Non-drug-dependent lasting time-delay condom and preparation method thereof

Abstract

The invention belongs to the technical field of reproductive health, and particularly relates to a non-drug persistent and delayed condom and a preparation method thereof. According to the condom, a layer of three-dimensional mesh gel is additionally arranged at the front end of a sperm storage bag on the inner side of a common condom; the formula of the gel comprises the following components in percentage by mass: 50-90% of hypertonic polyol; 0.25 to 2.5% of a lubricating excipient; 1-2% of a penetration aid; 1-3% of a thermosensitive phase change material; no less than 7% of deionized water; after gel in the condom is in contact with body fluid, a flexible lubricating film is rapidly formed on the surface of the glans penis, the friction coefficient is reduced to 0.05-0.1, mechanical stimulation is effectively buffered, the nerve ending activation frequency is slowed down, physical desensitization is achieved, and stimulation conduction delay is caused. Experiments show that the condom does not depend on drugs, is delayed, avoids traditional anesthesia type side effects, and is fast in recovery; and no stimulation and no toxicity are caused.

Description

Technical Field

[0001] The invention belongs to the technical field of reproductive health, and in particular relates to a condom and a preparation method thereof. Background Art

[0002] Existing condom technologies that can delay ejaculation mainly rely on the following two types of solutions: Anesthetic dependence: Local anesthetics such as benzocaine and lidocaine are used to suppress the sensitivity of nerve endings, but long-term use may lead to loss of pleasure, allergic reactions, and drug resistance (such as patents CN202122380551.3 and CN202122325571.0); Physical barrier type: uses a thickened sleeve (thickness above 0.08mm) or special texture design to reduce friction stimulation, but there are problems such as tactile dullness and wearing discomfort (such as the thickened ring design in patent CN202122325571.0). Summary of the Invention

[0003] The purpose of the present invention is to address the shortcomings of existing condom technology that can delay ejaculation and provide a non-drug-dependent long-lasting condom with a natural and comfortable delay effect and a preparation method thereof.

[0004] The non-drug-dependent, long-lasting condom provided by the present invention is based on existing conventional condoms, with an additional layer of three-dimensional mesh gel on the inner side of the condom, at the front end of the seminal vesicle (the area in contact with the male glans penis). Specifically: The formula composition of the gel is calculated by mass percentage: Hypertonic polyols: 50-90%; Lubricating excipient: 0.25-2.5%; Penetration aid: 1-2%; Thermosensitive phase change material: 1-3%; Deionized water: not less than 7%; The total amount meets 100%; in: The hypertonic polyol is selected from propylene glycol, glycerol, polyethylene glycol 200, and polyethylene glycol 300; preferably propylene glycol; The lubricating excipient is selected from sodium hyaluronate, sodium polyacrylate, carbomer, and hydroxyethyl cellulose; preferably carbomer; The penetration aid is azone or polysorbate-80; The thermosensitive phase change material uses a mixture of isododecane and isoparaffin, wherein isododecane accounts for 30-50%, and the isoparaffin is any one or two of C10-12 isoparaffin, C10-13 isoparaffin, and C11-12 isoparaffin.

[0005] The "non-drug dependent long-lasting delay" mentioned in the present invention refers to achieving long-lasting delay without using anesthetic drugs.

[0006] Preferably: The mass percentage of the hypertonic polyol is 80-90%; more preferably 805-90%; The mass percentage of the lubricating excipient is 0.8-2.2%, more preferably 1.2-2.0%.

[0007] The viscosity of the gel is 2000-5000 mPa.S, preferably, the viscosity of the gel is 3000-4000 mPa.S.

[0008] The thickness of the original condom is 0.03-0.07 mm, and the material is natural latex material or synthetic rubber material. The thickness of the additional gel layer is 20-50 μm; the overall thickness is 0.05-0.1 mm.

[0009] The pH value of the gel is 5.5-7.0, which matches the physiological environment of the human mucosa and ensures safety for long-term use.

[0010] The present invention provides a method for preparing non-drug-dependent delay condoms. The method comprises producing semi-finished condoms that have undergone conventional electrical testing using an existing production line and process flow. The seminal vesicles at the front of the condoms are then sprayed with a prepared gel composition using a gel spraying device. Approximately 200-500 mg of gel is sprayed onto the inner side of each condom, with the gel layer thickness controlled to be 20-50 μm. Preferably, 300-450 mg of gel is sprayed onto each condom, with a gel layer thickness of 30-50 μm.

[0011] The composite gel designed in this invention combines a hypertonic polyol with lubricating excipients (such as propylene glycol and carbomer) to form a three-dimensional mesh gel structure. Upon contact with body fluids, it quickly forms a flexible, lubricating film 20-50 μm thick on the glans penis. This reduces the coefficient of friction between the condom and the glans penis to 0.05-0.09 (compared to the approximately 0.2-0.4 friction coefficient on the male side of traditional latex condoms, which lack a lubricating gel layer). This effectively buffers mechanical stimulation, slows the activation frequency of nerve endings, and achieves physical desensitization, resulting in delayed stimulus conduction. Experimental studies have shown that the mechanism of action of this invention is primarily explained below.

[0012] Physical delay effect: The gel layer reduces the activation rate of nerve endings caused by friction frequency, resulting in slower friction → increased stimulation threshold → delayed ejaculation reflex arc, thereby naturally enhancing the user's ejaculation control ability and prolonging the duration of sexual life.

[0013] Moderate hypertonic desensitization mechanism: Physical and chemical regulation: Based on the relevant mechanism of slow nerve response------high osmotic pressure causes dehydration of neuronal cells, thereby reducing the efficiency of signal transmission between neurons.

[0014] By maintaining a high osmotic pressure environment of 5000-11000 mOsm / kg as a whole through the gel layer, an osmotic pressure gradient is generated to drive water outflow, reduce the efficiency of electrical signal conduction at nerve endings, form a slight dehydration effect locally, reduce the water content of local tissues, reduce the activity of nerve endings on the surface of the glans penis, and reduce the efficiency of stimulus conduction.

[0015] Functional balancing effect: The formula contains lubricating excipients to offset the friction discomfort caused by the hypertonic environment, balance the dehydration effect, and ensure the dual experience of "desensitization + comfort".

[0016] Temperature-responsive neuromodulatory effects: Bidirectional regulation of heat and cold: The thermosensitive phase change material in the gel releases a cooling effect at 32-36°C (5-10°C temperature difference), reducing the speed of nerve impulse conduction.

[0017] The present invention mainly has the following characteristics and advantages: (1) Non-drug dependence: Replace anesthetics through the synergistic effect of physical-hypertonic desensitization, avoid the side effects of traditional anesthesia, cold response, intelligent regulation, and rapid recovery; (2) Dynamic response performance: The gel is temperature sensitive, achieving natural adjustment of "cooling and desensitization during use and rapid recovery when stationary"; (3) Verification data shows that: Clinical trial data show that the ejaculation latency period is extended by about 50-110% (vs. traditional condoms). Among them, in the clinical trial with a total number of more than 200 cases of people with normal needs and non-premature ejaculation, the average intravaginal latent ejaculation time (IELT value) increased from about 11.6 minutes to about 14.5 minutes, an increase of about 2.9 minutes. Compared with the increase of about 3.1 minutes of the benzocaine delay condoms in the same period, the delay effect is comparable, and more than 85% of users reported no numbness. In the target population with a daily intravaginal latent ejaculation time (IELT value) of 3-8 minutes, the statistical data of more than 60 cases showed that the average IELT value increased from about 5.8 minutes to about 8.9 minutes, an increase of about 3.1 minutes, and the delay range exceeded 53%; (4) The biocompatibility evaluation was conducted according to GB / T 16886idtISO 10993 standards. The test results of the product of the present invention showed that the test sample did not cause skin sensitization, had no vaginal irritation, and was non-irritating to the skin of the penis. In terms of cytotoxicity, there was no significant difference between the two compared with ordinary latex condoms. DETAILED DESCRIPTION Example

[0018] The formula composition of the gel is calculated by mass percentage: Propylene glycol: 85%; Carbomer: 1%; Penetration aid: 2%; Thermosensitive phase change material: 2%; Deionized water: 10% The penetration aid is azone; the thermosensitive phase change material is a mixture of isododecane and C10-12 isoparaffin, in which isododecane accounts for 40%.

[0019] The thickness of the original condom is 0.06 mm, and the material is natural latex material or synthetic rubber material. The thickness of the additional gel layer is 50 μm.

[0020] In the present invention, the pH value of the gel is 5.5-6.5.

[0021] Data testing (1) Friction coefficient test: In a simulated vaginal environment (37°C, 60 reciprocating motions per minute), the friction resistance of the condom was 0.07±0.02, significantly lower than that of the traditional anesthesia condom (0.22±0.05) and the thickened physical barrier delay condom (0.32±0.08); (2) Osmotic pressure test: Gel samples were tested according to the United States Pharmacopoeia osmotic pressure test method (USP <785> ) method test, the osmotic pressure is 6500-7500 mOsm / kg; (3) Evaluation of delay effect: After use in 30 patients with premature ejaculation (IELT < 1 minute), the average ejaculation latency was prolonged to 3.2 ± 0.8 minutes (P < 0.01). Example

[0022] The formula composition of the gel is calculated by mass percentage: Propylene glycol: 90%; Carbomer: 1%; Penetration aid: 1%; Thermosensitive phase change material: 1%; Deionized water: 7%.

[0023] The penetration aid is polysorbate 80; the thermosensitive phase change material is a mixture of isododecane and C10-12 isoparaffin, in which isododecane accounts for 45%.

[0024] The thickness of the original condom is 0.05 mm, and the material is natural latex material or synthetic rubber material. The thickness of the additional gel layer is 30 μm.

[0025] In the present invention, the pH value of the gel is 6.0-6.5.

[0026] Data testing: (1) Friction coefficient test: In a simulated vaginal environment (37°C, 60 reciprocating motions per minute), the friction resistance of the condom was 0.063±0.018, significantly lower than that of the traditional anesthesia condom (0.22±0.05) and the thickened physical barrier delay condom (0.32±0.08); (2) Evaluation of delay effect: Among 30 normal sexual desire patients (the average IELT of ordinary condoms was 8.5±2.6 minutes), the average ejaculation latency period was prolonged to 13.2±3.5 minutes when the condoms in the examples were used (P<0.01).

[0027] Clinical comparative experiment (Example 1): The clinical trial data analysis mainly focused on the effects of medicated delay condoms (test device T) and control devices (R, the non-medicated gel delay condoms of the present invention) on male ejaculation latency time (IELT), and systematic statistics were made through ΔIELT (change from baseline after use).

[0028] (1) Conclusion of overall experimental effect: The overall difference in ΔIELT was not significant: The experimental device prolonged T by 3.07 minutes, while the control device prolonged R by 2.84 minutes; The difference was only 0.23 minutes, P=0.4896, and the difference was not statistically significant.

[0029] Conclusion: There was no significant difference between the test device and the control device in prolonging sexual intercourse duration, indicating that this product can achieve an effect comparable to that of drug-based delay products without relying on drug ingredients.

[0030] (2) Age-stratified analysis: ≤30 years old: No significant difference (P=0.7296), the ΔIELT of the two groups was almost equal.

[0031] >30 years: The ΔIELT of the experimental device was slightly better than that of the control device (0.59 minutes), but the difference was not significant (P=0.3006).

[0032] Conclusion: This product shows consistency in delay effect among different age groups, especially showing a better delay trend among people over 30 years old, which is in line with the experience expectations of mature users.

[0033] (3) Stratified analysis of IELT baseline (≤9.4 min, >9.4 min): ≤9.4 min: The difference was very small (0.07 min), P=0.8080.

[0034] >9.4min: The difference was 0.43 minutes, P=0.4472, which was also not significant.

[0035] Conclusion: People with different basic ejaculation latency times can all get a consistent delay experience from this product, and it is suitable for a wide user base.

[0036] (4) Stratified analysis by tester (self-test by male and female): There was no significant difference between the two groups (all P values ​​> 0.45), indicating that the subjective bias was small.

[0037] Conclusion: Verified by multi-dimensional measurement methods, the delay effect of this product is stable and reliable, and the subjective measurement consistency is good.

[0038] (5) Stratified analysis of circumcision: Uncircumcised users: The experimental device outperformed the control device (0.43 minutes), P = 0.2639; Circumcised users: The control device was slightly better, but the difference was not significant (P=0.5069).

[0039] Conclusion: Regardless of whether or not circumcision has been performed, this product shows good adaptability and delay performance, and is suitable for people with different physiological structures.

[0040] (6) Center-to-center differences analysis (different trial sites): There was no significant difference in most trial centers, but the data of individual centers fluctuated (such as center 08, P=0.0411, for trend reference).

[0041] Conclusion: Cross-center trials have verified that this product has good repeatability and regional adaptability, and its clinical effect is stable.

[0042] (7) Analysis of each cycle: Cycle 1: The experimental device was slightly superior (0.94 minutes), P = 0.1132; Second cycle: The control device was slightly better, but P=0.6138, no significant difference.

[0043] Conclusion: The product has a stable delay effect over different usage cycles, with no dependency or decreasing trend, and is suitable for regular daily use.

[0044] The clinical comparative experiment of Example 2 had similar feedback results to the clinical comparative trial of Example 1.

[0045] Overall conclusion: This non-medicated delay condom product achieves a delay effect equivalent to that of medicated condoms through polymer film desensitization, cold sensory intervention, and moderate hyperosmotic sensitivity control. Multi-dimensional clinical data shows that this product has good performance in prolonging sexual intercourse, maintaining the integrity of pleasure, and ensuring the comfort of partners; The product has shown good compatibility and safety in all types of populations (different ages, basic sensitivities, and foreskin conditions); The product has the innovative features of being drug-free, low-irritation and providing natural delay, providing the market with a new delay solution that is highly safe and highly accepted by users.

Claims

1. A non-drug dependent long-lasting condom, characterized in that: A layer of three-dimensional mesh gel is added to the front end of the sperm vesicle inside the existing condom; specifically: The formula composition of the gel is calculated by mass percentage: Hypertonic polyols: 50-90%; Lubricating excipient: 0.25-2.5%; Penetration aid: 1-2%; Thermosensitive phase change material: 1-3%; Deionized water: not less than 7%; The total amount meets 100%; in: The hypertonic polyol is selected from propylene glycol, glycerol, polyethylene glycol 200, and polyethylene glycol 300; The lubricating excipient is selected from sodium hyaluronate, sodium polyacrylate, carbomer, and hydroxyethyl cellulose; The penetration aid is azone or polysorbate-80; The thermosensitive phase change material adopts a mixture of isododecane and isoparaffin, wherein isododecane accounts for 30-50%; the isoparaffin is any one or two of C10-12 isoparaffin, C10-13 isoparaffin, and C11-12 isoparaffin.

2. The non-drug dependent long-lasting condom according to claim 1, characterized in that: The mass percentage of the lubricating excipient is 0.8-2.2%.

3. The non-drug dependent long-lasting condom according to claim 1, characterized in that: The viscosity of the gel is 2000-5000 mPa.S.

4. The non-drug dependent long-lasting condom according to claim 1, characterized in that: The thickness of the condom is 0.03-0.07 mm, and the material is natural latex material or synthetic rubber material. The thickness of the gel layer is 20-50 μm; the overall thickness is 0.05-0.1 mm.

5. The method for preparing the non-drug dependent long-lasting condom according to any one of claims 1 to 4, characterized in that: The conventional semi-finished condoms after electrical inspection are prepared by the existing production line and process flow. The prepared gel composition is sprayed on the seminal vesicle at the front end of the condom through a gel spraying device. 200-500 mg of gel is sprayed on the inner side of each condom, and the thickness of the gel layer is controlled to be 20-50 μm.