A cream for incontinence dermatitis in highland areas and a preparation method thereof

Abstract

This invention discloses an ointment for incontinence-related dermatitis in high-altitude areas and its preparation method, relating to the field of traditional Chinese medicine technology. The invention comprises active ingredients made from the following raw materials in parts by weight: *Lithospermum erythrorhizon*, *Angelica sinensis*, *Myrrh*, and frankincense; and a matrix composed of a mixture of ghee and sesame oil. *Lithospermum erythrorhizon* serves as the core ingredient, targeting damp-heat toxins, while *Angelica sinensis* improves local blood circulation and moisturizes the skin. The combination of *Lithospermum erythrorhizon* and *Angelica sinensis* emphasizes both clearing heat, cooling blood, detoxifying, nourishing blood, promoting blood circulation, and moisturizing dryness, targeting skin lesions from both "clearing" and "nourishing" dimensions. Frankincense and myrrh assist in reducing swelling, promoting tissue regeneration, and relieving pain. Frankincense and myrrh are used in small amounts as adjuvants, assisting in promoting blood circulation, relieving pain, and promoting tissue regeneration, avoiding excessively strong pungent properties. The four-herb combination covers the core pathological aspects of incontinence-related dermatitis, and the formula is simple and targeted, avoiding the complex interactions and irritation risks that may arise from multiple herbs. This achieves the goal of treating incontinence-related dermatitis in high-altitude areas.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to an ointment for incontinence-related dermatitis in high-altitude areas and its preparation method. Background Technology

[0002] In clinical nursing, incontinence-associated dermatitis, an irritant contact dermatitis caused by prolonged or repeated skin exposure to urine and feces, has become a common complication among disabled, elderly, and critically ill patients. Currently, conventional external treatments for this condition mainly fall into two categories: one uses skin protectants such as zinc oxide and petrolatum, which form a physical barrier on the skin surface to block irritants, but lack active anti-inflammatory and repair-promoting pharmacological effects, and are prone to hardening and cracking in low-temperature, dry environments at high altitudes, affecting user experience and protective efficacy; the other uses ointments containing corticosteroids or antibiotics, aiming to control inflammation and infection, but long-term use can lead to side effects such as skin atrophy and increased infection risk, and similarly neglects the fundamental repair of the damaged skin barrier.

[0003] In high-altitude areas, due to unique environmental factors such as low pressure, low oxygen, strong ultraviolet radiation, extreme dryness, and large diurnal temperature variations, residents commonly experience weakened skin barrier function, increased transepidermal water loss, and persistent inflammation induced by chronic hypoxia. This makes the pathological process of incontinence dermatitis more complex in high-altitude populations, manifesting as severe inflammatory responses, significantly delayed skin healing, and susceptibility to secondary infections and environmental damage (such as frostbite and photodamage). Existing conventional treatments often prove ineffective or lack adaptability in this complex pathological environment; for example, conventional ointment bases have poor spreadability at low temperatures, making it difficult to form a stable and durable protective layer. Summary of the Invention

[0004] The purpose of this invention is to provide an ointment for incontinence-related dermatitis in high-altitude areas and its preparation method, so as to achieve the purpose of treating incontinence-related dermatitis in high-altitude areas.

[0005] To achieve the above objectives, the present invention employs the following technical means: An ointment for incontinence-related dermatitis in high-altitude areas comprises active ingredients made from the following raw materials in parts by weight: 30-70 parts of Lithospermum erythrorhizon, 30-70 parts of Angelica sinensis, 3-10 parts of Myrrh, and 3-10 parts of Frankincense; And a base made up of ghee and sesame oil.

[0006] The formula uses Lithospermum erythrorhizon as its core ingredient to target damp-heat and toxic pathogens, while Angelica sinensis improves local blood circulation and moisturizes the skin. The combination of Lithospermum erythrorhizon and Angelica sinensis focuses on clearing heat, cooling blood, and detoxifying while simultaneously nourishing blood, promoting blood circulation, and moisturizing dryness, targeting skin lesions from both "clearing" and "nourishing" perspectives. Frankincense and myrrh assist in reducing swelling, promoting tissue regeneration, and relieving pain. Frankincense and myrrh are used in small doses as adjuvants, assisting in promoting blood circulation, relieving pain, and promoting tissue regeneration, while avoiding excessively strong pungent and dispersing properties. This four-herb combination covers the core pathological aspects of incontinence-related dermatitis, and its simple and targeted approach avoids the complex interactions and irritation risks that may arise from multiple herbs.

[0007] Sesame oil and ghee are selected as the base materials. Sesame oil is rich in antioxidants, which helps the drug penetrate and protects the skin; while ghee provides a sustained-release carrier and physical barrier. The combination of the two gives the formulation both sustained-release and protective properties.

[0008] Ghee, as a nearly pure fat matrix, allows for the slow release of fat-soluble drug components, resulting in a long-lasting and gentle effect. Simultaneously, this oil film locks in skin moisture, creating a stable, moist environment conducive to repair. The combination of these two elements achieves a synergistic effect of "slow-release medication" and "physical protection," addressing incontinence-related dermatitis from both "treatment" and "prevention" perspectives.

[0009] Preferably, the weight ratio of ghee to sesame oil is 1:0.1 to 1:0.5.

[0010] A method for preparing the aforementioned ointment for incontinence-related dermatitis in high-altitude areas includes the following steps: S1. Using the cold maceration method, sesame oil is used to soak gromwell and angelica, and then filtered to obtain gromwell oil; S2. Mix frankincense, myrrh and ghee, add the heated comfrey oil obtained in S1, and stir until well mixed; S3. Cool the mixture obtained in S2 to solidify and solidify.

[0011] The cold maceration method allows for the extraction of medicinal components that retain the original state of the herbs more completely. When combined with ghee, it can better exert the sustained-release properties and skin barrier mimicry function of ghee.

[0012] Preferably, in step S1, the gromwell root and angelica root are soaked in sesame oil, sealed and soaked for 7 to 14 days, and stirred once every 24 hours.

[0013] In this way, during the several-day soaking at room temperature, the sesame oil, as a fat-soluble solvent, simultaneously dissolves and extracts the fat-soluble and partially alcohol-soluble active ingredients from both Lithospermum erythrorhizon and Angelica sinensis. Through a dynamic equilibrium co-dissolution process, the components of the two herbs do not dissolve in isolation into the oil, but rather dissolve, exchange, and initially fuse together in the common medium of the oil phase. The volatile oils and phthalides abundant in Angelica sinensis are compatible with the naphthoquinone components such as shikonin and acetylshikonin in Lithospermum erythrorhizon, coexisting in the oil to form a complex extract with preliminary chemical bonding. The fat-soluble components of Angelica sinensis are used as a co-solvent or carrier to aid in the dissolution and stabilization of the fat-soluble active ingredients in Lithospermum erythrorhizon.

[0014] This avoids differences in composition and properties caused by brewing them separately. Furthermore, it prevents difficulties in forming a completely homogeneous system when subsequently mixed with ghee.

[0015] Furthermore, in step S2, frankincense and myrrh are first mixed with ghee paste, and then the comfrey oil obtained in S1 is heated to 80~90℃. The comfrey oil is then poured into the ghee mixture and stirred for 5~10 minutes.

[0016] Furthermore, in step S2, frankincense and myrrh are mixed with ghee in powder form.

[0017] This process, where the medicinal powder first comes into contact with the ghee paste, aims to allow the ghee to act as a medium for processing the frankincense and myrrh during the subsequent heating process. When hot comfrey oil at 80-90℃ is poured in, heat is transferred from the outside, causing the solid ghee to gradually melt from the outside in. During this process, the active ingredients of frankincense and myrrh are not directly added to the hot oil, but are gently heated, released, dispersed, and encapsulated within the gradually softening and melting ghee medium. This makes the medicinal properties of the two herbs more mellow and lasting.

[0018] During the preparation process, the drug powder is surrounded by solid ghee, resulting in a gentle heat transfer. The melting process of the ghee itself absorbs a large amount of heat, providing a buffered heat treatment environment for the drug components, which is more conducive to preserving their complete activity.

[0019] In addition, the aforementioned ointment for incontinence dermatitis in high-altitude areas is used in the preparation of drugs for treating incontinence dermatitis in high-altitude areas.

[0020] The present invention has the following beneficial effects during use: Ghee is a nearly pure fat matrix. If ghee is used as a paste, the medicinal ingredients must first diffuse out of the fat matrix before they can be absorbed by the skin. This process is naturally slower and more gradual than with water-soluble matrices.

[0021] Ghee softens but doesn't completely melt at body temperature, forming a continuous oily layer on the skin's surface. The drug dissolves and disperses within this oily layer, and as the oil is slowly absorbed and the drug molecules diffuse slowly, the drug is continuously released, preventing drastic fluctuations in blood drug concentration.

[0022] The lipid composition of ghee is similar to that of human sebum, allowing it to blend well and slowly deliver medication to the stratum corneum, further slowing down the absorption rate.

[0023] In high-altitude environments, where the cold temperatures of the plateau can cause ordinary plaster bases to harden, crack, and release unevenly, ghee softens at body temperature and retains a certain degree of plasticity at low temperatures, ensuring stable drug release even under large diurnal temperature variations.

[0024] High-altitude areas are dry, have strong ultraviolet radiation, and high wind speeds. The ghee ointment itself can form a protective oil film on the skin surface, locking in moisture, reducing irritation, creating a stable local microenvironment for the sustained release of medication, and at the same time playing an auxiliary therapeutic role.

[0025] Compared to commonly used mineral oils, silicone oils, or polymers as matrices, ghee, as a natural and biodegradable mixture, exhibits a more balanced affinity and release performance for the medicinal components of Lithospermum erythrorhizon due to its natural complex lipid structure.

[0026] The core component of Lithospermum erythrorhizon, shikonin, possesses potent non-steroidal anti-inflammatory effects, inhibiting the production of inflammatory mediators such as prostaglandins and leukotrienes, and rapidly relieving redness, swelling, heat, and pain. It also inhibits common bacteria such as Staphylococcus aureus and Escherichia coli, preventing and controlling secondary infections. Furthermore, it promotes granulation tissue growth and epithelial cell regeneration, accelerating wound healing. As a primary formula, it targets the "damp-heat toxins" in incontinence-related dermatitis.

[0027] The active ingredients in Angelica sinensis can dilate local capillaries, increase blood flow, bring nutrients and oxygen to damaged tissues, remove metabolic waste, and create conditions for repair. At the same time, it can also have a synergistic effect with Lithospermum erythrorhizon, helping Lithospermum erythrorhizon to reduce inflammation and pain. The volatile oils and oils in Angelica sinensis can moisturize dry and cracked skin caused by incontinence and repair the sebum film.

[0028] By using ghee and sesame oil together, with ghee as a base, the drug components are released in a sustained manner. At the same time, a hydrophobic protective film is formed on the skin, directly isolating the skin from the chemical irritation of urine and feces. It not only serves as a sustained-release layer for the drug but also forms a physical protective layer.

[0029] Sesame oil is rich in antioxidants such as vitamin E and sesamol, which have anti-inflammatory, moisturizing, and skin-penetrating effects. Mixing sesame oil with ghee adjusts the consistency and melting point of the ointment while enhancing transdermal drug absorption. Its antioxidant properties protect damaged skin from further oxidative damage.

[0030] Furthermore, addressing the issues of dry skin, fragile stratum corneum, and easy loss of the sebum film in high-altitude areas, ghee and sesame oil simulate and replenish the saturated and unsaturated fatty acids most lacking in high-altitude skin, directly rebuilding the sebum film. Angelica promotes local microcirculation, assisting in the repair of the sebum film.

[0031] Addressing the issue of slow wound healing due to high-altitude hypoxia, this treatment utilizes gromwell root to inhibit inflammatory pathways activated by low oxygen levels. Combined with angelica, frankincense, and myrrh, it improves local microcirculation and the hypoxic environment of the skin, promoting healing. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0033] Therefore, the following detailed description of embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0034] It should be noted that, unless otherwise specified, the embodiments and features described in this invention can be combined with each other. Example

[0035] A method for preparing an ointment for incontinence-related dermatitis in high-altitude areas includes the following steps: S1. Using the cold soaking method, soak 50 parts of gromwell root and 50 parts of angelica root in sesame oil, seal and soak for 7-14 days, stirring once every 24 hours, and filter to obtain gromwell root oil; S2. Grind 5 parts frankincense and 5 parts myrrh into powder, mix with ghee paste, add the aforementioned comfrey oil heated to 80~90℃, stir and mix well for 5~10 minutes; S3. Cool the mixture obtained in S2 to solidify and solidify.

[0036] In this embodiment, the total weight ratio of ghee to sesame oil used is 1:0.1 to 1:0.5. Example

[0037] A method for preparing an ointment for incontinence-related dermatitis in high-altitude areas includes the following steps: S1. Using the cold soaking method, soak 30 parts of Lithospermum erythrorhizon and 30 parts of Angelica sinensis in sesame oil, seal and soak for 7-14 days, stirring once every 24 hours, and filter to obtain Lithospermum erythrorhizon oil; S2. Grind 3 parts frankincense and 3 parts sesame into powder, mix with the paste-like ghee, add the aforementioned comfrey oil heated to 80~90℃, stir and mix well for 5~10 minutes; S3. Cool the mixture obtained in S2 to solidify and solidify.

[0038] In this embodiment, the total weight ratio of ghee to sesame oil used is 1:0.1 to 1:0.5. Example

[0039] A method for preparing an ointment for incontinence-related dermatitis in high-altitude areas includes the following steps: S1. Using the cold soaking method, soak 70 parts of Lithospermum erythrorhizon and 70 parts of Angelica sinensis in sesame oil, seal and soak for 7 to 14 days, stirring once every 24 hours, and filter to obtain Lithospermum erythrorhizon oil; S2. Grind 10 parts frankincense and 10 parts myrrh into powder, mix with ghee paste, add the aforementioned comfrey oil heated to 80-90℃, stir and mix well for 5-10 minutes; S3. Cool the mixture obtained in S2 to solidify and solidify.

[0040] In this embodiment, the total weight ratio of ghee to sesame oil used is 1:0.1 to 1:0.5. Example

[0041] Case 1 Segang's son, male, 1 month old.

[0042] 1. Diagnosis: Incontinence-related dermatitis, grade 1, mild 2. Clinical manifestations: The skin of the child's bilateral groin and perianal area is red and dense red rashes are visible, without edema or skin ulceration.

[0043] 3. Present Illness: The child had a fever for 2 days and was hospitalized for unknown cause. Upon arrival, a physical examination revealed redness and dense rashes on the skin of both groins and perianal area. The affected skin was diagnosed as incontinence dermatitis.

[0044] 4. Current symptoms: Multiple patches of erythema are distributed on the bilateral groin, perianal skin and inner thighs. Dense red rashes can be seen on the base of the erythema. The skin temperature at the erythema site is elevated. The child occasionally scratches and cries when touched. There is no edema or skin breakdown.

[0045] 5. Usage and dosage: Clean the affected skin with saline solution, apply the ointment prepared in Example 1 externally, 4-6 times a day, covering an area 3 cm larger than the wound. The ointment should completely cover the skin's base color, with a thickness of about 0.2-0.3 mm, and the ointment layer should be uniform and without lumps.

[0046] 6. Incontinence-related dermatitis healed after 4 days of treatment.

[0047] Comparative Example 1 The comfrey oil was prepared using conventional methods. An equal amount of comfrey (as in Example 1) was soaked in sesame oil for 7 days, then gently fried until withered, filtered, and the oil extracted. The remaining preparation process was the same as in Example 1.

[0048] Comparative Example 2 Take equal amounts of the herbs *Gromwell root*, *Angelica sinensis*, *Myrrh*, and *Boswellia carterii* as in Example 1, and obtain a mixed extract paste using conventional ethanol reflux extraction. Mix this extract evenly with a mixture of petrolatum and lanolin to prepare an ointment. The remaining processes are the same as in Example 1.

[0049] Comparative Example 3 Take an equal amount of the same amount of gromwell root, angelica root, myrrh, and frankincense as in Example 1, grind them into a fine powder, and mix them directly with melted ghee and sesame oil to make a paste. The remaining processes are the same as in Example 1.

[0050] Example 1 and Comparative Examples 1 to 3 described above were evaluated. In vitro anti-inflammatory experiments, skin barrier repair and transdermal absorption experiments, and high-altitude environment simulated efficacy experiments were used for evaluation and comparison.

[0051] Among them, compared with Comparative Examples 1 and 3, Example 1 significantly outperformed Comparative Example 1 in terms of anti-inflammatory inhibition of HIF-1α and promoting healing indices in the plateau simulation model using only comfrey oil. This indicates that the comfrey and ghee processing technology used in this invention has unique advantages over ordinary comfrey and conventional frying methods in dealing with hypoxia-related inflammation and efficiently extracting fat-soluble components.

[0052] Compared with Comparative Example 2, Example 1 showed more stable sustained-release characteristics in the transdermal absorption experiment; in the animal model, Example 1 was significantly better than the petrolatum-based solution of Comparative Example 2 in terms of skin barrier repair, i.e., reducing TEWL, and ointment stability under simulated low temperature conditions.

[0053] Furthermore, compared to all comparative examples, Example 1 achieved the best balance across multiple dimensions of comprehensive therapeutic index, including anti-inflammation, promotion of microcirculation, accelerated healing, and barrier repair. No comparative example simultaneously reached the level of the experimental group in all key indicators. For example, the simple mixture in Comparative Example 3 exhibited rapid drug release but poor duration of action.

[0054] Comparative Example 4 This comparative example uses Angelica sinensis, myrrh, frankincense and gromwell root from Example 1, but replaces the matrix with a modern polymeric gel matrix that is more commonly used in plains areas, has better stability, but lacks high-altitude adaptability. In this comparative example, a carbomer gel matrix is ​​used.

[0055] Example 1 and Comparative Example 4 were tested on a standard rat model of incontinence-induced dermatitis in a plain environment and a simulated plateau environment, respectively. After 7 days of treatment, skin barrier function, hypoxic inflammatory response, and the adaptability of the ointment to the environment were assessed. In the plain environment, Comparative Example 4 showed little difference in effect from Example 1, with Example 1 being slightly superior. However, in the plateau environment, Example 1 showed significantly better results than Comparative Example 4 in terms of lesion healing rate and inhibition of HIF-1α pathway-related inflammation. The skin barrier function recovery rate of Example 1 was significantly faster than that of the Comparative Example. The ointment of Example 1 showed significantly better spreadability and moisturizing durability at low temperatures than that of Comparative Example 4, where the gel dried and the film detached.

[0056] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A cream for incontinence-related dermatitis in high-altitude areas, characterized in that, It includes active ingredients made from the following raw materials in parts by weight: 30-70 parts of Lithospermum erythrorhizon, 30-70 parts of Angelica sinensis, 3-10 parts of Myrrh, and 3-10 parts of Frankincense; And a base made up of ghee and sesame oil.

2. The ointment for incontinence-related dermatitis in high-altitude areas according to claim 1, characterized in that, The weight ratio of ghee to sesame oil is 10:1 to 2:

1.

3. A method for preparing the ointment according to claim 1 or 2, characterized in that, Includes the following steps: S1. Using the cold maceration method, sesame oil is used to soak gromwell and angelica, and then filtered to obtain gromwell oil; S2. Mix frankincense, myrrh and ghee, add the heated comfrey oil obtained in S1, and stir until well mixed; S3. Cool the mixture obtained in S2 to solidify and solidify.

4. The preparation method according to claim 3, characterized in that, In step S1, the gromwell root and angelica root are soaked in sesame oil, sealed and soaked for 7 to 14 days, and stirred once every 24 hours.

5. The preparation method according to claim 3, characterized in that, In step S2, frankincense and myrrh are first mixed with ghee paste. Then, the comfrey oil obtained in S1 is heated to 80-90°C, and the comfrey oil is poured into the ghee mixture and stirred for 5-10 minutes.

6. The preparation method according to claim 3 or 5, characterized in that, In step S2, frankincense and myrrh are mixed with ghee in the powdered state of an ointment for treating incontinence dermatitis in high-altitude areas.

7. The use of the ointment for incontinence dermatitis in high-altitude areas as described in claim 1 or 2 in the preparation of a medicament for treating incontinence dermatitis in high-altitude areas.