A traditional Chinese medicine composition for treating anal sinusitis, a preparation method and use thereof

Abstract

The application provides a traditional Chinese medicine composition for treating anal sinusitis, and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from raw medicinal materials in the following weight ratio: 30-60 parts of white bletilla, 15-30 parts of hedgehog skin, 10-20 parts of typha angustifolia pollen, 15-30 parts of Senecio, 10-20 parts of gallnut, 10-20 parts of catechu, 15-30 parts of Panax notoginseng, 5-10 parts of aloe, 25-30 parts of borneol, 15-30 parts of Sophora flavescens, 5-15 parts of mirabilite, 15-30 parts of Corydalis, and 15-30 parts of Cyperus rotundus. The traditional Chinese medicine composition is well matched, can effectively improve the symptoms of anal sinusitis such as swelling, sagging, pain, and incomplete defecation, greatly improves the treatment effect of anal sinusitis, and is convenient for clinical use due to external administration and direct reaching of the lesion. The application provides a safe and effective traditional Chinese medicine composition for treating anal sinusitis, and has a good application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating anal sinusitis, its preparation method, and its uses. Background Technology

[0002] Anal cryptitis, also known as anal cryptitis, refers to acute or chronic inflammation occurring in the anal crypts and anal glands. In the acute phase, symptoms include burning, swelling, a feeling of heaviness, pain, anal dampness and itching, and a feeling of incomplete bowel movements. Anoscopy reveals congestion and edema of the affected anal crypts; some patients may have purulent or bloody discharge. Digital rectal examination reveals tenderness, induration, or depression in the anal crypts. In severe cases, complications such as perianal abscess and anal fistula may occur. If the condition recurs and symptoms persist, progressing to a chronic phase, some patients experience anxiety and depression, significantly impacting their quality of life. Western medicine primarily uses anti-inflammatory and analgesic drugs to relieve symptoms, but the efficacy is unsatisfactory, and long-term efficacy is uncertain. For severe cases, surgical treatment such as anal crypt incision and drainage or suture placement may be necessary. However, surgical treatment is costly and may involve numerous postoperative complications, such as anal heaviness and discomfort due to scarring. Therefore, conservative treatment is the primary clinical approach.

[0003] Anal cryptitis falls under the category of "visceral toxins" in Traditional Chinese Medicine (TCM). It is often caused by improper diet, excessive consumption of spicy, stimulating, and rich foods, leading to impaired spleen and stomach function, internal accumulation of dampness and toxins, and poor blood circulation, resulting in disease due to their accumulation in the anus. Patent application CN107551046A discloses a formula for treating anal cryptitis using four-leaf ginseng, Panax notoginseng, ginseng, Rehmannia glutinosa, donkey-hide gelatin, and Polygonum multiflorum as raw materials. This formula is decocted in water and taken orally to clear heat and relieve pain, primarily treating anal cryptitis. Patent application CN107890492A discloses a formula for treating anal cryptitis using Corydalis yanhusuo, Paeonia suffruticosa, Viola yedoensis, Semiaquilegia adoxoides, Sanguisorba officinalis, Pueraria lobata, Scutellaria baicalensis, Gentiana scabra, and Coptis chinensis as raw materials. This formula is also prepared as an oral preparation for treating anal cryptitis. However, currently, there are no standardized diagnostic and treatment guidelines for anal cryptitis in TCM, and treatment often relies on doctors' experience, resulting in uncertain efficacy. Meanwhile, most medications are administered orally. Due to the unique and hidden anatomical location and structure of the anal sinus, conventional oral methods are difficult to reach the affected area directly and exert their effects. Summary of the Invention

[0004] In order to address the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating anal sinusitis, its preparation method and uses.

[0005] This invention provides a traditional Chinese medicine composition for treating anal sinusitis, which is prepared from raw materials in the following weight ratio:

[0006] Bletilla striata 30-60 parts, hedgehog skin 15-30 parts, Typha pollen 10-20 parts, Senecio scandens 15-30 parts, Gallnut 10-20 parts, Catechu 10-20 parts, Panax notoginseng 15-20 parts, Aloe vera 5-10 parts, Borneol 25-30 parts, Sophora flavescens 15-30 parts, Glauber's salt 5-15 parts, Corydalis yanhusuo 15-30 parts, Cyperus rotundus 15-30 parts.

[0007] Furthermore, the aforementioned traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios:

[0008] 60 parts of Bletilla striata, 30 parts of hedgehog skin, 20 parts of Typha pollen, 30 parts of Senecio scandens, 20 parts of Gallnut, 20 parts of Catechu, 20 parts of Panax notoginseng, 10 parts of Aloe vera, 30 parts of Borneol, 30 parts of Sophora flavescens, 15 parts of Glauber's salt, 30 parts of Corydalis yanhusuo, and 30 parts of Cyperus rotundus.

[0009] Furthermore, the pollen mentioned is raw pollen.

[0010] Furthermore, the aforementioned traditional Chinese medicine composition is a preparation made from the active ingredients of the raw material powder or water and / or organic solvent extract of the raw material in the stated weight ratio, plus pharmaceutically acceptable excipients or auxiliary ingredients.

[0011] Furthermore, the preparation is a topical preparation.

[0012] Furthermore, the topical preparation is a solution, ointment, gel, or suppository.

[0013] This invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, which includes the following steps:

[0014] (1) Weigh the raw materials according to the stated weight ratio;

[0015] (2) The active pharmaceutical ingredient powder, or the water and / or organic solvent extract of the active pharmaceutical ingredient, plus pharmaceutically available excipients or auxiliary ingredients, is obtained.

[0016] Furthermore, the aforementioned preparation method includes the following steps:

[0017] (1) Grind the raw materials into powders separately, weigh the raw material powders according to the weight ratio, and mix them evenly;

[0018] (2) Take the mixed fatty acid glycerides as the matrix, heat and melt them, mix them evenly with the raw material powder in step (1), and then cool them to prepare suppositories.

[0019] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating anal sinusitis.

[0020] Furthermore, the drug has the functions of clearing heat and detoxifying, removing dampness and relieving itching, reducing swelling and relieving pain, removing blood stasis and stopping bleeding, and regulating qi and soothing the liver.

[0021] Anal cryptitis is characterized by significant pain, itching, and sores. Therefore, this invention, based on the theory of "all pain, itching, and sores belong to the heart" from the *Huangdi Neijing* (Yellow Emperor's Inner Classic), and combined with the four major pathogenic mechanisms of dampness, heat, blood stasis, and toxins, and guided by the holistic concept of Traditional Chinese Medicine, proposes a multi-target treatment method that clears the heart and detoxifies, reduces swelling and relieves pain, eliminates dampness and relieves itching, resolves blood stasis and stops bleeding, and regulates qi and soothes the liver. It provides a traditional Chinese medicine composition and its preparation method that can quickly relieve symptoms of anal cryptitis such as swelling, heaviness, pain, and incomplete defecation. Clinical application has achieved satisfactory clinical results.

[0022] This invention's herbal composition uses Sophora flavescens as the principal ingredient, Typha pollen, hedgehog skin, Bletilla striata, and Galla chinensis as assistant ingredients, Cyperus rotundus, Senecio scandens, Catechu, Panax notoginseng, Aloe vera, and Corydalis yanhusuo as adjuvant ingredients, and Glauber's salt and borneol as guiding ingredients. The *Compendium of Materia Medica* states that "Sophora flavescens specifically treats fire in the heart meridian," excelling in clearing heat and drying dampness, dispelling wind and killing parasites, and eliminating sores and relieving itching; therefore, it is used as the principal ingredient. The *Correct Interpretation of Materia Medica* states that Typha pollen specifically affects the blood… it treats the fragrant nature of qi, and also regulates qi, thus it can guide blood stasis and treat diseases of qi and blood stagnation, promoting the normal function of the heart in "governing blood circulation." Bletilla striata has astringent and hemostatic effects, reduces swelling and promotes tissue regeneration; it is used for various internal and external bleeding conditions and carbuncles. The *Shennong Bencao Jing* states that it "treats carbuncles, malignant sores, and boils, as well as injuries to the yin and dead tissue, and evil qi in the stomach." The *Bencao Gangmu* states that "Baiji (Radix Bletillae) also has the effect of reducing swelling and promoting tissue regeneration; it can be used to treat sores, whether they have ulcerated or not. It can disperse untreated sores and promote tissue regeneration in ulcerated sores." The *Bencao Jing Shu* says that "Hedgehog skin treats diseases caused by damp-heat in the large intestine and blood heat, as well as hemorrhoids with bleeding from the yin, with blood of various colors (red, white, and black) that does not stop." The *Yaoxing Lun* states that it "treats intestinal wind and bloody diarrhea, and hemorrhoids with a head that have not healed for many years." Clinical application has shown that hedgehog skin has remarkable effects in cooling the blood, detoxifying, and relieving pain. The lungs and large intestine are internally and externally related, and the anal sinus is the end of the large intestine. In this formula, gallnut (Radix Gallae) astringes the lungs, reduces fire, stops bleeding, and promotes tissue regeneration and wound healing. Catechu (Radix Catechu) also astringes, promotes tissue regeneration, heals, and stops bleeding. The *Diannan Materia Medica* states that *Senecio scandens* "washes away scabies, tinea, and skin lesions, and removes wind-heat from the skin," possessing excellent heat-clearing, detoxifying, insecticidal, and antipruritic effects. It is primarily used to treat carbuncles, boils, diarrhea, dysentery, and eczema. *Panax notoginseng* disperses blood stasis, stops bleeding, reduces swelling, and relieves pain, with the characteristic of stopping bleeding without leaving blood stasis and promoting blood circulation without harming new blood. Aloe vera clears heat, detoxifies, resolves blood stasis, and kills insects. *Treatise on the Nature of Medicinal Herbs* states that *Salmonella fuciformis* "treats heart heat, irritability, and stagnation in the five internal organs," possessing the power to clear heat, promote bowel movements, soften hard masses, dissipate nodules, clear heat, detoxify, and promote metabolism. Borneol clears heat and relieves pain; externally, it reduces swelling, relieves pain, and stops itching. Corydalis rhizome is pungent, bitter, and warming, entering both the blood and qi levels. It can move both qi within the blood and blood within the qi, ensuring smooth qi and blood flow, thus relieving pain; it is an excellent analgesic. Cyperus rotundus promotes qi circulation, relieves depression, regulates menstruation, and relieves pain. Promoting qi circulation eliminates tenesmus. The *Ben Cao Zheng Yi* states that Cyperus rotundus "has a very strong pungent taste and a rich aroma, both of which are due to its qi-regulating properties, thus it is specifically used to treat diseases caused by qi stagnation... Although it contains a mild and fluid-moving effect, its substance is firm, so while it moves easily, it can also hold its position, neither drying nor dispersing. These are its unique properties, thus it can be used frequently without adverse effects." The entire formula works to clear the heart and detoxify, reduce swelling and relieve pain, dispel dampness and relieve itching, resolve blood stasis and stop bleeding, and regulate qi and soothe the liver.

[0023] The herbal composition of this invention is precisely formulated and can effectively improve symptoms such as swelling, heaviness, pain, and incomplete bowel movements associated with anal cryptitis, greatly enhancing the treatment effect. Furthermore, its external application (prepared as suppositories or gels for intrarectal administration) directly targets the affected area, making it convenient for clinical use. This invention provides a safe and effective herbal composition for treating anal cryptitis, with promising application prospects.

[0024] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0025] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Detailed Implementation

[0026] The raw materials and equipment used in the specific embodiments of the present invention are all known products, obtained by purchasing commercially available products.

[0027] Example 1: Preparation of the Traditional Chinese Medicine Composition of the Present Invention

[0028] Formula (by weight of each raw material): Bletilla striata 60 parts, hedgehog skin 30 parts, raw Typha pollen 20 parts, Senecio scandens 30 parts, Gallnut 20 parts, catechu 20 parts, Panax notoginseng 20 parts, aloe vera 10 parts, borneol 30 parts, Sophora flavescens 30 parts, sodium sulfate 15 parts, Corydalis yanhusuo 30 parts, Cyperus rotundus 30 parts.

[0029] Preparation method (taking suppositories as an example):

[0030] The above thirteen herbs are pulverized into fine powder (100 mesh), sieved, and mixed evenly according to the above weight proportions. Then, an appropriate amount of mixed fatty acid glycerides (as a matrix) is heated and melted in a water bath at 60-80°C. While stirring, the above-mentioned herbal powder is added and stirred evenly. The mixture is then ground in a colloid mill, poured into molds at 40-50°C, cooled, and made into suppositories containing 3.0g of herbal powder per suppository.

[0031] Example 2: Preparation of the Traditional Chinese Medicine Composition of the Present Invention

[0032] Formula (by weight of each raw material): Bletilla striata 50 parts, hedgehog skin 25 parts, raw Typha pollen 15 parts, Senecio scandens 25 parts, Gallnut 18 parts, catechu 18 parts, Panax notoginseng 18 parts, aloe vera 8 parts, borneol 28 parts, Sophora flavescens 25 parts, sodium sulfate 12 parts, Corydalis yanhusuo 25 parts, Cyperus rotundus 25 parts.

[0033] Preparation method: Same as in Example 1.

[0034] Example 3: Preparation of the Traditional Chinese Medicine Composition of the Present Invention

[0035] Formula (by weight of each raw material): Bletilla striata 30 parts, hedgehog skin 15 parts, raw Typha pollen 10 parts, Senecio scandens 15 parts, Gallnut 10 parts, catechu 10 parts, Panax notoginseng 15 parts, aloe vera 5 parts, borneol 25 parts, Sophora flavescens 15 parts, sodium sulfate 5 parts, Corydalis yanhusuo 15 parts, Cyperus rotundus 15 parts.

[0036] Preparation method: Same as in Example 1.

[0037] Example 4: Preparation of the Traditional Chinese Medicine Composition of the Present Invention

[0038] Formula (by weight of each raw material): Bletilla striata 10 parts, hedgehog skin 10 parts, raw Typha pollen 10 parts, Senecio scandens 10 parts, Gallnut 10 parts, catechu 10 parts, Panax notoginseng 10 parts, aloe vera 10 parts, borneol 10 parts, Sophora flavescens 10 parts, sodium sulfate 10 parts, Corydalis yanhusuo 10 parts, Cyperus rotundus 10 parts.

[0039] Preparation method: Same as in Example 1.

[0040] The following specific experimental examples demonstrate the beneficial effects of the present invention.

[0041] Trial Case 1, Clinical Study

[0042] 1. Clinical Data

[0043] One hundred and fifty patients aged 18-65 years with anal sinusitis admitted to Nanchong Traditional Chinese Medicine Hospital from January 2022 to December 2023 were randomly divided into observation group (1), observation group (2), observation group (3), observation group (4), and control group, with 30 patients in each group. There were no statistically significant differences in gender, age, and course of disease among the five groups (P>0.05), making them comparable.

[0044] Inclusion criteria:

[0045] (1) Diagnostic criteria for anal cryptitis: ① Presence of anal distension, burning sensation, and accompanied by stinging or dull pain, with varying degrees of dampness or itching in the anal area; ② Anal palpation reveals tightness of the anal opening during digital rectal examination, with significant tenderness and induration in the affected anal crypts; ③ Anoscopy reveals congestion and edema in the anal crypts and anal valves, and significantly increased secretions from the anal crypts; ④ Probing reveals anal crypts. Criteria ① through ④ must be met simultaneously.

[0046] (2) The research subjects were informed and signed relevant consent forms.

[0047] Both (1) and (2) above need to be satisfied simultaneously.

[0048] Exclusion criteria:

[0049] (1) Those suffering from other serious anorectal diseases such as anal fissures, anal fistulas, perianal abscesses, mixed hemorrhoids, etc.;

[0050] (2) Severe organ dysfunction such as heart, liver, and kidney failure, AIDS, or malignant tumors;

[0051] (3) Those who cannot tolerate or complete the treatment;

[0052] (4) Patients who have used other related drugs within 1 week prior to enrollment.

[0053] If any one of (1) to (4) above is satisfied, it is excluded.

[0054] The general information of patients in each group is shown in Table 1.

[0055] Table 1. Comparison of general data (n=30, examples)

[0056]

[0057] Chi-square test and analysis of variance showed no statistically significant differences in gender, age, and disease duration among the five groups (p<0.05).

[0058] 2. Treatment methods

[0059] The control group was treated with indomethacin and furazolidone suppositories (Hubei Dongxin Pharmaceutical Co., Ltd., National Drug Approval Number 42022558, specification: each suppository contains 75mg indomethacin and 100mg furazolidone) inserted rectally. The observation groups (1) and (4) were treated with suppositories according to Example 1, (2) according to Example 2, (3) according to Example 3, and (4) according to Example 4. All groups used one suppository twice a day (one suppository each time), inserted rectally in the morning and evening (after defecation). Treatment lasted for three weeks as one course. The overall efficacy was observed after one week of cessation following the completion of one course of treatment.

[0060] 3. Clinical efficacy observation

[0061] Therapeutic criteria:

[0062] Cure: After treatment, all symptoms and signs of the patient completely disappeared, and examinations such as anoscopy showed normal results;

[0063] Significant improvement: After treatment, the patient's various symptoms and signs improved significantly;

[0064] Ineffective: The patient's symptoms and signs did not improve or worsened after treatment.

[0065] Overall effective rate = (cured + significantly effective) / total number of cases × 100%.

[0066] 4. Statistical methods

[0067] Data were processed using SPSS 25.0 software. Quantitative data were expressed as (x±s) and analyzed using t-tests. Count data were expressed as cases (n) and percentages (%) and analyzed using χ² tests. p<0.05 was considered statistically significant.

[0068] 5. Results

[0069] Compared with the control group, the differences in observation groups (1), (2), (3), and (4) were statistically significant (p < 0.05), and the overall effective rate was higher in all groups than in the control group. See Table 2.

[0070] Table 2. Comparison of overall effective rate and clinical efficacy (n, %)

[0071]

[0072] Effective and ineffective were binary variables, and the chi-square test was used. Compared with the control group, the observation groups (1), (2), (3), and (4) were all statistically significant (p<0.05), and the total effective rate was higher than that of the control group.

[0073] Compared with the control group, the observation groups (1), (2), and (3) were all statistically significant (p<0.05), and their cure rates were all higher than those of the control group; the observation group (4) was not statistically significant compared with the control group (p>0.05). See Table 3.

[0074] Table 3. Comparison of Cure Rate and Clinical Efficacy (n, %)

[0075]

[0076]

[0077] The Wilcoxon rank-sum test for one-way ordered data was used. Compared with the control group, the observation groups (1), (2), and (3) were all statistically significant (p<0.05), and the cure rate was higher than that of the control group. The observation group (4) was not statistically significant compared with the control group (p>0.05).

[0078] Intergroup comparison: The cure rates of observation groups (1), (2), (3), and (4) were compared. There was no statistically significant difference in cure rates among observation groups (1), (2), and (3) (p > 0.05). However, the cure rates among observation groups (1), (2), and (3) and observation group (4) were all statistically significant (p < 0.008), with the cure rates of all groups being higher than those of observation group (4). See Table 4.

[0079] Table 4. Comparison of Cure Rate and Clinical Efficacy (n, %)

[0080]

[0081]

[0082] The Wilcoxon rank-sum test for one-way ordered data was used, and the adjusted significance level was α = 0.05 / 6 = 0.008. The pairwise cure rates of observation groups (1), (2), (3) and (4) were compared, and the differences were statistically significant (p < 0.008), with the cure rate of observation group (4) being higher than that of observation group (4).

[0083] 6. Conclusion

[0084] The results of this study showed that: ① Compared with the control group, the total effective rate of the observation group was higher than that of the control group, and the difference was statistically significant; the cure rate of the observation group (1), observation group (2), and observation group (3) was higher than that of the control group, and the difference was statistically significant; the difference between the observation group (4) and the control group was not statistically significant. ② Comparison of cure rates among the observation groups: There was no statistically significant difference in cure rate and total effective rate among the observation groups (1), (2), and (3); the differences in cure rate and total effective rate among the observation groups (1), (2), (3), and (4) were all statistically significant, and the cure rate and total effective rate were higher than those of the observation group (4).

[0085] Therefore, it can be seen that the traditional Chinese medicine composition of the present invention has a definite curative effect on anal sinusitis.

[0086] In summary, the herbal composition of this invention is well-formulated and can effectively improve symptoms such as swelling, heaviness, pain, and incomplete bowel movements associated with anal cryptitis, greatly enhancing the therapeutic effect. Furthermore, its external application (prepared as suppositories or gels for intrarectal administration) directly targets the affected area, making it convenient for clinical use. This invention provides a safe and effective herbal composition for treating anal cryptitis, with promising application prospects.

Claims

1. A traditional Chinese medicine composition for treating anal sinusitis, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: Bletilla striata 30-60 parts, hedgehog skin 15-30 parts, Typha pollen 10-20 parts, Senecio scandens 15-30 parts, Gallnut 10-20 parts, Catechu 10-20 parts, Panax notoginseng 15-20 parts, Aloe vera 5-10 parts, Borneol 25-30 parts, Sophora flavescens 15-30 parts, Glauber's salt 5-15 parts, Corydalis yanhusuo 15-30 parts, Cyperus rotundus 15-30 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: 60 parts of Bletilla striata, 30 parts of hedgehog skin, 20 parts of Typha pollen, 30 parts of Senecio scandens, 20 parts of Gallnut, 20 parts of Catechu, 20 parts of Panax notoginseng, 10 parts of Aloe vera, 30 parts of Borneol, 30 parts of Sophora flavescens, 15 parts of Glauber's salt, 30 parts of Corydalis yanhusuo, and 30 parts of Cyperus rotundus.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The pollen mentioned is raw pollen.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that: It is a preparation made from the active ingredient of the raw material drug powder in the stated weight ratio, plus excipients or auxiliary ingredients acceptable to pharmaceuticals; the preparation is a suppository.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: (1) Weigh the raw materials according to the stated weight ratio; (2) The raw drug powder plus pharmaceutically usable excipients or auxiliary ingredients are used to make a suppository.

6. The preparation method according to claim 5, characterized in that: It includes the following steps: (1) Grind the raw materials into powders separately, weigh the raw material powders according to the weight ratio, and mix them evenly; (2) Take the mixed fatty acid glycerides as the matrix, heat and melt them, mix them evenly with the raw material powder in step (1), and then cool them to prepare suppositories.

7. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating anal sinusitis.

8. The use according to claim 7, characterized in that: The drug has the functions of clearing heat and detoxifying, removing dampness and relieving itching, reducing swelling and relieving pain, removing blood stasis and stopping bleeding, and regulating qi and soothing the liver.

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