CN105232958B - Traditional Chinese medicine composition for preparing medicine for treating myasthenia gravis - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating myasthenia gravis, which has an immune reconstitution function, can be used for preparing a medicine for treating immune system diseases, and is particularly suitable for treating the myasthenia gravis.

Description

A kind of traditional Chinese medicine composition for preparing the medicine for treating myasthenia gravis

technical field

The invention relates to a traditional Chinese medicine composition, which is a traditional Chinese medicine composition for regulating the function of the immune system, specifically a traditional Chinese medicine composition for preparing medicine for treating myasthenia gravis, and relates to the field of traditional Chinese medicine.

Background technique

The immune system is a defensive structure for the body to protect itself. It is mainly composed of lymphoid organs (thymus, lymph nodes, spleen, tonsils), lymphoid tissues in other organs, and lymphocytes and antigen-presenting cells throughout the body. The immune system has a high degree of discrimination and can accurately identify self and non-self substances to maintain the relative stability of the body; at the same time, it can also receive, transmit, expand, store and remember immune information, and respond positively and negatively to immune information And constantly adjust its responsiveness. The immune system mainly plays the role of physiological defense, self-stabilization and immune surveillance in the human body, and is the most important defense system for the human body to resist the invasion of pathogenic bacteria. Once the rabbit epidemic function is out of balance, it is easy to produce diseases. A low immune system can easily lead to bacterial, viral, and fungal infections, while an overactive immune system can induce autoimmune diseases.

The fast-paced and high-efficiency modern society often keeps people in a tense state of fierce competition, high psychological pressure, and overloaded operation for a long time. If this situation cannot be resolved in time, it is easy to cause physical and psychological diseases. When various factors induce the immune system to fail to play a protective role normally, it will cause immune function imbalance.

Myasthenia gravis is a chronic, autoimmune disease caused by nerve-muscle acetylcholine conduction disorders. It is mainly manifested as abnormal fatigue in certain striated muscles, which is usually aggravated after activity and relieved after rest. There are still many theories about the cause of myasthenia gravis: one is that the number of acetylcholine receptors (AchR) on the post-synaptic membrane of nerves is significantly reduced (about 70-80%), and there are anti-receptor proteins, which make the affected The body degenerates and the number decreases. The second is infection by a virus with the same or similar surface antigen as AchR, which causes the body's immune system to overreact and involves AchR, leading to the destruction of ArchR. Third, certain environmental factors such as environmental pollution cause immune disorders; external factors such as excessive fatigue, emotional agitation, and long-term malnutrition can also lead to the occurrence of myasthenia gravis.

Modern medical treatments for myasthenia gravis include:

1. Thymectomy, more than 90% of patients with myasthenia gravis have thymus abnormalities. Thymectomy is one of the effective treatment methods for myasthenia gravis. Weak patients, most patients improve significantly after thymectomy.

2. Cholinesterase inhibitors. These drugs are used for symptomatic treatment. They treat the symptoms but not the root cause. They cannot be used as a single drug for a long time, and the dosage should be gradually increased from a small dose. Commonly used are neostigmine methyl sulfate, pyridostigmine bromide.

3. Immunosuppression, commonly used immunosuppressants are: ① adrenal corticosteroids: prednisone, methylprednisolone, etc.; ② azathioprine; ③ cyclosporine A; ④ cyclophosphamide; ⑤ tacrolimus .

4. Plasma exchange, by removing the acetylcholine receptor antibody in the patient's blood, is often used to temporarily relieve the critical symptoms of patients with myasthenia gravis. If it is not assisted by other treatment methods, the curative effect will not exceed 2 months.

6. Intravenous injection of immunoglobulin, human immunoglobulin contains a variety of antibodies, which can neutralize autoantibodies and regulate immune function. Its effect is comparable to that of plasma exchange.

At present, the traditional Chinese medicine treatment of myasthenia gravis is getting more and more attention. Myasthenia gravis belongs to the category of "atrophy". According to the theory of traditional Chinese medicine, adding traditional Chinese medicine to the treatment can reduce the side effects caused by immunosuppressants, play an escort role in the treatment of myasthenia gravis, and can rebuild the effect of autoimmune function.

Traditional Chinese medicine believes that the occurrence, development and outcome of diseases depend on the ups and downs of good and evil, and are closely related to the immune function of the body. As early as 2,000 years ago, the "Nei Jing" pointed out the immunological thought of "righteousness exists inside, and evil cannot be done". The human body’s righteousness is strong, which can control the evils, so that it can’t get sick, and even if it happens, it keeps the evils on the body surface, and the disease is mild. If the righteousness is strong and the disease resistance is strong, then the back will be good; if the righteousness is weak and unable to resist the evil, the prognosis will be poor. Fuzheng refers to a treatment principle that supports the body's righteousness, strengthens the physique, and improves the body's ability to resist evils and diseases. Therefore, it can be seen that the theory of righteousness in traditional Chinese medicine is consistent with the enhancement of immunity in modern immunology.

The current TCM believes that myasthenia gravis lack of endowment, acquired disorders, or emotional stimulation, or injury by external pathogens, or untreated diseases, or lack of support after illness, can lead to deficiency of spleen and stomach qi, which gradually accumulates and becomes damaged. . Therefore, the pathogenesis of myasthenia gravis is mainly spleen and stomach damage. The spleen and stomach are the foundation of the acquired constitution, the source of qi and blood transformation, reside in the middle burner, and are the cardinal mechanism for the movement of qi up and down. The spleen governs ascending and transporting. If the spleen is deficient and qi sinks, the lifting and lifting will be weak. The upper eyelid belongs to the spleen, so the lifting of the eyelids will be weak and drooping. Satisfaction, which is related to the exterior and interior of the spleen, if the spleen is deficient and the stomach is also weak, the cardinal mechanism of ascending and descending will be unfavorable, and there will be no right to receive and receive, so the appetite will be loose and let out, and swallowing will be difficult; Qi) is responsible for respiration, runs through all the meridians, the Qi in the chest sinks, the Qi in the chest is difficult to continue, and the lungs are weak, so shortness of breath is not enough to breathe. If the Qi in the chest also sinks, the breath will stop, and the danger will be instant.

However, although the drugs of modern medicine can treat or cure some immune system diseases to a certain extent, they are less effective for intractable diseases, and taking such immunomodulatory drugs for a long time is more likely to completely break the fragile balance. Take medicine for life. The current traditional Chinese medicine treatment of myasthenia gravis is more about using Chinese medicine as an adjuvant treatment to reduce the side effects caused by Western medicine treatment, reduce the pain of patients, and improve the quality of life. At present, there is no report on the treatment of myasthenia gravis with traditional Chinese medicine alone.

Contents of the invention

In order to overcome the deficiencies in the prior art and provide better drugs for the treatment of myasthenia gravis, the applicant now discloses a traditional Chinese medicine composition.

After many years of research and treatment on the pathogenesis, etiology, and symptoms of myasthenia gravis, the applicant believes that the pathogenesis of myasthenia gravis lies in: lack of righteousness and invasion of external evils, and lack of righteousness and deficiency of visceral qi It is also the root cause. Therefore deficiency and excess run through the beginning and end of the disease, but the disease is mostly excess at the beginning, and then develops into deficiency after external pathogens damage the viscera. After continuous summarization and repeated exploration, the applicant proposed a brand-new TCM treatment theory for myasthenia gravis, that is, to strengthen the foundation and strengthen the body first, improve the body's ability to fight the disease, and then draw out the evil energy from the viscera and guide it downward. Accelerate the flow of healthy energy in the body, replenish the "deficiency of energy" in various organs due to the departure of evil energy.

Chinese medicine composition of the present invention is as follows:

A traditional Chinese medicine composition, characterized in that the raw materials include 1-45 parts of sealwort, 1-25 parts of Tibetan calamus, 1-37 parts of myrobalan, 1-45 parts of Shichangpu, 1-45 parts of myrobalan, 1 part of oriental strawberry - 23 parts, 1-10 parts of saffron, and at least one selected from 1-15 parts of catechin extract, 1-29 parts of Sedum japonicum, and 1-34 parts of Sagemus sageii.

Further, the raw materials include 1-45 parts of sealwort, 1-25 parts of Tibetan calamus, 1-37 parts of myrobalan, 1-45 parts of Shichangpu, 1-45 parts of myrobalan, 1-23 parts of oriental strawberry, 1-37 parts of saffron 10 parts, and at least two selected from 1-15 parts of catechin extract, 1-29 parts of Sedum japonicum, and 1-34 parts of Sagecrop.

Further, the raw materials include 1-45 parts of sealwort, 1-25 parts of Tibetan calamus, 1-37 parts of myrobalan, 1-45 parts of Shichangpu, 1-45 parts of myrobalan, 1-23 parts of oriental strawberry, 1-37 parts of saffron 10 parts, 1-15 parts of catechin paste, 1-29 parts of Sedum japonicum, and 1-34 parts of Sagemus.

Further, the weight dosage of each raw material is 3-38 parts of Polygonatum, 1-20 parts of Tibetan Calamus, 1-28 parts of Myrobalan, 1-37 parts of Shichangpu, 1-40 parts of Myrobalan, 1-18 parts of Oriental Strawberry .

Furthermore, the weight dosage of each raw material is 8-30 parts of Polygonatum, 5-17 parts of Tibetan Calamus, 5-20 parts of Myrobalan, 6-28 parts of Shichangpu, 15-31 parts of Myrobalan, 3-15 parts of Oriental Strawberry , 2-6 parts of saffron, 2-8 parts of catechin paste, 1-10 parts of Sedum japonicum, and 1-25 parts of sagera.

In this traditional Chinese medicine composition, Polygonatum, Tibetan Calamus, Myrobalan, Shichangpu, Myrobalan, Saffron, and Sage Herb are mainly used. Polygonatum has the functions of invigorating qi and nourishing yin, invigorating the spleen, moistening the lungs and kidneys, and consolidating the foundation of the body. Improve righteousness and refresh the mind; store calamus to warm the stomach, reduce inflammation and relieve pain, and adjust the cool medicine in the prescription so that the stomach will not catch cold; myrobalan restrains the lungs and relieves cough, astringent intestines and diarrhea, reduces fire and relieves throat, and helps Polygonatum to strengthen and solidify The merits of the root; Acorus calamus reduces dampness and appetizers, resuscitates and clears phlegm, and helps expel evil spirits in the body; Myrobalan root clears heat and detoxifies, astringes and nourishes blood, and blends various medicines; Saffron promotes blood circulation and removes blood stasis, cools blood and detoxifies, relieves depression and calms the nerves; Oriental strawberry has The effects of hemostasis, expectoration, and dry pus; these medicines work together to achieve the effects of detoxification, nourishing the viscera,

According to the differences in the individual constitution of the patient and the specific symptoms of the disease, you can choose to add medicinal materials such as catechu paste, sage, and Sedum japonicum. Catechu ointment has the effects of promoting blood circulation and stopping bleeding, stopping bleeding and promoting muscle growth, dampness and sores, and clearing lung and reducing phlegm. Coordinating with the above-mentioned medicines, it can enhance the efficacy of the prescription on the lungs, and at the same time increase the functions of promoting blood circulation and stopping bleeding, promoting muscle growth and suppressing sores. It is suitable for In patients with hematoma, sores, ulcers and so on. Sagewort relieves cough and eliminates phlegm, and relieves lung symptoms. Sedum japonicum has the effects of nourishing qi and activating blood circulation, dredging the meridians and relieving asthma. Coordinating with the above-mentioned drugs, it can enhance the effect of regulating qi and promoting the lungs of the prescription, and is suitable for chest tightness and asthma. The three herbs here can be added alone or in combination according to the situation.

In order to enhance the effect of one aspect of the traditional Chinese medicine composition, the composition provided by the present invention may also contain at least one selected from Astragalus, Pentazoa, Radix Pseudostellariae, Atractylodes Rhizome, Yam, and Gynostemma pentaphyllum. The above-mentioned medicines all have one of the effects of invigorating qi, strengthening the spleen, and strengthening the stomach. Adding these kinds of medicines into the prescription can specialize the care of the lung and spleen in the prescription, and is suitable for patients with qi deficiency and damaged spleen and stomach.

Similarly, in order to strengthen the nourishment and conditioning of the spleen and stomach in this prescription, the prescription can also include French pinellia, schisandra, tangerine peel, black plum, gallnut, red stone fat, and nutmeg. The above-mentioned medicines all have one of the effects of invigorating the spleen, appetizing, regulating qi or antidiarrheal. In clinical practice, some patients are physically weak and weak, resulting in damage to the spleen and stomach, inability to digest food and loss of appetite, which affects the intake of food and nutrition and aggravates the condition. The addition of these medicines can enhance the nourishment and regulation of the spleen and stomach by the traditional Chinese medicine composition, treat spleen and stomach lesions, regulate the function of the digestive tract, enhance appetite, improve nutrient intake, and increase the body's ability to resist diseases.

Furthermore, in order to strengthen the tonic effect of this prescription, at least one selected from cornus, cordyceps sinensis, Morinda officinalis, antler, Eucommia, dodder, rehmannia glutinosa, angelica, Polygonum multiflorum, Asparagus, Nansha ginseng can be added to the prescription. . The above-mentioned medicine has one of effects of tonifying yang, tonifying yin and tonifying blood. In clinical practice, the addition of these drugs can treat myasthenia gravis caused by malnutrition, but in practice, it is necessary to distinguish the syndrome type of the patient and apply dialectical treatment.

On the other hand, using the traditional Chinese medicine composition provided by the present invention, optionally adding suitable pharmaceutically acceptable adjuvants, can prepare the traditional Chinese medicine preparation capable of treating myasthenia gravis, and its method can be any conventional Chinese medicine preparation production method, producing Any conventional dosage form. Considering the patient's compliance and efficacy, the preparation is preferably an oral dosage form, more preferably buccal tablet, powder, capsule or oral liquid, more preferably buccal tablet, powder, oral liquid, most preferably powder.

The method of preparation can be:

1) After the raw materials are selected, weigh them, group them and put them away for later use;

2) Cut each group of raw materials into sections, grind them into powder separately, and pass through a No. 2 standard sieve;

3) mixing the powders to obtain the active pharmaceutical ingredient composition;

4) The active ingredient composition obtained in 3) is processed into a preparation according to the standard preparation procedure, adding pharmaceutical excipients according to the different preparation types.

For example, the method for preparing the provided traditional Chinese medicine composition into powder is as follows: use the provided traditional Chinese medicine composition, cut each raw material into sections, grind them into powder, and mix them to obtain the powder. When in use, the powder is taken according to the dosage standard, placed under the tongue for oral administration, swallowed after about 5-10 minutes, and can be drunk 30 minutes after swallowing.

For another example, the method of preparing the provided traditional Chinese medicine composition into an oral liquid: decoct the provided composition with water, then concentrate the decoction, and then add pharmaceutically acceptable flavoring agents, taste-masking agents, and diluents, For example, sucrose, refined honey, etc. are matched with it to make oral liquid, which is sterilized and filled into bottles. How to decoct, follow the general guidelines and customary means in this field, for example, nutmeg needs to be added in the prescription, then when decocting, the nutmeg should be dropped.

For another example, the method of preparing the provided traditional Chinese medicine composition into buccal tablets: mix the provided traditional Chinese medicine composition powder with suitable tablet excipients, such as mannitol, magnesium stearate, dextrin, etc., and wet granulate, Drying, granulation, and tableting.

In order to make each raw drug in the composition better exert its medicinal effect, it is preferable to carry out water extraction or alcohol extraction for each raw drug, and how to choose the solvent for extraction follows the common practice in this field. If Danshen is selected, extract it with water, take its water extract, concentrate and spray-dry it to obtain the water extract of Salvia Miltiorrhiza for preparation; if you choose nutmeg, carry out alcohol extraction of nutmeg, take its alcohol extract and concentrate it for preparation . But these cannot be used to limit the protection scope of the present invention.

In the absence of traditional Chinese medicine extraction conditions, the provided composition is preferably made into buccal tablets or powders.

The traditional Chinese medicine preparation disclosed by the invention has the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, moisturizing the lungs and eliminating phlegm, invigorating the spleen and appetizing, nourishing the nerves, stopping diarrhea and suppressing sores, has the ability to regulate the immunity of the body, and restores the unbalanced immune system to normal. It is suitable for It is especially suitable for the treatment of myasthenia gravis in diseases caused by immune imbalance.

Preferably, the dosage of each component of the composition used in the present invention is: 5-20 parts of sealwort, 1-30 parts of Tibetan calamus, 1-25 parts of myrobalan, 1-25 parts of Shichangbu, 1-25 parts of myrobalan .

More preferably, the dosage of each component of the composition used in the present invention is: Polygonatum 8-18 parts, Tibetan Calamus 3-27 parts, Myrobalan 3-22 parts, Shichangpu 4-21 parts, Maobula 5-17 parts 1-7 parts of saffron, 1-30 parts of sagera, 2-12 parts of catechin paste, 1-22 parts of oriental strawberry, 1-10 parts of Sedum japonicum.

The Chinese medicinal material involved in the scheme of the present invention is described as follows:

Polygonatum, Polygonatum sibiricum, Polygonatum sibiricum, Polygonatum kingianu Coll. Et Hemsl. or Polygonatum cyrtonema Hua, Polygonatum cathcartii Baker. .oppositifolium (Wall.) The dry rhizome of Royle. According to different shapes, it is commonly called "Rhubarb Rhizome", "Chicken Head Polygonatum" and "Ginger-shaped Polygonatum". Polygonatum has the effects of invigorating qi and nourishing yin, invigorating the spleen, moistening the lungs and nourishing the kidney. When Huang Jing is selected, it can increase the tonic effect of this prescription, and is suitable for people with physical weakness, fatigue, and listlessness. Modern technology can isolate steroidal saponins from Rhizome of Polygonatum Rhizome, including 2 furostenol-type saponins and 2 spirosterenol-type saponins. Belonging to the former are: 26-O-β-D-glucopyranosyl-22-O-methyl-(25)S-furostan-5-ene-3β,26-diol 3-O-β-alpha Allicotetraoside (26-O-β-D-glucopyranosyl-22-O-methyl-25(S)-furost-5-ene-3β, 26-diol3-O-β-lycotetraoside) is Siberia Polygonum A ( sibiricoside-A) and 26-O-β-D-glucopyranosyl-22-O-methyl-25(S)-furostan-5-ene-3β,14α,26-triol 3-O-β -Lycotetraoside (26-O-β-D-glucopyranosyl-22-O-methyl-25(S)-fruost-5-ene-3β,14α,26-triol 3-O-β-lycotetraoside) ie 14α-Hydroxysiberian polyglycoside A (14α-hydroxysibiricoside A); belongs to the latter: ((23S,25R)spirosta-5-ene-3β,14α,23-triol 3-O-β-lycotetraoside) ie Siberian glycoside B (sibiricoside B) and neoprazerigenin - A3-O-β-lycotetraoside (neoprazerigenin A 3-O-β-lycotetraoside). It also contains polygonatum polysaccharides A, B, and C, all of which have a relative molecular mass greater than 200,000, and are all condensed by glucose, mannose, and galacturonic acid in a molar ratio of 6:26:1 It also contains polygonatum oligosaccharides A, B, and C, with relative molecular masses of 1630, 862, and 472, respectively, and is formed by condensation of fructose and glucose in molar ratios of 8:1.4:1 and 2:1. Polygonatum has effects related to the above active ingredients.

Gnaphalium affine is a plant of the genus Gnaphalium affine in the Asteraceae family, also known as Gnaphalium affine. The dried whole herb or inflorescence is used as medicine, which has the effect of antitussive and expectorant. In the Tibetan medicine classic "Jingzhu Materia Medica", the name of the sage grass is recorded as "Xiangqing", which is divided into two types: yellow and white. In the third volume of "Chinese Tibetan Medicine" (edited by Qinghai Provincial Institute of Drug Control and Qinghai Provincial Institute of Tibetan Medicine, Shanghai Science and Technology Press, 1996), it is recorded that the white of "Ganda Bazaar" is Milky White Fragrant Green (Anaphalis lactcaMaxim ), and the yellow one is sage grass, both of which "cure Bacon's disease and remove tumors". And Xiangqing is a plant of the genus Xiangqing in the family Asteraceae, and the genus Xiangqing was once merged with the genus Mirabilis, and the two are mainly distinguished by the sterility of hermaphrodite flowers. It can be seen from this that, although Shamrock and Cymbidium belong to different species in plant taxonomy, they have a very close relationship and have the same effect. Therefore, sagebrush and cypress are used interchangeably.

Catechu cream is the peeled branch and dried decoction of leguminous Acacia catechu ( Acacia catechu (Lf)Willci. ), which has the functions of promoting blood circulation and relieving pain, stopping bleeding and promoting granulation, reducing dampness and sores, clearing lungs and reducing phlegm effect.

Sedum bulbiferum is Sedum bulbiferum (Sedum bulbiferum, also known as horse urine flower) of the genus Sedum in the Sedum family. The whole plant can be used as medicine, and its dry roots and rhizomes are the best. It has the effects of replenishing qi and activating blood circulation, dredging channels and relieving asthma.

Myrobalan, for the mature fruit of Terminalia chebula Retz., also known as Myrobalan, microhair Myrobalan. Myrobalan has the effects of astringing the lungs to relieve cough, astringent intestines to stop diarrhea, reducing fire and relieving sore throat. In the Tibetan medicine system, Myrobalan is the most commonly used Tibetan medicinal material, and is regarded as the "King of Tibetan Medicine". The fruit of myrobalan contains 23.60%-37.36% tannins, including: chebulic acid, chebulic acid, tanning material Yunshijing, chebulin, 2,3-O-digalloyl pomegranate tannin , Terminalia flavin, procheroic acid, glucose gallotannin, 1,3,6-trigalloyl glucose, gallic acid, and gallic acid, etc. It also contains triterpenes: terminalene acid, xayawangol. Also contains shikimic acid, dehydroshikimic acid, quinic acid, triacic acid, palmitic acid, hexyl gallate, trihexyl chebulinate, carotin, β-sitosterol, arabinose, fructose, glucose, sucrose , rhamnose and amino acids etc. It also contains sennoside, chebulin, tannase, polyphenol oxidase, peroxidase, ascorbic acid oxidase, etc. Modern research shows that Myrobalan also has certain anti-cancer effects.

Acorus calamus belongs to the dry root of Acorus tatarinowii, a grass-like perennial herb of the genus Calamus in the family Araceae. The rhizome of Shichangpu is used for medicinal purposes. It grows at an altitude of 20 meters to 2600 meters. It has the effects of reducing dampness and appetizing, resuscitating phlegm, refreshing and improving intelligence.

Saffron, the dry stigma of Crocus sativus L. in the family Iridaceae, contains crocitin, safranal, crocin and protocrocin, which have the function of promoting blood circulation. Dispelling blood stasis, removing heat from blood and detoxifying, resolving stagnation and calming the nerves. In addition, modern technology research shows that saffron has the functions of inhibiting cancer, regulating immunity and anti-oxidation.

Tibetan calamus is the dried rhizome of Tibetan calamus (Acorus calamus L.), which has the effects of warming the stomach, reducing inflammation and relieving pain. Tibetan calamus is also known as water calamus, white calamus, stinky calamus, mud calamus, and large calamus. The whole plant of Tibetan calamus contains a variety of active ingredients, and its rhizomes contain volatile oil. The main components in the oil are α-asarone and β-asarone, and other parts of the whole plant also contain volatile oil. It also contains vitamins, palmitic acid, irisin mixed fatty acids and sugar. The results of modern pharmacological tests show that Tibetan calamus has the effects of calming the nerves, sedating, anticonvulsant and cooling. In addition, there are pharmacological effects such as relieving smooth muscle spasm.

Fructus myrobalan, for the dry ripe fruit of Junziaceae Terminalia genus Pilelekon, has the effects of clearing heat and detoxifying, astringent and nourishing blood, and harmonizing various medicines. Its ethanol extract contains β-sitosterol, gallic acid, ellagic acid, ethyl gallic acid, Chehulagic acid (C41H30O27) and carbohydrates; it is also isolated from the fruit of myrobalan-cardiac steroidal saponins. The physiological activity of myrobalan is related to the above-mentioned active ingredients.

Oriental strawberry is the dried whole herb of the plant Fragaria orientalis Losinsk in the Rosaceae family. It has the functions of hemostasis, expectoration and dry pus. Oriental strawberry whole grass contains flavonoids, and contains a lot of tannin and so on. Sugars are 5.0-7.0%, total acid content is 1.175-326%, and fruit juice accounts for 70-80% of the fruit. In minority medicine practice, strawberry (F.elatior Elark.), rooted strawberry (F. filipendula Hemsi.), European strawberry (F.vescaL.) can be used as substitutes.

Pinellia ternata (Pinellia ternata (Thunb.) Breit.) is a processed product of Pinellia ternata (Thunb.) Breit. The processing method is: take clean pinellia, separate the size, soak for 10-12 days, gently stir and change the water twice a day until there is no dryness, then soak in alum water for 3 days, remove the alum water, soak in water for another 2 days, Add licorice and lime solution (take 20kg of licorice, add water to decoct twice, combine the decoction, pour into the lime solution made with appropriate amount of water) to soak, stir 1-2 times a day, and keep the pH value above 12.0, There is a slight tongue numbness in the mouth, and the cut surface is evenly yellow. Take it out, wash it, and dry it in the shade or at low temperature. For every 100kg of net pinellia, 20kg of licorice, 2kg of alum, and 30kg of quicklime are used. The product is spherical or broken into irregular granules. The surface is light yellowish white, yellow or brownish yellow. The quality is relatively crisp or hard and brittle, the cross-section is yellow or light yellow, and the grains are slightly hard and brittle. Slight gas, light and slightly sweet taste, slightly numb tongue feeling.

15 compounds can be obtained from the separation of pinellia, which are chrysophanol, succinic acid, n-hexadecanoic acid-1-glyceride, 3-O-(6'-O-palmitoyl-β-D-glucopyranosyl ) stigmaster-5-ene, p-dihydroxyphenol, hydroxymethylfurfural, o-dihydroxyphenol and β-sitosterol, carotene. The medicinal effects of pinellia are related to the above 15 compounds.

Schisandra is the dry mature fruit of Schisandra chinensis (Turcz.) Baill or Schisandra sphenanthera Rehd. et Wils. The former is called northern schisandra, the latter is southern schisandra, and northern schisandra is the best. Fructus Schisandra has the effects of astringing the lungs and nourishing the kidneys, promoting body fluid and suppressing sweat, astringent essence and diarrhea, calming the mind and calming the nerves. The analysis of the mature fruit of Schisandra chinensis by modern technology can separate a variety of active ingredients. Including volatile components, lignans and organic acids. Also contains citral (Citrdal), chlorophyll, sterols, vitamin C, vitamin E, sugars, resins and tannins. The volatile components are: Sesquicarene, β-Chamigrene, α-Cha migrene, Chamigrenol, β-bisabolene ( β-Bisabolene), α-Pinene, Camphene, β-Pinene, Myrcene, α-Terpinene, Limonene, γ-Terpinene, p-Cymene, Thymol methylether, Bornyl acetate, Citronellol acetate Citronellyl acetate, Linalool, Terpinene-4-ol, α-Terpineol, 2-Borneol, Aroma Citronellol, Benzoic acid, δ-Cadinene, β-Elemene, α-Ylangene, etc. Lignans are: Schizandrin, Deoxyschizandrin, γ-Schizandrin, Pseudo-γ-schizandrin, Wuweizisu B ), Schisandrol C, Isoschizandrin, Pregomisin, Neoschizandrin, Schizandrol, Schizandrol A, Schizandrol B B is Gomisin A), Schisandrin A, B, C, D, E (Schisantherin A, B, C, D, E), Rubschisantherin, Schisandrin acetdte, Schisandrin B ( Schisanhenol B), Schisandrin (Schisanhenol). There are also Gomisin (Gomisin) A, B, C, D, E, F, G, H, J, N, O, R, S, T, U; Table Gomisin (Epigomisin) O; Angeloylgomisin H, O, Q; Tigloylgomisin H, P; Angeloyisogomisin O; Benzoylgomisin H, O, P, Q; Benzoyl-isogomisin (Benzoyl-isogomisin) O, etc.

Tangerine peel is the dry and mature peel of Citrus reticulata Blanco and its cultivars of Rutaceae. The addition of dried orange peel in the present invention can make the prescription have the functions of regulating qi, invigorating spleen, drying dampness and resolving phlegm. In general application, dried tangerine peel can also be used together with Atractylodes atractylodes and Magnolia officinalis for stagnation of spleen and stomach Qi due to cold and dampness in the middle Jiao, abdominal distension and pain, nausea and vomiting, and diarrhea; Patients with abdominal distension and pain; it is used with Citrus aurantium and ginger, and it is used for chest obstruction and shortness of breath. Those skilled in the art can add, subtract, and modify prescriptions according to such compatibility principles according to actual medication requirements.

Black plum is the dry near-ripe fruit of Prunus mume (Sieb.) Sieb. et Zuce, a plant of the genus Prunus in the Rosaceae family. It has the effects of astringing the lungs, astringing the intestines, promoting body fluid, and soothing roundworms.

Gallnut is the plant on the leaves of Rhus chinensis Mill., Rhuspotaninii Maxim. or Rhus punjabensis Stew.var.sinica (Diels) Rehd.etWils. Galls are mainly formed by gall aphid (Melaphis chinensis (Bell) Baker) parasitism. Also known as Meretrix Meretrix, Baichongcang, Mufuzi, Salt Bran Leaf, and Shangzhuzi. It has the effects of astringing the lungs and reducing fire, astringent intestines and diarrhea, sweating, hemostasis, dampness and sores. Modern technology separates a variety of substances from Gallnut, and the main proven active substances include: Gallnut tannin, gallic acid, etc. Among them, Gallic tannin has been proved to have the functions of antibacterial, anti-caries, inhibition of mutation, scavenging free radicals and anti-oxidation.

Chishizhi is a silicate mineral kaolinite group kaolinite, also known as Chifu, Hongkaolin, Chishi soil, and laterite. It mainly contains aluminum silicate tetrahydrate, which has the effects of astringent intestines, hemostasis, promoting granulation and astringing sores. In practical application, red stone fat can also be forged to enhance hemostatic, antidiarrheal and astringent effects. The usual preparation method of calcined red stone resin is: take fine red stone resin powder, mix thoroughly with vinegar, rub strips, cut into sections, dry, illuminated calcined method (when the medicine is calcined, the method of not isolating the air is called the bright satin method.) calcined to Completely red. Mash when used.

Nutmeg is the dry seed kernel of Myristica fragrans Houtt., a plant of the Myristica family Myristica fragrans Houtt. Raw nutmeg has a lot of oil, which can partially smooth the intestines. After being wrapped in flour, wheat bran or talc powder, it can be simmered to remove most of the fat, eliminate the intestines smoothing effect, and further strengthen the effect of astringent intestines and diarrhea. Modern technology can separate methyl eugenol and methyl isoeugenol from nutmeg extract, which are the effective ingredients of nutmeg for antidiarrheal.

Astragalus, the main root of Astragalus membranaceus (Fisch.) Bunge., is the main root of Astragalus membranaceus (Fisch.) Bunge. , people's title, etc., Astragalus is sweet in taste, slightly warm in nature, and returns to the lung, spleen, liver, and kidney channels. It has the effects of invigorating qi and raising yang, benefiting health and solidifying the surface, diuresis and detumescence, healing sores and promoting muscle growth

Five-clawed Dragon is the root of Ficus hirta Vahl, a plant belonging to the genus Moraceae. It is also known as Sanlongclaw, Subcomb, Five-finger Maotao, and Five-finger Milk. Spicy and sweet in taste, flat in nature and slightly warm, it has the effects of invigorating the spleen and nourishing the lungs, promoting qi and dampness, relaxing tendons and activating collaterals. Traditional Chinese medicine or minority folk doctors in the Lingnan area are often used to treat spleen deficiency and edema, lack of food and weakness, tuberculosis cough, night sweats, vaginal discharge, postpartum angalactia, irregular menstruation, rheumatic arthralgia, edema and other diseases.

Pseudostellaria heterophylla (Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm.) is the dry tuberous root of Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm. Pseudostellariae Radix Pseudostellariae is sweet, slightly bitter, mild in nature, belongs to the spleen and lung meridian, and has the effect of invigorating qi and promoting body fluid.

Atractylodes macrocephala is a plant of the genus Atractylodes macrocephala (Atractylodes macrocephala Koidz.) in the family Asteraceae, also known as Jiji, Yushu, Dongbaizhu, Xizhu, Yangzhu, Wushu, mountain thistle, Yangjiaoji, and mountain mustard. Bitter, sweet, warm in nature, it belongs to the Spleen and Stomach Meridian, and has the effects of invigorating qi and invigorating the spleen, drying dampness and diuresis, solidifying the surface, antiperspirant, and preventing miscarriage.

Yam is the root of the yam (Common Yam Rhizome) of the yam family. It is also known as yam, yam, yam, Huai yam, Huai yam, white yam, water yam, hairy yam, and light yam. Sweet in taste, flat in nature, belongs to the spleen, lung and kidney meridians, has the effects of nourishing qi and nourishing yin, nourishing the spleen, lung and kidney, strengthening essence and arresting nocturnal emission.

Gynostemma, Gynostemma pentaphyllum (Thunb.) Makino, a herbaceous climbing plant of the family Cucurbitaceae, is also known as: paradise grass, gospel grass, super ginseng, compass bottom, rooting everywhere, aescin, five-leaf ginseng and Aescin etc. Bitter in the mouth, slightly sweet, cool in nature, it returns to the lung, spleen, and kidney meridians. It has the effects of invigorating the spleen and replenishing qi, resolving phlegm and relieving cough, clearing heat and detoxifying.

Cornus is the dried and mature pulp of Cornus officinalis Sieb. et Zucc., a plant of the genus Cornus in the family Cornaceae. Jujube, scorpion, rat arrow, jujube skin, cornus. Sour in taste, (astringent), slightly warm in nature, returns to Liver and Kidney meridians. It has the effects of nourishing the liver and kidney, astringent and astringent.

Cordyceps sinensis is the ergot fungus Cordyceps sinensis (Berk.) Sacc that parasitizes the larvae of the bat moth. Also known as Cordyceps, Cordyceps, and Chinese Cordyceps, it is a rare and precious nourishing medicinal material commonly used by Chinese folks. Cordyceps sinensis is sweet in taste and flat in nature, and belongs to the lung and kidney channels.

Morinda officinalis How is the dry root of Morinda officinalis How in Rubiaceae, also known as Jichangfeng, corn vine, black vine drill, rabbit intestine, triangular vine, and bran vine. Morinda officinalis is pungent in taste, sweet; slightly warm in nature. Return kidney, liver meridian, have the effect of tonifying kidney and supporting yang, expelling wind and removing dampness, strengthening muscles and strengthening bones.

Antler refers to the unossified and hairy young horns of the sika deer or red deer stag. Sweet, salty, warm in nature, it belongs to the kidney and liver meridians, and has the effects of strengthening kidney yang, benefiting essence and blood, strengthening muscles and bones, regulating Chong and Ren, strengthening the veins, and treating sores

Eucommia ulmoides is the dry bark of Eucommia ulmoides Oliver (Eucommia ulmoides Oliver), also known as silk neem bark, silk cotton bark, cotton bark, and gum tree. Sweet in taste, warm in nature, it belongs to the liver and kidney meridians, and has the effects of nourishing the liver and kidney, strengthening bones and muscles, and preventing miscarriage.

Cuscuta is the dried and mature seed of Cuscuta australis R.Br. or Cuscuta chinensis Lam. of Convolvulaceae. Sweet in taste and warm in nature, it belongs to the spleen meridian of liver, kidney, and has the effects of nourishing the kidney and strengthening essence, nourishing the liver and improving eyesight, stopping diarrhea and preventing miscarriage.

Rehmannia glutinosa, obtained from the root of Rehmannia glutinosa (Gaetn.) Libosch.ex Fisch. et Mey., which is a plant of the family Scrophulariaceae, is sweet and warm in nature. Return liver; Kidney channel. It has the effects of nourishing blood, nourishing essence and filling marrow.

Angelica sinensis is the dry root of Angelica sinensis (Oliv.) Diels, a plant of the genus Angelica sinensis (Oliv.) Diels. Angelica, sweet in taste, pungent, warm in nature, belongs to the liver, heart and spleen meridian, has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, moistening dryness and smoothing intestines.

Radix Polygoni Multiflori is the processed product of Polygonum multiflora (Fallopia multiflora (Thunb.) Harald) tuber root. It tastes bitter, sweet, astringent and warm in nature. Return liver, heart, kidney channel. It has the effects of invigorating liver and kidney, benefiting essence and blood, black beard and hair, and strengthening muscles and bones.

Asparagus is the root tuber of Asparagus chinchinensis (Lour.) Merr. in the family Asparagus. Also known as asparagus winter, asparagus is cold in nature, sweet in taste, slightly bitter. It has the effects of nourishing yin and clearing away heat, nourishing the lungs and nourishing the kidneys.

Adenophora tetraphylla (Thunb.) Fisch. or Adenophora stricta Miq. is the dried root of Adenophora tetraphylla (Thunb.) Fisch., which is produced in Northeast China, Inner Mongolia, Hebei, and Shanxi. , Shandong, East China, Guangdong, Guangxi, Yunnan, Sichuan, and Guizhou; sand ginseng is produced in Jiangsu, Anhui, Zhejiang, Jiangxi, and Hunan. Sweet in taste, slightly cold in nature, it belongs to the lung and stomach meridian, has the effects of nourishing yin and clearing lung, benefiting stomach and promoting body fluid, reducing phlegm and replenishing qi.

specific embodiment

The present invention is further illustrated below through several embodiments. It should be understood that all the examples listed are to help those skilled in the art to understand and implement the present invention, and not to limit the present invention in any form. All simple improvements and adjustments made on the basis of the present invention, as well as the equivalent or equivalent replacement of the raw materials, which fail to produce new substantive features and significant progress, shall be within the protection scope of the present invention .

Example 1 Composition prescription example

Several example prescriptions are given below, and the scope and object of each prescription are indicated. It should be noted that the listed prescriptions are not any restrictions on the composition of the prescriptions, but are only for specific examples. Those skilled in the art can adjust the prescription according to the different symptoms of the disease and the difference in the patient's constitution, and these adjustments should also be included in the protection scope of the present invention.

Prescription 1

Polygonatum 45g Tibetan calamus 25g Myrobalan 17g Shichangpu 35g

Myrobalan 45g, oriental strawberry 23g, saffron 5g, catechin cream 5g

Prescription 2

Polygonatum 45g Tibetan calamus 25g Myrobalan 17g Shichangpu 35g

Myrobalan 45g, oriental strawberry 23g, saffron 5g, catechin cream 5g

Sedum japonicum 29g

Prescription 3

Polygonatum 45g Tibetan calamus 25g Myrobalan 17g Shichangpu 35g

Myrobalan 45g, oriental strawberry 23g, saffron 5g, catechin cream 5g

Sedum japonicum 29g and sagegrass 34g

Prescription 4

Polygonatum 37g Tibetan calamus 20g Myrobalan 10g Shichangpu 35g

Myrobalan 45g, oriental strawberry 23g, saffron 5g, catechin cream 5g

Sedum sedum 29g Milky white fragrant green 30g

Prescription 5

Polygonatum 25g Tibetan calamus 22g Myrobalan 12g Shichangpu 32g

Myrobalan 41g, oriental strawberry 20g, saffron 3g, catechin cream 6g

Bud sedum 24g, sage grass 28g, astragalus 5g, five-clawed dragon 3g

Prescription 6

Polygonatum 25g Tibetan calamus 22g Myrobalan 12g Shichangpu 32g

Myrobalan 41g, oriental strawberry 20g, saffron 3g, catechin cream 6g

Sedum sedum 24g, sage grass 28g, pinellia 5g, schisandra 5g

Chenpi 7g

Prescription 7

Polygonatum 25g Tibetan calamus 22g Myrobalan 12g Shichangpu 32g

Myrobalan 41g, oriental strawberry 20g, saffron 3g, catechin cream 6g

Bud sedum 24g Milky white fragrant green 28g Cordyceps sinensis 10g

Prescription 8

Polygonatum 25g Tibetan calamus 15g Myrobalan 12g Shichangpu 16g

Myrobalan 27g, oriental strawberry 10g, saffron 4g, catechu cream 4g

Sedum sedum 8g, sagema 18g, dodder 4g, Polygonum multiflorum 2g

Example 2 Preparation Example

Example 1 Powder formulation

① provide the composition described in prescription 4 in embodiment 1.

② Grind each component finely and mix well.

Example 2 Powder formulation

① provide the composition described in prescription 6 in embodiment 1.

② Grind each component finely and mix well.

Example 3 Oral liquid preparation

① provide the composition described in prescription 2 in embodiment 1.

②Grind each component finely, soak in water for at least 2 hours, then decoct twice, 2 hours each time. The decoction was collected by filtration at the end of each decoction.

③Combine the decoction liquid, concentrate under reduced pressure, and filter to get the clear liquid.

④Take 10g of white honey, add appropriate amount of water to dissolve it into honey water, dilute the clear liquid in ③ with honey water, stir, and you get it.

Example 4 Hard Capsule Formulation

① provide the composition described in prescription 6 in embodiment 1.

②After finely grinding each component, soak in 95% ethanol for at least 14 hours, soak in this way for 3-4 times until the color of the soaking liquid is light, combine the soaking liquid, and filter.

③ After the filtered liquid is concentrated under reduced pressure to make a dry extract, add an appropriate amount of glidant or lubricant, such as magnesium stearate, talcum powder, etc., mix well, send it into a coating pan, and add a wetting agent such as ethanol or water Spray in the form of mist to make the powder wet and bonded into granules, and continue to roll until the granules are dry.

④Take the medicinal empty capsule, place it on the capsule filling plate, fill the granules in ③ into the capsule, and lock the capsule.

It should be noted that the above preparation examples are all based on a small amount of production. When large-scale production is required, the main dosage in the prescription should be increased in proportion, and appropriate industrial production equipment should be used at the same time, such as liquid filling machines, powder tablet presses, capsule filling machines, coating machines, etc.

Embodiment 3 animal efficacy experiment

1. Establishment of mouse animal model of immune myasthenia gravis

The antigen emulsion was prepared at a ratio of 1:2 between T. California AChR and complete Freund's adjuvant (CFA). Take a C57BL/6 mouse (about 16 g in weight), and inject the antigen emulsion at multiple points on the mouse's hind foot pads, tail base, and back, with an injection volume of 100 μL. One additional injection was given after 1 day, for a total of 2 additional injections. The activity of the mice was observed, and the weakness of the tail appeared on the 9th day, and the weakness of both hind limbs appeared on the 10th day, and the modeling was considered successful.

Suspend the drugs shown in prescriptions 1, 4, 6, and 7 with 0.5% sodium carboxymethylcellulose, so that the mass volume concentration of the drug is 71 mg/mL;

2. Grouping and experiment

The model mice were randomly divided into 6 groups, including adjuvant control group, positive control group, and Chinese medicine group 1-4, with 10 mice in each group. Another 10 healthy mice were used as the normal control group. Positive control drug is dexamethasone, intragastric administration (0.2mg/kg body weight), once a day, traditional Chinese medicine 1-4 group is the suspension of the drug indicated in prescription 1, 4, 6, 7, intragastric administration volume is 1ml/kg body weight, once a day; the negative control group was administered intragastrically with 0.5% sodium carboxymethylcellulose solution equal to the volume of the drug group, once a day; once a day. After 28 days, the mice in each group stopped the administration and continued to observe for 28 days.

3. Results

(1) Changes in body weight of mice during the first 28 days of continuous administration

The mice in each group were weighed on 0d, 7d, 14d, 21d, and 28d, and the average body weight was recorded (unit: g).

*Note: In the adjuvant group, one mouse died on the 15th day, and two mice died on the 26th day.

(2) After the last administration on the 28th day, the administration was stopped, and the changes in the body weight of the mice

The mice in each group were weighed on 35d, 42d, 49d, and 56d, and the average body weight was recorded (unit: g).

*Note: In the positive group, one mouse died on the 37th day, three mice died on the 46th day, and two mice died on the 52d day. A total of 6 mice died, the mortality rate was 60%.

**Note: In the adjuvant group, one mouse died on the 33rd day, three mice died on the 34th day, two mice died on the 42d day, and the last mouse died on the 45th day (body weight 8.0g). A total of 10 mice died, the mortality rate was 100%.

in conclusion:

①The condition of mice in the experimental group without drug treatment worsened over time, gradually leading to weakness in chewing and difficulty in eating, resulting in weight loss; those with severe conditions died.

② The positive group was treated with dexamethasone, which alleviated the difficulty of eating due to muscle weakness in the mice, so that they could partially resume normal activities and diet. As the treatment continued, the body weight increased. , body weight decreased again, and a dead individual appeared, indicating that the administration of dexamethasone for 1 month failed to fundamentally treat myasthenia gravis in mice.

③The Chinese medicine group was administered with the Chinese medicine composition provided by the present invention, and the onset of effect was slow, but the drug effect was relatively long-lasting, and the overall effect was basically the same as that of the positive group, and basically returned to the body weight level of normal mice at 28 days. , there were no dead individuals, and the body weight did not drop significantly, and remained basically stable.

The experimental results show that the traditional Chinese medicine composition provided by the invention can improve the symptoms of the mouse model of myasthenia gravis, and at the same time, compared with dexamethasone treatment, it has the advantage of lasting drug effect. The reason for the long-lasting drug effect may be that the traditional Chinese medicine composition provided by the present invention rebuilds the damaged immune system of mice.

Claims (4)

1. A Chinese medicinal composition for the treatment of myasthenia gravis, characterized in that the raw materials consist of 1-45 parts of Polygonatum, 1-25 parts of Tibetan Calamus, 1-37 parts of Myrobalan, 1-45 parts of Shichangpu, Maohe 1-45 parts of fruit, 1-23 parts of oriental strawberry, 1-10 parts of saffron, 1-15 parts of catechu paste, 1-29 parts of Sedum japonicum, and 1-34 parts of sagera. 2. The composition according to claim 1, characterized in that each raw material weight consumption is 3-38 parts of sealwort, 1-20 parts of Tibetan calamus, 1-28 parts of Myrobalan, 1-37 part of Shichangpu, and 1-37 parts of Myrobalan 1-40 parts, 1-18 parts of oriental strawberry, 1-8 parts of saffron, 1-10 parts of catechu paste, 1-25 parts of Sedum japonicum, 1-30 parts of sagera. 3. The composition according to claim 1, wherein the weight consumption of each raw material is 8-30 parts of Polygonatum, 5-17 parts of Tibetan Calamus, 5-20 parts of Myrobalan, 6-28 parts of Shichangpu, and 6-28 parts of Myrobalan 15-31 parts, 3-15 parts of oriental strawberry, 2-6 parts of saffron, 2-8 parts of catechu paste, 1-10 parts of Sedum japonicum, 1-25 parts of sagera. 4. A traditional Chinese medicine preparation for treating myasthenia gravis, characterized in that it is made from the composition provided by any one of claims 1-3, and at least one pharmaceutically acceptable adjuvant or carrier.