Traditional Chinese medicine composition for treating acute anal fissure and preparation method and application thereof

Abstract

The invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating acute anal fissure and a preparation method and application thereof, and the traditional Chinese medicine composition is composed of calcined gypsum, dragon's blood, frankincense and borneol. The traditional Chinese medicine composition treats blood-heat and intestine-dryness type acute anal fissure according to the treatment principle of clearing heat and stopping bleeding, promoting blood circulation to remove blood stasis and astringing and promoting tissue regeneration, can effectively improve anal fissure symptoms of patients, including anus pain degree, anus pain duration after defecation, hemafecia and constipation symptoms, and can improve various traditional Chinese medicine clinical symptoms of blood-heat and intestine-dryness type acute anal fissure of patients. The number of wound healing examples is increased, and good safety and long-term prognosis are achieved. The external medicinal preparation is wide in raw material source, relatively simple in preparation process, relatively low in cost, convenient to use and easy to popularize and apply.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating acute anal fissure, and a preparation method and application thereof. Background Art

[0002] Anal fissure is a common and frequently occurring disease in anorectal medicine. Statistics show that the incidence of anal fissure is approximately 16.1% of anorectal diseases, and the male incidence rate is approximately 1:1.6 compared to the female incidence rate. The anatomical manifestation of anal fissure is a full-thickness longitudinal fissure of the anal mucosa below the dentate line, about 0.5-1.0 cm long, accompanied by periodic severe pain during defecation, and its healing process is relatively difficult. Anal fissures often occur in the posterior midline of the anal canal, and may also appear in the anterior midline or lateral position of the anal canal, but lateral anal fissures are relatively rare. The main clinical manifestation of anal fissure is tearing-like severe pain during defecation, which is usually relieved after defecation, and is often accompanied by blood in the stool. The essence of anal fissure is an ischemic ulcer, that is, anal fissure is caused by spasm of the internal anal sphincter and insufficient blood supply to the anal canal. The pathogenesis of this disease is still unclear. Modern medicine believes that the formation of anal fissure is due to the interaction of multiple factors, including damage to the posterior wall structure of the anal canal, changes in the local biochemical environment of the anal canal, decreased skin elasticity, insufficient blood supply, and internal sphincter spasm leading to increased anal canal pressure.

[0003] Current treatments for anal fissures include primary care, medication, and surgery. The American Society of Colon and Rectal Surgeons' clinical practice guidelines state that primary care is highly safe, has few side effects, and should be the first choice for all types of anal fissures. Primary care includes lifestyle adjustments, stool softening medications, and warm sitz baths. Medical treatments for anal fissures aim to reduce spasm of the internal anal sphincter and primarily include the nitric oxide donor nitroglycerin and calcium channel blockers, as well as local injections of botulinum toxin. Medical treatment aims to reduce spasm of the internal anal sphincter and provides an option for patients who decline surgical treatment. Common surgical treatments for anal fissures include anal dilation, fissure resection, and internal sphincterotomy. Surgery is the ultimate treatment option for anal fissures and is often used to treat chronic anal fissures that persist after acute fissures have persisted for a long time. Unlike other treatments, surgical treatment can have a greater impact on the anus, potentially leading to anal paresthesia, difficulty defecating, or anal incontinence, seriously impacting the patient's quality of life. These effects will not only cause trouble to patients' daily lives, but may also affect their mental health and social interactions. Therefore, these potential complications and their long-term effects on patients need to be fully considered during surgical treatment.

[0004] In the drug treatment of anal fissure, nitroglycerin ointment is the recommended medication for anal fissure in the "Chinese Expert Consensus on Clinical Diagnosis and Treatment of Anal Fissure (2021 Edition)". Nitroglycerin is a nitric oxide donor that can effectively relieve pain caused by sphincter spasms and help promote the healing process. Studies have shown that nitric oxide acts as an inhibitory neurotransmitter of the internal anal sphincter, and is lipophilic and easier to enter the cell, thereby causing the corresponding vascular smooth muscle to relax, thereby relaxing the anal sphincter. However, the use of nitroglycerin ointment may lead to a variety of complications, such as headaches, decreased blood pressure when standing upright, difficulty passing gas, and a burning sensation in the anus. Among them, headaches have the highest incidence rate, which can be as high as more than 20%.

[0005] In the "Chinese Expert Consensus on Clinical Diagnosis and Treatment of Anal Fissure (2021 Edition)", traditional Chinese medicine treatment is strongly recommended for the treatment of anal fissure because of its ability to improve the local symptoms of anal fissure and promote the healing of the fissure. Therefore, we selected the traditional Chinese medicine ointment Qingru Shengji Cream to treat acute anal fissure of blood-heat and intestinal dryness, which effectively improved the patient's anal fissure symptoms, including the degree of anal pain, the duration of anal pain after defecation, blood in stool, and constipation symptoms, improved the clinical symptoms of TCM of acute anal fissure of blood-heat and intestinal dryness in patients, increased the number of wound healing cases, and reduced the occurrence of complications. Summary of the Invention

[0006] The present invention aims to provide a traditional Chinese medicine composition, preparation method, and application thereof for treating acute anal fissures. Through a rational combination of traditional Chinese medicine ingredients and a suitable preparation process, an externally applied ointment (hereinafter referred to as Qingru Shengji Ointment) is formulated. The ointment acts directly on the affected area, exerting the effects of clearing heat and stopping bleeding, promoting blood circulation and removing blood stasis, and astringing and promoting tissue regeneration.

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for treating acute anal fissure, which is composed of the following raw materials in parts by weight: 20-40 parts of calcined gypsum, 15-20 parts of dragon's blood, 15-20 parts of frankincense, and 1-5 parts of borneol.

[0008] Furthermore, the Chinese medicine composition for treating acute anal fissure is composed of the following raw materials in parts by weight: 30 parts of calcined gypsum, 18 parts of dragon's blood, 18 parts of frankincense, and 3 parts of borneol.

[0009] The second aspect of the present invention provides an external-use pharmaceutical preparation with the above-mentioned traditional Chinese medicine composition for treating acute anal fissure as an active ingredient. The external-use pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

[0010] Furthermore, the external pharmaceutical preparation is an ointment.

[0011] Furthermore, the ointment is prepared by the following method:

[0012] (A) weighing the medicinal material components, mixing them, and obtaining a mixture as a raw material;

[0013] (B) Adding pharmaceutically acceptable excipients to the mixture and preparing a common external ointment according to conventional preparation methods in the art.

[0014] Furthermore, the ointment is composed of calcined gypsum, dragon's blood, frankincense, and borneol in proportion, supplemented with medical vaseline as a matrix. Preferably, the calcined gypsum, dragon's blood, frankincense, and borneol are mixed in a mass ratio of 10:6:6:1 in the ointment, and the mass ratio of the drug powder to the medical vaseline after the ointment is formed is 1:3.

[0015] Furthermore, the preparation method of the ointment comprises the following steps:

[0016] (a) Raw material processing: Calcined gypsum, dragon's blood, frankincense, and borneol were finely ground in a pulverizer to a particle size of ≤150 μm to produce sterile fine powder that meets pharmacopoeial standards; the powder dryness was controlled at a relative humidity of ≤10%;

[0017] (b) Composition: Weigh the fine powder of medicinal materials according to the prescribed ratio, mix and stir evenly;

[0018] (c) Melting the ointment base: Heat medical-grade yellow vaseline in a water bath at 60-70°C until completely melted; continue stirring and maintain constant temperature.

[0019] (d) Paste preparation: Slowly add the premixed powder to the molten matrix in portions at a drug powder: matrix mass ratio of 1:3 while stirring to ensure uniform dispersion. Continue stirring for at least 15 minutes until a homogeneous, fine mixture is formed.

[0020] (e) Filling and sealing: Pour the paste into the sterilized medicine box while it is still warm, and seal it after it cools and solidifies.

[0021] Furthermore, the method of using the ointment is as follows: for external use, apply an appropriate amount of ointment to the affected area.

[0022] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating acute anal fissure.

[0023] A fourth aspect of the present invention provides a use of the external-use pharmaceutical preparation described above in the preparation of a drug for treating acute anal fissure.

[0024] Furthermore, the acute anal fissure is an acute anal fissure of the blood-heat and intestinal dryness type.

[0025] Chinese medicine composition of the present invention is based on heat-clearing and hemostasis-stopping, blood circulation-activating and stasis-removing, astringing and granulation-promoting as treatment principles. In the prescription, calcined gypsum, which is sweet, pungent and extremely cold, enters the lung and stomach meridians, is used externally to astringe and granulation-promoting, clear away heat and stop bleeding, can promote wound healing, reduce exudation, clear local heat toxins, and alleviate wound redness, swelling, heat and pain, and is the monarch drug. Dragon's blood, which is sweet, salty and flat, enters the heart and liver meridians, is mainly used to activate blood circulation and relieve pain, remove blood stasis and stop bleeding, to improve local blood stasis pain, relieve pain without leaving stasis; frankincense, which is pungent, bitter and warm, enters the heart, liver and spleen meridians, is mainly used to activate blood circulation and stop pain, and cooperates with Dragon's blood to enhance analgesic effect, can also reduce swelling and promote granulation, and assists calcined gypsum to promote wound repair. Both are blood circulation-activating and stasis-removing drugs, Dragon's blood is partial to hemostasis, while frankincense is partial to promoting the circulation of qi, and the two are astringent and dispersing drugs, which both prevent calcined gypsum from astringing too much and causing blood stasis, and strengthen local qi and blood circulation, and promote healing. The two herbs work together to promote blood circulation, dissipate blood stasis, promote qi flow, and relieve pain, serving as both adjuvants. Borneol, pungent, bitter, and slightly cold, enters the heart, spleen, and lung meridians. It clears heat, relieves pain, and promotes tissue regeneration, relieving the burning pain of anal fissures, inhibiting wound infection, and aiding in tissue regeneration. Its pungent and aromatic properties penetrate the skin, guiding the meridians, increasing absorption and aiding drug penetration into the perianal tissues. While used in small doses, it plays a crucial supporting role, embodying the principle of "small but effective," serving as an adjuvant.

[0026] The compatibility characteristics of the Chinese medicine composition of the present invention are:

[0027] 1) Use both cold and warm properties: Calcined gypsum is very cold, while frankincense is slightly warm. This prevents excessive coldness from stagnating Qi and blood, while also preventing warmness and dryness from aggravating local heat toxins.

[0028] 2) Combination of movement and stillness: Calcined gypsum is astringent, while Sanguisorba officinalis and frankincense activate blood circulation, achieving the goal of "stopping bleeding without leaving blood stasis, and removing blood stasis without damaging the body."

[0029] The advantages of the present invention are:

[0030] 1. The Chinese medicine composition of the present invention takes clearing away heat and stopping bleeding, promoting blood circulation and removing blood stasis, and astringing and promoting tissue regeneration as the treatment principles. It directly covers the wound surface by external application. The medicinal ingredients can effectively penetrate into the lesion and form a protective layer to reduce external stimulation and promote repair. It is effective in treating acute anal fissures of the blood-heat and intestinal dryness type, and its efficacy is not inferior to nitroglycerin ointment, and it has good safety and long-term prognosis.

[0031] 2. The Chinese medicine composition of the present invention can treat acute anal fissure of blood-heat and intestinal dryness type, and can effectively improve the patient's anal fissure symptoms, including the degree of anal pain, the duration of anal pain after defecation, blood in stool, and constipation symptoms, and improve the clinical symptoms of acute anal fissure of blood-heat and intestinal dryness type in patients with traditional Chinese medicine, increase the number of wound healing cases, and reduce the occurrence of complications.

[0032] 3. The Chinese medicine composition of the present invention has multiple active chemical components, which play a therapeutic effect on anal fissures and shorten the healing period through biological processes such as response to exogenous stimuli, negative regulation of apoptosis process, signal transduction, and molecular functions such as binding to proteins, binding to the same proteins, and binding to metal ions.

[0033] 4. The raw materials of the Chinese medicine ointment of the present invention are widely available, the preparation process is relatively simple, the cost is low, it is easy to use, and it is easy to promote and apply. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 . Comparison of anal pain levels between the two groups and within the same group before and after treatment.

[0035] Figure 2 Comparison of the duration scores of anal pain after defecation between the two groups and within the same group before and after treatment.

[0036] Figure 3 . Comparison of bloody stool scores between the two groups and within the group before and after treatment.

[0037] Figure 4 Comparison of constipation symptom scores between the two groups and within the group before and after treatment.

[0038] Figure 5 . Comparison of TCM syndrome scores between the two groups and within the group before and after treatment.

[0039] Figure 6 . Number of wound healing cases in the two groups. DETAILED DESCRIPTION

[0040] The specific implementation methods provided by the present invention are described in detail below with reference to the examples.

[0041] The experimental methods in the following examples, where specific conditions are not specified, are generally carried out under conventional conditions or the conditions recommended by the manufacturers. Unless otherwise specified, the medicinal materials used in the examples of the present invention can be obtained from Chinese medicinal material sales companies.

[0042] Example 1: Chinese medicine composition of the present invention

[0043] 20 parts of calcined gypsum, 15 parts of dragon's blood, 15 parts of frankincense, and 1 part of borneol.

[0044] Example 2: Chinese medicine composition of the present invention

[0045] 25 parts of calcined gypsum, 16 parts of dragon's blood, 16 parts of frankincense, and 2 parts of borneol.

[0046] Example 3: Chinese medicine composition of the present invention

[0047] 30 parts of calcined gypsum, 18 parts of dragon's blood, 18 parts of frankincense, and 3 parts of borneol.

[0048] Example 4: Chinese medicine composition of the present invention

[0049] 35 parts of calcined gypsum, 19 parts of dragon's blood, 19 parts of frankincense, and 4 parts of borneol.

[0050] Example 5: Chinese medicine composition of the present invention

[0051] 40 parts of calcined gypsum, 20 parts of dragon's blood, 20 parts of frankincense, and 5 parts of borneol.

[0052] Example 6: Preparation method of the ointment of the present invention

[0053] 1) Prescription composition

[0054] The ointment is composed of the following traditional Chinese medicine ingredients: calcined gypsum, dragon's blood, frankincense, and borneol, supplemented with medical vaseline as a base. The prescription traditional Chinese medicine ingredients are mixed in a mass ratio of 10:6:6:1, and the mass ratio of the powder to vaseline after the ointment is 1:3.

[0055] 2) Preparation process

[0056] a. Raw material processing: Calcined gypsum, dragon's blood, frankincense, and borneol are finely ground in a pulverizer and sieved using a 100-mesh standard sieve to ensure a particle size of ≤150μm to produce sterile fine powder that meets pharmacopoeial standards. The powder dryness is controlled at a relative humidity of ≤10%.

[0057] b. Composition of components: Weigh the fine powder of medicinal materials according to the prescription ratio, mix them in a clean container, and stir evenly to ensure uniform distribution of the powder.

[0058] Melt the ointment base: Heat medical-grade yellow vaseline in a constant-temperature water bath (60-70°C) until completely melted. Stir continuously and maintain a constant temperature.

[0059] d. Paste Preparation: Slowly add the premixed powder to the molten matrix in portions at a powder: matrix ratio of 1:3 while stirring to ensure uniform dispersion. Continue stirring for at least 15 minutes until a homogeneous, smooth mixture is formed.

[0060] eFilling and sealing: Pour the paste into the sterilized medicine box while it is still warm. After cooling and solidification, seal it tightly. Attach a label to indicate the batch number, preparation date, expiration date, etc.

[0061] 3) Quality control standards

[0062]

[0063] Example 7: Clinical trial of the ointment of the present invention (light milk-generating muscle ointment)

[0064] 1. Methods:

[0065] The results of multiple studies have found that nitroglycerin ointment can effectively reduce patients' visual analogue scale (VAS) scores, blood in stool scores, anal ulcer scores, and anal canal resting pressure, and improve the healing rate of anal fissures in patients. Therefore, a non-inferiority randomized controlled study was established with nitroglycerin ointment as the control group to evaluate the efficacy and safety of the ointment of the present invention (light milk progenitor cream) in the treatment of acute anal fissures. 98 patients with acute anal fissures of the blood-heat and intestinal dryness type who were admitted to the outpatient clinic of the Anorectal Department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from December 23, 2022 to February 15, 2024 were selected as the subjects of this study. These patients were divided into two groups using a random number table method, namely, the control group and the treatment group, with 49 patients in each group.

[0066] The control group received nitroglycerin ointment, while the treatment group received Qingru Shengji ointment (calcined gypsum, dragon's blood, frankincense, and borneol, prepared using the ratio and preparation method of Example 7). For external use, apply an appropriate amount of the ointment to the affected area. Both groups were treated for 2 weeks. Anal fissure symptoms were observed in both groups before treatment and on days 7 and 14 after treatment. Scores were compared for anal pain intensity, duration of anal pain after defecation, blood in stool, and constipation. Traditional Chinese Medicine (TCM) syndrome scores were also compared between the two groups before and after treatment. Wound healing, adverse events, and long-term follow-up were recorded.

[0067] 2. Results:

[0068] 1) General information: The two groups were comparable in terms of gender, age, height, weight, and BMI (P>0.05).

[0069] Table 1 Comparison of general information between the control group and the treatment group

[0070]

[0071] 2) Data Analysis: A non-inferiority test was conducted on the primary outcome measure (reduction in anal fissure symptom score compared to baseline after 14 days of treatment). Statistical analysis was performed on the severity of anal pain, duration of anal pain after defecation, blood in stool, constipation symptoms, and Traditional Chinese Medicine (TCM) syndrome scores.

[0072] I. Primary efficacy outcome measure: reduction in anal fissure symptom score compared to baseline after 14 days of treatment

[0073] The reduction in anal fissure symptom scores compared to baseline after 14 days of treatment conformed to a normal distribution. Hypothesis testing and confidence interval methods were used to verify the results of the non-inferiority test. The primary efficacy endpoint showed that the treatment group was non-inferior to the control group (P < 0.05). The treatment group was superior to the control group in improving the duration of anal pain after defecation, blood in stool, and TCM syndrome score in patients with acute anal fissures of the blood-heat and intestinal dryness type (P < 0.05). The control group was superior to the treatment group in alleviating the severity of anal pain in patients with acute anal fissures of the blood-heat and intestinal dryness type (P > 0.05).

[0074] Table 2 Comparison of the reduction of anal fissure symptom scores between the two groups after 14 days of treatment

[0075]

[0076] II. Anal pain score

[0077] Pre-treatment anal pain scores in both groups were significantly higher than those in the control group (P > 0.05), indicating that the pre-treatment anal pain scores in the two groups were comparable. Within-group comparisons revealed a downward trend in anal pain scores on days 7 and 14 in both groups (P < 0.05). Anal pain scores also decreased compared to day 7 in both groups (P < 0.05). Inter-group comparisons revealed a more significant decrease in VAS scores in the control group on days 7 and 14, but the difference was not statistically significant (P > 0.05).

[0078] Table 3 Comparison of anal pain between the two groups and within the same group before and after treatment

[0079]

[0080] Note: a P represents P<0.05 compared with the baseline value. b P represents P<0.05 compared with the seventh day.

[0081] III. Post-defecation anal pain duration score

[0082] The two groups were comparable in terms of post-treatment anal pain duration scores (P>0.05). Intra-group comparisons showed a significant decrease in post-treatment anal pain duration scores on both days 7 and 14 of treatment in both groups compared with pre-treatment scores (P<0.05). Compared with day 7, post-treatment anal pain duration scores also decreased significantly in both groups (P<0.05). Inter-group comparisons showed a greater decrease in post-treatment anal pain duration scores in the treatment group on both days 7 and 14 of treatment. The difference was not statistically significant on day 7 (P>0.05), but was statistically significant on day 14 (P<0.05).

[0083] Table 4 Comparison of the duration scores of anal pain after defecation between the two groups and within the same group before and after treatment

[0084]

[0085] Note: a P represents P<0.05 compared with the baseline value. b P represents P<0.05 compared with the seventh day.

[0086] IV. Blood in stool score

[0087] The two groups were comparable in terms of hematochezia scores before treatment (P>0.05). Within-group comparisons revealed a significant downward trend in hematochezia scores in both groups on days 7 and 14 after treatment (P<0.05), indicating that treatment was effective in alleviating hematochezia symptoms. Hematochezia scores also decreased in both groups compared to day 7 (P<0.05). Inter-group comparisons revealed a more rapid decrease in hematochezia scores in the treatment group on days 7 and 14 (P<0.05).

[0088] Table 5 Comparison of bloody stool scores between the two groups and within the same group before and after treatment

[0089]

[0090] Note: a P represents P<0.05 compared with the baseline value. b P represents P<0.05 compared with the seventh day.

[0091] V. Constipation symptom score

[0092] Comparison of constipation symptom scores before treatment between the two groups revealed no statistically significant difference (P>0.05), indicating that the two groups were comparable in terms of pre-treatment constipation symptoms (P>0.05). Intra-group comparisons revealed that constipation symptom scores decreased in both groups on days 7 and 14 of treatment compared with pre-treatment (P<0.05); compared with day 7, constipation symptom scores also decreased in both groups (P<0.05). Inter-group comparisons revealed that constipation symptom scores decreased more in the treatment group on days 7 and 14 of treatment, but the difference was not statistically significant (P>0.05).

[0093] Table 6 Comparison of constipation symptom scores between the two groups and within the same group before and after treatment

[0094]

[0095] Note: a P represents P<0.05 compared with the baseline value. b P represents P<0.05 compared with the seventh day.

[0096] VI. Traditional Chinese Medicine Syndrome Scoring

[0097] Comparison of TCM syndrome scores before treatment between the two groups was comparable (P>0.05). At 14 days of treatment, both groups showed a significant decrease compared to pre-treatment scores (P<0.05). The decrease in the treatment group was more significant than that in the control group (P<0.05), confirming that the intervention effect was more pronounced in the treatment group.

[0098] Table 7 Comparison of TCM syndrome scores between the two groups and within the group before and after treatment

[0099]

[0100] VII. Number of wound healing cases

[0101] Comparing the number of wound healing cases in the two groups, 32 cases were healed in the treatment group and 29 cases were healed in the control group after 2 weeks of treatment; after 4 weeks of medication, 41 cases were healed in the treatment group and 36 cases were healed in the control group. The number of healed cases in the treatment group was greater than that in the control group.

[0102] Table 8 Number of wound healing cases in the two groups (cases, n)

[0103]

[0104] VIII. Comparison of Efficacy

[0105] The effective rate of the control group was 93.9%, and that of the treatment group was 95.9%, with no statistical significance (P>0.05).

[0106] Table 9 Comparison of effective rates between the two groups after treatment

[0107]

[0108] IX. Adverse Events

[0109] Two patients in the treatment group experienced pruritus, for an adverse event rate of 4.1%. Seven patients in the treatment group experienced headache, one experienced dizziness, two experienced anal burning sensation, and two experienced eye pain, for an adverse event rate of 24.5%. The adverse event rate in the control group was significantly higher than in the treatment group (all events were mild and self-limited, with no cases requiring special medical intervention, and no serious adverse events occurred).

[0110] Table 10 Comparison of adverse events between the two groups (cases, n)

[0111]

[0112] X. Recurrence rate

[0113] The results showed that there were 7 relapses in the control group, with a relapse rate of 19.44%; there were 2 relapses in the treatment group, with a relapse rate of 4.88%. The relapse rate in the treatment group was significantly lower than that in the control group (P < 0.05).

[0114] Table 11 Comparison of recurrence rates in the two groups of patients 3 months after the end of medication

[0115]

[0116] 3) Inter-group comparison results: In terms of the primary efficacy indicator - the reduction in anal fissure symptom score compared with baseline after 14 days of treatment, the treatment group was non-inferior to the control group (P < 0.05). In terms of improving the duration of anal pain after defecation, blood in stool, and TCM syndrome score in patients with acute anal fissure due to blood-heat and intestinal dryness, the treatment group was superior to the control group (P < 0.05). In terms of relieving the degree of anal pain in patients with acute anal fissure due to blood-heat and intestinal dryness, the control group was superior to the treatment group (P > 0.05).

[0117] 4) Intra-group comparison results: There were statistically significant differences between the two groups in the improvement of anal pain intensity, duration of anal pain after defecation, blood in stool, constipation symptoms, and TCM syndrome scores before and after treatment (P < 0.05).

[0118] 5) During the treatment period, the incidence of adverse events in the treatment group was 4.1%, and the incidence of adverse events in the control group was 24.5%. During the follow-up three months after the end of medication, the recurrence rate in the treatment group was 4.88%, and the recurrence rate in the control group was 19.44%.

[0119] 3. Conclusion

[0120] 1) Qingru Shengji ointment is not inferior to nitroglycerin ointment in the treatment of acute anal fissure of blood-heat and intestinal dryness type, and has good safety and long-term prognosis.

[0121] 2) Qingru Shengji ointment can effectively improve the symptoms of anal fissures in patients with blood-heat and intestinal dryness, including the degree of anal pain, the duration of anal pain after defecation, blood in stool, and constipation. It can also improve the clinical symptoms of acute anal fissures in patients with blood-heat and intestinal dryness, and increase the number of wound healing cases.

[0122] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art may make various equivalent modifications or substitutions without departing from the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating acute anal fissure, characterized in that: The invention is composed of the following raw materials in parts by weight: 20-40 parts of calcined gypsum, 15-20 parts of dragon's blood, 15-20 parts of frankincense and 1-5 parts of borneol.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is composed of the following raw materials in parts by weight: 30 parts of calcined gypsum, 18 parts of dragon's blood, 18 parts of frankincense and 3 parts of borneol.

3. An external-use pharmaceutical preparation comprising the Chinese medicine composition for treating acute anal fissure as claimed in claim 1 or 2 as an active ingredient, characterized in that: The external-use pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

4. The external-use pharmaceutical preparation according to claim 3, characterized in that The external pharmaceutical preparation is an ointment.

5. The external-use pharmaceutical preparation according to claim 4, characterized in that The ointment is prepared by the following method: (A) weighing the medicinal material components, mixing them, and obtaining a mixture as a raw material; (B) Adding pharmaceutically acceptable excipients to the mixture and preparing a common external ointment according to conventional preparation methods in the art.

6. The external-use pharmaceutical preparation according to claim 5, characterized in that The preparation method of the ointment comprises the following steps: (a) Raw material processing: Calcined gypsum, dragon's blood, frankincense, and borneol were finely ground in a pulverizer to a particle size of ≤150 μm to produce sterile fine powder that meets pharmacopoeial standards; the powder dryness was controlled at a relative humidity of ≤10%; (b) Composition: Weigh the fine powder of medicinal materials according to the prescribed ratio, mix and stir evenly; (c) Melting the ointment base: Heat medical-grade yellow vaseline in a water bath at 60-70°C until completely melted; continue stirring and maintain constant temperature. (d) Paste Preparation: Slowly add the premixed powder to the molten matrix in portions, with stirring, at a drug powder:matrix mass ratio of 1:3, ensuring uniform dispersion. Continue stirring for at least 15 minutes until a homogeneous, smooth mixture is formed. (e) Filling and sealing: Pour the paste into the sterilized medicine box while it is still warm, and seal it after it cools and solidifies.

7. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating acute anal fissure.

8. Use according to claim 7, characterized in that The acute anal fissure is a blood-heat and intestinal dryness type acute anal fissure.

9. Use of the external-use pharmaceutical preparation according to any one of claims 3 to 6 in the preparation of a medicament for treating acute anal fissure.

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