Soft capsules for assisting in lowering blood lipids and a preparation method thereof

Abstract

This invention belongs to the field of health food and pharmaceutical technology, specifically relating to a soft capsule for assisting in lowering blood lipids and its preparation method. The soft capsule for assisting in lowering blood lipids provided by this invention consists of contents and a shell. The contents include the following components: peony seed oil, garlic oil, and an auxiliary protective agent. The shell is prepared from the following components: gelatin, glycerin, water, titanium dioxide, an anti-aging agent, and lemon yellow. The soft capsule for assisting in lowering blood lipids provided by this invention, through the rational ratio of garlic oil, peony seed oil, and the auxiliary protective agent, can jointly maintain the levels of blood lipids, blood pressure, and blood sugar in the human body, preventing the occurrence and development of thrombosis. Simultaneously, using a soft capsule as a carrier avoids the irritating taste of garlic oil, ensuring long-term safety, non-toxicity, and no side effects. It also avoids the problem of easy leakage of the contents, effectively improving its storage stability.

Description

Technical Field

[0001] This invention belongs to the field of health food and pharmaceutical technology, specifically relating to a soft capsule that helps lower blood lipids and its preparation method. Background Technology

[0002] In recent years, with the improvement of economic level, people's lifestyles have also changed. Cardiovascular and cerebrovascular diseases are the leading cause of death and disability worldwide, and have become the number one killer threatening human health. In my country, with the acceleration of population aging and urbanization, the prevalence of cardiovascular and cerebrovascular diseases is in a continuous upward phase.

[0003] Hyperlipidemia refers to a condition where one or more lipids in the blood plasma are elevated above normal levels due to abnormal lipid metabolism or transport. Lipids are insoluble or only slightly soluble in water and must bind to proteins to exist in the form of lipoproteins; therefore, hyperlipidemia is also known as hyperlipoproteinemia, which manifests as hypercholesterolemia, hypertriglyceridemia, or both. Hyperlipidemia can be divided into primary and secondary types. Modern clinical medical research suggests that high blood lipids not only lead to increased blood pressure but also increase the risk of cerebrovascular diseases such as cerebral arteriosclerosis and cerebral thrombosis.

[0004] Atherosclerosis, a systemic disease characterized by the accumulation of large amounts of lipids (mainly cholesterol and cholesterol esters) in the inner lining of arterial walls, forming atherosclerotic plaques, is a crucial pathological basis for cardiovascular diseases. Many factors contribute to atherosclerosis, with dyslipidemia being a major risk factor. This is primarily manifested by elevated levels of one or more of the following: total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C), or decreased levels of high-density lipoprotein cholesterol (HDL-C). Therefore, effectively lowering blood lipids plays a vital role in the treatment of cardiovascular diseases.

[0005] The most widely used medication for lowering blood lipids in clinical practice is statins. The most significant side effect of statins is liver damage, followed by muscle damage. With the development of modern nutrition science, functional foods have emerged. Using functional foods as dietary supplements and interventions as a foundational treatment for metabolic diseases is of great importance, as they can promote human health without causing side effects.

[0006] Therefore, it is essential to develop a health product that can help lower blood lipids and effectively prevent and treat cardiovascular diseases. Summary of the Invention

[0007] To address the problems existing in the prior art, the present invention aims to provide a soft capsule for assisting in lowering blood lipids and its preparation method. The soft capsule for assisting in lowering blood lipids provided by the present invention, through a reasonable ratio of garlic oil, peony seed oil, and auxiliary protective agents, can jointly maintain the levels of blood lipids, blood pressure, and blood sugar in the human body, prevent the occurrence and development of thrombosis, and effectively reduce cholesterol and triglycerides in human serum. Simultaneously, using a soft capsule as a carrier avoids the irritating taste of garlic oil, ensuring long-term safety, non-toxicity, and no side effects. It also avoids the problem of easy leakage of contents, effectively improving its storage stability.

[0008] The technical solution of this invention is:

[0009] A soft capsule for assisting in lowering blood lipids, comprising contents and a capsule shell, wherein the contents include the following components and their weight parts: 405-475 parts of peony seed oil, 10-70 parts of garlic oil, and 15-25 parts of auxiliary protective agent;

[0010] The capsule shell is prepared from the following components in parts by weight: 20-70 parts gelatin, 10-40 parts glycerin, 20-70 parts water, 0.3-0.7 parts titanium dioxide, 0.8-2 parts anti-aging agent, and 0.1-0.4 parts lemon yellow.

[0011] Further, the contents comprise the following components and their weight parts: 438-472 parts peony seed oil, 10-40 parts garlic oil, and 18-22 parts auxiliary protective agent; the capsule shell is prepared from the following components in weight parts: 30-60 parts gelatin, 20-35 parts glycerin, 30-60 parts water, 0.4-0.6 parts titanium dioxide, 1.0-1.6 parts anti-aging agent, and 0.2-0.3 parts lemon yellow.

[0012] Furthermore, the auxiliary protective agent in the contents is composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a weight ratio of 10–16:3–5:2–4.

[0013] Furthermore, the auxiliary protective agent in the contents is composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a weight ratio of 14:4:3.

[0014] Furthermore, the anti-aging agent in the capsule shell is a combination of tea polyphenols, cellulose acetate, and cassia seed extract.

[0015] Furthermore, the anti-aging agent in the capsule shell is composed of tea polyphenols, cellulose acetate, and cassia seed extract in a weight ratio of 5–9:1–4:1.

[0016] Furthermore, the titanium dioxide in the capsule shell is titanium dioxide powder with a particle size of 0.2–0.4 μm.

[0017] Furthermore, the weight ratio of the contents to the capsule shell is 1 to 5:1.

[0018] In addition, the present invention also provides a method for preparing the aforementioned soft capsule for assisting in lowering blood lipids, comprising the following steps:

[0019] S1. Stir and mix peony seed oil, garlic oil and auxiliary preservative at 20-30℃ until homogeneous and stable contents are formed;

[0020] S2. Take 5 parts gelatin and titanium dioxide and add 10 parts water to grind into titanium dioxide paste. Then transfer it to a gelling tank, add glycerin, lemon yellow, anti-aging agent and the remaining water; heat to 55-75℃, add the remaining gelatin, stir for 20-40 minutes; turn on the vacuum pump to remove foam, vacuum degree 0.06-0.08MPa, let stand for 20-40 minutes, release the liquid and filter to obtain the gel solution, keep it warm at 55-75℃ for later use.

[0021] S3. The contents obtained in step S1 and the gel obtained in step S2 are put into a rotary molding soft capsule machine to be pressed into soft capsules.

[0022] S4. Transfer the shaped soft capsules obtained in step S3 to a drying room for drying. Dry them for 10 to 30 hours at a temperature of 20 to 40°C and a relative humidity of 10 to 50%, controlling the moisture content of the capsules to 5 to 30%.

[0023] Furthermore, the stirring speed in step S1 is 40-60 r / min, and the stirring time is 30-40 min.

[0024] Furthermore, in step S1, the stirring speed is 50 r / min and the stirring time is 30 min.

[0025] Furthermore, in step S3, the adhesive solution is fed into a rotary molding soft capsule machine to compress soft capsules at a temperature of 15–30°C and a relative humidity of 30–65%.

[0026] The soft capsules prepared according to this invention for assisting in lowering blood lipids contain a reasonable combination of peony seed oil and garlic oil:

[0027] Garlic, the underground bulb of *Allium sativum* L. (family Liliaceae), is hailed as natural "medicinal plant gold," with a history of use as a seasoning and medicine spanning over four thousand years. Modern research indicates that garlic possesses numerous functions, including antibacterial and anti-inflammatory properties, lowering blood pressure and lipids, and prolonging clotting time. It exhibits significant preventative and therapeutic effects against diseases such as coronary heart disease, hypertension, and arteriosclerosis.

[0028] Garlic oil is a light yellow liquid extracted from garlic. It is known as a natural antibiotic. Its main components are allicin and various thioether compounds composed of allyl, propyl, and methyl groups, which are the material basis for the various pharmacological activities of garlic.

[0029] Peony seed oil, also known as peony oil, is a woody nut plant oil made from peony seed kernels through processes such as pressing, decolorization, and deodorization. Peony seed oil is rich in various unsaturated fatty acids, which account for 82.81% to 93.23% of its total oil content, including oleic acid (24%), linoleic acid (27%), and alpha-linolenic acid (43%). The alpha-linolenic acid content in peony seed oil is more than 54 times that of olive oil, often referred to as "liquid gold."

[0030] Oleic acid, a monounsaturated Omega-9 fatty acid, can regulate blood lipid levels, lower cholesterol, effectively reduce the occurrence of hypercholesterolemia and cardiovascular diseases, and lower the incidence of coronary heart disease. Linoleic acid, an essential fatty acid for the human body, can lower blood cholesterol and lipid levels, soften blood vessels, lower blood pressure, prevent atherosclerosis, and promote microcirculation. It is known as a "vascular cleanser" and has health benefits in preventing and treating atherosclerosis and cardiovascular diseases.

[0031] Alpha-linolenic acid (ALA) is an essential polyunsaturated fatty acid for the human body, and a crucial component of brain cells and tissue cells. ALA can be broken down into DHA, DPA, and EPA, essential for the body, under the action of metabolic enzymes. ALA has various functions, including enhancing intelligence and immunity, protecting vision, lowering blood lipids, blood sugar, and blood pressure, inhibiting hemorrhagic and thrombotic encephalopathy, preventing inflammation, and delaying aging. ALA not only increases cholesterol excretion but also inhibits HMG-CoA activity, reducing endogenous cholesterol synthesis. Furthermore, it inhibits lipase systems, enhances β-oxidation in mitochondria, reducing triglyceride synthesis and increasing its consumption, thus exerting its lipid-lowering effect.

[0032] Peony seed oil, rich in unsaturated fatty acids such as oleic acid, linoleic acid, and alpha-linolenic acid, can lower serum total cholesterol (TC), triglycerides (TG), low-density lipoprotein, and very low-density lipoprotein, while raising serum high-density lipoprotein. It can significantly reduce blood lipid and blood sugar levels and prevent the occurrence of hemorrhagic cerebrovascular disease and thrombotic disease.

[0033] The soft capsules provided by this invention use peony seed oil, which is rich in unsaturated fatty acids such as oleic acid, linoleic acid, and α-linolenic acid, instead of soybean oil in the prior art, as the filler for garlic oil soft capsules. While garlic oil exerts its antibacterial and antimicrobial effects, regulates the stomach and intestines, lowers blood lipid and blood sugar levels, and improves immunity, it can also supplement the body with unsaturated fatty acids such as oleic acid, linoleic acid, and α-linolenic acid. The two work synergistically to better maintain blood lipid and blood sugar levels, inhibit platelet aggregation, and prevent thrombosis.

[0034] Furthermore, the garlic oil and peony seed oil used in this invention are obtained using conventional extraction processes in the prior art. The peony seed oil used is purchased from Heze Zhonghe Jianyuan Biotechnology Co., Ltd. and is produced by low-temperature pressing. The garlic oil used is extracted by steam distillation from Jiangxi Yisenyuan Plant Fragrance Co., Ltd.

[0035] Furthermore, the capsule contents provided by this invention also contain an auxiliary protective agent. Experiments have shown that when an auxiliary protective agent composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a certain proportion is added, it can not only work together with peony seed oil and garlic oil to lower blood lipids, but also make the contents more uniform and stable, reducing the occurrence of oil leakage from the soft capsules.

[0036] Furthermore, in order to ensure that the soft capsules have good storage performance, the inventors of this application have creatively added an anti-aging agent composed of tea polyphenols, cellulose acetate and cassia seed extract to the capsule shell components. This can effectively improve the anti-aging performance of the capsule shell and prevent the soft capsules from aging, cracking, leaking oil and prolonging disintegration time caused by environmental factors during storage, thus effectively extending the shelf life of the soft capsules.

[0037] Compared with existing technologies, the soft capsules for assisting in lowering blood lipids and their preparation method provided by this invention have the following advantages:

[0038] (1) The soft capsules for lowering blood lipids provided by the present invention utilize a reasonable ratio of garlic oil and peony seed oil. While garlic oil plays a role in maintaining blood lipid levels, reducing inflammation and killing bacteria, enhancing immunity, lowering blood pressure and blood sugar, and preventing thrombosis, peony seed oil supplements the body with unsaturated fatty acids such as oleic acid, linoleic acid, and α-linolenic acid. Combined with the synergistic effect of auxiliary protective agents, they work together to maintain the body's blood lipid, blood pressure, and blood sugar levels and prevent the occurrence and development of thrombosis.

[0039] (2) The present invention uses soft capsules as carriers, which avoids the irritating taste of garlic oil to the human body. It is safe, non-toxic and has no side effects when taken for a long time. At the same time, it avoids the problem of easy leakage of contents and effectively improves its storage stability. Detailed Implementation

[0040] The present invention will be further described below through specific embodiments, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the protection scope of the present invention.

[0041] Unless otherwise specified, the reagents used in the following examples and comparative examples are conventional reagents, all of which can be purchased from conventional reagent manufacturers and distributors. Unless otherwise specified, the methods used are existing technologies. Information on some raw material manufacturers is as follows:

[0042] Sagein (CAS No.: 3650-09-7, Item No.: B21175); Cassia tora extract (CAS No.: 67979-25-3, Item No.: B20180); Flaxseed oil (CAS No.: 8001-26-1, Item No.: S25937); Polyglycerol ricinoleate (CAS No.: 114355-43-0, Item No.: T24778); Tea polyphenols (CAS No.: 84650-60-2, Item No.: S18152) were all purchased from Shanghai Yuanye Biotechnology Co., Ltd.

[0043] Example 1: A soft capsule for assisting in lowering blood lipids and its preparation method

[0044] A soft capsule for assisting in lowering blood lipids, comprising contents and a capsule shell, wherein the contents are composed of the following components and their weight proportions: 438 parts peony seed oil, 10 parts garlic oil, and 18 parts auxiliary protective agent;

[0045] The capsule shell is prepared from the following components in parts by weight: 30 parts gelatin, 20 parts glycerin, 30 parts water, 0.4 parts titanium dioxide, 1.0 part anti-aging agent, and 0.2 parts lemon yellow.

[0046] The protective agent in the contents is composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a weight ratio of 10:3:2.

[0047] The anti-aging agent in the capsule is composed of tea polyphenols, cellulose acetate and cassia seed extract in a weight ratio of 5:1:1.

[0048] The weight ratio of the contents to the capsule shell is 2:1.

[0049] The preparation method of the aforementioned soft capsule for assisting in lowering blood lipids includes the following steps:

[0050] S1. Stir peony seed oil, garlic oil and auxiliary preservative at 20℃ for 40 minutes at a stirring speed of 40 r / min to form a homogeneous and stable contents;

[0051] S2. Take 5 parts of gelatin and titanium dioxide with a particle size of 0.2-0.4μm, add 10 parts of water-milled titanium dioxide paste, then add it to a gelling tank, and add glycerin, lemon yellow, anti-aging agent and the remaining water; heat to 55℃, add the remaining gelatin, stir for 40min; turn on the vacuum pump to remove foam, the vacuum degree is 0.06-0.08MPa, let stand for 20min, release the liquid and filter to obtain the gel solution, keep it at 55℃ for later use;

[0052] S3. The contents obtained in step S1 and the gel obtained in step S2 are put into a rotary molding soft capsule machine and pressed into soft capsules at a temperature of 15°C and a relative humidity of 30%.

[0053] S4. Transfer the shaped soft capsules obtained in step S3 to a drying room for drying. Dry them for 30 hours at a temperature of 20°C and a relative humidity of 10%, controlling the moisture content of the capsules to 10%.

[0054] Example 2: A soft capsule for assisting in lowering blood lipids and its preparation method

[0055] A soft capsule for assisting in lowering blood lipids, comprising contents and a capsule shell, wherein the contents are composed of the following components and their weight proportions: 460 parts peony seed oil, 20 parts garlic oil, and 20 parts auxiliary protective agent;

[0056] The capsule shell is prepared from the following components in parts by weight: 50 parts gelatin, 30 parts glycerin, 50 parts water, 0.35 parts titanium dioxide, 1.3 parts anti-aging agent, and 0.3 parts lemon yellow.

[0057] The auxiliary protective agent in the contents is composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a weight ratio of 14:4:3.

[0058] The anti-aging agent in the capsule is composed of tea polyphenols, cellulose acetate and cassia seed extract in a weight ratio of 7:3:1.

[0059] The weight ratio of the contents to the capsule shell is 3:1.

[0060] The preparation method of the aforementioned soft capsule for assisting in lowering blood lipids includes the following steps:

[0061] S1. Stir peony seed oil, garlic oil and auxiliary preservative at 28°C for 30 minutes at a stirring speed of 50 r / min to form a homogeneous and stable mixture.

[0062] S2. Take 5 parts of gelatin and titanium dioxide with a particle size of 0.2-0.4μm, add 10 parts of water-milled ultrafine titanium dioxide paste, then add it to a gelling tank, then add glycerin, lemon yellow, anti-aging agent and the remaining water; heat to 60℃, add the remaining gelatin, stir for 30min; turn on the vacuum pump to remove foam, vacuum degree 0.06-0.08MPa, let stand for 30min, release the liquid and filter to obtain the gel solution, keep it at 60℃ for later use;

[0063] S3. The contents obtained in step S1 and the gel obtained in step S2 are put into a rotary molding soft capsule machine and pressed into soft capsules at a temperature of 20°C and a relative humidity of 50%.

[0064] S4. Transfer the shaped soft capsules obtained in step S3 to a drying room for drying. Dry them for 20 hours at a temperature of 30°C and a relative humidity of 30%, controlling the moisture content of the capsules to 20%.

[0065] Example 3: A soft capsule for assisting in lowering blood lipids and its preparation method

[0066] A soft capsule for assisting in lowering blood lipids, comprising contents and a capsule shell, wherein the contents are composed of the following components and their weight proportions: 472 parts peony seed oil, 40 parts garlic oil, and 22 parts auxiliary protective agent;

[0067] The capsule shell is prepared from the following components in parts by weight: 60 parts gelatin, 35 parts glycerin, 60 parts water, 0.6 parts titanium dioxide, 1.6 parts anti-aging agent, and 0.4 parts lemon yellow.

[0068] The protective agent in the contents is composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a weight ratio of 16:5:4.

[0069] The anti-aging agent in the capsule is composed of tea polyphenols, cellulose acetate and cassia seed extract in a weight ratio of 9:4:1.

[0070] The weight ratio of the contents to the capsule shell is 5:1.

[0071] The preparation method of the aforementioned soft capsule for assisting in lowering blood lipids includes the following steps:

[0072] S1. Stir peony seed oil, garlic oil and auxiliary preservative at 30°C for 35 minutes at a stirring speed of 60 r / min to form a homogeneous and stable mixture.

[0073] S2. Take 5 parts of gelatin and titanium dioxide with a particle size of 0.2-0.4μm, add 10 parts of water-milled ultrafine titanium dioxide paste, then add it to a gelling tank, then add glycerin, lemon yellow, anti-aging agent and the remaining water; heat to 75℃, add the remaining gelatin, stir for 20min; turn on the vacuum pump to remove foam, vacuum degree 0.06-0.08MPa, let stand for 40min, release the liquid and filter to obtain the gel solution, keep it at 75℃ for later use;

[0074] S3. The contents obtained in step S1 and the gel obtained in step S2 are fed into a rotary molding soft capsule machine and pressed into soft capsules at a temperature of 30°C and a relative humidity of 65%.

[0075] S4. Transfer the shaped soft capsules obtained in step S3 to a drying room for drying. Dry them for 10 hours at a temperature of 40°C and a relative humidity of 50%, controlling the moisture content of the capsules to 30%.

[0076] Comparative Example 1: A soft capsule for assisting in lowering blood lipids and its preparation method

[0077] Compared with Example 2, the difference in Comparative Example 1 is that the garlic oil in the contents of the soft capsule was replaced with flaxseed oil, while the other components and operations were the same as in Example 2.

[0078] Comparative Example 2: A soft capsule for assisting in lowering blood lipids and its preparation method

[0079] Compared with Example 2, the difference in Comparative Example 2 is that the polyglycerol ricinoleate in the auxiliary protective agent of the contents is replaced with glyceryl monostearate, while the other components and operations are the same as in Example 2.

[0080] Comparative Example 3: A soft capsule for assisting in lowering blood lipids and its preparation method

[0081] Compared with Example 2, the difference in Comparative Example 3 is that sarsaparilla acid is not added in the auxiliary protection of the contents, and the amount of vitamin E is increased accordingly. That is, the auxiliary protectant is composed of vitamin E and polyglycerol ricinoleate in a weight ratio of 18:3. Other components and operations are the same as in Example 2.

[0082] Comparative Example 4: A soft capsule for assisting in lowering blood lipids and its preparation method

[0083] Compared with Example 2, the difference in Comparative Example 1 is that the tea polyphenols in the anti-aging agent of the capsule shell are replaced with sodium ascorbate, while the other components and operations are the same as in Example 2.

[0084] Comparative Example 5: A soft capsule for assisting in lowering blood lipids and its preparation method

[0085] Compared with Example 2, the difference in Comparative Example 1 is that the cellulose acetate in the anti-aging agent of the capsule shell is replaced with ethyl cellulose, and other components and operations are the same as those in Example 2.

[0086] Experimental Example 1. Study on the effect of maintaining blood lipid levels of the soft capsule content for assisting in reducing blood lipid prepared by the present invention

[0087] 1. Materials and methods

[0088] 1.1 Test samples: The soft capsule contents for assisting in reducing blood lipid prepared in Examples 1-3 and Comparative Examples 1-3.

[0089] 1.2 Animals: 80 male SD rats, weighing 180-220 g, provided by Jinan Pengyue Experimental Animal Company, certificate number: SCXK(Lu)20220006.

[0090] 1.3 High-fat feed: Add 20.0% sucrose, 15.0% lard, 1.2% cholesterol, 0.2% sodium cholate, appropriate amounts of casein, calcium hydrogen phosphate, stone powder, etc. to the basic maintenance feed. Except for crude fat, the moisture, crude protein, crude fat, crude fiber, crude ash, calcium, and phosphorus of the model feed should meet the national standards of the maintenance feed. The basic maintenance feed and high-fat feed are purchased from Jinan Pengyue Experimental Animal Company.

[0091] 1.4 Reagents and instruments: Kits for TC (total cholesterol), TG (triglyceride), LDL-C (low-density lipoprotein), and HDL-C (high-density lipoprotein) are provided by Solarbio Science & Technology Co., Ltd.

[0092] 1.5 Recommended human dosage and dosage design: The recommended dosage for adults is 2 capsules / d (1 g / d), that is, 0.0167 g / (d·kg). Then the gavage dosage for rats is 104 mg / (d·kg).

[0093] 1.6 Test method: After feeding with the basic maintenance feed for 3 days, the rats are randomly divided into 2 groups according to their body weights. 10 rats are given the maintenance feed as the blank control group, and 70 rats are given the model feed as the model group.

[0094] After the model group is given the model feed for 1-2 weeks, the rats in the blank control group and the model group are bled without fasting. After bleeding, the serum is separated as soon as possible, and the levels of serum TC, TG, LDL-C, and HDL-C are measured.

[0095] According to the TC level, the model group is randomly divided into two groups (i.e., the model control group and the model drug administration group). There are no significant differences in TC, TG, LDL-C, and HDL-C between the two groups; compared with the blank control group (10 rats), the increases in TC, TG, LDL-C, and HDL-C in the model control group (10 rats) and the model drug administration group (60 rats) are significant, and it is determined that the model is established.

[0096] After grouping, the model drug administration group was divided into 6 groups, with 10 rats in each group. Each group was given the contents of the soft capsules prepared in Examples 1-3 and Comparative Examples 1-3 by gavage every day. The blank control group and the model control group were given the same volume of purified water at the same time. The blank control group continued to be given maintenance diet, while the model control group and the model drug administration group continued to be given model diet. The rats were weighed regularly. At the end of the experiment (after 5 consecutive weeks), blood was collected without fasting. After blood collection, serum was separated as soon as possible, and the serum TC, TG, LDL-C and HDL-C levels were measured.

[0097] 2 Experimental Results

[0098] 2.1 The effect of the soft capsules that help lower blood lipids on the body weight of rats is shown in Table 1.

[0099] Table 1. Effects of the soft capsules used to assist in lowering blood lipids on the body weight of rats (x±s, g)

[0100]

[0101] Table 1 shows the effect of garlic and peony seed oil soft capsules on rat body weight. Throughout the experiment, the growth and activity of rats in each group were normal. Comparing the body weight and weight gain of rats before and after the experiment, the body weight of rats in the model control group and the model drug administration group was higher than that of the blank control group. Compared with the model control group, the body weight of rats in Examples 1-3 was significantly reduced. The body weight of rats in Comparative Examples 1-3 also decreased, but the decrease was less than that in Examples 1-3.

[0102] 2.2 Effects of garlic and peony seed oil soft capsules on blood lipid levels in rats are shown in Tables 2, 3, 4 and 5.

[0103] Table 2. Effects of the lipid-lowering soft capsules on total cholesterol (TC) in rats.

[0104]

[0105] As shown in Table 2, before administration of the test substance, the serum total cholesterol levels in the model control group and the model drug administration group were significantly higher than those in the blank control group, indicating that the model was successfully established. After administration of the test substance, compared with the model control group and comparative groups 1-3, the total cholesterol (TC) values ​​in groups 1-3 of this invention were significantly lower, indicating that the contents of the soft capsules for assisting in lowering blood lipids provided by this invention can significantly reduce the serum total cholesterol level.

[0106] Table 3. Effects of soft capsules for lipid-lowering on triglyceride (TG) levels in rats.

[0107]

[0108] As shown in Table 3, before administration of the test substance, the serum triglyceride levels in the model control group and the model drug administration group were significantly higher than those in the blank control group. After administration of the test substance, compared with the model control group and comparative examples 1-3, the serum triglyceride (TG) levels in examples 1-3 of this invention were significantly lower, indicating that the contents of the soft capsules prepared by this invention for assisting in lowering blood lipids can significantly reduce serum triglyceride levels.

[0109] Table 4. Effects of soft capsules for assisting in lowering blood lipids on high-density lipoprotein-C in rats.

[0110]

[0111]

[0112] As shown in Table 4, before administration of the test substance, there was no significant difference in serum high-density lipoprotein (HDL-C) levels between the model control group and the model drug administration group compared to the blank control group. After administration of the test substance, compared to the model control group, serum HDL-C levels in groups 1-3 were significantly increased.

[0113] Table 5. Effects of the lipid-lowering soft capsules on low-density lipoprotein (LDL-C) in rats.

[0114]

[0115] As shown in Table 5, before administration of the test substance, the low-density lipoprotein (LDL) levels in the model control group and the model drug administration group were significantly higher than those in the blank control group. After administration of the test substance, the LDL levels in groups 1-3 were significantly lower than those in the model control group, but still higher than those in the blank control group, indicating that this product can significantly reduce serum LDL levels.

[0116] Example 2: Stability test of the soft capsule for assisting in lowering blood lipids according to the present invention.

[0117] 1. Experimental materials: Soft capsules for assisting in lowering blood lipids prepared in Examples 1-3 and Comparative Examples 1-5 of this invention.

[0118] 2. Test methods:

[0119] Referring to the accelerated testing in the Guidelines for Stability Testing of Raw Materials and Preparations in General Chapter 9001 of the 2020 edition of the Chinese Pharmacopoeia, the soft capsules for assisting in lowering blood lipids prepared in Examples 1-3 and Comparative Examples 1-5 of this invention were placed for 6 months at a temperature of 40±2℃ and a relative humidity of 75±5%. Samples were taken at the end of months 0, 3, and 6 during the test period to examine the disintegration time and appearance of the soft capsules. The method for detecting the disintegration time was the same as that in General Chapter 9021 of the 2020 edition of the Chinese Pharmacopoeia. The test results are shown in Table 6.

[0120] Table 6 Results of accelerated stability test of lipid-lowering soft capsules

[0121]

[0122]

[0123] As shown in Table 6, compared with the comparative examples, the soft capsules prepared in Examples 1-3 of this invention exhibited disintegration times within 20 minutes at 0, 3, and 6 months during accelerated testing (0-6 months). In contrast, in Comparative Examples 4 and 5, where the anti-aging agent composition was altered, the disintegration time was significantly prolonged after 3 months, and the capsules also showed signs of hardening and oil leakage. Comparative Example 2 also showed oil leakage at 6 months. This indicates that the soft capsules provided by this invention can effectively improve the storage stability of capsules, effectively solve the problem of disintegration time increasing over time, and reduce the occurrence of oil leakage.

[0124] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A soft capsule for assisting in lowering blood lipids, comprising contents and a shell, characterized in that, The contents include the following components and their weight percentages: 405-475 parts of peony seed oil, 10-70 parts of garlic oil, and 15-25 parts of auxiliary protective agent; The capsule shell is prepared from the following components in parts by weight: 20-70 parts gelatin, 10-40 parts glycerin, 20-70 parts water, 0.3-0.7 parts titanium dioxide, 0.8-2 parts anti-aging agent, and 0.1-0.4 parts lemon yellow; The auxiliary protective agent in the contents is composed of vitamin E, carrageenan, and polyglycerol ricinoleate in a weight ratio of 10~16:3~5:2~4; The anti-aging agent in the capsule is composed of tea polyphenols, cellulose acetate and cassia seed extract in a weight ratio of 5~9:1~4:

1.

2. The soft capsule for assisting in lowering blood lipids according to claim 1, characterized in that, The contents comprise the following components and their weight proportions: 438-472 parts peony seed oil, 10-40 parts garlic oil, and 18-22 parts auxiliary protective agent; the capsule shell is prepared from the following components in weight proportions: 30-60 parts gelatin, 20-35 parts glycerin, 30-60 parts water, 0.4-0.6 parts titanium dioxide, 1.0-1.6 parts anti-aging agent, and 0.2-0.3 parts lemon yellow.

3. The soft capsule for assisting in lowering blood lipids according to claim 1, characterized in that, The auxiliary protective agent in the contents is composed of vitamin E, sarsaparilla acid, and polyglycerol ricinoleate in a weight ratio of 14:4:

3.

4. The soft capsule for assisting in lowering blood lipids according to claim 1, characterized in that, The titanium dioxide in the capsule has a particle size of 0.2~0.4 μm.

5. The soft capsule for assisting in lowering blood lipids according to claim 1, characterized in that, The weight ratio of the contents to the capsule shell is 1 to 5:

1.

6. A method for preparing a soft capsule for assisting in lowering blood lipids according to any one of claims 1 to 5, characterized in that, Includes the following steps: S1. Stir and mix peony seed oil, garlic oil and auxiliary preservative at 20~30℃ until homogeneous to obtain the contents; S2. Take 5 parts gelatin and titanium dioxide and add 10 parts water to grind into titanium dioxide paste. Then add it to the gelling tank, and add glycerin, lemon yellow, anti-aging agent and the remaining water. Heat to 55-75℃, add the remaining gelatin, and stir for 20-40 min. Turn on the vacuum pump to remove foam. The vacuum degree is 0.06-0.08 MPa. After standing for 20-40 min, release the liquid and filter to obtain the gel solution. Keep it warm at 55-75℃ for later use. S3. The contents obtained in step S1 and the gel obtained in step S2 are put into a rotary molding soft capsule machine to be pressed into soft capsules. S4. Transfer the shaped soft capsules obtained in step S3 to a drying room for drying. Dry them for 10 to 30 hours at a temperature of 20 to 40°C and a relative humidity of 10 to 50%, controlling the moisture content of the capsules to 5 to 30%.

7. The method for preparing the soft capsule for assisting in lowering blood lipids according to claim 6, characterized in that, The stirring speed in step S1 is 40-60 r / min, and the stirring time is 30-40 min.

8. The method for preparing the soft capsule for assisting in lowering blood lipids according to claim 6, characterized in that, In step S3, the adhesive solution is fed into a rotary molding soft capsule machine and the soft capsules are pressed under conditions of 15-30°C and 30-65% relative humidity.

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