CN105232703B - A kind of Chinese medicine composition and its preparation method and application for treating cervical spondylotic myelopathy - Google Patents
A kind of Chinese medicine composition and its preparation method and application for treating cervical spondylotic myelopathy Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine compositions and its preparation method and application for treating cervical spondylotic myelopathy, it is mainly prepared by Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis, pheretima, Radix Angelicae Pubescentis, Herba Lycopi, pueraria lobata according to a certain weight ratio, it can be prepared to any common peroral dosage form.The traditional chinese medicine composition of the invention has qi and activate blood circulation, inducing diuresis for removing edema, and the effect removed obstruction in channels to relieve pain can safely, effectively treat cervical spondylotic myelopathy, spinal function is promoted to restore, and the pharmaceutical composition also has many advantages, such as no obvious toxic-side effects, without contraindication.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy, and in particular to a kind of Chinese medicine composition for treating cervical spondylotic myelopathy and its system
Preparation Method and application.
Background technique
Cervical spondylotic myelopathy is due to disc degradation and protrusion, centrum rear and uncovertebral joint osteoproliferation, posterior longitudinal ligament
Ossification, hypertrophy of ligamentum flavum or calcification, lead to compression of spinal cord, ischemic, the dysfunction of spinal cord, therefore myeloid form cervical vertebra then occur
Disease is one of spinal cord compression, can seriously be disabled, and the 10%~15% of whole cervical spondylosiss is accounted for, and is clinically to show most in cervical spondylosis
Serious type, serious person can lose activity of daily living.In recent years, it is ground for the TCM basis of cervical spondylotic myelopathy with clinic
Studying carefully becomes hot spot；It there is no generally acknowledged specific treatment medicine at present.
Inventor passes through many years Clinical Exploration, and according to tcm theory, cervical spondylotic myelopathy is main dialectical for qi deficiency to blood stasis
Card, the impetus decline of the deficiency of vital energy then gas so as to cause blood stasis, blood stasis then blockage of main and collateral channels to pain occur；Qi promoting blood production, gas
Empty then blood is also empty, then blood supports effect decline to the deficiency of blood, and skin loses in supporting, may occur in which extremity numbness；Muscles and bones is lost in supporting,
The then symptoms such as visible weakness of limbs, walking shakiness；Blood stasis heat then may occur in which burn feeling.According to tcm theory " gas row then blood
Row, control blood and first control gas " the rules for the treatment of, develop the present composition.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine compositions for treating cervical spondylotic myelopathy.The traditional chinese medicine composition of the invention energy
Effectively treatment cervical spondylotic myelopathy, for promoting spinal function to restore that there is significant effect.
Another object of the present invention is to provide the preparation method of the Chinese medicine composition.
It is a still further object of the present invention to provide the Chinese medicine compositions in preparation treatment cervical spondylotic myelopathy, promotes myeloid form
The application in drug that the postoperative spinal function of cervical spondylosis restores.The traditional chinese medicine composition of the invention is by inhibiting inflammatory mediator and promoting oxygen
The function of radicals scavenging promotes the recovery of spinal function, is mainly used in cervical spondylotic myelopathy and myeloid form cervical vertebra
The postoperative patient of disease.
The purpose of the present invention is what is be accomplished by the following way:
A kind of Chinese medicine composition for treating cervical spondylotic myelopathy, it is mainly made of the bulk pharmaceutical chemicals of following parts by weight:
Radix Astragali 30-40 parts by weight, dried orange peel 8-13 parts by weight, Radix Glycyrrhizae 4-10 parts by weight, ramulus cinnamomi 8-13 parts by weight, Rhizoma Et Radix Notopterygii 8-13
Parts by weight, Radix Salviae Miltiorrhizae 10-25 parts by weight, Poria cocos 8-13 parts by weight, Radix Angelicae Sinensis 15-18 parts by weight, centipede 1-2 parts by weight, rhizoma corydalis 8-
13 parts by weight, pheretima 8-13 parts by weight, Radix Angelicae Pubescentis 8-13 parts by weight, Herba Lycopi 8-13 parts by weight, pueraria lobata 15-18 parts by weight.
The preferably following parts by weight of the present composition:
30 parts by weight of Radix Astragali, 10 parts by weight of dried orange peel, 6 parts by weight of Radix Glycyrrhizae, 10 parts by weight of ramulus cinnamomi, 10 parts by weight of Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae
20 parts by weight, 10 parts by weight of Poria cocos, 15 parts by weight of Radix Angelicae Sinensis, 1 parts by weight of centipede, 10 parts by weight of rhizoma corydalis, 10 parts by weight of pheretima, solely
10 parts by weight, 10 parts by weight of Herba Lycopi, 15 parts by weight of pueraria lobata living.
Above-mentioned Chinese medicine composition, which conventionally can be decocted directly, to be taken or adopts with pharmaceutically acceptable auxiliary material
Any conventional preparation is prepared into the conventional method of Chinese materia medica preparation.Auxiliary material such as disintegrating agent, lubricant, binder etc., it is described
Dosage form is preferably mixture, pill, tablet, powder, granule, capsule or pill.Percentage composition of the present invention is
Weight percentage.
It is preferred that the preparation method of above-mentioned Chinese medicine composition includes the following steps: 5-10 times of gross weight of all bulk pharmaceutical chemicals dosing materials
The water of amount after impregnating 0.5-1 hours, decocts 2-4 times, and 1-2 hours each, filtering, merging filtrate is concentrated under reduced pressure into 45~55 DEG C
When relative density 1.20-1.25, add ethyl alcohol to stir evenly, make medical fluid alcohol content up to 50-70%, stand, filtration, filtrate decompression recycles second
Alcohol simultaneously continues to be concentrated.
Above-mentioned preparation method preferred steps are as follows: all medicinal materials are added into 8 times of water amounts, after impregnating 1 hour, decoct 2 times, every time 2
Hour, it filters, merging filtrate, relative density 1.20-1.25 when being concentrated under reduced pressure into 45~55 DEG C, takes advantage of slightly hot plus ethyl alcohol and stir evenly, make
Medical fluid alcohol content is stood up to 60%, filtration, decompression filtrate recycling ethanol and relative density when continuing to be concentrated into 50~60 DEG C
1.25-1.30。
The traditional chinese medicine composition of the invention can answer in preparation treatment cervical spondylotic myelopathy and the drug for promoting spinal function to restore
With.
Radix Astragali (Radix astragali) nature and flavor are sweet in side, and tepor has the function of tonifying Qi and lifting yang, invigorating qi for consolidating superficies, prevents osmanthus
Branch crosses the disadvantage of sweat, and Radix Angelicae Sinensis (Radix angelicae sinensis) nature and flavor sweet, acrid, warm has the function of promoting blood circulation and stopping pain, tonifying blood and regulating menstruation
Can, Radix Salviae Miltiorrhizae (Radix salviae miltiorrhizae) is bitter in taste, slightly cold, there is promoting blood circulation, the function of cooling blood and relieving pain.Osmanthus
Branch (Ramulus cinnamomi) nature and flavor acrid, sweet, warm have the function of Wen Jing, a surname's numbness, dredging collateral, Rhizoma Et Radix Notopterygii (Rhizoma et radix
Notopterygii) nature and flavor acrid, bitter, warm has the function of dispellieg cold and dampness, Radix Angelicae Pubescentis (Radix angelicae pubescentis)
Nature and flavor are pungent, bitter, tepor, have dispelling wind and eliminating dampness, the function of diffusing impediment and relieving pain.Rhizoma corydalis (Rhizoma corydalis) property acrid, bitter, warm,
Function with promoting flow of qi and blood circulation analgesic, Herba Lycopi (Herba lycopi) nature and flavor are pungent, bitter, tepor, the function with wind-damp dispelling, dried orange peel
(Pericarpium citri reticulatae) is bitter in taste, pungent, warm, has regulating qi-flowing for strengthening spleen, eliminating dampness and eliminating phlegm.Poria cocos (Poria)
Nature and flavor are sweet, light, flat, and the function with invigorating spleen for diuresis, pueraria lobata (Radix puerariae) property is sweet, pungent, cool, there is a liter function for saliva relaxing muscles and tendons.
Centipede (Scolopendra) nature and flavor are pungent, warm, toxic, have relieving convulsion and spasm, the function removed obstruction in channels to relieve pain, pheretima (Pheretima) nature and flavor
It is salty, cold, there is relieving convulsion and spasm, the function removed obstruction in channels to relieve pain, Radix Glycyrrhizae (Radix glycyrrhizae), nature and flavor are sweet, flat, have tonifying Qi beneficial
Spleen and middle emergency, the function of coordinating the drug actions of a prescription.All medicine compatibilities can make the micro- sweat of the heresy of cold-dampness and solve, and disease and evil is gone and healthy tendency is not hurt.
We are using Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae as monarch drug in a prescription, Radix Astragali qi and activate blood circulation, inducing diuresis for removing edema, Chinese angelica blood supplementing promoting blood circulation, and Radix Salviae Miltiorrhizae is living
Blood and dissolving stasis, cooling blood and relieving pain, three medicines are monarch drug in a prescription altogether, gather qi and activate blood circulation altogether, inducing diuresis for removing edema, the function of cooling blood and relieving pain；Ramulus cinnamomi warming meridian,
Eliminating cold to stop pain, notopterygium wind dispelling cold dispelling, expel endogenous wind to relieve convulsion, Radix Angelicae Pubescentis expelling wind and eliminating dampness, eliminating cold to stop pain, the analgesic of rhizoma corydalis blood-activating and qi-promoting, Herba Lycopi
Activating microcirculation and removing stasis medicinal, inducing diuresis for removing edema, dried orange peel qi-regulating eliminating dampness, Poria cocos invigorating the spleen excreting dampness, pueraria lobata promote the production of body fluid relaxing muscles and tendons, and centipede relieving convulsion and spasm, dredging collateral stop
Bitterly, pheretima relieve dizziness, high fever, infantile convulsions, epilepsy, etc., dredging collateral diuresis, ten medicines are ministerial drug altogether, and auxiliary monarch drug in a prescription gathers qi-regulating eliminating dampness, expelling wind and clearing away cold, promoting blood circulation, dredging meridian and relieving pain altogether
Function；Radix Glycyrrhizae coordinating the drug actions of a prescription is to make medicine, and full side's qi-replenishing and blood-enriching medicine compatibility promoting flow of qi and blood circulation medicine gathers qi and activate blood circulation altogether, and inducing diuresis for removing edema leads to
The function of network analgesic makes row then blood of bringing about the desired sensation, no pain by smooth breath.
It is further described below by way of preparation method of the test process to present composition active principle:
1, with the preferred decocting process condition of orthogonal experiment
1) Chinese medicine uses decocting process, and decocting time and number are to influence the fried principal element of effective component, reference
The routine operation that Chinese medicine decocts at present, by four factors, three horizontal progress L9(34) orthogonal test.
| A | Amount of water (again) | 5 | 8 | 10 |
| B | Soaking time (h) | 0 | 1 | 2 |
| C | Decocting time (h) | 1 | 1.5 | 2 |
| D | It decocts number (secondary) | 2 | 3 | 4 |
Be best collocation with solids yield mean-max under each factor different level, then comprehensively consider time saving, saving of labor,
Energy conservation and reference statistical handle conclusion, find out the optimised process of decoction.
2) operating method: taking 10 prescription medicine amounts, under the conditions of operation repetitive, presses L respectively9(34) orthogonal arrage arrangement
Nine experimental conditions decoct, and filtrate surveys dry spun (%), and every part of sample is done three times, and concrete outcome is shown in Table 1.
The L of 1 decocting process of table9(34) orthogonal arrage factor level table
As it can be seen from table 1 C factor influences maximum, it is secondly D, A, B.As seen from table, take second or the third of A horizontal
Preferably, the second level for taking B preferably, takes the third of C horizontal preferably, takes the third of D horizontal preferable, that is, impregnates 2 hours, add water 10
Times, it decocts 2 hours, decocts 4 times.It is verified, it is 25.23% by the technique dry spun, but this technique slightly shows time-consuming energy consumption, and
Using impregnating 1 hour, add 8 times of water amounts, decocts 2 times, 2 hours every time, dry spun 24.10%, the two differed only by 1.13%,
So can preferentially be used in actual production: impregnating 1 hour, add 8 times of water amounts, decoct 2 times, every time 2 hours.
3) purifying of decoction liquor
It is 24.10% by the process solids object yield, being directly made into finished product, daily dosage is bigger than normal, therefore need to be to concentration
Decoction liquor carries out necessary purification process.
Ethanol in proper amount is added in the decocting liquid of concentration can remove starch, natural gum, protein and polysaccharide therein etc.
Ingredient, determining alcohol is different, and the amount for removing impurity has notable difference.According to production experience, before alcohol precipitation the concentration of clear cream with
Relative density 1.20 or so preferably, takes advantage of slightly hot plus ethyl alcohol and carries out alcohol precipitation operation at 45~55 DEG C.Medical fluid is too dilute, and consumption alcohol amount is larger,
Increased costs, and insoluble matter is suspended in alcohol liquid, influences filter operation；Medical fluid is too dense, and sediment is formed comparatively fast, and amount is also more, has
Effect ingredient easily wraps up, and forms precipitating simultaneously, and in addition liquor strength is feeding-up, easily causes adherency loss, therefore thick paste is tentative before this product alcohol precipitation
Relative density 1.20 or so when being 45~55 DEG C.From table 2 it can be seen that again with water-soluble after extract dry when alcohol precipitation concentration is up to 50%
Solution, clarity is preferable, but alcohol precipitation operation is slightly difficult, and sediment suspends in the solution, therefore this product alcohol precipitation concentration is preferably 60%.
2 alcohol precipitation situation analysis table of table
Therefore this product production technology is preferred are as follows: all medicinal materials add 8 times of water amounts, after impregnating 1 hour, and decoction 2 times, 2 hours every time,
Merging filtrate, relative density 1.20~1.25 when being concentrated under reduced pressure into 45~55 DEG C are taken advantage of slightly hot plus ethyl alcohol and are stirred evenly, make medical fluid alcohol content
It up to 60%, stands, filtration, decompression filtrate recycling ethanol simultaneously continues the active component for being concentrated to get drug of the present invention.
Drug of the present invention has qi and activate blood circulation, inducing diuresis for removing edema, and the effect removed obstruction in channels to relieve pain can be applied to preparation treatment myeloid form
Neck
Vertebra disease and the drug for promoting cervical spondylotic myelopathy postoperative nerve functional rehabilitation.
Compared with the prior art pharmaceutical composition of the present invention the utility model has the advantages that results of animal shows Chinese medicine group of the present invention
It closes object and causes mouse writhing reaction model to significantly inhibit to glacial acetic acid, rat spinal cord compression model spinal cord can be promoted
The recovery of function, paraxylene causes mouse ear swelling model to significantly inhibit, by rat chronic spinal compression
Inhibit inflammatory reaction in model, so that the effect for promoting spinal function to restore is played, in the extensive of rat chronic spinal compression model
Multiple process plays the effect for promoting spinal function to restore by improving the function of scavenging activated oxygen in histocyte, and
By 61 Clinical analysis, prove that drug of the present invention has a better effect the recovery of CSM postoperative patient spinal function.This hair
Bright drug is a kind of Chinese materia medica preparation safely, effectively, nontoxic.
Detailed description of the invention
Fig. 1 sham-operation group, NS group and Chinese medicine high concentration group HE coloration result figure.
It is left in figure: the HE dyeing of sham-operation group, in: the HE dyeing of NS group, it is right: the HE dyeing of Chinese medicine high concentration group.
Concentration group, Chinese medicine low concentration group and neck rehabilitation group HE coloration result figure in Fig. 2 Chinese medicine.
It is left in figure: the HE dyeing of concentration group in Chinese medicine, in: the HE dyeing of Chinese medicine low concentration group, it is right: the HE of neck rehabilitation group
Dyeing.
Specific embodiment
The beneficial effect of the present invention will be further illustrated by the following test examples the drug, these test examples include this hair
The pharmacodynamic experiment and clinical observation on the therapeutic effect of bright drug are tested.Pharmaceutical composition group abbreviation Yiqi Huoxue Recipe of the present invention, preparation side
The same embodiment of method.
Test example 1
Pharmaceutical composition of the present invention is to rat spinal cord myelopathy model injured spinal tissue morphological change and impaired group
The influence of interior PGE2, PLA2 content is knitted, experimental result is as follows:
1 material
1.1 drugs and reagent Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis,
Dragon, Radix Angelicae Pubescentis, Herba Lycopi, pueraria lobata, neck rehabilitation (lot number: 490283), physiological saline, alcohol, Iodophor, penicillin, are purchased in Jiangsu
Institute of traditional Chinese medicine, province, pure water, paraformaldehyde is since the laboratory Nanjing University of Traditional Chinese Medicine Tang Zhongying provides, 10% chloraldurate, PGE2、
PLA2Kit, which is purchased, builds up biological study institute in Nanjing, and HE dyeing is surveyed in generation by Nanjing Women and Children Healthcare Hospital.
1.2 animal SD rats, male and female have both, and 60,200 ± 2g is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center,
SPF grades, credit number: SCXK (capital) 2012-0001.
2 methods
2.1 sample preparations take medicinal material to be prepared according to the formula of embodiment 1 and method, and (Chinese medicine presses adult clinical dosage
20 times be scaled high concentration, 10 times be scaled middle concentration, 5 times be scaled low concentration), high concentration is concentrated into 5.4g (crude drug)
ml-1, middle concentration be that high concentration is diluted to 2.7g (crude drug) ml with pure water equimultiple-1, low concentration be by middle concentration pure water etc.
It is diluted to 1.35g (crude drug) ml again-1；After neck rehabilitation mortar fine grinding, 0.17gml is configured to pure water-1；With ten thousand/
One balance weighs 10g chloraldurate, and it is spare to be configured to 10% chloraldurate with 100ml pure water.
2.2 rat spinal cord compression models:
SD rat 60, male and female have both, and 200 ± 2g of weight randomly selects 10, are sham-operation group (only exposure cervical vertebra vertebra
Plate is not stung except vertebral plate, does not cause rat spinal cord compression model), remaining 50 in 10% chloraldurate (0.4mlKg-1) fiber crops
Under liquor-saturated, the hair of rat nape, conventional iodophor disinfection are shaved with shaving machine, drape takes the long 3- of rat cervical vertebra Posterior midline approach
4cm cuts skin, subcutaneous, exposure neck and shoulder part muscle group, and finding spinous process of the seventh cervical vertebrae, (the available hand of all cervical spines touches, most
High prominence is), midsection muscle group is retracted to two sides from bottom to top, along spinous process two sides on No. 23 blade removing spinous process
Adhere to muscle, entire neck bone face can be exposed；It from spinous process of the seventh cervical vertebrae basal part detachment spinous process of the seventh cervical vertebrae and takes out, strikes off
Bone face adhering tissue is spare；The 5th or 6 cervical vertebra plates are up found from spinous process of the seventh cervical vertebrae, are stung except part vertebral plate, and take respective straight
The spinous process of the seventh cervical vertebrae bone block of diameter is implanted into intervertenral space, not occur loosening for degree, and snaps as far as possible to intraspinal tube, to there is upper limb
The twitch of muscle reflectivity is degree, sutures muscle, skin, only, art finishes 80,000 U/ of intramuscular injection penicillin.The continuous muscle note of penicillin
Penetrate 3 days, it is preoperative and it is postoperative need not fasting.It is postoperative to take list in order to avoid injury caused by mouse mutual extrusion is even dead
Cage feeds and is allowed to move freely, and does not lead to rats death 7 in art precisely since anaesthesia dosage controls during modeling, and 3
It may be because operation wound is died so as to cause cachexia greatly very much.
It 2.3 groupings and is administered to make the acute compressing of rat spinal cord switch to spinal cord in chronic compression, postoperative adaptability observation 2 weeks, to
Rat wound is taken after healing substantially mates nursing, and postoperative one day according to ramp test, the improvement Tarlov for improving Rivaling
Rat is randomly divided into 5 groups (i.e. the high, medium and low concentration groups of Yiqi Huoxue Recipe, neck rehabilitation group, NS group), QI invigorating by scoring, BBB scoring
The high, medium and low concentration group of blood circulation promoting recipe, neck rehabilitation group use 1ml100g-1Gastric infusion, NS group and sham-operation group gavage equivalent
(1ml·100g-1) NS, it is administered daily 1 time, continuous 4 weeks.
It is divided into two parts after 2.4 materials materials centered on pressure point, a part is put in save in 4% paraformaldehyde and be used for
HE dyeing, another part puts into liquid nitrogen, after be transferred in -70 DEG C of refrigerators and save, the used time takes out for detecting PLA2、PGE2Contain
Amount.
2.5 statistical analysis experimental datas using 18.0 software of SPSS carry out statistical procedures, measurement data with
It indicates, carries out one-way analysis of variance (ANOVA) and the LSD and Tamhane ' T2 (M) that compare two-by-two are examined, be poor with P < 0.05
It is different statistically significant.
3 results
1、PGE2、PLA2Content: concentration, Chinese medicine high concentration and neck rehabilitation can significantly reduce injured spinal tissue in Chinese medicine
Interior PGE2Content, the Yiqi Huoxue Recipe and neck rehabilitation of each concentration can significantly lower PLA in injured spinal tissue2Content, with
NS group compares that there were significant differences (P < 0.05), shows that Yiqi Huoxue Recipe has the function of inhibiting inflammatory reaction, improves around spinal cord
The hyperalgesic state of tissue, relieves pain, and achievees the effect that treat cervical spondylotic myelopathy, as a result see the table below 3:
PGE in 3 each group rat spinal tissues of table2、PLA2Content
Note: compared with NS group:*P<0.05；**P<0.01；***P<0.001
2, HE dye: see Fig. 1,2, nerve cell inner cell form is intact in sham-operation group, nuclear targeting be it is black-and-blue,
Nucleus is complete, and myeloid tissue's structure is normal, and no vacuole sample changes；The visible a large amount of nerve cell karyopycnosis of NS group, cell are swollen
Swollen, downright bad, visible cicatricial tissue and a large amount of big vacuole sample change in myeloid tissue；The visible a small amount of spinal cord of Chinese medicine high concentration group
Tissue cavity and cicatricial tissue, a small amount of karyopyknosis, there are a large amount of neuron cell around cavity, nucleus distribution by
Gradually integrated distribution；The visible myeloid tissue cavity of concentration group is smaller in Chinese medicine, a small amount of cicatricial tissue and karyopyknosis, nerve cell
Form tends to normally, and endochylema also gradually increases；The visible myeloid tissue of Chinese medicine low concentration group is in a large amount of small vacuole sample change and admittedly
The nucleus of contracting is distributed in free state, the normal neuron cell of existing forms；The visible more vacuole sample of neck rehabilitation group
Change and a small amount of cicatricial tissue, karyopyknosis, meronecrosis around have the neuron cell of normal morphology.
Research shows that tissue suffers oppression, damage can cause inflammatory reaction, PLA2It can promote prostaglandin, leukotriene, thrombus
The secretion of the important inflammatory mediator such as element, platelet activating factor, PGE2As a kind of Inflammatory Mediators, in addition to causing blood vessel dilatation
Outside, moreover it is possible to enhance local vascular permeability, stimulation spinal cord locally generates oedema.
This experiment makes rat spinal cord compression model using autologous rat spinous process of the seventh cervical vertebrae intervertebral implantation legal system to observe not
Yiqi Huoxue Recipe with concentration is to PGE in the morphological observation and injured spinal tissue of injured spinal tissue2、PLA2The shadow of content
It rings, by the research it can be proved that Yiqi Huoxue Recipe improves the hyperalgia shape of spinal cord surrounding tissue by inhibiting inflammatory reaction
State relieves pain, and inhibits the formation of injured spinal tissue vacuole, alleviates denaturation, the necrosis of nerve cell, to reach treatment ridge
The effect of marrow myelopathy.
Shadow of the drug of the present invention of test example 2 to SOD and MDA content in rat spinal cord myelopathy model injured spinal tissue
It rings
1 material
1.1 drugs and reagent Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis,
Dragon, Radix Angelicae Pubescentis, Herba Lycopi, pueraria lobata, neck rehabilitation (lot number: 490283), physiological saline, alcohol, Iodophor, penicillin, are purchased in Jiangsu
Institute of traditional Chinese medicine, province, pure water, 10% chloraldurate (Sinopharm Chemical Reagent Co., Ltd., lot number: 20140115).SOD and MDA examination
Agent box, which is purchased, to be built up biological study institute in Nanjing and is surveyed in generation by its research institute.
1.2 animal SD rats, male and female have both, and 60,200 ± 2g is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center,
SPF grades, credit number: SCXK (capital) 2012-0001.
2 methods
2.1 sample preparations take medicinal material to be prepared according to the formula of embodiment 1 and method, by 20 times of adult clinical dosage
Be scaled high concentration, 10 times be scaled middle concentration, 5 times be scaled low concentration, Chinese medicine high concentration is concentrated into 5.4g (crude drug) ml-1, high concentration is diluted to 2.7g (crude drug) ml with pure water equimultiple by concentration in Chinese medicine-1, Chinese medicine low concentration is by middle concentration pure water
Equimultiple is diluted to 1.35g (crude drug) ml-1；After neck rehabilitation mortar fine grinding, 0.17gml is configured to pure water-1；With very much
One of balance weigh 10g chloraldurate, it is spare to be configured to 10% chloraldurate with 100ml pure water.
2.2 rat spinal cord compression models
SD rat 60, male and female have both, and 200 ± 2g of weight randomly selects 10, are sham-operation group (only exposure cervical vertebra vertebra
Plate is not stung except vertebral plate, does not cause rat spinal cord compression model), remaining 50 in 10% chloraldurate (0.4mlKg-1) fiber crops
Under liquor-saturated, the hair of rat nape, conventional iodophor disinfection are shaved with shaving machine, drape takes the long 3- of rat cervical vertebra Posterior midline approach
4cm cuts skin, subcutaneous, exposure neck and shoulder part muscle group, and finding spinous process of the seventh cervical vertebrae, (the available hand of all cervical spines touches, most
High prominence is), midsection muscle group is retracted to two sides from bottom to top, along spinous process two sides on No. 23 blade removing spinous process
Adhere to muscle, entire neck bone face can be exposed；It from spinous process of the seventh cervical vertebrae basal part detachment spinous process of the seventh cervical vertebrae and takes out, strikes off
Bone face adhering tissue is spare；The 5th or 6 cervical vertebra plates are up found from spinous process of the seventh cervical vertebrae, are stung except part vertebral plate, and take respective straight
The spinous process of the seventh cervical vertebrae bone block of diameter is implanted into intervertenral space, not occur loosening for degree, and snaps as far as possible to intraspinal tube, to there is upper limb
The twitch of muscle reflectivity is degree, sutures muscle, skin, only, art finishes 80,000 U/ of intramuscular injection penicillin.The continuous muscle note of penicillin
Penetrate 3 days, it is preoperative and it is postoperative need not fasting.It is postoperative to take list in order to avoid injury caused by mouse mutual extrusion is even dead
Cage feeds and is allowed to move freely, and does not lead to rats death 7 in art precisely since anaesthesia dosage controls during modeling, and 3
It may be because operation wound is died so as to cause cachexia greatly very much.
It 2.3 groupings and is administered to make the acute compressing of rat spinal cord switch to spinal cord in chronic compression, postoperative adaptability observation 2 weeks, to
Rat wound is taken after healing substantially mates nursing, and postoperative one day according to ramp test, the improvement Tarlov for improving Rivaling
Rat is randomly divided into 5 groups (i.e. the high, medium and low concentration groups of Yiqi Huoxue Recipe, neck rehabilitation group, NS group), QI invigorating by scoring, BBB scoring
The high, medium and low concentration group of blood circulation promoting recipe, neck rehabilitation group use 1ml100g-1Gastric infusion, sham-operation group, NS group gavage equivalent
(1ml·100g-1) NS, it is administered daily 1 time, continuous 4 weeks.
2.4 materials are put into liquid nitrogen after taking out damaged tissues, after be transferred in -70 DEG C of refrigerators and save, the used time takes out for examining
Survey the content of SOD, MDA.
2.5 statistical analysis experimental datas using 18.0 software of SPSS carry out statistical procedures, measurement data with
It indicates, carries out one-way analysis of variance (ANOVA) and the LSD and Tamhane ' T2 (M) that compare two-by-two are examined, be poor with P < 0.05
It is different statistically significant.
The Yiqi Huoxue Recipe and JINGFUKANG KELI of 3 result various concentrations can dramatically increase in rat injured spinal tissue
The content (P < 0.05) of SOD, in Chinese medicine high concentration, Chinese medicine concentration and JINGFUKANG KELI can significantly reduce MDA content (P <
0.05).Show that Yiqi Huoxue Recipe has the function of promoting oxygen radical removing, as a result see the table below 4:
SOD, MDA content in 4 each group rat spinal tissues of table
Note: compared with NS group:*P<0.05；**P<0.01；***P<0.001
Studies have shown that ischemic and anoxic lead to the activation of certain endogenous materials after compression of spinal cord, lead to local free radical
Accumulation makes spinal cord vasopasm, occlusion, and blood flow is further reduced, oedema is aggravated, and causes serious neurological structure and function damage
Even degeneration necrosis.During compression of spinal cord secondary lesion, the oxygen radical that body generates directly is attacked in biomembrane
Unsaturated fatty acid, cause lipid peroxidation, form the lipid peroxide such as MDA.SOD can direct scavenging activated oxygen,
Avoid the injury of active oxygen.Therefore in tissue SOD content the height indirect reaction ability of body scavenging activated oxygen, and MDA
The severity attacked by free radical of height indirect reaction body cell.The two simultaneous determination can reflect oxygen radical indirectly
Content and peroxidatic reaction of lipid intensity, this experiment makes spinal cord using autologous rat spinous process of the seventh cervical vertebrae intervertebral implantation legal system
Compression model observes influence of the Yiqi Huoxue Recipe of various concentration to SOD and MDA content in damaged spinal cord, can by the research
To prove, compared with NS group, the Yiqi Huoxue Recipe and JINGFUKANG KELI of various concentration can dramatically increase rat damaged spinal cord group
The content (P < 0.05) of interior SOD is knitted, concentration and JINGFUKANG KELI can significantly reduce containing for MDA in Chinese medicine high concentration, Chinese medicine
It measures (P < 0.05).Show that Yiqi Huoxue Recipe has the function of promoting oxygen radical removing.
The influence of the pharmaceutical composition paraxylene of the present invention of test example 3 cause mouse ear swelling
1 material
1.1 drugs and reagent Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis,
Dragon, Radix Angelicae Pubescentis, Herba Lycopi, pueraria lobata, dexamethasone, physiological saline are purchased in Jiangsu TCM Hospital, and dimethylbenzene, pure water is by Nanjing
Medical pharmaceutical university Pharmacology Lab provides.
1.2 animal ICR mouse, male, 60,20 ± 2g is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center, and SPF grades, perhaps
It can the number of card: SCXK (capital) 2012-0001.
2 methods
2.1 sample preparations take medicinal material to be prepared according to the formula of embodiment 2 and method, and Chinese medicine presses adult clinical dosage
20 times be scaled high concentration, 10 times be scaled middle concentration, 5 times be scaled low concentration, it is (raw that Chinese medicine high concentration is concentrated into 5.4g
Medicine) ml-1, high concentration is diluted to 2.7g (crude drug) ml with pure water equimultiple by concentration in Chinese medicine-1, Chinese medicine low concentration will in it is dense
Degree is diluted to 1.35g (crude drug) ml with pure water equimultiple-1；0.075mg is configured to pure water after the fine grinding of dexamethasone mortar
ml-1。
The influence of 2.2 paraxylene induced mice ear swellings takes ICR mouse 60, and male, 20 ± 2g of weight is randomly divided into 5
Group, every group 12, group is respectively NS group, Yiqi Huoxue Recipe high concentration group 54gKg-1Concentration group in d group, Yiqi Huoxue Recipe
27g·Kg-1D group, Yiqi Huoxue Recipe low concentration group 13.5gKg-1D group, Dexamethasone group 0.75mgKg-1, using filling
Stomach administration, NS group is by gavaging equivalent (1ml100g-1) NS, dexamethasone and each dosage group of Yiqi Huoxue Recipe be administered daily 5 times,
After continuous 5 day, last dose 1 hour, dimethylbenzene 0.05ml is drawn with microsyringe, is applied to the left ear innner and outer sides of mouse,
Auris dextra is not painted with normal control.Mouse cervical dislocation is put to death after 1 hour, is cut bilateral auricle, is existed respectively with 9mm internal diameter punch
Round auricle is laid at the same position of bilateral auricle, and weighing, record auricular concha quality simultaneously calculate mouse ear swelling degree according to the following formula
And inhibiting rate.
Swelling=left ear ear weight-auris dextra ear weight
2.3 statistical analysis experimental datas using 18.0 software of SPSS carry out statistical procedures, measurement data with
It indicates, carries out one-way analysis of variance (ANOVA) and the LSD and Tamhanes ' T2 (M) that compare two-by-two are examined, be with P < 0.05
Difference is statistically significant.
The Yiqi Huoxue Recipe of the influence various concentration of 3 result paraxylene induced mice ear swellings is substantially reduced dimethylbenzene
Induced mice ear swelling, there were significant differences compared with the control group (P < 0.05), shows the Yiqi Huoxue Recipe of various concentration to two
Toluene induced mice inflammatory reaction significantly inhibits, and as a result see the table below 5:
The influence of 5 Yiqi Huoxue Recipe paraxylene induced mice ear swelling of table
Note: compared with NS group:*P<0.05；**P<0.01
Through the research it can be proved that compared with NS group, the mouse ear swelling of the high, medium and low dosage group of Yiqi Huoxue Recipe
Volume is substantially reduced, then illustrates that Yiqi Huoxue Recipe has the function of inhibiting caused by dimethylbenzene xylene ear swelling, but to mouse ear swelling
Inhibiting rate be not in apparent dose-dependence.It is certain to show that it has for preliminary anti-inflammatory activity research to Yiqi Huoxue Recipe
Anti-inflammatory effect.
4 Yiqi Huoxue Recipe of test example causes the influence of mouse writhing reaction to glacial acetic acid
1 material
1.1 drugs and reagent Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis,
Dragon, Radix Angelicae Pubescentis, Herba Lycopi, pueraria lobata, tramadol hydrochloride slow release tablet, physiological saline are purchased in Jiangsu TCM Hospital, 0.6% glacial acetic acid,
Pure water is provided by Nanjing University of Traditional Chinese Medicine's Pharmacology Lab.
1.2 animal ICR mouse, female, 60,20 ± 2g is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center, and SPF grades, perhaps
It can the number of card: SCXK (capital) 2012-0001.
2 methods
2.1 sample preparations take medicinal material to be prepared according to the formula of embodiment 1 and method, by 20 times of adult clinical dosage
Be scaled high concentration, 10 times be scaled middle concentration, 5 times be scaled low concentration, Chinese medicine high concentration is concentrated into 5.4g (crude drug) ml-1, high concentration is diluted to 2.7g (crude drug) ml with pure water equimultiple by concentration in Chinese medicine-1, Chinese medicine low concentration is by middle concentration pure water
Equimultiple is diluted to 1.35g (crude drug) ml-1；After tramadol hydrochloride slow release tablet mortar fine grinding, 2.5mg is configured to pure water
ml-1；It is placed in the pure water of 100ml with the glacial acetic acid that rubber head dropper draws 0.6ml and is configured to 0.6% glacial acetic acid.
2.2 glacial acetic acid cause mouse writhing model to take ICR mouse 60, and female, 20 ± 2g of weight is randomly divided into 5 groups, every group 12
Only, group is respectively NS group, Yiqi Huoxue Recipe high concentration group 54gKg-1Concentration group 27gKg in d group, Yiqi Huoxue Recipe-1D group, Yiqi Huoxue Recipe low concentration group 13.5gKg-1D group, tramadol hydrochloride slow release tablet group 25mgKg-1, QI invigorating work
Each concentration group in blood side and NS group animal use gastric infusion, and NS group gavages equivalent (1ml100g-1) NS, it is administered daily 1 time, even
It is 5 days continuous；Tramadol hydrochloride slow release tablet group animal gastric infusion 1 time.After mouse fasting (freely intaking) 12 hours, start to test.
After groups of animals last dose 30 minutes, (ip) 0.6% glacial acetic acid solution 1ml100g is injected intraperitoneally in every animal respectively-1.It sees
Mouse starts mouse writhing reaction (abdomen in the time (incubation period) and 20 minutes of writhing after examining and recording 0.6% glacial acetic acid of injection
Portion's recess, stretches hind leg, buttocks raises) number.
2.3 statistical analysis experimental datas using 18.0 software of SPSS carry out statistical procedures, measurement data with
It indicates, carries out one-way analysis of variance (ANOVA) and the LSD and Tamhane ' T2 (M) that compare two-by-two are examined, be poor with P < 0.05
It is different statistically significant.
The Yiqi Huoxue Recipe of influence various concentration of 3 results to glacial acetic acid induced mice writhing response is substantially reduced ice vinegar
The number of sour induced mice writhing response, there were significant differences compared with NS group (P < 0.05), and tramadol hydrochloride slow release tablet group is to ice
Acetic acid, which induces mouse writhing reaction, fairly obvious inhibiting effect (P < 0.001), shows the Yiqi Huoxue Recipe pair of various concentration
Glacial acetic acid induced mice writhing response significantly inhibits, and as a result see the table below 6:
Influence of 6 Yiqi Huoxue Recipe of table to glacial acetic acid induced mice writhing response
Note: compared with NS group:*P<0.05；**P<0.01；***P<0.001
Through the research it can be proved that compared with NS group, the mouse writhing of the high, medium and low dosage group of Yiqi Huoxue Recipe is anti-
The number answered is substantially reduced, then illustrates that Yiqi Huoxue Recipe has the function of that acetic acid is inhibited to cause mouse writhing reaction, but to small
The inhibiting rate of mouse writhing response is not in apparent dose-dependence and analgesic activity not as good as tramadol hydrochloride slow release tablet.To QI invigorating
The preliminary analgesic activity of blood circulation promoting recipe is studied, and shows that it has certain analgesic activity.
The research of spinal cord functional rehabilitation after 5 Yiqi Huoxue Prescription on Rat chronic spinal compression of test example
1 material
1.1 drugs and reagent Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis,
Dragon, Herba Lycopi, pueraria lobata, physiological saline, alcohol, Iodophor, penicillin, is purchased in Jiangsu TCM Hospital, pure water, 10% water Radix Angelicae Pubescentis
Conjunction chloral [Sinopharm Chemical Reagent Co., Ltd., lot number: 20140115], neck rehabilitation [the rich big pharmacy of benefit, lot number:
490283】。
1.2 animal SD rats, male and female have both, and 60,200 ± 2g is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center,
SPF grades, credit number: SCXK (capital) 2012-0001.
2 methods
2.1 sample preparations take medicinal material to be prepared according to the formula of embodiment 1 and method, and Chinese medicine presses adult clinical dosage
20 times be scaled high concentration, 10 times be scaled middle concentration, 5 times be scaled low concentration, it is (raw that Chinese medicine high concentration is concentrated into 5.4g
Medicine) ml-1, concentration is that high concentration is diluted to 2.7g (crude drug) ml with pure water equimultiple in Chinese medicine-1, Chinese medicine low concentration be by
Middle concentration is diluted to 1.35g (crude drug) ml with pure water equimultiple-1；After neck rehabilitation mortar fine grinding, 0.17g is configured to pure water
ml-1；10g chloraldurate is weighed with a ten thousandth balance, it is spare to be configured to 10% chloraldurate with 100ml pure water.
2.2 rat spinal cord compression models
SD rat 60, male and female have both, and 200 ± 2g of weight randomly selects 10, are sham-operation group (only exposure cervical vertebra vertebra
Plate is not stung except vertebral plate, does not cause rat spinal cord compression model), remaining 50 in 10% chloraldurate (0.4mlKg-1) fiber crops
Under liquor-saturated, the hair of rat nape, conventional iodophor disinfection are shaved with shaving machine, drape takes the long 3- of rat cervical vertebra Posterior midline approach
4cm cuts skin, subcutaneous, exposure neck and shoulder part muscle group, and finding spinous process of the seventh cervical vertebrae, (the available hand of all cervical spines touches, most
High prominence is), midsection muscle group is retracted to two sides from bottom to top, along spinous process two sides on No. 23 blade removing spinous process
Adhere to muscle, entire neck bone face can be exposed；It from spinous process of the seventh cervical vertebrae basal part detachment spinous process of the seventh cervical vertebrae and takes out, strikes off
Bone face adhering tissue is spare；The 5th or 6 cervical vertebra plates are up found from spinous process of the seventh cervical vertebrae, are stung except part vertebral plate, and take respective straight
The spinous process of the seventh cervical vertebrae bone block of diameter is implanted into intervertenral space, not occur loosening for degree, and snaps as far as possible to intraspinal tube, to there is upper limb
The twitch of muscle reflectivity is degree, sutures muscle, skin, only, art finishes 80,000 U/ of intramuscular injection penicillin.The continuous muscle note of penicillin
Penetrate 3 days, it is preoperative and it is postoperative need not fasting.It is postoperative to take list in order to avoid injury caused by mouse mutual extrusion is even dead
Cage feeds and is allowed to move freely, and does not lead to rats death 7 in art precisely since anaesthesia dosage controls during modeling, and 3
It may be because operation wound is died so as to cause cachexia greatly very much.
It 2.3 groupings and is administered to make the acute compressing of rat spinal cord switch to spinal cord in chronic compression, postoperative adaptability observation 2 weeks, to
Rat wound is taken after healing substantially mates nursing, and postoperative one day according to ramp test, the improvement Tarlov for improving Rivaling
Rat is randomly divided into 5 groups (i.e. the high, medium and low concentration groups of Yiqi Huoxue Recipe, neck rehabilitation group, NS group), QI invigorating by scoring, BBB scoring
The high, medium and low concentration group of blood circulation promoting recipe, neck rehabilitation group, sham-operation group, NS group animal use 1ml100g-1Gastric infusion, NS group fill
Take equivalent (1ml100g-1) NS, it is administered daily 1 time, continuous 4 weeks.
2.4 rat motor functions observation respectively when starting stomach-filling, stomach-filling 1 week when, 2 weeks when, 3 weeks when, 4 weeks when, use
Ramp test, improvement Tarlov scoring, the BBB for improving Rivaling score and carry out ethological observation to rat.
(1) improve the ramp test of Rivaling: it is oblique that the positive and negative both direction of tested rat point is placed in adjustable rubber face
On plate, measurement animal stops the maximum tilt angle of 10sec on inclined plate, is that the animal is oblique after the angle of both direction is average
The functional perspective of plate test.
(2) improve Tarlov standards of grading: 0 grade: hind leg non-activity cannot bear a heavy burden；1 grade: hind leg is visible movable but cannot
Weight bearing；2 grades: rearing activity is frequently or strong, cannot bear a heavy burden；3 grades: hind leg can support weight, can walk 1-2 step；4 grades: it can walk,
Only slight obstacle；5 grades: walking is normal.
(3) BBB scores: being divided into 0-21 points by rat behavior.
2.5 statistical analysis experimental datas using 18.0 software of SPSS carry out statistical procedures, measurement data with
It indicates, one-way analysis of variance (ANOVA) and the LSD and Tamhane ' T2 (M) that compare two-by-two inspection is carried out when homogeneity of variance, with
P < 0.05 is that difference is statistically significant.
The Yiqi Huoxue Recipe and neck rehabilitation of 3 result various concentrations dramatically increase the inclined plate empirical average degree of Rivaling
Number, Tarlov scoring, there were significant differences (P < 0.05) compared with NS group for BBB scoring, thus promote the recovery of rat spinal cord function,
As a result 7, table 8 and table 9 be see the table below:
Influence (degree) of 7 Yiqi Huoxue Recipe of table to improvement Rivaling ramp test
Note: compared with NS group:*P<0.05；**P<0.01；***P<0.001
Influence of 8 Yiqi Huoxue Recipe of table to improvement Tarlov scoring
Note:*P<0.05；**P<0.01；***P<0.001
The influence that 9 Yiqi Huoxue Recipe of table scores to BBB
Note: compared with NS group:*P<0.05；**P<0.01；***P<0.001
This experiment makes rat spinal cord compression model using autologous rat spinous process of the seventh cervical vertebrae intervertebral implantation legal system, by big
Mouse it is ethological observation to verify influence of the Yiqi Huoxue Recipe to damaged spinal cord functional rehabilitation, by the research it can be proved that with
NS group compares, the high, medium and low dosage group of Yiqi Huoxue Recipe be significantly increased Rivaling inclined plate experiment average degree,
Tarlov scoring, BBB scoring (P < 0.05) illustrate that Yiqi Huoxue Recipe has the function of that rat damaged spinal cord is promoted to restore.
Research of the present invention about functional neurologic recovery after Yiqi Huoxue Prescription on Rat chronic spinal compression, shows benefit
Gas blood circulation promoting recipe has the function of that certain promotion damaged spinal cord restores.
6 present invention treatment postoperative 61 clinical observations of cervical spondylotic myelopathy of test example
1 clinical data
General information choose 2 months in July, -2015 in 2013 all suffered from 2 groups of Jiangsu TCM Hospital's orthopedics and traumatology backbone CSM and
All use patient 61 of neck posterior approach mode.Treatment group totally 23, wherein male 20, female 3；Preoperative JOA scoring
(13.15 ± 1.75) divide, average age (61.6 ± 10.97) year.Control group totally 38, wherein male 28, female 10；It is preoperative
JOA scores (13.03 ± 2.15) point, average age (61.2 ± 12.03) year.2 groups are scored in age, gender and preoperative JOA
Aspect compares, not statistically significant, is comparable.
The diagnostic criteria of 1.2 diagnostic criteria CSM is used using the standard of " Second cervical spondylosis special topic informal discussion summary " [1]
The principle for checking and combining is learned in symptom, sign and influence.
1.3 are included in standard 1) meet CSM diagnosis；2) row neck posterior approach；3) age>30 year old and<85 years old；4) Syndrome Differentiation of Chinese Medicine
Card belongs to impotence card, shows as the weak useless use of muscle muscles and bones impotence, and tetraparesis is powerless, numb, and stride difficulty is very then paralysed, pink tongue,
Tongue fur is thin white, stringy and hesitant pulse.
1.4 exclusion criterias 1) it be not included in standard person；2) there are the apparent heart, brain and other organs serious condition person；3) tight
The pernicious deeline persons such as osteoporosis, Tuberculous disease, the tumour of weight；4) doctor can not be cooperated to observe and record or data
Curative effect person is not evaluated completely without method.
2 treatment methods
The surgical procedure of two groups of patients is completed by same group of doctor, is all made of neck way of escape art formula.
Control group: it is postoperative to give conventional treatment, give 3~5d of broad-spectrum antibiotic anti-infective therapy；Compound formula mannitol 250ml, often
Day 1 time, 3~5d of intravenous infusion；Dexamethasone 5mg, one time a day, 3~5d of intravenous infusion；Celecoxib 0.2g takes orally, 2 times a day, totally 2
Week；Mecobalamin capsules 0.5mg takes orally, 3 times a day.Even served 1 week is 1 course for the treatment of, totally 4 courses for the treatment of.
Treatment group: being expert at after neck posterior approach, and it is oral that Chinese medicine Yiqi Huoxue Recipe is given on the basis of conventional therapy.Recipe group
At: Radix Astragali 30g, dried orange peel 10g, Radix Glycyrrhizae 6g, ramulus cinnamomi 10g, Rhizoma Et Radix Notopterygii 10g, Radix Salviae Miltiorrhizae 20g, Poria cocos 10g, Radix Angelicae Sinensis 15g, centipede 2, prolong
Hu rope 10g, pheretima 10g, Radix Angelicae Pubescentis 10g, Herba Lycopi 10g, pueraria lobata 15g.It is decocted in water for oral dose, daily 1 dose, divides 2 times and take, even served 1 week and treated for 1
Journey, totally 4 courses for the treatment of.
3 clinical observation on the therapeutic effect
3.1 observation index and criterion of therapeutical effect are using the orthopedic association's neck marrow disease criterion (JOA point system) of Japan.It cures:
Improvement rate >=67% of integrated value, clinical manifestation are that compression of spinal cord is improved or had no exacerbation, and neck, limb function are substantially extensive
It is multiple, it does not influence normally to work and work.Improve: improvement rate<67% of integrated value and>=33%, clinical manifestation obtains for compression of spinal cord
To improving or having no exacerbation, original uncomfortable mitigation, neck, limb function are improved.Be not cured: improvement rate < 33% of integrated value faces
Bed shows as compression of spinal cord exacerbation occur, and pain and neck, limb function do not improve.
3.2 statistical method circumferential edges are handled through 18.0 software of SPSS.Qualitative index is described with percentage,
Quantitative target is with mean and standard deviationIt is described.Two groups of comparison statistical analysis use Chi-square Test, and it is corresponding to provide its
P value (P < 0.05 is statistically significant).
3.3 treatment results
3.3.1
10 general curative effect of table (n=60)
Note: compared with the control group,*P<0.05
Table 11JOA scoring
Note: compared with the control group,*P<0.05
As a result: having no the name of disease of CSM in China's traditional medicine, but combine the clinical manifestation of the disease, with " numbness described in Chinese medicine
Card ", " impotence card " are similar.The etiology and pathogenesis of CSM is asthenia with sthenia, and recipe used in this research, which is cured soup by sage, to be added and subtracted, and original side goes out
From " arteries and veins controls metal-inflicted wound because of card " volume 4, created by famous doctor's Zhu Zhenheng.I organizes by Long-term Clinical Observation, adds and subtracts spirit with the party
It is living to use.CSM is postoperative, outside patient's gas consumption blood trouble, blood stasis arteries and veins, the deficiency of vital energy then gas impetus decline so as to cause blood stasis, blood stasis
Then blockage of main and collateral channels is to pain occur；Qi promoting blood production, then blood is also empty for the deficiency of vital energy, the deficiency of blood then blood support effect decline, skin lose in
It supports, may occur in which extremity numbness；Muscles and bones is lost in supporting, then, it is seen that the symptoms such as weakness of limbs, walking shakiness；The clinically side's of sending use
Medicine principle is the viewpoint according to tcm theory " gas row then blood, control blood and first control gas ".Yiqi Huoxue Recipe employed herein has
Qi and activate blood circulation, inducing diuresis for removing edema, the function removed obstruction in channels to relieve pain.Using Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae as monarch drug in a prescription, Radix Astragali qi and activate blood circulation, Li Shui's we disappear
Swollen, Chinese angelica blood supplementing promoting blood circulation, Radix Salviae Miltiorrhizae promoting blood circulation, cooling blood and relieving pain, three medicines are monarch drug in a prescription altogether, gather qi and activate blood circulation altogether, inducing diuresis for removing edema, cool blood
The function of analgesic；Ramulus cinnamomi warming meridian, eliminating cold to stop pain, notopterygium wind dispelling cold dispelling, expel endogenous wind to relieve convulsion, Radix Angelicae Pubescentis expelling wind and eliminating dampness, eliminating cold to stop pain prolong
The analgesic of Hu rope blood-activating and qi-promoting, Herba Lycopi activating microcirculation and removing stasis medicinal, inducing diuresis for removing edema, dried orange peel qi-regulating eliminating dampness, Poria cocos invigorating the spleen excreting dampness, pueraria lobata promotes the production of body fluid easypro
Muscle, centipede relieving convulsion and spasm are removed obstruction in channels to relieve pain, and pheretima relieves dizziness, high fever, infantile convulsions, epilepsy, etc., dredging collateral diuresis, and ten medicines are ministerial drug altogether, auxiliary monarch drug in a prescription gather altogether qi-regulating eliminating dampness,
The function of expelling wind and clearing away cold, promoting blood circulation, dredging meridian and relieving pain；Radix Glycyrrhizae coordinating the drug actions of a prescription is to make medicine, makes row then blood of bringing about the desired sensation, no pain by smooth breath.Pass through 3
Moon Short-term Clinical Observation follow-up discovery, with Yiqi Huoxue Recipe for Treatment CSM postoperative patient, spinal function is largely obtained obviously
Improvement, acceptance rate is apparently higher than control group.Though non-row long term follow-up, treatment group's short term efficacy are obviously in increasing trend.Benefit
Why gas blood circulation promoting recipe can be obviously improved CSM postoperative patient spinal function, and the author thinks to essentially consist in by summarizing: 1) by changing
Kind spinal nerve local circulation, creates the necessary condition of neurological functional recovery；2) inhibit local inflammation, reduce spinal nerve thorn
Swash, eliminates corresponding symptom；3) improve the postoperative problem that has a delicate constitution of patient, provide good whole body base for spinal nerve recovery
Plinth.Therefore, the author thinks that the postoperative spinal cord function of CSM can be improved well from quasi- qi and activate blood circulation, this is further to grind
Study carefully its specific mechanism of action and provides clinical foundation.
7 acute toxicity test of test example
1.1 drugs and reagent Radix Astragali, dried orange peel, Radix Glycyrrhizae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Radix Salviae Miltiorrhizae, Poria cocos, Radix Angelicae Sinensis, centipede, rhizoma corydalis,
Dragon, Radix Angelicae Pubescentis, Herba Lycopi, pueraria lobata, physiological saline are purchased in Jiangsu TCM Hospital.
1.2 animal ICR mouse, male and female have both, and 20,20 ± 2g is provided by Nanjing University of Traditional Chinese Medicine's Pharmacology Lab.SPF
Grade, credit number: SYCK (Soviet Union) 2012-0004.
2 methods
The Chinese medicine composition that 2.1 sample preparations are prepared according to 1 method of embodiment is made into 8.5g (crude drug) ml-1, phase
When in 3 times of adult clinical dosage.
2.2 acute toxicity tests are tested using maximum dosage-feeding method, and ICR mouse 20, half male and half female, administration group 15
Only, NS group 5,2 groups are randomly divided by weight and gender: administration group, NS group.Fasting 12h, during which normal water, interior with most for 24 hours
Big mass concentration 8.5g (crude drug) ml-1, maximum volume (35mlkg that intragastric administration on mice can bear-1) gastric infusion 3 times,
Every 6h is administered once, and 3 times a day, the time is respectively 10:00,16::00,22:00, NS group stomach-filling equivalent (35mlkg-1) NS, most
Terminate fasting after single administration afterwards.The appearance action, reflex activity of mouse, amount of drinking water, stool and urine and survival feelings after observation administration
Condition etc..Including skin, mucous membrane, hair color, eyes, breathing, circulation, autonomous and central nervous system behavior expression, it is observed continuously 7
It.The characteristics of poisoning manifestations of accurate recording mouse and its appearing and subsiding time, toxic reaction and death time, if there is mouse
Death then dissects dead mouse, visually observes the change of the internal organs such as the heart, liver, spleen, lung, kidney, brain, stomach, small intestine, 7 day observation period
After, put to death all animals.
The acute toxicity tests of 3 result Yiqi Huoxue Recipes show the day maximum administration of Yiqi Huoxue Recipe gastric infusion
Amount is 892.5gkg-1(8.5g·ml-1*35ml·kg-1* 3 times), intragastric administration on mice administration after, Yiqi Huoxue Recipe group mouse in addition to
Except in the case of there is administration heel row brown loose stools, other obvious poisoning symptoms are had no, and brown loose stools should be with Yiqi Huoxue Recipe
It is middle related using a large amount of activating microcirculation and removing stasis medicinal, inducing diuresis for removing edema drug, the symptom of row's brown loose stools disappears in 1-2 days after medication
It loses.Each group mouse survives after observation 7 days, and no an example is dead, puts to death all mouse after the test.Yiqi Huoxue Recipe is to mouse
The acute toxicity tests see the table below 12:
The acute toxicity tests table of 12 Yiqi Huoxue Recipe of table to mouse
Learnt by the test of maximum dosage-feeding that it is 3 times a day administered, intragastric administration on mice day maximum dosage-feeding phase
As crude drug 892.5gkg-1, 315 times of adult dosage are equivalent to, each group mouse does not occur obvious urgency under maximum dosage
Property poisoning symptom, survives after 7 days, by the administration accumulated dose (85gkg of Yiqi Huoxue Recipe-1) speculate, LD50 is greater than 85g
kg-1, by the oral acute toxicity grading criteria of compound, Yiqi Huoxue Recipe belongs to practical non-toxic type (LD50 > 5gkg-1) experiment
The result shows that: Yiqi Huoxue Recipe is without acute toxicity, and the medicine is in this dosage range using being safe.
Embodiment 1
The water that each 8 times of raw medicinal material dosing material gross weight are measured after impregnating 1 hour, decocts 2 times, 2 hours every time, filters, close
And filtrate, relative density 1.20~1.25 when being concentrated under reduced pressure into 45~55 DEG C, it takes advantage of the ethyl alcohol that slightly hot plus mass concentration is 95% and stirs
It is even, make medical fluid alcohol content up to 60%, stand 24 hours, filtration, decompression filtrate recycling ethanol simultaneously continues that obtained medicine of the present invention is concentrated
The active component of object.
Embodiment 2
The water that each 8 times of raw medicinal material dosing material gross weight are measured after impregnating 1 hour, decocts 2 times, 2 hours every time, filters, close
And filtrate, relative density 1.20~1.25 when being concentrated under reduced pressure into 45~55 DEG C, it takes advantage of the ethyl alcohol that slightly hot plus mass concentration is 95% and stirs
It is even, make medical fluid alcohol content up to 60%, stand 24 hours, filtration, decompression filtrate recycling ethanol simultaneously continues that obtained medicine of the present invention is concentrated
The active component of object.
Embodiment 3
The water that each 8 times of raw medicinal material dosing material gross weight are measured after impregnating 1 hour, decocts 2 times, 2 hours every time, filters, close
And filtrate, relative density 1.20~1.25 when being concentrated under reduced pressure into 45~55 DEG C, it takes advantage of the ethyl alcohol that slightly hot plus mass concentration is 95% and stirs
It is even, make medical fluid alcohol content up to 60%, stands 24 hours, filtration, decompression filtrate recycling ethanol and when continuing to be concentrated into 50~60 DEG C
The active component (medicinal extract) of drug of the present invention is made in relative density 1.25~1.30.
Embodiment 4
Medicinal extract is prepared according to the concentration of 1 method of embodiment, then through dry obtained dry extract, by active component: Icing Sugar: paste
The weight ratio of smart (1:1:2.5) is pelletized, 80 DEG C of dryings, and aluminium foil bag is filled after whole grain and mixing to get the granule being prepared.
Embodiment 5
Medicinal extract is prepared according to the concentration of 1 method of embodiment, then through dry obtained dry extract, is added after dry extract is crushed
Particle is prepared according to common process in the auxiliary materials such as starch, then tablet is made in tabletting.
Embodiment 6
Medicinal extract is prepared according to the concentration of 1 method of embodiment, then through dry obtained dry extract, is added after dry extract is crushed
Particle is prepared according to common process in the auxiliary materials such as starch, then filling gelatine capsule leather obtains capsule.
Embodiment 7
Medicinal extract is prepared according to the concentration of 1 method of embodiment, then through dry obtained dry extract, is added after dry extract is crushed
Honeyed bolus is prepared according to common process in auxiliary material.
Embodiment 8
Medicinal extract is prepared according to the concentration of 3 method of embodiment, then through dry obtained dry extract, is added after dry extract is crushed
Dripping pill is prepared according to common process in auxiliary material.
Claims (7)
1. a kind of Chinese medicine composition for treating cervical spondylotic myelopathy, it is characterised in that it is made of the bulk pharmaceutical chemicals of following parts by weight:
Radix Astragali 30-40 parts by weight, dried orange peel 8-13 parts by weight, Radix Glycyrrhizae 4-10 parts by weight, ramulus cinnamomi 8-13 parts by weight, Rhizoma Et Radix Notopterygii 8-13 weight
Part, Radix Salviae Miltiorrhizae 10-25 parts by weight, Poria cocos 8-13 parts by weight, Radix Angelicae Sinensis 15-18 parts by weight, centipede 1-2 parts by weight, rhizoma corydalis 8-13 weight
Measure part, pheretima 8-13 parts by weight, Radix Angelicae Pubescentis 8-13 parts by weight, Herba Lycopi 8-13 parts by weight, pueraria lobata 15-18 parts by weight.
2. Chinese medicine composition according to claim 1, it is characterised in that it is made of the bulk pharmaceutical chemicals of following parts by weight:
30 parts by weight of Radix Astragali, 10 parts by weight of dried orange peel, 6 parts by weight of Radix Glycyrrhizae, 10 parts by weight of ramulus cinnamomi, 10 parts by weight of Rhizoma Et Radix Notopterygii, 20 weight of Radix Salviae Miltiorrhizae
Measure part, 10 parts by weight of Poria cocos, 15 parts by weight of Radix Angelicae Sinensis, 1 parts by weight of centipede, 10 parts by weight of rhizoma corydalis, 10 parts by weight of pheretima, Radix Angelicae Pubescentis 10
Parts by weight, 10 parts by weight of Herba Lycopi, 15 parts by weight of pueraria lobata.
3. Chinese medicine composition according to claim 1 or 2, it is characterised in that the composition and pharmaceutically acceptable auxiliary material system
At dosage form.
4. Chinese medicine composition according to claim 3, it is characterised in that the dosage form is mixture, pill, tablet, dissipates
Agent, granule, capsule or pill.
5. a kind of preparation method of Chinese medicine composition of any of claims 1 or 2, it is characterised in that this method includes following step
It is rapid:
By each 5-10 times of gross weight water measured of all bulk pharmaceutical chemicals dosing materials, after impregnating 0.5-1 hours, decoct 2-4 times, each 1-2 is small
When, filtering, merging filtrate, relative density 1.20-1.25, adds ethyl alcohol to stir evenly when being concentrated under reduced pressure into 45~55 DEG C, makes medical fluid alcohol-containing
Amount reaches 50-70%, stands, and filtration, decompression filtrate recycling ethanol simultaneously continues to be concentrated.
6. Chinese medicine composition of any of claims 1 or 2 is preparing qi and activate blood circulation, inducing diuresis for removing edema, in the drug removed obstruction in channels to relieve pain
Using.
7. Chinese medicine composition of any of claims 1 or 2 is in preparation treatment cervical spondylotic myelopathy and promotes cervical spondylotic myelopathy art
Application in the drug of neurological functional recovery afterwards.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104435195A (en) * | 2014-11-25 | 2015-03-25 | 成都市飞龙水处理技术研究所 | Orally-taken medicine for treating cervical spondylosis and preparation method thereof |
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2015
- 2015-11-02 CN CN201510731884.2A patent/CN105232703B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104435195A (en) * | 2014-11-25 | 2015-03-25 | 成都市飞龙水处理技术研究所 | Orally-taken medicine for treating cervical spondylosis and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 中药内服配合推拿手法治疗神经根型颈椎病82例;于向荣等，;《现代中医药》;20110131;第31卷(第1期);第35页 |
| 圣愈汤加减对脊髓型颈椎病术后脊髓功能状态的干预;夏建龙等，;《中国实验方剂学杂志》;20101130;第16卷(第15期);第201-204页 |
| 手法配合颈痛方治疗神经根型颈椎病250例;王德隆;《中国骨伤》;19981130;第11卷(第6期);第88-89页 |
| 益气活血方对脊髓型颈椎病患者术后脊髓功能的影响;张竞亮等，;《安徽中医药大学学报》;20140630;第33卷(第3期);第56-58页 |
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