Biocompatible capsule preparation for controlling and reducing weight of mammals

Abstract

The invention provides a biocompatible capsule preparation for controlling and reducing the body weight of mammals, the biocompatible capsule preparation comprises a capsule shell and polyoxyethylene particles encapsulated in the capsule shell, the capsule shell is gastric soluble and / or enteric soluble, the weight-average molecular weight of polyoxyethylene is 1 million Dalton to 7 million Dalton, and the weight-average molecular weight of polyoxyethylene is 1 million Dalton to 7 million Dalton. The average particle size of the polyoxyethylene particles is 0.5 [mu] m to 2000 [mu] m. The biocompatible capsule preparation disclosed by the invention can form a physical adhesive film on the surfaces of intestines and stomach, continuously wrap the surfaces of the intestines and stomach, increase satiety, reduce food intake and reduce heat absorption to a certain extent, so that the aim of reducing the fat content of a human body is fulfilled.

Description

Technical Field

[0001] The present invention relates to the field of biomedicine. Specifically, the present invention relates to a biocompatible capsule preparation for controlling and reducing the body weight of mammals. Background Art

[0002] Obesity is a chronic disease, which is related to various factors such as genetics, diet structure, and lifestyle. With the improvement of living standards, the number of overweight and obese people is increasing day by day. Obesity not only affects daily life and beauty effects, but also causes a series of concurrent diseases such as hypertension, hyperlipidemia, diabetes, and cardiovascular and cerebrovascular diseases, seriously endangering the health of obese people. Therefore, controlling body weight and losing weight have become important means for preventing and treating the above diseases and have gradually attracted people's attention.

[0003] At present, the ways of losing weight mainly include exercise and diet, surgical treatment, drug treatment and other means. There are certain limitations in losing weight through exercise and diet. When diet and exercise are difficult to play a role, other means are often needed to assist in treatment. Surgical treatments such as gastric resection and liposuction can play a role in losing weight to a certain extent, but the surgical price is expensive, and the risks of trauma and metabolic complications are relatively large, and they cannot be used repeatedly for a long time. Various weight loss drugs or health products are still the main means relied on in the weight loss market, including categories such as appetite suppression, inhibition of digestion and absorption, and promotion of energy consumption. Their mechanisms of action mostly involve metabolism and absorption through the human liver or kidneys to achieve the effect of losing weight. However, there are still many adverse reactions when taking such products. Taking such drugs for a long time will cause damage to the human liver or kidneys. Therefore, healthy weight loss products that do not involve metabolism and absorption have gradually gained the favor of the public. Among them, the gastric occupying expansion ball is an effective weight loss means. An expansion ball is placed in the stomach by means of an instrument, and then physiological saline or gas is injected, or gas is released by the reaction of substances in the ball, so that the expansion ball expands in the stomach, increasing the sense of fullness and reducing the intake of patients to achieve the weight loss effect. However, the expansion ball needs to exist in the stomach for a long time, which will cause compression on the stomach and cause the stomach to expand, resulting in effectiveness during the treatment period, but increased food intake and weight rebound after discontinuation. Another type of healthy weight loss product, gastric occupying capsules or oral liquids, need to be swallowed before meals. After that, the elastic material expands in the stomach to form a hydrogel to occupy the stomach space in advance, reducing the intake of patients to achieve the weight loss effect. However, it has the problems of short action time and frequent administration, and cannot fully play the weight loss effect. Therefore, there is an urgent need in the weight loss field for safe and healthy weight loss products that are convenient to use, have a long effect time, and do not involve metabolism and absorption, so as to bring healthy and effective treatment effects to obese patients.

[0004] In addition, there has been no report in the prior art on using polyoxyethylene to make a capsule preparation for controlling and reducing the body weight of mammals. Summary of the Invention

[0005] On the one hand, one of the objects of the present invention is to provide a biocompatible capsule preparation for controlling and reducing the weight of mammals, which comprises a capsule shell and polyoxyethylene particles encapsulated therein, wherein:

[0006] The capsule shell is gastric-soluble and / or enteric-soluble;

[0007] The weight-average molecular weight of polyoxyethylene is from 1 million to 7 million Daltons;

[0008] The average particle size of the polyoxyethylene particles is from 0.5 μm to 2000 μm.

[0009] In some embodiments of the present invention, after the mammalian oral administration of the capsule preparation, the capsule shell is soluble in the digestive tract, so that the encapsulated polyoxyethylene particles are released into the digestive tract and form a viscous film covering the digestive tract mucosa in the digestive tract.

[0010] In some embodiments of the present invention, the duration of the viscous film adhering to the digestive tract mucosa is not less than 24 hours.

[0011] In some embodiments of the present invention, the adhesion force of the viscous film to the digestive tract mucosa is not less than 1 N.

[0012] In some embodiments of the present invention, the average particle size of the polyoxyethylene particles is from 50 μm to 500 μm.

[0013] In some embodiments of the present invention, at a concentration of 1.0 - 2.0 wt%, the viscosity of the polyoxyethylene particles is 2000 - 4000 mPa·s.

[0014] In some embodiments of the present invention, after the mammalian oral administration of the capsule preparation, the dissolution time of the capsule shell in the digestive tract is from 10 seconds to 100 seconds.

[0015] In some embodiments of the present invention, the weight-average molecular weight of the polyoxyethylene is from 2 million to 4 million Daltons.

[0016] In some embodiments of the present invention, the capsule preparation further comprises a nutritional supplement encapsulated in the capsule shell.

[0017] On the other hand, another object of the present invention is to provide a pharmaceutical use of the capsule preparation according to the first aspect of the present invention, that is, to provide the application of the biocompatible capsule preparation in the preparation of a drug for controlling and reducing the weight of mammals.

[0018] The present invention has the following advantages over the prior art: By selecting polyoxyethylene particles with specific molecular weights and specific particle sizes, the present invention prepares them into a capsule preparation. Moreover, the capsule shell of the capsule preparation can dissolve in the digestive tract of mammals, thereby releasing the polyoxyethylene particles in the capsule and forming a physical adhesion film on the surface of the digestive tract. When the capsule shell is gastric-soluble and / or enteric-soluble, the polyoxyethylene particles can be positioned and released into the stomach or the intestine, forming a physical adhesion film on the surface of the stomach and intestine, continuously wrapping the surface of the stomach and intestine, increasing the sense of fullness, reducing food intake, and at the same time reducing the absorption of calories to a certain extent, so as to achieve the purpose of reducing the body fat content. In addition, when the biocompatible capsule preparation of the present invention contains an appropriate amount of nutritional supplements, it can obtain nutritional supplements while controlling weight.

[0019] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. Brief Description of the Drawings

[0020] Figure 1 It is a schematic diagram of the adhesion force test for evaluating the adhesion performance in the embodiment of the present invention;

[0021] Figure 2 It is a schematic diagram of the tolerance test for simulating the digestive tract environment in the embodiment of the present invention;

[0022] Figure 3 It is the erosion experiment result of capsule preparations #1-#4 in the embodiment of the present invention;

[0023] Figure 4 It is the erosion test result of comparative preparations #10 to #12. Detailed Description of the Embodiments

[0024] The technical solution of the present invention will be further elaborated below in conjunction with the exemplary embodiments and drawings of the present invention. Obviously, the embodiments described herein are only for illustrative purposes and do not exhaust all embodiments of the present invention. The following description of the exemplary embodiments is merely illustrative and does not constitute any limitation to the protection scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

[0025] Unless otherwise specifically stated, the numerical values and numerical ranges recited in the exemplary embodiments of the present invention do not constitute any limitation to the protection scope of the present invention. For the sake of brevity, the technologies and methods known to those of ordinary skill in the relevant art are not described in detail herein, but where appropriate, the known technologies and methods should be regarded as part of this specification. In all the examples recited herein, any specific value should be construed as merely exemplary and not constituting any limitation. Therefore, other examples other than the exemplary embodiments may have different values.

[0026] Example 1

[0027] This embodiment provides a series of capsule preparations #1 to #4 containing poly(ethylene oxide) (PEO) particles with different molecular weights for controlling and reducing the body weight of mammals. The shells of these capsules are gastric-soluble, and their encapsulates contain PEO particles with the physicochemical properties listed in Table 1 below.

[0028] Table 1 Exemplary capsule dosage forms and physicochemical parameters of the PEO contained therein

[0029]

[0030] The capsules in this embodiment can dissolve within 1 hour after being administered to the stomach of a mammal, thereby releasing the PEO particles encapsulated in the capsule shell. The PEO particles encapsulated in the capsule shell in this embodiment can be obtained through commercial channels or prepared by methods known in the art. The PEO particles in this embodiment are prepared by the following steps:

[0031] (a) Place PEO particles with different weight-average molecular weights as raw materials in a granulator;

[0032] (b) Add purified water to the raw materials placed in the granulator in step (a);

[0033] (c) Granulate and screen at 40°C to 60°C, and encapsulate the PEO particles with a particle size of 50 μm to 500 μm in the capsule shell to obtain a capsule preparation for controlling and reducing body weight. The weight of a single capsule can be determined according to the actual situation.

[0034] In order to evaluate the technical effects of the capsule preparations #1 to #4 in this embodiment, the viscosity of the PEO particles in each capsule preparation, the adhesion force of the PEO particles to the digestive tract mucosa, the adhesion effect on the digestive tract mucosa and the tolerance to the digestive tract environment, and the control effect of the capsule preparation on the body weight of mammals are tested respectively as follows.

[0035] 1.1 Viscosity test of PEO particles

[0036] In order to enable the viscous film covering the digestive tract mucosa formed by the capsule preparation in the digestive tract to have sufficient viscosity, the PEO particles of the present invention need to have a sufficient viscosity value. The viscosity tests of the capsule preparations #1 to #4 in this example are as follows:

[0037] 1.1.1 Purpose:

[0038] Test the viscosity of the raw material PEO particles used in the preparation of capsules #1 - #4 under the condition of 2% wt concentration. 1.1.2 Method:

[0039] Inspect according to the method specified in "Polyethylene Oxide" in the Pharmacopoeia of the People's Republic of China (2020 Edition, Volume IV): Weigh accurately 12 g of polyethylene oxide and place it in an 800 ml beaker. Add 125 ml of anhydrous isopropanol, and stir at high speed (400 r / min) to disperse evenly. Add 588 mL of carbon dioxide-free water, and continue to stir at high speed for 1 minute (splashing of the solution should be avoided). Then continue to stir slowly (60 r / min) for 3 hours until there is no gel in the solution (prevent the volatilization of water in an appropriate way). Place it in a water bath for 30 minutes to maintain the temperature of the solution at 25 ± 0.1 °C. Use a suitable rotational viscometer and rotor to inspect according to Method 3 of General Rule 0633 in the Pharmacopoeia of the People's Republic of China (2020 Edition, Volume IV).

[0040] 1.1.3 Results:

[0041] Table 2 Viscosity values of the raw material PEO particles used in capsules #1 - #4

[0042] #1 #2 #3 #4 Viscosity (mPa·s) 2800 3100 3350 3600

[0043] 1.2 Test on the adhesion force to the digestive tract mucosa:

[0044] The adhesion force between the viscous film covering the digestive tract mucosa formed by the capsule preparation in the digestive tract and the digestive tract mucosa is also one of the factors to achieve the present invention. The adhesion performance tests of the capsule preparations #1 to #4 in this example are as follows:

[0045] 1.2.1 Purpose:

[0046] Evaluate the adhesion performance of the PEO particles in capsules #1 to #4 through the adhesion force test.

[0047] 1.2.2 Test method:

[0048] In the present invention, the tester shown as Figure 1 is used for the test. Take an excised pig stomach, lay its mucosal layer outwards and fix it to the robotic arms at both ends of the adhesion force tester. Take 0.3 g of the PEO particles in each of the above-prepared capsule preparations #1 to #4 and scatter them evenly on the mucosal surface of the robotic arm at the lower end of the tester (about 2 cm 2), and then after about 10 seconds, it can be observed that a colloid is formed on the mucosal surface. Set the parameters of the test instrument: compression speed: 20 mm / min, switching condition: force ≤ -50 gf, pause time: 0.5 min, stretching speed: 20 mm / min, and run the instrument to test the adhesion force.

[0049] 1.2.3 Test results:

[0050] Table 3 Test results of the adhesion force of PEO particles to the digestive tract mucosa

[0051]

[0052] As can be seen from Table 3, the adhesion force of the PEO particles in the above capsule preparations #1 to #4 to the digestive tract mucosa is greater than 1 N.

[0053] 1.3 Test on the adhesion effect on the digestive tract mucosa and the tolerance to the digestive tract environment:

[0054] In order to achieve the purpose of controlling and reducing weight, the viscous film formed by the capsule preparation of the present invention covering the digestive tract mucosa in the digestive tract should last for a sufficient time, such as not less than 24 hours. The following is a simulation test on the duration of the exemplary capsule preparations #1 to #4 in the digestive tract environment.

[0055] 1.3.1 Purpose: To detect the adhesion force of PEO in the above capsule preparations #1 to #4 and the tolerance to the in vivo environment (artificial gastric juice and artificial intestinal juice) through the adhesion performance test.

[0056] 1.3.2 Method: Artificial gastric juice (pH = 1) and artificial intestinal juice (pH = 8) are prepared as standard solutions according to the Pharmacopoeia of the People's Republic of China (2020 Edition). Take 16.4 mL of dilute hydrochloric acid, add 800 mL of water and 10 g of pepsin, shake well to dissolve it completely, adjust the pH value to 1.3, and dilute with water to a constant volume of 1000 mL to obtain artificial gastric juice; take 6.8 g of potassium dihydrogen phosphate, add 500 mL of water to dissolve it, adjust the pH value to 6.8 with 0.1 mol / L sodium hydroxide solution, and weigh another 10 g of trypsin and dissolve it in an appropriate amount of water. Mix the two solutions and dilute with water to a constant volume of 1000 mL to obtain artificial intestinal juice.

[0057] In this embodiment, the inclined plate device as Figure 2 shown is used to simulate the digestive tract environment for testing the tolerance. Take the excised pig stomach or intestine for the test respectively, and lay the mucosal layer outwards flat on the inclined plate device according to Figure 2 shown. Scatter 0.3 g of each of the PEO particles in the above capsule preparations #1 to #4 evenly on the mucosa (about 2 cm 2) A small amount of dye was dropped for staining to facilitate observation. About 10 seconds after applying the PEO in capsule preparations #1 to #4 to the mucosa, it was observed that a colloid was formed on the mucosal surface. Subsequently, the colloid formed on the mucosal surface was flushed with artificial gastric juice or artificial intestinal juice at a rate of 2.5 L / 24 h, and the residence time of the colloid on the mucosal surface under the flushing conditions was observed.

[0058] 1.3.3 Results: The flushing experiment results of capsule preparations #1 - #4 are as Figure 3 shown.

[0059] It can be Figure 3 seen that in the simulated digestive tract environment (i.e., flushing with artificial gastric juice or artificial intestinal juice), the PEO particles in the capsule preparations of the present invention are released and can quickly form a viscous film on the surface of the digestive tract mucosa. This viscous film has sufficient tolerance to artificial gastric juice and artificial intestinal juice, and will not degrade and lose its adhesiveness due to the acidity of the stomach or the alkalinity in the intestine. At the same time, it has sufficient adhesive properties to the digestive tract mucosa, with an adhesive force greater than 1 N and can stay on the mucosal surface for at least 24 hours, which is sufficient to continuously wrap the surface of the stomach and intestines to exert its efficacy.

[0060] 1.4 Control effect of the capsule on body weight:

[0061] 1.4.1 Purpose: To explore the control effect of the capsule on the body weight of rats.

[0062] 1.4.2 Methods:

[0063] 1) Grouping: 50 experimental rats were divided into 5 groups, with 10 rats in each of the control group, experimental group #1, experimental group #2, experimental group #3, and experimental group #4.

[0064] 2) Animal condition: The body weight of the rats was 300 - 350 g and they were 10 weeks old.

[0065] 3) Specification and dosage: Gastric - soluble capsules, 10 mg / capsule, 4 capsules per rat per time, once a day.

[0066] 4) Administration method: Swallowing. Use straight forceps to hold the capsule and place it at the throat of the rat, and use a gavage needle to deliver drinking water to send the capsule down.

[0067] 5) Feeding: Each group of rats was provided with 1000 g of commercially available cereal feed, and the feed was replenished regularly every day.

[0068] 6) Operation plan: The experimental groups were given 4 capsules orally every day for 7 consecutive days. The control group was fed normally without treatment. The body weight and feed intake of each group of rats were measured and recorded at the same time every day (calculated according to the reduction of feed). 12 hours after the end of drug administration on the 7th day, each group of rats was dissected to observe the conditions of the intestines, stomach, and contents.

[0069] 7) Observation indicators: feed intake, body weight gain, feed absorption rate, gastrointestinal tract and its contents. Statistical data: feed intake = total feed intake in 7 days, body weight gain = body weight after 7 days - initial body weight, feed absorption rate = body weight gain / feed intake × 100%.

[0070] 1.4.3 Results:

[0071] Table 4. Weight control of capsule preparations #1 - #4 in rats

[0072] Feed intake (g) Weight gain (g) Feed absorption rate (%) Control group 194.11 66.34 34.18 #1 109.23 20.83 19.07 #2 105.35 22.18 21.05 #3 120.08 20.84 17.36 #4 113.15 23.14 20.45

[0073] Compared with the control group, the feed intake, feed absorption rate, and body weight gain of rats given capsules #1 - #4 were significantly reduced. The health status of the rats was observed to be good with the naked eye, and no visible abnormal changes were found in the observed stomach, intestine, and their contents. Thus, it can be seen that after the capsule preparation of the present invention is orally administered to the digestive tract, the PEO particles in the capsule are released, which can quickly form a viscous film on the surface of the gastrointestinal mucosa, continuously wrap the gastrointestinal surface to maintain satiety, affect the appetite of rats, reduce the intake of rats, and at the same time, the PEO forms a gel to wrap the gastrointestinal surface, which reduces the absorption of calories to a certain extent, and it is sufficient to fully exert the effect of controlling body weight and losing weight.

[0074] Example 2

[0075] The difference between this example and Example 1 is that the capsule preparation for controlling and reducing body weight contains polyoxyethylene (PEO) and nutritional supplements calcium, iron, vitamin A, and vitamin E, and the capsule shell is also gastric-soluble. The capsule preparations #5 to #9 in this example contain particles with the physical and chemical properties listed in Table 5 below, where:

[0076] Polyoxyethylene (PEO): average molecular weight of 2 million, particle size from 0.5 μm to 2000 μm;

[0077] Calcium, iron, vitamin A, vitamin E: particle size from 0.5 μm to 2000 μm.

[0078] Calcium: calcium lactate; iron: ferrous lactate; vitamin A: β-carotene; vitamin E: dl-α-tocopheryl acetate.

[0079] Table 5. Formulation ratios of capsule preparations #5 to #9

[0080] Capsule number Ratio #5 Polyethylene oxide = 100 #6 Polyethylene oxide: Calcium lactate = 99:1 #7 Polyethylene oxide: Ferrous lactate = 99:1 #8 Polyethylene oxide: β-Carotene = 99:1 #9 Polyethylene oxide: dl-α-Tocopheryl acetate = 99:1

[0081] The capsules in this example can dissolve within 1 hour after being administered to the stomach, thereby releasing the particle preparation encapsulated in the capsule shell. The particles encapsulated in the capsule shell are prepared by the following steps:

[0082] (a) Place PEO particles with different weight-average molecular weights as raw materials into a granulator.

[0083] (b) Add purified water to the raw materials placed in the granulator in step (a).

[0084] (c) Granulate and screen at 40°C to 60°C, and select PEO particles with a particle size of 50 μm to 500 μm.

[0085] (d) Mix the PEO particles selected in step (c) with calcium lactate (calcium), ferrous lactate (iron), β-carotene (vitamin A), and dl-α-tocopheryl acetate (vitamin E) according to Table 5, and encapsulate them in a capsule shell to obtain capsules for controlling and reducing weight.

[0086] 2.1 Control effect of the capsule on body weight

[0087] 2.1.1 Purpose: To explore the control effect of the capsule on the body weight of rats

[0088] 2.1.2 Methods:

[0089] 1) Grouping: 36 experimental rats were divided into 6 groups, with 6 rats in each of the control group, experimental group #5, experimental group #6, experimental group #7, experimental group #8, and experimental group #9.

[0090] 2) Animal status: The body weight of the rats was 360 - 400 g, and they were 10 weeks old.

[0091] 3) Specification and dosage: Gastric-soluble capsules, 10 mg / capsule, 4 capsules per rat per time, once a day.

[0092] 4) Administration method: Swallow. Use straight forceps to hold the capsule and place it at the throat of the rat, and use a gavage needle to deliver drinking water to send the capsule down.

[0093] 5) Feeding: Provide 1000 g of commercially available cereal feed for each group of rats, and regularly supplement the feed every day.

[0094] 6) Operation plan: The experimental groups were given 4 capsules orally every day for 7 consecutive days. The control group was fed normally without treatment. The body weight and feed intake of each group of rats were measured and recorded at the same time every day (calculated according to the reduction of feed). 12 hours after the end of drug administration on the 7th day, each group of rats was dissected to observe the intestines, stomach, and contents.

[0095] 7) Observation indicators: Feed intake, body weight gain, feed absorption rate, gastrointestinal tract and contents. Statistic data, feed intake = total feed intake in 7 days, body weight gain = body weight after 7 days - initial body weight, feed absorption rate = body weight gain / feed intake × 100%.

[0096] 2.4.3 Results:

[0097] Table 6 Weight control of capsule preparations #5 - #9 in rats

[0098] Feed intake (g) Weight gain (g) Feed absorption rate (%) Control group 210.35 70.78 33.65 #5 120.12 26.82 22.33 #6 111.56 26.47 23.73 #7 123.79 24.19 19.54 #8 128.80 27.32 21.21 #9 117.59 26.51 22.54

[0099] Compared with the control group, the feed intake, weight gain, and feed absorption rate of rats given capsule preparations #5 - #9 were significantly reduced; compared with the pure PEO experimental group #5, there were no significant differences in the feed intake, weight gain, and feed absorption rate of rats in the experimental groups #6, #7, #8, and #9 with the addition of calcium, iron, vitamin A, and vitamin E. The health status of the rats was observed to be good by naked eyes, and no visible abnormal changes were found in the stomach, intestine, and their contents. Thus, it can be seen that after the capsule of the present invention is orally administered to the digestive tract, the PEO particles in the capsule are released, and they can quickly and timely form a viscous film on the surface of the gastrointestinal mucosa, continuously wrap the gastrointestinal surface to maintain satiety, affect the appetite of rats, reduce the intake of rats, and at the same time, the PEO forms a gel to wrap the gastrointestinal surface, which reduces the absorption of calories to a certain extent. At the same time, the addition of trace elements such as calcium, iron, vitamin A, and vitamin E does not affect the weight loss effect of PEO, and can fully exert the effect of controlling and reducing weight.

[0100] To further illustrate the effect of the PEO particle preparation of the present invention with specific physicochemical properties (such as molecular weight) relative to the preparation containing other PEO particles, the following comparative examples are further provided herein.

[0101] In this comparative example, PEO particles with the physicochemical parameters listed in Table 7 below were used as raw materials, and comparative preparations #10 to #12 were prepared according to the same preparation steps as in Example 1.

[0102] Table 7 Physicochemical parameters of PEO contained in comparative preparations #10 - #12

[0103] Comparative preparation number Physicochemical parameters of PEO #10 Weight-average molecular weight: 600,000; Particle size: 0.5 μm to 2000 μm; #11 Weight-average molecular weight: 850,000; Particle size: 0.5 μm to 2000 μm; #12 Weight-average molecular weight: 10,000,000; Particle size: 0.5 μm to 2000 μm;

[0104] According to the same method as in Example 1, the adhesion effect, tolerance to the digestive tract mucosa, and the effect of promoting the repair of the digestive tract mucosa of comparative preparations #10 to #12 were detected.

[0105] 3.1 Adhesion force test on the digestive tract mucosa:

[0106] Table 8 Adhesion force test results of comparative preparations #10 - #12

[0107] #10 #11 #12 Adhesion force (N) 0.81 0.89 0.93

[0108] As can be seen from Table 8, the adhesion force of the PEO particles in the above Comparative Formulations #10 to #12 to the digestive tract mucosa is less than 1 N.

[0109] 3.2 Adhesion effect on the digestive tract mucosa and tolerance to the digestive tract environment:

[0110] The same method as in Example 1 was used for the test. In the inclined plate scouring experiment, under the scouring of artificial gastric juice or artificial intestinal juice, the colloidal adhesion residence time formed by the above Comparative Formulations #10 to #12 on the mucosal surface was less than 12 hours. The scouring test results of Comparative Formulations #10 to #12 are as Figure 4 shown.

[0111] The present invention has been specifically described above in conjunction with specific embodiments. These specific embodiments are merely exemplary and cannot be used to limit the protection scope of the present invention. Those skilled in the art can make various modifications, changes or substitutions to the present invention without departing from the essence and scope of the present invention. Therefore, various equivalent changes made in accordance with the present invention still fall within the scope covered by the present invention. For example, the dosage forms of the capsule preparations described in this patent include but are not limited to capsules, pills, tablets, granules or oral liquids.

Claims

1. A biocompatible capsule preparation for controlling and reducing the weight of mammals, comprising a capsule shell and polyoxyethylene particles encapsulated therein, wherein: The capsule shell is gastric-soluble and / or enteric-soluble; The weight-average molecular weight of polyoxyethylene is from 1 million to 7 million Daltons; The average particle size of the polyoxyethylene particles is from 0.5 μm to 2000 μm.

2. The capsule preparation according to claim 1, after the mammals are orally administered with the capsule preparation, the capsule shell is soluble in the digestive tract, so that the polyoxyethylene particles encapsulated therein are released into the digestive tract and form a viscous film covering the digestive tract mucosa in the digestive tract.

3. The capsule preparation according to claim 2, the duration of the viscous film adhering to the digestive tract mucosa is not less than 24 hours.

4. The capsule preparation according to claim 1, wherein The adhesion force of the viscous film to the digestive tract mucosa is not less than 1 N.

5. The capsule preparation according to claim 1, wherein The average particle size of the polyoxyethylene particles is from 50 μm to 500 μm.

6. The capsule preparation according to any one of claims 1 to 3, wherein, When the concentration of the polyoxyethylene particles is 2.0% wt, its viscosity is 2000 - 4000 mPa·s.

7. The capsule preparation according to claim 2, wherein, After the mammals are orally administered with the capsule preparation, the dissolution time of the capsule shell in the digestive tract is from 10 seconds to 100 seconds.

8. The capsule preparation according to claim 1, wherein The weight-average molecular weight of polyoxyethylene is from 2 million to 4 million Daltons.

9. The capsule preparation according to claim 1, wherein, The capsule preparation further comprises a nutritional supplement encapsulated in the capsule shell.

10. Use of the biocompatible capsule preparation according to any one of claims 1 to 9 in the preparation of a medicament for controlling and reducing the weight of mammals.

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