CN108524731B

CN108524731B - Traditional Chinese medicine composition for treating myasthenia gravis and preparation thereof

Info

Publication number: CN108524731B
Application number: CN201810769797.XA
Authority: CN
Inventors: 乞国艳
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-07-13
Filing date: 2018-07-13
Publication date: 2021-10-22
Anticipated expiration: 2038-07-13
Also published as: CN108524731A

Abstract

The invention discloses a traditional Chinese medicine composition for treating myasthenia gravis and a preparation thereof, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: radix Morindae officinalis, Saviae Miltiorrhizae radix, fructus Aurantii Immaturus, radix Codonopsis, radix astragali, bupleuri radix, Atractylodis rhizoma, radix Angelicae sinensis, cimicifugae rhizoma, Glycyrrhrizae radix, pericarpium Citri Tangerinae, fructus Lycii, rhizoma Dioscoreae, endothelium corneum Gigeriae Galli, fructus Chaenomelis, and Poria; the invention also discloses a pharmaceutical preparation and a dosage form for treating myasthenia gravis, wherein the pharmaceutical preparation consists of a traditional Chinese medicine composition and corresponding conventional pharmaceutical excipients. The traditional Chinese medicine composition disclosed by the invention is reasonable in formula and scientific in proportioning, achieves optimal drug effect synergy, and has a better treatment effect on severe myasthenia.

Description

Traditional Chinese medicine composition for treating myasthenia gravis and preparation thereof

Technical Field

The invention relates to the field of biological medicines, and relates to a traditional Chinese medicine composition for treating myasthenia gravis and a preparation thereof.

Background

Myasthenia Gravis (MG) is an autoimmune disease that mainly involves the receptor for acetylcholine (AchR) on the postsynaptic membrane of the neuromuscular junction. The clinical manifestations are partial or whole body skeletal muscle weakness and fatigue, aggravation of symptoms after activity, and alleviation of symptoms after rest and treatment with cholinesterase inhibitors (ChEI). The pathogenesis of this disease has not been completely elucidated to date.

The traditional Chinese medicine is mainly discussed in the aspects of spleen and stomach deficiency, spleen and kidney yang deficiency, liver and kidney yin deficiency, meridian deficiency and the like. The theory of spleen-stomach deficiency considers that the pathogenesis of MG is of spleen-stomach deficiency type. Because the spleen is the ' acquired root ' and the stomach is the ' sea of food, the spleen can transform food into essence and can irrigate the periphery to enrich the five internal organs, and the spleen and the stomach can transport and transport the essence and are closely matched. Dysfunction or disorder of spleen and stomach function, poor middle energizer and yang-qi and blood failing to nourish the extremities, and the muscles of the extremities cannot warm up, resulting in listlessness of the extremities.

The theory of yang deficiency of both spleen and kidney suggests that the physiological function of spleen depends on the promotion of kidney qi and kidney yin and kidney yang, and that essence stored in kidney depends on the moistening and cultivation of spleen, which mutually support and work. Both of them are mutually damaged, and the deficiency of both spleen and kidney, kidney essence deficiency, deficiency of both qi and blood, fatigue, weakness and hypofunction of the whole body, and atrophy-flaccidity syndrome.

The syndrome of liver-kidney yin deficiency is characterized by "blood sea", liver-blood deficiency, blood failing to nourish the muscles and tendons, flaccidity and indulgence of the tendons, liver-blood deficiency leading to liver-yang hyperactivity, yang hyperactivity transforming wind, liver-wind carrying phlegm stagnation in the tendons and vessels, and atrophy and disability of the limbs.

The speakers of deficient impairment of meridians think that the extra meridians and collaterals are deficient and damaged and the meridians and collaterals are deficient and stagnated, the extra meridians and the eight meridians run up and down and are distributed throughout the whole body, and the eight extra meridians are governing yin and yang, infiltrating and irrigating three yin and three yang, crossing twelve meridians, connecting the twelve meridians and the internal organs, and infiltrating and irrigating the twelve regular meridians if the extra meridians and the eight extra meridians are vigorous in qi and blood; the deficient impairment of meridians and collaterals, loss of nourishment of tendons and muscles, which leads to this disease.

Research on MG treatment by the traditional Chinese medicine has become a hotspot in the field of traditional Chinese medicine, wherein a spleen-tonifying and kidney-tonifying method for treating MD has a certain proportion, and a large number of clinical researches prove that the MD has unique advantages in the aspects of improving symptoms, reducing adverse reactions of hormones and immunosuppressants, reducing the recurrence rate, improving the life quality of patients and the like, but at present, a traditional Chinese medicine preparation for effectively treating myasthenia gravis is still needed clinically to cure the myasthenia gravis patients, and a theoretical basis is provided for deeply researching the action mechanism of the spleen-tonifying and kidney-tonifying method for treating the spleen-kidney deficiency type MG patients.

Disclosure of Invention

In order to make up for the defects of the prior art, one of the purposes of the invention is to provide a traditional Chinese medicine composition for treating myasthenia gravis.

The invention also aims to provide a pharmaceutical preparation for treating myasthenia gravis.

In order to achieve the purpose, the invention adopts the following technical scheme:

the invention provides a traditional Chinese medicine composition for treating myasthenia gravis, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 8-15 parts of morinda officinalis, 10-24 parts of salvia miltiorrhiza, 5-10 parts of immature bitter orange, 20-60 parts of codonopsis pilosula, 20-160 parts of astragalus membranaceus, 8-10 parts of radix bupleuri, 8-30 parts of bighead atractylodes rhizome, 8-15 parts of angelica sinensis, 8-10 parts of rhizoma cimicifugae, 3-6 parts of liquorice, 3-10 parts of pericarpium citri reticulatae, 6-15 parts of medlar, 12-30 parts of Chinese yam, 12-30 parts of endothelium corneum gigeriae galli, 6-15 parts of pawpaw and 15-30 parts of poria cocos.

Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 12 parts of morinda officinalis, 15 parts of salvia miltiorrhiza, 7 parts of immature bitter orange, 40 parts of codonopsis pilosula, 85 parts of astragalus membranaceus, 9 parts of radix bupleuri, 20 parts of bighead atractylodes rhizome, 12 parts of angelica sinensis, 9 parts of rhizoma cimicifugae, 5 parts of liquorice, 5 parts of pericarpium citri reticulatae, 10 parts of medlar, 25 parts of Chinese yam, 25 parts of endothelium corneum gigeriae galli, 12 parts of pawpaw and 20 parts of poria cocos.

The weight of the raw material medicines of the composition is calculated by crude medicines, and the raw material medicines are used as the proportion by weight, so that the raw material medicines can be increased or reduced in proportion during production, but the proportion of the raw material medicines in the weight proportion among the components is unchanged. The proportion of the weight proportion is obtained by scientific screening, the proportion of the components can be correspondingly adjusted, the increase or decrease is not more than 100%, and the drug effect is not changed.

In a second aspect, the present invention provides a pharmaceutical formulation comprising the Chinese medicinal composition of the first aspect of the present invention; or comprises the traditional Chinese medicine composition of the first aspect of the invention and a pharmaceutically acceptable carrier. Pharmaceutically acceptable carriers include, but are not limited to, fillers, binders, wetting agents, disintegrants, absorption enhancers, surfactants, adsorptive carriers, or lubricants.

According to the invention, the filler is understood to be an excipient diluent to increase the weight and volume of the tablet to facilitate tabletting; or it should be understood that the adjunct absorbent is intended to absorb excess liquid components of the feed. In the present invention, the filler is, for example, starch, sucrose, lactose, microcrystalline cellulose, or the like.

The binder is understood to mean a substance to which a viscous substance called a binder is added for granulation when the raw material drug itself is not viscous or insufficiently viscous. The binder is, for example, cellulose derivatives, alginates, gelatin, polyvinylpyrrolidone, and the like.

The wetting agent is understood to be a liquid which is not sticky to the medicament itself, but which wets the pharmaceutical raw materials and induces stickiness and granulation. The wetting agent is, for example, glycerol or the like.

By disintegrant is understood an excipient which can be added to a tablet to facilitate its rapid disintegration into fine particles in the gastrointestinal fluids. It is known that tablets have a high hardness after compression, and if they contain no auxiliary material which promotes disintegration, they disintegrate slowly in the gastrointestinal tract, affecting the therapeutic effect. The disintegrating agent is, for example, sodium carboxymethyl starch, hydroxypropyl cellulose, cross-linked carboxymethyl cellulose, agar, calcium carbonate, sodium bicarbonate, etc. The absorption enhancer is, for example, a quaternary ammonium compound.

The absorption enhancer is understood to be a substance which serves to increase the bioavailability of the pharmaceutical preparation. The absorption enhancer is, for example, a quaternary ammonium compound.

The surfactant is, for example, cetyl alcohol, sodium lauryl sulfate, etc.; the adsorption carrier is, for example, kaolin, bentonite, etc.

The lubricant is understood to be a chemical substance that facilitates improved tablet flow during granulation, prevents tablet material from sticking to the tablet machine die, and facilitates tablet demolding. The lubricant is, for example, talc, calcium and magnesium stearate, colloidal silica, polyethylene glycol, and the like.

Other adjuvants are, for example, flavoring agents, sweeteners, etc.

Preferably, the pharmaceutical preparation is an oral, topical, or injectable preparation.

Preferably, the oral dosage form is selected from water extract, oral liquid, tablets, pills, powder, granules, capsules, dripping pills or health-care tea oral preparation. The selection of appropriate excipients and formulation methods according to the dosage form needs is a routine technique within the skill of the art.

The third aspect of the present invention provides a preparation method of the traditional Chinese medicine composition of the first aspect of the present invention, the preparation method comprises the steps of:

weighing the traditional Chinese medicine raw materials according to the prescription amount, crushing, grinding, sieving, adding water, decocting for 2 times, mixing decoction liquids to obtain a decoction liquid, concentrating, precipitating, filtering, drying to obtain an extract, and crushing into powder.

A fourth aspect of the invention provides a use as claimed in any one of:

a. the application of the traditional Chinese medicine composition in preparing the medicine for treating myasthenia gravis is disclosed in the first aspect of the invention;

b. use of a pharmaceutical formulation according to the second aspect of the invention in the manufacture of a medicament for the treatment of myasthenia gravis.

Preferably, the myasthenia gravis in a is myasthenia gravis accompanied by poor transportation and transformation of the spleen and stomach, yellow and greasy tongue coating and dysphagia.

Preferably, the myasthenia gravis in b is myasthenia gravis accompanied by poor transportation and transformation of the spleen and stomach, yellow and greasy tongue coating and dysphagia.

The traditional Chinese medicine composition for treating myasthenia gravis is scientific and reasonable in formula, and the effects and the functions of the raw material medicines are as follows:

astragalus root, the root of Astragalus mongholicus (Fisch.) bge and Astragalus membranaceus (Fisch.) bge of Leguminosae, is slightly warm in nature and sweet in flavor, and enters spleen and lung meridians. Invigorating qi, consolidating superficial resistance, promoting urination, expelling toxin, expelling pus, and promoting granulation. They belong to the category of qi tonics under deficiency-tonifying herbs.

Radix Codonopsis is derived from root of radix Codonopsis belonging to family Campanulaceae. Sweet and mild in nature and taste, can be used for treating diseases of hand and foot due to the qi system of the channel, tonifying middle-jiao, replenishing qi and promoting the production of body fluid. It is indicated for weakness of spleen and stomach, deficiency of both qi and blood, lassitude, weakness, poor appetite, thirst, chronic diarrhea, and rectocele.

Atractylodis rhizoma is dried rhizome of Atractylodes macrocephala Koidz of Compositae. Sweet and bitter in taste, warm in nature, entering spleen and stomach meridians, and used for spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm and fluid retention, dizziness, palpitation, edema, spontaneous perspiration, threatened abortion.

Bupleuri radix is dried root of Bupleurum scorzonerifolium or Bupleurum scorzonerifolium of Umbelliferae, and is pungent, bitter and slightly cold in nature. It enters liver, gallbladder and lung meridians and has the actions of harmonizing exterior and interior, soothing liver and raising yang.

Cimicifugae rhizoma, which is dried rhizome of Cimicifuga racemosa, Cimicifuga dahurica or Cimicifuga racemosa of Ranunculaceae. Releasing exterior and promoting eruption, clearing heat and removing toxicity, and lifting yang qi. Pungent, slightly sweet and slightly cold, enter lung, spleen, stomach and large intestine meridians. Can be used for treating headache due to wind-heat evil, toothache, aphtha, sore throat, measles without adequate eruption, and macula due to yang toxin; prolapse of the anus and uterine prolapse.

Dang Gui is the root of Angelica sinensis of Umbelliferae, warm in nature, sweet and pungent in flavor. It enters liver meridian, heart meridian and spleen meridian. Tonify blood, activate blood, regulate menstruation, alleviate pain, moisten intestines and relieve constipation. They belong to the category of tonics.

Glycyrrhrizae radix, dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat or Glycyrrhiza glabra L of Leguminosae, has mild nature and sweet taste. They enter heart, stomach, spleen and lung meridians. Invigorating spleen and replenishing qi, relieving cough and eliminating phlegm, relieving spasm and relieving pain, and harmonizing drug property. They belong to qi tonics classified under deficiency tonics.

Pericarpium Citri Tangerinae, mature pericarp of Rutaceae plant fructus Citri Tangerinae and its cultivar, pungent, bitter and warm in nature. It enters spleen and lung meridians. Regulate qi-flowing for promoting appetite, dry dampness and resolve phlegm, treat spleen and stomach diseases. Belongs to qi-regulating herbs.

Lycium barbarum, a mature fruit of Lycium barbarum L.of Solanaceae, has mild nature and sweet taste, and enters liver and kidney meridians. Nourishing liver and kidney, replenishing vital essence and improving eyesight. They belong to the yin tonics classified under the deficiency tonics.

Morinda officinalis, dried root of Morinda officinalis of Rubiaceae, slightly warm in nature, sweet and pungent in flavor. It enters kidney and liver meridians. Tonify kidney yang, strengthen tendons and bones, dispel wind-damp. They belong to yang tonics classified under deficiency tonics.

Yam, a rhizome of Dioscorea opposita Thunb of Dioscoreaceae, is neutral in nature and sweet in taste. It enters spleen, lung and kidney meridians. Invigorating spleen and stomach, promoting fluid production, benefiting lung, invigorating kidney, and arresting seminal emission. They belong to the category of qi tonics under deficiency-tonifying herbs.

Endothelium corneum Gigeriae Galli is the inner wall of dry ballast of domestic chicken of Phasianidae, and has mild nature and sweet taste. It enters spleen meridian, stomach meridian, small intestine meridian and bladder meridian. Strengthening the stomach, promoting digestion, arresting seminal emission and stopping enuresis. Belongs to the category of digestant drugs.

Pawpaw is a nearly mature fruit of pawpaw belonging to the family Rosaceae, and has warm nature and sour taste. It enters liver and spleen meridians. Pacify liver, relax tendons, harmonize stomach and resolve dampness. Belongs to the category of antirheumatic and tendon and bone strengthening drugs under the antirheumatic drugs.

Salvia miltiorrhiza, root and rhizome of Salvia miltiorrhiza, a plant of Labiatae, is slightly cold in nature and bitter in taste. It enters heart and liver meridians. Removing blood stasis, relieving pain, promoting blood circulation, relieving dysmenorrhea, clearing away heart-fire, and relieving restlessness. Belongs to the blood-activating and menstruation-regulating herbs classified under the blood-activating and stasis-resolving herbs.

Immature bitter orange, the young fruit of Citrus aurantium of Rutaceae, is slightly cold in nature, bitter, pungent and sour in flavor, and enters spleen and stomach meridians. Break qi and remove food retention, resolve phlegm and disperse distention and fullness. Belongs to qi-regulating herbs.

Poria, sclerotium of Poria cocos (Schw.) wolf of Polyporaceae, has mild nature and sweet and light taste. They enter heart, lung, spleen and kidney meridians. Induce diuresis and drain dampness, invigorate spleen and calm heart. Belongs to the diuresis-inducing and edema-alleviating herbs classified under the diuresis-inducing and dampness-excreting herbs.

Coix seed, mature seed of Coix lacryma-jobi of Gramineae. Cool in nature, sweet and bland in flavor. It enters spleen, stomach and lung meridians. Invigorating spleen, removing dampness, relieving arthralgia, relieving diarrhea, clearing away heat, and expelling pus. Belongs to the diuresis and stranguria treatment drugs classified under the diuresis and dampness eliminating drugs.

The invention has the advantages and beneficial effects that:

the traditional Chinese medicine composition for treating myasthenia gravis provided by the invention is scientific and reasonable in formula, various components are cooperatively compatible, the medicine effect can be quickly exerted, the composition is safe, free of toxic and side effects, low in cost, convenient for patients to take, simple to prepare and suitable for industrial production.

Detailed Description

The present invention will be described in further detail with reference to examples. The following examples are intended to illustrate the invention only and are not intended to limit the scope of the invention. The experimental methods in the examples, in which specific conditions are not specified, are generally carried out under conventional conditions. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be within the scope of the invention.

The traditional Chinese medicine composition and the pharmaceutical preparation are prepared by scientific formula screening on the premise of applying the theoretical basis of traditional Chinese medicine and refining and processing on the premise of applying the scientific extraction process of traditional Chinese medicines.

EXAMPLE 1 preparation of the Chinese medicinal composition

1. Accurately weighing the following traditional Chinese medicine raw materials in parts by weight: 8 parts of morinda officinalis, 10 parts of salvia miltiorrhiza, 5 parts of immature bitter orange, 20 parts of codonopsis pilosula, 20 parts of astragalus membranaceus, 8 parts of radix bupleuri, 8 parts of bighead atractylodes rhizome, 8 parts of angelica sinensis, 8 parts of rhizoma cimicifugae, 3 parts of liquorice, 3 parts of pericarpium citri reticulatae, 6 parts of medlar, 12 parts of Chinese yam, 12 parts of endothelium corneum gigeriae galli, 6 parts of pawpaw and 15 parts of poria cocos.

2. Pulverizing the above Chinese medicinal materials, and mixing.

EXAMPLE 2 preparation of the Chinese medicinal composition

1. Accurately weighing the following traditional Chinese medicine raw materials in parts by weight: 15 parts of morinda officinalis, 24 parts of salvia miltiorrhiza, 10 parts of immature bitter orange, 60 parts of codonopsis pilosula, 160 parts of astragalus membranaceus, 10 parts of radix bupleuri, 30 parts of bighead atractylodes rhizome, 15 parts of angelica sinensis, 10 parts of rhizoma cimicifugae, 6 parts of liquorice, 10 parts of pericarpium citri reticulatae, 15 parts of medlar, 30 parts of Chinese yam, 30 parts of endothelium corneum gigeriae galli, 15 parts of pawpaw and 30 parts of poria cocos.

2. Pulverizing the above Chinese medicinal materials, grinding, sieving to obtain fine powder, decocting in water for 2 times, mixing decoctions, concentrating, precipitating, filtering, drying to obtain extract, and pulverizing into powder.

EXAMPLE 3 preparation of the Chinese medicinal composition

1. Accurately weighing the following traditional Chinese medicine raw materials in parts by weight: 12 parts of morinda officinalis, 15 parts of salvia miltiorrhiza, 7 parts of immature bitter orange, 40 parts of codonopsis pilosula, 85 parts of astragalus membranaceus, 9 parts of radix bupleuri, 20 parts of bighead atractylodes rhizome, 12 parts of angelica sinensis, 9 parts of rhizoma cimicifugae, 5 parts of liquorice, 5 parts of pericarpium citri reticulatae, 10 parts of medlar, 25 parts of Chinese yam, 25 parts of endothelium corneum gigeriae galli, 12 parts of pawpaw and 20 parts of poria cocos.

2. Pulverizing the above Chinese medicinal materials, grinding, sieving to obtain fine powder, stirring, reflux-extracting with 5-10 times of 80% ethanol for 2 times (each for 1-2 hr), filtering, mixing reflux solutions, concentrating to obtain fluid extract, decocting in water for 2 times, mixing decoctions, concentrating to obtain fluid extract, dissolving in 5-6 times of water, loading onto macroporous resin column, sequentially eluting with water and 40% ethanol, recovering ethanol eluate, further concentrating to obtain soft extract, and pulverizing into powder.

EXAMPLE 4 preparation of Chinese medicinal preparation

1. Tablet formulation

Taking the traditional Chinese medicine composition in the embodiment 1-3, adding dextrin, starch and magnesium stearate, wherein the mass ratio of the dextrin, the starch and the magnesium stearate to the extract of the traditional Chinese medicine composition is 0.3-0.8: 0.6-1: 0.1-0.7: 1, uniformly mixing, granulating, drying, tabletting and coating to obtain the traditional Chinese medicine tablet.

2. Capsule preparation

Taking the traditional Chinese medicine composition in the embodiment 1-3, adding dextrin, starch and aerosil, wherein the mass ratio of the dextrin, the starch and the aerosil to the extract of the traditional Chinese medicine composition is 0.2-0.6: 0.6-0.8: 0.2-0.6: 1, uniformly mixing, granulating, drying, and encapsulating to obtain the traditional Chinese medicine capsule.

3. Granules

Taking the traditional Chinese medicine composition in the embodiment 1-3, adding dextrin, starch and microcrystalline cellulose, wherein the mass ratio of the dextrin, the starch and the microcrystalline cellulose to the extract of the traditional Chinese medicine composition is 0.2-0.4: 0.4-0.5: 0.4-0.6: 1, uniformly mixing, granulating, drying and subpackaging to obtain the traditional Chinese medicine granule.

4. Oral liquid

Taking the traditional Chinese medicine composition in the embodiment 1-3, adding distilled water until the mass ratio of the distilled water to the extract of the traditional Chinese medicine composition is 0.4-0.8: 1, uniformly stirring, adding sucrose, refined honey, methyl hydroxybenzoate and ethylparaben, wherein the mass ratio of the sucrose, the refined honey, the methyl hydroxybenzoate and the ethylparaben to the extract of the traditional Chinese medicine composition is 0.2-0.3: 0.1-0.2: 0.01-0.1: 1, uniformly stirring, filtering, encapsulating, sterilizing and packaging to obtain the traditional Chinese medicine oral liquid.

5. Pill preparation

Taking the traditional Chinese medicine composition in the embodiment 1-3, adding starch and refined honey, wherein the mass ratio of the starch to the refined honey to the extract of the traditional Chinese medicine composition is 0.6-1.5: 1.4-1.5: 1, placing in a sugar coating pan, rotating a sugar coating machine, adding 70% ethanol, stirring, forming pills, drying, coating, and packaging to obtain the traditional Chinese medicine pills.

6. Drop pills

Adding pharmaceutic adjuvants of polyethylene glycol 2000, polyethylene glycol 4000 and cosolvent polyethylene glycol 6000 into the traditional Chinese medicine composition of examples 1-3, wherein the mass ratio of the polyethylene glycol 2000, the polyethylene glycol 4000 and the polyethylene glycol 6000 to the extract of the traditional Chinese medicine composition is 0.2-0.6: 0.4-0.8: 0.4-0.6: 1, uniformly mixing, heating and melting, uniformly stirring, transferring the molten mixed liquid into a dripping pill machine for dripping, wherein the dripping temperature is 70 ℃, the diameter of a dripping head is 2.5cm, a condensing agent is dimethyl silicone oil, and the condensing temperature is 0 ℃; dripping at a speed of 60 drops/min and a distance of 5.5cm, taking out the dripping pill from the outlet of the dripping pill machine, removing surface condensing agent, drying, and packaging to obtain the final product.

EXAMPLE 5 therapeutic Effect of the Chinese medicinal composition

1. Preparation of Experimental drugs

An oral liquid was prepared according to the method of example 4

2. Test population (inclusion criteria):

54 patients with myasthenia gravis with poor transportation and transformation of the spleen and stomach, yellow and greasy tongue coating and dysphagia were collected and divided into three groups, and the three groups were treated with the traditional Chinese medicine composition described in examples 1-3.

3. The evaluation standard of curative effect is as follows:

the clinical symptoms of healing completely disappear; the relapse is not seen after the medicine is stopped for two months.

The improvement of clinical symptoms is obviously relieved;

no significant improvement or worsening of ineffective clinical symptoms.

4. The curative effect results are as follows:

the treatment effect of the traditional Chinese medicine is shown in table 1, and the traditional Chinese medicine composition has a better treatment effect.

TABLE 1 statistics of treatment Effect

The above description of the embodiments is only intended to illustrate the method of the invention and its core idea. It should be noted that, for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications will also fall into the protection scope of the claims of the present invention.

Claims

1. The traditional Chinese medicine composition for treating myasthenia gravis is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 8-15 parts of morinda officinalis, 10-24 parts of salvia miltiorrhiza, 5-10 parts of immature bitter orange, 20-60 parts of codonopsis pilosula, 20-160 parts of astragalus membranaceus, 8-10 parts of radix bupleuri, 8-30 parts of bighead atractylodes rhizome, 8-15 parts of angelica sinensis, 8-10 parts of rhizoma cimicifugae, 3-6 parts of liquorice, 3-10 parts of pericarpium citri reticulatae, 6-15 parts of medlar, 12-30 parts of Chinese yam, 12-30 parts of endothelium corneum gigeriae galli, 6-15 parts of pawpaw and 15-30 parts of poria cocos.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 12 parts of morinda officinalis, 15 parts of salvia miltiorrhiza, 7 parts of immature bitter orange, 40 parts of codonopsis pilosula, 85 parts of astragalus membranaceus, 9 parts of radix bupleuri, 20 parts of bighead atractylodes rhizome, 12 parts of angelica sinensis, 9 parts of rhizoma cimicifugae, 5 parts of liquorice, 5 parts of pericarpium citri reticulatae, 10 parts of medlar, 25 parts of Chinese yam, 25 parts of endothelium corneum gigeriae galli, 12 parts of pawpaw and 20 parts of poria cocos.

3. A pharmaceutical preparation, which is prepared from the traditional Chinese medicine composition of claim 1 or 2 and a pharmaceutically acceptable carrier, and is an oral preparation.

4. The pharmaceutical formulation of claim 3, wherein the oral formulation is selected from the group consisting of oral liquid, tablet, pill, powder, granule, capsule.

5. The method for preparing the traditional Chinese medicine composition of claim 1 or 2, which is characterized by comprising the following steps:

6. Use according to any one of the following:

a. use of the Chinese medicinal composition of claim 1 or 2 for the preparation of a medicament for the treatment of myasthenia gravis;

b. use of a pharmaceutical preparation according to claim 3 or 4 for the preparation of a medicament for the treatment of myasthenia gravis.

7. The use of claim 6, wherein the myasthenia gravis in a is a myasthenia gravis with poor transportation and transformation of the spleen and stomach and yellow and greasy tongue coating.

8. The use of claim 7, wherein said myasthenia gravis in b is a myasthenia gravis with poor transportation and transformation of the spleen and stomach, and a yellow and greasy tongue coating.