A traditional Chinese medicine composition for treating diarrhea and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating diarrhea, and relates to the technical field of traditional Chinese medicine pharmacy. The application provides a traditional Chinese medicine composition for treating chronic diarrhea, which is prepared from madder, yuyulang, camphor tree bark, white peony root, jujube, licorice, lily, trichosanthes root and heron herb. The drugs are used together to have the functions of tonifying the spleen and stomach, astringing the lung to stop diarrhea and warming the middle and promoting qi. The traditional Chinese medicine composition can effectively relieve and improve the clinical symptoms of patients with chronic diarrhea, such as diarrhea, loss of appetite, lassitude and fatigue, and has a remarkable curative effect, so it is worthy of further clinical promotion and application.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmacy, and particularly relates to a traditional Chinese medicine composition for treating diarrhea and its application. Background Art

[0002] Diarrhea, as a common digestive system disease, is usually characterized by an increase in daily defecation volume, an increase in the number of daily bowel movements (more than 3 times), and a thin fecal nature. Patients will experience symptoms such as a sense of urgency to defecate and abdominal discomfort, and the symptoms will be relieved after defecation. When the diarrhea symptoms persist for more than 4 weeks or recur repeatedly, it is called chronic diarrhea. The etiology of chronic diarrhea is complex and the pathogenesis is also different. The common etiologies of foreign patients are diarrhea-predominant irritable bowel syndrome (IBS-D), inflammatory bowel disease (IBD), celiac disease, secretory diarrhea, giardiasis, etc. The etiologies of domestic patients are mainly chronic enteritis, IBD, intestinal polyps, and tumors. Therefore, the etiologies of chronic diarrhea are mostly intestinal dysfunction, bacterial infection, ulcers, inflammation, and tumors, etc., and also include allergies, immune deficiencies, and drug-induced etiologies. In addition, some extra-digestive system diseases, such as abnormal thyroid function, diabetes, etc., can also cause chronic diarrhea. With the rapid development of society, bad work and living habits have also led to chronic diarrhea being common and frequently occurring among sub-healthy people.

[0003] Modern medicine advocates treating chronic diarrhea mainly with symptomatic supportive treatment, mainly including using antibiotics to control infection, antidiarrheal drugs to relieve diarrhea symptoms, and correcting water and electrolyte disorders in the body, etc. The effect of treating diarrhea in the short term is very good, but it is relatively limited in improving the physiological function of the gastrointestinal tract. The efficacy will gradually decrease after long-term use, resulting in incomplete treatment and easy recurrence.

[0004] Chronic diarrhea belongs to the category of "long-term diarrhea" in traditional Chinese medicine's "diarrhea". The name of diarrhea was first recorded in "Huangdi Neijing·Suwen·Tongtianlun of Vital Energy", and was called "diarrhea", including "weak diarrhea", "profuse diarrhea", "pouring diarrhea", "noisy diarrhea", etc. Chen Wuzhe of the Song Dynasty recorded in "San因Ji Yi Bing Zheng Fang Lun·Xu Xie Xu Lun": "The diarrhea and dysentery described in medical books are the same as the so-called profuse diarrhea, noisy diarrhea, loose diarrhea, soft diarrhea, and watery food pouring down in the classics." It pointed out that although there are many names for this disease, they all fall under "diarrhea". Traditional Chinese medicine and traditional Chinese medicine follow the principle of dialectical treatment, emphasizing individualized treatment, with strong pertinence, not easy to produce drug resistance, small side effects, low price, convenient use and other advantages, and it has significant advantages in treating chronic diarrhea. Although there are already many traditional Chinese medicine formulas developed for treating chronic diarrhea in the prior art; however, due to the many etiologies of chronic diarrhea, its pathogenesis and treatment mechanism are not very clear, and its clinical treatment effect is not exact. Summary of the Invention

[0005] (1) Technical Problems to be Solved

[0006] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating diarrhea and its application.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] This invention provides a traditional Chinese medicine composition for treating diarrhea, which is composed of the following raw materials in parts by weight: 5-20 parts of Rubia cordifolia, 5-20 parts of Halloysite, 5-20 parts of Camphor bark, 5-20 parts of Paeonia lactiflora, 5-20 jujubes, 5-20 parts of Glycyrrhiza uralensis, 5-20 parts of Lilium brownii, 5-20 parts of Trichosanthes kirilowii root, and 5-20 parts of Agrimonia pilosa.

[0010] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-15 parts of Rubia cordifolia, 10-20 parts of Halloysite, 10-20 parts of Camphor bark, 10-20 parts of Paeonia lactiflora, 5-15 jujubes, 5-10 parts of Glycyrrhiza uralensis, 10-20 parts of Lilium brownii, 10-20 parts of Trichosanthes kirilowii root, and 5-15 parts of Agrimonia pilosa.

[0011] Furthermore, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 8 parts madder root, 18 parts halloysite, 16 parts camphor bark, 12 parts white peony root, 10 jujubes, 8 parts licorice root, 12 parts lily bulb, 14 parts trichosanthes root, and 8 parts agrimony.

[0012] The traditional Chinese medicine composition provided by this invention is used to prepare a drug for treating chronic enteritis. The traditional Chinese medicine composition can be prepared into a dosage form acceptable to the human body, including but not limited to any one of oral liquid, decoction, granules, pills, enema liquid, capsules, suppositories, and lyophilized powder.

[0013] The pharmacological effects of each medicinal material in the traditional Chinese medicine composition of this invention:

[0014] Madder root: Bitter in taste, cold in nature, enters the liver and heart meridians; cools the blood and stops bleeding, promotes blood circulation and removes blood stasis. It is mainly used for hemoptysis due to blood heat, hematemesis, epistaxis, hematuria, hematochezia, metrorrhagia, amenorrhea, postpartum abdominal pain due to blood stasis, traumatic injuries, rheumatic pain, jaundice, carbuncles, and hemorrhoids.

[0015] Yu Yu Liang: This is a hydroxide mineral called limonite, mainly containing basic iron oxide [FeO(OH)]. It has astringent and hemostatic effects. It is commonly used for chronic diarrhea, dysentery, rectal bleeding, metrorrhagia, and leukorrhea.

[0016] Camphor bark: pungent and bitter in taste, warm in nature, and enters the spleen, stomach, and lung meridians; it has the effects of dispelling wind and dampness, warming the stomach and harmonizing the middle jiao, killing parasites and healing sores. It is mainly used to treat rheumatic pain, stomach pain, vomiting and diarrhea, beriberi swelling and pain, traumatic injuries, scabies and sores, and insect stings.

[0017] White peony root: bitter and sour in taste, slightly cold in nature, and enters the liver and spleen meridians; it has the effects of nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening the liver and relieving pain, and calming liver yang. It is often used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache and dizziness.

[0018] Jujube: Sweet in taste and warm in nature, it enters the spleen and stomach meridians; it has the effects of tonifying the spleen and stomach, replenishing qi and promoting body fluids, regulating the body's defenses, and detoxifying; it is used to treat symptoms such as poor appetite due to stomach deficiency, loose stools due to spleen weakness, insufficient qi, blood and body fluids, disharmony between the body's defenses, palpitations, etc.; jujubes are rich in nutrients, including amino acids, sugars, vitamins and various trace elements, and contain a large number of nucleotide derivatives. Jujubes have a good auxiliary therapeutic effect on diseases such as tumors, hypertension, and hypercholesterolemia, and have the effects of delaying aging, anti-oxidation, improving immunity, and protecting the liver.

[0019] Licorice: Sweet in taste, neutral in nature, and enters the heart, spleen, lung, and stomach meridians; it has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing other medicines; it is used for symptoms such as spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive phlegm, carbuncles and boils, etc. Licorice is also good at harmonizing the properties of other medicines and reducing their toxicity.

[0020] Lily bulbs: They have the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind. Lily bulbs are often used to treat dry cough due to yin deficiency, cough with blood due to overwork, restlessness and palpitations, insomnia and dreaminess, and mental confusion.

[0021] Trichosanthes root: generally refers to Trichosanthes kirilowii root, which is sweet and slightly bitter in taste, slightly cold in nature, and enters the lung and stomach meridians; its specific effects are clearing heat and purging fire, promoting body fluid and quenching thirst, draining pus and reducing swelling; it treats symptoms such as thirst due to febrile diseases, diabetes, jaundice, dry cough with blood, carbuncles, and hemorrhoids; it mainly contains protein, polysaccharides, saponins, amino acids and other components; it has anti-tumor, antiviral and immune-regulating effects.

[0022] Agrimony: bitter and astringent in taste, neutral in nature; enters the heart and liver meridians; astringent and hemostatic, antimalarial, antidysentery, detoxifying, and tonifying; used for hemoptysis, hematemesis, metrorrhagia, malaria, bloody dysentery, carbuncles and boils, vulvar itching and leukorrhea, and exhaustion.

[0023] (III) Beneficial Effects

[0024] Chronic diarrhea falls under the category of "diarrhea" in Traditional Chinese Medicine. It is mostly caused by external pathogens, emotional imbalance, and improper diet. It is caused by persistent diarrhea or loose stools due to spleen and kidney yang deficiency. The treatment principle is to tonify the spleen and stomach, warm the middle jiao and promote qi circulation, and astringe the lungs to stop diarrhea. This invention provides a traditional Chinese medicine composition for treating chronic diarrhea, made from madder root, halloysite, camphor bark, white peony root, jujube, licorice root, lily bulb, trichosanthes root, and agrimony. In this composition, halloysite, with its astringent and antidiarrheal properties, is the principal ingredient, often used for chronic diarrhea and dysentery. Madder root and agrimony root are used as assistant ingredients to astringe and stop bleeding, and also have astringent properties to stop diarrhea. White peony root is the primary ingredient for tonifying qi and strengthening the spleen. Camphor bark dispels wind and dampness, warms the stomach and harmonizes the middle jiao. The sweetness of jujube, combined with white peony root, achieves the effects of tonifying the spleen and stomach, regulating qi and harmonizing the middle jiao, and eliminating dampness and stopping diarrhea. Lily bulb is a mild tonic, functioning to tonify qi and regulate the middle jiao, nourishing stomach yin without being greasy, supporting spleen earth and suppressing liver wood. Trichosanthes root clears heat and drains fire, generates fluids and quenches thirst. All of these are adjuvant ingredients. Licorice root is sweet and neutral in nature, tonifying the qi of the heart and spleen, and harmonizing the other ingredients. All the ingredients work together to tonify the spleen and stomach, astringe the lungs and stop diarrhea, warm the middle jiao and regulate qi.

[0025] Animal experiments have shown that the herbal composition of this invention has a good antidiarrheal effect on mouse models of diarrhea induced by senna leaves and castor oil, significantly reducing the frequency of diarrhea and exhibiting a certain inhibitory effect on the gastrointestinal tract of mice. Simultaneously, the herbal composition of this invention can effectively alleviate and improve clinical symptoms such as diarrhea, loss of appetite, and fatigue in patients with chronic diarrhea, demonstrating significant efficacy and warranting further clinical application. Attached Figure Description

[0026] Figure 1 The results show the effect of senna leaves on diarrhea in mice in each group. * and ** indicate that the differences between each treatment group and the model group are significant (P<0.05) and highly significant (P<0.01), respectively. # , ## The values ​​indicate that the differences between the control groups 1-3 and the low-dose group were statistically significant (P<0.05) and highly significant (P<0.01), respectively.

[0027] Figure 2 The results of the effect of castor oil on diarrhea in mice in each group are shown. * and ** indicate that the differences between each treatment group and the model group are significant (P<0.05) and highly significant (P<0.01), respectively. # , ## The values ​​indicate that the differences between the control groups 1-3 and the low-dose group were statistically significant (P<0.05) and highly significant (P<0.01), respectively.

[0028] Figure 3 The results of small intestinal propulsion rate in mice in each group are shown. * and ** indicate that the differences between each treatment group and the blank control group are significant (P<0.05) and highly significant (P<0.01), respectively. # , ##The values ​​indicate that the differences between the control groups 1-3 and the low-dose group were statistically significant (P<0.05) and highly significant (P<0.01), respectively. Detailed Implementation

[0029] 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 embodiments of the present invention, not all embodiments. Based on the 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.

[0030] Example 1

[0031] A traditional Chinese medicine composition for treating diarrhea, the composition comprising the following raw materials in parts by weight: 8 parts madder root, 18 parts halloysite, 16 parts camphor bark, 12 parts white peony root, 10 jujubes, 8 parts licorice root, 12 parts lily bulb, 14 parts trichosanthes root, and 8 parts agrimony.

[0032] The traditional Chinese medicine composition can be prepared into a dosage form acceptable to the human body, including but not limited to any one of oral liquid, decoction, granules, pills, enema liquid, capsules, suppositories, and lyophilized powder.

[0033] Example 2

[0034] The difference between this embodiment and Embodiment 1 is that...

[0035] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 5 parts madder root, 8 parts halloysite, 6 parts camphor bark, 5 parts white peony root, 5 jujubes, 5 parts licorice root, 6 parts lily bulb, 5 parts trichosanthes root, and 5 parts agrimony.

[0036] Example 3

[0037] The difference between this embodiment and Embodiment 1 is that...

[0038] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 14 parts madder root, 20 parts halloysite, 18 parts camphor bark, 16 parts white peony root, 14 jujubes, 16 parts licorice root, 16 parts lily bulb, 16 parts trichosanthes root, and 18 parts agrimony.

[0039] Example 4

[0040] The difference between this embodiment and Embodiment 1 is that...

[0041] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 8 parts madder root, 18 parts halloysite, 14 parts camphor bark, 8 parts white peony root, 7 jujubes, 10 parts licorice root, 16 parts lily bulb, 14 parts trichosanthes root, and 8 parts agrimony.

[0042] Example 5

[0043] The difference between this embodiment and Embodiment 1 is that...

[0044] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 6 parts madder root, 10 parts halloysite, 10 parts camphor bark, 10 parts white peony root, 6 jujubes, 8 parts licorice root, 8 parts lily bulb, 8 parts trichosanthes root, and 6 parts agrimony.

[0045] Example 6

[0046] The difference between this embodiment and Embodiment 1 is that...

[0047] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 5 parts madder root, 10 parts halloysite, 10 parts camphor bark, 10 parts white peony root, 5 jujubes, 5 parts licorice root, 10 parts lily bulb, 10 parts trichosanthes root, and 5 parts agrimony.

[0048] Example 7

[0049] The difference between this embodiment and Embodiment 1 is that...

[0050] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts madder root, 20 parts halloysite, 20 parts camphor bark, 20 parts white peony root, 15 jujubes, 10 parts licorice root, 20 parts lily bulb, 20 parts trichosanthes root, and 15 parts agrimony.

[0051] Example 8

[0052] The difference between this embodiment and Embodiment 1 is that...

[0053] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10 parts madder root, 18 parts halloysite, 16 parts camphor bark, 14 parts white peony root, 8 jujubes, 10 parts licorice root, 16 parts lily bulb, 12 parts trichosanthes root, and 10 parts agrimony.

[0054] Example 9

[0055] The difference between this embodiment and Embodiment 1 is that...

[0056] The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 12 parts madder root, 18 parts halloysite, 18 parts camphor bark, 12 parts white peony root, 10 jujubes, 8 parts licorice root, 14 parts lily bulb, 14 parts trichosanthes root, and 12 parts agrimony.

[0057] Experimental Example 1

[0058] 1. Materials and Methods

[0059] 1.1 Experimental Animals

[0060] 240 SPF-grade Kunming mice, weighing (20±2) g each, half male and half female.

[0061] 1.2 Test Drugs

[0062] The herbal extract of this invention consists of: 8 parts Rubia cordifolia, 18 parts Halloysite, 16 parts Camphor bark, 12 parts Paeonia lactiflora, 10 jujubes, 8 parts Glycyrrhiza uralensis, 12 parts Lilium brownii, 14 parts Trichosanthes kirilowii root, and 8 parts Agrimonia pilosa. The above-mentioned raw materials are weighed, washed, and soaked in three times their total weight of water for 30 minutes. Then, they are decocted for 40 minutes, filtered, and the filtrate is concentrated to a drug concentration of 1 g / mL (1 mL contains 1 g of raw herb). This is then diluted to a high dose of 200 mg / mL, a medium dose of 100 mg / mL, and a low dose of 50 mg / mL.

[0063] Ginseng and Atractylodes Macrocephala Powder: Prepared as a solution with a drug concentration of 50 mg / mL;

[0064] Atractylodes macrocephala stomach-soothing powder: Prepared as a solution with a drug concentration of 50mg / mL;

[0065] Montmorillonite powder: Prepared as a solution with a drug concentration of 50 mg / mL.

[0066] 1.3 Test Methods

[0067] 1.3.1 Effects on senna-induced diarrhea in mice

[0068] Prepare senna leaves with a crude drug concentration of 1 g / mL for later use. Eighty mice were randomly divided into eight groups (n=10 each, half male and half female) according to weight and sex. These included a blank control group, a model group, low-, medium-, and high-dose groups of the herbal extract from this invention, and control groups 1-3. The blank control group received the same volume of physiological saline. All other experimental groups were administered 0.3 mL / mouse of crude senna leaves by gavage. After 0.5 h, the low (50 mg / mL), medium (100 mg / mL), and high (200 mg / mL) groups of the herbal extract from this invention were administered 0.2 mL / 10 g by gavage. The blank control group received the same volume of physiological saline by gavage. Control groups 1-3 were administered Shenling Baizhu powder (50 mg / mL), Baizhu Anwei powder (50 mg / mL), and Montmorillonite powder (50 mg / mL), respectively, at a dose of 0.1 mL / 10 g. All mice were housed individually in cages with filter paper underneath. The filter paper was changed each time diarrhea occurred. Observations were conducted for 6 h, and the number of diarrhea episodes was recorded.

[0069] 1.3.2 Effects on castor oil-induced diarrhea in mice

[0070] The grouping and administration methods were the same as in 1.3.1. The blank control group was given the same volume of physiological saline, while the other experimental groups were given 0.2 mL of castor oil per animal by gavage. Other experimental treatments were the same as in 1.3.1.

[0071] 1.3.3 Experiment on small intestinal propulsion

[0072] Seventy mice were randomly divided into seven groups according to weight and sex, with ten mice in each group (half male and half female). These included a blank control group, low-, medium-, and high-dose groups of the herbal extract from this invention, and control groups 1-3. Each group was administered the corresponding drug via gavage at a dose of 0.2 mL per 10 g of body weight (same as the administration method for each experimental group in 1.3.1). The blank control group received an equal volume of physiological saline. Administration was once daily for four consecutive days. Mice in all groups were fasted for 24 hours starting on the third day after drug administration. On day 4 of the experiment, 1 hour after administration, mice were gavaged with 0.2 mL of Indian ink per 10 g of body weight. 20 minutes later, the mice were euthanized by cervical dislocation, the abdominal cavity was opened, the mesentery was separated, and the intestinal segment from the pylorus to the ileocecal junction was cut off. The segment was placed on a flat-bottomed tray, and the small intestine was gently pulled into a straight line. The length of the intestine was measured as the "total length of the small intestine", and the distance from the pylorus to the front edge of the ink was measured as the "distance of ink propulsion in the intestine". The propulsion rate of the small intestine was calculated as: Small intestine propulsion rate (%) = distance of ink propulsion in the small intestine / total length of the small intestine × 100%.

[0073] 1.4 Data Statistics and Analysis

[0074] Data statistical analysis and graphing were performed using Graphpad Prism 8.0 software. The results are expressed as mean ± standard deviation (Mean ± SD). The t-test was used to compare differences between groups, and P < 0.05 was considered statistically significant.

[0075] 2 Results

[0076] 2.1 Effects on senna-induced diarrhea in mice

[0077] Figure 1 This study presents the effects of the herbal extract of this invention on diarrhea induced by senna leaves in mice. Compared with the blank control group, the model group mice showed a significant increase in the number of diarrhea episodes within 6 hours, a significant decrease in activity frequency during the observation period, and exhibited lethargy, weakness, and watery stools with reduced solid contents, indicating successful model establishment. Compared with the model group, the number of diarrhea episodes in each treatment group was significantly reduced (P<0.01). The antidiarrheal effect of the herbal extract of this invention on the diarrhea model mice showed a dose-dependent increase, with the antidiarrheal effect becoming more pronounced with increasing drug concentration. Compared with the low-dose group, the number of diarrhea episodes in control group mice 1-3 was significantly higher than that in the low-dose group (P<0.05).

[0078] 2.2 Effects on castor oil-induced diarrhea in mice

[0079] Figure 2The results show the effect of the herbal extract of this invention on castor oil-induced diarrhea in mice. Compared with the model group, the number of diarrhea episodes in each treatment group was significantly reduced (P<0.01). The antidiarrheal effect of the herbal extract of this invention on diarrhea model mice showed a dose-dependent increase, with the antidiarrheal effect becoming more pronounced as the drug concentration increased. Compared with the low-dose group, the number of diarrhea episodes in control group 1 and control group 3 was significantly higher than that in the low-dose group (P<0.01).

[0080] 2.3 Effects on gastrointestinal motility

[0081] Figure 3 The results show the effect of the herbal extract of this invention on the small intestinal propulsion rate of mice. Compared with the blank control group, the small intestinal propulsion rate of mice in each treatment group was significantly reduced (P<0.01), indicating that the drugs in each treatment group could significantly reduce gastrointestinal motility and decrease small intestinal propulsion function. The inhibitory effect of the herbal extract of this invention on small intestinal motility in mice was dose-dependent, and the inhibitory effect became more obvious with the increase of drug concentration. Compared with the low-dose group, the small intestinal propulsion rate of mice in control groups 1 and 3 was significantly higher than that of the low-dose group (P<0.01), and the small intestinal propulsion rate of mice in control group 2 was significantly higher than that of the low-dose group (P<0.05).

[0082] 3. Conclusion

[0083] The above results indicate that the herbal composition of the present invention has a good antidiarrheal effect on mouse diarrhea models induced by senna leaves and castor oil, can significantly reduce the frequency of diarrhea, has a certain inhibitory effect on the gastrointestinal tract of mice, and its therapeutic effect is significantly better than other control drugs (Shenling Baizhu Powder, Baizhu Anwei Powder, Montmorillonite Powder).

[0084] Experimental Example 2

[0085] 1. Materials and Methods

[0086] 1.1 General Information

[0087] A total of 144 patients with chronic diarrhea were collected and randomly divided into a treatment group and a control group, with 72 patients in each group. In the treatment group, there were 39 males and 33 females; the mean age was (38.9±6.97) years; and the mean duration of illness was (6.09±2.77) months. In the control group, there were 42 males and 30 females; the mean age was (40.36±8.10) years; and the mean duration of illness was (6.57±3.01) months. There were no statistically significant differences between the two groups in terms of gender, age, duration of illness, and severity of disease (P>0.05), indicating comparability.

[0088] 1.2 Diagnostic criteria

[0089] The diagnostic criteria for chronic diarrhea are based on "Practical Internal Medicine," while the diagnostic and syndrome differentiation criteria in Traditional Chinese Medicine (TCM) are based on "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)" and "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine."

[0090] 1.3 Inclusion Criteria

[0091] The patient meets the diagnostic criteria for chronic diarrhea; has no history of mental illness; has been excluded from organic lesions of the gastrointestinal tract, malignant tumors, chronic schistosomiasis, chronic amoebic dysentery, and parasitic diseases; has no serious primary diseases of the heart, brain, liver, endocrine, immune system, hematopoietic system, etc.; and has signed informed consent forms with their family.

[0092] 1.4 Methods

[0093] 1.4.1 Treatment methods

[0094] Control group: treated with oral Bifidobacterium quadruple live bacteria tablets, 1.5 g / time, 3 times / day;

[0095] Treatment group: Oral administration of an oral liquid made from the traditional Chinese medicine composition of the present invention, wherein the oral liquid is made from the following raw materials in parts by weight: 8 parts of Rubia cordifolia, 18 parts of Halloysite, 16 parts of Camphor bark, 12 parts of Paeonia lactiflora, 10 jujubes, 8 parts of Glycyrrhiza uralensis, 12 parts of Lilium brownii, 14 parts of Trichosanthes kirilowii root, and 8 parts of Agrimonia pilosa; plus medically acceptable excipients to prepare an oral liquid with a raw drug content of 2g / mL, 10mL / time, 3 times / day.

[0096] Both groups of patients received the same basic treatment, such as fluid replacement and correction of electrolyte and acid-base imbalances. They were instructed to maintain a light, easily digestible diet and engage in appropriate exercise. One course of treatment lasted two weeks, and the efficacy was assessed after two courses.

[0097] 1.4.2 Criteria for Evaluating Therapeutic Effect

[0098] The criteria for judging the efficacy of treatment are based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)".

[0099] Cure: The frequency, amount, and consistency of bowel movements return to normal, and accompanying symptoms and signs disappear;

[0100] Significant effect: 2-3 bowel movements per day, nearly formed, or loose stools only once a day, with a total score of accompanying symptoms and signs reduced by ≥70% compared to before treatment;

[0101] Effective: Improved frequency and quality of bowel movements; total score of accompanying symptoms and signs reduced by ≥35% compared to before treatment;

[0102] Invalid: Those that do not meet the above standards;

[0103] Overall effective rate = cure rate + significant effect rate + effective rate.

[0104] 1.4.3 Observation Indicators

[0105] Clinical symptoms, signs, complete blood count, stool routine examination, complete biochemical panel, and adverse drug reactions were observed in both groups after treatment. According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)," symptoms such as diarrhea, loss of appetite, and fatigue were graded and quantified into four levels: none, mild, moderate, and severe, recorded as 0, 1, 2, and 4 points, respectively. The TCM symptom scores of the two groups were recorded before treatment and 4 weeks after treatment.

[0106] 1.4.4 Statistical Methods

[0107] Statistical analysis was performed using Graphpad Prism 8.0 software. Quantitative data were expressed as mean ± standard deviation, and t-tests were used between groups. Categorical data were expressed as percentages (%) and analyzed using the chi-square test. 2 The test was performed, and P < 0.05 was considered statistically significant.

[0108] 2 Results

[0109] 2.1 Clinical efficacy

[0110] As shown in Table 1, the total effective rate in the treatment group was 100%, and the cure rate was 79.71%; the total effective rate in the control group was 75.00%, and the cure rate was only 27.78%. The difference in efficacy between the two groups was statistically significant (P<0.05).

[0111] Table 1. Comparison of clinical efficacy between the two groups of patients (cases, %)

[0112]

[0113] 2.2 Symptom improvement

[0114] After treatment, the scores of symptoms such as diarrhea, loss of appetite, and fatigue in both groups were significantly lower than before treatment (P<0.05). After treatment, compared with the control group, the scores of symptoms such as diarrhea, loss of appetite, and fatigue in the treatment group were significantly lower than those in the control group (P<0.05).

[0115] Table 2 Comparison of symptom scores before and after treatment in the two groups of patients

[0116]

[0117] Note: *P<0.05 compared with pre-treatment levels in this group; *P<0.05 compared with the control group. # P<0.05.

[0118] 3. Summary

[0119] Chronic diarrhea belongs to the category of "diarrhea disease" in traditional Chinese medicine; it is mostly caused by being affected by external pathogens, emotional disorders, and improper diet; long-term dysentery that does not heal, resulting in continuous diarrhea or inability to control the slippery discharge due to spleen and kidney yang deficiency. The treatment principle is mainly to tonify the spleen and stomach, warm the middle jiao and promote qi movement, and astringe the lungs to stop diarrhea; in the traditional Chinese medicine composition of the present invention, limonitum has the effect of astringing the intestines and stopping diarrhea, and is often used for long-term diarrhea and dysentery as the monarch drug; the ministerial drugs are madder and agrimony, which can astringe to stop bleeding and also have an astringent property to stop diarrhea. White peony root is the most important drug for tonifying qi and strengthening the spleen. Cinnamomum camphora bark dispels wind and dampness, warms the stomach and harmonizes the middle. The sweetness of Chinese date, combined with white peony root, can achieve the effects of tonifying the spleen and stomach, promoting qi movement and harmonizing the middle, and promoting diuresis to stop diarrhea, etc.; Lily is a tonic for general use, with the functions of tonifying qi and regulating the middle, nourishing the stomach yin without being greasy, supporting the spleen earth and suppressing the liver wood. Trichosanthes root clears heat and purges fire, generates fluid and quenches thirst. All of the above are adjuvant drugs. Licorice has a sweet taste and a neutral nature, can tonify the qi of the heart and spleen, and harmonize all the drugs. The combination of all the drugs together plays the role of tonifying the spleen and stomach, astringing the lungs to stop diarrhea, and warming the middle jiao and promoting qi movement. The traditional Chinese medicine composition of the present invention can effectively relieve and improve the clinical symptoms of chronic diarrhea patients, with remarkable curative effects. The total effective rate for the treatment of chronic diarrhea can reach 100%, and the cure rate can reach 79.17%, which is worthy of further clinical promotion and application.

[0120] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diarrhea, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 5-20 parts of Rubia cordifolia, 5-20 parts of Halloysite, 5-20 parts of Camphor bark, 5-20 parts of Paeonia lactiflora, 5-20 jujubes, 5-20 parts of Glycyrrhiza uralensis, 5-20 parts of Lilium brownii, 5-20 parts of Trichosanthes kirilowii root, and 5-20 parts of Agrimonia pilosa.

2. The traditional Chinese medicine composition for treating diarrhea according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 5-15 parts madder root, 10-20 parts halloysite, 10-20 parts camphor bark, 10-20 parts white peony root, 5-15 jujubes, 5-10 parts licorice root, 10-20 parts lily bulb, 10-20 parts trichosanthes root, and 5-15 parts agrimony.

3. The traditional Chinese medicine composition for treating diarrhea according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 8 parts madder root, 18 parts halloysite, 16 parts camphor bark, 12 parts white peony root, 10 jujubes, 8 parts licorice root, 12 parts lily bulb, 14 parts trichosanthes root, and 8 parts agrimony.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating chronic diarrhea.

5. The use of the traditional Chinese medicine composition as described in claim 4 in the preparation of a medicament for treating chronic diarrhea, characterized in that, The traditional Chinese medicine composition can be prepared into any one of the following dosage forms: oral liquid, decoction, granules, pills, enema liquid, capsules, suppositories, or freeze-dried powder.

Images