A repair material for DMD atrophic muscles and its preparation method

Abstract

The present invention relates to a repair material for DMD atrophic muscle and a preparation method thereof, wherein the repair material comprises a Chinese medicine composition and a coating material in a mass ratio of 1:16-19; wherein the Chinese medicine composition comprises the following raw materials in parts by mass: 5-20 parts of rhodiola rosea, 2-20 parts of astragalus, 1-15 parts of liquorice, 1-13 parts of salvia miltiorrhiza, 2-15 parts of bupleurum, 3-13 parts of notoginseng, 1-14 parts of toosendan, 1-15 parts of dendrobium, 3-20 parts of wolfberry, 4-18 parts of angelica, 2-17 parts of citron, 1-11 parts of fructus aurantii, 1-12 parts of green peel, 1-10 parts of citronella, 1-10 parts of angelica dahurica, 1-10 parts of angelica pubescens, 1-12 parts of clematis, 1-10 parts of gentiana macrophylla and 1-15 parts of astragalus. The repair material for DMD atrophic muscle provided by the present invention can be used as a new therapeutic drug for Duchenne muscular dystrophy, and has good clinical application prospects and effects.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a repair material for DMD atrophied muscles and a preparation method thereof. Background Art

[0002] Duchenne muscular dystrophy (DMD) is a muscular dystrophy whose gene is located on the X chromosome. DMD is caused by a mutation in the dystrophin gene, which is an essential protein for connecting the intracellular skeleton and the extracellular matrix of muscle cells. In the process of muscle atrophy, increased protein degradation is the root cause of skeletal muscle atrophy. It is now recognized that almost all types of muscle atrophy, including skeletal muscle dystrophy, disuse muscle atrophy, denervation muscle atrophy, and muscle atrophy complicated by serious diseases such as advanced cancer cachexia and AIDS, have the ultimate common change of increased expression of the skeletal muscle-specific atrophy factor Atrogin~1. Skeletal muscle protein degradation is greater than synthesis, causing a decrease in the cross-sectional area of ​​skeletal muscle fibers and changes in muscle fiber type-related proteins, leading to the occurrence of muscle atrophy. Therefore, by inhibiting the expression of Atrogin~1, increasing the cross-sectional area of ​​muscle fibers and regulating the content of muscle fiber type-related proteins, the occurrence and development of skeletal muscle atrophy diseases can be prevented and treated to improve work and living ability.

[0003] Salidroside is a compound extracted from the dried roots and rhizomes or dried whole grass of the Crassulaceae plant Rhodiola rosea. Studies have shown that salidroside can inhibit the expression of the muscle atrophy-specific factor Atrogin~1 in skeletal muscle, the reduction of myotube diameter and skeletal muscle fiber cross-sectional area, increase the content of slow muscle fiber protein in skeletal muscle, and inhibit the expression of fast muscle fiber protein, thereby playing a role in preventing and combating muscle atrophy.

[0004] The symptoms of Duchenne muscular dystrophy belong to the category of paralysis in traditional Chinese medicine. Traditional Chinese medicine believes that muscular dystrophy is caused by the decline of spleen and stomach function due to factors such as insufficient qi and blood, mental weakness, and spleen and stomach weakness, which makes it impossible to absorb nutrients in food and transport nutrients to various parts of the body, thus causing muscle weakness in patients. When taking traditional Chinese medicine to treat muscular weakness, it is necessary to first nourish the spleen and stomach, then nourish the kidney and replenish qi, promote qi and blood circulation, and activate collaterals to relieve pain. Traditional Chinese medicine has great potential in the treatment of muscular dystrophy, so there is an urgent need for a traditional Chinese medicine compound repair material to delay the course of Duchenne muscular dystrophy. Summary of the invention

[0005] The purpose of the present invention is to provide a repair material for DMD atrophy muscles and a preparation method thereof, so as to provide a new therapeutic drug for Duchenne muscular dystrophy, which has good clinical application prospects and effects.

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

[0007] A repair material for DMD atrophied muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:16-19; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 5-20 parts of Rhodiola rosea, 2-20 parts of Astragalus, 1-15 parts of Licorice, 1-13 parts of Salvia miltiorrhiza, 2-15 parts of Bupleurum, 3-13 parts of Panax notoginseng, 1-14 parts of Toosendan fruit, 1-15 parts of Dendrobium, 3-20 parts of Lycium barbarum, 4-18 parts of Angelica sinensis, 2-17 parts of Citron, 1-11 parts of Citrus aurantium, 1-12 parts of Citronella, 1-10 parts of Cibotium barbarum, 1-10 parts of Angelica dahurica, 1-10 parts of Angelica dahurica, 1-12 parts of Clematis chinensis, 1-10 parts of Gentiana macrophylla and 1-15 parts of Astragalus membranaceus.

[0008] Further, the Chinese medicine composition includes the following raw materials in parts by mass: 10-17 parts of Rhodiola rosea, 7-14 parts of Astragalus, 4-10 parts of Licorice, 3-8 parts of Salvia miltiorrhiza, 6-10 parts of Bupleurum, 5-10 parts of Panax notoginseng, 3-8 parts of Toosendan fruit, 4-9 parts of Dendrobium, 5-11 parts of Lycium barbarum, 8-12 parts of Angelica sinensis, 4-10 parts of Citron, 3-7 parts of Citrus aurantium, 3-8 parts of Citrus aurantium, 2-6 parts of Cibotium barometz, 2-7 parts of Angelica dahurica, 3-8 parts of Clematis, 2-7 parts of Gentiana macrophylla and 4-11 parts of Astragalus membranaceus.

[0009] Further, 13 parts of Rhodiola rosea, 10 parts of Astragalus, 8 parts of Licorice, 6 parts of Salvia miltiorrhiza, 8 parts of Bupleurum, 7 parts of Panax notoginseng, 5 parts of Toosendan Fructus, 6 parts of Dendrobium, 9 parts of Lycium barbarum, 11 parts of Angelica sinensis, 7 parts of Citron, 5 parts of Fructus Aurantii Immaturus, 6 parts of Pericarpium Cibotii, 4 parts of Cibotium barometz, 5 parts of Angelica dahurica, 6 parts of Clematidis, 4 parts of Gentiana macrophylla and 9 parts of Astragalus.

[0010] Furthermore, the mass percentage of the Rhodiola rosea in the raw materials is greater than 8%.

[0011] The prior art has reported on the use of salidroside in the preparation of drugs for treating Duchenne muscular dystrophy, but experiments have shown that the effect of using rhodiola alone after extraction as a Chinese medicine raw material is not ideal. The present invention combines rhodiola with other various medicinal materials, and the Chinese medicine composition extracted with the optimal formula can be used as a therapeutic drug for Duchenne muscular dystrophy, which has good clinical application prospects and effects. The inventor unexpectedly found that when the mass of rhodiola in the formula system of the present invention accounts for more than 8% of the total mass of the raw materials, the repair material has a better effect. It is speculated that the active ingredient salidroside in the product under this condition is compounded with the other active ingredients to produce a better synergistic effect.

[0012] Furthermore, the method for preparing the coating material comprises the following steps:

[0013] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:5-8:0.3-0.5, react at 50-55°C for 3-5 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0014] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 3-5:1:5-10:10-15 are mixed evenly, and an esterification reaction is carried out at 35-40° C. for 3-5 hours. During the reaction, the pH is controlled to be 8-8.5, and the mixture is centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0015] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water are uniformly mixed in a mass ratio of 1-2:1:0.4-0.6:100 to obtain a coating material.

[0016] Furthermore, the concentration of hydrogen peroxide is 16-18wt%.

[0017] Furthermore, the deacetylation degree of water-soluble chitosan is greater than 85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd. Hydroxypropyl distarch phosphate was purchased from Hefei Shengrun Biological Products Co., Ltd.

[0018] The inventors found that the efficacy of the Chinese medicine composition prepared from raw materials would decrease after long-term storage. It is speculated that the active components in the Chinese medicine composition would deteriorate after long-term storage, thereby affecting the efficacy. In the early stage of the experiment, the inventors tried to use hydroxypropyl distarch phosphate for coating, but the effect was not ideal. By using hydroxypropyl distarch phosphate, water-soluble chitosan, and dextrin as a packaging material, the drug efficacy can still be maintained after 6 months of sealed and light-proof storage at room temperature (25°C). However, under actual storage conditions, the temperature difference in some areas is large, and the effect is still not ideal after storage under variable temperature conditions. The inventors modified hydroxypropyl distarch phosphate and compounded it with water-soluble chitosan and dextrin, which has better compatibility. The network structure formed by the packaging material can improve the uniformity and effectiveness of the package, improve the antioxidant effect, and improve the storage effect under variable temperature conditions.

[0019] The present invention also provides a method for preparing a repair material for DMD atrophied muscles, comprising the following steps:

[0020] (1) Weigh the raw materials according to the ratio, add water in an amount of 13 to 15 times the total mass of the raw materials, boil at 80 to 90° C. for 100 to 120 min, filter, add water in an amount of 8 to 10 times the total mass of the raw materials to the filter residue, boil at 60 to 70° C. for 70 to 90 min, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1 to 1.2, and vacuum dry to obtain a traditional Chinese medicine composition;

[0021] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0022] Furthermore, the vacuum drying conditions are: -100 KPa, 60-65° C., vacuum drying for 18-20 hours.

[0023] Furthermore, the microcapsule granulator has a vibration frequency of 1500 Hz, an electrode voltage of 600 V, an air pressure of 200 mbar, a nozzle diameter of 500 μm, and a flow rate of 10 mL / min.

[0024] The raw materials of the present invention are all commercially available.

[0025] Compared with the prior art, the advantages and beneficial effects of the present invention are:

[0026] 1. The present invention provides a repair material for DMD atrophied muscles and a preparation method thereof, which has the effect of slowing down the reduction rate of the inner diameter of muscle fibers and delaying the process of muscle loss. It can provide a new therapeutic drug for Duchenne muscular dystrophy and has good clinical application prospects and effects.

[0027] 2. The present invention combines Rhodiola rosea with other medicinal materials to extract the Chinese medicine composition with the optimal formula, which can be used as a therapeutic drug for Duchenne muscular dystrophy and has good clinical application prospects and effects. The inventor unexpectedly found that when the mass of Rhodiola rosea in the formula system of the present invention accounts for more than 8% of the total mass of the raw materials, the repair material has a better effect. It is speculated that the active ingredient salidroside in the product under this condition is compounded with the other active ingredients to produce a better synergistic effect.

[0028] 3. The present invention uses hydroxypropyl distarch phosphate, water-soluble chitosan and dextrin as the packaging material, and can maintain good efficacy after being sealed and stored away from light at room temperature (25°C) for 6 months. The inventor modified hydroxypropyl distarch phosphate and compounded it with water-soluble chitosan and dextrin to improve the storage effect under variable temperature conditions. DETAILED DESCRIPTION

[0029] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0030] Example 1

[0031] The present embodiment provides a repair material for DMD atrophy muscle, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 13 parts of Rhodiola rosea, 10 parts of Astragalus, 8 parts of Licorice, 6 parts of Salvia miltiorrhiza, 8 parts of Bupleurum, 7 parts of Panax notoginseng, 5 parts of Toosendan fruit, 6 parts of Dendrobium, 9 parts of Lycium barbarum, 11 parts of Angelica sinensis, 7 parts of Citron, 5 parts of Citrus aurantium, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica dahurica, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica pubescens, 6 parts of Clematidis, 4 parts of Gentiana macrophylla and 9 parts of Astragalus membranaceus.

[0032] The preparation method of the coating material comprises the following steps:

[0033] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0034] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0035] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0036] The concentration of hydrogen peroxide is 17wt%.

[0037] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0038] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0039] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0040] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0041] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0042] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0043] Example 2

[0044] The present embodiment provides a repair material for DMD atrophy muscle, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:16; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 10 parts of Rhodiola rosea, 7 parts of Astragalus, 4 parts of Licorice, 3 parts of Salvia miltiorrhiza, 6 parts of Bupleurum, 5 parts of Panax notoginseng, 3 parts of Toosendan fruit, 4 parts of Dendrobium, 5 parts of Lycium barbarum, 8 parts of Angelica sinensis, 4 parts of Citron, 3 parts of Citrus aurantium, 3 parts of Citrus aurantium, 3 parts of Citrus aurantium, 2 parts of Cibotium barbarum, 2 parts of Angelica dahurica, 3 parts of Clematis, 2 parts of Gentiana macrophylla and 4 parts of Astragalus membranaceus.

[0045] The preparation method of the coating material comprises the following steps:

[0046] (1) Mixing hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:5:0.5, reacting at 50°C for 5 hours, and drying to obtain oxidized hydroxypropyl distarch phosphate;

[0047] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 3:1:10:10 were mixed evenly, and an esterification reaction was carried out at 40°C for 3 hours. During the reaction, the pH was controlled to be 8.5, and the mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0048] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 2:1:0.4:100 are mixed evenly to obtain a coating material.

[0049] The concentration of hydrogen peroxide is 16wt%.

[0050] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0051] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0052] (1) Weigh the raw materials according to the ratio, add water 13 times the total weight of the raw materials, boil at 87°C for 115 minutes, filter, add water 8 times the total weight of the raw materials to the filter residue, boil at 64°C for 76 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.2, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0053] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0054] The vacuum drying conditions are: -100 KPa, 64° C., and vacuum drying for 20 h.

[0055] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0056] Example 3

[0057] The present embodiment provides a repair material for DMD atrophy muscle, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:19; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 17 parts of Rhodiola rosea, 14 parts of Astragalus, 10 parts of Licorice, 8 parts of Salvia miltiorrhiza, 10 parts of Bupleurum, 10 parts of Panax notoginseng, 8 parts of Toosendan fruit, 9 parts of Dendrobium, 11 parts of Lycium barbarum, 12 parts of Angelica sinensis, 10 parts of Citron, 7 parts of Citrus aurantium, 8 parts of Citrus aurantium, 6 parts of Cibotium barometz, 7 parts of Angelica dahurica, 8 parts of Clematis, 7 parts of Gentiana macrophylla and 11 parts of Astragalus membranaceus.

[0058] The preparation method of the coating material comprises the following steps:

[0059] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:8:0.3, react at 55°C for 3 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0060] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 5:1:5:15 were mixed evenly, and an esterification reaction was carried out at 35°C for 5 hours. During the reaction, the pH was controlled to be 8, and the mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0061] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1:1:0.6:100 are uniformly mixed to obtain a coating material.

[0062] The concentration of hydrogen peroxide is 16wt%.

[0063] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0064] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0065] (1) Weigh the raw materials according to the ratio, add water 13 times the total mass of the raw materials, boil at 80° C. for 100 min, filter, add water 8 times the total mass of the raw materials to the filter residue, boil at 60° C. for 70 min, combine the filtrates of the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and vacuum dry to obtain a traditional Chinese medicine composition;

[0066] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0067] The vacuum drying conditions are: -100 KPa, 65° C., and vacuum drying for 20 h.

[0068] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0069] Example 4

[0070] The present embodiment provides a repair material for DMD atrophy muscle, comprising a traditional Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the traditional Chinese medicine composition comprises the following raw materials in mass parts: the traditional Chinese medicine composition comprises the following raw materials in mass parts: 5 parts of Rhodiola rosea, 20 parts of Astragalus, 1 part of Licorice, 13 parts of Salvia miltiorrhiza, 2 parts of Bupleurum, 13 parts of Panax notoginseng, 1 part of Toosendan fruit, 15 parts of Dendrobium, 3 parts of Lycium barbarum, 4 parts of Angelica sinensis, 17 parts of Citron, 1 part of Citrus aurantium, 12 parts of Citrus aurantium, 1 part of Cibotium barbarum, 10 parts of Angelica dahurica, 1 part of Clematis, 1 part of Gentiana macrophylla and 15 parts of Astragalus membranaceus.

[0071] The preparation method of the coating material comprises the following steps:

[0072] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0073] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0074] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0075] The concentration of hydrogen peroxide is 17wt%.

[0076] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0077] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0078] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0079] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0080] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0081] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0082] Example 5

[0083] The present embodiment provides a repair material for DMD atrophy muscle, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:19; wherein the composition comprises 10 parts of Rhodiola rosea, 14 parts of Astragalus, 10 parts of Licorice, 8 parts of Salvia miltiorrhiza, 10 parts of Bupleurum, 10 parts of Panax notoginseng, 8 parts of Toosendan fruit, 9 parts of Dendrobium, 11 parts of Lycium barbarum, 12 parts of Angelica sinensis, 10 parts of Citron, 7 parts of Citrus aurantium, 8 parts of Citrus aurantium, 6 parts of Cibotium barometz, 7 parts of Angelica dahurica, 8 parts of Clematis chinensis, 7 parts of Gentiana macrophylla and 11 parts of Astragalus membranaceus.

[0084] The preparation method of the coating material comprises the following steps:

[0085] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0086] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0087] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0088] The concentration of hydrogen peroxide is 16wt%.

[0089] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0090] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0091] (1) Weigh the raw materials according to the ratio, add water 13 times the total mass of the raw materials, boil at 80° C. for 100 min, filter, add water 8 times the total mass of the raw materials to the filter residue, boil at 60° C. for 70 min, combine the filtrates of the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and vacuum dry to obtain a traditional Chinese medicine composition;

[0092] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0093] The vacuum drying conditions are: -100 KPa, 65° C., and vacuum drying for 20 h.

[0094] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0095] Example 6

[0096] The difference between this embodiment and embodiment 1 is that the raw material ratios of the Chinese medicine composition are different.

[0097] This comparative example provides a repair material for DMD atrophy muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 13 parts of Rhodiola rosea, 3 parts of Astragalus, 3 parts of Licorice, 2 parts of Salvia miltiorrhiza, 3 parts of Bupleurum, 4 parts of Panax notoginseng, 7 parts of Toosendan fruit, 1 part of Dendrobium, 3 parts of Lycium barbarum, 6 parts of Angelica sinensis, 13 parts of Citron, 11 parts of Citrus aurantium, 12 parts of Citrus aurantium, 10 parts of Cibotium barometz, 9 parts of Angelica dahurica, 11 parts of Clematidis, 4 parts of Gentiana macrophylla and 13 parts of Astragalus membranaceus.

[0098] The preparation method of the coating material comprises the following steps:

[0099] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0100] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0101] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0102] The concentration of hydrogen peroxide is 17wt%.

[0103] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0104] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0105] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0106] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0107] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0108] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0109] Example 7

[0110] The difference between this embodiment and embodiment 1 is that the raw material ratios of the Chinese medicine composition are different.

[0111] This comparative example provides a repair material for DMD atrophy muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 7 parts of Rhodiola rosea, 5 parts of Astragalus, 12 parts of Licorice, 3 parts of Salvia miltiorrhiza, 12 parts of Bupleurum, 4 parts of Panax notoginseng, 3 parts of Toosendan fruit, 13 parts of Dendrobium, 5 parts of Lycium barbarum, 6 parts of Angelica sinensis, 7 parts of Citron, 2 parts of Citrus aurantium, 4 parts of Citronella, 2 parts of Angelica dahurica, 1 part of Angelica dahurica, 10 parts of Clematis, 8 parts of Gentiana macrophylla and 3 parts of Astragalus membranaceus.

[0112] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0113] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0114] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0115] The concentration of hydrogen peroxide is 17wt%.

[0116] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0117] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0118] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0119] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0120] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0121] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0122] Example 8

[0123] The difference between this embodiment and embodiment 1 is that the raw material ratios of the Chinese medicine composition are different.

[0124] This comparative example provides a repair material for DMD atrophy muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 6 parts of Rhodiola rosea, 3 parts of Astragalus, 12 parts of Licorice, 10 parts of Salvia miltiorrhiza, 4 parts of Bupleurum, 4 parts of Panax notoginseng, 12 parts of Toosendan fruit, 11 parts of Dendrobium, 4 parts of Lycium barbarum, 15 parts of Angelica sinensis, 3 parts of Citron, 8 parts of Citrus aurantium, 5 parts of Citrus aurantium, 6 parts of Cibotium barbarum, 5 parts of Angelica dahurica, 9 parts of Clematidis, 8 parts of Gentiana macrophylla and 11 parts of Astragalus membranaceus.

[0125] The preparation method of the coating material comprises the following steps:

[0126] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0127] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0128] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0129] The concentration of hydrogen peroxide is 17wt%.

[0130] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0131] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0132] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0133] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0134] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0135] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0136] Example 9

[0137] The difference between this embodiment and embodiment 1 is that the raw material ratios of the Chinese medicine composition are different.

[0138] The present embodiment provides a repair material for DMD atrophy muscle, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 18 parts of Rhodiola rosea, 18 parts of Astragalus, 2 parts of Licorice, 5 parts of Salvia miltiorrhiza, 2 parts of Bupleurum, 12 parts of Panax notoginseng, 3 parts of Toosendan fruit, 5 parts of Dendrobium, 17 parts of Lycium barbarum, 5 parts of Angelica sinensis, 12 parts of Citron, 4 parts of Citrus aurantium, 12 parts of Citrus aurantium, 3 parts of Citronella, 2 parts of Angelica dahurica, 7 parts of Clematis, 2 parts of Gentiana macrophylla and 11 parts of Astragalus membranaceus.

[0139] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0140] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0141] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0142] The concentration of hydrogen peroxide is 17wt%.

[0143] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0144] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0145] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0146] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0147] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0148] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0149] Comparative Example 1

[0150] The difference between this comparative example and Example 1 is that only Rhodiola rosea is used as the raw material.

[0151] This comparative example provides a repair material for DMD atrophic muscle, comprising a Rhodiola rosea extract and a coating material in a mass ratio of 1:18;

[0152] The preparation method of the coating material comprises the following steps:

[0153] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0154] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0155] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0156] The concentration of hydrogen peroxide is 17wt%.

[0157] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0158] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0159] (1) Weigh the Rhodiola rosea raw material, add 14 times the weight of the raw material water, boil at 85°C for 110 min, filter, add 9 times the weight of the raw material water to the filter residue, boil at 65°C for 80 min, combine the two decoction filtrates, concentrate under reduced pressure to a relative density of 1.1, and vacuum dry to obtain the Rhodiola rosea extract;

[0160] (2) The Rhodiola rosea extract and the coating material are mixed in proportion, processed by a microencapsulation granulator, and dried to obtain a repair material for DMD atrophied muscles.

[0161] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0162] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0163] Comparative Example 2

[0164] The difference between this comparative example and Example 1 is that the coating material is hydroxypropyl distarch phosphate.

[0165] This comparative example provides a repair material for DMD atrophy muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 13 parts of Rhodiola rosea, 10 parts of Astragalus, 8 parts of Licorice, 6 parts of Salvia miltiorrhiza, 8 parts of Bupleurum, 7 parts of Panax notoginseng, 5 parts of Toosendan fruit, 6 parts of Dendrobium, 9 parts of Lycium barbarum, 11 parts of Angelica sinensis, 7 parts of Citron, 5 parts of Citrus aurantium, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica dahurica, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica pubescens, 6 parts of Clematidis, 4 parts of Gentiana macrophylla and 9 parts of Astragalus membranaceus.

[0166] The preparation method of the coating material comprises the following steps: uniformly mixing hydroxypropyl distarch phosphate and water in a mass ratio of 3.1:100 to obtain the coating material.

[0167] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0168] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0169] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0170] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0171] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0172] Comparative Example 3

[0173] The difference between this comparative example and Example 1 is that the coating material is modified hydroxypropyl distarch phosphate.

[0174] This comparative example provides a repair material for DMD atrophy muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 13 parts of Rhodiola rosea, 10 parts of Astragalus, 8 parts of Licorice, 6 parts of Salvia miltiorrhiza, 8 parts of Bupleurum, 7 parts of Panax notoginseng, 5 parts of Toosendan fruit, 6 parts of Dendrobium, 9 parts of Lycium barbarum, 11 parts of Angelica sinensis, 7 parts of Citron, 5 parts of Citrus aurantium, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica dahurica, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica pubescens, 6 parts of Clematidis, 4 parts of Gentiana macrophylla and 9 parts of Astragalus membranaceus.

[0175] The preparation method of the coating material comprises the following steps:

[0176] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0177] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0178] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 1.5:1:0.5:100 are mixed evenly to obtain a coating material.

[0179] The concentration of hydrogen peroxide is 17wt%.

[0180] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0181] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0182] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0183] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0184] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0185] Comparative Example 4

[0186] The difference between this comparative example and Example 1 is that the ratios of modified hydroxypropyl distarch phosphate, water-soluble chitosan and dextrin are different.

[0187] This comparative example provides a repair material for DMD atrophy muscles, comprising a Chinese medicine composition and a coating material in a mass ratio of 1:18; wherein the Chinese medicine composition comprises the following raw materials in mass parts: 13 parts of Rhodiola rosea, 10 parts of Astragalus, 8 parts of Licorice, 6 parts of Salvia miltiorrhiza, 8 parts of Bupleurum, 7 parts of Panax notoginseng, 5 parts of Toosendan fruit, 6 parts of Dendrobium, 9 parts of Lycium barbarum, 11 parts of Angelica sinensis, 7 parts of Citron, 5 parts of Citrus aurantium, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica dahurica, 6 parts of Citrus aurantium, 4 parts of Cibotium barometz, 5 parts of Angelica pubescens, 6 parts of Clematidis, 4 parts of Gentiana macrophylla and 9 parts of Astragalus membranaceus.

[0188] The preparation method of the coating material comprises the following steps:

[0189] (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:7:0.4, react at 53°C for 4 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate;

[0190] (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 4:1:7:13 were mixed evenly, and the mixture was subjected to esterification reaction at 37°C for 4 hours. During the reaction, the pH was controlled to be 8.2. The mixture was centrifuged and washed to obtain modified hydroxypropyl distarch phosphate;

[0191] (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water in a mass ratio of 0.5:0.5:2:100 are uniformly mixed to obtain a coating material.

[0192] The concentration of hydrogen peroxide is 17wt%.

[0193] The water-soluble chitosan has a deacetylation degree of >85%. It was purchased from Xi'an Bangqi Huiju Information Technology Co., Ltd. The dextrin was purchased from Jinan Shengxuan Chemical Co., Ltd.

[0194] The preparation method of the repair material of DMD atrophied muscle comprises the following steps:

[0195] (1) Weigh the raw materials according to the ratio, add water 14 times the total weight of the raw materials, boil at 85°C for 110 minutes, filter, add water 9 times the total weight of the raw materials to the filter residue, boil at 65°C for 80 minutes, combine the filtrates from the two decoctions, concentrate under reduced pressure to a relative density of 1.1, and dry in vacuum to obtain a traditional Chinese medicine composition;

[0196] (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

[0197] The vacuum drying conditions are: -100 KPa, 63° C., and vacuum drying for 19 h.

[0198] The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.

[0199] Performance Testing

[0200] Dosage:

[0201] 1. 5-6 week old dystrophin- / utrophin-gene double knockout C57BL / 6 mice were randomly divided into 20 mice in each group, and the repaired materials of Examples 1 to 9 and Comparative Example 1 were gavaged orally, and the model group was gavaged orally with pure water. 20 wild-type mice of the same litter were selected as the normal group and gavaged orally with pure water.

[0202] The repair materials prepared in Examples 1 to 9 and Comparative Example 1 were dissolved in water and gavaged once a day for 5 weeks at a dose of 10 g of crude drug / kg of mouse. The normal group and the model group were gavaged with pure water.

[0203] (1) Changes in the body weight of mice before and after administration. See Table 1 for details.

[0204] Table 1 Body weight changes before and after administration (unit: g)

[0205] Body weight before administration Body weight after administration Normal group 17.53±2.10 28.20±1.48 Model Group 17.21±1.01 19.94±1.65 Example 1 17.01±1.18 26.96±2.21 Example 2 17.15±1.33 26.63±2.47 Example 3 16.93±1.25 26.15±2.33 Example 4 17.19±1.36 23.12±2.45 Example 5 17.35±1.12 25.81±2.54 Example 6 17.01±1.14 23.62±2.40 Example 7 16.98±1.10 22.74±2.19 Example 8 17.05±1.09 23.57±2.05 Example 9 17.22±1.26 22.19±2.13 Comparative Example 1 17.18±1.17 20.42±2.26

[0206] (2) Changes in kyphosis index: The whole-body X-rays of the experimental animals were captured by a special scanner, and the ratio between the L1 and L2 lumbar segments of the spine was measured. The smaller the value, the more obvious the progression of kyphosis, thereby judging the improvement of muscle loss. See Table 2 for details.

[0207] Table 2 Changes in kyphosis index before and after administration

[0208] Kyphosis index before drug administration Kyphosis index after drug administration Normal group 6.23±0.34 6.47±0.80 Model Group 3.36±0.23 3.12±0.52 Example 1 3.20±0.30 5.53±0.76 Example 2 3.32±0.28 5.34±0.63 Example 3 3.47±0.17 5.22±0.45 Example 4 3.26±0.25 4.50±0.57 Example 5 3.39±0.34 5.02±0.48 Example 6 3.40±0.26 4.53±0.52 Example 7 3.31±0.31 4.41±0.49 Example 8 3.24±0.19 4.52±0.41 Example 9 3.23±0.16 4.54±0.67 Comparative Example 1 3.39±0.22 3.71±0.34

[0209] (3) Serum creatine kinase level: In patients with Duchenne muscular dystrophy, serum creatine kinase level is positively correlated with the percentage of muscle necrosis area. By analyzing the tail vein serum using a biochemical automatic analyzer, the serum creatine kinase concentration in each group of mice can be quantified to determine the improvement of muscle loss by the Chinese medicine composition. See Table 3 for details.

[0210] Table 3 Serum creatine kinase levels before and after administration (unit: IU / K)

[0211] Serum creatine kinase level before administration Serum creatine kinase level after drug administration Normal group 2557.34±129.54 2682.21±145.12 Model Group 3471.29±125.42 3591.35±164.29 Example 1 3459.53±120.45 2759.18±154.64 Example 2 3408.40±139.53 2819.23±160.67 Example 3 3400.46±152.58 2823.61±149.65 Example 4 3454.93±142.41 3252.18±152.81 Example 5 3325.43±152.50 3014.14±148.65 Example 6 3333.76±150.16 3201.84±154.63 Example 7 3401.58±149.11 3153.37±132.21 Example 8 3413.91±142.97 3298.03±135.60 Example 9 3429.27±153.13 3194.11±149.68 Comparative Example 1 3430.65±125.19 3319.42±157.26

[0212] Body weight measurement is one of the basic behavioral experiments for evaluating the muscle function of animals (especially rodents). The results show that the repairs prepared in Examples 1 to 9 of the present invention can increase the weight of mice to varying degrees after continuous administration for 5 weeks. The repairs prepared in Examples 1 to 3 of the present invention can significantly restore the kyphosis index, improve the spinal curvature of mice, and maintain muscle function. It can be seen from Example 5 that the efficacy of Rhodiola rosea will be reduced when the content in the system is less than 8%.

[0213] 2. Constant temperature test: The repaired product and the Chinese medicine composition prepared in Example 1 and the repaired products prepared in Comparative Examples 2 to 4 were sealed and stored away from light at 25°C for 6 months, and then administered according to the above method. See Table 4 for details.

[0214] Table 4 Effects after 6 months of constant temperature storage

[0215] Kyphosis index before drug administration Kyphosis index after drug administration Serum creatine kinase level before administration IU / K Serum creatine kinase level after administration IU / K Chinese medicine composition 3.15±0.24 4.04±0.52 3462.13±114.54 3213.53±142.50 Example 1 3.18±0.28 5.51±0.63 3442.14±115.57 2714.11±144.49 Comparative Example 2 3.20±0.29 4.56±0.67 3396.26±123.58 3061.63±139.52 Comparative Example 3 3.25±0.20 4.87±0.56 3401.50±121.43 2984.42±149.25 Comparative Example 4 3.17±0.31 5.21±0.65 3413.55±120.41 2853.14±140.56

[0216] 3. Temperature change test: The repaired product and the Chinese medicine composition prepared in Example 1 and the repaired products prepared in Comparative Examples 2 to 4 were sealed and stored in dark at 5°C, 25°C and 40°C for one month, for two cycles in total. After 6 months, the drugs were administered according to the above method. See Table 5 for details.

[0217] Table 5 Effects of variable temperature storage for 6 months

[0218] Kyphosis index before drug administration Kyphosis index after drug administration Serum creatine kinase level before administration IU / K Serum creatine kinase level after administration IU / K Chinese medicine composition 3.21±0.18 3.66±0.39 3462.73±120.42 3243.02±154.37 Example 1 3.31±0.21 5.49±0.43 3442.14±115.51 2798.09±140.54 Comparative Example 2 3.17±0.17 4.36±0.30 3396.91±115.36 3161.62±154.23 Comparative Example 3 3.15±0.15 4.64±0.47 3401.52±119.65 3024.11±153.42 Comparative Example 4 3.24±0.23 5.01±0.35 3413.35±117.28 2954.25±141.60

[0219] The results show that the storage performance of the repair material of Example 1 of the present invention is good, and the storage performance decreases to varying degrees when the wrapping material is changed.

[0220] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A repair material for DMD atrophied muscles, characterized in that: The invention comprises a Chinese medicine composition and a coating material in a mass ratio of 1:16-19; wherein the Chinese medicine composition is made of the following raw materials in mass parts: 5-20 parts of Rhodiola rosea, 2-20 parts of Astragalus, 1-15 parts of Licorice, 1-13 parts of Salvia miltiorrhiza, 2-15 parts of Bupleurum, 3-13 parts of Panax notoginseng, 1-14 parts of Toosendan fruit, 1-15 parts of Dendrobium, 3-20 parts of Lycium barbarum, 4-18 parts of Angelica sinensis, 2-17 parts of Citron, 1-11 parts of Citrus aurantium, 1-12 parts of Citronella, 1-10 parts of Cibotium barbarum, 1-10 parts of Angelica dahurica, 1-10 parts of Angelica dahurica, 1-12 parts of Clematis chinensis, 1-10 parts of Gentiana macrophylla and 1-15 parts of Astragalus membranaceus.

2. The repair material for DMD atrophied muscle according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by mass: 10-17 parts of rhodiola rosea, 7-14 parts of astragalus, 4-10 parts of liquorice, 3-8 parts of salvia miltiorrhiza, 6-10 parts of bupleurum, 5-10 parts of notoginseng, 3-8 parts of toosendan fruit, 4-9 parts of dendrobium, 5-11 parts of wolfberry, 8-12 parts of angelica, 4-10 parts of citron, 3-7 parts of aurantium, 3-8 parts of green peel, 2-6 parts of citronella, 2-7 parts of angelica pubescens, 3-8 parts of clematis, 2-7 parts of gentiana macrophylla and 4-11 parts of astragalus.

3. The repair material for DMD atrophied muscle according to claim 2, characterized in that: 13 parts of Rhodiola rosea, 10 parts of Astragalus, 8 parts of Licorice, 6 parts of Salvia miltiorrhiza, 8 parts of Bupleurum, 7 parts of Panax notoginseng, 5 parts of Toosendan Fructus, 6 parts of Dendrobium, 9 parts of Lycium barbarum, 11 parts of Angelica sinensis, 7 parts of Citron, 5 parts of Fructus Aurantii Immaturus, 6 parts of Pericarpium Cibotii, 4 parts of Cibotium barometz, 5 parts of Angelica dahurica, 6 parts of Clematidis, 4 parts of Gentiana macrophylla and 9 parts of Astragalus.

4. The repair material for DMD atrophied muscle according to claim 3, characterized in that: The mass percentage of the Rhodiola rosea in the raw materials of the traditional Chinese medicine composition is greater than 8%.

5. The repair material for DMD atrophied muscle according to claim 1, characterized in that: The preparation method of the coating material comprises the following steps: (1) Mix hydroxypropyl distarch phosphate, water and hydrogen peroxide in a mass ratio of 1:5-8:0.3-0.5, react at 50-55°C for 3-5 hours, and dry to obtain oxidized hydroxypropyl distarch phosphate; (2) Under a nitrogen atmosphere, oxidized hydroxypropyl distarch phosphate, octenyl succinic anhydride, ethanol and water in a mass ratio of 3-5:1:5-10:10-15 are mixed evenly, and an esterification reaction is carried out at 35-40° C. for 3-5 hours. During the reaction, the pH is controlled to be 8-8.5, and the mixture is centrifuged and washed to obtain modified hydroxypropyl distarch phosphate; (3) Modified hydroxypropyl distarch phosphate, water-soluble chitosan, dextrin and water are uniformly mixed in a mass ratio of 1-2:1:0.4-0.6:100 to obtain a coating material.

6. The repair material for DMD atrophied muscle according to claim 5, characterized in that: The concentration of hydrogen peroxide is 16-18wt%.

7. The method for preparing a repair material for DMD atrophied muscle according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Weigh the raw materials according to the ratio, add water in an amount of 13 to 15 times the total weight of the raw materials, boil at 80 to 90° C. for 100 to 120 minutes, filter, add water in an amount of 8 to 10 times the total weight of the raw materials to the filter residue, boil at 60 to 70° C. for 70 to 90 minutes, combine the filtrates of the two decoctions, concentrate under reduced pressure, and dry in a vacuum to obtain a traditional Chinese medicine composition; (2) The Chinese medicine composition and the coating material are mixed according to a certain proportion, processed by a microencapsulation granulator, and then dried to obtain a repair material for DMD atrophic muscle.

8. The method for preparing a repair material for DMD atrophied muscle according to claim 7, characterized in that: Concentrate under reduced pressure to a relative density of 1.1~1.

2.

9. The method for preparing a repair material for DMD atrophied muscle according to claim 8, characterized in that: The vacuum drying conditions are: -100 KPa, 60-65° C., vacuum drying for 18-20 hours.

10. The method for preparing a repair material for DMD atrophied muscle according to claim 8, characterized in that: The vibration frequency of the microcapsule granulator was 1500 Hz, the electrode voltage was 600 V, the air pressure was 200 mbar, the nozzle diameter was 500 μm, and the flow rate was 10 mL / min.