A traditional Chinese medicine composition for diarrhea-predominant irritable bowel syndrome, a preparation method and application thereof

Abstract

The application relates to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating diarrhea type irritable bowel syndrome, a preparation method and application thereof. The traditional Chinese medicine composition comprises 4-8 parts of honeyed Ephedra, 4-9 parts of cassia twig, 1-5 parts of asarum, 4-9 parts of dried ginger, 9-20 parts of white peony root, 6-14 parts of fried licorice, 4-8 parts of Schisandra chinensis, 6-14 parts of dried tangerine or orange peel, 4-15 parts of prepared aconite, 9-20 parts of poria, 5-15 parts of bran-fried atractylodes, 9-20 parts of kudzu root, 3-9 parts of raw ginger and 7-14 parts of jujube. The traditional Chinese medicine composition provided by the application takes prepared aconite and dried ginger as monarchs, honeyed Ephedra, cassia twig, asarum, poria and atractylodes as ministers, Schisandra chinensis, white peony root, kudzu root, raw ginger and jujube as assistants, and fried licorice as an enabler. The traditional Chinese medicine composition has the effects of warming yang and stopping diarrhea, invigorating the spleen and harmonizing the stomach, is safe and reliable, can effectively reduce the diarrhea frequency, relieve abdominal discomfort, regulate the intestinal and stomach motility, and has remarkable effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, its preparation method, and its application. Background Technology

[0002] Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic functional gastrointestinal disorder associated with changes in stool consistency or frequency. Clinical symptoms include abdominal pain, bloating, and discomfort. The prevalence in Asian countries is 5%–10%, characterized by recurrent episodes and often accompanied by psychological symptoms such as anxiety and depression. The pathophysiological mechanisms of IBS-D are not fully understood in modern medicine, but potential mechanisms may include abnormal brain-gut axis interactions, visceral hypersensitivity, abnormal gastrointestinal motility, activation of the immune-nervous system by low-grade intestinal inflammation, intestinal microecological imbalance, and acute or chronic stress.

[0003] Currently, modern medical treatment for diarrhea-predominant irritable bowel syndrome (IBS) primarily focuses on symptom relief, commonly using medications such as antidiarrheals, antispasmodics, antibiotics that are not absorbed by the intestines, and antidepressants. However, these treatments have drawbacks, including the use of multiple medications, high dosages, significant side effects, poor patient compliance, and recurrence of symptoms after discontinuation of medication. These factors increase the financial burden on patients and severely impact their quality of life. Therefore, how to safely and effectively treat diarrhea-predominant IBS is an urgent clinical problem that needs to be solved. Summary of the Invention

[0004] In view of the technical problems of existing drugs for treating diarrhea-predominant irritable bowel syndrome, such as the large number of drug types, large dosages, obvious side effects, poor patient compliance, and recurrence of symptoms after drug withdrawal, this invention provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, its preparation method, and its application.

[0005] To achieve the above objectives, the embodiments of the present invention employ the following technical solutions:

[0006] A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, the composition comprising the following components in parts by weight: 4-8 parts honey-processed ephedra, 4-9 parts cinnamon twig, 1-5 parts asarum, 4-9 parts dried ginger, 9-20 parts white peony root, 6-14 parts prepared licorice root, 4-8 parts schisandra fruit, 6-14 parts tangerine peel, 4-15 parts prepared aconite root, 9-20 parts poria cocos, 5-15 parts stir-fried atractylodes lancea root, 9-20 parts kudzu root, 3-9 parts fresh ginger, and 7-14 parts jujube.

[0007] Compared to existing technologies, the traditional Chinese medicine combination provided by this invention for treating diarrhea-predominant irritable bowel syndrome comprises 14 herbs that work synergistically through a principal-assistant-adjuvant-guide approach. Specifically, processed aconite root strengthens the primordial yang, warms the spleen, and dispels cold stagnation; dried ginger warms the spleen and stomach, transforms cold phlegm, and eliminates dampness. These two herbs, being pungent and warm, assist yang, warm the spleen and intestines, dispel cold, and eliminate dampness, serving as the principal herbs. Ephedra, being pungent and warm, dispels cold and unblocks the meridians; cinnamon twig warms the middle jiao, assists yang, transforms qi, and promotes water metabolism; asarum invigorates kidney yang, eliminates stagnation of cold, consolidates cold, dispels wind, and relieves pain; and poria strengthens the spleen and stomach and benefits the middle jiao. The formula consists of five herbs: Atractylodes lancea (to expel dampness from the spleen, dispel turbidity, and stop diarrhea), which are the assistant herbs; Schisandra chinensis (to nourish qi and yin, astringe the intestines and stop diarrhea); Paeonia lactiflora (to astringe the liver and spleen, relieve spasms and stop cramps), which together prevent Ephedra sinica (to disperse too much and damage yang qi) and Asarum heterotropoides (to disperse too much and damage yin fluids), and also alleviate the pungent, warm, and drying effects of Aconitum carmichaelii (to dry ginger) and Zingiber officinale (to dry ginger) that deplete yin fluids; Citrus reticulata (to strengthen the spleen and regulate qi, dry dampness and resolve phlegm); Pueraria lobata (to raise spleen qi, benefit the intestines and stop diarrhea); Zingiber officinale (to fresh ginger) and Ziziphus jujuba (to tonify qi and harmonize the middle jiao, warm the intestines and nourish the spleen), which together are the adjuvant herbs; Glycyrrhiza uralensis (to harmonize the middle jiao and benefit the spleen, and harmonize the other herbs), which is the guiding herb. The combination of these herbs combines warming and dispersing, dispersing and astringing, with both dispersing and astringing properties, opening and closing, addressing both the exterior and interior, warming and unblocking the three jiaos, and relieving external cold; thus, it activates kidney yang, promotes spleen yang, disperses lung qi, dispels wind-cold, eliminates water retention, provides a source for warming and transformation, and has the power to disperse and descend, thereby eliminating all symptoms.

[0008] Furthermore, the traditional Chinese medicine composition provided by this invention has a simple drug composition, is convenient to take, safe and reliable, and has no drug toxicity or side effects. It can effectively reduce the frequency of diarrhea, relieve abdominal discomfort, and promote gastrointestinal motility, with significant effects. It provides a convenient, reliable, non-toxic drug suitable for long-term use for the clinical treatment of diarrhea-predominant irritable bowel syndrome, and has high practical value.

[0009] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 5-7 parts honey-processed ephedra, 5-7 parts cinnamon twig, 2-4 parts asarum, 5-7 parts dried ginger, 12-18 parts white peony root, 8-12 parts prepared licorice root, 5-7 parts schisandra fruit, 8-12 parts tangerine peel, 6-12 parts prepared aconite root, 12-18 parts poria cocos, 7-12 parts stir-fried atractylodes lancea root, 12-17 parts kudzu root, 5-7 parts fresh ginger, and 9-12 parts jujube.

[0010] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 6 parts honey-processed ephedra, 6 parts cinnamon twig, 3 parts asarum, 6 parts dried ginger, 15 parts white peony root, 10 parts prepared licorice root, 6 parts schisandra fruit, 10 parts tangerine peel, 9 parts prepared aconite root, 15 parts poria cocos, 9 parts stir-fried atractylodes lancea root, 15 parts kudzu root, 6 parts fresh ginger, and 10 parts jujube.

[0011] The pharmacological effects of each traditional Chinese medicine component in this invention are as follows:

[0012] Honey-processed ephedra: It has a pungent and slightly bitter taste, is warm in nature, and enters the lung and bladder meridians; it can induce sweating to relieve exterior syndromes, promote lung function to relieve asthma, promote diuresis to reduce swelling, and dispel cold and stagnation; it is used for wind-cold exterior syndromes, chest tightness and cough, edema due to wind, wind-cold arthralgia, yin carbuncles, phlegm nodules, etc.; modern pharmacological studies have proven that it has anti-inflammatory, analgesic, and anti-allergic effects.

[0013] Cinnamon twig: It has a pungent and sweet taste, is warm in nature, and enters the heart, lung, and bladder meridians. It can induce sweating and relieve muscle tension, warm the meridians and promote blood circulation, assist yang and transform qi, and calm the upward rushing qi and descend the rebellious qi. It is used for wind-cold exterior syndrome, cold pain in the wrist and abdomen, phlegm retention, edema due to water retention, palpitations, and running piglet syndrome. It also has the effects of strengthening the stomach, relieving pain, anti-inflammation, anti-allergy, and lowering blood pressure.

[0014] Asarum: It has a pungent taste and warm nature, and enters the heart, lung and kidney meridians; it dispels cold and releases the exterior, dispels wind and relieves pain, opens the nasal passages, warms the lungs and transforms phlegm; it is used for colds due to wind and cold, headache, toothache, rheumatic pain, sinusitis, cough and asthma due to phlegm, and closed syndrome; it has analgesic, anti-inflammatory, antibacterial, sedative, antidepressant and cancer cell inhibitory effects.

[0015] Dried ginger: It is pungent and hot in nature, and enters the spleen, stomach, kidney, heart and lung meridians; it warms the middle and dispels cold, restores yang and unblocks the meridians, warms the lungs and transforms phlegm; it is used for spleen and stomach cold syndrome, cold limbs and weak pulse, collapse of yang syndrome, cough and asthma due to cold phlegm; modern pharmacological studies have proven that it has anti-thrombotic and heart failure-improving effects.

[0016] White peony root: bitter and sour in taste, slightly cold in nature, enters the liver and spleen meridians; nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang; used for blood deficiency and chlorosis, hypochondriac pain, limb spasms, liver yang hyperactivity syndrome, headache and dizziness; has anti-platelet aggregation, blood-tonifying, and antidepressant effects.

[0017] Prepared licorice root: sweet in taste, neutral in nature, and enters the stomach, heart, lung, and spleen meridians; it tonifies the middle energizer and replenishes qi, eliminates phlegm and stops cough, relieves spasms and pain, and harmonizes the properties of other herbs; it has the effects of treating spleen and stomach weakness, harmonizing various herbs, and has modern pharmacological effects against ulcers.

[0018] Schisandra chinensis: Sour and sweet in taste, warm in nature; enters the lung, heart, and kidney meridians; has the effects of astringing and consolidating, replenishing qi and promoting body fluids, tonifying the kidneys and calming the mind; used for chronic cough and wheezing, nocturnal emission and spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to fluid depletion, internal heat and thirst, palpitations and insomnia; modern pharmacological studies have proven that it has the effects of protecting the liver, enhancing immunity, sedation, antidepressant, antioxidant, antitumor, and protecting the myocardium.

[0019] Dried tangerine peel: pungent in taste and warm in nature; enters the lung and spleen meridians; has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm; used for chest and abdominal distension, poor appetite, vomiting and diarrhea; modern pharmacological research has proven that it has the effects of regulating gastrointestinal motility, promoting gastric juice secretion, protecting the liver and gallbladder, relieving asthma, antibacterial, and antitumor.

[0020] Prepared aconite root: It has a pungent and sweet taste; it is hot in nature; it enters the heart, kidney, and spleen meridians; it has the effects of restoring yang and rescuing from collapse, tonifying fire and assisting yang, dispelling cold and relieving pain; it is used for symptoms such as kidney yang deficiency, spleen yang deficiency, abdominal pain, and loose stools; modern pharmacological studies have also proven that it has cardiotonic effects and anti-inflammatory and analgesic effects.

[0021] Poria cocos: It is neutral in nature and enters the spleen and heart meridians; it has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, calming the mind and soothing the nerves; it is used for symptoms such as edema and abdominal distension, phlegm and cough, vomiting, spleen deficiency and poor appetite, diarrhea, and palpitations; modern pharmacological studies have proven that it has the effects of regulating gastrointestinal function, anti-tumor, sedation, and antibacterial.

[0022] Stir-fried Atractylodes lancea: pungent and bitter in taste; warm in nature; enters the spleen, stomach, and liver meridians; has the effects of drying dampness and strengthening the spleen, dispelling wind and cold; used for dampness obstructing the middle jiao, abdominal distension, diarrhea, and edema; modern pharmacological studies have proven that it has the effects of regulating gastrointestinal function, inhibiting uterine smooth muscle, and resisting pathogenic microorganisms.

[0023] Kudzu root: sweet and pungent in taste, cool in nature; enters the spleen, stomach and lung meridians; relieves muscle tension and fever, promotes body fluid production and quenches thirst, detoxifies alcohol; used to treat exogenous fever, stiff neck and back pain, and promotes body fluid production.

[0024] Ginger: It has a pungent taste and slightly warm properties; it enters the lung, spleen, and stomach meridians; it warms the middle jiao and stops vomiting, relieves exterior symptoms and dispels cold; it is used to treat spleen and stomach deficiency and cold, and spleen and stomach dysfunction caused by cold and dampness, and improve symptoms such as bloating, stomach pain, and loose stools; modern pharmacological studies have proven that it can inhibit bacterial growth and prevent digestive tract infections.

[0025] Jujube: sweet in taste, warm in nature, and enters the spleen and stomach meridians; it tonifies the middle energizer and replenishes qi, nourishes blood and calms the mind, strengthens the spleen and stomach; it is used to relieve symptoms such as spleen and stomach weakness, loose stools, and unformed stools; modern pharmacological studies have shown that it can enhance muscle strength, enhance immunity, promote calcium absorption, and reduce intestinal peristalsis.

[0026] The present invention also provides a method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, comprising at least the following steps:

[0027] Weigh each component according to the designed ratio, add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger and jujube to water, soak, heat and decoct, filter the extract to obtain the Chinese medicine composition for treating diarrhea-type irritable bowel syndrome.

[0028] The present invention provides a method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. The process is simple, convenient, safe and environmentally friendly, and can retain the active ingredients of each traditional Chinese medicine to the maximum extent, thus ensuring the efficacy of the traditional Chinese medicine composition.

[0029] Preferably, the soaking temperature is 15℃-25℃ and the soaking time is 30min-60min.

[0030] The optimal soaking temperature allows water to fully contact the various Chinese medicinal herbs, achieving good wetting and penetration effects, which is beneficial for subsequent decoction and extraction, fully extracting the active ingredients of each Chinese medicinal herb. At the same time, it avoids the decomposition of the effective components of Chinese medicinal herbs caused by prolonged soaking.

[0031] Preferably, the heating and simmering temperature is 80℃-100℃, and the heating and simmering time is 30min-40min.

[0032] Optimal heating and decoction temperatures and times can ensure that the active ingredients of traditional Chinese medicine are not destroyed while improving the extraction rate.

[0033] Preferably, the amount of water used is 6-8 times the total mass of the Chinese herbal medicine.

[0034] The optimal amount of water added can improve the extraction effect.

[0035] The present invention also provides the use of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in any of the above claims in the preparation of a drug for treating diarrhea-predominant irritable bowel syndrome.

[0036] The present invention also provides a traditional Chinese medicine preparation for treating diarrhea-predominant irritable bowel syndrome, comprising any one of the traditional Chinese medicine compositions for treating diarrhea-predominant irritable bowel syndrome.

[0037] The traditional Chinese medicine preparation for treating diarrhea-predominant irritable bowel syndrome provided by this invention contains the above-mentioned herbal extracts. The combined use of these herbs, with their complementary effects, works synergistically to warm the Yang, stop diarrhea, strengthen the spleen, and harmonize the stomach. It is safe, reliable, and has no toxic side effects. It can effectively reduce the frequency of diarrhea, relieve abdominal discomfort, regulate gastrointestinal motility, and has significant effects.

[0038] Furthermore, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients. These excipients may be selected from at least one or more conventionally used excipients, lubricants, disintegrants, fillers, or binders in the art.

[0039] Preferably, the dosage form of the traditional Chinese medicine preparation is granules, capsules, tablets or pills.

[0040] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome can be made into granules, capsules, tablets or pills using conventional formulation methods in the art. The present invention does not impose special limitations on the preparation process of each dosage form, and the specific process conditions can be adjusted by those skilled in the art through conventional experiments.

[0041] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome can be formulated into a traditional Chinese medicine preparation that is convenient to carry and use, and easy to operate.

[0042] The traditional Chinese medicine composition and preparation for treating diarrhea-predominant irritable bowel syndrome (IBS) provided by this invention further improve the clinical symptoms of IBS through the synergistic effect of the components. Furthermore, all the raw materials used in this invention are readily available and simple to obtain, enabling convenient improvement of IBS clinical symptoms. It is easy to use, has no toxic side effects, is suitable for long-term use, and the condition is less likely to recur after discontinuation. This invention provides a new method for the efficient and safe treatment of IBS and has high application value. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0044] Example 1

[0045] This invention provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. The composition comprises the following components in parts by weight: 8 parts honey-processed ephedra, 8 parts cinnamon twig, 3 parts asarum, 6 parts dried ginger, 20 parts white peony root, 10 parts prepared licorice root, 4 parts schisandra fruit, 14 parts tangerine peel, 9 parts prepared aconite root, 20 parts poria cocos, 12 parts stir-fried atractylodes lancea root, 15 parts kudzu root, 9 parts fresh ginger, and 12 parts jujube.

[0046] The preparation method of the above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome includes at least the following steps:

[0047] Weigh each component according to the designed ratio, and add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger, and jujube to water with a total weight of 6-8 times the total weight of the Chinese medicine. Soak at 20°C for 50 minutes, heat to 100°C and decoct for 30 minutes. Filter the extract to obtain the Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome.

[0048] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared into traditional Chinese medicine granules using conventional methods.

[0049] Example 2

[0050] This invention provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. The composition comprises the following components in parts by weight: 4 parts honey-processed ephedra, 9 parts cinnamon twig, 5 parts asarum, 9 parts dried ginger, 15 parts white peony root, 12 parts prepared licorice root, 6 parts schisandra fruit, 12 parts tangerine peel, 15 parts prepared aconite root, 15 parts poria cocos, 15 parts stir-fried atractylodes lancea root, 18 parts kudzu root, 7 parts fresh ginger, and 14 parts jujube.

[0051] The preparation method of the above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome includes at least the following steps:

[0052] Weigh each component according to the designed ratio, and add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger, and jujube to water with a total weight of 6 times the Chinese medicine. Soak at 25°C for 40 minutes, heat to 80°C and decoct for 40 minutes. Filter the extract to obtain the Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome.

[0053] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared into traditional Chinese medicine tablets using conventional methods.

[0054] Example 3

[0055] This invention provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. The composition comprises the following components in parts by weight: 5 parts honey-processed ephedra, 4 parts cinnamon twig, 1 part asarum, 4 parts dried ginger, 12 parts white peony root, 6 parts prepared licorice root, 8 parts schisandra fruit, 10 parts tangerine peel, 4 parts prepared aconite root, 12 parts poria cocos, 5 parts stir-fried atractylodes rhizome, 9 parts kudzu root, 3 parts fresh ginger, and 7 parts jujube.

[0056] The preparation method of the above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome includes at least the following steps:

[0057] Weigh each component according to the designed ratio, and add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger, and jujube into water with a total weight of 8 times the weight of the Chinese medicine. Soak at 15°C for 60 minutes, heat to 90°C and decoct for 35 minutes. Filter the extract to obtain the Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome.

[0058] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared into traditional Chinese medicine capsules using conventional methods.

[0059] Example 4

[0060] This invention provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. The composition comprises the following components in parts by weight: 6 parts honey-processed ephedra, 8 parts cinnamon twig, 4 parts asarum, 8 parts dried ginger, 9 parts white peony root, 14 parts prepared licorice root, 5 parts schisandra fruit, 6 parts tangerine peel, 12 parts prepared aconite root, 9 parts poria cocos, 12 parts stir-fried atractylodes lancea root, 20 parts kudzu root, 8 parts fresh ginger, and 12 parts jujube.

[0061] The preparation method of the above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome includes at least the following steps:

[0062] Weigh each component according to the designed ratio, and add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger, and jujube to water with a total weight of 7 times the Chinese medicine. Soak at 20°C for 45 minutes, heat to 80°C and decoct for 35 minutes. Filter the extract to obtain the Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome.

[0063] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared into traditional Chinese medicine pills using conventional methods.

[0064] Example 5

[0065] This invention provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. The composition comprises the following components in parts by weight: 6 parts honey-processed ephedra, 6 parts cinnamon twig, 3 parts asarum, 6 parts dried ginger, 15 parts white peony root, 10 parts prepared licorice root, 6 parts schisandra fruit, 10 parts tangerine peel, 9 parts prepared aconite root, 15 parts poria cocos, 9 parts stir-fried atractylodes lancea root, 15 parts kudzu root, 6 parts fresh ginger, and 10 parts jujube.

[0066] The preparation method of the above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome includes at least the following steps:

[0067] Weigh each component according to the designed ratio, and add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger, and jujube into water with a total weight of 6 times the total weight of the Chinese herbs. Soak at 25°C for 30 minutes, heat to 90°C and decoct for 30 minutes. Filter the extract to obtain the Chinese herbal composition for treating diarrhea-predominant irritable bowel syndrome.

[0068] The above-mentioned traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared into traditional Chinese medicine granules using conventional methods.

[0069] Comparative Example 1

[0070] This comparative example provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. Its raw material composition and dosage are exactly the same as in Example 5, except that the tangerine peel in Example 5 is replaced with an equal amount of Acanthopanax senticosus root bark, and the Poria cocos is replaced with an equal amount of Eupatorium fortunei. All other components are exactly the same as in Example 5. Specifically:

[0071] 6 parts honey-processed ephedra, 6 parts cinnamon twig, 3 parts asarum, 6 parts dried ginger, 15 parts white peony root, 10 parts prepared licorice root, 6 parts schisandra fruit, 10 parts eleutherococcus bark, 9 parts prepared aconite root, 15 parts eupatorium, 9 parts stir-fried atractylodes rhizome, 15 parts kudzu root, 6 parts fresh ginger, and 10 parts jujube.

[0072] A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared using the exact same method as in Example 5. This composition was then prepared into traditional Chinese medicine granules using the same method as in Example 5.

[0073] Comparative Example 2

[0074] This comparative example provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome. Its raw material composition and dosage are exactly the same as in Example 5, except that 15 parts of hyacinth bean and 15 parts of stir-fried Atractylodes macrocephala are added to the formula of Example 5. Specifically:

[0075] 6 parts honey-processed ephedra, 6 parts cinnamon twig, 3 parts asarum, 6 parts dried ginger, 15 parts white peony root, 10 parts prepared licorice root, 6 parts schisandra fruit, 10 parts dried tangerine peel, 9 parts prepared aconite root, 15 parts poria cocos, 9 parts stir-fried atractylodes lancea root, 15 parts kudzu root, 6 parts fresh ginger, 10 parts jujube, 15 parts hyacinth bean, and 15 parts stir-fried atractylodes macrocephala.

[0076] A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome was prepared using the exact same method as in Example 5. This composition was then prepared into traditional Chinese medicine granules using the same method as in Example 5.

[0077] To better illustrate the characteristics of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome provided in the embodiments of the present invention, the efficacy of the traditional Chinese medicine compositions for treating diarrhea-predominant irritable bowel syndrome prepared in Example 5 and Comparative Examples 1-2 will be tested below.

[0078] The invention will be further described in detail below with reference to clinical trials and typical cases.

[0079] I. Clinical Trials

[0080] 1. Clinical data:

[0081] 1.1 General Information

[0082] Sixty-four patients with diarrhea-predominant irritable bowel syndrome (IBS) were selected from outpatient and inpatient treatment and randomly divided into four groups using electronic randomization: the treatment group (Example 1), the treatment group (Comparative Example 1), the treatment group (Comparative Example 2), and the control group, with 16 patients in each group. In the Example 1 treatment group, there were 8 males and 8 females, with a mean age of (41.75 ± 10.07 years). In the Comparative Example 1 treatment group, there were 7 males and 9 females, with a mean age of (39.65 ± 12.63 years). In the Comparative Example 2 treatment group, there were 8 males and 8 females, with a mean age of (40.95 ± 11.12 years). In the control group, there were 9 males and 7 females, with a mean age of (40.33 ± 11.12 years). There were no statistically significant differences in general characteristics among the groups (P > 0.05), indicating comparability.

[0083] 1.2 Diagnostic criteria

[0084] The diagnostic criteria for Western medicine refer to the Rome IBS diagnostic criteria and the 2020 Chinese Expert Consensus on Diarrhea-Predominant Irritable Bowel Syndrome; the diagnostic criteria for Traditional Chinese Medicine refer to the Expert Consensus on the Diagnosis and Treatment of Diarrhea-Predominant Irritable Bowel Syndrome and the Principles for Clinical Guidance Research of New Traditional Chinese Medicine Drugs.

[0085] Specifically:

[0086] (1) Recurrent abdominal pain or discomfort (referring to discomfort that is difficult to describe as pain) for at least 3 days per month in the past 3 months, and accompanied by 2 or more of the following: ① changes in the frequency of bowel movements during the onset of the disease (increased); ② changes in the consistency of the stool during the onset of the disease (loose stool); ③ improvement of symptoms after defecation.

[0087] (2) The current symptoms have lasted for at least 3 months and there was at least one symptom episode in the 6 months prior to the diagnosis.

[0088] (3) During research or clinical validation, the frequency of pain or abdominal discomfort at least 2 days per week is a condition for entering the screening period.

[0089] Diagnostic criteria exclude organic diseases that can cause the above symptoms.

[0090] 1.3 Inclusion Criteria

[0091] ① Meets the diagnostic criteria under section “1.2”; ② Age 18-70 years; ③ Has not taken any medications that may affect bowel function or cause pain within the past month; ④ The patient understands this study and has signed an informed consent form.

[0092] 1.4 Exclusion Criteria

[0093] ① Age <18 years or >70 years; ② Diarrhea caused by tumors, bacterial or viral infections, poisoning, etc.; ③ Participation in other clinical trials; ④ Taking medications that may affect intestinal function or cause pain within the past month; ⑤ Pregnant or lactating women; ⑥ Comorbid mental illness, inflammatory bowel disease, or severe cardiovascular, hepatic, renal, or cerebrovascular diseases; ⑦ Refusal of traditional Chinese medicine treatment.

[0094] 1.5 Termination of the test

[0095] ① Those who fail to take medication as prescribed or interrupt treatment, making it impossible to determine the effectiveness of the treatment;

[0096] ② Those with poor compliance, or those who experience complications or special physiological changes and are not suitable to continue.

[0097] 2. Treatment methods:

[0098] In the example, the treatment group, the comparative treatment group, and the control group were all given Bifidobacterium lactis triple live bacteria tablets (Inner Mongolia Shuangqi Pharmaceutical Co., Ltd., National Drug Approval Number S19980004, 500mg / tablet) orally, 2 tablets 3 times a day; the treatment lasted for 4 weeks. During this period, patients were advised not to eat spicy, cold, or gastrointestinal irritating foods and dairy products.

[0099] 2.1 Example Treatment group: The extract of the traditional Chinese medicine composition prepared in Example 5 of the present invention was administered orally, 2 bags (200 mL each bag) twice a day for 4 weeks.

[0100] 2.2 Comparative Treatment Group 1: The extract of the traditional Chinese medicine composition prepared in Comparative Example 1 of this invention was administered orally, 2 bags (200 mL each) twice a day for 4 weeks.

[0101] 2.3 Comparative Treatment Group 2: The extract of the traditional Chinese medicine composition prepared in Comparative Example 2 of this invention was administered orally, 2 bags (200 mL per bag) twice a day for 4 weeks.

[0102] 2.4 Control group: The placebo of the Chinese medicine of the present invention (200g of rice roasted until charred and 1 / 20 of the original dose of the medicine in Example 5) was given. The extract was prepared by the method in Example 5. Two bags (200mL each) were given twice a day, and the medicine was taken orally for 4 weeks.

[0103] 3 Observation Indicators:

[0104] Clinical symptoms: abdominal pain, abdominal distension, frequent bowel movements, decreased appetite, dry mouth, and bitter taste. Symptom scores are accumulated based on the severity of the patient's clinical symptoms: severe (3 points), moderate (2 points), mild (1 point), and none (0 points). Higher scores indicate more severe symptoms, and vice versa. Records are kept weekly during treatment.

[0105] 4. Efficacy evaluation criteria:

[0106] Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the following criteria are defined: Clinically cured: Symptoms and signs disappear or basically disappear, and the symptom score decreases by ≥95%; Significantly effective: Symptoms and signs are significantly improved, and the symptom score decreases by ≥70%; Effective: Symptoms and signs improve, and the symptom score decreases by ≥30%; Ineffective: Clinical symptoms and signs do not improve or worsen, and the symptom score decreases by less than 30% compared to before. The nimodipine method is used to calculate the percentage decrease in symptom score.

[0107] 5. Before and after treatment, routine blood, urine, and stool tests, electrocardiograms, liver and kidney function tests, and observation of gastrointestinal adverse reactions were performed on the patient.

[0108] 6. Statistical methods

[0109] Data were statistically analyzed using SPSS 25.0 software. Quantitative data conforming to a normal distribution were expressed as mean ± standard deviation (x ± s). Paired t-tests were used for comparisons within groups before and after treatment; for comparisons between groups, if a normal distribution was met, an independent samples t-test was used; otherwise, a rank-sum test was used. Rank-sum tests were used for graded efficacy assessment data. A p-value < 0.05 was considered statistically significant.

[0110] 7. Treatment results:

[0111] 7.1 Comparison of total scores of main symptoms after treatment in the four groups of patients: abdominal pain, abdominal distension, frequent bowel movements, poor appetite, dry mouth and bitter taste.

[0112] Table 1 Total score of main symptoms after treatment

[0113]

[0114] Note: There was no statistically significant difference in the total symptom scores before treatment among the four groups (P>0.05). There were statistically significant differences between the three treatment groups compared to before treatment. * P < 0.05, compared with the control group after treatment, △ P < 0.05.

[0115] As shown in Table 1, there was no statistically significant difference in the total symptom scores before treatment among the four groups (P > 0.05). However, in the treatment group of the example, the total symptom score decreased significantly after treatment (*P < 0.05). Furthermore, compared with the control group, the total symptom score decreased significantly after treatment in the treatment group of the example (*P < 0.05). △ P < 0.05. Meanwhile, the treatment group in the example was more effective than the comparative treatment group 1 and the comparative treatment group 2.

[0116] 7.2 Comparison of clinical efficacy results among the four groups of patients

[0117] As shown in Table 2, in the treatment group of the example, 9 cases were clinically cured, 4 cases showed significant improvement, 2 cases showed improvement, and 1 case showed no improvement, with a total effective rate of 93.75%. In the comparative treatment group 1, 7 cases were clinically cured, 4 cases showed significant improvement, 3 cases showed improvement, and 2 cases showed no improvement, with a total effective rate of 87.50%. In the comparative treatment group 2, 6 cases were clinically cured, 5 cases showed significant improvement, 1 case showed improvement, and 4 cases showed no improvement, with a total effective rate of 75.00%. In the control group, 5 cases were clinically cured, 5 cases showed significant improvement, 1 case showed improvement, and 5 cases showed no improvement, with a total effective rate of 68.75%. There were significant differences among the four groups (P < 0.05).

[0118] Table 2 Clinical efficacy results of the four groups of patients

[0119]

[0120] 7.3 Adverse reaction results in the four groups of patients

[0121] As shown in Table 3, the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome provided in this embodiment of the invention consists of 14 medicinal materials. The principal, assistant, adjuvant, and guide herbs complement each other, and the whole formula works together to warm the yang, stop diarrhea, strengthen the spleen and stomach. It is safe, reliable, and has no toxic side effects. It can effectively reduce the frequency of diarrhea, relieve abdominal discomfort, regulate gastrointestinal motility, and has significant effects.

[0122] Table 3 Adverse Reactions

[0123]

[0124] Note: Compared with the control group, the treatment group showed P < 0.05.

[0125] II. Typical Cases

[0126] 1. Name: Wang, Gender: Male, Age: 42, Date of Consultation: 2023-09-03

[0127] Chief complaint: Diarrhea for 5 years.

[0128] Present illness: The patient developed diarrhea 5 years ago without any obvious cause. Currently, he has 5-8 bowel movements per day, which are unformed, intermittent abdominal pain, occasional borborygmus, aversion to cold in the abdomen, dry mouth, good appetite, good sleep, red tongue with black coating, and a thready and slippery pulse.

[0129] Past medical history and other medical history: History of gastric polyps

[0130] Allergy history: Denies any history of food or drug allergies.

[0131] Auxiliary examinations: September 3, 2023: electronic gastroscopy: carditis, chronic atrophic gastritis with erosion; September 3, 2023: electronic colonoscopy: chronic proctitis.

[0132] The Chinese herbal granules prepared in Example 5 of this invention were taken, two sachets each time, twice a day. The above symptoms were relieved after two days of treatment, and the symptoms completely disappeared after another seven days of treatment.

[0133] 2. Name: Yang, Gender: Female, Age: 54, Date of Consultation: 2023-09-03

[0134] Chief complaint: Intermittent abdominal distension and discomfort, and diarrhea for more than 2 years.

[0135] Present illness: The patient developed abdominal distension and discomfort, diarrhea, and indigestion two years ago without any apparent cause. The diarrhea was exacerbated after consuming cold or raw foods. She also experienced difficulty passing gas, had three loose bowel movements a day, felt incomplete evacuation, and had irregular menstruation.

[0136] Past medical history and other medical history: Previous health condition was generally good.

[0137] Allergy history: Seafood allergy.

[0138] Auxiliary examination: Electronic colonoscopy on September 3, 2023: Chronic proctitis.

[0139] The above symptoms disappeared after taking the Chinese herbal granules prepared in Example 5 of this invention, two sachets each time, twice a day, for 10 days.

[0140] 3. Name: Gao, Gender: Male, Age: 33, Date of Consultation: 2023-04-25

[0141] Chief complaint: Diarrhea for 3 months.

[0142] Present illness: diarrhea, borborygmus, normal appetite, frequent borborygmus after meals, normal sleep, many dreams, 4-5 bowel movements per day, unformed stools, enlarged tongue with slight teeth marks, and white, greasy tongue coating.

[0143] Past medical history and other medical history: Previously healthy, denies other medical history.

[0144] The above symptoms were relieved after taking the Chinese herbal granules prepared in Example 5 of this invention, two packets each time, twice a day, for three days. After another five days of treatment, the above symptoms completely disappeared.

[0145] 4. Name: Li, Gender: Male, Age: 58, Date of Consultation: 2023-09-22

[0146] Chief complaint: Intermittent diarrhea for more than one year.

[0147] Present illness: The patient developed diarrhea without any apparent cause 1 year ago, with 2-4 loose stools per day, accompanied by abdominal distension and pain, aversion to cold, reduced appetite, and normal urination. He did not seek medical treatment and the symptoms did not improve, so he came to see a doctor. His tongue was pale red with a white and slippery coating, and his pulse was deep.

[0148] Past medical history and other medical history: Previously healthy, denies other medical history.

[0149] Allergy history: Denies allergies to drugs or food.

[0150] The above symptoms were alleviated after taking the Chinese herbal granules prepared in Example 5 of this invention, two packets each time, twice a day, for 7 days. After another 10 days of treatment, the above symptoms basically disappeared.

[0151] 5. Name: Lu, Gender: Male, Age: 40, Date of Consultation: 2023-08-29

[0152] Chief complaint: Intermittent diarrhea for more than 6 months.

[0153] Present illness: The patient experiences diarrhea after overeating spicy and irritating foods, and is prone to diarrhea after catching a cold. Occasionally, the patient experiences a feeling of heaviness in the back and is sensitive to cold. There is no dry mouth, bitter taste, heartburn, or acid reflux. The patient has a good appetite, sleeps well, and has one bowel movement per day with normal consistency. The patient has a red tongue with a yellow and greasy coating, and a soft and slow pulse.

[0154] Past medical history and other medical history: Previous health condition was generally good.

[0155] Allergy history: Denies allergies to drugs or food.

[0156] After taking the traditional Chinese medicine granules prepared in Example 5 of this invention, two packets each time, twice a day, for eight days, the above symptoms basically disappeared.

[0157] 6. Name: Ms. Hu, Gender: Female, Age: 61, Date of Consultation: 2023-09-14

[0158] Chief complaint: Intermittent abdominal pain accompanied by diarrhea for more than one month.

[0159] Present illness: Abdominal pain accompanied by diarrhea, 3-4 times / day, aversion to cold in the epigastric region and preference for warmth, borborygmus, dry mouth, good appetite, occasional poor sleep at night, dark red tongue with white coating, thus came to see a doctor.

[0160] Past medical history and other medical history: history of hypertension.

[0161] Allergy history: Denies allergies to drugs or food.

[0162] The above symptoms were alleviated after taking the Chinese herbal granules prepared in Example 5 of this invention, two packets each time, twice a day, for 6 days. After another 12 days of treatment, the above symptoms completely disappeared.

[0163] The traditional Chinese medicine compositions prepared in other embodiments can achieve therapeutic effects that are basically equivalent to those in Example 5.

[0164] In summary, the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome provided by this invention has the characteristics of simple formulation, convenient use, reliable efficacy, and no toxic side effects. It can also improve the degree of clinical symptom improvement of diarrhea-predominant irritable bowel syndrome, accelerate the recovery of gastrointestinal function, and has no toxic side effects, making it suitable for long-term use.

[0165] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 4-8 parts honey-processed ephedra, 4-9 parts cinnamon twig, 1-5 parts asarum, 4-9 parts dried ginger, 9-20 parts white peony root, 6-14 parts prepared licorice root, 4-8 parts schisandra fruit, 6-14 parts tangerine peel, 4-15 parts prepared aconite root, 9-20 parts poria cocos, 5-15 parts stir-fried atractylodes lancea root, 9-20 parts kudzu root, 3-9 parts fresh ginger, and 7-14 parts jujube.

2. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 5-7 parts honey-processed ephedra, 5-7 parts cinnamon twig, 2-4 parts asarum, 5-7 parts dried ginger, 12-18 parts white peony root, 8-12 parts prepared licorice root, 5-7 parts schisandra fruit, 8-12 parts tangerine peel, 6-12 parts prepared aconite root, 12-18 parts poria cocos, 7-12 parts stir-fried atractylodes lancea root, 12-17 parts kudzu root, 5-7 parts fresh ginger, and 9-12 parts jujube.

3. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 2, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 6 parts honey-processed ephedra, 6 parts cinnamon twig, 3 parts asarum, 6 parts dried ginger, 15 parts white peony root, 10 parts prepared licorice root, 6 parts schisandra fruit, 10 parts tangerine peel, 9 parts prepared aconite root, 15 parts poria cocos, 9 parts stir-fried atractylodes lancea root, 15 parts kudzu root, 6 parts fresh ginger, and 10 parts jujube.

4. The method for preparing the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome according to any one of claims 1-3, characterized in that, Include at least the following steps: Weigh each component according to the designed ratio, add the weighed ephedra, cinnamon twig, asarum, dried ginger, white peony root, prepared licorice root, schisandra fruit, tangerine peel, prepared aconite root, poria cocos, stir-fried atractylodes rhizome, kudzu root, fresh ginger and jujube to water, soak, heat and decoct, filter the extract to obtain the Chinese medicine composition for treating diarrhea-type irritable bowel syndrome.

5. The method for preparing the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 4, characterized in that, The soaking temperature is 15℃-25℃, and the soaking time is 30min-60min.

6. The method for preparing the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 4, characterized in that, The heating and simmering temperature is 80℃-100℃, and the heating and simmering time is 30min-40min.

7. The method for preparing the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 4, characterized in that, The amount of water used is 6-8 times the total mass of the Chinese medicinal herbs.

8. The use of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome according to any one of claims 1-3 in the preparation of a medicament for treating diarrhea-predominant irritable bowel syndrome.

9. A traditional Chinese medicine preparation for treating diarrhea-predominant irritable bowel syndrome, characterized in that, It is made from the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in any one of claims 1-3.

10. The traditional Chinese medicine preparation for treating diarrhea-predominant irritable bowel syndrome as described in claim 9, characterized in that: The dosage form of the traditional Chinese medicine preparation is granules, capsules, tablets, or pills.

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