A traditional Chinese medicine composition for stopping diarrhea and removing hemorrhoids, a preparation method of tablets thereof and application thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine formula, and specifically discloses a traditional Chinese medicine composition for stopping diarrhea and removing hemorrhoids, and a preparation method and application of a tablet thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 110-150 parts of radix puerariae powder; 110-150 parts of hovenia dulcis fruit powder; 40-60 parts of mulberry powder; 40-60 parts of fructus mume powder; 5-8 parts of hawthorn powder; 20-30 parts of ginseng powder; 15-20 parts of galangal powder; 10-15 parts of amomum villosum powder; and 40-60 parts of curcuma powder. The traditional Chinese medicine composition can be used as a raw material to prepare an oral conditioning preparation for improving chronic diarrhea of the spleen deficiency and damp-heat type, relieving the swelling and pain of hemorrhoids, and stopping diarrhea. Different from the limitation of traditional products that only stop diarrhea or only treat hemorrhoids, the nine-ingredient formula of the present application can simultaneously consider invigorating the spleen, stopping diarrhea, clearing heat, promoting blood circulation, and removing hemorrhoids, and solve the vicious cycle of diarrhea inducing hemorrhoids and hemorrhoids aggravating diarrhea.

Description

Technical Field

[0001] This invention relates to the technical field of traditional Chinese medicine formulations, specifically disclosing a traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids, its tablet preparation method, and its application. Background Technology

[0002] Diarrhea and hemorrhoids are extremely common anorectal and gastrointestinal diseases in clinical practice, and the two often induce each other and recur repeatedly. Diarrhea is mostly caused by spleen and stomach weakness, damp-heat accumulation, cold-dampness trapping the spleen, and intestinal qi disorder. Long-term diarrhea will continuously irritate the rectal and perianal mucosa, causing congestion and varicose veins in the perianal area; while hemorrhoid prolapse and perianal inflammation will cause intestinal peristalsis disorder, aggravate loose stools and persistent diarrhea, forming a vicious cycle.

[0003] The core pathogenesis of hemorrhoids is the accumulation of damp-heat in the lower abdomen, stagnation of qi and blood, and disharmony of the meridians. Clinical manifestations include anal swelling and pain, rectal bleeding, prolapse of hemorrhoids, and a feeling of heaviness and itching. Diarrhea is characterized by loose stools, increased frequency, abdominal distension and pain, and a feeling of heaviness in the anus. Existing related products have significant defects: (1) Single targeted therapy, which only stops diarrhea or only eliminates hemorrhoids, cannot address the pathogenesis of both diseases in a coordinated manner, resulting in a high recurrence rate; (2) Chemical antidiarrheal drugs and topical hemorrhoid ointments are mostly symptomatic relief, and long-term use can easily lead to intestinal dependence and local skin irritation; oral hemorrhoid medications are mostly cold and can damage the spleen, which can aggravate spleen deficiency and diarrhea. (3) Commercial Chinese medicine preparations have simple formulations and lack multiple combinations of strengthening the spleen and consolidating the foundation, clearing heat and drying dampness, promoting blood circulation and removing blood stasis, and astringing and consolidating the intestines. They are slow to take effect and have poor suitability for people with spleen deficiency and damp-heat stagnation type diarrhea and hemorrhoids.

[0004] Therefore, developing a food-medicine homology composition that simultaneously improves chronic diarrhea, reduces swelling, relieves pain and stops bleeding, addresses both the symptoms and the root cause, and is suitable for long-term internal use has high clinical value and market demand. Summary of the Invention

[0005] Traditional Chinese medicine theory holds that diarrhea and hemorrhoids share a common origin, stemming from spleen deficiency and impaired digestion, damp-heat accumulation, and blood stasis around the anus. Spleen deficiency leads to impaired water metabolism and loose stools; damp-heat forces its way down to the large intestine, obstructing blood flow around the anus, resulting in hemorrhoids. Therefore, treatment should follow a simultaneous approach of strengthening the spleen and intestines, clearing heat and drying dampness, astringing and stopping diarrhea, and promoting blood circulation and removing blood stasis. Currently available herbal remedies for anorectal problems often include herbs like Sanguisorba officinalis, Coptis chinensis, and Poria cocos, which are considered heat-clearing and dampness-draining. However, these bitter, cold, and bland herbs can easily damage the spleen and stomach's yang energy, providing only short-term symptom relief and failing to address the root cause of chronic diarrhea due to spleen deficiency. Therefore, they are not suitable for long-term internal use.

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids, as well as its tablet preparation method and application.

[0007] This invention provides a traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids, using the following technical solution: A traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids comprises the following components in parts by weight: 110-150 servings of kudzu root powder; 110-150 servings of Hovenia dulcis powder; 40-60 parts mulberry powder; 40-60 portions of dried plum powder; 5-8 parts hawthorn powder; 20-30 servings of ginseng powder; 15-20 parts galangal powder; 10-15 parts of Amomum villosum powder; 40-60 parts turmeric powder.

[0008] The formulation principle of this invention lies in the fact that the nine medicinal and edible ingredients are combined in a layered manner, with the principal, assistant, adjuvant, and guide herbs working together to balance the two core effects of strengthening the spleen and intestines to stop diarrhea and clearing heat and dispersing blood stasis to eliminate hemorrhoids. The formula also combines cold and hot herbs and takes into account both tonifying and purging properties. Chief herbs: Pueraria lobata and Hovenia dulcis Kudzu root is cool in nature and has a sweet and pungent taste. It enters the spleen, stomach, and large intestine meridians. It can raise yang and stop diarrhea, enhance the clear yang qi of the spleen and stomach, and improve chronic diarrhea and anal distension caused by spleen deficiency and sinking. Puerarin can regulate intestinal peristalsis, reduce intestinal mucosal edema, and relieve perianal congestion.

[0009] Hovenia dulcis clears heat and promotes diuresis, clears damp-heat in the large intestine, and removes dampness from the perianal area, thus reducing diarrhea and hemorrhoids induced by damp-heat at the root. The two herbs combined raise yang to stop diarrhea and clear damp-heat in the lower jiao, directly addressing the core pathogenesis of both diarrhea and hemorrhoids.

[0010] The following are the ingredients: mulberry, dried plum, and turmeric. Ume plums have a sour and astringent properties, which can astringe the large intestine, quickly reduce the frequency of bowel movements, and relieve watery stools; the acidic components protect the intestinal mucosa and reduce perianal exudation and itching.

[0011] Mulberries nourish yin and moisten dryness, nourish blood and cool blood, relieve hemorrhoid bleeding and mucosal damage, and also help with prolonged diarrhea that depletes yin and blood.

[0012] Turmeric promotes blood circulation and removes blood stasis, clearing varicose veins around the anus, dissipating blood stasis in hemorrhoids, and relieving anal swelling and pain. Simultaneously, it reduces inflammation and swelling, alleviating damage from both intestinal and perianal inflammation. The three ingredients work synergistically to astringe and stop diarrhea, cool the blood and stop bleeding, disperse blood stasis and eliminate hemorrhoids, rapidly improving various symptoms of swelling, pain, and bleeding.

[0013] Adjuvant herbs: hawthorn, ginseng, galangal, and amomum. Ginseng greatly replenishes vital energy, strengthens the spleen and replenishes qi, consolidates the foundation and nourishes the source, improves the root cause of spleen and stomach weakness, and prevents recurrent diarrhea; it also promotes the repair of intestinal mucosa and enhances the resistance of perianal tissue.

[0014] Amomum villosum and Alpinia galanga warm the spleen, dispel dampness, regulate qi and harmonize the stomach, resolve cold and dampness in the intestines, relieve abdominal distension and pain, neutralize the cold nature of Prunus mume and Pueraria lobata, and avoid the defect of coldness damaging the spleen and aggravating loose stools.

[0015] Hawthorn can aid digestion, promote qi circulation, and relieve blood stasis, thus improving diarrhea caused by food stagnation and helping to clear blood stasis around the anus.

[0016] The formula's overall logic is as follows: the principal herb invigorates Yang and clears dampness to address the root cause of the disease; the assistant herbs astringe and stop bleeding, promote blood circulation and reduce swelling to treat the symptoms; and the adjuvant herbs strengthen the spleen, warm the middle Jiao, regulate Qi and harmonize the stomach to consolidate the fundamental cause. This achieves a four-in-one approach: stopping diarrhea and consolidating the intestines, reducing swelling and relieving pain, stopping bleeding and eliminating hemorrhoids, and strengthening the spleen and consolidating the fundamental cause, simultaneously improving both diarrhea and hemorrhoids, treating both the symptoms and the root cause.

[0017] Unlike existing traditional Chinese medicine formulas that simply use bitter and cold herbs to clear heat, this invention uses warm-natured adjuvant herbs to balance the cold nature of the principal and assistant herbs, allowing for long-term use without harming the spleen and stomach. Furthermore, it limits the combination to a fixed nine herbs, as adding additional conventional proctological herbs would disrupt the balance of the formula and reduce efficacy. This invention features a unique and optimized formula system.

[0018] It should be noted that among the nine ingredients mentioned above, kudzu root, Japanese raisin tree fruit, mulberry, dried plum, turmeric, ginseng, galangal, amomum, and hawthorn have different recorded uses in existing technologies. Some of these herbs are found in different combinations in hangover-relieving and liver-protecting compositions, and there are also publicly reported cases of preparing hangover-relieving and liver-protecting products using several of these herbs as main ingredients. However, the aforementioned existing technologies all focus on the efficacy of hangover relief and liver protection, targeting symptoms such as alcohol-induced liver damage and damp-heat accumulation in the middle jiao, which is unrelated to this. From the perspective of traditional Chinese medicine pathology, hangover-relieving and liver-protecting formulas mostly target damp-heat and yin-blood deficiency caused by alcohol toxicity, treating it with heat-clearing and detoxifying, and nourishing yin and blood; while the diarrhea and hemorrhoids targeted by this invention have a core pathology of spleen deficiency and impaired transport, damp-heat accumulation, and blood stasis around the anus, treating it with spleen-strengthening and intestinal-consolidating, heat-clearing and dampness-drying, and blood-activating and stasis-removing methods. The two differ significantly in etiology, pathology, and treatment. To date, there are no reports in the existing technology of combining the above nine ingredients according to the principal, assistant, adjuvant, and guide combination logic described in this invention and using them to treat chronic diarrhea complicated with hemorrhoids due to spleen deficiency and damp-heat.

[0019] As the optimal formula, the traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids includes the following components in parts by weight: 130 servings of kudzu root powder; 130 portions of Hovenia dulcis powder; 50 portions of mulberry powder; 50 portions of dried plum powder; 6.5 portions of hawthorn powder; 25 portions of ginseng powder; 18 portions of galangal powder; 13 parts of cardamom powder; 50 parts turmeric powder.

[0020] Preferably, the puerarin content in the kudzu root powder is ≥2.5%.

[0021] Preferably, the content of dihydromyricetin in the Hovenia dulcis powder is ≥1.0%.

[0022] Preferably, the curcumin content in the turmeric powder is ≥3.0%.

[0023] This invention also provides a method for preparing a traditional Chinese medicine composition tablet for stopping diarrhea and relieving hemorrhoids, using the following technical solution: A method for preparing a traditional Chinese medicine composition tablet for stopping diarrhea and relieving hemorrhoids includes the following steps: S1. Weigh out the following ingredients according to the formula: kudzu root powder, Japanese raisin tree fruit powder, mulberry powder, dried plum powder, hawthorn powder, ginseng powder, galangal powder, amomum powder, and turmeric powder. Pass each ingredient through an 80-100 mesh sieve for later use. S2. Put the above main ingredients into a three-dimensional mixer and mix for 15-30 minutes to ensure that all components are fully and evenly mixed. S3. Add molding auxiliary materials and continue mixing for 10-20 minutes; S4. Compress the tablets using dry tableting technology or wet granulation; S5. The finished product is obtained by aluminum-plastic packaging.

[0024] Preferably, dry tableting technology is used in step S4, which eliminates the need for granulation and drying processes and directly compresses tablets. Each tablet weighs approximately 500-520 mg, and the active ingredients are not degraded by high temperatures, resulting in higher bioavailability.

[0025] Preferably, the molding auxiliary material is one or both of microcrystalline cellulose or magnesium stearate.

[0026] Preferably, the molding auxiliary materials are microcrystalline cellulose and magnesium stearate. By weight, the amount of microcrystalline cellulose accounts for 5% to 9% of the total amount of the main material, preferably 6% to 7%; the amount of magnesium stearate accounts for 0.6% to 1.1% of the total amount of the main material, preferably 0.8% to 1.0%.

[0027] The present invention also provides an application of a traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids, wherein the above-mentioned traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids is used as a raw material to prepare an oral conditioning preparation for improving chronic diarrhea of ​​spleen deficiency and damp-heat type and relieving hemorrhoid swelling, pain and bleeding.

[0028] Preferably, the oral conditioning preparation includes, but is not limited to, oral dosage forms such as compressed candy, solid beverage, capsules, and oral liquid.

[0029] Compared with the prior art, the present invention has at least the following beneficial effects: 1. Two-way synchronous conditioning and synergistic mechanism: Breaking through the limitations of traditional products that only stop diarrhea or treat hemorrhoids, it also takes into account strengthening the spleen and stopping diarrhea, clearing heat and promoting blood circulation to eliminate hemorrhoids, breaking the vicious cycle of diarrhea inducing hemorrhoids and hemorrhoids aggravating diarrhea, and simultaneously improving diarrhea symptoms and relieving perianal swelling. 2. Unique formulation, not a simple combination of herbs: The nine herbs are layered and combined in a principal, assistant, adjuvant and guide manner. The prescription test shows that the overall efficacy of the prescription is significantly higher than the simple superposition of the efficacy of a single herb. Adding additional herbs commonly used in proctology, such as Sanguisorba officinalis, Coptis chinensis, and Poria cocos, would disrupt the balance of cold and heat and greatly reduce the effect of stopping diarrhea and relieving hemorrhoids. There is no conventional combination inspiration from existing technologies. 3. Rapid onset of action and low recurrence rate with long-term use: The whole powder is dry-compressed, and the active ingredients are not destroyed by high temperature, resulting in high bioavailability; it can reduce the frequency of bowel movements and relieve anal distension and pain in the short term, and shrink hemorrhoids and strengthen the spleen and stomach with long-term use, and it is not easy to relapse after stopping the medication. 4. Mild medicinal properties and high safety: All raw materials are food and medicine of the same origin, with a balance of cold and heat, and no side effects of bitter and cold damaging the spleen or sour and astringent causing stagnation of qi. It is suitable for long-term daily conditioning for people with spleen deficiency and chronic diarrhea and mixed hemorrhoids, and there are no adverse reactions such as stomach pain or perianal irritation throughout the process. 5. Simple production process, suitable for large-scale production: The dry direct pressure process eliminates the granulation and drying processes, resulting in low energy consumption, short production cycle, and lower equipment investment costs. 6. Good patient compliance: The tablets are sweet and sour with no strong bitter taste, and the tablet size is moderate, making them convenient to take and carry. Detailed Implementation

[0030] To make the above-mentioned objectives, features and advantages of the invention more apparent and understandable, the invention will be further described in detail below with reference to specific embodiments.

[0031] All raw materials used in the composition of this invention are commercially available compliant products, and all meet the standards for raw materials of food and medicine homology and health food. Among them, the raw material quality control standards are: puerarin in kudzu root powder ≥2.5%, dihydromyricetin in jujube seed powder ≥1.0%, and curcumin in turmeric powder ≥3.0%.

[0032] Example 1 (Optimal Proportioning Scheme) A traditional Chinese medicine composition tablet for stopping diarrhea and relieving hemorrhoids, the raw material dosage (mg) per tablet is shown in Table 1: Table 1. Raw material ratio of single piece in the optimal embodiment

[0033] Preparation method: S1. All raw material powders are passed through an 80-mesh sieve and set aside. S2. Weigh out the following ingredients according to the formula: kudzu root powder, Japanese raisin tree fruit powder, mulberry powder, dried plum powder, hawthorn powder, ginseng powder, galangal powder, amomum powder, and turmeric powder. Add them to a three-dimensional mixer and mix at a uniform speed for 20 minutes. S3. Add microcrystalline cellulose type 102 and magnesium stearate, and continue mixing for 15 minutes. The mixing uniformity RSD is ≤3%. S4. Dry direct tableting using a rotary tablet press, with a theoretical single tablet weight of 512.1 mg and a tablet diameter of 12 mm; S5. Individually packaged in aluminum-plastic blister packs, with the outer bag sealed to prevent moisture, resulting in finished tablets.

[0034] Dosage and administration: Take 2 tablets with warm water after breakfast and dinner each day; for severe diarrhea or acute hemorrhoid swelling and pain, the dosage can be increased to 3 tablets each time, with a maximum daily dose of 6 tablets.

[0035] Example 2 (Low-dose range regimen) Only the lower limit dosage of each main ingredient is used, while the dosage of excipients remains unchanged. The dosage of raw materials per tablet (mg) is shown in Table 2: Table 2 Single tablet ratio in low-dose examples

[0036] The preparation method is the same as in Example 1.

[0037] Example 3 (High-dose range protocol) The maximum dosage of each main ingredient is used, with minor adjustments for excipients. The dosage of raw materials per tablet (mg) is shown in Table 3. Table 3 Single tablet ratio in high-dose examples

[0038] The preparation method is the same as in Example 1.

[0039] Performance testing To fully verify the multiple effects of this invention in stopping diarrhea, eliminating hemorrhoids, reducing inflammation, and strengthening the body, animal pharmacological model experiments, synergistic control experiments of the principal, assistant, adjuvant, and guide herbs, interference control experiments with added ingredients, double-blind human trials, and control experiments with the absence of single medicinal materials were conducted.

[0040] The standardized operating procedures for the detection indicators involved in the following tests are as follows: 1. Stool grading criteria (0~4 points) 0 points: Formed, dry stool with no fecal stains around the anus; 1 point: Soft, formed stool, with a small amount of dirt around the anus; 2 points: Pasty, soft stool, slight perianal staining; 3 points: Watery stool, with extensive wetting of the perianal area; 4 points: Watery diarrhea, with a large area of ​​loose stool contamination at the bottom of the cage.

[0041] Scoring was conducted at the same time each day, and the average score of a single rat over 7 days was used as statistical data.

[0042] 2. Perianal swelling detection After the last administration, the rats were anesthetized, and the maximum diameter of the perianal swelling in the transverse and longitudinal directions was measured with vernier calipers. The swelling volume was then calculated. In this experiment, the perianal swelling lesions in rats approximate a hemispherical ellipsoid of revolution. The lesions are attached to the perianal surface, protruding outwards, with their base adhering to the skin. The Z-axis (height H perpendicular to the skin) is limited by the animal's anatomical position and cannot be directly and accurately measured with calipers. Preliminary experiments showed a strong correlation between the height of the perianal edema protrusion and the maximum transverse width of the swelling. Therefore, a simplified ellipsoid of revolution formula was used to calculate the swelling volume. V=π / 6×L×W 2 in, L: Maximum longitudinal diameter of perianal swelling (along the head and tail of the anus); W: Maximum transverse diameter of swelling around the anus (from left to right sides of the anus); After modeling, the perianal swelling lesion expanded more significantly to the left and right. The height of the lesion protrusion was approximately equal to half the width of the horizontal axis. Therefore, the Z-axis (vertical protrusion height) was equivalent to the horizontal radius. Substituting this into the formula for the rotating ellipsoid, the above formula was derived.

[0043] This calculation method is a commonly used simplified evaluation technique in the field of animal models of localized swelling of the anorectal surface. It is not a strict three-dimensional measurement and is mainly used for relative comparison between groups to calculate the swelling inhibition rate, rather than to obtain the absolute true volume of the lesion. Throughout the experiment, all groups of animals used the same measurement method and calculation formula, and the comparison conditions between groups were consistent, which did not affect the relative efficacy evaluation results.

[0044] Formula for calculating swelling inhibition rate: Swelling inhibition rate = (average swelling volume of model group - average swelling volume of drug-treated group) ÷ average swelling volume of model group × 100%.

[0045] 3. Perianal vascular permeability test Thirty minutes after the last administration, rats were injected via tail vein with 0.5% Evans blue saline solution. Thirty minutes later, the rats were sacrificed, and an equal weight of perianal tissue was harvested. The dye was extracted by soaking the tissue in formamide at a constant temperature, and the absorbance was measured at 590 nm using an enzyme-linked immunosorbent assay (ELISA) reader. The lower the absorbance, the less vascular exudation and the lower the permeability. The rate of reduction in vascular permeability was used for intergroup comparison.

[0046] 4. Detection of intestinal inflammatory factors IL-6 and TNF-α Rat colonic mucosal tissue was taken, weighed, and homogenized at low temperature with protein lysis buffer. The supernatant was collected by centrifugation, and the concentrations of IL-6 and TNF-α were quantitatively detected using an ELISA kit. The unit was pg / mg tissue, and the lower the value, the stronger the anti-inflammatory effect.

[0047] 5. Detection of the area of ​​hematoma in the perianal tissue Perianal tissue was fixed, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE); the total area of ​​the ecchymotic plaque was calculated using image analysis software after microscopic imaging. The reduction rate of ecchymosis area = (average ecchymosis area in the model group - average ecchymosis area in the drug treatment group) ÷ average ecchymosis area in the model group × 100%.

[0048] I. Basic Animal Efficacy Tests Experimental model: SPF-grade male SD rats, weighing 180-220g; a spleen deficiency and chronic diarrhea model was established by gavage administration of senna leaf decoction for 7 consecutive days; on the 7th day, a perianal congestion and edema hemorrhoid model was established by applying 5% acetic acid around the anus.

[0049] Experimental Groups: a. Blank control group: No modeling was performed + equal volume of physiological saline was administered by gavage; b. Model control group: After modeling, the model was administered an equal volume of physiological saline by gavage; c. Positive control group: After modeling, patients were administered a suspension of Sanguisorba officinalis and Sophora japonica fruit pills (800 mg / kg) by gavage; d. Low-dose group of the present invention: After modeling, the tablet suspension of Example 1 (300 mg / kg) was administered by gavage; e. High-dose group of the present invention: after modeling, the tablet suspension of Example 1 (600mg / kg) was administered by gavage.

[0050] Each of the above experimental groups consisted of 10 SD rats. The dosage units for groups c, d, and e are mg / kg, representing the daily dose per kilogram of rat body weight. During the administration period, each group was administered the drug via gavage at a fixed time each day for 7 consecutive days. In the experimental procedure, the gavage volume was determined by a ratio of 1 mL of drug solution per 100g rat, and the required suspension concentration for each dosage group was calculated accordingly. Specifically, the *Diyu Huaijiao Wan* (commercially available, conforming to the standards of the Chinese Pharmacopoeia) was ground into a fine powder using a mortar and pestle, and an appropriate amount was accurately weighed, then mixed with physiological saline and vortexed to prepare a uniform suspension. The suspension preparation method was the same for both the low-dose and high-dose groups.

[0051] Result 1: Indicators for improvement in diarrhea; the experimental results for each group are shown in Table 4. Table 4 Comparison of diarrhea indicators among groups

[0052] Note: Compared with the model control group, *p<0.05, **p<0.01.

[0053] Conclusion: This composition significantly reduces the frequency and severity of diarrhea, and the high-dose antidiarrheal effect is superior to that of the commercially available positive control, Di Yu Huai Jiao Wan.

[0054] Result 2: Indicators of perianal swelling and congestion in hemorrhoids; the experimental results for each group are shown in Table 5. Table 5 Comparison of indicators for improvement in perianal swelling and congestion among different groups

[0055] Note: Compared with the model control group, *p<0.05, **p<0.01.

[0056] Conclusion: The formulation composition of this invention can significantly reduce perianal edema, dissipate hemorrhoidal congestion, and reduce perianal vascular exudation, demonstrating outstanding hemorrhoid-reducing effects.

[0057] Result 3: Intestinal inflammatory factors; the experimental results for each group are shown in Table 6. Table 6 Comparison of intestinal inflammatory factor detection results among groups

[0058] Note: Compared with the model control group, *p<0.05, **p<0.01.

[0059] Conclusion: The formulation composition of the present invention can significantly inhibit intestinal inflammation, repair damaged intestinal mucosa, and reduce the recurrence of diarrhea from the root cause.

[0060] The results of the animal efficacy tests (daily frequency of diarrhea, loose stool score, perianal swelling, perianal congestion area, perianal vascular permeability, and intestinal inflammatory factors) of the tablets in Examples 2 and 3 were not significantly different from those in Example 1 (p > 0.05), proving that the dosage range of the formulation is stable and effective.

[0061] II. Experiment on the separation of monarch, minister, and assistant formulas Experimental Objective To demonstrate the synergistic effect among the principal, assistant, and adjuvant herbs in this formula, the complete nine-herb formula was divided into a principal herb group, an assistant herb group, and an adjuvant herb group, and animal experiments were conducted to compare the effects.

[0062] Experimental Groups Principal herbs: 130mg kudzu root powder + 130mg Japanese raisin tree fruit powder (only two principal herbs); Assistant herbs: 50mg mulberry powder + 50mg dried plum powder + 50mg turmeric powder (only three herbs); The adjuvant and guide group consists of ginseng powder 25mg, galangal powder 18mg, amomum powder 13mg, and hawthorn powder 6.5mg (only four adjuvant and guide herbs). Complete formula test group: Complete tablets containing all nine main ingredients and standard excipients from Example 1.

[0063] The modeling, drug dosage, and detection indicators of each group were completely consistent with the above-mentioned basic animal experiments.

[0064] Data from the split-component control experiment Table 8. Data from the dismantling test

[0065] Note: The decrease rate / inhibition rate mentioned above are calculated based on the results of the model control group.

[0066] Disassembly test conclusions The two core indicators, the perianal swelling inhibition rate and the intestinal IL-6 inflammation reduction rate, showed that the actual efficacy of the complete nine-herb formula was significantly higher than the theoretical superposition value of the three split formulas, indicating that the nine-herb formula of this scheme has obvious synergistic effects. The principal herb alone only has a mild effect of raising yang and removing dampness, the assistant herb alone only has a short-term astringent and hemostatic effect, and the adjuvant herb alone only has a slow effect of strengthening the spleen and warming the middle. No matter how the formula is split, it cannot achieve the triple effects of stopping diarrhea, eliminating hemorrhoids, and strengthening the spleen and consolidating the foundation at the same time. Only when the nine herbs are fixed in the principal, assistant, adjuvant and adjuvant combination can they simultaneously intervene in the three complex pathogenesis of spleen deficiency, damp heat and blood stasis.

[0067] III. Interference Control Experiment with Added Flavors Experimental Objective In proctology clinics, Poria cocos, Sanguisorba officinalis, and Coptis chinensis are routinely added to treat hemorrhoids with damp-heat syndrome. This experiment verifies that adding the above-mentioned herbs to the nine herbs of this invention will disrupt the original balance of cold and heat and reduce the efficacy of all core herbs. This proves that the fixed combination of the nine herbs in this invention is the exclusive optimal solution for "spleen deficiency with chronic diarrhea and hemorrhoids". The existing conventional simple drug addition approach is difficult to achieve the ideal effect of stopping diarrhea and eliminating hemorrhoids.

[0068] Experimental Groups All groups used the same nine main ingredients as in Example 1, with an additional 50mg of medicinal material added per tablet, and the total amount of excipients was slightly adjusted to ensure consistent tablet weight; the modeling and testing indicators were standardized.

[0069] Flavored control test data Table 9. Data from the Flavoring Interference Test

[0070] Conclusion of the flavoring interference test Adding Poria cocos, Sanguisorba officinalis, and Coptis chinensis significantly reduced the three core effects of stopping diarrhea, reducing swelling, and anti-inflammation. Poria cocos is mildly diuretic and can deplete spleen qi with prolonged use, exacerbating spleen deficiency and loose stools. Sanguisorba officinalis and Coptis chinensis are extremely cold in nature, which counteracts the warming and spleen-strengthening effects of Alpinia galanga and Amomum villosum, disrupting the balance of cold and heat in this formula. The cold nature of these herbs can damage the spleen and aggravate the recurrence of diarrhea. The existing approach of adding commonly used herbs in proctology is difficult to achieve the effect of "strengthening the spleen and consolidating the foundation for long-term conditioning." It is evident that the nine-herb formula of this invention has built a synergistic balance. Adding other herbs not only fails to enhance efficacy but also disrupts the original synergistic balance, leading to a significant decrease in the effects of stopping diarrhea and treating hemorrhoids.

[0071] IV. Human Trial Testing Subjects: Sixty volunteers aged 28-55 years with spleen deficiency and damp-heat type diarrhea complicated with mixed hemorrhoids; inclusion criteria: ≥3 loose stools per day, anal swelling and pain, post-defecation bleeding, perianal distension, and no serious organic intestinal lesions. Participants were randomly assigned to a placebo control group and an experimental group, with 30 participants in each group, in a double-blind design.

[0072] Trial protocol: The experimental group took 4 tablets of Example 1 after breakfast and dinner daily; the control group took an equal amount of starch placebo for 28 consecutive days. After 28 days of continuous use, the group was followed up for 1 month after discontinuation to assess relapse.

[0073] Observation indicators: daily bowel movement frequency, time for rectal bleeding to disappear, anal swelling and pain score (0-10 points), degree of hemorrhoid shrinkage, and recurrence. Among them, the measurement of hemorrhoids refers to the calculation method of the perianal distended volume mentioned above; recurrence refers to the recurrence of at least two of the following conditions: ≥3 loose bowel movements per day, anal swelling and pain, post-defecation bleeding, and perianal distension.

[0074] The results of the placebo control group and the experimental group are shown in Table 7: Table 7

[0075] Human trial conclusions: This composition can quickly astringe and stop diarrhea, stop bleeding and reduce swelling, and continuous use can shrink hemorrhoids; by strengthening the spleen and consolidating the foundation, it can regulate the root cause and greatly reduce the recurrence rate after stopping the medication; there are no adverse reactions such as stomach pain, constipation, perianal irritation, or internal heat throughout the course of treatment. The formula is made from food and medicine and has high safety. It is suitable for long-term internal use by people with spleen deficiency, chronic diarrhea and hemorrhoids.

[0076] The technical solution provided by the invention has been described in detail above. Specific examples have been used to illustrate the principle and implementation of the invention. The description of the above embodiments is only for the purpose of helping to understand the method and core idea of ​​the invention. At the same time, for those skilled in the art, there will be changes in the specific implementation and application scope based on the idea of ​​the invention. Therefore, the content of this specification should not be construed as a limitation of the invention.

Claims

1. A traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids, characterized in that, The components include the following parts by weight: 110-150 servings of kudzu root powder; 110-150 servings of Hovenia dulcis powder; 40-60 parts mulberry powder; 40-60 portions of dried plum powder; 5-8 parts hawthorn powder; 20-30 servings of ginseng powder; 15-20 parts galangal powder; 10-15 parts of Amomum villosum powder; 40-60 parts turmeric powder.

2. The traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids according to claim 1, characterized in that, The components include the following parts by weight: 130 servings of kudzu root powder; 130 portions of Hovenia dulcis powder; 50 portions of mulberry powder; 50 portions of dried plum powder; 6.5 portions of hawthorn powder; 25 portions of ginseng powder; 18 parts galangal powder; 13 parts of cardamom powder; 50 parts turmeric powder.

3. The traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids according to claim 1, characterized in that, The kudzu root powder contains ≥2.5% puerarin.

4. The traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids according to claim 1, characterized in that, The content of dihydromyricetin in the Hovenia dulcis powder is ≥1.0%.

5. The traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids according to claim 1, characterized in that, The curcumin content in the turmeric powder is ≥3.0%.

6. A method for preparing a tablet of a traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids as described in any one of claims 1-5, characterized in that, Includes the following steps: S1. Weigh out the following ingredients according to the formula: kudzu root powder, Japanese raisin tree fruit powder, mulberry powder, dried plum powder, hawthorn powder, ginseng powder, galangal powder, amomum powder, and turmeric powder. Pass each ingredient through an 80-100 mesh sieve for later use. S2. Put the above main ingredients into a three-dimensional mixer and mix for 15-30 minutes to ensure that all components are fully and evenly mixed. S3. Add molding auxiliary materials and continue mixing for 10-20 minutes; S4. Compress the tablets using dry tableting technology or wet granulation; S5. The finished product is obtained by aluminum-plastic packaging.

7. The preparation method according to claim 6, characterized in that, In step S4, dry compression technology is used, and each tablet weighs approximately 500-520 mg.

8. The preparation method according to claim 6, characterized in that, The molding auxiliary material is one or both of microcrystalline cellulose or magnesium stearate.

9. The application of a traditional Chinese medicine composition for stopping diarrhea and relieving hemorrhoids as described in any one of claims 1-5, characterized in that, The above-mentioned Chinese herbal composition for stopping diarrhea and relieving hemorrhoids was used as a raw material to prepare an oral conditioning preparation for improving chronic diarrhea caused by spleen deficiency and damp-heat, and relieving swelling, pain and bleeding of hemorrhoids.

10. The application according to claim 9, characterized in that, The oral conditioning preparations include, but are not limited to, oral dosage forms such as compressed candy, solid beverages, capsules, and oral liquids.

Images