A traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer.

Abstract

This invention discloses a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer, belonging to the field of traditional Chinese medicine technology. The formula includes: a softening and stasis-resolving composition, a diuretic and mass-eliminating composition, and a liver-soothing and detoxifying composition. This invention, through the combination of these three types of compositions, allows turtle shell, leech, and dung beetle to exert the effects of softening and dispersing masses, breaking up blood stasis and eliminating masses; astragalus, lepidium seed, and eupatorium to achieve the effects of invigorating qi and promoting diuresis, relieving bloating and fullness; and bupleurum, salvia miltiorrhiza, oldenlandia diffusa, and poria cocos to achieve the purpose of soothing the liver and relieving depression, promoting blood circulation and detoxifying, and strengthening the spleen and eliminating dampness. The three types of compositions work synergistically to address the core pathogenesis of cirrhosis with ascites and early-stage liver cancer, intervening in the pathological process of the disease from multiple dimensions of resolving stasis, promoting diuresis, soothing the liver, and detoxifying, thus achieving overall conditioning and targeted intervention for liver diseases.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer. Background Technology

[0002] Cirrhosis is a common chronic progressive liver disease in clinical practice. When the disease progresses to the decompensated stage, ascites often occurs as a complication, significantly increasing the patient's health risks. At the same time, cirrhosis is also an important cause of early-stage liver cancer. The combination of ascites and early-stage liver cancer can further aggravate liver damage and bodily dysfunction. Western medicine treatments for this type of disease often have significant side effects and poor long-term tolerance, making it difficult to simultaneously address liver repair and disease control. Traditional Chinese medicine, characterized by holistic conditioning and gentle treatment, has unique advantages in the intervention of chronic liver diseases and has become an important direction for the clinical treatment and drug development of cirrhosis, ascites, and early-stage liver cancer.

[0003] However, existing traditional Chinese medicines for cirrhosis with ascites and early-stage liver cancer have some shortcomings. The formulations often fail to rationally address the underlying mechanisms of softening and resolving masses, promoting diuresis and eliminating lumps, and soothing the liver and detoxifying. The combinations of medicinal materials cannot achieve synergistic effects on multiple targets. The processing techniques for medicinal materials are crude, the toxicity control of animal-derived drugs is inadequate, and there is no standardized process for the pretreatment of plant-derived drugs. The extraction process often relies on traditional water decoction, which fails to fully release the active ingredients, resulting in low utilization of effective components. Furthermore, the powder and paste mixtures tend to agglomerate during preparation, leading to poor uniformity of the finished product content and insufficient stability of efficacy, making it difficult to achieve ideal therapeutic effects and meet the standards for medication. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of existing technologies and provide a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer. This invention combines three types of ingredients: softening and resolving stasis, promoting diuresis and eliminating masses, and soothing the liver and detoxifying. Turtle shell, leech, and dung beetle exert their effects of softening and resolving stasis and eliminating masses; astragalus, lepidium seed, and eupatorium achieve the effects of invigorating qi and promoting diuresis, relieving bloating and fullness; and bupleurum, salvia miltiorrhiza, oldenlandia diffusa, and poria cocos achieve the effects of soothing the liver and relieving depression, promoting blood circulation and detoxifying, and strengthening the spleen and eliminating dampness. The three types of ingredients work synergistically to address the core pathogenesis of cirrhosis with ascites and early-stage liver cancer, intervening in the pathological process of the disease from multiple dimensions of resolving stasis, promoting diuresis, soothing the liver, and detoxifying, thus achieving overall conditioning and targeted intervention for liver diseases.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: In one aspect, a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer, the formula comprising, by weight:

[0006] Composition for softening hard masses and removing blood stasis: 20-80 parts;

[0007] Diuretic and symptomatic composition: 30-100 parts;

[0008] Basic composition for soothing the liver and detoxifying: 40-120 parts.

[0009] Furthermore, the softening and blood-activating composition comprises turtle shell, leech, and dung beetle, and the mass ratio of turtle shell, leech, and dung beetle in the softening and blood-activating composition is 2~4:1~3:0.5~2; the turtle shell is mixed with vinegar and then left to soak until the vinegar is completely absorbed, and then stir-fried until the texture is crisp; the leech is stir-fried with preheated talcum powder until the surface is slightly yellow; the dung beetle is soaked in rice wine until the rice wine is completely absorbed, and then stir-fried until the surface is dry.

[0010] Furthermore, the diuretic and symptomatic relief composition comprises Astragalus membranaceus, Lepidium apetalum, and Lycopus lucidus, wherein the mass ratio of Astragalus membranaceus, Lepidium apetalum, and Lycopus lucidus in the diuretic and symptomatic relief composition is 3~5:1~2.5:1~2; the Astragalus membranaceus is mixed with refined honey, moistened, and then stir-fried until it is no longer sticky; the Lepidium apetalum is stir-fried until the surface is slightly puffed up; the Lycopus lucidus is sprayed with rice wine, mixed, moistened, and then stir-fried until the surface is slightly dry.

[0011] Furthermore, the basic composition for soothing the liver and detoxifying includes Bupleurum, Salvia miltiorrhiza, Hedyotis diffusa, and Poria cocos. The mass ratio of Bupleurum, Salvia miltiorrhiza, Hedyotis diffusa, and Poria cocos in the basic composition is 1~2:1~3:2~5:1~2.5. Bupleurum is mixed with vinegar, moistened, and then stir-fried until the surface is slightly dry. Salvia miltiorrhiza is sprayed with rice wine, mixed, moistened, and then stir-fried until the surface is brownish-yellow. Hedyotis diffusa is dried after drying treatment, and Poria cocos is pulverized Poria cocos powder.

[0012] On the other hand, a method for preparing a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer, the specific steps of which are as follows:

[0013] Ultrafine processing: Each medicinal material in the softening and blood-activating composition is processed separately, then mixed together and ultrafinely pulverized to obtain ultrafine powder;

[0014] Enzymatic hydrolysis and decoction extraction: The medicinal materials in the diuretic and sedative composition and the liver-soothing and detoxifying basic composition are processed separately and then mixed. Water and compound enzyme are added and enzymatic hydrolysis is carried out. After enzymatic hydrolysis, the enzyme is inactivated by heating and decocted. After filtration, the filtrate is concentrated under reduced pressure to obtain a clear extract.

[0015] Batch mixing and homogenization: The ultrafine powder is added to the clear paste in batches and stirred and homogenized to obtain a mixed paste;

[0016] Pill making and drying: Add refined honey to the mixed paste, mix evenly, make into pills, and dry at low temperature to obtain the honey pill product.

[0017] Furthermore, in the ultrafine processing, turtle shell is mixed with vinegar and allowed to soak until the vinegar is completely absorbed, then stir-fried until crisp and cooled for later use; leeches are mixed with preheated talc powder and stir-fried until the surface is slightly yellow, then the talc powder is sieved out and cooled for later use; dung beetles are soaked in rice wine until the rice wine is completely absorbed, then stir-fried until the surface is dry and cooled for later use, thus completing the processing separately; after being mixed evenly, they are ultrafine pulverized using an ultrafine pulverizing device. The ultrafine pulverizing environment temperature is -20~-5℃, and the ultrafine pulverizing time is 30~90min. After ultrafine pulverization, ultrafine powder with a particle size D90 of 5~15μm is obtained, and the ultrafine pulverization process is carried out in a low-temperature and sealed environment.

[0018] Furthermore, in the enzymatic hydrolysis and decoction extraction, Astragalus membranaceus is mixed with refined honey, moistened, stir-fried until not sticky, and then cooled for later use; Lepidium apetalum is stir-fried until the surface is slightly puffed up and a fragrance is released, then removed and cooled for later use; Lycopus lucidus is sprayed with rice wine, mixed, moistened, stir-fried until the surface is slightly dry, and then cooled for later use; Bupleurum chinense is mixed with vinegar, moistened, stir-fried until the surface is slightly dry, and then cooled for later use; Salvia miltiorrhiza is sprayed with rice wine, mixed, moistened, stir-fried until the surface is brownish-yellow, and then cooled for later use; Hedyotis diffusa is the dried product after drying treatment; Poria cocos is the powdered Poria cocos; and all of the diuretic and sedative composition and the liver-soothing and detoxifying basic composition are used. After the medicinal materials are processed, they are mixed evenly, and then 6 to 12 times the total mass of water is added. Then, a compound enzyme, which is a mixture of cellulase and pectinase in a mass ratio of 1:0.5 to 1:2, is added. The amount of compound enzyme added is 0.5 to 2% of the total mass of the medicinal materials. The pH of the system is then adjusted to 4.0 to 6.0, and enzymatic hydrolysis is carried out at 40 to 60°C for 1 to 3 hours. After enzymatic hydrolysis, the temperature is raised to 90 to 100°C to inactivate the enzyme, and the mixture is decocted for 0.5 to 2 hours. After filtration, the filtrate is collected and concentrated under reduced pressure until the relative density at 60°C is 1.10 to 1.25, to obtain a clear extract.

[0019] Furthermore, in the batch mixing and homogenization, the ultrafine powder is added to the clear paste in 2 to 4 batches. After each addition, the mixture is stirred and homogenized at a speed of 100 to 300 r / min for 5 to 15 minutes. After the ultrafine powder added in the previous batch is completely dispersed and evenly distributed, the next batch of ultrafine powder is added. After all the mixing is completed, a uniform and lump-free mixed paste is obtained.

[0020] Furthermore, in the pelleting and drying process, 20% to 50% of refined honey by total mass is added to the mixed paste, stirred and mixed evenly, and fed into a pelleting machine to form pellets. The weight of each pellet is controlled at 5 to 10g. The pellets are then placed in a low-temperature environment of 30 to 50°C for drying until the moisture content of the pellets is ≤12%. Drying is then stopped, and the pellets are cooled to room temperature to obtain the honey pellet product.

[0021] Compared with existing technologies, this traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer has the following beneficial effects:

[0022] I. This invention utilizes a combination of three types of ingredients: softening and resolving stasis, promoting diuresis and eliminating masses, and soothing the liver and detoxifying. This allows turtle shell, leech, and dung beetle to soften and disperse stasis, break up masses, and eliminate blood stasis; astragalus, lepidium seed, and eupatorium to invigorate qi, promote diuresis, and relieve bloating; and bupleurum, salvia miltiorrhiza, oldenlandia diffusa, and poria cocos to soothe the liver, relieve depression, invigorate blood, detoxify, strengthen the spleen, and eliminate dampness. The synergistic effect of these three ingredients addresses the core pathogenesis of cirrhosis with ascites and early-stage liver cancer, intervening in the pathological process of the disease from multiple dimensions—resolving stasis, promoting diuresis, soothing the liver, and detoxifying—to achieve holistic conditioning and targeted intervention for liver diseases.

[0023] II. This invention reduces the toxicity of animal-derived medicines in the softening and blood-activating composition by processing them, uses low-temperature ultrafine methods to break down the cell walls of the medicines to ensure the full dissolution of active ingredients, and uses a combination of enzymatic hydrolysis and decoction to destroy the cell wall structure of plant-derived medicines in the diuretic and sedative composition and the liver-soothing and detoxifying basic composition to release internal active ingredients. It avoids powder agglomeration by using batch mixing methods to ensure uniform distribution of the preparation components, and stabilizes the preparation morphology through standardized pill-making and low-temperature drying processes, so that the active ingredients of the medicines are completely preserved and evenly distributed, providing process support for the stable efficacy of the medicine.

[0024] Other advantages, objectives and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination or study, or may be learned from the practice of the invention. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without any creative effort.

[0026] Figure 1 A flowchart illustrating the preparation method of a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer;

[0027] Figure 2 A framework diagram of a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer;

[0028] Figure 3 This is a framework diagram of batch mixing and homogenization in the preparation method of a traditional Chinese medicine formula for treating cirrhosis, ascites, and early-stage liver cancer. Detailed Implementation

[0029] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with the accompanying drawings and preferred embodiments, is provided below.

[0030] Example 1:

[0031] Raw material preparation (by weight):

[0032] Composition for softening hard masses and removing blood stasis: 50 parts;

[0033] Diuretic and symptomatic composition: 65 parts;

[0034] Basic composition for soothing the liver and detoxifying: 80 parts.

[0035] In the combination for softening hardness and removing blood stasis, the mass ratio of turtle shell, leech, and dung beetle is 3:2:1; in the combination for promoting diuresis and eliminating masses, the mass ratio of astragalus, lepidium seed, and eupatorium is 4:1.8:1.5; and in the basic combination for soothing the liver and detoxifying, the mass ratio of bupleurum, salvia miltiorrhiza, oldenlandia diffusa, and poria cocos is 1.5:2:3.5:1.8.

[0036] Preparation method:

[0037] Ultra-fine processing: Weigh the turtle shell, leech, and dung beetle from the softening and blood-activating composition according to the mass ratio, and process them separately: Take the turtle shell, add edible vinegar at a ratio of 20g of edible vinegar per 100g of turtle shell, mix well, seal and let it moisten for 2 hours until the vinegar is completely absorbed by the medicinal material and there is no free vinegar residue. Place it in a 180℃ stir-frying device and stir-fry until the medicinal material is brittle and can be easily crushed with a light tap. Remove and let it cool to room temperature for later use. Take the leech, first place talcum powder in a stir-frying container, preheat to 150℃, add the leech at a ratio of 40g of talcum powder per 100g of leech, and continuously stir-fry until the surface of the leech is uniformly light yellow. Quickly sift out all the talcum powder. Let the herbs cool to room temperature before use. Take dung beetles and add 10g of rice wine per 100g of dung beetles. Soak them in rice wine, then seal and let stand for 1 hour until the rice wine is completely absorbed by the herbs. Place them in a 160℃ stir-frying equipment and stir-fry until the surface of the herbs is dry and there are no visible signs of moisture. Remove and let cool to room temperature before use. Mix the processed turtle shell, leeches, and dung beetles evenly and put them into a low-temperature ultra-fine pulverizing equipment. Control the temperature of the chamber of the low-temperature ultra-fine pulverizing equipment to -12℃ and keep it sealed throughout the process to avoid contact between the material and the outside air. Start the low-temperature ultra-fine pulverizing equipment and continue pulverizing for 60 minutes to obtain ultra-fine powder with a particle size D90 of 10μm. Seal and store for later use. Figure 1 As shown.

[0038] Enzymatic hydrolysis and decoction extraction: Weigh all the medicinal materials from the diuretic and sedative composition and the liver-soothing and detoxifying basic composition according to the mass ratio, and complete the processing operations separately: Take Astragalus membranaceus, add refined honey at a ratio of 25g of refined honey per 100g of Astragalus membranaceus, mix well, seal and moisten for 1.5h until the refined honey completely penetrates the interior of the medicinal material, place it in a 170℃ stir-frying device and stir-fry until the surface of the medicinal material is deep yellow and not sticky, then let it cool for later use; Take Lepidium apetalum, place it in a 150℃ stir-frying device and stir-fry until the surface of the medicinal material is slightly bulging, then remove and let it cool for later use; Take Lycopus lucidus, spray it with rice wine at a ratio of 10g of rice wine per 100g of Lycopus lucidus and mix well, then seal and let it cool for later use. Soak the herbs in rice wine for 1 hour until fully absorbed, then stir-fry at 160℃ until the surface is slightly dry. Let cool and set aside. Take Bupleurum root, add vinegar at a ratio of 15g vinegar per 100g Bupleurum root and mix well. Soak in a sealed container for 1 hour until fully absorbed, then stir-fry at 170℃ until the surface is slightly dry. Let cool and set aside. Take Salvia miltiorrhiza root, spray with rice wine at a ratio of 10g Salvia miltiorrhiza root and mix well. Soak in a sealed container for 1 hour until fully absorbed, then stir-fry at 160℃ until the surface turns brownish-yellow. Let cool and set aside. Use Hedyotis diffusa that meets medicinal standards. The dried product, Poria cocos, is prepared using powder that has been pulverized through an 80-mesh sieve. No further processing is required; it can be used directly. The diuretic and symptomatic composition is mixed evenly with all the processed medicinal materials from the liver-soothing and detoxifying basic composition. This mixture is then placed in an extraction tank, and purified water (9 times the total mass of the processed medicinal materials) is added. A compound enzyme, a 1:1 mass ratio of cellulase and pectinase, is then added, with the total amount of the compound enzyme being 1.2% of the total mass of the processed medicinal materials. The pH of the extraction system is adjusted to 5.0 with food-grade citric acid, and the temperature inside the extraction tank is maintained at a stable 50°C. The enzyme is then sealed. The mixture was decomposed for 2 hours to fully break down the cellulose and pectin in the cell walls of the medicinal materials. After enzymatic hydrolysis, the temperature was raised to 95℃ and maintained for 30 minutes to completely inactivate the complex enzymes and avoid enzyme residue. After enzyme inactivation, the mixture was decocted for another 1.2 hours. After decoction, the mixture was filtered under pressure through a 200-mesh sieve to remove all the dregs. All the filtrate was collected and transferred to a vacuum concentration tank for concentration under reduced pressure. During the concentration process, samples were taken every 30 minutes and kept at a constant temperature of 60℃. The relative density was measured using a hydrometer until the relative density of the concentrate stabilized at 1.18 at 60℃, yielding a clear extract. This extract was then sealed for later use. Figure 2 As shown.

[0039] Batch mixing and homogenization: The prepared ultrafine powder is added evenly to the clear paste in three batches, with each batch containing 1 / 3 of the ultrafine powder. The mixture is stirred and mixed using a stirring device at a speed of 200 rpm for 10 minutes. Once the previously added ultrafine powder is completely dispersed in the clear paste, with no visible particles or agglomerates, the next batch of ultrafine powder is added. After all the ultrafine powder has been added, the mixture is stirred and homogenized for another 5 minutes to obtain a uniform, lump-free mixed paste. Figure 3 As shown.

[0040] Pelletizing and Drying: Add 35% of refined honey to the mixed paste and stir thoroughly for 15 minutes until the materials are completely blended and have a uniform texture. Feed the mixture into a fully automatic pelleting machine, adjust the pellet output parameters of the equipment, and make pellets with a weight of 7g each. Spread the pellets evenly on the tray of the hot air circulating drying equipment, control the drying temperature to be stable at 40℃, and carry out low-temperature drying. During the drying process, take samples every 2 hours to test the moisture content of the pellets until the moisture content of the pellets is ≤12%. Stop drying, take out the pellets and let them cool naturally to room temperature to obtain the honey pills.

[0041] Finished product testing: The total flavonoid content in the finished honey pills was determined by ultraviolet spectrophotometry, and the result was 12.3 mg / g; the total polysaccharide content in the finished honey pills was determined by the phenol-sulfuric acid method, and the result was 36.8 mg / g; the content of effective components in 10 randomly sampled finished honey pills was determined by high performance liquid chromatography, and the content uniformity RSD was 2.7%; the residue of toxic animal drug components was detected by high performance liquid chromatography, and the hirudin residue met the pharmaceutical standards; the in vitro dissolution rate of effective components was determined by the rotating basket method after 45 min, and the result was 89.2%; the formula in this embodiment is mild, with a balanced proportion of softening and diuretic components, and is suitable for clinical scenarios such as mild cirrhosis with a small amount of ascites and postoperative consolidation and conditioning of early liver cancer.

[0042] Example 2:

[0043] Raw material preparation (by weight):

[0044] Composition for softening hard masses and removing blood stasis: 70 parts;

[0045] Diuretic and symptomatic composition: 90 parts;

[0046] Basic composition for soothing the liver and detoxifying: 80 parts.

[0047] In the softening and stasis-removing composition, the mass ratio of turtle shell, leech, and dung beetle is 3:2:1; in the diuretic and mass-eliminating composition, the mass ratio of astragalus, lepidium seed, and eupatorium is 4:1.8:1.5; and in the liver-soothing and detoxifying basic composition, the mass ratio of bupleurum, salvia miltiorrhiza, oldenlandia diffusa, and poria cocos is 1.5:2:3.5:1.8.

[0048] Preparation method:

[0049] Ultra-fine processing: Weigh the turtle shell, leech, and dung beetle from the softening and blood-activating composition according to the mass ratio, and process them separately: Take the turtle shell, add edible vinegar at a ratio of 20g of edible vinegar per 100g of turtle shell, mix well, seal and let it moisten for 2 hours until the vinegar is completely absorbed by the medicinal material and there is no free vinegar residue. Place it in a 180℃ stir-frying device and stir-fry until the medicinal material is brittle and can be easily crushed by light tapping. Remove and let it cool to room temperature for later use. Take the leech, first place talcum powder in a stir-frying container, preheat to 150℃, add the leech at a ratio of 40g of talcum powder per 100g of leech, and stir-fry continuously until the surface of the leech is uniformly light yellow. Sift out any impurities. Prepare talc powder and let it cool to room temperature for later use. Take dung beetles and add 10g of rice wine per 100g of dung beetles. Soak the dung beetles in a sealed container for 1 hour until the rice wine is completely absorbed by the medicinal material. Place the container in a 160℃ stir-frying equipment and stir-fry until the surface of the medicinal material is dry and there are no visible signs of moisture. Remove the container and let it cool to room temperature for later use. Mix the prepared turtle shell, leeches, and dung beetles evenly and put them into a low-temperature ultra-fine pulverizing equipment. Control the temperature of the chamber of the low-temperature ultra-fine pulverizing equipment to -12℃ and keep it sealed throughout the process. Then start the low-temperature ultra-fine pulverizing equipment and continue pulverizing for 60 minutes to obtain ultra-fine powder with a particle size D90 of 10μm. Seal the container for later use.

[0050] Enzymatic hydrolysis and decoction extraction: Weigh all the medicinal materials from the diuretic and sedative composition and the liver-soothing and detoxifying basic composition according to the mass ratio, and complete the processing operations separately: Take Astragalus membranaceus, add refined honey at a ratio of 25g of refined honey per 100g of Astragalus membranaceus, mix well, seal and moisten for 1.5h until the refined honey completely penetrates the interior of the medicinal material, place it in a 170℃ stir-frying device and stir-fry until the surface of the medicinal material is deep yellow and not sticky, then let it cool for later use; Take Lepidium apetalum, place it in a 150℃ stir-frying device and stir-fry until the surface of the medicinal material is slightly bulging, then remove and let it cool for later use; Take Lycopus lucidus, spray it with rice wine at a ratio of 10g of rice wine per 100g of Lycopus lucidus. Mix well, seal and let it soak for 1 hour until the rice wine is completely absorbed. Then, stir-fry in a 160℃ stir-frying equipment until the surface of the herbs is slightly dry. Let cool and set aside. Take Bupleurum root, add vinegar at a ratio of 15g vinegar per 100g Bupleurum root and mix well. Seal and let it soak for 1 hour until the vinegar is completely absorbed. Then, stir-fry in a 170℃ stir-frying equipment until the surface of the herbs is slightly dry. Let cool and set aside. Take Salvia miltiorrhiza root, spray with rice wine at a ratio of 10g Salvia miltiorrhiza root and mix well. Seal and let it soak for 1 hour until the rice wine is completely absorbed. Then, stir-fry in a 160℃ stir-frying equipment until the surface of the herbs turns brownish-yellow. Let cool and set aside. White flower... Hedyotis diffusa is dried to meet pharmaceutical standards, and Poria cocos is ground into powder that has passed through an 80-mesh sieve. No further processing is required; all processed herbs from the diuretic and symptomatic combination and the liver-soothing and detoxifying basic combination are mixed evenly and placed in an extraction tank. Nine times the total weight of purified water is added, followed by a compound enzyme consisting of cellulase and pectinase in a 1:1 mass ratio, with the total added amount being 1.2% of the total herbal weight. The pH of the extraction system is adjusted to 5.0 with food-grade citric acid, and the temperature inside the extraction tank is maintained at a stable 50°C. Enzymatic hydrolysis was performed for 2 hours to fully decompose the cellulose and pectin in the cell walls of the medicinal materials. After hydrolysis, the temperature was raised to 95°C and maintained for 30 minutes to completely inactivate the complex enzyme. After enzyme inactivation, the decoction was continued for 1.2 hours. After decoction, the mixture was filtered under pressure through a 200-mesh sieve to remove all the dregs and collect all the filtrate. The filtrate was then transferred to a vacuum concentration tank for vacuum concentration. During the concentration process, samples were taken every 30 minutes and kept at a constant temperature of 60°C. The relative density was measured using a hydrometer until the relative density of the concentrate stabilized at 1.18 at 60°C, yielding a clear extract. This extract was then sealed for later use.

[0051] Batch mixing and homogenization: Add the ultrafine powder evenly to the clear paste in 3 batches, adding 1 / 3 of the ultrafine powder each time, and then mix it with a stirring device, controlling the stirring speed at 200 r / min, and continue stirring and homogenizing for 10 min; after the ultrafine powder added in the previous batch is completely dispersed in the clear paste, with no visible particles or agglomerates, add the next batch of ultrafine powder; after all the ultrafine powder has been added, continue stirring and homogenizing for 5 min to obtain a uniform and lump-free mixed paste for later use.

[0052] Pelletizing and Drying: Add 35% of refined honey to the mixed paste and stir thoroughly for 15 minutes until the materials are completely blended and have a uniform texture. Feed the mixture into a fully automatic pelleting machine, adjust the pellet output parameters of the equipment, and make pellets with a weight of 7g each. Spread the pellets evenly on the tray of the hot air circulating drying equipment, control the drying temperature to be stable at 40℃, and carry out low-temperature drying. During the drying process, take samples every 2 hours to test the moisture content of the pellets until the moisture content of the pellets is ≤12%. Stop drying, take out the pellets and let them cool naturally to room temperature to obtain the honey pills.

[0053] Finished product testing: The total flavonoid content in the finished honey pills was determined by ultraviolet spectrophotometry, and the result was 15.7 mg / g; the total polysaccharide content in the finished honey pills was determined by the phenol-sulfuric acid method, and the result was 45.2 mg / g; the content of effective components in 10 randomly sampled finished honey pills was determined by high performance liquid chromatography, and the content uniformity RSD was 3.1%; the residue of toxic animal drug components was detected by high performance liquid chromatography, and the leech residue met the pharmaceutical standards; the in vitro dissolution rate of effective components was determined by the rotating basket method after 45 minutes, and the result was 88.5%; This second example increases the total dosage of the components for softening and removing blood stasis and promoting diuresis and eliminating masses, resulting in a stronger effect of breaking up blood stasis and promoting diuresis, which is suitable for clinical scenarios of moderate to severe cirrhosis with moderate to large amounts of ascites and conservative treatment of early liver cancer.

[0054] Comparative example:

[0055] Raw material preparation (by weight):

[0056] Bupleurum 15 parts, white peony root 12 parts, immature bitter orange 10 parts, atractylodes macrocephala 20 parts, polyporus umbellatus 15 parts, alisma plantago-aquatica 15 parts, and scutellaria barbata 20 parts.

[0057] Preparation method:

[0058] Bupleurum, white peony root, immature bitter orange peel, atractylodes macrocephala, polyporus umbellatus, alisma plantago-aquatica, and scutellaria barbata are mixed evenly and pulverized using a conventional universal pulverizer, passing through an 80-mesh sieve to obtain mixed herbal powder. The mixed herbal powder is put into an extraction tank, and purified water with 10 times the total mass of the herbs is added. The mixture is heated to 100℃ and decocted twice under normal pressure, each time for 1.5 hours. The two decoctions are combined, filtered through a 200-mesh sieve to remove the dregs, and the filtrate is concentrated under normal pressure to a clear extract with a relative density of 1.18 at 60℃. 35% of the total mass of refined honey is added to the clear extract, stirred and mixed evenly, and fed into a pill-making machine to form pills weighing 7g each. The pills are dried at 40℃ until the moisture content is ≤12% to obtain the honey pill product.

[0059] Finished product testing: The total flavonoid content in the finished honey pills was determined by ultraviolet spectrophotometry, and the result was 6.2 mg / g; the total polysaccharide content was determined by the phenol-sulfuric acid method, and the result was 18.7 mg / g; the content of active ingredients in 10 randomly sampled honey pills was determined by high performance liquid chromatography, and the content uniformity RSD was 10.2%; the in vitro dissolution rate of active ingredients was determined by the rotating basket method after 45 minutes, and the result was 52.6%.

[0060] In summary, a comparison of the test results of Examples 1 and 2 with the comparative example shows that Examples 1 and 2 have significant technical advantages. At the formulation level, the modular formulation of the three types of compositions allows for flexible adjustment of the weight proportions of each composition to meet the clinical treatment needs of different disease severity and to satisfy differentiated medication scenarios. At the process level, it can significantly increase the retention of active ingredients in medicinal materials, significantly improve the uniformity of the distribution of effective ingredients in the preparation, and at the same time control the residue of toxic components through the processing technology, ensuring medication safety, improving the dissolution efficiency of effective ingredients, and providing reliable support for the stable efficacy of the drug.

[0061] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer, characterized in that, This formula, by weight, includes: Composition for softening hard masses and removing blood stasis: 20-80 parts; Diuretic and symptomatic composition: 30-100 parts; Basic composition for soothing the liver and detoxifying: 40-120 parts.

2. The traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 1, characterized in that, The softening and blood-activating composition comprises turtle shell, leech, and dung beetle, with a mass ratio of turtle shell, leech, and dung beetle of 2-4:1-3:0.5-2. The turtle shell is mixed with vinegar and left to soak until the vinegar is completely absorbed, then stir-fried until crisp. The leech is stir-fried with preheated talcum powder until the surface is slightly yellow. The dung beetle is soaked in rice wine until the rice wine is completely absorbed, then stir-fried until the surface is dry.

3. The traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 1, characterized in that, The diuretic and symptomatic relief composition comprises Astragalus membranaceus, Lepidium apetalum, and Lycopus lucidus, wherein the mass ratio of Astragalus membranaceus, Lepidium apetalum, and Lycopus lucidus in the composition is 3-5:1-2.5:1-2; the Astragalus membranaceus is mixed with refined honey, moistened, and then stir-fried until it is no longer sticky; the Lepidium apetalum is stir-fried until the surface is slightly puffed up; the Lycopus lucidus is sprayed with rice wine, mixed, moistened, and then stir-fried until the surface is slightly dry.

4. The traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 1, characterized in that, The basic composition for soothing the liver and detoxifying includes Bupleurum, Salvia miltiorrhiza, Hedyotis diffusa, and Poria cocos. The mass ratio of Bupleurum, Salvia miltiorrhiza, Hedyotis diffusa, and Poria cocos in the basic composition for soothing the liver and detoxifying is 1~2:1~3:2~5:1~2.

5. Bupleurum is mixed with vinegar, moistened, and then stir-fried until the surface is slightly dry. After being sprayed and mixed with rice wine, Danshen was left to moisten and then stir-fried until its surface turned brownish-yellow; Baihuasheshecao was made from dried product after drying treatment, and Fuling was made from Fuling powder after pulverization.

5. A method for preparing a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer, wherein the preparation method is applicable to the traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer as described in any one of claims 1-4, characterized in that, The specific steps of this preparation method are as follows: Ultrafine processing: Each medicinal material in the softening and blood-activating composition is processed separately, then mixed together and ultrafinely pulverized to obtain ultrafine powder; Enzymatic hydrolysis and decoction extraction: The medicinal materials in the diuretic and sedative composition and the liver-soothing and detoxifying basic composition are processed separately and then mixed. Water and compound enzyme are added and enzymatic hydrolysis is carried out. After enzymatic hydrolysis, the enzyme is inactivated by heating and decocted. After filtration, the filtrate is concentrated under reduced pressure to obtain a clear extract. Batch mixing and homogenization: The ultrafine powder is added to the clear paste in batches and stirred and homogenized to obtain a mixed paste; Pill making and drying: Add refined honey to the mixed paste, mix evenly, make into pills, and dry at low temperature to obtain the honey pill product.

6. The method for preparing a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 5, characterized in that, In the aforementioned ultrafine processing, turtle shell is mixed with vinegar and allowed to soak until the vinegar is completely absorbed, then stir-fried until crisp and cooled for later use; leeches are mixed with preheated talc powder and stir-fried until the surface is slightly yellow, then the talc powder is sieved out and cooled for later use; dung beetles are soaked in rice wine until the rice wine is completely absorbed, then stir-fried until the surface is dry and cooled for later use, thus completing the processing of each ingredient separately; after being mixed evenly, the mixture is ultrafine pulverized using an ultrafine pulverizing device. The ultrafine pulverization environment temperature is -20~-5℃, and the ultrafine pulverization time is 30~90min. After ultrafine pulverization, ultrafine powder with a particle size D90 of 5~15μm is obtained, and the ultrafine pulverization process is carried out in a low-temperature and sealed environment.

7. The method for preparing a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 5, characterized in that, In the enzymatic hydrolysis and decoction extraction, Astragalus membranaceus is mixed with refined honey, moistened, stir-fried until not sticky, and then cooled. Lepidium apetalum is stir-fried until the surface slightly puffs up and a fragrant aroma is released, then removed and cooled. Lycopus lucidus is sprayed with rice wine, mixed, moistened, stir-fried until the surface is slightly dry, and then cooled. Bupleurum chinense is mixed with vinegar, moistened, stir-fried until the surface is slightly dry, and then cooled. Salvia miltiorrhiza is sprayed with rice wine, mixed, moistened, stir-fried until the surface is brownish-yellow, and then cooled. Hedyotis diffusa is the dried product after drying treatment. Poria cocos is the powdered Poria cocos. All medicinal materials in the diuretic and sedative composition and the liver-soothing and detoxifying basic composition are complete. After processing, mix the ingredients thoroughly, add 6-12 times the total mass of water, then add a compound enzyme, which is a mixture of cellulase and pectinase in a mass ratio of 1:0.5-1:2, at a concentration of 0.5-2% of the total mass of the ingredients. Adjust the pH of the system to 4.0-6.0 and enzymatically hydrolyze the mixture at 40-60℃ for 1-3 hours. After enzymatic hydrolysis, heat the mixture to 90-100℃ to inactivate the enzyme and decoct for 0.5-2 hours. Filter the mixture and concentrate the filtrate under reduced pressure until the relative density at 60℃ is 1.10-1.25 to obtain a clear extract.

8. The method for preparing a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 5, characterized in that, In the batch mixing and homogenization process, the ultrafine powder is added to the paste in 2 to 4 batches. After each addition, the paste is stirred and homogenized at a speed of 100 to 300 r / min for 5 to 15 minutes. After the ultrafine powder added in the previous batch is completely dispersed and evenly distributed, the next batch of ultrafine powder is added. After all the mixture is completed, a uniform and lump-free mixed paste is obtained.

9. The method for preparing a traditional Chinese medicine formula for treating cirrhosis with ascites and early-stage liver cancer according to claim 5, characterized in that, In the pill-making and drying process, 20% to 50% of refined honey by total mass is added to the mixed paste, stirred and mixed evenly, and then fed into a pill-making machine to form pills. The weight of each pill is controlled at 5 to 10g. The pills are then placed in a low-temperature environment of 30 to 50℃ for drying until the moisture content of the pills is ≤12%. Drying is then stopped, and the pills are cooled to room temperature to obtain the honey pill product.

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