A mild cleansing ostomy skin protectant composition and method of making same

Abstract

This invention discloses a mild cleansing stoma skin protectant composition and its preparation method, belonging to the field of stoma skin care medical device technology. The composition uses an amino acid-based anionic surfactant as the core cleanser, compounded with natural polysaccharide moisturizers, water-soluble cellulose film-forming agents, polyol moisturizers, osmotic pressure regulators, a phosphate buffer system, and mild antibacterial preservatives, with purified water added to bring the volume to 100%. The preparation process includes five steps: pre-dispersion, main dissolution, buffer system preparation, preservative dissolution, and mixing and refining. This invention achieves five functions in one: mild cleansing, long-lasting moisturizing, barrier repair, mild antibacterial and infection prevention, and isolation protection. The product is mild and low in irritation, forms a water-resistant film, has a stable system, and a refreshing feel. It effectively solves problems such as irritation, infection, maceration, and damage to the skin around the stoma, and is suitable for long-term care of various types of stoma skin, especially for sensitive, damaged, and severely adhesive residue-prone areas, with strong clinical applicability. Patient satisfaction is ≥92%.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology for stoma skin care preparations, and is mainly used for stoma patients in departments such as proctology. Specifically, it relates to a mild and low-irritant stoma skin protectant for stoma and surrounding skin care, which has moisturizing, repairing, antibacterial, isolation and film-forming functions. In particular, it relates to a mild rinse-type stoma skin protectant and its preparation method, which has an amino acid anionic surfactant, natural polysaccharide moisturizer, water-soluble cellulose film-forming agent and polyol moisturizer as the core system. Background Technology

[0002] An ostomy is an artificially created passageway between the intestines and the abdominal wall, established for medical purposes such as treating intestinal diseases. The opening is called a stoma, through which urine and feces are expelled. The most common cause of ostomies is rectal cancer. Rectal cancer can be classified as low, mid, or high rectal cancer based on the tumor's location. In my country, low rectal cancer is particularly prevalent, accounting for approximately 75%. Low rectal cancer often requires the placement of an artificial anus. This involves surgically cutting a section of the colon and fixing the end away from the anus to the outside of the abdomen, allowing feces to exit through this opening instead of the anus. Statistics show that there are currently over 1.1 million ostomy patients in my country, and the number is increasing by approximately 100,000 per year. This small ostomy can bring significant changes to a person's life. Nursing difficulties, managing complications, odor leakage, and other challenges often trouble our ostomy patients, placing considerable pressure on their mental and physical health. Sadness, helplessness, confusion, and exhaustion are common occurrences. They crave warmth, understanding, and care, yet are ashamed to express it. The psychological and physical trauma caused by ostomy surgery may far outweigh the disease itself; therefore, ostomy patients, as a special social group, need more care and support from the entire society. During long-term rehabilitation and daily life, the skin around the stoma is constantly exposed to highly irritating excretions such as feces, intestinal fluid, and urine. Simultaneously, it is subjected to multiple physical and chemical irritations, including traction from the stoma baseplate adhesive, repeated tearing, and friction from clothing, making it highly susceptible to complications such as skin maceration, redness, swelling, itching, erosion, contact dermatitis, and even secondary infections. Clinical data shows that more than half of ostomy patients experience varying degrees of peristaltic skin damage, severely impacting their quality of life, the effectiveness of ostomy supplies, and their mental health. Currently, common stoma skin protectants on the market are mainly composed of film-forming agents, alcohol solvents, preservatives, and common surfactants. In actual use, they generally have the following defects.

[0003] High skin irritation: Some products use alcohol, strong alkalinity, or surfactants with strong degreasing ability, which can easily damage the skin barrier and cause stinging and burning sensations on sensitive or damaged skin.

[0004] Allergic reactions: People who are allergic to adhesive materials (such as acrylates) or preservatives may develop contact dermatitis, which manifests as rashes, itching, blisters, etc.

[0005] Lacking moisturizing and repairing abilities: Most products only focus on film-forming isolation and lack long-lasting moisturizing and barrier repair ingredients, which can easily lead to dry and fragile skin with long-term use.

[0006] Unable to prevent or avoid stoma skin infections: Currently available products cannot prevent or avoid complications such as skin maceration, redness, swelling, itching, erosion, contact dermatitis, and even secondary infections.

[0007] Lack of cleaning function: It is unable to clean and handle excrement leakage, odor, and other issues that seriously affect the patient's quality of life.

[0008] Poor system stability: It is prone to problems such as layering, precipitation, separation of effective components, and discoloration, which affect product quality and usage effect, and thus affect usage safety.

[0009] Poor skin feel: sticky, whitish, and difficult to apply, affecting patient experience and usage compliance.

[0010] Therefore, it is necessary to develop a truly gentle and non-irritating product with high moisturizing and repairing effects, capable of cleaning excrement and odor, and nourishing the skin. The development of stoma skin protectants that offer good symmetry, prevent and avoid stoma skin infections, have stable systems, and are easy to manufacture have become urgent technical problems in clinical practice. Summary of the Invention

[0011] To address the shortcomings of existing technologies, this invention provides a mild cleansing stoma skin protectant and its preparation method. By scientifically combining a moisturizing and repairing system, a buffering and isotonic system, and a film-forming and antibacterial system, it achieves a five-in-one function of "mild cleansing + long-lasting moisturizing + barrier repair + mild antibacterial prevention of infection + isolation and protection," thus solving the problems of existing products such as high irritation, poor moisturizing, allergic infection, lack of cleansing function, and insufficient stability.

[0012] The technical problem to be solved.

[0013] Reduce product irritation and make it suitable for sensitive, broken, and fragile skin after ostomy.

[0014] Choose safe and biocompatible materials to reduce allergic reactions.

[0015] It enhances the skin's moisturizing and barrier repair capabilities, reducing dryness, maceration, and redness.

[0016] It achieves low-concentration, broad-spectrum, and mild antibacterial activity, reducing the risk of infection.

[0017] Choose a suitable amino acid surfactant to enhance cleaning and deodorizing effects while avoiding irritation.

[0018] Optimize the formula and process to improve product stability and avoid stratification, precipitation, and separation.

[0019] The innovative liquid gel film formation enhances adhesion and isolation effects while ensuring a refreshing and non-sticky feel on the skin, improving the overall skin experience.

[0020] Technical solution

[0021] This invention discloses a composition of a mild rinsing stoma skin protectant, which, by weight percentage, comprises the following components:

[0022] Natural polysaccharide moisturizer 0.01%～5.0% 0.02%～4.0% Selected food-grade ingredients, purity ≥99%, with excellent synergistic moisturizing and repairing properties. Water-soluble cellulose film-forming agents 0.01%～5.00% 0.02%～4.0% Low viscosity, good film-forming properties and does not turn white. Polyol moisturizer 2%～30% 3%～28% Pharmaceutical grade, forming an "internal replenishment and external locking" moisturizing system with natural polysaccharides. Amino acid anionic surfactants 1%～30% 2%～28% C12 fatty acid chain + neutral amino acid residues, CMC value 7.8–12.5 mmol / L Osmotic pressure regulator 0.2%～3.0% 0.3%～2.5% Adjust the osmotic pressure to 280–320 mOsm / kg to match the body fluids. First buffer salt 0.02%～3.50% 0.05%～2.50% Combined with a second buffer salt in a 1:1 to 2:1 ratio to maintain pH stability. Second buffer salt 0.02%～3.50% 0.05%～2.50% Synergistically control pH between 5.0 and 7.5. Mild antibacterial preservative 0.01%～4.00% 0.03%～3.00% Broad-spectrum and gentle, with an antibacterial rate of ≥99%. Purified water Replenish to 100% Supplement to 100% Meets the purified water standards of the Chinese Pharmacopoeia

[0023] Preferred proportions of the present invention

[0024] Option 1 (Routine Care): 5% of routine cleansing amino acid surfactant + other components added within the preferred range (suitable for most stoma skin).

[0025] Option 2 (Extremely Sensitive Skin): 4% ultra-low irritant amino acid surfactant + 2% conventional cleansing amino acid surfactant + other components added within the preferred range (suitable for postoperative acute phase and eroded skin).

[0026] Option 3 (Stubborn Adhesive Cleaning): 6% strong cleaning amino acid surfactant + 3% regular cleaning amino acid surfactant + other components added within the preferred range (suitable for scenarios with frequent stoma base replacement and high adhesive residue).

[0027] In the preferred embodiments described above, the components work synergistically within the stated weight percentage range, which can significantly improve the performance of the product.

[0028] When amino acid surfactants are compounded, the cleaning power is improved by 15% to 20% (adhesive removal rate ≥95%) and the irritation is reduced by 30% (primary irritation index PII ≤0.4).

[0029] The buffer system maintains a pH fluctuation of ≤0.3 within the temperature range of 4℃ to 45℃, ensuring long-term stability.

[0030] Film formation time is controlled between 30 and 60 seconds, film adhesion is ≥0.5N / 25mm, and water immersion resistance is ≥8 hours.

[0031] All amino acid surfactants can achieve a stickiness removal rate of over 90% at a concentration of 2% to 5%, avoiding the sticky feeling problem caused by high concentrations.

[0032] Functions and mechanisms of action of each component.

[0033] Natural polysaccharide moisturizer: This natural small-molecule sugar moisturizer has extremely high biocompatibility. It can form a breathable moisturizing film on the skin surface, reducing moisture evaporation, stabilizing skin protein structure, soothing dry, sensitive, and damaged skin, enhancing skin tolerance and barrier function, and repairing stoma and surrounding skin. Tests have shown that a 0.5% concentration can increase skin moisture content by 10%–15%.

[0034] Water-soluble cellulose-based film-forming agents: acting as thickeners, suspending agents, and auxiliary film-forming agents, they improve system uniformity and stability, enhance spreadability, create a continuous and uniform film layer, increase adhesion, and prevent peeling. A moist and gentle gel protective layer effectively isolates excrement, secretions, and adhesive irritants; the viscosity of a 2% aqueous solution is controlled at 200–500 mPa·s, ensuring film-forming properties while avoiding application difficulties.

[0035] Polyol moisturizer: A classic, gentle moisturizer that absorbs moisture from the air and deep into the skin, working synergistically with natural polysaccharides to achieve "internal hydration + external moisture retention," reducing irritation from excretions and improving skin feel. When combined with natural polysaccharides in a 3:1 ratio, the moisturizing time can be extended to over 6 hours, superior to the effect of using a single ingredient.

[0036] Amino acid-based anionic surfactants (performance correlation)

[0037] Regular cleaning type C12 Glutamic acid (neutral) 8.5～10.2 0.6 88～90 Conventional stoma skin High-efficiency cleaning type C12 Glycine (neutral) 7.8～9.5 0.5 92～94 Adhesive residue severely affects skin High moisturizing type C12 Glutamic acid (neutral) 9.0～11.3 0.5 89～91 Dry stoma skin Ultra-low irritation C12 Glutamic acid (neutral) 10.2～12.5 0.3 89～91 Extremely sensitive / eroded skin in recovery period

[0038] Specific component mechanism

[0039] Regular cleansing type: C12 fatty acid chain (ensuring cleaning power) + glutamic acid residue (providing gentleness). After skin irritation testing, no redness or stinging reaction was observed at a 2% concentration. It has a removal rate of ≥88% for adhesive residue and can also help emulsify other components in the system to improve stability.

[0040] High-efficiency cleaning type: C12 fatty acid chain + glycine residues, pH value 5.5-6.5 (consistent with skin pH), lowest CMC value (7.8-9.5mmol / L), high-efficiency cleaning at low concentration, with a removal rate of ≥92% for stubborn adhesives, suitable for scenarios where stoma base plates are frequently replaced.

[0041] High-moisturizing type: The only difference from the regular cleansing type is the cationic form, which has better moisturizing properties (skin moisture increases by 25% to 30% after use), making it suitable for dry ostomy skin.

[0042] Ultra-low irritation type: Short-chain optimized structure, primary irritation index (PII) ≤0.3, suitable for extremely sensitive skin in the postoperative acute phase, erosion recovery period, etc., with a refreshing and non-tightening feel; Common mechanism: All connect fatty acid chains and amino acid residues through "amide bonds", avoiding the irritation caused by the "sulfate ester bonds" of traditional surfactants. At the same time, amino acid residues can form hydrogen bonds with the stratum corneum of the skin, enhancing moisturizing and repairing effects; The selection of C12 fatty acid chains can balance cleansing power (avoiding insufficient cleansing by C10-) and gentleness (avoiding the sticky feel of C14+).

[0043] Osmotic pressure regulator, first buffer salt, and second buffer salt: constitute an isotonic buffer system, making the product's osmotic pressure close to that of human body fluids (280~320mOsm / kg), reducing stinging and burning sensations when applied to broken or sensitive skin; the first buffer salt and the second buffer salt are compounded in a ratio of 1:1 to 2:1, which can maintain pH stability (fluctuation ≤0.3) within the range of 4℃~45℃, improving comfort and system stability.

[0044] Mild antibacterial preservative: This is a broad-spectrum, mild antibacterial agent, preferably of the low-irritant type. It has a good inhibitory effect on common pathogenic bacteria such as Staphylococcus aureus, Escherichia coli, and Candida albicans (inhibition rate ≥99%). It can take effect at low concentrations (0.03%~0.5%), has extremely low irritation and no sensitization, and is suitable for long-term medical care. When compounded, it can reduce the dosage of a single preservative and further reduce the risk of irritation.

[0045] Purified water: As a dissolving and dispersing medium, it ensures the purity of the formula, is free of impurities, and has low irritation. It must meet the purified water standard of the 2020 edition of the Chinese Pharmacopoeia, Part II, with a resistivity ≥18.2 MΩ・cm (25℃) and total organic carbon ≤0.5 mg / L.

[0046] Preparation method.

[0047] A method for preparing a mild rinsing stoma skin protectant includes the following steps.

[0048] Pre-dispersion: Weigh the natural polysaccharide moisturizer and water-soluble cellulose film-forming agent according to the formula, add them to the polyol moisturizer, and stir at high speed for 15-20 minutes at 30-35℃ and 500-800 rpm until dispersed without particles and uniformly fine; Key control points: The temperature needs to be controlled at 30-35℃. Below 28℃, the film-forming agent is prone to clumping, and above 38℃, the moisturizer may be locally degraded; Abnormal handling: If the film-forming agent clumps, the temperature can be raised to 32-35℃, 1%-2% polyol can be added, and stirring can be extended for 5-8 minutes until the clumping disappears.

[0049] Main dissolution: Slowly add 70% of the formulated amount of purified water to the system, and stir continuously for 20-30 minutes at 25-30℃ and 300-500 rpm until the natural polysaccharide moisturizer and water-soluble cellulose film-forming agent are completely dissolved and the system is transparent and uniform; Key control points: The water temperature should not exceed 35℃ to avoid degradation of the moisturizer; The stirring speed should not be lower than 300 rpm to ensure sufficient dissolution; Abnormal handling: If the system becomes turbid, the stirring speed can be increased to 450-500 rpm and the stirring time extended by 10 minutes, or 5%-10% purified water can be added (the amount of water in subsequent steps needs to be reduced accordingly).

[0050] Preparation of the buffer system: Weigh the osmotic pressure regulator, the first buffer salt, and the second buffer salt in sequence, and dissolve them in the remaining 30% purified water (water temperature 20-25℃). After stirring until completely dissolved, slowly add the above main solution while stirring (200-300 rpm) for 10-15 minutes. Measure the pH value to be 5.5-7.0. Key control points: The ratio of the first buffer salt to the second buffer salt must be accurate (1:1-2:1) to ensure pH stability. Abnormal handling: If pH > 7.2 (alkaline), add 0.5 mL of 0.1 mol / L hydrochloric acid solution dropwise, stir for 2 minutes, and then retest. If pH < 5.3 (acidic), add 0.3 mL of 0.1 mol / L sodium hydroxide solution dropwise until the pH reaches the target value.

[0051] Preservative dissolution: Weigh out the mild antibacterial preservative and add 2-3 times its weight of purified water (water temperature 50-70℃). Heat and stir simultaneously (100-200 rpm) until completely dissolved. Key control points: Control the dissolution temperature appropriately to avoid evaporation loss and ensure complete dissolution. Abnormal handling: If the preservative is not completely dissolved, raise the temperature to 65-70℃ and stir for 5-8 minutes. If stratification occurs, add 1-2 times the amount of purified water and continue stirring until homogeneous.

[0052] Mixing and Refining: Cool the fully dissolved preservative solution to 30–35°C and slowly add it to the above system. Stir continuously at 300–400 rpm for 20–25 minutes until the system is completely homogeneous, without stratification or particles. Then filter through a 0.22 μm microporous membrane (filtration pressure ≤ 0.3 MPa) to obtain a mild rinsing stoma skin protectant. Key control points: The temperature must be lowered to 30–35°C before filtration to avoid high temperature damage to the filter membrane; the filtration pressure should be ≤ 0.3 MPa to prevent damage to the gel structure. Abnormal handling: If the filter membrane is clogged, replace the 0.22 μm filter membrane, reduce the feed rate (≤ 50 mL / min), or pre-treat with a 5 μm filter membrane; if a small amount of precipitation appears after filtration, stir again for 10 minutes and filter again.

[0053] The beneficial effects of this invention.

[0054] Extremely gentle, zero risk of irritation: It adopts an amino acid surfactant + alcohol-free + strong irritant preservative system. After clinical trial on 30 ostomy patients (for 7 consecutive days), there was no redness, stinging or sensitization reaction, and the skin tolerance score was ≥4.8 points (out of 5). Compared with commercially available products, the irritation is significantly reduced (see table below).

[0055] Embodiment 4 of the present invention 0.4 0% 0% Commercially available product A 1.8 35% 12% Commercially available product B 1.2 18% 8%

[0056] Double moisturizing and deep repair: Natural polysaccharides and polyols work synergistically to increase skin moisture content by 20%–30% after use, with moisturizing time ≥4 hours. Skin barrier function (TEWL) test results show that after 2 weeks of use, the TEWL value decreases by 15%–20% (the lower the TEWL value, the better the barrier function); superior to commercially available products (moisturizing time 1.5–3 hours, TEWL value decrease 5%–10%).

[0057] Mild antibacterial properties and safe protection: The preservative has an antibacterial rate of ≥99% against Staphylococcus aureus, Escherichia coli, and Candida albicans, with a continuous antibacterial time of ≥24 hours. In clinical trials, the infection rate was reduced from 25% (average level of commercially available products) to 8%. It is effective at low concentrations, with extremely low irritation and no sensitization.

[0058] Innovative liquid gel membrane formation with excellent isolation effect: Natural polysaccharides and cellulose film-forming agents synergistically form a liquid gel membrane with a film formation time of 30-60 seconds and a membrane thickness of 5-10μm. In the immersion test of simulated excrement (pH 4.0-8.0), the membrane integrity is maintained for ≥8 hours, effectively blocking irritants. Compared with commercially available products, the water resistance time of the membrane is significantly extended (commercially available products 4-8 hours), and it does not turn white or sticky.

[0059] Enhanced cleaning and odor removal functions: Amino acid surfactants (especially compound formulations) have a removal rate of ≥95% for excrement and an adsorption rate of ≥85% for odor substances (such as indole and skatole); compared with commercially available products, the cleaning effect is better (see table below).

[0060] Embodiment 4 of the present invention 95～97 98～99 89～91 Commercially available product A 82～85 90～92 75～80 Commercially available product B 88～90 92～94 80～85

[0061] The system is stable, without stratification or precipitation: under accelerated stability testing (6 months) at -4℃ (cold resistance) and 45℃ (heat resistance), the product showed no stratification, no discoloration, and no precipitation, with a viscosity change rate ≤5% and pH fluctuation ≤0.3; superior to commercially available products (viscosity change rate 8%~15%, some products show stratification).

[0062] Skin feel optimization: The product viscosity is controlled at 100-1000 mPa・s (25℃), which makes it smooth and unobstructed when applied. After the film is formed, it is not sticky or white. The skin feel satisfaction rate of 50 users is ≥92% (average score 4.6 points); which is better than commercially available products (satisfaction rate 75%-85%, average score 3.8-4.2 points). Detailed Implementation

[0064] The present invention will be further described in detail below with reference to specific embodiments. This formulation uses amino acid-based anionic surfactants as the core for cleaning, combined with natural polysaccharide moisturizers, water-soluble cellulose film-forming agents, polyol moisturizers, and other moisturizing, thickening, and buffering components. Inorganic salts are added to adjust the viscosity and stability of the system, and mild antibacterial preservatives are used to ensure shelf life. Purified water is added to bring the total volume to 100%. Four differentiated embodiments are designed below (including three single-component and one compound-component group). The content of all components is within a weight percentage range, strictly adhering to the given content range, facilitating fine-tuning as needed in actual production.

[0065] Example 1 (Conventional Cleaning Single System)

[0066] A mild rinsing stoma skin cleansing and protective agent, comprising by weight percentage: natural polysaccharide moisturizer: 0.03%–3.50%, water-soluble cellulose film-forming agent: 0.03%–3.50%, polyol moisturizer: 3%–26%, conventional cleansing amino acid surfactant: 3%–27%, osmotic pressure regulator: 0.4%–2.3%, first buffer salt: 0.06%–2.00%, second buffer salt: 0.06%–2.00%, mild antibacterial preservative: 0.04%–2.50%, and purified water: to 100%.

[0067] Performance tests were conducted on the product of Example 1.

[0068] Skin irritation test: According to GB / T16886.10-2017, patch tests were performed on 10 subjects with intact skin and 5 subjects with broken skin. There were no redness, swelling or stinging reactions, and the irritation score (PII) was 0.6.

[0069] Moisturizing performance: Using a Corneometer CM825 tester, skin moisture content increased by 20% to 22% after use, and remained at 60% of the initial increase after 4 hours.

[0070] Liquid gel film performance: film formation time 45-60 seconds, film adhesion 0.5-0.6 N / 25 mm (tested with a tensile testing machine), water immersion resistance 8-10 hours, no cracking.

[0071] Antibacterial properties: According to QB / T2738-2012, the antibacterial rates against Staphylococcus aureus, Escherichia coli, and Candida albicans are 99.2%, 99.1%, and 98.8%, respectively.

[0072] Cleaning and odor removal performance: 88%–90% removal rate of stoma adhesive residue (tested by image analysis method), and 85%–87% adsorption rate of indole (tested by gas chromatography method).

[0073] Stability testing: Accelerated testing at -4℃ and 45℃ for 6 months showed no stratification, precipitation, or discoloration. The viscosity change rate was 4.2% (NDJ-5S rotational viscometer, 60 rpm), and the pH fluctuation was 0.2. The test results indicate that this product is gentle, has good cleaning and care functions, is safe and stable, and provides comprehensive effects, meeting the long-term skin care needs of ostomy patients.

[0074] Example 2 (High-efficiency cleaning single system).

[0075] Specific component content (weight percentage): Natural polysaccharide moisturizer: 0.05%–3.00%, water-soluble cellulose film-forming agent: 0.05%–3.00%, polyol moisturizer: 4%–23%, powerful cleansing amino acid surfactant: 4%–24%, osmotic pressure regulator: 0.5%–1.5%, first buffer salt: 0.07%–1.80%, second buffer salt: 0.07%–2.00%, mild antibacterial preservative: 0.05%–2.30%, purified water: make up to 100%.

[0076] Performance tests were conducted on the product of Example 2.

[0077] Skin irritation test: The trial was conducted on 15 subjects (including 8 patients within 3 months post-surgery). No redness or sensitization reaction was observed, and the irritation score (PII) was 0.5.

[0078] Moisturizing performance: After use, the skin's moisture content increases by 22% to 24%, and remains at 65% of the initial increase after 4 hours.

[0079] Liquid gel membrane properties: film formation time 35-45 seconds, film adhesion 0.6-0.7 N / 25 mm, water immersion resistance 9-11 hours.

[0080] Antibacterial properties: The antibacterial rates against Staphylococcus aureus, Escherichia coli, and Candida albicans were 99.3%, 99.2%, and 99.0%, respectively.

[0081] Cleaning and odor removal performance: Adhesive residue removal rate of 92% to 94%, skatole adsorption rate of 87% to 89%.

[0082] Stability test: After 6 months of accelerated testing at -4℃ and 45℃, there was no stratification, no precipitation, no discoloration, viscosity change rate of 3.8%, and pH fluctuation of 0.15.

[0083] Example 3 (Ultra-low irritation single system)

[0084] Specific component content (weight percentage): Natural polysaccharide moisturizer: 0.08%–2.50%, water-soluble cellulose film-forming agent: 0.08%–2.50%, polyol moisturizer: 5%–20%, ultra-low irritation amino acid surfactant: 4%–24%, osmotic pressure regulator: 0.6%–1.3%, first buffer salt: 0.08%–1.50%, second buffer salt: 0.08%–1.50%, mild antibacterial preservative: 0.06%–2.00%, purified water: make up to 100%.

[0085] Performance tests were conducted on the product of Example 3.

[0086] Skin irritation test: In 5 patients in the recovery period of erosion, no stinging or burning sensation was observed after 7 days of continuous use, and the irritation score (PII) was 0.3.

[0087] Moisturizing performance: After use, the skin's moisture content increases by 25% to 30%, and this increase is maintained at 70% of the initial level after 4 hours.

[0088] Liquid gel film performance: film formation time 30-40 seconds, film adhesion 0.4-0.5N / 25mm, lighter and thinner texture, suitable for sensitive skin.

[0089] Antibacterial properties: The antibacterial rates against Staphylococcus aureus, Escherichia coli, and Candida albicans were 99.1%, 99.0%, and 98.9%, respectively.

[0090] Cleaning and odor removal performance: Adhesive residue removal rate 89%~91%, odor adsorption rate 86%~88%.

[0091] Stability test: Accelerated test at -4℃ and 45℃ for 6 months showed no stratification, no precipitation, no discoloration, viscosity change rate of 4.0%, and pH fluctuation of 0.18.

[0092] Example 4 (Combined All-Round System)

[0093] Specific component content (weight percentage): Natural polysaccharide moisturizer: 0.05%–3.00%, water-soluble cellulose film-forming agent: 0.05%–3.00%, polyol moisturizer: 4%–25%, conventional cleansing + strong cleansing compound amino acid surfactant: 5%–25%, osmotic pressure regulator: 0.4%–2.0%, first buffer salt: 0.06%–2.00%, second buffer salt: 0.06%–2.00%, mild antibacterial preservative: 0.05%–2.20%, purified water: make up to 100%.

[0094] Performance tests were conducted on the product of Example 4 (highlighting the advantages of compound formulation).

[0095] Skin irritation test: 20 subjects (including 10 long-term users) tried the product, and the irritation score (PII) was 0.4, taking into account both gentleness and suitability.

[0096] Moisturizing performance: After use, the skin's moisture content increases by 23% to 26%, and remains at 68% of the initial increase after 4 hours.

[0097] Liquid gel membrane performance: film formation time 35-50 seconds, film adhesion 0.6-0.8 N / 25 mm, water immersion resistance 10-12 hours, superior to single system.

[0098] Antibacterial properties: The antibacterial rate against the three pathogenic bacteria is ≥99.2%, and the duration of antibacterial action is ≥24 hours.

[0099] Cleaning and odor removal performance: Adhesive residue removal rate of 95% to 97% (superior to 88% to 94% of single system), odor adsorption rate of 89% to 91%.

[0100] Stability test: Accelerated test at -4℃ and 45℃ for 6 months, viscosity change rate 3.5%, pH fluctuation 0.12, stability is better than single system.

[0101] A comprehensive comparison with commercially available products.

[0102] Overall score (10 points) 9.2 6.5 7.8 Patient satisfaction 92% 65% 78% Long-term usage recommendation rate 95% 58% 72%

[0103] The above description of the three sets of embodiments disclosed enables those skilled in the art to implement or use the present invention. Various modifications and parameter adjustments to these embodiments will be readily apparent to those skilled in the art, and the core formulation principles defined herein can be implemented in other similar formulation embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not limited to the specific embodiments shown herein, but is to be accorded the widest scope of protection consistent with the formulation principles and novel features disclosed herein.

Claims

1. A gentle cleansing ostomy skin protectant composition characterized in that, By weight percentage, it includes: 0.01%–5.0% natural polysaccharide moisturizer, 0.01%–5.0% water-soluble cellulose film-forming agent, 2.0%–30.0% polyol moisturizer, 1.0%–30.0% amino acid anionic surfactant, 0.2%–3.0% osmotic pressure regulator, 0.02%–3.5% first buffer salt, 0.02%–3.5% second buffer salt, 0.01%–4.0% mild antibacterial preservative, and purified water to bring the total to 100%.

2. The composition of claim 1, wherein, The amino acid-based anionic surfactant is one or more of anionic surfactants that combine C12 fatty acid chains with neutral amino acid residues, and its CMC value (25°C) is 7.8–12.5 mmol / L.

3. The composition of claim 1, wherein, The first and second buffer salts are phosphates, and their mass ratio is 1:1 to 2:

1. The pH value of the composition is 5.0 to 7.

5.

4. The composition of claim 1, wherein, The osmotic pressure regulator makes the osmotic pressure of the composition system 280-320 mOsm / kg, which is isotonic.

5. The composition of claim 1, wherein, The mild antibacterial preservative is a low-irritant, broad-spectrum antibacterial agent with an inhibition rate of ≥99% against Staphylococcus aureus, Escherichia coli, and Candida albicans.

6. A process for preparing the mild cleansing ostomy skin protectant composition according to any one of claims 1 to 5, characterized in that, The process includes the following steps: (1) adding natural polysaccharide moisturizer and water-soluble cellulose film-forming agent to polyol moisturizer and stirring and dispersing them evenly at 30-35℃ and 500-800rpm; (2) adding 70% of the formula amount of purified water and stirring at 25-30℃ and 300-500rpm until completely dissolved; (3) dissolving the osmotic pressure regulator, the first buffer salt, and the second buffer salt in the remaining 30% of purified water, adding them to the above system and adjusting the pH to 5.5-7.0; (4) dissolving the mild antibacterial preservative in purified water by heating and then cooling; (5) mixing the components, stirring evenly and filtering through a microporous membrane to obtain the finished product.

7. The production method according to claim 6, characterized by, Step (5) uses a 0.22μm filter membrane for filtration, with a filtration pressure ≤0.3MPa, and the viscosity of the resulting product is 100~1000mPa・s (25℃).

8. Use of a composition according to any one of claims 1 to 5, characterized in that, This product provides gentle cleansing, moisturizing, repairing, isolating, protecting, inhibiting bacteria and preventing infection, and eliminating odors around the stoma. It is especially suitable for long-term stoma care.