Dark plum extract enteric-coated preparation and application thereof in fatty liver
By developing enteric-coated preparations for black plum extract, using the combination of traditional Chinese medicine extract powder and probiotic bacteria powder, combined with the design of isolation layer and coating layer, the problem of lack of oral health products in the prior art to effectively prevent fatty liver is solved, and effective prevention of fatty liver is achieved.
Patent Information
- Application Number
- CN202411849172.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-16
- Publication Date
- 2025-03-14
AI Technical Summary
The prior art lacks effective oral health products to prevent fatty liver, and mainly relies on lifestyle changes.
Develop an enteric-coated preparation of black plum extract, ensuring rapid release and absorption of black plum extract in the intestine by including Chinese medicine extract powder and probiotic powder in the core layer of the drug, and using an isolation layer and a coating layer in the packaging.
This preparation can effectively improve the intestinal environment, promote the absorption of traditional Chinese medicine extracts and probiotics, reduce the total cholesterol and triglyceride content in the liver, thereby preventing fatty liver.
Smart Images
Figure CN119606900A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of medicines, in particular to an enteric-coated preparation of a black plum extract and application thereof in treating fatty liver. Background Art
[0002] Fatty liver disease is a liver disease associated with metabolic disorders, characterized by excessive fat accumulation in the liver. It is a global health problem, and its incidence is increasing worldwide with the prevalence of obesity and diabetes. Fatty liver disease is divided into non-alcoholic fatty liver disease (NAFLD) and alcoholic fatty liver disease (AFLD). NAFLD is the more common type and is closely related to lifestyle and eating habits.
[0003] Currently, there is no specific drug to treat fatty liver. Prevention is the main approach, which focuses on lifestyle changes, including healthy diet, increased physical activity, weight control, and avoiding excessive drinking. Therefore, it is necessary to find an oral health product that can prevent fatty liver, which can be combined with lifestyle changes such as healthy diet and physical activity to better prevent fatty liver. Summary of the invention
[0004] The purpose of the present invention is to provide an enteric-coated preparation of black plum extract and its application in fatty liver, and the purpose is to overcome the above-mentioned problems existing in the prior art.
[0005] To achieve the above object, the present invention provides the following technical solutions: An enteric-coated preparation of black plum extract, comprising a drug core layer, an isolation layer and a coating layer from the inside to the outside, wherein the drug core layer comprises a main drug pill and an auxiliary drug pill; The main pills contain 10-12 parts of Chinese medicine extract powder, 30-35 parts of probiotic powder, 8-15 parts of pill accelerator and 5-10 parts of disintegrating agent; The auxiliary pills contain 30-50 parts of black plum extract powder, 8-15 parts of pill accelerators and 15-30 parts of disintegrating agents.
[0006] Furthermore, the Chinese medicine extract powder is extracted and concentrated by decoction of Polygonum multiflorum, Crataegus pinnatifida, Salvia miltiorrhiza, Paeonia lactiflora, Fructus Lycii and Cassiae obtusifolia, and then processed and dried by ultrafine grinding technology.
[0007] Furthermore, the raw materials of the above-mentioned Chinese medicine extract powder include 7-10 parts of Polygonum multiflorum, 7-10 parts of Crataegus pinnatifida, 15-20 parts of Salvia miltiorrhiza, 7-10 parts of White Peony Root, 13-15 parts of Lycium barbarum and 3-4 parts.
[0008] Furthermore, the pill-forming agent is a mixture of maltodextrin and inulin, and the disintegrant is sodium carboxymethyl starch.
[0009] A method for preparing the enteric-coated preparation of the black plum extract as described above, wherein the main pills are prepared by the following method: 8 parts of Polygonum multiflorum, 7 parts of Crataegus pinnatifida, 15 parts of Salvia miltiorrhiza, 8 parts of Paeonia lactiflora, 14 parts of Lycium barbarum and 3 parts of Cassia tora are decocted with water for 2-2.5 hours and extracted twice; the extract is filtered and concentrated to obtain a Chinese medicine extract concentrate with a concentration of 0.4 g crude drug / ml; the extract is processed and dried using ultrafine grinding technology to obtain a Chinese medicine extract powder for later use; 12 parts of Chinese herbal extract powder, 35 parts of probiotic powder, 10 parts of pill accelerator, 5 parts of disintegrating agent and 10-15 parts of distilled water at a temperature of 30-39° C. are mixed and then made into pills.
[0010] Further, the auxiliary pills are prepared by the following method: Grind the pulp of black plum into a powder of 55-60 mesh, put it in a container, add distilled water at a liquid-solid ratio of (14-15):1, soak for 90-100 minutes, heat to 85-90°C, reflux and extract for 1.2-1.5 hours, extract twice, filter and concentrate the extract to obtain a black plum extract concentrate with a specific gravity of 1.07g / ml, and set aside; 45 parts of black plum extract powder, 10 parts of pill accelerator, 15 parts of disintegrant and 8-10 parts of distilled water at a temperature of 50-55° C. are mixed and then made into pills.
[0011] Further, the isolation layer is prepared by the following method: 2% hydroxypropyl methylcellulose is used to coat the outer surface of the main pill with a first isolation layer; the auxiliary pill is closely attached to the surface of the first isolation layer and placed in an oven at 40-45°C for drying; The second isolation layer is coated on the outer surface of the first isolation layer and the auxiliary pills with 2% hydroxypropyl methylcellulose, and then placed in an oven at 45-50°C for drying.
[0012] An application of any of the above enteric-coated preparations of black plum extract, using the enteric-coated preparation of black plum extract as a drug for preventing fatty liver.
[0013] Furthermore, the probiotics in the probiotic powder are Lactobacillus rhamnosus LGG.
[0014] Compared with the prior art, the present invention has the following beneficial effects: First, in the present invention, the Chinese medicine extract powder of the main pill is obtained by extracting and granulating from Polygonum multiflorum, Crataegus pinnatifida, Salvia miltiorrhiza, Paeonia lactiflora, Fructus Lycii and Cassiae cassiae through water decoction, which can soothe the liver and spleen, reduce fat and remove blood stasis. The auxiliary pill of the enteric-coated preparation of Prunus mume extract is a Prunus mume extract obtained by water decoction, which is rich in organic acids such as citric acid and malic acid, can improve the intestinal environment, promote the attachment, growth and activity of the probiotics of the main pill in the intestine, form an intestinal barrier, maintain and restore intestinal health, enhance the body's immunity, etc., and promote the absorption of the Chinese medicine extract powder in the intestine. In addition, citric acid and malic acid can inhibit the activity of intestinal lipase, thereby preventing the digestion of dietary lipids in the digestive tract. It can be seen that the present invention can prevent fatty liver.
[0015] Secondly, in the present invention, when encapsulating the isolation layer, the thickness of the isolation layer at the main pill is made greater than its thickness at the auxiliary pill, so that the auxiliary pill is released in the intestine before the main pill and improves the intestinal environment, further promoting the absorption of the Chinese medicine extract powder of the main pill in the intestine, the attachment, growth and activity of probiotics in the intestine, and greatly improving the efficacy of the enteric-coated preparation.
[0016] Third, in the present invention, the main pills have more pill promoters and less disintegrating agents than the auxiliary pills, while the auxiliary pills have less pill promoters and more disintegrating agents. This can make the auxiliary pills decompose and release more quickly in the intestine than the main pills, further increase the time difference between the auxiliary pills and the main pills, and provide enough time for the auxiliary pills to improve the intestinal environment, so that the main pills can better exert their efficacy, further improving the efficacy of the enteric-coated preparation. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Figure 1 This is a partial cross-sectional view of an enteric-coated preparation of black plum extract in the present invention.
[0018] Figure 2 This is a schematic half-section diagram of an enteric-coated preparation of black plum extract in the present invention.
[0019] Figure 3 This is a table showing the average body weight of mice in each group in the animal experiment.
[0020] Figure 4 This is a numerical table of the average total cholesterol content in the liver tissue of each group of mice in the animal experiment.
[0021] Figure 5 This is a numerical table of the average triglyceride content in the liver tissue of each group of mice in the animal experiment. DETAILED DESCRIPTION
[0022] The specific implementation of the present invention is described below with reference to the accompanying drawings. In order to fully understand the present invention, many details are described below, but for those skilled in the art, the present invention can be implemented without these details.
[0023] like Figure 1 , an enteric-coated preparation of black plum extract, comprising, from inside to outside, a drug core layer 1, an isolation layer 2 and a coating layer 3, wherein the drug core layer 1 comprises a main drug pill 11 and an auxiliary drug pill 12; The main pill 11 contains 10-12 parts of Chinese medicine extract powder, 30-35 parts of probiotic powder, 8-15 parts of pill promoter and 5-10 parts of disintegrating agent; wherein the Chinese medicine extract powder is extracted and concentrated by Polygonum multiflorum, Crataegus, Salvia miltiorrhiza, Paeonia lactiflora, Lycium barbarum and Cassia tora by water decoction, and then processed and dried by ultrafine grinding technology.
[0024] Preferably, the raw materials of the Chinese medicine extract powder include 7-10 parts of Polygonum multiflorum, 7-10 parts of Crataegus pinnatifida, 15-20 parts of Salvia miltiorrhiza, 7-10 parts of White Peony Root, 13-15 parts of Lycium barbarum and 3-4 parts of Radix Glehniae.
[0025] In one embodiment, the probiotics in the probiotic powder are Lactobacillus rhamnosus LGG.
[0026] The auxiliary pill 12 contains 30-50 parts of black plum extract powder, 8-15 parts of pill accelerator and 15-30 parts of disintegrating agent.
[0027] In one embodiment, the pill enhancer is a mixture of maltodextrin and inulin, and the disintegrant is sodium starch glycolate.
[0028] In one embodiment, the surface of the main pill 11 is wrapped with a first isolation layer 21; one side of the auxiliary pill 12 is closely attached to the first isolation layer 1. The outer surfaces of the first isolation layer 1 and the auxiliary pill 12 are wrapped with a second isolation layer 22, and the isolation layer 2 is composed of the first isolation layer 1 and the second isolation layer 22. The thickness of the isolation layer 2 at the main pill 11 is greater than its thickness at the auxiliary pill 12. Preferably, the thickness of the first isolation layer 1: the second isolation layer 22 is (0.5-1):1.
[0029] like Figure 1 A method for preparing the above-mentioned enteric-coated preparation of black plum extract comprises the following steps: (1) Preparation of main pill 11: 8 parts of Polygonum multiflorum, 7 parts of Crataegus pinnatifida, 15 parts of Salvia miltiorrhiza, 8 parts of Paeonia lactiflora, 14 parts of Lycium barbarum and 3 parts of Cassia tora are decocted with water for 2-2.5 hours, and extracted twice; the extract is filtered and concentrated to obtain a Chinese medicine extract concentrate with a concentration of 0.4 g crude drug / ml; ultrafine grinding technology is used to process and dry the Chinese medicine extract powder for standby use; preferably, the processing temperature of the ultrafine grinding technology is 60-80°C, and the drying temperature is 40-45°C.
[0030] Mix 12 parts of Chinese medicine extract powder, 35 parts of probiotic powder, 10 parts of pill promoter, 5 parts of disintegrant and 10-15 parts of distilled water at a temperature of 30-39°C, and then make pills. It should be noted that in order to prevent the activity of probiotics from decreasing, mixing and pilling must be carried out in anoxic or anaerobic environment. Pill promoters contain maltodextrin and inulin. Specifically, maltodextrin and inulin are put into a wet granulation pot, distilled water is added and stirred for granulation, placed in a fluidized bed for drying, and sieved to obtain granules; the disintegrant is sodium carboxymethyl starch. Of course, pill promoters and disintegrants can also be made of other suitable existing materials, and there are no excessive restrictions on this.
[0031] (2) Preparation of auxiliary pills 12: The pulp of black plum is ground into a powder of 55-60 mesh, placed in a container, and distilled water is added at a liquid-to-solid ratio of (14-15):1, soaked for 90-100 minutes, heated to 85-90°C and refluxed for extraction for 1.2-1.5 hours, extracted twice, and the extract is filtered and concentrated to obtain a black plum extract concentrate with a specific gravity of 1.07 g / ml; ultrafine grinding technology is used to process and dry the black plum extract powder for standby use; preferably, the processing temperature of the ultrafine grinding technology is 60-80°C, and the drying temperature is 40-45°C.
[0032] Mix 45 parts of black plum extract powder, 10 parts of pill promoter, 15 parts of disintegrant and 8-10 parts of distilled water at a temperature of 50-55°C, and then make pills. Among them, the pill promoter contains maltodextrin and inulin. Specifically, maltodextrin and inulin are put into a wet granulation pot, distilled water is added and stirred for granulation, placed in a fluidized bed for drying, and sieved to obtain granules; the disintegrant is sodium carboxymethyl starch. Of course, pill promoters and disintegrants can also be made of other suitable existing materials, and there are no excessive restrictions on this.
[0033] (2) Preparation of isolation layer 2: 2% hydroxypropyl methylcellulose is used to coat the outer surface of the main pill 11 with a first isolation layer 21; the auxiliary pill 12 is closely attached to the surface of the first isolation layer 1, and is placed in a 40-45°C oven for drying, so that one side of the auxiliary pill 12 is fixedly bonded to the first isolation layer 21; The second isolation layer 22 is coated on the outer surface of the first isolation layer 1 and the auxiliary pill 12 with 2% hydroxypropyl methylcellulose, and placed in an oven at 45-50°C for drying. The isolation layer 2 is composed of the first isolation layer 1 and the second isolation layer 22. The thickness of the isolation layer 2 at the main pill 11 is greater than the thickness at the auxiliary pill 12. Preferably, the thickness of the first isolation layer 1: the second isolation layer 22 is (0.5-1):1.
[0034] (3) Preparation of coating layer 3: The coating layer 3 is coated on the outside of the isolation layer 2 by using a fluidized bed and dried, thereby obtaining an enteric preparation.
[0035] In one embodiment, distilled water is heated, a plasticizer and an emulsifier are added and mixed, an anti-adherent agent is added and mixed, and then an acrylic resin is added to obtain a coating solution; of course, the coating layer 3 and its preparation are conventional techniques for enteric preparations, and can be adjusted according to needs in practice, and no excessive restrictions are made here.
[0036] The present invention also discloses and protects the use of the enteric-coated preparation of the black plum extract, which is used as a drug for preventing fatty liver. The probiotics in the probiotic powder are Lactobacillus rhamnosus LGG.
[0037] Animal experiments 1. Test conditions Male 5-week-old KM mice (Kunming mice) weighing 32±0.5 g were purchased from Liaoning Changsheng Biotechnology Co., Ltd. Eight KM mice were divided into six groups and housed in ventilated cages. The ambient temperature was 21±1°C, the relative humidity was 50-60%, and the light cycle was 12 hours light and 12 hours dark. KM mice had free access to food and distilled water.
[0038] 2. Experimental Grouping (1) Control group 1: fed with normal diet for 7 weeks and then with saline; (2) Control group 2: fed with 45% high-fat diet for 7 weeks and saline; (3) Control group 3: fed with 45% high-fat feed for 7 weeks, and fed with the main pills of the present invention (the main pills are coated with an isolation layer and a coating layer, and the thickness of the isolation layer is equivalent to the thickness of the second isolation layer); (4) Control group 4: fed with 45% high-fat diet for 7 weeks, and fed with the auxiliary pills of the present invention (the auxiliary pills are coated with an isolation layer and a coating layer, and the thickness of the isolation layer is equivalent to the thickness of the second isolation layer); (5) Control group 5: fed with 45% high-fat feed for 7 weeks, and fed with the main pills and auxiliary pills of the present invention at the same time (the main pills and auxiliary pills are separately packaged with an isolation layer and a coating layer, and the thickness of the isolation layer is equivalent to the thickness of the second isolation layer); (6) Target group 6: fed with 45% high-fat diet for 7 weeks and fed with the enteric-coated preparation of the black plum extract of the present invention; 3. Test and Inspection The body weight of each group of KM mice, as well as the total cholesterol and triglyceride content in the liver tissue, were detected and recorded, and the average values of each group were plotted into a table, as shown in Figure 3 , Figure 4 and Figure 5 shown.
[0039] like Figure 3As shown, in terms of weight, the value of control group 1 is the smallest, the value of target group 6 and control groups 2-4 are higher than that of control group 1, and the value of control group 2 is the largest; in addition, the difference between the values of target group 6 and control group 1 is the smallest.
[0040] like Figure 4 As shown, in terms of total cholesterol content, the control group 1 had the smallest value, the target group 6 and the control groups 2-4 were all higher than the control group 1, and the control group 4 had the largest value; in addition, the difference between the values of the target group 6 and the control group 1 was the smallest, followed by the control group 5.
[0041] like Figure 5 As shown, in terms of triglyceride content, the control group 1 has the smallest value, the target group 6 and the control groups 2-4 are all higher than the control group 1, and the control group 2 has the largest value; in addition, the difference between the values of the target group 6 and the control group 1 is the smallest, followed by the control group 5.
[0042] In summary, the main pills of the present invention can significantly reduce the total cholesterol content and triglyceride content of liver tissue, and the auxiliary pills can significantly reduce the triglyceride content of liver tissue, with little effect on the total cholesterol content; and the finished product of the present invention, the enteric-coated preparation of ebony extract, can significantly reduce the total cholesterol content and triglyceride content of liver tissue, and the effect is 3-5 times better than that of the control group. Therefore, the enteric-coated preparation of ebony extract disclosed in the present invention can effectively prevent fatty liver and can be used as a health product or medicine for preventing fatty liver.
[0043] The above is only a specific implementation of the present invention, but the design concept of the present invention is not limited thereto. Any non-substantial changes to the present invention using this concept shall be deemed as an infringement of the protection scope of the present invention.
Claims
1. An enteric-coated preparation of black plum extract, comprising, from inside to outside, a drug core layer (1), an isolation layer (2) and a coating layer (3), characterized in that: The drug core layer (1) comprises a main drug pill (11) and an auxiliary drug pill (12); The main pill (11) comprises 10 to 12 parts of Chinese medicine extract powder, 30 to 35 parts of probiotic powder, 8 to 15 parts of pill accelerator and 5 to 10 parts of disintegrating agent; The auxiliary pill (12) comprises 30 to 50 parts of black plum extract powder, 8 to 15 parts of pill accelerator and 15 to 30 parts of disintegrating agent.
2. The enteric-coated preparation of black plum extract according to claim 1, characterized in that: The Chinese medicine extract powder is prepared by extracting and concentrating Polygonum multiflorum, hawthorn, salvia miltiorrhiza, white peony root, wolfberry fruit and cassia tora by water decoction, and then processing and drying by ultrafine grinding technology.
3. The enteric-coated preparation of black plum extract according to claim 2, characterized in that: The raw materials of the Chinese medicine extract powder include 7 to 10 parts of Polygonum multiflorum, 7 to 10 parts of Crataegus pinnatifida, 15 to 20 parts of Salvia miltiorrhiza, 7 to 10 parts of White Peony Root, 13 to 15 parts of Lycium barbarum and 3 to 4 parts of.
4. The enteric-coated preparation of black plum extract according to claim 1, characterized in that: The pill accelerator is a mixture of maltodextrin and inulin, and the disintegrant is sodium carboxymethyl starch.
5. A method for preparing the enteric-coated preparation of black plum extract according to any one of claims 2, 3 or 4, characterized in that: The main pill (11) was prepared by the following method; 8 parts of Polygonum multiflorum, 7 parts of Crataegus pinnatifida, 15 parts of Salvia miltiorrhiza, 8 parts of Paeonia lactiflora, 14 parts of Lycium barbarum and 3 parts of Cassia tora are decocted with water for 2-2.5 hours and extracted twice; the extract is filtered and concentrated to obtain a Chinese medicine extract concentrate with a concentration of 0.4 g crude drug / ml; the extract is processed by ultrafine grinding technology (temperature 60-90°C) and dried (temperature 100-110°C) to obtain a Chinese medicine extract powder for standby use; 12 parts of Chinese herbal extract powder, 35 parts of probiotic powder, 10 parts of pill accelerator, 5 parts of disintegrating agent and 10-15 parts of distilled water at a temperature of 30-39° C. are mixed and then made into pills.
6. The enteric-coated preparation of black plum extract according to claim 5, characterized in that: The auxiliary pill (12) is prepared by the following method; The pulp of black plum is ground into a powder of 55-60 mesh, placed in a container, and distilled water is added at a liquid-solid ratio of (14-15):1, soaked for 90-100 minutes, heated to 85-90°C, refluxed for extraction for 1.2-1.5 hours, extracted twice, and the extract is filtered and concentrated to obtain a black plum extract concentrate with a specific gravity of 1.07 g / ml; ultrafine grinding technology is used to process and dry to obtain a black plum extract powder for later use; 45 parts of black plum extract powder, 10 parts of pill accelerator, 15 parts of disintegrant and 8-10 parts of distilled water at a temperature of 50-55° C. are mixed and then made into pills.
7. The enteric-coated preparation of black plum extract according to claim 5 or 6, characterized in that: The isolation layer (2) is prepared by the following method; A first isolation layer (21) is coated on the outer surface of the main drug pill (11) using 2% hydroxypropyl methylcellulose; the auxiliary drug pill (12) is closely attached to the surface of the first isolation layer (21) and placed in an oven at 40 to 45°C for drying; A second isolation layer (22) is coated on the outer surface of the first isolation layer (1) and the auxiliary pills (12) with 2% hydroxypropyl methylcellulose, and the coating is placed in an oven at 45 to 50°C for drying.
8. An application of the enteric-coated preparation of black plum extract according to any one of claims 1 to 4, characterized in that: The enteric-coated preparation of black plum extract is used as a medicine for preventing fatty liver.
9. An application of the enteric-coated preparation of black plum extract as claimed in claim 8, characterized in that: The probiotics of the probiotic powder are Lactobacillus rhamnosus LGG.