A traditional Chinese medicine composition for treating gallstones, a traditional Chinese medicine preparation and a preparation method thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating gallstone, traditional Chinese medicine agent and preparation method thereof.The traditional Chinese medicine composition is composed of the following weight parts of raw materials: 30-60 parts of giant knotweed, 10-35 parts of soapberry thorn, 20-40 parts of saussurea, 20-40 parts of vinegar fumitory, 20-40 parts of bran-fried bitter orange fruit, 25-60 parts of fried chicken gizzard, 20-40 parts of vinegar galangal, 20-40 parts of stone see through.The traditional Chinese medicine composition for treating gallstone and traditional Chinese medicine agent in the present application have the advantages of convenient use, good treatment effect, significant curative effect, no toxic side effects, not easy to relapse, etc.

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 treating gallstones, a traditional Chinese medicine preparation and a preparation method thereof. BACKGROUND

[0002] According to epidemiological investigations, the incidence of gallbladder stones in China is about 10%, and the incidence increases with age. If gallstone treatment is not timely, the gallbladder will be repeatedly stimulated by the stones, which can induce acute cholecystitis, induce biliary pancreatitis, and even cause gallbladder cancer. At the same time, diseases such as obesity, pregnancy, high-fat diet, diabetes, gastric surgery, hemolytic anemia, and cirrhosis are related to the occurrence of gallbladder stones. The current treatment methods for gallstone disease include surgical treatment and endoscopic treatment. However, they all belong to invasive treatment and can cause other complications, and are prone to recurrence, increasing the pain of patients. There is a lack of "effective" oral drugs for treating gallstone disease in clinical practice. Currently, oral stone-dissolving drugs often cause diarrhea, liver damage, and stone surface calcification, and the residues after stone dissolution form new stones, which makes it difficult to achieve ideal therapeutic effects. Therefore, it is one of the important tasks of the medical community to find an effective traditional Chinese medicine for treating gallstone disease. Gallstones can be divided into cholesterols and bile pigments. In terms of treatment, they can be divided into oral drug dissolution and direct infusion drug dissolution. However, the drugs for treating gallstones in the prior art generally have low efficiency and are prone to recurrence.

[0003] In view of the above, it is necessary to provide a traditional Chinese medicine composition for treating gallstones, a traditional Chinese medicine preparation 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 treating gallstones, a traditional Chinese medicine preparation and a preparation method thereof, which are convenient to use, have good treatment effect, significant curative effect, no toxic side effects, and are not prone to recurrence.

[0005] In a first aspect, the present application provides a traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials by weight:

[0006] 30-60 parts of giant knotweed, 10-35 parts of soapberry thorn, 20-40 parts of costun, 20-40 parts of vinegar corydalis, 20-40 parts of fried bitter orange, 25-60 parts of fried chicken gizzard, 20-40 parts of vinegar corydalis, and 20-40 parts of stone see.

[0007] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0008] Rhizoma Polygoni Cuspidati 45-55 parts, Radix Pini 25-35 parts, Radix Aucklandiae 25-35 parts, Rhizoma Corydalis 25-35 parts, Fructus Aurantii Immaturus 25-35 parts, Endothelium Corneum Gigeriae Galli 25-35 parts, Rhizoma Curcumae 25-35 parts, Herba Humuli 25-35 parts.

[0009] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0010] Rhizoma Polygoni Cuspidati 30 parts, Radix Pini 20 parts, Radix Aucklandiae 20 parts, Rhizoma Corydalis 20 parts, Fructus Aurantii Immaturus 20 parts, Endothelium Corneum Gigeriae Galli 30 parts, Rhizoma Curcumae 20 parts, Herba Humuli 20 parts.

[0011] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0012] Rhizoma Polygoni Cuspidati 45 parts, Radix Pini 25 parts, Radix Aucklandiae 25 parts, Rhizoma Corydalis 25 parts, Fructus Aurantii Immaturus 25 parts, Endothelium Corneum Gigeriae Galli 25 parts, Rhizoma Curcumae 25 parts, Herba Humuli 25 parts.

[0013] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0014] Rhizoma Polygoni Cuspidati 60 parts, Radix Pini 20 parts, Radix Aucklandiae 40 parts, Rhizoma Corydalis 40 parts, Fructus Aurantii Immaturus 40 parts, Endothelium Corneum Gigeriae Galli 60 parts, Rhizoma Curcumae 40 parts, Herba Humuli 40 parts.

[0015] The present application provides a traditional Chinese medicine agent for treating gallstones in a second aspect, and the traditional Chinese medicine agent comprises the traditional Chinese medicine composition for treating gallstones in the first aspect of the present application.

[0016] The present application provides a preparation method of the traditional Chinese medicine agent for treating gallstones in the second aspect of the present application in a third aspect, and the method comprises the following steps:

[0017] (1) soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1-2 hours;

[0018] (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, and filtering to obtain filtrate;

[0019] (3) concentrating the filtrate to a thick paste with a relative density of 1.20-1.25 at an ambient temperature of 80℃;

[0020] (4) mixing the thick paste with corn starch at a mass ratio of 1:(1.5-2.0) uniformly, then granulating, drying, and whole-granulating to obtain the traditional Chinese medicine agent for treating gallstones.

[0021] Preferably, 8-12 times of the total mass of the raw materials is added in water during the first decocting; and / or 8-12 times of the mass of the residue is added in water during the second decocting.

[0022] Preferably, in step (1), the soaking is performed for 1.5 hours; in step (2), 10 times of the total mass of the raw materials is added in water during the first decocting, and 10 times of the mass of the residue is added in water during the second decocting; in step (2), the standing is performed for 24 hours; and / or in step (4), the thick paste is mixed with corn starch at a mass ratio of 1:1.5.

[0023] Preferably, in step (4), the corn starch is added into the thick paste and mixed uniformly to obtain a medicine mass, the medicine mass is wet granulated, then dried at 60-70℃ for 3-4 hours, and finally granulated to obtain the traditional Chinese medicine preparation for treating gallstones.

[0024] Compared with the prior art, the present application has at least the following beneficial effects:

[0025] (1) The traditional Chinese medicine is selected to treat the gallstone disease in the present application. The gallstone is a kind of digestive system disease, which is caused by the change of the concentration ratio of cholesterol and bile acid and the factors causing the bile acid stasis. Therefore, the cholesterol content should be improved and the bile secretion should be promoted at first when treating the gallstone. The traditional Chinese medicine theory believes that the treatment of the gallstone should be based on the treatment of the liver and the theory of the liver and gallbladder jointly governing the discharge. The main effects are clearing heat and removing dampness, removing yellow, soothing the liver and regulating qi. The bitter cold and the acrid warm are used together. However, the gallstone has the characteristics of high recurrence rate, poor stone discharge, and difficult stone dissolution. The attack period is often combined with infection and pain. The pharmacological experiment and the clinic show that the traditional Chinese medicine composition for treating the gallstone in the present application has remarkable curative effect.

[0026] (2) The traditional Chinese medicine composition for treating the gallstone in the present application is based on the pathogenesis of the gallstone disease and the traditional Chinese medicine theory. The main treatment is to discharge the stone by clearing heat and removing dampness, removing the stone by promoting bile secretion, warming the channels and removing dampness to relieve pain. After taking the medicine, the accumulation is removed, the qi is promoted, the blood is broken and the blood stasis is removed. The medicine has the effects of removing inflammation and relieving pain, regulating the liver and qi, and regulating the viscera. Therefore, the discharge of the stone in the body is accurate, and the recurrence after recovery is not easy.

[0027] (3) The traditional Chinese medicine composition for treating the gallstone in the present application has the effects of removing the stone and discharging the stone, treating the symptoms and the root cause, and is suitable for the gallbladder disease caused by various reasons, especially for the cholelithiasis, and has no adverse reactions and toxic side effects.

[0028] (4) The traditional Chinese medicine preparation in the present application is simple to prepare and convenient to take, has remarkable curative effect, and fast recovery speed.

[0029] (5) The in vitro stone dissolution test results of the present application show that the gallstone treatment traditional Chinese medicine administration group can significantly dissolve the stones, and there is a significant difference (P<0.05) compared with the model control group after 15 days of administration. In addition, the traditional Chinese medicine composition for treating gallstones in the present application has good anti-inflammatory effects on dimethylbenzene and egg white, which indicates that the traditional Chinese medicine composition for treating gallstones in the present application has anti-inflammatory effects. Gallstones are often accompanied by inflammatory reactions, causing symptoms such as abdominal pain and fever in patients. The traditional Chinese medicine for treating gallstones in the present application has anti-inflammatory effects, which can reduce inflammatory symptoms, help reduce pain associated with inflammation, make patients feel more comfortable during treatment, and thus improve the quality of life of patients. Inflammation caused by gallstones can lead to complications such as cholecystitis and cholecystitis. The anti-inflammatory effects of the traditional Chinese medicine composition in the present application can help reduce the risk of complications, making treatment safer. Inflammatory reactions can cause tissue edema and bile stasis, thereby increasing the formation and fixation of stones. The anti-inflammatory effects of the traditional Chinese medicine composition in the present application can help reduce these inflammatory reactions, making the bile more smooth and promoting the elimination of stones. In addition, the anti-inflammatory effects of the traditional Chinese medicine composition in the present application can help create a more favorable environment for treatment, improving treatment effectiveness. For example, in stone-dissolving drug therapy, reducing inflammation can make it easier for the traditional Chinese medicine composition to enter the interior of the stones, improving the stone-dissolving effect.

[0030] (6) The rat bile flow influence test results of the present application show that the traditional Chinese medicine composition for treating gallstones in the present application has a significant effect of increasing bile flow, which indicates that the traditional Chinese medicine composition in the present application can promote the elimination of stones by increasing bile flow, thereby effectively reducing symptoms. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 is the stone-dissolving results chart of the blank control group, the low-dose group of the traditional Chinese medicine agent in Example 1, and the high-dose group of the traditional Chinese medicine agent in Example 1 during the in vitro stone-dissolving test of the present application. In the chart, (a) is the blank control group, (b) is the low-dose group, and (c) is the high-dose group. DETAILED DESCRIPTION

[0032] To make the objectives, 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 making creative efforts fall within the scope of protection of the present application.

[0033] The present application provides, in a first aspect, a traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials in parts by weight:

[0034] Huzhang 30-60 parts (e.g., 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, or 60 parts), Zaocengzhi 10-35 parts (e.g., 10, 12, 14, 16, 18, 20, 22, 25, 28, 30, 32, or 35 parts), Muxiang 20-40 parts (e.g., 20, 22, 25, 28, 30, 32, 35, 38, or 40 parts), Duanhuisu 20-40 parts (e.g., 20, 22, 25, 28, 30, 32, 35, 38, or 40 parts), Guchao Zhishi 20-40 parts (e.g., 20, 22, 25, 28, 30, 32, 35, 38, or 40 parts), Chaojinejin 25-60 parts (e.g., 25, 30, 35, 40, 45, 50, 55, or 60 parts), Chaoe'zhu 20-40 parts (e.g., 20, 22, 25, 28, 30, 32, 35, 38, or 40 parts), Shijiancha 20-40 parts (e.g., 20, 22, 25, 28, 30, 32, 35, 38, or 40 parts).

[0035] The traditional Chinese herbal medicine is selected to treat gallstone disease. The gallstone is a kind of digestive system disease. The change of the concentration ratio of cholesterols and bile acids and the factors causing the bile acid stasis can all lead to the formation of the gallstone. Therefore, when the gallstone is treated, the cholesterols content should be improved and the bile secretion should be promoted. The traditional Chinese medicine believes that the theory of "treating the gallbladder disease from the liver" and "the liver and gallbladder jointly governing the discharge" is embodied. The effect is mainly to clear heat, remove dampness, relieve jaundice, soothe the liver and regulate qi. The bitter cold is mainly used and the acrid warm is used together. However, the gallstone disease has the characteristics of high recurrence rate, poor stone discharge, and difficult stone dissolution. The attack period is often combined with infection and pain. The pharmacological experiment and the clinic show that the Chinese herbal composition for treating the gallstone in the application has remarkable curative effect. The Chinese herbal composition for treating the gallstone in the application is based on the pathogenesis of the gallstone disease and the theory of traditional Chinese medicine. The treatment is mainly to discharge the stone. The heat is cleared and the dampness is removed. The bile is discharged and the stone is discharged. The meridian is warmed and the dampness is removed to stop the pain. After the composition is taken, the accumulation is removed, the qi is regulated, the blood is broken and the blood stasis is removed. The composition has the effects of removing inflammation and stopping pain, regulating the liver and regulating qi, and adjusting the viscera. Therefore, the discharge of the stone in the body is accurate and the recurrence after the treatment is not easy. The Chinese herbal composition for treating the gallstone in the application has the effects of inhibiting the stone and discharging the stone. The disease is treated from the root and the branch. The composition is suitable for the gallbladder disease caused by various reasons, especially suitable for the gallstone disease, and has no adverse reactions and toxic side effects. The Chinese herbal composition for treating the gallstone in the application has the multiple effects. The composition not only has the good stone dissolution effect for treating the gallstone, but also can inhibit the formation of the gallstone and has the good prevention effect. In addition, the composition has the effects of resisting inflammation and resisting swelling.

[0036] The traditional Chinese medicine composition for treating gallstones of the present application uniquely comprises eight ingredients, namely, rhizoma polygoni avicularis, soapberry thorn, radix aucklandiae, rhizoma corydalis, fructus aurantii immaturus, endo-duck, rhizoma curcumae and semen astragali complanati; the present application finds that, among the eight traditional Chinese medicine ingredients, the synergistic effect of the five ingredients, namely, rhizoma polygoni avicularis, soapberry thorn, rhizoma corydalis, rhizoma curcumae and semen astragali complanati, is crucial to the traditional Chinese medicine composition for treating gallstones, the five ingredients complement each other and are indispensable, and if any of the five ingredients is absent from the traditional Chinese medicine composition, the effect of treating gallstones will be significantly reduced; the five ingredients, namely, rhizoma polygoni avicularis, soapberry thorn, rhizoma corydalis, rhizoma curcumae and semen astragali complanati, play a key role in the traditional Chinese medicine composition, and their synergistic effect not only exhibits the unique advantages of traditional Chinese medicine, but also provides a comprehensive and effective method for treating gallstones.

[0037] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0038] Rhizoma polygoni avicularis 45-55 parts (e.g., 45, 46, 47, 48, 49, 50, 51, 52, 53, 54 or 55 parts), soapberry thorn 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), radix aucklandiae 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), rhizoma corydalis 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), fructus aurantii immaturus 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), endo-duck 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), rhizoma curcumae 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), and semen astragali complanati 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts).

[0039] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0040] Rhizoma polygoni avicularis 45-55 parts (e.g., 45, 46, 47, 48, 49, 50, 51, 52, 53, 54 or 55 parts), soapberry thorn 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), radix aucklandiae 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), rhizoma corydalis 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), fructus aurantii immaturus 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), endo-duck 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), rhizoma curcumae 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts), and semen astragali complanati 25-35 parts (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 parts).

[0041] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0042] Rhizoma Polygoni Cuspidati 45 parts, Radix Paeoniae Alba 25 parts, Radix Aucklandiae 25 parts, Rhizoma Corydalis 25 parts, Fructus Aurantii Immaturus 25 parts, Fructus Citri Sarcodactylis 25 parts, Rhizoma Curcumae 25 parts, Herba Gnaphalii 25 parts.

[0043] According to some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight:

[0044] Rhizoma Polygoni Cuspidati 60 parts, Radix Paeoniae Alba 20 parts, Radix Aucklandiae 40 parts, Rhizoma Corydalis 40 parts, Fructus Aurantii Immaturus 40 parts, Fructus Citri Sarcodactylis 60 parts, Rhizoma Curcumae 40 parts, Herba Gnaphalii 40 parts.

[0045] The present application provides in a second aspect a traditional Chinese medicine preparation for treating gallstones, which is the traditional Chinese medicine composition for treating gallstones according to the first aspect of the present application.

[0046] The present application provides in a third aspect a preparation method of the traditional Chinese medicine preparation for treating gallstones according to the second aspect of the present application, which comprises the following steps:

[0047] (1) soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1-2 hours;

[0048] (2) adding water to each raw material after the soaking 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, and filtering to obtain filtrate;

[0049] (3) concentrating the filtrate to a thick paste with a relative density of 1.20-1.25 at an ambient temperature of 80℃;

[0050] (4) mixing the thick paste with corn starch at a mass ratio of 1:(1.5-2.0) uniformly, and then granulating, drying, and sizing to obtain the traditional Chinese medicine preparation for treating gallstones; the traditional Chinese medicine preparation in the present application is simple to prepare, convenient to take, has remarkable curative effect, and has fast healing speed; in the present application, the traditional Chinese medicine preparation is also referred to as traditional Chinese medicine composition granules.

[0051] According to some preferred embodiments, when performing the first decocting, 8-12 times the total mass of the raw materials of water is added, i.e. the amount of water is 8-12 times the total mass of the raw materials; and / or when performing the second decocting, 8-12 times the mass of the residue of water is added, i.e. the amount of water is 8-12 times the mass of the residue.

[0052] According to some preferred embodiments, in step (1), the soaking is performed for 1.5 hours; in step (2), 10 times the total weight of the raw materials is added in the first decoction, and 10 times the weight of the residue is added in the second decoction; in step (2), the standing is performed for 24 hours; and / or in step (4), the thick paste is mixed with corn starch (an auxiliary material) at a weight ratio of 1:1.5.

[0053] According to some specific embodiments, the preparation of the Chinese medicinal preparation for treating gallstones is as follows: the raw materials are weighed and soaked in water for 1.5 hours; decocted twice, the first time for 1 hour with 10 times the water, and the second time for 1 hour with 10 times the water, the decoctions are combined and allowed 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°C hot measurement); the thick paste is mixed with corn starch at a mass ratio of 1:1.5; and then granulated, dried, and sized to obtain 1000 g of granules.

[0054] In the present application, the granulation is wet granulation, and the specific conditions of decoction, granulation, drying (drying), sizing, etc. are not limited, and are conventional techniques in the art.

[0055] According to some preferred embodiments, in step (4), corn starch is added to the thick paste and mixed uniformly to obtain a mass, which is then wet granulated, dried at 60-70°C for 3-4 hours, and sized to obtain the Chinese medicinal preparation for treating gallstones.

[0056] According to some specific embodiments, the granules of the Chinese medicinal composition of the present application are obtained by mixing the water extract of the prescription Chinese medicinal composition with corn starch as an auxiliary material to form wet granules, and then drying the wet granules at 60-70°C for 3-4 hours. The obtained dry granules are sieved with a 10-mesh sieve to remove large particles and with an 80-mesh sieve to remove fine powder, thereby obtaining the Chinese medicinal preparation for treating gallstones.

[0057] The present application will be further described below by way of examples, but the scope of protection of the present application is not limited to these examples. The present application can have other various embodiments, and those skilled in the art can make various corresponding changes and modifications to the present application without departing from the spirit and essence of the present application, and these corresponding changes and modifications shall all fall within the scope of protection of the claims appended to the present application.

[0058] Example 1

[0059] A traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials in parts by weight: 60 parts of giant knotweed rhizome, 20 parts of soapberry spine, 40 parts of costus root, 40 parts of rhizoma corydalis, 40 parts of fried bitter orange fruit, 60 parts of fried chicken gizzard, 40 parts of rhizoma curcumae, and 40 parts of semen astragali complanati.

[0060] A traditional Chinese medicine preparation for treating gallstones made of the above traditional Chinese medicine composition for treating gallstones, and the preparation method is as follows: soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1.5 hours; adding water with a mass 10 times that of the total raw materials into each raw material after soaking to perform first decocting for 1 hour, 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℃; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:1.5, then performing granulation, drying (drying at 65℃ for 3.5 hours), and whole granulation (removing large particles using a 10-mesh sieve and removing fine powder using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for treating gallstones (traditional Chinese medicine composition granules for treating gallstones).

[0061] Example 2

[0062] A traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials in parts by weight: 30 parts of giant knotweed rhizome, 20 parts of soapberry spine, 20 parts of costus root, 20 parts of rhizoma corydalis, 20 parts of fried bitter orange fruit, 30 parts of fried chicken gizzard, 20 parts of rhizoma curcumae, and 20 parts of semen astragali complanati.

[0063] A traditional Chinese medicine preparation for treating gallstones made of the above traditional Chinese medicine composition for treating gallstones, and the preparation method is as follows: soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1.5 hours; adding water with a mass 10 times that of the total raw materials into each raw material after soaking to perform first decocting for 1 hour, 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℃; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:1.5, then performing granulation, drying (drying at 65℃ for 3.5 hours), and whole granulation (removing large particles using a 10-mesh sieve and removing fine powder using an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for treating gallstones (traditional Chinese medicine composition granules for treating gallstones).

[0064] Example 3

[0065] A traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials in parts by weight: 45 parts of giant knotweed, 25 parts of soapberry thorn, 25 parts of costus, 25 parts of vinegar corydalis, 25 parts of wheat-cooked bitter orange fruit, 25 parts of fried chicken gizzard, 25 parts of vinegar cuperus, and 25 parts of stone deervetch.

[0066] A traditional Chinese medicine preparation for treating gallstones made of the above traditional Chinese medicine composition for treating gallstones, and the preparation method is as follows: soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1.5 hours; adding water with a mass 10 times that of the total raw materials into each soaked raw material to perform first decocting for 1 hour, 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℃; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:1.5, then performing granulation, drying (drying at 65℃ for 3.5 hours), and whole granulation (removing large particles with a 10-mesh sieve and removing fine powder with an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for treating gallstones (traditional Chinese medicine composition granules for treating gallstones).

[0067] Comparative Example 1

[0068] A traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials in parts by weight: 20 parts of soapberry thorn, 40 parts of costus, 40 parts of vinegar corydalis, 40 parts of wheat-cooked bitter orange fruit, 60 parts of fried chicken gizzard, 40 parts of vinegar cuperus, and 40 parts of stone deervetch.

[0069] A traditional Chinese medicine preparation for treating gallstones made of the above traditional Chinese medicine composition for treating gallstones, and the preparation method is as follows: soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1.5 hours; adding water with a mass 10 times that of the total raw materials into each soaked raw material to perform first decocting for 1 hour, 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℃; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:1.5, then performing granulation, drying (drying at 65℃ for 3.5 hours), and whole granulation (removing large particles with a 10-mesh sieve and removing fine powder with an 80-mesh sieve) to obtain the traditional Chinese medicine preparation for treating gallstones.

[0070] Comparative Example 2

[0071] A traditional Chinese medicine composition for treating gallstones, which is composed of the following raw materials in parts by weight: 60 parts of giant knotweed, 40 parts of costus, 40 parts of vinegar corydalis, 40 parts of wheat-cooked bitter orange fruit, 60 parts of fried chicken gizzard, 40 parts of vinegar cuperus, and 40 parts of stone deervetch.

[0072] The traditional Chinese medicine composition for treating gallstones is prepared into a traditional Chinese medicine preparation for treating gallstones by the following method: soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1.5 h; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 1 h, filtering to obtain a first decocting liquid and 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 h, filtering to obtain a second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 h, filtering to obtain a filtrate; concentrating the filtrate into a thick paste with a relative density of 1.25 at an ambient temperature of 80℃; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:1.5, then performing granulation, drying (drying at 65℃ for 3.5 h), 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 treating gallstones.

[0073] Comparative Example 3

[0074] A traditional Chinese medicine composition for treating gallstones, which is composed of raw materials in the following proportions by weight: 60 parts of giant knotweed rhizome, 20 parts of soapberry spine, 40 parts of costus root, 40 parts of fried bitter orange fruit, 60 parts of fried chicken gizzard, 40 parts of vinegarized corydalis, and 40 parts of stone-deervetch.

[0075] The traditional Chinese medicine composition for treating gallstones is prepared into a traditional Chinese medicine preparation for treating gallstones by the following method: soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1.5 h; adding water with a mass 10 times that of the total raw material into each raw material after soaking to perform first decocting for 1 h, filtering to obtain a first decocting liquid and 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 h, filtering to obtain a second decocting liquid, combining the first decocting liquid and the second decocting liquid, standing for 24 h, filtering to obtain a filtrate; concentrating the filtrate into a thick paste with a relative density of 1.25 at an ambient temperature of 80℃; mixing the thick paste with corn starch uniformly according to a mass ratio of 1:1.5, then performing granulation, drying (drying at 65℃ for 3.5 h), 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 treating gallstones.

[0076] Comparative Example 4

[0077] A traditional Chinese medicine composition for treating gallstones, which is composed of raw materials in the following proportions by weight: 60 parts of giant knotweed rhizome, 20 parts of soapberry spine, 40 parts of costus root, 40 parts of vinegarized corydalis, 40 parts of fried bitter orange fruit, 60 parts of fried chicken gizzard, and 40 parts of stone-deervetch.

[0078] The traditional Chinese medicine preparation for treating gallstones, made from the above-mentioned herbal composition, is prepared as follows: Each ingredient of the herbal composition is soaked in water for 1.5 hours; 10 times the total mass of water is added to the soaked ingredients for a first decoction of 1 hour, followed by filtration to obtain the first decoction and residue; then 10 times the mass of water is added to the residue for a second decoction of 1 hour, followed by filtration to obtain the second decoction; the first and second decoctions are combined, allowed to stand for 24 hours, and then filtered to obtain the filtrate; the filtrate is concentrated to a thick paste with a relative density of 1.25 at 80°C; the thick paste is mixed evenly with corn starch at a mass ratio of 1:1.5, then granulated, dried (at 65°C for 3.5 hours), and granulated (using a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the traditional Chinese medicine preparation for treating gallstones.

[0079] Comparative Example 5

[0080] A traditional Chinese medicine composition for treating gallstones, the composition comprising the following raw materials in parts by weight: 60 parts of Polygonum cuspidatum, 20 parts of Gleditsia sinensis thorns, 40 parts of Aucklandia lappa, 40 parts of Corydalis yanhusuo (processed with vinegar), 40 parts of Citrus aurantium (processed with wheat bran), 60 parts of chicken gizzard lining (processed with vinegar), and 40 parts of Curcuma zedoaria (processed with vinegar).

[0081] The traditional Chinese medicine preparation for treating gallstones, made from the above-mentioned herbal composition, is prepared as follows: Each ingredient of the herbal composition is soaked in water for 1.5 hours; 10 times the total mass of water is added to the soaked ingredients for a first decoction of 1 hour, followed by filtration to obtain the first decoction and residue; then 10 times the mass of water is added to the residue for a second decoction of 1 hour, followed by filtration to obtain the second decoction; the first and second decoctions are combined, allowed to stand for 24 hours, and then filtered to obtain the filtrate; the filtrate is concentrated to a thick paste with a relative density of 1.25 at 80°C; the thick paste is mixed evenly with corn starch at a mass ratio of 1:1.5, then granulated, dried (at 65°C for 3.5 hours), and granulated (using a 10-mesh sieve to remove large particles and an 80-mesh sieve to remove fine powder) to obtain the traditional Chinese medicine preparation for treating gallstones.

[0082] Comparative Example 6

[0083] A traditional Chinese medicine composition comprises the following raw materials in parts by weight: 120 parts Artemisia capillaris, 45 parts Citrus aurantium, 75 parts Curcuma longa, 30 parts Glycyrrhiza uralensis, 30 parts Aucklandia lappa, 60 parts Lysimachia christinae, 45 parts Polygonum cuspidatum, 45 parts Abrus precatorius, 45 parts Gentiana scabra, 60 parts Corydalis yanhusuo (processed with vinegar), 45 parts Melia toosendan (stir-fried), 45 parts Crataegus pinnatifida, and 45 parts Bupleurum chinense.

[0084] The traditional Chinese medicine preparation is prepared by using the traditional Chinese medicine composition, and the preparation method is as follows: the raw materials of the traditional Chinese medicine composition are soaked in water for 1.5 hours; 10 times the total mass of the raw materials of water is added to the soaked raw materials for the first decoction for 1 hour, and then filtered to obtain the first decoction and the filter residue; then 10 times the mass of the filter residue of water is added to the filter residue for the second decoction for 1 hour, and then filtered to obtain the second decoction; the first decoction and the second decoction are combined, and then left to stand for 24 hours; then filtered to obtain the filtrate; the filtrate is concentrated to a thick paste with a relative density of 1.25 at an environmental temperature of 80 DEG C; and the thick paste is mixed with corn starch at a mass ratio of 1:1.5, and then granulated, dried (dried at 65 DEG C for 3.5 hours), 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.

[0085] Comparative example 7

[0086] A traditional Chinese medicine composition is composed of the following raw materials in parts by weight: Herba veronicastrae 200 parts, cat grass 200 parts, sea gold sand 80 parts, radix bupleuri 80 parts, plantago 100 parts, herba silybi 200 parts, medicinal leaven 100 parts, saussurea 100 parts, citri sarcodactylis 100 parts, capillaris 100 parts, poria 100 parts, and licorice 100 parts.

[0087] The traditional Chinese medicine preparation is prepared by using the traditional Chinese medicine composition, and the preparation method is as follows: the raw materials of the traditional Chinese medicine composition are soaked in water for 1.5 hours; 10 times the total mass of the raw materials of water is added to the soaked raw materials for the first decoction for 1 hour, and then filtered to obtain the first decoction and the filter residue; then 10 times the mass of the filter residue of water is added to the filter residue for the second decoction for 1 hour, and then filtered to obtain the second decoction; the first decoction and the second decoction are combined, and then left to stand for 24 hours; then filtered to obtain the filtrate; the filtrate is concentrated to a thick paste with a relative density of 1.25 at an environmental temperature of 80 DEG C; and the thick paste is mixed with corn starch at a mass ratio of 1:1.5, and then granulated, dried (dried at 65 DEG C for 3.5 hours), 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.

[0088] The curative effect of the traditional Chinese medicine preparation for treating gallstones is described by a clinical curative effect observation experiment, and the specific process is as follows:

[0089] I. General information

[0090] 100 patients with gallstones are selected as the control group and the treatment group, respectively.

[0091] II. Diagnostic criteria

[0092] (I) Symptoms and signs

[0093] The patient has hypochondriac pain, dry mouth, abdominal distension, poor appetite, occasional stomach pain, dry mouth, fatigue, dry and itchy eyes, sticky and unsmooth stool, and yellow urine.

[0094] (II) Imaging examination

[0095] Hepatobiliary ultrasonography: gallbladder shape and size are abnormal, rough, and multiple strong echoes can be seen inside, with poor transmission of cyst and bile, and echo filling can be seen in the gallbladder.

[0096] III. Treatment method

[0097] Treatment group 1: orally take the gallstone treating traditional Chinese medicine preparation prepared in Example 1 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; treatment group 2: orally take the gallstone treating traditional Chinese medicine preparation prepared in Example 2 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; treatment group 3: orally take the gallstone treating traditional Chinese medicine preparation prepared in Example 3 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 1: orally take Lidanpaishi tablets (Anhui Renhe Pharmaceutical Co., Ltd., State Drug Standard Z34020352) 10 tablets each time, twice a day, morning and evening, continuously take for 28 days; control group 2: orally take the gallstone treating traditional Chinese medicine preparation prepared in Comparative Example 1 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 3: orally take the gallstone treating traditional Chinese medicine preparation prepared in Comparative Example 2 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 4: orally take the gallstone treating traditional Chinese medicine preparation prepared in Comparative Example 3 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 5: orally take the gallstone treating traditional Chinese medicine preparation prepared in Comparative Example 4 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 6: orally take the gallstone treating traditional Chinese medicine preparation prepared in Comparative Example 5 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 7: orally take the traditional Chinese medicine preparation prepared in Comparative Example 6 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment; control group 8: orally take the traditional Chinese medicine preparation prepared in Comparative Example 7 of the present application: 10 grams each time, twice a day, morning and evening, 28 days as a course of treatment, take a course of treatment.

[0098] IV. Efficacy evaluation standard

[0099] Cure: symptoms such as hypochondriac pain, bitter mouth, abdominal distension, poor appetite, and gallbladder stones are eliminated;

[0100] Marked effect: hypochondriac pain, bitter mouth, abdominal distension, poor appetite, and gallbladder stone size are significantly improved after taking the medicine;

[0101] Effectiveness: hypochondriac pain, bitter mouth, abdominal distension, poor appetite, and gallbladder stone size are alleviated after taking the medicine;

[0102] Invalid: hypochondriac pain, bitter mouth, abdominal distension, poor appetite, gallbladder stone size, etc. have no change compared with before taking medicine.

[0103] V. Therapeutic effect

[0104] The effect of the treatment group 1 of the application is: cured: 84 cases, markedly effective: 10 cases, effective: 6 cases, invalid: 0 cases, and the total effective rate reaches 100%. The effect of the treatment group 2 of the application is: cured: 68 cases, markedly effective: 24 cases, effective: 8 cases, invalid: 0 cases, and the total effective rate reaches 100%. The effect of the treatment group 3 of the application is: cured: 76 cases, markedly effective: 16 cases, effective: 8 cases, invalid: 0 cases, and the total effective rate reaches 100%. The results are shown in Table 1.

[0105] Table 1: Comparison of clinical effects.

[0106]

[0107] The comparison of the treatment group 1 taking the traditional Chinese medicine preparation of the application and the control group 1 taking the existing similar drugs shows that the existing similar drugs taken by the control group 1 have a cure rate of 10.00% for gallstone and a total effective rate of 84.00%, while the drugs of the application taken by the treatment group 1 have a cure rate of 84.00% for gallstone and a total effective rate of 100%. Meanwhile, the patients with marked effect in the control group 1 and the treatment group 1 are followed up once every 6 months, and through 3 years of follow-up statistics, 6 of the 10 cured patients in the control group 1 relapse, accounting for 60.00%, and none of the 84 cured patients in the treatment group 1 relapse.

[0108] Therefore, the traditional Chinese medicine preparation for treating gallstone provided by the application has a cure rate, a marked effect rate and an effective rate that are obviously higher than those of the existing similar drugs in the market and has no recurrence. It can be known from the above experimental research results that the traditional Chinese medicine composition and the traditional Chinese medicine preparation for treating gallstone provided by the application can obviously achieve the purpose of treating gallstone.

[0109] The application also carries out in-vitro stone dissolution test on the traditional Chinese medicine composition for treating gallstone in the embodiments 1-3 of the application, compares the differences in stone dissolution capacity of the traditional Chinese medicine administration groups 1-3 and the control groups 1-7 through the determination of the weight of the stones, and the specific differences are as follows:

[0110] I. Experimental materials

[0111] The gallstones are collected from the gallbladder resection surgery of Heilongjiang Province Chinese Medicine Research Institute.

[0112] II. Operation method:

[0113] ① 120 pieces of cholesterol stones with similar shape, size and weight were washed and dried, and then evenly divided into 12 groups: a blank control group, a high-dose group of the traditional Chinese medicine preparation of group 1, a low-dose group of the traditional Chinese medicine preparation of group 1, a high-dose group of the traditional Chinese medicine preparation of group 2, a high-dose group of the traditional Chinese medicine preparation of group 3, a high-dose group of the traditional Chinese medicine control preparation of group 1, a high-dose group of the traditional Chinese medicine control preparation of group 2, a high-dose group of the traditional Chinese medicine control preparation of group 3, a high-dose group of the traditional Chinese medicine control preparation of group 4, a high-dose group of the traditional Chinese medicine control preparation of group 5, a high-dose group of the traditional Chinese medicine control preparation of group 6, and a high-dose group of the traditional Chinese medicine control preparation of group 7. The traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine preparation of group 1 was the traditional Chinese medicine preparation in Example 1, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine preparation of group 2 was the traditional Chinese medicine preparation in Example 2, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine preparation of group 3 was the traditional Chinese medicine preparation in Example 3, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 1 was the traditional Chinese medicine preparation in Comparative Example 1, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 2 was the traditional Chinese medicine preparation in Comparative Example 2, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 3 was the traditional Chinese medicine preparation in Comparative Example 3, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 4 was the traditional Chinese medicine preparation in Comparative Example 4, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 5 was the traditional Chinese medicine preparation in Comparative Example 5, the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 6 was the traditional Chinese medicine preparation in Comparative Example 6, and the traditional Chinese medicine preparation used in the high-dose group of the traditional Chinese medicine control preparation of group 7 was the traditional Chinese medicine preparation in Comparative Example 7.

[0114] ② Each gallstone was placed in a ground-mouth test tube containing 10 mL of reagent. The gallstone dissolving reagent of the blank control group was normal saline, the reagent of the high-dose group was a traditional Chinese medicine preparation aqueous solution with a concentration of 0.4 g / mL, and the reagent of the low-dose group was a traditional Chinese medicine preparation aqueous solution with a concentration of 0.2 g / mL.

[0115] ③ The test tube was placed in a 37℃ electric heating constant temperature incubator, observed once every 24 h, and the liquid was replaced. The gallstones were taken out on the 16th day, placed in a 60℃ drying box for constant temperature incubation for 4 h, dried, weighed, and the gallstone dissolution rate was calculated. The dissolution rate was calculated according to the formula: dissolution rate = (weight before dissolution - weight after dissolution) / weight before dissolution × 100%. The dissolution rate of each group was calculated according to the formula, and the mean and standard deviation of the dissolution rate of each group were calculated, and the t test was performed to compare the significance of the difference between groups.

[0116] Table 2: Results of the in vitro gallstone dissolution experiment of the traditional Chinese medicine preparation for treating gallstones.

[0117]

[0118] From the results of Table 2, the dissolution rate of the traditional Chinese medicine administration group 1 (high dose group and low dose group) has significant difference compared with the blank control group, which shows that the administration group has good solubility to gallstones, and the high dose group of the traditional Chinese medicine administration group has the highest solubility to cholesterin stones; thus, it can be seen that the traditional Chinese medicine agent for treating gallstones has significant dissolution effect on gallstones, and the high dose group has the most obvious effect. In the in vitro dissolution test of the present application, the gallstones are taken out on the 16th day, and the dissolution result photos of the blank control group, the low dose group of the traditional Chinese medicine agent in Example 1 and the high dose group of the traditional Chinese medicine agent in Example 1 are observed, as shown in Table 2. Figure 1

[0119] The present application adopts the traditional Chinese medicine agent for treating gallstones in Example 1 to carry out the main pharmacodynamics test.

[0120] In order to verify the pharmacodynamic characteristics of the traditional Chinese medicine agent for treating gallstones, the pharmacodynamic experiments such as anti-inflammatory and bile secretion are carried out, and the specific experimental results are as follows:

[0121] Medicines and reagents:

[0122] 1. Traditional Chinese medicine group 1: the traditional Chinese medicine agent for treating gallstones in Example 1; traditional Chinese medicine group 2: the traditional Chinese medicine agent for treating gallstones in Example 2; traditional Chinese medicine group 3: the traditional Chinese medicine agent for treating gallstones in Example 3; traditional Chinese medicine control group 1: the traditional Chinese medicine agent in Comparative Example 1; traditional Chinese medicine control group 2: the traditional Chinese medicine agent in Comparative Example 2; traditional Chinese medicine control group 3: the traditional Chinese medicine agent in Comparative Example 3; traditional Chinese medicine control group 4: the traditional Chinese medicine agent in Comparative Example 4; traditional Chinese medicine control group 5: the traditional Chinese medicine agent in Comparative Example 5; traditional Chinese medicine control group 6: the traditional Chinese medicine agent in Comparative Example 6; traditional Chinese medicine control group 7: the traditional Chinese medicine agent in Comparative Example 7;

[0123] 2. Indometacin tablets, production enterprise: Shanghai Jinbuhuan Lanqiao Pharmaceutical Co., Ltd., approval number: State Drug Standard Number H41021631;

[0124] 3. Ursodeoxycholic acid tablets, production enterprise: Shanghai Shangyi Pharmaceutical Factory Co., Ltd., approval number: State Drug Standard Number H31021875.

[0125] Animals: Kunming mice, SD rats, Wistar rats, all provided by the Institute of Traditional Chinese Medicine.

[0126] Methods and results:

[0127] I. Effect on mouse ear swelling

[0128] Principle: after the skin of the ear shell is swelled by the inflammatory agent, the weight of the inflammatory ear shell of the administration group and the control group is observed and measured, and the difference of the swelling rate is compared.

[0129] Operation method:​

[0130] ①Take Kunming male mice (18-20 g) 140, randomly divided into 14 groups, 10 each.

[0131] ②All intragastrically administered, each day to treat gallstones in traditional Chinese medicine 4g / kg, 8g / kg, 12g / kg, respectively, recorded as low-dose group, medium-dose group and high-dose group; indomethacin control group each day to give indomethacin 8mg / kg, 0.9% saline (NS) 0.3mL / 10g each day. Continuous 3 days, at 1 hour after intragastric administration, under ether anesthesia, in the left ear before and after two sides coated with 100% xylene 0.1mL.

[0132] ③1h after the mice were decapitated, along the auricle baseline cut off two ears, with a 9mm diameter punch in the same area down the round ear piece (removed ear and coated with the site of inflammation coincides), using a tissue balance. The left ear piece weight minus the right ear weight is the degree of swelling, swelling inhibition rate = (blank control group swelling degree - the degree of swelling of the administration group) / the degree of swelling of the blank control group x 100%. According to the formula, the mean and standard deviation of the swelling inhibition rate of each group was calculated, and t test was used to compare the significant difference between groups. The results of the indomethacin group were 65.55%, the high-dose group of traditional Chinese medicine group 1 was 76.33%, the medium-dose group of traditional Chinese medicine group 1 was 72.27%, and the low-dose group of traditional Chinese medicine group 1 was 64.01%. The results are shown in Table 3. Statistical processing, indomethacin control group, traditional Chinese medicine group and blank control group, there were significant differences (p<0.05); indomethacin group and traditional Chinese medicine group had no significant difference (p>0.05).

[0133] Evaluation: This method is simple, without special equipment, fast, less drug, suitable for screening of anti-inflammatory drugs.

[0134] Table 3: The effect of traditional Chinese medicine for treating gallstones on mouse ear swelling.

[0135]

[0136]

[0137] Note: Compared with the model control group, *P<0.05, **P<0.01.

[0138] As shown in the data of Table 3, the Chinese medicine agent 4 g / kg, 8 g / kg, 12 g / kg for treating gallstones in the present application has a significant inhibitory effect on the mouse ear swelling caused by dimethylbenzene. The above experimental results prove that the Chinese medicine agent for treating gallstones in Example 1 of the present application has a significant anti-inflammatory effect, and the effect is most obvious 1 h after the administration of the inflammatory agent.

[0139] II. Effect on the foot swelling of Wistar rats

[0140] Fifty Wistar rats with a body weight of 140-160 g, half male and half female, were randomly divided into 5 groups according to the body weight, 10 rats in each group, namely, a saline group, a high-dose group of the Chinese medicine agent for treating gallstones, a middle-dose group of the Chinese medicine agent for treating gallstones, a low-dose group of the Chinese medicine agent for treating gallstones, and an indomethacin group. All the rats were administered intragastrically, the Chinese medicine groups were administered the Chinese medicine agent for treating gallstones 4 g / kg, 8 g / kg, 12 g / kg per day, the low-dose group, the middle-dose group and the high-dose group used the Chinese medicine agent for treating gallstones in Example 1, the indomethacin group was administered indomethacin 8 mg / kg per day, and the blank group (the saline group) was administered 0.9% normal saline (NS) 0.3 mL / 10 g per day. Before the experiment, the right hind ankle joints of the rats were marked, and the right hind foot volume of each rat was measured twice using a foot volume meter, and the average value was taken as the normal foot volume. Thirty minutes after the administration, 10% fresh egg white solution 0.1 mL was subcutaneously injected into the right hind foot of each rat to cause inflammation, and the inflamed foot volume was measured at 0.5 h, 1 h, 2 h, 4 h, 6 h after the inflammation, respectively. The ratio of the change value of the right hind foot volume before and after the inflammation to the normal foot volume was calculated, i.e., the swelling rate was obtained, and the results are shown in Table 4 below.

[0141] Table 4: Effect of the Chinese medicine agent for treating gallstones on the foot swelling caused by egg white (X±s, n=10).

[0142]

[0143]

[0144] As shown in the experimental results of Table 4, during the period from 0.5 h to 6 h after the administration, the foot swelling rate of each administration group was significantly reduced compared with the saline group, and the difference was most significant in the high-dose group. One hour after the administration, the high-dose group, the middle-dose group and the low-dose group had a significant difference compared with the saline group, and the high-dose group had a very significant difference compared with the saline group. Two hours after the administration, the high-dose group, the middle-dose group and the low-dose group had a significant difference compared with the saline group. The high-dose group, the middle-dose group and the low-dose group had a significant difference compared with the saline group.

[0145] III. Effect on the bile flow of SD rats

[0146] Take 200±20g, SD rats 140, half of each sex, the rats are divided into 14 groups, high dose group 4g / kg, middle dose group 8g / kg, low dose group 12g / kg, ursodeoxycholic acid 8mg / kg positive control group, normal saline (0.9% normal saline (NS) 0.3mL / 10g) such as volume of blank control group, the dosage is all continuous gavage 8 days, once a day. 12 hours before the experiment, fasting without water. When the experiment, each mouse is anesthetized with chloral hydrate 0.55mg / kg intraperitoneal injection, fixed on the fixed plate in supine position, along the midline incision 2cm, open the abdominal cavity, find the pylorus, turn the duodenum, find the white and tough bile duct in the mesentery of the descending duodenum, tie the nipple part, make a "V" shape incision towards the liver, insert a 5.5 gauge needle for bile duct puncture, fix the needle to form a fistula to drain bile, collect bile with a beaker. After the operation, clamp the abdominal wall with a hemostat, cover with saline gauze. After 20 minutes of stabilization, collect 30 minutes of bile, then each group of rats is given drug from the duodenum. Collect bile every 30 minutes after drug administration, a total of 3 times, record the bile flow, calculate the percentage increase in bile flow after drug administration. Bile flow increase rate=(bile flow after drug administration-bile flow before drug administration) / bile flow before drug administration, the results are shown in Table 5.

[0147] Table 5: the effect of traditional Chinese medicine agents for treating gallstones on rat bile flow.

[0148]

[0149] From Table 5, it can be seen that the traditional Chinese medicine agents for treating gallstones of the present application can significantly increase the bile flow of rats, reduce bile stasis, and can inhibit the formation of gallstones to a certain extent, achieving the effect of promoting bile secretion.

[0150] The part not described in detail in the present application is the technology known to those skilled in the art, which can be selected by those skilled in the art as needed.

[0151] Finally, it should be noted that: the above examples are only used to illustrate the technical solutions of the present application, and not to limit them; although detailed description has been made with reference to the foregoing examples, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing examples, or make equivalent replacement for part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions 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 treating gallstones, characterized in that, The traditional Chinese medicine composition is composed of raw materials in the following weight parts: Rhizoma Polygoni Cuspidati 30-60 parts, Radix Paeoniae Alba 10-35 parts, Radix Aucklandiae 20-40 parts, Rhizoma Corydalis 20-40 parts, Fructus Aurantii Immaturus 20-40 parts, Semen Galli Astringens 25-60 parts, Rhizoma Curcumae 20-40 parts, Herba Humuli 20-40 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of raw materials in the following weight parts: Rhizoma Polygoni Cuspidati 45-55 parts, Radix Paeoniae Alba 25-35 parts, Radix Aucklandiae 25-35 parts, Rhizoma Corydalis 25-35 parts, Fructus Aurantii Immaturus 25-35 parts, Semen Galli Astringens 25-35 parts, Rhizoma Curcumae 25-35 parts, Herba Humuli 25-35 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of raw materials in the following weight parts: Rhizoma Polygoni Cuspidati 30 parts, Radix Paeoniae Alba 20 parts, Radix Aucklandiae 20 parts, Rhizoma Corydalis 20 parts, Fructus Aurantii Immaturus 20 parts, Semen Galli Astringens 30 parts, Rhizoma Curcumae 20 parts, Herba Humuli 20 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of raw materials in the following weight parts: Rhizoma Polygoni Cuspidati 45 parts, Radix Paeoniae Alba 25 parts, Radix Aucklandiae 25 parts, Rhizoma Corydalis 25 parts, Fructus Aurantii Immaturus 25 parts, Semen Galli Astringens 25 parts, Rhizoma Curcumae 25 parts, Herba Humuli 25 parts.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of raw materials in the following weight parts: Rhizoma Polygoni Cuspidati 60 parts, Radix Paeoniae Alba 20 parts, Radix Aucklandiae 40 parts, Rhizoma Corydalis 40 parts, Fructus Aurantii Immaturus 40 parts, Semen Galli Astringens 60 parts, Rhizoma Curcumae 40 parts, Herba Humuli 40 parts.

6. A traditional Chinese medicine preparation for treating gallstones, characterized in that: The traditional Chinese medicine preparation is made of the traditional Chinese medicine composition for treating gallstones according to any one of claims 1 to 5.

7. The preparation method of the traditional Chinese medicine agent for treating gallstones according to claim 6, characterized in that, The method comprises the following steps: (1) soaking each raw material of the traditional Chinese medicine composition for treating gallstones in water for 1-2 hours; (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; (3) concentrating the filtrate to thick paste with relative density of 1.20-1.25 at ambient temperature of 80℃; (4) mixing the thick paste with corn starch uniformly according to mass ratio of 1:(1.5-2.0), then performing granulation, drying and whole-granulation to obtain the traditional Chinese medicine preparation for treating gallstones.

8. The preparation method according to claim 7, characterized in that: when performing the first decocting, 8-12 times of water of the total mass of each raw material is added; and / or when performing the second decocting, 8-12 times of water of the mass of the residue is added.

9. The preparation method according to claim 7, characterized in that: in step (1), the soaking is performed for 1.5 hours; in step (2), when performing the first decocting, 10 times of water of the total mass of each raw material is added, and when performing the second decocting, 10 times of water of the mass of the residue is added; in step (2), the standing is performed for 24 hours; and / or in step (4), the thick paste is mixed with corn starch uniformly according to mass ratio of 1:1.

5.

10. The preparation method according to any one of claims 7 to 9, characterized in that: In step (4), corn starch is added into the thick paste and mixed uniformly to obtain a medicine mass. The medicine mass is subjected to wet granulation, then dried at 60-70°C for 3-4h, and finally granulated to prepare the traditional Chinese medicine preparation for treating gallstones.

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