A composition of xingwen, purgation of turbidity and fat elimination for treating MAFLD of phlegm turbidity obstruction

Abstract

The application belongs to the field of traditional Chinese medicine compositions, and relates to a pungent-warm purgative and fat-dissolving composition for treating phlegm turbidity resistance syndrome MAFLD, which is composed of the following raw materials in parts by weight: Ficus pumila var. Lashioensis 20-30 parts, Morinda officinalis 8-15 parts, Rosa rugosa 10-20 parts, Preknow 10-15 parts, Allium bakeri 5-10 parts, Disporum 20-30 parts, Polyporus 15-20 parts, Pteridium aquilinum 15-20 parts, and Sedum lineare 10-15 parts. The application is based on the pathogenesis characteristics of'spleen and kidney qi dysbolism and phlegm turbidity accumulation in liver', and is guided by the theory of viscera qi, and the treatment method of 'warm yang and transport, dry dampness and phlegm, and ascending clear and descending turbid' is established. The composition has good treatment effect (the total effective rate reaches 97.67%), and is not easy to relapse after treatment. In addition, the overall drug cost of the composition is low, which can significantly reduce the economic pressure of long-term medication of patients while ensuring the treatment effect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine compositions, and more specifically, relates to a pungent and warm purgative and lipid-reducing composition for treating MAFLD syndrome with phlegm-dampness obstruction. Background Technology

[0002] Metabolic dysfunction-associated fatty liver disease (MAFLD) refers to a metabolic disease characterized by diffuse macrovesicular steatosis of hepatocytes, caused by multiple factors excluding excessive alcohol consumption. In its early stages, hepatocytes undergo fatty degeneration, followed by hepatocyte swelling and eventually liver fibrosis. MAFLD can lead to cirrhosis, liver cancer, and various extrahepatic complications such as cardiovascular disease, type 2 diabetes, and chronic kidney disease. Cardiovascular disease, extrahepatic malignancies, and hepatocellular carcinoma are the leading causes of death in MAFLD patients. Currently, modern medicine lacks specific drugs for MAFLD. In contrast, Traditional Chinese Medicine (TCM) emphasizes holistic assessment and syndrome differentiation, offering unique advantages and promising prospects in treating MAFLD. Furthermore, it offers personalized, multi-pathway, and multi-target treatment options, aligning well with the treatment needs of MAFLD.

[0003] Metabolic fatty liver disease (MAFLD) is a Western medical term. Traditional Chinese medicine lacks a systematic overview and a corresponding name for it, but it does record many symptoms similar to MAFLD. The earliest mention appears in the *Nan Jing* (Classic of Difficult Issues), Chapter 56: "The accumulation in the liver is called fatty qi," indicating a strong correlation between diet and MAFLD. MAFLD is primarily characterized by distension and dull pain in the hypochondrium and abdomen, fatigue, poor appetite, abdominal distension, and obesity. Based on these symptoms and signs, physicians throughout history have categorized the disease under various classifications, including "liver lumps," "liver obstruction," "fatty qi," "accumulation syndrome," "hypochondriac pain," and "epigastric fullness." In 2023, an expert consensus defined MAFLD as "liver lumps," a name that remains in use today. The term "lumps" specifically refers to "accumulations hidden between the hypochondrium," which closely matches the fatty deposits in the liver, hepatomegaly, and increased echogenicity observed on ultrasound in MAFLD.

[0004] The *Suwen* (Plain Questions) chapter 20, "Discussion on the Differentiation of Meridians," states: "When food and drink enter the stomach, their essence and qi circulate and are transported upwards to the spleen. The spleen disperses this essence, which ascends to the lungs, regulates the water passages, and descends to the bladder. The water essence is distributed throughout the body, flowing through the five meridians." The qi transformation of the internal organs participates in the metabolism of food essence and body fluids. When the body's qi transformation function is imbalanced, it can cause dysfunction of the internal organs, leading to disease. The *Suwen* chapter "Discussion on Pain" states: "All diseases arise from qi." Various reasons can cause dysfunction in the qi transformation of the internal organs, preventing food and drink from being transformed into essential substances. Instead, they transform into dampness, phlegm, turbidity, and other yin evils and turbid qi that remain in the body, giving rise to various diseases. The *Leijing* (Classified Canon) states: "Qi transformation is the qi in the kidneys, the fire within yin," clearly defining the role of kidney qi transformation. If the spleen and kidneys are deficient, and the qi transformation function is disordered, the essence of food and drink cannot be properly transported and transformed, instead producing phlegm and turbidity, which stagnate in the liver, resulting in this disease.

[0005] Western medicine treatment mainly focuses on lifestyle interventions and drug therapy, but its efficacy is limited and it has certain side effects. Traditional Chinese medicine (TCM), through holistic regulation and syndrome differentiation, has significant potential in improving lipid metabolism and liver inflammation in MAFLD patients. Common TCM syndromes in MAFLD clinical practice include liver stagnation and spleen deficiency, damp-heat accumulation, phlegm obstruction, and phlegm-blood stasis. Among them, liver stagnation and spleen deficiency syndrome is characterized by distending pain in the hypochondrium, depression and discomfort, fatigue, abdominal distension and discomfort, loss of appetite, nausea and vomiting, irregular bowel movements, frequent sighing, pale red tongue with a thin white or white coating and teeth marks, and a wiry and thready pulse. Damp-heat accumulation syndrome is characterized by distending pain in the right hypochondrium, sticky and unsatisfactory bowel movements, abdominal distension or pain, jaundice, yellow urine, general heaviness, sticky, dry and bitter mouth, red tongue with a yellow and greasy coating, and a wiry and slippery or soft and rapid pulse. Phlegm-dampness obstruction syndrome manifests as obesity, discomfort or distension in the right hypochondrium, general heaviness, sticky and unsatisfactory bowel movements, abdominal distension, fatigue, loss of appetite, dizziness, nausea, pale tongue, white and greasy tongue coating, and a deep and slippery pulse. Phlegm-blood stasis syndrome manifests as stabbing or dull pain in the hypochondrium, a mass under the ribs, a sallow complexion, fullness in the chest and epigastrium, expectoration of phlegm, poor appetite, aversion to oily foods, obesity, heaviness in the limbs, a dark red tongue with ecchymosis, a large tongue with teeth marks on the edges, a greasy tongue coating, and a wiry and slippery or hesitant pulse. Targeted Chinese herbal combinations should be used for different syndrome types.

[0006] Currently, there are many commonly used or publicly available traditional Chinese medicine preparations for the treatment of MAFLD. However, there are few existing traditional Chinese medicine preparations that target the syndrome of phlegm and turbidity obstruction. This results in a lack of targeted methods for the diagnosis and treatment of MAFLD patients with phlegm and turbidity obstruction in clinical application, leading to problems such as poor treatment effects and low overall effectiveness. For example, Shugan Quzhi Capsules are a commonly used traditional Chinese medicine for MAFLD. They have the effects of soothing the liver and regulating qi, promoting blood circulation and removing blood stasis, and eliminating dampness and phlegm. According to existing literature (The effect of Shugan Quzhi Capsules on TLR4 / MyD88 / NF-κB signaling pathway and blood lipids in patients with non-alcoholic fatty liver disease, Chinese Medical Innovation, August 2025, 22(24)1-5.), Shugan Quzhi Capsules can improve the levels of liver function indicators [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT)], with a total effective rate of 95%. However, it is not clear which type of MAFLD it treats. Long-term use of the drug is costly and economically burdensome. Moreover, in clinical application, it was found that its effect on improving the symptoms of obesity and general heaviness in MAFLD with phlegm obstruction was not good.

[0007] Chinese patent CN106806814A discloses a "traditional Chinese medicine composition for treating non-alcoholic fatty liver and its preparation method." This traditional Chinese medicine composition is made from raw materials including Fructus Aurantii Immaturus, Semen Plantaginis, Radix Paeoniae Rubra, Gallus Galli Gizzard, Rhizoma Curcumae, Radix Panaxe Alba, Rhizoma Anemarrhenae, Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Radix Scrophulariae, Radix Adenophorae, Radix Ophiopogonis, Radix Polygonati, Rhizoma Polygonati, Radix Trichosanthis, Fructus Corni, Fructus Lycii, Fructus Ligustri Lucidi, Herba Epimedii, Cortex Moutan, Cortex Poriae, Radix Aconitum, Rhizoma Alisma, and Fructus Schisandrae. This traditional Chinese medicine composition has the effect of preventing and treating hepatic steatosis and protecting liver function. However, the prescription disclosed in this application requires a large amount of raw materials and has a high cost for long-term use, which is not conducive to widespread clinical use.

[0008] Chinese patent CN116983377B discloses a traditional Chinese medicine composition, preparation, and application for treating non-alcoholic fatty liver disease with phlegm-dampness obstruction syndrome. The active ingredients of the traditional Chinese medicine composition are composed of the following components by weight: 2-10 parts of ginger-processed Pinellia ternata, 2-10 parts of dried tangerine peel, 10-20 parts of Poria cocos, 10-20 parts of stir-fried Atractylodes macrocephala; 2-10 parts of Bupleurum chinense, 5-15 parts of Curcuma longa, 10-20 parts of Sedum sarmentosum, 10-20 parts of stir-fried Paeonia lactiflora, 8-16 parts of Pogostemon cablin, 2-10 parts of Acorus tatarinowii; 25-35 parts of Serissa japonica, 10-20 parts of Ganoderma lucidum, 5-15 parts of Schisandra chinensis; and 2-10 parts of prepared Glycyrrhiza uralensis. This traditional Chinese medicine composition has the effect of improving waist circumference, body mass index, related liver function and blood lipid levels, and liver morphology on imaging. However, the prescription disclosed in this application is complicated, the cost of medication is high, the economic burden is heavy, and the affordability and accessibility of long-term use are limited, which is not conducive to widespread clinical use. Therefore, it is necessary to provide a traditional Chinese medicine composition with low cost and good therapeutic effect for treating non-alcoholic fatty liver disease with phlegm-dampness obstruction syndrome. Summary of the Invention

[0009] The inventors of this application discovered in long-term clinical practice that the pathogenesis of MAFLD involves the liver, spleen, and kidneys. It is mainly caused by a variety of factors such as spleen deficiency, liver stagnation, qi stagnation, phlegm accumulation, and diet. Based on the theory of visceral qi transformation, the pathogenesis of MAFLD is "abnormal spleen and kidney qi transformation, phlegm accumulation in the liver," with phlegm obstruction being an important TCM syndrome. Based on this, this invention provides a warming and pungent purgative composition for treating metabolic-related fatty liver disease (MAFLD) with phlegm obstruction syndrome. Based on the pathogenesis of MAFLD—"abnormal spleen and kidney qi transformation, phlegm accumulation in the liver"—and guided by the theory of visceral qi transformation, it adopts the treatment principle of "warming yang to assist transportation, drying dampness to resolve phlegm, and ascending clear qi and descending turbid qi" to restore the spleen and kidney qi transformation function, thus eliminating the generation of phlegm at its root. This composition uses widely available, inexpensive, and easily accessible medicinal materials, resulting in low overall medication costs and significantly reducing the economic burden of long-term medication for patients. It possesses good long-term economic efficiency and accessibility. This formula has achieved good clinical efficacy. With an efficacy rate exceeding 97%, this formula is tailored to the specific symptoms and targets phlegm-dampness. It has a targeted improvement effect on the core syndromes of MAFLD caused by phlegm-dampness obstruction [the scores of symptoms such as obesity, general heaviness, fatigue, sticky and unsatisfactory bowel movements, and abdominal distension were significantly lower in the treatment group than in the control group]. It can also regulate lipid metabolism [serum TG, TC, and LDL-C decreased significantly after treatment] and improve liver function [ALT, AST, and GGT decreased significantly after treatment]. This composition restores the spleen and kidney qi transformation and prevents the regeneration of phlegm-dampness, achieving both symptomatic and root-cause treatment, providing a highly effective and safe treatment option for MAFLD caused by phlegm-dampness obstruction.

[0010] To achieve the above objectives, the present invention adopts the following technical solution: A warm and pungent composition for treating MAFLD (manasthenia gravis) with phlegm-dampness obstruction, comprising the following ingredients in parts by weight: 20-30 parts of Ficus hirta, 8-15 parts of Morinda officinalis, 10-20 parts of Rosa chinensis, 10-15 parts of Citrus aurantium, 5-10 parts of Allium macrostemon, 20-30 parts of Clematis armandii, 15-20 parts of Polyporus umbellatus, 15-20 parts of Lophatherum gracile, and 10-15 parts of Sedum sarmentosum.

[0011] As a preferred embodiment of the present invention, the pungent and warm purgative and fat-reducing composition comprises the following raw materials in parts by weight: 25-30 parts of five-finger peach, 8-15 parts of morinda root, 15-20 parts of rose, 10-15 parts of yarrow seed, 5-10 parts of allium macrostemon, 25-30 parts of bulrush leaf, 15-20 parts of poria cocos, 15-20 parts of light bamboo leaf, and 10-15 parts of creeping sedum.

[0012] As a preferred embodiment of the present invention, the pungent and warm purgative and fat-reducing composition is composed of the following raw materials in parts by weight: 25 parts of five-finger peach, 8 parts of morinda root, 15 parts of rose, 10 parts of yarrow seed, 5 parts of allium macrostemon, 25 parts of bulrush leaf, 15 parts of poria cocos, 15 parts of light bamboo leaf, and 10 parts of creeping sedum.

[0013] The above-mentioned pungent and warm purgative and lipid-reducing composition provided by the present invention has been proven through clinical trials to have a good therapeutic effect on patients with metabolic-related fatty liver disease due to phlegm-dampness obstruction syndrome, with an effective rate of up to 97.67%. Therefore, this composition can be used in the preparation of drugs for treating MAFLD due to phlegm-dampness obstruction syndrome.

[0014] The dosage form of the drug for treating MAFLD (mandibular phlegm-dampness obstruction syndrome) described in this invention is an oral preparation, which is selected from any one of granules, tablets, capsules, powders, decoctions, or pills.

[0015] This invention also provides a decoction for treating MAFLD with phlegm-dampness obstruction, the decoction being composed of the following ingredients in parts by weight: 20-30 parts of Ficus hirta, 8-15 parts of Morinda officinalis, 10-20 parts of Rosa chinensis, 10-15 parts of Citrus aurantium, 5-10 parts of Allium macrostemon, 20-30 parts of Clematis armandii, 15-20 parts of Polyporus umbellatus, 15-20 parts of Lophatherum gracile, and 10-15 parts of Sedum sarmentosum. The preparation method of the decoction is as follows: Wash and soak the following herbs: *Ficus hirta*, *Morinda officinalis*, *Citrus aurantium*, *Allium macrostemon*, *Clematis armandii*, *Polyporus umbellatus*, *Lophatherum gracile*, and *Sedum sarmentosum*. First decoction: Heat the soaked herbs over high heat until boiling, then reduce to low heat and simmer for 30-60 minutes. Pour out the first decoction, filter it through a sieve, and store the decoction in a clean container. Second decoction: Add water to the dregs, covering them by 1-2 cm. Bring to a boil over high heat, then reduce to low heat and simmer for 30-50 minutes. When 15 minutes have elapsed, add the reserved washed rose petals to the pot and continue simmering until the time is up. Mix the filtered decoction with the first decoction.

[0016] The Five-Finger Peach in the composition provided by this invention invigorates the spleen and replenishes qi. It is sweet in taste and warm in nature, and has the effects of invigorating qi and strengthening the spleen, eliminating phlegm and dampness. As the principal ingredient, it invigorates the middle qi, restores the normal function of qi transformation in the middle jiao, prevents the generation of phlegm and dampness, and prevents food and water from becoming the source of turbidity. This is the meaning of "treating the root cause of the disease".

[0017] Morinda officinalis, Rosa chinensis, and Asarum heterotropoides are used as assistant herbs. Morinda officinalis is sweet, pungent, and slightly warm, and enters the liver and kidney meridians. It tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. Its warming and tonifying effect on kidney qi, combined with the principal herb, not only tonifies the kidney and aids in the transformation of qi, but also warms the spleen and aids in digestion. This ensures that kidney yang is sufficient for qi transformation, and spleen yang is invigorated for the proper transformation of food and water, thus preventing the formation of phlegm at its root. Rosa chinensis is sweet and warm, and enters the liver meridian. It soothes the liver, relieves stagnation, invigorates blood, and regulates menstruation. It directly enters the liver meridian, guiding stagnant liver qi upwards and restoring the smooth flow of wood qi. Combined with the principal herb, it soothes the liver and spleen, helps the middle jiao to return to normal, and invigorates blood, preventing phlegm from accumulating into blood stasis over time. Asarum heterotropoides is bitter and cold, and enters the liver, gallbladder, stomach, and bladder meridians. It soothes the liver, regulates qi, disperses stagnation, promotes urination, invigorates blood, and relieves pain. It not only promotes urination and guides turbidity downwards, but also effectively enters the blood, clearing stagnation of qi and blood in the meridians, preventing phlegm and turbidity from attaching. Modern research shows that *Cephalotaxus fortunei* has liver-protective, antioxidant, antibacterial, and anti-inflammatory effects. When combined with rose petals, *Cephalotaxus fortunei* regulates qi and blood; when blood flows smoothly, qi flows smoothly, and when qi flows smoothly, phlegm dissipates. Simultaneously, it promotes urination and guides turbidity downwards.

[0018] Allium macrostemon, Clematis chinensis leaves, Polyporus umbellatus, and Lophatherum gracile are used as adjuvant herbs. Allium macrostemon is pungent, bitter, and warm, and enters the heart, lung, stomach, and large intestine meridians. It has the effects of promoting yang and dispersing stagnation, and regulating qi and relieving stagnation. Its pungent and warm nature promotes yang and is good at dispersing stagnation of yin turbidity. Phlegm turbidity is a yin evil, which cannot be transformed without yang. Its warm nature is like a gentle fire, which can dissolve stagnant phlegm turbidity. When combined with Morinda officinalis, the yang of the upper jiao is unblocked and the yang of the lower jiao is replenished. The yang qi circulates in the upper and lower jiaos, so the qi transformation and circulation are uninterrupted, and phlegm turbidity has no source to generate. Clematis chinensis leaves are slightly sour and cool in nature. They have the effects of promoting digestion, resolving stagnation, clearing heat and promoting diuresis. When combined with Ficus hirta, Ficus hirta tonifies the spleen and raises yang to help digestion, while Clematis chinensis leaves eliminate turbidity and remove accumulated stagnation. When the two are combined, the stagnation in the middle jiao is relieved, and the spleen's function of digestion and transformation is restored to normal. Modern research shows that *Broussonetia papyrifera* leaves can improve blood lipids and lower triglyceride, total cholesterol, and LDL cholesterol levels. *Polyporus umbellatus*, sweet, bland, and neutral in nature, enters the kidney and bladder meridians. It has diuretic and dampness-draining effects. When combined with *Ficus hirta*, *Ficus hirta* tonifies the spleen and raises yang to strengthen the middle jiao qi, while *Polyporus umbellatus* drains and removes turbidity to guide dampness from the lower jiao. One ascends and the other descends, one tonifies and the other drains, clearing away the turbid. *Lophatherum gracile* leaves, sweet, bland, and cold in nature, enter the heart, stomach, and small intestine meridians. It has the effects of clearing heat and purging fire, relieving irritability and thirst, and promoting urination. It facilitates urination, clears heat and removes turbidity, providing an outlet for pathogens. When combined with *Polyporus umbellatus*, *Lophatherum gracile* leaves synergistically enhance the diuretic and turbidity-draining effects; when combined with *Broussonetia papyrifera* leaves, they work together to eliminate phlegm and turbidity. Modern research shows that *Lophatherum gracile* leaves have anti-inflammatory, antioxidant, antibacterial, antiviral, antitumor, anti-fatigue, liver damage prevention, and serum total cholesterol-lowering effects.

[0019] Sedum sarmentosum is used as the guiding herb. It is sweet, bland, and cool in nature, and enters the liver, gallbladder, and small intestine meridians. It guides other herbs directly to the liver, eliminating phlegm and turbidity accumulated there. Simultaneously, Sedum sarmentosum has the effects of clearing heat and dampness, detoxifying, and reducing swelling. It assists Polyporus umbellatus and Lophatherum gracile in eliminating phlegm and turbidity, while also balancing the pungent and drying properties of other warming herbs such as Morinda officinalis and Allium macrostemon, ensuring the entire formula is warming and tonifying without generating heat, and transforming turbidity without harming yin. When combined with Sedum sarmentosum, it clears and eliminates phlegm and turbidity, preventing phlegm and turbidity from transforming into heat. Combined with Polyporus umbellatus and Lophatherum gracile, it enhances the dampness-eliminating effect. At the same time, Sedum sarmentosum can inhibit lipid accumulation and improve abnormal transaminase levels, thereby slowing the progression of MAFLD. The entire formula addresses both the root cause and the symptoms, tonifying the spleen and kidneys to restore the root of qi transformation, and transforming phlegm and turbidity to relieve liver congestion, allowing the essence to be transported, turbid fats to be transformed, and the liver to be restored to harmony.

[0020] Advantages and beneficial effects of the present invention: (1) Through extensive clinical practice, this invention summarizes the core pathogenesis of MAFLD as “abnormal spleen and kidney qi transformation, phlegm accumulation in the liver”. It breaks through the previous limited perspective of treating MAFLD by focusing on symptoms such as “phlegm,” “damp heat,” “blood stasis,” and “phlegm stasis”, and by treating the liver and spleen. It clearly points out that the dysfunction of spleen and kidney qi transformation is not only the source of pathological products such as phlegm and blood stasis, but also the root cause of the occurrence and development of MAFLD. It deepens the understanding of the pathogenesis of MAFLD in traditional Chinese medicine and establishes the treatment method of “warming yang to assist transportation, drying dampness to resolve phlegm, and ascending clear qi and descending turbid qi” under the guidance of the theory of visceral qi transformation. By restoring the qi transformation function of spleen and kidney, the phlegm that has stopped can be eliminated, and the phlegm that has not yet been generated has no source to continue. It eliminates the regeneration of phlegm from the root and provides new ideas and methods for the clinical prevention and treatment of MAFLD.

[0021] (2) The formula of this invention is concise and simple, and the ingredients are highly effective. The composition provided consists of only 9 medicinal materials. The ingredients are simple and the combination is rigorous. The whole formula takes five-finger peach as the chief ingredient, which strengthens the spleen and replenishes qi and restores its qi transformation; Morinda officinalis, Rosa chinensis and Asarum heterotropoides as assistant ingredients, which warm yang and promote circulation, soothe the liver and regulate qi, and promote diuresis and eliminate turbidity; Allium macrostemon, Buzha leaf, Polyporus umbellatus and Lophatherum gracile as adjuvant ingredients, which promote yang, eliminate phlegm, eliminate dampness and reduce turbidity; Sedum sarmentosum as the guide ingredient, which guides the medicine to the liver and balances the warming and drying. The whole formula is warm but not drying, tonifying but not stagnant, and draining but not harmful. Together, they achieve the effects of warming yang and promoting circulation, drying dampness and eliminating phlegm, and promoting the ascending of clear qi and the descending of turbidity.

[0022] (3) The pungent and warm purgative and lipid-reducing composition provided by this invention has significant clinical efficacy. It has a targeted improvement effect on the core syndrome of MAFLD with phlegm-dampness obstruction, with a high overall effective rate of 97.67%. Moreover, it is not easy to relapse after treatment, and it is particularly suitable for patients with metabolic-related fatty liver disease with phlegm-dampness obstruction. In terms of TCM syndrome improvement, compared with the control group, it can significantly reduce the syndrome scores of obesity, general heaviness, fatigue, sticky and unsatisfactory stools, and abdominal distension, effectively relieving the core symptoms of obesity, right hypochondriac discomfort or distension, general heaviness, and sticky and unsatisfactory stools.

[0023] (4) The pungent and warm purgative and lipid-reducing composition provided by the present invention also has the effect of regulating liver lipid metabolism and improving liver function. It can significantly reduce the levels of total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C), and can also effectively reduce alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyl transferase (GGT), with the reduction magnitude being statistically significant.

[0024] (5) The pungent and warm purgative and lipid-reducing composition provided by the present invention can effectively reduce the accumulation of lipid turbidity in the liver, and the overall improvement in fatty liver grade is significantly better than that of the control group. Ultrasound imaging results show that after intervention, a large number of patients transformed from moderate and severe fatty liver to mild and normal grades, and the number of moderate and severe fatty liver cases decreased significantly (from 34 cases to 6 cases); compared with the control group, the proportion of fatty liver reversal after taking the pungent and warm purgative and lipid-reducing composition was higher, and the degree of improvement was more prominent.

[0025] (6) The pungent and warm purgative and lipid-reducing composition provided by the present invention selects widely produced, inexpensive and readily available medicinal materials, and the overall cost of medication is low. The price of each dose of Chinese medicine is about 20 yuan. On the basis of ensuring the therapeutic effect, it can significantly reduce the economic pressure of long-term medication for patients. It has good long-term application economy and medication accessibility, and overcomes the problem of long-term medication cost caused by the general neglect of the compatibility of medicinal materials in existing Chinese medicine compositions. It lacks comprehensive consideration of the economic burden of medication for patients and the accessibility of primary clinical practice.

[0026] (7) In the preparation of the decoction of this invention, the rose petals are added to the pot after the flowers have been added to preserve their volatile oils and aromatic properties, ensuring that the effects of "soothing the liver and relieving depression, and regulating qi and blood" are fully realized. If the decoction is cooked for too long, the aroma will be lost, the ability to regulate qi will be greatly reduced, and the relief of symptoms of qi stagnation such as hypochondriac pain will be affected, resulting in a decrease in the long-term efficacy of lowering lipids and protecting the liver. Therefore, the "added last" process must be strictly followed in the preparation of the decoction, which is one of the key technical points to ensure the clinical efficacy of the patented formula. Detailed Implementation

[0027] This invention discloses a pungent and warm purgative and lipid-reducing composition for treating metabolic-related fatty liver disease caused by phlegm-dampness obstruction. Those skilled in the art can refer to the content of this document and appropriately modify the component parameters or process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included within the scope of protection of this invention.

[0028] Example 1:

[0029] This embodiment provides a pungent and warm purgative and lipid-reducing composition for treating metabolic-related fatty liver disease (MAFLD) with phlegm-dampness obstruction syndrome. The pungent and warm purgative and lipid-reducing composition is composed of the following raw materials in parts by weight: 30g of five-finger peach, 10g of morinda root, 15g of rose, 15g of yarrow seed, 5g of allium macrostemon, 25g of bulrush leaf, 15g of polyporus umbellatus, 15g of light bamboo leaf, and 10g of creeping sedum.

[0030] The composition provided in this embodiment can be formulated into any one of granules, tablets, capsules, powders, decoctions, or pills for actual use. Among the above dosage forms, decoctions have the advantages of being simple and easy to prepare, fast absorption, and able to quickly exert their medicinal effects, therefore decoctions are preferred. The decoction is prepared by decocting water and then removing the residue to obtain the juice.

[0031] Specifically, the preparation method of the decoction is as follows: Wash and soak the medicinal materials (except for the rose petals); First decoction: Heat the soaked medicinal materials over high heat (strong heat), bring to a boil, then reduce to low heat (gentle heat) and simmer for 45-60 minutes. Pour out the first decoction, filter it with a strainer, and store the decoction in a clean container; Second decoction: Add water to the dregs, covering them by 1-2 cm, bring to a boil over high heat, then reduce to low heat and simmer for 30-45 minutes; When 15 minutes have passed, add the reserved washed rose petals to the pot, continue simmering until the time is up, mix the filtered decoction with the first decoction, and stir well. The combined decoction constitutes one dose. Take half (approximately 150ml) twice daily, after breakfast and dinner.

[0032] Example 2:

[0033] This embodiment provides a pungent and warm purgative and lipid-reducing composition for treating metabolic-related fatty liver disease (MAFLD) with phlegm-dampness obstruction syndrome. The composition consists of the following raw materials by weight: 25g of five-finger peach, 8g of morinda root, 15g of rose, 10g of yarrow seed, 5g of allium macrostemon, 25g of bulrush leaf, 15g of polyporus umbellatus, 15g of light bamboo leaf, and 10g of creeping sedum.

[0034] The composition provided in this embodiment is preferably taken as a decoction, and the preparation method of the decoction is the same as in Example 1.

[0035] It should be noted that, in clinical use, the composition provided by this invention can be adjusted according to the severity of the patient's symptoms and the duration of the illness. For example, for patients with significant abdominal distension, the dosage of *Bu Zha Ye* can be increased to 30g; for patients with significant dizziness and nausea, the dosage of *Zhu Ling* can be increased to 20g. Of course, the dosage of each ingredient in the above composition, regardless of any adjustments, must be controlled within the following range: *Wu Zhi Mao Tao* 20-30g, *Ba Ji Tian* 8-15g, *Yue Ji Hua* 10-20g, *Yu Zhi Zi* 10-15g, *Xie Bai* 5-10g, *Bu Zha Ye* 20-30g, *Zhu Ling* 15-20g, *Dan Zhu Ye* 15-20g, and *Sedum sarmentosum* 10-15g.

[0036] The composition provided by this invention is guided by the theory of visceral qi transformation. It treats metabolic-related fatty liver disease by combining warming yang to promote circulation, drying dampness and resolving phlegm, and ascending clear qi and descending turbid qi. This formula has been used for many years at the Affiliated Hospital of Changchun University of Traditional Chinese Medicine and has a good therapeutic effect on patients with metabolic-related fatty liver disease with phlegm-turbidity obstruction syndrome. The following clinical data illustrates the therapeutic effect of the herbal composition of this invention. 1. General Information: Ninety patients with MAFLD (Maniculum vulgare syndrome) due to phlegm-dampness obstruction who visited the Department of Hepatobiliary and Gastroenterology at the Affiliated Hospital of Changchun University of Traditional Chinese Medicine between January 2024 and February 2026 were selected and randomly divided into a treatment group (n=45) and a control group (n=45) using a random number table. During the study, two patients in the treatment group and four patients in the control group dropped out due to loss to follow-up or failure to follow the study protocol, resulting in a final enrollment of 84 patients. The treatment group consisted of 43 patients, including 22 males and 21 females, with a mean age of (39.94±10.14) years. The control group consisted of 41 patients, including 20 males and 21 females, with a mean age of (42.77±9.33) years. There were no significant differences in age or gender composition between the two groups (P>0.05), indicating comparability.

[0037] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria: The diagnostic criteria for MAFLD, based on the "International Expert Consensus on the New Definition of Metabolic Fatty Liver Disease" in Western medicine, require a diagnosis of hepatic steatosis through liver biopsy, blood biomarkers, or imaging evidence, and must also meet one of the following three conditions: (1) Overweight or obesity (BMI > 23 kg / m² in Asian populations) 2 Or, for Caucasian individuals, a BMI > 25 kg / m² 2 ); (2) Type 2 diabetes; (3) Meets at least two components of metabolic syndrome: ① Waist circumference: Asian men ≥ 90cm and Asian women ≥ 80cm; ② Blood pressure ≥130 / 85 mmHg or currently receiving antihypertensive medication; ③ Plasma triglycerides ≥1.70 mmol / L or currently receiving lipid-lowering medication; ④ Plasma high-density lipoprotein cholesterol: men <1.0 mmol / L and women <1.3 mmol / L or currently receiving lipid-lowering medication; ⑤ Prediabetes [i.e., fasting blood glucose level of 5.6-6.9 mmol / L or 2-hour postprandial blood glucose level of 7.8-11.0 mmol / L or glycated hemoglobin level of 5.7%-6.4%]; ⑥ Homeostasis Model Assessment (HOMA) - Insulin Resistance Index ≥ 2.5; ⑦ Plasma high-sensitivity C-reactive protein (hs-CRP) level >2 mg / L.

[0038] 2.2 Diagnostic criteria for TCM syndrome types: The TCM syndrome differentiation criteria for MAFLD are based on the "Expert Consensus Opinion on the Diagnosis and Treatment of Non-Alcoholic Fatty Liver Disease in Traditional Chinese Medicine (2017)" and the "Consensus Opinion on the Diagnosis and Treatment of Integrative Traditional Chinese and Western Medicine".

[0039] Phlegm-dampness obstruction syndrome: (1) Main symptoms: obesity; discomfort or distension in the right hypochondrium; general heaviness; sticky and unsatisfactory bowel movements.

[0040] (2) Secondary symptoms: abdominal distension; fatigue and weakness; loss of appetite; dizziness; nausea.

[0041] (3) Tongue and pulse: The tongue is pale, the tongue coating is white and greasy, and the pulse is deep and slippery.

[0042] Syndrome identification: The presence of two primary symptoms and one or two secondary symptoms, along with reference to tongue and pulse characteristics, is sufficient for accurate diagnosis.

[0043] 3. Inclusion criteria: (1) Meets the Western medical diagnostic criteria for MAFLD; (2) Meets the TCM syndrome differentiation criteria for phlegm-dampness obstruction syndrome; (3) Age between 18 and 70 years old; (4) Liver function indicators showed that alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were elevated for more than 4 weeks, and both ALT and AST were less than twice the upper limit of normal. (5) The patient agrees to participate in the study and signs an informed consent form; (6) Those with complete and unmissing relevant inspection and examination data; (7) No hepatoprotective drugs or other systemic treatments for MAFLD have been received in the short term.

[0044] 4. Exclusion criteria: (1) History of chronic liver disease or cirrhosis; positive for hepatitis B or hepatitis C virus; history of cancer; history of gastrointestinal surgery or trauma; (2) Those with serious organic diseases of the heart, brain and other organs and serious abnormalities of the blood system; those with alcoholic fatty liver disease or fatty liver caused by other factors; (3) Patients with mental illness; those who have been taking antihypertensive drugs, hypoglycemic drugs, lipid-lowering drugs, liver-protecting and enzyme-lowering drugs, or glucocorticoids for a long time; those who are allergic to the drugs used in this invention; (4) Pregnant or breastfeeding women; (5) Those with missing medical records.

[0045] 5. Treatment methods: 5.1 Basic Treatment Plan: Establish correct lifestyle habits and a healthy diet, including a low-fat, low-sugar diet, reducing the intake of high-calorie foods, moderate exercise, and controlling body weight.

[0046] 5.2 Treatment regimen for the treatment group: The basic treatment involves a warming and purging formula to reduce turbidity and fat. The formula consists of: 25g of *Ficus hirta*, 8g of *Morinda officinalis*, 15g of *Rosa chinensis*, 10g of *Citrus aurantium*, 5g of *Allium macrostemon*, 25g of *Clerodendrum trichotomum*, 15g of *Polyporus umbellatus*, 15g of *Lophatherum gracile*, and 10g of *Sedum sarmentosum*. One dose is taken daily, decocted in water and taken twice daily, after breakfast and dinner.

[0047] 5.3 Treatment regimen for the control group: In addition to basic treatment, Gynostemma pentaphyllum total glycosides tablets (Guangdong Baiyunshan Hutchison Whampoa Chinese Medicine Co., Ltd., specification 20mg*80 tablets / box, national drug approval number Z10900032) were administered, 3 tablets each time, 3 times a day. Taken with warm water.

[0048] Both groups were treated for 12 weeks, during which time other medications were discontinued.

[0049] 6. Observation of therapeutic effects: 6.1 Observation indicators: (1) TCM syndrome score: Referring to the consensus opinion on the diagnosis and treatment of non-alcoholic fatty liver disease with integrated traditional Chinese and Western medicine (2017) and the clinical guidance principle of new Chinese medicine, the main symptoms and secondary symptoms were graded and scored: all symptoms were divided into four levels according to severity: none, mild, moderate and severe. The main symptoms were scored as 0, 2, 4 and 6 points respectively, and the secondary symptoms were scored as 0, 1, 2 and 3 points respectively. The syndrome scores of the two groups of patients before and after treatment were compared.

[0050] (2) Laboratory indicators: Blood lipid and liver function indicators were measured in both groups of patients before treatment and 12 weeks after treatment. The main indicators included TC (total cholesterol), TG (triglycerides), LDL-C (low-density lipoprotein cholesterol), ALT (alanine aminotransferase), AST (aspartate aminotransferase), and GGT (gamma-glutamyl transferase).

[0051] (3) Imaging indicators: Liver ultrasound of the two groups of patients before and after treatment.

[0052] 6.2 Efficacy criteria: Formulated with reference to the relevant criteria in the "Guiding Principles for Clinical Research of New Chinese Medicines".

[0053] (1) Cure: Symptoms and signs completely disappear; laboratory tests indicate that liver function and blood lipid indicators return to normal; liver ultrasound shows normal liver echogenicity and clear visualization of the intravascular structures in the liver.

[0054] (2) Marked effect: Symptoms and signs are significantly reduced; laboratory tests show that ALT decreases by more than 50%, and the improvement of blood lipids meets any of the following: TC decrease amplitude ≥20% or TG decrease amplitude ≥40% or LDL-C decrease ≥30%; liver ultrasound indicates that the degree of fatty liver is reduced by 1-2 grades.

[0055] (3) Effective: Symptoms are alleviated, positive signs are reduced compared with before; laboratory tests show that 30% < ALT decrease ≤50%, and the improvement of blood lipids meets any of the following: TC decrease amplitude ≥10% but <20%, or TG decrease amplitude >10% but <40%, or LDL-C decrease ≥10% but <30%. Liver ultrasound indicates that the degree of fatty liver is reduced by 1 grade.

[0056] (4) Ineffective: Symptoms and signs show no significant change or are aggravated; the decrease amplitude of various liver function and blood lipid indicators does not reach the above criteria or is aggravated; liver ultrasound indicates that the degree of fatty liver has no significant change.

[0057] 7. Safety indicators: (1) Indicators such as electrocardiogram, blood routine, urine routine, stool routine and renal function are monitored before and after treatment.

[0058] (2) Adverse reactions unrelated to MAFLD that occur during the treatment period are recorded and managed.

[0059] 8. Statistical methods: All data are analyzed using SPSS 23.0 statistical software. Measurement data are expressed as mean ± standard deviation ( ) For samples conforming to normal distribution, t-test is adopted; for samples conforming to non-normal distribution, rank sum test is adopted; for comparison of ranked data between groups, Mann-Whitney U rank sum test is adopted. Enumeration data are expressed as frequency and rate (%), and x 2 test is adopted; P<0.05 is regarded as the difference being statistically significant.

[0060] 9. Treatment results: 9.1 Comparison of comprehensive efficacy between the treatment group and the control group: Comparing the overall efficacy of the treatment group and the control group, the total effective rate of the treatment group was 97.67%, which was significantly higher than that of the control group (68.29%), and the difference was statistically significant (P<0.01). See Table 1 for details.

[0061] Table 1. Comparison of overall therapeutic effects between the treatment group and the control group [n(%)] Treatment group 43 13（30.23） 20（46.51） 9（20.93） 1（2.33） <![CDATA[42(97.67) a ]]> control group 41 7（17.07） 10（24.39） 11（26.82） 13（31.71） 28（68.29） Note: Compared with the control group, a P < 0.01.

[0062] 9.2. Comparison of TCM symptom scores between the treatment group and the control group after treatment: After treatment, the TCM syndrome scores of the treatment group and the control group were compared. The TCM symptoms (obesity, discomfort or distension in the right hypochondrium, general heaviness, sticky and unsatisfactory stools, abdominal distension, fatigue, loss of appetite, dizziness and nausea) in the treatment group were all lower than those in the control group, and the differences were statistically significant (P<0.05). See Table 2 for details.

[0063] Table 2 Comparison of TCM syndrome scores between the treatment group and the control group after treatment ( ,point) Obesity (main symptom) <![CDATA[0.84±0.54 a ]]> 1.92±0.73 Discomfort or distension in the right hypochondrium (main symptom) <![CDATA[0.56±0.45 a ]]> 1.64±0.68 Feeling heavy and lethargic throughout the body (main symptom) <![CDATA[0.60±0.72 a ]]> 1.48±1.21 Sticky and uncomfortable stools (main symptom) <![CDATA[0.81±0.54 a ]]> 1.79±0.67 Abdominal distension (secondary symptom) <![CDATA[0.24±0.57 a ]]> 0.59±0.82 Fatigue and weakness (secondary symptom) <![CDATA[0.38±0.74 a ]]> 0.83±0.95 Loss of appetite (secondary symptom) <![CDATA[0.57±0.32 a ]]> 0.96±0.71 Dizziness (secondary symptom) <![CDATA[0.31±0.49 a ]]> 0.64±0.58 Nausea (secondary symptom) <![CDATA[0.28±0.36 a ]]> 0.56±0.45 Note: Compared with the control group, a P<0.05.

[0064] 9.3 Comparison of liver function indicators before and after treatment between the treatment group and the control group: Comparison of liver function indicators before and after treatment between the treatment group and the control group: Before treatment, there was no statistically significant difference in ALT, AST, and GGT levels between the two groups (P>0.05); After treatment, ALT, AST, and GGT levels in both groups improved compared with before treatment, and the improvement in the treatment group was greater than that in the control group, with statistically significant differences (P<0.05), as detailed in Table 3.

[0065] Table 3 Comparison of various liver function indicators before and after treatment in the treatment group and the control group ( (U / L)

[0066] Note: Compared with the pre-treatment level in this group. a P<0.05; compared with the control group after treatment, b P<0.05.

[0067] 9.4 Comparison of blood lipid levels before and after treatment between the treatment group and the control group: Comparison of blood lipid indicators before and after treatment between the treatment group and the control group: Before treatment, there were no statistically significant differences in TG, TC, and LDL-C between the two groups (P>0.05); After treatment, TG, TC, and LDL-C in both groups improved compared with before treatment, and the improvement in the treatment group was greater than that in the control group, with statistically significant differences (P<0.05), as detailed in Table 4.

[0068] Table 4 Comparison of blood lipid levels before and after treatment in the treatment group and the control group ( (mmol / L)

[0069] Note: Compared with the pre-treatment level in this group. a P<0.05: Compared with the control group after treatment, b P<0.05.

[0070] 9.5 Comparison of ultrasound indicators between the treatment group and the control group after treatment: The degree of fatty liver under ultrasound after treatment was compared between the treatment group and the control group. The improvement in the treatment group was greater than that in the control group, and the difference was statistically significant (P<0.05). See Table 5 for details.

[0071] Table 5 Comparison of ultrasound indicators between the treatment group and the control group after treatment (cases)

[0072] 10. Safety Assessment: Both groups of patients showed no abnormal changes in electrocardiogram, blood routine, urine routine, stool routine, and renal function indicators before and after treatment, and no adverse events occurred.

[0073] Typical case: Mr. Zhang, male, 55 years old. First visit on March 18, 2024. The patient habitually consumes greasy and barbecued foods, has little physical activity, and has gradually gained weight over the past two years, currently gaining approximately 7 kg. He denies a history of alcohol consumption and any specific medication use. There is no history of liver disease or hereditary diseases in his family. Recently, he has frequently experienced right hypochondriac fullness and discomfort, general fatigue and weakness, a sticky and bitter taste in his mouth upon waking, chest and epigastric fullness, which worsens after meals, dizziness, general heaviness, poor appetite, and loose, sticky, and unsatisfactory stools 2-3 times daily. His tongue has a white, greasy coating and teeth marks. His pulse is deep and wiry. Examination: Liver function tests: ALT 84.6 U / L, AST 63.7 U / L, GGT 98 U / L; Blood lipids: TG 1.64 mmol / L, TC 5.99 mmol / L, LDL-C 4.01 mmol / L; Gastrointestinal ultrasound showed moderate fatty liver and an uneven gallbladder wall. Traditional Chinese Medicine (TCM) diagnosis: Liver obstruction (phlegm-dampness retention syndrome); Western medicine diagnosis: Metabolic-related fatty liver disease. Treatment principle: warming yang and promoting circulation, drying dampness and resolving phlegm, and promoting the ascending of clear qi and descending of turbid qi. A warm and pungent formula for purging turbidity and reducing fat is prescribed: 25g of *Ficus hirta*, 8g of *Morinda officinalis*, 15g of *Rosa chinensis*, 10g of *Cephalotaxus fortunei*, 5g of *Allium macrostemon*, 25g of *Clerodendrum trichotomum*, 15g of *Polyporus umbellatus*, 15g of *Lophatherum gracile*, and 10g of *Sedum sarmentosum*. This formula is prepared by the pharmacy of our hospital (Affiliated Hospital of Changchun University of Traditional Chinese Medicine). The decoction is prepared in water to obtain approximately 300ml of liquid. The dosage is approximately 150ml each time, twice daily, after breakfast and dinner, for a total of 10 doses.

[0074] Second visit: The patient's rib pain and discomfort were significantly reduced (frequency decreased from 4-5 times daily to 2 times daily), fatigue and weakness improved (no significant fatigue after half a day of work), a significant reduction in sticky and bitter taste in the mouth upon waking, a reduction in chest and epigastric fullness (only slight bloating after eating), a reduction in dizziness (only dizziness on rainy days), and a reduction in general heaviness (only general heaviness after exertion). Appetite was good, and bowel movements were less loose, with the sticky and uncomfortable feeling almost completely gone, occurring 2-3 times daily. The tongue coating was thin and white, and the teeth marks were lighter than before. The pulse was wiry. Therefore, the dosage of Polyporus umbellatus was increased to 20g to enhance its diuretic and turbidity-eliminating effects. The dosages of the other medications remained unchanged. The patient was to continue taking the medication for 15 doses, using the same method as before.

[0075] Third visit: The distending pain in the hypochondrium has completely disappeared; fatigue and weakness have been largely relieved (no discomfort in daily activities); the sticky and bitter taste in the mouth upon waking has disappeared; the chest and epigastric fullness has disappeared; appetite and bowel movements are basically normal. Tongue and pulse: The tongue is pale red with a thin white coating; the teeth marks have become lighter; the pulse is wiry. Follow-up related tests: ALT is 37.4 U / L, AST is 31.1 U / L, GGT is 47.8 U / L; blood lipids: TG is 1.47 mmol / L, TC is 4.63 mmol / L, LDL-C is 3.22 mmol / L. The patient's symptoms are improving, and liver function and blood lipid levels have returned to normal. However, considering the patient's tongue coating and pulse indicate that phlegm and dampness are gradually dissipating and spleen deficiency is gradually recovering, further adjustments are needed to consolidate the therapeutic effect. Therefore, the prescription has been adjusted as follows: 25g of *Ficus hirta*, 8g of *Morinda officinalis*, 15g of *Rosa chinensis*, 10g of *Cephalotaxus fortunei*, 5g of *Allium macrostemon*, 30g of *Clematis armandii*, 20g of *Polyporus umbellatus*, 15g of *Lophatherum gracile*, and 10g of *Sedum sarmentosum*. The focus is on eliminating dampness and turbidity, while preventing recurrence. The patient was advised to maintain a light diet, moderate exercise (30 minutes of brisk walking daily), and avoid alcohol consumption to prevent a rebound. A follow-up 6 months after starting the medication showed that the patient's tongue and pulse were normal, liver function and blood lipid levels were normal, and the condition did not recur.

[0076] The patient is a middle-aged male who habitually enjoys a rich and fatty diet, engages in little physical activity, and has experienced gradual weight gain. This has depleted his spleen qi, preventing the proper transformation of food essence into phlegm and dampness, leading to qi stagnation and further affecting the function of the middle jiao (middle burner). Phlegm obstructing the hypochondrium causes liver dysfunction, resulting in right hypochondriac distension; phlegm obstructing the middle jiao causes chest and epigastric fullness and poor appetite; spleen deficiency leading to insufficient qi and blood production causes fatigue; prolonged phlegm stagnation transforming into heat causes a sticky and bitter taste in the mouth; phlegm obstructing the upper body causes dizziness; phlegm and dampness flowing to the limbs cause general heaviness; and phlegm and dampness flowing downwards cause loose and sticky stools. Therefore, the treatment principle is to warm the yang and promote circulation, dry dampness and resolve phlegm, and promote the ascending of clear qi and descending of turbid qi. Five-finger peach (Ficus hirtaecarpa) is used to tonify the spleen and raise yang, replenishing the qi of the middle jiao to address the root cause; Morinda officinalis (Morinda officinalis) is used to warm and tonify kidney qi. The root of Qi transformation, combined with five-finger peach root, replenishes fire to generate earth, helping the spleen Yang to be invigorated and the transformation of food and water to be successful; rose flower soothes the liver and relieves depression, invigorates blood and unblocks the meridians, clearing away the liver Qi stagnation caused by dampness and turbidity; allium macrostemon, pungent and warm, invigorates Yang and disperses the stagnation of Yin turbidity, combined with morinda root, allows Yang Qi to circulate throughout the body and Qi transformation to be continuous; sesame seed promotes urination to provide an outlet for phlegm and turbidity, and invigorates the meridians to remove the stagnation of phlegm and turbidity; polyporus umbellatus promotes diuresis and eliminates dampness to remove the symptoms of phlegm and turbidity; sedum leaf, bamboo leaf, and sedum sarmentosum reduce fat and turbidity, and clear damp heat. The whole formula works together to warm Yang and promote circulation, dry dampness and resolve phlegm, and promote the ascent of clear Qi and the descent of turbidity, thus leading to recovery from the disease.

[0077] Ms. Tian, ​​female, 32 years old, first visit on April 16, 2024. She reported that in early January 2024, due to busy work schedules, late nights, overeating, and excessive sedentary behavior, her weight increased from 54 kg to 67 kg within two months. She then dieted for 21 days, losing approximately 5 kg. She denied any history of alcohol consumption or specific medication use, and there was no history of liver disease or hereditary diseases in her family. Recently, she frequently experienced right hypochondriac distension, which worsened with emotional fluctuations; abdominal distension and fullness, which worsened after meals but could be relieved spontaneously; dizziness; heaviness and soreness in the limbs; aversion to wind; weakness in the lower back and knees; poor appetite; and loose stools, 1-2 times daily. Her tongue was pale red, swollen with teeth marks, and had a white coating, thick and greasy at the root; her pulse was wiry, and the right radial pulse was deep and weak. Liver function tests: ALT 69.2 U / L, AST 47.5 U / L, GGT 89.3 U / L; Blood lipids: TG 1.19 mmol / L, TC 6.23 mmol / L, LDL-C 4.57 mmol / L; Gastrointestinal ultrasound showed: severe fatty liver, rough gallbladder wall, and cholesterol crystals in the gallbladder wall. Traditional Chinese Medicine diagnosis: Liver obstruction (phlegm-dampness retention syndrome); Western medicine diagnosis: Metabolic-related fatty liver disease. Treatment principle: warming yang and promoting digestion, drying dampness and resolving phlegm, and promoting the ascending of clear qi and descending of turbid qi. A warm and pungent formula for purging turbidity and reducing lipids is prescribed: 25g of *Ficus hirta*, 8g of *Morinda officinalis*, 15g of *Rosa chinensis*, 10g of *Citrus aurantium*, 5g of *Allium macrostemon*, 25g of *Clematis chinensis* leaf, 15g of *Polyporus umbellatus*, 15g of *Lophatherum gracile* leaf, and 10g of *Sedum sarmentosum*. Prepared by the pharmacy of our hospital (Affiliated Hospital of Changchun University of Traditional Chinese Medicine), decoct in water to obtain the decoction (about 300ml), take about 150ml each time, twice a day, after breakfast and dinner, for a total of 10 doses.

[0078] Second visit: The patient's hypochondriac distension and discomfort have significantly decreased (frequency of attacks has decreased from 6-8 times per day to 3-4 times, worsening with emotional fluctuations); fatigue and weakness have improved (no significant fatigue after half a day of work); abdominal distension and discomfort have decreased (only after overeating); dizziness has decreased (only after poor sleep); limb heaviness and soreness have decreased (only after exertion); aversion to wind has decreased; lower back and knee weakness has decreased (only after prolonged sitting and exertion); appetite has increased; and loose stools have decreased to 1-2 times per day. The tongue is red and moist with teeth marks, the coating is white and slightly greasy, and the coating at the root is slightly thinner than the previous visit; the pulse is wiry, and the right Guan and Chi pulses are weak. Therefore, the dosage of Morinda officinalis was increased to 15g to enhance its kidney-tonifying and yang-boosting effects; the dosage of Rosa chinensis was increased to 20g to enhance its liver-soothing and depression-relieving effects; the dosage of Buzhaye was increased to 30g to enhance its digestive and stagnation-relieving effects; and the dosage of Polyporus umbellatus was increased to 20g and Sedum sarmentosum to 15g to enhance its diuretic and turbidity-eliminating effects. The dosages of the other drugs remained unchanged. The patient continued to take the medication for 15 doses, using the same method as before.

[0079] Third visit: The distending pain in the hypochondrium has completely disappeared; fatigue and weakness have been largely relieved (no discomfort in daily activities); chest and epigastric fullness have disappeared; limb heaviness and soreness have disappeared; aversion to wind has disappeared; lower back and knee weakness have disappeared; appetite and bowel movements are basically normal. Tongue and pulse: Pale red tongue with a thin white coating; teeth marks have become lighter; pulse is wiry. Follow-up related examinations: ALT 38.7 U / L, AST 35.4 U / L, GGT 36.4 U / L; blood lipids: TG 1.06 mmol / L, TC 3.29 mmol / L, LDL-C 2.84 mmol / L. Ultrasound of the digestive system showed: the gallbladder wall was not smooth. The patient's symptoms are now improving, and liver function, blood lipids, and digestive system ultrasound have returned to normal. However, considering the patient's tongue coating and pulse indicate that phlegm and dampness are gradually dissipating, and spleen and kidney deficiency is gradually recovering, further adjustments are needed to consolidate the therapeutic effect. Therefore, the prescription has been adjusted as follows: 25g of *Ficus hirta*, 10g of *Morinda officinalis*, 18g of *Rosa chinensis*, 10g of *Citrus aurantium*, 5g of *Allium macrostemon*, 30g of *Clerodendrum trichotomum*, 20g of *Polyporus umbellatus*, 15g of *Lophatherum gracile*, and 15g of *Sedum sarmentosum*. The focus is on warming yang and promoting digestion, eliminating dampness and turbidity, while preventing recurrence. The patient was advised to maintain a light diet, moderate exercise (30 minutes of jogging daily), and avoid overeating. A follow-up 6 months after starting the medication showed that the patient's tongue and pulse were normal, liver function and blood lipid levels were normal, and the condition did not recur. The patient was advised to have regular physical examinations and receive health education on diet and lifestyle.

[0080] The patient is a 32-year-old young woman. Due to a busy work schedule and long hours of staying up late, her kidney yang was depleted. This, coupled with overeating, sedentary lifestyle, and excessive lying down, damaged her spleen and stomach's digestive function. The kidneys are the foundation of innate constitution, while the spleen is the foundation of acquired constitution; the two support and promote each other. Kidney yang is the root of all yang energy in the body, and spleen yang is rooted in kidney yang, much like fire generates earth. When kidney yang is insufficient, spleen yang loses its warming and digestive function, leading to a decline in the body's ability to transform and digest nutrients. As a result, phlegm and turbidity accumulate in the liver, causing this condition. The phlegm and turbidity obstruct the hypochondrium, disrupting liver function, hence the right hypochondriac distension and fullness. Emotional distress and stagnation of liver qi cause right hypochondriac distension that worsens with emotional fluctuations; phlegm obstructing the middle jiao leads to chest and epigastric fullness and poor appetite; spleen deficiency resulting in insufficient production of qi and blood causes fatigue and weakness; phlegm obscuring the sensory orifices causes dizziness; dampness, being heavy and turbid, flows to the limbs, causing heaviness and soreness in the limbs; kidney yang deficiency causes aversion to wind and weakness in the lower back and knees; phlegm and dampness descending to the large intestine, obstructing the separation of clear and turbid substances, causes loose stools. Therefore, the treatment principle is to warm yang and promote circulation, dry dampness and resolve phlegm, and promote the ascending of clear qi and descending of turbid qi. Five-finger peach (Ficus hirta) tonifies qi and strengthens the spleen, warming and tonifying the middle jiao to address the root cause. Morinda officinalis warms the kidneys and assists yang, restoring the root of qi transformation. The combination of these two herbs, with Morinda officinalis warming the innate qi and five-finger peach tonifying the acquired qi, restores the body's qi transformation to normal. Rose (Rosa chinensis) combined with Asarum heterotropoides (Zanthoxylum bungeanum) soothes the liver meridian to relieve qi stagnation, promotes urination to eliminate turbid qi, and regulates the body's vital functions. Allium macrostemon, with its pungent and warm properties, invigorates Yang and disperses stagnation of Yin turbidity. Combined with Morinda officinalis, it assists in the transformation of Yang into Qi. Polyporus umbellatus, with its mild and diuretic properties, promotes urination and eliminates existing dampness and turbidity. Combined with Ficus hirta, it allows clear Yang to ascend and turbid Yin to descend. Buzhaye (a type of herb) aids digestion and relieves stagnation. Lophatherum gracile (another herb) clears heat and promotes diuresis, guiding turbidity away through urination while preventing phlegm and turbidity from accumulating and transforming into heat. Sedum sarmentosum (another herb) clears heat and detoxifies, lowers enzymes, protects the liver, and clears residual pathogens from the liver meridian. The entire formula addresses the liver, spleen, and kidneys simultaneously. It warms Yang and assists in the transformation of Qi to treat the root cause, dries dampness and resolves phlegm to treat the symptoms, and promotes the ascent of clear Qi and the descent of turbid Qi to restore normal Qi transformation, thus eliminating pathogens and restoring the body's balance, and allowing the liver to return to its normal function.

[0081] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pungent and warm purgative and lipid-reducing composition for treating MAFLD (manasthenia gravis) due to phlegm-dampness obstruction, characterized in that, The pungent and warm purgative and fat-reducing composition is composed of the following raw materials in parts by weight: 20-30 parts of five-finger peach, 8-15 parts of morinda root, 10-20 parts of rose, 10-15 parts of yam, 5-10 parts of allium macrostemon, 20-30 parts of bulrush leaf, 15-20 parts of poria cocos, 15-20 parts of lophatherum gracile, and 10-15 parts of sedum sarmentosum.

2. The pungent and warm purging and lipid-reducing composition for treating MAFLD with phlegm-dampness obstruction syndrome according to claim 1, characterized in that, The pungent and warm purgative and fat-reducing composition is composed of the following raw materials in parts by weight: 25-30 parts of five-finger peach, 8-15 parts of morinda root, 15-20 parts of rose, 10-15 parts of yarrow seed, 5-10 parts of allium macrostemon, 25-30 parts of bulrush leaf, 15-20 parts of poria cocos, 15-20 parts of lophatherum gracile, and 10-15 parts of sedum sarmentosum.

3. The pungent and warm purging and lipid-reducing composition for treating MAFLD with phlegm-dampness obstruction syndrome according to claim 1, characterized in that, The pungent and warm purgative and fat-reducing composition is composed of the following raw materials in parts by weight: 25 parts of five-finger peach, 8 parts of morinda root, 15 parts of rose, 10 parts of yarrow seed, 5 parts of allium macrostemon, 25 parts of bulrush leaf, 15 parts of poria cocos, 15 parts of light bamboo leaf, and 10 parts of creeping sedum.

4. The use of the warm and pungent purgative and lipid-reducing composition for treating MAFLD with phlegm-dampness obstruction as described in any one of claims 1 to 3 in the preparation of a medicament for treating MAFLD with phlegm-dampness obstruction.

5. The application according to claim 4, characterized in that, The dosage form of the drug for treating MAFLD (manipulated phlegm-dampness obstruction syndrome) is an oral preparation, which is selected from any one of granules, tablets, capsules, powders, decoctions, or pills.

6. A decoction for treating MAFLD (mandibular dysphagia) due to phlegm-dampness obstruction, characterized in that, The decoction is composed of the following ingredients in parts by weight: 20-30 parts of five-finger peach, 8-15 parts of morinda root, 10-20 parts of rose, 10-15 parts of yarrow seed, 5-10 parts of allium macrostemon, 20-30 parts of bulrush leaf, 15-20 parts of polyporus umbellatus, 15-20 parts of lophatherum gracile, and 10-15 parts of sedum sarmentosum. The preparation method of the decoction is as follows: Wash and soak the following herbs: *Ficus hirta*, *Morinda officinalis*, *Citrus aurantium*, *Allium macrostemon*, *Clematis armandii*, *Polyporus umbellatus*, *Lophatherum gracile*, and *Sedum sarmentosum*. First decoction: Heat the soaked herbs over high heat until boiling, then reduce to low heat and simmer for 30-60 minutes. Pour out the first decoction, filter it through a sieve, and store the decoction in a clean container. Second decoction: Add water to the dregs, covering them by 1-2 cm. Bring to a boil over high heat, then reduce to low heat and simmer for 30-50 minutes. When 15 minutes have elapsed, add the reserved washed rose petals to the pot and continue simmering until the time is up. Mix the filtered decoction with the first decoction.

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