A perianal care topical herbal ointment composition and method of making same

Abstract

The present application belongs to the technical field of external use of traditional Chinese medicine ointment, in particular to a perianal nursing external use of herbal ointment composition and a preparation method thereof. The perianal nursing external use of herbal ointment composition is composed of only seven medicinal materials, which can achieve multiple effects of clearing heat and drying dampness, converging and resolving nodules, reducing swelling and relieving itching. The specific combination of wood roe resolving nodules and reducing swelling, and borneol clearing heat and relieving pain, and promoting the transdermal absorption of other drug components is the key in the prescription, and the combination of the two produces an unexpected synergistic effect. Superfine crushing significantly reduces the particle size of the medicinal materials, greatly increases the specific surface area of the effective components, is beneficial to the release of the effective components from the matrix and the penetration of the skin cuticle, and at the same time, the ointment is delicate and has high comfort in use. Low-temperature feeding can effectively avoid the loss of borneol due to high temperature volatilization, ensure the stability of borneol content in the finished product, and ensure the cooling and penetration effect. The ointment does not contain hormones, antibiotics and other components, only contains natural herbal medicinal materials and petrolatum matrix, has no obvious irritation, and can be used for a long time.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external ointment technology, specifically relating to a herbal ointment composition for perianal care and its preparation method. Background Technology

[0002] Perianal congestion, swelling, itching, and a feeling of heaviness are common local discomforts. Prolonged sitting, spicy food, irregular bowel movements, and postpartum recovery can all lead to poor blood circulation, tissue exudation, and sensitive, itchy skin in the perianal area. Several perianal diseases can also cause these symptoms. Specifically, common causes include: hemorrhoids causing venous congestion and dilation, leading to swelling and a feeling of heaviness, with the prolapsed tissue irritating the skin and causing itching; perianal eczema causing itching, with scratching resulting in redness, oozing, and swelling; anal gland infection causing local inflammation, manifesting as persistent heaviness, dull pain, redness, swelling, itching, and a feeling of incomplete bowel movement; and perianal abscess causing congestion, swelling, and a feeling of heaviness and pain, all of which can inconvenience daily life.

[0003] Most commercially available topical anal preparations currently on the market are formulated with a single antibacterial ingredient, focusing on cleansing and inhibiting bacteria, but with limited effects in dispersing nodules and astringing, and little improvement on discomfort symptoms such as anal distension and swelling. Furthermore, some conventional formulas often contain hormones or antibiotics, posing certain safety risks with long-term use. Summary of the Invention

[0004] The present invention aims to provide a topical herbal ointment composition for perianal care and its preparation method. This topical herbal ointment composition for perianal care improves the problems of swelling, itching, and discomfort in the perianal area through a specific combination of medicinal materials and a refined preparation process.

[0005] Currently, there is a lack of herbal ointments for perianal care that are simple in formulation, have controllable processing, and stable efficacy, making it difficult to meet the needs of daily, long-term perianal care. In traditional Chinese medicine formulas, herbs such as Sophora flavescens, Dictamnus dasycarpus, Portulaca oleracea, Galla chinensis, and Sanguisorba officinalis have effects such as clearing heat and drying dampness, relieving itching, astringing, and stopping bleeding. However, existing formulas are mostly complex, with numerous ingredients, making quality control difficult. Furthermore, they lack the specific combination of Momordica cochinchinensis (for dispersing nodules and reducing swelling) and Galla chinensis (for astringing and consolidating), failing to fully utilize the synergistic effects between the herbs. Some herbal ointments also suffer from large particle sizes, making it difficult for active ingredients to penetrate the stratum corneum and resulting in a grainy texture and poor user comfort. Therefore, it is necessary to develop a well-formulated, stable, safe, and comfortable herbal ointment for perianal care.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A topical herbal ointment composition for perianal care is provided, comprising the following ingredients by weight: 18-22 parts of Sophora flavescens, 13-17 parts of Dictamnus dasycarpus, 13-17 parts of Portulaca oleracea, 8-12 parts of Galla chinensis, 8-12 parts of Momordica cochinchinensis, 13-17 parts of Sanguisorba officinalis, 13-17 parts of Borneol, and petrolatum to bring the total to 1000 parts.

[0007] Preferably, the weight parts of each raw material are: 20 parts Sophora flavescens, 15 parts Dictamnus dasycarpus, 15 parts Portulaca oleracea, 10 parts Gallnut, 10 parts Momordica cochinchinensis, 15 parts Sanguisorba officinalis, 15 parts Borneol, and Vaseline to make up to 1000 parts.

[0008] The preparation method of the perianal care topical herbal ointment composition includes the following steps: (1) Take Sophora flavescens, Dictamnus dasycarpus, Portulaca oleracea, Galla chinensis, Momordica cochinchinensis and Sanguisorba officinalis, clean them separately and mix them together, pulverize them and pass them through a 200-400 mesh sieve, preferably through a 300 mesh sieve, to obtain ultrafine medicinal powder; (2) Heat the petroleum jelly until it is completely melted, cool it to a temperature not exceeding 50°C, preferably 40-50°C, add borneol and stir until completely dissolved; (3) Add the above ultrafine powder into the petrolatum system, stir and mix thoroughly at a stirring rate of 30-60 rpm for 20-40 minutes, and cool naturally to room temperature to obtain the external ointment.

[0009] This topical herbal ointment composition for perianal care is for external application to the perianal area only and should not be taken internally.

[0010] The formulation mechanism of this perianal care herbal ointment is as follows: Sophora flavescens: bitter and cold in nature, it has the functions of clearing heat and drying dampness, killing parasites and promoting diuresis. External application can inhibit harmful microorganisms on the perianal surface and alleviate itching and discomfort caused by local damp-heat accumulation; Dictamnus dasycarpus: bitter and cold in nature, it has the functions of clearing heat and drying dampness, dispelling wind and detoxifying, and can soothe perianal skin itching and reduce local irritation; Purslane: sour and cold in nature, it has the functions of clearing heat and detoxifying, cooling blood and stopping bleeding, and can reduce local inflammatory stress and tissue exudation; Gallnut: sour and astringent and cold in nature, it has the functions of astringing the lungs and reducing fire, astringing the intestines and stopping diarrhea, astringing sweat and stopping bleeding, and astringing dampness and healing sores. It is rich in tannins and has a good astringent effect, which can reduce perianal tissue exudation and promote... Local swelling reduction; Sanguisorba officinalis: bitter, sour, and slightly cold in nature, it has the functions of cooling blood and stopping bleeding, detoxifying and astringing sores, and can improve perianal subcutaneous bleeding and mucosal congestion; Momordica cochinchinensis: bitter, slightly sweet, and cool in nature, it has the functions of dispersing nodules and reducing swelling, attacking toxins and healing sores, and is the key medicine in the formula for dispersing nodules and reducing swelling, and can relieve local swelling and heaviness in the perianal area; Borneol: bitter, pungent, and slightly cold in nature, it has the functions of opening the orifices and refreshing the mind, clearing heat and relieving pain. External application can promote the transdermal absorption of other drug components, improve the overall onset speed, and bring a cooling and comfortable feeling; Vaseline: as an ointment base, it has the characteristics of strong occlusiveness, good moisturizing properties, and stable chemical properties. It can form a protective film on the surface of the perianal skin, reduce external irritation, and promote the release and absorption of drug components.

[0011] The formula uses Sophora flavescens and Dictamnus dasycarpus as its base for clearing heat, drying dampness, and relieving itching; Portulaca oleracea and Sanguisorba officinalis cool the blood, detoxify, and improve local congestion; Galla chinensis astringes and consolidates, reducing exudation; Momordica cochinchinensis disperses nodules, reduces swelling, and relieves a feeling of heaviness; Borneol clears heat, relieves pain, and promotes penetration; and Vaseline matrix moisturizes, seals, and protects the wound. The seven herbs work synergistically to clear heat, dry dampness, astringe, disperse nodules, reduce swelling, and relieve itching, resulting in an overall effect superior to using any single herb alone.

[0012] Compared with existing technologies, the beneficial effects of this invention are as follows: The herbal ointment composition for perianal care is concise and reasonable, with significant synergistic effects. Using only seven medicinal herbs, it achieves multiple effects such as clearing heat and drying dampness, astringing and dispersing nodules, reducing swelling and relieving itching. The key to the formula is the specific combination of *Momordica cochinchinensis* (for dispersing nodules and reducing swelling) and borneol (for clearing heat and relieving pain, and promoting transdermal absorption of other medicinal components). The combination of these two herbs can significantly improve perianal swelling, itching, and a feeling of heaviness. Comparative experiments have confirmed the unexpected synergistic effect. The 300-mesh ultrafine grinding significantly reduces the particle size of the medicinal herbs. The significantly increased specific surface area of ​​the active ingredients facilitates their release from the matrix and penetration through the stratum corneum to exert their effects. The cream's fine texture also provides a high level of comfort. Low-temperature feeding below 50℃ effectively prevents the loss of borneol due to high-temperature volatilization, ensuring a stable borneol content in the finished product and guaranteeing a cooling and penetrating effect. This cream contains no hormones or antibiotics, only natural herbal ingredients and a petrolatum matrix, exhibiting no significant irritation and suitable for long-term use. Furthermore, the preparation process is simple, with clearly defined parameters, and easy quality control, making it suitable for large-scale industrial production. Detailed Implementation

[0013] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention. The Chinese medicinal materials used in the following embodiments all comply with the relevant standards of Part I of the 2020 edition of the Chinese Pharmacopoeia, and the petrolatum complies with the relevant standards of Part IV of the 2020 edition of the Chinese Pharmacopoeia.

[0014] Example 1: A topical herbal ointment composition for perianal care A topical herbal ointment composition for perianal care, comprising the following ingredients by weight: 20 parts Sophora flavescens, 15 parts Dictamnus dasycarpus, 15 parts Portulaca oleracea, 10 parts Gallnut, 10 parts Momordica cochinchinensis, 15 parts Sanguisorba officinalis, 15 parts Borneol, and 900 parts Vaseline (to be made up to 1000 parts).

[0015] The preparation method of this perianal care topical herbal ointment composition is as follows: (1) Take Sophora flavescens, Dictamnus dasycarpus, Portulaca oleracea, Galla chinensis, Momordica cochinchinensis (processed to remove oil) and Sanguisorba officinalis, clean them separately and mix them together, pulverize them with an ultra-fine pulverizer, pass them through a 300-mesh sieve to obtain ultra-fine medicinal powder, and set them aside for later use; (2) Take the prescribed amount of petroleum jelly, heat it in a water bath until it is completely melted, stop heating, cool it to 48°C, add borneol, and stir until it is completely dissolved; (3) Add the above ultrafine powder into the petroleum jelly system and stir at a speed of 45 rpm for 30 minutes to make the powder evenly dispersed. Let it cool naturally to room temperature and fill it to obtain the finished ointment.

[0016] The resulting ointment is a yellowish-brown to brownish-yellow ointment with a fragrant aroma, a cooling sensation, and a fine, uniform texture without any grainy feel.

[0017] Example 2: A topical herbal ointment composition for perianal care A topical herbal ointment composition for perianal care, comprising the following raw materials by weight: 18 parts Sophora flavescens, 13 parts Dictamnus dasycarpus, 13 parts Portulaca oleracea, 8 parts Gallnut, 8 parts Momordica cochinchinensis, 13 parts Sanguisorba officinalis, 13 parts Borneol, and 914 parts Vaseline (to bring the total to 1000 parts).

[0018] The preparation method of this perianal care topical herbal ointment composition is as follows: (1) Take Sophora flavescens, Dictamnus dasycarpus, Portulaca oleracea, Galla chinensis, Momordica cochinchinensis (processed to remove oil) and Sanguisorba officinalis, clean them separately and mix them together, pulverize them with an ultra-fine pulverizer, pass them through a 200-mesh sieve to obtain ultra-fine medicinal powder, and set them aside for later use; (2) Take the prescribed amount of petroleum jelly, heat it in a water bath until it is completely melted, stop heating, cool it to 50°C, add borneol, and stir until it is completely dissolved; (3) Add the above ultrafine powder into the petroleum jelly system and stir at a speed of 30 rpm for 40 minutes to make the powder evenly dispersed. Let it cool naturally to room temperature and fill it to obtain the finished ointment.

[0019] The resulting ointment is a yellowish-brown ointment with a uniform texture and a fragrant odor.

[0020] Example 3: A topical herbal ointment composition for perianal care A topical herbal ointment composition for perianal care, comprising the following raw materials by weight: 22 parts Sophora flavescens, 17 parts Dictamnus dasycarpus, 17 parts Portulaca oleracea, 12 parts Gallnut, 12 parts Momordica cochinchinensis, 17 parts Sanguisorba officinalis, 17 parts Borneol, and 886 parts Vaseline (to be made up to 1000 parts).

[0021] The preparation method of this perianal care topical herbal ointment composition is as follows: (1) Take Sophora flavescens, Dictamnus dasycarpus, Portulaca oleracea, Galla chinensis, Momordica cochinchinensis (processed to remove oil) and Sanguisorba officinalis, clean them separately and mix them together, pulverize them with an ultra-fine pulverizer, pass them through a 400-mesh sieve to obtain ultra-fine medicinal powder, and set them aside for later use; (2) Take the prescribed amount of petroleum jelly, heat it in a water bath until it is completely melted, stop heating, cool it to 42°C, add borneol, and stir until it is completely dissolved; (3) Add the above ultrafine powder into the petroleum jelly system and stir at a speed of 60 rpm for 20 minutes to make the powder evenly dispersed. Let it cool naturally to room temperature and fill it to obtain the finished ointment.

[0022] The resulting ointment is a brownish-brown ointment with a fine and uniform texture and a fragrant and refreshing odor.

[0023] Comparative Example 1 (without Momordica cochinchinensis seeds) A topical herbal ointment composition for perianal care, by weight, comprises the following raw materials: 20 parts Sophora flavescens, 15 parts Dictamnus dasycarpus, 15 parts Portulaca oleracea, 10 parts Gallnut, 15 parts Sanguisorba officinalis, 15 parts Borneol, and petrolatum to make up to 1000 parts (i.e., removing Momordica cochinchinensis, with the remaining components and amounts consistent with Example 1); the preparation method is the same as in Example 1.

[0024] Comparative Example 2 (with borneol removed) A topical herbal ointment composition for perianal care, by weight, comprises the following raw materials: 20 parts Sophora flavescens, 15 parts Dictamnus dasycarpus, 15 parts Portulaca oleracea, 10 parts Galla chinensis, 10 parts Momordica cochinchinensis, 15 parts Sanguisorba officinalis, and petrolatum to make up to 1000 parts (i.e., removing borneol, with the remaining components and amounts consistent with Example 1); the preparation method is the same as in Example 1 (without adding borneol).

[0025] Comparative Example 3 (without Momordica cochinchinensis and borneol) A topical herbal ointment composition for perianal care, by weight, comprises the following raw materials: 20 parts Sophora flavescens, 15 parts Dictamnus dasycarpus, 15 parts Portulaca oleracea, 10 parts Gallnut, 15 parts Sanguisorba officinalis, and petrolatum to make up to 1000 parts; (i.e., simultaneously removing Momordica cochinchinensis and borneol, with the remaining components and dosages consistent with Example 1); the preparation method is the same as in Example 1.

[0026] Comparative Example 4 (100 mesh powder) The raw material composition is the same as in Example 1. The preparation method involves pulverizing the raw material through a 100-mesh sieve, and the remaining steps are the same as in Example 1.

[0027] Comparative Example 5 (feeding at 70℃) The raw material composition is the same as in Example 1. In the preparation method, borneol is added when the petrolatum is cooled to 70°C. The remaining steps are the same as in Example 1.

[0028] Experiment 1: Comparative Experiment on Synergistic Effects of Formulas 1. Experimental objective: To verify the synergistic effect of Momordica cochinchinensis and borneol in the composition of the present invention, and the effect of the complete formula on improving perianal discomfort symptoms.

[0029] 2. Subjects: Eighty volunteers aged 20-65 years with symptoms of perianal swelling, itching, and a feeling of heaviness were selected and randomly divided into four groups of 20 each. There were no significant differences in age, gender, or symptom severity among the groups.

[0030] 3. Experimental Methods: The ointments of Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3 were applied once each morning and evening after cleaning the perianal area, for 7 consecutive days. The time for relief of itching, reduction of swelling, and reduction of heaviness were observed and recorded. Significant symptom relief (symptom score decrease ≥50%) was used as the effective criterion.

[0031] 4. Symptom scoring criteria: Itching, swelling, and heaviness are each scored from 0 to 3 points, with 0 points indicating no symptoms, 1 point indicating mild symptoms, 2 points indicating moderate symptoms, and 3 points indicating severe symptoms.

[0032] 5. Experimental Results: Example 1 (Complete Formula) 20 2 3 2.5 95.0 Comparative Example 1 (without Momordica cochinchinensis seeds) 20 3 3.5 3 65.0 Comparative Example 2 (without borneol) 20 3.5 4.5 4 70.0 Comparative Example 3 (without Momordica cochinchinensis and borneol) 20 4.5 6 6.5 45.0 6. Results Analysis: As shown in the table above, the complete formula group in Example 1 had significantly shorter times for itch relief, swelling reduction, and heaviness reduction compared to the comparative groups, with a total effective rate of 95.0%. In Comparative Example 1, removing *Momordica cochinchinensis* significantly prolonged the time for swelling and heaviness reduction, indicating that *Momordica cochinchinensis* plays a key role in dispersing nodules and reducing swelling. In Comparative Example 2, removing borneol prolonged the time for symptom relief, indicating that borneol's penetration-enhancing effect can improve the overall onset speed. In Comparative Example 3, removing both *Momordica cochinchinensis* and borneol resulted in the worst effect, with a total effective rate of only 45.0%. These results indicate that *Momordica cochinchinensis* and borneol have a synergistic effect in the formula of this invention, and the complete formula produced unexpected technical effects.

[0033] Experiment 2: Effect of Feeding Temperature on Camphor Retention Rate 1. Experimental objective: To investigate the retention rate of borneol in the finished product under different feeding temperatures and to determine the optimal feeding temperature range.

[0034] 2. Experimental methods: According to the prescription of Example 1, the ointments prepared by Example 1, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 were used respectively. The content of borneol in the finished product was determined by gas chromatography (GC), and the borneol retention rate (actual content / theoretical feed amount × 100%) was calculated.

[0035] 3. Experimental Results: Group 1 (Example 3) 42 14.82 98.8 Group 2 (Example 1) 48 14.55 97.0 Group 3 (Example 2) 50 14.36 95.7 4 groups (Comparative Example 5) 70 8.42 56.1 4. Results Analysis: As shown in the table above, the feeding temperature has a significant impact on the borneol retention rate. When the feeding temperature is below 50℃, the borneol retention rate is above 95%, with minimal loss. When the temperature rises to 70℃, the retention rate drops to 56.1%, indicating significant loss of borneol due to high-temperature volatilization. Therefore, controlling the feeding temperature to no more than 50℃ can effectively retain the active ingredients of borneol and ensure stable product quality.

[0036] Experiment 3: Accelerated Stability Test 1. Experimental objective: To investigate the stability of the ointment of the present invention under accelerated conditions.

[0037] 2. Test method: The ointment prepared in Example 1 was placed at a temperature of 40℃±2℃ and a relative humidity of 75%±5% for 6 months. Samples were taken at 0, 1, 2, 3 and 6 months to examine the properties, borneol content, microbial limit and other indicators.

[0038] 3. Experimental Results: 0 months Yellowish-brown ointment with an aromatic odor 14.55 Compliant 1 month Yellowish-brown ointment with an aromatic odor 14.48 Compliant 2 months Yellowish-brown ointment with an aromatic odor 14.36 Compliant 3 months Yellowish-brown ointment with an aromatic odor 14.21 Compliant 6 months Yellowish-brown ointment with an aromatic odor 14.02 Compliant 4. Results Analysis: After 6 months of accelerated stability testing, the ointment's properties showed no significant changes. The borneol content decreased from 14.55 mg / g to 14.02 mg / g, a decrease of only 3.6%, and the microbial limits remained within the specified limits. This indicates that the ointment of this invention has good stability and its quality is controllable within its shelf life.

[0039] Typical Cases Case 1: Mr. Zhang, male, 42 years old, office worker, sedentary lifestyle. Chief complaint: Recurrent perianal swelling and itching for more than 3 months, worsening in the past week. Present illness: Due to prolonged sitting, the patient has experienced recurrent perianal distension and discomfort for the past 3 months, accompanied by perianal skin itching, especially at night, affecting sleep. One week ago, the symptoms worsened after eating spicy food. Mild swelling, redness, and significant itching were visible around the anus, without ulceration or bleeding. Tongue: Pale red with yellow greasy coating. Usage: After cleaning the perianal area with warm water morning and evening, apply an appropriate amount of the ointment from Example 1 to the affected area and gently massage until absorbed. Use continuously for 7 days. Results: On the 2nd day of use, perianal itching was significantly reduced, and sleep was normal at night; on the 4th day, perianal swelling began to subside, and the feeling of heaviness decreased; on the 7th day, perianal swelling was basically subsided, itching and heaviness symptoms disappeared, and skin redness subsided, returning to normal. No recurrence was observed during the 1-month follow-up.

[0040] Case 2: Ms. Li, female, 35 years old, teacher. Chief complaint: Perianal distension and discomfort with dampness for 2 months. Present illness: Two months ago, the patient developed a feeling of perianal distension without obvious cause, which worsened after standing or sitting for a long time, accompanied by perianal dampness and discomfort, and occasional itching. Examination revealed mild edema of the perianal skin, without obvious masses or ulceration. Usage: After cleaning the perianal area after defecation and before bedtime each day, apply an appropriate amount of the ointment from Example 1, and use continuously for 10 days. Results: On the 3rd day of use, the perianal dampness was reduced, and the feeling of distension was somewhat relieved; on the 7th day of use, the feeling of distension was significantly reduced, and the perianal skin was dry and comfortable; on the 10th day of use, the symptoms of distension and dampness completely disappeared, and the perianal skin returned to normal. Follow-up for 2 months showed no recurrence of symptoms.

[0041] Case 3: Mr. Wang, male, 55 years old, retired worker. Chief complaint: Perianal itching and dampness for more than half a year. Present illness: The patient had experienced recurrent perianal itching and dampness for the past six months. The symptoms worsened after scratching, and various topical antipruritic ointments were ineffective. Examination revealed thickened and rough perianal skin with pigmentation and a few scratch marks, but no obvious exudate. Usage: After cleaning the perianal area in the morning and evening, apply an appropriate amount of ointment from Example 1 and gently massage. Use continuously for 14 days. Results: On the 5th day of use, perianal itching was significantly reduced, and the dampness improved; on the 10th day, itching basically disappeared, and the roughness of the skin was reduced; on the 14th day, the itching and dampness completely disappeared, the perianal skin was smoother than before, and the pigmentation was reduced. Follow-up for 3 months showed that the symptoms were stable, and no significant itching recurred.

[0042] Case 4: Ms. Liu, female, 28 years old, 2 months postpartum. Chief complaint: Postpartum perianal swelling and pain for 1 week. Present illness: Due to an episiotomy during vaginal delivery, the patient developed perianal swelling and a feeling of heaviness postpartum, accompanied by mild pain, which worsened during defecation, affecting postpartum recovery. Examination revealed mild edema of the perianal tissue, without significant bleeding or ulceration. Usage: After cleaning the perianal area with warm water after each bowel movement and before bedtime, apply an appropriate amount of ointment from Example 1 gently to the swollen area for 7 consecutive days. Results: On the 2nd day of use, the perianal swelling began to decrease, and the pain was relieved; on the 5th day, the swelling significantly subsided, the feeling of heaviness decreased, and the discomfort during defecation was significantly improved; on the 7th day, the perianal swelling completely subsided, the pain and heaviness disappeared, and postpartum recovery was smooth.

[0043] Case 5: Mr. Chen, male, 38 years old, truck driver. Chief complaint: Recurrent perianal distension and itching for 1 year, worsening for 3 days. Present illness: Due to his occupation, the patient sits for long periods while driving, and has experienced recurrent perianal distension and itching for 1 year, with symptoms worsening after long-distance driving. Three days ago, after continuous driving, the symptoms worsened, with significant perianal distension, itching, and dampness. Examination revealed mild perianal swelling and redness of the skin. Usage: After cleaning the perianal area morning and evening, and before and after long-distance driving, apply an appropriate amount of the ointment from Example 1. Use continuously for 14 days, while avoiding prolonged sitting and engaging in regular physical activity. Results: On the 3rd day of use, itching and dampness were reduced; on the 7th day, the distension was significantly relieved, and the swelling subsided; on the 14th day, all discomfort symptoms disappeared, and the perianal skin returned to normal. Preventive use before subsequent long-distance driving did not result in any further significant discomfort.

[0044] The above typical cases demonstrate that the herbal ointment composition for perianal care of the present invention has a good effect on improving the discomfort symptoms such as perianal swelling, itching, distension, and dampness caused by different groups of people and different causes. It has a fast onset of action, is comfortable to use, has no obvious adverse reactions, and is suitable for daily perianal care.

[0045] It should be noted that, in this document, terms such as “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0046] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A topical herbal ointment composition for perianal care, characterized in that, By weight, it contains the following ingredients: 18-22 parts Sophora flavescens, 13-17 parts Dictamnus dasycarpus, 13-17 parts Portulaca oleracea, 8-12 parts Gallnut, 8-12 parts Momordica cochinchinensis, 13-17 parts Sanguisorba officinalis, 13-17 parts Borneol, and Vaseline to make up to 1000 parts.

2. The perianal care topical herbal ointment composition according to claim 1, characterized in that, By weight, it contains the following ingredients: 20 parts Sophora flavescens, 15 parts Dictamnus dasycarpus, 15 parts Portulaca oleracea, 10 parts Gallnut, 10 parts Momordica cochinchinensis, 15 parts Sanguisorba officinalis, 15 parts Borneol, and Vaseline to make up to 1000 parts.

3. The method for preparing the perianal care external herbal ointment composition according to claim 1 or 2, characterized in that, The preparation method includes the following steps: (1) Take Sophora flavescens, Dictamnus dasycarpus, Portulaca oleracea, Galla chinensis, Momordica cochinchinensis and Sanguisorba officinalis, grind them into powder and pass them through a 200-400 mesh sieve to obtain ultrafine powder; (2) Heat the petroleum jelly until melted, cool it to a temperature not exceeding 50°C, add borneol and stir until completely dissolved; (3) Add the above-mentioned powder into the petrolatum system, stir and mix thoroughly, and let it cool naturally to obtain the external ointment.

4. The method for preparing the perianal care external herbal ointment composition according to claim 3, characterized in that, The sieve size after crushing in step (1) is 300 mesh.

5. The method for preparing the perianal care external herbal ointment composition according to claim 3, characterized in that, The cooling temperature mentioned in step (2) is 40-50℃.

6. The method for preparing the perianal care external herbal ointment composition according to claim 3, characterized in that, In step (3), the mixing time is 20 to 40 minutes and the mixing speed is 30 to 60 revolutions per minute.