Application of traditional Chinese medicine composition in preparation of medicine for treating postoperative wounds

Abstract

The invention provides a traditional Chinese medicine composition and application of a combined composition containing the traditional Chinese medicine composition in preparation of a medicine for treating postoperative wounds. The traditional Chinese medicine composition and the combined composition containing the traditional Chinese medicine composition can be used for treating postoperative wound surfaces, especially low-position simple anal fistula postoperative wound surfaces, and can be used for remarkably relieving postoperative wound surface pain, reducing wound surface secretions and promoting wound surface healing.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to application of a traditional Chinese medicine composition in preparing a medicine for treating postoperative wounds. Background Art

[0002] Anal fistula refers to an abnormal channel formed by the anorectum or anal canal communicating with the skin around the anus. It is formed after surgical incision and drainage of perianal abscesses or spontaneous rupture. It is divided into low-position simple (complex) anal fistula and high-position simple (complex) anal fistula. It usually consists of three parts: primary internal opening, fistula and secondary external opening. Low-position simple anal fistula is the most common in clinical practice. It can occur at any age and is more common in men. Anal fistula cannot heal itself, and repeated swelling, pain and pus discharge affect work and life. Anal fistulas that recur have a tendency to become malignant. At present, surgical treatment is the only means of clinically curing anal fistula. During the operation of low-position simple anal fistula, the external opening, fistula and internal opening are removed together to form a shuttle-shaped radial wound. The wound cannot be sutured after surgery and is open. Factors such as exposure of nerve endings, stimulation by fecal contamination, and discharge of liquefied necrotic tissue can lead to pain and slow healing of the wound after surgery. Summary of the invention

[0003] In order to improve the above technical problems, the present invention provides an application of a traditional Chinese medicine composition in the preparation of a medicine for treating postoperative wounds, wherein the traditional Chinese medicine composition can alleviate postoperative wound pain, reduce wound secretions and promote wound healing.

[0004] The present invention provides an application of a traditional Chinese medicine composition in preparing a medicine for treating postoperative wounds, wherein the traditional Chinese medicine composition comprises the following components:

[0005] Coptis chinensis, Picrorhizoma Catechu, Inkjeta, Borneol, Bear Bile Powder, Artificial Musk, Bezoar and Ox Bile.

[0006] In some embodiments, the postoperative wound includes a hemorrhoid postoperative wound, an anal fissure postoperative wound, or anal fistula postoperative wound; preferably, the postoperative wound is an anal fistula postoperative wound.

[0007] In some embodiments, the wound after anal fistula surgery includes a low-position simple (complex) type anal fistula surgery wound and a high-position simple (complex) type anal fistula surgery wound, preferably a low-position simple anal fistula surgery wound.

[0008] In some embodiments, the wound after anal fistula surgery is a moist heat injection type wound after anal fistula surgery.

[0009] In some embodiments, treating a post-operative wound comprises at least one of the following:

[0010] 1) Relieve postoperative wound pain;

[0011] 2) Reduce wound secretions;

[0012] 3) Promote wound healing.

[0013] In some embodiments, the Chinese medicine composition comprises the following components in parts by weight:

[0014] 50-65 parts of coptis root, 50-65 parts of picrorhizome, 50-65 parts of catechu, 105-125 parts of fragrant ink, 3-4 parts of borneol, 10.2-12 parts of bear bile powder, 2-3.5 parts of artificial musk, 2-3.5 parts of bezoar, and 80-98 parts of ox bile.

[0015] In some embodiments, the Chinese medicine composition comprises the following components in parts by weight:

[0016] 54 parts of coptis root, 54 parts of picrorhizome, 54 parts of catechu, 108 parts of fragrant ink, 3.3 parts of borneol, 10.8 parts of bear gall powder, 2.7 parts of artificial musk, 2.7 parts of bezoar, and 87 parts of ox bile.

[0017] In some embodiments, the preparation method of the traditional Chinese medicine composition is as follows:

[0018] (1) grinding coptis root, catechu and cyperus rotundus into fine powder, then adding bezoar and mixing to obtain a fine powder composition;

[0019] (2) dissolving the bear bile powder in water to obtain a bear bile powder aqueous solution; concentrating and filtering the ox bile to obtain ox bile paste;

[0020] (3) mixing the ox bile paste and bear bile powder aqueous solution in step (2), adding the mixture to the fine powder composition in step (1), mixing and stirring to form granules;

[0021] (4) Grinding borneol and artificial musk, and mixing them with the particles obtained in step (3) to obtain the traditional Chinese medicine composition.

[0022] In some embodiments, the traditional Chinese medicine composition optionally further comprises a pharmaceutically acceptable carrier or excipient.

[0023] In some embodiments, the traditional Chinese medicine composition is prepared as an external medicine.

[0024] In some embodiments, the dosage form of the topical agent is selected from powder, ointment, suppository, solution, liniment or spray.

[0025] In some embodiments, the traditional Chinese medicine composition is Wanying Capsule Granules.

[0026] In some embodiments, the Chinese medicine composition is applied onto a vaseline gauze strip and then placed toward the postoperative wound surface.

[0027] Beneficial Effects

[0028] The present invention provides an application of a Chinese medicine composition in preparing a medicine for treating postoperative wounds. The Chinese medicine composition can treat postoperative wounds, especially treat postoperative wounds of low-position simple anal fistula, and can significantly reduce postoperative wound pain, reduce wound secretions and promote wound healing. DETAILED DESCRIPTION

[0029] The technical scheme of the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the following embodiments are only exemplary descriptions and explanations of the present invention and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are included in the scope that the present invention is intended to protect.

[0030] Unless otherwise specified, the raw materials and reagents used in the following examples are commercially available or can be prepared by known methods.

[0031] The prescription of Wanying Capsule: 54 parts of Coptis chinensis, 54 parts of Picrorhizon, 54 parts of Catechu, 108 parts of Moxiang, 3.3 parts of Borneol, 10.8 parts of Bear Bile Powder, 2.7 parts of Artificial Musk, 2.7 parts of Bezoar, and 87 parts of Ox Bile.

[0032] Example 1

[0033] 1 Materials and methods

[0034] 1.1 General Information and Standards

[0035] A total of 90 patients who underwent surgery for low-position simple anal fistula of damp-heat type from February 2021 to December 2022 were prospectively selected as research subjects and divided into a control group and an observation group using the random number table method, with 45 cases in each group.

[0036] Diagnostic criteria: (Traditional Chinese medicine and Western medicine diagnostic criteria: formulated with reference to the relevant standards of the "Guidelines for the Diagnosis and Treatment of Common Diseases in Anorectal Medicine of Traditional Chinese Medicine" published in 2012)

[0037] 1. TCM diagnostic criteria - symptoms of damp-heat descending anal fistula: Main symptoms: ① red tongue, yellow and greasy fur, slippery and rapid pulse; ② ulcers around the anus, often overflowing with pus, thick pus, white or yellow; ③ obvious local redness, swelling, heat and pain; ④ cord-like objects extending into the anus when pressed. Secondary symptoms: ① poor appetite, heavy body; ② uncomfortable bowel movements, short and dark urine. The damp-heat descending syndrome can be diagnosed if at least one of the above main symptoms ① and main symptoms ②③④ is present, plus any of the secondary symptoms.

[0038] 2. Western medicine diagnostic criteria - low-position simple anal fistula: a chronic, pathological tube between the perianal skin and the anorectum. Clinical manifestations and symptoms: recurrent perianal swelling and pain, pus discharge, and fever during the acute inflammatory period. Local inspection and visual examination can reveal the shape, position and secretions of the external opening. For shallow anal fistulas, cord-like nodules and their course can be felt around the anus. Rectal digital examination can touch the internal opening, depressions and nodules; the anal sphincter function can be roughly assessed. The internal opening is in the anal crypt, and there is only one fistula channel that passes through the subcutaneous or superficial part of the external sphincter and communicates with the skin.

[0039] Inclusion criteria: (1) aged 18 to 65 years, both men and women; (2) patients undergoing anal fistula surgery for the first time, with normal anal appearance and function; (3) patients who met the diagnostic criteria and underwent low anal fistula resection under local anesthesia; (4) patients with postoperative wound area of ​​4 to 16 cm 2 between.

[0040] Exclusion criteria: (1) patients with other anal and perianal diseases, such as anal abscess, other types of anal fistula, and perianal eczema; (2) patients with a history of chronic diarrhea, constipation, or poor blood sugar control, or patients with affected healing after radiotherapy or chemotherapy; (3) patients with a history of severe heart, brain, kidney, or other organ diseases; (4) patients with active infectious diseases; (5) patients with a history of mental illness or alcohol or drug abuse; (6) patients who are pregnant or breastfeeding; (7) patients who are allergic to the medication used.

[0041] Dropout criteria: (1) patients who failed to undergo follow-up examinations on schedule and whose medical records were incomplete; (2) patients who had adverse events during the observation period and needed to be unblinded.

[0042] 1.2 Methods

[0043] Both groups of patients underwent low anal fistula resection under local infiltration anesthesia by physicians with intermediate or higher qualifications. All cases were given intravenous antibiotics for 3 days to prevent infection after surgery. Starting from the first day after surgery, routine dressing changes were performed twice a day. When changing the dressing, the wound and surrounding skin were first cleaned and disinfected with iodine cotton balls. The treatment group was given 2 capsules of Wanying capsule powder, which was evenly applied to the vaseline gauze strip, and the powder was placed on the wound surface. The control group was only given vaseline gauze strips to be placed on the wound surface, and sterile gauze was applied to the wound surface and fixed with adhesive tape. In principle, dressings were changed in the morning and evening, 2 times / day (can be increased if necessary), and the observation period was 21 days. After discharge, patients returned to the hospital for dressing changes every 2-3 days, and unified precautions after discharge were implemented.

[0044] 1.3 Observation indicators

[0045] 1.3.1 General data observation indicators: age, gender, and postoperative wound area of ​​the included cases.

[0046] 1.3.2 Efficacy observation indicators: Evaluate the wound conditions (pain level, wound secretion conditions) before the first dressing change on the 1st, 3rd, 7th, 14th, and 21st days, record the wound area and wound healing rate; calculate the efficacy on the 21st day.

[0047] 1.3.2.1 Pain index: The following criteria are formulated with reference to the VAS score:

[0048] 0 points: (VAS = 0 points) No pain, natural expression.

[0049] 2 points: (0 < VAS ≤ 3 points) Slight pain, no obvious painful expression, no need for treatment.

[0050] 4 points: (3 < VAS ≤ 5 points) Moderate pain, indifferent expression, can be tolerated without drug treatment in the short term.

[0051] 6 points: (5 < VAS ≤ 7 points) Severe pain, painful expression, difficult to tolerate without drug treatment.

[0052] 8 points: (7 < VAS ≤ 10 points) Intense pain, extremely painful expression, need to add drugs such as dolantin and morphine to relieve pain.

[0053] 1.3.2.2 Secretion exudation index: Refer to the relevant clinical research of Liu Qiujiang, Lin Kangquan, Xie Xiangyu, etc. Clinical research on compound berberine sulfate ointment for pain relief and wound healing after anal fissure surgery [J]. China Medicine and Pharmacy, 2015, 5(18): 30 - 33. Combined with the actual situation, the following criteria are formulated based on the number of layers of permeated gauze: (Sterile gauze specification: 7.5*7.5cm - 8P)

[0054] 0 points: The gauze is permeated by exudate ≤ 4 layers.

[0055] 2 points: The gauze is permeated by exudate > 4 layers, but ≤ 8 layers.

[0056] 4 points: The gauze is permeated by exudate > 8 layers, but ≤ 16 layers.

[0057] 6 points: The gauze is permeated by exudate > 16 layers.

[0058] 1.3.2.3 Wound area and wound healing rate: The size of the wound on the day of surgery is the original area; record it after calculation according to the measurement method on the 3rd, 7th, 14th, and 21st days respectively. Before dressing change, let the patient relax fully, gently place the sterile film on it, trace the outline of the wound, and calculate the area using an electrocardiogram grid (1mm) paper. It is stipulated that if it exceeds half a grid, it is calculated as one grid size. The wound healing rate on the nth day (%) = (initial area - wound area on the nth day) / initial area × 100%.

[0059] 1.4 Efficacy judgment criteria

[0060] The overall efficacy evaluation was based on the Traditional Chinese Medicine Industry Standard of the People's Republic of China, "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes", and the efficacy determination criteria were formulated in combination with clinical practice (Wang Hua. Acupuncture [M]. Beijing: Higher Education Press, 2008, 222-256).

[0061] ① Healed: The wound surface is completely covered by epithelial tissue, wound exudate disappears, and pain is completely eliminated;

[0062] ② Significantly effective: The wound area was reduced by 75%, the wound exudate was significantly improved, the pain was basically eliminated, and the patient's symptoms were significantly relieved;

[0063] ③ Improvement: The wound area is reduced by 25%, the wound exudate is improved, the pain is mild, and the symptoms are improved;

[0064] ④ Ineffective: The wound area was reduced by less than 25%, the pain was not significantly relieved, the wound exudate did not change significantly, and the symptoms did not improve significantly.

[0065] Treatment effectiveness = cure rate + marked effectiveness rate + improvement rate.

[0066] 1.5 Statistical analysis

[0067] SPSS 20.0 statistical software was used for statistical analysis, and the quantitative data were The paired t-test was used for the difference between the groups, the single sample t-test was used for the comparison of means, and the X-test was used for the comparison of count data. 2 Value test, when P < 0.05, the difference was statistically significant.

[0068] 2. Results

[0069] According to the inclusion, exclusion and dropout criteria set out in the clinical research plan, a total of 90 cases were collected, and 86 cases were able to enter the final statistical analysis. Among them, 2 cases in the observation group withdrew from the observation, and 2 cases in the control group withdrew from the observation, all because the patients failed to insist on follow-up examinations and dressing changes midway.

[0070] 2.1 Comparison of general data: A total of 86 patients were observed effectively. Before treatment, the two groups of patients were statistically analyzed in terms of gender (chi-square test), age (t test), wound area (t test), etc. There was no significant difference in general data between the two groups (P>0.05), and they were comparable. See Table 1.

[0071] Table 1 Comparison of general information

[0072]

[0073] 2.2 Comparison of clinical efficacy

[0074] Table 2 Comparison of pain scores (x±s, points)

[0075]

[0076]

[0077] The pain scores of the two groups were compared. The difference was not statistically significant on the first and 21st days after surgery. The difference was statistically significant. The analgesic effect of the observation group was significant, especially in the early stage.

[0078] Table 3 Comparison of secretion exudation scores (x±s, points)

[0079]

[0080] Comparison between the two groups showed that there was no statistically significant difference between the two groups on the first day, P>0.05; on the 3rd, 7th, 14th, and 21st days, P<0.001, with significant differences, indicating that the observation group can effectively reduce secretion exudation and facilitate wound healing.

[0081] Table 4 Comparison of wound healing rates between the two groups (x±s, %)

[0082]

[0083] The results showed that the wound healing rate of the observation group was better than that of the control group at all stages (P < 0.05), and it was more obvious in the middle and late stages (P < 0.001).

[0084] Table 5 Comparison of overall efficacy between the two groups

[0085]

[0086] X the number of valid cases in the two groups 2 Test, p < 0.05, the overall therapeutic effect of the observation group was better than that of the control group.

[0087] 3. Discussion

[0088] The above experiment showed that the pain scores of the two groups on the first and 21st day after surgery were P>0.05, with no statistically significant difference; on the 3rd, 7th, and 14th days, P<0.001, with significant differences, which was statistically significant, indicating that Wanying Capsule had a significant analgesic effect, which was more obvious in the early stage. The secretion exudation score was P>0.05 on the first day, with no statistically significant difference; on the 3rd, 7th, 14th, and 21st days, P<0.001, with significant differences, indicating that Wanying Capsule can effectively reduce secretion exudation and facilitate wound healing. The wound healing rate of the Wanying Capsule group was better than that of the control group at all stages (P<0.05), and it was more obvious in the middle and late stages (p<0.001). The total effective rate of the Wanying Capsule group was 97.6%, and the total effective rate of the control group was 83.7%. The overall efficacy of the two groups was compared, and the difference was statistically significant (P<0.05), indicating that the overall efficacy of the treatment group was significantly higher than that of the control group.

[0089] Therefore, the above embodiments show that Wanying Capsule Powder can promote postoperative wound healing in patients with low-position simple anal fistula of damp-heat type, and has a definite effect on improving symptoms such as pain in the middle and late stages and wound secretions.

[0090] The above is a description of the exemplary specific implementation of the present invention. It should be understood that the protection scope of the present invention is not limited to the above exemplary implementation. Any modification, equivalent substitution, improvement, etc. made by those skilled in the art within the spirit and principle of the present invention shall be included in the protection scope of the claims of this application.

Claims

1. Use of a Chinese medicine composition in preparing a medicine for treating postoperative wounds, the Chinese medicine composition comprising the following components: coptis root, picrorhizome, catechu, fragrant ink, borneol, bear bile powder, artificial musk, bezoar and ox bile.

2. The use according to claim 1, characterized in that: The postoperative wound surface includes the postoperative wound surface of hemorrhoids, the postoperative wound surface of anal fissure, and the postoperative wound surface of anal fistula; preferably, the postoperative wound surface of anal fistula; Preferably, the postoperative wound of anal fistula includes the postoperative wound of low-position simple (complex) type anal fistula and the postoperative wound of high-position simple (complex) type anal fistula, preferably the postoperative wound of low-position simple type anal fistula; Preferably, the wound after anal fistula surgery is a moist heat injection type wound after anal fistula surgery.

3. The use according to claim 1 or 2, characterized in that: Treatment of postoperative wounds includes at least one of the following: 1) Relieve postoperative wound pain; 2) Reduce wound secretions; 3) Promote wound healing.

4. The use according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 50-65 parts of coptis root, 50-65 parts of picrorhizome, 50-65 parts of catechu, 105-125 parts of fragrant ink, 3-4 parts of borneol, 10.2-12 parts of bear gall powder, 2-3.5 parts of artificial musk, 2-3.5 parts of bezoar, 80-98 parts of ox bile; Preferably, the Chinese medicine composition comprises the following components in parts by weight: 54 parts of coptis root, 54 parts of picrorhizome, 54 parts of catechu, 108 parts of fragrant ink, 3.3 parts of borneol, 10.8 parts of bear gall powder, 2.7 parts of artificial musk, 2.7 parts of bezoar, and 87 parts of ox bile.

5. The use according to any one of claims 1 to 4, characterized in that: The preparation method of the Chinese medicine composition is as follows: (1) grinding coptis root, catechu and cyperus rotundus into fine powder, then adding bezoar and mixing to obtain a fine powder composition; (2) dissolving the bear bile powder in water to obtain a bear bile powder aqueous solution; concentrating and filtering the ox bile to obtain ox bile paste; (3) mixing the ox bile paste and bear bile powder aqueous solution in step (2), adding the mixture to the fine powder composition in step (1), mixing and stirring to form granules; (4) Grinding borneol and artificial musk, and mixing them with the particles obtained in step (3) to obtain the traditional Chinese medicine composition.

6. The use according to any one of claims 1 to 5, characterized in that: The traditional Chinese medicine composition may also optionally contain a pharmaceutically acceptable carrier or excipient.

7. The use according to any one of claims 1 to 6, characterized in that: The traditional Chinese medicine composition is prepared as an external medicine.

8. The use according to any one of claim 7, characterized in that: The dosage form of the external medicine is selected from powder, ointment, suppository, solution, liniment or spray.

9. The use according to any one of claims 1 to 8, characterized in that: The Chinese medicine composition is Wanying capsule granules.

10. The use according to any one of claims 1 to 9, characterized in that: Apply the Chinese medicine composition behind the vaseline gauze and place it toward the postoperative wound surface.

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