A human body lubricating liquid and its preparation method and application

Abstract

The present invention belongs to the technical field of lubricating materials, and specifically relates to a human body lubricating liquid and a preparation method and application thereof. The raw materials of the human body lubricating liquid include: compound polyol, hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt, xanthan gum, pH regulator and water. The lubricating liquid of the present invention has excellent and lasting lubricating effect, does not contain preservatives, has good antibacterial and mildew-proof properties, is easy to clean, has excellent biocompatibility with human skin, and does not cause allergies, irritation and other uncomfortable effects.

Description

Technical Field

[0001] The invention belongs to the technical field of lubricating materials, and in particular relates to a human body lubricating liquid and a preparation method and application thereof. Background Art

[0002] Currently, condom lubricants on the market are mainly divided into three types: water-based, oil-based, and silicone-based. Among them, oil-based lubricants contain grease in addition to water, which is not easy to clean, not environmentally friendly, and can cause local skin allergies. Silicone lubricants are relatively thick and have a longer-lasting effect, but they can cause certain damage to items of the same material, and oil-based and silicone-based lubricants have odors, which affects the user experience.

[0003] Due to the structural characteristics of the water-soluble lubricant itself, it is not only inferior to the oil lubricant in terms of lubricity, but also has poor compatibility with natural latex and low stability. In addition to being difficult to infiltrate latex condoms, it will also cause condoms to turn white and swell, thus affecting the quality of condoms and the user's experience. For example, Chinese invention patent application CN106421935A discloses a water-soluble condom lubricant, which is composed of glycerol, sodium hyaluronate, sodium citrate, methylaminoproline, and water. It has been verified that the lubricant has passed the accelerated aging test (placed in a 70°C stability test box for 7 days) in the "Technical Requirements and Experimental Methods for Natural Latex Condoms", causing the natural latex condoms to turn white and swell; and the pH of the lubricant is 7-9, which is alkaline, which will increase the pH of the female vagina and easily cause vaginal pH damage.

[0004] Chinese invention patent application CN106581780A discloses a lubricant and its preparation method and application. The lubricant includes the following components in weight percentage: thickener 0.1-1.0%, lubricant 0.1-1.0%, moisturizer 3.0-10.0%, pH adjuster 0.1-2.0%, preservative 0.3-2.0%, and the balance is sterile water; the preservative component is added to the lubricant formula, and improper selection and use of the preservative will cause adverse effects such as allergies and inflammation on the female reproductive system.

[0005] In addition, the spreading area of ​​water-soluble condom liquid on natural rubber latex condoms per unit time is smaller than that of silicone oil lubricant, that is, it takes longer to completely soak and cover the condom; the lubrication time is shorter than that of silicone oil lubricant, etc. And the problem faced by water-soluble condom liquid and silicone oil lubricant at the same time: the surface tension of the liquid on the packaging material (aluminum foil bag) is low, resulting in a certain amount of lubricant remaining in the packaging bag when the condom is taken out, thereby increasing the product cost.

[0006] Therefore, it is urgent to develop a water-soluble lubricant with better wettability with natural rubber latex, better lubrication function and higher safety. Summary of the invention

[0007] In view of the deficiencies of the prior art, the present invention provides a human body lubricating liquid and a preparation method and application thereof. When the lubricating liquid is used as a lubricating liquid for condoms, it has excellent lubricating performance, a large spreading area on natural latex condoms per unit time, good antibacterial and mildew-proof properties, is easy to clean, has excellent biocompatibility with human skin, and does not cause allergies, irritation, and other uncomfortable effects.

[0008] The present invention is achieved through the following technical solutions:

[0009] A human body lubricating liquid, the raw materials of which include: compound polyol, hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt, xanthan gum, pH regulator and water.

[0010] Preferably, the raw materials of the human body lubricating fluid include, by mass percentage, 15%-25% compound polyol, 0.5%-1.0% hyaluronate, 0.2%-0.4% konjac glucomannan, 0.1%-0.3% chitosan quaternary ammonium salt, 0.1%-0.3% xanthan gum, 0.05%-0.3% pH adjuster and the balance water.

[0011] Preferably, the compound polyol is selected from any two or more of propylene glycol, glycerol, butylene glycol, polyethylene glycol, diglycerol and sorbitol.

[0012] Further preferably, the compound polyol is a mixture of glycerol, propylene glycol and sorbitol, and the mass ratio of the glycerol, propylene glycol and sorbitol is 2-4:2-4:1.

[0013] Preferably, the hyaluronate is selected from any one of sodium hyaluronate, zinc hyaluronate, magnesium hyaluronate and potassium hyaluronate, preferably sodium hyaluronate.

[0014] Furthermore, the weight average molecular weight of the hyaluronate is in the range of 1.3 million to 1.8 million.

[0015] Preferably, the pH regulator is lactic acid or sodium citrate, and the amount of the pH regulator is such that the pH of the lubricating fluid is maintained at 5.5-6.5.

[0016] The present invention also relates to a method for preparing the above human body lubricating liquid, comprising the following steps:

[0017] (1) mixing hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt and water to obtain a mixture 1;

[0018] (2) Add the compounded polyol and xanthan gum to the mixture 1, stir evenly, and then add a pH adjuster to obtain the human body lubricant.

[0019] Preferably, the mixing speed in step (1) is 1500-2000 rpm, and the mixing time is 20-30 min; the stirring time in step (2) is 10-20 min, and the stirring temperature is 40-60°C.

[0020] The present invention also relates to the application of the human body lubricating liquid or the human body lubricating liquid prepared by the above preparation method in family planning products and medical devices.

[0021] Preferably, the human lubricating fluid is used in a condom.

[0022] The konjac glucomannan (KGM) added to the human body lubricating liquid of the present invention is a natural polysaccharide extracted from konjac tubers, and has special physical and chemical functions such as good water absorption, film-forming property and gel property. The KGM molecule contains a large number of hydroxyl groups, which is conducive to the formation of hydrated molecules between the KGM molecules and water molecules through hydrogen bonding. When the KGM molecules act on the aqueous solution, they can combine with a large number of water molecules through hydrogen bonding, molecular dipole and other forces to form a hydrogen bond network structure, and have good water-based lubrication properties.

[0023] Chitosan quaternary ammonium salt (hydroxypropyltrimethylammonium chloride chitosan (HACC)) is an important chitosan derivative with good water solubility, moisture retention, antibacterial and flocculation properties. HACC solution is a non-Newtonian fluid. At a higher speed, HACC can be dispersed more evenly, has a stronger binding force with water, and the lubricating effect of the lubricant in the condom is better.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] (1) In the present invention, sodium hyaluronate, konjac glucomannan, and chitosan quaternary ammonium salt produce a synergistic effect. Sodium hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt, and water form a network structure, which can be uniformly adhered to the surface of the condom under certain temperature and stirring conditions, and has an excellent and long-lasting lubricating effect.

[0026] (2) The lubricating liquid of the present invention does not contain preservatives, has excellent antibacterial and antifungal properties, is easy to clean, has excellent biocompatibility with human skin, and does not cause allergic, irritating or other uncomfortable effects.

[0027] (3) The lubricating liquid of the present invention shortens the infiltration time of the lubricating liquid and the natural rubber latex condom, thus saving costs. DETAILED DESCRIPTION

[0028] The present invention will be further described in detail below in conjunction with specific examples. The following examples are not intended to limit the present invention, but are only intended to illustrate the present invention. The experimental methods used in the following examples are generally conventional, unless otherwise specified, and the materials, reagents, etc. used in the following examples are commercially available, unless otherwise specified.

[0029] Konjac glucomannan, product number PK2989, was purchased from Hefei Bomei Biotechnology Co., Ltd.;

[0030] Chitosan quaternary ammonium salt, product number 56-13-98, was purchased from Xi'an Qianyecao Biotechnology Co., Ltd.;

[0031] Sodium hyaluronate (molecular weight 1.3 million), product number RYHZ01, was purchased from Xi’an Ruiying Biotechnology Co., Ltd.;

[0032] Xanthan gum, model: food grade, was purchased from Henan Junmao Biotechnology Co., Ltd.

[0033] Example 1

[0034] A human body lubricant, whose raw materials are, by mass percentage, 20% compound polyol (8.6% glycerol, 8.6% propylene glycol, 2.8% sorbitol), 0.8% sodium hyaluronate, 0.3% konjac glucomannan, 0.2% chitosan quaternary ammonium salt, 0.2% xanthan gum, 0.1% lactic acid and 78.4% water.

[0035] The preparation method of the above-mentioned human body lubricating fluid is:

[0036] (1) mixing sodium hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt and water at 1800 rpm for 25 min to obtain a mixture 1;

[0037] (2) Continue stirring, add the compound polyol and xanthan gum to the mixture 1, stir at 50° C. for 15 min, add lactic acid after the mixture is uniform, adjust the pH to 6.0, and obtain the human body lubricant.

[0038] Example 2

[0039] A human body lubricant, whose raw materials are, by mass percentage, 22% of compound polyol (10% glycerol, 10% propylene glycol, 2% sorbitol), 1.0% of sodium hyaluronate, 0.2% of konjac glucomannan, 0.1% of chitosan quaternary ammonium salt, 0.1% of xanthan gum, 0.3% of sodium citrate and 76.3% of water.

[0040] The preparation method of the above-mentioned human body lubricating fluid is:

[0041] (1) mixing sodium hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt and water at 1500 rpm for 30 min to obtain a mixture 1;

[0042] (2) Continue stirring, add the compound polyol and xanthan gum to the mixture 1, stir at 40° C. for 20 min, add sodium citrate after mixing evenly, adjust the pH to 6.5, and obtain the human body lubricant.

[0043] Example 3

[0044] A human body lubricant, comprising the following raw materials, by mass percentage: 15% compound polyol (6.5% glycerol, 6.5% propylene glycol, 2% sorbitol), 0.5% sodium hyaluronate, 0.4% konjac glucomannan, 0.3% chitosan quaternary ammonium salt, 0.3% xanthan gum, 0.05% lactic acid and 83.45% water.

[0045] The preparation method of the above-mentioned human body lubricating fluid is:

[0046] (1) mixing sodium hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt and water at 2000 rpm for 20 min to obtain a mixture 1;

[0047] (2) Continue stirring, add the compound polyol and xanthan gum to the mixture 1, stir at 60° C. for 10 min, add lactic acid after the mixture is uniformly mixed, adjust the pH to 5.5, and obtain the human body lubricant.

[0048] Comparative Examples 1-4

[0049] The difference between Comparative Examples 1-4 and Example 1 is that the addition ratios of sodium hyaluronate, konjac glucomannan and chitosan quaternary ammonium salt are different.

[0050] Table 1 Addition amount of sodium hyaluronate, konjac glucomannan and chitosan quaternary ammonium salt

[0051]

[0052] Comparative Example 5

[0053] The difference between this comparative example and Example 1 is only that the preparation method is different.

[0054] The preparation method of human body lubricating fluid is:

[0055] (1) Sodium hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt, compound polyol, xanthan gum, lactic acid and water were mixed at 1800 rpm for 25 min, then heated to 50° C. and stirred for 15 min to obtain a human lubricating fluid.

[0056] Effect test

[0057] 1. Accelerated aging test of natural rubber latex condoms

[0058] The natural rubber latex condoms containing different lubricants were tested according to the accelerated aging test (placed in a 70℃ stability test chamber for 7 days) in the "Technical Requirements and Experimental Methods for Natural Rubber Latex Condoms" to investigate the whitening and swelling of natural rubber latex.

[0059] The results show that the lubricants of Examples 1-3 and Comparative Examples 1-5 are very compatible with natural latex condoms, and there is no whitening under the test conditions, and no changes in physical properties such as breakage and damage.

[0060] 2. Lubrication durability test

[0061] The lubrication durability effect of the product was determined by testing its dynamic friction coefficient. The dynamic friction coefficient μ of the lubricating liquid in each embodiment and comparative example was tested according to the method in GB / T10006-2021 "Determination of friction coefficient of plastic film and sheet". The results are shown in Table 2 below.

[0062] Table 2 Dynamic friction coefficient of lubricating fluid

[0063]

[0064] 3. Moisture test

[0065] Weigh 5 g of the lubricating liquid of Examples 1-3 and Comparative Examples 1-5 respectively, put them in a weighing bottle, and place them in a constant temperature and humidity chamber (40°C, relative humidity of 30%) without covering. Take them out and weigh them after 24 hours, and calculate the mass difference. The water content of the sample before the test is recorded as m1, and the water content of the sample after the test is recorded as m2. Calculate the moisture retention rate: moisture retention rate = m1 / m2×100%.

[0066] The test results are shown in Table 3 below.

[0067] Table 3 Moisture retention test results

[0068]

[0069] 4. Experimental calculation of the spreading rate of lubricating fluid on natural latex condoms

[0070] Weigh several bare natural latex condoms of the same material and cut them into 5 cm×5 cm square films. Take the lubricating liquid prepared in Examples 1-3 and Comparative Examples 1-5 of the same gram weight and drop them on the square films at the same height, observe the liquid spreading after 10 minutes, and calculate the spreading area S and spreading rate. The specific method is as follows:

[0071] At the time point, the shape was recorded on the film with a marker pen according to the spreading morphology, the film was washed and dried, and a transparent weighing paper (5 cm × 5 cm, average weight 0.07 g) was used to cover the film, and the edge of the spreading area was drawn on the weighing paper, and the excess paper edge was cut off, and the mass was recorded An, and the spreading area was calculated: S = (5 cm × 5 cm × An) / 0.07 g, and the spreading rate was obtained: S / T (min) × 100%. The test results are shown in Table 4 below.

[0072] Table 4 Spreading area and spreading rate test results

[0073]

[0074] Within a certain period of time, the larger the spreading area, the greater the wetting rate, and the better the wettability of the lubricant to the natural latex condom.

[0075] 5. Antibacterial performance test

[0076] According to the antibacterial performance test method of dissolution antibacterial (inhibitory) products in Appendix C of GB15979-2002 "Sanitary Standards for Disposable Hygiene Products", the antibacterial performance of human body lubricants was tested. The human body lubricants of Examples 1-3 have inhibitory effects on Staphylococcus aureus (ATCC6538), Escherichia coli (ATCC25922), and Candida albicans (ATCC10231). The test results are shown in Table 5.

[0077] 6. Sensitivity and vaginal irritation test

[0078] The test was conducted in accordance with the method specified in GB / T16886.10-2017 "Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Test". In the rabbit vaginal irritation test, the vaginal irritation score ≤ 4 was determined to be extremely mild irritation, and the score 0 was no irritation; in the skin sensitization test, level 0 was no sensitization reaction, and levels 1-3 corresponded to mild to severe sensitization. The test results are shown in Table 5.

[0079] Table 5 Antibacterial performance, sensitization and vaginal irritation test results

[0080]

[0081] The above detailed description is a specific description of one feasible embodiment of the present invention. The embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not deviate from the present invention should be included in the scope of the technical solution of the present invention.

Claims

1. A human body lubricating fluid, characterized in that: The raw materials of the human body lubricant are, by mass percentage, 15%-25% of a composite polyol, 0.5%-1.0% of hyaluronate, 0.2%-0.4% of konjac glucomannan, 0.1%-0.3% of chitosan quaternary ammonium salt, 0.1%-0.3% of xanthan gum, 0.05%-0.3% of a pH regulator, and the balance of water; The preparation method of the human body lubricating liquid comprises the following steps: (1) mixing hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt and water to obtain a mixture 1; (2) Add the compounded polyol and xanthan gum to the mixture 1, stir evenly, and then add a pH adjuster to obtain the human body lubricant.

2. The human body lubricating fluid according to claim 1, characterized in that: The compound polyol is selected from any two or more of propylene glycol, glycerol, butylene glycol, polyethylene glycol, diglycerol and sorbitol.

3. The human body lubricating fluid according to claim 2, characterized in that: The compound polyol is a mixture of glycerol, propylene glycol and sorbitol, and the mass ratio of the glycerol, propylene glycol and sorbitol is 2-4:2-4:

1.

4. The human body lubricating fluid according to claim 1, characterized in that: The hyaluronate is selected from any one of sodium hyaluronate, zinc hyaluronate, magnesium hyaluronate and potassium hyaluronate.

5. The human body lubricating fluid according to claim 1, characterized in that: The pH regulator is lactic acid or sodium citrate, and the amount of the pH regulator is such that the pH of the lubricating fluid is maintained at 5.5-6.

5.

6. A method for preparing the human body lubricating fluid according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) mixing hyaluronate, konjac glucomannan, chitosan quaternary ammonium salt and water to obtain a mixture 1; (2) Add the compounded polyol and xanthan gum to the mixture 1, stir evenly, and then add a pH adjuster to obtain the human body lubricant.

7. The preparation method according to claim 6, characterized in that: The mixing speed in step (1) is 1500-2000 rpm, and the mixing time is 20-30 min; the stirring time in step (2) is 10-20 min, and the stirring temperature is 40-60°C.

8. Use of the human lubricating fluid described in any one of claims 1 to 5 or the human lubricating fluid prepared by the preparation method described in any one of claims 6 to 7 in family planning products and medical devices.

9. The use according to claim 8, characterized in that: Application of the human lubricating fluid in condoms.

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