Traditional Chinese medicine composition for treating liver and gallbladder damp-heat type cholelithiasis and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating liver and gallbladder damp-heat type cholelithiasis and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention comprises the following components: radix bupleuri, ginger, honeysuckle, costus root, szechwan chinaberry fruit, scutellaria baicalensis, white paeony root, pinellia ternate, immature bitter orange, endothelium corneum gigeriae galli, rheum officinale, lygodium japonicum and jujube. The traditional Chinese medicine composition is combined with the SELECT concept minimally invasive surgery technology, so that the functions of gastrointestinal tracts can be improved, abdominal distension and abdominal pain can be relieved, repair of biliary tract injury can be promoted, and the effect on treating liver and gallbladder damp-heat type cholelithiasis is remarkable.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to cholelithiasis of the liver and gallbladder damp-heat type, specifically to a traditional Chinese medicine composition for treating cholelithiasis of the liver and gallbladder damp-heat type, its preparation method and application. Background Technology

[0002] Gallstones (GD) are a common clinical disease. GD is challenging to treat, prone to recurrence, and has a high complication rate. Improper diagnosis and treatment can easily lead to liver damage, making it one of the most pressing clinical problems to be solved. Currently, with the continuous development of medical equipment such as laparoscopy and endoscopy, and the advancement of minimally invasive techniques, the diagnosis and treatment of GD are becoming increasingly minimally invasive. However, a multidisciplinary team (MDT) model has not yet been established in this area, which is detrimental to the assessment, diagnosis, and treatment of complex gallstones, and also hinders the full utilization of the advantages of traditional Chinese medicine. The SELECT concept (Spyglass, ERCP, Laparoscopy, EUS, Choledochoscopy, Traditional Chinese Medicine, SELECT) for minimally invasive treatment of GD using integrated traditional Chinese and Western medicine was proposed precisely to address this challenge. It emphasizes two key aspects: first, a multidisciplinary team collaboratively develops the optimal multi-scope combined minimally invasive surgical procedure; and second, it highlights the application of traditional Chinese medicine in the perioperative period.

[0003] Traditional medicine believes that cholelithiasis belongs to the category of 'dantong' and 'chepin'. The 'Shi Re Chapter' of 'Suwen' points out that the pain in the lateral costal region is caused by the invasion of damp-heat and toxic factors into the middle jiao, and the stagnation of liver and gallbladder. 'Jingjian' of 'Medical Classics' elaborates on the treatment of this disease by clearing and draining damp-heat. The main pathogenesis of this disease is the failure of liver to disperse and the failure of gallbladder to descend. The stagnation of bile for a long time leads to the generation of damp-heat, which accumulates in the gallbladder and turns into sand and stone after a long time. Therefore, the treatment of this disease should follow the principle of soothing the liver and draining the gallbladder, clearing heat and draining dampness. Literature retrieval shows that the main type of TCM syndrome of this disease is liver and gallbladder damp-heat. In view of the many problems existing in the diagnosis and treatment of cholelithiasis, it is of great practical and social significance to carry out the research on cholelithiasis in the combination of traditional Chinese and western medicine. Professor Shangdong's team first proposed the concept of SELECT (Spyglass, ERCP, Laparoscopy, EUS, Choledochoscopy, Traditional Chinese Medicine, SELECT) in the minimally invasive treatment of cholelithiasis in the combination of traditional Chinese and western medicine, which has been widely recognized at home and abroad. This concept emphasizes the selection of optimal minimally invasive surgery combined with multiple endoscopes, and highlights the application of traditional Chinese medicine in the perioperative period. According to the different types and distribution characteristics of hepatolithiasis, the concept uses Spyglass Direct Visualization System (Spyglass DS), Endoscopic Retrograde Cholangiopancreatography (ERCP), Laparoscope (LA), Endoscopic Ultrasonography (EUS), Choledochoscope, and other minimally invasive treatments combined with multiple endoscopes, emphasizes the combination of traditional Chinese medicine in the perioperative period, and plays the advantages of traditional Chinese medicine in accelerating the recovery of patients and preventing or delaying the recurrence of stones. The concept of minimally invasive treatment in the combination of traditional Chinese and western medicine realizes the minimally invasive, diversified and individualized treatment in the combination of traditional Chinese and western medicine.

[0004] Chinese patent CN101607067A discloses a traditional Chinese medicine preparation for treating gallstones, with the following weight ratios of various components: 10-20 parts of Citrus aurantium, 10-20 parts of Salvia miltiorrhiza, 10-20 parts of Lysimachia christinae, 10-20 parts of Curcuma longa, 10-20 parts of Bupleurum chinense, 10-20 parts of Angelica sinensis, 10-20 parts of Paeonia lactiflora, 10-20 parts of Evodia rutaecarpa, 10-20 parts of Glauber's salt ... dahurica, and chicken gizzard. The formula contains 10-20 parts of each of the following herbs: Prunella vulgaris, Scutellaria baicalensis, Artemisia capillaris, Melia toosendan, Clematis chinensis, Crataegus pinnatifida, Scutellaria barbata, Lygodium japonicum, Curcuma longa, and Poria cocos. However, this traditional Chinese medicine preparation has a long treatment course for gallstones, ranging from a minimum of 30 days to a maximum of 90 days, with an average of 50 days.

[0005] Chinese patent CN113262287A discloses a traditional Chinese medicine oral formula for treating cholecystitis with gallstones. It is composed of a self-formulated formula for dissolving gallstones using Bupleurum, including: Bupleurum 15g, Scutellaria baicalensis 9g, Paeonia lactiflora 9g, Citrus aurantium 12g, Ziziphus jujuba 12g, Rheum palmatum 6g, Gallus gallus domesticus gizzard lining 12g, Lonicera japonica 9g, Gardenia jasminoides 9g, Taraxacum mongolicum 12g, Artemisia capillaris 12g, Pinellia ternata 8g, Paeonia lactiflora 12g, Zingiber officinale 15g, and Aucklandia lappa 9g. However, the ingredients are complex and the cost is relatively high. Summary of the Invention

[0006] This invention addresses the problem of poor efficacy in treating hepatobiliary damp-heat type cholelithiasis in existing technologies by providing a traditional Chinese medicine composition for treating hepatobiliary damp-heat type cholelithiasis, its preparation method, and its application. Guided by the SELECT concept and combined with previous clinical practice, a prospective, randomized controlled clinical trial was conducted to combine optimized modern minimally invasive techniques with the classic traditional Chinese medicine formula Da Chai Hu Tang in the diagnosis and treatment of globus dysplasia (GD). The practical value of the SELECT concept was evaluated through relevant indicators, and the safety and efficacy of the traditional Chinese medicine composition provided by this invention in minimally invasive treatment of GD were explored, aiming to achieve minimally invasive, diversified, and individualized treatment of GD using integrated traditional Chinese and Western medicine.

[0007] To achieve the above objectives, the present invention provides the following technical solution: On the one hand, the present invention provides a traditional Chinese medicine composition for treating cholelithiasis of the liver and gallbladder damp-heat type, the components of which include Bupleurum chinense, ginger, honeysuckle, costus root, Sichuan pepper, scutellaria baicalensis, white peony root, pinellia ternata, immature bitter orange, chicken gizzard lining, rhubarb, lygodium japonicum and jujube.

[0008] Preferably, the components of the traditional Chinese medicine composition include Bupleurum 13-17g, ginger 13-17g, honeysuckle 8-12g, costus 8-12g, melia 8-12g, radix scrophulariae 7-11g, white peony root 7-11g, pinellia 7-11g, immature bitter orange 7-11g, gizzard 7-11g, rhubarb 4-8g, sea gold sand 4-8g, and jujube 3-5 pieces.

[0009] Preferably, the components of the traditional Chinese medicine composition include the following prescription: A: Bupleurum 15g, ginger 15g, honeysuckle 10g, costus 10g, melia 10g, radix scrophulariae 9g, white peony root 9g, pinellia 9g, immature bitter orange 9g, gizzard 9g, rhubarb 6g, sea gold sand 6g, and jujube 4 pieces; B: Bupleurum 13g, ginger 13g each, honeysuckle 12g, costus 12g, melia 12g each, radix scrophulariae 7g, white peony root 7g, pinellia 7g, immature bitter orange 7g, gizzard 7g each, rhubarb 8g, sea gold sand 8g each, jujube 3 pieces; C: Bupleurum 17, ginger 17g each, honeysuckle 8g, costus 8g, melia 8g each, radix scrophulariae 11g, white peony root 11g, pinellia 11g, immature bitter orange 11g, gizzard 11g each, rhubarb 4g, sea gold sand 4g each, jujube 5 pieces.

[0010] Specifically, the components of the traditional Chinese medicine composition are Bupleurum 15g, ginger 15g, honeysuckle 10g, costus 10g, melia 10g, radix scrophulariae 9g, white peony root 9g, pinellia 9g, immature bitter orange 9g, gizzard 9g, rhubarb 6g, sea gold sand 6g, and jujube 4 pieces.

[0011] The present application adopts the Da Chaihu Decoction of soothing liver and benefiting gallbladder, clearing heat and dampness, the Bupleurum in the prescription can disperse the evil of liver and gallbladder; the radix scrophulariae can clear heat and resolve depression, and clear the evil of lesser yang, the rhubarb can attack and purge, the immature bitter orange can break up and disperse qi, and eliminate stagnation and distension, the white peony root can be sour and sweet, and can astringe yin, and can directly reach the position of the lateral costae; the sea gold sand can clear heat, benefit dampness, and stop pain, the pinellia can descend adverse flow and harmonize the stomach, and disperse and resolve; the gizzard can digest food and resolve stones, the jujube and ginger can synergistically enhance the effect of invigorating the spleen and promoting appetite, and the whole prescription is compatible with soothing liver and benefiting gallbladder, and clearing heat and dampness. Modern pharmacological researches prove that the Bupleurum can coordinate the movement of the digestive system, and promote the discharge of bile into the intestinal tract; the radix scrophulariae contains baicalin, which has the functions of anti-inflammatory and anti-allergic reaction, can regulate the proportion of cholic acid in bile, and promote the excretion of bilirubin; the flavonoid glycosides in the immature bitter orange have the functions of bidirectional regulation of the movement of the intestinal and gastric tracts, and can benefit gallbladder and relieve pain; the emodin glycosides in the rhubarb can promote the excretion and secretion of bile and pancreatic juice; the white peony root has the effect of relieving hepatitis, cirrhosis, and other anti-liver damage effects; the water decoction alcohol precipitation liquid in the pinellia can protect the liver, and improve immunity, and accelerate the excretion function of bilirubin in blood; the trans-p- coumarin in the sea gold sand has the effects of benefiting gallbladder and protecting liver; the gizzard contains keratin, which can increase the excretion and discharge of bile.

[0012] In another aspect, the present application provides a preparation method of the traditional Chinese medicine composition, comprising the following steps: weighing the medicinal materials and crushing, decocting to obtain juice, and decocting 300-600 mL of soup per dose.

[0013] Preferably, 400 mL of soup is decocted per dose.

[0014] In another aspect, the present application provides the use of the traditional Chinese medicine composition in the treatment of cholelithiasis.

[0015] Preferably, the cholelithiasis is cholelithiasis of damp-heat type of liver and gallbladder.

[0016] Preferably, the cholelithiasis includes extrahepatic bile duct stones and / or gallbladder stones.

[0017] Preferably, the use further includes combination with SELECT minimally invasive surgery.

[0018] Compared with the prior art, the present application has the following beneficial effects: The traditional Chinese medicine composition provided by the present application has remarkable effect on the treatment of cholelithiasis, and the combination with SELECT minimally invasive surgery guided by the concept can significantly reduce the TCM symptom score and liver function index. DETAILED DESCRIPTION

[0019] Unless otherwise specified, all raw materials and reagents in the present application are purchased from commercial suppliers, and experiments are performed according to the operating instructions. Unless otherwise specified, the instruments, equipment, devices, etc. used in the present application are conventional instruments, equipment, devices, etc. and experiments are performed according to the operating instructions and the matching reagents.

[0020] In order to make the purpose, technical scheme and advantages of the present application more clear, the present application is further described in detail below with examples. Unless otherwise specified in the examples, the experiments are performed according to the conventional conditions or the conditions recommended by the manufacturers. Unless otherwise specified, all reagents or instruments are conventional products that can be purchased on the market. In order to better illustrate the present application, numerous specific details are given in the following detailed description. The specific examples described herein are only used to explain the present application and do not constitute any limitation on the present application.

[0021] Example 1: Preparation of the traditional Chinese medicine composition The traditional Chinese medicine composition provided in this example comprises 15 g of Radix Bupleuri and ginger, 10 g of Lonicera japonica, Aucklandia lappa, and Fructus Meliae, 9 g of Radix Scrophulariae, Radix Paeoniae Alba, Rhizoma Pinelliae, Fructus Aurantii, and Endothelium Corneum Corii Asini, 6 g of Radix et Rhizoma Rhei and Corolla Asteris, and 4 pieces of Fructus Jujubae. The preparation of the decoction is performed by the decoction room of the hospital pharmacy: according to the conventional method in the art, following the Management Norms for Decoction Room of Traditional Chinese Medicine in Medical Institutions, the medicinal materials are weighed and crushed, 400 mL of soup is decocted per dose, and the decoction is packaged in 2 bags (200 mL per bag).

[0022] Example 2: Preparation of the Chinese medicine composition The Chinese medicine composition provided in this example comprises Bupleurum falcatum, Zingiber officinale, each 13 g, Lonicera japonica, Aucklandia lappa, Melia toosendan, each 12 g, Scutellaria baicalensis, Paeonia lactiflora, Pinellia ternata, Citrus aurantium, Nidus Vespae, each 7 g, Rheum officinale, and Fructus Crataegi 3. The preparation method of the decoction is the same as that of Example 1.

[0023] Example 3: Preparation of the Chinese medicine composition The Chinese medicine composition provided in this example comprises Bupleurum falcatum, Zingiber officinale, each 17 g, Lonicera japonica, Aucklandia lappa, Melia toosendan, each 8 g, Scutellaria baicalensis, Paeonia lactiflora, Pinellia ternata, Citrus aurantium, Nidus Vespae, each 11 g, Rheum officinale, and Fructus Crataegi 5. The preparation method of the decoction is the same as that of Example 1.

[0024] Comparative Example 1: Preparation of the Chinese medicine composition Prepared according to the method of Example 1, with the only difference that Lonicera japonica is replaced by an equal amount of Forsythia suspensa.

[0025] Comparative Example 2: Preparation of the Chinese medicine composition Prepared according to the method of Example 1, with the only difference that Aucklandia lappa is replaced by an equal amount of Areca catechu.

[0026] Comparative Example 3: Preparation of the Chinese medicine composition Prepared according to the method of Example 1, with the only difference that Melia toosendan is replaced by an equal amount of Corydalis yanhusuo.

[0027] Comparative Example 4: Preparation of the Chinese medicine composition Prepared according to the method of Example 1, with the only difference that Lonicera japonica is 6 g and Melia toosendan is 14 g in the Chinese medicine composition.

[0028] Test Example 1: Safety evaluation of the Chinese medicine composition The Chinese medicine composition provided in this test example comprises Bupleurum falcatum, Zingiber officinale, each 22.5 g, Lonicera japonica, Aucklandia lappa, Melia toosendan, each 15 g, Scutellaria baicalensis, Paeonia lactiflora, Pinellia ternata, Citrus aurantium, Nidus Vespae, each 13.5 g, Rheum officinale, and Fructus Crataegi 6, which is 1.5 times the amount of the composition in Example 1. The preparation method of the decoction is the same as that of Example 1.

[0029] Prospectively collect 20 healthy volunteers aged 18-60 years, take the above-mentioned decoction, one dose (400 mL) per day, 200 mL after breakfast and dinner, continuously for 1 week; after the end, conduct routine blood test and related physical examination, and the results show that there is no abnormal index and physical discomfort.

[0030] Test Example 2: Application of the Chinese medicine composition in treating cholelithiasis of liver and gallbladder damp-heat type 1. Research method and object Prospectively collect 180 patients diagnosed with cholelithiasis in the First Affiliated Hospital of Henan University of Chinese Medicine from June 2024 to June 2025, and randomly divide them into 9 groups. The experimental group (traditional Chinese medicine decoction + SELECT team minimally invasive surgery) has 140 cases (including 7 groups, 20 people in each group), the control group A (ursodeoxycholic acid tablets + SELECT team minimally invasive surgery) has 20 cases, and the control group B (ursodeoxycholic acid tablets + traditional minimally invasive surgery) has 20 cases.

[0031] 2. Diagnostic criteria 2.1. Western diagnostic criteria The diagnostic criteria refer to the opinion points of "2021 Japanese Society of Gastroenterology Evidence-based Clinical Practice Guidelines: Cholelithiasis" and the relevant content of Shackelford "Surgery of the Digestive System: Hepatobiliary and Pancreatic Surgery Volume" 8th edition.

[0032] (1) Clinical symptoms and signs: right upper abdominal, subxiphoid pain (distending pain, colic, stabbing pain, etc.), which can radiate to the right shoulder and back, and can be accompanied by anorexia, nausea and vomiting, abdominal distension, etc. When the bile duct is blocked, skin and sclera jaundice, yellow urine, skin itching, chills and fever, etc. appear.

[0033] (2) Laboratory indicators: abnormal liver function (AST, ALT, DBIL, TBIL elevated), ALP elevated, urine bilirubin positive; when the bile duct is infected, white blood cells, neutrophils, CRP, PCT (procalcitonin) and other infection indicators may rise.

[0034] (3) Imaging examination: according to color Doppler ultrasound, CT, MRCP, cholangiography, ERCP, etc. Stones in the bile duct can be seen, with or without bile duct obstruction and dilation.

[0035] 2.2. Judgment of TCM syndrome type This invention takes cases of liver and gallbladder damp-heat type as the main research object, and the TCM diagnostic criteria for syndrome type correspond to the 2023 edition of "Expert Consensus on Diagnosis and Treatment of Acute and Chronic Cholecystitis and Cholelithiasis".

[0036] (1) Main symptoms: ① Right costal or upper abdominal pain, which can radiate to the right shoulder; ② Yellowish urine; ③ Diarrhea or constipation; ④ Fever and chills; ⑤ Yellowish complexion.

[0037] (2) Secondary symptoms: ① Dry mouth, bitter taste, and sticky mouth; ② Abdominal distension and poor appetite; ③ General heaviness and fatigue; ④ Nausea and vomiting.

[0038] (3) Tongue and pulse: red tongue, yellow and greasy fur, and slippery and rapid pulse.

[0039] Note: Determine the syndrome type: 2 main symptoms + 1 or 2 secondary symptoms; for patients with no obvious clinical symptoms, combine tongue and pulse manifestations and laboratory tests.

[0040] 3. Inclusion, exclusion, elimination and dropout criteria 3.1. Inclusion criteria: (1) Meet the above diagnostic criteria, including gallbladder stones, gallbladder stones combined with extrahepatic bile duct stones, and extrahepatic bile duct stones, wherein the intrahepatic bile duct stones are distributed in the third level bile duct (including the third level bile duct) below the bile duct (including the second level bile duct branch: left inner lobe, left outer lobe, right front lobe, right back lobe bile duct, first level bile duct: left and right hepatic duct, common bile duct).

[0041] (2) Patients with repeated attacks of cholelithiasis and poor response to medical treatment.

[0042] (3) No history of biliary tract surgery.

[0043] (4) Patients willing to accept traditional Chinese medicine and minimally invasive surgery treatment.

[0044] (5) Sign a written informed consent form.

[0045] (6) Life expectancy ≥ 6 months.

[0046] 3.2. Exclusion criteria: (1) Pregnant or lactating women, less than 18 years old or more than 85 years old.

[0047] (2) Patients with hepatobiliary cancer, pancreatic cancer, ampullary tumor, severe systemic infection, and sepsis.

[0048] (3) Patients with severe primary diseases of heart, brain, blood vessels, liver, kidney, tumor and hematopoietic system, and patients with mental illness.

[0049] (4) Patients with drug abuse history, poor compliance and allergy to the drug who have not been taking the drug continuously and regularly.

[0050] (5) Exclude asymptomatic cholelithiasis.

[0051] 3.3. Elimination criteria: (1) Patients with severe complications such as anaphylaxis, shock, liver failure, and kidney failure during observation.

[0052] (2) Subjects who require termination of participation in the study.

[0053] 3.4. Dropout criteria: (1) Patients with serious adverse events, unexpected situations, and worsening conditions.

[0054] (2) Patients who refuse to continue treatment for various reasons.

[0055] (3) Patients who cannot be followed up and lost.

[0056] 4. Treatment method 4.1 Minimally invasive surgery and general treatment Under the guidance of the SELECT minimally invasive concept, the subjects in the experimental group and control group A underwent the best surgical plan based on their specific condition and the location of the stones, emphasizing multi-scope combined one-stage surgical treatment. The subjects in control group B were not included in the SELECT team management and underwent minimally invasive surgery using traditional methods, including staged surgery or laparoscopic choledochotomy for stone removal as the first choice. All three groups of subjects received general symptomatic treatment such as anti-infection, fluid replacement, and liver-protecting drugs during the perioperative period.

[0057] The subjects in this study were patients with extrahepatic bile duct stones or gallbladder stones. The optimal surgical plan was selected based on the specific condition and location of the stones. (1) Extrahepatic bile duct stones: There are two main treatment methods: ERCP stone removal or laparoscopic common bile duct exploration (LCBDE).

[0058] (2) Gallbladder stones: Gallbladder stones are the most common and relatively simple pathological type of stones in the biliary system. Laparoscopic cholecystectomy (LC) is the mainstream surgical procedure.

[0059] The key point of the Select concept is to perform a single-stage surgery for cases with both extrahepatic bile duct stones and gallbladder stones (in the past, ERCP was often performed first, followed by elective laparoscopic cholecystectomy, which would increase the number of surgeries and costs for patients).

[0060] 4.2 Experimental Grouping Experimental group: Divided into 7 groups, the patients took the Chinese herbal decoction prepared in Examples 1-3 and Comparative Examples 1-4 on the day after the SELECT concept minimally invasive surgery; one dose (400mL) per day, taken warm after breakfast and dinner, 200mL each time, for 4 consecutive weeks.

[0061] Control group A: The day after SELECT minimally invasive surgery, patients took ursodeoxycholic acid tablets (Sichuan Difit Pharmaceutical Co., Ltd., National Drug Approval Number H51021463, specification 50mg / tablet) orally, 10mg / (kg·d), divided into two doses in the morning and evening, for 4 consecutive weeks.

[0062] Control group B: Ursodeoxycholic acid tablets were administered orally on the day after traditional minimally invasive surgery, 10 mg / (kg·d), divided into two doses in the morning and evening, for 4 consecutive weeks.

[0063] 5. Observation Indicators (1) TCM syndrome score: Record the TCM syndrome scores before and after 4 weeks of treatment. Refer to the relevant standards in "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (in effect)" to record the patient's relevant indicators such as jaundice, dry mouth, nausea, abdominal distension, constipation, and diarrhea. Score 0, 2, 4, and 6 for none, mild, moderate, and severe, respectively.

[0064] (2) Laboratory tests: Detect the patient's blood routine (white blood cell count, neutrophil count, hemoglobin), C-reactive protein (CRP), liver function, kidney function, serum amylase, lipase, electrolytes, and immune system-related indicators (CD4+ T cells, CD8+ T cells).

[0065] 6. Statistical methods Data analysis was performed using IBM SPSS 29.0 statistical software. For measurement data that meet the normal distribution and homogeneity of variance, analysis of variance was used. For data that do not meet the above conditions, non-parametric test was used; for count data, X 2 test was used; for ordinal data, Ridit analysis was used; P value less than 0.05 was statistically significant.

[0066] 7. Test results (1) The TCM syndrome score results of each group showed that the scores after treatment were lower than before treatment, and the scores of different experimental groups after treatment were lower than those of the control group. The treatment effect of SELECT concept minimally invasive surgery was better than that of traditional minimally invasive surgery. See Table 1 for specific data.

[0067] Table 1 TCM syndrome score

[0068] Note: In the same column, the same letter indicates no significant difference between data (P>0.05), and different letters indicate significant difference (P<0.05).

[0069] (2) In terms of blood routine test, the indicators of different groups after treatment were better than before treatment, and the indicators of different experimental groups after treatment were better than those of the control group. The treatment effect of SELECT concept minimally invasive surgery was better than that of traditional minimally invasive surgery. The liver function index data statistics were focused on, and the results are shown in Table 2.

[0070] Table 2 Liver function indicators

[0071] Note: ALT is glutamic-pyruvic transaminase (U / L), AST is glutamic-oxalacetic transaminase (U / L), TBIL is total bilirubin (μmol / L), TP is total protein (g / L); the same column data, marked the same letter indicates no significant difference between the data (P>0.05), marked different letters represent significant difference (P<0.05).

[0072] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present application, and not to limit the scope of protection of the present application, the ordinary skilled in the art of the present application to the technical solutions of the simple modification or equivalent replacement, do not deviate from the essential and scope of the present application technical solutions.

Claims

1. A traditional Chinese medicine composition for treating cholelithiasis of the liver and gallbladder damp-heat type, characterized in that, The components of the traditional Chinese medicine composition include Bupleurum, ginger, honeysuckle, costus root, Sichuan pepper, scutellaria, white peony root, pinellia, immature bitter orange, chicken gizzard lining, rhubarb, lygodium japonicum, and jujube.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises 13-17g of Bupleurum chinense, 13-17g of fresh ginger, 8-12g of honeysuckle, 8-12g of costus root, 8-12g of Sichuan pepper, 7-11g of Scutellaria baicalensis, 7-11g of white peony root, 7-11g of Pinellia ternata, 7-11g of immature bitter orange, 7-11g of chicken gizzard lining, 4-8g of rhubarb, 4-8g of Lygodium japonicum, and 3-5 jujubes.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The components of the traditional Chinese medicine composition include the following formulas: A: Bupleurum 15g, fresh ginger 15g, honeysuckle 10g, costus root 10g, Sichuan pepper 10g, scutellaria 9g, white peony root 9g, pinellia 9g, immature bitter orange 9g, chicken gizzard lining 9g, rhubarb 6g, lygodium japonicum 6g, and 4 jujubes; B: Bupleurum 13g, fresh ginger 13g, honeysuckle 12g, costus root 12g, Sichuan pepper 12g, scutellaria 7g, white peony root 7g, pinellia 7g, immature bitter orange 7g, chicken gizzard lining 7g, rhubarb 8g, lygodium japonicum 8g, jujube 3 pieces. C: Bupleurum 17g, fresh ginger 17g, honeysuckle 8g, costus root 8g, Sichuan pepper 8g, scutellaria 11g, white peony root 11g, pinellia 11g, immature bitter orange 11g, chicken gizzard lining 11g, rhubarb 4g, lygodium japonicum 4g, jujube 5 pieces.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition consists of 15g of Bupleurum chinense, 15g of fresh ginger, 10g of honeysuckle, 10g of Aucklandia lappa, 10g of Melia toosendan, 9g of Scutellaria baicalensis, 9g of Paeonia lactiflora, 9g of Pinellia ternata, 9g of Citrus aurantium, 9g of chicken gizzard lining, 6g of rhubarb, 6g of Lygodium japonicum, and 4 jujubes.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The steps include: weighing and crushing the medicinal materials, decocting them to extract the juice, and decocting 300-600mL of juice for each dose.

6. The preparation method according to claim 5, characterized in that, Each dose should be decocted into 400mL of soup.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the treatment of cholelithiasis.

8. The application according to claim 7, characterized in that, The cholelithiasis mentioned is the liver and gallbladder damp-heat type cholelithiasis.

9. The application according to claim 7, characterized in that, The cholelithiasis includes extrahepatic bile duct stones and / or gallbladder stones.

10. The application according to claim 8 or 9, characterized in that, The application also includes integration with SELECT minimally invasive surgery.

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