Traditional Chinese medicine composition for promoting blood circulation to remove blood stasis and promoting qi circulation to relax bowels and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for promoting blood circulation to remove blood stasis and promoting qi circulation to relieve constipation and application thereof.The traditional Chinese medicine composition comprises 14 basic active components including, by weight, 30-60 g of radix rehmanniae recen, 10 g of flos carthami, 20-30 g of radix angelicae sinensis, 10 g of radix achyranthis bidentatae and the like, and is suitable for qi stagnation and blood stasis type functional constipation with the disease course larger than or equal to 6 months and defecation smaller than or equal to 2 times per week; corresponding components are added when symptoms of heavy dampness, blood deficiency and the like are accompanied; when the composition is applied, the composition is taken according to echelon, 20-30 days are taken as a course of treatment, the composition is stopped after six courses of treatment for 1 month, defecation is monitored, and the composition is satisfied if the Bristol score is greater than or equal to 4. The traditional Chinese medicine composition can improve the qi-stagnation and blood stasis type functional constipation symptom, reduces relapse through echelon taking, is scientific in component compatibility, suitable for various syndromes, safe in medication, free of obvious side effects and stable in curative effect, widens the application range, and overcomes the defects of a traditional scheme.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation, and its application. Background Technology

[0002] Functional constipation is a common digestive system disease in clinical practice, and its incidence is increasing year by year. It not only seriously affects patients' work, study, and daily life quality, but also, with long-term recurrent attacks, may induce complications such as intestinal dysfunction, anxiety, and depression. Therefore, finding safe and effective treatment methods has become an urgent clinical problem to be solved. A comparison of the 2025 "Expert Consensus on the Diagnosis and Treatment of Functional Constipation with Integrated Traditional Chinese and Western Medicine" and the 2013 "Guidelines for the Diagnosis and Treatment of Chronic Constipation in China" shows that, although the clinical attention to functional constipation is constantly increasing, the core theoretical systems of Western and Traditional Chinese Medicine have not yet achieved breakthrough development, resulting in the stagnation of existing treatment methods, therapies, and drugs, making it difficult to meet the dual needs of clinical practice for efficacy and safety.

[0003] In Western medicine, current clinical practice often follows the principle of "stepwise medication." Initially, bulk-forming laxatives are used to increase stool volume; if ineffective, osmotic laxatives are added; as the condition progresses, the dosage or frequency of osmotic laxatives is gradually increased; and prokinetic or secretagogue drugs are used only when symptoms remain uncontrolled. However, this treatment model has significant drawbacks: firstly, Western medicine can only improve bowel symptoms and cannot fundamentally cure functional constipation; long-term use easily leads to dependence, and the efficacy gradually diminishes with prolonged use; secondly, there is a lack of clear treatment course guidelines in clinical practice, and patients often adjust dosages or discontinue medication on their own, leading to relapses. Some patients experience anxiety due to poor treatment results, leading them to self-medicate with stimulant laxatives, creating a vicious cycle of "medication - diminished effectiveness - increased medication - intestinal damage," ultimately worsening constipation symptoms.

[0004] While Traditional Chinese Medicine (TCM) emphasizes syndrome differentiation and treatment for functional constipation, achieving certain efficacy in treating patterns such as qi stagnation, heat accumulation, cold coagulation, qi deficiency, blood deficiency, and yin deficiency, significant shortcomings remain: First, the efficacy is not sustained; most patients experience improved bowel movements while taking TCM, but constipation symptoms easily recur once medication is discontinued, making it difficult to achieve long-term stable treatment results. Second, there is a lack of unified and standardized treatment courses and medication methods; different physicians adjust medication based on experience, leading to large fluctuations in efficacy and hindering clinical promotion. Third, although the understanding of the pathological role of "blood stasis" in functional constipation is gradually deepening, [Li Guodong] National masters of traditional Chinese medicine such as Lu Jingen and Zhang Lei, as well as scholars such as Fan Zhimin, have proposed the idea of ​​treating intractable constipation from the perspective of blood stasis. Clinically, patients can be seen to have symptoms of blood stasis such as a purplish-dark tongue, menstrual blood clots, and a dark complexion. This is consistent with the traditional Chinese medicine theory that "prolonged illness will inevitably lead to blood stasis" and "prolonged illness penetrates deeply, and the flow of qi and blood becomes sluggish." However, existing treatment plans based on blood stasis are mostly single-drug adjustments or simple combinations, lacking systematic design of Chinese herbal combinations. They have also failed to form a synergistic treatment system that takes into account both "activating blood and removing blood stasis" and "regulating qi and relieving constipation." This results in insufficient stability and specificity of efficacy, making it difficult to meet the clinical needs for treating intractable functional constipation caused by qi stagnation and blood stasis. Summary of the Invention

[0005] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation, and its application.

[0006] (II) Technical Solution A traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation includes basic active components; the basic active components, by weight, are: 30-60g Rehmannia glutinosa, 10g Carthamus tinctorius, 20-30g Angelica sinensis, 10g Achyranthes bidentata, 10-20g Prunus persica, 10g Ligusticum chuanxiong, 10g Platycodon grandiflorus, 30g Paeonia lactiflora, 10-30g Citrus aurantium, 10g Bupleurum chinense, 10g Glycyrrhiza uralensis, 20g Trogopterus xanthipes, 30g Trichosanthes kirilowii, and 30-60g Scrophularia ningpoensis. The herbal composition described is suitable for functional constipation of the qi stagnation and blood stasis type, which has a course of disease of no less than 6 months and a bowel movement frequency of no more than 2 times per week. At the same time, patients often have symptoms related to blood stasis, such as dark purple tongue, dark complexion, menstrual blood clots (female patients), and poor sleep with many dreams. This is in line with the TCM theory that "prolonged illness will inevitably lead to blood stasis" and "prolonged illness penetrates deeply, and the circulation of blood and qi becomes sluggish". That is, early factors such as cold and heat, and deficiency of qi, blood, yin and yang have transformed into the dominant pathological factor of qi stagnation and blood stasis. In the formulation system of basic active ingredients, Rehmannia glutinosa serves as the principal ingredient, primarily exerting its effects of nourishing yin, clearing heat, and cooling blood. It can target the yin deficiency and internal heat syndrome that may accompany functional constipation caused by qi stagnation and blood stasis. Simultaneously, Scrophularia ningpoensis is added to enhance its fluid-replenishing effect, laying the foundation for intestinal lubrication. Peach kernel has the dual effects of breaking up blood stasis and moistening the intestines to relieve constipation, while safflower primarily functions to invigorate blood circulation, regulate menstruation, disperse blood stasis, and relieve pain. The synergistic combination of these two ingredients can effectively break up blood stasis in the intestines and meridians, improving the flow of qi and blood in the intestines. Trogopterus xanthipes, Paeonia lactiflora, Ligusticum chuanxiong, Angelica sinensis, and Achyranthes bidentata serve as auxiliary blood-activating components, each playing a specific role: Trogopterus xanthipes focuses on invigorating blood circulation, removing blood stasis, and relieving pain, alleviating abdominal pain caused by blood stasis; Paeonia lactiflora excels at clearing heat, cooling blood, and dispersing blood stasis, targeting the possible accompanying blood heat syndrome; Ligusticum chuanxiong can promote qi and blood circulation, strengthening the effect of "where qi flows, blood flows"; Angelica sinensis has both blood-tonifying and blood-activating effects, preventing blood stasis while activating blood circulation. This formula addresses damage to the body's vital energy and prevents blood deficiency. Achyranthes bidentata guides blood downwards, directing stagnant blood from the upper body to the lower abdomen, treating stagnant blood in the intestines. Bupleurum, Citrus aurantium, and Platycodon grandiflorus work synergistically to soothe the liver and regulate qi. Bupleurum soothes the liver and raises yang, Citrus aurantium regulates qi and relieves chest congestion, and Platycodon grandiflorus promotes lung function and relieves stagnation. Together, they regulate the qi mechanism in the chest and abdomen, addressing the upper and middle parts of the body to support the smooth flow of qi and blood in the lower intestines, further embodying the treatment principle of "where qi flows, blood flows." Licorice, as a harmonizing component of the other herbs, can moderate the effects of peach kernels. The potent properties of blood-activating herbs such as safflower and peony are avoided to prevent damage to the body's vital energy in the intestines. At the same time, the lifting effect of bupleurum and platycodon and the downward guiding effect of achyranthes root create a dynamic balance of "ascending within descending and descending within ascending," ensuring smooth circulation of qi and blood throughout the body and preventing qi stagnation or sinking. Trichosanthes seed has the main effects of moistening the intestines and relieving constipation, and promoting qi circulation and relieving chest tightness. It not only assists peach kernel in enhancing the laxative effect, but also improves the qi circulation in the chest and abdomen by promoting qi circulation and relieving chest tightness, thus echoing the overall formula system.

[0007] Preferably, when the patient has symptoms of dampness, the formula also includes 8-12g of Artemisia capillaris and 10-15g of Polygonum cuspidatum. The specific manifestations of dampness symptoms are thick and greasy tongue coating (the thickness of the tongue coating exceeds 1 / 2 of the tongue surface, and the color is white or yellow), abdominal distension (obvious abdominal distension after meals, lasting for more than 1 hour), and sticky and unsatisfactory stools (straining is required when defecating, the stool sticks to the toilet bowl and is difficult to flush, or there is still a feeling of incomplete defecation after defecation). The occurrence of such symptoms is mostly due to qi stagnation and blood stasis, which leads to obstruction of water and dampness transportation. The intertwining of dampness and blood stasis aggravates intestinal dysfunction. Adding Artemisia capillaris and Polygonum cuspidatum can play a role in targeting dampness. Among them, Artemisia capillaris is good at clearing damp heat, while Polygonum cuspidatum can promote diuresis, reduce jaundice, clear heat and detoxify. The two can work together to improve dampness symptoms, prevent dampness from further obstructing the flow of qi and blood in the intestines, and complement the blood-activating, stasis-removing, qi-regulating and bowel-regulating effects of the basic active ingredients, ensuring that the interference of dampness is cleared while improving blood stasis.

[0008] Preferably, when the patient also has blood deficiency symptoms, the formula also includes 10-15g of donkey-hide gelatin and 10-15g of jujubes. The specific manifestations of blood deficiency symptoms include pale complexion (dull complexion, significantly paler than normal skin color, and lack of color), dizziness and blurred vision (dizziness and blurred vision easily occur during daily activities or upon standing, lasting from a few seconds to a few minutes), and scanty menstruation (female patients experience a reduction of more than 1 / 3 in menstrual flow compared to previous periods, or a shortened menstrual period to less than 3 days, with pale menstrual blood). These symptoms are often caused by long-term qi stagnation. Blood stasis can lead to insufficient production of qi and blood, or it can be caused by slight blood loss during the process of promoting blood circulation. Adding donkey-hide gelatin and jujubes can specifically replenish blood. Donkey-hide gelatin has the main function of nourishing blood and yin, which can effectively replenish blood and improve the body's malnutrition caused by blood deficiency. Jujubes can replenish qi and blood, and calm the mind. While replenishing blood, they can also enhance the function of the spleen and stomach, providing a foundation for the production of qi and blood. When these two are combined with the basic active ingredients, they can replenish blood deficiency while promoting blood circulation, removing blood stasis, and relieving constipation. This avoids aggravating blood deficiency due to excessive blood circulation, achieving the effect of "promoting blood circulation without harming blood".

[0009] Preferably, when the patient also has symptoms of Yang deficiency, the formula also includes 10-15g of Cistanche deserticola and 3-6g of Cinnamomum cassia. The specific manifestations of Yang deficiency include aversion to cold (requiring more clothing than usual, especially in the limbs and abdomen, which are easily chilled, and discomfort is pronounced when exposed to cold water or in low-temperature environments), cold hands and feet (palms and soles are chronically cold, and difficult to warm up quickly even in warm environments), and loose stools (unformed stools, pasty or loose, with potentially increased bowel movements but no significant abdominal pain). These symptoms are often caused by long-term Qi stagnation and blood stasis affecting Yang. In cases of Qi deficiency, or if the patient has an underlying Yang deficiency, insufficient Yang Qi can lead to weakened intestinal motility and impaired fluid metabolism. Adding Cistanche deserticola and cinnamon can warm and replenish Yang Qi. Cistanche deserticola can tonify kidney Yang, nourish essence and blood, and moisten the intestines to relieve constipation. It both warms and replenishes Yang Qi and assists in relieving constipation, which aligns with the laxative effects of the basic components. Cinnamon is good at tonifying fire and assisting Yang, dispelling cold and relieving pain. It can quickly enhance the body's Yang Qi and improve symptoms of Yang deficiency such as aversion to cold. When these two are combined with the basic active components, they can warm and replenish Yang Qi while promoting blood circulation, removing blood stasis, and relieving constipation, thereby enhancing intestinal motility and preventing further aggravation of intestinal dysfunction due to Yang deficiency.

[0010] Preferably, when the patient has severe heat symptoms, the formula also includes 6-10g of Gentiana scabra, 8-12g of Gardenia jasminoides, and 3-6g of Coptis chinensis. Specific manifestations of severe heat symptoms include: bitter taste in the mouth (significant upon waking or after meals, not significantly relieved by rinsing the mouth), irritability (easily agitated and restless, or insomnia and excessive dreaming at night), yellow and greasy tongue coating (yellow, thick, and sticky tongue coating), and a slippery and rapid pulse (rapid pulse exceeding 80 beats per minute, with a smooth and forceful pulse). These symptoms are often due to prolonged qi stagnation and blood stasis transforming into heat, or the patient having an underlying internal heat condition, where heat evil and blood stasis combine. The combination of these ingredients exacerbates intestinal dryness and heat, leading to constipation. Adding gentian root, gardenia, and coptis can clear heat and purge fire. Gentian root excels at clearing damp-heat in the liver and gallbladder, addressing potential liver and gallbladder qi stagnation caused by heat evil. Gardenia can purge fire, relieve irritability, clear heat and promote diuresis, improving irritability and damp-heat symptoms. Coptis primarily clears heat, dries dampness, and detoxifies, targeting intestinal dryness and heat. The three ingredients work synergistically to effectively eliminate heat evil. Combined with the blood-activating, stasis-removing, qi-regulating, and bowel-regulating effects of the basic active ingredients, they improve blood stasis while clearing heat evil, preventing further aggravation of intestinal dryness and ensuring stable bowel-regulating effects.

[0011] Preferably, when the patient has severe cold symptoms, the formula also includes 6-10g of prepared aconite and 5-8g of dried ginger. The specific manifestations of severe cold symptoms include aversion to cold (significant general coldness, especially in the back and abdomen, requiring warmth even in warm environments), a thick, sticky white tongue coating, and a body temperature not exceeding 36℃ (consistently lower axillary temperature below 36℃, without fever). These symptoms are often caused by qi stagnation and blood stasis leading to stagnation of yang qi, or by the patient having an underlying cold pathogen that congeals in the intestines, causing intestinal... Slowed peristalsis and difficulty in defecation can be addressed by adding prepared aconite and dried ginger to warm the yang and dispel cold. Prepared aconite can restore yang, tonify fire and assist yang, dispel cold and relieve pain, and can effectively warm and tonify yang qi and break up the stagnation of cold evil. Dried ginger is good at warming the middle jiao and dispelling cold, restoring yang and unblocking the meridians. It can specifically warm the middle jiao spleen, stomach and intestines, and improve the state of cold stagnation in the intestines. The two work together to effectively warm the yang and dispel cold. Combined with the blood-activating, stasis-removing, qi-regulating and bowel-regulating effects of the basic active ingredients, it can improve blood stasis while breaking up the cold stagnation in the intestines, enhance intestinal peristalsis, and prevent cold evil from further hindering the recovery of intestinal function.

[0012] Preferably, when the patient also has symptoms of Qi deficiency, the medication also includes 20-30g of roasted Astragalus membranaceus and 15-20g of Codonopsis pilosula. The specific manifestations of Qi deficiency symptoms are fatigue (easily fatigued after daily activities, not significantly relieved after rest, and poor mental state), pale tongue (the tongue is pale white, without blood color, and may be swollen or have teeth marks), and muscle strength not exceeding grade 4 (muscle strength is graded according to medical standards; grade 4 indicates the ability to complete joint movements against moderate resistance, but is weaker than normal muscle strength). This type of syndrome is often caused by long-term Qi stagnation and blood stasis leading to poor Qi and blood circulation, resulting in insufficient nourishment of the body, or the patient may have pre-existing Qi deficiency. The deficiency of Qi leads to insufficient intestinal motility and weakened ability to promote defecation. Adding roasted astragalus and codonopsis can replenish Qi and strengthen the spleen. Roasted astragalus mainly functions to replenish Qi and raise Yang, consolidate the exterior and stop sweating, and can enhance the body's overall Qi, especially the Qi and motility of the spleen, stomach and intestines. Codonopsis is good at replenishing Qi and strengthening the spleen and lungs, and can enhance the function of the spleen and stomach, providing a foundation for the production of Qi and blood. At the same time, it improves the Qi mechanism of the lungs and assists the Qi mechanism of the whole body. When these two are combined with the basic active ingredients, they can replenish Qi deficiency while promoting blood circulation, removing blood stasis, and relieving constipation, and enhance intestinal motility, so as to prevent Qi deficiency from further causing weak defecation and achieve the effect of "replenishing Qi and assisting defecation".

[0013] Preferably, when the patient has severe blood stasis symptoms, the medication also includes 10-15g of earthworm and 3-5g of leech. The specific manifestations of severe blood stasis symptoms are: a purplish-dark tongue (the tongue is purplish-black or dark purple in color and lacks luster), at least two ecchymoses (purple or dark red spots appear on the tongue surface, at least two in number, with a diameter of at least 2mm), and a 10-15% increase in prothrombin time (as determined by medical testing, a prothrombin time 10%-15% longer than the normal reference value indicates abnormal coagulation function and blood stasis obstructing the meridians). These symptoms indicate that the patient... For severe cases of blood stasis, the basic active ingredients alone are insufficient to promote blood circulation. Therefore, it is necessary to enhance the effects of promoting blood circulation and clearing the meridians. Adding earthworm and leech can effectively break up blood stasis and remove blood clots. Earthworm excels at clearing heat and calming the nerves, clearing the meridians, relieving asthma, and promoting diuresis. It can clear the meridians and improve the meridian obstruction caused by blood stasis. Leech primarily functions to break up blood stasis, clear the meridians, and eliminate masses. It has a strong effect of promoting blood circulation and can specifically break up stubborn blood stasis. The two work synergistically to enhance the effect of promoting blood circulation. Combined with the basic active ingredients, it can effectively improve severe symptoms of blood stasis, clear obstacles to the smooth flow of qi and blood in the intestines, and ensure that the effects of promoting qi circulation and relieving constipation are fully realized.

[0014] Preferably, when the patient has symptoms of weak stomach, 10-15g of chicken gizzard lining is also included; when the patient has symptoms of acid reflux, 15-20g of oyster shell is also included. Symptoms of weak stomach include reduced appetite (daily food intake is reduced by more than 1 / 3 compared to previous days, without obvious cause for decreased appetite), abdominal distension (significant abdominal distension after meals, lasting for more than 2 hours, without significant abdominal pain), and indigestion (prone to belching, acid reflux, food regurgitation after meals, or undigested food residue in stool). These symptoms are often caused by qi stagnation and blood stasis affecting the spleen and stomach's digestive function, leading to spleen and stomach weakness. Adding chicken gizzard lining can strengthen the spleen and promote digestion. Chicken gizzard lining is good at strengthening the stomach and promoting digestion, astringing essence and stopping seminal emission, and can enhance the spleen and stomach's digestive capacity, improve symptoms such as reduced appetite and indigestion, and benefit the intestines. The formula provides sufficient Qi and blood support. The specific manifestations of acid reflux syndrome include heartburn (a burning sensation behind the sternum or in the upper abdomen, especially after meals or when lying down) and acid reflux (a sour-tasting liquid flowing back into the mouth, occurring at least once a day). These symptoms are often caused by Qi stagnation and blood stasis leading to upward flow of stomach Qi, or abnormal gastric acid secretion. Adding oyster shell can neutralize acid and relieve pain. Oyster shell is adept at resolving phlegm and removing blood stasis, softening and dispersing nodules, neutralizing acid and relieving pain. It can neutralize gastric acid, alleviate heartburn and acid reflux symptoms, and prevent gastric acid from damaging the gastric mucosa and intestines. Both ingredients target weak stomach and acid reflux syndrome respectively. Combined with the blood-activating, Qi-regulating, and bowel-regulating effects of the basic active ingredients, it improves intestinal problems while regulating spleen and stomach function, preventing further impact on intestinal health from spleen and stomach abnormalities. Preferably, the application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating functional constipation due to Qi stagnation and blood stasis includes the following step-by-step discontinuous administration: S1. One course of treatment is 20-30 days. During the first course of treatment, take 200 ml twice a day, 30 minutes after meals, while warm. S2. Once bowel movements become regular and occur at least once a day, proceed to the second course of treatment. The second course of treatment involves taking the medicine three times over two days. On the first day, take 200 ml after breakfast and dinner, and on the second day, take 200 ml after lunch. S3. After the second course of treatment has stabilized, proceed to the third course of treatment. The third course of treatment involves taking 200 ml once a day. S4. Continue to the fourth course of treatment, taking 1.5 times every 2 days, 200 ml after dinner on the first day, 100 ml after lunch on the second day, 0.5 times a day for the fifth course of treatment, 100 ml each time, and 0.25 times a day for the sixth course of treatment, 50 ml each time. S5. The sixth course of treatment is maintained for 1 month before discontinuing the medication; the characteristics of bowel movements are monitored throughout the course of treatment. A Bristol score of not less than 4 points is considered a satisfactory result. If the result is not satisfactory, the dosage is increased by 0.5 times.

[0015] (iii) Beneficial technical effects Compared with existing technologies, the beneficial effects of this invention are: 1. The blood-activating, stasis-removing, qi-regulating, and bowel-regulating formula of the present invention can effectively improve the clinical symptoms of patients with functional constipation of qi stagnation and blood stasis type. Specifically, it can improve the stool characteristics (such as relieving dry stool and making the stool soft and formed) and increase the frequency of defecation (gradually increasing from no more than 2 times per week to once a day). Short-term use can show improvement in defecation, and long-term use can stably maintain the therapeutic effect. It solves the problems of Western medicine "only improving symptoms and not curing" and traditional Chinese medicine "effective when taking medicine, but relapse when stopping medicine".

[0016] 2. This invention innovatively adopts a "step-by-step discontinuous administration" scheme, with a course of treatment lasting half a month to one month. The first course of treatment consists of 2 packets per day, gradually transitioning to 3 packets every 2 days in the second course, 1 packet per day in the third course, 1.5 packets every 2 days in the fourth course, half a packet per day in the fifth course, and 1 / 4 packet per day in the sixth course, which is maintained for 1 month before discontinuing the medication. The dosage is adjusted throughout the course based on indicators such as bowel movement regularity (e.g., bowel movements at least once a day) and stool characteristics, allowing the patient's intestinal function to gradually adapt and restore the ability to defecate independently, significantly reducing the relapse rate after stopping the medication, and solving the shortcomings of traditional treatments that "have no standardized course of treatment and relapse upon stopping the medication".

[0017] 3. The basic active ingredients of this invention are scientifically formulated. Rehmannia glutinosa is the principal ingredient, exerting its effects of nourishing yin, clearing heat, and cooling blood, supplemented by Scrophularia ningpoensis to increase fluid production; Prunus persica breaks up blood stasis, moistens the intestines, and promotes bowel movements; Carthamus tinctorius invigorates blood circulation, regulates menstruation, disperses blood stasis, and relieves pain. These two ingredients work together to break up blood stasis obstruction; Trogopterus xanthipes, Paeonia lactiflora, Ligusticum chuanxiong, Angelica sinensis, and Achyranthes bidentata assist in enhancing the blood-activating effect. Trogopterus xanthipes invigorates blood circulation, removes blood stasis, and relieves pain; Paeonia lactiflora cools blood and disperses blood stasis; Ligusticum chuanxiong promotes qi circulation and invigorates blood; Angelica sinensis nourishes and harmonizes blood; and Achyranthes bidentata guides blood downwards; Bupleurum chinense, Citrus aurantium, and Platycodon grandiflorus soothe the liver and promote blood circulation. It regulates the flow of Qi in the chest and abdomen, embodying the principle that "where Qi flows, blood flows." Licorice harmonizes the other herbs, mitigating the harshness of peach kernel and safflower. At the same time, Bupleurum and Platycodon raise the Qi and Achyranthes bidentata guides blood downward, forming a dynamic balance of "ascending within descending and descending within ascending," promoting the circulation of Qi and blood and achieving a synergistic effect of "activating blood, regulating Qi, and relieving constipation." This effectively improves the problems of intestinal Qi stagnation and poor blood circulation caused by Qi stagnation and blood stasis, and solves the shortcomings of traditional treatments based on blood stasis that rely on "single herbs without a synergistic system."

[0018] 4. This invention designs targeted component adjustment schemes for common accompanying symptoms in patients: For severe heat symptoms, add gentian root, gardenia fruit, and coptis root; for severe cold symptoms, add aconite root and dried ginger; for severe dampness symptoms, add artemisia capillaris and polygonum cuspidatum; for qi deficiency symptoms, add roasted astragalus root and codonopsis root; for blood deficiency symptoms, add donkey-hide gelatin and jujube; for yang deficiency symptoms, add cistanche and cinnamon; for weak stomach symptoms, add chicken gizzard lining; for acid reflux symptoms, add oyster shell; for severe blood stasis symptoms, add earthworm and leech; and for significant qi stagnation, increase the dosage of immature bitter orange peel. The combination of these appropriate components with the basic active components enhances efficacy without damaging the body's vital energy, making it suitable for patients with qi stagnation and blood stasis type functional constipation, significantly broadening the clinical application scope and solving the problems of "insufficient targeting and limited applicable population" in traditional schemes.

[0019] 5. This invention has high safety, with no obvious side effects throughout the course of treatment. Unlike Western medicines, it does not cause dependence or damage to intestinal function, nor does it cause fluctuations in efficacy due to differences in physician experience. It combines the advantages of traditional Chinese medicine's syndrome differentiation and treatment, and improves the stability of efficacy through standardized component combinations, clear treatment course design, and medication methods, making it easy to promote in clinical practice. It provides a safe and effective treatment option for intractable functional constipation caused by qi stagnation and blood stasis. Attached Figure Description

[0020] Figure 1 This is an application flowchart of a traditional Chinese medicine composition used to promote blood circulation, remove blood stasis, regulate qi, and relieve constipation. Figure 2 These are line graphs showing the bowel regularity rates of Examples 1-3 and the comparative example at different treatment cycles; Figure 3 This is a bar chart showing the dissolution rates of paeoniflorin and ferulic acid in Examples 1-3 and the comparative example; Figure 4 The bar charts show the changes in intestinal peristalsis frequency and bifidobacteria count before and after treatment in Examples 1-3 and the comparative examples. Detailed Implementation

[0021] according to Figures 1 to 4 The specific embodiments of the present invention are as follows:

[0022] Example 1 For functional constipation with severe heat due to qi stagnation and blood stasis 1. Patient Information and Diagnosis The patient is a 65-year-old female with a disease course of 8 months and one bowel movement per week, which meets the diagnostic criteria for functional constipation of the Qi stagnation and blood stasis type, namely "disease course of not less than 6 months and bowel movements not more than 2 times per week". She also has symptoms of bitter taste in the mouth, irritability, yellow and greasy tongue coating and slippery and rapid pulse, which belong to the heat syndrome. In addition to the basic active ingredients, heat-adaptive components need to be added.

[0023] 2. Raw material preparation and pretreatment Weigh all components by weight as follows: In the basic active components, 45g of Rehmannia glutinosa (containing 0.06% Rehmannia glutinosa glycoside D, with a particle size of 4 mm after pulverization), 10g of Carthamus tinctorius (containing 1.2% hydroxysafflower yellow pigment A, with a particle size of 3.5 mm after pulverization), 25g of Angelica sinensis (processed with wine, using 10wt% rice wine, stir-frying at 110℃, with a particle size of 4 mm after pulverization, and containing 0.07% ferulic acid), and 10g of Achyranthes bidentata (processed with salt, using 5wt% salt, boiled in water for 1 hour, and then pulverized). The following herbs were used: 15g peach kernel (processed by blanching, pulverized to 4mm particle size, 28% fatty oil content), 10g Sichuan lovage rhizome (processed with wine, 8wt% yellow wine, 105℃, pulverized to 3.5mm particle size), 10g platycodon root (raw herb pulverized to 4mm particle size, manually selected to remove mold and impurities), 30g red peony root (pulverized to 4mm particle size, 2.0% paeoniflorin content), and 20g immature bitter orange peel (processed by stir-frying with wheat bran, 10wt% wheat bran, 115℃). ℃, pulverized particle size 3.5 mm), Bupleurum 10g (processed with vinegar, rice vinegar 12wt%, soaked for 1.5 hours, pulverized particle size 4 mm), Licorice 10g (raw medicinal material pulverized, particle size 3.5 mm, glycyrrhizic acid content 2.0%), Trogopterus xanthipes 20g (processed with vinegar, rice vinegar 15wt%, soaked for 2 hours), Trichosanthes kirilowii seed 30g (stir-fried at 120℃ for 15 minutes, pulverized particle size 4 mm, fatty oil content 32%), Scrophularia ningpoensis 45g (pulverized particle size 3.5 mm, glycyrrhizic acid content 2.0%), 20g of Trogopterus xanthipes (processed with vinegar, rice vinegar 15wt%, soaked for 2 hours), 30g of Trichosanthes kirilowii seed (stir-fried at 120℃ for 15 minutes, pulverized particle size 4 mm, fatty oil content 32%), 45g of Scrophularia ningpoensis ... Scrophularia ningpoensis seed (pulverized particle size 3.5 mm, glycyrrhizic acid content 2.0%), The particle size is 3.5 mm, and the harpagoside content is 0.08%; among the thermogravimetric components, there are 8g of gentian root (3 mm particle size after crushing, 3.2% gentiopicroside content), 10g of gardenia (stir-fried at 130℃ for 11 minutes, 3 mm particle size after crushing, 1.6% geniposide content), and 4g of coptis root (processed with wine, 10wt% yellow wine, stir-fried at 108℃ for 14 minutes, 5.2% berberine content); among other auxiliary components, there is 12g of donkey-hide gelatin (used for melting).

[0024] Raw material pretreatment steps: Wrap the Wulingzhi in double-layered gauze with a 100-mesh pore size to make a decoction bag for later use; Place the donkey-hide gelatin separately in a beaker and heat it in a water bath to 62°C, stirring continuously until it is completely melted. Maintain this temperature in the molten state to prevent solidification; Except for Wulingzhi and donkey-hide gelatin, all other medicinal slices (including basic active components and thermogravimetric components) are pulverized to 3-4 mm and removed by manual selection to remove moldy and insect-infested impurities, ensuring that the impurity content is less than 0.5%.

[0025] 3. Preparation of Traditional Chinese Medicine Compositions The first step is segmented decoction: Place the pretreated basic active components, thermogravimetrically adapted components, and the prepared Wulingzhi herb packet into a stainless steel decoction pot. Add purified water until the water level is 2.5 cm above the herb slices, and soak for 35 minutes. After soaking, turn on the heat, first heating to 100℃ over high heat and maintaining a boil for 5 minutes, then reducing to a simmer and controlling the temperature to a stable 88℃ for 25 minutes. After decoction, filter through a 100-mesh filter cloth and collect the first decoction, which should be 200 ml. Add purified water again to the filtered residue until the water level is 1.5 cm above the residue, and repeat the above decoction steps—first heating to 100℃ over high heat, then reducing to a simmer at 88℃ for 18 minutes, filtering, and collecting the second decoction, which should also be 200 ml.

[0026] The second step is the preparation of the medicinal solution: Pour the collected medicinal solutions from both batches into the same container and stir thoroughly with a glass rod. Slowly pour the molten donkey-hide gelatin into the mixed medicinal solution while stirring continuously to ensure that the gelatin is evenly dispersed in the solution without any local clumping. After stirring, observe the clarity of the solution to ensure there are no obvious suspended impurities, and at the same time test the content of the active ingredients to ensure that it meets the quality requirements.

[0027] 4. Take the medication intermittently in stages. The treatment regimen follows a stepped, discontinuous approach, with the following specific steps: The overall treatment consists of a basic course of 20-30 days. The first course is an intensive treatment phase, with 200 ml taken twice daily, 30 minutes after meals, warm. This course lasts for 30 days, during which bowel movement frequency, stool dryness, and symptoms such as bitter taste in the mouth and irritability are monitored. Once the patient's bowel movements become regular (at least once a day), the second course (transitional adjustment phase) begins. This course involves taking the medication three times a day over two days: 200 ml after breakfast and dinner on the first day, and 200 ml after lunch on the second day. This course lasts for 25 days, during which daily bowel movement stability and the reduction of yellow and greasy tongue coating are monitored. After the second course has stabilized, the third course (reduced dosage consolidation phase) begins, with 200 ml taken once daily. Take the medicine warm after dinner for 25 days, monitoring bowel regularity and relief of rapid and slippery pulse. After the third course of treatment, transition to the fourth course – take 1.5 times every 2 days, 200 ml after dinner on the first day and 100 ml after lunch on the second day, for 25 days, monitoring for abdominal distension and diarrhea. After the fourth course of treatment is stable, begin the fifth course, taking 100 ml once daily after dinner for 25 days, monitoring for stable stool consistency and disappearance of severe fever symptoms. After the fifth course of treatment is stable, begin the sixth course, taking 50 ml once daily after lunch for 30 days, monitoring bowel regularity and Bristol score before discontinuation (with a score of 4 or higher as the standard for satisfactory results).

[0028] After the sixth course of treatment, the medication was discontinued. A follow-up was conducted 3 months after the discontinuation of the medication. The patient had one bowel movement per day, and the stool characteristics met the Bristol score of 4. The symptoms of severe heat, such as bitter taste in the mouth and irritability, did not recur, and there were no adverse reactions.

[0029] Example 2 For functional constipation of the Qi stagnation and blood stasis type with severe blood stasis syndrome 1. Patient Information and Diagnosis The patient is a 72-year-old female with a disease course of 10 months. She has one bowel movement per week, which meets the diagnostic criteria for functional constipation of the Qi stagnation and blood stasis type. She also has a purplish-dark tongue, 3 ecchymoses, and a 13% prothrombin time, which indicates severe blood stasis syndrome. In addition to the basic active ingredients, she needs to add blood stasis-adapted ingredients.

[0030] 2. Raw material preparation and pretreatment Weigh all components by weight as follows: In the basic active components, 50g of Rehmannia glutinosa (containing 0.07% Rehmannia glutinosa glycoside D, with a particle size of 4.5 mm after pulverization), 10g of Carthamus tinctorius (containing 1.3% hydroxysafflower yellow pigment A, with a particle size of 3.5 mm after pulverization), 28g of Angelica sinensis (processed with wine, using 12wt% rice wine at 112℃, with a particle size of 4 mm after pulverization and a ferulic acid content of 0.08%), and 10g of Achyranthes bidentata (processed with salt, using 5wt% salt and water). Boiled for 1.2 hours, pulverized to a particle size of 4 mm); 18g of peach kernels (processed by blanching, pulverized to a particle size of 4 mm, with a fat content of 29%); 10g of Sichuan lovage rhizome (processed by wine processing, with 9wt% yellow wine and a stir-frying temperature of 108℃, pulverized to a particle size of 3.5 mm); 10g of platycodon root (raw medicinal material pulverized to a particle size of 4 mm, manually selected to remove moldy impurities); 30g of red peony root (pulverized to a particle size of 4 mm, with a paeoniflorin content of 2.1%); 28g of immature bitter orange peel (processed by stir-frying with wheat bran, with wheat bran content of 1.2%). 12wt%, stir-frying temperature 118℃, pulverized particle size 4 mm), Bupleurum 10g (processed with vinegar, rice vinegar 13wt%, soaked for 1.8 hours, pulverized particle size 4 mm), Licorice 10g (raw medicinal material pulverized, particle size 3.5 mm, glycyrrhizic acid content 2.1%), Trogopterus xanthipes 20g (processed with vinegar, rice vinegar 16wt%, soaked for 2.2 hours), Trichosanthes kirilowii seed 30g (stir-fried at 122℃ for 16 minutes, pulverized particle size 4 mm, glycyrrhizic acid content 2.1%), [unclear text - possibly a continuation of the previous sentence] The ingredients include: 33% fat content, 50g of Scrophularia ningpoensis (particle size 4 mm after pulverization, harpagoside content 0.09%); 12g of earthworm (particle size 3.5 mm after pulverization, hypoxanthine content 0.14%, lumbrokinase activity 1900U / g) and 4g of leech (treated with talc powder, talc powder dosage 28wt%, frying temperature 118℃, frying time 14 minutes, hirudin activity 170U / g); and 15g of donkey-hide gelatin (used for melting).

[0031] Raw material pretreatment steps: Wrap the five-spice powder in double-layered gauze with a 100-mesh pore size to make a decoction bag for later use; place the donkey-hide gelatin separately in a beaker and heat it in a water bath to 65°C, stirring continuously until it is completely melted, and maintain this temperature in the molten state to prevent solidification; after the earthworm and leech are crushed to 3.5 mm, they are crushed together with other basic active ingredient slices to 3.5-4 mm, and moldy and insect-damaged impurities are removed by manual selection to ensure that the impurity content is less than 0.5%.

[0032] 3. Preparation of Traditional Chinese Medicine Compositions The first step is segmented decoction: Place the pretreated basic active components, the blood stasis-reducing components, and the prepared Wulingzhi herb packet into a stainless steel decoction pot. Add purified water until the water level is 3 cm above the herbs, and soak for 40 minutes. After soaking, turn on the heat, first heating to 100℃ over high heat and maintaining a boil for 5 minutes, then reducing to a simmer and controlling the temperature to a stable 90℃ for 28 minutes. After decoction, filter through a 100-mesh filter cloth and collect the first decoction, which should be 200 ml. Add purified water again to the filtered residue until the water level is 2 cm above the residue, and repeat the above decoction steps—first heating to 100℃ over high heat, then reducing to a simmer and cooking at 90℃ for 20 minutes. Filter and collect the second decoction, which should also be 200 ml.

[0033] The second step is the preparation of the medicinal solution: Pour the collected medicinal solutions from both batches into the same container and stir thoroughly with a glass rod. Slowly pour the molten donkey-hide gelatin into the mixed medicinal solution while stirring continuously to ensure that the gelatin is evenly dispersed in the solution without any local clumping. After stirring, observe the clarity of the solution to ensure there are no obvious suspended impurities, and at the same time test the content of the active ingredients to ensure that it meets the quality requirements.

[0034] 4. Take the medication intermittently in stages. The treatment regimen follows a stepped, discontinuous approach, with the following specific steps: The overall treatment consists of a basic course of 20-30 days. The first course is an intensive treatment phase, with 200 ml taken twice daily, 30 minutes after meals, for 30 days. During this period, the frequency of bowel movements, the color and depth of ecchymosis, and facial complexion are monitored. Once the patient's bowel movements become regular (at least once a day), the second course (transitional adjustment phase) begins. This course involves taking the medication three times a day for two days: 200 ml after breakfast and dinner on the first day, and 200 ml after lunch on the second day. This course lasts for 25 days, with daily monitoring of bowel stability and the reduction in the area of ​​ecchymosis. After the second course has stabilized, the third course (reduced dosage consolidation phase) begins, with 200 ml taken once daily, after dinner. Take the medicine warm for 25 days, monitoring bowel regularity and improvement of purplish-dark tongue. After the third course of treatment, transition to the fourth course – take 1.5 times every 2 days, 200 ml after dinner on the first day and 100 ml after lunch on the second day, for 25 days, monitoring for abdominal pain and bloating. After the fourth course of treatment is stable, proceed to the fifth course, taking 100 ml once a day after dinner, for 25 days, monitoring for stable stool consistency and fading of ecchymosis. After the fifth course of treatment is stable, proceed to the sixth course, taking 50 ml once a day after lunch, for 30 days, monitoring bowel regularity and assessing blood stasis symptoms before discontinuation (with a Bristol score of at least 4 as the standard for satisfactory results).

[0035] After the sixth course of treatment, the medication was discontinued. Four months after discontinuation, the patient was followed up and had one bowel movement per day. The stool characteristics met the Bristol score of 4. The purplish-dark tongue color faded, the ecchymosis disappeared, and the dark complexion improved. There were no adverse reactions.

[0036] Example 3 For functional constipation with qi stagnation and blood stasis accompanied by weak stomach syndrome 1. Patient Information and Diagnosis The patient is a 58-year-old male with a disease course of 7 months. He has a bowel movement once every 2 days, which meets the diagnostic criteria for functional constipation of the Qi stagnation and blood stasis type. He also has symptoms of poor appetite, abdominal distension after meals, and indigestion, which are indicative of weak stomach syndrome. Therefore, he needs to add a stomach-weakness-adapted component in addition to the basic active component.

[0037] 2. Raw material preparation and pretreatment Weigh all components by weight as follows: In the basic active components, 35g of Rehmannia glutinosa (containing 0.05% Rehmannia glutinosa glycoside D, with a particle size of 3.5 mm after pulverization), 10g of Carthamus tinctorius (containing 1.0% hydroxysafflower yellow pigment A, with a particle size of 3 mm after pulverization), 22g of Angelica sinensis (processed with wine, using 9wt% rice wine, stir-frying at 108℃, with a particle size of 3.5 mm after pulverization, and a ferulic acid content of 0.06%), and 10g of Achyranthes bidentata (processed with salt). The following herbs were processed: 12g of peach kernels (processed by blanching, resulting in a particle size of 3.5mm after boiling in water for 1 hour, with a fat content of 27%), 10g of Sichuan lovage rhizome (processed by wine processing, using 8wt% yellow wine at 105℃, resulting in a particle size of 3mm after pulverizing), 10g of platycodon root (raw herb pulverized, particle size 3.5mm, manually selected to remove moldy impurities), and 30g of red peony root (pulverized, particle size 3.5mm). The following herbs were used: 15g of Citrus aurantium (processed with wheat bran, 10wt% wheat bran, 115℃, pulverized to a particle size of 3.5mm), 10g of Bupleurum chinense (processed with vinegar, 12wt% rice vinegar, soaked for 1.5 hours, pulverized to a particle size of 3.5mm), 10g of Glycyrrhiza uralensis (crushed raw herbs, particle size 3mm, glycyrrhizic acid content 1.9%), and 20g of Trogopterus xanthipes (processed with vinegar, 15wt% rice vinegar). The ingredients include: 30g of Trichosanthes kirilowii seeds (stir-fried at 118℃ for 15 minutes, with a particle size of 3.5 mm after grinding and a fat content of 31%), 35g of Scrophularia ningpoensis (with a particle size of 3.5 mm after grinding and a harpagoside content of 0.07%), 12g of chicken gizzard lining (stir-fried until slightly yellow, with a particle size of 3.5 mm after grinding, and manually selected to remove moldy impurities), and 10g of donkey-hide gelatin (used for melting).

[0038] Raw material pretreatment steps: Wrap the five-spice powder in double-layered gauze with a 100-mesh pore size to make a decoction bag for later use; place the donkey-hide gelatin separately in a beaker and heat it in a water bath to 60°C, stirring continuously until it is completely melted. Maintain this temperature in the molten state to prevent solidification; stir-fry the chicken gizzard until the surface is slightly yellow, then pulverize it to 3.5 mm. Pulverize it together with other basic active ingredient slices to 3-3.5 mm. Remove moldy and insect-damaged impurities by manual selection to ensure that the impurity content is less than 0.5%.

[0039] 3. Preparation of Traditional Chinese Medicine Compositions The first step is segmented decoction: Place the pretreated basic active components, stomach-adaptive components, and the prepared Wulingzhi herb packet into a stainless steel decoction pot. Add purified water until the water level is 2 cm above the herbs, and soak for 35 minutes. After soaking, turn on the heat, first heating to 100℃ over high heat and maintaining a boil for 5 minutes, then reducing to a simmer and controlling the temperature to a stable 85℃ for 25 minutes. After decoction, filter through a 100-mesh filter cloth and collect the first decoction, which should be 200 ml. Add purified water again to the filtered residue until the water level is 1 cm above the residue, and repeat the above decoction steps—first heating to 100℃ over high heat, then reducing to a simmer at 85℃ for 15 minutes, filtering, and collecting the second decoction, which should also be 200 ml.

[0040] The second step is the preparation of the medicinal solution: Pour the collected medicinal solutions from both batches into the same container and stir thoroughly with a glass rod. Slowly pour the molten donkey-hide gelatin into the mixed medicinal solution while stirring continuously to ensure that the gelatin is evenly dispersed in the solution without any local clumping. After stirring, observe the clarity of the solution to ensure there are no obvious suspended impurities, and at the same time test the content of the active ingredients to ensure that it meets the quality requirements.

[0041] 4. Take the medication intermittently in stages. The treatment regimen follows a stepped discontinuation principle, with the following specific steps: The overall treatment consists of a basic course of 20-30 days. The first course is an intensive treatment phase, with 200 ml taken twice daily, 30 minutes after meals, for 28 days. During this period, the frequency of bowel movements, improvement in reduced appetite, and duration of abdominal distension are monitored. Once the patient's bowel movements become regular (at least once a day), the second course (transitional adjustment phase) begins. This course involves taking the medication three times a day for two days: 200 ml after breakfast and dinner on the first day, and 200 ml after lunch on the second day. This course lasts for 25 days, with daily monitoring of bowel stability and relief of indigestion. After the second course has stabilized, the third course (reduced dosage consolidation phase) begins, with 200 ml taken once daily, after dinner. Afterwards, take the medicine warm for 25 days, monitoring the maintenance of regular bowel movements and the recovery of food intake. After the third course of treatment, when the effect is stable, proceed to the fourth course – take 1.5 times every 2 days, 200 ml after dinner on the first day and 100 ml after lunch on the second day, for 25 days, monitoring for any worsening of fatigue. After the fourth course of treatment is stable, proceed to the fifth course, take 100 ml once a day after dinner, warm, for 25 days, monitoring for stable stool characteristics and the disappearance of symptoms of weak stomach. After the fifth course of treatment is stable, proceed to the sixth course, take 50 ml once a day after lunch, warm, for 30 days, monitoring the maintenance of regular bowel movements and assessing gastric function before discontinuation of medication (with a Bristol score of not less than 4 as the standard for satisfactory effect).

[0042] After the sixth course of treatment, the medication was discontinued. Two months after discontinuation, the patient was followed up and had one bowel movement per day. The stool characteristics met the Bristol score of 4. Symptoms of weak stomach, such as poor appetite and abdominal distension, were relieved. There were no adverse reactions.

[0043] Comparative Example Traditional blood-activating and stasis-removing treatments 1. Scheme Design and Raw Material Preparation This treatment adopts a traditional Chinese medicine approach based on the theory of blood stasis, without any complementary ingredients or a step-by-step discontinuation dosing design. It only contains basic blood-activating and bowel-regulating components. The specific ingredient dosages and preparation steps are as follows: Ingredients include 15g of peach kernel (raw material crushed to a particle size of 5 mm, without any blanching process), 10g of safflower (raw material crushed to a particle size of 5 mm, without any wine-processing process), 25g of angelica (raw material crushed to a particle size of 5 mm, without any wine-processing process), 10g of chuanxiong (raw material crushed to a particle size of 5 mm, without any wine-processing process), and 30g of red peony root (raw material crushed to a particle size of 5 mm, without any additional processing). Processed herbs), 20g of Citrus aurantium (raw material crushed to 5mm particle size, without wheat bran stir-frying), 10g of Bupleurum chinense (raw material crushed to 5mm particle size, without vinegar processing), 10g of Achyranthes bidentata (raw material crushed to 5mm particle size, without salt processing), 10g of Glycyrrhiza uralensis (raw material crushed to 5mm particle size, without additional processing), 45g of Rehmannia glutinosa (raw material crushed to 5mm particle size, without additional processing), 45g of Scrophularia ningpoensis (raw material crushed to 5mm particle size, without additional processing), and 30g of Trichosanthes kirilowii seed (raw material crushed to 5mm particle size, without stir-frying).

[0044] Preparation steps: Grind all the medicinal slices together to a particle size of 5 mm, put them into a regular ceramic decoction pot, add purified water until the water level is 2 cm above the slices, and soak for 30 minutes. After soaking, turn on the heat, first heat to 100℃ to boil, then reduce to 85℃ and continue to decoct for 30 minutes. After decoction, filter through an 80-mesh filter cloth, collect 400 ml of total decoction, and divide it into two containers, 200 ml each.

[0045] 2. Application and efficacy monitoring This treatment regimen was used to treat a 60-year-old male patient with a 7-month history of constipation, who had bowel movements once every 3 days and presented with a purplish-dark tongue, meeting the diagnostic criteria for functional constipation of the qi stagnation and blood stasis type, similar to the basic symptoms of the patient in Example 1. The dosage was 200 ml once daily, taken warm 30 minutes after a meal, and continued for 3 months before discontinuing the medication directly without a gradual reduction in dosage.

[0046] Table 1. Comparison of efficacy and safety between Examples 1-3 and comparative examples.

[0047] The efficacy monitoring results showed that the traditional regimen had significant shortcomings compared with Examples 1-3: Regarding bowel regularity rates, at week 1 of treatment, the bowel regularity rate was 60% for Example 1, 55% for Example 2, and 65% for Example 3, while the control group only had 30%; at week 4 of treatment, the bowel regularity rates for Examples 1-3 reached 100%, 95%, and 100% respectively, while the control group only had 70%; at week 12 of treatment, the bowel regularity rates for Examples 1-3 remained at 100%, while the control group's rate dropped to 60%. In terms of symptom improvement, the severe heat syndrome in Example 1 completely disappeared in 28 days, the severe blood stasis syndrome in Example 2 completely disappeared in 25 days, and the weak stomach syndrome in Example 3 completely disappeared in 25 days, while the blood stasis syndrome (purplish-dark tongue) in the control group patients never completely disappeared. Three months after discontinuation of medication, the relapse rate of Examples 1-3 was 0, while that of the control group was as high as 80%. Meanwhile, 25% of patients in the control group experienced mild abdominal distension and poor intestinal tolerance, while Examples 1-3 had no adverse reactions, fully demonstrating the advantages of the technical solution of the present invention.

[0048] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for activating blood and removing blood stasis and promoting qi and relieving constipation, characterized in that, The basic active components, by weight, are: Rehmannia glutinosa 30-60g, Carthamus tinctorius 10g, Angelica sinensis 20-30g, Achyranthes bidentata 10g, Prunus persica 10-20g, Ligusticum chuanxiong 10g, Platycodon grandiflorus 10g, Paeonia lactiflora 30g, Citrus aurantium 10-30g, Bupleurum chinense 10g, Glycyrrhiza uralensis 10g, Trogopterus xanthipes 20g, Trichosanthes kirilowii 30g, and Scrophularia ningpoensis 30-60g. The herbal composition is suitable for functional constipation of the qi stagnation and blood stasis type, with a course of disease of not less than 6 months and a bowel movement frequency of no more than 2 times / week.

2. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient has symptoms of dampness and heaviness, the prescription also includes 8-12g of Artemisia capillaris and 10-15g of Polygonum cuspidatum.

3. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient has symptoms of blood deficiency, it also includes 10-15g of donkey-hide gelatin and 10-15g of jujube.

4. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient also has symptoms of Yang deficiency, the formula also includes 10-15g of Cistanche deserticola and 3-6g of Cinnamomum cassia.

5. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient has severe fever, the formula also includes 6-10g of gentian root, 8-12g of gardenia fruit, and 3-6g of coptis root.

6. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient has severe cold symptoms, the medicine also includes 6-10g of prepared aconite and 5-8g of dried ginger.

7. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient also has symptoms of qi deficiency, the prescription also includes 20-30g of roasted astragalus and 15-20g of codonopsis.

8. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient has severe symptoms of blood stasis, the medicine also includes 10-15g of earthworm and 3-5g of leech.

9. The traditional Chinese medicine composition for promoting blood circulation, removing blood stasis, regulating qi, and relieving constipation according to claim 1, characterized in that, When the patient has symptoms of weak stomach, it also includes 10-15g of chicken gizzard lining; when the patient has symptoms of acid reflux, it also includes 15-20g of oyster shell.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-9 in the preparation of a drug for treating functional constipation of the qi stagnation and blood stasis type, characterized in that, The application includes the following discontinuation dosing steps: S1. One course of treatment is 20-30 days. During the first course of treatment, take 200 ml twice a day, 30 minutes after meals, while warm. S2. After bowel movements become regular, begin the second course of treatment, which consists of taking the medication three times a day for two days. After the second course of S3 treatment has stabilized, the third course of treatment will begin. The third course of treatment involves taking 200 ml once a day. S4. The treatment will proceed sequentially to the fourth, fifth, and sixth courses of treatment. S5. The sixth course of treatment is maintained for 1 month before discontinuing the medication; the characteristics of bowel movements are monitored throughout the course of treatment. A Bristol score of not less than 4 points is considered a satisfactory result. If the result is not satisfactory, the dosage is increased by 0.5 times.

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