A Jinqian Dantong drug combination for postoperative intervention of cholelithiasis and its application

Abstract

The present invention discloses a Jinqian Dantong pharmaceutical combination for postoperative intervention of cholelithiasis and its application, belonging to the field of pharmaceutical technology. The Jinqian Dantong pharmaceutical combination for postoperative intervention of cholelithiasis includes: a Jinqian Dantong composition and chenodeoxycholic acid; the Jinqian Dantong composition includes Glechoma longituba, Lysimachia christinae, Polygonum cuspidatum, Artemisia capillaris, Bupleurum chinense, Taraxacum mongolicum, Cyperus rotundus, Salvia miltiorrhiza, Cassia obtusifolia and Prunus mume. After performing cholecystolithotomy for patients with cholelithiasis, by combining traditional Chinese medicine ingredients (Jinqian Dantong composition) with western medicine (chenodeoxycholic acid) for intervention, the postoperative stone recurrence rate can be reduced and the quality of life of patients can be improved.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and particularly relates to a Jinqian Dantong drug combination for postoperative intervention of cholelithiasis and its application. Background Art

[0002] Cholelithiasis is a general term in modern medicine for gallbladder stones and bile duct stones. It is a common and frequently-occurring disease in hepatobiliary surgery, specifically referring to the disease of stone formation in the bile duct and gallbladder. Clinically, the main symptoms include abdominal pain, chills and fever, jaundice, nausea and vomiting, etc. As one of the common acute abdominal diseases, suppurative cholangitis, biliary pancreatitis, biliary tract obstruction, and even gallbladder perforation caused by cholelithiasis are more harmful, seriously affecting people's quality of life and life health. Therefore, active and effective treatment for cholelithiasis is extremely important.

[0003] Cholelithiasis has the characteristics of high recurrence rate, difficult stone dissolution, and unsmooth stone expulsion. The treatment of cholelithiasis still mainly relies on surgery, and usually adopts two treatment methods: cholecystectomy and gallbladder-preserving lithotomy. The former not only causes damage to the bile duct, but also cannot retain the gallbladder function, affecting the digestion and absorption of the body. Gallbladder-preserving lithotomy mainly includes methods such as ultrasonic lithotripsy, laparoscopic lithotomy, endoscopic lithotomy, and traditional drug stone dissolution. Although it avoids the disadvantages of cholecystectomy, it cannot remove the root cause of stone formation, and has a high postoperative residual stone rate and the probability of stone recurrence. Although surgical treatment has a quick effect, due to its high postoperative residual stone rate, complication rate, and recurrence rate, the treatment effect is often not satisfactory.

[0004] At present, there is no good method in medical research to prevent stone recurrence after gallbladder-preserving lithotomy. The main preventive measures in Western medicine include taking litholytic drugs such as oral ursodeoxycholic acid and chenodeoxycholic acid, but these drugs are relatively expensive and will produce relatively large adverse reactions after long-term use. Local perfusion litholysis and extracorporeal shock wave lithotripsy itself have the potential risk of stone recurrence and are generally not used as treatment means for preventing stone recurrence. In addition, the effect of preventing stone recurrence by changing diet and living habits is relatively limited.

[0005] Traditional Chinese medicine has good curative effects on the treatment of cholelithiasis, prevention of stone formation, and postoperative rehabilitation. It has the advantages of non-invasive, safe and reliable curative effect, and small side effects. It also has remarkable effects in the litholysis and stone expulsion treatment of cholelithiasis and prevention of gallstone regeneration, having advantages that Western medicine does not have. The treatment of cholelithiasis with traditional Chinese medicine has a long history. Compared with simply performing minimally invasive gallbladder-preserving surgery, taking traditional Chinese medicine for soothing the liver and promoting bile flow as adjuvant treatment after surgery can reduce the probability of stone recurrence in patients.

[0006] The journal article ("Clinical Observation on the Residual Stone Rate and Recurrence Rate of Postoperative Cholelithiasis Treated with Dandelion and Saxifrage Decoction Combined with Western Medicine", Xu Yifan et al., Journal of Qiannan Medical College for Nationalities, 2022, 35(04)) selected 60 patients who underwent cholecystolithiasis / common bile duct stone surgery in Qiannan Traditional Chinese Medicine Hospital from September 2021 to August 2022. They were divided into an observation group and a control group (n = 30) using the random control method. The control group was given routine symptomatic treatment with Western medicine after surgery, and the observation group was given Dandelion and Saxifrage Decoction on the basis of the control group after surgery, and the medicine was taken continuously for 4 weeks. The traditional Chinese medicine symptoms, postoperative residual stone rate, incidence of adverse reactions, and stone recurrence rate at 6 and 12 months after surgery were evaluated in both groups. The results showed that: at 7 days and 1 month after surgery, the traditional Chinese medicine symptom scores of both groups gradually decreased (P < 0.05); B-ultrasound was rechecked at 7 days after surgery, and no stone residues were found in both groups; there was no significant difference in the stone recurrence rate between the two groups at 6 months after surgery (P > 0.05); at 12 months after surgery, there was a significant difference in the stone recurrence rate between the two groups (P < 0.05); no adverse reactions occurred during the medication period in both groups. The incidence of adverse reactions in the observation group after surgery (6.67%) was significantly lower than that in the control group (33.33%), and the difference was statistically significant (P < 0.05). It can be seen that Dandelion and Saxifrage Decoction can promote the stone expulsion efficiency and reduce the stone recurrence rate.

[0007] The journal article ("Effect of Traditional Chinese Medicine for Dissolving Stones and Promoting Bile Discharge on the Tendency of Bile Lithogenesis in Patients with Cholelithiasis after ERCP Stone Extraction", Liu Yang et al., Chinese and Foreign Health Digest, Issue 12, 2014) studied the effect of traditional Chinese medicine for dissolving stones and promoting bile discharge on the tendency of bile lithogenesis in patients with cholelithiasis after endoscopic retrograde cholangiopancreatography (ERCP) stone extraction. 144 patients with cholelithiasis who underwent ERCP, EST, basket stone extraction, and ENBD were randomly divided into a traditional Chinese medicine for dissolving stones and promoting bile discharge group, an Ursodeoxycholic Acid (UDCA) group, and a control group. The contents of total bilirubin (TB), direct bilirubin (DB), cholesterol (CH), phospholipid (PHL), and total bile salt (TBS) in bile were measured on the 1st day, 7th day, and 14th day after surgery, and the lithogenic index (L.I.), indirect bilirubin percentage (UCB%), and comprehensive value of bile lithogenesis tendency (z value) were calculated. At the same time, follow-up was carried out for 3 - 12 months, with an average of 6 months; the patients underwent abdominal B-ultrasound, CT, and MRCP examinations every 3 months or when abdominal pain symptoms occurred. The results showed that after 1 year of follow-up, the recurrence rate of gallstones in the traditional Chinese medicine for dissolving stones and promoting bile discharge group decreased significantly (P < 0.05). It can be seen that traditional Chinese medicine for dissolving stones and promoting bile discharge can regulate the bile components, thereby dissolving stones, inhibiting the formation of gallstones, and reducing the recurrence of gallstones.

[0008] In summary, it can be seen that it is feasible to use traditional Chinese medicine for conditioning after surgery to reduce the recurrence probability of cholelithiasis. However, the conditioning period of traditional Chinese medicine is usually long, and the effect of dissolving stones is quite limited. The effect of using only traditional Chinese medicine for postoperative conditioning still needs to be improved. The commonly used Western medicine for treating cholelithiasis is mainly chenodeoxycholic acid, which has good effects such as dissolving stones. Therefore, the combined use of traditional Chinese and Western medicine, acting on the biliary system together, is expected to increase the curative effect, reduce the recurrence rate of stones, and improve the quality of life of patients.

[0009] Based on this, the present invention provides a Jinqian Dantong drug combination for postoperative intervention of cholelithiasis and its application. After performing cholecystolithotomy on patients with cholelithiasis, by using a combination of traditional Chinese medicine ingredients (Jinqian Dantong composition) and Western medicine (chenodeoxycholic acid) for intervention, the recurrence rate of postoperative stones can be reduced. Summary of the Invention

[0010] Aiming at the problems existing in the prior art, the present invention provides a Jinqian Dantong drug combination for postoperative intervention of cholelithiasis and its application. The Jinqian Dantong drug combination for postoperative intervention of cholelithiasis includes: Jinqian Dantong composition and chenodeoxycholic acid; the Jinqian Dantong composition includes Glechoma longituba (Nakai) Kupr., Lysimachia christinae Hance, Polygonum cuspidatum Sieb. et Zucc., Artemisia capillaris Thunb., Bupleurum chinense DC., Taraxacum mongolicum Hand.-Mazz., Cyperus rotundus L., Salvia miltiorrhiza Bunge, Cassia obtusifolia L., and Prunus mume Sieb. et Zucc. After performing cholecystolithotomy on patients with cholelithiasis, by using a combination of traditional Chinese medicine ingredients (Jinqian Dantong composition) and Western medicine (chenodeoxycholic acid) for intervention, the recurrence rate of postoperative stones can be reduced.

[0011] To achieve the above object, in the first aspect, the present invention provides a Jinqian Dantong drug combination for postoperative intervention of cholelithiasis, including:

[0012] Jinqian Dantong composition and chenodeoxycholic acid; the Jinqian Dantong composition includes Glechoma longituba (Nakai) Kupr., Lysimachia christinae Hance, Polygonum cuspidatum Sieb. et Zucc., Artemisia capillaris Thunb., Bupleurum chinense DC., Taraxacum mongolicum Hand.-Mazz., Cyperus rotundus L., Salvia miltiorrhiza Bunge, Cassia obtusifolia L., and Prunus mume Sieb. et Zucc.

[0013] In a preferred embodiment, the Jinqian Dantong composition includes, by weight: 10-25 parts of Glechoma longituba (Nakai) Kupr., 10-20 parts of Lysimachia christinae Hance, 5-15 parts of Polygonum cuspidatum Sieb. et Zucc., 10-20 parts of Artemisia capillaris Thunb., 3-7 parts of Bupleurum chinense DC., 5-15 parts of Taraxacum mongolicum Hand.-Mazz., 3-8 parts of Cyperus rotundus L., 3-8 parts of Salvia miltiorrhiza Bunge, 3-8 parts of Cassia obtusifolia L., and 3-8 parts of Prunus mume Sieb. et Zucc.

[0014] In a preferred embodiment, the Jinqian Dantong composition includes, by weight: 20 parts of Glechoma longituba (Nakai) Kupr., 15 parts of Lysimachia christinae Hance, 10 parts of Polygonum cuspidatum Sieb. et Zucc., 15 parts of Artemisia capillaris Thunb., 5 parts of Bupleurum chinense DC., 10 parts of Taraxacum mongolicum Hand.-Mazz., 5 parts of Cyperus rotundus L., 5 parts of Salvia miltiorrhiza Bunge, 5 parts of Cassia obtusifolia L., and 5 parts of Prunus mume Sieb. et Zucc.

[0015] In a preferred embodiment, the preparation process of the Jinqian Dantong composition includes the following steps:

[0016] Weigh each medicinal material according to the formula, add water for extraction, and concentrate or dry the extraction solution to obtain the Jinqiandantong composition.

[0017] In a preferred embodiment, the mass-to-volume ratio of the medicinal material to water is 1 g:5 - 20 mL, the extraction temperature is 40 - 60 °C, the extraction time is 2 - 8 h, and the number of extraction times is 1 - 4 times.

[0018] In a preferred embodiment, the concentration is to concentrate to a crude drug content of 10 - 50 g / 10 mL.

[0019] In a preferred embodiment, the dosage form of the Jinqiandantong composition is granules, capsules, tablets, pills, dripping pills, powders or oral liquids.

[0020] In a preferred embodiment, the Jinqiandantong composition further comprises pharmaceutically acceptable excipients.

[0021] In a preferred embodiment, the excipients include at least one of starch, dextrin, calcium carbonate, talc, and microcrystalline cellulose.

[0022] In a preferred embodiment, the unit dose of the Jinqiandantong composition is 1 - 5 g of crude drug / kg / d, and the unit dose of chenodeoxycholic acid is 10 - 15 mg / kg / d.

[0023] In a second aspect, the present invention provides the application of the aforementioned Jinqiandantong drug combination for postoperative intervention of cholelithiasis in the preparation of a drug for postoperative intervention of cholelithiasis.

[0024] The beneficial effects of the present invention are as follows:

[0025] 1. The Jinqiandantong drug combination for postoperative intervention of cholelithiasis provided by the present invention, after performing cholecystolithotomy on cholelithiasis patients, by combining traditional Chinese medicine ingredients (Jinqiandantong composition) with western medicine (chenodeoxycholic acid) for intervention, can reduce the TC content in serum and bile, promote the secretion of TBA, and regulate the ratio of TC to TBA, thereby reducing the risk of cholelithiasis recurrence and the postoperative stone recurrence rate.

[0026] 2. The Jinqiandantong drug combination for postoperative intervention of cholelithiasis of the present invention combined with cholecystolithotomy has a good therapeutic effect on cholelithiasis, can reduce the recurrence probability of cholelithiasis, and avoid gallbladder wall thickening and improve gallbladder contraction function. Detailed implementation manners

[0027] The present invention will be further described below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer as the description progresses. However, these embodiments are merely exemplary and do not impose any limitation on the scope of the present invention. Those skilled in the art should understand that without departing from the spirit and scope of the present invention, modifications or substitutions can be made to the details and forms of the technical solutions of the present invention, but such modifications and substitutions all fall within the protection scope of the present invention.

[0028] It is worth noting that the raw materials used in the present invention are all ordinary commercially available products, and no specific limitation is imposed on their sources.

[0029] Example 1

[0030] Preparation of the Jinqian Dantong composition:

[0031] The composition by weight is as follows: 20 parts of Glechoma longituba, 15 parts of Lysimachia christinae, 10 parts of Polygonum cuspidatum, 15 parts of Artemisia capillaris, 5 parts of Bupleurum chinense, 10 parts of Taraxacum mongolicum, 5 parts of Cyperus rotundus, 5 parts of Salvia miltiorrhiza, 5 parts of Cassia obtusifolia, and 5 parts of Prunus mume;

[0032] The preparation process is as follows:

[0033] Weigh each medicinal material according to the formula, add water for extraction according to the mass-volume ratio of medicinal material to water of 1 g:10 mL, the extraction temperature is 50 °C, the extraction time is 4 h, repeat the extraction 2 times, combine the extraction liquids, and concentrate to a crude drug content of 28.5 g / 10 mL to obtain the Jinqian Dantong composition.

[0034] Example 2

[0035] Preparation of the Jinqian Dantong composition:

[0036] The composition by weight is as follows: 15 parts of Glechoma longituba, 20 parts of Lysimachia christinae, 5 parts of Polygonum cuspidatum, 20 parts of Artemisia capillaris, 7 parts of Bupleurum chinense, 5 parts of Taraxacum mongolicum, 8 parts of Cyperus rotundus, 3 parts of Salvia miltiorrhiza, 8 parts of Cassia obtusifolia, and 3 parts of Prunus mume;

[0037] The preparation process is as follows:

[0038] Weigh each medicinal material according to the formula, add water for extraction according to the mass-volume ratio of medicinal material to water of 1 g:20 mL, the extraction temperature is 40 °C, the extraction time is 8 h, take the extraction liquid and concentrate to a crude drug content of 28 g / 10 mL to obtain the Jinqian Dantong composition.

[0039] Example 3

[0040] Preparation of the Jinqian Dantong composition:

[0041] The formula is as follows: 25 parts of Glechoma longituba, 10 parts of Lysimachia christinae, 15 parts of Polygonum cuspidatum, 10 parts of Artemisia capillaris, 3 parts of Bupleurum chinense, 15 parts of Taraxacum mongolicum, 3 parts of Cyperus rotundus, 8 parts of Salvia miltiorrhiza, 3 parts of Cassia obtusifolia, and 8 parts of Prunus mume;

[0042] The preparation process is as follows:

[0043] Weigh each medicinal material according to the formula, add water for extraction according to the mass-volume ratio of medicinal material to water being 1 g:5 mL, the extraction temperature is 60 °C, the extraction time is 3 h, repeat the extraction 2 times, combine the extraction solutions, and concentrate to a crude drug content of 29 g / 10 mL to obtain the said Jinqiandantong composition.

[0044] Comparative Example 1

[0045] Except using Fructus Aurantii Immaturus to replace Taraxacum Mongolicum Hand.-Mazz., the rest is the same as Example 1.

[0046] Comparative Example 2

[0047] Except that the extraction temperature is 80 °C, the rest is the same as Example 1.

[0048] Comparative Example 3

[0049] Except that the extraction temperature is 25 °C, the rest is the same as Example 1.

[0050] Application Example 1

[0051] Therapeutic effect on rabbits with cholecystolithiasis model

[0052] 1. Establishment of rabbit cholecystolithiasis model: 110 healthy adult male rabbits, weighing 3.5 - 4.5 kg, were fed a lithogenic diet (high-cholesterol feed: 1.2% cholesterol, 98.8% ordinary feed) at room temperature of 23 ± 2 °C for 5 weeks, with free drinking water.

[0053] 2. Endoscopic gallbladder-preserving lithotomy: The rabbits after modeling were anesthetized intravenously with 3% sodium pentobarbital (30 mg / kg) and fixed in the supine position on the rabbit table. The abdominal hair was removed, and the skin of the operative area was routinely disinfected with iodophor under aseptic operation. An upper midline abdominal incision was made to enter the abdomen. After aspirating the bile completely with a syringe at the bottom of the gallbladder, a purse-string suture opening with a diameter of 4 mm was made at the bottom of the gallbladder with 5-0 nylon non-invasive suture. The stones in the gallbladder were removed completely, and after washing with 0.9% sodium chloride solution, the abdomen was closed layer by layer.

[0054] 3. Group Intervention: The model rabbits with different grades of stones were evenly distributed into each group and intervened as follows: The control group was given a normal diet, the model group was given a lithogenic diet (high-cholesterol feed: 1.2% cholesterol, 98.8% normal feed), the groups of Examples 1-3 and Comparative Examples 1-3 were given a lithogenic diet (high-cholesterol feed: 1.2% cholesterol, 98.8% normal feed) + chenodeoxycholic acid (10 mg / kg / d) + the corresponding Jinqian Dantong composition (5 mL / d), the group of Comparative Example 4 was given a lithogenic diet (high-cholesterol feed: 1.2% cholesterol, 98.8% normal feed) + chenodeoxycholic acid (10 mg / kg / d), the group of Comparative Example 5 was given a lithogenic diet (high-cholesterol feed: 1.2% cholesterol, 98.8% normal feed) + the Jinqian Dantong composition of Example 1 (5 mL / d), and the group of Basic Example 1 was given a lithogenic diet (high-cholesterol feed: 1.2% cholesterol, 98.8% normal feed) + ursodeoxycholic acid (10 mg / kg / d) + the Jinqian Dantong composition of Example 1 (5 mL / d). The rabbits in each group were fed in an isolated animal house, allowed free access to water, and continuously fed for 6 weeks.

[0055] 4. Serum Index Determination: After 6 weeks of intervention, 4 mL of blood was collected from the marginal ear vein, centrifuged at 3000 r / min for 10 min to obtain serum, and the contents of cholesterol (TC) and total bile acid (TBA) were measured using an automatic biochemical analyzer (Mindray BS-350S automatic biochemical analyzer). The results are shown in Table 1.

[0056] 5. Bile Index Determination: After 6 weeks of intervention, after fasting and water deprivation for 12 h, the rabbits were anesthetized intravenously with 3% pentobarbital sodium (30 mg / kg), fixed in the supine position on a rabbit table, the abdomen was depilated, the gallbladder was separated after opening the abdominal cavity, bile was collected, and the contents of cholesterol (TC) and total bile acid (TBA) were measured using an automatic biochemical analyzer (Mindray BS-350S automatic biochemical analyzer). The results are shown in Table 1.

[0057] Table 1 Serum and Bile Indexes of Rabbits

[0058]

[0059] Note: Different letters represent significant differences between groups.

[0060] Research shows that cholesterol stones are the most common type of gallbladder stones. The formation mechanism involves excessive TC content in bile, imbalance in the ratio of TC to TBA, abnormal biliary dynamics, etc. Supersaturation of TC concentration in bile is the most important physiological change in the formation of gallbladder cholesterol stones. When the TC component in bile increases, the TC content and the TC / phospholipid ratio in the cell membrane of gallbladder smooth muscle increase, which will cause a huge spatial movement hindrance to the fatty acyl chains of phospholipids, resulting in thickening and stiffness of the cell membrane, destruction of the membrane protein function, and thus affecting the contraction function of gallbladder smooth muscle. An increase in TC content and an imbalance in the ratio of TC to TBA in bile indicate an increased probability of gallstone recurrence. Since the contents of TC and TBA in serum are correlated with the composition of bile, the recurrence probability of gallstone disease after surgery can be evaluated by characterizing the contents of TC and TBA in serum and bile.

[0061] As can be seen from Table 1, the contents of TC and TBA in the serum of Examples 1 - 3 are close to those of the control group, both lower than those of the model group, and there are significant differences between them and the model group; the TC contents in the bile of Examples 1 - 3 are close to those of the control group, both lower than those of the model group, and there are significant differences between them and the model group. Moreover, the TBA contents of Examples 1 - 3 are higher than those of the control group and the model group. The above results indicate that after cholecystolithotomy, intervention with the Jinqian Dantong drug combination of Examples 1 - 3 can reduce the TC contents in serum and bile, promote the secretion of TBA in bile, regulate the ratio of TC to TBA, and thus reduce the recurrence risk of gallstone disease.

[0062] Comparing Example 1 with Comparative Examples 4 - 5, it can be seen that the combined use of traditional Chinese medicine ingredients (Jinqian Dantong composition) and western medicine (chenodeoxycholic acid) has a greater improvement than the sum of using traditional Chinese medicine ingredients (Jinqian Dantong composition) alone or western medicine (chenodeoxycholic acid) alone, indicating that the combined use of traditional Chinese medicine ingredients (Jinqian Dantong composition) and western medicine (chenodeoxycholic acid) has a synergistic effect.

[0063] In addition, comparing Example 1 with Comparative Examples 1 - 3, it can be seen that the specific composition and preparation process of traditional Chinese medicine ingredients (Jinqian Dantong composition) also have a greater impact on the exertion of its effect. Comparing Example 1 with Basic Example 1, it can be seen that the specific type of western medicine also has a greater impact on the cooperation with traditional Chinese medicine ingredients. The combined use of Jinqian Dantong composition and chenodeoxycholic acid has a better effect than the combination of Jinqian Dantong composition and ursodeoxycholic acid, indicating that traditional Chinese medicine ingredients (Jinqian Dantong composition) and chenodeoxycholic acid have a better cooperation effect.

[0064] Application Example 2

[0065] Clinical Application of Cholecystolithotomy Combined with Jinqian Dantong Drug Combination in the Treatment of Gallstone Disease

[0066] 1. Case information: A total of 198 cases, aged 20 - 71 years old, with an average age of 36 years old, and the male - female ratio was 30:70. They were divided into 3 groups according to the treatment order, namely the control group, Example 1 group, and Basic Example 1 group, with 66 cases in each group.

[0067] 2. Inclusion criteria: The gallbladder has function, with clinical symptoms, and it is diagnosed by B - ultrasound that there are stones in the gallbladder. Intrahepatic bile duct and common bile duct stones are excluded. During the operation, the laparoscopic observation shows that the gallbladder has a good shape and there is no severe adhesion between the gallbladder and surrounding tissues; there are no surgical and anesthesia contraindications; gallbladder cancer is excluded; the patient has the willingness to undergo endoscopic minimally invasive cholecystolithotomy.

[0068] 3. Treatment methods

[0069] After tracheal intubation combined with intravenous anesthesia, endoscopic minimally invasive cholecystolithotomy was performed. After the endoscopic minimally invasive cholecystolithotomy in the control group, routine anti - inflammatory symptomatic treatment was given. On the second day after the endoscopic minimally invasive cholecystolithotomy in the Example 1 group, on the basis of the control group, the Jinqian Dantong composition (raw drug content 90 g / d) + chenodeoxycholic acid (10 mg / kg / d) of Example 1 was given. On the second day after the endoscopic minimally invasive cholecystolithotomy in the Basic Example 1 group, on the basis of the control group, the Jinqian Dantong composition (raw drug content 90 g / d) + ursodeoxycholic acid (10 mg / kg / d) of Example 1 was given. The Example 1 group and the Basic Example 1 group were given combined medication continuously for 30 days.

[0070] 4. Observation indicators

[0071] After the operation, follow - up was carried out. B - ultrasound re - examination was performed every 3 months, and the thickness of the gallbladder wall, gallbladder contraction function, and whether the gallbladder stones recurred after 2 years of treatment were recorded. The results are shown in Table 2.

[0072] Table 2 Follow - up results after 2 years of treatment

[0073] Group Number of recurrence cases / case Recurrence proportion / % Gallbladder wall thickness / mm Gallbladder contraction function (%) Control group 7 10.61 3.22±0.53 35.52±3.51 Example 1 group 0** 0** 2.53±0.46* 49.34±4.45* Basic Example 1 group 2* 3.03* 2.88±0.49 42.33±4.14

[0074] Note: * indicates P < 0.05 compared with the control group; ** indicates P < 0.01 compared with the control group.

[0075] It can be seen from Table 2 that compared with the control group, both the Example 1 group and the Basic Example 1 group can reduce the recurrence probability of cholelithiasis, avoid gallbladder wall thickening, and improve gallbladder contraction function. However, there are significant differences in each index between the Example 1 group and the control group, and the effect is better than that of the Basic Example 1 group, indicating that the traditional Chinese medicine component (Jinqian Dantong composition) and chenodeoxycholic acid have a better cooperative effect.

[0076] The solution of the present invention is not limited to the technical means disclosed above, but also includes technical solutions composed of any combination of the above technical features. The above is the specific implementation manner of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. A Jinqian Dantong drug combination for postoperative intervention of cholelithiasis, characterized in that, It is composed of Jinqian Dantong composition, chenodeoxycholic acid and pharmaceutically acceptable excipients; the Jinqian Dantong composition is composed of 10-25 parts by weight of Glechoma longituba, 10-20 parts by weight of Lysimachia christinae, 5-15 parts by weight of Polygonum cuspidatum, 10-20 parts by weight of Artemisia capillaris, 3-7 parts by weight of Bupleurum chinense, 5-15 parts by weight of Taraxacum mongolicum, 3-8 parts by weight of Cyperus rotundus, 3-8 parts by weight of Salvia miltiorrhiza, 3-8 parts by weight of Cassia obtusifolia and 3-8 parts by weight of Prunus mume; The preparation process of the Jinqian Dantong composition comprises the following steps: weighing each medicinal material according to the formula, adding water for extraction, and concentrating or drying the extraction solution to obtain the Jinqian Dantong composition; Among them, the mass-volume ratio of the medicinal material to water is 1g:5-20mL, the extraction temperature is 40-60°C, the extraction time is 2-8h, and the extraction times are 1-4 times; The unit dose of the Jinqian Dantong composition is 1-5g crude drug / kg / d, and the unit dose of chenodeoxycholic acid is 10-15mg / kg / d.

2. The combination of Jinqian Dantong drugs according to claim 1, characterized in that, The Jinqian Dantong composition is composed of 20 parts by weight of Glechoma longituba, 15 parts by weight of Lysimachia christinae, 10 parts by weight of Polygonum cuspidatum, 15 parts by weight of Artemisia capillaris, 5 parts by weight of Bupleurum chinense, 10 parts by weight of Taraxacum mongolicum, 5 parts by weight of Cyperus rotundus, 5 parts by weight of Salvia miltiorrhiza, 5 parts by weight of Cassia obtusifolia and 5 parts by weight of Prunus mume.

3. The combination of Jinqian Dantong drugs according to claim 1, characterized in that, The concentration is concentrated to a crude drug content of 10-50g / 10mL.

4. The combination of Jinqian Dantong drugs according to claim 1, characterized in that, The dosage form of the Jinqian Dantong composition is granule, capsule, tablet, pill, powder or oral liquid.

5. Use of the Jinqian Dantong drug combination for postoperative intervention of cholelithiasis according to any one of claims 1-4 in the preparation of a drug for postoperative intervention of cholelithiasis.

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