Water-soluble lubricant, method for preparing the same, and use thereof

Abstract

The application discloses a water-soluble lubricant and a preparation method and application thereof. The water-soluble lubricant comprises the following components in percentage by mass: beta-(1,3) glucan 1.5-3%; polyether modified polydimethylsiloxane 3-5%; PEG-40 hydrogenated castor oil 1.5-3%; phosphatidylcholine 1-2%; thickening agent 0.1-0.5%; and the balance is water. The water-soluble lubricant formula of the application adopts a beta-(1,3) glucan and polyether modified polydimethylsiloxane composite system, simultaneously selects PEG-40 hydrogenated castor oil and phosphatidylcholine for compounding to form a composite emulsifying system, and adds a small amount of thickening agent to obtain a high-stability lubricant system, effectively solves the phase separation problem of hydrophobic silicone oil and hydrophilic glucan, and realizes a water-soluble lubricant with excellent lubricating performance, rapid water solubility, good biocompatibility and degradation.

Description

Technical Field

[0001] The present invention relates to the technical field of polymer materials, and in particular to a water-soluble lubricant and a preparation method and application thereof. Background Art

[0002] Traditional condom lubricants are primarily categorized as silicone-based and water-soluble. While silicone-based lubricants offer excellent lubrication durability and hydrophobic properties, they are poorly biodegradable and easily remain in the body, potentially disrupting the vaginal microbiome. Furthermore, compatibility with certain materials (such as silicone rubber) must be considered. Common water-soluble lubricants typically use cellulose derivatives (such as hydroxyethyl cellulose), polyacrylic acids (such as carbomer), polyvinyl pyrrolidone, or natural colloids (such as xanthan gum) as their primary thickening and lubricating components, combined with humectants such as glycerin and propylene glycol. While these lubricants are easy to clean and have good compatibility, they often suffer from issues such as insufficient lubrication durability (especially in dilute body fluids), easy drying and stickiness, and the need for high levels of synthetic polymers or preservatives to maintain viscosity or prevent microbial growth. In recent years, while attempts have been made to incorporate natural polysaccharides (such as hyaluronic acid and chitosan) into lubricant formulations to improve biocompatibility, hyaluronic acid is expensive and offers limited lubricity improvements, while chitosan is poorly soluble at physiological pH and may cause irritation. Therefore, there is an urgent need to develop a new water-soluble condom lubricant formulation that combines excellent lubricity (including initial lubricity, lubricity retention, and dilution resistance), rapid water solubility (easily cleaned), and good biocompatibility and degradability. Summary of the Invention

[0003] In order to overcome the deficiencies of the above-mentioned prior art, the object of the present invention is to provide a water-soluble lubricant having excellent lubrication performance, rapid water solubility, good biocompatibility and degradability.

[0004] The present invention is achieved through the following technical solutions:

[0005] A water-soluble lubricant comprising the following components by mass percentage:

[0006] β-(1,3) glucan 1.5%-3%;

[0007] Polyether modified polydimethylsiloxane 3%-5%;

[0008] PEG-40 hydrogenated castor oil 1.5%-3%;

[0009] Phosphatidylcholine 1%-2%;

[0010] Thickener 0.1%-0.5%;

[0011] The balance is water.

[0012] The lubricant of the present invention adopts a composite system of β-(1,3) glucan and polyether-modified polydimethylsiloxane. β-(1,3) glucan serves as the core film-forming matrix, providing structural support and long-lasting moisturizing properties in the system. It can fully swell in water to form a continuous three-dimensional network colloidal structure, which not only gives the lubricant suitable viscoelasticity but also reduces evaporation loss through hydrogen bonding. Its natural polysaccharide properties also ensure biocompatibility and biodegradability. Polyether-modified polydimethylsiloxane combines the hydrophobic lubricity of silicone with the water solubility of polyether segments. In the formulation system of the present invention, the polyether segments are embedded in the glucan colloidal network and stably dispersed through hydrophobic interactions, providing an instantaneous slippery feel and avoiding sticky residue.

[0013] Preferably, the average molecular weight of the β-(1,3) glucan is 100,000-500,000 Da. The β-(1,3) glucan of the present invention can be prepared by self-production or purchased commercially.

[0014] Preferably, the kinematic viscosity of the polyether-modified polydimethylsiloxane at 25°C is 150-500 mm 2 / s.

[0015] The present invention selects PEG-40 hydrogenated castor oil and phosphatidylcholine to form a composite emulsification system. PEG-40 hydrogenated castor oil acts as a nonionic surfactant to reduce the interfacial tension between polysiloxane and water phase, thereby promoting the uniformity of the emulsion. Phosphatidylcholine acts as an amphoteric molecule, and its phosphate group forms electrostatic adsorption with the hydroxyl group of dextran, while the hydrophobic tail chain anchors the silicone molecule. These dual effects enhance the stability of the system. At the same time, phosphatidylcholine simulates the cell membrane structure, thereby enhancing skin affinity and repairing the barrier function.

[0016] Preferably, the mass ratio of the PEG-40 hydrogenated castor oil to phosphatidylcholine is (1.5-3):1.

[0017] Low addition of thickener can produce a synergistic thickening effect with dextran colloid, preventing viscosity loss during high-temperature storage, and imparting shear thinning properties, ensuring smooth extension during application and anti-settling when standing.

[0018] Preferably, the thickener is selected from at least one of xanthan gum, gellan gum, sodium carboxymethyl cellulose and sodium alginate.

[0019] Preferably, the water is deionized water.

[0020] The present invention also provides a method for preparing the water-soluble lubricant, comprising the following steps:

[0021] S1. Add β-(1,3) glucan to water at 55-65°C and stir until it swells to form a uniform, transparent colloid.

[0022] S2. PEG-40 hydrogenated castor oil and phosphatidylcholine were added to the colloid obtained in step S1, the system temperature was maintained at 55-65 ° C, and homogenized to obtain a mixed solution;

[0023] S3. To the mixture obtained in step S2 was added dropwise polyether-modified polydimethylsiloxane and homogenized to obtain a uniform solution system;

[0024] S4. After the system is cooled to below 40°C, a thickener is added and stirred until all components are completely dissolved. Then, citric acid is added to adjust the pH of the system to 6.5-7.5, vacuum degassing is performed, and the mixture is filtered with a sterile filter membrane to prepare the water-soluble lubricant.

[0025] Furthermore, in step S1, the stirring speed is 300-400 rpm, and the stirring time is 0.5-1 hour;

[0026] Furthermore, the homogenization speed in step S2 is 8000-8500 rpm, and the homogenization time is 5-10 minutes;

[0027] Furthermore, in step S3, the dropping speed of the polyether-modified polydimethylsiloxane is 2-3 mL / min, the homogenization speed is 15000-20000 rpm, and the homogenization time is 20-25 minutes;

[0028] Furthermore, in step S4, the stirring speed is 150-250 rpm, and the stirring time is 20-30 minutes.

[0029] As a preferred embodiment, the vacuum degassing is performed using a vacuum degassing tank, setting the vacuum degree to ≥ 0.09 MPa, and removing bubbles for 15-25 minutes.

[0030] As a preferred embodiment, filtration is performed using a 0.22 μm sterile filter membrane.

[0031] The present invention also provides use of the water-soluble lubricant in condoms.

[0032] The present invention further provides a condom comprising a condom body and a lubricant attached to the inner surface and / or outer surface of the condom body, wherein the lubricant is the water-soluble lubricant described in the present invention.

[0033] The present invention has the following beneficial effects:

[0034] The water-soluble lubricant formula of the present invention adopts a composite system of β-(1,3) glucan and polyether-modified polydimethylsiloxane, and simultaneously selects PEG-40 hydrogenated castor oil and phosphatidylcholine to form a composite emulsification system, and adds a small amount of thickener to obtain a highly stable lubricant system. This effectively solves the phase separation problem of hydrophobic silicone oil and hydrophilic glucan, and realizes a water-soluble lubricant with excellent lubricating properties, rapid water solubility, good biocompatibility and degradability, and has good application prospects in condom products. DETAILED DESCRIPTION

[0035] The present invention is described in detail below with reference to specific embodiments. The following examples will help those skilled in the art to further understand the present invention, but are not intended to limit the present invention in any form. It should be noted that, for those skilled in the art, several variations and improvements can be made without departing from the scope of the present invention. These all fall within the scope of protection of the present invention. It should be noted that, if there are any processes that are not particularly described in detail below, they can be implemented or understood by those skilled in the art with reference to the prior art. Reagents or instruments used that do not indicate the manufacturer are deemed to be conventional products that can be purchased commercially.

[0036] The raw materials used in the examples and comparative examples of the present invention are described below, but are not limited to these materials:

[0037] β-(1,3) glucan 1: average molecular weight 340,000 Da, homemade;

[0038] β-(1,3) glucan 2: average molecular weight 33000 Da, homemade;

[0039] β-(1,3) glucan 3: average molecular weight 1800000 Da, homemade;

[0040] The preparation method of β-(1,3) glucan refers to Chinese patent application CN202311566094.4.

[0041] Polyether modified polydimethylsiloxane 1: kinematic viscosity 150 mm 2 / s (25℃), KF-355A, Shin-Etsu silicone;

[0042] Polyether modified polydimethylsiloxane 2: kinematic viscosity 430 mm 2 / s (25℃), KF-353, Shin-Etsu silicone;

[0043] Polyether modified polydimethylsiloxane 3: kinematic viscosity 70 mm 2 / s (25℃), KF-351A, Shin-Etsu silicone;

[0044] Polyether modified polydimethylsiloxane 4: kinematic viscosity 920 mm 2 / s (25℃), KF-615A, Shin-Etsu silicone;

[0045] PEG-40 hydrogenated castor oil: BASF Eumulgin CO 40;

[0046] Phosphatidylcholine: MacLean L708752;

[0047] Thickener: xanthan gum, KELTROLCG-F, CP Kelco;

[0048] Water: deionized water.

[0049] The preparation method of the water-soluble lubricant of embodiment is as follows:

[0050] S1. Prepare the ingredients according to the ratio and add β-(1,3) glucan to water at 60°C. Stir with a mechanical stirrer at 350 rpm for 1 hour to form a uniform, transparent colloid.

[0051] S2. PEG-40 hydrogenated castor oil and phosphatidylcholine were added to the colloid obtained in step S1, the system temperature was maintained at 60 ° C, and the mixture was homogenized at 8000 rpm for 10 minutes using a high-speed homogenizer to obtain a mixed solution;

[0052] S3. The polyether-modified polydimethylsiloxane was slowly added dropwise to the mixture obtained in step S2 through a constant pressure dropping funnel at a rate of 2 mL / min. After the addition was complete, the speed of the high-speed homogenizer was immediately increased to 20,000 rpm and homogenization was continued for 20 minutes to obtain a uniform solution system.

[0053] S4. After the system is cooled to below 40°C, a thickener is added and stirred at 200 rpm using a mechanical stirrer for 20 minutes to completely dissolve all components. Citric acid is then added to adjust the pH of the system to 7.0. Bubbles are removed using a vacuum degassing tank (set to a vacuum degree of 0.09 MPa) for 20 minutes. Finally, the solution is filtered through a 0.22 μm sterile filter membrane to prepare the water-soluble lubricant.

[0054] Related performance test methods:

[0055] 1. Lubrication performance test:

[0056] Place a natural rubber latex condom (i.e., the condom body without lubricant) in an aluminum foil bag; maintain the lubricant at a temperature of 60±5°C, stir, and rapidly add lubricant to the aluminum foil bag, with the amount of lubricant added being 5% of the weight of the condom; seal the aluminum foil bag to obtain a condom containing lubricant, which serves as a lubrication performance test sample.

[0057] (1) Dynamic friction coefficient test: Take a condom that has been placed in an environment of 25°C for 24 hours, open the aluminum foil bag and take out the condom, cut the condom into a single layer of sheet to obtain a test sample, and test the dynamic friction coefficient according to the standard GB10006-2021, which is recorded as μ D1 The smaller the dynamic friction coefficient, the better the lubrication performance.

[0058] (2) Anti-dilution ability test: Take a condom that has been placed in an environment of 25℃ for 24 hours, open the aluminum foil bag, add vaginal secretion simulation liquid (water, pyridine, squalene, urea, acetic acid, lactic acid, propylene glycol in a mass ratio of 100:2:2:2:1:3:2), and the mass ratio of vaginal secretion simulation liquid to lubricant is 1:10. After mixing evenly, take out the condom and cut it into a single layer of sheets to obtain a test sample. Test its dynamic friction coefficient, recorded as μ D2 .

[0059] (3) Durability test: Take a condom that has been placed in an environment of 25°C for 24 hours, open the aluminum foil bag and take out the condom, cut the condom into a single-layer sheet to obtain a test sample, and use an SRV reciprocating friction and wear machine to perform a reciprocating linear friction test. The friction pair of the test sample is a silicone plate. Under a load of 200N, the test sample repeatedly moves forward and backward on the surface of the silicone plate (i.e., linear friction). The moving rate is 20cm / s, the displacement is 20cm, and the test time is 300s. After the reciprocating linear friction test, the dynamic friction coefficient of the sample is tested and recorded as μ D3 .

[0060] 2. Water solubility test:

[0061] 0.5g of lubricant was evenly coated on a 25×25mm glass slide (Ra=0.8μm) as the test sample. The lubricant-coated glass slide was immersed in 400mL of deionized water in a constant temperature water bath (25±0.5°C). The dissolution process was recorded with a high-speed camera, and the particle size change was monitored in real time using a laser scattering instrument. The timing was stopped when no oil film was observed to remain on the glass slide and the laser scattering instrument detected a D50 particle size of ≤10μm. The test was repeated 5 times and the average value was recorded as the dissolution time.

[0062] Table 1: Distribution ratios of each group in Examples 1-5 (by mass percentage) and related performance test results

[0063]

[0064] Table 2: Distribution ratios (by mass percentage) of each group in comparative examples 1-8 and related performance test results

[0065]

[0066] As can be seen from the results of the above examples and comparative examples, the water-soluble lubricant formulation of the present invention adopts a composite system of β-(1,3) glucan and polyether-modified polydimethylsiloxane, and simultaneously selects PEG-40 hydrogenated castor oil and phosphatidylcholine to form a composite emulsification system, and adds a small amount of thickener to obtain a highly stable lubricant system, thereby achieving a water-soluble lubricant with excellent lubrication performance (dynamic friction coefficient <0.04, good durability, and strong anti-dilution ability) and rapid water solubility.

[0067] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present invention rather than to limit them. Although the embodiments of the present invention are described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the embodiments of the present invention can still be modified or replaced by equivalents, and these modifications or equivalent replacements cannot cause the modified technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A water-soluble lubricant, characterized in that: Calculated by mass percentage, it includes the following components: β-(1,3) glucan 1.5%-3%; Polyether modified polydimethylsiloxane 3%-5%; PEG-40 hydrogenated castor oil 1.5%-3%; Phosphatidylcholine 1%-2%; Thickener 0.1%-0.5%; The balance is water; The average molecular weight of the β-(1,3) glucan is 100,000-500,000 Da; The kinematic viscosity of the polyether-modified polydimethylsiloxane at 25° C. is 150-500 mm 2 / s; The mass ratio of the PEG-40 hydrogenated castor oil to phosphatidylcholine is (1.5-3):1; The thickener is selected from at least one of xanthan gum, gellan gum, sodium carboxymethyl cellulose and sodium alginate; and the water is deionized water.

2. The method for preparing the water-soluble lubricant according to claim 1, wherein The following steps are involved: S1. Add β-(1,3) glucan to water at 55-65°C and stir until it swells to form a uniform, transparent colloid. S2. PEG-40 hydrogenated castor oil and phosphatidylcholine were added to the colloid obtained in step S1, the system temperature was maintained at 55-65 ° C, and homogenized to obtain a mixed solution; S3. Add polyether-modified polydimethylsiloxane dropwise to the mixture obtained in step S2 and homogenize to obtain a uniform solution system; S4. After the system is cooled to below 40°C, a thickener is added and stirred until all components are completely dissolved. Then, citric acid is added to adjust the pH of the system to 6.5-7.5, vacuum degassing is performed, and the mixture is filtered with a sterile filter membrane to prepare the water-soluble lubricant.

3. The method for preparing a water-soluble lubricant according to claim 2, wherein: In step S1, the stirring speed is 300-400 rpm, and the stirring time is 0.5-1 hour; in step S2, the homogenization speed is 8000-8500 rpm, and the homogenization time is 5-10 minutes; in step S3, the dropping speed of polyether-modified polydimethylsiloxane is 2-3 mL / min, the homogenization speed is 15000-20000 rpm, and the homogenization time is 20-25 minutes; in step S4, the stirring speed is 150-250 rpm, and the stirring time is 20-30 minutes.

4. Use of the water-soluble lubricant according to claim 1 in condoms.

5. A condom, characterized in that: The condom comprises a condom body and a lubricant attached to the inner surface and / or the outer surface of the condom body, wherein the lubricant is selected from the water-soluble lubricant according to claim 1.

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