Composition for rapidly eliminating atheromatous plaque, preparation and preparation method

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a composition for rapidly reversing and fading atheromatous plaques, a preparation and a preparation method, and the composition provided by the invention comprises hevea brasiliensis seed oil, pseudo-ginseng, ginseng and policosanol. The composition disclosed by the invention is reasonable in compatibility, has the effects of regulating glycolipid metabolism, stabilizing and reducing atherosclerotic plaque and protecting vascular elasticity, and has the effects of reducing whole blood viscosity and plasma viscosity and obviously reducing the plaque and reducing the plaque volume compared with western medicine simvastatin. Therefore, the medicine disclosed by the invention combines tonifying and eliminating, is safer, more effective, mild and lasting, has a multi-target and multi-effect action mechanism, can remarkably reverse and eliminate atherosclerotic plaques, provides theoretical support for the research of the traditional Chinese medicine channel tropism theory, and provides a safer treatment product for atherosclerotic patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a composition, a preparation and a preparation method for rapidly reversing and eliminating atherosclerotic plaques. Background Art

[0002] Atherosclerosis (AS) is a general term for a series of degenerative and proliferative lesions, such as thickening and hardening of the walls of large and medium-sized arteries, which eventually lead to poor elasticity of the blood vessel walls and narrowing of the lumen. It is a syndrome that affects arterial blood vessels. It is a chronic inflammatory response in the arterial wall, mainly caused by the accumulation of macrophage white blood cells and promoted by low-density lipoprotein (plasma protein that carries cholesterol and triglycerides), without sufficient removal of fat and cholesterol from macrophages by functional high-density lipoprotein (HDL) (see apoA-1Milano). It is often called hardening or atherosclerosis of the arteries. It is caused by the formation of multiple plaques in the arteries.

[0003] The stability of atherosclerotic plaques is closely related to the occurrence of cardiovascular and cerebrovascular events. The rupture of vulnerable plaques is a common and important cause of acute cerebral infarction, acute myocardial infarction and other critical cardiovascular and cerebrovascular diseases. Modern medical research has shown that taking statins is the main treatment for atherosclerosis and stabilizing vulnerable plaques. Statins stabilize plaques through anti-inflammatory effects that are not dependent on their lipid-lowering dominant properties, thereby reducing acute cardiac events and playing an important role in the primary and secondary clinical prevention of patients with coronary heart disease. At the same time, the safety of statins has also been a concern. The most common problem is elevated serum transaminases. It can lead to deterioration of liver function in patients. Therefore, it is urgent to find new effective prescriptions in the field of traditional Chinese medicine, give full play to the clinical advantages of traditional Chinese medicine in the intervention and treatment of AS, provide patients with alternative clinical options, and provide potential treatments and measures to reduce the occurrence of cardiovascular clinical events. Summary of the invention

[0004] In order to overcome the above technical defects, the present invention develops the advantages of traditional Chinese medicine health care, targets the fundamental pathogenesis of atherosclerosis, adopts Chinese medicinal materials with small side effects for rational combination, and provides a composition, preparation and preparation method for rapidly reversing and eliminating atherosclerotic plaques, which can regulate glucose and lipid metabolism, stabilize and reduce atherosclerotic plaques, and protect vascular elasticity.

[0005] One of the purposes of the present invention is to provide a composition for rapidly reversing and eliminating atherosclerotic plaques, comprising rubber tree seed oil, Panax notoginseng, ginseng and polyunsaturated fatty alcohol.

[0006] Rubber tree seed oil: The main components of rubber tree seeds are unsaturated fatty acids oleic acid (ω-9), linoleic acid (ω-6), linolenic acid (ω-3), phytosterols, plant flavonoids, etc. Animal and clinical studies have shown that rubber seed oil has the effect of lowering blood lipids and cholesterol. It has a good effect on patients with cardiovascular and cerebrovascular diseases because it contains unsaturated fatty acids, which are easy to absorb, transport, and digest, and do not deposit in the blood vessels in the body to cause vascular degeneration. Phytosterols inhibit the absorption of cholesterol in the competitive absorption site of the small intestine. It also inhibits the synthesis of cholesterol in the liver and accelerates the dissolution and elimination of existing cholesterol in the blood.

[0007] Panax notoginseng: warm in nature, sweet and slightly bitter in taste, enters the liver meridian and stomach meridian, dissipates blood stasis and stops bleeding, reduces swelling and relieves pain. It has the effects of dissipating blood stasis and stopping bleeding, promoting blood circulation and relieving pain. It is mainly used to treat various bleeding syndromes, blood stasis and swelling, traumatic injuries, etc., which are caused by blood stasis.

[0008] Ginseng: sweet, slightly bitter, slightly warm in nature; enters the lung meridian and heart meridian. It nourishes the spleen and lungs, promotes the production of body fluids, calms the mind and improves intelligence. It is mainly used to treat qi deficiency, weak pulse, spleen deficiency, sinking of middle qi, lung deficiency, wheezing and coughing, shortness of breath and fatigue, thirst due to loss of body fluids, thirst due to deficiency heat, insomnia and forgetfulness, palpitations, blood deficiency, sallow complexion, impotence and cold uterus, etc.

[0009] Policosanol: It reduces blood cholesterol levels by inhibiting the liver's ability to synthesize cholesterol, while increasing high-density lipoprotein levels and reducing triglyceride and very low-density lipoprotein levels, thereby protecting the cardiovascular system.

[0010] The inventors selected rubber tree seed oil, Panax notoginseng, ginseng, and polyunsaturated glycolipid as raw materials, which can regulate sugar and lipid metabolism, stabilize and reduce atherosclerotic plaques, protect vascular elasticity, and have obvious clinical advantages.

[0011] Further, the composition comprises: 1-3000 parts by weight of rubber tree seed oil; for example, 5-2500 parts by weight, or 50-2000 parts by weight, or 100-1500 parts by weight, or 300-1000 parts by weight; and

[0012] 1-50 parts by weight of Panax notoginseng; for example 1-40 parts by weight, or 1-30 parts by weight, or 3-15 parts by weight, or 5-15 parts by weight; and

[0013] 1-50 parts by weight of ginseng; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-20 parts by weight, or 5-12 parts by weight; and

[0014] 1-50 parts by weight of Policosanol; for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 1-10 parts by weight.

[0015] In this specification, the "weight parts" of each Chinese herbal medicine represent the dosage ratio of each Chinese herbal medicine, rather than the actual mass unit. According to the actual situation, the unit weight part can be any mass, such as 1 weight part can be 1g, 500g or 1kg, or even 15g, 30g, etc.

[0016] Further, the Panax notoginseng includes Panax notoginseng powder and Panax notoginseng extract; and / or

[0017] The ginseng includes at least one of ginseng powder and ginseng extract;

[0018] The rubber tree seed oil contains w-3 content ≥18wt%, w-6 content ≥36wt%, total triterpenoid content >15wt%, and total polyphenol content >0.006wt%.

[0019] Furthermore, the Panax notoginseng powder is selected from raw and cooked Panax notoginseng powder; the Panax notoginseng extract is selected from extracts of Panax notoginseng stems and leaves, Panax notoginseng flowers, Panax notoginseng taproots, Panax notoginseng cut ends, and Panax notoginseng fibrous roots;

[0020] The inventor added red yeast rice extract to gelatin to protect the heart and vascular system, improve endothelial function and reduce arteriosclerosis.

[0021] The above preparations can be prepared according to methods known in the art into suitable administration forms or dosage forms for human use.

[0022] In addition, if necessary, colorants, preservatives, perfumes, flavoring agents, sweeteners or other materials may be added to the pharmaceutical preparations.

[0023] Furthermore, the pharmaceutical excipients include any one or more of fillers, binders, wetting agents, disintegrants, cosolvents, solubilizers, osmotic pressure regulators, surfactants, coating materials, colorants, pH regulators, antioxidants, antibacterial agents or buffers.

[0024] Furthermore, the coating is prepared from a glue solution and a red yeast rice extract, wherein the glue solution includes 8-12 parts by weight of gelatin, 3-5 parts by weight of glycerol, and 9-15 parts by weight of purified water.

[0025] The third object of the present invention is to provide a method for preparing a soft capsule preparation, comprising the following steps:

[0026] S1. Preparation of soft capsule preparation contents: Weigh the contents of each component according to the ratio, sequentially add Panax notoginseng extract, ginseng extract, polyunsaturated alcohol to rubber tree seed oil, emulsify and mix well, and set aside;

[0027] S2. Preparation of soft capsule coating: Weigh the components of the soft capsule coating according to the ratio, put the red yeast rice extract and pharmaceutical excipients into the glue tank, heat and stir until completely dissolved, evacuate the glue to a bubble-free solution, filter the glue after the viscosity test is qualified, and set aside;

[0028] S3. Pill pressing, shaping, and drying: The prepared contents are placed in the material storage barrel of a pill press, and the glue liquid is placed in the glue storage barrel of the pill press. The pill press is started to quantitatively press the contents into soft capsules; after forming, the soft capsules are shaped and then dried until the moisture content of the rubber reaches 8% to 10%.

[0029] Further, the contents in S1 include: 1-3000 parts by weight of rubber tree seed oil; for example, 5-2500 parts by weight, or 50-2000 parts by weight, or 100-1500 parts by weight, or 300-1000 parts by weight; and

[0030] 1-50 parts by weight of the Panax notoginseng extract; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-15 parts by weight, or 5-15 parts by weight; and

[0031] 1-50 parts by weight of ginseng extract; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-20 parts by weight, or 5-12 parts by weight; and

[0032] 1-50 parts by weight of Policosanol; for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 1-10 parts by weight.

[0033] Furthermore, the S2 coating comprises: 8-20 parts by weight of gelatin, 3-10 parts by weight of glycerol, 5-25 parts by weight of purified water and 0.2-10 parts by weight of red yeast rice extract.

[0034] Furthermore, S2 specifically comprises: adding red yeast rice extract and glycerin purified water into a stirring tank,

[0035] Stir and emulsify the mixture, heat it, when the temperature in the tank rises to 65-75℃, add the rubber powder, stir evenly, when the temperature in the tank rises to 70-80℃, keep it warm and evacuate for 2-4h, when the temperature drops to 55℃, keep it warm for later use.

[0036] Beneficial effects: The present invention is the first to rationally combine rubber tree seed oil, Panax notoginseng, ginseng, and polyunsaturated alcohol to regulate sugar and lipid metabolism, stabilize and reduce atherosclerotic plaques, and protect vascular elasticity. Compared with Western medicine statins, it reduces whole blood viscosity and plasma viscosity, and has obvious effects of reversing and disappearing plaques and reducing plaque volume. It can be seen that the drug of the present invention combines tonic and elimination, is safer and more effective, mild and long-lasting, and has a multi-target and multi-effect mechanism of action, which can significantly eliminate atherosclerotic plaques, provide theoretical support for the study of TCM meridian theory, provide safer therapeutic drugs for patients with atherosclerosis, improve patient compliance, and strengthen the management of patients with cardiovascular diseases. DETAILED DESCRIPTION

[0037] In order to make those skilled in the art better understand the technical solution of the present invention, the present invention is described in detail below in conjunction with specific embodiments. The experimental methods in the following examples that do not specify specific conditions are usually based on conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, percentages and parts are calculated by weight. Unless otherwise defined, all professional and scientific terms used in the text have the same meanings as those familiar to those skilled in the art. In addition, any method and material similar or equivalent to the recorded content can be applied to the present invention. The preferred implementation methods and materials described in the text are for demonstration purposes only.

[0038] The endpoints and any values ​​of the ranges disclosed in this article are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of each range, the endpoint values ​​of each range and the individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this article.

[0039] The present invention is based on the syndrome of deficiency of the root and excess of the superficial in atherosclerosis, selects rubber tree seed oil, Panax notoginseng, ginseng and polyunsaturated glycol for reasonable combination, and has the effects of regulating sugar and lipid metabolism, stabilizing and reducing atherosclerotic plaques and protecting vascular elasticity.

[0040] According to the present invention, on the one hand, a composition for rapidly reversing and regressing atherosclerotic plaques is provided, comprising rubber tree seed oil, Panax notoginseng, ginseng, and polyunsaturated fatty alcohol.

[0041] Based on the theory of traditional Chinese medicine, Panax notoginseng is warm in nature, sweet and slightly bitter in taste, and belongs to the liver meridian and stomach meridian. It can dissipate blood stasis and stop bleeding, and relieve swelling and pain. It has the effects of removing blood stasis and stopping bleeding, promoting blood circulation and relieving pain. It is mainly used to treat various bleeding syndromes, such as blood stasis, swelling and pain, and injuries from falls, which belong to blood stasis blockage; Ginseng is sweet, slightly bitter, and slightly warm in nature; it belongs to the lung meridian and heart meridian. It has the effects of tonifying the spleen and lungs, promoting body fluid, calming the mind and improving intelligence. It is mainly used to treat qi deficiency and impotence, weak pulse, spleen deficiency, sinking of middle qi, lung deficiency, wheezing and coughing, shortness of breath and fatigue, thirst due to loss of body fluid, thirst due to deficiency heat, insomnia and forgetfulness, palpitations, blood deficiency and sallow complexion, impotence and cold uterus, etc.

[0042] However, there are few reports on the application of rubber tree seed oil, Panax notoginseng, ginseng and polyunsaturated alcohol in rapidly eliminating atherosclerotic plaques. The present invention rationally combines rubber tree seed oil, Panax notoginseng, ginseng and polyunsaturated alcohol to exert the synergistic effects of removing blood stasis and resolving phlegm, invigorating qi and activating blood circulation, thereby achieving the effect of "drug-adjuvant combination".

[0043] In some specific embodiments, the composition comprises: 1-3000 parts by weight of rubber tree seed oil; for example, 5-2500 parts by weight, or 50-2000 parts by weight, or 100-1500 parts by weight, or 300-1000 parts by weight; and

[0044] 1-50 parts by weight of Panax notoginseng; for example 1-40 parts by weight, or 1-30 parts by weight, or 3-15 parts by weight, or 5-15 parts by weight; and

[0045] 1-50 parts by weight of ginseng; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-20 parts by weight, or 5-12 parts by weight; and

[0046] 1-50 parts by weight of Policosanol; for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 1-10 parts by weight.

[0047] In some specific embodiments, the Panax notoginseng includes one or a combination of raw and cooked Panax notoginseng powder, Panax notoginseng stems and leaves, Panax notoginseng flowers, Panax notoginseng taproots, Panax notoginseng cut ends, and Panax notoginseng fibrous root extracts; and / or

[0048] The ginseng includes at least one of ginseng powder and ginseng extract;

[0049] The rubber tree seed oil has a w-3 content of ≥18wt%, a w-6 content of ≥36wt%, and a total triterpene content of >

[0050] 15wt%, total polyphenol content>0.006wt%.

[0051] In some specific embodiments, polyunsaturated fatty alcohol is rice bran fatty alcohol, which is extracted from rice bran and belongs to the class of polyphenols. It has good antioxidant properties, can help neutralize free radicals, reduce the damage to cells caused by oxidative stress, and can affect cholesterol metabolism, especially by inhibiting the absorption of cholesterol in the intestine to reduce low-density lipoprotein cholesterol (LDL-C) in the blood.

[0052] In a second aspect, the present invention provides a soft capsule preparation, comprising contents and a soft capsule coating; the contents are the composition described in any one of claims 1-3; the soft capsule coating is composed of a red yeast rice extract and pharmaceutical excipients acceptable in the art, and the amount of the red yeast rice extract added is 1-10%wt of the total mass of the soft capsule coating.

[0053] In some specific embodiments, the red yeast rice extract is red yeast rice, which is a liquid red yeast pigment obtained by extracting red yeast rice with ethanol or a product extracted, crystallized and refined from a deep culture medium of Monascus purpureus. It contains natural statins (such as Monacolin K). These ingredients can inhibit HMG-CoA reductase in the liver, thereby reducing the synthesis of cholesterol in the body, and have antioxidant properties and certain anti-inflammatory effects and immunomodulatory abilities.

[0054] The above preparations can be prepared according to methods known in the art into suitable administration forms or dosage forms for human use.

[0055] In addition, if necessary, colorants, preservatives, perfumes, flavoring agents, sweeteners or other materials may be added to the pharmaceutical preparations.

[0056] In some specific embodiments, the pharmaceutical excipients include any one or more of fillers, binders, wetting agents, disintegrants, cosolvents, solubilizers, osmotic pressure regulators, surfactants, coating materials, colorants, pH regulators, antioxidants, antibacterial agents or buffers.

[0057] In some specific embodiments, the soft capsule coating is prepared from a gelatin solution and a red yeast rice extract, wherein the gelatin solution includes 8-12 parts by weight of gelatin, 3-5 parts by weight of glycerol, and 9-15 parts by weight of purified water.

[0058] In a third aspect, the present invention provides a method for preparing a soft capsule preparation, comprising the following steps:

[0059] S1. Preparation of soft capsule preparation contents: Weigh the contents of each component according to the ratio, sequentially add Panax notoginseng extract, ginseng extract, polyunsaturated alcohol to rubber tree seed oil, emulsify and mix well, and set aside;

[0060] S2. Preparation of soft capsule coating: Weigh the components of the soft capsule coating according to the ratio, put the red yeast rice extract and pharmaceutical excipients into the glue tank, heat and stir until completely dissolved, evacuate the glue to a bubble-free solution, filter the glue after the viscosity test is qualified, and set aside;

[0061] S3. Pill pressing, shaping, and drying: The prepared contents are placed in the storage barrel of a soft capsule pill pressing machine, and the glue liquid is placed in the glue storage barrel of the soft capsule pill pressing machine. The pill pressing machine is started to quantitatively press the contents into soft capsules; after forming, the soft capsules are shaped and then dried until the moisture content of the rubber reaches 8% to 10%.

[0062] In some specific embodiments, the contents in S1 include: 1-3000 parts by weight of rubber tree seed oil; for example, 5-2500 parts by weight, or 50-2000 parts by weight, or 100-1500 parts by weight, or 300-1000 parts by weight; and

[0063] 1-50 parts by weight of the Panax notoginseng extract; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-15 parts by weight, or 5-15 parts by weight; and

[0064] 1-50 parts by weight of ginseng extract; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-20 parts by weight, or 5-12 parts by weight; and

[0065] 1-50 parts by weight of Policosanol; for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 1-10 parts by weight.

[0066] Furthermore, the soft capsule coating in S2 comprises: 8-20 parts by weight of gelatin, 3-10 parts by weight of glycerol, 5-25 parts by weight of purified water and 0.1-10 parts by weight of red yeast rice extract.

[0067] Further, S2 is specifically as follows: add the red yeast rice extract to purified water, stir and heat to 80°C, then add glycerin and gelatin in sequence, stir evenly, keep warm and evacuate for 2-4 hours, cool to 55°C, keep warm for later use

[0068] It is understood by those skilled in the art that the "parts by weight" of each Chinese herbal medicine refers to the dosage ratio of each Chinese herbal medicine, rather than the actual unit of mass. According to the actual situation, the unit part by weight can be any mass, such as 1 part by weight can be 1g, 500g or 1kg, or even 15g, 30g, etc.

[0069] It will be appreciated by those skilled in the art that the dosage of the pharmaceutical composition of the present invention depends on many factors, such as the nature and severity of the allergic asthma to be prevented or treated, the sex, age, weight and individual response of the patient or animal, the route of administration and the number of administrations, etc. The above dosage can be administered in a single dosage form or divided into several, such as two, three or four dosage forms. The dosage level must be selected based on the specific route of administration, the severity of the condition to be treated, and the condition and previous medical history of the patient to be treated. However, the practice in the art is to start the dosage from a level lower than that required to obtain the desired therapeutic effect and gradually increase the dosage until the desired effect is obtained.

[0070] The composition and drug of the present invention can be administered in an amount of 10 mg-10 g of active ingredient / kg body weight, for example, 200 mg of active ingredient / kg body weight, 3 g of active ingredient / kg body weight, 4 g of active ingredient / kg body weight, or 10 mg of active ingredient / kg body weight.

[0071] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be considered as limiting the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be obtained commercially.

[0072] Example 1 Composition for Rapidly Reversing and Relieving Atherosclerotic Plaques

[0073] 2500 parts by weight of rubber tree seed oil, 30 parts by weight of Panax notoginseng, 35 parts by weight of ginseng, and 25 parts by weight of policosanol.

[0074] Example 2 Composition for Rapidly Reversing and Relieving Atherosclerotic Plaques

[0075] 1500 parts by weight of rubber tree seed oil, 20 parts by weight of Panax notoginseng, 25 parts by weight of ginseng, and 15 parts by weight of polyunsaturated glycol.

[0076] Example 3 Composition for Rapidly Reversing and Relieving Atherosclerotic Plaques

[0077] 1200 parts by weight of rubber tree seed oil, 10 parts by weight of Panax notoginseng, 12 parts by weight of ginseng, and 10 parts by weight of polyunsaturated glycol.

[0078] Example 4 Composition for Rapidly Reversing and Relieving Atherosclerotic Plaques

[0079] 900 parts by weight of rubber tree seed oil, 5 parts by weight of Panax notoginseng, 5 parts by weight of ginseng, and 5 parts by weight of polyunsaturated glycol.

[0080] Example 5 Composition for Rapidly Reversing and Relieving Atherosclerotic Plaques

[0081] 700 parts by weight of rubber tree seed oil, 8 parts by weight of Panax notoginseng, 7 parts by weight of ginseng, and 5 parts by weight of polyunsaturated glycol.

[0082] Example 6 Composition for Rapidly Reversing and Relieving Atherosclerotic Plaques

[0083] 400 parts by weight of rubber tree seed oil, 5 parts by weight of Panax notoginseng, 3 parts by weight of ginseng, and 6 parts by weight of polyunsaturated fatty alcohol.

[0084] Example 7 Soft Capsule Coating

[0085] 20 parts by weight of gelatin, 8 parts by weight of glycerin, 20 parts by weight of purified water, and 5 parts by weight of red yeast rice.

[0086] Example 8 Soft Capsule Coating

[0087] 8 parts by weight of gelatin, 5 parts by weight of glycerin, 15 parts by weight of purified water, and 2.5 parts by weight of red yeast rice.

[0088] Example 9 Soft Capsule Coating

[0089] 10 parts by weight of gelatin, 3.5 parts by weight of glycerin, 9 parts by weight of purified water, and 0.8 parts by weight of red yeast rice.

[0090] Example 10 Soft Capsule Coating

[0091] 20 parts by weight of gelatin, 7 parts by weight of glycerol, 18 parts by weight of purified water, and 1 part by weight of red yeast rice.

[0092] Example 11 Preparation of soft capsule preparation

[0093] Weigh the components according to the ratio of Example 1, add Panax notoginseng extract, ginseng extract and polyunsaturated alcohol to rubber tree seed oil in turn, emulsify and mix evenly, and set aside; weigh the components according to the ratio of Example 7, put red yeast rice, glycerin and purified water into a gelatinization tank, stir and heat to 80°C, add gelatin, stir evenly, keep warm and evacuate for 2-4 hours, cool to 55°C, and keep warm for use.

[0094] Example 12 Preparation of soft capsule preparation

[0095] Weigh the components according to the ratio of Example 4, add Panax notoginseng extract, ginseng extract and polyunsaturated alcohol to rubber tree seed oil in turn, emulsify and mix evenly, and set aside; weigh the components according to the ratio of Example 9, add red yeast rice and glycerin purified water into a stirring tank, stir and mix, and heat. When the temperature in the tank rises to 65-75°C, add rubber powder and stir evenly. When the temperature in the tank rises to 70-80°C, keep warm and evacuate for 2-4h. When the temperature drops to 55°C, keep warm and set aside.

[0096] Example 13 Preparation of soft capsule preparation

[0097] 1. Weigh each component according to the ratio of Example 4, add Panax notoginseng extract, ginseng extract, and polyunsaturated alcohol to rubber tree seed oil in turn, emulsify and mix evenly, and set aside; weigh each component according to the ratio of Example 10, add red yeast rice and glycerol purified water into a stirring tank, stir and mix, heat, and when the temperature in the tank rises to 65-75°C, add rubber powder and stir evenly. When the temperature in the tank rises to 70-80°C, keep warm and evacuate for 2-4h, cool to 55°C, and keep warm for use.

[0098] Comparative Example 1

[0099] The same as Example 12, except that no red yeast rice is added.

[0100] Investigate the clinical effect of the soft capsule preparation of the present invention

[0101] Study subjects: A total of 60 patients diagnosed with carotid atherosclerosis, including 30 males and 30 females, aged 42 to 76 years old, with an average age of (59.00±8.74) years old.

[0102] Treatment plan: The patient took the soft capsule prepared in Example 12 every day, 3 times a day, 6 capsules each time, before breakfast and lunch, and half an hour before going to bed at night. Continuous use for 3 months is a course of treatment. The changes in the levels of carotid artery intima-media thickness (IMT), carotid atherosclerotic plaques, blood pressure, fasting blood sugar, and blood lipids in the observation group were checked before and after taking the medicine within 15 days, and the safety indicators of blood routine, urine routine, liver function, and kidney function were checked.

[0103] The efficacy indicators are shown in Table 1.

[0104] Table 1

[0105]

[0106] The treatment effects are shown in Table 2 below:

[0107]

[0108] It can be seen that 38 cases of carotid atherosclerotic plaques were significantly effective, with a significant effect rate of 63.33%, and 14 cases were effective, with an effective rate of 23.33%, indicating that it has the effect of reversing and ablating atherosclerotic plaques. All 60 patients had no gastrointestinal and other adverse reactions after taking it for 3 months.

[0109] The following is a further explanation based on specific cases:

[0110] Ms. Li, 77 years old, had hypertension for 20 years, hyperlipidemia for 15 years, and carotid atherosclerosis for 20 years. She took the capsules of the composition of the present invention three times a day, 6 capsules each time, for three consecutive months, and her hyperlipidemia symptoms improved. As the blood viscosity decreased, the elasticity of blood vessels was restored, and the patient's hypertension symptoms were also improved.

[0111] Mr. Zhang, 64 years old, had hyperlipidemia for 7 years and fatty liver for 5 years. He took the capsules of the composition of the present invention three times a day, 8 capsules each time, and after taking it for three consecutive months, his hyperlipidemia decreased. At the same time, due to the cure of fatty liver, the patient's liver function index also returned to normal.

[0112] Ms. Huang, 72 years old, had mild hyperlipidemia for 3 years. She reported that she had long-term dizziness. She took the capsules of the composition of the present invention, 2 capsules three times a day, and the dizziness symptoms improved after taking it for half a month. She continued to take the capsules of the composition of the present invention, 2 capsules three times a day, and her blood lipids returned to normal after taking it for three months.

[0113] Mr. Gao, 55 years old, had facial paralysis and slightly uncoordinated walking after cerebral infarction before taking the patented formula composition. He took the composition capsules of the present invention three times a day, 10 capsules each time, and his talking and movement returned to normal after taking it for six months.

[0114] Finally, it should be noted that the above description is only a preferred embodiment of the present invention. Under the guidance of the present invention, those skilled in the art can make a variety of similar expressions without violating the purpose and claims of the present invention, and such changes all fall within the protection scope of the present invention.

Claims

1. A composition for rapidly reversing and eliminating atherosclerotic plaques, characterized in that: Includes rubber tree seed oil, Panax notoginseng, ginseng, and polyunsaturated fatty acid.

2. The composition according to claim 1, characterized in that The composition comprises: 1-3000 parts by weight of rubber tree seed oil; for example, 5-2500 parts by weight, or 50-2000 parts by weight, or 100-1500 parts by weight, or 300-1000 parts by weight; and 1-50 parts by weight of Panax notoginseng; for example 1-40 parts by weight, or 1-30 parts by weight, or 3-15 parts by weight, or 5-15 parts by weight; and 1-50 parts by weight of ginseng; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-20 parts by weight, or 5-12 parts by weight; and 1-50 parts by weight of Policosanol; for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 1-10 parts by weight.

3. The composition according to claim 1 or 2, characterized in that The Panax notoginseng comprises Panax notoginseng powder, Panax notoginseng extract or a combination thereof; and / or The ginseng comprises at least one of ginseng powder and ginseng extract; and / or The rubber tree seed oil has a w-3 content of ≥18wt%, a w-6 content of ≥36wt%, and a total triterpene content of > 15wt%, total polyphenol content>0.006wt%.

4. A soft capsule preparation, characterized in that: The soft capsule comprises contents and a coating; the contents are the composition according to any one of claims 1 to 3; the soft capsule coating is composed of red yeast rice extract and pharmaceutical excipients acceptable in the art, and the amount of the red yeast rice extract added is 1-15%wt of the total mass of the soft capsule coating.

5. The preparation according to claim 4, characterized in that The pharmaceutical excipients include any one or more of fillers, binders, wetting agents, disintegrants, cosolvents, solubilizers, osmotic pressure regulators, surfactants, coating materials, colorants, pH regulators, antioxidants, antibacterial agents or buffers.

6. The preparation according to claim 4, characterized in that The coating is prepared from a glue solution and a red yeast rice extract, wherein the glue solution comprises 8-12 parts by weight of gelatin, 3-5 parts by weight of glycerol and 9-15 parts by weight of purified water.

7. A method for preparing a soft capsule preparation, characterized in that: The following steps are involved: S1. Preparation of soft capsule preparation contents: Weigh the contents of each component according to the ratio, sequentially add Panax notoginseng extract, ginseng extract, polyunsaturated alcohol to rubber tree seed oil, emulsify and stir to mix evenly, and set aside; S2. Preparation of soft capsule coating: According to the ratio of the coating components, the red yeast rice extract and pharmaceutical excipients are put into the glue tank, heated and stirred until completely dissolved, evacuated to the glue without bubbles, and the viscosity of the glue is tested and filtered, and set aside; S3. Pill pressing, shaping, and drying: The prepared contents are placed in the storage barrel of a soft capsule pill pressing machine, and the glue liquid is placed in the glue storage barrel of the soft capsule pill pressing machine. The pill pressing machine is started to quantitatively press the contents into soft capsules; after forming, the soft capsules are shaped and then dried until the moisture content of the rubber reaches 8% to 10%.

8. The preparation method according to claim 7, characterized in that: The contents in S1 include: 1-3000 parts by weight of rubber tree seed oil; for example, 5-2500 parts by weight, or 50-2000 parts by weight, or 100-1500 parts by weight, or 300-1000 parts by weight; and 1-50 parts by weight of the Panax notoginseng extract; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-15 parts by weight, or 5-15 parts by weight; and 1-50 parts by weight of ginseng extract; for example, 1-40 parts by weight, or 1-30 parts by weight, or 3-20 parts by weight, or 5-12 parts by weight; and 1-50 parts by weight of Policosanol; for example, 1-40 parts by weight, or 1-30 parts by weight, or 1-20 parts by weight, or 1-10 parts by weight.

9. The preparation method according to claim 7, characterized in that: The coating in S2 comprises: 8-20 parts by weight of gelatin, 3-10 parts by weight of glycerol, 5-25 parts by weight of purified water and 0.2-10 parts by weight of red yeast rice extract.

10. The preparation method according to claim 9, characterized in that: The S2 is specifically as follows: add red yeast rice extract and glycerin purified water into a stirring tank, stir and mix, and heat. When the temperature in the tank rises to 65-75°C, add rubber powder and stir evenly. When the temperature in the tank rises to 70-80°C, keep the temperature and evacuate for 2-4 hours. When the temperature drops to 55℃, keep warm for later use.

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