CN107115483B

CN107115483B - Pharmaceutical composition for treating muscular dystrophy and myasthenia and application thereof

Info

Publication number: CN107115483B
Application number: CN201710355881.2A
Authority: CN
Inventors: 马宇振; 马俊鹏; 邢盼盼; 马腾飞
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-05-02
Filing date: 2017-05-02
Publication date: 2020-09-29
Anticipated expiration: 2037-05-02
Also published as: CN107115483A

Abstract

The invention belongs to a pharmaceutical composition for treating muscular dystrophy and myasthenia and an application thereof; the pharmaceutical composition is prepared from the following raw materials: fructus Corni, fructus Lycii, radix Polygoni Multiflori Preparata, fructus Gardeniae, caulis Spatholobi, endothelium corneum Gigeriae Galli and fructus Hordei Germinatus; has the advantages of low cost, good effect of treating muscular dystrophy and myasthenia, stable quality control, naturalness, no toxicity, stable effect and suitability for long-term administration.

Description

Pharmaceutical composition for treating muscular dystrophy and myasthenia and application thereof

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a pharmaceutical composition for treating muscular dystrophy and myasthenia and application thereof.

Background

The diseases of muscular dystrophy and myasthenia are diseases which are not available in medicine and can be treated in the world at present, the modern medicine considers that the disease belongs to a hereditary disease, the patient mostly has symptoms in 3-5 years old, gait abnormality gradually occurs, walking and swinging are commonly called as duck walking, difficulty in going upstairs and difficulty in rising and falling in squatting, the patient often turns over firstly and is in a supine position when lying down, the head is lifted firstly, the patient holds the knees and thighs with two hands, and slowly stands up with the trunk, when the patient is asked for a doctor in a large hospital, a doctor can tell the patient that the medicine for treating the disease is not developed up to present, the patient can only go home to see the disease condition of the patient to be aggravated in one day, the diseases of incapability of holding objects by hands and feet, and even mouth and throat eating and eye opening are difficult, or the disease is accompanied with muscular atrophy, and the applicant considers the disease to be a congenital deficiency, liver and kidney deficiency, and spleen and stomach are affected, liver governs tendons, liver injury causes the four limbs not to be used by people, tendons and vessels are contracture, kidney stores essence, essence and blood are generated mutually, essence injury cannot irrigate the ends of the four limbs, essence deficiency causes blood deficiency, blood deficiency cannot nourish bones and muscles, stomach is the valley sea, is the growth of zongzhi, spleen and stomach are not good in operation, essence and blood generation is insufficient, or due to the occlusion of damp-heat turbidity, dampness is taken down, liver, kidney, spleen and stomach are out of function, and the disease is gradually changed.

Disclosure of Invention

The invention aims to overcome the defects in the prior art and provide the pharmaceutical composition for treating muscular dystrophy and myasthenia, which has the advantages of low cost, good effect of treating muscular dystrophy and myasthenia, stable quality control, naturalness, no toxicity and stable effect, and is suitable for long-term administration, and the application thereof.

The purpose of the invention is realized as follows: the pharmaceutical composition is prepared from the following raw materials: fructus Corni, fructus Lycii, radix Polygoni Multiflori Preparata, fructus Gardeniae, caulis Spatholobi, endothelium corneum Gigeriae Galli and fructus Hordei Germinatus.

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 20-46 parts of cornus officinalis, 12-30 parts of wolfberry fruit, 10-40 parts of radix polygoni multiflori preparata, 10-15 parts of cape jasmine, 10-20 parts of caulis spatholobi, 10-20 parts of endothelium corneum gigeriae galli and 25-35 parts of raw malt.

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 25-37 parts of cornus officinalis, 16-24 parts of wolfberry fruit, 18-25 parts of prepared fleece-flower root, 10-13 parts of cape jasmine fruit, 15-19 parts of suberect spatholobus stem, 15-19 parts of chicken's gizzard-membrane and 28-30 parts of raw malt.

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 36 parts of cornus officinalis, 23.5 parts of wolfberry fruit, 18 parts of prepared fleece-flower root, 12 parts of cape jasmine fruit, 18 parts of suberect spatholobus stem, 16 parts of chicken's gizzard-membrane and 28 parts of raw malt.

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 30 parts of cornus officinalis, 18 parts of wolfberry fruit, 20 parts of prepared fleece-flower root, 10 parts of cape jasmine fruit, 15 parts of suberect spatholobus stem, 15 parts of chicken's gizzard-membrane and 30 parts of raw malt.

The invention provides application of the pharmaceutical composition in preparing a pharmaceutical composition for treating muscular dystrophy and myasthenia.

The pulp of dogwood fruit, the fruit of Chinese wolfberry, the prepared fleece flower root, the fruit of cape jasmine, the caulis spatholobi, the endothelium corneum gigeriae galli and the raw malt can be directly obtained by market. The invention can be decocted or the raw materials are respectively crushed, sieved and mixed according to the parts by weight, and then the mixture is filled into capsules or pressed into tablets; or mixing with pharmaceutically acceptable carrier or diluent, and making into capsule or tablet.

The invention is mainly used for treating muscular dystrophy and myasthenia, taking decoction as an example, each pair of traditional Chinese medicines is decocted twice, one time is taken every day, one month is a treatment course, and six to eight treatment courses are required to be continuously taken; in particular, special groups such as pregnant women need to follow medical advice when taking the medicine, and no special adverse reaction is found at present. Treatment according to the present invention means treatment after onset of disease and does not represent intervention prior to onset of disease.

The invention uses radix polygoni multiflori preparata, cornus officinalis and medlar to tonify liver and kidney, replenish essence and blood, strengthen tendons and bones, astringe essence and qi, strengthen deficiency and eliminate turbid pathogen and reduce dampness to supplement congenital deficiency as the monarch, uses endothelium corneum gigeriae galli and raw malt to regulate spleen and stomach, and is an active ministerial for qi and blood biochemical; the technical scheme is characterized in that chicken's gizzard-membrane and raw malt are used for regulating spleen and stomach, the qi and blood biochemical activities are active, the qi and blood biochemical activities are continuous, the bones and muscles can nourish essence and blood to reach the meridians of four limbs, blood can be obtained from two hands, and blood can be obtained from two feet, and the disease can be quickly cured.

Cornus officinalis: sour, astringent and slightly warm. The functional indications are as follows: tonifying liver and kidney, arresting seminal emission and arresting sweating: can be used for treating soreness of waist, spermatorrhea, dizziness, menorrhagia, frequent micturition, and spontaneous perspiration due to deficiency of liver and kidney.

Wolfberry fruit: sweet and mild; it enters liver and kidney meridians. Nourishing liver and kidney, replenishing vital essence and improving eyesight. The medlar has rich nutrient components and is a natural raw material with comprehensive nutrition at present. The medlar contains a large amount of protein, amino acid, vitamin, iron, zinc, phosphorus, calcium and other nutrient components necessary for human body, has three pharmacological actions of promoting and regulating immunologic function, protecting liver and resisting aging, and has irreplaceable medicinal value. The lycium barbarum polysaccharide is one of the most important and most critical components in lycium barbarum, can promote the phagocytic capacity of abdominal cavity macrophages, has the functions of improving metabolism, regulating endocrine, promoting protein synthesis, accelerating liver detoxification, repairing damaged liver cells, inhibiting cholesterol and triglyceride, and has obvious protection and repair effects on lipid peroxidation damage of the liver. Has effects in invigorating qi, nourishing liver and kidney, resisting aging, quenching thirst, and warming body.

Radix polygoni multiflori preparata: the product is in the form of irregular shriveled block, and has a thickness of about 1 cm. Dark brown or dark brown surface, uneven. Hard, keratotic, tan or black. Light smell, slightly sweet and bitter taste. The functional indications are as follows: tonify liver and kidney, replenish essence and blood, blacken beard and hair, strengthen bones and muscles, resolve turbidity and reduce blood fat. Can be used for treating blood deficiency, sallow complexion, giddiness, tinnitus, premature gray hair, soreness of waist and knees, numbness of limbs, metrorrhagia, leukorrhagia, and hyperlipidemia.

Gardenia: bitter and cold. Enter heart, liver, lung and stomach meridians. The functional indications are as follows: clear heat, purge fire, cool blood. It is used to treat febrile diseases, vexation, insomnia, jaundice, gonorrhea, diabetes, conjunctival congestion, pharyngalgia, hematemesis, epistaxis, dysentery with blood, hematuria, pyocutaneous disease due to heat toxin, sprain, and swelling and pain.

Caulis spatholobi: is bitter in taste; slightly sweet; and (4) temperature. The heart meridian; spleen meridian. The main treatment is as follows: promoting blood circulation and relaxing muscles and tendons; nourish blood and regulate menstruation. Numbness of the dominant hand and foot; paralysis of limbs; rheumatic arthralgia; irregular menstruation of women; dysmenorrhea; amenorrhea. The functions are as follows: tonify blood, activate blood and dredge collaterals. Can be used for treating menoxenia, blood deficiency, sallow complexion, numbness, paralysis, and rheumatalgia.

Endothelium corneum gigeriae galli: sweet and cold; entering spleen, stomach, small intestine and bladder meridians; the functional indications are as follows: remove food stagnation, strengthen spleen and stomach. It is used to treat dyspepsia, emesis, regurgitation, dysentery, malnutritional stagnation, diabetes, enuresis, pharyngitis, tonsillitis, ulcerative gingivitis, and aphtha.

Raw malt: sweet and neutral. It enters spleen and stomach meridians. The efficacy is as follows: move qi and promote digestion, invigorate spleen and stimulate appetite, remove milk and relieve distension. The main treatment is as follows: indigestion, abdominal distension and pain, spleen deficiency with poor appetite, milk sweat accumulation, breast swelling and pain, and women's lactation cessation.

The invention has the advantages of low cost, good effect of treating muscular dystrophy and myasthenia, stable quality control, naturalness, no toxicity, stable effect and suitability for long-term administration.

Detailed Description

The invention relates to a pharmaceutical composition for treating muscular dystrophy and myasthenia and application thereof; the pharmaceutical composition is prepared from the following raw materials: fructus Corni, fructus Lycii, radix Polygoni Multiflori Preparata, fructus Gardeniae, caulis Spatholobi, endothelium corneum Gigeriae Galli and fructus Hordei Germinatus.

In order to explain the present invention more clearly, the present invention will now be further described with reference to specific examples. Specific examples are as follows:

example one

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 47 parts of cornus officinalis, 31 parts of wolfberry fruit, 42 parts of prepared fleece-flower root, 9 parts of cape jasmine fruit, 9 parts of suberect spatholobus stem, 15 parts of chicken's gizzard-membrane and 24.5 parts of raw malt.

Example two

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 48 parts of cornus officinalis, 25 parts of wolfberry fruit, 40 parts of prepared fleece-flower root, 16 parts of cape jasmine fruit, 21 parts of suberect spatholobus stem, 9 parts of chicken's gizzard-membrane and 36 parts of raw malt.

EXAMPLE III

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 20 parts of cornus officinalis, 12 parts of wolfberry fruit, 10 parts of prepared fleece-flower root, 10 parts of cape jasmine fruit, 10 parts of suberect spatholobus stem, 10 parts of chicken's gizzard-membrane and 25 parts of raw malt.

Example four

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 46 parts of cornus officinalis, 30 parts of wolfberry fruit, 40 parts of prepared fleece-flower root, 15 parts of cape jasmine fruit, 20 parts of suberect spatholobus stem, 20 parts of chicken's gizzard-membrane and 35 parts of raw malt.

EXAMPLE five

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 33 parts of cornus officinalis, 21 parts of medlar, 25 parts of prepared fleece-flower root, 12.5 parts of gardenia, 15 parts of suberect spatholobus stem, 15 parts of chicken's gizzard-membrane and 30 parts of raw malt.

EXAMPLE six

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 25 parts of cornus officinalis, 16 parts of wolfberry fruit, 18 parts of prepared fleece-flower root, 10 parts of cape jasmine fruit, 15 parts of suberect spatholobus stem, 15 parts of chicken's gizzard-membrane and 28 parts of raw malt.

EXAMPLE seven

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 37 parts of cornus pulp, 24 parts of medlar, 25 parts of prepared fleece-flower root, 13 parts of gardenia, 19 parts of suberect spatholobus stem, 19 parts of chicken's gizzard-membrane and 30 parts of raw malt.

Example eight

A pharmaceutical composition for treating muscular dystrophy and myasthenia comprises the following raw materials in parts by weight: 31 parts of cornus officinalis, 20 parts of wolfberry fruit, 21.5 parts of prepared fleece-flower root, 11.5 parts of cape jasmine fruit, 17 parts of suberect spatholobus stem, 17 parts of chicken's gizzard-membrane and 29 parts of raw malt.

Example nine

Example ten

The above examples are merely illustrative for clearly illustrating the present invention and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art upon reference to the above description. It is not necessary or necessary to exhaustively enumerate all embodiments herein, and obvious variations or modifications can be made without departing from the scope of the invention as claimed.

Case 1, a certain girdling woman, a 40-year-old woman, a Deng city Longshangxiang, no obvious reasons for weakness of both lower limbs and no obvious reasons for walking in 2009, later reasons for weakness of both lower limbs to aggravate walking gait and teeter diagnosis, the patient is diagnosed in a hospital affiliated to the university of Zhejiang, the improvement related diagnosis is that the patient is diagnosed with multiple myositis and lumbar disc herniation, the patient is better treated and discharged, the curative effect of intermittent oral western medicine treatment is poor after discharge, the myocardial enzyme spectrum is examined in the first hospital in Nanyang in 2013 in 5 months in the south yang city in 20160 AST 60/L, LDH 39518 64/L, HBDH343U/L, CK3442U/L, CK-MB109U/L, the myocardial enzyme spectrum is examined in Zhejiang mountain hospital in 7 months in the same year in 7 months in Zhejiang province AST175.4U/L, LDH752.3U/L, CK7976.1U/L, CK-MB U/L, the patient is ineffectively treated by oral traditional Chinese medicine, the patient is ineffective, the patient is diagnosed with no effect, the patient is diagnosed in 2016, the patient is diagnosed in 7 months in four months, the same year, the patient is diagnosed with AST type AST 2, the patient is diagnosed with the myocardial enzyme spectrum, the patient is diagnosed with the myocardial ischemia type of the patient, the myocardial ischemia type, the⁹L, red blood cell 3.8 × 10¹²/L, hemoglobin 111g/L, platelets 169 × 10⁹And L. And (3) diagnosis: muscular dystrophy. Traditional Chinese medicine typing: damp-heat stagnation due to liver and kidney deficiency. Therapeutic principle: to nourish liver and kidney, induce diuresis and clear heat. The ninth embodiment of the invention is adopted for treatment, and the administration method comprises the following steps: decocting with water, taking one dose every day, continuously taking the medicine for six courses of treatment, and performing electromyography diagnosis: the tibialis anterior muscle and the quadriceps femoris muscle have no obvious myogenic damage and neurogenic damage, the lower limbs walk powerfully, and the user can climb the stairs independently, so that the daily life is as usual.

Case 2: ningji, male, 8 years old, Dunzhou city turbulent river street office. No obvious cause of weakness of the lower limbs appears in 8 months in 2013, and the adult can walk but stumble on foot. The brain CT examination performed in TCM college in Dengzhou shows that: no obvious abnormality is seen in the brain parenchyma, and the brain parenchyma is not treated. Lumbar MRI was performed in 2014 at 10 months 2 to the central hospital of south yang: no obvious abnormality was observed. Electromyography: bilateral sural and tibial nerve abnormalities. Namely, the third subsidiary hospital of Zhengzhou university: AST447U/L, ASTM89U/L, CK34310U/L, CK-MB1200U/L, LDH2232U/L and HBDH 1486U/L. The related examination was performed from 28 days 2 month 2014 to the first hospital of Beijing university: ALT 135U/L, AST 147U/L, LDH 1006U/L, HBDH782U/L, CK > 8000U/L, CK-MB > 308 ng/ml. The detection result of the hereditary myopathy shows that: the deletion variation of 48-50 exons of the DMD gene of the detected subject is found. No large fragment variation of the parent DMD gene of the subject is found. The diagnosis is as follows: the effect is not obvious when the prednisone acetate tablets with 15mgBid are orally taken due to muscular dystrophy. Symptoms gradually worsen in nearly eight months and develop to the upper floor without strength. For the visit of our hospital before further treatment. And (3) diagnosis: muscular dystrophy. Traditional Chinese medicine typing: damp-heat stagnation due to liver and kidney deficiency. Therapeutic principle: to nourish liver and kidney, induce diuresis and clear heat. The sixth embodiment of the invention is adopted for treatment, and the taking method comprises the following steps: decocting with water, taking one dose every day, continuously taking for eight treatment courses, and rechecking serum enzymes: CK184IU/L, CK-MB < 5 ng/ml. Electromyography: no obvious abnormality was found in the bilateral sural and tibial nerves. Serum enzymes are checked repeatedly in 2016, and the patient can walk normally with powerful lower limbs.

Case 3: Huang-Shi, male, 5 years old, Hubei filial senser. When a patient suffers from hand-foot-and-mouth disease in 2010 and 8 months, the transaminase is high, then CK1087U/L is found, electromyogram is not abnormal, the patient is diagnosed in a Hospital of Hebei province, the patient is diagnosed with myasthenia gravis through perfect correlation examination, walking is unstable at that time, the patient needs to hold the knee during squatting, the muscle strength is reduced, medicines, massage physiotherapy and other treatments are used all the time, the effect is not ideal, and the patient is diagnosed in the hospital for further treatment at present. The diagnosis after the completion of relevant examination in our hospital is as follows: muscular dystrophy. Traditional Chinese medicine typing: damp-heat stagnation due to liver and kidney deficiency. Therapeutic principle: the medicine is used for treating liver and kidney, and removing dampness and clearing heat, and the administration method comprises the following steps: decocting with water, taking one dose every day, continuously taking for ten treatment courses, and rechecking serum enzymes: CK86IU/L, CK-MB < 5 ng/ml. Electromyography: no obvious abnormality was observed. Serum enzymes are checked repeatedly in 2015 for a plurality of times and are in a normal range, walking is normal, and people can normally go to school without holding knees when squatting and standing.

The present invention is further described below in connection with clinical trials conducted in my hospital, namely the Zhenyu blood disease Hospital in Deng, Henan:

1. case selection: the selected cases are patients with muscular dystrophy in our hospital, and 39 patients with muscular dystrophy, 26 patients with male and 13 patients with female are selected; the course of disease is 30 days to 10 months; pseudohypertrophic muscular dystrophy in 23 cases and limb girdle muscular dystrophy in 16 cases.

2. Diagnostic criteria: according to the national administration of traditional Chinese medicine, the curative effect standard of the diagnosis of the traditional Chinese medicine diseases, the diagnosis is confirmed according to the illness state, the serum enzyme and the electromyogram of the patient.

3. The treatment method comprises the following steps: the medicine is taken daily according to the taking method of the invention, 150ml is taken with empty stomach each time, one month is a treatment course, the rest is carried out for 4 days, the next treatment course is carried out, six treatment courses are generally continuously taken until clinical symptoms and signs disappear, the curative effect is consolidated, two treatment courses are taken, and the medicine is taken once after 3 months of follow-up.

4. The evaluation standard of the curative effect is as follows:

(1) basically curing: clinical signs of the myasthenia symptom disappear, serum enzymes are normal through laboratory examination, no abnormality is caused through electromyogram examination, and relapse does not occur after one year of follow-up visit.

(2) And (3) relieving: clinical myasthenia symptom basically disappears, the serum enzyme is higher in laboratory examination, and no abnormality exists in electromyogram examination. The disease condition is stable and has no recurrence after 6 months of follow-up visit.

(3) The obvious progress is as follows: clinical signs of myasthenia symptom are obviously improved, laboratory examination shows that serum enzyme is higher, and electromyogram examination shows that the clinical signs of myasthenia symptom are obviously improved. The patient is stable and does not relapse after 3 months of follow-up.

(4) And (4) invalidation: after six courses of treatment, no obvious improvement on clinical symptom and physical sign, and no obvious improvement on serum enzyme and electromyogram in laboratory examination.

5. The treatment effect is as follows: the invention is applied to 39 patients with muscular dystrophy in clinic for six courses of treatment until the clinical symptom and physical sign disappear, and after the examination and check are normal, the curative effect is consolidated, two courses of treatment are taken, and the curative effect evaluation standard is applied to evaluate the curative effect: 25 cases are basically cured, and the cure rate is about 64.1%; relief 9 cases, about 23%; 3 cases of obvious improvement, about 7.7%; the ineffective rate is 2 cases, accounting for about 5.1 percent. The total effective rate is about 94.9%, and the effective rate in the invention refers to basic cure, relief and obvious progress.

Claims

1. A pharmaceutical composition for treating muscular dystrophy and myasthenia, which is characterized in that: the pharmaceutical composition is prepared from the following raw materials in parts by weight: 20-46 parts of cornus officinalis, 12-30 parts of wolfberry fruit, 10-40 parts of radix polygoni multiflori preparata, 10-15 parts of cape jasmine, 10-20 parts of caulis spatholobi, 10-20 parts of endothelium corneum gigeriae galli and 25-35 parts of raw malt.

2. The pharmaceutical composition for treating muscular dystrophy and muscle weakness according to claim 1 wherein: the pharmaceutical composition is prepared from the following raw materials in parts by weight: 25-37 parts of cornus officinalis, 16-24 parts of wolfberry fruit, 18-25 parts of prepared fleece-flower root, 10-13 parts of cape jasmine fruit, 15-19 parts of suberect spatholobus stem, 15-19 parts of chicken's gizzard-membrane and 28-30 parts of raw malt.

3. The pharmaceutical composition for treating muscular dystrophy and muscle weakness according to claim 1 wherein: the pharmaceutical composition is prepared from the following raw materials in parts by weight: 36 parts of cornus officinalis, 23.5 parts of wolfberry fruit, 18 parts of prepared fleece-flower root, 12 parts of cape jasmine fruit, 18 parts of suberect spatholobus stem, 16 parts of chicken's gizzard-membrane and 28 parts of raw malt.

4. The pharmaceutical composition for treating muscular dystrophy and muscle weakness according to claim 1 wherein: the pharmaceutical composition is prepared from the following raw materials in parts by weight: 30 parts of cornus officinalis, 18 parts of wolfberry fruit, 20 parts of prepared fleece-flower root, 10 parts of cape jasmine fruit, 15 parts of suberect spatholobus stem, 15 parts of chicken's gizzard-membrane and 30 parts of raw malt.

5. Use of a pharmaceutical composition according to any one of claims 1 to 4 for the preparation of a pharmaceutical composition for the treatment of muscular dystrophy, muscle weakness.