A traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, a traditional Chinese medicine preparation and a preparation method thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition of resolving turbidity and reducing fat, traditional Chinese medicine and preparation method thereof.The traditional Chinese medicine composition is composed of the following weight parts of raw materials: 5-15 parts of Herba siegesbeckiae, 10-35 parts of cuttle bone, 15-35 parts of Ganoderma lucidum, 15-40 parts of leaf of buzhaye, 10-25 parts of Salvia miltiorrhiza, 5-30 parts of Fructus Aurantii, 15-40 parts of Silybum marianum, 10-30 parts of leaf of Apocynum venetum.The traditional Chinese medicine composition of resolving turbidity and reducing fat and traditional Chinese medicine in the present application can improve liver damp-heat accumulation, and is beneficial to harmonize liver and spleen, nourish liver and kidney, reduce dampness and turbidity, so as to achieve the exact effect of regulating liver and reducing fat, suitable for fatty liver and other related diseases caused by damp-heat accumulation and liver stagnation and spleen deficiency, with significant curative effect, fast healing speed, no adverse reactions and toxic side effects, and no easy recurrence after recovery.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, a traditional Chinese medicine agent and a preparation method thereof. BACKGROUND

[0002] In recent years, with the improvement of living standards and quality, the dietary structure has changed greatly, the incidence of fatty liver is getting higher and higher, and fatty liver has become a common chronic disease. Fatty liver disease is a clinical pathological syndrome caused by various causes, which is a disorder of liver lipid metabolism and dynamic balance, so that the liver cells accumulate lipids, and the liver cells are fatty degenerative. Traditional Chinese medicine does not have the disease name of fatty liver, according to its clinical manifestations, it can be classified into 'liver accumulation', 'fullness', 'accumulation','mass', 'hypochondriac pain' and other categories, and its disease is in the liver, which is closely related to the spleen. Long-term illness can lead to liver damage, spleen and stomach dysfunction and cardiovascular disease, and its incidence is increasing year by year. Although some western medicines have rapid lipid-lowering effect, they can cause liver toxicity and other serious side effects, and it is difficult to achieve the ideal therapeutic effect, therefore, it is one of the important tasks of the current medical field to find an effective traditional Chinese medicine for regulating liver and reducing fat (resolving turbidity and reducing fat and protecting liver).

[0003] In view of the above, it is necessary to provide a traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, a traditional Chinese medicine agent and a preparation method thereof. SUMMARY

[0004] In order to solve one or more technical problems in the prior art, the present application provides a traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, a traditional Chinese medicine agent and a preparation method thereof, which are convenient to use, have good treatment effect, significant curative effect, no toxic side effects and are not easy to relapse.

[0005] The present application provides, in a first aspect, a traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight:

[0006] Radix et Rhizoma Herbae Equiseti 5-15 parts, bone 10-35 parts, Ganoderma 15-35 parts, leaves 15-40 parts, Salvia miltiorrhiza 10-25 parts, Citrus aurantium 5-30 parts, Silybum marianum 15-40 parts, Apocynum venetum 10-30 parts.

[0007] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Radix et Rhizoma Herbae Equiseti 10-15 parts, bone 10-30 parts, Ganoderma 20-35 parts, leaves 20-40 parts, Salvia miltiorrhiza 15-25 parts, Citrus aurantium 10-30 parts, Silybum marianum 15-30 parts, Apocynum venetum 10-20 parts.

[0008] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Herba siegesbeckiae 15 parts, cuttle bone 15 parts, Ganoderma lucidum 30 parts, Rubus chingii Hu 20 parts, Salvia miltiorrhiza 15 parts, Citrus aurantium 20 parts, Silybum marianum 20 parts, Apocynum venetum 15 parts.

[0009] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Ganoderma lucidum 20 parts, Rubus chingii Hu 25 parts, Salvia miltiorrhiza 15 parts, Citrus aurantium 15 parts, Silybum marianum 25 parts, Apocynum venetum 10 parts.

[0010] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 10 parts, Ganoderma lucidum 20 parts, Rubus chingii Hu 20 parts, Salvia miltiorrhiza 15 parts, Citrus aurantium 10 parts, Silybum marianum 15 parts, Apocynum venetum 10 parts.

[0011] The second aspect of the present application provides a traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 5-15 parts, cuttle bone 10-35 parts, Ganoderma lucidum 15-35 parts, Rubus chingii Hu 15-40 parts, Carapax Trionycis 10-25 parts, Magnolia officinalis 5-30 parts, Silybum marianum 15-40 parts, Apocynum venetum 10-30 parts.

[0012] The third aspect of the present application provides a traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 5-15 parts, cuttle bone 10-35 parts, Ganoderma lucidum 15-35 parts, Rubus chingii Hu 15-40 parts, Carapax Trionycis 10-25 parts, Magnolia officinalis 5-30 parts, Silybum marianum 15-40 parts, Apocynum venetum 10-30 parts, Cyperus rotundus 10-25 parts.

[0013] The fourth aspect of the present application provides a traditional Chinese medicine agent for resolving turbidity, reducing fat and protecting liver, which comprises the traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver according to the first aspect of the present application or the second aspect of the present application or the third aspect of the present application.

[0014] The fifth aspect of the present application provides a preparation method of the traditional Chinese medicine agent for resolving turbidity, reducing fat and protecting liver according to the fourth aspect of the present application, which comprises the following steps:

[0015] (1) soaking each raw material of the traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver in water for 1-2 hours;

[0016] (2) adding water to each raw material soaked in step (1) to perform first decocting, filtering to obtain first decocting liquid and residue, then adding water to the residue to perform second decocting, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing, filtering to obtain filtrate;

[0017] (3) concentrating the filtrate to thick paste with relative density of 1.20-1.25 at ambient temperature of 80℃.

[0018] (4) mixing the thick paste and corn starch according to a mass ratio of 1:(1.5-2.0), granulating, drying and granulating to obtain the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver.

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

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

[0021] (1) The present application selects traditional Chinese herbal medicine to regulate liver and reduce fat (resolve turbidity, reduce fat and protect liver). The pathological feature of non-alcoholic fatty liver is excessive deposition of fat 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. According to traditional Chinese medicine, fat is formed by water and nutrient essence, mainly depending on physiological functions such as kidney metabolism, spleen transformation and liver discharge. Once the function of viscera is out of balance, the metabolism stops, and the fat is formed by the exudation of meridians into blood. Therefore, the treatment should be mainly based on removing damp heat, assisting in regulating liver and spleen, and reducing dampness and clearing heat. The pharmacological experiment and clinical tests show that the traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver in the present application has remarkable curative effect.

[0022] (2) The traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver in the present application is based on removing damp heat, treating the disease by promoting qi, relieving depression, removing dampness and regulating liver and spleen. After taking the composition, the damp heat accumulation in liver can be improved, the liver and spleen can be regulated, the liver and kidney can be nourished, and the dampness can be reduced, so that the exact effect of regulating liver and reducing fat can be achieved, and the disease is not easy to relapse.

[0023] (3) The traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver in the present application reduces dampness and regulates liver and spleen, treats both symptoms and root causes, is suitable for fatty liver and other related diseases caused by damp heat accumulation and liver stagnation and spleen deficiency, and has no adverse reactions and toxic side effects.

[0024] (4) The traditional Chinese medicine preparation in the present application is simple to prepare, convenient to take, has remarkable curative effect and fast recovery speed.

[0025] (5) The high blood fat model test results show that the serum TC, TG and LDL-C levels of the turbidity-reducing and lipid-lowering and liver-protecting traditional Chinese medicine composition are significantly reduced, and the blood lipid abnormality is obviously improved. The difference is significant (P<0.05) compared with the model control group after 15 days of administration. In addition, the turbidity-reducing and lipid-lowering and liver-protecting traditional Chinese medicine composition can also reduce dampness and turbidity, regulate the liver and spleen, and has the effect of regulating the liver and spleen, so that the patient feels more comfortable during the treatment process, thereby improving the quality of life of the patient. Fatty liver can cause lipid metabolism disorder, weight gain, liver fatty degeneration and other symptoms, and the disease may cause a series of complications of metabolic disorders. The traditional Chinese medicine composition can help reduce the risk of complications and make the treatment safer. In addition, the ganoderma lucidum contained in the turbidity-reducing and lipid-lowering and liver-protecting traditional Chinese medicine composition can delay the aging of the body, reduce the production of lipid peroxides, and improve the antioxidant capacity of the body, thereby better playing the role of regulating the liver and reducing the lipid. The traditional Chinese medicine composition can help create a more favorable treatment environment and improve the treatment effect. For example, in the high blood fat model rat experiment, the rat β-oxidation related enzyme can be adjusted to improve the lipid metabolism and play a therapeutic role in the liver damage of non-alcoholic fatty liver disease in rats. DETAILED DESCRIPTION

[0026] To make the objects, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be described below in conjunction with the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work belong to the scope of protection of the present application.

[0027] The present application provides a traditional Chinese medicine composition for resolving turbidity and reducing fat and protecting liver in the first aspect, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 5-15 parts (for example, 5, 8, 10, 12, 14 or 15 parts), bone of cuttle 10-35 parts (for example, 10, 13, 15, 18, 20, 22, 25, 28, 30, 32 or 35 parts), Ganoderma lucidum 15-35 parts (for example, 15, 18, 20, 23, 25, 28, 30, 32 or 35 parts), Folium Gynostegnma 15-40 parts (for example, 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), Radix Salviae Miltiorrhizae 10-25 parts (for example, 10, 12, 15, 18, 20, 23 or 25 parts), Fructus Aurantii 5-30 parts (for example, 5, 8, 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts), Herba Silybum marianum 15-40 parts (for example, 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), Folium Apocyni Veneti 10-30 parts (for example, 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts).

[0028] The present application selects traditional Chinese herbal medicine to regulate liver and reduce fat. The pathological characteristics of non-alcoholic fatty liver disease is excessive deposition of fat in liver cells caused by non-alcoholic and liver damaging factors. Metabolic syndrome formed under unreasonable diet and living habits gradually deteriorates into chronic liver disease. Traditional Chinese medicine believes that fat is produced by postnatal water and nutrient essence, mainly depending on physiological functions such as kidney gasification, spleen transformation and liver discharge, and spreads throughout the body with body fluid. Once the function of each viscera is out of order, the body fluid stops spreading, and the fat is formed by the phlegm wet from the meridians into the blood. Therefore, the treatment should be mainly based on removing damp heat, and auxiliary regulating liver and spleen. The pharmacological experiment and clinical practice show that the traditional Chinese medicine composition for resolving turbidity and reducing fat and protecting liver has remarkable curative effect. According to the pathogenesis of fatty liver and traditional Chinese medicine theory, the composition is mainly based on removing damp heat, and is suitable for treating fatty liver and other related diseases caused by damp heat accumulation and liver stagnation and spleen deficiency. After taking the composition, it can improve the symptoms of liver damp heat accumulation, and is beneficial to regulating liver and spleen, nourishing liver and kidney, and reducing dampness, thereby achieving the exact effect of regulating liver and reducing fat, and the patient is not easy to relapse after recovery.

[0029] The traditional Chinese medicine composition for resolving turbidity and reducing fat and protecting liver in the present application reduces dampness and turbidity and regulates liver and spleen, and treats both symptoms and root causes. It is suitable for fatty liver and other related diseases caused by damp heat accumulation, liver stagnation and spleen deficiency, and has no adverse reactions and toxic side effects.

[0030] The traditional Chinese medicine composition for resolving turbidity and reducing fat and protecting liver of the present application contains eight ingredients, i.e., Herba Siegesbeckiae, Ossis Sepiae, Ganoderma lucidum, Folium Gynostegmatidis, Radix Salviae Miltiorrhizae, Fructus Aurantii, Herba Silybum marianum and Folium Apocyni Veneti; the present application finds that, among the eight ingredients, the synergistic effect of the six ingredients, i.e., Herba Siegesbeckiae, Ossis Sepiae, Folium Gynostegmatidis, Folium Apocyni Veneti, Ganoderma lucidum and Herba Silybum marianum, has excellent effect of regulating liver and reducing fat, and the synergistic effect of the six ingredients helps to effectively reduce dampness and turbidity, clear heat and reduce dampness, and has good effect of resolving turbidity and reducing fat and protecting liver, the six ingredients complement each other and are indispensable, and if any ingredient is absent from the traditional Chinese medicine composition, the effect of regulating liver and reducing fat (resolving turbidity and reducing fat and protecting liver) will be significantly reduced; the six ingredients, i.e., Herba Siegesbeckiae, Ossis Sepiae, Folium Gynostegmatidis, Folium Apocyni Veneti, Ganoderma lucidum and Herba Silybum marianum, play a key role in the traditional Chinese medicine composition, and the synergistic effect of the six ingredients not only shows the unique advantages of traditional Chinese medicine, but also provides a comprehensive and effective method for regulating liver and reducing fat.

[0031] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: Herba Siegesbeckiae 10-15 parts (e.g., 10, 11, 12, 13, 14 or 15 parts), Ossis Sepiae 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), Ganoderma lucidum 20-35 parts (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), Folium Gynostegmatidis 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), Radix Salviae Miltiorrhizae 15-25 parts (e.g., 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 parts), Fructus Aurantii 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), Herba Silybum marianum 15-30 parts (e.g., 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 parts), and Folium Apocyni Veneti 10-20 parts (e.g., 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts).

[0032] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: Herba Siegesbeckiae 15 parts, Ossis Sepiae 15 parts, Ganoderma lucidum 30 parts, Folium Gynostegmatidis 20 parts, Radix Salviae Miltiorrhizae 15 parts, Fructus Aurantii 20 parts, Herba Silybum marianum 20 parts, and Folium Apocyni Veneti 15 parts.

[0033] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Ganoderma lucidum 20 parts, Rubus suavissimus 25 parts, Salvia miltiorrhiza 15 parts, Citrus aurantium 15 parts, Silybum marianum 25 parts, Apocynum venetum 10 parts.

[0034] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 10 parts, Ganoderma lucidum 20 parts, Rubus suavissimus 20 parts, Salvia miltiorrhiza 15 parts, Citrus aurantium 10 parts, Silybum marianum 15 parts, Apocynum venetum 10 parts.

[0035] The present application provides, in a second aspect, a traditional Chinese medicine composition for resolving turbidity, reducing fat, and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 5-15 parts (e.g. 5, 8, 10, 12, 14 or 15 parts), cuttle bone 10-35 parts (e.g. 10, 13, 15, 18, 20, 22, 25, 28, 30, 32 or 35 parts), Ganoderma lucidum 15-35 parts (e.g. 15, 18, 20, 23, 25, 28, 30, 32 or 35 parts), Rubus suavissimus 15-40 parts (e.g. 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), Carapax trionycis 10-25 parts (e.g. 10, 12, 15, 18, 20, 23 or 25 parts), Magnolia officinalis 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), Apocynum venetum 10-30 parts (e.g. 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts). The present application finds that, in the traditional Chinese medicine composition for resolving turbidity, reducing fat, and protecting liver, when containing Herba siegesbeckiae, cuttle bone, Rubus suavissimus, Apocynum venetum, Ganoderma lucidum, and Silybum marianum, the Magnolia officinalis can replace Citrus aurantium, and Carapax trionycis can replace Salvia miltiorrhiza, and the traditional Chinese medicine composition obtained can effectively resolve turbidity, reduce fat, and protect liver, and has good effects on resolving turbidity, reducing fat, and protecting liver.

[0036] The present application provides a traditional Chinese medicine composition for removing phlegm and lowering lipid in a third aspect, which is composed of the following raw materials by weight: Herba siegesbeckiae 5-15 parts (for example, 5, 8, 10, 12, 14 or 15 parts), bone of cuttle 10-35 parts (for example, 10, 13, 15, 18, 20, 22, 25, 28, 30, 32 or 35 parts), Ganoderma lucidum 15-35 parts (for example, 15, 18, 20, 23, 25, 28, 30, 32 or 35 parts), Folium Gendarussa 15-40 parts (for example, 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), Carapax Trionycis 10-25 parts (for example, 10, 12, 15, 18, 20, 23 or 25 parts), Magnolia officinalis 5-30 parts (for example, 5, 8, 10, 13, 15, 18, 20, 23, 25, 28 or 30 parts), Herba Silybum marianum 15-40 parts (for example, 15, 18, 20, 22, 25, 28, 30, 32, 35, 38 or 40 parts), Folium Apocyni veneti 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 application, Cyperus rotundus can also be added to the traditional Chinese medicine composition for removing phlegm and lowering lipid.

[0037] The present application provides a traditional Chinese medicine agent for removing phlegm and lowering lipid in a fourth aspect, which comprises the traditional Chinese medicine composition for removing phlegm and lowering lipid in the first aspect of the present application or the second aspect of the present application or the third aspect of the present application.

[0038] The present application provides a preparation method of the traditional Chinese medicine agent for removing phlegm and lowering lipid in the fourth aspect of the present application, which comprises the following steps:

[0039] (1) soaking each raw material of the traditional Chinese medicine composition for removing phlegm and lowering lipid in water for 1-2 hours;

[0040] (2) adding water to each raw material soaked in step (1) to perform first decocting, filtering to obtain first decocting liquid and residue, then adding water to the residue to perform second decocting, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing, filtering to obtain filtrate;

[0041] (3) concentrating the filtrate to thick paste with relative density of 1.20-1.25 at ambient temperature of 80℃;

[0042] (4) mixing the thick paste with corn starch uniformly according to mass ratio of 1:(1.5-2.0), then granulating, drying and whole-granulating to obtain the traditional Chinese medicine agent for removing phlegm and lowering lipid; the traditional Chinese medicine agent in the present application is simple to prepare, convenient to take, has remarkable curative effect and fast recovery speed; in the present application, the traditional Chinese medicine agent is also recorded as traditional Chinese medicine composition granules.

[0043] According to some preferred embodiments, in the first decoction, 8-12 times of water of the total weight of the raw materials is added, i.e. the amount of water is 8-12 times of the total weight of the raw materials; and / or in the second decoction, 8-12 times of water of the weight of the residue is added, i.e. the amount of water is 8-12 times of the weight of the residue.

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

[0045] According to some specific embodiments, the preparation of the traditional Chinese medicine agent for removing turbidity, reducing fat and protecting liver is as follows: the raw materials are weighed and soaked in water for 1.5 hours; decocted twice, the first time with 10 times of water for 2 hours, and the second time with 10 times of water for 1 hour, the decoction is combined and left to stand for 24 hours, and then filtered; the obtained filtrate is concentrated under reduced pressure to a thick paste with a concentration of 1.20-1.25 (80℃ hot measurement); the thick paste is mixed with corn starch at a mass ratio of 1:2; and then granulated, dried, and sized to obtain 1000g granules.

[0046] In the present application, the granulation is wet granulation, and the specific conditions of decoction, granulation, drying (drying), sizing, etc. are not limited, which are the conventional techniques in the art.

[0047] According to some preferred embodiments, in step (4), corn starch is added to the thick paste and mixed uniformly to obtain a mass, and then the mass is wet granulated, dried at 60-70℃ for 3-4 hours, and sized to obtain the traditional Chinese medicine agent for removing turbidity, reducing fat and protecting liver.

[0048] According to some specific embodiments, the granules of the traditional Chinese medicine composition of the present application are obtained by mixing the water extract of the prescription traditional Chinese medicine composition with corn starch as adjuvant to form wet granules, and then drying the wet granules at 60-70℃ for 3-4 hours, removing the large particles with a 10-mesh sieve and the fine powder with an 80-mesh sieve, to obtain the traditional Chinese medicine agent for removing turbidity, reducing fat and protecting liver.

[0049] The application will be further described below by way of examples, but the scope of protection of the application is not limited to these examples. The application can also have other various embodiments, and those skilled in the art can make various corresponding changes and modifications according to the application without departing from the spirit and essence of the application, and these corresponding changes and modifications shall all fall within the scope of protection of the claims appended to the application.

[0050] Example 1

[0051] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 15 parts, cuttle bone 15 parts, Ganoderma lucidum 30 parts, Rubus corchorifolius 20 parts, Salvia miltiorrhiza 15 parts, Fructus aurantii 20 parts, Silybum marianum 20 parts, Apocynum venetum 15 parts.

[0052] A traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver, which is prepared from the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver described above, and the preparation method is as follows: the raw materials of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver are soaked in water for 1.5 h; 10 times the total mass of the raw materials in water is added to the soaked raw materials for the first time of decocting for 2 h, and then filtered to obtain the first decoction and the filter residue; 10 times the mass of the filter residue in water is added to the filter residue for the second time of decocting for 1 h, and then filtered to obtain the second decoction; the first decoction and the second decoction are combined, and then left to stand for 24 h, and then filtered to obtain the filtrate; the filtrate is concentrated to a thick paste with a relative density of 1.25 at an ambient temperature of 80℃; the thick paste is mixed with corn starch at a mass ratio of 1:2, and then granulated, dried (dried at 65℃ for 3.5 h), and granulated (the large particles are removed by using a 10-mesh sieve, and the fine powder is removed by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0053] Example 2

[0054] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Ganoderma lucidum 20 parts, Rubus corchorifolius 25 parts, Salvia miltiorrhiza 15 parts, Fructus aurantii 15 parts, Silybum marianum 25 parts, Apocynum venetum 10 parts.

[0055] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:2, granulating, drying (drying at 65°C for 3.5 hours), and whole granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0056] Example 3

[0057] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver is prepared from the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 10 parts, Ganoderma lucidum 20 parts, Rubus corchorifolius 20 parts, Salvia miltiorrhiza 15 parts, Fructus aurantii 10 parts, Herba Silybum marianum 15 parts, and Apocynum venetum 10 parts.

[0058] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:2, granulating, drying (drying at 65°C for 3.5 hours), and whole granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0059] Example 4

[0060] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver is prepared from the following raw materials in parts by weight: Herba siegesbeckiae 15 parts, cuttle bone 20 parts, Ganoderma lucidum 25 parts, Rubus corchorifolius 25 parts, Salvia miltiorrhiza 20 parts, Fructus aurantii 25 parts, Herba Silybum marianum 25 parts, and Apocynum venetum 15 parts.

[0061] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; uniformly mixing the thick paste with corn starch at a mass ratio of 1:2, granulating, drying (drying at 65°C for 3.5 hours), and whole granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0062] Comparative Example 1

[0063] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver is composed of the following raw materials in parts by weight: 25 parts of cuttle bone, 20 parts of ganoderma lucidum, 25 parts of bupleurum falcatum, 15 parts of salvia miltiorrhiza, 15 parts of immature bitter orange fruit, 25 parts of herba silybum marianum, and 10 parts of roxburgh rose leaf.

[0064] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; uniformly mixing the thick paste with corn starch at a mass ratio of 1:2, granulating, drying (drying at 65°C for 3.5 hours), and whole granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0065] Comparative Example 2

[0066] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver is composed of the following raw materials in parts by weight: 10 parts of siegesbeckia orientalis, 20 parts of ganoderma lucidum, 25 parts of bupleurum falcatum, 15 parts of salvia miltiorrhiza, 15 parts of immature bitter orange fruit, 25 parts of herba silybum marianum, and 10 parts of roxburgh rose leaf.

[0067] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:2, then performing granulation, drying (drying at 65°C for 3.5 hours), and whole granulation (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0068] Comparative Example 3

[0069] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver is prepared from the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Folium blumeae 25 parts, Radix salviae miltiorrhizae 15 parts, Fructus aurantii 15 parts, Herba silybi 25 parts, and Folium cannabis 10 parts.

[0070] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:2, then performing granulation, drying (drying at 65°C for 3.5 hours), and whole granulation (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0071] Comparative Example 4

[0072] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver is prepared from the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Ganoderma lucidum 20 parts, Radix salviae miltiorrhizae 15 parts, Fructus aurantii 15 parts, Herba silybi 25 parts, and Folium cannabis 10 parts.

[0073] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; uniformly mixing the thick paste with corn starch at a mass ratio of 1:2, granulating, drying (drying at 65°C for 3.5 hours), and whole granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0074] Comparative Example 5

[0075] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Ganoderma lucidum 20 parts, Folium blumeae 25 parts, Salvia miltiorrhiza 15 parts, Fructus aurantii 15 parts, and Folium rubus suavissimi 10 parts.

[0076] The method for preparing the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain first decocting liquid and residue, then adding water with a mass 10 times that of the residue into the residue to perform second decocting for 1 hour, filtering to obtain second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain filtrate; concentrating the filtrate into thick paste with a relative density of 1.25 at an ambient temperature of 80°C; uniformly mixing the thick paste with corn starch at a mass ratio of 1:2, granulating, drying (drying at 65°C for 3.5 hours), and whole granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for removing phlegm, reducing fat and protecting liver (traditional Chinese medicine composition granules for removing phlegm, reducing fat and protecting liver).

[0077] Comparative Example 6

[0078] A traditional Chinese medicine composition for removing phlegm, reducing fat and protecting liver, which is composed of the following raw materials in parts by weight: Herba siegesbeckiae 10 parts, cuttle bone 25 parts, Ganoderma lucidum 20 parts, Folium blumeae 25 parts, Salvia miltiorrhiza 15 parts, Fructus aurantii 15 parts, and Folium rubus suavissimi 10 parts.

[0079] The method for preparing the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver is as follows: soaking each raw material of the traditional Chinese medicine composition for resolving turbidity, reducing fat and protecting liver in water for 1.5 hours; adding water with a mass 10 times that of the total mass of the raw materials into each raw material after soaking to perform first decocting for 2 hours, filtering to obtain a first decocting liquid and a filter residue, then adding water with a mass 10 times that of the filter residue into the filter residue to perform second decocting for 1 hour, filtering to obtain a second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 hours, filtering to obtain a filtrate; concentrating the filtrate to a thick paste with a relative density of 1.25 at an ambient temperature of 80 DEG C; uniformly mixing the thick paste with corn starch according to a mass ratio of 1:2, granulating, drying (drying at 65 DEG C for 3.5 hours), and whole-granulating (removing large particles by using a 10-mesh sieve and removing fine powder by using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver (traditional Chinese medicine composition granules for resolving turbidity, reducing fat and protecting liver).

[0080] The present application is described by clinical efficacy observation experiment to illustrate the efficacy of the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver prepared by the examples 1-4 of the present application, and the specific process is as follows:

[0081] I. General information

[0082] 100 patients with non-alcoholic fatty liver were selected as the control group and the treatment group, respectively.

[0083] II. Diagnostic criteria

[0084] (I) Symptoms and signs

[0085] The patients are generally accompanied by obesity, high fasting blood glucose, and blood lipid disorder, and some patients have right upper discomfort, fatigue or weakness, and sleep is still acceptable.

[0086] (II) Imaging examination

[0087] B-ultrasound diagnosis: diffuse enhancement of liver area near field echo (stronger than kidney and spleen), far field echo gradually attenuated, unclear display of intrahepatic duct structure, mild to moderate enlargement of liver, round and blunt edge of liver right lobe capsule and transverse echo display unclear or incomplete.

[0088] III. Treatment method

[0089] Treatment group 1: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Example 1 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; treatment group 2: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Example 2 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; treatment group 3: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Example 3 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; treatment group 4: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Example 4 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; control group 1: orally taking Sanqi Lipid-liver Pill (Yunnan Yuyao Biopharmaceutical Co., Ltd., State Drug Approval Z20025353) 1 bag each time, 3 times a day, morning and evening, continuously taking for 14 days; control group 2: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Comparative Example 1 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; control group 3: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Comparative Example 2 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; control group 4: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Comparative Example 3 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; control group 5: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Comparative Example 4 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; control group 6: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Comparative Example 5 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment; control group 7: orally taking the traditional Chinese medicine preparation for removing turbidity and reducing fat and protecting liver prepared in Comparative Example 6 of the present application: 10 g each time, twice a day, morning and evening, 14 days as a course of treatment, taking a course of treatment.

[0090] IV. Efficacy evaluation criteria

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

[0092] Marked effect: blood lipid and blood glucose indexes tend to be normal, and symptoms such as right upper abdominal discomfort are obviously improved compared with before treatment;

[0093] Effectiveness: blood lipid and blood glucose indexes gradually become normal, and symptoms such as right upper abdominal discomfort are alleviated compared with before treatment;

[0094] Ineffectiveness: blood lipid and blood glucose indexes and symptoms such as right upper abdominal discomfort have no change compared with before treatment.

[0095] V. Treatment effect

[0096] The treatment group 1 of the present application has the following effects: 82 cases of cure, 10 cases of significant effect, 8 cases of effectiveness, and 0 case of invalid, and the total effective rate is 100%. The treatment group 2 of the present application has the following effects: 74 cases of cure, 18 cases of significant effect, 8 cases of effectiveness, and 0 case of invalid, and the total effective rate is 100%. The treatment group 3 of the present application has the following effects: 66 cases of cure, 22 cases of significant effect, 12 cases of effectiveness, and 0 case of invalid, and the total effective rate is 100%. The treatment group 4 of the present application has the following effects: 86 cases of cure, 9 cases of significant effect, 5 cases of effectiveness, and 0 case of invalid, and the total effective rate is 100%. The results are shown in Table 1.

[0097] Table 1: Comparison of clinical effects.

[0098]

[0099] The comparison of the treatment group 1 taking the traditional Chinese medicine preparation of the present application and the control group 1 taking the existing similar drugs shows that the cure rate of the control group 1 taking the existing similar drugs for non-alcoholic fatty liver is 11.00%, and the total effective rate is 82.00%, while the cure rate of the treatment group 1 taking the drug of the present application for non-alcoholic fatty liver is 82.00%, and the total effective rate is 100%. Meanwhile, the cured patients in the above-mentioned control group 1 and treatment group 1 are followed up once every 6 months, and after 3 years of follow-up statistics, 6 out of 11 cured patients in the control group 1 relapse, accounting for 54.5%, and no one relapses in the 82 cured patients in the treatment group 1.

[0100] Therefore, the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver provided by the present application has significantly higher cure rate, significant effect rate and effective rate than the existing similar drugs in the market, and has no recurrence. From the above experimental research results, it can be seen that the traditional Chinese medicine composition and the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver provided by the present application can significantly achieve the purpose of regulating liver and reducing fat.

[0101] The present application also studies the protective effect of the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver in the present application on non-alcoholic fatty liver disease, which is as follows:

[0102] A non-alcoholic fatty liver disease rat model is made by using HFD high-fat feed, and the rats are given a certain number of the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver in the present application every day, to observe whether the traditional Chinese medicine preparation for resolving turbidity, reducing fat and protecting liver in the present application has the effect of relieving non-alcoholic fatty liver disease.

[0103] 1. Test animals and feed

[0104] 60 clean grade SD male rats, weighing 170-210g. The rats are given 12h day-night rhythm, free activity and diet, and are adaptively fed for 6d before starting modeling, grouping and drug administration. The rats are fed with basic feed and high-fat feed.

[0105] 2. Test method

[0106] 2.1 Model establishment: SD rats in the model group were fed with high-fat diet for 6 weeks to induce a non-alcoholic fatty liver model. The control group was given ordinary feed, and the body weight was recorded every week. Three rats were randomly selected from the normal group and the model group, respectively, for examination, and liver tissue was taken for pathological section. Fat accumulation in liver tissue was found, extensive lipid vacuoles were produced, and liver function was detected to confirm the success of the induced model.

[0107] 2.2 Experimental grouping and administration

[0108] The rats were randomly divided into 5 groups of 12 according to quality. The control group, the model group, the low, medium and high dose treatment groups of the traditional Chinese medicine agent product for resolving turbidity and reducing fat and protecting liver (fed with high-fat diet for 6 weeks like the model group). The model group and the control group were given equal amount of 0.9% sodium chloride solution by gavage every day, and the gavage was continued for 15 days; the treatment groups were given the traditional Chinese medicine agent product for resolving turbidity and reducing fat and protecting liver in Example 1 of the present application by gavage according to the drug amount of 1.26, 2.52 and 5.04 (g / kg) respectively every day, and the administration was continued for 15 days.

[0109] 2.3 Detection index and method

[0110] 2.3.1 General condition and liver index: The spirit, activity, and fur color of the rats were observed. The rats were weighed after fasting for 12 h, anesthetized with diethyl ether, and the liver was removed and weighed to calculate the liver index = liver wet weight (g) / body weight (g) x 100%, and 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, and the results are shown in Tables 3 and 4. Liver homogenate was prepared, and the supernatant content detection solution was stored in an ultra-low temperature refrigerator for testing. The operation steps for liver fat detection were performed according to the instruction manual of the kit.

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

[0113] Group Body 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 493.00 ± 26.78 ＊ ]] 13.56 ± 1.31 ＊ ]] 2.75 ± 0.15 ＊ ]] Low-dose treatment group 481.64±33.72 11.67 ± 1.26 # ]] 2.42 ± 0.14 # ]] Medium-dose treatment group 477.00±45.26 11.43 ± 1.66 # ]] 2.40 ± 0.22 # ]] High-dose treatment group 469.25 ± 46.50 # ]] 11.26 ± 1.58 # ]] 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 traditional Chinese medicine agent product treatment group was significantly reduced (P < 0.05). Compared with the model group, the liver index of the traditional Chinese medicine agent product treatment group showed a downward trend (P < 0.05).

[0116] Table 3: Effect on blood lipid levels of each group of rats (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 1.58 ± 0.79 # ]] 0.36±0.18 1.38±0.78 0.33 ± 0.12 # ]] Medium-dose treatment group 1.51 ± 0.76 # ]] 0.25 ± 0.23 # ]] 1.24±0.51 0.36 ± 0.14 # ]] High-dose treatment group 1.28 ± 0.84 # ]] 0.22 ± 0.16 # ]] 1.13 ± 0.16 # ]] 0.39 ± 0.20 # ]]

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

[0119] Table 4: Effect on liver function indicators of each group of rats (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 contents of TC, TG and LDL-C in the model group were obviously increased, and the content of HDL-C was obviously decreased, which indicated that the high-fat feed modeling was successful. Compared with the model group, the contents of TC, TG and LDL-C in the high-dose treatment group of the traditional Chinese medicine product were obviously decreased (P<0.05), which indicated that the traditional Chinese medicine product had a good therapeutic effect. The HDL-C detection results showed that, compared with the model group, the treatment group had an obvious effect on increasing HDL-C (P<0.05), as shown in Table 3.

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

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

[0126] The part not described in detail in the present application is the technology known to those skilled in the art, and those skilled in the art can select as needed.

[0127] Finally, it should be noted that the above examples are only used to illustrate the technical solutions of the present application, and are not intended to limit the same; although the foregoing examples have been described in detail, those of ordinary skill in the art should understand that the technical solutions recorded in the foregoing examples can still be modified, or some technical features therein can be replaced by equivalents; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A traditional Chinese medicine composition for clearing turbidity, lowering lipids, and protecting the liver, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Siegesbeckia orientalis 5-15 parts, cuttlebone 10-35 parts, Ganoderma lucidum 15-35 parts, Buzha leaf 15-40 parts, Salvia miltiorrhiza 10-25 parts, Citrus aurantium 5-30 parts, Milk thistle 15-40 parts, Apocynum venetum leaf 10-30 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10-15 parts of Siegesbeckia orientalis, 10-30 parts of cuttlebone, 20-35 parts of Ganoderma lucidum, 20-40 parts of Bulbus buergerianum, 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.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts of Siegesbeckia orientalis, 15 parts of cuttlebone, 30 parts of Ganoderma lucidum, 20 parts of Bulbus buergerianum leaf, 15 parts of Salvia miltiorrhiza, 20 parts of Citrus aurantium, 20 parts of Silybum marianum, and 15 parts of Apocynum venetum leaf.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10 parts of Siegesbeckia orientalis, 25 parts of cuttlebone, 20 parts of Ganoderma lucidum, 25 parts of Bulbus buergerianum leaf, 15 parts of Salvia miltiorrhiza, 15 parts of Citrus aurantium, 25 parts of Silybum marianum, and 10 parts of Apocynum venetum leaf.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10 parts of Siegesbeckia orientalis, 10 parts of cuttlebone, 20 parts of Ganoderma lucidum, 20 parts of Bulbus buzae leaves, 15 parts of Salvia miltiorrhiza, 10 parts of Citrus aurantium, 15 parts of Silybum marianum, and 10 parts of Apocynum venetum leaves.

6. A traditional Chinese medicine preparation for clearing turbidity, lowering lipids, and protecting the liver, characterized in that: The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition for clearing turbidity, lowering lipids, and protecting the liver as described in any one of claims 1 to 5.

7. The preparation method of the traditional Chinese medicine preparation for clearing turbidity, lowering lipids, and protecting the liver as described in claim 6, characterized in that, The method includes the following steps: (1) Soak each ingredient of the traditional Chinese medicine composition for clearing turbidity, lowering lipids and protecting the liver in water for 1-2 hours; (2) Add water to each raw material after soaking in step (1) for the first decoction, filter to obtain the first decoction and filter residue, then add water to the filter residue for the second decoction, filter to obtain the second decoction, combine the first decoction and the second decoction, let stand, filter to obtain the filtrate. (3) Concentrate the filtrate to a thick paste with a relative density of 1.20~1.25 at an ambient temperature of 80℃; (4) Mix the thick paste and corn starch in a mass ratio of 1:(1.5~2.0) evenly, then granulate, dry and granulate to obtain a traditional Chinese medicine preparation for clearing turbidity, lowering lipids and protecting the liver.

8. The preparation method according to claim 7, 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 process involves drying at 60-70℃ for 3-4 hours.

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