CN101559156A - Application of traditional Chinese medicine composition in preparing medicament for curing chronic inflammatory demyelinating polyneuropathy - Google Patents

Application of traditional Chinese medicine composition in preparing medicament for curing chronic inflammatory demyelinating polyneuropathy Download PDF

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CN101559156A
CN101559156A CNA2008100548082A CN200810054808A CN101559156A CN 101559156 A CN101559156 A CN 101559156A CN A2008100548082 A CNA2008100548082 A CN A2008100548082A CN 200810054808 A CN200810054808 A CN 200810054808A CN 101559156 A CN101559156 A CN 101559156A
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rhizoma
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CN101559156B (en
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吴以岭
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Hebei Yiling Pharmaceutical Research Institute Co Ltd
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Abstract

The invention discloses an application of traditional Chinese medicine composition in preparing medicament for curing chronic inflammatory demyelinating polyneuropathy. The traditional Chinese medicine composition can effectively cure chronic inflammatory demyelinating polyneuropathy by benefiting vital energy, nourishing, promoting blood circulation and removing meridian obstruction.

Description

The application of a kind of Chinese medicine composition in preparation treatment chronic inflammatory demyelinative polyneuropathy medicine
Technical field
The present invention relates to a kind of new purposes of Chinese medicine composition, particularly, relate to the application of a kind of Chinese medicine composition in the medicine of preparation treatment chronic inflammatory demyelinative polyneuropathy, belong to the Chinese medicine application.
Background technology
Chronic inflammatory demyelinative polyneuropathy (Chronic Inflammatory DemyelinatingPolyneuropathy, CIDP, below all be called for short CIDP) be common Neurology Department disease, report prevalence child 0.5/10 ten thousand abroad, the adult is 1.0~2.0/10 ten thousand.It is the acquired demyelinating disease that involves peripheral nervous system, is feature with recurrence or progressivity near-end and far-end myasthenia, can be with sensory disturbance.Present most scholar thinks that CIDP is that the target of immune attack is perineural myelin by the autoimmune disease of cell and the common mediation of humoral immunization.
CIDP is the autoimmune disease of damage spinal nerves myelin and axon.The governor vessel of traditional Chinese medical science eight extra-channel has something in common at the spinal cord that follows on capable position and the function with doctor trained in Western medicine." difficult " cloud: " the governor vessel person arises from down Yu's (Changqiang acupoint that refers to the spinal column lower end) of the utmost point, and in ridge (spinal cord), goes up to windy mansion, goes into to belong to brain " through 28 difficulties.Governor vessel is through ridge, on lead in brain, be equivalent to the central nervous system of modern medicine, follow the walking along the street line along it and prop up the horizontal network that does not go out and belong to branch and also be similar to peripheral nervous system; Say that from function spinal cord has conduction brain signal domination muscular movement effect, governor vessel is then commanded the whole body yang-energy, and the traditional Chinese medical science is thought sun initiatively, commands the whole body yang-energy that is is to command whole body motion.Spinal nerves then is the branch that sends from spinal cord, and the traditional Chinese medical science is thought and other person is network, superintends and directs network so spinal nerves should be called in the traditional Chinese medical science.Superintending and directing network does not have clearly in traditional Chinese medical science ancient books and mentions, but " element ask flaccidity opinion " have cloud " the bright main profit penis of sun; the chong channel master is oozed and irritated Creek paddy; ...; all belong to dai channel and network in governor vessel ", have channels to link to each other between visible " governor vessel " and " Creek paddy ", " penis ", be and superintend and direct network; there is similarity its position with the spinal nerves of modern medicine between governor vessel and muscle.
Superintend and direct network and belong to meridians, so primary disease belongs to " network disease " category.Channel system is divided the network of meridians and the network of venation, just gas network and blood network.The motion of no blood in the spinal nerves surely belongs to the gas network, so its card genus deficiency in origin and excess in superficiality, the natural endowment deficiency, or fatigued mistake is foster, causes positive QI-insufficiency, and deficiency of qi and blood, channels lose supports, and network void is not flourish.Inanition then unable operation in network road is through gas, and the network gas stasis of blood stagnates not smooth, eventually to the resistance of the channels stasis of blood, channels damage." this Tibetan of Ling Shu Miraculous Pivot or Divine Axis " said: " the passages through which vital energy circulates person, so qi and blood circulation promotion and seek negative and positive moistens muscles and bones, sharp joint person also." so the spreading that channels damages then QI and blood nutrition is affected, muscle muscles and bones is lost the symptom that occurs various CIDP such as the unable and numb pain of atrophy in making moist.
The Clinical symptoms of CIDP comprises limb adynamia, anesthesia and the key areflexia etc. of progressivity or recurrent.At random, double blinding and placebo-controlled study confirm, traditional treatment such as steroid swash rope, intravenous immune ball egg obviously is better than placebo from the short term efficacy of (IG) and plasmapheresis (PE), the patient of 60-80% can expect to improve, but still lacks the research report of long-term efficacy.For many years also have more about azathioprine, cyclophosphamide, encircle the report that rope A, interferon, lymph radiotherapy etc. are used for the treatment of CIDP, but lack prospective randomized controlled trial and come their curative effect (Zhang Wenxing really, Cui Liying. the therapeutic advance of chronic inflammatory demyelinative polyneuropathy. Chinese neuromedicine magazine, the 4th the 10th phase of volume of October in 2005).Chinese medicine has special advantages on treatment CIDP, not only have good curative effect, and no obvious adverse reaction has very positive effect to reducing recurrence simultaneously.
The present invention is the improvement invention of carrying out on the basis of No. 200510055258.2 patent, quotes in full the content of this patent document record at this.The invention provides and relate to the application of a kind of Chinese medicine composition in the medicine of preparation treatment chronic inflammatory demyelinative polyneuropathy.Chinese medicine composition of the present invention is supported by QI invigorating and is superintended and directed, promoting blood circulation to remove obstruction in the collateral, can treat chronic inflammatory demyelinative polyneuropathy effectively.
Summary of the invention
The object of the invention provides the application of a kind of Chinese medicine composition in preparation treatment chronic inflammatory demyelinative polyneuropathy medicine, and described Chinese medicine composition is made by following bulk drugs:
Radix Astragali 300-400 part Radix Rehmanniae 300-400 part Caulis Spatholobi 300-400 part Ramulus Cinnamomi 80-120 part Radix Angelicae Sinensis 100-150 part Rhizoma Chuanxiong 150-200 part Semen Litchi 150-200 part Rhizoma Anemarrhenae 80-120 part Ramulus Mori 80-120 part Radix Cynanchi Paniculati 80-120 part Rhizoma Corydalis 70-120 part Herba Ephedrae 50-100 part Pheretima 30-60 part.
Preferably, this Chinese medicine composition is made by following bulk drugs:
45 parts of 68 parts of Pheretimas of 91 portions of Herba Ephedraes of 102 parts of Rhizoma Corydalis of 113 parts of Radix Cynanchi Paniculatis of 113 parts of Ramulus Moris of 170 parts of Rhizoma Anemarrhenaes of 170 parts of Semen Litchis of 136 parts of Rhizoma Chuanxiongs of 113 parts of Radix Angelicae Sinensis of 340 parts of Ramulus Cinnamomi of 340 portions of Caulis Spatholobis of 340 parts of Radix Rehmanniae of the Radix Astragali.
Or:
30 parts of 50 parts of Pheretimas of 70 portions of Herba Ephedraes of 80 parts of Rhizoma Corydalis of 80 parts of Radix Cynanchi Paniculatis of 80 parts of Ramulus Moris of 150 parts of Rhizoma Anemarrhenaes of 150 parts of Semen Litchis of 100 parts of Rhizoma Chuanxiongs of 80 parts of Radix Angelicae Sinensis of 300 parts of Ramulus Cinnamomi of 300 portions of Caulis Spatholobis of 300 parts of Radix Rehmanniae of the Radix Astragali.
Or:
60 parts of 100 parts of Pheretimas of 120 portions of Herba Ephedraes of 120 parts of Rhizoma Corydalis of 120 parts of Radix Cynanchi Paniculatis of 120 parts of Ramulus Moris of 200 parts of Rhizoma Anemarrhenaes of 200 parts of Semen Litchis of 150 parts of Rhizoma Chuanxiongs of 120 parts of Radix Angelicae Sinensis of 400 parts of Ramulus Cinnamomi of 400 portions of Caulis Spatholobis of 400 parts of Radix Rehmanniae of the Radix Astragali.
Or:
60 parts of 100 parts of Pheretimas of 120 portions of Herba Ephedraes of 120 parts of Rhizoma Corydalis of 120 parts of Radix Cynanchi Paniculatis of 120 parts of Ramulus Moris of 200 parts of Rhizoma Anemarrhenaes of 150 parts of Semen Litchis of 150 parts of Rhizoma Chuanxiongs of 120 parts of Radix Angelicae Sinensis of 300 parts of Ramulus Cinnamomi of 300 portions of Caulis Spatholobis of 300 parts of Radix Rehmanniae of the Radix Astragali.
More preferably, the active component of Chinese medicine composition of the present invention is made up of following ingredients
1), the Radix Astragali, Herba Ephedrae, Ramulus Mori, Rhizoma Corydalis, Caulis Spatholobi, Rhizoma Chuanxiong, add 8-12 respectively and doubly measure 50-80% ethanol, reflux, extract, 1-3 time, extraction time was respectively 1-3 hour, filter, merge extractive liquid,, residue discards, reclaiming ethanol does not extremely have the alcohol flavor, the fluid extract of relative density 1.02-1.06 when being evaporated to 60 ℃ of heat surveys;
2), Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati, add 5-8 times of water gaging, soaked 20-40 minute, steam distillation is carried oil time 5-8 hour, the volatile oil of extraction;
3), Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati have extracted filtered decocting liquid behind the volatile oil;
4), Radix Rehmanniae, Semen Litchi, the Rhizoma Anemarrhenae, Pheretima and Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati extract the residue merging behind the volatile oil, add 8-12 times of water gaging, heating decocts 1-3 time, time was respectively 1-3 hour, filter, merge extractive liquid,, residue discards, relative density is the clear paste of 1.20-1.24 when being evaporated to 60 ℃ of heat surveys, add 95% ethanol to determining alcohol 50-70%, 5-10 ℃ left standstill 18-36 hour, filtered, decompression filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, the fluid extract of relative density 1.02-1.06 when being evaporated to 60 ℃ of hot surveys.
In the Chinese medicine composition of the present invention, the latin name of raw medicinal material and processing method thereof are from " Chinese medicine voluminous dictionary " (in July, 1977, front page, Shanghai science tech publishing house) and " Chinese pharmacopoeia (version in 2005, Chemical Industry Press).
Chinese medicinal composition preparation of the present invention can also be routinely preparation process, for example, the preparation technology of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record, make the acceptable any conventional dosage form of pharmaceutics, for example capsule, tablet, granule, pill, powder, oral liquid etc.
In the application of the present invention, described Chinese medicine composition is a kind of in capsule, tablet, granule, pill, powder, the oral liquid formulations, for above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.For making above-mentioned dosage form can realize pharmacy of Chinese materia medica, need when these dosage forms of preparation, to add acceptable other adjuvant of pharmacy (adjuvant of each dosage form record among the Fan Biting " pharmacy of Chinese materia medica ", Shanghai Science Press December in 1997 the 1st edition).
Perhaps, preparation of the present invention is preferably made by following preparation method:
1), Radix Astragali 300-400 part Radix Rehmanniae 300-400 part Caulis Spatholobi 300-400 part Ramulus Cinnamomi 80-120 part Radix Angelicae Sinensis 100-150 part Rhizoma Chuanxiong 150-200 part Semen Litchi 150-200 part Rhizoma Anemarrhenae 80-120 part Ramulus Mori 80-120 part Radix Cynanchi Paniculati 80-120 part Rhizoma Corydalis 70-120 part Herba Ephedrae 50-100 part Pheretima 30-60 part
2), the side's of getting Chinese crude drug, clean respectively, coarse crushing is about 5-10mm granule, in proportion weighing.
3) take by weighing the Radix Astragali, Herba Ephedrae, Ramulus Mori, Rhizoma Corydalis, Caulis Spatholobi, Rhizoma Chuanxiong, in proportion, add 8-12 respectively and doubly measure 50-80% ethanol, reflux, extract, 1-3 time, extraction time was respectively 1-3 hour.Filter, merge extractive liquid,, residue discards.Reclaim ethanol to there not being the alcohol flavor, be evaporated to relative density 1.02-1.06 (60 ℃ of heat are surveyed) fluid extract, standby.
4) take by weighing Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati, in proportion, add 5-8 times of water gaging, soaked 20-40 minute, steam distillation extracts volatile oil, carries time 5-8 hour, and volatile oil device is in addition collected.Decocting liquid filters, and is standby.
5) take by weighing Radix Rehmanniae, Semen Litchi, the Rhizoma Anemarrhenae, Pheretima, in proportion, and carry oil back residue and merge, add 8-12 times of water gaging, heating decocts 1-3 time, and the time was respectively 1-3 hour, filters, merge extractive liquid,, residue discards, and is evaporated to relative density 1.20-1.24 clear paste (60 ℃ of heat are surveyed), add 95% ethanol to determining alcohol 50-70%, 5-10 ℃ left standstill 18-36 hour, filtered, and decompression filtrate recycling ethanol is to there not being the alcohol flavor, be evaporated to relative density 1.02-1.06 (60 ℃ of heat are surveyed) fluid extract, standby.
6), with starch, the dextrin mixing is put in the spray granulation machine, with step 2) gained alcohol extraction fluid extract and step 4) gained water extract-alcohol precipitation fluid extract mix and spray into granulation, granulate sprays into volatile oil, airtight half an hour, makes required dosage form, promptly.
Perhaps, preparation of the present invention is preferably made by following preparation method:
1), 68 parts of Pheretimas of 91 portions of Herba Ephedraes of 102 parts of Rhizoma Corydalis of 113 parts of Radix Cynanchi Paniculatis of 113 parts of Ramulus Moris of 170 parts of Rhizoma Anemarrhenaes of 170 parts of Semen Litchis of 136 parts of Rhizoma Chuanxiongs of 113 parts of Radix Angelicae Sinensis of 340 parts of Ramulus Cinnamomi of 340 portions of Caulis Spatholobis of 340 parts of Radix Rehmanniae of the Radix Astragali are 45 parts
Preparation method:
2), the side's of getting Chinese crude drug, clean respectively, coarse crushing is about 5-10mm granule, in proportion weighing.
3) take by weighing the Radix Astragali, Herba Ephedrae, Ramulus Mori, Rhizoma Corydalis, Caulis Spatholobi, Rhizoma Chuanxiong, in proportion, add 10 times of amounts, 8 times of amount 60% ethanol respectively, reflux, extract, 2 times, extraction time was respectively 2,1.5 hours.Filter, merge extractive liquid,, residue discards.Reclaim ethanol to there not being the alcohol flavor, be evaporated to relative density 1.02-1.06 (60 ℃ of heat are surveyed) fluid extract, standby.
4) take by weighing Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati, in proportion, add 7 times of water gagings, soaked 30 minutes, steam distillation extracts volatile oil, carries 6 hours time, and volatile oil device is in addition collected.Decocting liquid filters, and is standby.
5) take by weighing Radix Rehmanniae, Semen Litchi, the Rhizoma Anemarrhenae, Pheretima, in proportion, and carry oil back residue and merge, add 9 times of water gagings, heating decocts 2 times, and the time was respectively 2,1.5 hours, filters, merge extractive liquid,, residue discards, and is evaporated to relative density 1.20-1.24 clear paste (60 ℃ of heat are surveyed), add 95% ethanol to determining alcohol 60%, 5-10 ℃ left standstill 24 hours, filtered, and decompression filtrate recycling ethanol is to there not being the alcohol flavor, be evaporated to relative density 1.02-1.06 (60 ℃ of heat are surveyed) fluid extract, standby.
6), with starch, the dextrin mixing is put in the spray granulation machine, alcohol extraction fluid extract and water extract-alcohol precipitation fluid extract is mixed spraying into granulation, granulate sprays into volatile oil, airtight half an hour, makes required dosage form, promptly.
The specific embodiment
Embodiment 1: the preparation of medicine of the present invention
1), 68 parts of Pheretimas of 91 portions of Herba Ephedraes of 102 parts of Rhizoma Corydalis of 113 parts of Radix Cynanchi Paniculatis of 113 parts of Ramulus Moris of 170 parts of Rhizoma Anemarrhenaes of 170 parts of Semen Litchis of 136 parts of Rhizoma Chuanxiongs of 113 parts of Radix Angelicae Sinensis of 340 parts of Ramulus Cinnamomi of 340 portions of Caulis Spatholobis of 340 parts of Radix Rehmanniae of the Radix Astragali are 45 parts
Preparation method:
2), the side's of getting Chinese crude drug, clean respectively, coarse crushing is about 5-10mm granule, in proportion weighing.
3) take by weighing the Radix Astragali, Herba Ephedrae, Ramulus Mori, Rhizoma Corydalis, Caulis Spatholobi, Rhizoma Chuanxiong, in proportion, add 10 times of amounts, 8 times of amount 60% ethanol respectively, reflux, extract, 2 times, extraction time was respectively 2,1.5 hours.Filter, merge extractive liquid,, residue discards.Reclaim ethanol to there not being the alcohol flavor, be evaporated to relative density 1.02-1.06 (60 ℃ of heat are surveyed) fluid extract, standby.
4) take by weighing Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati, in proportion, add 7 times of water gagings, soaked 30 minutes, steam distillation extracts volatile oil, carries 6 hours time, and volatile oil device is in addition collected.Decocting liquid filters, and is standby.
5) take by weighing Radix Rehmanniae, Semen Litchi, the Rhizoma Anemarrhenae, Pheretima, in proportion, and carry oil back residue and merge, add 9 times of water gagings, heating decocts 2 times, and the time was respectively 2,1.5 hours, filters, merge extractive liquid,, residue discards, and is evaporated to relative density 1.20-1.24 clear paste (60 ℃ of heat are surveyed), add 95% ethanol to determining alcohol 60%, 5-10 ℃ left standstill 24 hours, filtered, and decompression filtrate recycling ethanol is to there not being the alcohol flavor, be evaporated to relative density 1.02-1.06 (60 ℃ of heat are surveyed) fluid extract, standby.
6), with starch, the dextrin mixing is put in the spray granulation machine, alcohol extraction fluid extract and water extract-alcohol precipitation fluid extract is mixed spraying into granulation, granulate sprays into volatile oil, and is encapsulated airtight half an hour, promptly.
In order to confirm the curative effect of traditional Chinese medicine composition for treating chronic inflammatory demyelinative polyneuropathy of the present invention, use the capsule (to call medicine of the present invention in the following text) that makes by the foregoing description 1 method to carry out following clinical trial.
Experimental example:
1 clinical data
All cases all are in August, 2005-2006 Hebei Yi Ling hospital outpatient and inpatients between year October, all meet the diagnostic criteria that practical neurological determines, are divided into treatment group and matched group at random.36 examples are organized in treatment, wherein male 12 examples, women 24 examples, male VS woman=1: 2, the range of age 19-52 year, year mean age (34.47 ± 11.86), the course of disease scope 7-26 month, average course of disease (14.14 ± 6.52) month.Matched group is totally 34 examples, wherein male 11 examples, women 23 examples, male VS woman=1: 2.09, the range of age 20-56 year, year mean age (30.53 ± 12.66), the course of disease scope 6-29 month, average course of disease (14.32 ± 6.76) month.Sex, age and the course of disease are learned by statistics and are handled no significant difference (P all>0.05) before two groups of treatments, have comparability.
2 Therapeutic Method
2.1 oral medicine of the present invention (being produced by Shijiazhuang Yiling Pharmaceutical Co., Ltd), oral 6/time, 3 times on the 1st are organized in treatment.Oral prednisone sheet 1.0mg/ (kgd) simultaneously, early morning, decoction being taken at a draught successively decreased after taking for 3 weeks, subtracted 5mg weekly to maintenance dose 10~15mg/d.
2.2 matched group simple oral prednisone sheet, usage is the same.Treat altogether for two groups and observed 90 days.
3 observation index and statistical method
3.1 observation index
Clinical symptoms index: 1. extremity muscular strength: with 0~5 grade of rating method.It is 5 minutes that 0 grade of muscular strength is paralysed fully; 1 grade of muscular strength is 4 minutes; 2 grades of muscular strengths are 3 minutes; 3 grades of muscular strengths are 2 minutes; 4 grades of muscular strengths are 1 minute; 5 grades of muscular strengths are 0 minute.Score value is high more, and symptom is heavy more.2. amyotrophy: from asymptomatic to light,, the severe atrophy divides 0~3 grade, score value is high more, symptom is heavy more.3. function grading:, be divided into 0~6 functional level with reference to the Hughes method.0 grade: healthy people; 1 grade: light symptoms and sign are arranged but can work; 2 grades: independent ambulation surpasses 5m; 3 grades: under others helps, walk more than the 5m; 4 grades: wheelchair or bed, under helping, can not walk 5m; 5 grades: need to use respirator; 6 grades: death.4. sensory function evaluation:, be divided into 0~4 grade with reference to the Hughes method.0 grade: normal; 1 grade: have subjective sensation unusual but do not have objective sign; 2 grades: the wrist ankle goes down or disappears far feeling; 3 grades: patella ulnaris goes down or disappears far feeling; 4 grades: the shoulder arm goes down or disappears far feeling.Score value is high more, and symptom is heavy more.
Nerve conduction velocity detects: select the heavier lower limb nerve of patient's clinical symptoms, measure the motor nerve conduction velocity and the sural nerve sensory nerve conduction velocity of common peroneal nerve respectively.
Cerebrospinal fluid protein is checked: observe every variation before and after the treatment of patient's cerebrospinal fluid protein value.
3.2 the statistical method measurement data is checked with t, enumeration data x 2Check, the ranked data rank test.
4 criterions of therapeutical effect and therapeutic outcome
4.1 clinical symptoms curative effect judging standard
Each clinical symptoms integral and calculating summation before and after will treating, and calculate the branch rate that subtracts.
Produce effects: subtract branch rate 〉=70%.
Effectively: 30%≤branch rate<70% subtracted.
Invalid: as to subtract branch rate<30%.
Annotate: computing formula (nimodipine method):
Subtract branch rate=[integration before (integration before the treatment-treatment back integration) ÷ treatment] * 100%.
4.2 clinical symptoms total effects therapeutic outcome sees Table 1.
Table 1 liang group treatment back clinical efficacy relatively
36 examples are organized in treatment, produce effects 7 examples, effective 22 examples, total effective rate 80.55%.Matched group 34 examples, produce effects 3 examples, effective 15 examples, total effective rate 52.94%.Statistical procedures has significant difference, shows that clinical symptoms total effects treatment group obviously is better than matched group.
4.3 2 groups of electromyograms improve relatively see Table 2, table 3.
Common peroneal nerve motor conduction velocity measured value compares (meter per second) before and after the table 2 liang group treatment
The treatment group Matched group The t value The P value
The example number 36 34
Before the treatment 27.70±5.43 28.10±5.52 t=-0.2831 P=0.7781
After the treatment 34.83±3.90 32.70±4.39 t Control=-5.8480 t Right=3.5743 P Control=0.0000 P Right=0.0007
Difference 7.13±5.75 4.60±2.65 t=2.1933 P=0.0323
Sural nerve sensation conduction velocity measured value compares (meter per second) before and after the table 3 liang group treatment
The treatment group Matched group The t value The P value
The example number 36 34
Before the treatment 28.67±5.55 26.97±5.89 t=1.1511 P=0.2544
After the treatment 32.67±5.74 29.10±5.15 t Control=-2.7435 t Right=-1.4941 P Control=0.0081 P Right=0.1406
Difference 4.00±3.04 2.13±2.99 t=2.3973 P=0.0198
The electromyogram inspection all has important value to diagnosis and the prognosis of CIDP.Electromyography common peroneal nerve motor conduction velocity and sural nerve sensation conduction velocity result show, the treatment group all has clear improvement to two nerve conduction velocity, with the matched group comparative statistics significant difference is arranged, illustrate that the treatment group speeds more obvious than matched group for the injured nerve conduction velocity.Show the neurotrophy protective effect that medicine of the present invention is good.
4.4 changing, 2 groups of cerebrospinal fluid protein relatively see Table 4.
The cerebrospinal fluid protein measured value compares (g/L) before and after the table 4 liang group treatment
The treatment group Matched group The t value The P value
The example number 30 30
Before the treatment 0.87±0.30 0.86±0.31 t=0.1240 P=0.9017
After the treatment 0.62±0.19 0.72±0.22 t Control=3.8288 t Right=2.0412 P Control=0.0003 P Right=0.0458
Difference 0.25±0.25 0.14±0.16 t=-2.0152 P=0.0485
CIDP patient's cerebrospinal fluid protein of 80% increases, and the protein content fluctuation is bigger, usually at 0.75-2g/L.This result of study shows that most of patient's cerebrospinal fluid protein has decline in various degree along with the alleviating of the state of an illness, and medicine group of the present invention has shown more tangible cerebrospinal fluid protein downward trend than matched group, and be in a bad way degree and protein content of checking has dependency.
5 conclusions
Drug effect of the present invention is supported based on QI invigorating and is superintended and directed, promoting blood circulation to remove obstruction in the collateral.The modern pharmacological research result shows that also the Radix Astragali has the effect of " adaptogen " sample to nervous system, blood circulation, but enhancing body's immunological function can be regulated neural, function of immune system, and the autoimmunity nervous system disease is had better curative effect.The contained Radix Astragali is warded off the immunosuppressive action that can resist andrographolide more in the Radix Astragali.Above clinical experimental study confirms, curative effect of medication of the present invention obviously is better than the simple western medicine matched group, adverse reaction rate and relapse rate all significantly are lower than matched group in the course of treatment simultaneously, illustrate that Drug therapy chronic inflammatory demyelinative polyneuropathy of the present invention has good curative effect.
In sum, after using Drug therapy of the present invention, the every index of patient's clinical symptoms is obviously improved, and total effective rate is apparently higher than matched group, and does not have tangible untoward reaction and side effect.Therefore medicine of the present invention can be treated chronic inflammatory demyelinative polyneuropathy effectively.

Claims (8)

1, the application of a kind of Chinese medicine composition in preparation treatment chronic inflammatory demyelinative polyneuropathy medicine is characterized in that this Chinese medicine composition made by following bulk drugs:
Radix Astragali 300-400 part Radix Rehmanniae 300-400 part Caulis Spatholobi 300-400 part Ramulus Cinnamomi 80-120 part
Radix Angelicae Sinensis 100-150 part Rhizoma Chuanxiong 150-200 part Semen Litchi 150-200 part Rhizoma Anemarrhenae 80-120 part
Ramulus Mori 80-120 part Radix Cynanchi Paniculati 80-120 part Rhizoma Corydalis 70-120 part Herba Ephedrae 50-100 part
Pheretima 30-60 part.
2, application according to claim 1 is characterized in that described Chinese medicine composition made by following bulk drugs:
136 parts of 113 parts of Radix Angelicae Sinensis of 340 parts of Ramulus Cinnamomi of 340 portions of Caulis Spatholobis of 340 parts of Radix Rehmanniae of the Radix Astragali
102 parts of 113 parts of Radix Cynanchi Paniculatis of 113 parts of Ramulus Moris of 170 parts of Rhizoma Anemarrhenaes of 170 parts of Semen Litchis of Rhizoma Chuanxiong
45 parts of 68 parts of Pheretimas of 91 portions of Herba Ephedraes of Rhizoma Corydalis.
3, application according to claim 1 is characterized in that described Chinese medicine composition made by following bulk drugs:
100 parts of 80 parts of Radix Angelicae Sinensis of 300 parts of Ramulus Cinnamomi of 300 portions of Caulis Spatholobis of 300 parts of Radix Rehmanniae of the Radix Astragali
80 parts of 80 parts of Radix Cynanchi Paniculatis of 80 parts of Ramulus Moris of 150 parts of Rhizoma Anemarrhenaes of 150 parts of Semen Litchis of Rhizoma Chuanxiong
30 parts of 50 parts of Pheretimas of 70 portions of Herba Ephedraes of Rhizoma Corydalis.
4, application according to claim 1 is characterized in that described Chinese medicine composition made by following bulk drugs:
150 parts of 120 parts of Radix Angelicae Sinensis of 400 parts of Ramulus Cinnamomi of 400 portions of Caulis Spatholobis of 400 parts of Radix Rehmanniae of the Radix Astragali
120 parts of 120 parts of Radix Cynanchi Paniculatis of 120 parts of Ramulus Moris of 200 parts of Rhizoma Anemarrhenaes of 200 parts of Semen Litchis of Rhizoma Chuanxiong
60 parts of 100 parts of Pheretimas of 120 portions of Herba Ephedraes of Rhizoma Corydalis.
5, application according to claim 1 is characterized in that described Chinese medicine composition made by following bulk drugs:
150 parts of 120 parts of Radix Angelicae Sinensis of 300 parts of Ramulus Cinnamomi of 300 portions of Caulis Spatholobis of 300 parts of Radix Rehmanniae of the Radix Astragali
120 parts of 120 parts of Radix Cynanchi Paniculatis of 120 parts of Ramulus Moris of 200 parts of Rhizoma Anemarrhenaes of 150 parts of Semen Litchis of Rhizoma Chuanxiong
60 parts of 100 parts of Pheretimas of 120 portions of Herba Ephedraes of Rhizoma Corydalis.
6, as each described application among the claim 1-5, it is characterized in that the active component of described Chinese medicine composition is made up of following ingredients:
1), the Radix Astragali, Herba Ephedrae, Ramulus Mori, Rhizoma Corydalis, Caulis Spatholobi, Rhizoma Chuanxiong, add 8-12 respectively and doubly measure 50-80% ethanol, reflux, extract, 1-3 time, extraction time was respectively 1-3 hour, filter, merge extractive liquid,, residue discards, reclaiming ethanol does not extremely have the alcohol flavor, the fluid extract of relative density 1.02-1.06 when being evaporated to 60 ℃ of heat surveys;
2), Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati, add 5-8 times of water gaging, soaked 20-40 minute, steam distillation is carried oil, the time is 5-8 hour, the volatile oil that is extracted;
3), Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati have extracted filtered decocting liquid behind the volatile oil;
4), Radix Rehmanniae, Semen Litchi, the Rhizoma Anemarrhenae, Pheretima and Ramulus Cinnamomi, Radix Angelicae Sinensis, Radix Cynanchi Paniculati extract the residue merging behind the volatile oil, add 8-12 times of water gaging, heating decocts 1-3 time, time was respectively 1-3 hour, filter, merge extractive liquid,, residue discards, relative density is the clear paste of 1.20-1.24 when being evaporated to 60 ℃ of heat surveys, add 95% ethanol to determining alcohol 50-70%, 5-10 ℃ left standstill 18-36 hour, filtered, decompression filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, the fluid extract of relative density 1.02-1.06 when being evaporated to 60 ℃ of hot surveys.
7, according to the arbitrary described application of claim 1-5, the preparation formulation that it is characterized in that described Chinese medicine composition is capsule, tablet, granule, pill, powder or oral liquid.
8, application according to claim 6, the preparation formulation that it is characterized in that described Chinese medicine composition is capsule, tablet, granule, pill, powder or oral liquid.
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CN100364590C (en) * 2005-03-17 2008-01-30 河北以岭医药研究院有限公司 Medicine for treating peripheral nervous disease of diabets mellitus and prepn. method

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104288388A (en) * 2014-10-27 2015-01-21 哈尔滨金玉科技开发有限公司 Medicament for treating acute inflammatory demyelinating polyneuropathies and preparation method of medicament

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