CN101513510A - Traditional Chinese medicine compound preparation for treating spinal cord injury and method for preparing same - Google Patents
Traditional Chinese medicine compound preparation for treating spinal cord injury and method for preparing same Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine compound preparation (Jisuikang) for treating spinal cord injury (SCI) and a method for preparing same. The compound preparation is prepared from the following components by a certain proportion: milk veteh, root of red rooted salvia, hemlock parsley, red paeonia, Chinese angelica, leech, centipede, Chinese rhubarb, rhizoma alismatis, Tuckahoe, dried immature fruit of citron orange, bark of magnolia, broomrape, herba epimedii, Chinese Polyphaga, plantain seed and bitter cardamom. The method comprises the following steps: adding water to Chinese angelica, hemlock parsley, dried immature fruit of citron orange and bark of magnolia and soaking; extracting volatile oil by adopting the vapor distillation method; adding water to the residues of the volatile oil and the other 13 components, decocting for twice and concentrating the filter liquor; carrying out the alcohol extraction with alcohol and concentrating; adding the volatile oil and evenly stirring; and adding excipients of different preparation forms and preparing into oral liquid, granules, capsules or tablets by adopting the conventional preparation method. According to pharmacologic tests and clinical application results, the compound preparation has the analgesic and anti-inflammatory effects, and the overall effect on treating SCI is better than that in the existing report of the like product; the recovery rate of the compound preparation reaches above 95%; good clinical results are achieved; furthermore, the compound preparation has the advantages of low price and convenient administration.
Description
One, technical field:
The present invention relates to field of Chinese herbal medicine technology, relate to a kind of compound Chinese medicinal preparation and preparation method for the treatment of spinal cord injury specifically.
Two, background technology
(mostly spinal cord injury SCI) is that wound causes spinal cord or cauda equina nerve generation damage in various degree, causes its impaired plane following motion, sensation, reflection and sphincter dysfunction to spinal cord injury.According to statistics, the sickness rate of SCI is 2,0/1,000,000～4,0/1,000,000 in the world wide, and main cause is high falling, vehicle accident and sports etc., and Chang Bingfa accounts for 14% of spinal fracture in spinal fracture.Because its pathology is complicated, western medical treatment mainly is an operative treatment, reduction fracture dislocation of spine as early as possible, and stabilizing spine, early stage decompression to the regenerated treatment of spinal nerves, is still located the experimental stage.In recent years, Chinese medicine has one's own knack to the treatment of SCI and has obtained some progress.
1 Chinese medicine
Chinese medicine SCI often carries out by stages, and the initial stage hinders because of the bone break the muscle, the governor vessel damage, and the stagnant network resistance of the stasis of blood, the zang-fu organs qi movement disorder, imbalance of YIN and YANG, quadriplegia, two constipations are puckery, control suitable circulation of qi promoting repercussive, expel the heat-evil the mediation governor vessel under rushing down.With the passing of time middle and late stage hinders network resistance because of superintending and directing, the QI and blood consume, the internal organs weakness, insufficiency of kidney-YANG, it is not normal gasify, limbs wither weak need not, urinary incontinence or acraturesis, constipation, controlling should reunion of bone, kidney invigorating and YANG supporting, temperature three-way meridian.LuBing Quan looses with Ma Dan and treats patient's SCI 20 examples, does not have function by Frankle grading standard 3 routine A levels and recovers, and all the other 17 routine major parts have been recovered former work.Ma Dan is diffusing, and composition is Radix Salviae Miltiorrhizae, Semen Strychni, equal energy blood circulation promoting and blood stasis dispelling, and microcirculation improvement improves blood supply, stops the downright bad again of spinal cord.Su Yin etc. think that Semen Strychni can produce the treatment principle of similar heavy dose of steroid but do not have the toxic and side effects of steroid, and the electrophysiologic response of its excited spinal cord and bulbar center is exhaled prevention and is declined, and reduces the positive effect that has that central high fever reacts and answer acute ulcer.But in use should strict control dosage and attention processing procedure.The thunder Qingyun is early stage SHENMAI ZHUSHEYE treatment SCI 13 examples of using on the basis of Comprehensive Treatment, result's 3 examples of fully recovering, produce effects 9 examples, invalid 1 example, Lei Shi thinks that spinal cord injury often causes injury vasospasm, organize congestion and edema, produce Hypoxia and ischemia, and the Radix Ginseng in the SHENMAI ZHUSHEYE has the tissue of raising to anoxybiotic tolerance, and have the heart tonifying function, can promote the operation of blood, thereby improved microcirculation, alleviated degeneration, the necrosis of tissue, so just favourable tissue repair regeneration, and Radix Ginseng can be accelerated the conduction of neural impulse, increases the effect of trained reflex.Therefore conduction may also have certain assosting effect to the neural impulse after the damage.
Heating, urinary tract infection etc. all are common complications of patient SCI.The traditional Chinese medical science thinks, heating belongs to fever due to yin deficiency behind the SCI, is the big wound in cloudy Tianjin, or feels exopathogen again after the impairment of YIN and cause, and treatment is when according to the diathermanous method of yin nourishing, the side of sending group medicine, and also very important benefiting vital QI and blood, taste, to reach equilibrium between yin and yang, taste perfect, and QI and blood is vigorous.Zhang Shaodong etc. are clinical in heating 8 examples behind the sweet wormwood herb and turtle shell Tonga flavor treatment SCI, and fever of the body all moves back.The governor vessel damage, deficiency of kidney-QI is the main syndrome of SCI, the principles of formulating prescriptions kidney-replenishing of paraplegia health electuary such as Xu Jianpeng, the dredging DU Meridian arteries and veins, promoting blood circulation to remove obstruction in the collateral significantly improves the urine S-IgA of paralyses patient, and the urinary tract infection incidence rate obviously descends.
2 acupuncture
To the treatment of SCI, acupuncture is the method for the homely usefulness of most doctors always, and its effect also is sure.The differentiation of syndromes of meridian of traumatic paralysis is that governor vessel is impaired, qi depression to blood stasis, and venation is obstructed, and acupuncture can be led to accent governor vessel yang-energy, makes the strong marrow of kidney completely reach therapeutic purposes.According to this theory, based on acupuncture, at Spinal Cord two ends inserting needle end to end, 20 examples according to different symptoms point selection treatment based on syndrome differentiation such as quadriplegia, paraplegia and vesical dysfunctions, are treated again altogether by through sick institute in quiet, and effective percentage reaches 90%.Li Taoying thinks that the folder governor vessel follows urinary bladder channel outward in the paravertebral point, all has corresponding posterior ramus of spinal nerve companion row and arteriovenous to distribute under every cave.Muscular tension can be adjusted in this cave of acupuncture, the alleviating vascular spasm, mediation governor vessel and urinary bladder channel improve the partial nutriture of pathological changes, and can directly stimulate posterior ramus of spinal nerve through the cave, regulate its function of nervous system, muscle is shunk strongly, reduce the dysfunction of spinal cord, impel impaired neuranagenesis, tolerations such as the compressing that raising spinal nerves cell causes pathological changes, anoxia, thus the limb function of paralysis is recovered gradually.Xu Jianpeng etc. are the main Chinese medicine paraplegia health treatment spinal cord injury that cooperates with the electro-acupuncture on Du meridian, to improving sensation, the dyskinesia, local circulation obstacle, muscular spasm and the pain of suffering from limb, improving bladder function and sexual dysfunction all has satisfied curative effect.
Detrusor of bladder can not shrink and will cause urine retention behind the SCI, has increased the chance of urinary tract infection.The traditional Chinese medical science thinks that acupuncture can be regulated bladder function, influences spinal micturition center, promote the foundation of low level reflex arc, the contraction and the musculus sphincter of external urethra that cause detrusor are open, the dysuria of bladder is got rid of, thereby prevented to put for a long time the urinary system infection that catheter causes.Sp 6 is the cave of spleen, liver, the intersection of kidney three yin meridians, liver controlling conveyance and dispersion, and kidney master folding, The spleen has the function to transport and transform nutrients, and the three yin meridians network can be dredged in this cave of acupuncture, opens water channel, dredges a surname's part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels functioning of bladder and makes and urinate logically.Bu Guangping and Liu Jinjun all pull out catheter with acusector sp 6 treatment SCI urine retention after the treatment.
Spinal injury merges patient SCI, and through the early treatment, it is stable that spinal column recovers, and all emphasizes to carry out in early days functional exercise.For the stable paralyses patient that no longer recovers of function of nervous system, though recover through rehabilitation function of nervous system, its movable function still can have quite significantly progressively, for the research of treatment in this respect, remains the scholar further to be explored again.
In sum, treatments such as Chinese medicine, acupuncture can improve Spinal Cord district microcirculation, promote the reparation of neuron and nerve fiber, thereby have promoted the recovery of SCI, and effectively prevent the generation of complication.As seen, the effect of Chinese medicine SCI is sure, and its wide prospect is arranged, but its definite theoretical basis and therapeutic scheme are still waiting further research and standard.
According to statistics, the sickness rate of SCI is about 20～4,0/1,000,000 in the world wide, and along with the fast development of traffic and building industry, incidence rate rises year by year." domestic research to treatment by Chinese herbs spinal cord injury at present mainly rests on the experimental stage, and clinical research only sporadically appears in indivedual clinical reports, does not make systematic study.
Three, summary of the invention:
1. technical problem to be solved by this invention:
Provide a kind of compound Chinese medicinal preparation for the treatment of spinal cord injury and preparation method thereof.
2. the compound Chinese medicinal preparation (spinal cord health) of treatment spinal cord injury is characterized in that this compound Chinese medicinal preparation is made by following materials of weight proportions medicine:
Radix Astragali 20-30 gram, Radix Salviae Miltiorrhizae 20-30 gram, Rhizoma Chuanxiong 10-16 gram, Radix Paeoniae Rubra 10-16 gram, Radix Angelicae Sinensis 10-16 gram, Hirudo 8-12 gram, Scolopendra 5-10 gram, Radix Et Rhizoma Rhei 8-12 gram, Rhizoma Alismatis 10-16 gram, Poria 10-16 gram, Fructus Aurantii Immaturus 10-16 gram, Cortex Magnoliae Officinalis 10-16 gram, Herba Cistanches 10-16 gram, Herba Epimedii 10-16 gram, Eupolyphaga Seu Steleophaga 10-16 gram, Semen Plantaginis 15-20 gram, Fructus Alpiniae Oxyphyllae 8-12 gram.
The preparation method of above-mentioned compound Chinese medicinal preparation is characterized in that preparation process is as follows:
(1). get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis and soak, extract, collect volatile oil with steam distillation, standby;
(2). the medicinal residues behind the said extracted volatile oil and all the other 13 flavor Chinese medicines are merged, decoct with water, filter, filtering residue decocts with water again, filters, and merges decoction liquor twice, concentrates;
(3). add ethanol in above-mentioned concentrated solution, leave standstill cold preservation, filter, also concentrated, static after-filtration or centrifugal add above-mentioned volatile oil, stir evenly behind the decompression recycling ethanol;
(4). add the relevant adjuvant of different dosage form,, make oral liquid, granule, capsule or tablet with conventional formulation method.
Above-mentioned preparation method is characterized in that getting in the step (1) Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis and soaked 2-2.5 hour, extracts 4-6 hour with steam distillation.
Above-mentioned preparation method, it is characterized in that merging, add 12 times of water gagings at medicinal residues described in the step (2) and all the other 13 flavor medicines, decocted 2-2.5 hour, filter, filtering residue adds 10 times of water gagings again, decocts 1-2 hour, filters, merge filtrate twice, being concentrated into medicine liquid volume and medical material weight ratio is 1: 0.8-1.2.
Above-mentioned preparation method is characterized in that adding in the step (3) ethanol and reaches 60% to containing the alcohol amount, leaves standstill cold preservation 22-26 hour, filters, and decompression recycling ethanol and measured value when being concentrated into 1.05,60 ℃ of relative densities leave standstill and filter after 22-26 hour or centrifugal.
The application of above-mentioned compound Chinese medicinal preparation in preparation treatment spinal cord injury medicine.
3. the compound Chinese medicinal preparation among the present invention (spinal cord health) shows to have following remarkable result through the result of pharmacological testing:
(1) analgesic activity of spinal cord health research:
Purpose: observation spinal cord health is to mice analgesic activity method: adopt hot plate method, two kinds of methods of writhing method, observe the mice pain reaction that spinal cord health 12.5g/kg, three dosage groups of 25g/kg, 50g/kg cause hot plate and turn round body times influence result; Pain threshold due to the hot plate of two dosage groups raisings of spinal cord health 25g/kg, 50g/kg mice stimulates compares (P＜0.05) with model group.Spinal cord health 25g/kg dosage group can prolong the incubation period that acetic acid causes that writhing response occurs, with model group relatively there were significant differences (P＜0.05, P＜0.01〉conclusion; Prompting spinal cord health has certain analgesic activity to chemical, physical property stimulation.
(2) antiinflammatory action of spinal cord health research
1. the spinal cord health is to the influence of mice granuloma induced by implantation of cotton pellets weight change
Spinal cord health 50g/kg dosage group all can obviously reduce granulation tissue weight as a result, with the normal saline group significant difference (P＜0.05) is arranged relatively.The effect that prompting spinal cord health has certain anti-chronic property inflammation.
2. the spinal cord health is to the influence of vascular permeability
The result shows: two dosage groups of spinal cord health 12.5g/kg, 25g/kg all can suppress acetic acid induced mice abdominal cavity capillary permeability to be increased, with model control group significant difference (P＜0.05 is arranged relatively, P＜0.01), prompting spinal cord health has certain antiinflammatory action.
(3) the anti-spinal cord injury effect research of spinal cord health
The result shows; The gradient that rat climbs plate after the modeling obviously descends, and 3 dosage groups were recovered since the 7th day, with model group notable difference (P＜0.05) is arranged relatively in 7,14 days.
The two hind leg function of nervous system of rat obviously descend after the modeling, and 3 dosage groups of spinal cord health were recovered since the 3rd day, with model group notable difference (P＜0.05) are arranged relatively in 3,7,14 days.Prompting spinal cord health can be improved the two hind leg function of nervous system of Spinal Cord Injury in Rats due to the weight method, has certain anti-spinal cord injury effect.
Urinary incontinence, hematuria all appearred in each spinal cord injury animal in the 2nd day, disappear in 3-5 days, and its urinary incontinence, hematuria be the no significant difference of each group on light and heavy degree, persistent period and extinction time.
Pathological examination results shows: historrhexis all appears in the model group rat spinal cord, and tissue has the blister cavities that forms behind the hemorrhage and hemorrhagic necrosis than splintery.Neurocyte swelling is more obvious, and the neurocyte that has is beyond recognition, and the cinereum matter boundary is unclear, and central canal partly disappear or off normal, the adhesion of spinal cord edge.That the heavy dose of group of administration rat spinal cord is organized is hemorrhage, degree of necrosis is lighter, and it is few to form blister cavities, and neurocyte swelling is not obvious, and neurocyte is abundant, white matter district edema, spinal cord cortical areas blur margin.Middle dosage group neurocyte is few, and the subregion has the cavity to form edge adhesion, central canal off normal.Small dose group white matter district edema, wherein a side has the cavity to form.The strong positive group is similar to heavy dose of group, and the edge adhesion is not obvious.
The present invention carries out clinical research simultaneously on the basis of experiment, not only proof " spinal cord health " has confirmed " spinal cord health " therapeutic effect to people's spinal cord injury simultaneously more clinically to the therapeutical effect of animal spinal cord damage.
The present invention sets forth the treatment mechanism of Chinese medicine to spinal cord injury from analgesia, antiinflammatory aspect first, has opened up new approaches, the new method of treatment by Chinese herbs spinal cord injury experimentation.Adopt Allen ' s method to carry out the animal modeling simultaneously, from the anti-spinal cord injury effect of function and morphology confirmation " spinal cord health ".Patient's random packet, observe motion, sensation scoring and spinal cord injury classification situation simultaneously in the clinical research, avoid single index that the drawback of spinal cord injury can not be described fully, " spinal cord health " therapeutical effect to spinal cord injury is described from many aspects.Clinical evaluation all adopts numeral that spinal function is quantized, and makes the result more accurate credible, compares with the curative effect in the report, and total effect of Chinese medicine " spinal cord health " treatment is significantly better than similar report (recovery rate reaches more than 95%).Result of study finds that also medicine does not become parallel relation to the therapeutical effect of spinal cord injury motion and sensation.
" spinal cord health " belongs to pure Chinese medicinal preparation, form by traditional Chinese medical science traditional theory prescription, through modern science and technology proof determined curative effect, and complication such as electrolyte disturbances that Western medicine occurs such as life-time service diuretic, steroid, edema, resistance reduction, easy infection have been avoided, take for a long time, have no side effect, for therapy of combining Chinese and Western medicine spinal cord injury has been opened up new road." spinal cord health " is cheap, and taking convenience obtains the favorable comment of extensive patients in clinical use, obtain good clinical effectiveness.The whole nation is annual to be had surplus in the of 40,000 the people just bearing spinal cord injury to bring their misery approximately, and the definite curative effect of " spinal cord health " they expected just, it can effectively improve the motion and the general function of patients with spinal cord injury, improve these patients' quality of life and living standard greatly, and make their social construction of having an opportunity to join in once more, create social value, so its wide use promotion prospect will bring immeasurable economy and social benefit.
" spinal cord health " added by BUYANG HUANWU TANG, decoction for removing blood stasis, Xiao Chengqi Tang etc. and simplifies sanction, prescription has Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Astragali, Radix Salviae Miltiorrhizae, Eupolyphaga Seu Steleophaga, Radix Paeoniae Rubra, Herba Epimedii, Radix Et Rhizoma Rhei etc., selected all medical instrument blood circulation promoting and blood stasis dispelling rush down heat clearing away down, the merit of tonneau governor vessel.Reuse the vigour of the big tonifying the spleen and stomach of the Radix Astragali among the spinal cord Kang Fang, as a means of source of generating QI and blood, make gas prosperous capable with short blood, the stasis of blood is removed ruton, blood stasis dispelling and just not hindering, and help the power of all medicines, be to be monarch drug; Chinese Angelica blood replonishing and battalion, YANG promoting growth while YIN promoting generation so then, the prosperous gas of blood is given birth to, and has blood stasis dispelling not hinder the wonderful of blood; The pain relieving of CHUANSHAO promoting flow of QI and blood is ministerial drug altogether; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra all can activating blood circulation to dissipate blood stasis and dredge the collateral, and Radix Paeoniae Rubra still can clearing away heat and cooling blood, prevent and treat body intractable fever after the spinal cord injury; Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga are insect medicine, equal energy drastically removing blood stasis and resolving static blood, and wherein Scolopendra, Eupolyphaga Seu Steleophaga still have the effect of removing obstruction in the collateral to relieve pain, reunion of fractured tendons and bones; Herba Epimedii, Herba Cistanches tonification kidney yang, the reinforcing primordial QI reinforcing; Radix Et Rhizoma Rhei, Cortex Magnoliae Officinalis, long-pending reality are Xiao Chengqi Tang, energy purging heat to relax the bowels, circulation of qi promoting dissipating blood stasis; Herba Lycopi, Rhizoma Alismatis, Semen Plantaginis are share promoting diuresis to eliminate damp pathogen, and clearing heat and freeing strangury does not effectively solve after the spinal cord injury two just freely, and damp-heat gonorrhoea more than is adjuvant drug.All medicines share the effect of playing blood circulation promoting and blood stasis dispelling, regulating QI to relieve pain, the multiple marrow of collateral dredging, diuresis relieving constipation altogether, and are consistent with total rule of treatment of " blood stasis dispelling dredging DU Meridian, liver and kidney tonifying, QI and blood regulating ".Can improve Spinal Cord district microcirculation and hypoxic-ischemic state, effectively improve the function of internal sphincter of urinary bladder, regulate energy metabolism and keep water-electrolyte balance, alleviate pathological changes such as hemorrhage, edema, promote the recovery of spinal cord injury, prevent the spinal cord secondary injury, avoid occurring complication such as urinary tract infection.
The pharmacological testing that carries out with the spinal cord health of compound Chinese medicinal preparation of the present invention development.
1 test material
1.1 test drug and reagent
Spinal cord health: 4.8g (crude drug)/g (extractum) 76.5g (crude drug)/60kg provides lot number 030701 by Jiangsu TCM Hospital
Tramadol hydrochloride: the safe company limited of German Glan, lot number 20030522
Glacial acetic acid: Nanjing chemical reagent factory lot number 040319
Ibuprofen: Zhangjagang City, Jiangsu pharmaceutical factory lot number 040412
Aspirin: water-soluble of aspirin, Astra (Wuxi) pharmaceutical Co. Ltd, lot number 20030927.
Pentobarbital sodium: Beijing chemical reagents corporation, 020402, Q (H82-F158-2002)
Dexamethasone injection: the permanent auspicious pharmaceutical Co. Ltd in Lianyun Harbour lot number 030415
1.2 animal
Kunming mice, ♀ ♂ dual-purpose is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center, laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0053; Experimental animal feeding credit number: SCXK (Soviet Union) 2002-0012SD rat, ♀ ♂ dual-purpose is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center, laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0053; Experimental animal feeding credit number: SCXK (Soviet Union) 2002-0012
1.3 instrument
Constant water bath box: go up the grand experimental facilities company limited of Nereid
Analytical balance: the HANGPING FA2104 of Shanghai balance equipment factory
FA1004 electronic balance: Shanghai balance factory
YXQ-280 electric heating High pressure steam sterilizer Shanghai Medical Apparatus and Instruments Factory
LDZ-5 type high speed centrifuge: Beijing Medical Centrifugal Machine Factory
YSD-4G type pharmacology physiology is used instrument more: Bengbu Medical College-Bangbu radio two factories
PHS-25 type acidity tester: Shanghai thunder magnetic instrument plant
2. experimental condition
Before and after the administration, experimental animal, sub-cage rearing, feed complete feed (medical bioengineering company is worked in coordination with in Jiangsu, and Nanjing herding poultry Science Institute special animals feed factory provides) is freely drunk water 24 ± 5 ℃ of room temperatures.
3. statistical method
Quantitative response data result adopts the t-check, and qualitative response data result adopts rank test.
4. test method and result
4.1 spinal cord health analgesic activity research
1. the spinal cord health causes the analgesic activity of pain to the mice hot plate method
[1]
Get body weight 18-22g, 100 of Kunming white mice (♀), regulating hot plate temperature is 55 ℃ ± 0.5 ℃, all 120v that surpasses give it up.Every mice pain threshold of sequentially determining is selected 60 of qualified mices, is divided into 5 groups of (1) model group at random by body weight: give isopyknic normal saline; (2) tramadol hydrochloride group: 133mg/kg; (3) spinal cord health I group: 12.5g/kg (4) spinal cord health II group: 25g/kg; (5) spinal cord health III group: 50g/kg; The continuous ig administration of each dosage group of spinal cord health 5 days, tramadol hydrochloride group and the preceding ig administration of test 1 time, measure every mice pain threshold, after the administration respectively at 30,60,90,120min, survey each mice pain threshold, is still analgesia reaction of 150v as mice at voltage, and its pain threshold calculates with 150v, also calculates the analgesia percentage rate simultaneously.The results are shown in Table 1.
Table 1 spinal cord health causes the analgesic activity (X ± SD) of pain to the mice hot plate method
Compare * P＜0.05 with model group, * * P＜0.01, () is that percentage rate is improved in the threshold of pain
Experimental result shows: two dosage groups of spinal cord health 25g/kg, 50g/kg can suppress the mice pain reaction that electricity irritation causes, relatively there were significant differences (P＜0.05, P＜0.01) with model group, shows that the spinal cord health has certain analgesic activity.
2. the mouse writhing due to the spinal cord health Dichlorodiphenyl Acetate causes the analgesic activity of pain
Get body weight 18-22g, 50 of Kunming mouses, ♂, ♀ dual-purpose are divided into 5 groups at random by body weight, 10 every group.(1) model group: give isopyknic normal saline; (2) ibuprofen group: 0.6g/kg; (3) spinal cord health I group: 12.5g/kg; (4) spinal cord health II group: 25g/kg; (5) spinal cord health III group: 50g/kg; The continuous ig administration of each dosage group of spinal cord health 5 days, ibuprofen group and the preceding ig administration of test 1 time, 30min after the last administration, the acetic acid 0.2ml/ of every Mus ip0.6% are only. and observe immediately and write down behind the injection acetum and the writhing response number of times occurs in 30 minutes, and calculate the analgesia percentage rate.The results are shown in Table 2.
Table 2 spinal cord health is to the analgesic activity (X ± SD) that body causes pain that turns round of mice
Compare with model group
*P＜0.05,
*P＜0.01
The result shows: spinal cord health 25g/kg dosage group can prolong writhing response and incubation period occur, with model group relatively there were significant differences (P＜0.05, P＜0.01 〉, show that the spinal cord health has certain analgesic activity.
4.2 the antiinflammatory action of spinal cord health research
1. the spinal cord health is to the influence of mice granuloma induced by implantation of cotton pellets weight change
Get body weight 18-22g, 60 of Kunming mouses, ♂, ♀ dual-purpose are implanted two 10mg sterilization cotton balls respectively in the both sides armpit is subcutaneous, and behind the operation stitching, be divided into mice next day: (1) model group: give isopyknic normal saline; (2) aspirin group: 0.6g/kg; (3) spinal cord health I group: 12.5g/kg; (4) spinal cord health II group: 25g/kg; (5) spinal cord health III group: 50g/kg; Each group is pressed the 10ml/kg gastric infusion, gives 8 altogether.Time mouth takes off vertebra execution mice after the drug withdrawal, takes out cotton balls, rejects fatty tissue.Take by weighing the dry weight (60 ℃ of oven dry) of cotton balls, calculate granulation tissue dry weight and suppression ratio thereof.
The influence that table 3 spinal cord health forms the mice granuloma induced by implantation of cotton pellets (X ± SD, n=12)
Compare * P＜0.05, * * P＜0.01 with the normal saline matched group.
Spinal cord health 50g/kg dosage group all can obviously reduce granulation tissue weight as a result, with the normal saline group significant difference (P＜0.05, P＜0.01) is arranged relatively.The effect that prompting spinal cord health has certain anti-chronic property inflammation.
2. the influence of spinal cord health Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability increase
50 of Male Kunming strain mice are divided into 5 groups at random by body weight, 10 every group.(1) model control group: give isopyknic normal saline; (2) aspirin group: 0.6g/kg; (4) spinal cord health I group: 12.5g/kg; (4) spinal cord health II group: 25g/kg; (5) spinal cord health III group: 50g/kg; Administration volume 20ml/kg, behind each dosage group intravenous administration on same day 20min of spinal cord health, tail vein injection 0.5% azovan blue normal saline solution 0.1ml/10g, lumbar injection 0.6% acetic acid 0.1ml/10g immediately is behind the 20min, the disconnected execution of cervical vertebra dislocation mice, open the abdominal cavity, wash the abdominal cavity repeatedly three times, collect cleaning mixture with the 5ml normal saline, centrifugal (1000rpm) 5min measures trap (OD value) at ultraviolet spectrophotometer 590nm place.The results are shown in Table 4.
Table 4 spinal cord health Dichlorodiphenyl Acetate causes the influence that the mice capillary permeability increases (X ± S)
Compare * P＜0.05, * * P＜0.01 with model control group
The result shows: two dosage groups of spinal cord health 12.5g/kg, 25g/kg all can suppress acetic acid induced mice abdominal cavity capillary permeability to be increased, with model control group significant difference (P＜0.05 is arranged relatively, P＜0.01), prompting spinal cord health has certain antiinflammatory action.
4.3 the anti-spinal cord injury effect research of spinal cord health
4.3.1 experimental technique
[8]60 of SD rats are divided into 6 groups at random.I.e. (1) sham operated rats; (2) model group; (3) Dexamethasone group: 0.6g/kg; (4) spinal cord health I group: 0.19g/kg; (5) spinal cord health II group: 0.38g/kg; (6) spinal cord health III group: 0.76g/kg.Sham operated rats and model group give the normal saline of equivalent, administration volume 20ml/kg.Successive administration 5d, after last administration 30,10% hydration nitrogen aldehyde 0.4ml/100g intraperitoneal injection of anesthesia is fixed on the operating-table rat is prostrate then.Carry on the back the stage casing median incision under the aseptic condition, it is no good to appear the T9-10 spinous process, and the exposing spinal cord dura mater uses Allen ' s spinal cord beating device, adopts the 10g weight vertically to fall from the height apart from dura mater 25mm, causes the rat spinal cord moderate lesion.
4.3.2 observation index
1. the influence that the rats with spinal cord injury swash plate is tested; Get the wide 0.5m plank of long 1m, rat is positioned over the plank top, the angle of inclination that does not fall with rat is its observation index, with the motion conditions of the muscle of reflection rat.Respectively organize rat after the modeling and repeat aforesaid operations respectively at postoperative 1d, 3d, 7d, 14d.
2. the rats with spinal cord injury that influences of rats with spinal cord injury muscular strength being pressed the two hind leg neurological functional recovery situations of the Tarlov standard evaluation rat of improveing respectively at postoperative 1d, 3d, 7d, 14d, is 5 minutes with muscular tension before the art.
3. to the influence of urinary incontinence, hematuria; Observe the urinary incontinence of postoperative rats with spinal cord injury, the situation of hematuria.
4. histopathologic examination; Dissect ejector sleeve and take out a damage section spinal cord, place again and carry out back in the 4% paraformaldehyde liquid and fix.Will the section of damage and damage go up each about 0.5cm routine paraffin wax embedding of hypomere, 5um serial section.Pathological change is observed in all sites section all carrying out HE dyeing.
4.3.3 experimental result
Experimental result shows; As can be seen from Table 5, the gradient that rat climbs plate after the modeling obviously descends, and 3 dosage groups were recovered since the 7th day, with model group notable difference (P＜0.05) is arranged relatively in 7,14 days.
As can be seen from Table 6, the two hind leg function of nervous system of rat obviously descend after the modeling, and 3 dosage groups of spinal cord health were recovered since the 3rd day, with model group notable difference (P＜0.05) are arranged relatively in 3,7,14 days.Prompting spinal cord health can be improved the two hind leg function of nervous system of Spinal Cord Injury in Rats due to the weight method, has certain anti-spinal cord injury effect.
Urinary incontinence, hematuria all appearred in each spinal cord injury animal in the 2nd day, disappear in 3-5 days, and its urinary incontinence, hematuria be the no significant difference of each group on light and heavy degree, persistent period and extinction time.
Pathological examination results shows: historrhexis all appears in the model group rat spinal cord, and tissue has the blister cavities that forms behind the hemorrhage and hemorrhagic necrosis than splintery.Neurocyte swelling is more obvious, and the neurocyte that has is beyond recognition, and the cinereum matter boundary is unclear, and central canal partly disappear or off normal, the adhesion of spinal cord edge.That the heavy dose of group of administration rat spinal cord is organized is hemorrhage, degree of necrosis is lighter, and it is few to form blister cavities, and neurocyte swelling is not obvious, and neurocyte is abundant, white matter district edema, spinal cord cortical areas blur margin.Middle dosage group neurocyte is few, and the subregion has the cavity to form edge adhesion, central canal off normal.Small dose group white matter district edema, wherein a side has the cavity to form.The strong positive group is similar to heavy dose of group, and the edge adhesion is not obvious.
Table 5 spinal cord health is climbed influence (n=10, the X ± S) of plate test to Spinal Cord Injury in Rats due to the weight method
Compare * P＜0.05, * * P＜0.01 with model control group
Table 6 spinal cord health is to the influence of the two hind leg function of nervous system of Spinal Cord Injury in Rats due to the weight method (X ± S)
Compare * P＜0.05, * * P＜0.01 with model control group
5, conclusion:
(1) analgesic activity of spinal cord health research:
1. the spinal cord health causes the analgesic activity of pain to the mice electricity irritation
Two dosage groups of spinal cord health 25g/kg, 50g/kg can suppress the mice pain reaction that electricity irritation causes, relatively there were significant differences (P＜0.05, P＜0.01) with model group, shows that the spinal cord health has certain analgesic activity.
2. the mouse writhing due to the spinal cord health Dichlorodiphenyl Acetate causes the analgesic activity of pain
Spinal cord health 25g/kg dosage group all can suppress the mouse writhing reaction that acetic acid causes, with model group relatively there were significant differences (P＜0.05, P＜0.01 〉, show that the spinal cord health has certain analgesic activity.
(2) antiinflammatory action of spinal cord health research
1. the spinal cord health is to the influence of mice granuloma induced by implantation of cotton pellets weight change
Spinal cord health 50g/kg dosage group all can obviously reduce granulation tissue weight, with the normal saline group significant difference (P＜0.01) is arranged relatively.The effect that prompting spinal cord health has certain anti-chronic property inflammation.
2. the spinal cord health is to the influence of vascular permeability
The optical density value that two dosage groups of spinal cord health 12.5g/kg, 25g/kg can reduce by acetic acid induced mice abdominal cavity eluate increases, and with model group notable difference (P＜0.05, P＜0.01) is arranged relatively, and prompting: the spinal cord health has certain antiinflammatory action.
(3) the anti-spinal cord injury effect research of spinal cord health
The result shows; The gradient that rat climbs plate after the modeling obviously descends, and 3 dosage groups were recovered since the 7th day, with model group notable difference (P＜0.05) is arranged relatively in 7,14 days.
The two hind leg function of nervous system of rat obviously descend after the modeling, and 3 dosage groups of spinal cord health were recovered since the 3rd day, with model group notable difference (P＜0.05) are arranged relatively in 3,7,14 days.Prompting spinal cord health can be improved the two hind leg function of nervous system of Spinal Cord Injury in Rats due to the weight method, has certain anti-spinal cord injury effect.
Urinary incontinence, hematuria all appearred in each spinal cord injury animal in the 2nd day, disappear in 3-5 days, and its urinary incontinence, hematuria be the no significant difference of each group on light and heavy degree, persistent period and extinction time.
Pathological examination results shows: historrhexis all appears in the model group rat spinal cord, and tissue has the blister cavities that forms behind the hemorrhage and hemorrhagic necrosis than splintery.Neurocyte swelling is more obvious, and the neurocyte that has is beyond recognition, and the cinereum matter boundary is unclear, and central canal partly disappear or off normal, the adhesion of spinal cord edge.That the heavy dose of group of administration rat spinal cord is organized is hemorrhage, degree of necrosis is lighter, and it is few to form blister cavities, and neurocyte swelling is not obvious, and neurocyte is abundant, white matter district edema, spinal cord cortical areas blur margin.Middle dosage group neurocyte is few, and the subregion has the cavity to form edge adhesion, central canal off normal.Small dose group white matter district edema, wherein a side has the cavity to form.The strong positive group is similar to heavy dose of group, and the edge adhesion is not obvious.
Clinical trial:
1 physical data
Total case load 84 people, wherein male 64 examples, women 20 examples, at 18～67 years old age, the neck marrow damages 17 examples, and the breast marrow damages 3 examples, and waist sacrum marrow damages 46 examples, injury of cauda equina 18 examples, operator 54 examples.Be divided into treatment group and matched group at random, matched group adopts conventional therapy, and the treatment group adds on the matched group basis with Chinese medicine " spinal cord health ".
2 observation of curative effect
2.1 sensation standards of grading
Sensation is checked, and must to look into part be both sides 28 the dermatotome key points separately of having a physical examination.Each key point will be checked 2 kinds of sensations, i.e. acupuncture feel and light touch, and evaluate marking respectively by 3 grades.The bilateral total points is 112 minutes.
The 0=disappearance, 1=obstacle (partial impairment or sensation change, and comprise hyperesthesia), 2=is normal, and NT=can't check
Disposable safe pin commonly used is checked in the acupuncture feel, and Cotton Gossypii is used in the light touch inspection.When inspection was felt in acupuncture, the sensation that can not distinguish passivity and sharp sexual stimulus should be chosen as 0 grade.
The check point of both sides sensation key point is as follows.Asterisk refers to be positioned at the key point in the midclavicular line.
C
2---occipital tuberosity T
8---the 8th intercostal
*
C
3---supraclavicular fossa T
9---the 9th intercostal
*
C
4---the acromioclavicular joint top T
10---the 10th intercostal (umbilicus level)
*
C
5---fossa cubitalis outside T
11---the 11st intercostal
*
C
6---thumb T
12---the inguinal ligament middle part
C
7---middle finger L
1---T
12With L
2Between last 1/2 place
C
8---little finger of toe L
2---the thigh front middle part
T
1---the inboard L of the fossa cubitalis
3---condyle in the femur
T
2---axillary fossa L
4---internal malleolus
T
3---the 3rd intercostal
*L
5---instep the 3rd metatarsophalangeal joints
T
4---the 4th intercostal (milk-line)
*S
1---outside of heel
T
5---the 5th intercostal
*S
2— — popliteal nest mid point
T
6---the 6th intercostal (xiphoid-process level)
*S
3---ischial tuberosity
T
7---the 7th intercostal
*S
4～5---around the anus (as a plane)
Except that inspection to these both sides key points, also require the examiner to refer to detect the examination external anal sphincter as anus, feel to be classified as existence or disappearance.This inspection is used for judging that damage is completeness or imperfection.
2.2 motion standards of grading
The project of must looking into that motion is checked is the both sides crucial flesh in the 10 pairs of muscle segments separately of having a physical examination.Checks sequence is for from the top down.The muscular strength of each muscle is divided into six grades, is designated as 0～5 fen respectively according to progression.
0: paralysis fully
1: can touch maybe and can see muscle contraction
2: under no centrifugal force, carry out the active movement of total joint scope
3: antagonism centrifugal force carries out the active movement of total joint scope
4: under the anti-resistance of moderate, carry out the active movement of total joint scope
5: normal muscular strength (can resist resistance to carry out the normal activity of total joint scope fully)
NT: can't check
The muscle (bilateral) of using above-mentioned muscular strength staging inspection is as follows.Select these muscle to be because they are consistent with the innervation of corresponding sections, and be convenient to the clinical dorsal position inspection (other position is usually avoided when spinal cord injury) of doing.The bilateral total points is 100 minutes.
C
5---bend anconeus (biceps brachii m., brachialis)
C
6---wrist extensor (extensor carpi radialis longus and and brevis)
C
7---stretch anconeus (triceps brachii)
C
8---the middle finger flesh (intrinsic finger musculus flexor) of counting on one's fingers
T
1---abductor of fifth finger
L
2---bend hip flesh (iliopsoas)
L
3---stretch knee joint flesh (quadriceps femoris)
L
4---ankle extensor of the back (tibialis anterior)
L
5---extensor hallucis longus (extensor hallucis longus)
S
1---ankle sole of the foot musculus flexor (gastrocnemius, musculus soleus)
Except that the both sides of top these muscle are checked, also to check external anal sphincter, refer to inspection sensation sphincters contract with anus, evaluation is classified as and exists or disappearance, and this inspection only is used to judge whether to be complete injury.
2.3 the judgement of spinal cord injury degree
The now much external ASIA criteria for classifications (according to Frankel classification revision) that adopt are divided into and are Pyatyi:
The infringement of A completeness does not have any sensorimotor function in the sacrum section and keeps.
The infringement of B imperfection comprises sacrum section (S below neural plane
4, S
5) the cenesthesia function, but do not have motor function.
There is motor function in the infringement of C imperfection below neural plane, and the muscular strength of most of crucial flesh is less than 3 grades.
There is motor function in the infringement of D imperfection below neural plane, and the muscular strength of most of crucial flesh is more than or equal to 3 grades.
E normal threshold of feeling and motor function are normal.
2.4 inspection record
When the patient being admitted to hospital according to above standard and sense of touch, pain sensation scoring, motion scoring and the spinal cord injury classification situation of treatment one course of treatment (three weeks) when finishing all record faithfully on record.
3 efficacy evaluations and statistical method
According to the unified observation table itemized record result who formulates, the curative effect statistics of each observation index relatively waits in the group and all should carry out statistical procedures.Seesaw, feel that according to treatment scoring changes, analyze its normal distribution, whether it has diversity to adopt the T inspection statistics, thereby whether evaluation has therapeutic effect.The rank check is adopted in the fractionated variation of spinal cord injury before and after the treatment, and two groups of treatments efficiently relatively adopt X 2 test to add up, The data SPSS11.0 software statistics is handled, with P＞0.05 is there was no significant difference, P≤0.05 is for there being significant difference, and P≤0.01 is for there being significant differences.
4 results
4.1 (seeing Table 7) compared in the sensation scoring before and after two groups of treatments
The sensation scoring relatively before and after the table 7 liang group treatment
Annotate: with compare before this group is treated,
*P＜0.05 and is compared after the treatment of control group,
△P＞0.05.
The scoring relatively (seeing Table 8) 4.2 two groups of treatments seesaw
Table 8 a liang group treatment seesaws scoring relatively
Annotate: with compare before this group is treated,
*P＜0.05 and is compared after the treatment of control group,
△P＜0.05.
4.3 the damaged ASIA size scale of spinal cord is than (table 9,10,11) before and after two groups of treatments
The damaged ASIA classification of spinal cord before and after the table 9 liang group treatment
Annotate: the numeral in the table behind the corresponding grid of same letter is the case load that improve the treatment back.
As can be seen from Table 9, in the treatment group, 1 grade of person's 25 example of neurological functional recovery, 2 grades of person's 4 examples.In the matched group, 1 grade of person's 18 example of neurological functional recovery, 2 grades of person's 1 examples.The overall improvement rate of treatment group (ASIA classification raise 1 grade or more than) is 69.05% (29/42), and matched group is 45.24% (19/42), and the two has significant difference (P＜0.05) through X 2 test.
Be divided into Three Estate according to the differential curative effect with two groups of cases of function before and after the treatment, function no change person curative effect grade is 0 before and after the treatment, and treating forward step one-level person curative effect grade after the treatment is 1, and function progress secondary person curative effect grade is 2, two groups and relatively sees Table 10:
Each curative effect grade case load relatively before and after the table 10 liang group treatment
Annotate: two groups of difference row ranks and inspection, H=2.35, P＜0.05.
Return to normal (E level) and can walk or hold up and turn walking but the full person's (D level) of residual some function of nervous system is useful recovery, A～C level is a paraplegia.Useful recovery rate is organized in treatment and matched group relatively sees Table 11:
The table 11 liang useful recovery rate of group relatively
Annotate: two groups of useful recovery rates are through blocking ten thousand check p＞0.05.
Conclusion
The clinical research result is consistent with experimental result, proof " spinal cord health " can promote the recovery of patients with spinal cord injury motor function, improve the overall function of nervous system (p＜0.05) of patients with spinal cord injury, but there was no significant difference (p＞0.05) is compared in the improvement effect of sensory function, useful recovery rate with matched group.
Four. the specific embodiment
The prescription of embodiment 1. compound Chinese medicinal preparation (spinal cord health) is formed:
The Radix Astragali 30 grams, Radix Salviae Miltiorrhizae 30 grams, Rhizoma Chuanxiong 12 grams, Radix Paeoniae Rubra 12 grams, Radix Angelicae Sinensis 12 grams, Hirudo 10 grams, Scolopendra 5 grams, Radix Et Rhizoma Rhei 10 grams, Rhizoma Alismatis 10 grams, Poria 10 grams, Fructus Aurantii Immaturus 10 grams, Cortex Magnoliae Officinalis 10 grams, Herba Cistanches 2 grams, Herba Epimedii 12 grams, Eupolyphaga Seu Steleophaga 10 grams, Semen Plantaginis 15 grams, Fructus Alpiniae Oxyphyllae 10 grams.
The preparation technology of compound preparation:
1. the method for making of mixture: above 17 flavors, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis were soaked 2 hours, extracted 5 hours with steam distillation, collected volatile oil, and be standby; Medicinal residues and all the other 13 flavor Chinese medicines merge, and add 12 times of water gagings, decoct 2 hours, filter, and filtering residue adds 10 times of water gagings again, decocts 1.5 hours, filters, and merges decoction liquor twice, and being concentrated into medicine liquid volume and medical material weight ratio is 1: 1; Add ethanol and reach 60% to containing the alcohol amount, left standstill cold preservation 24 hours, filter, decompression recycling ethanol also is concentrated into relative density 1.05 (60 ℃), leave standstill filtration or centrifugal after 24 hours, add volatile oil, stir evenly, add sodium benzoate, simple syrup, adjust total amount, mixing, promptly.
Instructions about how to take medicine: each 30ml, day clothes three times.
2. the method for making of granule: above 17 flavors, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis were soaked 2 hours, extracted 5 hours with steam distillation, collected volatile oil, adopt the saturated water solution method enclose with beta cyclodextrin after, filter behind the oven drying at low temperature standby; Fructus Alpiniae Oxyphyllae, the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Hirudo, Scolopendra, Radix Et Rhizoma Rhei, Rhizoma Alismatis, Poria, Herba Cistanches, Herba Epimedii, Eupolyphaga Seu Steleophaga, Semen Plantaginis and above-mentioned medicinal residues merge, add 12 times of water gagings, decocted 2 hours, and filtered, filtering residue adds 10 times of water gagings again, decocted 1.5 hours, filter, merge decoction liquor twice, being concentrated into medicine liquid volume and medical material weight ratio is 1: 1, add ethanol and reach 60% to containing the alcohol amount, left standstill cold preservation 24 hours, and filtered, decompression recycling ethanol also is concentrated into relative density 1.05 (60 ℃), be spray dried to fine powder, add as volatile oil clathrate compound, and an amount of dextrin, mixing, the dry method roll extrusion is granulated, promptly.
Usage: oral, every day 3 times, each 12 grams; Anemia of pregnant woman and woman month are withdrawn menstrual period, and the child follows the doctor's advice.
Specification: 12 gram/bags, 10 bag/bags.
Storage: put shady and cool dry place.
The prescription of embodiment 2. compound Chinese medicinal preparation (spinal cord health):
The Radix Astragali 30 grams, Radix Salviae Miltiorrhizae 30 grams, Rhizoma Chuanxiong 12 grams, Radix Paeoniae Rubra 12 grams, Radix Angelicae Sinensis 12 grams, Hirudo 10 grams, Scolopendra 5 grams, Radix Et Rhizoma Rhei 10 grams, Rhizoma Alismatis 10 grams, Poria 10 grams, Fructus Aurantii Immaturus 10 grams, Cortex Magnoliae Officinalis 10 grams, Herba Cistanches 2 grams, Herba Epimedii 12 grams, Eupolyphaga Seu Steleophaga 10 grams, Semen Plantaginis 15 grams, Fructus Alpiniae Oxyphyllae 10 grams.
The preparation technology of compound preparation:
1. the method for making of mixture: above 17 flavors, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis were soaked 2.5 hours, extracted 6 hours with steam distillation, collected volatile oil, and be standby.Medicinal residues and all the other 13 flavor Chinese medicines merge, and add 12 times of water gagings, decoct 2.5 hours, filter, filtering residue adds 10 times of water gagings again, decocts 2.0 hours, filters, and merges decoction liquor twice, be concentrated into medicine liquid volume and the medical material weight ratio is 1: 1.2, add ethanol and reach 60%, left standstill cold preservation 26 hours to containing the alcohol amount, filter, decompression recycling ethanol also concentrates, and leaves standstill filtration or centrifugal after 26 hours, add volatile oil, stir evenly, add sodium benzoate, simple syrup, adjust total amount, mixing, promptly.
Instructions about how to take medicine: each 30ml, day clothes three times.
2. the method for making of granule: above 17 flavors, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis were soaked 2 hours, extracted 5 hours with steam distillation, collected volatile oil, adopt the saturated water solution method enclose with beta cyclodextrin after, filter behind the oven drying at low temperature standby; Fructus Alpiniae Oxyphyllae, the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Hirudo, Scolopendra, Radix Et Rhizoma Rhei, Rhizoma Alismatis, Poria, Herba Cistanches, Herba Epimedii, Eupolyphaga Seu Steleophaga, Semen Plantaginis and above-mentioned medicinal residues merge, add 12 times of water gagings, decocted 2 hours, and filtered, filtering residue adds 10 times of water gagings again, decocted 1.5 hours, filter, merge decoction liquor twice, being concentrated into medicine liquid volume and medical material weight ratio is 1: 1, add ethanol and reach 60% to containing the alcohol amount, left standstill cold preservation 24 hours, and filtered, decompression recycling ethanol also is concentrated into relative density 1.05 (60 ℃), be spray dried to fine powder, add as volatile oil clathrate compound, and an amount of dextrin, mixing, the dry method roll extrusion is granulated, promptly.
Usage: oral, every day 3 times, each 12 grams; Anemia of pregnant woman and woman month are withdrawn menstrual period, and the child follows the doctor's advice.
Specification: 12 gram/bags, 10 bag/bags.
Storage: put shady and cool dry place.
3. the method for making of capsule:
With the method for making of above-mentioned 2 granules, behind the dry granulation, irritate hard capsule, promptly.
Usage: oral, every day 3 times, each 3-4 grain.
Claims (6)
1. compound Chinese medicinal preparation for the treatment of spinal cord injury is characterized in that this compound preparation is made by following materials of weight proportions medicine:
Radix Astragali 20-30 gram, Radix Salviae Miltiorrhizae 20-30 gram, Rhizoma Chuanxiong 10-16 gram, Radix Paeoniae Rubra 10-16 gram, Radix Angelicae Sinensis 10-16 gram, Hirudo 8-12 gram, Scolopendra 5-10 gram, Radix Et Rhizoma Rhei 8-12 gram, Rhizoma Alismatis 10-16 gram, Poria 10-16 gram, Fructus Aurantii Immaturus 10-16 gram, Cortex Magnoliae Officinalis 10-16 gram, Herba Cistanches 10-16 gram, Herba Epimedii 10-16 gram, Eupolyphaga Seu Steleophaga 10-16 gram, Semen Plantaginis 15-20 gram, Fructus Alpiniae Oxyphyllae 8-12 gram.
2. method for preparing claims 1 described compound Chinese medicinal preparation is characterized in that preparation process is as follows:
(1). get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis and soak, extract, collect volatile oil with steam distillation, standby;
(2). the medicinal residues behind the said extracted volatile oil and all the other 13 flavor Chinese medicines are merged, decoct with water, filter, filtering residue decocts with water again, filters, and merges decoction liquor twice, concentrates;
(3). add ethanol in above-mentioned concentrated solution, leave standstill cold preservation, filter, also concentrated, static after-filtration or centrifugal add above-mentioned volatile oil, stir evenly behind the decompression recycling ethanol;
(4). add the relevant adjuvant of different dosage form,, make oral liquid, granule, capsule or tablet with conventional formulation method.
3. according to claims 2 described preparation methoies, it is characterized in that getting in the step (1) Radix Angelicae Sinensis, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis and soaked 2-2.5 hour, extracted 4-6 hour with steam distillation.
4. according to claims 2 described preparation methoies, it is characterized in that merging, add 12 times of water gagings at medicinal residues described in the step (2) and all the other 13 flavor medicines, decocted 2-2.5 hour, filter, filtering residue adds 10 times of water gagings again, decocts 1-2 hour, filters, merge filtrate twice, being concentrated into medicine liquid volume and medical material weight ratio is 1: 0.8-1.2.
5. preparation method according to claim 2 is characterized in that adding in the step (3) ethanol and reaches 60% to containing the alcohol amount, leaves standstill cold preservation 22-26 hour, filter, decompression recycling ethanol and measured value when being concentrated into 1.05,60 ℃ of relative densities leave standstill and filter after 22-26 hour or centrifugal.
6. the application of compound Chinese medicinal preparation as claimed in claim 1 in preparation treatment spinal cord injury medicine.
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| CN105477137A (en) * | 2015-12-14 | 2016-04-13 | 翟凤艳 | Traditional Chinese medicine decoction for treating spinal cord injury |
| CN115844957A (en) * | 2023-01-03 | 2023-03-28 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | Traditional Chinese medicine composition for treating acute spinal cord injury in acute stage and using method thereof |
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| CN1130218C (en) * | 2001-04-29 | 2003-12-10 | 韩凤岳 | Chinese medicine preparation for treating spinal damage and its preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105477137A (en) * | 2015-12-14 | 2016-04-13 | 翟凤艳 | Traditional Chinese medicine decoction for treating spinal cord injury |
| CN115844957A (en) * | 2023-01-03 | 2023-03-28 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | Traditional Chinese medicine composition for treating acute spinal cord injury in acute stage and using method thereof |
| CN115844957B (en) * | 2023-01-03 | 2023-09-26 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | Traditional Chinese medicine composition for treating acute spinal cord injury in acute stage and application method thereof |
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