CN104721366B - A kind of Chinese medicine composition and its application - Google Patents
A kind of Chinese medicine composition and its application Download PDFInfo
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Abstract
The present invention provides a kind of Chinese medicine compositions, including following components: 190~200g of Rehmannia glutinosa, 190~200g of Cortex Eucommiae, 1~5g of Moschus, 190~200g of Radix Angelicae Sinensis, 90~105g of Radix Notoginseng, 50~62g of olibanum, 55~65g of myrrh, 95~105g of Chinese ephedra, 30~45g of mustard seed, 60~70g of cortex cinnamomi 15~25g Radix Paeoniae Alba, 95~105g of Rhizoma Atractylodis Macrocephalae, 15~25g of Radix Glycyrrhizae.The composition is used to treat spondylotic radiculopathy neck, lumbar vertebra disease, Osteoarthritis, traumatic arthritis, the purposes of femoral head inflammation and scapulohumeral periarthritis.Composition is with strong points, medicine source is abundant, cheap, has popularizing value.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of Chinese medicine composition and its application.
Background technique
Cervical spondylosis is that cervical intervertebral disk degenerative change and its secondary pathological change involve structures surrounding (spinal cord, nerve
Root, vertebral artery, ligament etc.) there is the clinical syndrome of corresponding symptom, nerve root cervical vertebra sickness is also referred to as numbness pain myelopathy, mostly by
Intervertebral foramen is influenced in lesions such as the calcification of ligament of neck plumpness, disc degeneration, osteophytosis to narrow, root compression and occur
The symptoms such as various pain, numbness, out of strength, amyotrophia and sign.Modern studies have found that neck chronic strain posterior longitudinal ligament, joint
It is out of hand and misplace to can lead to articuli intervertebrales mobility for capsule faulty restoration；In addition what is formed after muscle, tendon injury is viscous
Company, cicatricial tissue etc. can cause cervical vertebra two sides muscular strength unbalance, destroy dynamic equilibrium, cause cervical vertebra system biological mechanics function disorderly
Disorderly, accelerate intervertebral disc degeneration, regression hyperplastic tissue forces to make peace stimulation to nerve root equipressure, clinical symptoms occurs.
At present in the treatment based on Non-surgical combined treatment, traditional Chinese medicine treatment is an important hand of non-operative treatment
Section, it is found by the applicant that summarizing discovery nerve root cervical vertebra sickness in the application in the clinical practice of medical treatment cervical spondylosis with the stagnation of the circulation of vital energy
Blood stasis, deficiency of the liver and kidney are common, in conjunction with ancient literature, clinical experience and modern medicine to pathogenetic research achievement, gradually
Recognize that " caused by liver and kidney deficiency, qi depression to blood stasis, obstruction of meridians and collaterals " is the important pathogenesis of nerve root cervical vertebra sickness；It is strong using kidney tonifying accordingly
Muscle, nourshing blood and promoting blood circulation, the therapy removed obstruction in channels to relieve pain are made Chinese medicine preparation treatment nerve root cervical vertebra sickness and often obtain good effect.
Summary of the invention
The present invention provides a kind of Chinese medicine composition and its applications, it is therefore intended that develops and a kind of treats nerve root cervical vertebra sickness
A kind of curative effect certainly pure Chinese medicinal preparation, further mention the treatment level of cervical and lumbar diseases.
The present invention is realized especially by following technical scheme:
A kind of Chinese medicine composition, including following components: 190~200g of Rehmannia glutinosa, 190~200g of Cortex Eucommiae, 1~5g of Moschus,
190~200g of Radix Angelicae Sinensis, 90~105g of Radix Notoginseng, 50~62g of olibanum, 55~65g of myrrh, 95~105g of Chinese ephedra, 30~45g of mustard seed,
60~70g of cortex cinnamomi 15~25g Radix Paeoniae Alba, 95~105g of Rhizoma Atractylodis Macrocephalae, 15~25g of Radix Glycyrrhizae.
Preferably, a kind of Chinese medicine composition, including following components: Rehmannia glutinosa 194g, Cortex Eucommiae 194g, Moschus 3.2g, Radix Angelicae Sinensis
194g, Radix Notoginseng 98g, olibanum 58g, myrrh 58g, Chinese ephedra 98g, mustard seed 39g, cortex cinnamomi 19g Radix Paeoniae Alba 65g, Rhizoma Atractylodis Macrocephalae 98g, Radix Glycyrrhizae 19g.
The present composition is prepared by the following method: 1) recipe quantity Moschus being taken to grind into 100 mesh fine powders；2) 2/3 is taken to work as
Return, Radix Notoginseng is ground into 100 mesh fine powders；3) 1/3 Radix Angelicae Sinensis, remaining each taste medicine are taken, 10 mesh coarse powder are ground into, 8 times of amount water is added to decoct 2
Secondary, 2 hours every time, decoction liquor merged, and filtration is concentrated into relative density 1.2~1.4 under the conditions of 60 DEG C, and appropriate amount of starch is added,
It mixes, is dried to dry cream, is ground into 100 mesh fine powders；4) progressively increase principle by equivalent, above-mentioned three kinds of fine powders are uniformly mixed, both
The present composition.
Application the present invention provides the composition as treatment spondylotic radiculopathy neck and lumbar vertebrae medicine.
The present invention also provides the compositions to be used as treatment Osteoarthritis, traumatic arthritis, femoral head are scorching and
The application of scapulohumeral periarthritis drug.
The present composition can need that any pharmaceutically acceptable dosage form can be prepared into according to processing, and configuration is logical
Often by well known to a person skilled in the art processing methods to prepare, i.e., the present composition and liquid solvent or solid carrier are mixed
It closes, is prepared adding at least one surfactant, wherein being more preferably tablet, granule, oral solution and capsule.
The present composition can used before through dilution or directly by user under normal conditions, and of the present invention group
Close the dosage of object are as follows: adult 1.8g is primary, 2 times a day.
The present composition also has the function of anti-inflammatory, analgesia and detumescence.
The medical mechanism of the present composition: radix rehmanniae preparata temperature compensation ying blood, Tianjing Busuiye medicinal, Cortex Eucommiae tonify the liver and kidney in side, strong muscle
Bone, helps radix rehmanniae preparata with blood-nourishing, and two medicines are monarch drug in a prescription altogether.Numbness is controlled in Chinese angelica blood supplementing promoting blood circulation, analgesic；Pseudo-ginseng blood-circulation-invigovating stagnation resolvation analgesic therapy, be traumatology it
Key medicine, and energy Xu-tonic, treat consumptive damage；Olibanum, myrrh mutually must be used, interior to declare logical internal organs qi and blood, and external enwergy reaches warp thoroughly
Network, promoting blood circulation, promoting qi circulation and relieving pain, Moschus property and flavor of peppery and warm, it is extremely strong that fragrance walks to alter power, is good at blood circulation, swelling and pain relieving, above-mentioned medicine
Object is ministerial drug altogether, and power is specially imitated macro.Cortex cinnamomi property is hot, enters blood system, and warming meridian, solution cold dispelling are solidifying；A small amount of Chinese ephedra pungent-warm is declared up to defending
Logical hair key opens the flesh natural fibre line of meat, cold dispelling is coagulated；Semen brassicae pungent-warm, up to outside flesh side film, warming cold phlegm, activating collaterals and eliminating stagnation.Said medicine is assistant altogether
Medicine.All medicines are pungent dry, easily consume impairment of yin blood, hinder digestion, therefore plus Rhizoma Atractylodis Macrocephalae invigorating the spleen is aid digestion, Radix Paeoniae Alba nourishing blood and liver, relieving spasm to stop pain and system
All medicines it is dry.Licorice is to make, and is detoxified and coordinating the drug actions of a prescription.All medicines share plays kidney-invigorating and tendon-reinforcing altogether, nourshing blood and promoting blood circulation, removes obstruction in channels to relieve pain it
Effect.
The invention has the benefit that weak link is found out on the basis of deeply and carefully analysis forefathers' medication experience, and
According to modern pharmacological research achievement and the clinical gains in depth of comprehension of development person, proposition has innovation, has clinical needs, prescription with strong points,
A kind of pure Chinese medicine composition for treating nerve root cervical vertebra sickness is proposed, the composition medicine source is abundant, and it is cheap, it is worth into one
Step promotes and applies.
Specific embodiment
The present invention will be further explained with reference to the examples below, as described below, is only to preferable implementation of the invention
Example, not limits the present invention, any person skilled in the art is possibly also with the disclosure above
Technology contents be changed to the equivalent embodiment changed on an equal basis.Without departing from the concept of the present invention, according to the present invention
Technical spirit any simple modification or equivalent variations that following embodiment is made, fall within the scope of protection of the present invention.
Application Example one
Embodiment 1
A kind of Chinese medicine composition, including following components: Rehmannia glutinosa 190g, Cortex Eucommiae 200g, Moschus 5g, Radix Angelicae Sinensis 190g, Radix Notoginseng
105g, olibanum 50g, myrrh 65g, Chinese ephedra 105g, mustard seed 45g, cortex cinnamomi 15g Radix Paeoniae Alba 60g, Rhizoma Atractylodis Macrocephalae 105g, Radix Glycyrrhizae 15g.
The composition is prepared by the following method:
1) recipe quantity Moschus is taken to grind into 100 mesh fine powders；
2) 2/3 Radix Angelicae Sinensis, Radix Notoginseng is taken to be ground into 100 mesh fine powders；
3) 1/3 Radix Angelicae Sinensis, remaining each taste medicine are taken, 10 mesh coarse powder are ground into, adds 8 times of amount water to decoct 2 times, 2 hours every time, decocts
Liquid merges, and filtration is concentrated into relative density 1.2~1.4 under the conditions of 60 DEG C, and appropriate amount of starch is added, and mixes, is dried to dry cream,
It is ground into 100 mesh fine powders；
4) progressively increase principle by equivalent, above-mentioned three kinds of fine powders be uniformly mixed, both the present composition.
Embodiment 2
A kind of Chinese medicine composition, including following components: Rehmannia glutinosa 200g, Cortex Eucommiae 190g, Moschus 1g, Radix Angelicae Sinensis 200g, Radix Notoginseng
90g, olibanum 62g, myrrh 55g, Chinese ephedra 95g, mustard seed 30g, cortex cinnamomi 25g Radix Paeoniae Alba 70g, Rhizoma Atractylodis Macrocephalae 95g, Radix Glycyrrhizae 25g.
The preparation method is the same as that of Example 1.
Embodiment 3
A kind of Chinese medicine composition, including following components: Rehmannia glutinosa 194g, Cortex Eucommiae 194g, Moschus 3.2g, Radix Angelicae Sinensis 194g, three
Seven 98g, olibanum 58g, myrrh 58g, Chinese ephedra 98g, mustard seed 39g, cortex cinnamomi 19g Radix Paeoniae Alba 65g, Rhizoma Atractylodis Macrocephalae 98g, Radix Glycyrrhizae 19g.
The preparation method is the same as that of Example 1.
Application Example two
Embodiment 4
1~3 composition of the embodiment of the present invention is packed into zero capsule, capsule is made, according to version Chinese Pharmacopoeia in 2010
Requirement of one Ⅻ A of annex to Chinese medicine capsules disintegration time limited is disintegrated the capsule of Examples 1 to 3 composition preparation
The inspection in time limit, the results are shown in Table 1, and three batches of samples reach the requirement of States Pharmacopoeia specifications, therefore the disintegration time limited of this product should accord with
Close the regulation in one Ⅻ A of annex of version Chinese Pharmacopoeia in 2010.
Table 1 disintegration time limited test result
| Sample lot number | Standard regulation | Inspection result | Conclusion |
| Embodiment 1 | It should be no more than 30 minutes | It is disintegrated within 9 minutes | Meet regulation |
| Embodiment 2 | It should be no more than 30 minutes | It is disintegrated within 10 minutes | Meet regulation |
| Embodiment 3 | It should be no more than 30 minutes | It is disintegrated within 8 minutes | Meet regulation |
The anti-inflammatory effect of 5 composition of embodiment is tested
Experimental drug: 3 composition of the embodiment of the present invention is used.
Experimental animal: mouse, Kunming kind, cleaning grade, Hebei province's Experimental Animal Center provide, quality certification number 1106130；Greatly
Mouse, Wistar, cleaning grade, Hebei province's Experimental Animal Center provide, quality certification number 1107163,1106124,1107085,
1108072。
Laboratory apparatus: electronic analytical balance (AR1140/C), Ao Haosi (Shanghai) company；Rat toes swelling instrument, by
The production of Science and Technology Ltd., Dou Tai alliance；Adjustable pipette is produced by Shanghai Lei Bo Analytical Instrument Co., Ltd.
1) influence swollen to mouse auricular concha caused by dimethylbenzene xylene
Test method: taking 18~21g of weight mouse 50, and male is divided into 5 groups at random, gavages large, medium and small dose respectively
The suspension of the present composition of amount, (2g/kg, 1g/kg, 0.5mg/kg are made into 0.1g/ml, 0.05g/ with 0.5%CMC
Ml, 0.025g/ml, 0.2ml/10g), (5g/kg is made into 0.25g/ml, 0.2ml/ with 0.5%CMC to JINGFUKANG KELI suspension
10g) and the 0.5%CMC of same volume.It is administered once daily, successive administration 5 days, (is deprived of food but not water after 1h is administered in last time
12 hours), each group mouse right ear melted paraxylene 0.05ml (dripping front and back sides) is given respectively, and cervical dislocation puts to death mouse after 4h, cuts
Double two ears, alignment lay ears auricle, rapid assay balance weighing with diameter 0.6cm punch, and calculate auricular concha swelling degree,
Swelling=auris dextra weight-Zuo Erchong.It the results are shown in Table 2.
The influence result that table 2 swells to mouse auricular concha caused by dimethylbenzene xylene
It can be seen that from upper table 2, with blank group ratio, the large, medium and small dosage present composition and JINGFUKANG KELI group can be shown
It is swollen to write mitigation mouse auricular concha caused by dimethylbenzene xylene, is substantially reduced auricular concha swelling degree (P < 0.01).
2) to the influence of rat egg white toes swelling
180~200g of weight rat 50 is taken, male is divided into 5 groups at random, gavages the large, medium and small dosage present invention respectively
Composition suspension (1.38g/kg, 0.69g/kg, 0.345mg/kg, with 0.5%CMC be made into 0.138g/ml, 0.069g/ml,
0.0345g/ml, 1ml/100g), (3.3g/kg is made into 0.33g/ml, 1ml/ with 0.5%CMC to JINGFUKANG KELI suspension
100g) and the 0.5%CMC of same volume.It is administered once daily, successive administration 5 days；It crossed in the 5th day in ankle, uses vola pedis
Volume measuring apparatus measures rat or so rear vola pedis normal volume, and each group fills relative medicine, after administration 0.5, gives every rat left side
The fresh albumen 0.1mL of vola pedis injection 10% behind the right side, point in 0.5 after egg white, 1,2,3,4,5h with toes capacity measurer again
Secondary survey rat or so rear toes volume, and swelling rate is calculated, it the results are shown in Table 3.
Influence result of the table 3 to rat egg white toes swelling
As seen from Table 3, no significant difference (P > 0.05) between the normal toes volume of each group illustrates that grouping is uniform；With blank
Group ratio, big, the middle dosage present composition and JINGFUKANG KELI group can significantly mitigate big caused by egg white in administration 30min~6h
The pedal swelling (P < 0.01) of mouse；The low dose of present composition 30min~4h can rat caused by substantially reduced egg white foot
Plantar swelling (P < 0.05)
3) to the influence of Rat Carrageenan colloidality toes swelling
180~200g of weight rat 50 is taken, male is divided into 5 groups at random, gavages the large, medium and small dosage present invention respectively
Composition suspension (1.38g/kg, 0.69g/kg, 0.345mg/kg, with 0.5%CMC be made into 0.138g/ml, 0.069g/ml,
0.0345g/ml, 1ml/100g), (3.3g/kg is made into 0.33g/ml, 1ml/ with 0.5%CMC to JINGFUKANG KELI suspension
100g) and the 0.5%CMC of same volume.It is administered once daily, successive administration 5 days；It first crossed in ankle in the 5th day, with foot
Plantar volume measuring apparatus measures rat or so rear vola pedis normal volume, and each group fills relative medicine, after administration 0.5, gives every rat
Vola pedis injects the Irish moss suspension 0.1mL of 1% concentration behind left and right, point 0.5 after to egg white, 1,2,3,4,5,6h holds with toes
Product measuring instrument surveys the rear toes volume of rat or so again, and calculates swelling rate.It the results are shown in Table 4.
Influence result of the table 4 to Rat Carrageenan colloidality toes swelling
As can be seen from Table 4, no significant difference (P > 0.05) between the normal toes volume of each group illustrates that grouping is uniform；With blank
Group ratio, large, medium and small dosage bone, which aches quiet Capsules group and JINGFUKANG KELI group, can significantly mitigate carragheen in administration 30min~4h
The pedal swelling (P < 0.01) of caused rat；5h is administered, big, middle dosage bone, which aches quiet Capsules group and JINGFUKANG KELI group, significantly to be subtracted
The pedal swelling (P < 0.01) of rat caused by light carragheen；6h is administered, large dosage of bone aches quiet Capsules group and JINGFUKANG KELI group can
The significant pedal swelling (P < 0.01) for mitigating rat caused by carragheen, middle dosage bone aches quiet Capsules group can substantially reduced carragheen institute
Cause the pedal swelling (P < 0.05) of rat.
4) influence that swollen hyperplasia of rat granuloma is formed
190~210g of weight rat 50 is taken, male is divided into 5 groups at random, and 10% hydration is injected intraperitoneally in each group rat
It is small first to cut 1cm long to partly sterilised on the inside of rat thigh root with 75% alcohol, the tincture of iodine for chloralization (0.3ml/100g)
Mouthful, 20mg is implanted into subcutaneous, skin suture, local penicillin disinfection from incision through autoclaved cotton balls；From the operation same day
It rises, each group rat gavages large, medium and small dosage present composition suspension (1.38g/kg, 0.69g/kg, 0.345g/ respectively
Kg is made into 0.138g/ml, 0.069g/ml, 0.0345g/ml, 1ml/100g with 0.5%CMC), JINGFUKANG KELI suspension
The 0.5%CMC of (3.3g/kg is made into 0.33g/ml, 1ml/100g with 0.5%CMC) and same volume.It is administered once daily, continuously
Administration 7 days；After last dose 1h, cervical dislocation puts to death rat, opens former notch, cotton balls is taken together with surrounding connective tissue
Out, adipose tissue is rejected, is put into 70 DEG C of baking ovens and dries, is weighed, subtracting raw cotton ball weight is granuloma amount.It the results are shown in Table 5.
5 bone of table aches the influence that quiet Capsule in Rats granuloma induced by implantation of cotton pellets is formed
It can be seen that from upper table 5, with blank group ratio, large dosage of present composition and JINGFUKANG KELI group can be significantly inhibited greatly
The formation (P < 0.01) of mouse granuloma induced by implantation of cotton pellets, in, the low dose of present composition can obviously inhibit the shape of swollen hyperplasia of rat granuloma
At (P < 0.05).
By being tested above it is found that the large, medium and small dosage present composition and JINGFUKANG KELI group can significantly mitigate mouse
Auricular concha caused by dimethylbenzene xylene is swollen, is substantially reduced auricular concha swelling degree.Greatly, the middle dosage present composition and JINGFUKANG KELI group are being administered
30min~6h can significantly mitigate the pedal swelling of rat caused by egg white；The low dose of present composition can be bright in 30min~4h
The aobvious pedal swelling for mitigating rat caused by egg white.The large, medium and small dosage present composition and JINGFUKANG KELI group are being administered
30min~4h can significantly mitigate the pedal swelling of rat caused by carragheen；Be administered 5h, big, the middle dosage present composition and
JINGFUKANG KELI group can significantly mitigate the pedal swelling of rat caused by carragheen；6h, large dosage of present composition and neck is administered
Multiple recovering particles group can significantly mitigate the pedal swelling of rat caused by carragheen, and the middle dosage present composition can substantially reduced OK a karaoke club
The pedal swelling of rat caused by glue.Large dosage of present composition and JINGFUKANG KELI group can significantly inhibit swollen hyperplasia of rat granuloma
Formation, in, the low dose of present composition can obviously inhibit the formation of swollen hyperplasia of rat granuloma.The present composition pair simultaneously
The inhibiting effect that acute inflammation, chronic inflammation have had.
The analgesic activity of 6 composition of embodiment
Experimental drug: 3 composition of embodiment；JINGFUKANG KELI, the production of Chengde neck rehabilitation medicine company, lot number 110308；Ice vinegar
Acid, Tianjin Heng Xing chemical reagent Manufacturing Co., Ltd, lot number 20100621；Examination is learned in sodium carboxymethylcellulose, perseverance Xinghua, Tianjin
The production of agent Manufacturing Co., Ltd, lot number 20060723；Carrageenan, Sigma Co., USA, lot number 145H1227；Physiological saline,
Zhengzhou Yonghe Pharmaceutical Co's production, lot number 10042210.
Experimental animal: mouse, Kunming kind, cleaning grade, Hebei province's Experimental Animal Center provide, quality certification number 1106125,
1106127、1106129。
Laboratory apparatus: electronic analytical balance (AR1140/C), Ao Haosi (Shanghai) company；The intelligent hot-plate instrument of RB -200, at
The production of Science and Technology Ltd., Dou Tai alliance；Adjustable pipette is produced by Shanghai Lei Bo Analytical Instrument Co., Ltd.
1) paratartaric acid antimony potassium causes the influence of mouse writhing reaction
18~21g of weight is taken, Kunming mouse 50, half male and half female is randomly divided into 5 groups, gavages large, medium and small dose respectively
Measure 3 composition suspension of embodiment (2g/kg, 1g/kg, 0.5mg/kg, with 0.5%CMC be made into 0.1g/ml, 0.05g/ml,
0.025g/ml, 0.2ml/10g), JINGFUKANG KELI suspension (5g/kg is made into 0.25g/ml, 0.2ml/10g with 0.5%CMC)
With the 0.5%CMC of same volume.It is administered once daily, successive administration 5 days, (it is small to be deprived of food but not water 12 in last time administration 30min
When), the 0.6% acetum 0.1ml/10g newly prepared is injected intraperitoneally in each group, observes mouse immediately and first appears writhing response
Incubation period and 10min in, (mark of writhing response: stretching, extension hind leg, abdomen shrink indent to the writhing number in 15min, simultaneously
Limbs distortion, lift stern erect tail).It the results are shown in Table 6.
Table 6 causes the influence of mouse writhing reaction to 0.6% acetic acid
As can be seen from Table 6, with blank group ratio, each administration group only has to extend to 0.6% acetic acid cause mouse writhing incubation period to become
Gesture；The large, medium and small dosage present composition can substantially reduce mouse writhing number (P < 0.01), JINGFUKANG KELI in 10min
Group can obviously reduce writhing number (P < 0.05) in mouse 10min.
2) influence of mouse pain is caused to hot plate method
Weight 19~22g female mice is taken, first (55 ± 0.5 DEG C) the screening normal threshold of pains of mouse on hot-plate instrument before testing,
All threshold of pains are greater than 30s (threshold of pain is insensitive) or are less than 3s (threshold of pain is too sensitive), abandon and do not have to, select threshold of pain qualified mice 50,
5 groups are randomly divided by mouse pain threshold size；Large, medium and small dose delivery example 3 composition suspension (2g/kg, 1g/ are gavaged respectively
Kg, 0.5mg/kg are made into 0.1g/ml, 0.05g/ml, 0.025g/ml, 0.2ml/10g with 0.5%CMC), JINGFUKANG KELI is mixed
The 0.5%CMC of suspension (5g/kg is made into 0.25g/ml, 0.2ml/10g with 0.5%CMC) and same volume.It is administered once daily, even
Continuous administration 5 days, measures in hot-plate instrument again in last time administration 30min (being deprived of food but not water 12 hours), 60min, 90min
The mouse threshold of pain, and calculate threshold of pain raising value.The same mouse threshold of pain before the different time threshold of pain-administration after threshold of pain raising value=administration,
When all threshold of pain raising values are negative, based on 0.It the results are shown in Table 7.
Table 7 causes the influence result (not providing) of mouse pain to hot plate method
As seen from Table 7, mouse threshold of pain no significant difference (P > 0.05) before each group is administered illustrates that grouping is uniform；With blank
Group ratio, is administered 30min, and large dosage of present composition can significantly improve the mouse threshold of pain (P < 0.05)；60min, large dosage is administered
The present composition and JINGFUKANG KELI group can significantly improve the mouse threshold of pain (P < 0.05)；It is administered 90min, this hair of big, middle dosage
Bright composition and JINGFUKANG KELI group are remarkably improved the mouse threshold of pain (P < 0.01)；120min is administered, each administration group is only improved
The trend of the mouse threshold of pain.
3) influence of mouse pain is caused to tail pressurized method
18~21g of weight, Kunming mouse are taken, male is used as tender point, by mouse root of the tail at from mouse root of the tail 1cm
Portion is placed on self-control tenderness instrument, and gradually rotary presser, occurs shouting as pain index with mouse, pressurization of stopping rotating, and reads rotation
Turn lattice numerical value as pain threshold, screen mouse 60 that the tenderness threshold of pain is 9~15 lattice, be randomly divided into 5 groups, gavage respectively it is big or middle,
(2g/kg, 1g/kg, 0.5mg/kg are made into 0.1g/ml, 0.05g/ with 0.5%CMC to low dose of 3 composition suspension of embodiment
Ml, 0.025g/ml, 0.2ml/10g), (5g/kg is made into 0.25g/ml, 0.2ml/ with 0.5%CMC to JINGFUKANG KELI suspension
10g) and the 0.5%CMC of same volume.It is administered once daily, successive administration 5 days, (is deprived of food but not water in last time administration 30min
12 hours), 60min, again by mouse tail root be placed in self-control tenderness instrument on, measure the mouse threshold of pain.It the results are shown in Table 8.
8 bone of table aches the influence that quiet capsule causes mouse pain to tail pressurized method
As can be seen from Table 8, mouse tenderness threshold of pain no significant difference (P > 0.05) before each group is administered illustrates that grouping is uniform；With
Blank group ratio, big, 3 composition of middle dosage embodiment and JINGFUKANG KELI group are remarkably improved the pressure in mouse 30min and 60min
The pain threshold of pain (P < 0.01)
Therefore, the large, medium and small dosage present composition can substantially reduce mouse writhing number in 10min, neck rehabilitation
Grain group can obviously reduce writhing number in mouse 10min.Large dosage of present composition can significantly improve mouse administration 30min pain
Threshold, large dosage of present composition and JINGFUKANG KELI group can significantly improve the mouse administration threshold of pain 60min, this hair of big, middle dosage
Bright composition and JINGFUKANG KELI group are remarkably improved the threshold of pain of mouse administration 90min.Greatly, the middle dosage present composition and neck
Multiple recovering particles group is remarkably improved in the tenderness threshold of pain of mouse 30min and 60min.
Influence of 7 composition of embodiment to rat blood stasis models
Experimental drug: 3 composition of embodiment；JINGFUKANG KELI, the production of Chengde neck rehabilitation medicine company, lot number 110308；Ice vinegar
Acid, Tianjin Heng Xing chemical reagent Manufacturing Co., Ltd, lot number 20100621；Examination is learned in sodium carboxymethylcellulose, perseverance Xinghua, Tianjin
The production of agent Manufacturing Co., Ltd, lot number 20060723；Dexamethasone, Jiangsu Lianshui Pharmaceutical Co., Ltd.'s production, lot number
0912253；Sodium chloride injection, Zhengzhou Yonghe Pharmaceutical Co's production, lot number 11050454.
Experimental animal: rat, SD, cleaning grade are provided by Hebei province's Experimental Animal Center, quality certification number 1108073.
Laboratory apparatus: TGL-16G desk centrifuge, Anting Scientific Instrument Factory, Shanghai's production；Glass point sample capillary (internal diameter
0.5mm, pipe range 100ml), the production of instrument plant, Huaxi Medical Univ；Blood sedimentation tube, Hematocrit tube, Beijing Puli is raw, and instrument has
The production of limit company；Automatic blood rheometer (LBY-N6K), Pulisheng Instruments Co., Ltd., Beijing's production, model: DY89-1；Liver
Plain anticoagulant tube, the production of Shandong Olympic Competition spy Medical Devices Co., Ltd..
Cleaning grade male rat 72 are taken, takes 12 to be only used as blank control group at random, remaining 60 rat makes blood stasis model,
5 groups of rats of modeling are divided in every morning intramuscular injection of dexamethasone sodium phosphate injection 0.2mg/kg (0.1ml/100g), big,
In, low dose of bone aches quiet capsule suspension (1.38g/kg, 0.69g/kg, 0.345mg/kg is made into 0.138g/ with 0.5%CMC
Ml, 0.069g/ml, 0.0345g/ml, 1ml/100g), (3.3g/kg is made into JINGFUKANG KELI suspension with 0.5%CMC
0.33g/ml, 1ml/100g) and same volume 0.5%CMC；Isometric 0.5%CMC is injected and gavaged to blank control group；Daily
Gavage relative medicine in the afternoon；It being administered once daily, successive administration 10 days, the 2h (fasting 12h) after administration in the 11st day, eyeball takes blood,
The clotting time is measured with capillary tube method；It separately takes blood anticoagulant heparin, surveys whole blood viscosity, Plasma Viscosity, erythrocyte sedimentation rate, hematocrit, complete
Blood reduced viscosity, K value.It the results are shown in Table 9.
9 bone of table ache quiet Capsule in Rats blood stasis model hemorheology influence (N=12)
As can be seen from Table 9, with blank control group ratio, model group rats whole blood viscosity height cuts, in cut, undercut, plasma viscosity,
Hematocrit and erythrocyte sedimentation rate significantly increase (P < 0.01), illustrate to make blood stasis model success.With model group ratio, large, medium and small dosage
The present composition and JINGFUKANG KELI group can be such that whole blood viscosity height cuts, in cut, undercut and erythrocyte sedimentation rate significantly reduce (P < 0.01)；
Greatly, the middle dosage present composition and JINGFUKANG KELI group can make plasma viscosity significantly reduce (P < 0.01)；Large dosage of present invention
Composition and JINGFUKANG KELI group can make hematocrit be substantially reduced (P < 0.05).
Influence of the embodiment 8 to rat cervical vertebra disease model
Experimental drug: 3 composition of embodiment；JINGFUKANG KELI, the production of Chengde neck rehabilitation medicine company, lot number 110308；Injection
With Ceftriaxone Sodium, Shanghai Xinya Pharmaceutical Industry Co. Ltd.'s production, lot number 100924；Sodium chloride injection, the pharmacy of Zhengzhou Yonghe County have
The production of limit company, lot number 11050454.
Experimental animal: rat, SD, male, cleaning grade, by Zhejiang Province's Experimental Animal Center quality certification number 0019168.
Laboratory apparatus: Rivlin inclined plate；16 row's spiral X-ray machine of Siemens.
Weight 200-250g male SD rat 60 is taken, is randomly divided into 6 groups, every group rat 10.Wherein 5 groups of rats make neck
Vertebra disease model, modeling rat with after 10% chloraldurate 3.5ml/kg intraperitoneal injection of anesthesia in nape preserved skin, sterile working, just
Middle notch is about 2-3cm, cuts skin, subcutaneous, hemostasis, cutting platysma, head, neck, half spine of atlanto longissimus, costocervicalis and head
Flesh, and cut off 1cm in case the broken ends of fractured bone heal, layer-by-layer suture；Another group is sham-operation group, in addition to not cutting off muscle group, remaining operation
Ibid.Modeling is administered after 10 weeks, 5 groups of modeling gavage respectively large, medium and small 3 composition suspension of dose delivery example (1.38g/kg,
0.69g/kg, 0.345mg/kg are made into 0.138g/ml, 0.069g/ml, 0.0345g/ml, 1ml/100g with 0.5%CMC), neck
The multiple recovering particles suspension (0.5%CMC of (3.3g/kg is made into 0.33g/ml, 1ml/100g with 0.5%CMC) and same volume；It is false
The 0.5%CMC of operation group filling same volume.It is administered once daily, successive administration 4 weeks, is referred to after last 1 time 12 mouse of administration
(motor function evaluates ramp test standard: using improvement Rivlin and Talor method for mark detection.Inclined plate motor function: by rat
Long axis of body is consistent with the inclined plate longitudinal axis, and inclined plate is every to increase 5 °, and rat can stop 10s, record the maximum angle of inclined plate and horizontal plane；
The motor function of inclined plate experimental evaluation is measured with the angle of inclined plate, and angle is lower, power is unbalance, and cervical spondylosis is more serious).
X line piece scoring: after 10% chloraldurate 3.5mL/kg intraperitoneal injection of anesthesia, take the photograph respectively cervical vertebra just, side position x light
Piece；Standards of grading are as follows:
Cervical vertebrae physiological is bent (0-3 points): there is (0 point) in physiological bending, physiological bending is slight stiff (1 point) physiological bending
It loses (2 points), physiological bending completely loses and has recurvation (3 points)；Centrum front and rear edge spur (0-3 points): slight to increase without (0 point)
Raw (1 point), moderate hyperplasia (2 points), severe hyperplasia (3 points)；Vertebra asks that gap is narrow (0-3 points): normal (0 point), mild stenosis (1
Point), moderate stenosis (2 points), severe stenosis (3 points)；Uncovertebral joint and zygapophysial joint (0-3 points): normal (0 point) obscures not
(1 point) clearly, slight hyperplasia harden (2 points), and bright silicon hyperplasia hardens (3 points).Power is unbalance, and the scoring of molded line image is higher, and power is unbalance
Cervical spondylosis is more serious.It the results are shown in Table 10.
10 bone of table aches the influence of quiet Capsule in Rats cervical vertebra disease model
As can be seen from Table 10, with blank group ratio, model group swash plate angle is substantially reduced (P < 0.01), and X-ray film scoring is significant
Increase (P < 0.01), illustrates to make the success of rat cervical vertebra disease model.With model group ratio, the large, medium and small dosage present composition and neck
Multiple recovering particles group can dramatically increase rat swash plate angle (P < 0.01), big, the middle dosage present composition and JINGFUKANG KELI group
Rat X-ray film scoring (P < 0.05) can significantly be mitigated.
9 clinical effectiveness of embodiment
During in July, 2009 in July, 2008-, 3 composition of Application Example treats nerve root cervical vertebra sickness 180, in
To follow-up and compareed with neck rehabilitation Capsules group after half a year, its late result, recurrence rate and safety are evaluated.
In experimental group 180: male 100, female 80, the age is 34.61 ± 6.16 years old average between 21-58 years old, disease
Journey 8 months -6 years；In control group 180: male 112, female 68, the age between 20-60 years old, average 37.52 ± 7.35
Year, the course of disease 7 months -6 years.
Curative effect of disease standard:
(1) clinical recovery: >=95% is reduced before relatively treating after the symptoms such as cervicodynia, numbness or dizziness, sign score treatment；
(2) effective: the symptoms such as cervicodynia, numbness or dizziness, sign score treatment after relatively treat before reduce>=70%,<95%；
(3) effectively: the symptoms such as cervicodynia, numbness or dizziness, sign score treatment after relatively treat before reduce>=30%,<70%；
(4) invalid: to reduce before relatively being treated after the symptoms such as cervicodynia, numbness or dizziness, sign score treatment less than 30%
After treatment end, by statistical analysis, observation group be significantly better than in terms of overall clinical efficacy rate control group (P <
0.05) 11, are specifically shown in Table.
Clinical efficacy comparison after 11 two groups of patient's treatments of table
Two groups are reacted without obvious digestion road in duration of medication, examine blood, urine excrement normal before medication, after duration of medication and drug withdrawal
Rule and Liver and kidney function are showed no results abnormity index, illustrate under normal circumstances, and the present composition is to human body without bad anti-
It answers, safety is good, without apparent toxic side effect.
Claims (5)
1. a kind of Chinese medicine composition for treating nerve root cervical vertebra sickness, it is characterised in that be made of the following components: Rehmannia glutinosa 190~
200g, 190~200g of Cortex Eucommiae, 1~5g of Moschus, 190~200g of Radix Angelicae Sinensis, 90~105g of Radix Notoginseng, 50~62g of olibanum, myrrh 55~
65g, 95~105g of Chinese ephedra, 30~45g of mustard seed, 60~70g of cortex cinnamomi 15~25g Radix Paeoniae Alba, 95~105g of Rhizoma Atractylodis Macrocephalae, 15~25g of Radix Glycyrrhizae.
2. a kind of Chinese medicine composition for treating nerve root cervical vertebra sickness according to claim 1, it is characterised in that by following
Component is made: Rehmannia glutinosa 194g, Cortex Eucommiae 194g, Moschus 3.2g, Radix Angelicae Sinensis 194g, Radix Notoginseng 98g, olibanum 58g, myrrh 58g, Chinese ephedra
98g, mustard seed 39g, cortex cinnamomi 19g, Radix Paeoniae Alba 65g, Rhizoma Atractylodis Macrocephalae 98g, Radix Glycyrrhizae 19g.
3. it is according to claim 1 or 2 treatment nerve root cervical vertebra sickness Chinese medicine composition, it is characterised in that: by with
The preparation of lower section method:
1) recipe quantity Moschus is taken to grind into 100 mesh fine powders；
2) 2/3 Radix Angelicae Sinensis, Radix Notoginseng is taken to be ground into 100 mesh fine powders；
3) 1/3 Radix Angelicae Sinensis, remaining each taste medicine are taken, 10 mesh coarse powder are ground into, adds 8 times of amount water to decoct 2 times, 2 hours every time, decoction liquor was closed
And filter, it is concentrated into relative density 1.2~1.4 under the conditions of 60 DEG C, appropriate amount of starch is added, mixes, is dried to dry cream, crushes
At 100 mesh fine powders；
4) progressively increase principle by equivalent, above-mentioned three kinds of fine powders are uniformly mixed, the Chinese medicine composition is made.
4. the Chinese medicine composition for the treatment of nerve root cervical vertebra sickness according to claim 1 or 2, it is characterised in that: composition
Tablet, granule, oral solution or capsule is made.
5. application of the composition of any of claims 1 or 2 as preparation treatment nerve root cervical vertebra sickness drug.
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