A traditional Chinese medicine composition for treating gallstones and its application

Abstract

This invention provides a traditional Chinese medicine composition for treating gallstones and its application. It comprises the following raw materials in parts by weight: Bupleurum chinense 6-12 parts, Scutellaria baicalensis 6-12 parts, Curcuma longa 2-5 parts, Artemisia capillaris 3-8 parts, Lysimachia christinae 2-6 parts, Coptis chinensis 4-8 parts, Anemarrhena asphodeloides 3-8 parts, Ophiopogon japonicus 3-8 parts, Citrus reticulata peel (processed with vinegar) 1-3 parts, Paeonia lactiflora 1-3 parts, Astragalus membranaceus 1-5 parts, Poria cocos 1-5 parts, Prunus persica kernel (processed with vinegar) 1-5 parts, Trichosanthes kirilowii peel 1-5 parts, Amomum villosum 1-5 parts, Pogostemon cablin 1-5 parts, Liquidambar formosana 1-5 parts, Luffa cylindrica 1-5 parts, Gleditsia sinensis thorns 1-5 parts, Coix lacryma-jobi 1-5 parts, Zea mays silk 1-5 parts, and Taraxacum mongolicum 1-5 parts. The traditional Chinese medicine composition of this invention has high safety, no toxic side effects, and exhibits synergistic effects among its components, resulting in good therapeutic efficacy and reduced adverse reactions.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition for treating gallstones and its application. Background Technology

[0002] Cholelithiasis, also known as gallstones, refers to the formation of stones in the biliary system, including the gallbladder or bile ducts. Biliary tract infection is a common disease. Based on the location of the stones, they are divided into gallbladder stones and bile duct stones. After stones form in the gallbladder, they can irritate the gallbladder mucosa, causing not only chronic inflammation but also secondary infection and acute inflammation when stones become lodged in the neck of the gallbladder or cystic duct. There are many treatment methods for cholelithiasis, mainly two: surgical treatment (including minimally invasive laparoscopic surgery) and non-surgical treatment, which involves a combination of traditional Chinese and Western medicine for symptomatic relief. For larger stones that are unresponsive to medication, surgical removal of the gallbladder can quickly eradicate the lesion and is the best approach. However, surgery has certain indications. Minimally invasive surgery only requires three small incisions of 2-3 cm in the abdomen. The procedure is simple, minimally invasive, and recovery is fast; however, minimally invasive surgery is difficult to remove small stones and may induce stone formation.

[0003] Clinically, cholecystitis, cholelithiasis, and gallbladder polyps are often treated together. While traditional Chinese medicine doesn't explicitly discuss cholecystitis, cholelithiasis, and gallbladder polyps as separate conditions, the *Ling Shu* (Spiritual Pivot) states, "When evil resides in the liver, there is pain in both hypochondria." Based on clinical manifestations, cholecystitis, cholelithiasis, and gallbladder polyps can be categorized under "jaundice," "hypochondriac pain," and "gallbladder distension." Their pathological changes involve the liver and gallbladder, and are closely related to the spleen and stomach.

[0004] The formation of gallstones is a complex process involving multiple factors. Among these, stagnation of liver qi and impaired gallbladder function are the root cause of the disease. The gallstones themselves, being tangible pathological products of phlegm, blood stasis, damp heat, etc., are the symptoms. Based on the principle in the *Neijing* (Inner Canon of Medicine) that "one must address the root cause and its underlying condition," it is essential to clear the liver and gallbladder, eliminate dampness, and expel stones to treat the root cause; and to dissolve the stones to treat the symptoms.

[0005] (1) Clearing the liver and gallbladder, and promoting diuresis and expelling stones are the basic treatment principles.

[0006] Based on the fundamental pathogenesis of liver qi stagnation and impaired gallbladder function, characterized by "accumulation and obstruction," the main treatment principle is to soothe the liver, relieve stagnation, and promote bile flow to expel stones. Liver qi stagnation is the root cause of many diseases; therefore, treatment "must be combined with methods to harmonize the liver. Harmonizing the liver means relieving stagnation, opening blockages, resolving blood stasis, clearing phlegm, and simultaneously promoting both ascending and descending functions. When the liver is harmonious, the qi of the three jiaos (upper, middle, and lower burners) will be properly regulated, and then all diseases will be resolved." In this case, relieving liver stagnation, clearing the gallbladder, eliminating heat and dampness, resolving phlegm and dispersing blood stasis, harmonizing the spleen and stomach, and restoring normal ascending and descending functions will eliminate all symptoms. Soothing the liver is designed for liver dysfunction and liver qi stagnation; promoting bile flow is designed for poor bile excretion and internal damp-heat. Soothing the liver and promoting bile flow complement each other. The ascending and dispersing of liver qi helps the gallbladder to function smoothly and descend; the harmonious and descending of gallbladder qi facilitates the ascending and smooth flow of liver qi, preventing stagnation. Therefore, soothing the liver itself can benefit the gallbladder, and benefiting the gallbladder helps to smooth the flow of liver qi. When the liver and gallbladder are in harmony and their ascending and descending functions are normal, they can regulate the spleen and stomach, smooth the flow of qi and blood, and regulate the three jiaos. As the saying goes, "The qi transformation of all the viscera and the twelve meridians must rely on the qi of the liver and gallbladder to be stimulated and invigorated, so that they can be regulated and free from disease."

[0007] (2) Softening and dispersing lumps and dissolving stones are important treatment principles.

[0008] While actively improving clinical symptoms, it is crucial to address the softening, dissolving, and facilitating effects of polyps and stones themselves. This aligns with the principle in the *Neijing* (Inner Canon of Medicine) of "dispersing what is lumpy" and "dissolving what is hard." Lithodissolving therapy can loosen the structure of stones, facilitating their reduction in size until they are expelled as fragments or dissolved in bile, reducing inflammatory stimulation of the biliary system and promoting bile flow. The selection of the properties and flavors of these medications is important. Commonly used are pungent, salty, or sour herbs. Pungent herbs disperse and promote circulation, clearing the channels and dispersing lumps; salty herbs soften and descend, entering the blood to dissolve stones; sour herbs, derived from the wood element, enter the liver and gallbladder, softening and dispersing lumps. Gastric acid digests food, and through its putrefactive action, even insects, which are mobile, become still upon contact with acid, thus losing their mobility. Therefore, the ability of acid to dissolve stones is logical. Dispersing "lumps" is not only aimed at the stones themselves, but also at pathological products such as phlegm and blood stasis, which also fall under the category of "stagnation". Therefore, it is advisable to choose products that soften and disperse lumps while also resolving phlegm or promoting blood circulation and removing blood stasis.

[0009] A search revealed numerous existing technologies disclosing traditional Chinese medicine compositions for treating gallstones. For example, CN110327449A discloses a traditional Chinese medicine composition for treating gallstones, which addresses the increasingly unsatisfactory stone-dissolving and expelling effects of existing gallstone treatments. The traditional Chinese medicine composition of this invention is made from the following raw materials in parts by weight: Aconitum carmichaelii 20-30g, Zingiber officinale (processed) 20-30g, Clove 10-15g, Curcuma longa 20-30g, Chicken gizzard lining 20-30g, Evodia rutaecarpa 5-10g, Glycyrrhiza uralensis (processed) 10-15g, Curcuma longa 15-20g, and Bupleurum chinense 15-20g. The traditional Chinese medicine composition described in CN117679481A consists of the following raw materials in parts by weight: 30-60 parts of Polygonum cuspidatum, 10-35 parts of Gleditsia sinensis thorns, 20-40 parts of Aucklandia lappa, 20-40 parts of Corydalis yanhusuo (processed with vinegar), 20-40 parts of Citrus aurantium (processed with wheat bran), 25-60 parts of chicken gizzard lining (processed with vinegar), 20-40 parts of Curcuma zedoaria (processed with vinegar), and 20-40 parts of Hedyotis diffusa.

[0010] The use of traditional Chinese medicine (TCM) compositions to treat gallstones is currently a hot research topic. Providing a TCM composition that is safe, has no toxic side effects, has good therapeutic effects, and reduces adverse reactions for the treatment of gallstones is of great significance. Summary of the Invention

[0011] In view of the shortcomings of the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating gallstones. This composition has high safety, no toxic side effects, and the drug components produce a synergistic effect, resulting in good therapeutic effect and reduced adverse reactions.

[0012] The technical solution of this invention is:

[0013] A traditional Chinese medicine composition for treating gallstones, comprising the following raw materials in parts by weight: Bupleurum chinense 6-12 parts, Scutellaria baicalensis 6-12 parts, Curcuma longa 2-5 parts, Artemisia capillaris 3-8 parts, Lysimachia christinae 2-6 parts, Coptis chinensis 4-8 parts, Anemarrhena asphodeloides 3-8 parts, Ophiopogon japonicus 3-8 parts, Citrus reticulata peel (processed with vinegar) 1-3 parts, Paeonia lactiflora 1-3 parts, Astragalus membranaceus 1-5 parts, Poria cocos 1-5 parts, Prunus persica (processed with vinegar) 1-5 parts, Trichosanthes kirilowii peel 1-5 parts, Amomum villosum 1-5 parts, Pogostemon cablin 1-5 parts, Liquidambar formosana 1-5 parts, Luffa cylindrica 1-5 parts, Gleditsia sinensis thorns 1-5 parts, Coix lacryma-jobi 1-5 parts, Zea mays silk 1-5 parts, Taraxacum mongolicum 1-5 parts.

[0014] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating gallstones is composed of the following raw materials in parts by weight: Bupleurum chinense 8 parts, Scutellaria baicalensis 8 parts, Curcuma longa 4 parts, Artemisia capillaris 6 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Anemarrhena asphodeloides 6 parts, Ophiopogon japonicus 6 parts, Citrus reticulata peel (processed with vinegar) 3 parts, Paeonia lactiflora 3 parts, Astragalus membranaceus 3 parts, Poria cocos 3 parts, Prunus persica (processed with vinegar) 3 parts, Trichosanthes kirilowii peel 3 parts, Amomum villosum 3 parts, Pogostemon cablin 3 parts, Liquidambar formosana 3 parts, Luffa cylindrica 3 parts, Gleditsia sinensis thorns 3 parts, Coix lacryma-jobi 3 parts, Zea mays 3 parts, and Taraxacum mongolicum 3 parts.

[0015] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating gallstones is composed of the following raw materials in parts by weight: Bupleurum chinense 10 parts, Scutellaria baicalensis 10 parts, Curcuma longa 4 parts, Artemisia capillaris 5 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Anemarrhena asphodeloides 6 parts, Ophiopogon japonicus 6 parts, Citrus reticulata peel (processed with vinegar) 2 parts, Paeonia lactiflora 2 parts, Astragalus membranaceus 4 parts, Poria cocos 4 parts, Prunus persica (processed with vinegar) 4 parts, Trichosanthes kirilowii peel 4 parts, Amomum villosum 4 parts, Pogostemon cablin 4 parts, Liquidambar formosana 3 parts, Luffa cylindrica 3 parts, Gleditsia sinensis 3 parts, Coix lacryma-jobi 3 parts, Zea mays 3 parts, and Taraxacum mongolicum 3 parts.

[0016] In a preferred embodiment of the present invention, the method for preparing the traditional Chinese medicine composition for treating gallstones involves decocting the above-mentioned raw materials with water. The first decoction is prepared by adding 14-16 times the amount of water and decocting for 1.5-2 hours, with Amomum villosum and Pogostemon cablin added 30-40 minutes before the completion of the first decoction. The second decoction is prepared by adding 12-14 times the amount of water and decocting for 1-2 hours. The decoctions are combined, filtered, and the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 1.20-1.30 (60°C). The paste is then dried, pulverized into a fine powder, mixed evenly, and granulated.

[0017] The present invention also provides that the dosage form of the traditional Chinese medicine composition includes any one of tablets, granules, pills, capsules and oral liquids.

[0018] The present invention also provides the application of the traditional Chinese medicine composition in the preparation of a medicament for treating gallstones.

[0019] The present invention will be further explained and described below.

[0020] The effects of each herbal ingredient in this invention:

[0021] Bupleurum: Pungent, bitter, slightly cold. It enters the liver, gallbladder, and lung meridians. Its functions include dispersing and reducing fever, soothing the liver and relieving stagnation, and raising yang qi. It is used for colds with fever and alternating chills and fever; liver qi stagnation, chest and rib pain, and irregular menstruation; qi deficiency and prolapse, gastroptosis, nephroptosis, uterine prolapse, and chronic diarrhea with rectal prolapse. In addition, it can reduce fever and treat malaria, and is a commonly used medicine for treating malaria with chills and fever.

[0022] Scutellaria baicalensis: Bitter, cold. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. Its functions include clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used for damp-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice; lung-heat cough, high fever and thirst; carbuncles and boils; bleeding due to blood heat; and fetal restlessness due to fetal heat.

[0023] Anemarrhena asphodeloides: Bitter, sweet, and cold in nature. It enters the lung, stomach, and kidney meridians. Its functions include clearing heat and purging fire, nourishing yin and moistening dryness. It is used for exogenous febrile diseases with high fever and thirst; cough due to lung heat, dry cough due to yin deficiency; steaming bone fever; internal heat and thirst; and constipation due to yin deficiency and intestinal dryness.

[0024] Ophiopogon japonicus: Sweet, slightly bitter, slightly cold. It enters the heart, lung, and stomach meridians. Its functions include nourishing yin and moistening the lungs, benefiting the stomach and promoting fluid production, clearing the heart and relieving irritability. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat; stomach yin deficiency, thirst due to fluid depletion, internal heat and thirst, constipation due to intestinal dryness; heart yin deficiency and febrile diseases causing heat disturbance to the heart, irritability and insomnia.

[0025] Turmeric: pungent, bitter, and cold in nature; enters the liver, gallbladder, heart, and lung meridians. Its functions include promoting blood circulation and relieving pain, regulating qi and relieving stagnation, clearing heat from the heart and cooling the blood, and promoting bile secretion and reducing jaundice. It is used for qi stagnation and blood stasis, stabbing pain in the chest and hypochondrium, chest pain, irregular menstruation, amenorrhea, dysmenorrhea, breast distension and pain; delirium due to febrile diseases, epilepsy and mania; hematemesis and epistaxis due to blood heat, retrograde menstruation in women; damp-heat in the liver and gallbladder, jaundice, dark urine, gallbladder distension and hypochondriac pain.

[0026] Poria cocos: Sweet, bland, and neutral. It enters the heart, lung, spleen, and kidney meridians. Its functions include promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind. It is used for edema with scanty urine; phlegm retention with dizziness and palpitations; spleen deficiency with poor appetite, loose stools and diarrhea; restlessness, palpitations, and insomnia.

[0027] Coptis chinensis: Bitter, cold. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Its functions include clearing heat and drying dampness, purging fire and detoxifying. It is used for damp-heat fullness, vomiting, diarrhea; high fever with delirium, excessive heart fire, restlessness and insomnia, palpitations; hematemesis and epistaxis due to blood heat; vomiting and acid reflux due to stomach heat, thirst, toothache due to stomach fire; carbuncles and boils, red and swollen eyes, sores in the mouth and tongue; eczema and damp sores, ear discharge.

[0028] Artemisia capillaris: Bitter, pungent, slightly cold. Enters the spleen, stomach, liver, and gallbladder meridians. Functions: Clears damp-heat, promotes bile secretion and reduces jaundice. Used for jaundice with scanty urine; damp-heat syndrome; damp sores and itching. Amomum villosum: Pungent, warm. Enters the spleen, stomach, and kidney meridians. Functions: Resolves dampness and improves appetite, warms the middle jiao and stops diarrhea, regulates qi and calms the fetus. Used for dampness obstructing the middle jiao, spleen and stomach qi stagnation, epigastric fullness and lack of appetite; spleen and stomach deficiency and cold, vomiting and diarrhea; morning sickness during pregnancy, and threatened abortion.

[0029] Trichosanthes peel: sweet, cold; enters the lung and stomach meridians. Functions: clears heat and resolves phlegm, regulates qi and relieves chest tightness. Used for phlegm-heat cough, chest tightness and hypochondriac pain. Lysimachia: sweet, bland, salty, slightly cold. Enters the liver, gallbladder, kidney, and bladder meridians. Functions: promotes diuresis and relieves jaundice, promotes urination and relieves strangury, detoxifies and reduces swelling. Used for damp-heat jaundice, gallbladder distension and hypochondriac pain; urinary stones, painful urination; carbuncles and boils, snake bites.

[0030] Lulutong (Luffa cylindrica): Bitter, neutral. Enters the liver and kidney meridians. Functions: dispels wind and invigorates blood circulation, promotes diuresis, and regulates menstruation. Used for rheumatic pain, numbness and contracture, hemiplegia due to stroke; edema and abdominal distension; traumatic injuries; irregular menstruation, amenorrhea; insufficient lactation, and blocked lactation.

[0031] Loofah sponge: Sweet, neutral. Enters the lung, stomach, and liver meridians. Functions: dispels wind, unblocks meridians, invigorates blood, and promotes lactation. Used for rheumatic pain, muscle spasms; chest and rib pain; insufficient lactation, and mastitis.

[0032] Burnt peach kernels: bitter, sweet, neutral. Enters the heart, liver, and large intestine meridians. Functions: invigorates blood circulation and removes blood stasis, moistens the intestines and promotes bowel movements, relieves cough and asthma. Used for amenorrhea and dysmenorrhea due to blood stasis, postpartum abdominal pain, abdominal masses, traumatic injuries; lung abscess, intestinal abscess; constipation due to intestinal dryness; cough and asthma.

[0033] White peony root: bitter, sour, slightly cold. It enters the liver and spleen meridians. Its functions include nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening the liver and relieving pain, and calming liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, metrorrhagia; spontaneous sweating, night sweats; pain in the hypochondrium and abdomen, spasms and pain in the limbs; and liver yang hyperactivity, headache and dizziness.

[0034] Vinegar-processed green tangerine peel: Bitter, pungent, and warm. It enters the liver, gallbladder, and stomach meridians. Its functions include soothing the liver and regulating qi, eliminating stagnation and accumulation. It is used for liver qi stagnation, chest and rib pain, hernia pain, mastitis; food stagnation and qi stagnation, abdominal distension and pain; abdominal masses, and chronic malaria lumps.

[0035] Gleditsia sinensis thorns: pungent and warm in nature; enters the liver and stomach meridians. Functions include reducing swelling and promoting pus drainage, and killing parasites. Used for early-stage carbuncles or boils that have formed pus but have not yet ulcerated; also used externally for scabies and leprosy.

[0036] Coix Seed: Sweet, bland, and cool. Enters the spleen, stomach, and lung meridians. Functions: Promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea, relieves numbness, drains pus, detoxifies and dissipates nodules. Used for edema, beriberi edema, difficulty urinating; spleen deficiency diarrhea; damp-heat numbness and contracture; lung abscess, intestinal abscess; warts, cancer. Patchouli: Pungent and slightly warm. Enters the spleen, stomach, and lung meridians. Aromatic and eliminates dampness, harmonizes the stomach and stops vomiting, releases exterior pathogens and relieves summer heat. Used for dampness obstructing the middle jiao, epigastric and abdominal distension; vomiting; summer-dampness exterior syndrome, early stage of damp-heat syndrome, fever, fatigue, chest tightness; cold-dampness blocking summer heat, abdominal pain, vomiting, and diarrhea. Astragalus: Sweet and slightly warm. Enters the spleen and lung meridians. Functions: Tonifies qi and raises yang, strengthens the defensive qi and consolidates the exterior, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves numbness, promotes pus drainage and detoxification, and promotes tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, edema and scanty urine, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia; lung qi deficiency, cough, asthma and shortness of breath; spontaneous sweating due to superficial deficiency; internal heat and thirst; blood deficiency and chlorosis, deficiency of both qi and blood; qi deficiency and blood stasis, hemiplegia, numbness and pain; qi and blood deficiency, carbuncles and boils that are difficult to ulcerate, and chronic ulcers that do not heal.

[0037] Corn silk: Sweet, neutral. Enters the bladder, liver, and gallbladder meridians. Promotes diuresis and reduces swelling; eliminates dampness and relieves jaundice. Used for edema and jaundice.

[0038] Dandelion: Bitter, sweet, and cold in nature. It enters the liver and stomach meridians. Its functions include clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting diuresis and relieving strangury. It is used for carbuncles, boils, mastitis, lung abscess, intestinal abscess, scrofula; damp-heat jaundice, and painful urination due to heat. In addition, this herb also has the effect of clearing the liver and improving eyesight, and is used to treat red, swollen, and painful eyes caused by liver fire.

[0039] Amomum villosum, pungent and warm. It enters the spleen, stomach, and kidney meridians; its functions include resolving dampness and invigorating the stomach, warming the middle jiao and stopping diarrhea, regulating qi and calming the fetus. It is used for dampness obstructing the middle jiao, spleen and stomach qi stagnation, epigastric fullness and lack of appetite; spleen and stomach deficiency and cold, vomiting and diarrhea; morning sickness during pregnancy, and threatened abortion.

[0040] The prescription of this invention is explained as follows: This disease is mostly caused by emotional distress, improper diet, or pathogenic factors such as damp-heat or phlegm-dampness, leading to stagnation of liver and gallbladder qi, obstruction of damp-heat, or internal accumulation of phlegm-dampness. This results in impaired descending and dispersing function, causing gallbladder qi stagnation, which eventually forms stones over time. Liver qi stagnation and impaired gallbladder descending function are the basic pathogenesis. Traditional Chinese medicine treatment should follow the principle of "treating the symptoms in acute cases and treating the root cause in chronic cases," and should be based on syndrome differentiation and treatment, with clearing and draining the liver and gallbladder as the main approach, supplemented by promoting diuresis and expelling stones as the main treatment principle.

[0041] The principal herb, Bupleurum, is pungent, bitter, and cold in nature. Its aromatic properties allow it to disperse and ascend, making it particularly effective at dispersing pathogenic factors in the Shaoyang meridian (half-exterior, half-interior) and harmonizing Shaoyang. It is a key herb for treating Shaoyang syndrome. Its pungent and bitter properties effectively regulate liver qi, relieving liver stagnation. The *Pharmacopoeia of Herbs* states, "Bupleurum is light and clear in nature, primarily ascending and dispersing; its taste is slightly bitter, primarily soothing the liver." The *Explanation of Materia Medica* believes that Bupleurum, being light and clear, ascends gallbladder qi; when gallbladder qi is unblocked, the liver can disperse essence, and food stagnation will naturally subside. Scutellaria baicalensis, bitter, dries dampness, clears heat, and descends qi; its cold nature clears heat and detoxifies. Entering the gallbladder, it clears Shaoyang pathogenic heat; entering the spleen and large intestine, it dries damp-heat in the stomach and intestines, making it a commonly used herb for clearing heat, drying dampness, purging fire, and detoxifying. The *Ben Cao Jing Shu* states, "Scutellaria baicalensis, in its nature, is clear and astringent, thus eliminating pathogens; its bitter taste dries dampness; its cold nature overcomes heat, therefore it treats various types of heat." When these two herbs are combined, Bupleurum chinense (Chai Hu) dispels external pathogens, while Scutellaria baicalensis (Huang Qin) drains internal heat. Bupleurum chinense (Chai Hu) raises clear qi and relieves stagnation, while Scutellaria baicalensis (Huang Qin) lowers turbidity and purges fire. Together, they raise clear qi and lower turbidity, relieve stagnation and reduce fever, harmonize the exterior and interior, and harmonize the lesser yang, thereby regulating the liver and gallbladder qi and eliminating internal heat. Together, they serve as the principal herbs. The assistant herb, Artemisia capillaris (Yin Chen), is bitter and cold, effectively clearing heat, promoting diuresis, and relieving jaundice. The *Ben Cao Jing Shu* states, "Artemisia capillaris is primarily used for wind-dampness, cold-heat, pathogenic heat accumulation, jaundice, yellowing of the whole body, difficulty urinating, and fever in the head; all these are diseases caused by damp-heat in the Yangming and Taiyin meridians. Its bitter and cold properties dry dampness and clear heat; once the damp-heat is gone, all symptoms will subside. It is an essential medicine for clearing dampness and heat accumulation." Anemarrhena asphodeloides is bitter, sweet, and cold, with the effects of clearing heat and purging fire, nourishing yin and moistening dryness; Ophiopogon japonicus is sweet, slightly bitter, and slightly cold, with the effects of nourishing yin and moistening the lungs, benefiting the stomach and generating fluids, clearing the heart and relieving irritability; Coptis chinensis is bitter and cold, with the effects of clearing heat and drying dampness, purging fire and detoxifying. These four herbs, when combined, assist the principal herb in regulating the Qi of the liver and gallbladder, clearing internal damp-heat, ensuring that the heat is removed without harming yin, and together they serve as assistant herbs.

[0042] Adjuvant herbs: For liver and gallbladder dysfunction leading to qi stagnation and pain, turmeric and vinegar-processed green tangerine peel are added to assist bupleurum in soothing the liver, regulating qi, and relieving stagnation; white peony root softens the liver and relieves pain; for spleen deficiency causing dampness and heat accumulation, which easily damages body fluids, astragalus and poria are added to tonify qi and strengthen the spleen; roasted peach kernel invigorates blood and removes blood stasis; trichosanthes peel moistens the lungs, clears heat, regulates qi, resolves phlegm, and relieves cough, clearing chest and diaphragm obstruction; for gallbladder qi invading the stomach, causing stomach disharmony, amomum and patchouli are added to harmonize the stomach, relieve nausea, and stop vomiting; for prolonged damp heat stagnation, which depletes bile and forms stones, lysimachia, luffa, and loofah are added to dispel wind, unblock meridians, promote diuresis, and expel stones; soapberry thorns, coix seed, corn silk, and dandelion clear heat, detoxify, reduce swelling, and drain pus. These are all adjuvant herbs.

[0043] The combined effects of these herbs promote both the flow of qi and blood, addressing both the exterior and interior of the body; the combination of clearing and descending herbs addresses both the root cause and the symptoms. The primary focus is on harmonizing the Shao Yang meridian, while also harmonizing the stomach qi, thus resolving the pathogenic factors and restoring the body's regulatory functions, thereby eliminating the various symptoms. Overall, the formula is meticulously crafted and appropriately combined, ensuring its effectiveness in clinical practice.

[0044] Compared with the prior art, the advantages of the present invention are:

[0045] 1. Pharmacokinetic studies have shown that the herbal composition of this invention can significantly reduce the serum TG and TBA levels and the gallstone formation rate in mice with gallstone model, improve the turbidity of the gallbladder, and significantly improve pathological changes such as hepatocyte degeneration or necrosis, perichondral inflammatory cell infiltration, and degeneration of gallbladder and bile duct epithelial cells. It can also significantly reduce the serum TBIL, DBI1, and TBA levels in rats with intrahepatic cholestasis model, and has a certain repairing effect on pathological changes such as degeneration of bile duct epithelial cells in the portal area of ​​the liver, perichondral fibrous connective tissue hyperplasia, and inflammatory cell infiltration.

[0046] 2. Clinical efficacy has demonstrated that patients treated with the herbal composition of this invention showed significant improvements in gallstone diameter and gallbladder wall thickness, as well as a significant decrease in liver and gallbladder function indicators (TC and TBIL). Comparison of TCM syndrome scores before and after treatment showed improvements in indicators such as paroxysmal colic in the right upper quadrant, chest tightness, loss of appetite, bitter and sticky taste in the mouth, nausea and vomiting, and yellowing of the eyes. Adverse reactions were minimal and significantly lower than those of existing products.

[0047] 3. Repeated-dose toxicity test and single-dose toxicity test of the traditional Chinese medicine composition of the present invention administered orally to rats for 3 months showed that the traditional Chinese medicine composition of the present invention has high safety and no toxic side effects.

[0048] 4. The preparation method of the traditional Chinese medicine composition of the present invention is simple and has a high efficacy rate in clinical trials.

[0049] 5. Compared with the formulation of traditional Chinese medicine, the synergistic effect between the drugs in the traditional Chinese medicine composition of the present invention is stronger and the therapeutic effect is better.

[0050] The detailed structure of the present invention will be further described below with reference to the accompanying drawings and specific embodiments. Attached Figure Description

[0051] Figure 1 The effect of the traditional Chinese medicine composition in the examples on the degree of gallstone formation in mice. Note: A is the blank control group, B is the model control group, C is the low-dose group of the traditional Chinese medicine group in Example 1, D is the medium-dose group of the traditional Chinese medicine group in Example 1, E is the high-dose group of the traditional Chinese medicine group in Example 1, and F is the positive control group.

[0052] Figure 2The images show histopathological findings of rat liver and gallbladder tissue (HE, ×200). Note: A is the blank control group, B is the model control group, C is the low-dose group of the traditional Chinese medicine composition of Example 1, D is the medium-dose group of the traditional Chinese medicine composition of Example 1, E is the high-dose group of the traditional Chinese medicine composition of Example 1, and F is the positive control group.

[0053] Figure 3 The images show histopathological findings of rat liver tissue (HE, ×200). Note: A is the blank control group, B is the model control group, C is the low-dose group of the traditional Chinese medicine composition of Example 1, D is the medium-dose group of the traditional Chinese medicine composition of Example 1, E is the high-dose group of the traditional Chinese medicine composition of Example 1, and F is the positive control group.

[0054] Figure 4 This is a detailed process flow diagram of the preparation method in the embodiments.

[0055] The present invention will be further explained and described below with reference to the accompanying drawings and specific embodiments. Detailed Implementation

[0056] Example 1

[0057] A traditional Chinese medicine composition for treating gallstones comprises the following ingredients in parts by weight: Bupleurum chinense 8 parts, Scutellaria baicalensis 8 parts, Curcuma longa 4 parts, Artemisia capillaris 6 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Anemarrhena asphodeloides 6 parts, Ophiopogon japonicus 6 parts, Citrus reticulata peel (processed with vinegar) 3 parts, Paeonia lactiflora 3 parts, Astragalus membranaceus 3 parts, Poria cocos 3 parts, Prunus persica (processed with vinegar) 3 parts, Trichosanthes kirilowii peel 3 parts, Amomum villosum 3 parts, Pogostemon cablin 3 parts, Liquidambar formosana 3 parts, Luffa cylindrica 3 parts, Gleditsia sinensis thorns 3 parts, Coix lacryma-jobi 3 parts, Zea mays silk 3 parts, and Taraxacum mongolicum 3 parts.

[0058] Preparation method: The above 22 ingredients are decocted twice with water. For the first decoction, add 14 times the amount of water and decoct for 1.5 hours (add Amomum villosum and Pogostemon cablin 30 minutes before the first decoction is completed). For the second decoction, add 12 times the amount of water and decoct for 1 hour. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.20-1.30 (60℃). Dry, pulverize into fine powder, add an appropriate amount of dextrin, mix evenly, granulate, dry, granulate, mix, and encapsulate to obtain the final product.

[0059] Detailed formulation process: Based on the preparation of three batches of pilot-scale samples and combined with the actual situation of large-scale production, the formulation process of this preparation is shown in Table 1:

[0060] Table 1 Preparation process

[0061]

[0062]

[0063] Example 2: Single-dose toxicity test of the traditional Chinese medicine composition prepared in Example 1 administered orally to rats.

[0064] Objective: This study used SD rats to orally administer the traditional Chinese medicine composition prepared in Example 1 three times within 24 hours and observed them continuously for 14 days. The results of the acute toxicity test in SD rats were used to understand the degree of toxicity and the organs involved, so as to provide a basis for the dose design and selection of toxicity indicators for repeated administration toxicity tests.

[0065] Methods: Forty SPF-grade SD rats (half male and half female, weighing 174.5–202.3 g) were selected and housed in cages measuring 475 mm × 350 mm × 200 mm, with 5 rats per cage. They were housed according to the international (GB14925-2010) requirements for SPF-grade laboratory animal environmental conditions, and underwent quarantine and environmental acclimatization for 5 days. They were randomly divided into two groups based on body weight: a blank control group and a group containing the traditional Chinese medicine composition prepared in Example 1 (cumulative dose 150.7 g crude drug / kg), with 20 rats in each group. Before the experiment, the rats were fasted but allowed free access to water for at least 12 hours. They were then orally administered 20 mL / kg of pure water or the traditional Chinese medicine composition prepared in Example 1, three times a day. The animals were closely observed and recorded for 0–4 hours after each administration, noting the characteristics of poisoning, the onset and recovery time of toxic reactions, and mortality. Observations were then conducted twice daily, once in the morning and once in the afternoon, for 14 consecutive days. The experimental animals were weighed on the day of administration, before administration, and on the 4th, 7th, 10th and 14th days after administration. Changes in body weight and mortality were recorded.

[0066] Results calculation and statistics:

[0067] Data were rounded to the nearest whole number. Statistical analysis was performed using SPSS 16.0. Weight values ​​were expressed as mean ± standard deviation (X ± S). A t-test was used to compare two groups when they met the criteria of normality and homogeneity of variance; the Mann-Whitney Test was used when data did not meet the criteria of normality or homogeneity of variance. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly significant.

[0068] Experimental Results: 1) Effects on general activity, poisoning symptoms, and mortality in experimental animals: Within 0-4 hours after each oral gavage administration, no significant abnormalities were observed in the behavior, mental state, and diet of rats in the blank control group and the group containing the traditional Chinese medicine composition prepared in Example 1. No related toxic reactions or animal deaths were observed. After 14 consecutive days of observation following administration, no significant abnormalities were observed in the behavior, mental state, and diet of rats in the blank control group and the group containing the traditional Chinese medicine composition prepared in Example 1. No related toxic reactions or animal deaths were observed.

[0069] 2) Effect on body weight: The experimental animals were weighed before administration on the day of administration and on days 4, 7, 10, and 14 after administration. Compared with the blank control group at the same time, there was no statistically significant difference in body weight between the experimental animals in the group with the traditional Chinese medicine composition prepared in Example 1. The above results indicate that under the conditions of this experiment, oral administration of the traditional Chinese medicine composition prepared in Example 1 three times to rats had no significant effect on the body weight of the rats.

[0070] 3) Gross anatomical observation of SD rats at the end of the experiment: no obvious abnormalities were found on the surface and cut surface of any organ.

[0071] Conclusion: Under the conditions of this experiment, rats were orally administered the traditional Chinese medicine composition prepared in Example 1 at a volume of 20 mL / kg, three times a day, with a cumulative dose of 150.7 g crude drug / kg, which is equivalent to 81 times the clinical dose per kilogram of body weight for adults (the daily dose for adults is 1.871 g crude drug / kg). No obvious toxic reactions or deaths were observed in the experimental animals.

[0072] Table 2. Effects of the traditional Chinese medicine composition prepared in Example 1 on the body weight of SD rats (n=20, )

[0073]

[0074] Table 3. Effects of the traditional Chinese medicine composition prepared in Example 1 on the body weight of female SD rats (n=10, )

[0075]

[0076] Table 4. Effects of the traditional Chinese medicine composition prepared in Example 1 on the body weight of male SD rats (n=10, )

[0077]

[0078] Table 5. Effects of the traditional Chinese medicine composition prepared in Example 1 on the body weight of SD rats (n=20, )

[0079]

[0080] Table 6. Effects of the traditional Chinese medicine composition prepared in Example 1 on the body weight of female SD rats (n=10, )

[0081]

[0082] Table 7. Effects of the traditional Chinese medicine composition prepared in Example 1 on the body weight of male SD rats (n=10, )

[0083]

[0084] Example 3: Toxicity test of rats after oral administration of the traditional Chinese medicine composition prepared in Example 1 for 3 months.

[0085] Objective: This study was conducted in accordance with national GLP guidelines. SD rats were orally administered different doses of the traditional Chinese medicine composition prepared in Example 1 for 3 consecutive months (13 weeks), followed by a 2-week recovery period. The results of the rat toxicity test were used to predict potential adverse clinical reactions of the test substance, including the nature, severity, dose-response and time-response relationships, and reversibility of adverse reactions. The study also aimed to identify the target organs or tissues for repeated administration of the test substance, highlighting key indicators to be monitored in clinical trials. This research provides a reference for estimating the starting dose and safe dosage range for repeated administration in clinical trials, monitoring toxic reactions in clinical trials, remedial measures, and clinical medication.

[0086] Methods: Eighty qualified SD rats, half male and half female, weighing 175.3–224.4 g and measuring 475 × 350 × 200 mm, were selected. 3 Five rats were housed in cages. They were raised according to the international (GB14925-2010) SPF-grade laboratory animal environmental conditions requirements, and underwent quarantine and environmental acclimatization for 6 days. They were randomly divided into four groups of 20 rats each, based on sex and weight: a blank control group, and low, medium, and high dose groups of the traditional Chinese medicine composition prepared in Example 1 (18.9, 37.8, and 75.3 g crude drug / kg, respectively). The drug was administered via gavage at a volume of 15 mL / kg for 3 consecutive months (13 weeks). At the end of the administration period (week 13) and the end of the recovery period (week 15), 40 rats (half male and half female) were dissected as planned. Examinations included: general clinical observation; weight and food intake measurements; hematological, blood biochemistry, coagulation, and organ coefficient measurements; gross anatomy; and histopathological examination.

[0087] Results Calculation and Statistics: Data in this experiment were rounded to the nearest whole number. Statistical analysis was performed using SPSS 16.0. Measurement data such as body weight, food intake, hematological parameters, coagulation parameters, biochemical parameters, and organ coefficients were expressed as mean ± standard deviation (X ± s). Systemic anatomy and histopathology results were assessed using qualitative indicators. Normality and homogeneity of variance were tested for measurement data. If normality was satisfied (P > 0.05), one-way ANOVA was used for statistical analysis, and LSD+Dunnet (homogeneous variance) or Tamhane's T2 (non-homogeneous variance) was used for comparison based on the homogeneity of variance. If normality was not satisfied (P < 0.05), the Kruskal-Wallis test was used, and the Mann-Whitney test was used for pairwise comparisons. Statistical results were presented with α = 0.05 as the test limit, where P < 0.05 indicated a statistically significant difference, and P < 0.01 indicated a statistically significant difference. Biological significance was considered in the evaluation.

[0088] Results: All experimental animals were euthanized as planned during the experiment, and no abnormal deaths of experimental animals occurred during the experiment.

[0089] General clinical observation: During the observation period, compared with the blank control group, no abnormal reactions related to drug toxicity were observed in the appearance, behavior, secretions of various cavities, and general condition of the experimental animals in each dosage group of the traditional Chinese medicine composition prepared in Example 1.

[0090] Body weight: Compared with the blank control group at the same time, the dosage groups of the traditional Chinese medicine composition prepared in Example 1 had no significant effect on the body weight of rats.

[0091] Food intake: Compared with the blank control group at the same time, the dosage groups of the traditional Chinese medicine composition prepared in Example 1 had no significant effect on the average food intake of rats.

[0092] Hematological examination: Compared with the blank control group at the same time, no toxicological changes were observed in the hematological indicators of each dose group of the traditional Chinese medicine composition prepared in Example 1. The results showed that the traditional Chinese medicine composition prepared in Example 1 had no significant effect on the hematological indicators of rats.

[0093] Blood biochemistry tests: Compared with the blank control group at the same time, no toxicologically significant changes were observed in the blood biochemistry indicators of each dose group of the traditional Chinese medicine composition prepared in Example 1. The results show that the traditional Chinese medicine composition prepared in Example 1 has no significant effect on the blood biochemistry indicators of rats.

[0094] Coagulation test: Compared with the blank control group at the same time, no toxicologically significant changes were observed in the coagulation indicators of each dose group of the traditional Chinese medicine composition prepared in Example 1. The results show that the traditional Chinese medicine composition prepared in Example 1 has no significant effect on the coagulation indicators of rats.

[0095] Organ coefficient: Compared with the blank control group at the same time, the organ coefficients of each dose group of the traditional Chinese medicine composition prepared in Example 1 showed no significant abnormalities. The results indicate that the traditional Chinese medicine composition prepared in Example 1 had no significant effect on the organ coefficient index of rats.

[0096] Gross dissection: No significant changes were observed in the color, size, and texture of the organs of the experimental animals dissected at the end of the administration period, the end of the recovery period, the blank control group, and the low, medium, and high dose groups of the traditional Chinese medicine composition prepared in Example 1.

[0097] Pathological examination: At the end of the administration period and the end of the recovery period, the experimental animals in the high-dose group of the traditional Chinese medicine composition prepared in Example 1 were dissected. There were no significant differences between them and the blank control group at the same time. No pathological changes with toxicological significance were found.

[0098] Conclusion: Under the conditions of this experiment, no significant drug-related adverse event (NOAEL) was observed in SD rats after oral administration of the traditional Chinese medicine composition prepared in Example 1 for 3 months. The NOAEL was 75.3 g crude drug / kg (equivalent to 40 times the clinically intended dose for a 70 kg adult and 6.4 times the equivalent dose).

[0099] Table 8. Effects of the traditional Chinese medicine composition prepared in Example 1 on animal body weight (g, )

[0100]

[0101]

[0102] Note: There were no statistically significant differences among the dose groups compared with the blank control group.

[0103] Table 9. Effect of the traditional Chinese medicine composition prepared in Example 1 on the average feed intake of animals (g / animal / day). )

[0104]

[0105] Note: There were no statistically significant differences among the dose groups compared with the blank control group.

[0106] Table 10. Effects of the traditional Chinese medicine composition prepared in Example 1 on animal hematology.

[0107]

[0108] Note: Compared with the blank control group, * P<0.05, ** P<0.01.

[0109] Table 11 Effects of the traditional Chinese medicine composition prepared in Example 1 on animal blood biochemical indicators

[0110]

[0111] Note: Compared with the blank control group, *P<0.05

[0112] Table 12 Effects of the traditional Chinese medicine composition prepared in Example 1 on animal coagulation

[0113]

[0114]

[0115] Note: There were no statistically significant differences among the dose groups compared with the blank control group.

[0116] Table 13 Effects of the prepared traditional Chinese medicine composition on animal organ coefficients ( mg / g

[0117]

[0118] Note: Compared with the blank control group, * P<0.05, ** P<0.01.

[0119] Example 4: Pharmacokinetic data of the traditional Chinese medicine composition from Example 1

[0120] Experiment 1: Effects of the traditional Chinese medicine composition of Example 1 on a mouse model of gallstones

[0121] 1. Experimental Objective

[0122] This experiment investigated the therapeutic effect of the traditional Chinese medicine composition of Example 1 on a mouse model of gallstones by replicating the model, providing experimental evidence for the clinical application of the traditional Chinese medicine composition of Example 1.

[0123] 2.1 Test Materials

[0124] Test substance (sample): The traditional Chinese medicine composition of Example 1 (Guyitang (Hunan) Health Technology Co., Ltd.), content: 1g of dry powder is equivalent to 5.46g of crude drug, proposed clinical dosage: 131g of crude drug / day, proposed route of administration: oral, proposed course of treatment: 1 month, positive control drug, name: Lidan Paishi Tablets, specification: 0.525g*80 tablets, manufacturer: Kuihua Pharmaceutical Group Co., Ltd.

[0125] Laboratory animals: 60 SPF-grade male C57BL / 6J mice, weighing between 17.3 and 22.9 g; (Hunan Silek Jingda Laboratory Animal Co., Ltd.)

[0126] Test method:

[0127] Grouping and Dosing

[0128] Sixty qualified male C57BL / 6J mice were randomly divided into four groups according to body weight: a blank control group, a model control group, a low-dose group (8.52 g of medicinal slices / kg), a medium-dose group (17.03 g of medicinal slices / kg), and a high-dose group (34.06 g of medicinal slices / kg) of Example 1, and a positive control group (choleretic and litholytic tablets group, 2.73 g / kg), with 10 mice in each group. Except for the blank control group, the mice in the other groups were fed a high-fat, high-cholesterol diet containing 15% fat, 1% cholesterol, and 0.5% sodium cholate, with added bile salts to induce gallstones, for 8 weeks. After grouping, the mice in each group were administered the corresponding dose of drug by gavage at 20 mL / kg, while the blank control group and the model control group were administered an equal volume of pure water by gavage, once a day for 8 consecutive weeks.

[0129] Dosage setting and grouping

[0130] In this study, the equivalent dose of the traditional Chinese medicine composition in Example 1 for mice was set as the medium dose, 0.5 times the equivalent dose as the low dose, and twice the equivalent dose as the high dose. The positive control group (choleretic and litholytic tablets) had an adult clinical dose of 10.5 g / day, which was converted to an equivalent dose of 1.365 g / kg for mice. Twice the equivalent dose was used as the dosage (2.73 g / kg). A blank control group and a model control group were also set up, as detailed in Table 14.

[0131] Table 14 Dosage design of each group of the traditional Chinese medicine composition in Example 1

[0132]

[0133] Note: 1g of dry extract powder is equivalent to 5.46g of raw medicinal material.

[0134] Drug preparation method

[0135] Positive control group: 6 tablets (3.15g) of choleretic and litholytic tablets were crushed and diluted with pure water to 23mL (0.137g / mL); Low-dose group: 1.56g of choleretic and litholytic granules were weighed and diluted with pure water to 20mL (0.078g granules / mL); Medium-dose group: 3.12g of choleretic and litholytic granules were weighed and diluted with pure water to 20mL (0.156g granules / mL); High-dose group: 6.24g of choleretic and litholytic granules were weighed and diluted with pure water to 20mL (0.312g granules / mL). The prepared volume was adjusted weekly according to the mice's weight changes.

[0136] 4.4 Detection Indicators

[0137] 1. General observation: Closely observe and record the physical appearance, behavior, secretions, excretions, and diet of each group of experimental animals after modeling and drug administration. If any experimental animal is found to be dead or near death, it should be dissected and observed promptly. The weight of the experimental animals should be measured weekly.

[0138] 2. After the last administration, mice were fasted overnight and blood was collected to detect the levels of total bile acids (TBA), total cholesterol (TC), and triglycerides (TG) in the serum;

[0139] 3. Record the details of gallstone formation;

[0140] 4. Take a portion of liver tissue (including bile ducts), fix it, dehydrate it, embed it in paraffin, section it, and perform pathological histological examination after staining with hematoxylin and eosin.

[0141] Data processing and statistical analysis

[0142] SPSS 16.0 software was used for data analysis. Experimental data are expressed as mean ± standard deviation. This indicates that when comparing multiple groups with homogeneous variances, normality and homogeneity of variance tests are performed. If normality is satisfied (P>0.05), one-way ANOVA is used for statistical analysis, and either LSD+Dunnet (homogeneous variance) or Tamhane's T2 (non-homogeneous variance) is selected for comparison based on the homogeneity of variance. If normality is not satisfied (P<0.05), the Kruskal-Wallis test is used, and pairwise comparisons are performed using the Mann-Whitney test. Statistical results are presented with α=0.05 as the test limit, where P<0.05 is considered statistically significant, and its biological significance is considered during evaluation.

[0143] 5.1 Effect on gallstone formation rate in gallstone model mice

[0144] In the model control group, 8 mice developed cholesterol stones, with a stone formation rate of 80%. No stones formed in the blank control group. Compared with the model control group, the high-dose group and the choleretic and litholytic tablet group of the traditional Chinese medicine composition in Example 1 significantly reduced the stone formation rate, and the gallbladder turbidity of the stone-forming mice was significantly improved. The low-dose group showed slight improvement in gallbladder turbidity and stone formation. Gallbladder stone formation is shown in Table 15. Figure 1 .

[0145] Table 15 Effect of the traditional Chinese medicine composition of Example 1 on lithotripsy rate in mice

[0146]

[0147] 5.2 Effects on serum levels of total cholesterol (TC), triglycerides (TG), and total bile acids (TBA) in mice are shown in Tables 1-3. Compared with the blank control group, serum TC, TG, and TBA levels in the model control group were significantly increased (P<0.01), indicating successful model establishment. Compared with the model control group, TG levels in the low, medium, and high dose groups of the traditional Chinese medicine composition in Example 1 and the positive control group were significantly decreased (P<0.01), while TBA levels in the high dose group and the choleretic and litholytic tablet group were significantly decreased. The remaining groups showed no significant effect. These results indicate that the traditional Chinese medicine composition in Example 1 has a significant therapeutic effect on gallstone model mice.

[0148] Table 16. Effects of the traditional Chinese medicine composition of Example 1 on TC, TG, and TBA levels in mice (x±s, n=10)

[0149]

[0150] Note: Compared with the blank control group, "**" indicates P<0.01, "*" indicates P<0.05; compared with the model control group, "△△" indicates P<0.01.

[0151] Liver and gallbladder histopathological examination results

[0152] In the blank control group, the hepatocytes of mice were arranged in an orderly manner, with only a few experimental animals showing mild hepatocyte degeneration or very little inflammatory cell infiltration. The remaining experimental animals showed no hepatocyte degeneration or necrosis, no sinusoidal congestion, and no degeneration or inflammatory cell infiltration in the gallbladder and portal ducts. In the model control group, except for animal 2M08, the livers of all experimental animals showed varying degrees of pathological changes, mainly hepatocyte degeneration or necrosis, periductal inflammatory cell infiltration, and degeneration of the gallbladder and bile duct epithelial cells. Compared with the model control group, the severity of liver lesions in mice at all dosage groups of the traditional Chinese medicine composition in Example 1 and in the positive control group showed a certain degree of relief: the number of hepatocyte degeneration or necrosis foci decreased, and the degree of inflammatory cell infiltration lessened. Among them, the medium and high dose groups of the traditional Chinese medicine composition in Example 1 showed lower severity of liver lesions and fewer lesions. Microscopic observation revealed that the average scores for liver and gallbladder lesions in mice from the blank control group, model control group, low-, medium-, and high-dose groups of the traditional Chinese medicine composition from Example 1, and positive control group were 0.3, 2.8, 2.2, 1.8, 1.8, and 1.8, respectively. Pathological scoring results showed that the model control group had a significantly higher score than the blank control group (P<0.01); compared with the model control group, there were no significant differences in the low-, medium-, and high-dose groups of the traditional Chinese medicine composition from Example 1 and the choleretic and litholytic tablet group, but a decreasing trend was observed. Results are shown in Table 17, and pathological images are shown below. Figure 2 .

[0153] Table 17. Effects of the traditional Chinese medicine composition of Example 1 on the liver and gallbladder of a mouse model of gallstones (pathological scores, x±s, n=10)

[0154]

[0155] Note: Compared with the blank control group, "**" indicates P<0.01.

[0156] from Figure 2 As observed, in the blank control group, hepatocytes were arranged in an orderly manner, with no degeneration or necrosis, no congestion in the sinusoids, and no bile duct degeneration or inflammatory cell infiltration in the portal area; in the model control group, hepatocytes around the smooth gallbladder showed moderate tension lipid deposition and fine vacuolar degeneration; in the low-dose group of the traditional Chinese medicine composition in Example 1, mild inflammatory cell infiltration was observed around the interlobular bile ducts of the liver; in the medium-dose group of the traditional Chinese medicine composition in Example 1, hepatocytes showed mild tension lipid deposition and fine vacuolar degeneration; in the high-dose group of the traditional Chinese medicine composition in Example 1, local hepatocytes showed fine vacuolar degeneration; and in the positive control group, a very small amount of inflammatory cell infiltration was observed around the interlobular bile ducts of the liver.

[0157] 6. Conclusion

[0158] The experimental results showed that, under the conditions of this experiment, the traditional Chinese medicine composition of Example 1 significantly reduced the serum TG and TBA levels in gallstone model mice and the gallstone formation rate in the gallbladder, improved the turbidity of the gallbladder, and significantly improved pathological changes such as hepatocyte degeneration or necrosis, perichondral inflammatory cell infiltration, and degeneration of gallbladder and bile duct epithelial cells. In summary, this indicates that the traditional Chinese medicine composition of Example 1 has a significant therapeutic effect on gallstone model mice.

[0159] Experiment 2: Effects of the traditional Chinese medicine composition of Example 1 on a rat model of intrahepatic cholestasis

[0160] Experimental objective:

[0161] This experiment investigated the therapeutic effect of the traditional Chinese medicine composition of Example 1 on rats with intrahepatic cholestasis by replicating the rat model, providing experimental evidence for the clinical application of Qingdan Paishi Granules.

[0162] Test method:

[0163] Sixty qualified SD rats were randomly divided into four groups (n=10 per group, half male and half female) according to weight and sex: a blank control group, a model control group, low (5.90 g crude drug / kg), medium (11.79 g crude drug / kg), and high (23.58 g crude drug / kg) dose groups of the traditional Chinese medicine composition from Example 1, and a positive control group (choleretic and litholytic tablets group, 1.89 g / kg). Except for the blank control group, all other groups of rats were administered α-naphthyl isothiocyanate (ANIT) via gavage to induce intrahepatic cholestasis. ANIT was diluted with corn oil to 1.6%, and except for the blank control group, all other groups of rats were administered 5 mL / kg once a week for a total of four weeks. During the modeling period, each group of rats was administered the corresponding dose of the drug by gavage at 10 mL / kg, while the blank control group and the model control group were administered an equal volume of pure water by gavage once a day for four consecutive weeks. Blood samples were collected 48 hours after the last ANIT gavage to measure serum levels of total bilirubin (TBL), direct bilirubin (DBIl), and total bile acids (TBA); liver tissue was taken for histopathological examination.

[0164] Experimental results

[0165] 1.1 Effects on serum TBIL, DBI1 and TBA levels in rats

[0166] The results are shown in Table 2-2. Compared with the blank control group, the serum levels of TBIL, DBI1, and TBA in the model control group rats were significantly increased (P<0.01), indicating successful model establishment. Compared with the model control group, the serum levels of TBIL and DBI1 in the low, medium, and high dose groups of the traditional Chinese medicine composition of Example 1 and the positive control group (choleretic and litholytic tablet group) were significantly or significantly decreased (P<0.05 or P<0.01), and the serum levels of TBA in the low, high dose groups of the traditional Chinese medicine composition of Example 1 and the positive control group (choleretic and litholytic tablet group) were significantly decreased (P<0.05). These results indicate that the traditional Chinese medicine composition of Example 1 has a significant therapeutic effect on cholestasis model rats.

[0167] Table 18. Effects of the traditional Chinese medicine composition of Example 1 on TBIL, DBI1, and TBA levels in rats (x±s, n=10)

[0168]

[0169] Note: Compared with the blank control group, "**" indicates P<0.01; compared with the model control group, "△" indicates P<0.05; "△△" indicates P<0.01.

[0170] 1.2 Pathological observation results of rat liver tissue

[0171] In the blank control group, rats showed orderly arrangement of hepatocyte cords, no hepatocyte degeneration or necrosis, no sinusoidal congestion, and no bile duct degeneration or inflammatory cell infiltration in the portal area. In the model control group, rats showed degeneration of bile duct epithelial cells in the portal area, proliferation of fibrous connective tissue around the bile ducts, moderate inflammatory cell infiltration dominated by neutrophils, and localized hepatocyte necrosis. Compared with the model control group, the liver lesions in all dosage groups of the traditional Chinese medicine composition in Example 1 and the positive control group were alleviated to some extent: the degree of bile duct epithelial cell degeneration and proliferation of fibrous connective tissue around the bile ducts was reduced, and the number of inflammatory cell infiltrations was decreased. Among them, the medium dosage group of the traditional Chinese medicine composition in Example 1 showed a lower degree of liver lesions and fewer lesions. Microscopic observation revealed that the mean liver lesion severity scores of rats in the blank control group, model control group, low-, medium-, and high-dose groups of the traditional Chinese medicine composition in Example 1, and positive control group were 0.0, 6.4, 5.1, 4.1, 4.8, and 5.1, respectively. Pathological scoring results showed that the model control group had a significantly higher score than the blank control group (P<0.01); compared with the model control group, the medium-dose group of the traditional Chinese medicine composition in Example 1 had a significantly lower score (P<0.05); there were no significant differences between the low-, high-dose groups of the traditional Chinese medicine composition in Example 1 and the positive control group, but a decreasing trend was observed. Results are shown in Table 19 and pathological images are shown below. Figure 3 .

[0172] Table 19. Effects of the Traditional Chinese Medicine Composition of Example 1 on the Liver of Rats with Intrahepatic Cholestasis Model (x±s, n=10)

[0173]

[0174] Note: Compared with the blank control group, "**" indicates P<0.01; compared with the model control group, "△" indicates P<0.05.

[0175] from Figure 3Histopathological images of rat liver tissue (HE, ×200) show that in the blank control group, hepatocytes are arranged in an orderly manner, with no degeneration or necrosis, no congestion in the sinusoids, and no bile duct degeneration or inflammatory cell infiltration in the portal area. In the model control group, bile duct epithelial cells in the portal area show degeneration, periductal fibrous connective tissue hyperplasia, and moderate inflammatory cell infiltration, mainly composed of neutrophils. In the low-dose group of the traditional Chinese medicine composition in Example 1, bile duct epithelial cells in the portal area show degeneration, periductal fibrous connective tissue hyperplasia, and mild to moderate inflammatory cell infiltration. In the medium-dose group of the traditional Chinese medicine composition in Example 1, the bile duct epithelial cells in the portal area showed degeneration, and a small number of inflammatory cells, mainly neutrophils, were observed to infiltrate. In the high-dose group of the traditional Chinese medicine composition in Example 1, the bile duct epithelial cells in the portal area showed degeneration, and mild fibrous connective tissue hyperplasia was observed around the bile duct, with inflammatory cells, mainly neutrophils, being observed. In the positive control group, the bile duct epithelial cells in the portal area showed degeneration, and mild fibrous connective tissue hyperplasia was observed around the bile duct, with inflammatory cells, mainly neutrophils, being observed.

[0176] in conclusion

[0177] The experimental results showed that, under the conditions of this experiment, the traditional Chinese medicine composition of Example 1 significantly reduced the serum levels of TBIL, DBI1, and TBA in rats with intrahepatic cholestasis, and had a certain repairing effect on pathological changes such as degeneration of bile duct epithelial cells in the portal area of ​​the liver, proliferation of periductal fibrous connective tissue, and inflammatory cell infiltration. The results indicate that the traditional Chinese medicine composition of Example 1 has a significant therapeutic effect on rats with intrahepatic cholestasis.

[0178] Example 5: Clinical analysis data of the traditional Chinese medicine composition of Example 1 of this invention.

[0179] A total of 240 patients with gallstones were selected for this study. These patients were randomly divided into four groups using a random number table: a traditional Chinese medicine (TCM) control group 1, a TCM control group 2, a positive control group, and Example 1 group, with 60 patients in each group. In TCM control group 1, there were 39 male patients and 21 female patients, aged 37–60 years, with a mean age of (48.37±4.15) years and a disease duration of 1–5 months, with a mean duration of (2.12±0.46) months. In TCM control group 2, there were 35 male patients and 25 female patients, aged 35–58 years, with a mean age of (48.13±3.97) years and a disease duration of 1–5 months, with a mean duration of (2.17±0.42) months. In the positive control group, there were 3 male patients... Of the 7 cases, 23 were female, aged 38–59 years (mean age 48.11±4.09 years), with a disease duration of 1–5 months (mean 2.14±0.45 months). In Example 1 group, there were 34 male and 26 female patients, aged 36–59 years (mean age 48.26±4.17 years), with a disease duration of 1–5 months (mean 2.17±0.41 months). There were no statistically significant differences in age and disease duration among the four groups (P>0.05).

[0180] Diagnostic criteria for Western medicine: Referencing the "Consensus Opinion on the Diagnosis and Treatment of Chronic Cholecystitis and Gallstones in Chinese Internal Medicine," the diagnostic criteria for chronic cholecystitis with gallstones in the middle and elderly include: persistent discomfort and pain in the right upper quadrant, which may be accompanied by nausea, belching, abdominal distension, heartburn, acid reflux, etc. Some patients may experience mild tenderness or percussion pain in the gallbladder area, and ultrasound may reveal gallstones. Diagnostic criteria for Traditional Chinese Medicine: Referencing the "Guidelines for the Diagnosis and Treatment of Digestive Diseases in Traditional Chinese Medicine," the diagnostic criteria for chronic cholecystitis with gallstones in the middle and elderly include: paroxysmal colic in the right upper quadrant, nausea and vomiting, chest tightness, poor appetite, bitter and sticky taste in the mouth, abdominal distension, yellowing of the eyes, constipation, dark yellow urine, red tongue with a yellow and greasy coating, and a wiry and slippery pulse.

[0181] Inclusion criteria: Patients met the clinical diagnostic criteria for gallstones in both traditional Chinese and Western medicine; gallstones were 1–5 cm in diameter; patients were aged 35–60 years, with a disease duration of 1 month–5 years; patients were not allergic; and patients had no coagulation disorders.

[0182] Exclusion criteria: gallstones larger than 5cm in diameter; impaired consciousness or dementia; critically ill patients, patients with psychological disorders, or those unable to communicate; and patients with mental disorders.

[0183] Observation indicators and efficacy criteria: Cured: All symptoms such as paroxysmal colic in the right upper quadrant, nausea and vomiting, chest tightness and loss of appetite, bitter and sticky taste in the mouth, and abdominal distension disappeared, with a reduction of 90% or more in the TCM syndrome score; Significantly Effective: Symptoms such as paroxysmal colic in the right upper quadrant, nausea and vomiting, chest tightness and loss of appetite, bitter and sticky taste in the mouth, and abdominal distension significantly improved, with a reduction of 70% or more but less than 90% in the TCM syndrome score; Effective: Symptoms such as paroxysmal colic in the right upper quadrant, nausea and vomiting, chest tightness and loss of appetite, bitter and sticky taste in the mouth, and abdominal distension improved to some extent, with a reduction of 30% or more but less than 70% in the TCM syndrome score; Ineffective: Symptoms such as paroxysmal colic in the right upper quadrant, nausea and vomiting, chest tightness and loss of appetite, bitter and sticky taste in the mouth, and abdominal distension disappeared, with a reduction of 30% or more but less than 70% in the TCM syndrome score; If symptoms such as abdominal distension do not improve significantly, and the TCM syndrome score decreases by less than 30%, the total effective rate is calculated as: cure rate + significant improvement rate + effective rate. The TCM syndrome score assesses the degree of improvement in symptoms such as paroxysmal colic in the right upper quadrant, chest tightness, loss of appetite, bitter and sticky taste in the mouth, nausea, vomiting, and yellowing of the eyes. Scores of 0, 1, 2, and 3 correspond to asymptomatic, mild, moderate, and severe symptoms, respectively. Fasting venous blood is drawn from patients to measure liver and gallbladder function-related indicators. Total cholesterol (TC) is measured using enzyme-linked immunosorbent assay (ELISA), and total bilirubin (TBIL) is measured using the diazo method. Ultrasound is used to measure the diameter of gallstones and the thickness of the gallbladder wall before and after treatment. Adverse reactions in each group are recorded and observed.

[0184] Treatment

[0185] Positive control group (Western medicine group): Patients took ursodeoxycholic acid capsules (Anshi Pharmaceutical (Zhongshan) Co., Ltd.; specification: 250mg / 14 capsules) after dinner, 2 capsules each night; and took cefdinir capsules (Jiangsu Hansoh Pharmaceutical Group Co., Ltd.; specification: 0.1g×10 capsules; 3 times / day, 1 capsule / time) orally for 1 month.

[0186] Traditional Chinese medicine control group 1; raw materials: Bupleurum chinense 8 parts, Scutellaria baicalensis 8 parts, Curcuma longa 4 parts, Artemisia capillaris 6 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts; preparation method is the same as in Example 1.

[0187] Comparative Example 2 of Traditional Chinese Medicine: Raw materials: Bupleurum chinense 10 parts, Scutellaria baicalensis 10 parts, Curcuma longa 4 parts, Artemisia capillaris 5 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Citrus reticulata peel (processed with vinegar) 2 parts, Paeonia lactiflora 2 parts, Astragalus membranaceus 4 parts, Poria cocos 4 parts, Prunus persica (processed with vinegar) 4 parts, Trichosanthes kirilowii peel 4 parts, Amomum villosum 4 parts, Pogostemon cablin 4 parts. Preparation method is the same as in Example 1.

[0188] The traditional Chinese medicine composition group of Example 1.

[0189] The traditional Chinese medicine control group 1, the traditional Chinese medicine comparative group 2, and the traditional Chinese medicine composition group of Example 1 were all administered orally. One packet (13g per packet, equivalent to 43.67g of medicinal slices) was taken three times a day for one month.

[0190] Statistical methods: SPSS 16.0 statistical software was used for data processing and analysis in this study. The t-test was used to compare continuous data, and the chi-square test was used to compare categorical data. P < 0.05 was considered statistically significant.

[0191] Table 20 Comparison of treatment efficacy among four groups of patients with gallstones [n(%)]

[0192]

[0193]

[0194] Note: Compared with the traditional Chinese medicine control group 1, "*" indicates P<0.05; "**" indicates P<0.01; compared with the traditional Chinese medicine control group 2, "#" indicates P<0.05; compared with the positive control group, "▲" indicates P<0.05.

[0195] Compared with the traditional Chinese medicine control group 1, Example 1 and the positive control group showed better efficacy, which was statistically significant (P<0.05 or P<0.01). The traditional Chinese medicine control group 2 showed better efficacy, but there was no statistical significance (P>0.05). Compared with the traditional Chinese medicine control group 2, Example 1 showed better efficacy, which was statistically significant (P<0.05). Compared with the positive control group, Example 1 showed better efficacy, which was statistically significant (P<0.05).

[0196] Table 21 Comparison of adverse reaction incidence among the four groups of patients [n(%)]

[0197]

[0198] Note: Compared with the positive control group, "*" indicates P<0.05;

[0199] Compared with the positive control group, the incidence of adverse reactions in the traditional Chinese medicine control group 1, traditional Chinese medicine control group 2, and Example 1 was significantly reduced, and the difference was statistically significant (P<0.05); there was no significant difference in the incidence of adverse reactions among the traditional Chinese medicine control group 1, traditional Chinese medicine control group 2, and Example 1 groups, and the difference was not statistically significant (P>0.05).

[0200] Table 22 Comparison of TCM syndrome scores before and after treatment in four groups of patients with gallstones Unit: points

[0201]

[0202]

[0203] Note: Compared with the traditional Chinese medicine control group 1 after treatment, "*" indicates P<0.05, and "**" indicates P<0.01; compared with the traditional Chinese medicine control group 2 after treatment, "#" indicates P<0.05, and "##" indicates P<0.01; compared with the positive control group, "▲" indicates P<0.05; compared with the same group before treatment, "Δ" indicates P<0.05, and "ΔΔ" indicates P<0.01.

[0204] Table 23 Comparison of liver and gallbladder function indicators before and after treatment in four groups of patients with gallstones

[0205]

[0206]

[0207] Note: Compared with the Chinese medicine control group 1 after treatment, "*" indicates P<0.05; compared with the Chinese medicine control group 2 after treatment, "#" indicates P<0.05; compared with the positive control group, "▲" indicates P<0.05; compared with the same group before treatment, "Δ" indicates P<0.05, and "ΔΔ" indicates P<0.01.

[0208] Table 24 Comparison of gallstone diameter and gallbladder wall thickness before and after treatment in four groups of patients with gallstones. Unit: mm

[0209]

[0210] Note: Compared with the traditional Chinese medicine control group 1 after treatment, "*" indicates P<0.05, "**" indicates P<0.01; compared with the traditional Chinese medicine control group 2 after treatment, "#" indicates P<0.05; "##" indicates P<0.01; compared with the positive control group, "▲" indicates P<0.05; compared with the same group before treatment, "Δ" indicates P<0.05, "ΔΔ" indicates P<0.01.

[0211] Example 1 showed significantly better efficacy than the traditional Chinese medicine control groups 1 and 2, and the positive control group. Before and after treatment, the diameter of gallstones and the thickness of the gallbladder wall improved in all four groups (P<0.05 or P<0.01), with Example 1 showing significantly better efficacy than the control groups (P<0.05). After treatment, liver and gallbladder function indicators (TC, TBIL) decreased in all groups (P<0.05 or P<0.01), with Example 1 showing significantly lower levels of TC and TBIL than the control groups (P<0.05). The efficacy of Group 1 was significantly higher than that of the control groups (P<0.05 or P<0.01); the TCM syndrome scores before and after treatment showed improvement in indicators such as paroxysmal colic in the right upper quadrant, chest tightness and loss of appetite, bitter and sticky taste in the mouth, nausea and vomiting, and yellowing of the eyes (P<0.05 or P<0.01); the indicators of Group 1 after treatment were lower than those of the control groups (P<0.05 or P<0.01); the side effects of Group 1 were significantly reduced compared with the Western medicine group (P<0.05); the overall efficacy of Group 1 was significantly better than that of the control groups (P<0.05 or P<0.01).

[0212] Example 6

[0213] A traditional Chinese medicine composition for treating gallstones comprises the following raw materials in parts by weight: Bupleurum chinense 10 parts, Scutellaria baicalensis 10 parts, Curcuma longa 4 parts, Artemisia capillaris 5 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Anemarrhena asphodeloides 6 parts, Ophiopogon japonicus 6 parts, Citrus reticulata peel (processed with vinegar) 2 parts, Paeonia lactiflora 2 parts, Astragalus membranaceus 4 parts, Poria cocos 4 parts, Prunus persica (processed with vinegar) 4 parts, Trichosanthes kirilowii peel 4 parts, Amomum villosum 4 parts, Pogostemon cablin 4 parts, Liquidambar formosana 3 parts, Luffa cylindrica 3 parts, Gleditsia sinensis thorns 3 parts, Coix lacryma-jobi 3 parts, Zea mays 3 parts, and Taraxacum mongolicum 3 parts. The preparation method is the same as in Example 1, and the effects are similar to those of the traditional Chinese medicine composition in Example 1, which will not be repeated here.

[0214] The above description is a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and concept of the present invention, should be covered within the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating gallstones, characterized in that, It is made from the following ingredients in parts by weight: Bupleurum chinense 6-12 parts, Scutellaria baicalensis 6-12 parts, Curcuma longa 2-5 parts, Artemisia capillaris 3-8 parts, Lysimachia christinae 2-6 parts, Coptis chinensis 4-8 parts, Anemarrhena asphodeloides 3-8 parts, Ophiopogon japonicus 3-8 parts, Citrus reticulata peel (vinegar-processed) 1-3 parts, Paeonia lactiflora 1-3 parts, Astragalus membranaceus 1-5 parts, Poria cocos 1-5 parts, Prunus persica (processed with vinegar) 1-5 parts, Trichosanthes kirilowii peel 1-5 parts, Amomum villosum 1-5 parts, Pogostemon cablin 1-5 parts, Liquidambar formosana 1-5 parts, Luffa cylindrica 1-5 parts, Gleditsia sinensis thorns 1-5 parts, Coix lacryma-jobi 1-5 parts, Corn silk 1-5 parts, Taraxacum mongolicum 1-5 parts.

2. The traditional Chinese medicine composition for treating gallstones according to claim 1, characterized in that, Made from the following ingredients in parts by weight: Bupleurum chinense 8 parts, Scutellaria baicalensis 8 parts, Curcuma longa 4 parts, Artemisia capillaris 6 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Anemarrhena asphodeloides 6 parts, Ophiopogon japonicus 6 parts, Citrus reticulata peel (processed with vinegar) 3 parts, Paeonia lactiflora 3 parts, Astragalus membranaceus 3 parts, Poria cocos 3 parts, Prunus persica (processed with vinegar) 3 parts, Trichosanthes kirilowii peel 3 parts, Amomum villosum 3 parts, Pogostemon cablin 3 parts, Liquidambar formosana 3 parts, Luffa cylindrica 3 parts, Gleditsia sinensis thorns 3 parts, Coix lacryma-jobi 3 parts, Corn silk 3 parts, Taraxacum mongolicum 3 parts.

3. The traditional Chinese medicine composition for treating gallstones according to claim 1, characterized in that, Made from the following ingredients in parts by weight: Bupleurum chinense 10 parts, Scutellaria baicalensis 10 parts, Curcuma longa 4 parts, Artemisia capillaris 5 parts, Lysimachia christinae 4 parts, Coptis chinensis 6 parts, Anemarrhena asphodeloides 6 parts, Ophiopogon japonicus 6 parts, Citrus reticulata peel 2 parts, Paeonia lactiflora 2 parts, Astragalus membranaceus 4 parts, Poria cocos 4 parts, Prunus persica 4 parts, Trichosanthes kirilowii peel 4 parts, Amomum villosum 4 parts, Pogostemon cablin 4 parts, Liquidambar formosana 3 parts, Luffa cylindrica 3 parts, Gleditsia sinensis 3 parts, Coix lacryma-jobi 3 parts, Corn silk 3 parts, Taraxacum mongolicum 3 parts.

4. The traditional Chinese medicine composition for treating gallstones according to any one of claims 1-3, characterized in that, The preparation method includes: adding water to the above raw materials and decocting them. For the first decoction, add 14-16 times the amount of water and decoct for 1.5-2 hours. Among them, Amomum villosum and Pogostemon cablin are added 30-40 minutes before the first decoction is completed. For the second decoction, add 12-14 times the amount of water and decoct for 1-2 hours. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.20-1.30, dry, pulverize into fine powder, mix evenly, and granulate.

5. The traditional Chinese medicine composition for treating gallstones according to any one of claims 1-3, characterized in that, The dosage form of the traditional Chinese medicine composition is any one of tablets, granules, pills, capsules, and oral liquids.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating gallstones.

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