CN101601740B - Medicament for treating myasthenia gravis and preparation method thereof - Google Patents
Medicament for treating myasthenia gravis and preparation method thereof Download PDFInfo
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Abstract
The invention provides a medicament for treating myasthenia gravis and a preparation method thereof. The medicament for treating myasthenia gravis is prepared from Chinese ephedra, aconites, asarum, astragalus roots, ginseng, Chinese angelica roots, atractylodes rhizome, dodders, and the like. The medicament for treating myasthenia gravis promotes the circulation of qi and blood, nourishes muscles and has good effects on collecting yang, restoring qi and removing obstruction in channels. Clinical experiments prove that the medicament for treating myasthenia gravis can effectively treat myasthenia gravis.
Description
Technical field
The present invention relates to a kind of medicine of treating myasthenia gravis and preparation method thereof, belong to field of Chinese herbal.
Background technology
(myasthenia gravis is the acquired autoimmune disease of a kind of general that involves neuromuscular junction place postsynaptic membrane acetylcholinergic receptor MG) to myasthenia gravis, and sickness rate is 8,/10 ten thousand, and is ascendant trend year by year.The touching difficulty of this disease more has certain disability rate, case fatality rate, and therefore, WHO classifies myasthenia gravis as difficult treatment.
Myasthenia gravis (MG) belongs to the traditional Chinese medical science " flaccidity " category, because the primary disease clinical symptoms is various, TCM Document has different names of disease to describe to it, but the main clinical manifestation that descends according to its movable back muscular strength, the master traditional Chinese medical science " flaccidity is sick " category.Ancient Chinese medicine doctor argumentation to myopathy from different aspects is for the certain theory basis has been established in the research of primary disease.The record of relevant myopathy, head is shown in " interior warp ", and its pathogenesis to the disease card has been mentioned relevant with the eight extra-channel pathological changes." element ask flaccidity opinion " discussed etiology and pathogenesis, syndrome-classification and the principle of treatment of myopathy for the special piece of writing of myopathy is discussed, and points out the dashing of myopathy and eight extra-channel, superintends and directs, dai channel is relevant, and main cause is the interior-heat impairment of body fluid, and penis loses profit, so that vertical of the soft relaxation of flaccidity is a myopathy.What the Lin Peiqin of the Qing Dynasty " type card control carry " had a disease of controlling " the smooth strange network of temperature row " says that " well-known doctor of Qing Dynasty medical notes case Xu Yu platform " also said: " flaccidity due to malnutrition of tendons, the atrophic debility of bones all belong to eight extra-channel network disease ", it is relevant with eight extra-channel and channels pathological changes all to speak of primary disease." eight extra-channel is deficient, very unit decays " is that myasthenia gravis is fallen ill originally, and " channels is empty to stagnate " is to further develop the key that increases the weight of.
Doctor trained in Western medicine does not have a kind of effective therapy up to now.At present methods such as hormones, immunosuppressant, anticholinergic medicine, radiotherapy chemotherapy, plasmapheresis, thymusectomy that adopt more, but these methods courses of treatment is long, side effect is big, and the state of an illness is repeatedly.
Summary of the invention
The present invention provides a kind of medicine of treating myasthenia gravis, and this medicine is processed by following bulk drugs:
Herba Ephedrae 65-115 Radix Aconiti Lateralis Preparata 210-390 Herba Asari 45-80 Radix Astragali 200-400 Radix Ginseng 85-155 Radix Angelicae Sinensis 80-160 Rhizoma Atractylodis Macrocephalae 110-190 Semen Cuscutae 170-310 Placenta Hominis 30-60 Cornu Cervi Pantotrichum 20-40 Radix Glycyrrhizae 40-80 Semen Strychni 3.5-6.5.
The crude drug part by weight of medicine of the present invention is preferably:
Herba Ephedrae 65 Radix Aconiti Lateralis Preparatas 390 Herba Asaris 80 Radixs Astragali 400 Radix Ginsengs 85 Radix Angelicae Sinensis 160 Rhizoma Atractylodis Macrocephalaes 110 Semen Cuscutae 170 Placenta Hominiss 60 Cornu Cervi Pantotrichums 20 Radix Glycyrrhizaes 40 Semen Strychni 3.5.
Perhaps
Herba Ephedrae 115 Radix Aconiti Lateralis Preparatas 210 Herba Asaris 45 Radixs Astragali 200 Radix Ginsengs 155 Radix Angelicae Sinensis 80 Rhizoma Atractylodis Macrocephalaes 190 Semen Cuscutae 310 Placenta Hominiss 30 Cornu Cervi Pantotrichums 40 Radix Glycyrrhizaes 80 Semen Strychni 6.5.
Perhaps
Herba Ephedrae 90 Radix Aconiti Lateralis Preparatas 300 Herba Asaris 60 Radixs Astragali 300 Radix Ginsengs 120 Radix Angelicae Sinensis 120 Rhizoma Atractylodis Macrocephalaes 150 Semen Cuscutae 240 Placenta Hominiss 40 Cornu Cervi Pantotrichums 30 Radix Glycyrrhizaes 60 Semen Strychni 5.
Perhaps
Herba Ephedrae 70 Radix Aconiti Lateralis Preparatas 260 Herba Asaris 49 Radixs Astragali 360 Radix Ginsengs 150 Radix Angelicae Sinensis 140 Rhizoma Atractylodis Macrocephalaes 120 Semen Cuscutae 210 Placenta Hominiss 35 Cornu Cervi Pantotrichums 35 Radix Glycyrrhizaes 45 Semen Strychni 4.
Perhaps
Herba Ephedrae 100 Radix Aconiti Lateralis Preparatas 320 Herba Asaris 70 Radixs Astragali 260 Radix Ginsengs 100 Radix Angelicae Sinensis 90 Rhizoma Atractylodis Macrocephalaes 170 Semen Cuscutae 260 Placenta Hominiss 50 Cornu Cervi Pantotrichums 27 Radix Glycyrrhizaes 70 Semen Strychni 6.
Preferably, Cornu Cervi Pantotrichum is that Pulveratum Cornu Cervi Pantotrichum, Radix Glycyrrhizae are Radix Glycyrrhizae Preparata in the above-mentioned raw materials medicine.
Medicament form of pharmaceutical preparation of the present invention is decoction, capsule, tablet, granule, powder or pill; 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 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., and 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.
Preferably, the method for preparing of medicine group decoction of the present invention may further comprise the steps and makes:
1) take by weighing Radix Aconiti Lateralis Preparata in proportion, after being decocted first 1 hour, the Herba Ephedrae of additional proportion amount, Herba Asari, the Radix Astragali, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Semen Cuscutae, Radix Glycyrrhizae, decoct 1 hour again after, filter;
2) after Radix Ginseng is fried in shallow oil filtration in addition, with step 1) gained decocting liquid mixing;
3) take by weighing Placenta Hominis in proportion, Cornu Cervi Pantotrichum, Semen Strychni are ground into fine powder respectively, pour step 2) gained mixing water decocting liquid promptly gets.
Reuse Radix Aconiti Lateralis Preparata in the medicine side of the present invention, close the sun that Herba Ephedrae, Herba Asari rouse oneself decadence, promoting the flow of QI in the collateral by warming the meridian is added with the Radix Astragali, Radix Ginseng, Rhizoma Atractylodis Macrocephalae QI invigorating invigorating YANG; Beneficial smart hemopoietic such as Placenta Hominis, Cornu Cervi Pantotrichum, warm kidney-Yang invigorating, with YANG invigorating originally; Make continuing of sun, Semen Strychni, Herba Ephedrae property are loose and are walked to scurry, and being open to the custom reaches network; According to modern pharmacological research two medicines the effect of excitor nerve is arranged all, so share at medicine, it is multiple to receive yang-energy; Through the good effect of ruton, medicine Wen Liqiyang of the present invention, to hold up unit to shake ruined, and clinical experiment confirms effectively to treat myasthenia gravis.
Preferably, medicine of the present invention can effectively be treated the ocular type myasthenia gravis.
The consumption of Chinese medicine composition of the present invention by the crude drug gross weight, was 120～200 gram/days, but takes every day once, preferably divided and took for 2-3 time.
The specific embodiment
Following embodiment is used to illustrate the preparation of medicine of the present invention, but it can not constitute any restriction to scope of the present invention.
Embodiment 1
The preparation of decoction
Prescription:
Herba Ephedrae 90g Radix Aconiti Lateralis Preparata 300g Herba Asari 60g Radix Astragali 300g Radix Ginseng 120g Radix Angelicae Sinensis 120g Rhizoma Atractylodis Macrocephalae 150g Semen Cuscutae 240g Placenta Hominis 40g Pulveratum Cornu Cervi Pantotrichum 30g Radix Glycyrrhizae Preparata 60g Semen Strychni 5g.
Method for preparing:
1) take by weighing Radix Aconiti Lateralis Preparata in proportion, after being decocted first 1 hour, the Herba Ephedrae of additional proportion amount, Herba Asari, the Radix Astragali, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Semen Cuscutae, Radix Glycyrrhizae, decoct 1 hour again after, filter;
2) after Radix Ginseng is fried in shallow oil filtration in addition, with step 1) gained decocting liquid mixing;
3) take by weighing Placenta Hominis in proportion, Cornu Cervi Pantotrichum, Semen Strychni are ground into fine powder respectively, pour step 2) gained mixing water decocting liquid promptly gets.
Embodiment 2
The preparation of decoction
Prescription:
Herba Ephedrae 65g Radix Aconiti Lateralis Preparata 390g Herba Asari 80g Radix Astragali 400g Radix Ginseng 85g Radix Angelicae Sinensis 160g Rhizoma Atractylodis Macrocephalae 110g Semen Cuscutae 170g Placenta Hominis 60g Cornu Cervi Pantotrichum 20g Radix Glycyrrhizae 40g Semen Strychni 3.5g.
Method for preparing:
1) take by weighing Radix Aconiti Lateralis Preparata in proportion, after being decocted first 1 hour, the Herba Ephedrae of additional proportion amount, Herba Asari, the Radix Astragali, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Semen Cuscutae, Radix Glycyrrhizae, decoct 1 hour again after, filter;
2) after Radix Ginseng is fried in shallow oil filtration in addition, with step 1) gained decocting liquid mixing;
3) take by weighing Placenta Hominis in proportion, Cornu Cervi Pantotrichum, Semen Strychni are ground into fine powder respectively, pour step 2) gained mixing water decocting liquid promptly gets.
Embodiment 3
The preparation of tablet
Prescription:
Herba Ephedrae 115g Radix Aconiti Lateralis Preparata 210g Herba Asari 45g Radix Astragali 200g Radix Ginseng 155g Radix Angelicae Sinensis 80g Rhizoma Atractylodis Macrocephalae 190g Semen Cuscutae 310g Placenta Hominis 30g Cornu Cervi Pantotrichum 40g Radix Glycyrrhizae 80g Semen Strychni 6.5g.
Method for preparing:
Process tablet by conventional method for preparing.
Embodiment 4
The preparation of capsule
Prescription:
Herba Ephedrae 70g Radix Aconiti Lateralis Preparata 260g Herba Asari 49g Radix Astragali 360g Radix Ginseng 150g Radix Angelicae Sinensis 140g Rhizoma Atractylodis Macrocephalae 120g Semen Cuscutae 210g Placenta Hominis 35g Pulveratum Cornu Cervi Pantotrichum 35g Radix Glycyrrhizae Preparata 45g Semen Strychni 4g.
Method for preparing:
Process capsule by conventional method for preparing.
Embodiment 5
The preparation of granule
Prescription:
Herba Ephedrae 100g Radix Aconiti Lateralis Preparata 320g Herba Asari 70g Radix Astragali 260g Radix Ginseng 100g Radix Angelicae Sinensis 90g Rhizoma Atractylodis Macrocephalae 170g Semen Cuscutae 260g Placenta Hominis 50g Pulveratum Cornu Cervi Pantotrichum 27g Radix Glycyrrhizae Preparata 70g Semen Strychni 6g.
Method for preparing:
Process capsule by conventional method for preparing.
Embodiment 6
The preparation of powder
Prescription:
Herba Ephedrae 70g Radix Aconiti Lateralis Preparata 260g Herba Asari 49g Radix Astragali 360g Radix Ginseng 150g Radix Angelicae Sinensis 140g Rhizoma Atractylodis Macrocephalae 120g Semen Cuscutae 210g Placenta Hominis 35g Pulveratum Cornu Cervi Pantotrichum 35g Radix Glycyrrhizae Preparata 45g Semen Strychni 4g.
Method for preparing:
Process powder by conventional method for preparing.
Experimental example
For illustrating the activity of traditional Chinese medicine composition for treating myasthenia gravis of the present invention, use decoction (to call medicine of the present invention in the following text) to carry out following clinical trial according to embodiment 1 preparation.
1 clinical data
1.1 the whole cases of physical data are Hebei Yi Ling hospital inpatient, totally 78 examples are divided into treatment group and matched group at random, matched group 38 examples, wherein male 22 examples, women 16 examples, year at age 12～48 (average 33).Osserman typing: I type (ocular type) 10 examples (26%), II type 12 examples (32%), III type 8 examples (21%), IV type 8 examples (21%).40 examples are organized in treatment, wherein male 23 examples, women 17 examples, year at age 11～47 (average 34).Osserman typing: I type (ocular type) 14 examples (35%), II type 13 examples (32.5%), III type 7 examples (17.5%), IV type 6 examples (15%).Two groups of MethodsThe cases enrolled do not have significant difference (P＞0.05) through statistical analysis.
1.2 diagnostic criteria 1. meet western medicine diagnostics standard and typing standard [Xu Xianhao. neuroimmunology [M]. Beijing: Beijing Medical University, combined publication society of China Concord Medical Science University, 1992.185].2. Western medicine is only taken pyridostigmine bromide and the patient of intravenous applications gamma globulin or promoting the circulation of blood slurry replacement therapy not in nearly three months.
2. method
2.1 Therapeutic Method
Matched group is used anticholinesterase drug, corticosteroid, is reached immunosuppressant according to patient's clinical manifestation and Osserman typing.Pyridostigmine, dosage are that 60mg is oral, 4 times/d, can confirm individuation dosage according to patient's symptom.Heavy dose of prednisone, begin with 60～80mg/d oral, decrement low relatively maintenance dose extremely gradually when symptom takes a turn for the better, the next day obey 5～15mg/d.The methylprednisolone flooding, the case that crisis or heavy dose of prednisone can not alleviate takes place repeatedly can try out, 1g/d, logotype 3～5d as not obtaining satisfactory effect a course of treatment, at a distance from repeating a course of treatment 2 weeks again, treats 2～3 courses of treatment.
The treatment group take 1 dose of medicine of the present invention every day (be equivalent to embodiment 1 make total amount 1/10), take at twice, the course of treatment same matched group.
2.2 efficacy assessment standard
The myasthenia gravis efficacy evaluation adopts clinical definitely keeping the score and scoring method relatively [Sun Hong is etc. myasthenia gravis patient's clinical absolute point system and the Chinese department of neurology magazine of point system [J] relatively, 1997,30 (2): 87-90. for Wang Xiuyun, Xu Xianhao].
Clinical relative score >=95% of fully recovering;
Clinical relative score >=80-95% is almost recovered;
The clinical relative score >=50-80% of produce effects;
Clinical relative score >=25-50% takes a turn for the better;
Invalid clinical relative score≤25%.
2.3 statistical analysis adopts the SPSS13 statistical analysis software to analyze, enumeration data adopts χ
2Analyze, with P＜0.05 standard of significant difference the most.
3 results
3.1 efficacy result
Treatment group curative effect comparative result is seen table 1, and visible by table, it is 92.5% that clinical total effective rate is organized in treatment, is significantly higher than matched group.
Table 1 liang group clinical efficacy comparative result n (%)
*Compare P＜0.05 with matched group
3.2 ocular type curative effect
Treatment is organized 10 routine ocular type myasthenia gravis patients and is all cured, and shows that medicine of the present invention is good especially for ocular type patient's curative effect.
3.3 a situation arises in untoward reaction
The treatment group is not found obvious adverse reaction, and pernicious vomiting 4 examples appear in matched group, ataxia 2 examples, 6 examples of suffering from abdominal pain.
4 conclusions
Medicine to sum up of the present invention can effectively be treated myasthenia gravis, and is particularly good especially for ocular type myasthenia gravis patient curative effect, and western medicine does not have obvious adverse reaction relatively.
Claims (10)
1. a medicine of treating myasthenia gravis is characterized in that, this medicine is processed by following bulk drugs:
Herba Ephedrae 65-115 Radix Aconiti Lateralis Preparata 210-390 Herba Asari 45-80 Radix Astragali 200-400 Radix Ginseng 85-155
Radix Angelicae Sinensis 80-160 Rhizoma Atractylodis Macrocephalae 110-190 Semen Cuscutae 170-310 Placenta Hominis 30-60 Cornu Cervi Pantotrichum 20-40
Radix Glycyrrhizae 40-80 Semen Strychni 3.5-6.5.
2. medicine as claimed in claim 1 is characterized in that, this medicine is processed by following bulk drugs:
Herba Ephedrae 65 Radix Aconiti Lateralis Preparatas 390 Herba Asaris 80 Radixs Astragali 400 Radix Ginsengs 85 Radix Angelicae Sinensis 160 Rhizoma Atractylodis Macrocephalaes 110
Semen Cuscutae 170 Placenta Hominiss 60 Cornu Cervi Pantotrichums 20 Radix Glycyrrhizaes 40 Semen Strychni 3.5.
3. medicine as claimed in claim 1 is characterized in that, this medicine is processed by following bulk drugs:
Herba Ephedrae 115 Radix Aconiti Lateralis Preparatas 210 Herba Asaris 45 Radixs Astragali 200 Radix Ginsengs 155 Radix Angelicae Sinensis 80 Rhizoma Atractylodis Macrocephalaes 190
Semen Cuscutae 310 Placenta Hominiss 30 Cornu Cervi Pantotrichums 40 Radix Glycyrrhizaes 80 Semen Strychni 6.5.
4. medicine as claimed in claim 1 is characterized in that, this medicine is processed by following bulk drugs:
Herba Ephedrae 90 Radix Aconiti Lateralis Preparatas 300 Herba Asaris 60 Radixs Astragali 300 Radix Ginsengs 120 Radix Angelicae Sinensis 120 Rhizoma Atractylodis Macrocephalaes 150
Semen Cuscutae 240 Placenta Hominiss 40 Cornu Cervi Pantotrichums 30 Radix Glycyrrhizaes 60 Semen Strychni 5.
5. medicine as claimed in claim 1 is characterized in that, this medicine is processed by following bulk drugs:
Herba Ephedrae 70 Radix Aconiti Lateralis Preparatas 260 Herba Asaris 49 Radixs Astragali 360 Radix Ginsengs 150 Radix Angelicae Sinensis 140 Rhizoma Atractylodis Macrocephalaes 120
Semen Cuscutae 210 Placenta Hominiss 35 Cornu Cervi Pantotrichums 35 Radix Glycyrrhizaes 45 Semen Strychni 4.
6. medicine as claimed in claim 1 is characterized in that, this medicine is processed by following bulk drugs:
Herba Ephedrae 100 Radix Aconiti Lateralis Preparatas 320 Herba Asaris 70 Radixs Astragali 260 Radix Ginsengs 100 Radix Angelicae Sinensis 90 Rhizoma Atractylodis Macrocephalaes 170
Semen Cuscutae 260 Placenta Hominiss 50 Cornu Cervi Pantotrichums 27 Radix Glycyrrhizaes 70 Semen Strychni 6.
7. like each described medicine among the claim 1-6, it is characterized in that Cornu Cervi Pantotrichum is that Pulveratum Cornu Cervi Pantotrichum, Radix Glycyrrhizae are Radix Glycyrrhizae Preparata in the said crude drug.
8. like each described medicine among the claim 1-6, it is characterized in that the preparation formulation of said medicine is decoction, capsule, tablet, granule, powder or pill.
9. the process for preparing medicine described in claim 8 is characterized in that may further comprise the steps and processes decoction:
1) take by weighing Radix Aconiti Lateralis Preparata in proportion, after being decocted first 1 hour, the Herba Ephedrae of additional proportion amount, Herba Asari, the Radix Astragali, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Semen Cuscutae, Radix Glycyrrhizae, decoct 1 hour again after, filter;
2) after Radix Ginseng is fried in shallow oil filtration in addition, with step 1) gained decocting liquid mixing;
3) take by weighing Placenta Hominis in proportion, Cornu Cervi Pantotrichum, Semen Strychni are ground into fine powder respectively, pour step 2) gained mixing water decocting liquid promptly gets.
10. like the medicine of each said treatment myasthenia gravis among the claim 1-6, it is characterized in that said myasthenia gravis is the ocular type myasthenia gravis.
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| CN103549074B (en) * | 2013-10-13 | 2014-11-12 | 太仓市伟基生物科技有限公司 | Power lifting tea |
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| CN1389245A (en) * | 2002-08-01 | 2003-01-08 | 宋鑫博 | Composite Chinese medicine for treating atrophy and flaccid paralysis of legs |
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