Polypeptide composition and use thereof

A polypeptide composition combining semaglutide with coenzyme Q10, nucleotide derivatives, sulfur-containing amino acids, collagen tripeptide, and polyeicosanol addresses gastrointestinal side effects and alcohol sensitivity, enhancing patient compliance and efficacy.

HK40134535APending Publication Date: 2026-07-10SHENZHEN READLINE BIOTECH CO LTD

Patent Information

Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
SHENZHEN READLINE BIOTECH CO LTD
Filing Date
2026-04-01
Publication Date
2026-07-10

AI Technical Summary

Technical Problem

Existing semaglutide formulations suffer from significant gastrointestinal side effects such as bloating, diarrhea, and constipation, and are sensitive to alcohol consumption, limiting patient compliance and clinical applicability.

Method used

A polypeptide composition comprising a GLP-1 receptor agonist (semaglutide or tirzepatide) combined with coenzyme Q10, nucleotide derivatives, sulfur-containing amino acid derivatives, collagen tripeptide, polyeicosanol, and human milk oligosaccharides to enhance absorption efficiency and reduce gastrointestinal discomfort and alcohol sensitivity.

Benefits of technology

The composition significantly reduces gastrointestinal adverse reactions and improves alcohol tolerance, maintaining drug efficacy and broadening the clinical applicability of semaglutide.

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Abstract

The invention discloses a polypeptide composition and application thereof. The composition comprises a GLP-1 receptor agonist and any one or more of the following synergistic active components: (1) coenzyme Q10; (2) a nucleotide derivative; (3) a sulfur-containing amino acid derivative; (4) collagen tripeptide; (5) policosanol; the GLP-1 receptor stimulant is semeglutide or tilpotide, and the GLP-1 receptor stimulant is stemeglutide or tiall. According to the delivery system adopted by the invention, the absorption efficiency of the medicine is improved, the gastrointestinal tract discomfort reactions, including abdominal distension, diarrhea, constipation and the like, related to oral taking of the semeglutide are remarkably reduced, and the medicine taking experience and compliance of a patient are improved. In addition, the preparation disclosed by the invention is relatively low in sensitivity to drinking, the drug effect is not obviously influenced, and the alcohol tolerance of a patient is not easily changed, so that the clinical application range of the semeglutide is widened.
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Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202511571767.4 (22) Application Date 2025.10.30 (71) Applicant Shenzhen Ruidelin Biotechnology Co., Ltd. Address 518100, 3rd Floor, Building 2, Shenzhen Biological Incubation Base, No. 10, Gaoxin Middle Road, Maling Community, Yuehai Street, Nanshan District, Shenzhen, Guangdong Province (72) Inventors Pan Junfeng Liu Jian (74) Patent Agency Shenzhen Zhiqu Intellectual Property Agency (General Partnership) 44486 Patent Attorney Liu Ting (51) Int.Cl. A61K 38 / 26 (2006.01) A23L 33 / 10 (2016.01) A23L 33 / 13 (2016.01) A23L 33 / 17 (2016.01) A23L 33 / 18(2016.01) A23L 33 / 125(2016.01) A61K 38 / 06(2006.01) A61K 38 / 39(2006.01) A61K 31 / 702(2006.01) A61K 31 / 4172(2006.01) A61K 31 / 7076(2006.01) A61K 31 / 706(2006.01) A61K 47 / 10(2017.01) A61P 3 / 06(2006.01) A61P 3 / 04(2006.01) (54) Invention Title: A polypeptide composition and its application (57) Abstract: This invention discloses a polypeptide composition and its application. The composition comprises a GLP-1 receptor agonist and any one or more of the following synergistic active ingredients: (1) coenzyme Q10; (2) nucleotide derivatives; (3) sulfur-containing amino acid derivatives; (4) collagen tripeptide; (5) polyeicosanol; wherein the GLP-1 receptor agonist is semaglutide or telpolide. The delivery system employed in this invention significantly reduces gastrointestinal discomfort associated with oral semaglutide, including bloating, diarrhea, and constipation, while improving drug absorption efficiency, thus improving patient experience and compliance. Furthermore, the formulation of this invention has low sensitivity to alcohol consumption, does not significantly affect efficacy, and is unlikely to alter patients' alcohol tolerance, thereby broadening the clinical applicability of semaglutide. Claims 1 page, Description 13 pages, Drawings 1 page, CN 121221745 A 2025.12.30 CN 1 21 22 17 45 A 1. A polypeptide composition, characterized in that it comprises a GLP-1 receptor agonist and any one or more of the following synergistic active ingredients: (1) coenzyme Q10; (2) nucleotide derivatives; (3) sulfur-containing amino acid derivatives; (4) collagen tripeptide; (5) polyeicosanol;(6) Human milk oligosaccharides; the GLP-1 receptor agonist is smegglutide or telpolide. 2. The polypeptide composition according to claim 1, characterized in that, by weight, the GLP-1 receptor agonist is 3-90 parts, the coenzyme Q10 is 1-50 parts, the nucleotide derivative is 2-500 parts, the sulfur-containing amino acid derivative is 1-60 parts, the collagen tripeptide is 1-500 parts, the polyeicosanol is 1-300 parts, and the human milk oligosaccharide is 1-300 parts. 3. The polypeptide composition according to claim 1, characterized in that the coenzyme Q10, nucleotide derivative, sulfur-containing amino acid derivative, collagen tripeptide, octacosanol, or human milk oligosaccharide is a natural extract, fermentation product, chemically synthesized product, or a pharmaceutically acceptable salt or ester thereof. 4. The polypeptide composition according to claim 1, characterized in that the polypeptide composition is an oral preparation. 5. The polypeptide composition according to claim 4, characterized in that the dosage form of the oral preparation is tablets, powders, capsules, or granules. 6. The polypeptide composition according to claim 1, wherein the polypeptide composition is a pharmaceutical or health product. 7. The polypeptide composition according to claim 6, wherein the pharmaceutical comprises one or more pharmaceutically acceptable carriers or excipients. 8. The polypeptide composition according to claim 1, wherein the carrier or excipient comprises any one or more of diluents, fillers, binders, disintegrants, lubricants, flow aids, granulators, coating agents, wetting agents, cosolvents, suspending agents, emulsifiers, sweeteners, flavoring agents, masking agents, colorants, anti-caking agents, humectants, chelating agents, plasticizers, thickeners, antioxidants, preservatives, stabilizers, surfactants, and buffers. 9. The use of the polypeptide composition according to any one of claims 1 to 8 in the preparation of lipid-lowering drugs or health products. 10. The use of the polypeptide composition according to any one of claims 1 to 8 in the preparation of drugs or health products for the prevention or treatment of obesity. Claims 1 / 1 Page 2 CN 121221745 A A polypeptide composition and its application technical field

[0001] This invention relates to the field of biotechnology, and particularly to a polypeptide composition and its application. Background Art

[0002] Semaglutide is a long-acting GLP-1 receptor agonist, originally used to treat type II diabetes. In recent years, it has been found to have good weight loss effects and has been approved for the treatment of obesity and overweight-related diseases. It achieves weight control and metabolic improvement through mechanisms such as delaying gastric emptying, enhancing satiety, and reducing appetite.

[0003] Although the above-mentioned technologies have made some breakthroughs in improving the bioavailability of oral semaglutide, there are still obvious shortcomings. First, in the currently published studies, patients who discontinued treatment with semaglutide tablets due to adverse events,The high proportion of patients discontinuing treatment due to gastrointestinal adverse events is mainly attributed to these events. Common adverse reactions include bloating, diarrhea, and constipation, which affect patient compliance and long-term treatment efficacy. Secondly, these formulations impose certain restrictions on post-drug behavior. For example, drinking alcohol during administration can affect the efficacy of the drug and may also alter an individual's metabolic response to alcohol, further limiting its clinical application.

[0004] Therefore, there is an urgent need to develop a new adjuvant that can significantly reduce gastrointestinal side effects and decrease the interaction with lifestyle factors such as alcohol consumption while maintaining or enhancing the weight loss of semaglutide oral administration, thereby improving the patient's experience and compliance. Summary of the Invention

[0005] In view of the deficiencies in the prior art, the present invention proposes a polypeptide composition and its application. The present invention provides an alternative for oral delivery of semaglutide that can effectively improve the oral efficacy of semaglutide without relying on SNAC, while reducing its gastrointestinal side effects and efficacy after alcohol consumption, and improving alcohol tolerance.

[0006] The present invention provides a polypeptide composition comprising a GLP-1 receptor agonist and any one or more of the following synergistic active ingredients: (1) coenzyme Q10; (2) a nucleotide derivative; (3) a sulfur-containing amino acid derivative; (4) a collagen tripeptide; (5) a polyeicosanol; (6) human milk oligosaccharides (HMOs); wherein the GLP-1 receptor agonist is smegglutide or telposide.

[0007] Preferably, the nucleotide derivative is nicotinamide adenine dinucleotide (NAD+) or β-nicotinamide mononucleotide (NMN).

[0008] Preferably, the sulfur-containing amino acid derivative is ergothioneine.

[0009] Preferably, the polyeicosanol is octacosanol.

[0010] The polypeptide composition provided by the present invention, by synergistically introducing active ingredients with multiple functions such as antioxidation, energy metabolism promotion, intestinal protection and central regulation, while maintaining the hypoglycemic and weight loss effects of GLP-1 drugs, significantly reduces gastrointestinal discomfort caused by oral preparations, and improves the ability to metabolize alcohol and the stability of efficacy during medication, taking into account efficacy, safety and lifestyle adaptability, and has good clinical translation potential.

[0011] The human milk oligosaccharides (also known as human milk oligosaccharides or human milk oligosaccharides) include 3-SL, 6'-SL, 2-FL, DFL, etc.

[0012] In some embodiments, the GLP-1 receptor agonist is 3 to 90 parts by weight, such as 3, 10, 20, 30, 40, 50, 60, 80, or 90 parts, preferably 12 to 83 parts, and more preferably 17 to 80 parts. Since different patients have significant differences in weight, basal metabolism, and drug tolerance, low doses can be used in health supplements or light...For symptomatic intervention, high doses are suitable for pharmaceutical preparations to ensure efficacy, ensuring clinical suitability and avoiding side effects caused by overdose.

[0013] The coenzyme Q10 is 1 to 50 parts, such as 1, 5, 10, 15, 20, 25, 30, 40, 50 parts, preferably 4 to 45 parts, more preferably 10 to 42 parts; GLP-1 receptor agonists often cause gastrointestinal reactions due to increased energy metabolism burden when exerting weight loss and blood sugar control effects. In this invention, coenzyme Q10 can improve mitochondrial efficiency and reduce gastrointestinal motility imbalance caused by insufficient energy, thereby forming a synergistic effect with smegglutinin, ensuring efficacy and reducing the incidence of bloating and constipation.

[0014] The nucleotide derivative is 2-500 parts, such as 2, 10, 50, 100, 200, 300, 400, 500 parts, etc., preferably 50-460 parts, more preferably 65-410 parts; this application found that nucleotide derivative supplementation can enhance the metabolic capacity of the intestine and liver. When combined with smegglutide, it not only improves the stability of drug absorption, but also unexpectedly improves the efficiency of alcohol metabolism and reduces the fluctuation of drug efficacy after patients drink alcohol.

[0015] The sulfur-containing amino acid derivative is 1-60 parts, such as 1, 5, 10, 15, 20, 30, 40, 50, 60 parts, etc., preferably 3-55 parts, more preferably 12-50 parts; oral administration of smegglutide may cause mild irritation to the gastrointestinal mucosa. This invention found that the antioxidant protective effect of sulfur-containing amino acid derivatives can significantly buffer this local reaction. When combined with smegglutide, it shows a significant reduction in gastrointestinal discomfort and improved compliance.

[0016] The collagen tripeptide is 1-500 parts, such as 1, 5, 10, 15, 20, 50, 100, 200, 300, 400, 500 parts, etc., preferably 50-480 parts, more preferably 65-440 parts; the collagen tripeptide can repair the intestinal barrier and improve the digestive burden caused by delayed gastric emptying of semagraft. After the two work together, the patient's diarrhea and indigestion symptoms are significantly reduced, and the stable absorption of the drug is guaranteed.

[0017] The polyeicosanol is 1-300 parts, such as 1, 5, 10, 50, 100, 200, 300 parts, etc., preferably 3-280 parts, more preferably 10-250 parts; the polyeicosanol can improve the cell membrane lipid environment, promote the transmembrane absorption efficiency of semagraft, and at the same time relieve the local discomfort caused by drug aggregation, making the drug effect more stable.

[0018] The human milk oligosaccharide is 1-300 parts, such as 1, 5, 10, 50, 100, 200, 300 parts, preferably 3-280 parts, more preferably 10-250 parts; HMOs can rebuild the intestinal microecology, complement smegglutinin, reduce discomfort caused by flora imbalance, and further improve drug absorption and tolerance.

[0019] In some embodiments, the polypeptide composition is an oral formulation. Common side effects of GLP-1 drugs are injection dependence and gastrointestinal adverse reactions after oral administration. This invention, through the rational combination of active ingredients, can improve oral tolerability.

[0020] In some embodiments, the dosage form of the oral formulation is tablets, powders, capsules, or granules; the dosage form facilitates precise dosage control, taste masking, and improved stability. In particular, capsules and granules can prevent the active substances from prematurely degrading in gastric acid, further reducing gastrointestinal irritation.

[0021] In some embodiments, the polypeptide composition is a drug or health product.

[0022] In some embodiments, the drug includes one or more pharmaceutically acceptable carriers or excipients.

[0023] In some embodiments, the carrier or excipient includes any one or more of the following: diluent, filler, binder, disintegrant, lubricant, glidant, granulator, coating agent, wetting agent, cosolvent, suspending agent, emulsifier, sweetener, flavoring agent, masking agent, colorant, anti-caking agent, humectant, antioxidant, preservative, stabilizer, and buffer.

[0024] The present invention also provides the application of the peptide composition in the preparation of lipid-lowering drugs or health products.

[0025] The present invention also provides the application of the peptide composition in the preparation of drugs or health products for the prevention or treatment of obesity.

[0026] In summary, compared with the prior art, the present invention achieves the following technical effects: 1. The delivery system adopted in the present invention significantly reduces gastrointestinal discomfort reactions associated with oral smegglutide, including bloating, diarrhea, and constipation, while improving the patient's medication experience and compliance.

[0027] 2. The formulation of the present invention showed reduced sensitivity to alcohol intake during the test, better drug stability after patients drank alcohol, and improved tolerability, without significantly affecting the drug efficacy, thereby broadening the clinical application scope of smegglutide.

[0028] 3. The present invention improves the oral absorption efficiency of the drug while taking into account safety and lifestyle compatibility, and has good clinical application prospects and market promotion value. Brief Description of the Drawings

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 is a line graph of weight change in obese mice within 7 days of administration in Experiment Example 1 of the present invention; Figure 2 is a statistical graph of blood alcohol content in rats in Experiment Example 3 of the present invention. Detailed Embodiments

[0031] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0032] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the materials and reagents used can be obtained from commercial sources.

[0033] The raw materials used in the present invention are all self-made in the laboratory. Among them, the HMOs used in Examples 35-37 are 6'-SL, and the HMOs used in the other examples are 3-SL.

[0034] Experimental Example 1 Study on the weight control and metabolic regulation effects of smegglutide preparation in a diet-induced obesity model The purpose of this study is to evaluate the therapeutic effect of the preparation of the present invention on obese mice induced by a high-fat diet.

[0035] Six-week-old male C57BL / 6J mice were selected for the experiment. Before the formal experiment, all mice were acclimatized to the experimental environment for one week. After the acclimatization period, they were randomly divided into three groups: model group, control group, and experimental group. The model group mice were fed a standard diet, while the control group and each experimental group mice were continuously fed a high-fat diet. All groups had free access to food and water. The specific formula of the high-fat diet was: 78.8% ordinary diet, 1% cholesterol, 0.2% ox bile salts, 10% egg yolk powder, and 10% lard. The modeling period continued until the weight of the experimental group mice reached or exceeded 40 g, which was considered a successful modeling. Throughout the modeling process, weight changes were recorded weekly to ensure a continuous growth trend. After the model was established, the evaluation phase began. By detecting metabolic parameters such as fasting blood glucose, blood lipid indicators, insulin sensitivity index, and oral glucose tolerance test (OGTT), the obesity status and related metabolic disorders of the mice were comprehensively evaluated.

[0036] Referring to the grouping in Table 1, there were 6 mice in each group. The model group was given PBS buffer, with a dosage volume of 0.4 mL / mouse per group; the control group and each experimental group were administered the drug by gavage. According to the equivalent dose conversion method (i.e., "body surface area conversion method") introduced in "Pharmacological Experimental Methodology" edited by Professor Xu Shuyun, the equivalent human dose was converted to the mouse dosage, with a human dose of 70 kg / mouse of 40 g. The mouse gavage dosage used 0.5% CMC-Na (carboxymethyl cellulose sodium) as the solvent, diluted with a precision pipette before gavage. Each group was administered the drug once daily for 7 consecutive days, and the weight of all mice was measured daily. The weight change (g) was calculated by subtracting the weight before the first administration from the weight at each detection time point.

[0037] Table 1 Mouse Grouping Instructions 4 / 13 pages 6 CN121221745 A Instruction Manual 5 / 13 Page 7 CN 121221745 A

[0038] The results are shown in Table 2: Table 2 Weight change of obese mice within 7 days of administration (g, Mean±SD, n=6) Instruction Manual 6 / 13 Page 8 CN 121221745 A Instruction Manual 7 / 13 Page 9 CN 121221745 A

[0039] ** indicates p<0.001 compared with the model control group, * indicates p<0.05 compared with the model control group. The mean line graph is shown in Figure 1.

[0040] In this embodiment, the contribution of different components to the weight loss effect was systematically evaluated by fixing the daily intake of simeter in mice. As can be seen from the results in Table 2, the weight gain of some experimental groups slowed down significantly after the 3rd day of administration. Example 11 showed the most outstanding performance, with a weight loss of -6.3 g on the 5th day, which was significantly better than any other single or dual additive combination, and the standard deviation was only 0.2 g, with the smallest individual variation. At low doses, the weight loss effect of a single component is weak, but when used in combination, it can show a synergistic effect, improving the weight loss effect. This indicates that the polypeptide composition of the present invention exhibits good weight management ability and metabolic regulation in a diet-induced obese mouse model, and the weight loss effect is similar to that of the control group.

[0041] Experimental Example 2 Evaluation of the alleviating effect of semaglutide preparation on related gastrointestinal adverse reactions 114 adult volunteers were recruited, half male and half female, with each volunteer having a BMI ≥24 kg / m2 or ≥28 kg / m2. All subjects first underwent a 20-week semaglutide adaptation period, and only subjects who tolerated the 2.4 mg dose in the 20th week could participate in the randomized experiment. Due to intolerance to 2.4 mg semaglutide and some personal reasons, 14 subjects were excluded, and finally 110 subjects participated in the experiment. The 110 volunteers were randomly divided into 22 groups, with 5 people in each group. The 22 groups are as follows: Experimental groups 1-20; Control group: semaglutide + SNAC; Placebo group: placebo (physiological saline).

[0042] Administration method: Oral, 400 mg / day per person. According to the grouping in Table 1, the total dose of each group is 400 mg, each group includes compound components, magnesium stearate 5g, and the rest is supplemented by microcrystalline cellulose.

[0043] At the baseline period and 6 months after the intervention, the subjects were assessed by a questionnaire on gastrointestinal adverse reactions (nausea, diarrhea, vomiting) to evaluate the moderating effect of Examples 1-20 on adverse reactions caused by semaglutide.

[0044] The statistical results are shown in Table 3: Table 3 Statistical results of the number of adverse reactions of subjects

[0045] As can be seen from the results in Table 3, the composition of the present invention significantly reduced the common adverse reactions of semaglutide during oral administration.The gastrointestinal adverse reactions were reduced, improving the tolerance and medication compliance of the subjects.

[0046] Experiment 3 Evaluation of the regulatory effect of blood alcohol concentration after drinking Male SD rats weighing 300 g ± 30 g were divided into 22 groups, with 5 rats in each group; the 22 groups are as follows: Examples 1 to 20, the comparative group is smegglutinin 56 mg + SNAC 300 mg, and the model group is distilled water. The examples and the comparative group were administered the compositions prepared in Examples 1 to 20 of this invention and the compositions of the comparative group by gavage 1 hour before ejaculation, respectively; the model group was administered an equal amount of distilled water by gavage. After gavage administration, the experimental group, the comparative group, and the model group were administered 38% alcohol by gavage at a volume fraction of 1 mL / kg. 2 hours after gavage administration, the blood alcohol content of the rats was tested.

[0047] The test results are shown in Table 4 and Figure 2; Table 4: Alcohol content in rat blood

[0048] Among them, there were statistically significant differences between Examples 1-20 and the control group (*p<0.05, **p<0.01, ***p<0.001).

[0049] As can be seen from the results in Table 4, the model group showed the highest blood alcohol concentration, indicating that its alcohol metabolism capacity was the lowest. The blood alcohol concentration of the control group did not change significantly compared with the model group and was still at a high level. In contrast, Examples 1-20 showed significant alcohol clearance capacity, and the blood alcohol concentration was generally lower than that of the control group. This invention improves the lifestyle compatibility of smegglutinin, especially suitable for people who need to balance weight management and daily drinking habits.

[0050] Example 4: Study on the intervention effect of alcohol-induced drunkenness. Kunming mice weighing about 40g were divided into a blank group (1 group), a model group (1 group of Smecta 56mg + SNAC 300mg, according to the instruction manual, pages 10 / 13, CN 121221745 A), and 60 experimental groups. The 60 experimental groups were divided into 20 high-dose groups (Examples 40-60), 20 medium-dose groups (Examples 1-20), and 20 low-dose groups (Examples 21-40), with 10 mice in each group. The blank group was given 0.4 mL of water per mouse by gavage daily, while the model group and experimental groups were given 0.4 mL of alcohol per mouse by gavage daily. One hour before gavage, the blank group was given 0.4 mL of water per mouse by gavage; one hour before gavage, the model group was given 0.4 mL of water per mouse by gavage; one hour before gavage, the experimental groups were given 0.4 mL of alcohol per mouse by gavage, with the dosage as in Table 1. The mice were treated continuously for 10 days, and the righting reflex was observed within 1 hour after oral administration of alcohol on days 8, 9, and 10. If a mouse could not turn over on its own within 30 seconds after being placed in a back position, it was considered to be intoxicated, and this was repeated 5 times.

[0051] The intoxication rate was calculated by conducting an experiment with 10 mice for 3 days, which is equivalent to 30 mice being tested within 3 days.Each mouse was turned over 5 times, and if the righting reflex disappeared in all 5 times, it was considered an intoxicated mouse.

[0052] The test results are shown in Table 5; Table 5 Test results of mouse anti-intoxication test Instruction manual 11 / 13 pages 13 CN 121221745 A

[0053] As can be seen from the results in Table 5, the medium dose has a better effect on relieving alcohol, while the high dose group has a worse effect on relieving alcohol than the medium dose group. This indicates that the content of simele is not directly proportional to the alcohol-relieving effect, and the low dose group also has a certain effect on relieving alcohol compared to the model group. Instruction manual 12 / 13 pages 14 CN 121221745 A

[0054] In summary, the present invention, through the synergistic design of specific polypeptide compositions, solves the problems of gastrointestinal adverse reactions and alcohol sensitivity in the clinical use of oral GLP-1 drugs while maintaining the efficacy, and significantly improves patient compliance and the scope of applicable population.

[0055] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention. Specification 13 / 13 pages 15 CN 121221745 A Figure 1 Figure 2 Specification Drawings 1 / 1 page 16 CN 121221745 A Abstract The present invention discloses a polypeptide composition and use thereof. The polypeptide composition includes a GLP-1 receptor agonist and any one or more of the following synergistic active components: (1) coenzyme Q10; (2) a nucleotide derivative; (3) a sulfur-containing amino acid derivative; (4) collagen tripeptide; (5) policosanol; and the GLP-1 receptor agonist is semaglutide or tirzepatide. The delivery system used in the present invention improves drug absorption efficiency and significantly reduces gastrointestinal sideeffects associated with oral administration of semaglutide, including abdominal distension, diarrhea, and constipation, thereby improving the administration experience and compliance of patients. In addition, the formulation of the present invention exhibits low sensitivity to alcohol consumption, does not significantly affect pharmacological effect, and is not likely to alter patient alcohol tolerance, thereby expanding the clinical applicability of semaglutide.

Claims

1. A polypeptide composition, characterized in that, The GLP-1 receptor agonist and any one or more of the following synergistically active ingredients: (1) coenzyme Q10; (2) nucleotide derivative; (3) sulfur-containing amino acid derivative; (4) collagen tripeptide; (5) poly-omega-alkanol; (6) human milk oligosaccharide. The GLP-1 receptor agonist is semaglutide or tirzepitide.

2. The polypeptide composition of claim 1, wherein, The GLP-1 receptor agonist is 3-90 parts by weight, the coenzyme Q10 is 1-50 parts by weight, the nucleotide derivative is 2-500 parts by weight, the sulfur-containing amino acid derivative is 1-60 parts by weight, the collagen tripeptide is 1-500 parts by weight, the poly-omega-alkanol is 1-300 parts by weight, and the human milk oligosaccharide is 1-300 parts by weight.

3. The polypeptide composition of claim 1, wherein The coenzyme Q10, nucleotide derivative, sulfur-containing amino acid derivative, collagen tripeptide, poly-omega-alkanol, or human milk oligosaccharide is a natural extract, fermentation product, chemical synthesis, or pharmaceutically acceptable salt or ester thereof.

4. The polypeptide composition of claim 1, wherein The polypeptide composition is an oral preparation.

5. The polypeptide composition of claim 4, wherein, The oral preparation is in the form of tablets, powder, capsules, or granules.

6. The polypeptide composition of claim 1, wherein The polypeptide composition is a drug or health product.

7. The polypeptide composition of claim 6, wherein, The drug includes one or more pharmaceutically acceptable carriers or excipients.

8. The polypeptide composition of claim 1, wherein The carriers or excipients include any one or more of diluents, fillers, binders, disintegrants, lubricants, glidants, granulating agents, coating agents, wetting agents, cosolvents, suspending agents, emulsifying agents, sweeteners, flavoring agents, taste-masking agents, coloring agents, anticaking agents, humectants, chelating agents, plasticizers, viscosity-increasing agents, antioxidants, preservatives, stabilizers, surfactants, and buffers.

9. Use of the polypeptide composition of any one of claims 1-8 in the preparation of a lipid-lowering drug or health product.

10. Use of the polypeptide composition of any one of claims 1-8 in the preparation of a drug or health product for preventing or treating obesity.