CN103372132A - Traditional Chinese medicine composition for treating ankylosing spondylitis, and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating ankylosing spondylitis, and preparation method thereof Download PDFInfo
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- CN103372132A CN103372132A CN2012101145282A CN201210114528A CN103372132A CN 103372132 A CN103372132 A CN 103372132A CN 2012101145282 A CN2012101145282 A CN 2012101145282A CN 201210114528 A CN201210114528 A CN 201210114528A CN 103372132 A CN103372132 A CN 103372132A
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Abstract
The invention discloses a traditional Chinese medicine composition for treating ankylosing spondylitis. The traditional Chinese medicine composition is prepared from pharmacodynamic components or pharmacodynamic components and pharmaceutical acceptable auxiliary materials, wherein the pharmacodynamic components are prepared from rhizoma cibotii, rhizoma anemarrhenae, caulis sinomenii, gypsum, honeysuckle stem, rhizoma atractylodis, herba siegesbeckiae, golden cypress and achyranthes root as materials. The traditional Chinese medicine composition has the effects of tonifying kidney and strengthening bones, and clearing away heat and eliminating dampeness, and is suitable for ankylosing spondylitis kidney deficiency and damp heat; more than 300 sufferers are in clinic treatment; the effective rate can be up to 87.27%; significant clinical effects are obtained; the traditional Chinese medicine composition is good in safety. The invention also discloses a preparation method of the traditional Chinese medicine composition.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of ankylosing spondylitis, belong to the field of Chinese medicines; The invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
Ankylosing spondylitis be a kind of agnogenic, take axis joint chronic inflammatory disease as main general pathological changes; pathological changes is mainly involved sacroiliac joint; intervertebral disc fibrosis and near ligament calcification and bony ankylosis often occur, and its characteristic pathological change is tendon, ligament, bone attachment point pathological changes.
Whole nation distinguished veteran doctors of TCM Yan Xiaoping teaches clinical 40 over-carriages, and diagnosis and treatment patients with ankylosing spondylitis more than 9000 examples in long-term clinical course, sum up the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs system of ankylosing spondylitis.The relevant names of disease of tcm that professor Yan Xiaoping proposes primary disease is " severe hunch-back ", and the proposition primary disease can be the guiding principle determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs according to cold and heat, she thinks that primary disease can be the guiding principle determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs according to cold and heat, and developed the treatment primary disease effective Chinese medicine composition of ankylosing spondylitis of damp-heat syndrome of suffering from a deficiency of the kidney, thereby finished the present invention.
Summary of the invention
An object of the present invention is to provide a kind of Chinese medicine composition for the treatment of ankylosing spondylitis.
Another object of the present invention provides the preparation method of the Chinese medicine composition of this treatment ankylosing spondylitis.
The present composition is comprised of composition and effectiveness or composition and effectiveness and pharmaceutically acceptable adjuvant, wherein said composition and effectiveness is made by following raw materials according: select Rhizoma Cibotii to make monarch drug, it is the rhizome of Dicksoniaceae plant Cibotium barometz (L.) J. Sm., has invigorating the liver and kidney, removes the effect in rheumatism, strong waist foot and sharp joint; Select the Rhizoma Anemarrhenae and Caulis Sinomenii to make ministerial drug, wherein Caulis Sinomenii is the rattan of menispermaceous plants Sinomenium acutum, magnificent Radix Stephaniae Tetrandrae or bluish glaucoma vine Caulis Sinomenii etc., has the effect of wind-damp dispelling and diuresis; The Rhizoma Anemarrhenae is the rhizome of the liliaceous plant Rhizoma Anemarrhenae, has the effect of nourishing YIN to lower pathogenic fire and moistening dryness for relaxing bowels; Select Gypsum Fibrosum, Caulis Lonicerae, Rhizoma Atractylodis, Herba Siegesbeckiae, Cortex Phellodendri to make adjuvant drug, wherein Caulis Lonicerae is the caprifoliaceae plant stem and leaf of Radix Ophiopogonis, has the effect of heat clearing away, dispelling toxins and dredging collaterals; Rhizoma Atractylodis are the rhizome of feverfew RHIZOMA ATRACTYLODIS IANCEAE or Atractylis chinensis, have the effect of spleen invigorating, dampness, resolving depression; Herba Siegesbeckiae is the herb of feverfew Herba Siegesbeckiae, Herba Siegesbeckiae or siegesbeckia glabrescens Makino, has the effect of wind-damp dispelling, relieving rigidity of muscles and joints and blood pressure lowering; Cortex Phellodendri is the bark of rutaceae Cortex Phellodendri or wampee, has the effect of heat clearing away, dampness, pathogenic fire purging and detoxifcation; Gypsum Fibrosum is the Ore of Sulfates mineral gypsum, has the effect that the expelling pathogenic factors from muscles for clearing heat relieving restlessness is quenched the thirst; Select Radix Achyranthis Bidentatae to make medicine, it is the root of amaranthaceous plant Radix Achyranthis Bidentatae, has the effect of tonifying liver and kidney and strengthening bones and muscles.With these drug regimens, has the effect of invigorating the kidney and strengthening the bones and clearing away heat and eliminating dampness.Preferably use Radix Achyranthis Bidentatae.
The consumption of these flavour of a drug is monarch drug Rhizoma Cibotii 10-15 weight portion; Ministerial drug Rhizoma Anemarrhenae 10-15 weight portion and Caulis Sinomenii 10-15 weight portion; Adjuvant drug Gypsum Fibrosum 25-30 weight portion, Caulis Lonicerae 25-30 weight portion, Rhizoma Atractylodis 5-10 weight portion, Herba Siegesbeckiae 10-15 weight portion, Cortex Phellodendri 5-10 weight portion; Make medicine Radix Achyranthis Bidentatae 5-10 weight portion.
Research finds, following preferred flavour of a drug consumption can be so that compositions obtains better curative effect:
Monarch drug Rhizoma Cibotii 15 weight portions; The ministerial drug Rhizoma Anemarrhenae 15 weight portions and Caulis Sinomenii 15 weight portions; Adjuvant drug Gypsum Fibrosum 30 weight portions, Caulis Lonicerae 30 weight portions, Rhizoma Atractylodis 10 weight portion, Herba Siegesbeckiaes 15 weight portions, Cortex Phellodendri 10 weight portions; Make medicine Radix Achyranthis Bidentatae 10 weight portions.
The present composition can be made oral formulations such as decoction, granule, the watered pill, tablet, medicinal tea etc. according to the conventional method of field of traditional Chinese with pharmaceutically acceptable adjuvant with the flavour of a drug of above-mentioned consumption.Preferred water or ethanol extraction are made pill, tablet, granule etc. with pharmaceutic adjuvant again.
The preparation method of the present composition preferably takes by weighing raw material; Pulverize, medical material is added water decocted together 30-60 minute, filter, filtering residue is added water cover powder continuation decoction 30 minutes, refilter, merge filtrate twice, concentrated, make oral formulations with pharmaceutic adjuvant.
The easypro ridge ball of heat clearing away of the present invention has the merit of invigorating the kidney and strengthening the bones, clearing away heat and eliminating dampness, is applicable to the ankylosing spondylitis card and belongs to the damp and hot card of suffering from a deficiency of the kidney.Clinical treatment patient more than 300 examples, effective percentage reaches 87.27%, has obtained significant clinical efficacy, and safety is good.
Embodiment
Preparation example 1
Take by weighing Rhizoma Cibotii 150 grams; The Rhizoma Anemarrhenae 150 grams, Caulis Sinomenii 150 grams, Gypsum Fibrosum 300 grams, Caulis Lonicerae 300 grams, Rhizoma Atractylodis 100 Ke, Herba Siegesbeckiaes 150 grams, Cortex Phellodendri 100 grams, Radix Achyranthis Bidentatae 100 grams; Pulverizing decocted the medical material water 40 minutes together, filtered, and filtering residue is added water cover powder continuation decoction 30 minutes, refiltered, and merged filtrate twice, and concentrated pill obtains the easypro ridge ball of heat clearing away.
Preparation example 2
Take by weighing Rhizoma Cibotii 100 grams; The Rhizoma Anemarrhenae 150 grams, Caulis Sinomenii 100 grams, Gypsum Fibrosum 250 grams, Caulis Lonicerae 250 grams, Rhizoma Atractylodis 100 Ke, Herba Siegesbeckiaes 100 grams, Cortex Phellodendri 100 grams, Radix Achyranthis Bidentatae 100 grams; Pulverize, the medical material water was decocted 40 minutes together, filter, filtering residue is added water cover powder continuation decoction 30 minutes, refilter, merge filtrate twice, concentrated, add starch, granulation.
Test example: heat clearing away the suffer from a deficiency of the kidney clinical efficacy of damp-heat syndrome of ridge pill for curing ankylosing spondylitis that relaxes
The prepared heat clearing away of embodiment 1 is relaxed the ridge ball at Ministry of Public Health China-Japan Friendship Hospital clinical application, now 55 routine patients are wherein carried out clinical efficacy is summarized in down.
1 data and method
1.1 the case source: 55 patients with ankylosing spondylitis are all from June, 2009-2010 year China-Japan Friendship Hospital's traditional Chinese medical science Rheumatology outpatient service in June and inpatient.
1.2 case inclusion criteria and exclusion standard
(1) inclusion criteria: 1. meet the New York standard that Americanism damp disease association revised in 1984; 2. age 16-65 year; 3. meet " severe hunch-back " the damp-heat syndrome diagnostic criteria of suffering from a deficiency of the kidney, with reference to " guideline of clinical investigations of new Chinese medicine treatment numbness disease ", teach the clinical empirical summary gained in conjunction with establish one's virtue professor and Yan Xiaoping of Jiao.The damp-heat syndrome of suffering from a deficiency of the kidney: waist sacrum, back, buttocks are ached, heavy, stiff discomfort, indistinctive fever, continuously do not understand, sweating is vexed, the glutinous greasy or xerostomia of bitter taste wish drink not, or see that oppression sensation over the epigastrium and anorexia, large loose stool are soft, or viscid not well; that yellowish or reddish urine or companion see redness and swelling of joints Zhuo Re inflammation pain; or hydrops is arranged, bend and stretch limitation of activity, body of the tongue is partially red; greasy fur or yellow greasy or dirty greasy, deep-rolling pulse, stringy and rolling pulse or stringy and thready pulse number.
(2) exclusion standard: 1. gestation or breast-feeding female patient; 2. can not anti-receptor to this medicine; The serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system and psychotic are arranged; 3. late period serious joint deformity, afunction the patient; 4. other seronegative spondyloanthropathy are arranged simultaneously or be associated with other rheumatismal patients; 5. the person that uses the hormone medicine in the recent period; 6. this studies the patient that digestive tract ulcer is arranged in front 1 month; 7. just participating at present or studying the patient who participated in the clinical observation of other treatment ankylosing spondylitis in front 1 month at this.
1.3 treatment and observational technique
(1) Therapeutic Method: selected case is all given the easypro ridge pill for curing of heat clearing away, and every day 3 times, each 1 bag, be 1 month the course for the treatment of.The medicine that does not newly add other treatment ankylosing spondylitis in the treatment.
(2) observation index: 1. clinical symptoms and sign: patient's overall assessment, function index, pantalgia, hypnalgia, morning stiff time, arthroncus number, arthroncus integration, refer to that distance, jaw handle distance, thorax mobility, Schober levy; 2. tcm syndrome integration: comprise xerostomia, whole body heating, redness and swelling of joints, joint heating, body of the tongue, tongue fur, urine situation, stool situation.Every is divided into four grades of 0-3, and each symptom total points is the tcm syndrome integration; 3. lab testing: erythrocyte sedimentation rate, C reactive protein, routine blood test, routine urinalysis, just routine, hepatic and renal function, electrocardiogram; 4. close observation may occur in the clinical trial process any untoward reaction or adverse events are recorded faithfully.
1.4 therapeutic evaluation
(1) evaluation index: leading indicator comprises 7: pantalgia, arthroncus number, arthroncus integration, stiff time in morning, tcm syndrome integration, ESR, CRP; (2) less important index is 6: refer to that distance, jaw handle distance, thorax mobility, Schober levy, patient's overall assessment, function index.
(2) the standard of curative effect evaluation (national Bureau of Drugs Supervision " guideline of clinical investigations of new Chinese medicine treatment ankylosing spondylitis " in 2002) clinical recovery: at least 4 improvement 〉=95% in 7 leading indicators; Produce effects: at least 4 improvement 〉=70% in 7 leading indicators, or at least 4 improvement 〉=70% in 6 less important indexs; Effectively: at least 4 improvement 〉=30% in 7 leading indicators, or at least 4 improvement 〉=30% in 6 less important indexs; Invalid: as not reach These parameters or increase the weight of.
(3) evaluation of untoward reaction: the evaluation of untoward reaction divides 3 grades, 1 grade: slight uncomfortable, do not affect routine work; 2 grades: moderate is uncomfortable, affects routine work; 3 grades: severe is uncomfortable, obviously affects routine work.
1.5 statistical method: adopt SPSS17.0 software to carry out statistical procedures.Curative effect compares between two groups, and according to circumstances measurement data will adopt two sample t check, or the Wilcoxon rank test, front and back Comparison of therapeutic employing repeated measure variance analysis in the group, enumeration data X 2 test, ranked data Wilcoxon rank test.Statistical test all adopts two-sided test, and the significance,statistical boundary is defined as P<0.05.
2 results
2.1 ordinary circumstance
Select altogether 55 examples, male 51 examples wherein, women 4 examples.The course of disease 6 months-35 years.Year mean age (31.08 ± 9.66), average course of disease (7.35 ± 7.03) year.
2.2 general curative effect analysis
Heat clearing away ridge pill for curing ankylosing spondylitis damp-heat syndrome patient clinical 6 examples of fully recovering of suffering from a deficiency of the kidney of relaxing account for 10.91%, and produce effects 23 examples account for 41.82%, and effective 48 examples account for 87.27%, and invalid 7 examples account for 12.73%, and total effective rate is 87.27%.
2.3 the curative effect index changes before and after the treatment
Stiff time of pantalgia, arthroncus integration, morning, ESR, CRP have utmost point significant difference before and after the treatment, and the tcm syndrome integration, there were significant differences for the arthroncus number, specifically sees Table 1.
2.4 the secondary efficacy index changes before and after the treatment
Treatment Patients Before And After overall assessment has utmost point significant difference, function index, refers to that distance, Schober levy that there were significant differences, and the jaw handle specifically sees Table 2 apart from, thorax mobility no significant difference.
2.5 untoward reaction
All promoting the circulation of blood before and after the 55 routine patient treatments, urine, just routine, Liver and kidney merit and Electrocardioscopy, unusual without 1 example.All patients is showed no serious adverse reaction, does not also have because of untoward reaction to withdraw from the observer, has 1 example (being classified as 1 grade) patient to occur taking medicine to feel sick afterwards, vomiting, alleviates after changing medicine time through instructing.
Annotate: compare * P<0.05, * * P<0.01 before and after the treatment.
Annotate: compare * P<0.05, * * P<0.01 before and after the treatment.
Claims (7)
1. Chinese medicine composition for the treatment of ankylosing spondylitis, it is characterized in that it is composition and effectiveness or composition and effectiveness and pharmaceutically acceptable adjuvant composition, wherein said composition and effectiveness is to be made by the raw material of following weight portion: Rhizoma Cibotii 10-15 weight portion, Rhizoma Anemarrhenae 10-15 weight portion, Caulis Sinomenii 10-15 weight portion, Gypsum Fibrosum 25-30 weight portion, Caulis Lonicerae 25-30 weight portion, Rhizoma Atractylodis 5-10 weight portion, Herba Siegesbeckiae 10-15 weight portion, Cortex Phellodendri 5-10 weight portion and Radix Achyranthis Bidentatae 5-10 weight portion.
2. Chinese medicine composition according to claim 1, wherein said composition and effectiveness is to be made by the raw material of following weight portion: Rhizoma Cibotii 15 weight portions, the Rhizoma Anemarrhenae 15 weight portions, Caulis Sinomenii 15 weight portions, Gypsum Fibrosum 30 weight portions, Caulis Lonicerae 30 weight portions, Rhizoma Atractylodis 10 weight portion, Herba Siegesbeckiaes 15 weight portions, Cortex Phellodendri 10 weight portions and Radix Achyranthis Bidentatae 10 weight portions.
3. Chinese medicine composition according to claim 1 and 2, wherein said Radix Achyranthis Bidentatae is Radix Achyranthis Bidentatae.
4. according to claim 1,2 or 3 described Chinese medicine compositions, wherein said compositions is oral formulations.
5. the Chinese medicine composition preparation method of the described treatment ankylosing spondylitis of claim 4, it comprises the following steps: to take by weighing Rhizoma Cibotii 10-15 weight portion, Rhizoma Anemarrhenae 10-15 weight portion, Caulis Sinomenii 10-15 weight portion, Gypsum Fibrosum 25-30 weight portion, Caulis Lonicerae 25-30 weight portion, Rhizoma Atractylodis 5-10 weight portion, Herba Siegesbeckiae 10-15 weight portion, Cortex Phellodendri 5-10 weight portion and Radix Achyranthis Bidentatae 5-10 weight portion; Pulverize, the medical material water was decocted 30-60 minute together, filter, filtering residue is added water cover powder continuation decoction 30 minutes, refilter, merge filtrate twice, concentrated, make oral formulations with pharmaceutic adjuvant.
6. Chinese medicine composition preparation method according to claim 5, the raw material that wherein takes by weighing is: Rhizoma Cibotii 15 weight portions, the Rhizoma Anemarrhenae 15 weight portions, Caulis Sinomenii 15 weight portions, Gypsum Fibrosum 30 weight portions, Caulis Lonicerae 30 weight portions, Rhizoma Atractylodis 10 weight portion, Herba Siegesbeckiaes 15 weight portions, Cortex Phellodendri 10 weight portions and Radix Achyranthis Bidentatae 10 weight portions.
7. according to claim 5 or 6 described Chinese medicine composition preparation methoies, wherein said Radix Achyranthis Bidentatae is Radix Achyranthis Bidentatae.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101507802A (en) * | 2008-02-17 | 2009-08-19 | 闫凤宝 | Medicine for treating ankylosing spondylitis |
CN102188496A (en) * | 2010-03-15 | 2011-09-21 | 阎小萍 | Chinese medicine for treating ankylosing spondylitis and preparation method thereof |
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Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101507802A (en) * | 2008-02-17 | 2009-08-19 | 闫凤宝 | Medicine for treating ankylosing spondylitis |
CN102188496A (en) * | 2010-03-15 | 2011-09-21 | 阎小萍 | Chinese medicine for treating ankylosing spondylitis and preparation method thereof |
Non-Patent Citations (2)
Title |
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汪元 等: "强直性脊柱炎中医药研究进展", 《江苏中医药》 * |
谢学光: "中医药治疗强直性脊柱炎的研究现状", 《山西中医》 * |
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Application publication date: 20131030 |