Traditional Chinese medicine composition for dissolving turbidity, reducing lipid and protecting liver, traditional Chinese medicine preparation and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for dissolving turbidity, reducing lipid and protecting liver, a traditional Chinese medicine preparation and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 to 15 parts of herba siegesbeckiae, 10 to 35 parts of cuttle bone, 15 to 35 parts of lucid ganoderma, 15 to 40 parts of folium microcotis, 10 to 25 parts of radix salviae miltiorrhizae, 5 to 30 parts of fructus aurantii immaturus, 15 to 40 parts of silybum marianum and 10 to 30 parts of folium apocyni veneti. The traditional Chinese medicine composition and the traditional Chinese medicine preparation for dissolving turbidity, reducing lipid and protecting liver can improve the symptom of damp-heat accumulation of liver, and are beneficial for regulating liver and spleen, nourishing liver and kidney and reducing dampness and turbidity, so that the exact effects of regulating liver and reducing lipid are achieved, and the traditional Chinese medicine composition and the traditional Chinese medicine preparation are suitable for fatty liver and other related diseases caused by damp-heat accumulation and liver stagnation and spleen deficiency, and are remarkable in curative effect, high in curing speed and free of toxic and side effects. Moreover, after being cured, the traditional Chinese medicine is not easy to relapse.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver, a traditional Chinese medicine agent and a preparation method thereof. Background Art

[0002] In recent years, with the improvement of living standards and quality, the dietary structure has undergone tremendous changes, and the incidence of fatty liver has become increasingly high, becoming a common chronic disease. Fatty liver disease is a clinical pathological syndrome caused by a variety of causes of liver lipid metabolism disorders and homeostasis disorders, resulting in lipid accumulation in liver cells and fatty degeneration of liver cells. There is no name for fatty liver in traditional Chinese medicine. According to its clinical manifestations, it can be classified into the categories of "liver accumulation", "fullness", "accumulation", "lumps", "flank pain", etc. Its location is in the liver and is closely related to the spleen. Long-term illness can lead to liver damage, spleen and stomach dysfunction, and cardiovascular diseases, and its incidence rate is increasing year by year. Although some Western medicines have a rapid lipid-lowering effect, they can cause serious side effects such as hepatotoxicity, and it is difficult to achieve an ideal therapeutic effect. Therefore, finding a Chinese medicine that can effectively regulate liver and reduce lipids (clear turbidity, reduce lipids and protect the liver) is one of the important topics in the current medical community.

[0003] In summary, it is very necessary to provide a Chinese medicine composition, Chinese medicine agent and preparation method thereof for clearing turbidity, lowering lipids and protecting the liver. Summary of the invention

[0004] In order to solve one or more technical problems existing in the prior art, the present invention provides a traditional Chinese medicine composition, a traditional Chinese medicine agent and a preparation method thereof for clearing turbidity, reducing lipids and protecting the liver, which is easy to use, has good therapeutic effect, significant therapeutic effect, no toxic side effects, and is not prone to recurrence.

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver, wherein the traditional Chinese medicine composition is composed of the following raw materials in parts by weight:

[0006] 5-15 parts of Siegesbeckia scabra, 10-35 parts of cuttlefish bone, 15-35 parts of Ganoderma lucidum, 15-40 parts of Buza leaves, 10-25 parts of Salvia miltiorrhiza, 5-30 parts of Citrus aurantium, 15-40 parts of Silybum marianum, and 10-30 parts of Apocynum venetum leaves.

[0007] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10-15 parts of Siegesbeckia herb, 10-30 parts of cuttlefish bone, 20-35 parts of Ganoderma lucidum, 20-40 parts of Buza leaves, 15-25 parts of Salvia miltiorrhiza, 10-30 parts of Citrus aurantium, 15-30 parts of Silybum marianum, and 10-20 parts of Apocynum venetum leaves.

[0008] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Siegesbeckia herb, 15 parts of Cuttlefish bone, 30 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 20 parts of Citrus aurantium, 20 parts of Silybum marianum, and 15 parts of Apocynum venetum leaves.

[0009] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum, and 10 parts of Apocynum venetum leaves.

[0010] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 10 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 10 parts of Citrus aurantium, 15 parts of Silybum marianum, and 10 parts of Apocynum venetum leaves.

[0011] The second aspect of the present invention provides a traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of Siegesbeckia herb, 10-35 parts of cuttlefish bone, 15-35 parts of Ganoderma lucidum, 15-40 parts of Buza leaves, 10-25 parts of turtle shell, 5-30 parts of Magnolia officinalis, 15-40 parts of Milk thistle and 10-30 parts of Apocynum venetum leaves.

[0012] In a third aspect, the present invention provides a traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of Siegesbeckia herb, 10-35 parts of cuttlefish bone, 15-35 parts of Ganoderma lucidum, 15-40 parts of Buza leaves, 10-25 parts of turtle shell, 5-30 parts of Magnolia officinalis, 15-40 parts of Silybum marianum, 10-30 parts of Apocynum venetum leaves, and 10-25 parts of Cyperus rotundus.

[0013] The present invention provides a traditional Chinese medicine for clearing turbidity, reducing lipids and protecting the liver in a fourth aspect, the traditional Chinese medicine comprising the traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver as described in the first aspect, the second aspect or the third aspect of the present invention.

[0014] The present invention provides in a fifth aspect a method for preparing the turbidity-clearing, lipid-reducing and liver-protecting Chinese medicinal preparation according to the fourth aspect of the present invention, the method comprising the following steps:

[0015] (1) Soaking the raw materials of the traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver in water for 1 to 2 hours;

[0016] (2) adding water to the raw materials soaked in step (1) for a first decoction, filtering to obtain a first decoction and a filter residue, then adding water to the filter residue for a second decoction, filtering to obtain a second decoction, combining the first decoction and the second decoction, standing, filtering, and obtaining a filtrate;

[0017] (3) concentrating the filtrate to a thick paste having a relative density of 1.20 to 1.25 at an ambient temperature of 80° C.;

[0018] (4) The thick paste and corn starch are mixed evenly in a mass ratio of 1:(1.5-2.0), and then granulated, dried, and granulated to obtain a traditional Chinese medicine for clearing turbidity, lowering lipids, and protecting the liver.

[0019] Preferably, the mass ratio of the thick paste to corn starch is 1:2; the granulation is wet granulation; and / or the drying is drying at 60-70° C. for 3-4 hours.

[0020] Compared with the prior art, the present invention has at least the following beneficial effects:

[0021] (1) The present invention uses traditional Chinese herbal medicine to regulate the liver and reduce fat (clear turbidity, reduce fat and protect the liver). The pathological characteristics of non-alcoholic fatty liver disease are excessive fat deposition in liver cells caused by non-alcoholic and liver-damaging factors. The metabolic syndrome formed under unreasonable diet and living habits gradually deteriorates into chronic liver disease. Traditional Chinese medicine believes that fat is produced by the essence of acquired water and grain, and mainly depends on the physiological functions of kidney qi transformation, spleen transportation and transformation, and liver drainage to spread throughout the body with body fluid. Once the dysfunction of various internal organs stops the distribution of body fluid, it will be transformed into phlegm and dampness, which will seep into the blood through the meridians to form fat. The treatment should focus on removing dampness and heat, supplemented by regulating the liver and spleen. The treatment should focus on reducing dampness and turbidity and clearing heat and removing dampness. The efficacy test and clinical results show that the Chinese medicine composition for clearing turbidity, reducing fat and protecting the liver in the present invention has significant efficacy.

[0022] (2) The Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver in the present invention is based on the pathogenesis of fatty liver and the theory of traditional Chinese medicine, and is based on the elimination of dampness and heat as the main method, and is suitable for promoting the flow of qi, relieving depression, eliminating dampness, and regulating the liver and spleen. After taking it, it can not only improve the symptoms of dampness and heat accumulation in the liver, but also help to harmonize the liver and spleen, nourish the liver and kidneys, and reduce dampness and turbidity, thereby achieving the definite effect of regulating the liver and lowering lipids, and it is not easy to relapse after recovery.

[0023] (3) The Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in the present invention can simultaneously reduce dampness and turbidity and harmonize the liver and spleen, treating both the symptoms and the root causes, and is suitable for fatty liver and other related diseases caused by damp-heat accumulation, liver depression and spleen deficiency, and has no adverse reactions and toxic side effects.

[0024] (4) The Chinese medicine of the present invention is simple to prepare, easy to take, has significant curative effect and fast healing speed.

[0025] (5) The results of the hyperlipidemia model test constructed by the present invention show that the serum TC, TG and LDL-C levels of the group receiving the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver are significantly reduced, and the dyslipidemia is significantly improved. There is a significant difference between the group receiving the medicine for 15 days and the model control group (P<0.05). In addition, the Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver can also reduce dampness and turbidity, and harmonize the liver and spleen. The Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver has the effect of harmonizing the liver and spleen, making the patients feel more comfortable during the treatment process, thereby improving the patients' quality of life. Fatty liver can cause lipid metabolism disorders, weight gain, hepatic fatty degeneration, etc. in patients. This disease may cause complications of a series of metabolic disorders. The Chinese medicine composition of the present invention helps to reduce the risk of complications and make the treatment safer. In addition, the Ganoderma lucidum contained in the traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver of the present invention can delay the aging of the body, reduce the production of lipid peroxides, and improve the body's antioxidant capacity, thereby better playing the role of regulating the liver and reducing lipids; the traditional Chinese medicine composition of the present invention helps to create an environment that is more conducive to treatment and improve the treatment effect. For example, in the experiment of constructing a rat model of hyperlipidemia, it can regulate the enzymes related to β-oxidation of the rats, thereby improving fat metabolism, and playing a therapeutic role on the liver damage of non-alcoholic fatty liver in rats. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0027] In a first aspect, the present invention provides a traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts (for example, 5, 8, 10, 12, 14 or 15 parts) of Siegesbeckia scabra, 10-35 parts (for example, 10, 13, 15, 18, 20, 22, 25, 28, 30, 32 or 35 parts) of cuttlefish bone, 15-35 parts (for example, 15, 18, 20, 23, 25, 28, 30, 32 or 35 parts) of Ganoderma lucidum, 15-40 parts (for example, 15, 18, 20, 22, 25 , 28, 30, 32, 35, 38 or 40 parts), 10-25 parts (e.g. 10, 12, 15, 18, 20, 23 or 25 parts) of Salvia miltiorrhiza, 5-30 parts (e.g. 5, 8, 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts) of Citrus aurantium, 15-40 parts (e.g. 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts) of Silybum marianum, and 10-30 parts (e.g. 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts) of Apocynum venetum.

[0028] The present invention selects traditional Chinese herbal medicine to regulate liver and reduce fat. The pathological characteristics of non-alcoholic fatty liver are excessive fat deposition in liver cells caused by non-alcoholic and liver-damaging factors. The metabolic syndrome formed under unreasonable diet and living habits gradually deteriorates into chronic liver disease. Chinese medicine believes that fat is produced by the essence of acquired water and grain, and mainly depends on the physiological functions of kidney gasification, spleen transportation, liver drainage, etc. to spread throughout the body with body fluid. Once the dysfunction of various internal organs stops the distribution of body fluid, it will be transformed into phlegm and dampness, which will be infiltrated into blood by meridians to form fat. It should be mainly to remove dampness and heat, supplemented by harmonizing the liver and spleen, and the treatment should be mainly to reduce dampness and turbidity and clear heat and dampness. The efficacy test and clinical results show that the Chinese medicine composition for removing turbidity, reducing fat and protecting the liver in the present invention has significant efficacy. The Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver in the present invention is based on the pathogenesis of fatty liver and the theory of traditional Chinese medicine, and is mainly based on removing dampness and heat. The treatment is suitable for promoting qi, relieving depression, removing dampness, and regulating the liver and spleen. After taking it, it can not only improve the symptoms of dampness and heat accumulation in the liver, but also help to harmonize the liver and spleen, nourish the liver and kidneys, and reduce dampness and turbidity, thereby achieving the definite effect of regulating the liver and reducing lipids, and it is not easy to relapse after recovery.

[0029] The Chinese medicinal composition for clearing turbidity, reducing lipids and protecting the liver in the present invention can simultaneously reduce dampness and turbidity and harmonize the liver and spleen, treating both the symptoms and the root causes, and is suitable for fatty liver and other related diseases caused by damp-heat accumulation, liver depression and spleen deficiency, and has no adverse reactions and toxic side effects.

[0030] The traditional Chinese medicine composition for clearing turbidity, reducing blood lipid and protecting liver of the present invention uniquely comprises eight ingredients, namely, Herba Siegesbeckiae, Sepia Bone, Ganoderma Lucidum, Buzha Leaf, Salvia Miltiorrhiza, Fructus Aurantii Immaturus, Milk Thistle and Dogbane Leaf; the present invention finds through research that among the eight traditional Chinese medicine ingredients, the synergistic effect of Herba Siegesbeckiae, Sepia Bone, Buzha Leaf, Dogbane Leaf, Ganoderma Lucidum and Milk Thistle has excellent liver regulating and blood lipid lowering effects on the traditional Chinese medicine composition, and the coordinated effect of Herba Siegesbeckiae, Sepia Bone, Buzha Leaf, Dogbane Leaf, Ganoderma Lucidum and Milk Thistle helps to effectively reduce dampness and turbidity. , clearing away heat and dampness, and having a good effect on clearing turbidity, lowering lipids and protecting the liver. These six ingredients complement each other and work synergistically with each other and are indispensable. If any one of the ingredients is missing in the traditional Chinese medicine composition, the effect of regulating liver and lowering lipids (clearing turbidity, lowering lipids and protecting the liver) will be significantly reduced; the six ingredients of Siegesbeckia herb, cuttlefish bone, Buza leaf, Luobu Ma leaf, Ganoderma lucidum and Milk thistle in the present invention play a key role in the traditional Chinese medicine composition, and their synergistic effect not only demonstrates the unique advantages of traditional Chinese medicine, but also provides a comprehensive and effective method for regulating liver and lowering lipids.

[0031] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-15 parts (e.g., 10, 11, 12, 13, 14 or 15 parts) of Siegesbeckia scabra, 10-30 parts (e.g., 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 parts) of Cuttlefish bone, 20-35 parts (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts) of Ganoderma lucidum, 20-40 parts (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 parts), 15-25 parts (e.g. 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 parts) of Salvia miltiorrhiza, 10-30 parts (e.g. 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 parts) of Citrus aurantium , 26, 27, 28, 29 or 30 parts), milk thistle 15-30 parts (for example 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 parts), and dogbane leaves 10-20 parts (for example 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts).

[0032] According to some preferred embodiments, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Siegesbeckia herb, 15 parts of Cuttlefish bone, 30 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 20 parts of Citrus aurantium, 20 parts of Silybum marianum, and 15 parts of Apocynum venetum leaves.

[0033] According to some preferred embodiments, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum, and 10 parts of Apocynum venetum leaves.

[0034] According to some preferred embodiments, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 10 parts of Cuttlefish bone, 20 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 10 parts of Citrus aurantium, 15 parts of Silybum marianum, and 10 parts of Apocynum venetum leaves.

[0035] In a second aspect, the present invention provides a traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts (for example, 5, 8, 10, 12, 14 or 15 parts) of Siegesbeckia scabra, 10-35 parts (for example, 10, 13, 15, 18, 20, 22, 25, 28, 30, 32 or 35 parts) of cuttlefish bone, 15-35 parts (for example, 15, 18, 20, 23, 25, 28, 30, 32 or 35 parts) of Ganoderma lucidum, 15-40 parts (for example, 15, 18, 20, 22, 25 , 28, 30, 32, 35, 38 or 40 parts), Carapace of Turtle 10-25 parts (e.g., 10, 12, 15, 18, 20, 23 or 25 parts), Cortex Magnoliae Bark 5-30 parts (e.g., 5, 8, 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts), Silybum Marianum 15-40 parts (e.g., 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), Leaf of Apocynum venetum 10-30 parts (e.g., 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts). The present invention finds that in a traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver, when the six most critical ingredients of Siegesbeckia, cuttlefish bone, Buza leaf, Apocynum venetum leaf, Ganoderma lucidum and Silybum marianum are contained, Magnolia officinalis can be used to replace Citrus aurantium, and Carapax tricolor can be used to replace Salvia miltiorrhiza, and a traditional Chinese medicine composition that can effectively reduce dampness and turbidity, clear away heat and dampness, and has a good effect on clearing turbidity, reducing lipids and protecting the liver can be obtained.

[0036] In a third aspect, the present invention provides a traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts (e.g., 5, 8, 10, 12, 14 or 15 parts) of Siegesbeckia scabra, 10-35 parts (e.g., 10, 13, 15, 18, 20, 22, 25, 28, 30, 32 or 35 parts) of cuttlefish bone, 15-35 parts (e.g., 15, 18, 20, 23, 25, 28, 30, 32 or 35 parts) of Ganoderma lucidum, 15-40 parts (e.g., 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts) of Buza leaves, 10-25 parts (e.g., 10, 12, 15, 18, 20, 23 or 25 parts), magnolia bark 5-30 parts (for example 5, 8, 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts), milk thistle 15-40 parts (for example 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), apocynum venetum leaf 10-30 parts (for example 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts), cyperus rotundus 10-25 parts (for example 10, 13, 15, 17, 20, 22 or 25 parts); in the present invention, cyperus rotundus can also be added to the traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver.

[0037] The present invention provides a traditional Chinese medicine for clearing turbidity, reducing lipids and protecting the liver in a fourth aspect, the traditional Chinese medicine comprising the traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver as described in the first aspect, the second aspect or the third aspect of the present invention.

[0038] The present invention provides in a fifth aspect a method for preparing the turbidity-clearing, lipid-reducing and liver-protecting Chinese medicinal preparation according to the fourth aspect of the present invention, the method comprising the following steps:

[0039] (1) Soaking the raw materials of the traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver in water for 1 to 2 hours;

[0040] (2) adding water to the raw materials soaked in step (1) for a first decoction, filtering to obtain a first decoction and a filter residue, then adding water to the filter residue for a second decoction, filtering to obtain a second decoction, combining the first decoction and the second decoction, standing, filtering, and obtaining a filtrate;

[0041] (3) concentrating the filtrate to a thick paste having a relative density of 1.20 to 1.25 at an ambient temperature of 80° C.;

[0042] (4) The thick paste and corn starch are mixed evenly in a mass ratio of 1: (1.5-2.0), and then granulated, dried, and granulated to obtain a Chinese medicine for clearing turbidity, lowering lipids, and protecting the liver; the Chinese medicine in the present invention is simple to prepare, easy to take, has significant therapeutic effects, and a fast healing speed; in the present invention, the Chinese medicine is also recorded as a Chinese medicine composition granule.

[0043] According to some preferred embodiments, during the first decoction, water in an amount of 8 to 12 times the total mass of the raw materials is added, that is, the amount of water is 8 to 12 times the total mass of the raw materials; and / or during the second decoction, water in an amount of 8 to 12 times the mass of the filter residue is added, that is, the amount of water is 8 to 12 times the mass of the filter residue.

[0044] According to some preferred embodiments, in step (1), water is added for soaking for 1.5 hours; in step (2), water of 10 times the total mass of the raw materials is added during the first decoction, and water of 10 times the mass of the filter residue is added during the second decoction; in step (2), the mixture is allowed to stand for 24 hours; and / or in step (4), the thick paste is evenly mixed with corn starch (auxiliary material) in a mass ratio of 1:2.

[0045] According to some specific embodiments, the preparation of the traditional Chinese medicine for clearing turbidity, lowering lipids and protecting the liver is as follows: weigh each weight portion of the traditional Chinese medicine raw materials and soak them in water for 1.5 hours; decoct twice, the first time with 10 times the water for 2 hours, the second time with 10 times the water, decoct for 1 hour, combine the decoctions, let stand for 24 hours, and filter; decompress the obtained filtrate to a thick paste of 1.20 to 1.25 (80°C thermal measurement); mix the thick paste with corn starch in a mass ratio of 1:2; then granulate, dry, and granulate to obtain 1000g of granules.

[0046] In the present invention, the granulation is wet granulation. The present invention does not limit the specific conditions of decoction, granulation, drying (drying), granulation, etc., which are conventional techniques in the art.

[0047] According to some preferred embodiments, in step (4): corn starch is added to the thick paste and mixed evenly to obtain a drug mass, the drug mass is wet granulated, and then dried at 60-70° C. for 3-4 hours, and granulated to obtain a traditional Chinese medicine for clearing turbidity, lowering lipids and protecting the liver.

[0048] According to some specific embodiments, the Chinese medicine composition granules described in the present invention are obtained by concentrating the water extract of the prescription Chinese medicine composition into a thick paste; mixing it with the auxiliary material corn starch and wet granulating it. The process of making wet granules is: adding corn starch to the thick paste, running the mixer to form a number of drug agglomerates, and the drug agglomerates are promptly passed through a swinging granulator with a 14-mesh screen to obtain wet granules, and the wet granules are dried at 60-70°C for 3-4 hours. The obtained dry granules are sieved with a 10-mesh sieve to remove large particles, and sieved with an 80-mesh sieve to remove fine powder, thereby obtaining the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver.

[0049] The present invention will be further described below by way of examples, but the protection scope of the present invention is not limited to these embodiments. The present invention may also have other various embodiments, and those skilled in the art may make various corresponding changes and deformations according to the present invention without departing from the spirit and essence of the present invention, but these corresponding changes and deformations shall all belong to the protection scope of the claims attached to the present invention.

[0050] Example 1

[0051] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Siegesbeckia herb, 15 parts of cuttlefish bone, 30 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 20 parts of Citrus aurantium, 20 parts of Silybum marianum and 15 parts of Apocynum venetum leaves.

[0052] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0053] Example 2

[0054] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum and 10 parts of Apocynum venetum leaves.

[0055] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0056] Example 3

[0057] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 10 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 10 parts of Citrus aurantium, 15 parts of Silybum marianum and 10 parts of Apocynum venetum leaves.

[0058] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0059] Example 4

[0060] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Siegesbeckia herb, 20 parts of cuttlefish bone, 25 parts of Ganoderma lucidum, 25 parts of Buza leaves, 20 parts of Salvia miltiorrhiza, 25 parts of Citrus aurantium, 25 parts of Silybum marianum and 15 parts of Apocynum venetum leaves.

[0061] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0062] Comparative Example 1

[0063] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of cuttlefish bone, 20 parts of ganoderma lucidum, 25 parts of buzia leaves, 15 parts of salvia miltiorrhiza, 15 parts of immature bitter orange, 25 parts of milk thistle and 10 parts of dogbun leaves.

[0064] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0065] Comparative Example 2

[0066] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 20 parts of Ganoderma lucidum, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum and 10 parts of Apocynum venetum leaves.

[0067] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0068] Comparative Example 3

[0069] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of Sepia bone, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum and 10 parts of Apocynum venetum leaves.

[0070] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0071] Comparative Example 4

[0072] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum and 10 parts of Apocynum venetum leaf.

[0073] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0074] Comparative Example 5

[0075] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, and 10 parts of Apocynum venetum leaves.

[0076] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0077] Comparative Example 6

[0078] A traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckia herb, 25 parts of cuttlefish bone, 20 parts of Ganoderma lucidum, 25 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, and 25 parts of Silybum marianum.

[0079] The preparation method of the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver prepared by the above-mentioned Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver is as follows: soak the raw materials of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver in water for 1.5 hours; add 10 times the total mass of water of each raw material to each soaked raw material for the first decoction for 2 hours, filter to obtain a first decoction and a filter residue, then add 10 times the mass of water of the filter residue to the filter residue for a second decoction for 1 hour, filter to obtain a second decoction, combine the first decoction and the second decoction, let stand for 24 hours, filter to obtain a filtrate; concentrate the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mix the thick paste with corn starch in a mass ratio of 1:2, granulate, dry (dry at 65°C for 3.5 hours), and sieve (use a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the Chinese medicinal preparation for clearing turbidity, lowering lipids and protecting the liver (granules of the Chinese medicinal composition for clearing turbidity, lowering lipids and protecting the liver).

[0080] The present invention illustrates the efficacy of the Chinese medicine products for clearing turbidity, lowering lipids and regulating liver prepared by using Examples 1 to 4 of the present invention through clinical efficacy observation experiments, as follows:

[0081] 1. General Information

[0082] 100 patients with nonalcoholic fatty liver disease were selected as the control group and the treatment group, respectively.

[0083] 2. Diagnostic Criteria

[0084] (I) Symptoms and signs

[0085] Patients are generally accompanied by obesity, high fasting blood sugar, and dyslipidemia. Some patients sometimes have discomfort in the upper right part, fatigue or weakness, but sleep is acceptable.

[0086] (II) Imaging examination

[0087] Ultrasound diagnosis: diffuse enhancement of near-field echo in the liver (stronger than that in the kidney and spleen), gradual attenuation of far-field echo, unclear intrahepatic duct structure, mild to moderate enlargement of the liver, blunt edge corners, unclear or incomplete echo of the right lobe capsule and diaphragm.

[0088] 3. Treatment Methods

[0089] Treatment group 1: oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in Example 1 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, one course of treatment; Treatment group 2: oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in Example 2 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, one course of treatment; Treatment group 3: oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in Example 3 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days is a course of treatment, and one course of treatment is taken; Treatment group 4: oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in Example 4 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days is a course of treatment, and one course of treatment is taken; Control group 1: oral administration of Sanqi Zhigan Pills (Yunnan Yuyao Biopharmaceutical Co., Ltd., National Medicine Standard Z20025353) 1 bag each time, 3 times a day, divided into morning and evening, for 14 consecutive days; Control group 2: oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in Comparative Example 1 of the present invention : 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, take one course of treatment; Control group 3: Oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in comparative example 2 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, take one course of treatment; Control group 4: Oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in comparative example 3 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, take one course of treatment; Control group 5: Oral administration of the comparative example of the present invention 4: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, one course of treatment; Control group 6: Oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in comparative example 5 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, one course of treatment; Control group 7: Oral administration of the Chinese medicine for clearing turbidity, lowering lipids and protecting the liver prepared in comparative example 6 of the present invention: 10 grams each time, twice a day, divided into morning and evening, 14 days as a course of treatment, one course of treatment.

[0090] IV. Efficacy evaluation criteria

[0091] Cured: blood lipid and blood sugar indexes are normal, and symptoms such as right upper abdominal discomfort are eliminated;

[0092] Marked effect: blood lipid and blood sugar indexes approached normal, and symptoms such as right upper abdominal discomfort were significantly improved compared with before medication;

[0093] Effective: blood lipid and blood sugar indexes gradually return to normal, and symptoms such as right upper abdominal discomfort are alleviated compared with medication;

[0094] Ineffective: There was no change in blood lipid and blood sugar indexes, right upper abdominal discomfort and other symptoms compared with before medication.

[0095] 5. Treatment Effect

[0096] The effects of the treatment group 1 of the present invention were: 82 cases were cured, 10 cases were markedly effective, 8 cases were effective, and 0 cases were invalid, and the total effective rate was 100%; the effects of the treatment group 2 of the present invention were: 74 cases were cured, 18 cases were markedly effective, 8 cases were effective, and 0 cases were invalid, and the total effective rate was 100%; the effects of the treatment group 3 of the present invention were: 66 cases were cured, 22 cases were markedly effective, 12 cases were effective, and 0 cases were invalid, and the total effective rate was 100%; the effects of the treatment group 4 of the present invention were: 86 cases were cured, 9 cases were markedly effective, 5 cases were effective, and 0 cases were invalid, and the total effective rate was 100%. The results are shown in Table 1.

[0097] Table 1: Comparison of clinical effects.

[0098]

[0099] The treatment group 1 taking the Chinese medicine of the present invention is compared with the control group 1 taking the existing similar medicine. Through the above comparison data, it can be seen that the control group 1 taking the existing similar medicine has a cure rate of 11.00% for non-alcoholic fatty liver disease and a total effective rate of 82.00%, while the treatment group 1 taking the medicine of the present invention has a cure rate of 82.00% for non-alcoholic fatty liver disease and a total effective rate of 100%. At the same time, the cured patients of the above control group 1 and the treatment group 1 are revisited every 6 months. After 3 years of revisit statistics, 6 of the 11 cured patients in the control group 1 relapsed, accounting for 54.5%, and no one of the 82 cured patients in the treatment group 1 relapsed.

[0100] Therefore, the Chinese medicine product for clearing turbidity, reducing lipids and protecting the liver provided by the present invention has a cure rate, significant efficacy and effective rate for treating non-alcoholic fatty liver disease that are significantly higher than similar drugs currently available on the market and has no recurrence. From the above experimental research results, it can be seen that the Chinese medicine composition and Chinese medicine for clearing turbidity, reducing lipids and protecting the liver provided by the present invention can significantly achieve the purpose of regulating the liver and reducing lipids.

[0101] The present invention also studies the protective effect of the turbidity-clearing, lipid-lowering and liver-protecting Chinese medicine product of the present invention on non-alcoholic fatty liver disease, as follows:

[0102] A rat model of non-alcoholic fatty liver disease was prepared using a HFD high-fat diet, and the Chinese medicinal product for clearing turbidity, lowering lipids and protecting the liver of the present invention was given to the rats a certain number of times every day to observe whether the Chinese medicinal product for clearing turbidity, lowering lipids and protecting the liver of the present invention has the effect of alleviating non-alcoholic fatty liver disease.

[0103] 1. Experimental animals and feed

[0104] 60 clean-grade SD male rats, weighing 170-210g, were used. The rats were given a 12-hour circadian rhythm, free-movement diet, and adaptive feeding for 6 days before modeling and grouping and drug administration. The rats were fed with basic feed and high-fat feed.

[0105] 2. Test methods

[0106] 2.1 Model establishment: The SD rat modeling group was fed a high-fat diet for 6 weeks to induce non-alcoholic fatty liver model, and the control group was given a normal diet, and the body weight (body weight) was recorded weekly. Three rats were randomly selected from the normal group and the model group for killing and examination, and the liver tissue was taken for pathological sections, and fat accumulation in the liver tissue was found, and extensive lipid vacuoles were produced. The liver function test confirmed that the induced model was successful.

[0107] 2.2 Experimental groups and drug administration

[0108] The rats were randomly divided into 5 groups of 12 rats each according to their weight. The control group, model group, and low, medium, and high dose treatment groups of the Chinese medicine product for clearing turbidity, reducing lipids and protecting the liver of the present invention (fed with high-fat diet for 6 weeks like the model group). The model group and the control group were gavaged with an equal amount of 0.9% sodium chloride aqueous solution every day for 15 consecutive days; the treatment group was gavaged with the Chinese medicine product for clearing turbidity, reducing lipids and protecting the liver in Example 1 of the present invention at a dosage of 1.26, 2.52, and 5.04 (g / kg) every day for 15 consecutive days.

[0109] 2.3 Detection indicators and methods

[0110] 2.3.1 General condition and liver index: observe the spirit, activity, coat color, etc. of the rats. After fasting for 12 hours, weigh and kill the rats. After ether anesthesia, remove the liver and weigh the liver weight. Calculate the liver index = liver wet weight (g) / body weight (g) × 100%. The results are shown in Table 2.

[0111] 2.3.2 Index detection: The absorbance of TC, TG, HDL, LDL, AST and ALT in serum was measured by an enzyme marker, and the content or activity was calculated according to the formula in the instruction manual. The results are shown in Table 3 and Table 4. Liver homogenate was prepared, and the supernatant content detection liquid was kept and stored in an ultra-low temperature refrigerator for testing. The liver fat detection operation steps were carried out according to the kit instructions.

[0112] Table 2: Body weight, liver wet weight and liver index of rats in each group (n=12, x±s)

[0113] Group Weight / g Liver wet weight / g Liver index (100%) Control group 483.00±27.46 11.35±1.91 2.35±0.30 Model Group <![CDATA[493.00±26.78 ＊ ]]> <![CDATA[13.56±1.31 ＊ ]]> <![CDATA[2.75±0.15 ＊ ]]> Low-dose treatment group 481.64±33.72 <![CDATA[11.67±1.26 # ]]> <![CDATA[2.42±0.14 # ]]> Medium dose treatment group 477.00±45.26 <![CDATA[11.43±1.66 # ]]> <![CDATA[2.40±0.22 # ]]> High-dose treatment group <![CDATA[469.25±46.50 # ]]> <![CDATA[11.26±1.58 # ]]> <![CDATA[2.39±0.16 # ]]>

[0114] Note: Compared with the control group ＊ P<0.05, compared with the model group, # P<0.05.

[0115] Compared with the model group, the final body weight of the high-dose treatment group was significantly reduced (P<0.05), and the liver weight of the treatment group of the Chinese medicine product of the present invention was significantly reduced (P<0.05). Compared with the model group, the liver index of the treatment group of the Chinese medicine product of the present invention showed a downward trend (P<0.05).

[0116] Table 3: Effects on blood lipid levels in rats of each group (n=12, x±s, mmol / L)

[0117] Group TC TG LDL-C HDL-C Control group 1.53±0.42 0.34±0.15 1.34±0.56 0.42±0.03 Model Group 1.72±0.68 0.54±0.33 1.53±0.72 0.23±0.06 Low-dose treatment group <![CDATA[1.58±0.79 # ]]> 0.36±0.18 1.38±0.78 <![CDATA[0.33±0.12 # ]]> Medium dose treatment group <![CDATA[1.51±0.76 # ]]> <![CDATA[0.25±0.23 # ]]> 1.24±0.51 <![CDATA[0.36±0.14 # ]]> High-dose treatment group <![CDATA[1.28±0.84 # ]]> <![CDATA[0.22±0.16 # ]]> <![CDATA[1.13±0.16 # ]]> <![CDATA[0.39±0.20 # ]]>

[0118] Note: Compared with the model group, # P<0.05.

[0119] Table 4: Effects on liver function indexes of rats in each group (n=12, x±s, U / L)

[0120]

[0121]

[0122] Note: Compared with the control group ＊ P<0.05, compared with the model group, △ P<0.05, ＊ P<0.01.

[0123] The TC, TG and LDL-C contents of the model group increased significantly, and the HDL-C content decreased significantly, indicating that the high-fat diet model was successfully established. Compared with the model group, the TC, TG and LDL-C contents of the high-dose treatment group of the Chinese medicine product of the present invention were significantly reduced (P < 0.05), indicating that it has a good therapeutic effect. The HDL-C detection results showed that compared with the model group, the treatment group had a significant effect on increasing HDL-C (P < 0.05), as shown in Table 3.

[0124] Compared with the control group, the AST and ALT levels in the serum and liver homogenate of the rats in the model group were significantly increased (P<0.05), confirming that the liver function of the rats in the model group was damaged; compared with the model group, the serum ALT and AST of the rats in the medium and high-dose treatment groups were significantly improved (P<0.05 or P<0.01), and the ALT and AST in the liver of the rats in the high-dose treatment group were significantly decreased (P<0.05), as shown in Table 4.

[0125] The above studies show that the Chinese medicine product of the present invention can significantly improve non-alcoholic fatty liver disease, reduce the body weight, wet liver weight and liver index of rats fed a high-fat diet, and has a good therapeutic and regulatory effect on liver fat and blood lipids. It can reduce TC, TG, LDL-C, ALT, AST, and increase HDL-C, and plays a good regulatory and protective role on hyperlipidemia and liver damage induced by a high-fat diet.

[0126] The parts of the present invention that are not described in detail are well-known technologies to those skilled in the art, and those skilled in the art can make selections as needed.

[0127] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although detailed descriptions have been made with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of Siegesbeckia scabra, 10-35 parts of cuttlefish bone, 15-35 parts of Ganoderma lucidum, 15-40 parts of Buza leaves, 10-25 parts of Salvia miltiorrhiza, 5-30 parts of Citrus aurantium, 15-40 parts of Silybum marianum, and 10-30 parts of Apocynum venetum leaves.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 10-15 parts of Siegesbeckia scabra, 10-30 parts of cuttlefish bone, 20-35 parts of Ganoderma lucidum, 20-40 parts of Buza leaves, 15-25 parts of Salvia miltiorrhiza, 10-30 parts of Citrus aurantium, 15-30 parts of Silybum marianum, and 10-20 parts of Apocynum venetum leaves.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Siegesbeckiae, 15 parts of Ossobucus, 30 parts of Ganoderma lucidum, 20 parts of Buza leaves, 15 parts of Salvia miltiorrhiza, 20 parts of Fructus Aurantii Immaturus, 20 parts of Silybum marianum, and 15 parts of Apocynum venetum leaves.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckiae, 25 parts of Ossobucus, 20 parts of Ganoderma Lucidum, 25 parts of Buza Leaves, 15 parts of Salvia miltiorrhiza, 15 parts of Fructus Aurantii Immaturus, 25 parts of Silybum Marianum, and 10 parts of Apocynum venetum Leaves.

5. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Siegesbeckiae, 10 parts of Ossobucus, 20 parts of Ganoderma Lucidum, 20 parts of Buza Leaves, 15 parts of Salvia miltiorrhiza, 10 parts of Fructus Aurantii Immaturus, 15 parts of Silybum Marianum, and 10 parts of Apocynum venetum Leaves.

6. A Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of Siegesbeckia scabra, 10-35 parts of cuttlefish bone, 15-35 parts of ganoderma lucidum, 15-40 parts of Buza leaves, 10-25 parts of turtle shell, 5-30 parts of Magnolia officinalis, 15-40 parts of Silybum marianum, and 10-30 parts of Apocynum venetum leaves.

7. A Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of Siegesbeckia scabra, 10-35 parts of cuttlefish bone, 15-35 parts of ganoderma lucidum, 15-40 parts of Buza leaves, 10-25 parts of turtle shells, 5-30 parts of Magnolia officinalis, 15-40 parts of Silybum marianum, 10-30 parts of Apocynum venetum leaves, and 10-25 parts of Cyperus rotundus.

8. A Chinese medicine for clearing turbidity, lowering lipids and protecting the liver, characterized in that: The Chinese medicine comprises the Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver according to any one of claims 1 to 5 or claim 6 or claim 7.

9. The method for preparing the turbidity-clearing, lipid-lowering and liver-protecting Chinese medicine according to claim 8, characterized in that: The method comprises the following steps: (1) Soaking the raw materials of the traditional Chinese medicine composition for clearing turbidity, reducing lipids and protecting the liver in water for 1 to 2 hours; (2) adding water to the raw materials soaked in step (1) for a first decoction, filtering to obtain a first decoction and a filter residue, then adding water to the filter residue for a second decoction, filtering to obtain a second decoction, combining the first decoction and the second decoction, standing, filtering, and obtaining a filtrate; (3) concentrating the filtrate to a thick paste having a relative density of 1.20 to 1.25 at an ambient temperature of 80° C.; (4) The thick paste and corn starch are mixed evenly in a mass ratio of 1:(1.5-2.0), and then granulated, dried, and granulated to obtain a traditional Chinese medicine for clearing turbidity, lowering lipids, and protecting the liver.

10. The preparation method according to claim 9, characterized in that: The mass ratio of the thick paste to corn starch is 1:2; The granulation is wet granulation; and / or The drying is carried out at 60-70° C. for 3-4 hours.

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