Traditional Chinese medicine formula for treating systemic myasthenia gravis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine formula for treating systemic myasthenia gravis and a preparation method thereof. The traditional Chinese medicine formula comprises the following raw materials in parts by weight: 6-12 parts of astragalus membranaceus, 1-2 parts of rhizoma atractylodis, 4-6 parts of semen coicis, 1-3 parts of radix pseudostellariae, 3-5 parts of eucommia ulmoides, 2-4 parts of fried rhizoma atractylodis macrocephalae, 1-3 parts of pericarpium citri reticulatae, 1-3 parts of rhizoma cimicifugae, 2-4 parts of angelica sinensis, 1-2 parts of cinnamon, 1-3 parts of prepared rehmannia root, 2-4 parts of platycodon grandiflorum, 2-4 parts of fried fructus aurantii and 4-6 parts of pawpaw. The traditional Chinese medicine composition is wide in treatment range, free of age limitation, remarkable in curative effect on patients suffering from diseases of all ages, exact in curative effect on eye muscle type, mild, moderate and severe whole body type patients and free of obvious side effects.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine formula for treating generalized myasthenia gravis and a preparation method thereof. Background Art

[0002] Myasthenia gravis (MG) is an autoimmune disease with a certain disability rate and mortality rate. In terms of treatment, Western medicine often uses cholinesterase inhibitors, adrenocortical hormones and immunosuppressants such as cyclophosphamide and azathioprine, but the relapse rate is high after reduction or discontinuation of medication, and long-term use has great side effects, which can easily lead to patient intolerance. Thymectomy therapy can only relieve 1 / 3 of MG patients, and the condition of 1 / 3 of patients will worsen. Although new biological agents take effect quickly, most families cannot afford them due to their high prices.

[0003] Although there is no concept of MG in traditional Chinese medicine, it can be classified as a "paralysis disease" based on the symptoms. As early as in the Yellow Emperor's Classic of Internal Medicine, there was a special chapter on paralysis. After continuous development and innovation by doctors of all generations, traditional Chinese medicine has gradually been accepted by the majority of myasthenia gravis patients for its advantages of safety, effectiveness and affordable prices, and its development prospects are very broad.

[0004] At present, most of the patents for Chinese herbal compound treatment of myasthenia gravis (such as CN102793882B and CN101601740B) do not clearly show the efficacy for children with the disease and elderly patients with late onset, or only target ocular myasthenia gravis. Summary of the invention

[0005] In view of the above-mentioned technical problems, the present invention provides a Chinese medicine formula for treating generalized myasthenia gravis and a preparation method thereof. The present invention has a wider treatment scope, no age limit, significant efficacy for patients of all ages, and definite efficacy for patients with ocular muscle type, mild, moderate and severe generalized type, without obvious side effects, which mainly solves the problem of limited treatment scope of existing Chinese medicine formulas.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions.

[0007] A Chinese medicine formula for treating generalized myasthenia gravis, comprising the following raw materials in parts by weight: 6-12 parts of astragalus, 1-2 parts of atractylodes, 4-6 parts of coix seeds, 1-3 parts of pseudoginseng, 3-5 parts of eucommia, 2-4 parts of stir-fried atractylodes, 1-3 parts of dried tangerine peel, 1-3 parts of cimicifuga, 2-4 parts of angelica, 1-2 parts of cinnamon, 1-3 parts of prepared rehmannia, 2-4 parts of platycodon, 2-4 parts of stir-fried aurantium, and 4-6 parts of papaya. (One part is 5 grams)

[0008] A method for preparing a Chinese medicine prescription for treating generalized myasthenia gravis comprises the following specific steps:

[0009] (1) Take medicine according to the proportion of Chinese medicine raw materials;

[0010] (2) crushing into coarse powder;

[0011] (3) adding 8-10 times the volume of 0-70% ethanol and reflux twice, each time for 1 hour, and combining the extracts;

[0012] (4) concentrating under reduced pressure and recovering ethanol to prepare a Chinese medicine formula for treating generalized myasthenia gravis.

[0013] The present invention also provides a traditional Chinese medicine preparation for treating generalized myasthenia gravis, which comprises the traditional Chinese medicine formula described in the above scheme and pharmaceutically approved auxiliary materials.

[0014] Preferably, the dosage forms of the Chinese medicine preparation include mixtures, tablets, capsules, granules, pills, syrups, decoctions and soups.

[0015] The preparation method of the mixture in the pharmaceutical preparation of the present invention is as follows:

[0016] (1) preparing a Chinese medicine prescription according to the above steps;

[0017] (2) Add appropriate amount of 20% benzoic acid ethanol solution and 24% potassium sorbate solution, stir well, refrigerate for more than 48 hours, filter, add water to adjust to 5.5g of crude drug per ml, stir well, and fill to obtain the mixture.

[0018] The method for preparing tablets in the pharmaceutical preparation of the present invention is as follows:

[0019] (1) preparing a Chinese medicine prescription according to the above steps;

[0020] (2) concentrating the Chinese medicine formula prepared in step (1) into a paste;

[0021] (3) adding an appropriate amount of starch to the extract prepared in step (2) and mixing well to form granules, drying, and tableting to form tablets.

[0022] The preparation method of the capsule in the pharmaceutical preparation of the present invention is as follows:

[0023] (1) preparing a Chinese medicine prescription according to the above steps;

[0024] (2) concentrating the Chinese medicine formula prepared in step (1) into a paste;

[0025] (3) The extract prepared in step (2) is dried, crushed, sieved, and filled into capsule shells to obtain capsules.

[0026] The preparation method of the granules in the pharmaceutical preparation of the present invention is as follows:

[0027] (1) preparing a Chinese medicine prescription according to the above steps;

[0028] (2) concentrating the Chinese medicine formula prepared in step (1) into a paste;

[0029] (3) adding appropriate amounts of starch and sucrose to the extract prepared in step (2) to form granules; or adding appropriate amounts of dextrin to form granules; or adding appropriate amounts of starch and aspartame to form granules.

[0030] The method for preparing the pills in the pharmaceutical preparation of the present invention is as follows:

[0031] (1) preparing a Chinese medicine prescription according to the above steps;

[0032] (2) concentrating the Chinese herbal medicine extract prepared in step (1) into a paste;

[0033] (3) Forming the extract mass prepared in step (2) into pills to obtain pills.

[0034] The preparation method of the syrup in the pharmaceutical preparation of the present invention is as follows:

[0035] (1) preparing a Chinese medicine prescription according to the above steps;

[0036] (2) Add an appropriate amount of sucrose and heat until completely dissolved. After the temperature drops to an appropriate level, add the soluble drug, stir to dissolve, and filter;

[0037] (3) Add distilled water to the filter to reach the specified volume to obtain syrup.

[0038] The preparation method of the decoction paste in the pharmaceutical preparation of the present invention is as follows:

[0039] (1) preparing a Chinese medicine prescription according to the above steps;

[0040] (2) Add half the amount of water and 0.1% tartaric acid to sucrose or honey, heat and dissolve until the sugar solution turns golden yellow, and then convert it into refined sugar;

[0041] (3) Mixing the concentrated Chinese herbal extract prepared in step (1) with the sugar or honey prepared in step (2), and continuing to heat until a thick semi-fluid preparation is obtained to obtain a decoction.

[0042] The decoction preparation method in the pharmaceutical preparation of the present invention is as follows:

[0043] (1) Soaking: Add 500 ml of water and completely immerse the above-mentioned medicinal materials for more than 30 minutes;

[0044] (2) Utensils: Use casserole, ceramic pot or stainless steel pot;

[0045] (3) Decoction method: ① Bring the mixture to a boil over high heat, then reduce the heat and boil for 25 minutes to obtain 150 ml of decoction; ② Add water until the herbs are completely submerged, and boil twice according to method ①, obtaining 150 ml of decoction each time; ③ Mix the decoctions from the three decoctions to make a decoction.

[0046] The present invention is composed of astragalus, atractylodes, coix seed, pseudoginseng, eucommia, stir-fried atractylodes, tangerine peel, cimicifuga, angelica, stir-fried atractylodes, cinnamon bark, rehmannia root, platycodon, stir-fried fructus aurantii, and papaya, which can nourish the spleen and kidney, remove dampness and remove turbidity. The spleen is the foundation of the acquired constitution, the source of qi and blood biochemical, and is located in the middle jiao, which is the pivot of the ascending and descending entry and exit of qi. If the spleen is healthy, the lung fluid is available, the liver and kidney fluid and blood are replenished, the ancestral tendons are moistened, and the organs can be beneficial. The spleen is responsible for ascending and transporting. If the spleen is weak and the qi is sunken, the lifting is weak. The upper eyelid belongs to the spleen, which can cause the eyelid to be weak and drooping; the spleen is responsible for muscles and limbs, and the spleen is deficient in biochemical nourishment, so the limbs are flaccid and cannot be used. Spleen disease can also affect the kidney. The kidney is the foundation of the congenital constitution, which is responsible for storing essence, bone production and marrow, and the original yin and yang in the kidney can nourish the limbs and bones, and warm and nourish the spleen and soil. If the kidney is deficient, the five internal organs are not nourished, and the tendons and bones are not used. Therefore, the normal function of tendons and veins depends on the warm nourishment of spleen, kidney, qi, blood, yin and yang. If one is deficient, the other will be affected, resulting in deficiency of both spleen and kidney, muscle malnutrition, and then disease. Moreover, the lingering and difficult to cure condition of contemporary MG patients, the gradual aggravation of the condition, and the development to systemic type are mostly related to the obstruction of dampness. Therefore, this prescription is designed to inhibit the development of MG by the method of "tonifying the spleen and kidney, removing dampness and turbidity", and has a significant effect on patients with ocular muscle type and systemic type.

[0047] In the formula, Astragalus membranaceus replenishes the middle Qi, consolidates the superficial Qi, and raises the yang and lifts the sunken; Atractylodes lancea dries dampness and strengthens the spleen, while Coix seed strengthens the spleen and removes dampness, enhancing the function of strengthening the spleen and removing dampness; Pseudostellariae Radix and Atractylodes macrocephala strengthen the spleen and replenish Qi; Tangerine peel regulates Qi and harmonizes the stomach, making the medicine nourishing without stagnation; Cimicifuga ephedra raises the Yangming Qi, raises the yang and lifts the sunken; Angelica sinensis and Rehmannia glutinosa nourish blood and nourish Yin, assisting Astragalus membranaceus in replenishing Qi and blood; Eucommia ulmoides replenishes the liver and kidneys, strengthens the tendons and bones; Cinnamon bark replenishes fire and helps yang, and guides fire back to the origin; Platycodon grandiflorum and stir-fried Citrus aurantium rise and fall, promote and disperse, and regulate the Qi; Papaya relaxes the tendons and activates the collaterals, harmonizes the stomach and eliminates dampness. All the medicines are used together, with excellent compatibility, and together achieve the function of nourishing the spleen and kidneys, removing dampness and removing turbidity.

[0048] The formula uses a lot of Astragalus, which tastes sweet and slightly warm. It enters the spleen and lung meridians, replenishes the middle Qi, consolidates the exterior Qi, raises the yang and lifts the sunken, and is the main medicine; it is matched with Atractylodes and Pseudostellaria baicalensis, which can dry dampness, strengthen the spleen and replenish Qi, and are the ministers, enhancing the spleen-strengthening effect of Astragalus; it is supplemented with Coix seed, stir-fried Atractylodes, Platycodon, and stir-fried Citrus aurantium to strengthen the spleen, eliminate dampness and promote Qi circulation, while Angelica, cinnamon, Eucommia, and Rehmannia root can nourish blood, nourish yin, and tonify the kidney, and papaya and tangerine peel can regulate Qi, harmonize the stomach and eliminate dampness, making the medicine nourishing without stagnation; Cimicifuga can raise the Yangming Qi and assist Astragalus in raising the yang and lifting the sunken, and is the adjuvant.

[0049] Compared with the prior art, the beneficial effects of the present invention are as follows.

[0050] The present invention is the first time that the inventor has proposed a new Chinese medicine formula based on the treatment principle of "tonifying the spleen and kidney, removing dampness and clearing turbidity" by inheriting the academic thought of predecessors in treating MG and combining his own clinical work experience. It has a definite clinical efficacy and can effectively help patients with ocular muscle type and systemic MG reduce or stop taking western medicine and reduce the adverse reactions of western medicine.

[0051] The invention has a wider application scope, can treat patients with ocular myasthenia gravis and mild, moderate and severe generalized myasthenia gravis, and can be taken by both children and the elderly, with clear efficacy and no toxic side effects. In addition, the invention takes effect earlier, about 1 month, and can better help patients improve symptoms and improve their quality of life. DETAILED DESCRIPTION

[0052] For better understanding and implementation, the present invention is further described below in conjunction with examples. Unless otherwise specified, the examples of the present invention are only used to explain the present invention and are not intended to limit the scope of protection of the present invention.

[0053] A Chinese medicine formula for treating generalized myasthenia gravis, comprising the following raw materials in parts by weight: 6-12 parts of astragalus, 1-2 parts of atractylodes, 4-6 parts of coix seeds, 1-3 parts of pseudoginseng, 3-5 parts of eucommia, 2-4 parts of stir-fried atractylodes, 1-3 parts of dried tangerine peel, 1-3 parts of cimicifuga, 2-4 parts of angelica, 1-2 parts of cinnamon, 1-3 parts of prepared rehmannia, 2-4 parts of platycodon, 2-4 parts of stir-fried aurantium, and 4-6 parts of papaya. (One part is 5 grams)

[0054] A method for preparing a Chinese medicine prescription for treating generalized myasthenia gravis, comprising the following specific steps:

[0055] (1) Take medicine according to the proportion of Chinese medicine raw materials;

[0056] (2) crushing into coarse powder;

[0057] (3) adding 8-10 times the volume of 0-70% ethanol and reflux twice, each time for 1 hour, and combining the extracts;

[0058] (4) concentrating under reduced pressure and recovering ethanol to prepare a Chinese medicine formula for treating generalized myasthenia gravis.

[0059] The present invention also provides a traditional Chinese medicine preparation for treating generalized myasthenia gravis, which comprises the traditional Chinese medicine formula described in the above scheme and pharmaceutically approved auxiliary materials.

[0060] Preferably, the dosage forms of the Chinese medicine preparation include mixtures, tablets, capsules, granules, pills, syrups, decoctions and soups.

[0061] The preparation method of the composition in the pharmaceutical preparation of the present invention is as follows:

[0062] (1) preparing a Chinese medicine prescription according to the above steps;

[0063] (2) Add appropriate amount of 20% benzoic acid ethanol solution and 24% potassium sorbate solution, stir well, refrigerate for more than 48 hours, filter, add water to adjust to 5.5g of crude drug per ml, stir well, and fill to obtain the mixture.

[0064] The tablets in the pharmaceutical preparation of the present invention are prepared by the following method:

[0065] (1) preparing a Chinese medicine prescription according to the above steps;

[0066] (2) concentrating the Chinese medicine formula prepared in step (1) into a paste;

[0067] (3) adding an appropriate amount of starch to the extract prepared in step (2) and mixing well to form granules, drying, and tableting to form tablets.

[0068] The capsule in the pharmaceutical preparation of the present invention is prepared by the following method:

[0069] (1) preparing a Chinese medicine prescription according to the above steps;

[0070] (2) concentrating the Chinese medicine formula prepared in step (1) into a paste;

[0071] (3) The extract prepared in step (2) is dried, crushed, sieved, and filled into capsule shells to obtain capsules.

[0072] The granules in the pharmaceutical preparation of the present invention are prepared by the following method:

[0073] (1) preparing a Chinese medicine prescription according to the above steps;

[0074] (2) concentrating the Chinese medicine formula prepared in step (1) into a paste;

[0075] (3) adding appropriate amounts of starch and sucrose to the extract prepared in step (2) to form granules; or adding appropriate amounts of dextrin to form granules; or adding appropriate amounts of starch and aspartame to form granules.

[0076] The pills in the pharmaceutical preparation of the present invention are prepared by the following method:

[0077] (1) preparing a Chinese medicine prescription according to the above steps;

[0078] (2) concentrating the Chinese herbal medicine extract prepared in step (1) into a paste;

[0079] (3) Forming the extract mass prepared in step (2) into pills to obtain pills.

[0080] The syrup in the pharmaceutical preparation of the present invention is prepared by the following method:

[0081] (1) preparing a Chinese medicine prescription according to the above steps;

[0082] (2) Add an appropriate amount of sucrose and heat until completely dissolved. After the temperature drops to an appropriate level, add the soluble drug, stir to dissolve, and filter;

[0083] (3) Add distilled water to the filter to reach the specified volume to obtain syrup.

[0084] The decoction paste in the pharmaceutical preparation of the present invention is prepared by the following method:

[0085] (1) preparing a Chinese medicine prescription according to the above steps;

[0086] (2) Add half the amount of water and 0.1% tartaric acid to sucrose or honey, heat and dissolve until the sugar solution turns golden yellow, and then convert it into refined sugar;

[0087] (3) Mixing the concentrated Chinese herbal extract prepared in step (1) with the sugar or honey prepared in step (2), and continuing to heat until a thick semi-fluid preparation is obtained to obtain a decoction.

[0088] The decoction preparation method in the pharmaceutical preparation of the present invention is as follows:

[0089] (1) Soaking: add 500 ml of water, and completely immerse 6-12 parts of Astragalus, 1-2 parts of Atractylodes, 4-6 parts of Coix seeds, 1-3 parts of Pseudostellariae, 3-5 parts of Eucommia, 2-4 parts of stir-fried Atractylodes, 1-3 parts of Tangerine peel, 1-3 parts of Cimicifuga, 2-4 parts of Angelica, 1-2 parts of Cinnamon, 1-3 parts of Rehmannia root, 2-4 parts of Platycodon, 2-4 parts of stir-fried Citrus aurantium, and 4-6 parts of Papaya for more than 30 minutes;

[0090] (2) Utensils: Use casserole, ceramic pot or stainless steel pot;

[0091] (3) Decoction method: ① Bring the mixture to a boil over high heat, then reduce the heat and boil for 25 minutes to obtain 150 ml of decoction; ② Add water until the herbs are completely submerged, and boil twice according to method ①, obtaining 150 ml of decoction each time; ③ Mix the decoctions from the three decoctions to make a decoction.

[0092] Example 1.

[0093] A Chinese medicine formula for treating generalized myasthenia gravis, with specific dosages of: 12 parts of Astragalus, 2 parts of Atractylodes, 6 parts of Coix seeds, 3 parts of Radix Pseudostellariae, 5 parts of Eucommia, 4 parts of stir-fried Atractylodes macrocephala, 3 parts of dried orange peel, 2 parts of Cimicifuga heracleifolia, 3 parts of Angelica sinensis, 2 parts of Cinnamon bark, 3 parts of Rehmannia root, 3 parts of Platycodon grandiflorum, 3 parts of stir-fried Citrus aurantium, and 6 parts of Papaya. (1 part is 5 grams)

[0094] Preparation method: ① Soak: add 500ml of water, completely immerse the above-mentioned medicinal materials, and soak for more than 30 minutes;

[0095] ②Utensils: stainless steel pot;

[0096] ③Decoction method: (1) Bring to a boil over high heat, then reduce heat and boil for 25 minutes to obtain 150 ml of medicinal juice; (2) Add water until the medicinal materials are completely submerged, and boil twice according to method (1), each time obtaining 150 ml of medicinal juice; (3) Mix the medicinal juices boiled three times to obtain the decoction of the Chinese medicine formula.

[0097] ④Dosage: Take orally twice a day, 150 ml each time.

[0098] Example 2.

[0099] 1. A total of 25 children with ocular myasthenia gravis from January 2020 to January 2022 were selected, including 10 males and 15 females. The onset age was 1-15 years old, with an average age of (6.60±3.99) years old. All children took pyridostigmine bromide tablets for the first visit, and 12 of them were treated with combined prednisone acetate tablets.

[0100] 2. Treatment method: Add the prescription of Example 1 to the original treatment.

[0101] 3. Clinical scale scoring and efficacy assessment

[0102] Referring to the "Clinical Absolute Scoring and Relative Scoring Methods for Myasthenia Gravis Patients", the absolute scoring method is used to evaluate the severity of symptoms, and the relative scoring method is used to evaluate the efficacy. The clinical relative score of myasthenia gravis = [(total score before treatment - total score after treatment) / total score before treatment] × 100%.

[0103] Recovery: relative clinical score of myasthenia gravis ≥ 95%;

[0104] Basically cured: relative clinical score of myasthenia gravis 80% to 95%;

[0105] Markedly effective: the relative clinical score of myasthenia gravis is 50% to 79%;

[0106] Improvement: The relative clinical score of myasthenia gravis is 25% to 49%;

[0107] Ineffective: Myasthenia gravis clinical relative score ≤ 25%.

[0108] Total clinical effective rate = (improvement + marked effect + basic recovery + recovery / total number of cases) × 100%.

[0109] Table 1 Effectiveness results.

[0110]

[0111] Example 3.

[0112] 1. A total of 176 patients with MG who were diagnosed between January 2020 and December 2022 were selected and divided into two groups according to their age of onset, including 72 cases in the early-onset myasthenia gravis (EOMG) group (onset age <50 years old) and 104 cases in the late-onset myasthenia gravis (LOMG) group (onset age ≥50 years old). The EOMG group included 28 males and 44 females, with an onset age of 12 to 48 years old and a course of 1 to 24 months. The Myasthenia Gravis Foundation of America (MGFA) classified 40 cases of type I, 27 cases of type II (6 cases of type IIa, 21 cases of type IIb), and 5 cases of type III. 67 patients took Western medicine at the first visit; the LOMG group included 59 males and 45 females, with an onset age of 50 to 79 years old and a course of 1 to 36 months. The MGFA classified 52 cases of type I, 40 cases of type II (12 cases of type IIa, 28 cases of type IIb), and 12 cases of type III. 86 patients took Western medicine at the first visit. All patients have taken the prescription of Example 1 for 6 months. Compare the symptom changes and Western medicine dosage of the patients before and after taking the medicine.

[0113] 2. Treatment method: Add the prescription of Example 1 to the original treatment.

[0114] 3. Clinical scale scoring and efficacy assessment

[0115] Referring to the "Clinical Absolute Scoring and Relative Scoring Methods for Myasthenia Gravis Patients", the absolute scoring method is used to evaluate the severity of symptoms, and the relative scoring method is used to evaluate the efficacy. The clinical relative score of myasthenia gravis = [(total score before treatment - total score after treatment) / total score before treatment] × 100%.

[0116] Recovery: relative clinical score of myasthenia gravis ≥ 95%;

[0117] Basically cured: relative clinical score of myasthenia gravis 80% to 95%;

[0118] Markedly effective: the relative clinical score of myasthenia gravis is 50% to 79%;

[0119] Improvement: The relative clinical score of myasthenia gravis is 25% to 49%;

[0120] Ineffective: Myasthenia gravis clinical relative score ≤ 25%.

[0121] Total clinical effective rate = (improvement + marked effect + basic recovery + recovery / total number of cases) × 100%.

[0122] Table 2 Reduction of absolute clinical scores of the two groups of patients within 6 months of medication

[0123]

[0124] Note: Intra-group comparison: EOMG group: ▲●◇Compared with 0 month treatment, P<0.05; LOMG group: *★Compared with 0 month treatment, P<0.05.

[0125] Table 3 Effectiveness of two groups of patients after taking the medicine for one month (n)

[0126]

[0127] Table 4 Effectiveness of the two groups of patients after taking the medicine for 3 months (n)

[0128]

[0129] Table 5 Effectiveness of the two groups of patients after taking the medicine for 6 months (n)

[0130]

[0131] Table 6 Reduction of Western medicine dosage in two groups of patients within 6 months of medication

[0132]

[0133] Note: Intra-group comparison, EOMG group: *▲●Comparison of 3 months of treatment with 0 months of treatment, P<0.05; LOMG group:

[0134] #Comparison of the dosage of pyridostigmine bromide between the 3rd month of treatment and the 0th month of treatment, P<0.05, &◇Comparison of the dosage of pyridostigmine bromide between the 6th month of treatment and the 0th month of treatment, P<0.05. Inter-group comparison, ○△Comparison of the dosage of prednisone acetate and tacrolimus per person at the 6th month of treatment, P<0.05.

[0135] According to the data presented in the table, it can be clearly seen that the clinical effects of patients in the EOMG group and the LOMG group were significantly improved after taking the medicine; the following is a comprehensive summary of the study:

[0136] 1. Decrease in absolute clinical scores

[0137] The results of the study showed that after taking the drug for 6 months, the absolute clinical scores of the patients in the EOMG group and the LOMG group showed a downward trend, that is, the myasthenia gravis symptoms of the patients were continuously alleviated. This shows that the present invention has a positive effect on improving the clinical symptoms of myasthenia gravis patients.

[0138] 2. Significant improvement in efficiency

[0139] The effective rates of the EOMG group after taking Chinese medicine for 1, 3, and 6 months were 61.11%, 84.72%, and 94.44%, respectively; the effective rates of the LOMG group after taking Chinese medicine for 1, 3, and 6 months were 45.19%, 77.88%, and 91.35%, respectively. The effective rates of the two groups of patients increased with the increase of medication time, and the MG-ARS scores of the two groups at each time point were lower than those of the previous node, and the MG-ARS scores of the patients in the EOMG group after taking the medicine for 1 month were significantly lower than those before treatment, and the difference was statistically significant (P<0.05); the MG-ARS scores of the patients in the LOMG group after taking the medicine for 3 months were significantly lower than those before treatment, and the difference was statistically significant (P<0.05), indicating that the onset time of EOMG after taking the prescription described in Example 1 is about 1 month, and the onset time of LOMG is about 3 months.

[0140] 3. The use of Western medicine continues to decrease

[0141] Within 6 months of taking the drug, the dosage of western medicine in both the EOMG group and the LOMG group showed a trend of continuous reduction. This indicates that the drug can not only effectively improve the clinical symptoms of patients, but also reduce the dependence of patients on western medicine to a certain extent and reduce the risk of drug side effects.

[0142] in conclusion

[0143] In summary, the present invention showed significant therapeutic effects on both EOMG and LOMG patients. By taking the prescription continuously, the patient's absolute clinical score decreased, the symptoms were continuously relieved, the treatment efficiency was significantly improved, and the amount of western medicine was continuously reduced. This research result provides a new idea and option for the treatment of myasthenia gravis patients.

Claims

1. A Chinese medicine formula for treating generalized myasthenia gravis, characterized in that: The raw materials include the following parts by weight: 6-12 parts of astragalus, 1-2 parts of atractylodes, 4-6 parts of coix seeds, 1-3 parts of pseudoginseng, 3-5 parts of eucommia, 2-4 parts of stir-fried atractylodes share , 1~3 parts of dried tangerine peel, 1~3 parts of cimicifuga, 2~4 parts of angelica, 1~2 parts of cinnamon, 1~3 parts of rehmannia root, 2~4 parts of platycodon, 2~4 parts of stir-fried aurantium, 4~6 parts of papaya.

2. The method for preparing the Chinese medicine prescription for treating generalized myasthenia gravis according to claim 1, wherein the specific steps are as follows: (1) Take medicine according to the proportion of Chinese medicine raw materials; (2) crushing into coarse powder; (3) adding 8-10 times the volume of 0-70% ethanol and reflux twice, each time for 1 hour, and combining the extracts; (4) concentrating under reduced pressure and recovering ethanol to prepare a Chinese medicine formula for treating generalized myasthenia gravis.

3. A Chinese medicine preparation for treating generalized myasthenia gravis, characterized in that: The traditional Chinese medicine preparation comprises the traditional Chinese medicine formula described in the above scheme and pharmaceutically approved auxiliary materials.

4. The Chinese medicine preparation according to claim 3, characterized in that: The dosage forms of the traditional Chinese medicine preparation include mixture, tablet, capsule, granule, pill, syrup, decoction and soup.

5. The Chinese medicine preparation according to claim 4, characterized in that: The preparation method of the decoction is as follows: (1) Soaking: Add 500 ml of water and completely immerse the medicinal material of claim 1 for more than 30 minutes; (2) Utensils: Use a clay pot, ceramic pot or stainless steel pot; (3) Decoction method: ① Bring to a boil over high heat, then reduce heat and boil for 25 minutes to obtain 150 ml of decoction; ② Add water until the herbs are completely submerged, and boil twice according to method ①, each time obtaining 150 ml of decoction; ③ Mix the decoctions from the three times to make a decoction.

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