Preparation and application of medicinal and edible composition for assisting dialysis treatment

By providing a medicinal and food homologous composition containing Chinese herbal components such as ginseng, angelica, saffron, cinnamon, wolfberry, honeysuckle, etc., the problem of discomfort symptoms caused by long-term peritoneal dialysis is solved, and effective relief of symptoms caused by dialysis and improvement of renal function indicators is achieved.

CN120131797APending Publication Date: 2025-06-13SHANGHAI FENGLIN BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202311711009.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-12-13
Publication Date
2025-06-13

AI Technical Summary

Technical Problem

Long-term peritoneal dialysis will cause dysfunction of catheter, increased intraperitoneal pressure, abnormal sugar and lipid metabolism, peritoneal failure and cardiovascular complications, affecting the continuity of dialysis treatment and causing patients to suffer from repeated complications.

Method used

Provide a medicinal and food homologous composition for assisting dialysis treatment, including ginseng, angelica, saffron, cinnamon, wolfberry, honeysuckle and other Chinese herbal components, and add additives such as thickening agents, emulsifiers and preservatives. Through the preparation method of decoction and mixed liquid, a drug suitable for alleviating adverse symptoms caused by dialysis is formed.

Benefits of technology

This medicinal and food homologous composition can effectively relieve adverse symptoms caused by dialysis, such as low back pain, abdominal pain, anorexia, soreness in the hands and feet, chest tightness and shortness of breath, etc., significantly improve renal function indicators, reduce the risk of complications in patients, and improve the continuity of dialysis treatment.

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Abstract

The invention provides a medicinal and edible composition for assisting dialysis treatment. The medicinal and edible composition is characterized by comprising Chinese herbal medicine components, wherein the Chinese herbal medicine components are selected from ginseng, angelica sinensis, stigma croci, cinnamon, fructus lycii and honeysuckle; the mass ratio of the ginseng to the Chinese angelica is 1: (0.8-1); the mass ratio of the ginseng to the stigma croci is (4-7): 1; the mass ratio of the ginseng to the cinnamon is (1.5-2.5): 1; the mass ratio of the ginseng to the fructus lycii is 1: (0.8-1); the mass ratio of the ginseng to the honeysuckle is 1: (0.8-1). The component can be used as a medicine for treating and relieving bad symptoms caused by dialysis.
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Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine compound, and specifically, to the preparation and application of a medicine and food homology composition for assisting dialysis treatment. Background Art

[0002] Peritoneal dialysis is a dialysis method that uses the body's own peritoneum as a dialysis membrane. Through the exchange of solutes and water between the dialysate infused into the abdominal cavity and the plasma components in the capillaries on the other side of the peritoneum, the retained metabolites and excessive water in the body are removed, and at the same time, the substances necessary for the body are supplemented through the dialysate. By continuously updating the peritoneal dialysis fluid, the purpose of kidney replacement or supportive treatment is achieved. However, long-term peritoneal dialysis can cause catheter dysfunction, such as catheter displacement, catheter blockage, etc.; hernia, leakage, etc. caused by increased intra-abdominal pressure; abnormal sugar and lipid metabolism; peritoneal function failure; cardiovascular complications, etc.

[0003] Currently, when such situations occur, the dialysis is often suspended or other drug treatments are used to restore the body indicators before the dialysis treatment can be continued. This affects the continuity of dialysis treatment and also causes patients to be troubled by repeated complications. Summary of the Invention

[0004] The present invention aims to overcome the above defects and provides a medicine and food homology composition for the discomfort symptoms caused by dialysis to assist in treatment and relieve the discomfort symptoms.

[0005] A medicine and food homology composition for assisting dialysis treatment provided by the present invention is characterized in that:

[0006] It contains Chinese herbal medicine components;

[0007] Among them, the above-mentioned Chinese herbal medicine components are selected from ginseng, angelica, saffron, cinnamon, wolfberry, honeysuckle;

[0008] The mass ratio of the above-mentioned ginseng to angelica is 1:0.8 - 1;

[0009] The mass ratio of the above-mentioned ginseng to saffron is 4 - 7:1;

[0010] The mass ratio of the above-mentioned ginseng to cinnamon is 1.5 - 2.5:1;

[0011] The mass ratio of the above-mentioned ginseng to wolfberry is 1:0.8 - 1;

[0012] The mass ratio of the above-mentioned ginseng to honeysuckle is 1:0.8 - 1.

[0013] During the preparation process, a large amount of pure water generally needs to be added for decocting.

[0014] Furthermore, a medicine and food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that:

[0015] It also contains auxiliaries;

[0016] The dosage of the above-mentioned auxiliaries is 8-15% of the total weight of the Chinese herbal medicine components;

[0017] The above-mentioned auxiliaries are selected from one or more of thickeners, emulsifiers, and preservatives.

[0018] Furthermore, a medicine and food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that it is composed of the following components in mass percentages:

[0019] Ginseng 18%-20%;

[0020] Angelica sinensis 18%-20%;

[0021] Saffron 3%-4%;

[0022] Cinnamon 9%-10%;

[0023] Wolfberry fruit 18%-20%;

[0024] Honeysuckle flower 18%-20%;

[0025] The balance is auxiliaries.

[0026] During the preparation process, a large amount of pure water generally needs to be added for decocting.

[0027] Furthermore, a medicine and food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that the specific preparation method is as follows:

[0028] After mixing the Chinese herbal medicine components, add 1-5 times the amount of pure water and soak for 30 minutes. After boiling over high heat, turn to medium heat and continue to decoct for 10-60 minutes. Pour out the decoction, add water again and decoct for 10-60 minutes, and finally combine the two decoctions.

[0029] Furthermore, a medicine and food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that when the above-mentioned auxiliaries contain an emulsifier, dissolve the emulsifier in the decoction of the Chinese herbal medicine, and use it after fully mixing.

[0030] Furthermore, a medicine and food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that when the above-mentioned auxiliaries contain a preservative, dissolve it in the mixed solution prepared by the above method and then use it.

[0031] Furthermore, a medicine and food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that when the above-mentioned auxiliaries contain a thickener, add the thickener to pure water, dissolve and mix well before using.

[0032] Furthermore, a medicine-food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that it is made from the following components by mass percentage:

[0033] Ginseng 18%-20%;

[0034] Angelica sinensis 18%-20%;

[0035] Saffron 3%-4%;

[0036] Cinnamon 9%-10%;

[0037] Wolfberry fruit 18%-20%;

[0038] Honeysuckle flower 18%-20%;

[0039] Sodium carboxymethylcellulose 4%-4.5%;

[0040] Sucrose fatty acid ester 4%-4.5%;

[0041] Potassium sorbate 4%-4.5%.

[0042] Furthermore, a medicine-food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that it is used for assisting treatment and relieving the adverse symptoms caused by dialysis.

[0043] Furthermore, a medicine-food homologous composition for assisting dialysis treatment provided by the present invention is characterized in that it is used as a drug for down-regulating at least one of the indexes of urea, uric acid, creatinine, retinol-binding protein, and β2-microglobulin to approach the standard value. Detailed implementation manners

[0044] In this embodiment, a traditional Chinese medicine compound composition mainly composed of ginseng, angelica sinensis, saffron, cinnamon, wolfberry fruit, and honeysuckle flower is provided. In this formula, based on the characteristics of the following components: that is, ginseng has the effects of greatly tonifying primordial qi, invigorating the spleen and benefiting the lung, promoting the production of body fluid, and tranquilizing the mind and improving intelligence. It is mainly used for treating symptoms such as collapse of qi due to deficiency, feeble pulse, deficiency of the spleen qi, sinking of the middle qi, cough and asthma due to lung deficiency, shortness of breath and fatigue, thirst due to fluid deficiency, consumptive thirst with deficiency heat, insomnia and forgetfulness, palpitation and anxiety, and sallow complexion due to blood deficiency. Angelica sinensis has the effects of enriching blood and regulating menstruation, promoting blood circulation to relieve pain, and moistening the intestines and relaxing bowel movements. It is mainly used for treating symptoms such as sallow complexion due to blood deficiency, various pains due to blood deficiency, blood stasis, and blood cold, and constipation due to intestinal dryness. Saffron has the effects of promoting blood circulation to remove blood stasis, dispersing stasis and relieving stasis, and cooling blood and detoxifying. Cinnamon has the effects of tonifying fire and assisting yang, dispersing cold and relieving pain, and promoting blood circulation and dredging channels. It is used for treating symptoms such as deficiency of kidney yang, dizziness and red eyes, and cold pain in the heart and abdomen. Wolfberry fruit has the effects of nourishing the liver and kidney and improving eyesight. It is mainly used for treating symptoms such as yin deficiency of the liver and kidney and premature aging syndrome. Honeysuckle flower has the effects of clearing heat and detoxifying and dispersing wind and heat. Based on a specific formula, the effect of being able to use it to relieve the adverse symptoms caused by dialysis is achieved. Specifically as follows:

[0045] Implementation Case 1: A Medicinal and Edible Homologous Composition for Assisting Dialysis Treatment and Its Preparation Method

[0046] Formula:

[0047] Ginseng: 10 g

[0048] Angelica sinensis: 10 g

[0049] Saffron: 2 g

[0050] Cinnamon: 5 g

[0051] Wolfberry fruit: 10 g

[0052] Honeysuckle flower: 10 g

[0053] Sodium carboxymethyl cellulose (thickener): 2 g

[0054] Sucrose fatty acid ester (emulsifier): 2 g

[0055] Potassium sorbate (preservative): 2 g

[0056] Purified water: 500 ml

[0057] Method:

[0058] Take 1.8 - 2.2 g of sodium carboxymethyl cellulose in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Mix the ginseng, angelica sinensis, saffron, cinnamon, wolfberry fruit, and honeysuckle flower in the formula, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the sodium carboxymethyl cellulose solution and mix well. Dilute with pure water to 450 - 550 ml and mix well. Divide into portions and sterilize.

[0059] Experiment 1. Selection of Emulsifier

[0060] In the experimental compound, keep other components consistent, and use sucrose fatty acid ester with HLB 15, sucrose fatty acid ester with HLB 13, and sucrose fatty acid ester with HLB 11 as emulsifiers for testing, and observe their stability.

[0061] Experimental steps:

[0062] 1. Take 1.8 - 2.2 g of carboxymethyl cellulose sodium in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Mix the ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formula, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of HLB15 sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the carboxymethyl cellulose sodium solution and mix well. Dilute with pure water to 450 - 550 ml, mix well. Dispense and sterilize to obtain the formula aqueous solution - 1. Let this aqueous solution stand at room temperature for 1 week, visually observe whether there is a "phase change" process in the solution stability state, such as the solution becoming a colloid, clear becoming turbid, etc. If so, it is considered unstable.

[0063] 2. Take 1.8 - 2.2 g of carboxymethyl cellulose sodium in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Mix the ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formula, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of HLB13 sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the carboxymethyl cellulose sodium solution and mix well. Dilute with pure water to 450 - 550 ml, mix well. Dispense and sterilize to obtain the formula aqueous solution - 2. Let this aqueous solution stand at room temperature for 1 week, visually observe whether there is a "phase change" process in the solution stability state, such as the solution becoming a colloid, clear becoming turbid, etc. If so, it is considered unstable.

[0064] 3. Take 1.8 - 2.2 g of carboxymethyl cellulose sodium in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Mix the ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formula, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of HLB11 sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the carboxymethyl cellulose sodium solution and mix well. Dilute with pure water to 450 - 550 ml, mix well. Dispense and sterilize to obtain the formula aqueous solution - 3. Let this aqueous solution stand at room temperature for 1 week, visually observe whether there is a "phase change" process in the solution stability state, such as the solution becoming a colloid, clear becoming turbid, etc. If so, it is considered unstable.

[0065] Experimental Results

[0066] Table 1 Experimental Results of Emulsifier Selection

[0067] Formulation aqueous solution - 1 Formulation aqueous solution - 2 Formulation aqueous solution - 3 Emulsifier HLB15 Sucrose fatty acid ester HLB13 Sucrose fatty acid ester HLB11 Sucrose fatty acid ester Stability Stable Relatively stable Relatively stable

[0068] Experiment 2. Selection of thickeners

[0069] In the experimental compound, other components were kept consistent, and sodium carboxymethylcellulose, xanthan gum, and resistant dextrin were respectively selected as thickeners for the experiment to observe the viscosity.

[0070] Experimental procedures

[0071] 1. Take 1.8 - 2.2 g of sodium carboxymethylcellulose in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Mix the ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formula, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the sodium carboxymethylcellulose solution and mix well. Dilute with pure water to 450 - 550 ml, mix well. Dispense and sterilize to obtain Formula Aqueous Solution - 4. Visually inspect whether the solution has good stability. If it is clear and transparent and no phase change occurs after standing for 7 days, the stability is good; after standing for another 7 days, observe its softening property. If it becomes solid after 7 days and cannot be stirred or weighed, it is considered that the rheology is poor or the viscosity is high; if it remains in a liquid state and is convenient to measure with a dropper or other containers, it is considered that the rheology is good.

[0072] 2. Take 1.8 - 2.2 g of xanthan gum in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Mix the ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formula, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the xanthan gum solution and mix well. Dilute with pure water to 450 - 550 ml, mix well. Dispense and sterilize to obtain Formula Aqueous Solution - 5. Visually inspect whether the solution has good stability. If it is clear and transparent and no phase change occurs after standing for 7 days, the stability is good; after standing for another 7 days, observe its softening property. If it becomes solid after 7 days and cannot be stirred or weighed, it is considered that the rheology is poor or the viscosity is high; if it remains in a liquid state and is convenient to measure with a dropper or other containers, it is considered that the rheology is good.

[0073] 3. Take 1.8 - 2.2 g of formulated resistant dextrin, add it to 10 - 30 ml of pure water, mix well and set aside. Take the ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formulation, mix them, and soak them in 2 times the amount of pure water for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 1.8 - 2.2 g of sucrose fatty acid ester and 1.8 - 2.2 g of potassium sorbate, dissolve and mix well. Add the resistant dextrin solution and mix well. Dilute with pure water to 450 - 550 ml and mix well. Package and sterilize to obtain the formulated aqueous solution - 6. Visually inspect whether the solution has good stability. If it is clear and transparent and no phase change is observed after standing for 7 days, the stability is good; after standing for another 7 days, observe its softening property. If it becomes solid after 7 days and cannot be stirred or weighed, it is considered that the rheology is poor or the viscosity is high; if it remains in a liquid state and is convenient to measure with containers such as droppers, it is considered that the rheology is good.

[0074] Experimental results

[0075] Table 2 Experimental results of thickener selection

[0076] Formulation aqueous solution - 4 Formulation aqueous solution - 5 Formulation aqueous solution - 6 Thickener Sodium carboxymethyl cellulose Xanthan gum Resistant dextrin Stability Stable Stable Stable Rheology Good Good Good

[0077] Example 2: A medicated and edible homologous composition for assisting dialysis treatment and its preparation method

[0078] Formulation:

[0079] Ginseng: 15 g

[0080] Angelica: 15 g

[0081] Saffron: 3 g

[0082] Cinnamon: 8 g

[0083] Wolfberry: 15 g

[0084] Honeysuckle: 15 g

[0085] Sodium carboxymethyl cellulose (thickener): 3 g

[0086] Sucrose fatty acid ester (emulsifier): 3 g

[0087] Potassium sorbate (preservative): 3 g

[0088] Purified water: 500 ml

[0089] Method:

[0090] Take 2.8 - 3.2 g of sodium carboxymethylcellulose in the formula, add it to 10 - 30 ml of pure water, mix well and set aside. Take ginseng, angelica, saffron, cinnamon, wolfberry, and honeysuckle in the formula, mix them, add 2 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 30 minutes. Pour out the decoction, add water and decoct for another 20 minutes. Finally, combine the two decoctions. Add 2.8 - 3.2 g of sucrose fatty acid ester and 2.8 - 3.2 g of potassium sorbate, dissolve and mix well. Add the sodium carboxymethylcellulose solution and mix well. Dilute with pure water to 450 - 550 ml, mix well. Package and sterilize.

[0091] Case 3 of implementation: An application case of a medicine - food homologous composition for assisting dialysis treatment and its preparation method. Case 1. Li Mou, male, born in 1983, engaged in the catering industry, a chef

[0092] The patient visited the nephrology outpatient clinic, complaining of low back pain, abdominal pain, anorexia, soreness in hands and feet, chest tightness and shortness of breath. After examination, the main indicators showed reduced renal function and needed dialysis treatment. Due to various discomfort symptoms during dialysis and the deviation of each index from the normal value, the patient intended to seek traditional Chinese medicine for simultaneous conditioning treatment. 。 Recommend the medicine - food homologous composition 1. During dialysis, take it twice a day for 15 consecutive days. After the review and examination of the main indicators, they were all significantly improved, the above - mentioned symptoms basically disappeared, and the curative effect was remarkable. There was no recurrence after stopping the medicine for one month.

[0093] Table 3 Comparison of the results of the main examination items of nephropathy patients before and after taking the medicine during dialysis

[0094]

[0095] To sum up, the aqueous solutions of the formulas obtained in Case 1 and Case 2 of implementation can be stored for a long time and show good stability. The aqueous solution of the formula obtained in Case 3 of implementation can be used to assist dialysis treatment. The above are only the preferred implementation cases of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A medicated and edible homologous composition for assisting dialysis treatment, characterized in that: it contains Chinese herbal medicine components; wherein, the Chinese herbal medicine components are selected from ginseng, angelica, saffron, cinnamon, wolfberry fruit, honeysuckle flower; the mass ratio of ginseng to angelica is 1:0.8 - 1; the mass ratio of ginseng to saffron is 4 - 7:1; the mass ratio of ginseng to cinnamon is 1.5 - 2.5:1; the mass ratio of ginseng to wolfberry fruit is 1:0.8 - 1; the mass ratio of ginseng to honeysuckle flower is 1:0.8 - 1.

2. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 1, characterized in that: it further contains an auxiliary agent; the dosage of the auxiliary agent is 8 - 15% of the total weight of the Chinese herbal medicine components; the auxiliary agent is selected from one or more of a thickening agent, an emulsifying agent, and a preservative.

3. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 2, characterized in that, it is composed of the following components in mass percentage: ginseng 18% - 20%; angelica 18% - 20%; saffron 3% - 4%; cinnamon 9% - 10%; wolfberry fruit 18% - 20%; honeysuckle flower 18% - 20%; auxiliary agent the balance.

4. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 1, characterized in that, the specific preparation method is as follows: After mixing the Chinese herbal medicine components, add 1 - 5 times the amount of pure water and soak for 30 minutes. Bring to a boil over high heat and then turn to medium heat, continue to decoct for 10 - 60 minutes, pour out the decoction liquid, add water and decoct for 10 - 60 minutes again, and finally combine the two decoction liquids.

5. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 2, characterized in that: When the auxiliary agent contains an emulsifying agent, dissolve the emulsifying agent in the decoction liquid of the Chinese herbal medicine, and use it after fully mixing.

6. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 5, characterized in that: When the auxiliary agent contains a preservative, dissolve it in the mixed solution prepared as claimed in claim 5 and then use it.

7. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 2, characterized in that: When the auxiliary agent contains a thickening agent, add the thickening agent to pure water, dissolve and mix evenly before using.

8. A medicated and edible homologous composition for assisting dialysis treatment as claimed in claim 1, characterized in that, it is manufactured from the following components in mass percentage: ginseng 18% - 20%; angelica 18% - 20%; saffron 3% - 4%; cinnamon 9% - 10%; wolfberry fruit 18% - 20%; honeysuckle flower 18% - 20%; sodium carboxymethylcellulose 4% - 4.5%; sucrose fatty acid ester 4% - 4.5%; potassium sorbate 4% - 4.5%.

9. A medicated and edible homologous composition for assisting dialysis treatment as claimed in any one of claims 1 - 8, characterized in that: as a drug for treating and alleviating adverse symptoms caused by dialysis.

10. A medicated and edible homologous composition for assisting dialysis treatment as claimed in any one of claims 1 - 8, characterized in that: as a drug for down - regulating at least one of the indicators of urea, uric acid, creatinine, retinol - binding protein, β2 - microglobulin to approach the standard value.