A traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and its preparation method

Abstract

This invention relates to a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease (NAFLD) and its preparation method, belonging to the field of traditional Chinese medicine technology. By weight, the traditional Chinese medicine composition for treating NAFLD comprises the following components: 45-55 parts of *Smilax china*, 20-35 parts of mole cricket, 10-20 parts of *Eclipta prostrata*, 15-24 parts of *Plantago asiatica*, 5-12 parts of *Dioscorea opposita*, and 3-8 parts of licorice. The traditional Chinese medicine composition provided by this invention uses *Smilax china* as the principal herb, mole cricket as the assistant herb, *Eclipta prostrata* and *Plantago asiatica* as adjuvant herbs, and *Dioscorea opposita* and licorice as guiding herbs. Through multiple mechanisms of action, including clearing heat and dampness, detoxifying, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression, it comprehensively treats various pathogenesis mechanisms of NAFLD. Under the principle of principal, assistant, adjuvant, and guiding herbs, the various drugs cooperate to exert the best therapeutic effect, providing a new traditional Chinese medicine treatment plan for NAFLD patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and its preparation method. Background Technology

[0002] Nonalcoholic fatty liver disease (NAFLD), an increasingly serious chronic liver disease in contemporary society, has become a major challenge in the global public health field. NAFLD refers to a pathological state caused by excessive fat accumulation in liver cells without a history of excessive alcohol consumption. It has a long course and complex symptoms, often accompanied by abnormal liver function, dyslipidemia, and other complications, severely impacting patients' health and quality of life. Currently, modern medicine primarily employs a comprehensive approach to treat NAFLD, including drug intervention, dietary adjustments, and lifestyle modifications. However, these drugs often have significant side effects, unstable efficacy, and a heavy economic burden due to long-term treatment. Therefore, finding a safe, effective, and economical treatment method for NAFLD is of significant practical importance.

[0003] The stem of *Acanthopanax quinquefolia*, a plant in the family Clematis chinensis, is mainly used clinically to treat rheumatic pain, back pain, stomach pain, and injuries from falls and blows.

[0004] Mole crickets are the dried whole insects of the mole cricket family. Clinically, they are used to treat urinary tract stones, edema, ascites due to cirrhosis, chronic nephritis, and uremia.

[0005] Small-leaved lotus is the dried, mature fruit of the Berberidaceae plant *Prunella vulgaris*. Clinically, it is used to treat conditions such as amenorrhea due to blood stasis, dystocia, stillbirth, and placental retention.

[0006] Plantain is the dried or fresh whole herb of Plantago asiatica or Plantago asiatica var. chinensis, belonging to the Plantaginaceae family. Clinically, it is used to treat ailments such as heat accumulation in the bladder, difficulty urinating, urinary tract infections, leukorrhea, summer heat diarrhea, epistaxis, hematuria, liver heat causing red eyes, sore throat, carbuncles, and boils.

[0007] Dioscorea bulbifera is the tuber of the plant Dioscorea bulbifera in the Dioscoreaceae family. Clinically, it is mainly used to treat various hemorrhagic diseases such as respiratory bleeding, nosebleeds, gastrointestinal bleeding, and urinary tract bleeding.

[0008] Licorice is the dried root and rhizome of Glycyrrhiza uralensis, Glycyrrhiza inflata, or Glycyrrhiza glabra, all belonging to the legume family. Clinically, it is used to treat symptoms such as spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, and abdominal and limb cramps and pain.

[0009] Traditional Chinese medicine (TCM), a treasure of my country's traditional medicine, possesses a unique theoretical foundation and rich practical experience. In recent years, increasing research has demonstrated the significant advantages of TCM in treating NAFLD. TCM combinations can be tailored to each patient's specific condition and constitution, achieving therapeutic effects such as soothing the liver and spleen, promoting digestion and removing blood stasis, and lowering lipids and clearing turbidity. Furthermore, TCM combinations offer advantages such as fewer side effects, high safety, and stable efficacy, providing patients with more treatment options. However, current technology has not reported the combined application of the aforementioned herbs—including *Aristolochia debilis*, *Corydalis yanhusuo*, *Lysimachia foenum-graecum*, *Plantago asiatica*, *Dioscorea opposita*, and licorice—in the treatment of non-alcoholic fatty liver disease. Summary of the Invention

[0010] To address the above problems, this invention provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and its preparation method.

[0011] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, wherein the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components in parts by weight:

[0012] 45-55 parts of *Impatiens balsamina*, 20-35 parts of mole cricket, 10-20 parts of *Echeveria elegans*, 15-24 parts of *Plantago asiatica*, 5-12 parts of *Dioscorea opposita*, and 3-8 parts of licorice.

[0013] Furthermore, the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components in parts by weight:

[0014] 50 parts of Shield Wing Vine, 30.5 parts of Mole Cricket, 14 parts of Small-leaved Lotus, 19 parts of Plantain, 8 parts of Dioscorea opposita, and 5 parts of Licorice.

[0015] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease as described in any one of the first aspects, the preparation method comprising the following steps:

[0016] The first reflux extraction was performed by adding Shield Winged Vine into water to obtain Shield Winged Vine extract;

[0017] Mole crickets were subjected to supercritical extraction to obtain mole cricket extract;

[0018] The small-leaved lotus, plantain, yam and licorice were added to ethanol for a second reflux extraction to obtain a mixed extract;

[0019] The extracts of *Aristolochia debilis*, *Mole Cricket*, and the mixed extracts were pulverized, mixed, and sieved to obtain the traditional Chinese medicine composition.

[0020] Furthermore, the working conditions parameters for the first reflux extraction include: a temperature of 53–57°C, a pressure of 8–12 kPa, an extraction time of 1–3 hours, an extraction frequency of 1–3 times, and the weight of water added being 5–10 times the weight of the *Pteris vittata*.

[0021] Furthermore, the temperature of the first reflux extraction is 55°C, and the pressure of the first reflux extraction is 10 kPa.

[0022] Furthermore, the operating conditions for the supercritical extraction include: the extraction medium is supercritical carbon dioxide fluid, the pressure is 42–48 MPa, the temperature is 48–60 °C, and the time is 1–2 hours.

[0023] Furthermore, the working conditions parameters for the second reflux extraction include: a temperature of 85–95°C, an extraction time of 1–3 hours, an extraction frequency of 1–3 times, and the weight of ethanol added being 5–10 times the total weight of the four herbs: *Erigeron simsii*, *Plantago asiatica*, *Dioscorea opposita*, and *Glycyrrhiza uralensis*.

[0024] Furthermore, the ethanol is 95% ethanol by volume fraction.

[0025] The technical solutions provided in the embodiments of the present invention have at least the following advantages compared with the prior art:

[0026] This invention provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease (NAFLD). The composition uses *Aristolochia debilis* as the principal herb, *Mole cricket* as the assistant herb, *Eclipta prostrata* and *Plantago asiatica* as adjuvant herbs, and *Dioscorea opposita* and *Glycyrrhiza uralensis* as guiding herbs. Through multiple mechanisms of action, including clearing heat and dampness, detoxifying, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression, it comprehensively treats various pathogenesis-related aspects of NAFLD. Following the principle of principal, assistant, adjuvant, and guiding herbs, the various herbs work synergistically to achieve the best therapeutic effect, providing a new traditional Chinese medicine treatment option for NAFLD patients. Specifically:

[0027] The principal herb, *Tetrapanax papyriferus*, can clear heat and promote diuresis, effectively removing damp-heat pathogens from the liver, reducing liver inflammation, and helping to improve liver metabolic function, thereby alleviating the pathological changes of fatty liver. As the principal herb, *Tetrapanax papyriferus* plays a dominant role in the formula, targeting the core pathogenesis of NAFLD—damp-heat accumulation—and exerting its main therapeutic effects of clearing heat, promoting diuresis, and detoxifying.

[0028] Assistant herb: Mole cricket has the effects of promoting blood circulation, removing blood stasis, softening and dispersing nodules. It can improve liver blood circulation, accelerate the metabolism and excretion of fat in the liver, reduce lipid deposition in the liver, and thus alleviate the degree of fatty liver. As an assistant herb, mole cricket assists the principal herb, *Smilax china*, to further enhance the therapeutic effect of NAFLD.

[0029] Adjunctive herbs: *Euphorbia milii* and *Plantago asiatica*. *Euphorbia milii* has the effects of soothing the liver and relieving depression, clearing heat and promoting diuresis. Working synergistically with *Aristolochia debilis*, it can more comprehensively clear damp-heat from the liver and reduce liver inflammation. *Plantago asiatica* has diuretic and swelling-reducing effects, helping to eliminate excess water and toxins from the body, reducing the burden on the liver, and further promoting the recovery of NAFLD. *Euphorbia milii* and *Plantago asiatica*, as adjunctive herbs, assist the principal and assistant herbs in exerting their therapeutic effects, while also treating concurrent symptoms or symptoms of NAFLD.

[0030] The guiding herbs are: Dioscorea bulbifera and licorice. Dioscorea bulbifera can invigorate the spleen and replenish qi, enhance the digestive and metabolic functions of the spleen and stomach, and provide a favorable internal environment for liver recovery. Licorice has the effect of harmonizing various herbs and detoxifying, which can alleviate drug interactions and reduce potential drug damage to the liver. At the same time, its anti-inflammatory effect also helps to reduce the inflammatory response of the liver. As guiding herbs, Dioscorea bulbifera and licorice play a role in harmonizing various herbs and enhancing their efficacy in the prescription.

[0031] In summary, the traditional Chinese medicine composition provided by this invention utilizes multiple mechanisms of action, including clearing heat and dampness, detoxifying, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression, to comprehensively treat various pathogenesis mechanisms of NAFLD. Following the principle of monarch-minister-assistant-guide drug compatibility, the various drugs work synergistically to achieve the best therapeutic effect, providing an effective traditional Chinese medicine treatment plan for NAFLD patients. Attached Figure Description

[0032] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0033] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0034] Figure 1 This is a schematic flowchart illustrating the preparation method of the traditional Chinese medicine composition for treating non-alcoholic fatty liver provided in an embodiment of the present invention. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] Unless otherwise specified, all raw materials, reagents, instruments and equipment used in this invention can be purchased from the market or prepared by existing methods.

[0037] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, wherein the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components in parts by weight:

[0038] 45-55 parts of *Impatiens balsamina*, 20-35 parts of mole cricket, 10-20 parts of *Echeveria elegans*, 15-24 parts of *Plantago asiatica*, 5-12 parts of *Dioscorea opposita*, and 3-8 parts of licorice.

[0039] This invention provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease (NAFLD). The composition uses *Aristolochia debilis* as the principal herb, *Mole cricket* as the assistant herb, *Eclipta prostrata* and *Plantago asiatica* as adjuvant herbs, and *Dioscorea opposita* and *Glycyrrhiza uralensis* as guiding herbs. Through multiple mechanisms of action, including clearing heat and dampness, detoxifying, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression, it comprehensively treats various pathogenesis-related aspects of NAFLD. Following the principle of principal, assistant, adjuvant, and guiding herbs, the various herbs work synergistically to achieve the best therapeutic effect, providing a new traditional Chinese medicine treatment option for NAFLD patients. Specifically:

[0040] The principal herb, *Tetrapanax papyriferus*, can clear heat and promote diuresis, effectively removing damp-heat pathogens from the liver, reducing liver inflammation, and helping to improve liver metabolic function, thereby alleviating the pathological changes of fatty liver. As the principal herb, *Tetrapanax papyriferus* plays a dominant role in the formula, targeting the core pathogenesis of NAFLD—damp-heat accumulation—and exerting its main therapeutic effects of clearing heat, promoting diuresis, and detoxifying.

[0041] Assistant herb: Mole cricket has the effects of promoting blood circulation, removing blood stasis, softening and dispersing nodules. It can improve liver blood circulation, accelerate the metabolism and excretion of fat in the liver, reduce lipid deposition in the liver, and thus alleviate the degree of fatty liver. As an assistant herb, mole cricket assists the principal herb, *Smilax china*, to further enhance the therapeutic effect of NAFLD.

[0042] Adjunctive herbs: *Euphorbia milii* and *Plantago asiatica*. *Euphorbia milii* has the effects of soothing the liver and relieving depression, clearing heat and promoting diuresis. Working synergistically with *Aristolochia debilis*, it can more comprehensively clear damp-heat from the liver and reduce liver inflammation. *Plantago asiatica* has diuretic and swelling-reducing effects, helping to eliminate excess water and toxins from the body, reducing the burden on the liver, and further promoting the recovery of NAFLD. *Euphorbia milii* and *Plantago asiatica*, as adjunctive herbs, assist the principal and assistant herbs in exerting their therapeutic effects, while also treating concurrent symptoms or symptoms of NAFLD.

[0043] The guiding herbs are: Dioscorea bulbifera and licorice. Dioscorea bulbifera can invigorate the spleen and replenish qi, enhance the digestive and metabolic functions of the spleen and stomach, and provide a favorable internal environment for liver recovery. Licorice has the effect of harmonizing various herbs and detoxifying, which can alleviate drug interactions and reduce potential drug damage to the liver. At the same time, its anti-inflammatory effect also helps to reduce the inflammatory response of the liver. As guiding herbs, Dioscorea bulbifera and licorice play a role in harmonizing various herbs and enhancing their efficacy in the prescription.

[0044] In summary, the traditional Chinese medicine composition provided by this invention utilizes multiple mechanisms of action, including clearing heat and dampness, detoxifying, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression, to comprehensively treat various pathogenesis mechanisms of NAFLD. Following the principle of monarch-minister-assistant-guide drug compatibility, the various drugs work synergistically to achieve the best therapeutic effect, providing an effective traditional Chinese medicine treatment plan for NAFLD patients.

[0045] In some specific embodiments, the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components in parts by weight:

[0046] 50 parts of Shield Wing Vine, 30.5 parts of Mole Cricket, 14 parts of Small-leaved Lotus, 19 parts of Plantain, 8 parts of Dioscorea opposita, and 5 parts of Licorice.

[0047] Preferably, through dosage screening experiments, it was found that the traditional Chinese medicine composition of the present invention with the above-mentioned proportions has a better therapeutic effect on non-alcoholic fatty liver disease.

[0048] Secondly, the present invention provides a method for preparing the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease as described in any of the first aspects, such as... Figure 1 As shown, the preparation method includes the following steps:

[0049] The first reflux extraction was performed by adding Shield Winged Vine into water to obtain Shield Winged Vine extract;

[0050] Mole crickets were subjected to supercritical extraction to obtain mole cricket extract;

[0051] The small-leaved lotus, plantain, yam and licorice were added to ethanol for a second reflux extraction to obtain a mixed extract;

[0052] The extracts of *Aristolochia debilis*, *Mole Cricket*, and the mixed extracts were pulverized, mixed, and sieved to obtain the traditional Chinese medicine composition.

[0053] The method for preparing the traditional Chinese medicine composition provided by this invention is simple, requires no additional specific equipment, and is suitable for industrial-scale mass production. Furthermore, this preparation method is based on the traditional Chinese medicine composition described in any one of the first aspects, and therefore possesses at least the beneficial effects of any one of the solutions in the first aspect; these will not be repeated in this invention document.

[0054] In some specific embodiments, the working conditions parameters of the first reflux extraction include: temperature of 53-57°C, pressure of 8-12 kPa, extraction time of 1-3 hours, extraction times of 1-3 times, and the weight of water added is 5-10 times the weight of the *Pteris vittata*.

[0055] This invention has found that the reflux extraction parameters of *Peony Root* are crucial to the efficacy of the extracted product. The *Peony Root* extract obtained by vacuum distillation extraction using the aforementioned suitable temperature and pressure exhibits better therapeutic effects on non-alcoholic fatty liver disease. More preferably, the temperature of the first reflux extraction is 55°C, and the pressure of the first reflux extraction is 10 kPa.

[0056] In some specific embodiments, the operating conditions of the supercritical extraction include: the extraction medium is supercritical carbon dioxide fluid, the pressure is 42-48 MPa, the temperature is 48-60°C, and the time is 1-2 hours.

[0057] In some specific embodiments, the working conditions parameters for the second reflux extraction include: a temperature of 85-95°C, an extraction time of 1-3 hours, an extraction number of 1-3 times, and the weight of ethanol added being 5-10 times the total weight of the four herbs: *Euphorbia hirta*, *Plantago asiatica*, *Dioscorea opposita*, and *Glycyrrhiza uralensis*.

[0058] In some specific embodiments, the ethanol is 95% ethanol by volume fraction.

[0059] It should be noted that, unless otherwise specified or limited, the raw materials used in the traditional Chinese medicine composition for treating non-alcoholic fatty liver and its preparation method provided in the embodiments of the present invention can all be commercially available products; at the same time, unless otherwise specified or limited, the process steps and parameters involved can all be carried out in accordance with existing traditional Chinese medicine composition preparation processes or using existing equipment in a conventional operating manner.

[0060] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed according to national standards. If no corresponding national standard exists, then generally accepted international standards, conventional conditions, or conditions recommended by the manufacturer are followed.

[0061] Example 1

[0062] This example provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease. By weight, the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components:

[0063] 50 parts of Shield Wing Vine, 30.5 parts of Mole Cricket, 14 parts of Small-leaved Lotus, 19 parts of Plantain, 8 parts of Dioscorea opposita, and 5 parts of Licorice.

[0064] The preparation method of the above-mentioned traditional Chinese medicine composition for treating non-alcoholic fatty liver includes the following steps:

[0065] Step (1): Add the shield-wing vine to water and perform a first reflux extraction at 55°C and 10KPa pressure for 2 hours. The weight of the water added is 8 times the weight of the shield-wing vine. The extraction is performed twice. Filter to obtain the first reflux extract. Combine the first reflux extracts and concentrate and dry under reduced pressure to constant weight to obtain shield-wing vine extract.

[0066] Step (2): The mole crickets were ground and passed through a 100-mesh sieve and then added to a supercritical device for supercritical extraction. The extraction medium was supercritical carbon dioxide fluid with a flow rate of 15 kg / h, an extraction pressure of 45 MPa, a temperature of 52°C, and a time of 1.5 hours. The resulting extract was kept at 5°C for 2 hours and then centrifuged at 6000 r / min for 20 minutes to remove the bottom precipitate. The supernatant was then vacuumed in a vacuum chamber at 45°C for 12 hours to obtain the mole cricket extract.

[0067] Step (3): Add *Echeveria elegans*, *Plantago asiatica*, *Dioscorea opposita* and licorice to 95% ethanol. The weight of the added ethanol is 8 times the total weight of the four ingredients. Then, perform a second reflux extraction at 90°C for 2 hours. The extraction is performed twice. Filter to obtain the second reflux extract. Combine the obtained second reflux extracts and concentrate under reduced pressure and dry to constant weight to obtain a mixed extract.

[0068] Step (4): The extract of *Aristolochia debilis* obtained in step (1), the extract of mole cricket obtained in step (2), and the mixed extract obtained in step (3) are pulverized, mixed, and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition.

[0069] Example 2

[0070] This example provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease. By weight, the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components:

[0071] 45 parts of Shield Wing Vine, 20 parts of Mole Cricket, 10 parts of Small-leaved Lotus, 15 parts of Plantain, 5 parts of Dioscorea opposita, and 3 parts of Licorice.

[0072] The preparation method of the above-mentioned traditional Chinese medicine composition for treating non-alcoholic fatty liver includes the following steps:

[0073] Step (1): Add the shield-wing vine to water and perform a first reflux extraction at 53°C and 8KPa pressure for 2 hours. The weight of the water added is 8 times the weight of the shield-wing vine. The extraction is performed twice. Filter to obtain the first reflux extract. Combine the first reflux extracts and concentrate and dry under reduced pressure to constant weight to obtain shield-wing vine extract.

[0074] Step (2): Grind the mole crickets and pass them through a 100-mesh sieve. Then, add them to a supercritical device for supercritical extraction. The extraction medium is supercritical carbon dioxide fluid. The flow rate of the supercritical carbon dioxide fluid is 15 kg / h, the extraction pressure is 42 MPa, the temperature is 48°C, and the time is 1.5 hours. The obtained extract is kept at 5°C for 2 hours. Then, it is centrifuged at 6000 r / min for 20 minutes to remove the bottom precipitate. The supernatant is vacuumed in a vacuum box at 45°C for 12 hours to obtain the mole cricket extract.

[0075] Step (3): Add *Echeveria elegans*, *Plantago asiatica*, *Dioscorea opposita* and licorice to 95% ethanol. The weight of the added ethanol is 8 times the total weight of the four ingredients. Then, perform a second reflux extraction at 90°C for 2 hours. The extraction is performed twice. Filter to obtain the second reflux extract. Combine the obtained second reflux extracts and concentrate under reduced pressure and dry to constant weight to obtain a mixed extract.

[0076] Step (4): The extract of *Aristolochia debilis* obtained in step (1), the extract of mole cricket obtained in step (2), and the mixed extract obtained in step (3) are pulverized, mixed, and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition.

[0077] Example 3

[0078] This example provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease. By weight, the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease comprises the following components:

[0079] 55 parts of Shield Wing Vine, 35 parts of Mole Cricket, 20 parts of Small-leaved Lotus, 24 parts of Plantain, 12 parts of Dioscorea bulbifera, and 8 parts of Licorice.

[0080] The preparation method of the above-mentioned traditional Chinese medicine composition for treating non-alcoholic fatty liver includes the following steps:

[0081] Step (1): Add the shield-wing vine to water and perform a first reflux extraction at 57°C and 12KPa pressure for 2 hours. The weight of the water added is 8 times the weight of the shield-wing vine. The extraction is performed twice. Filter to obtain the first reflux extract. Combine the first reflux extracts and concentrate and dry under reduced pressure to constant weight to obtain shield-wing vine extract.

[0082] Step (2): Grind the mole crickets and pass them through a 100-mesh sieve. Then, add them to a supercritical device for supercritical extraction. The extraction medium is supercritical carbon dioxide fluid. The flow rate of the supercritical carbon dioxide fluid is 15 kg / h, the extraction pressure is 48 MPa, the temperature is 60℃, and the time is 1.5 hours. The obtained extract is kept at 5℃ for 2 hours. Then, it is centrifuged at 6000 r / min for 20 min to remove the bottom precipitate. The supernatant is vacuumed in a vacuum box at 45℃ for 12 hours to obtain the mole cricket extract.

[0083] Step (3): Add *Echeveria elegans*, *Plantago asiatica*, *Dioscorea opposita* and licorice to 95% ethanol. The weight of the added ethanol is 8 times the total weight of the four ingredients. Then, perform a second reflux extraction at 90°C for 2 hours. The extraction is performed twice. Filter to obtain the second reflux extract. Combine the obtained second reflux extracts and concentrate under reduced pressure and dry to constant weight to obtain a mixed extract.

[0084] Step (4): The extract of *Aristolochia debilis* obtained in step (1), the extract of mole cricket obtained in step (2), and the mixed extract obtained in step (3) are pulverized, mixed, and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition.

[0085] Comparative Example 1

[0086] This example provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver and its preparation method. The only difference from Example 1 is that the temperature of the first reflux extraction in step (1) is 85°C and the pressure of the first reflux extraction is 51 kPa (i.e., changing the reflux extraction parameters of *Aristolochia debilis*); the other steps and parameters are the same.

[0087] The preparation method of the above-mentioned traditional Chinese medicine composition for treating non-alcoholic fatty liver includes the following steps:

[0088] Step (1): Add the shield-wing vine to water and perform a first reflux extraction at 85℃ and 51KPa pressure for 2 hours. The weight of the water added is 8 times the weight of the shield-wing vine. The extraction is performed twice. Filter to obtain the first reflux extract. Combine the obtained first reflux extracts and concentrate and dry under reduced pressure to constant weight to obtain shield-wing vine extract.

[0089] Step (2): The mole crickets were ground and passed through a 100-mesh sieve and then added to a supercritical device for supercritical extraction. The extraction medium was supercritical carbon dioxide fluid with a flow rate of 15 kg / h, an extraction pressure of 45 MPa, a temperature of 52°C, and a time of 1.5 hours. The resulting extract was kept at 5°C for 2 hours and then centrifuged at 6000 r / min for 20 minutes to remove the bottom precipitate. The supernatant was then vacuumed in a vacuum chamber at 45°C for 12 hours to obtain the mole cricket extract.

[0090] Step (3): Add *Echeveria elegans*, *Plantago asiatica*, *Dioscorea opposita* and licorice to 95% ethanol. The weight of the added ethanol is 8 times the total weight of the four ingredients. Then, perform a second reflux extraction at 90°C for 2 hours. The extraction is performed twice. Filter to obtain the second reflux extract. Combine the obtained second reflux extracts and concentrate under reduced pressure and dry to constant weight to obtain a mixed extract.

[0091] Step (4): The extract of *Aristolochia debilis* obtained in step (1), the extract of mole cricket obtained in step (2), and the mixed extract obtained in step (3) are pulverized, mixed, and passed through a 200-mesh sieve to obtain the traditional Chinese medicine composition.

[0092] Comparative Example 2

[0093] This example provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and its preparation method. The only difference from Example 1 is that, by weight, the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease includes the following components: 30.5 parts of *Aristolochia debilis*, 50 parts of *Mole cricket*, 14 parts of *Eclipta prostrata*, 19 parts of *Plantago asiatica*, 8 parts of *Dioscorea opposita*, and 5 parts of licorice (i.e., the compatibility and dosage relationship in the traditional Chinese medicine composition is changed); the remaining steps and parameters are the same.

[0094] The preparation method of the above-mentioned traditional Chinese medicine composition for treating non-alcoholic fatty liver is the same as that in Example 1.

[0095] Test case

[0096] This example demonstrates the in vivo animal experiment testing the therapeutic effects of the traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-2 on non-alcoholic fatty liver disease.

[0097] Test Methods: Eighty healthy male SD rats, weighing 180-200g, were randomly divided into eight groups: one normal control group, one model control group, one positive control group, and five drug-treated experimental groups, with ten rats in each group. The normal control group was fed a standard basal diet without modeling and received an equal amount of physiological saline daily without medication. The model control group was fed a high-fat diet (formula: 10% lard, 7% sucrose, 5% casein, 5% fishmeal, 2% maltodextrin, 0.1% methionine, with the remainder being the basal diet) to establish a non-alcoholic fatty liver disease model; no medication was administered, and an equal amount of physiological saline was given daily. The positive control group was fed a high-fat diet (same as above) to establish a non-alcoholic fatty liver disease model. Drug administration began in week 7 of the experimental modeling period, with diammonium glycyrrhizate 75mg / kg administered at a volume of 10ml / kg once daily. In the experimental group, a non-alcoholic fatty liver disease (NAFLD) animal model was established by feeding rats a high-fat diet (as above). Starting from week 7 of modeling, rats were administered an aqueous solution of the traditional Chinese medicine composition provided in the examples and comparative examples at a concentration of 6.5 g crude drug / kg via gavage once daily. The administration continued for 6 weeks, with rats weighed weekly and dosage adjusted according to weight changes. After the administration period, the animals were fasted for 12 hours and weighed. Rats in each group were anesthetized with 10% chloral hydrate (3 ml / kg), and blood was collected from the abdominal aorta. The blood was centrifuged at 3000 rpm for 10 min, and the serum was separated, aliquoted, and stored at -20℃. Serum ALT (alanine aminotransferase) and TG (triglycerides) levels were detected using an automated biochemical analyzer. Experimental data were processed and analyzed using statistical software. Statistically significant results are expressed as mean ± standard deviation, as shown in Tables 1 and 2.

[0098] Table 1

[0099]

[0100]

[0101] Table 2

[0102] Test group TG (mmol / L) normal control group 0.75±0.29 Model control group 2.03±0.50 Positive control group 1.57±0.38 Example 1: Drug administration experimental group 1.04±0.27 Example 2: Drug administration experimental group 1.51±0.35 Example 3: Drug administration experimental group 1.39±0.32 Comparative Example 1 Dosing Experiment Group 1.72±0.41 Comparative Example 2 Dosing Experiment Group 1.88±0.46

[0103] As shown in Tables 1 and 2, compared with Comparative Examples 1-2, the traditional Chinese medicine compositions obtained in Examples 1-3 of this invention have more significant effects on liver damage repair and blood lipid reduction in rats with non-alcoholic fatty liver disease. Among them, the traditional Chinese medicine composition provided in Example 1 has the best effect and is slightly better than the positive control group in the treatment of rats with non-alcoholic fatty liver disease.

[0104] In summary, this invention provides a traditional Chinese medicine composition for treating non-alcoholic fatty liver disease (NAFLD) and its preparation method. This invention utilizes *Aristolochia debilis* as the principal ingredient, *Lysimachia foenum-graecum* as the assistant ingredient, *Eclipta prostrata* and *Plantago asiatica* as adjuvant ingredients, and *Dioscorea opposita* and *Glycyrrhiza uralensis* as guiding ingredients. Through multiple mechanisms of action, including clearing heat and dampness, detoxifying, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression, it comprehensively treats various pathogenesis-related aspects of NAFLD. Following the principle of principal, assistant, adjuvant, and guiding ingredients, the various drugs work synergistically to achieve the best therapeutic effect, providing a new traditional Chinese medicine treatment option for NAFLD patients.

[0105] Various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of the invention; therefore, it should be considered that the range description has specifically disclosed all possible subranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the range referred to.

[0106] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for treating non-alcoholic fatty liver disease, characterized in that, The traditional Chinese medicine composition for treating non-alcoholic fatty liver disease is made from the following components in parts by weight: 45-55 parts of Shield Wing Vine, 20-35 parts of Mole Cricket, 10-20 parts of Small-leaved Lotus, 15-24 parts of Plantain, 5-12 parts of Dioscorea opposita, and 3-8 parts of Licorice; The preparation method of the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease includes the following steps: The first reflux extraction was performed by adding Shield Winged Vine into water to obtain Shield Winged Vine extract; Mole crickets were subjected to supercritical extraction to obtain mole cricket extract; The small-leaved lotus, plantain, yam and licorice were added to ethanol for a second reflux extraction to obtain a mixed extract; The extracts of *Aristolochia debilis*, *Mole Cricket*, and the mixed extracts were pulverized, mixed, and sieved to obtain the traditional Chinese medicine composition. The working conditions for the first reflux extraction include: a temperature of 53-57°C, a pressure of 8-12 kPa, an extraction time of 1-3 hours, an extraction frequency of 1-3 times, and the weight of water added being 5-10 times the weight of the *Pteris vittata*.

2. The traditional Chinese medicine composition for treating non-alcoholic fatty liver disease according to claim 1, characterized in that, The traditional Chinese medicine composition for treating non-alcoholic fatty liver disease is made from the following components in parts by weight: 50 parts of Shield Wing Vine, 30.5 parts of Mole Cricket, 14 parts of Small-leaved Lotus, 19 parts of Plantain, 8 parts of Dioscorea opposita, and 5 parts of Licorice.

3. The method for preparing the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease according to claim 1, characterized in that, The temperature of the first reflux extraction is 55°C, and the pressure of the first reflux extraction is 10 kPa.

4. The method for preparing the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease according to claim 1, characterized in that, The operating conditions for supercritical extraction include: the extraction medium is supercritical carbon dioxide fluid, the pressure is 42~48 MPa, the temperature is 48~60℃, and the time is 1~2 hours.

5. The method for preparing the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease according to claim 1, characterized in that, The working conditions for the second reflux extraction include: a temperature of 85-95℃, an extraction time of 1-3 hours, an extraction frequency of 1-3 times, and the weight of ethanol added being 5-10 times the total weight of the four herbs: *Erigeron simsii*, *Plantago asiatica*, *Dioscorea opposita*, and licorice.

6. The method for preparing the traditional Chinese medicine composition for treating non-alcoholic fatty liver disease according to claim 1, characterized in that, The ethanol is 95% ethanol by volume fraction.

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