Traditional Chinese medicine composition for treating recovery period of acute pancreatitis and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating acute pancreatitis in the recovery period, which is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 20-30 parts of radix bupleuri, 15-25 parts of radix curcumae, 10-20 parts of polygonum cuspidatum, 18-22 parts of radix paeoniae alba and the like. The traditional Chinese medicine composition has the effects of soothing liver-qi stagnation, clearing residual evil, softening liver and relieving urgency, relieving spasm and pain, relaxing pancreaticobiliary sphincter spasm, invigorating spleen and replenishing qi, promoting blood circulation and removing blood stasis, promoting digestion and relieving stasis, and regulating qi and harmonizing stomach, and has a good treatment effect on patients with liver depression and spleen deficiency syndrome type pancreatitis in the recovery period.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine composition for treating the recovery period of acute pancreatitis and its uses. Background Technology

[0002] Acute pancreatitis is a digestive disease of the pancreas caused by abnormal activation of pancreatic enzymes, which may lead to dysfunction of other organs. It usually occurs in adults, with an annual incidence of 5-30 per 100,000, and the incidence is showing an increasing trend year by year. Pancreatitis is often caused by a variety of factors, mainly including gallstones, alcohol, and hyperlipidemia. The main symptom of acute pancreatitis is sudden onset of persistent upper abdominal pain, which may be accompanied by nausea, vomiting, abdominal distension, and fever. Severe cases may develop hypotension or shock and are complicated by multiple organ dysfunction, leading to a high mortality rate. General treatment methods include fasting, gastrointestinal decompression, oxygen therapy, and nutritional support. For severe abdominal pain, pethidine can be given for analgesia. Proton pump inhibitors can be used to inhibit gastric acid secretion. Somatostatin and its analogues, such as octreotide, can be used to inhibit pancreatic enzymes. Protease inhibitors include gabexate and ulinastatin. For concurrent infections, antibiotics are used, with broad-spectrum antibiotics such as imipenem-cilastatin and third-generation cephalosporins being selected. Metronidazole can be combined to treat anaerobic bacterial infections.

[0003] Because acute pancreatitis has a rapid onset, treatment at the hospital typically involves modern medical methods or traditional Chinese medicine purgatives to prevent the condition from worsening. After symptoms are controlled, the patient enters the recovery period. Due to prolonged fasting, patients often exhibit weakness. At this stage, large amounts of food or the use of qi-tonifying herbs often fail to achieve the desired therapeutic effect. Therefore, continued treatment with medication for the recovery period of acute pancreatitis is necessary. The core mechanism of traditional Chinese medicine in treating pancreatitis lies in its multi-target regulatory effect, which can both alleviate local inflammatory responses and improve overall systemic function. Through a comprehensive effect of inhibiting pancreatic enzyme activation, reducing tissue edema, and promoting gastrointestinal motility, it aims to control the progression of the disease. Summary of the Invention

[0004] This invention relates to a traditional Chinese medicine composition for treating acute pancreatitis (recovery phase) and its uses. This invention can treat acute pancreatitis (recovery phase) of the liver-stagnation and spleen-deficiency syndrome type, promote bile secretion, and relax the pancreatobiliary sphincter.

[0005] This invention provides a traditional Chinese medicine composition for treating the recovery period of acute pancreatitis, which is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Bupleurum chinense 20-30 parts, Curcuma longa 15-25 parts, Polygonum cuspidatum 10-20 parts, Paeonia lactiflora 18-22 parts, Glycyrrhiza uralensis 5-15 parts, Atractylodes macrocephala 10-20 parts, Poria cocos 20-30 parts, Salvia miltiorrhiza 15-25 parts, Artemisia capillaris 20-30 parts, Lysimachia christinae 15-25 parts, Gallus gallus domesticus gizzard lining 8-12 parts, Citrus reticulata peel 20-30 parts, Citrus aurantium 20-30 parts, stir-fried malt 15-25 parts, and roasted germinated barley 20-30 parts.

[0006] The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Bupleurum 25 parts, Curcuma longa 20 parts, Polygonum cuspidatum 15 parts, Paeonia lactiflora 20 parts, Glycyrrhiza uralensis 10 parts, Atractylodes macrocephala 15 parts, Poria cocos 25 parts, Salvia miltiorrhiza 20 parts, Artemisia capillaris 25 parts, Lysimachia christinae 20 parts, Gallus gallus domesticus gizzard lining 10 parts, Citrus reticulata peel 25 parts, Citrus aurantium 25 parts, stir-fried malt 20 parts, and roasted germinated barley 25 parts.

[0007] The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Bupleurum 20 parts, Curcuma longa 25 parts, Polygonum cuspidatum 10 parts, Paeonia lactiflora 22 parts, Glycyrrhiza uralensis 5 parts, Atractylodes macrocephala 20 parts, Poria cocos 20 parts, Salvia miltiorrhiza 25 parts, Artemisia capillaris 20 parts, Lysimachia christinae 25 parts, Gallus gallus domesticus gizzard lining 8 parts, Citrus reticulata peel 30 parts, Citrus aurantium 20 parts, stir-fried malt 25 parts, and roasted germinated barley 20 parts.

[0008] The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Bupleurum chinense 30 parts, Curcuma longa 15 parts, Polygonum cuspidatum 20 parts, Paeonia lactiflora 18 parts, Glycyrrhiza uralensis 15 parts, Atractylodes macrocephala 10 parts, Poria cocos 30 parts, Salvia miltiorrhiza 15 parts, Artemisia capillaris 30 parts, Lysimachia christinae 15 parts, Gallus gallus domesticus gizzard lining 12 parts, Citrus reticulata peel 20 parts, Citrus aurantium 30 parts, stir-fried malt 15 parts, and roasted germinated barley 30 parts.

[0009] The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis is prepared as follows: weigh the raw materials of traditional Chinese medicine according to the proportion, add water and decoct twice. For the first decoction, add 12-18 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. For the second decoction, add 8-12 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08-1.12 at 60°C. Add a flavoring agent to prepare the compound.

[0010] The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis is prepared as follows: weigh the raw materials of traditional Chinese medicine according to the proportion, add water and decoct twice. For the first decoction, add 15 times the amount of water and decoct for 1 hour, then filter through a 200-mesh filter cloth. For the second decoction, add 10 times the amount of water and decoct for 1 hour, then filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.10 at 60°C. Add a flavoring agent to prepare the compound.

[0011] The application of the traditional Chinese medicine composition for treating the recovery period of acute pancreatitis in the preparation of a medicine for treating the recovery period of acute pancreatitis.

[0012] The application of the traditional Chinese medicine composition for treating the recovery period of acute pancreatitis in the preparation of drugs for treating the recovery period of acute pancreatitis, which belongs to the syndrome of liver stagnation and spleen deficiency.

[0013] The application of the traditional Chinese medicine composition for treating the recovery period of acute pancreatitis in the preparation of drugs that promote bile secretion and relax the pancreatic and bile duct sphincter.

[0014] The descriptions of symptoms such as "spleen and heart pain" in *Ling Shu: Jue Bing*, "chest binding" in *Shang Han Lun*, and "heart and spleen pain" in *Gu Jin Yi Jian* are basically consistent with the manifestations of acute pancreatitis. To prevent the condition from worsening, acute pancreatitis is treated with modern medical methods or traditional Chinese medicine purgatives. After the symptoms are controlled, the patient enters the recovery period, where the pancreatic and systemic infections are brought under control. Key indicators of recovery from acute pancreatitis include a return to normal body temperature and restoration of digestive function.

[0015] Zhu Danxi, in his *Danxi Xinfa* (Danxi's Heart Method) on "Heart and Spleen Pain," states that the cause of heart pain is often due to a habitual consumption of hot and spicy foods. The heat depletes the blood and body fluids, leading to blood stasis, which then stagnates in the stomach, causing pain. *Gujin Yijian* (Mirror of Ancient and Modern Medicine) also states: "Stomach, heart, and spleen pain can be caused by various factors, including exposure to cold, consumption of cold foods, internal heat, pre-existing phlegm or stagnant blood, anger causing qi stagnation, or pain caused by parasites." While the etiology of acute pancreatitis is complex, the pathogenesis during an attack is generally characterized by qi stagnation and intense heat toxicity.

[0016] In clinical practice, the commonly used treatments for acute pancreatitis mainly focus on clearing heat and purging. However, excessive use of such medications depletes the body's vital energy (Qi). Furthermore, patients with acute pancreatitis require prolonged periods of fasting and fluid restriction, resulting in a state of high metabolism and high energy expenditure. Gastrointestinal decompression and anti-inflammatory treatments also further damage the body's vital energy. The pathogenesis of acute pancreatitis in the recovery period evolves from the initial accumulation of heat and toxins to a deficiency of vital energy, coupled with lingering pathogenic factors, spleen and stomach disharmony, and symptoms such as spleen deficiency with dampness or residual pathogenic factors leading to masses and accumulations. Clinical manifestations in the recovery period of acute pancreatitis include: fatigue, loss of appetite, mild abdominal distension, possibly accompanied by nausea, abdominal pain, and low-grade fever. The tongue is pale red with a slightly greasy coating, and the pulse is thready. The syndrome is attributed to liver stagnation and spleen deficiency, with pathogenic factors cleared but vital energy weakened, lingering damp-heat toxins, and deficiency of both the spleen and liver. If one simply switches to a purely tonifying approach (such as Liu Jun Zi Tang), it may "close the door to let the enemy in," causing the remaining damp-heat and stagnant toxins to reignite; if one continues to clear heat, it may easily damage the already weakened spleen and stomach qi.

[0017] The liver governs the free flow of Qi, while the spleen governs its transformation and transportation; the liver stores blood, while the spleen governs its control. The relationship between the liver and spleen is primarily manifested in their mutual support in regulating Qi and transportation, and their coordination in storing and controlling blood. The liver regulates the flow of Qi, aiding digestion; a healthy spleen ensures a source for the production of Qi and blood, and a nourished liver allows for smooth and unobstructed Qi flow, facilitating the free flow of Qi. When the liver fails to regulate Qi, stagnation occurs, leading to chest and rib distension and pain, frequent sighing, depression, or irritability. Therefore, for the liver stagnation and spleen deficiency syndrome exhibited during the recovery period of acute pancreatitis, Bupleurum, Curcuma, and Polygonum cuspidatum are used to soothe the liver, relieve stagnation, and clear residual pathogens. Bupleurum soothes the liver, relieves stagnation, and regulates Qi; Curcuma not only promotes Qi circulation and relieves stagnation but also invigorates blood, relieves pain, promotes bile secretion, and reduces jaundice—one herb with three uses; Polygonum cuspidatum clears heat, detoxifies, eliminates dampness, reduces jaundice, and invigorates blood circulation. The three herbs work together to target the three major residual pathogenic factors: "liver stagnation," "damp-heat," and "blood stasis." They clear away residual pathogenic factors from multiple dimensions—qi, blood, dampness, and heat—rather than simply clearing heat. Additionally, white peony root and licorice root are used to soothe the liver, relieve spasms and pain, derived from the Peony and Licorice Decoction in the *Shang Han Lun*, effectively relaxing spasms of the pancreatic and bile duct sphincter. Bupleurum root, turmeric, Polygonum cuspidatum, white peony root, and licorice root are the principal herbs in this invention.

[0018] This invention employs Atractylodes macrocephala, Poria cocos, and Salvia miltiorrhiza to invigorate the spleen and replenish qi, promote blood circulation and remove blood stasis. Among them, Atractylodes macrocephala and Poria cocos invigorate the spleen and replenish qi, dry dampness and promote diuresis, and restore the spleen's function of transporting and transforming qi (supporting the body's resistance); Salvia miltiorrhiza promotes blood circulation, removes blood stasis, cools the blood and eliminates carbuncles, and clears stagnation in the local microcirculation of the pancreas (eliminating pathogens). Artemisia capillaris and Lysimachia christinae clear heat and promote diuresis, and soothe the liver and gallbladder. This invention uses Atractylodes macrocephala, Poria cocos, Salvia miltiorrhiza, Artemisia capillaris, and Lysimachia christinae as assistant herbs to enhance the liver-soothing, depression-relieving, spasmolytic, and analgesic effects of the principal herbs.

[0019] This formula uses chicken gizzard lining, dried tangerine peel, immature bitter orange peel, roasted malt, and roasted barley sprouts as adjuvant herbs. It has the effects of promoting digestion, regulating qi, and harmonizing the stomach. Targeting the digestive fragility during the recovery period, chicken gizzard lining invigorates the spleen and promotes digestion, specifically treating food stagnation and abdominal distension; dried tangerine peel regulates qi, strengthens the spleen, dries dampness, and harmonizes the stomach; immature bitter orange peel breaks up qi stagnation, eliminates food accumulation, and relieves distension; roasted malt and roasted barley sprouts aid digestion. Addressing the most typical symptoms of "loss of appetite and abdominal distension" in patients recovering from pancreatitis, it clears obstacles to the recovery of spleen and stomach function, embodying the principle of "treating stagnation while simultaneously tonifying."

[0020] This invention is composed of Bupleurum, Curcuma longa, Polygonum cuspidatum, Paeonia lactiflora, Glycyrrhiza uralensis, Atractylodes macrocephala, Poria cocos, Salvia miltiorrhiza, Artemisia capillaris, Lysimachia christinae, Gallus gallus domesticus gizzard lining, Citrus reticulata peel, Citrus aurantium, roasted malt, and roasted germinated barley. It can soothe the liver and relieve depression, clear away residual pathogens, soften the liver and relieve spasms, relieve pain, relax pancreatic and bile duct sphincter spasms, strengthen the spleen and replenish qi, promote blood circulation and remove blood stasis, promote digestion and eliminate food stagnation, regulate qi and harmonize the stomach. It has a good therapeutic effect on patients in the recovery period of acute pancreatitis with liver depression and spleen deficiency syndrome. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the described embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] Example 1: Take 250g of Bupleurum chinense, 200g of Curcuma longa, 150g of Polygonum cuspidatum, 200g of Paeonia lactiflora, 100g of Glycyrrhiza uralensis, 150g of Atractylodes macrocephala, 250g of Poria cocos, 200g of Salvia miltiorrhiza, 250g of Artemisia capillaris, 200g of Lysimachia christinae, 100g of chicken gizzard lining, 250g of Citrus reticulata peel, 250g of Citrus aurantium, 200g of roasted malt, and 250g of roasted germinated barley. The preparation method is as follows: Weigh the Chinese herbal raw materials according to the proportion, add water and decoct twice. For the first decoction, add 15 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. For the second decoction, add 10 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.10 at 60℃. Add sucrose to prepare a compound.

[0023] Example 2: Take 200g of Bupleurum chinense, 250g of Curcuma longa, 100g of Polygonum cuspidatum, 220g of Paeonia lactiflora, 50g of Glycyrrhiza uralensis, 200g of Atractylodes macrocephala, 200g of Poria cocos, 250g of Salvia miltiorrhiza, 200g of Artemisia capillaris, 250g of Lysimachia christinae, 80g of chicken gizzard lining, 300g of Citrus reticulata peel, 200g of Citrus aurantium, 250g of roasted malt, and 200g of roasted germinated barley. The preparation method is as follows: Weigh the Chinese herbal raw materials according to the proportion, add water and decoct twice. For the first decoction, add 12 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. For the second decoction, add 12 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08 at 60℃. Add stevioside to prepare a compound preparation.

[0024] Example 3: Take 300g of Bupleurum chinense, 150g of Curcuma longa, 200g of Polygonum cuspidatum, 180g of Paeonia lactiflora, 150g of Glycyrrhiza uralensis, 100g of Atractylodes macrocephala, 300g of Poria cocos, 150g of Salvia miltiorrhiza, 300g of Artemisia capillaris, 150g of Lysimachia christinae, 120g of chicken gizzard lining, 200g of Citrus reticulata peel, 300g of Citrus aurantium, 150g of roasted malt, and 300g of roasted germinated barley. The preparation method is as follows: Weigh the Chinese herbal raw materials according to the proportion, add water and decoct twice. For the first decoction, add 18 times the amount of water and decoct for 1 hour, then filter through a 200-mesh filter cloth. For the second decoction, add 8 times the amount of water and decoct for 1 hour, then filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.12 at 60℃. Add protein sugar to prepare a compound.

[0025] Example 4: Pharmacodynamic study of the bile secretion-promoting effect of the present invention

[0026] Establishment of the experimental model of pancreatitis: Forty SD rats were randomly divided into four groups of 10 each: normal group, model group, treatment group (40 mg / kg) according to Example 1 of this invention, and positive control drug (Xiangsha Liujun Pill, National Drug Approval Number Z41021828, produced by Zhongjing Wanxi Pharmaceutical Co., Ltd., batch number: 20211210) treatment group (40 mg / kg). Except for the normal group, the other three groups of rats were fasted for 12 hours before the operation, anesthetized by intraperitoneal injection, and the bile duct and pancreatic duct near the porta hepatis were blocked by micro-arterial clamps. 0.4 mL of 2% trinitrobenzenesulfonic acid (prepared with ethanol phosphate buffer) was injected into the bile duct and the duodenum was located and the papillary opening was confirmed. The duodenal wall was cut open about 0.5 cm on the opposite side of the papilla, and a single-channel manometry tube was inserted retrogradely through the papillary opening so that the measuring hole was located at the sphincter of Oddi. The manometry tube was then fixed and used to measure the pressure of the sphincter of Oddi. The medication was administered orally via gavage one week after surgery, for three consecutive weeks.

[0027] Experimental procedure: Four weeks after modeling and drug administration, surgery was performed to locate the opening of the bile and pancreatic ducts in the small intestine. Bile was collected for half an hour, and the bile flow rate of each group was measured. The bile was sent for testing, and the Oddi sphincter pressure was measured using a computer-controlled gastrointestinal motility monitor.

[0028] The experimental results are shown in Table 1-2:

[0029] Table 1. Bile flow rate and bilirubin concentration in each group

[0030]

[0031] Compared with the normal group: *P<0.05, **P<0.01; Compared with the model group: #P<0.05, ##P<0.01

[0032] Table 2 Comparison of Oddi sphincter (SO) kinetic indices among groups

[0033]

[0034] Compared with the normal group: *P<0.05, **P<0.01; Compared with the model group: #P<0.05, ##P<0.01

[0035] Table 1 shows that, compared with the model group, the bile flow rate and total bilirubin content in the bile of rats in Example 1 and the positive drug group of this invention were significantly increased, and the increase was more pronounced in Example 1 compared with the model group, indicating that this invention has a bile secretion-promoting effect on pancreatitis. Table 2 shows that the basal pressure, peak pressure, and contraction frequency of SO in the model group were significantly higher than those in the normal group, indicating that the "contraction / spasm" of the sphincter can lead to pancreatic duct hypertension during pancreatitis attacks. However, after administration of Example 1 of this invention, the basal pressure, peak pressure, and contraction frequency of SO were significantly lower than those in the model group, indicating that this invention can relax the pancreatobiliary sphincter.

[0036] Example 5: Clinical Study

[0037] Clinical data of 100 patients in the recovery phase of acute pancreatitis admitted to the hospital from May 2022 to October 2024 were collected. Patients were divided into a control group and an observation group, with 50 patients in each group, based on different treatment methods used during the recovery phase. The control group consisted of 28 males and 22 females, aged 26-63 years, with a mean age of 48.27 years. The observation group consisted of 24 males and 26 females, aged 28-65 years, with a mean age of 47.38 years. There were no statistically significant differences in general characteristics between the two groups (P>0.05).

[0038] Diagnostic Criteria: Inclusion Criteria: Clinically diagnosed, meeting the relevant diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Acute Pancreatitis (2014 Edition)," and in the recovery period after active treatment, with normal body temperature and restored digestive function. Traditional Chinese Medicine Diagnostic Criteria: The recovery period syndrome of acute pancreatitis is classified as liver qi stagnation and spleen deficiency, with clinical manifestations including fatigue, poor appetite, mild abdominal distension, possibly accompanied by nausea, abdominal pain, and low-grade fever. The tongue is pale red with a slightly greasy coating, and the pulse is thready.

[0039] Treatment methods: All patients with acute pancreatitis received symptomatic treatment upon admission, including fasting, fluid restriction, gastrointestinal decompression, maintenance of blood volume and electrolyte balance, analgesia, liver protection, antispasmodics, anti-inflammatory drugs, anti-infection drugs, and nutritional support. After the condition improved and the patient entered the recovery period, the control group was given Xiangsha Liujun Pill (National Medicine Approval Number Z41021828) from Zhongjing Wanxi Pharmaceutical Co., Ltd., 12 pills at a time, 3 times a day; the observation group took the compound prepared in Example 1, with a daily dosage of Bupleurum chinense 25g, Curcuma longa 20g, Polygonum cuspidatum 15g, Paeonia lactiflora 20g, Glycyrrhiza uralensis 10g, Atractylodes macrocephala 15g, Poria cocos 25g, Salvia miltiorrhiza 20g, Artemisia capillaris 25g, Lysimachia christinae 20g, Gallus gallus domesticus gizzard lining 10g, Citrus reticulata peel 25g, Citrus aurantium 25g, roasted malt 20g, and roasted germinated barley 25g, 3 times a day.

[0040] Observation indicators: (1) Compare the clinical efficacy of the two groups: Ineffective, the patient's clinical symptoms, signs and blood test indicators did not improve; Effective, the patient's clinical symptoms, signs and blood test indicators improved, but the patient could not get out of bed; Significantly effective, the patient's clinical symptoms and signs basically disappeared, the blood test indicators returned to normal, and the patient could get out of bed 3-5 times / day, each time for 5-15 minutes; Cured, the patient's clinical symptoms, signs and blood test indicators completely returned to normal, and the patient could get out of bed normally. Total effective = Effective + Significantly effective + Cured. And compare the time of treatment effectiveness. (2) For all acute pancreatitis, blood and urine amylase returned to normal on days 1, 4, 6 and 10 before meals, and blood glucose was detected by fully automated biochemical analyzer. (3) Comparison of serum inflammatory mediator indicators between the two groups: 5 mL of fasting venous blood was collected from patients before treatment and 7 days after treatment. The blood was centrifuged at 3500 r / min for 10 min with a centrifugation radius of 10 cm to obtain the supernatant serum. Interleukin-6 (IL-6) and interleukin-8 (IL-8) were detected by indirect immunofluorescence assay. See Table 3-6.

[0041] Experimental results:

[0042] Table 3 Comparison of clinical efficacy between the two groups

[0043]

[0044] Table 4 Comparison of the effective treatment time between the two groups

[0045]

[0046] Table 5. Blood glucose changes during the recovery period of acute pancreatitis (mmol / L)

[0047]

[0048] Table 6 Comparison of serum inflammatory mediator indicators between the two groups (ng / mL)

[0049]

[0050] Compared with pre-treatment levels: *P<0.05, **P<0.01; Compared with the control group: #P<0.05, ##P<0.01

[0051] As shown in Tables 3-6, in the control group, 50 patients with acute pancreatitis in the recovery period diagnosed with liver stagnation and spleen deficiency were treated with Xiangsha Liujun Pills. Of these, 18 were cured, 10 showed significant improvement, 9 showed improvement, and 13 showed no improvement, with an effective rate of 74%. In the observation group, 50 patients with acute pancreatitis in the recovery period diagnosed with liver stagnation and spleen deficiency were treated with the compound prepared in Example 1 of this invention. Of these, 25 were cured, 14 showed significant improvement, 7 showed improvement, and 4 showed no improvement, with an effective rate of 92%. This indicates that the present invention is more effective than the control group in treating acute pancreatitis patients in the recovery period diagnosed with liver stagnation and spleen deficiency. Furthermore, in the control group, the average treatment time for the 37 effective cases was 16.76 ± 5.48 days; in the observation group, the average treatment time for the 46 effective cases was 10.98 ± 4.67 days, which was also faster than in the control group.

[0052] Blood glucose test results showed that the blood glucose level of patients with acute pancreatitis during the recovery period gradually decreased on days 1, 4, 6 and 10 after medication. However, the control group did not recover to normal levels by day 10, while the observation group had recovered to normal levels by day 10. This indicates that the compound prepared in Example 1 of this invention has better efficacy than Xiangsha Liujun Pill.

[0053] The results of serum inflammatory mediator indicators showed that after treatment, IL-6 and IL-8 in both the observation group and the control group were lower than before treatment, with significant differences; the average IL-6 and IL-8 in the observation group were lower than those in the control group after treatment, with significant differences; indicating that the present invention can effectively alleviate clinical symptoms, reduce the level of inflammatory mediators, improve serum biochemical indicators, and promote the body's recovery, with better effects than the control group.

[0054] The embodiments of the present invention are given for illustrative and descriptive purposes only, and are not intended to be exhaustive or to limit the invention to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art. The embodiments were chosen and described in order to better illustrate the principles and practical application of the invention, and to enable those skilled in the art to understand the invention and to design various embodiments with various modifications suitable for a particular purpose.

Claims

1. A traditional Chinese medicine composition for treating the recovery period of acute pancreatitis, characterized in that, It is prepared from the following Chinese medicinal materials in parts by weight: Bupleurum chinense 20-30 parts, Curcuma longa 15-25 parts, Polygonum cuspidatum 10-20 parts, Paeonia lactiflora 18-22 parts, Glycyrrhiza uralensis 5-15 parts, Atractylodes macrocephala 10-20 parts, Poria cocos 20-30 parts, Salvia miltiorrhiza 15-25 parts, Artemisia capillaris 20-30 parts, Lysimachia christinae 15-25 parts, Gallus gallus domesticus gizzard lining 8-12 parts, Citrus reticulata peel 20-30 parts, Citrus aurantium 20-30 parts, stir-fried malt 15-25 parts, and roasted germinated barley 20-30 parts.

2. The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1, characterized in that, It is prepared from the following Chinese medicinal materials in parts by weight: Bupleurum 25 parts, Curcuma longa 20 parts, Polygonum cuspidatum 15 parts, Paeonia lactiflora 20 parts, Glycyrrhiza uralensis 10 parts, Atractylodes macrocephala 15 parts, Poria cocos 25 parts, Salvia miltiorrhiza 20 parts, Artemisia capillaris 25 parts, Lysimachia christinae 20 parts, Gallus gallus domesticus gizzard lining 10 parts, Citrus reticulata peel 25 parts, Citrus aurantium 25 parts, stir-fried malt 20 parts, and roasted germinated barley 25 parts.

3. The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1, characterized in that, It is prepared from the following Chinese medicinal materials in parts by weight: Bupleurum 20 parts, Curcuma longa 25 parts, Polygonum cuspidatum 10 parts, Paeonia lactiflora 22 parts, Glycyrrhiza uralensis 5 parts, Atractylodes macrocephala 20 parts, Poria cocos 20 parts, Salvia miltiorrhiza 25 parts, Artemisia capillaris 20 parts, Lysimachia christinae 25 parts, Gallus gallus domesticus gizzard lining 8 parts, Citrus reticulata peel 30 parts, Citrus aurantium 20 parts, stir-fried malt 25 parts, and roasted germinated barley 20 parts.

4. The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1, characterized in that, It is prepared from the following Chinese medicinal materials in parts by weight: Bupleurum chinense 30 parts, Curcuma longa 15 parts, Polygonum cuspidatum 20 parts, Paeonia lactiflora 18 parts, Glycyrrhiza uralensis 15 parts, Atractylodes macrocephala 10 parts, Poria cocos 30 parts, Salvia miltiorrhiza 15 parts, Artemisia capillaris 30 parts, Lysimachia christinae 15 parts, Gallus gallus domesticus gizzard lining 12 parts, Citrus reticulata peel 20 parts, Citrus aurantium 30 parts, stir-fried malt 15 parts, and roasted germinated barley 30 parts.

5. The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1, characterized in that, The preparation method is as follows: Weigh the Chinese herbal raw materials according to the proportion, add water and decoct twice. For the first decoction, add 12-18 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. For the second decoction, add 8-12 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08-1.12 at 60℃. Add flavoring agents to prepare a compound preparation.

6. The traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 5, characterized in that, The preparation method is as follows: Weigh the Chinese herbal raw materials according to the proportion, add water and decoct twice. For the first decoction, add 15 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. For the second decoction, add 10 times the amount of water and decoct for 1 hour. Filter through a 200-mesh filter cloth. Combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.10 at 60℃. Add flavoring agent to prepare a compound.

7. The use of the traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1 in the preparation of a medicament for treating the recovery period of acute pancreatitis.

8. The use of the traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1 in the preparation of a medicament for treating the recovery period of acute pancreatitis, characterized in that, The recovery period of acute pancreatitis falls under the category of liver stagnation and spleen deficiency syndrome.

9. The use of the traditional Chinese medicine composition for treating the recovery period of acute pancreatitis as described in claim 1 in the preparation of a drug that promotes bile secretion and relaxes the pancreatobiliary sphincter.

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