Traditional Chinese medicine composition for treating cognitive hypofunction and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating cognitive hypofunction, and belongs to the technical field of traditional Chinese medicine compositions.The traditional Chinese medicine composition is prepared from, by mass, 60-70 parts of cereal powder, 25-35 parts of active effective ingredients and 3-5 parts of additives, the traditional Chinese medicine composition comprises the following raw materials: 6-10 parts of angelica sinensis, 6-10 parts of prepared rehmannia root, 6-9 parts of glossy privet fruit, 10-15 parts of lycium ruthenicum, 6-10 parts of semen cuscutae, 3-6 parts of radix curcumae, 3-5 parts of rhizoma acori graminei, 3-5 parts of pericarpium citri reticulatae, 3-6 parts of turmeric, 10-15 parts of poria with hostwood and 3-5 parts of semen brassicae. According to the invention, the idea of homology of medicine and food is adopted, and medicinal materials with different action mechanisms are selected to activate blood, tonify the kidney, clear the brain and the like, so that the comprehensive conditioning effect is realized. Traditional Chinese medicinal materials with homology of medicine and food are combined with cereal powder to prepare leisure food such as pastries and the like, the absorption efficiency is improved by adding vegetable fat (such as olive oil or linseed oil), and when people enjoy delicious food in daily leisure, early intervention can be realized, and the compliance and convenience of patients are improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for treating cognitive impairment and a preparation method thereof. Background Art

[0002] Cognitive impairment refers to a decline in an individual's ability in the cognitive field. Its manifestations may vary due to individual differences and specific reasons, but generally include the following aspects: 1. Decreased memory, difficulty remembering new information or recalling old information. 2. Difficulty concentrating, easily distracted, and difficulty focusing on a task. 3. Weakened language ability, difficulty finding words, and unclear expression. 4. Executive dysfunction, decreased ability to plan, organize, and complete tasks. 5. Spatial perception disorder, difficulty identifying and locating objects. 6. Decreased judgment.

[0003] Cognitive impairment may be caused by a variety of reasons, including physiological reasons, such as the natural decline of brain function with age, leading to cognitive impairment; pathological reasons, such as Alzheimer's disease, Parkinson's disease, cerebrovascular disease, diabetes, hypertension and other diseases, as well as external factors such as brain trauma, infection, and poisoning. Among them, post-stroke cognitive impairment (PSCI) refers to various types and degrees of cognitive dysfunction caused by acute cerebrovascular disease, which is an important part of vascular cognitive impairment. Clinical symptoms of PSCI are divided into post-stroke non-dementia cognitive impairment (PS-VCINI) and post-stroke dementia (PSD). According to research, the incidence of PSCI and brain PSD is about 60% and 25% 3 months after stroke.

[0004] Current drug treatments include cholinesterase inhibitors, non-competitive N-methyl-D-aspartate receptor antagonists, and other drugs. For example, donepezil can improve the patient's wire-joining test and MMSE scores; galantamine can improve the patient's behavioral scores, but gastrointestinal adverse reactions may occur; memantine can improve the degree of aphasia after stroke; and patients can also use calf blood protein-free extract for treatment, which may improve their cognitive function.

[0005] Alzheimer's disease has a great impact on patients, especially cognitive dysfunction after stroke has a greater impact on patients than physical dysfunction. It not only reduces the quality of life of stroke patients, but also brings serious psychological and economic burdens to their families and society. More and more scholars and medical staff advocate the importance of early intervention for Alzheimer's disease and PSCI. The early addition of traditional Chinese medicine to treat Alzheimer's disease and PSCI has significant efficacy and few side effects, which is worthy of clinical promotion and application. Summary of the invention

[0006] The present invention aims to provide a Chinese medicine composition for treating cognitive impairment and a preparation method thereof, adopts the idea of ​​medicine and food being of the same origin for food therapy, emphasizes the combination of the nutritional value of food with the efficacy of Chinese medicine, promotes health, alleviates diseases, reduces the patient's resistance to taking medicine, and increases the patient's compliance and convenience in taking medicine.

[0007] The technical solution adopted by the present invention to achieve its purpose is as follows:

[0008] A traditional Chinese medicine composition for treating cognitive impairment comprises, by weight, 60-70 parts of cereal powder, 25-35 parts of active ingredients, and 3-5 parts of additives. The active ingredients are calculated by weight, and the raw materials include 6-10 parts of angelica sinensis, 6-10 parts of rehmannia root, 6-9 parts of glossy privet fruit, 10-15 parts of black wolfberry, 6-10 parts of dodder seed, 3-6 parts of curcuma, 3-5 parts of calamus, 3-5 parts of tangerine peel, 3-6 parts of turmeric, 10-15 parts of poria, and 3-5 parts of white mustard seeds.

[0009] Preferably, the cereal flour comprises one or any combination of rice flour, glutinous rice flour, oat flour, millet flour, buckwheat flour and quinoa flour.

[0010] Preferably, the additives include sweeteners and vegetable oils.

[0011] Preferably, the active ingredients are embedded with gum arabic, soybean polysaccharide and sodium alginate.

[0012] Preferably, the active ingredients are enzymatically treated with a composite enzyme, wherein the composite enzyme is cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase, and neutral protease, and the mass ratio is 1:0.5:0.2:1.

[0013] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0014] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, tangerine peel, turmeric, Poria and white mustard, add water for water extraction, concentrate the water extract into a thick paste with a relative density of 1.3-1.4, freeze-dried into powder, and set aside;

[0015] S2. The drug residue after water extraction is ultrafinely crushed, and then water and complex enzyme are added for enzymolysis to obtain an enzymatic solution, and the enzymatic solution is ultrasonically treated for 20-30min, filtered, concentrated and dried to obtain an enzymatic powder;

[0016] S3. Take gum arabic, soybean polysaccharide and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2, stir and mix, spray dry to obtain an embedded powder;

[0017] S4. Mix the grain powder, embedding powder and additives, and steam them into cakes to obtain the product.

[0018] Preferably, in step S1, the conditions for water extraction are: the amount of water is 3-5 times that of the traditional Chinese medicine composition, the water extraction temperature is 80-90°C, the water extraction time is 0.5-1h, and the number of water extractions is 2-3 times.

[0019] Preferably, in step S2, the complex enzyme is composed of cellulase, L-cysteine ​​binding protease, polyphenol oxidase and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the complex enzyme is 0.6-0.8%, the enzymolysis temperature is 40-60°C, the enzymolysis time is 1-2h, and the enzymolysis pH is 6-7.

[0020] Preferably, in step S3, the mass ratio of embedding agent to powder is 2:1, the embedding agent concentration is 10-15%, the embedding agent is composed of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6, and the obtained embedding powder is crushed to 30-50 μm.

[0021] Preferably, the temperature of the hot air flow for spray drying is set to 140-160° C., and the spray drying time is set to 5-8 min.

[0022] The beneficial effects of the present invention are:

[0023] The present invention adopts the concept of medicine and food being of the same origin, and achieves the effect of comprehensive conditioning by selecting medicinal materials with different mechanisms of action to activate blood circulation, tonify the kidney, and clear the brain. The Chinese medicinal materials with the same origin of medicine and food are used together with grain flour to prepare snack foods such as cakes, and the absorption efficiency is improved by adding vegetable oils (such as olive oil or linseed oil). Early intervention can be achieved while enjoying food in daily leisure time, cognitive function can be improved, and patient compliance and convenience can be improved.

[0024] The angelica, rehmannia root and black wolfberry in the present invention nourish the liver and kidney and replenish blood; the fructus ligustris and the cuscuta seed have the effect of nourishing the kidney and replenishing essence, and are helpful to improve cognitive function; the turmeric and the calamus have the effects of opening the orifices and refreshing the mind, promoting qi and relieving depression, and are especially effective in improving cognitive function decline and mood disorders; the tangerine peel, turmeric, white mustard and the like can promote qi and blood circulation, open the orifices, and are helpful to improve brain blood circulation; the poria has the effect of calming the mind and stabilizing the mind, and is helpful to improve sleep disorders and anxiety.

[0025] The present invention uses gum arabic, soybean polysaccharide and sodium alginate as embedding agents to embed active effective ingredients, which can improve the stability of ingredients and prevent the degradation of effective ingredients of medicinal materials during storage and processing; it can mask the bitter taste, reduce the irritation of the drug, and improve the patient's acceptance and compliance and taste by combining with grain powder; it can also control the release of the drug to make it last longer in the body. The embedding process can significantly improve the application value of the medicine-food homology formula and improve its stability and bioavailability.

[0026] The present invention uses cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase and neutral protease in a mass ratio of 1:0.5:0.2:1 as a composite enzyme, and performs enzymolysis on the drug residue after water extraction again, fully extracts the effective components of the Chinese medicinal materials, and expands the types of effective substances. For example, after water extraction of black wolfberry, enzymolysis treatment is performed, and when HPLC (high performance liquid chromatography) is detected, the content of the active ingredient increases by about 5%. Enzymolysis after water extraction can reduce the amount of composite enzyme used and reduce costs. DETAILED DESCRIPTION

[0027] The present invention is described in detail below in conjunction with specific embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work should belong to the scope of protection of the present invention. 1. Specific embodiments

[0029] Example 1

[0030] A Chinese medicine composition for treating cognitive impairment, comprising 47 parts of rice flour, 23 parts of glutinous rice flour, 25 parts of active ingredients, 2 parts of honey, and 3 parts of linseed oil, wherein the active ingredients, by weight, include 8 parts of angelica, 8 parts of Rehmannia glutinosa, 7 parts of Ligustrum lucidum, 12 parts of black wolfberry, 8 parts of Cuscuta australis, 5 parts of Curcuma aromatica, 4 parts of Acorus calamus, 4 parts of dried orange peel, 5 parts of Curcuma longa, 12 parts of Poria, and 4 parts of Sinapis alba. The active ingredients are enzymatically treated with a composite enzyme composed of cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1; and the active ingredients are embedded in an embedding agent composed of gum arabic, soybean polysaccharide, and sodium alginate.

[0031] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0032] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 80 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0033] S2. The drug residue after water extraction was ultrafinely ground, and then 5 times water and a composite enzyme were added for enzymolysis to obtain an enzymolysis solution, wherein the composite enzyme was composed of cellulase, L-cysteine-binding protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the composite enzyme was 0.8%, the enzymolysis temperature was 50 ° C, the enzymolysis time was 1.5h, the enzymolysis pH was 6.5, and the enzymolysis solution was ultrasonically treated for 30min, filtered, concentrated and dried to obtain an enzymolysis powder;

[0034] S3. Take gum arabic, soybean polysaccharide and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2, the mass ratio of the embedding agent to the powder is 2:1, the embedding agent concentration is 15%, and the embedding agent is composed of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6, stir and mix, spray dry at 150°C for 7min, obtain embedding powder, and grind the obtained embedding powder into 30-50μm;

[0035] S4. Mix the cereal flour, embedding powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake. The product is obtained.

[0036] Example 2

[0037] A Chinese medicine composition for treating cognitive impairment, comprising 40 parts of rice flour, 20 parts of glutinous rice flour, 35 parts of active ingredients, 2 parts of honey, and 3 parts of linseed oil, wherein the active ingredients, by weight, include 6 parts of angelica sinensis, 6 parts of Rehmannia glutinosa, 6 parts of Ligustrum lucidum, 10 parts of black wolfberry, 6 parts of Cuscuta australis, 3 parts of Curcuma aromatica, 3 parts of Acorus calamus, 3 parts of dried orange peel, 3 parts of Curcuma longa, 10 parts of Poria cocos, and 3 parts of white mustard. The active ingredients are enzymatically treated with a composite enzyme composed of cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1; the active ingredients are embedded in an embedding agent composed of gum arabic, soybean polysaccharide, and sodium alginate.

[0038] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0039] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 90 ° C, water extraction time 0.5h, water extraction times 3 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0040] S2. The drug residue after water extraction was ultrafinely ground, and then 5 times water and a composite enzyme were added for enzymolysis to obtain an enzymolysis solution, wherein the composite enzyme was composed of cellulase, L-cysteine-binding protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the composite enzyme was 0.6%, the enzymolysis temperature was 40 ° C, the enzymolysis time was 2h, the enzymolysis pH was 7, and the enzymolysis solution was ultrasonically treated for 30min, filtered, concentrated and dried to obtain an enzymolysis powder;

[0041] S3. Take gum arabic, soybean polysaccharide and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2, the mass ratio of the embedding agent to the powder is 2:1, the embedding agent concentration is 10%, the embedding agent is composed of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6, stir and mix, spray dry at 140°C for 8min to obtain an embedding powder, and grind the obtained embedding powder to 30-50μm;

[0042] S4. Mix the cereal flour, embedding powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake. The product is obtained.

[0043] Example 3

[0044] A Chinese medicine composition for treating cognitive impairment, comprising 45 parts of rice flour, 20 parts of glutinous rice flour, 30 parts of active ingredients, 3 parts of honey, and 2 parts of linseed oil, wherein the active ingredients, by weight, include 10 parts of angelica sinensis, 10 parts of Rehmannia glutinosa, 9 parts of Ligustrum lucidum, 15 parts of Lycium barbarum, 10 parts of Cuscuta australis, 6 parts of Curcuma aromatica, 5 parts of Acorus calamus, 5 parts of dried orange peel, 6 parts of Curcuma longa, 15 parts of Poria cocos, and 5 parts of Sinapis alba. The active ingredients are enzymatically treated with a composite enzyme composed of cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1; and the active ingredients are embedded in an embedding agent composed of gum arabic, soybean polysaccharide, and sodium alginate.

[0045] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0046] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 85 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0047] S2. The drug residue after water extraction was ultrafinely ground, and then 5 times water and a composite enzyme were added for enzymolysis to obtain an enzymolysis solution, wherein the composite enzyme was composed of cellulase, L-cysteine-binding protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the composite enzyme was 0.7%, the enzymolysis temperature was 60 ° C, the enzymolysis time was 1h, the enzymolysis pH was 6, and the enzymolysis solution was ultrasonically treated for 30min, filtered, concentrated and dried to obtain an enzymolysis powder;

[0048] S3. Take gum arabic, soybean polysaccharide and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2, the mass ratio of the embedding agent to the powder is 2:1, the embedding agent concentration is 12%, and the embedding agent is composed of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6, stir and mix, spray dry at 160°C for 5min, obtain embedding powder, and grind the obtained embedding powder into 30-50μm;

[0049] S4. Mix the cereal flour, embedding powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake. The product is obtained.

[0050] Comparative Example 1

[0051] A Chinese medicine composition for treating cognitive impairment, comprising 47 parts of rice flour, 23 parts of glutinous rice flour, 25 parts of active ingredients, 2 parts of honey, and 3 parts of linseed oil, wherein the active ingredients, by weight, include 8 parts of angelica sinensis, 8 parts of Rehmannia glutinosa, 7 parts of Ligustrum lucidum, 12 parts of black wolfberry, 8 parts of Cuscuta australis, 5 parts of Curcuma aromatica, 4 parts of Acorus calamus, 4 parts of dried orange peel, 5 parts of Curcuma longa, 12 parts of Poria cocos, and 4 parts of Sinapis alba. The active ingredients are enzymatically treated with a composite enzyme consisting of cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1.

[0052] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0053] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 80 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0054] S2. The drug residue after water extraction was ultrafinely ground, and then 5 times water and a composite enzyme were added for enzymolysis to obtain an enzymolysis solution, wherein the composite enzyme was composed of cellulase, L-cysteine-binding protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the composite enzyme was 0.8%, the enzymolysis temperature was 50 ° C, the enzymolysis time was 1.5h, the enzymolysis pH was 6.5, and the enzymolysis solution was ultrasonically treated for 30min, filtered, concentrated and dried to obtain an enzymolysis powder;

[0055] S3. The powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2 are crushed to 30-50 μm;

[0056] S4. Mix the cereal flour, crushed powder, enzymatic powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake to obtain the product.

[0057] Comparative Example 2

[0058] A Chinese medicine composition for treating cognitive impairment, comprising 47 parts of rice flour, 23 parts of glutinous rice flour, 25 parts of active ingredients, 2 parts of honey, and 3 parts of linseed oil, wherein the active ingredients, by weight, include 8 parts of angelica, 8 parts of Rehmannia glutinosa, 7 parts of Ligustrum lucidum, 12 parts of black wolfberry, 8 parts of Cuscuta australis, 5 parts of Curcuma aromatica, 4 parts of Acorus calamus, 4 parts of dried orange peel, 5 parts of Curcuma longa, 12 parts of Poria, and 4 parts of white mustard. The active ingredients are embedded in an embedding agent composed of gum arabic, soybean polysaccharide, and sodium alginate.

[0059] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0060] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 80 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0061] S2. Gum arabic, soybean polysaccharide and sodium alginate were dissolved in water, and the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2 were added. The mass ratio of the embedding agent to the powder was 2:1, and the embedding agent concentration was 15%. The embedding agent consisted of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6. The mixture was stirred and spray-dried at 150°C for 7 minutes to obtain an embedding powder, which was crushed to 30-50 μm.

[0062] S4. Mix the cereal flour, embedding powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake. The product is obtained.

[0063] Comparative Example 3

[0064] A traditional Chinese medicine composition for treating cognitive impairment, comprising, by weight, 47 parts of rice flour, 23 parts of glutinous rice flour, 25 parts of active effective ingredients, 2 parts of honey, and 3 parts of linseed oil. The active effective ingredients, by weight, include 8 parts of angelica sinensis, 8 parts of rehmannia root, 7 parts of glossy privet fruit, 12 parts of black wolfberry, 8 parts of dodder seed, 5 parts of curcuma, 4 parts of calamus, 4 parts of tangerine peel, 5 parts of turmeric, 12 parts of poria, and 4 parts of white mustard seed.

[0065] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0066] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta chinensis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 80 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, crushed to 30-50μm, and set aside;

[0067] S2. Mix the cereal flour, powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make a cake to obtain the product.

[0068] Comparative Example 4

[0069] A Chinese medicine composition for treating cognitive impairment, comprising 47 parts of rice flour, 23 parts of glutinous rice flour, 25 parts of active ingredients, 2 parts of honey, and 3 parts of linseed oil, wherein the active ingredients, by weight, include 8 parts of angelica, 8 parts of Rehmannia glutinosa, 7 parts of Ligustrum lucidum, 12 parts of Lycium barbarum, 8 parts of Cuscuta australis, 5 parts of Curcuma aromatica, 4 parts of Acorus calamus, 4 parts of dried orange peel, 5 parts of Curcuma longa, 12 parts of Poria, and 4 parts of Sinapis alba. The active ingredients are enzymatically treated with a composite enzyme composed of cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1; and the active ingredients are embedded in an embedding agent composed of gum arabic and sodium alginate.

[0070] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0071] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 80 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0072] S2. The drug residue after water extraction was ultrafinely ground, and then 5 times water and a composite enzyme were added for enzymolysis to obtain an enzymolysis solution, wherein the composite enzyme was composed of cellulase, L-cysteine-binding protease, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the composite enzyme was 0.8%, the enzymolysis temperature was 50 ° C, the enzymolysis time was 1.5h, the enzymolysis pH was 6.5, and the enzymolysis solution was ultrasonically treated for 30min, filtered, concentrated and dried to obtain an enzymolysis powder;

[0073] S3. Take gum arabic and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolyzed powder obtained in step S2, the mass ratio of the embedding agent to the powder is 2:1, the embedding agent concentration is 15%, the embedding agent is composed of gum arabic and sodium alginate in a mass ratio of 1.4:0.6, stir and mix, spray dry at 150°C for 7min, obtain embedding powder, and crush the obtained embedding powder to 30-50μm;

[0074] S4. Mix the cereal flour, embedding powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake. The product is obtained.

[0075] Comparative Example 5

[0076] A Chinese medicine composition for treating cognitive impairment, comprising 47 parts of rice flour, 23 parts of glutinous rice flour, 25 parts of active ingredients, 2 parts of honey, and 3 parts of linseed oil, wherein the active ingredients, by weight, include 8 parts of angelica sinensis, 8 parts of Rehmannia glutinosa, 7 parts of Ligustrum lucidum, 12 parts of Lycium barbarum, 8 parts of Cuscuta australis, 5 parts of Curcuma aromatica, 4 parts of Acorus calamus, 4 parts of dried orange peel, 5 parts of Curcuma longa, 12 parts of Poria cocos, and 4 parts of Sinapis alba. The active ingredients are enzymolyzed by a composite enzyme composed of cellulase, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.2:1; and the active ingredients are embedded in an embedding agent composed of gum arabic, soybean polysaccharide, and sodium alginate.

[0077] A method for preparing a Chinese medicine composition for treating cognitive impairment comprises the following steps:

[0078] S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, dried orange peel, turmeric, Poria and white mustard, add 3 times water for water extraction, water extraction temperature 80 ° C, water extraction time 1h, water extraction times 2 times, the water extracts are combined and concentrated into a thick paste with a relative density of 1.3, freeze-dried into powder, and set aside;

[0079] S2. The drug residue after water extraction was ultrafinely ground, and then 5 times water and a composite enzyme were added for enzymolysis to obtain an enzymolysis solution, wherein the composite enzyme was composed of cellulase, polyphenol oxidase, and neutral protease in a mass ratio of 1:0.2:1, the mass concentration of the composite enzyme was 0.8%, the enzymolysis temperature was 50 ° C, the enzymolysis time was 1.5h, the enzymolysis pH was 6.5, and the enzymolysis solution was ultrasonically treated for 30min, filtered, concentrated and dried to obtain an enzymolysis powder;

[0080] S3. Take gum arabic, soybean polysaccharide and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2, the mass ratio of the embedding agent to the powder is 2:1, the embedding agent concentration is 15%, and the embedding agent is composed of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6, stir and mix, spray dry at 150°C for 7min, obtain embedding powder, and grind the obtained embedding powder into 30-50μm;

[0081] S4. Mix the cereal flour, embedding powder and additives, add water and knead into dough, let it stand for 20 minutes, and steam it in boiling water to make cake. The product is obtained.

[0082] 2. Product form and taste experience

[0083] Table 1

[0084] project form Taste Example 1 Steamed Cake Soft, no bitter or irritating taste Example 2 Steamed Cake Soft, no bitter or irritating taste Example 3 Steamed Cake Soft, no bitter or irritating taste Comparative Example 1 Steamed Cake Obvious pungent taste, bad taste Comparative Example 2 Steamed Cake Soft, no bitter or irritating taste Comparative Example 3 Steamed Cake Strong Chinese herbal flavor, poor taste Comparative Example 4 Steamed Cake Soft, no bitter or irritating taste Comparative Example 5 Steamed Cake Soft, no bitter or irritating taste

[0085] 3. Application Test

[0086] 1. Provide early intervention treatment to patients after stroke to reduce the severity of cognitive impairment.

[0087] The subjects were 160 patients who were treated after stroke in Shijiazhuang People's Hospital, including 72 females and 88 males, with an average age of 58 years old. Patients with a history of cognitive impairment were excluded. Each group had 20 people, and each person ate 2-3 pieces of steamed cakes (about 30g / piece) per day. The degree of cognitive impairment was determined by medical history, physical examination, cognitive screening scale assessment (MMSE, MoCA, NIHSS), muscle tone changes, and brain neurotransmitter levels.

[0088] Mini-Mental State Examination (MMSE): A commonly used scale for screening cognitive functions in clinical practice, it can comprehensively, accurately and quickly reflect the intellectual status and degree of cognitive impairment of the subjects, and provide a scientific basis for clinical psychology diagnosis, treatment and neuropsychology research. This scale is simple and easy to use, and is widely used at home and abroad. It is the preferred scale for dementia screening.

[0089] The scale includes the following 7 aspects: time orientation, place orientation, immediate memory, attention and calculation, delayed memory, language, and visual space. There are 30 questions in total, and each correct answer is scored 1 point, and an incorrect answer or an unknown answer is scored 0 points. The total score range of the scale is 0-30 points. The test results are closely related to the cultural level, and the normal boundary value is divided as follows: illiterate > 17 points, primary school > 20 points, junior high school and above > 24 points.

[0090] Montreal Cognitive Assessment (MoCA): It is an assessment tool used to quickly screen for abnormal cognitive function. It includes 11 examination items in 8 cognitive areas, including attention and concentration, executive function, memory, language, visual construction skills, abstract thinking, calculation and orientation. The total score is 30 points, and ≥26 points is normal. It has high sensitivity, covers important cognitive areas, and has a short test time, making it suitable for clinical application.

[0091] The National Institutes of Health Stroke Scale (NIHSS) is a clinically used scale to assess the degree of neurological deficit after stroke. It has high reliability and validity, with an internal consistency of 0.95. It is widely used in clinical practice. It includes 10 items: level of consciousness (7 points), gaze (2 points), visual field loss (3 points), facial paralysis (3 points), limb movement disorder (16 points), ataxia (2 points), sensation (2 points), language (3 points), dysarthria (2 points), and neglect (2 points). The total score is 42 points. A score of ≤4 points indicates mild stroke, 5-15 points indicates moderate stroke, and 16-42 points indicates severe stroke. The higher the score, the more severe the neurological deficit.

[0092] Changes in muscle tension: Using muscle status testing system The changes of muscle tension of biceps brachii and quadriceps femoris at rest and under maximum voluntary contraction were measured.

[0093] Results: During the experiment, 8 of the subjects who ate the steamed cake of comparative example 1 gave up because they could not accept the steamed cake with the taste of Chinese medicine. 6 of the subjects who ate the steamed cake of comparative example 3 gave up because they could not accept the steamed cake with the taste of Chinese medicine.

[0094] Table 2 Changes in MMSE scores before and after consumption

[0095]

[0096]

[0097] Table 3 Changes in MoCa scores before and after consumption

[0098] deal with Before consumption After consumption Example 1 20.12±2.78 22.08±2.81 Example 2 20.06±2.84 22.10±2.83 Example 3 20.05±3.12 22.07±3.07 Comparative Example 1 20.08±2.81 21.37±2.76 Comparative Example 2 20.13±3.05 21.34±3.02 Comparative Example 3 20.07±2.88 21.05±2.98 Comparative Example 4 20.11±3.07 21.82±3.01 Comparative Example 5 20.04±2.93 21.63±3.03

[0099] Table 4 Changes in NIHSS scores before and after consumption

[0100] deal with Before consumption After consumption Example 1 10.83±1.65 9.61±1.24 Example 2 10.74±1.58 9.52±1.21 Example 3 10.92±1.49 9.73±1.25 Comparative Example 1 10.78±1.72 10.15±1.19 Comparative Example 2 10.84±1.26 10.12±1.20 Comparative Example 3 10.81±1.73 10.26±1.23 Comparative Example 4 10.76±1.55 9.85±1.18 Comparative Example 5 10.75±1.38 9.93±1.25

[0101] Table 5 Comparison of brain neurotransmitter levels before and after consumption

[0102]

[0103] Early intervention for post-stroke patients can reduce the degree of cognitive impairment, effectively relieve symptoms such as depression, sleep disorders, forgetfulness, promote cerebral blood circulation, and enhance the transmission of brain neurotransmitters.

[0104] 2. Improvement of Alzheimer's disease

[0105] The test subjects were 120 dementia patients admitted to Shijiazhuang People's Hospital, including 64 females and 56 males with an average age of 63 years. Patients with a history of cognitive impairment were excluded. There were 15 people in each group, and each person ate 2 pieces of steamed cakes (weight about 30g / piece) per day.

[0106] TCM diagnostic criteria (refer to TCM Disease Diagnosis and Efficacy Criteria):

[0107] (1) Memory: including the weakened ability to remember recent and distant events;

[0108] (2) Judgment: Decreased ability to judge and recognize people, objects, time, and place;

[0109] (3) Calculation ability: The ability to calculate and count backwards is impaired;

[0110] (4) Orientation: reduced ability to identify spatial positions and structures;

[0111] (5) Language ability: including the ability to understand other people's language and answer questions in an organized manner.

[0112] (6) Personality: Being withdrawn, having an apathetic expression, speaking in a long-winded and repetitive manner, being selfish and narrow-minded, being stubborn and obstinate, or being happy for no reason, being easily excited or angry, etc.

[0113] Those who have a decline in memory, judgment, and calculation ability, accompanied by 1-2 other symptoms, can be diagnosed with dementia.

[0114] Criteria for judging efficacy:

[0115] Markedly effective: Most of the main symptoms have returned to normal, orientation is basically sound, answers to questions are basically correct, reactions are normal, and the patient can take care of himself.

[0116] Effective: The main symptoms are alleviated or partially disappeared, the patient can basically take care of himself, and answer questions basically correctly, but the reaction is slow, and the intelligence and personality are still impaired.

[0117] Ineffective: The main symptoms remain unchanged or even continue to develop.

[0118] result:

[0119] Table 6

[0120] deal with Significant effect efficient invalid Example 1 10 5 0 Example 2 9 5 1 Example 3 9 6 0 Comparative Example 1 6 3 1 Comparative Example 2 8 6 1 Comparative Example 3 4 5 2 Comparative Example 4 8 7 0 Comparative Example 5 7 7 1

[0121] During the experiment, 5 subjects who ate the steamed cake of comparative example 1 gave up because they could not accept the steamed cake with the taste of traditional Chinese medicine. 4 subjects who ate the steamed cake of comparative example 3 gave up because they could not accept the steamed cake with the taste of traditional Chinese medicine. After the other patients ate it, their dementia condition was basically improved, and the effectiveness was high.

Claims

1. A Chinese medicine composition for treating cognitive impairment, characterized in that: The invention comprises 60-70 parts of cereal powder, 25-35 parts of active ingredients and 3-5 parts of additives in proportion by weight. The active ingredients are calculated in proportion by weight, and the raw materials include 6-10 parts of angelica sinensis, 6-10 parts of rehmannia root, 6-9 parts of glossy privet fruit, 10-15 parts of black wolfberry, 6-10 parts of dodder seed, 3-6 parts of curcuma aromatica, 3-5 parts of calamus calamus, 3-5 parts of tangerine peel, 3-6 parts of turmeric, 10-15 parts of poria and 3-5 parts of white mustard seed.

2. A Chinese medicine composition for treating cognitive impairment according to claim 1, characterized in that: The cereal flour includes one or any combination of rice flour, glutinous rice flour, oat flour, millet flour, buckwheat flour and quinoa flour.

3. A Chinese medicine composition for treating cognitive impairment according to claim 1, characterized in that: The additives include sweeteners and vegetable oils.

4. A Chinese medicine composition for treating cognitive impairment according to claim 1, characterized in that: The active ingredients are embedded with gum arabic, soybean polysaccharide and sodium alginate.

5. A Chinese medicine composition for treating cognitive impairment according to claim 1, characterized in that: The active ingredients are enzymatically treated with a composite enzyme, wherein the composite enzyme comprises cellulase, L-cysteine-binding protease, polyphenol oxidase and neutral protease, and the mass ratio is 1:0.5:0.2:

1.

6. A method for preparing a Chinese medicine composition for treating cognitive impairment, characterized in that: The following steps are involved: S1. Take angelica, Rehmannia root, Ligustrum lucidum, black wolfberry, Cuscuta australis, Curcuma zedoaria, Acorus calamus, tangerine peel, turmeric, Poria and white mustard, add water for water extraction, concentrate the water extract into a thick paste with a relative density of 1.3-1.4, freeze-dried into powder, and set aside; S2. The drug residue after water extraction is ultrafinely crushed, and then water and complex enzyme are added for enzymolysis to obtain an enzymatic solution, and the enzymatic solution is ultrasonically treated for 20-30min, filtered, concentrated and dried to obtain an enzymatic powder; S3. Take gum arabic, soybean polysaccharide and sodium alginate and dissolve them in water, add the powder obtained in step S1 and the enzymatic hydrolysis powder obtained in step S2, stir and mix, spray dry to obtain an embedded powder; S4. Mix the grain powder, embedding powder and additives, and steam them into cakes to obtain the product.

7. The method for preparing a Chinese medicine composition for treating cognitive impairment according to claim 6, characterized in that: In step S1, the conditions for water extraction are: the amount of water is 3-5 times of the traditional Chinese medicine composition, the water extraction temperature is 80-90°C, the water extraction time is 0.5-1h, and the number of water extractions is 2-3 times.

8. The method for preparing a Chinese medicine composition for treating cognitive impairment according to claim 6, characterized in that: In step S2, the complex enzyme is composed of cellulase, L-cysteine ​​conjugated protease, polyphenol oxidase and neutral protease in a mass ratio of 1:0.5:0.2:1, the mass concentration of the complex enzyme is 0.6-0.8%, the enzymolysis temperature is 40-60°C, the enzymolysis time is 1-2h, and the enzymolysis pH is 6-7.

9. The method for preparing a Chinese medicine composition for treating cognitive impairment according to claim 6, characterized in that: In step S3, the mass ratio of embedding agent to powder is 2:1, the embedding agent concentration is 10-15%, the embedding agent is composed of gum arabic, soybean polysaccharide and sodium alginate in a mass ratio of 1:0.4:0.6, and the obtained embedding powder is crushed to 30-50 μm.

10. The method for preparing a Chinese medicine composition for treating cognitive impairment according to claim 6, characterized in that: The hot air flow temperature of the spray drying was set to 140-160°C and the spray drying time was set to 5-8 minutes.

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