A traditional Chinese medicine composition for hemorrhoid department, its fumigating and washing powder and application

Abstract

The present invention provides a traditional Chinese medicine composition for hemorrhoids, its fumigation powder and application. A traditional Chinese medicine composition for hemorrhoids is composed of the following raw materials: Bauhinia championii (Benth.) Benth., Callicarpa nudiflora Hook. et Arn., Momordica cochinchinensis (Lour.) Spreng., Melicope pteleifolia (Champ. ex Benth.) T. G. Hartley. The mass ratio of Bauhinia championii (Benth.) Benth., Callicarpa nudiflora Hook. et Arn., Momordica cochinchinensis (Lour.) Spreng., Melicope pteleifolia (Champ. ex Benth.) T. G. Hartley is 25-35:25-35:25-35:25-35. The present invention adopts scientific formula with Bauhinia championii (Benth.) Benth., Callicarpa nudiflora Hook. et Arn., Momordica cochinchinensis (Lour.) Spreng., Melicope pteleifolia (Champ. ex Benth.) T. G. Hartley. Taking Bauhinia championii (Benth.) Benth. as the monarch drug to dispel wind and dampness, promote qi and activate blood circulation; taking Callicarpa nudiflora Hook. et Arn. as the minister drug to disperse stasis and stop bleeding, detoxify and reduce swelling; Momordica cochinchinensis (Lour.) Spreng. has the effects of dissipating binds and reducing swelling, attacking toxins and treating sores, serving as the assistant drug; Melicope pteleifolia (Champ. ex Benth.) T. G. Hartley clearing heat, detoxifying, dispelling wind and dampness serves as the messenger drug; the whole formula synergistically enhances the effect, has definite curative effect on the wound healing after operation of patients with mixed hemorrhoids, can significantly improve the relevant traditional Chinese medicine syndromes, reduce the pain of patients, also has a significant improvement on the anorectal function, shortens the cure time, so it is worthy of promotion in clinical practice.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for hemorrhoids, its fumigating and washing powder, and its application. Background Art

[0002] Surgical treatment is the main method in the diversified treatment of mixed hemorrhoids. However, due to the particularity and complexity of the anatomical structure and physiological function of the anal canal, and the open surgical wound will damage the local tissue due to defecation stimulation, resulting in complications such as anal edema, pain, bleeding, constipation, difficulty in urination, anal distension, and delayed wound healing, reducing the quality of life of patients after surgery and bringing great physical and mental pain. Therefore, the management of the wound surface after mixed hemorrhoid surgery, especially the fumigating and sitz bath therapy, can directly act on the affected area with drugs, and the curative effect is definite. Further in-depth research on it is of great significance.

[0003] At home and abroad, each anorectal center mainly focuses on symptomatic treatment such as anti-infection, pain relief, and hemostasis in the treatment of mixed hemorrhoid complications; while traditional Chinese medicine treatment is based on syndrome differentiation and treatment to achieve the purpose of detumescence, pain relief, and promoting blood circulation to remove blood stasis. The clinical observation shows that its curative effect is stable. Especially in the traditional Chinese medicine fumigating and sitz bath, the drug directly acts on the affected area, through the effects of cleaning, heat, and drug power. It has low cost, is easy to operate, and can promote the subsidence of edema, relieve pain, reduce bleeding, and early wound healing. Zhang Li et al. conducted a Meta-analysis on the treatment of postoperative pain of hemorrhoids by traditional Chinese medicine fumigating and sitz bath, and believed that using traditional Chinese medicine fumigating and sitz bath to treat the pain of patients after hemorrhoid surgery can improve the clinical effective rate of patients and reduce the incidence of adverse reactions.

[0004] The commonly used drugs in the fumigating and washing therapy in clinical practice include Phellodendron amurense, Galla chinensis, Sophora flavescens, mirabilite, alum, and borneol. Wang Yanhua et al. found through statistical analysis of relevant traditional Chinese medicine fumigating and washing literature that the most commonly used traditional Chinese medicines are Phellodendron amurense and Sophora flavescens, with a usage rate of 61.1%; followed by mirabilite, with a usage rate of 44.4%; then Galla chinensis and Rheum palmatum, with usage rates of 38.9% and 33.3% respectively. However, Yin Yue et al. believe that due to the non-uniform prescription, it is inconvenient to use and carry. The composition is complex, and its treatment mechanism has always been unclear, lacking clear pharmacodynamic evidence. Therefore, the dosage form of traditional Chinese medicine for fumigating and washing needs to be improved and perfected. And the experience of Li medicine in treating hemorrhoids mostly exists in the form of passed down from generation to generation by ancestors, without systematic theoretical research and low commercialization degree, making it difficult to meet the development needs of modern clinical practice. The present invention conducts a large number of studies, mainly using Li medicine, and formulates a scientific prescription to develop a new traditional Chinese medicine formula. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition for hemorrhoids, its fumigating and washing powder, and its application.

[0006] The technical solution of the present invention is realized as follows:

[0007] A traditional Chinese medicine composition for hemorrhoids, which is composed of the following raw materials: Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis, Melicope pteleifolia. The mass ratio of Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis, Melicope pteleifolia is 25-35:25-35:25-35:25-35:25-35.

[0008] Further, the traditional Chinese medicine composition is composed of the following raw materials by weight: 25-35 g of Bauhinia championii, 25-35 g of Callicarpa nudiflora, 25-35 g of Momordica cochinchinensis, 25-35 g of Melicope pteleifolia.

[0009] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials by weight: 30 g of Bauhinia championii, 30 g of Callicarpa nudiflora, 30 g of Momordica cochinchinensis, 30 g of Melicope pteleifolia.

[0010] A traditional Chinese medicine fumigating and washing powder is prepared from the traditional Chinese medicine composition of the present invention.

[0011] Further, for the traditional Chinese medicine fumigating and washing powder, the Chinese medicinal materials of Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis, and Melicope pteleifolia are respectively taken according to the formula, ground into fine powder together, and the traditional Chinese medicine fumigating and washing powder is obtained.

[0012] The traditional Chinese medicine composition according to any one of the present invention is used in the preparation of a drug for postoperative complications of mixed hemorrhoids.

[0013] The traditional Chinese medicine composition according to any one of the present invention is used in the preparation of a drug for pain and wound edema after mixed hemorrhoid surgery.

[0014] The traditional Chinese medicine composition according to any one of the present invention is used in the preparation of a drug for promoting wound healing of patients after mixed hemorrhoid surgery.

[0015] Bauhinia championii: Bauhinia championii tastes bitter and is flat, and is non-toxic. It has the effects of expelling wind and removing dampness, promoting qi circulation and activating blood circulation; flavonoids, phenolic acids, sterols and other compounds can be separated from Bauhinia championii, and its extract has pharmacological activities such as antioxidant, analgesic, anti-inflammatory, anti-infection, and anti-platelet aggregation.

[0016] Callicarpa nudiflora: Callicarpa nudiflora has the effects of dissipating stasis and stopping bleeding, detoxifying and detumescence; the pharmacological effects of Callicarpa nudiflora mainly include hemostasis, anti-inflammatory, antibacterial, antioxidant and cytotoxic effects.

[0017] Momordica cochinchinensis: Momordica cochinchinensis has the effects of dissipating binds and detumescence, attacking toxins and treating sores, and Momordica cochinchinensis has anti-inflammatory, anti-viral and antibacterial effects.

[0018] Melicope pteleifolia leaf: Melicope pteleifolia leaf has the effects of clearing heat, detoxifying, expelling wind and removing dampness, and has obvious anti-allergic, anti-inflammatory, anti-carcinogen-inducing and anti-parasitic effects, with high safety and good skin drug resistance.

[0019] Compared with the prior art, the beneficial effects of the present invention are:

[0020] (1) The present invention uses Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis, and Evodia lepta leaves for scientific formula. Taking Bauhinia championii as the monarch drug to dispel wind and dampness, promote qi and activate blood circulation; taking Callicarpa nudiflora as the minister drug to disperse stasis and stop bleeding, detoxify and reduce swelling; Momordica cochinchinensis has the effects of dissipating nodules and reducing swelling, attacking toxins and treating sores, serving as the assistant drug; Evodia lepta leaves clearing heat, detoxifying, dispelling wind, and removing dampness as the guiding drug; the whole formula synergistically enhances the efficacy, has a definite curative effect on the wound healing of patients after mixed hemorrhoid surgery, can significantly improve the relevant traditional Chinese medicine syndromes, reduce the pain of patients, and also significantly improve the anorectal function, shorten the cure time, and is worthy of promotion in clinical practice.

[0021] (2) The fumigation and washing powder prepared from the traditional Chinese medicine composition of the present invention is used for fumigation and washing to treat the postoperative complications of anorectal diseases, which is safe, has few side effects, low cost, is simple and easy to operate, has a high acceptance degree by patients, and has good clinical efficacy.

[0022] (3) The fumigation and washing powder prepared by the present invention is applied to the postoperative complications of mixed hemorrhoids: anal pain and wound edema. This medicament is simple to prepare, uses fewer medicinal materials and has a lower cost, achieving good clinical efficacy, taking into account the clinical scientificity and operability well, being easy to promote, and providing new ideas and methods for the traditional Chinese medicine treatment of postoperative complications of anorectal diseases. Detailed implementation mode

[0023] To better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention. The experimental methods used in the embodiments of the present invention are all conventional methods unless otherwise specified. The materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial channels unless otherwise specified.

[0024] Example 1

[0025] Traditional Chinese medicine composition: Take 30 g each of Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis (shelled), and Evodia lepta leaves, grind them into fine powder together to obtain the fumigation and washing powder.

[0026] Example 2

[0027] Traditional Chinese medicine composition: Take 25 g of Bauhinia championii, 35 g of Callicarpa nudiflora, 25 g of Momordica cochinchinensis (shelled), and 35 g of Evodia lepta leaves, grind the medicinal materials into fine powder together to obtain the fumigation and washing powder.

[0028] Example 3

[0029] Traditional Chinese medicine composition: Take 35 g of Bauhinia championii, 25 g of Callicarpa nudiflora, 35 g of Momordica cochinchinensis (shelled), and 25 g each of Evodia lepta leaves, grind the medicinal materials into fine powder together to obtain the fumigation and washing powder.

[0030] Comparative example 1 (control group)

[0031] Traditional Chinese medicine composition (Galla chinensis decoction): Take 30 g each of Galla chinensis, mirabilite, Taxillus chinensis, Nelumbo nucifera receptacle, and Schizonepeta tenuifolia, grind them into fine powder together for standby.

[0032] Experimental Example

[0033] 1 Materials and Methods

[0034] 1.1 General Information

[0035] The clinical data and materials of 120 patients with mixed hemorrhoids after surgery who were hospitalized in the Anorectal Department of Hainan Provincial Hospital of Traditional Chinese Medicine from 2021 to 2023 were selected for comparison. According to the random number table method, they were randomly divided into a research group and a control group, with 60 cases in each group.

[0036] 1.2 Inclusion Criteria

[0037] Meeting the diagnostic criteria for mixed hemorrhoids in the "Diagnosis and Treatment Guidelines for Hemorrhoids in China (2020)" and all the resection methods used were external dissection and internal ligation for mixed hemorrhoids; 2) Normal cognitive ability and good compliance; 3) Aged 18 - 65 years old, aware of this study, voluntarily participated, and signed the informed consent form.

[0038] 1.3 Exclusion Criteria

[0039] Exclusion criteria: 1) Having an allergic reaction to the drugs used in this study; 2) Only having internal hemorrhoids or external hemorrhoids; 3) Having severe insufficiency of important organs such as the liver and kidneys; 4) Lactating or pregnant women; 5) Having severe mental illness.

[0040] 1.4 Treatment Methods

[0041] (1) Research Group: The fumigation and washing powder prepared in Example 1 (taking 30g each of Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis (shelled), and Evodia lepta leaves, and grinding them into fine powder);

[0042] (2) Control Group: The Galla Chinensis Decoction prepared in Comparative Example 1 (taking 30g each of Galla chinensis, mirabilite, Taxillus chinensis, lotus receptacle, and Schizonepeta tenuifolia, and grinding them into fine powder).

[0043] Usage method: Place the drug into the anorectal fumigation and washing instrument, add 2000 ml of water, adjust the water temperature to 42 °C, and sit in the bath for 15 minutes each time. Fumigate and wash once in the morning and evening after surgery.

[0044] After fumigation and washing in both groups, routine treatment was given as follows. Perform routine postoperative wound disinfection and dressing change, apply a gauze strip infiltrated with vaseline to the wound surface, and then bandage it with sterile gauze.

[0045] 1.3 Observation indicators Refer to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Diseases" in 2017. Clinical observations were carried out on the 3rd day, 7th day, and 14th day after surgery. The scoring criteria are as follows:

[0046] ① Pain condition:

[0047] 0 points: Completely painless;

[0048] 1 point: mild pain but tolerable, no impact on sleep;

[0049] 2 points: persistent pain, disturbed sleep;

[0050] 3 points: Intense and persistent pain, severe sleep disturbance, requiring analgesic treatment.

[0051] ②Edema:

[0052] 0 points: no edema in the affected area;

[0053] 1 point: edema is less than 0.5 cm from the surgical margin and less than 0.5 cm above the skin;

[0054] 2 points: Edema is 0.5-1.0 cm away from the surgical margin and 0.5-1.0 cm above the skin

[0055] 3 points: Edema is greater than 1.0 cm from the surgical margin and greater than 1.0 cm above the skin.

[0056] ③ Wound healing time: The time when the wound is completely epithelialized is the wound healing time.

[0057] 1.4 Statistical methods SPSS 25.0 statistical software was used for analysis, and the measurement data were expressed as mean ± standard deviation. If the data are in accordance with the normal distribution, the t test is performed, and if they are not in accordance with the normal distribution, the rank sum test is performed. 2 Test; P < 0.05 indicated that the difference was statistically significant.

[0058] 2 Results:

[0059] 2.1 Comparison of gender between the two groups of patients

[0060] A total of 120 patients were included in this study, including 60 in the study group (29 males and 31 females) and 60 in the control group (31 males and 29 females). (See Table 1)

[0061] Table 1 Comparison of gender between the two groups of patients

[0062]

[0063] Note: The chi-square test was used to compare gender between groups. 2 =0.133, P=0.855>0.05, there was no statistically significant difference in gender between the two groups, and they were comparable.

[0064] 2.2 Comparison of age between the two groups of patients

[0065] Among the 60 cases in the treatment group and 60 cases in the control group included, the age range of the study group was between 19 and 59 years old; the age range of the control group was between 22 and 63 years old (see Table 2 for details).

[0066] Table 2 Comparison of ages of two groups of patients

[0067]

[0068] Note: The ages of the two groups of cases included both met the normal distribution. The independent samples t-test was used between groups. After statistics, t = -1.826, p = 0.07 > 0.05, indicating that there was no statistical significance in the age distribution between the two groups and they were comparable.

[0069] 2.3 Comparison of pain curative effects of two groups of patients

[0070] For the study on the curative effect of wound pain, the wound pain scores of the study group 3 days after surgery were significantly lower than those of the control group (P < 0.05), with statistical significance. There was no obvious statistical difference between the two groups 7 days and 14 days after surgery. (P > 0.05) (see Table 3 for details) Table 3 Comparison of wound pain scores at each time point after surgery between two groups

[0071]

[0072] 2.4 Comparison of wound edema conditions of two groups of patients

[0073] For the study on the curative effect of wound edema, the wound pain scores of the study group 3 days, 7 days, and 14 days after surgery were significantly lower than those of the control group (P < 0.05), with statistical significance. (see Table 4 for details)

[0074] Table 4 Comparison of wound edema scores at each time point after surgery between two groups

[0075]

[0076]

[0077] Note: Since the two groups of data did not conform to the normal distribution, the rank sum test (non-parametric Mann-Whitney test) was used. 2.5 Comparison of wound healing times of two groups of patients

[0078] The wound healing time of the study group was significantly lower than that of the control group (P < 0.05), with statistical significance. (see Table 5 for details)

[0079] Table 5 Comparison of wound healing times of two groups of patients

[0080]

[0081] 3 Conclusion

[0082] The fumigating and washing agent prepared by the present invention can effectively relieve the clinical symptoms of patients after external dissection and internal ligation of mixed hemorrhoids, relieve the anal pain of patients, reduce bleeding, improve granulation growth, promote wound healing, shorten the length of hospital stay, and has definite curative effect.

[0083] The above are only the preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A traditional Chinese medicine fumigation and washing powder for postoperative complications of mixed hemorrhoids, characterized in that, It is composed of raw materials with the following weights: 25-35 g of Bauhinia championii, 25-35 g of Callicarpa nudiflora, 25-35 g of Momordica cochinchinensis, and 25-35 g of leaves of Evodia lepta.

2. The traditional Chinese medicine fumigation powder according to claim 1, characterized in that, It is composed of raw materials with the following weights: 30 g of Bauhinia championii, 30 g of Callicarpa nudiflora, 30 g of Momordica cochinchinensis, and 30 g of leaves of Evodia lepta.

3. The traditional Chinese medicine fumigation powder according to claim 1, wherein, Take the Chinese medicinal herbs of Bauhinia championii, Callicarpa nudiflora, Momordica cochinchinensis, and leaves of Evodia lepta respectively according to the formula, grind them into fine powder together, and then the traditional Chinese medicine fumigation and washing powder can be obtained.

4. The traditional Chinese medicine fumigation and washing powder described in any one of claims 1-2 is used in the preparation of a drug for treating pain and wound edema after mixed hemorrhoid surgery.

5. The traditional Chinese medicine fumigation and washing powder described in any one of claims 1-2 is used in the preparation of a drug for promoting wound healing after surgery for patients with mixed hemorrhoids.

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