Antibacterial silica gel and preparation process thereof

Abstract

The invention relates to the technical field of foam dressings, in particular to antibacterial silica gel and a preparation process thereof. The antibacterial silica gel is prepared from a component A, a component B and an antibacterial agent according to the mass ratio of 1: 1: (1%-2%), raw materials of the component A comprise vinyl silicone oil, a platinum catalyst and methyl silicone oil, raw materials of the component B comprise vinyl silicone oil, hydrogen-containing silicone oil, methyl silicone oil and a modifier, and in the component A and the component B, the content of the platinum catalyst in the component A and the content of the methyl silicone oil in the component B are 1: 1%-2%. The molar ratio of vinyl to silicon hydrogen in the vinyl silicone oil and the hydrogen-containing silicone oil is 1: (1.2-2.67); the modifier accounts for 3-5wt% of the total mass of other materials in the component B; the modifier is at least one of an acrylic phosphate monomer and an acrylic monomer; the modifier is adopted in the antibacterial silica gel, so that the network structure degree, strength, water absorption and moisture retention of the silica gel are improved, the silica gel can be promoted to slowly release the antibacterial agent, the slow release performance of the antibacterial silica gel is further improved, and the antibacterial silica gel has relatively stable antibacterial and bactericidal effects.

Description

Technical Field

[0001] The invention relates to the technical field of foam dressings, and in particular to an antibacterial silicone gel and a manufacturing process thereof. Background Art

[0002] Wound dressing pads are mainly used for chronic wounds and wounds with moderate or higher exudate to absorb exudate and provide a good healing environment. Self-adhesive wound dressings were often used in previous wound care processes.

[0003] Silicone gel can promote epithelial cell metabolism, inhibit capillary proliferation, improve local blood circulation, promote epithelial repair, and has good elasticity. It is currently widely used in high-end wound care to treat burns, scalds and other skin scar hyperplasia. Its main products are silicone dressings.

[0004] In order to cope with the problem of bacterial infection in patients with large-area burns, the silicone dressings developed on the market mainly add silver to the silicone foam layer to achieve antibacterial effect. Silicone dressings containing silver have the following two main problems: First, they are expensive, costing hundreds or even thousands of yuan per piece, which increases the burden on patients; second, silver is a heavy metal and direct contact with the skin may cause heavy metal poisoning. Currently, silver is generally attached to the foam layer in the form of sodium zirconium silver phosphate. The release of silver in silicone dressings is related to the exudate of the wound and the sustained-release effect of silicone dressings. If the wound exudate is less, silver will basically not be released; when the exudate is more, the silver in the silicone dressing is released faster in a shorter time, which may cause silver poisoning, resulting in the risk of unsatisfactory antibacterial effect or silver poisoning of the silver-containing silicone dressing. Summary of the invention

[0005] In order to solve the problem that the sustained release of antibacterial agents in existing antibacterial dressings is highly dependent on the amount of wound exudate and there is a risk of silver poisoning, the present application provides an antibacterial silicone gel and a production process thereof.

[0006] In a first aspect, the present application provides an antibacterial silicone gel:

[0007] An antibacterial silicone gel comprises a component A, a component B and an antibacterial agent in a mass ratio of 1:1:(0.1%-0.2%), wherein the raw materials of the component A comprise vinyl silicone oil, a platinum catalyst and methyl silicone oil, and the raw materials of the component B comprise vinyl silicone oil, hydrogen-containing silicone oil, methyl silicone oil and a modifier, wherein the molar ratio of vinyl silicone oil to vinyl and silicon hydrogen in the hydrogen-containing silicone oil in the component A and the component B is 1:(1.2-2.67); the modifier accounts for 3-5wt% of the total mass of other materials in the component B; and the modifier is at least one of an acrylic acid phosphate monomer and an acrylic acid monomer.

[0008] In the present application, the silicone gel is modified by a modifier, and the acrylic acid phosphate monomer and acrylic acid monomer in the modifier participate in the network structure of the silicone gel through unsaturated bonds. The modifier is more evenly dispersed in the network structure of the silicone gel, which can not only improve the network structure and strength of the silicone gel, but also improve the water absorption and moisture retention of the silicone gel, and promote the sustained release of antibacterial agents from the silicone gel, thereby improving the sustained release performance of the antibacterial silicone gel, and making the antibacterial silicone gel have a more stable antibacterial and bactericidal effect.

[0009] The antibacterial effect of the prepared bacterial silica gel can reach 99.99%, and PHMB is non-irritating to the skin, oral cavity, and vagina, and is skin-friendly and warm. PHMB has a large molecular weight and is not easily absorbed by the human digestive system and respiratory system. Even if it is swallowed into the human body, it will be naturally excreted from the body through the digestive tract, so there is no need to worry. Therefore, it can contact the skin and is relatively safe.

[0010] Furthermore, the antibacterial agent is sodium silver zirconium phosphate or polyhexamethylene biguanide hydrochloride.

[0011] The polar groups in the antibacterial silicone gel in the present application have certain interactions with the polar metal elements in sodium silver zirconium phosphate and with the amino and / or amine groups of polyhexamethylene biguanide, thereby enabling the silicone gel to release the antibacterial agent more slowly.

[0012] Among them, the rich amino and / or amine groups in polyhexamethylene biguanide further enhance the water absorption and moisturizing properties of the antibacterial silicone gel. In addition, polyhexamethylene biguanide is cheap and has a simple synthesis process, which to a certain extent solves the cost of use for patients. In addition, polyhexamethylene biguanide is safer and more antibacterial.

[0013] Furthermore, the raw materials of the A component, by mass, include 100 parts of vinyl silicone oil, 0.01-0.02 parts of platinum catalyst, and 80-90 parts of methyl silicone oil; the raw materials of the B component, by mass, include 80 parts of vinyl silicone oil, 60-70 parts of terminal side-group hydrogenated silicone oil, 10-15 parts of modifier, and 120 parts of methyl silicone oil.

[0014] Furthermore, the vinyl content of the vinyl silicone oil is 0.1-0.3 mmol / g and the molecular weight is 10000-50000; Furthermore, the platinum catalyst is chloroplatinic acid with a Pt content of 30-50 wt%.

[0015] Furthermore, the hydrogen-containing silicone oil is a terminal side group hydrogen-containing silicone oil, and the molecular weight of the terminal side group hydrogen-containing silicone oil is 500-6000 and the hydrogen content is 0.8-1.5 mmol / g.

[0016] Methyl silicone oil makes the antibacterial silicone gel have excellent softness, elasticity and hardness, which enables the prepared silicone gel dressing to have better contact with the wound skin under a certain pressure and have better comfort performance, thereby enabling the antibacterial silicone gel to better play its antibacterial and skin repair role.

[0017] Furthermore, the molecular weight of the methyl silicone oil is 20,000-50,000.

[0018] In the second aspect, the present application provides a preparation process of an antibacterial silicone gel:

[0019] A preparation process of antibacterial silicone gel comprises the following preparation steps:

[0020] Preparation of component A: Mix and stir the raw materials of component A to obtain component A;

[0021] Preparation of component B: Mix and stir the raw materials of component B to prepare component B;

[0022] Preparation of antibacterial silicone gel: Component A, component B and the antibacterial agent are mixed according to a certain proportion, and stirred for 30-50 minutes to prepare the antibacterial silicone gel.

[0023] Furthermore, the stirring speed in the preparation of component A, the preparation of component B and the preparation of antibacterial silicone gel is 300-500 rpm.

[0024] Furthermore, in the preparation of the A component, the temperature is controlled at 20-40°C; in the preparation of the B component, the temperature is controlled at 20-40°C and stirred for 2-3 hours; in the preparation of the antibacterial silicone gel, the temperature is controlled at 20-35°C.

[0025] Beneficial effects:

[0026] 1. The present application adopts a modifier in the antibacterial silicone gel to improve the network structure and strength, water absorption and moisture retention of the silicone gel, which can promote the sustained release of antibacterial agents from the silicone gel, thereby improving the sustained release performance of the antibacterial silicone gel, and making the antibacterial silicone gel have a more stable antibacterial and bactericidal effect.

[0027] 2. The preferred antibacterial agent is polyhexamethylene biguanide, which further improves the water absorption and moisturizing properties of the antibacterial silicone gel, thereby improving the sustained release effect and antibacterial properties of the antibacterial silicone gel. DETAILED DESCRIPTION

[0028] In order to make the technical solution of the present invention clearer, the present invention is further described in detail below in conjunction with specific embodiments.

[0029] Embodiment 1: An antibacterial silicone gel, the preparation process of which comprises the following preparation steps:

[0030] Preparation of component A: Add the raw materials of component A (the raw materials used in component A are shown in Table 1) into a reaction kettle, control the temperature at 30°C, stir at 400 rpm, stir for 2.5 hours, and prepare component A for standby use.

[0031] Preparation of component B: Add the raw materials of component B (the raw materials used in component B are shown in Table 1) into a reaction kettle and stir for 2.5 hours at a stirring speed of 400 rpm to obtain component B for standby use.

[0032] Preparation of antibacterial silicone gel: Component A, component B and antibacterial agent (polyhexamethylene biguanide hydrochloride) were mixed in a mass ratio of 1:1:0.1%, and stirred at a temperature of 20-35°C for 40 minutes to prepare antibacterial silicone gel.

[0033] Table 1. Raw materials of component A in the antibacterial silicone gel of Example 1 and types, types and amounts of raw materials used in component B

[0034]

[0035] Example 2: An antibacterial silicone gel, which differs from Example 1 in that the antibacterial agent uses an equal amount of sodium zirconium phosphate silver to replace polyhexamethylene biguanide hydrochloride.

[0036] Example 3: An antibacterial silicone gel, which differs from Example 1 in that the modifier uses an acrylic acid monomer to replace the acrylic acid phosphate monomer in equal amounts.

[0037] Example 4: An antibacterial silicone gel, which differs from Example 3 in that the antibacterial agent uses an equal amount of sodium zirconium phosphate silver to replace polyhexamethylene biguanide hydrochloride.

[0038] Example 5: An antibacterial silicone gel, which differs from Example 1 in that the raw materials of component A and component B use different types, types and amounts of raw materials (as shown in Table 2) and the preparation process parameters are set differently. The preparation process includes the following preparation steps:

[0039] Preparation of component A: Add the raw materials of component A (the raw materials used in component A are shown in Table 2) into the reaction kettle, control the temperature at 40°C, stir at 500 rpm, stir for 3 hours, and prepare component A for standby use.

[0040] Preparation of component B: Add the raw materials of component B (the raw materials used in component B are shown in Table 2) into a reaction kettle and stir for 3 hours at a stirring speed of 500 rpm to obtain component B for standby use.

[0041] Preparation of antibacterial silicone gel: Component A, component B and an antibacterial agent (polyhexamethylene biguanide hydrochloride) were mixed in a mass ratio of 1:1:0.2%, and stirred for 30 minutes to prepare the antibacterial silicone gel.

[0042] Table 2. Raw materials of component A in the antibacterial silicone gel of Example 5 and types, types and amounts of raw materials used in component B

[0043]

[0044] Example 6: An antibacterial silicone gel, which differs from Example 1 in that the raw materials of component A and component B use different types, types and amounts of raw materials (as shown in Table 3) and the preparation process parameters are set differently. The preparation process includes the following preparation steps:

[0045] Preparation of component A: Add the raw materials of component A (the raw materials used in component A are shown in Table 3) into the reaction kettle, control the temperature at 20°C, stir at 300 rpm, stir for 2 hours, and prepare component A for standby use.

[0046] Preparation of component B: Add the raw materials of component B (the raw materials used in component B are shown in Table 3) into a reaction kettle and stir for 2 hours at a stirring speed of 300 rpm to obtain component B for standby use.

[0047] Preparation of antibacterial silicone gel: Component A, component B and an antibacterial agent (polyhexamethylene biguanide hydrochloride) were mixed in a mass ratio of 1:1:0.1%, and stirred for 50 minutes to prepare the antibacterial silicone gel.

[0048] Table 3. Raw materials of component A and types, types and amounts of raw materials used in component B in Example 6

[0049]

[0050] Performance testing:

[0051] 1. Antibacterial properties:

[0052] 10 g of the antibacterial silicone gels of Examples 1 to 6 and Comparative Example 1 and a control group (the difference between the control group and the antibacterial silicone gel of Example 1 is that the silicone gel does not use an antibacterial agent) were prepared into experimental samples of 10*10 cm and 0.5 mm thickness, and placed on a 10*10 cm, 0.5 mm thick plate containing bacteria (colony density of 300 cfu / cm 2 ) on gauze, and then place it at 25°C and 70% humidity for 7 days. Then, the colonies on the gauze are cultured to confirm the colony number.

[0053] The bacteria used were Gram-positive bacteria: Staphylococcus aureus; the fungi were: Candida albicans.

[0054] The water content is ①5wt%; ②15wt%; ③25wt%;

[0055] Under the same water density, the bacterial colony reduction rate = (the number of colonies in the control group - the number of colonies in the experimental group) / the number of colonies in the control group. For each experiment, N = 3 and the average value is taken. The experimental results are shown in Table 4.

[0056] Table 4. Test results of antibacterial properties of antibacterial silicone gels of Examples 1 to 6

[0057]

[0058] 2. Sustained release performance:

[0059] 10 g of the antibacterial silicone gel of Examples 1 to 6 was prepared into a 5 cm*5 cm experimental sample, and then put into 1 L of purified water (water without any ions), and placed at 25°C after covering the lid; sampling was continued for 12 days, and the content of the antibacterial agent was measured by atomic absorption spectroscopy. The test results are shown in Table 5.

[0060] Table 5. Test results of the content of antibacterial agent in the antibacterial silicone gel of Examples 1 to 6

[0061]

[0062] If no modifier is used in the antibacterial silicone gel in Example 1, the hardness and strength of the prepared antibacterial silicone gel are low, close to liquid, cannot be formed, will disperse in water, and the antibacterial agent will be released very quickly.

[0063] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An antibacterial silicone gel, characterized in that: The invention comprises a component A, a component B and an antibacterial agent in a mass ratio of 1:1:(0.1%-0.2%), wherein the raw materials of the component A comprise vinyl silicone oil, a platinum catalyst and methyl silicone oil, and the raw materials of the component B comprise vinyl silicone oil, hydrogen-containing silicone oil, methyl silicone oil and a modifier, and the molar ratio of vinyl silicone oil to vinyl and silicon hydrogen in the hydrogen-containing silicone oil in the component A and the component B is 1:(1.2-2.67); the modifier accounts for 3-5wt% of the total mass of other materials in the component B; and the modifier is at least one of an acrylic acid phosphate monomer and an acrylic acid monomer.

2. The antibacterial silicone gel according to claim 1, characterized in that: The antibacterial agent is sodium silver zirconium phosphate or polyhexamethylene biguanide hydrochloride.

3. The antibacterial silicone gel according to claim 1, characterized in that: The raw materials of the A component, by mass, include 100 parts of vinyl silicone oil, 0.01-0.02 parts of platinum catalyst, and 80-90 parts of methyl silicone oil; the raw materials of the B component, by mass, include 80 parts of vinyl silicone oil, 60-70 parts of terminal side-group hydrogenated silicone oil, 10-15 parts of modifier, and 120 parts of methyl silicone oil.

4. The antibacterial silicone gel according to claim 3, characterized in that: The vinyl content of the vinyl silicone oil is 0.1-0.3 mmol / g and the molecular weight is 10000-50000.

5. The antibacterial silicone gel according to claim 3, characterized in that: The platinum catalyst is chloroplatinic acid with a Pt content of 30-50wt%.

6. The antibacterial silicone gel according to claim 3, characterized in that: The hydrogen-containing silicone oil is a terminal side group hydrogen-containing silicone oil, and the molecular weight of the terminal side group hydrogen-containing silicone oil is 500-6000 and the hydrogen content is 0.8-1.5 mmol / g.

7. The antibacterial silicone gel according to claim 3, characterized in that: The molecular weight of the methyl silicone oil is 20,000-50,000.

8. The preparation process of the antibacterial silicone gel according to any one of claims 1 to 7, characterized in that: The method comprises the following preparation steps: Preparation of component A: Mix and stir the raw materials of component A to obtain component A; Preparation of component B: Mix and stir the raw materials of component B to prepare component B; Preparation of antibacterial silicone gel: Component A, component B and the antibacterial agent are mixed according to a certain proportion, and stirred for 30-50 minutes to prepare the antibacterial silicone gel.

9. The preparation process of the antibacterial silicone gel according to claim 8, characterized in that: The stirring speed in the preparation of component A, component B and antibacterial silicone gel is 300-500 rpm.

10. The preparation process of the antibacterial silicone gel according to claim 8, characterized in that: In the preparation of the A component, the temperature is controlled at 20-40°C; in the preparation of the B component, the temperature is controlled at 20-40°C and stirred for 2-3 hours; in the preparation of the antibacterial silicone gel, the temperature is controlled at 20-35°C.

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