet, sour, it is mild-natured；Return liver and kidney channel；With effect：Dispelling stasis of blood and stimulating the menstrual flow, nourishing liver and kidney, strengthening the bones and muscles, diuresis are logical
The effect of drenching, ensurining proper downward flow of the blood；For menostasis, dysmenorrhea, soreness of waist and knee joint, muscles and bones is powerless, stranguria, oedema, headache, dizziness, toothache, day
Sore is spitted blood, bleeding from five sense organs or subcutaneous tissue.
Lycopodium calvatum：Bitter, micro-pungent, it is warm-natured；There is the effect of dispelling wind and eliminating dampness, relaxing tendons and activating collaterals；For joint pain, bend and stretch not
Benefit.
Rhizoma Chuanxiong：Pungent scattered temperature is logical, can activating microcirculation and removing stasis medicinal and promoting qi circulation and relieving pain for " the gas medicine in blood " have sensible qi and blood function
Effect, therefore control all pains of the chest side of body of qi depression to blood stasis, abdomen；The expansible cerebrovascular reduces vascular resistence, dramatically increases brain blood flow, improves
Microcirculation.
The root of Chinese clematis：It can wind-damp dispelling, diuresis, promoting menstruation, analgesia；Control damp and hot chill, migraines, jaundice edema, fish-bone fishbone larynx, waist
Knee legs and feet crymodynia.
Great burdock achene：Acrid flavour, hardship, it is cold in nature；It attaches to the lung and stomach meridians；Dispelling wind and heat from the body, clearing heat and detoxicating promoting eruption, promoting the dispersing function of the lung relieving sore-throat dissipate swollen.
Raw Radix Paeoniae Alba：It can analgesia, antispastic, dissolving stasis, promoting menstruation；Property bitter, acid, it is slightly cold；Return liver, the spleen channel；Yin is held back in blood-nourishing, and soft liver is stopped
Bitterly, Pinggan Yang；Calming the liver and relieving pain, nourishing blood for regulating menstruation, astringing YIN to stop sweating；It withers for headache and dizziness, hypochondriac pain, abdominal pain, four limbs contraction pain, the deficiency of blood
Huang, irregular menstruation, spontaneous perspiration, night sweat.
Pueraria lobata：Expelling pathogenic factors from muscles and skin is brought down a fever, and is promoted the production of body fluid, promoting eruption, Shengyang Zhixie；It has a headache for fever caused by exogenous pathogens, stiff nape and back is thirsty, it quenches one's thirst,
Hypertension neck pain.
Ramulus cinnamomi：It is acrid flavour, sweet, it is warm-natured；Return lung, the heart, bladder meridian；There is the effect of sweating expelling pathogenic factors from muscles and skin, warming meridian, helps yang transforming qi.
Rhizoma Et Radix Notopterygii：Acrid flavour, hardship, it is warm-natured；Return bladder, kidney channel；Dissipate exterior cold, wind-damp dispelling, sharp joint, analgesic；Main affection of exogenous wind-cold, head
Bitterly lossless, mimeograph cold-dampness numbness, geomantic omen edema, sore swollen toxin.
Pawpaw：Contain more tannin and organic acid in medicinal pawpaw fresh fruit, sugared content is relatively low, keeps its mouthfeel sour
It is puckery, it should not eat raw.But its fruits nutrition is abundant, is rich in vitamin.
Arisaema cum bile：Bitter, micro-pungent, it is cool in nature；There is clearing away fire and eliminating phlegm, relieve dizziness, high fever, infantile convulsions, epilepsy, etc. the effect of calming the frightened；For apoplexy, infantile convulsion, epilepsy, head
Bitterly, dizziness, asthma are coughed.
Safflower：There is the effect of promoting blood circulation, dredging channels, removing blood stasis and relieving pain.Modern study show safflower can platelet aggregation-against, subtract
Light brain edema, the ability for improving the anti-hypoxic-ischemic of brain, enhancing immunocompetence.
Stir-baked OLIBANUM：Acrid flavour, hardship, it is warm-natured；Blood-activating and qi-promoting analgesic, detumescence and promoting granulation；For chest impediment and cardialgia, gastral cavity pain, dysmenorrhea
Menostasis, postpartum stasis, abdominal mass abdominal pain, rheumatic arthralgia, muscle arteries and veins contraction, traumatic injury, carbuncle swells sore.
Stir-baked MYRRHA with vinegar：There is the effect of scattered stasis pain, detumescence and promoting granulation；For chest impediment and cardialgia, gastral cavity pain, dysmenorrhea menostasis, postpartum
Stasis blocking, abdominal pain, rheumatic arthralgia, traumatic injury, the treatment of the illnesss such as carbuncle swells sore.
The preparation method > of < pharmaceutical composition
A variety of method preparations can be used in pharmaceutical composition of the invention.
First preferred embodiment according to the present invention, the preparation method of described pharmaceutical composition include following step
Suddenly：
(1) by ramulus mori, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae, lycopodium calvatum, Rhizoma Chuanxiong, the root of Chinese clematis, great burdock achene, Radix Paeoniae Alba, pueraria lobata, ramulus cinnamomi,
Rhizoma Et Radix Notopterygii, pawpaw, arisaema cum bile, safflower, olibanum, myrrh and Radix Glycyrrhizae mixing, use water as solvent extraction, obtain extracting solution；
(2) extracting solution is concentrated, is dry, pulverize, obtain described pharmaceutical composition.
Second preferred embodiment according to the present invention, the preparation method include the following steps：
(1 ') pulverising step：The Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile are crushed, mixed powder is obtained；
(2 ') extraction step：By the olibanum, myrrh, great burdock achene, raw Radix Paeoniae Alba, ramulus mori, pueraria lobata, rhizoma cibotii, Fructus Liquidambaris, ox
Knee, lycopodium calvatum, the root of Chinese clematis, pawpaw and Radix Glycyrrhizae are mixed to get mixture, and water is added as solvent in the mixture and is extracted,
Obtain extracting solution；
(3 ') concentration step：The extracting solution is subjected to concentration, obtains concentrate；
(4 ') mixing step：The mixed powder is uniformly mixed with the concentrate, dry, pulverize, obtain the medicine
Compositions.
Preparation method according to the present invention, in step (1 '), the Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile can divide
Not Fen Sui after mix, obtain the mixed powder；After the Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile can also being mixed again
It crushes, obtains the mixed powder.The partial size of the mixed powder can be 65~100 mesh, preferably 70~90 mesh, more preferably
For 80 mesh.When mixed powder has the partial size, be conducive to subsequent suitable solid pharmaceutical preparation be made.
Preparation method according to the present invention, in step (2 '), the olibanum, myrrh, great burdock achene, raw Radix Paeoniae Alba, ramulus mori, Pueraria lobota
Root, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae, lycopodium calvatum, the root of Chinese clematis, pawpaw and Radix Glycyrrhizae can be fed intake in the form of medicine materical crude slice, can also be by crushing
After feed intake, be not particularly limited.In one embodiment, these medicinal materials are fed intake in the form of medicine materical crude slice.Abstraction process it
Before, the mixture can be soaked in water 15~60 minutes, so that medicinal material be made to soften, be conducive to subsequent extraction operation.It is described
In abstraction process, extracting method can be water heating and refluxing extraction method or decocting method, and preferably water heating and refluxing extraction method.?
In the abstraction process, extraction time is 1~4 time, and each extraction time is 0.5~2 hour, and each amount of water is the mixing
2~8 times of object weight.Preferably, in the abstraction process, extraction time is 2~3 times, and each extraction time is 1~2 small
When, each amount of water is 2~6 times of the mixture weight.According to a preferred embodiment of the present invention, the extraction side
Method is water heating and refluxing extraction method；Extraction time is 3 times, and each extraction time is respectively 1.5 hours, 1 hour and 1 hour,
Each amount of water is 2~4 times of the mixture weight.
Preparation method according to the present invention, in step (3 '), thickening temperature is 90~99 DEG C, preferably 95~99 DEG C.It is dense
The vacuum degree of contracting is -0.05~-0.1MPa, preferably -0.06~-0.08MPa, more preferably -0.07MPa.In addition, mixing
Before step, the temperature of the concentrate may remain in 60 DEG C or more, preferably remain in 70 DEG C or more, cooling to prevent concentrate
Condensation, influences subsequent mixing step.
In step (4 '), the concentrate is uniformly mixed with the mixed powder for preparation method according to the present invention.It is excellent
Selection of land, the mixed processes carry out in mixing and blending machine.The incorporation time of mixed processes can be 20~45 minutes, preferably
25~40 minutes, so that the concentrate is uniformly mixed with the mixed powder.In the present invention, using concentrate with mix medicine
The step of powder mixes, is conducive to mixed powder and is dispersed in concentrate, thus uniformly mixed material easy to form.It is described
Drying process is preferably dried in vacuo, and drying temperature is preferably 60~70 DEG C.The pulverizing process is to be crushed to 50 mesh hereinafter, excellent
Choosing is crushed to 60 mesh or less.
< preparation >
The present invention also provides a kind of pharmaceutical preparation for treating cervical spondylosis or lumbar vertebra disease, it includes above-mentioned pharmaceutical composition,
And pharmaceutically acceptable auxiliary material.The pharmaceutical preparation can be dosage form conventional in field, there is no limit.Preferably, institute
Stating pharmaceutical preparation is peroral dosage form, such as tablet, pill, capsule, granule, oral solution, decoction, vina.It is highly preferred that institute
Stating pharmaceutical preparation is oral solid formulation.According to a preferred embodiment of the present invention, the pharmaceutical preparation is granule.
In the present invention, the pharmaceutical preparation is granule comprising pharmaceutical composition, glucose, starch and the poly- dimension of crosslinking
Ketone, wherein described pharmaceutical composition, the weight ratio of grape sugar and starch are 0.8~1.2:0.5~0.7:0.25~0.5；It is described
The weight of crospovidone is 2~5wt% of described pharmaceutical composition, grape sugar and starch total weight.
Pharmaceutical preparation according to the present invention, it is preferable that described pharmaceutical composition, the weight ratio of grape sugar and starch are 0.9
~1.1:0.55~0.65:0.3~0.45, more preferably 1:0.6:0.4.The weight of the crospovidone is the medicine group
Close the 2.5~4wt%, more preferably 3wt% of object, grape sugar and starch total weight.
Due to containing a large amount of crude drug powders in pharmaceutical composition of the invention, relative difficulty of pelletizing.Using of the invention
Supplementary product consumption and proportion are conducive to that qualified granule is made, and are conducive to disintegration and dissolution.
The preparation method > of < pharmaceutical preparation
A variety of method preparations can be used in pharmaceutical preparation of the invention.A preferred embodiment according to the present invention, medicine
The preparation method of object preparation includes the preparation step of aforementioned pharmaceutical compositions, further includes following steps：
It A. is 0.8~1.2 according to weight ratio by described pharmaceutical composition, glucose and starch:0.5~0.7:0.25~
0.5 is uniformly mixed, and obtains the first mixture；
B. first mixture is uniformly mixed with crospovidone, obtains the second mixture；Wherein, the crosslinking is poly-
The weight for tieing up ketone is 2~5wt% of the mixture weight；
C. the ethanol water that the second mixture concentration is 40~50vol% is pelletized, whole grain is dried, obtained
Particle；Particle dries 48h or more under ventilation state；
D., the particle is dried to water content at 60~70 DEG C lower than 6wt%, obtains dried material, sterilized, packaging,
Obtain the granule.
Preparation method according to the present invention, in step A, the partial size of described pharmaceutical composition is 50 mesh hereinafter, preferably crushing
To 60 mesh.When the partial size for the pharmaceutical composition that the preparation step of pharmaceutical composition obtains is not in above range, by its powder
It is broken in above range.The weight ratio of described pharmaceutical composition, glucose and starch can be 0.8~1.2:0.5~0.7:
0.25~0.5, preferably 0.9~1.1:0.55~0.65:0.3~0.45, more preferably 1:0.6:0.4.For of the invention
For pharmaceutical composition, using such proportion, advantageously form suitable softwood, thus be conducive to subsequent granulation process into
Row.
Preparation method according to the present invention, in step B, the weight of the crospovidone be the mixture weight 2~
5wt%, preferably 2.5~4wt%, more preferably 3wt%.
Preparation method according to the present invention in step C, carries out wet granulation using the ethanol water of 40~50vol%,
Conducive to the preparation of softwood and the formation of particle.In step D, it is preferable that the sterilizing methods are：The dried material is placed in purple
Under outer lamp in 1m, sterilize 20~45min, preferably 25~40min, more preferably 30~35min.
< pharmaceutical applications >
Pharmaceutical composition of the invention has good therapeutic effect for cervical spondylosis, lumbar vertebra disease, especially for improvement
It is good to alleviate cervicodynia, pain in the loins, radiculalgia, numb limb and limitation of activity caused by cervical spondylosis or lumbar vertebra disease etc. effect
It is good.Therefore, the purposes of the drug for the treatment of cervical spondylosis or lumbar vertebra disease is used to prepare the present invention also provides above-mentioned pharmaceutical composition.This
In invention, it is preferable that the cervical spondylosis or lumbar vertebra disease have the diseases such as cervicodynia, pain in the loins, radiculalgia, numb limb and limitation of activity
Shape.
Embodiments of the present invention are specifically described below by way of specific embodiment.
Embodiment 1
Take ramulus mori 9kg, rhizoma cibotii 9kg, Fructus Liquidambaris 7.5kg, radix achyranthis bidentatae 4.5kg, lycopodium calvatum 4.5kg, Rhizoma Chuanxiong 3.6kg, the root of Chinese clematis
3.6kg, great burdock achene 3kg, raw Radix Paeoniae Alba 3kg, pueraria lobata 3kg, ramulus cinnamomi 3kg, Rhizoma Et Radix Notopterygii 3kg, pawpaw 3kg, arisaema cum bile 3kg, safflower 3kg,
Stir-baked OLIBANUM 2.4kg, stir-baked MYRRHA with vinegar 2.4kg and Radix Glycyrrhizae 1.5kg, are made pharmaceutical composition with the following method：
(1) by ramulus mori, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae, lycopodium calvatum, Rhizoma Chuanxiong, the root of Chinese clematis, great burdock achene, Radix Paeoniae Alba, pueraria lobata, ramulus cinnamomi,
Rhizoma Et Radix Notopterygii, pawpaw, arisaema cum bile, safflower, olibanum, myrrh and Radix Glycyrrhizae mixing, use water as solvent extraction 3 times, amount of water is followed successively by
The 10 times of amounts, 10 times of amounts, 8 times of amounts of medicinal material total weight are stated, extraction time is followed successively by 1.5h, 1h, 1h, obtains extracting solution；
(2) extracting solution is concentrated, is dry, pulverize, obtain described pharmaceutical composition.
Embodiment 2
Take ramulus mori 9kg, rhizoma cibotii 9kg, Fructus Liquidambaris 9kg, radix achyranthis bidentatae 4.5kg, lycopodium calvatum 4.5kg, Rhizoma Chuanxiong 3.6kg, the root of Chinese clematis
3.6kg, great burdock achene 3kg, raw Radix Paeoniae Alba 3kg, pueraria lobata 3kg, ramulus cinnamomi 3kg, Rhizoma Et Radix Notopterygii 3kg, pawpaw 2.7kg, arisaema cum bile 2.7kg, safflower
2.7kg, stir-baked OLIBANUM 2.1kg, stir-baked MYRRHA with vinegar 2.1kg and Radix Glycyrrhizae 1.5kg, are made pharmaceutical composition using following steps：
(1 ') pulverising step：Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile are crushed to 80 mesh respectively, is uniformly mixed, obtains
To mixed powder；
(2 ') extraction step：By stir-baked OLIBANUM, stir-baked MYRRHA with vinegar, great burdock achene, raw Radix Paeoniae Alba, ramulus mori, pueraria lobata, rhizoma cibotii, Fructus Liquidambaris, ox
Knee, lycopodium calvatum, the root of Chinese clematis, pawpaw and Radix Glycyrrhizae are mixed to get mixture, and the mixture is soaked in water 30 minutes, is then added
Water is as solvent heating and refluxing extraction 3 times, and amount of water is followed successively by 240kg, 180kg and 180kg, and it is small that extraction time is followed successively by 1.5
When, 1 hour and 1 hour, obtain extracting solution；
(3 ') concentration step：By the extracting solution at 98 DEG C, vacuum degree be -0.07MPa under carry out concentration, obtain
Concentrate keeps the temperature of the concentrate at 70 DEG C or more；
(4 ') mixing step：The mixed powder is placed in mixing and blending machine with the concentrate and mixes 30 minutes, 65
It is dry, pulverize at DEG C to 60 meshes are crossed, obtains described pharmaceutical composition.
Embodiment 3
Take ramulus mori 12kg, rhizoma cibotii 9kg, Fructus Liquidambaris 7.5kg, radix achyranthis bidentatae 4.5kg, lycopodium calvatum 4.5kg, Rhizoma Chuanxiong 3.6kg, the root of Chinese clematis
3.6kg, great burdock achene 3kg, raw Radix Paeoniae Alba 3kg, pueraria lobata 3kg, ramulus cinnamomi 3kg, Rhizoma Et Radix Notopterygii 3kg, pawpaw 3kg, arisaema cum bile 3kg, safflower 3kg,
Stir-baked OLIBANUM 1.8kg, stir-baked MYRRHA with vinegar 1.8kg and Radix Glycyrrhizae 1.2kg, are made pharmaceutical composition using following steps：
(1 ') pulverising step：Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile are crushed to 80 mesh respectively, is uniformly mixed, obtains
To mixed powder；
(2 ') extraction step：By stir-baked OLIBANUM, stir-baked MYRRHA with vinegar, great burdock achene, raw Radix Paeoniae Alba, ramulus mori, pueraria lobata, rhizoma cibotii, Fructus Liquidambaris, ox
Knee, lycopodium calvatum, the root of Chinese clematis, pawpaw and Radix Glycyrrhizae are mixed to get mixture, and the mixture is soaked in water 40 minutes, is then added
For water as solvent heating and refluxing extraction 2 times, amount of water is followed successively by 240kg, 240kg, extraction time be followed successively by 1.5 hours, it is 1.5 small
When, obtain extracting solution；
(3 ') concentration step：By the extracting solution at 99 DEG C, vacuum degree be -0.07MPa under carry out concentration, obtain
Concentrate keeps the temperature of the concentrate at 70 DEG C or more；
(4 ') mixing step：The mixed powder is placed in mixing and blending machine with the concentrate and mixes 35 minutes, 65
It is dry, pulverize at DEG C to 60 meshes are crossed, obtains described pharmaceutical composition.
Embodiment 4
Granule is prepared using following steps：
It A. is 1 according to weight ratio by the pharmaceutical composition of embodiment 2, glucose and starch:0.6:0.4 is uniformly mixed, and obtains
To the first mixture；
B. first mixture is uniformly mixed with crospovidone, obtains the second mixture；Wherein, the crosslinking is poly-
The weight for tieing up ketone is the mixture weight 3wt%；
C. second mixture is pelletized with the ethanol water that concentration is 50vol%, whole grain is dried, and particle is obtained；
Particle dries 48h or more under ventilation state.
D., the particle is dried to water content at 65 DEG C lower than 6wt%, dried material is obtained, by the dried material
It is placed under ultraviolet lamp in 1m, sterilizes 30 minutes, packaging obtains the granule, and specification is 7g/ bags.
Experimental example 1
1. observing object
1.1 case sources：Baotou central hospital Neurology patient 200 is moved in continuous selection.
1.2 case inclusion criterias
Selection is with the patient of cervicodynia, pain in the loins, radiculalgia, numb limb and limitation of activity cardinal symptom, diagnostic criteria symbol
It closes《Parting, diagnosis and the non-operative treatment Consensus of experts 2016 of cervical spondylosis》,《Protrusion of lumber intervertebral disc is examined with radiculopathy
Disconnected and treatment (2013 editions)》In diagnostic criteria；The range of age was at 18~80 years old；Disease time is within 1 week.
1.3 case exclusion criterias
Merge other organs severe dysfunction, such as acute scheming infarction, heart failure, liver and kidney failure, severe sense
Dye, coagulation disorders etc.；Exclude cervicodynia, pain in the loins, radiculalgia, numb limb and limitation of activity disease caused by other reasons
Shape；It is unable to the patient of partner treatment and follow-up.
2. method
2.1 group technology：It is designed using randomised controlled trials.Using table of random number by case be divided into observation group with compare
Group, two groups in terms of gender, age, the course of disease without significant difference.
2.2 treatment method：
(1) control group uses Primary Care, uses conventional medicine, physiotherapy and physical therapy etc..
(2) observation group adds the granule of the embodiment of the present invention 4 on the scheme of Primary Care, and 1 bag every time, daily 3
It is secondary, it continuously takes 14 days.
2.3 efficacy determination methods
2.3.1 criterion of therapeutical effect：It is effective：Pain symptom disappearance or substantially reduced after treatment；Effectively：Pain symptom changes after treatment
It is kind, it lies down asymptomatic when rest；In vain：Pretherapy and post-treatment symptom is unchanged.
2.3.2 drug safety is evaluated：Before treatment, measured after treatment 14 days patient's hepatic and renal function, blood urine it is conventional,
The test evaluations drug safety such as electrocardiogram.
2.4 statistical method
Data are analyzed using SPSS15.0 statistical software.Measurement data is examined using t, and enumeration data uses mean ± standard
Difference indicates.P<0.05 indicates there is statistical significance.
3. experimental result
3.1 two groups of patient's curative effects compare, and see Table 1 for details
1 two groups of patient outcomes of table compare
| Group | Number of cases | It is effective | Effectively | In vain |
| Treatment group | 100 | 51 | 40 | 9 |
| Control group | 100 | 31 | 43 | 26 |
It is obtained by list analysis, treatment group's obvious effective rate 51%, total effective rate 91%；Control group obvious effective rate 31%, always has
Efficiency 74%, two groups of comparing differences have statistical significance.Treatment group's effect is prompted to be better than control group.
The observation of 3.2 adverse events
Relative physiologic index after treating 14 days to two groups of patients is analyzed, and does not find obvious exception, this prompt is taken
The Chinese medicine composition has safety.
4. conclusion
Cervicodynia caused by cervical spondylosis or lumbar vertebra disease, pain in the loins, nerve root can be effectively relieved in Chinese medicine composition of the invention
Bitterly, numb limb and limitation of activity, it is significant in efficacy.Medication patient physical signs does not find significant exception, drug safety, without obvious
Toxic side effect.The above-mentioned symptom of cervical spondylosis or lumbar vertebra disease can be effectively relieved in treatment course at 14 days, rapid-action.
Present invention is not limited to the embodiments described above, without departing from the essence of the present invention, this field skill
Any deformation, improvement, the replacement that art personnel are contemplated that each fall within the scope of the present invention.
Claims (10)
1. a kind of for treating the pharmaceutical composition of cervical spondylosis or lumbar vertebra disease, which is characterized in that described pharmaceutical composition is by including
The bulk pharmaceutical chemicals of following component are made：
8~15 parts by weight of ramulus mori, 8~15 parts by weight of rhizoma cibotii, 6~10 parts by weight of Fructus Liquidambaris, 3~6 parts by weight of radix achyranthis bidentatae, lycopodium calvatum 3
~6 parts by weight, 2.5~5 parts by weight of Rhizoma Chuanxiong, 2.5~5 parts by weight of the root of Chinese clematis, 2~5 parts by weight of great burdock achene, 2~5 weight of Radix Paeoniae Alba
Part, 2~5 parts by weight of pueraria lobata, 2~5 parts by weight of ramulus cinnamomi, 2~5 parts by weight of Rhizoma Et Radix Notopterygii, 2~5 parts by weight of pawpaw, 2~5 weight of arisaema cum bile
Part, 2~5 parts by weight of safflower, 1~2.5 parts by weight of 1.5~3 parts by weight of olibanum, 1.5~3 parts by weight of myrrh and Radix Glycyrrhizae.
2. the preparation method of pharmaceutical composition according to claim 1, which is characterized in that include the following steps：
(1) by the ramulus mori, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae, lycopodium calvatum, Rhizoma Chuanxiong, the root of Chinese clematis, great burdock achene, Radix Paeoniae Alba, pueraria lobata, ramulus cinnamomi,
Rhizoma Et Radix Notopterygii, pawpaw, arisaema cum bile, safflower, olibanum, myrrh and Radix Glycyrrhizae mixing, use water as solvent extraction, obtain extracting solution；
(2) extracting solution is concentrated, is dry, pulverize, obtain described pharmaceutical composition.
3. the preparation method of pharmaceutical composition according to claim 1, which is characterized in that include the following steps：
(1 ') pulverising step：The Rhizoma Chuanxiong, safflower, ramulus cinnamomi, Rhizoma Et Radix Notopterygii and arisaema cum bile are crushed, mixed powder is obtained；
(2 ') extraction step：By the olibanum, myrrh, great burdock achene, Radix Paeoniae Alba, ramulus mori, pueraria lobata, rhizoma cibotii, Fructus Liquidambaris, radix achyranthis bidentatae, stretch muscle
Grass, the root of Chinese clematis, pawpaw and Radix Glycyrrhizae are mixed to get mixture, and water is added as solvent in the mixture and is extracted, is mentioned
Take liquid；
(3 ') concentration step：The extracting solution is subjected to concentration, obtains concentrate；
(4 ') mixing step：The mixed powder is uniformly mixed with the concentrate, dry, pulverize, obtain the medicine group
Close object.
4. preparation method according to claim 3, which is characterized in that in step (1 '), the partial size of the mixed powder is
65~100 mesh.
5. preparation method according to claim 3, which is characterized in that in step (2 '), before extraction, the mixture
It is soaked in water 15~60 minutes；The method of extraction is heating and refluxing extraction method, and extraction time is 1~4 time, and each extraction time is
0.5~2 hour, each amount of water was 2~8 times of the mixture weight.
6. preparation method according to claim 3, which is characterized in that in step (3 '), thickening temperature is 90~99 DEG C, dense
The vacuum degree of contracting is -0.05~-0.1MPa.
7. a kind of for treating the pharmaceutical preparation of cervical spondylosis or lumbar vertebra disease, which is characterized in that the pharmaceutical preparation includes according to power
Benefit require 1 described in pharmaceutical composition or the pharmaceutical composition according to the method preparation of any one of claim 2~6.
8. pharmaceutical preparation according to claim 7, which is characterized in that the pharmaceutical preparation is granule, the drug system
Agent further includes glucose, starch and crospovidone, and described pharmaceutical composition, the weight ratio of grape sugar and starch be 0.8~
1.2:0.5~0.7:0.25~0.5；The weight of the crospovidone is described pharmaceutical composition, grape sugar and starch gross weight
2~5wt% of amount.
9. the preparation method of pharmaceutical preparation according to claim 8, which is characterized in that include the following steps：
It A. is 0.8~1.2 according to weight ratio by described pharmaceutical composition, glucose and starch:0.5~0.7:0.25~0.5 is mixed
It closes uniformly, obtains the first mixture；
B. first mixture is uniformly mixed with crospovidone, obtains the second mixture；Wherein, the crospovidone
Weight be 2~5wt% of the mixture weight；
C. the ethanol water that the second mixture concentration is 40~50vol% is pelletized, whole grain is dried, and particle is obtained；
Particle dries 48h or more under ventilation state；
D., the particle is dried to water content at 60~70 DEG C lower than 6wt%, obtains dried material, sterilized, packaging obtains
The granule.
10. pharmaceutical composition according to claim 1 or the medicine according to the method preparation of any one of claim 2~6
Compositions are used to prepare the purposes of the drug for the treatment of cervical spondylosis or lumbar vertebra disease.
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Application publication date: 20181130 |