CN105535448B

CN105535448B - Traditional Chinese medicine composition for treating children myasthenia gravis

Info

Publication number: CN105535448B
Application number: CN201610129957.5A
Authority: CN
Inventors: 乞国艳
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-03-07
Filing date: 2016-03-07
Publication date: 2020-09-29
Anticipated expiration: 2036-03-07
Also published as: CN105535448A

Abstract

The invention discloses a traditional Chinese medicine composition for treating children myasthenia gravis, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-120 parts of astragalus membranaceus, 10-30 parts of codonopsis pilosula, 10-20 parts of bighead atractylodes rhizome, 5-8 parts of radix bupleuri, 5-8 parts of rhizoma cimicifugae, 5-10 parts of angelica sinensis, 5-10 parts of cornus officinalis, 5-10 parts of morinda officinalis, 5-10 parts of semen cuscutae, 8-24 parts of Chinese yam, 6-30 parts of radix polygoni multiflori preparata, 5-12 parts of caulis spatholobi, 5-12 parts of medlar, 3-6 parts of liquorice, 3-6 parts of pericarpium citri reticulatae and 3-10 parts of radix ophiopogonis. The traditional Chinese medicine provided by the invention is reasonable in compatibility, free of toxic and side effects, convenient to process, low in cost, obvious in effect of treating the myasthenia gravis of children, and suitable for clinical popularization and application.

Description

Traditional Chinese medicine composition for treating children myasthenia gravis

Technical Field

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

Background

Myasthenia gravis is one of the intractable diseases of the nervous system, and the symptoms are as follows: drooping of the eyelids on one or both sides, weakness of the limbs, difficulty swallowing and slurred speech.

Traditionally, people use three methods of anticholinesterase drugs, thymectomy and radiotherapy to treat myasthenia gravis, but anticholinesterase drugs such as neostigmine and pyridostigmine are temporary and locally effective drugs, which only can temporarily delay the attack of diseases, and long-term administration can cause damage to acetylcholine receptors in human bodies, so that the diseases are more serious. There are also many reports of serious side effects in medical applications using anticholinesterase drugs. On one hand, the curative effect is not ideal by surgical methods such as thymus resection and radiotherapy, and the effect of more than five years is to be observed; on the other hand, the operation method can only be used for patients with myasthenia gravis with the symptoms of thymic tumor, and the application range is narrow. The newly appeared plasma exchange principle in recent years can only be used for critically ill myasthenia gravis patients, the curative effect can only be maintained for about two weeks, the cost is high, and the practical value is low.

According to the traditional Chinese medicine, the myasthenia gravis belongs to flaccidity symptoms in the traditional Chinese medicine category, so that the traditional Chinese medicine is adopted for treating the myasthenia gravis in a targeted manner to achieve a certain effect.

Disclosure of Invention

The traditional Chinese medicine composition is simple in preparation method, good in curative effect, safe to use, free of side effects and suitable for being widely applied clinically.

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 of children, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-120 parts of Astragalus (Astragalus membranaceus (Fisch.) Bge.), 10-30 parts of CODONOPSIS pilosula (RADIX Codonopsis), 10-20 parts of bighead Atractylodes rhizome (Atractylodes macrocepha), 5-8 parts of RADIX Bupleuri (RADIX Bupleuri), 5-8 parts of RHIZOMA CIMICIFUGAE (RHIZOMA Cimicifugae), 5-10 parts of Angelica (Angelica sinensis (Oliv.) Diels.), 5-10 parts of dogwood (Cornus officinalis Sieb. Et Zucc) and 5-10 parts of Morinda officinalis (Morinda), 5-10 parts of semen cuscutae (Cuscuta chinensis Lam.), 8-24 parts of Chinese yam (Dioscorea opposita), 6-30 parts of radix polygoni multiflori preparata (cntRoa), 5-12 parts of caulis spatholobi (Millettia reticulata Benth.), 5-12 parts of medlar (Fructus Lycii), 3-6 parts of liquorice (Glycyrriza Uralensis Fisch.G. Glabra L.), 3-6 parts of dried orange peel (PERICARPIUM) and 3-10 parts of radix ophiopogonis (Ophiogon japonica (Linn.f.) Ker-Gawl.).

Further, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 60 parts of astragalus, 20 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 6 parts of radix bupleuri, 6 parts of cimicifugae foetidae, 7 parts of angelica, 7 parts of cornus officinalis, 7 parts of morinda officinalis, 7 parts of semen cuscutae, 16 parts of Chinese yam, 18 parts of prepared fleece-flower root, 8 parts of caulis spatholobi, 8 parts of medlar, 5 parts of liquorice, 4 parts of dried orange peel and 6 parts of radix ophiopogonis.

The invention provides a medicinal preparation for treating myasthenia gravis of children, which comprises the traditional Chinese medicine composition.

Furthermore, the dosage form of the pharmaceutical preparation is a conventional dosage form in pharmaceutics. The dosage forms include, but are not limited to, tablets, capsules, pills, granules, suspensions, powders, dripping pills, oral liquids, injections, infusions, freeze-dried powder injections, ointments, gels, patches, suppositories and the like. Preferred dosage forms are oral dosage forms such as tablets, capsules, pills, granules, syrups, mixtures and the like.

Further, the pharmaceutical preparation further comprises a pharmaceutically acceptable carrier, and the pharmaceutically acceptable carrier of the present invention includes but is not limited to:

diluent agent: starch, powdered sugar, lactose, dextrin, microcrystalline cellulose, inorganic salts, sugar alcohols, etc.

Wetting agent and binder: purified water, ethanol, gelatin, polyethylene glycol, cellulose derivatives, and the like.

Disintegrating agent: starch, sodium carboxymethyl starch, cellulose derivatives, crospovidone, and the like.

Lubricant: magnesium stearate, aerosil, talcum powder, polyethylene glycol and the like.

Cosolvent: water, ethanol, glycerol, propylene glycol, liquid paraffin, vegetable oil, etc.

Flavoring agent: sucrose, monosaccharide, aromatic, etc.

Preservative: benzoic acid, sorbic acid, methyl esters, ethyl esters, propyl esters, and the like.

Other suitable auxiliary materials can be added in the preparation process according to requirements, and the application of the auxiliary materials is well known in the field of preparation. The skilled person can select from the available formulation adjuvants according to the needs of the actual formulation.

The traditional Chinese medicine composition can be prepared by the following method: cleaning the medicinal materials, oven drying, grinding into fine powder, mixing, adding appropriate medicinal adjuvants, and making into pharmaceutically acceptable dosage forms such as tablet, capsule, pill, granule, etc.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: cleaning the Chinese medicinal materials, oven drying, pulverizing, extracting with common extraction solvent such as water and ethanol for several times, mixing extractive solutions, filtering, and concentrating the filtrate to obtain extract. Then drying the paste, pulverizing, adding appropriate pharmaceutical adjuvants, and making into pharmaceutically acceptable dosage forms such as tablet, capsule, pill, granule, etc.

As an alternative technical solution, the preparation method comprises the following steps: cleaning part of the Chinese medicinal materials, oven drying, pulverizing, extracting with common extraction solvent such as water and ethanol for several times, mixing extractive solutions, filtering, and concentrating the filtrate to obtain extract. Then drying and pulverizing the paste. The rest part of the Chinese medicinal materials are ground, pulverized, mixed with paste powder, and added with proper pharmaceutical adjuvants to make into pharmaceutically acceptable dosage forms such as tablet, capsule, pill, granule, etc.

The traditional Chinese medicine composition can also be prepared by the most conventional method of water boiling or alcohol precipitation after water boiling in the field of traditional Chinese medicines.

The traditional Chinese medicine composition can also be prepared by the following steps: cleaning the Chinese medicinal materials, oven drying, grinding into fine powder, and mixing.

The invention provides an application of the traditional Chinese medicine composition in preparing a medicine for treating children myasthenia gravis.

The invention provides application of the medicinal preparation in preparing a medicament for treating the myasthenia gravis of children.

The invention has the following advantages and beneficial effects:

the traditional Chinese medicine composition has the advantages of rich and natural sources, simple preparation process, low preparation cost, good curative effect, safety and no side effect, and is suitable for clinical popularization and use.

Detailed Description

For a better understanding and practice, the present invention is further illustrated below with reference to the following examples. Unless otherwise specified, the examples of the present invention are only for explaining the present invention and are not meant to limit the scope of the present 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: 10 parts of astragalus, 10 parts of codonopsis pilosula, 10 parts of bighead atractylodes rhizome, 5 parts of radix bupleuri, 5 parts of cimicifugae foetidae, 5 parts of angelica, 5 parts of cornus officinalis, 5 parts of morinda officinalis, 5 parts of semen cuscutae, 8 parts of Chinese yam, 6 parts of prepared fleece-flower root, 5 parts of caulis spatholobi, 5 parts of medlar, 3 parts of liquorice, 3 parts of dried orange peel and 3 parts of radix ophiopogonis.

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: 120 parts of astragalus, 30 parts of codonopsis pilosula, 20 parts of bighead atractylodes rhizome, 8 parts of radix bupleuri, 8 parts of cimicifugae foetidae, 10 parts of angelica, 10 parts of cornus officinalis, 10 parts of morinda officinalis, 10 parts of semen cuscutae, 24 parts of Chinese yam, 30 parts of prepared fleece-flower root, 12 parts of caulis spatholobi, 12 parts of medlar, 6 parts of liquorice, 6 parts of dried orange peel and 10 parts of radix ophiopogonis.

2. The above traditional Chinese medicine raw materials are decocted with five times of water twice, two hours each time. Filtering, mixing filtrates, standing for 48 hr, collecting supernatant, concentrating under reduced pressure to obtain fluid extract, pulverizing into fine powder, or concentrating under reduced pressure to obtain soft extract.

EXAMPLE 3 preparation of the Chinese medicinal composition

1. Accurately weighing the following traditional Chinese medicine raw materials: 60 parts of astragalus, 20 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 6 parts of radix bupleuri, 6 parts of cimicifugae foetidae, 7 parts of angelica, 7 parts of cornus officinalis, 7 parts of morinda officinalis, 7 parts of semen cuscutae, 16 parts of Chinese yam, 18 parts of prepared fleece-flower root, 8 parts of caulis spatholobi, 8 parts of medlar, 5 parts of liquorice, 4 parts of dried orange peel and 6 parts of radix ophiopogonis.

2. Refluxing the above materials with three times of 85% ethanol for three times, one hour each time. Mixing filtrates, concentrating under reduced pressure to obtain fluid extract, pulverizing into fine powder, or concentrating under reduced pressure to obtain soft extract.

EXAMPLE 4 preparation of pharmaceutical formulations

1. Preparation of oral liquid

(1) Preparing the traditional Chinese medicine composition clear paste according to the method in the embodiment 1-the embodiment 3;

(2) adding 20% benzoic acid ethanol solution 5ml and 24% potassium sorbate solution 5ml, stirring, refrigerating for more than 48 hr, filtering, adding water to adjust to content of crude drug 5.5g per ml, stirring, and bottling to obtain oral liquid.

2. Preparation of syrup

(2) adding adjuvants such as sucrose, sorbic acid, and water, stirring, and making syrup.

3. Preparation of tablets

(2) adding adjuvants such as starch, ethanol, and pulvis Talci, and making into tablet.

4. Preparation of capsules

(2) adding adjuvants such as starch, ethanol, dextrin, and magnesium stearate, and making into capsule.

5. Preparation of granules

(2) adding adjuvants including sugar powder, starch, dextrin, and ethanol, and making into granule.

6. The preparation method of the pill comprises the following steps:

(1) preparing a thick paste of the Chinese medicinal composition according to the method in example 2-example 3;

(2) and (4) making the paste into pills.

7. The preparation method of the mixture comprises the following steps:

(1) preparing a thick extract of the Chinese herbal medicine extract according to the method of example 1-example 3;

(2) adding adjuvants such as sucrose, ethyl ester, water, and sorbic acid, and stirring to obtain mixture.

EXAMPLE 5 therapeutic Effect of the Chinese medicinal composition

1. Preparation of Experimental drugs

Preparation of comparative drug a: weighing 60 parts of astragalus membranaceus, 20 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 10-30 parts of poria cocos, 10 parts of cimicifuga foetida, 10 parts of radix bupleuri, 10 parts of wolfberry fruit, 10 parts of angelica sinensis, 10 parts of pericarpium citri reticulatae, 5 parts of honey-fried licorice root, 10 parts of semen cuscutae, 10 parts of semen coicis, 10 parts of malt, 10 parts of Chinese yam and 10 parts of cornus pulp. Decocting with five times of water twice, each for two hours, filtering, mixing filtrates, standing for 48 hr, collecting supernatant, and concentrating under reduced pressure to obtain fluid extract; adding 20% benzoic acid ethanol solution 5ml and 24% potassium sorbate solution 5ml, stirring, refrigerating for more than 48 hr, filtering, adding water to adjust to content of crude drug 5.5g per ml, stirring, and bottling to obtain oral liquid.

Preparation of comparative drug B: weighing 120 parts of astragalus membranaceus, 20 parts of radix pseudostellariae, 60 parts of codonopsis pilosula, 20 parts of bighead atractylodes rhizome, 6 parts of radix bupleuri, 6 parts of cimicifugae foetidae, 7 parts of angelica sinensis, 20 parts of Chinese yam, 6 parts of cortex albiziae, 18 parts of prepared fleece-flower root, 7 parts of morinda officinalis, 6 parts of mulberry, 5 parts of liquorice, 4 parts of pericarpium citri reticulatae, 3 parts of fructus aurantii, 20 parts of caulis spatholobi, 10 parts of medlar and 6 parts of radix. Decocting with five times of water twice, each for two hours, filtering, and mixing filtrates. Standing for 48 hr, collecting supernatant, and concentrating under reduced pressure to obtain fluid extract; adding 20% benzoic acid ethanol solution 5ml and 24% potassium sorbate solution 5ml, stirring, refrigerating for more than 48 hr, filtering, adding water to adjust to content of crude drug 5.5g per ml, stirring, and bottling to obtain oral liquid.

The preparation of the traditional Chinese medicine composition of the invention comprises the following steps: weighing 60 parts of astragalus mongholicus, 20 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 6 parts of radix bupleuri, 6 parts of cimicifugae foetidae, 7 parts of angelica sinensis, 7 parts of cornus officinalis, 7 parts of morinda officinalis, 7 parts of semen cuscutae, 16 parts of Chinese yam, 18 parts of radix polygoni multiflori preparata, 8 parts of caulis spatholobi, 8 parts of medlar, 5 parts of liquorice, 4 parts of pericarpium citri reticulatae and 6 parts of radix ophiopogonis. Decocting with five times of water twice, each for two hours, filtering, mixing filtrates, standing for 48 hr, collecting supernatant, and concentrating under reduced pressure to obtain fluid extract; adding 20% benzoic acid ethanol solution 5ml and 24% potassium sorbate solution 5ml, stirring, refrigerating for more than 48 hr, filtering, adding water to adjust to content of crude drug 5.5g per ml, stirring, and bottling to obtain oral liquid.

2. The test population: the number of children patients is 120, the children patients are randomly divided into 3 groups, and all the patients are confirmed to be myasthenia gravis patients through the following diagnosis standards:

(1) neostigmine test was positive: electromyography checks that the action potential of repeated electrical nerve stimulation is attenuated.

(2) Positive for serum anti-acetylcholine antibody.

Respectively administering a contrast medicament A, a contrast medicament B and the traditional Chinese medicine composition,

the dosage is 150-200ml each time, and the preparation is administered three times daily. The treatment effect was observed after continuous administration for one month.

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

and (3) curing: clinical symptoms and physical signs disappear completely, and no relapse occurs in three months;

the method has the following advantages: improvement in clinical symptoms and signs;

and (4) invalidation: there was no improvement in clinical symptoms and signs.

4. Therapeutic results

The effective rate of the traditional Chinese medicine composition reaches 100%, the effect is better than that of the comparative medicine A and the comparative medicine B, and the specific data are shown in Table 1.

TABLE 1 statistics of efficacy results

The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.

Claims

1. The traditional Chinese medicine composition for treating children myasthenia gravis is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-120 parts of astragalus membranaceus, 10-30 parts of codonopsis pilosula, 10-20 parts of bighead atractylodes rhizome, 5-8 parts of radix bupleuri, 5-8 parts of rhizoma cimicifugae, 5-10 parts of angelica sinensis, 5-10 parts of cornus officinalis, 5-10 parts of morinda officinalis, 5-10 parts of semen cuscutae, 8-24 parts of Chinese yam, 6-30 parts of radix polygoni multiflori preparata, 5-12 parts of caulis spatholobi, 5-12 parts of medlar, 3-6 parts of liquorice, 3-6 parts of pericarpium citri reticulatae and 3-10 parts of radix ophiopogonis.

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: 60 parts of astragalus, 20 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 6 parts of radix bupleuri, 6 parts of cimicifugae foetidae, 7 parts of angelica, 7 parts of cornus officinalis, 7 parts of morinda officinalis, 7 parts of semen cuscutae, 16 parts of Chinese yam, 18 parts of prepared fleece-flower root, 8 parts of caulis spatholobi, 8 parts of medlar, 5 parts of liquorice, 4 parts of dried orange peel and 6 parts of radix ophiopogonis.

3. A pharmaceutical preparation for treating myasthenia gravis in children, comprising the Chinese medicinal composition of claim 1 or 2.

4. The pharmaceutical formulation of claim 3, wherein the dosage form of the pharmaceutical formulation is a pharmaceutically conventional oral dosage form.

5. The pharmaceutical formulation according to claim 4, wherein the oral dosage form is oral liquid, syrup, granule, pill, tablet, capsule, mixture.

6. The preparation method of the traditional Chinese medicine composition of claim 1 or 2, which is characterized by comprising the following steps: cleaning the Chinese medicinal materials, oven drying, grinding into fine powder, and mixing.

7. The preparation method of the traditional Chinese medicine composition of claim 1 or 2, which is characterized by comprising the following steps: cleaning the Chinese medicinal materials, oven drying, pulverizing, extracting for several times, mixing extractive solutions, filtering, concentrating the filtrate to obtain extract, drying, pulverizing, and mixing.

8. A method for preparing a Chinese medicinal composition as claimed in claim 1 or 2, wherein the method comprises decocting the Chinese medicinal materials in water or decocting in water and precipitating with ethanol.

9. The use of a Chinese medicinal composition according to claim 1 or 2 in the preparation of a medicament for the treatment of myasthenia gravis in children.

10. Use of a pharmaceutical formulation according to any one of claims 3 to 5 in the manufacture of a medicament for the treatment of myasthenia gravis in children.