Male time-delay spray as well as preparation method and application thereof

Abstract

The invention discloses a male delay spray and a preparation method and application thereof, and belongs to the technical field of spray preparations. The invention relates to a male time-delay spray, which is prepared from the following ingredients in parts by weight: 30 to 40 parts of polyethylene glycol, 5 to 10 parts of glycerol, 20 to 25 parts of lotus seed coat extracts, 5 to 9 parts of zedoary turmeric oil, 4 to 5 parts of peppermint oil, 0.5 to 1 part of clove oil, 0.001 to 1 part of preservatives and 300 to 400 parts of water. The spray takes plant extracts as active ingredients, does not contain anesthetic western medicine ingredients, and is high in safety; the effects of astringency inducing and desensitization of the lotus seed coat extract, the local blood circulation promoting effect of the zedoary turmeric oil and the clove oil and the cooling and desensitization effect of the peppermint oil synergistically play a role, the functions of promoting erection, enhancing hardness, securing essence and delaying time are achieved, and the traditional Chinese medicine composition is suitable for improving the sexual life quality of patients suffering from premature ejaculation and has a good application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of spray preparation, in particular to a male delay spray, a preparation method and application thereof. BACKGROUND

[0002] Under the influence of fast-paced modern life, increasing work pressure and unhealthy living habits, the incidence of male erectile dysfunction (ED), premature ejaculation (PE) and other reproductive health problems is increasing year by year. Premature ejaculation, as one of the most common male sexual dysfunction, has a global prevalence rate of 20%-30% among adult men. Premature ejaculation not only directly affects the quality of sexual life, but also easily leads to tension in partner relationships, male psychological anxiety, inferiority and other chain problems, which has a serious negative impact on the physical and mental health and life happiness of patients. Therefore, the development of safe, effective and convenient premature ejaculation improvement products has become an important research direction in the field of reproductive health.

[0003] The prior art pursues rapid delay effect by adding excessive high-concentration local anesthetics (such as lidocaine, prilocaine, tetracaine, etc.), which can reduce sensitivity by inhibiting the sensory conduction of the nerve endings of the glans penis, but it is easy to cause excessive numbness of the glans penis, which not only weakens the sexual pleasure, but also may even cause erectile difficulty. The delay products prepared from natural extracts contain strong irritant solvents such as ethanol and propylene glycol, and some insect and plant root components, which make it difficult to control the quality of the products and cause psychological burden of mixed use.

[0004] The prior art CN119837941A discloses a male product delay spray, which puts Cnidium monnieri extract, Epimedium extract, clove extract, Zanthoxylum bungeanum extract, Cistanche extract, Cynomorium songaricum extract and Piper methysticum extract into water and ethanol dissolution solution, stirs and completes, and then fills. The spray can effectively delay and reduce irritation, as recorded in the invention. However, the spray obviously contains strong irritant components such as Zanthoxylum bungeanum, Piper methysticum and ethanol, and the content is relatively large, which obviously easily causes strong irritation to the male penis skin and affects the sexual pleasure of the patient.

[0005] The prior art CN118340813A discloses an external use traditional Chinese medicine erection assisting spray, which is prepared by mixing clove, Cnidium monnieri, Radix et Rhizoma Aconiti, Radix et Rhizoma Linderae, Rubia cordifolia, Chamaemelum nobile, Cynomorium songaricum, Epimedium, Araneae, Angelica sinensis, Galla chinensis and Morinda officinalis. The components are too complex, such as Araneae, which is an insect egg component. The use of the above components is easy to cause infection of unknown bacteria or viruses, which is not conducive to the health and hygiene of both parties during sexual intercourse. Moreover, the specification does not prove the efficacy of erection assistance.

[0006] The prior art CN112057529A discloses a traditional Chinese medicine spray for male erectile dysfunction, and mainly contains ginseng, saffron, medlar, leech, earthworm, prepared frankincense, jiangxiang, sandalwood, centipede and herba epimedii, and further includes cistanche, ganoderma lucidum and astragalus etc. The spray can improve hardness and prevent premature ejaculation, as recorded in the specification of the application. Similarly, the spray contains leech, earthworm and centipede, which results in complex composition of the spray and causes health and hygiene problems of both men and women, and even psychological rejection.

[0007] In summary, the existing male delay spray has significant technical defects in terms of component safety, effect stability, use experience and bioavailability, and it is difficult to meet the use requirements of consumers for "safety, effectiveness, comfort and controllability". Therefore, developing a male delay spray with safe components, no obvious side effects, stable effect, controllable delay effect and good use experience has become a technical problem to be solved in the field of spray preparation technology, and it is of great significance to promote the technical upgrading and market development of male reproductive health products. SUMMARY

[0008] In order to overcome the deficiencies of the prior art, the purpose of the present application is to provide a male delay spray and its preparation method and application, which can achieve the technical effects of safe components, no obvious side effects, stable effect, controllable delay effect and good use experience.

[0009] The present application is realized by the following technical solutions:

[0010] In the first aspect, the present application provides a male delay spray, which comprises, by weight: 30-40 parts of polyethylene glycol, 5-10 parts of glycerol, 20-25 parts of lotus leaf extract, 5-9 parts of zedoary oil, 4-5 parts of peppermint oil, 0.5-1 part of clove oil, 0.001-1 part of preservative and 300-400 parts of water.

[0011] Preferably, the male delay spray comprises, by weight: 35 parts of polyethylene glycol, 8 parts of glycerol, 23 parts of lotus leaf extract, 6 parts of zedoary oil, 4.5 parts of peppermint oil, 0.8 parts of clove oil, 0.01-0.2 parts of preservative and 350 parts of water.

[0012] The preparation method of the lotus leaf extract is as follows: the lotus leaf is crushed, sieved (40-80 mesh) and soaked in water; after softening, the water is removed, 70-90% ethanol is used as the solvent, the liquid-solid ratio is 5-15 mL / g, and 70-100 W ultrasonic extraction is performed for 0.5-2 h; the filtrate is collected, the filter residue is extracted twice, the filtrates are combined, concentrated, and freeze-dried to obtain the lotus leaf extract.

[0013] Preferably, the sieve mesh is 60 mesh; the ethanol concentration is 80%; the liquid-solid ratio is 10 mL / g; the ultrasonic power is 80 W; and the ultrasonic extraction is performed for 1 h.

[0014] Preferably, the polyethylene glycol has a molecular weight selected from the group consisting of 400-2000 Da; further preferably 600-1000 Da.

[0015] Preferably, the preservative is selected from the group consisting of at least one of cationic surfactants, parabens, sorbates, benzoic acids.

[0016] Preferably, the preservative is selected from the group consisting of at least one of benzalkonium chloride, benzalkonium bromide, potassium sorbate, nipagin.

[0017] Preferably, the water is sterile deionized water.

[0018] In a second aspect, the present application provides a preparation method of the male time-extended spray of the first aspect, the method comprising the following steps: uniformly mixing polyethylene glycol, glycerol, lotus seed coat extract, zedoary oil, peppermint oil, clove oil, preservative, and water in a certain amount, high-pressure homogenization, filtration sterilization, and sub-packaging.

[0019] Preferably, the method is: mixing lotus seed coat extract, zedoary oil, peppermint oil, clove oil, and preservative in a certain amount to obtain an oil phase; dissolving polyethylene glycol and glycerol in water in a certain amount to obtain an aqueous phase; adding the oil phase into the aqueous phase, uniformly mixing by shearing stirring, high-pressure homogenization, filtration sterilization, and sub-packaging.

[0020] Lotus seed coat is the seed coat of Nelumbonucifera, which has the effects of astringency, tonifying yang, etc. in the traditional Chinese medicine system, tastes sweet and astringent, is neutral in nature, and is related to the heart and spleen meridians, and has a mild effect. Lotus seed coat contains a large amount of tannins, which have a significant astringent effect (also the material basis of the traditional Chinese medicine "astringent" effect), can reduce mucous membrane secretion, promote local tissue contraction, and reduce sensitivity.

[0021] Zedoary oil is a volatile oil extracted from the rhizomes of Curcumazedoaria, Curcumakwangsiensis, etc. It is rich in zedoary alcohol, zedoary diketone, etc. and has anti-inflammatory and blood microcirculation improving effects.

[0022] Peppermint oil is a volatile oil extracted from fresh stems and leaves of Menthahaplocalyx or Menthapiperita, etc. by water vapor distillation, which is rich in menthol, menthone, menthyl esters, etc. and has anti-inflammatory, cooling, antipruritic, and desensitizing effects.

[0023] Cloves oil is a volatile oil extracted from the dried flower buds or leaves of Syzygium aromaticum (also known as Syzygium aromaticum) by steam distillation, which is rich in eugenol, beta-caryophyllene and other components, and has strong antibacterial, local analgesic, anti-inflammatory, muscle spasm relief, blood circulation improvement, warming and other effects.

[0024] Compared with the prior art, the application has the following technical effects.

[0025] The application provides a male time-delaying spray, which contains polyethylene glycol, glycerol, lotus leaf extract, zedoary oil, peppermint oil, cloves oil, preservative and water.

[0026] The lotus leaf extract, zedoary oil, peppermint oil and cloves oil all belong to fat-soluble components, and the extract component is relatively simple compared with the traditional Chinese medicine extract time-delaying preparation component in the prior art, and the quality is controllable. Secondly, the lotus leaf extract is rich in alkaloids, tannins and other astringent components, and can effectively warm the kidney yang, astringe the essence and shrink the urine, and reduce the sensitivity; the strong cold and hot feeling produced by the peppermint oil and the cloves oil can quickly reduce the sensitivity of the skin of the glans penis, and divert the attention of the nerves, so that the effect of delaying ejaculation can be achieved in a short time; the cloves oil (eugenol) and the zedoary oil can stimulate local capillary dilation and promote blood circulation, and have the effects of promoting erection and enhancing hardness. The peppermint oil, the cloves oil and the zedoary oil all contain volatile components, have the characteristics of easy effect, and can meet the immediate needs of patients; meanwhile, the oily components are beneficial to lubrication. The lotus leaf extract, the zedoary oil, the peppermint oil and the cloves oil have the effects of promoting erection, enhancing hardness, astringing essence and delaying time through the functions of astringing and astringing, promoting blood circulation, cooling and reducing sensitivity.

[0027] The polyethylene glycol and the glycerol are used as soothing and moisturizing bases, and have good lubricating and moisturizing effects; in addition, the polyethylene glycol has the effect of non-ionic surfactant, and the polyethylene glycol and the glycerol both have the thickening effect, so that the stability of the spray can be maintained, and the oil phase and the water phase can be effectively prevented from being separated; the polyethylene glycol has the film-forming property, and can form a flexible lubricating film on the surface of the penis after use, so that the sensitivity can be moderately reduced without causing a foreign body sensation; in addition, the polyethylene glycol and the glycerol can together provide a water moist touch, and neutralize the greasy feeling of the plant extract components. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present application will be clearly and completely described below with the embodiments of the present application. The described embodiments are only some of the preferred embodiments of the present application, but not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of the present application.

[0029] In the embodiments, the experimental methods used are conventional or general methods in the art if no special instructions are given, and the materials, reagents and the like used can be obtained from commercial channels if no special instructions are given.

[0030] The raw materials used in the examples and comparative examples will be described as follows:

[0031] Glycerol: purchased from Shanghai Haohong Biomedicine Co., Ltd.

[0032] Polyethylene glycol (1000 Da): Shanghai Research Biochemical Technology Co., Ltd.

[0033] Curcuma zedoary oil: purchased from Shanghai Yuan Ye Biotechnology Co., Ltd.

[0034] Peppermint oil: purchased from Jiangxi Baicao Pharmaceutical Co., Ltd.

[0035] Clove oil: Jiangxi Baicao Pharmaceutical Co., Ltd.

[0036] Nipagin methyl ester (hydroxybenzyl methyl ester): purchased from Shanghai Maikelin Biotechnology Co., Ltd.

[0037] The component raw materials used in the embodiments and comparative examples of the present application are commercially available raw materials unless otherwise specified, and the component raw materials used in each parallel experiment are the same.

[0038] Preparation of lotus leaf extract (self-made):

[0039] The lotus leaf was crushed, sieved (60 mesh), and softened by water immersion for 2 h. After softening, the water was removed, and 80% ethanol was used as the solvent, the liquid-solid ratio was 10 mL / g, and 80W ultrasonic extraction was performed for 1 h. The filtrate was collected after filtration, the filter residue was extracted twice, and the filtrate was combined. After concentration, freeze-drying was performed for 5 h to obtain the lotus leaf extract.

[0040] Preparation of lotus seed extract (self-made, used in comparative examples):

[0041] The lotus seed was crushed, sieved (60 mesh), and softened by water immersion for 2 h. After softening, the water was removed, and 80% ethanol was used as the solvent, the liquid-solid ratio was 10 mL / g, and 80W ultrasonic extraction was performed for 1 h. The filtrate was collected after filtration, the filter residue was extracted twice, and the filtrate was combined. After concentration, freeze-drying was performed for 5 h to obtain the lotus seed extract.

[0042] Example 1

[0043] A male time-delay spray, by weight parts, comprising: polyethylene glycol 35 parts, glycerol 8 parts, lotus leaf extract 23 parts, zedoary oil 6 parts, peppermint oil 4.5 parts, clove oil 0.8 parts, nipagin methyl ester (preservative) 0.05 parts, sterile deionized water 350 parts.

[0044] The preparation method is as follows:

[0045] The lotus leaf extract, zedoary oil, peppermint oil, clove oil, and preservative are mixed in the required amounts, and the mixture is stirred at room temperature at 200 rpm by magnetic stirring until uniform to obtain an oil phase; the polyethylene glycol and glycerol are dissolved in sterile deionized water in the required amounts to obtain an aqueous phase; the oil phase is added to the aqueous phase, and the mixture is stirred at 1000 rpm by shearing until uniform; the mixture is subjected to high-pressure homogenization at 1100 bar for 3 cycles using a high-pressure homogenizer (model: AH-BASIC30), and then filtered using a 0.22 μm filter membrane to remove bacteria and is divided into portions.

[0046] Examples 2-4 and Comparative Examples 1-5

[0047] Examples 2-4 and Comparative Examples 1-5 are prepared by the same method as Example 1, except that the components or the amounts of the components are adjusted.

[0048] Table 1: Ingredient table (weight parts) of examples and comparative examples

[0049]

[0050] Note: Blank indicates that the component is not contained.

[0051] Skin irritation test:

[0052] 1) The male time-delay sprays described in Examples 1-4 and Comparative Examples 1-5 are used for the skin irritation test, and the test subjects are BALB / c nude mice, 6 mice per group (3 male and 3 female mice are randomly selected), 20 μL of the spray is applied to the outer part of the right ear auricle (thin skin) of the mice twice a day, in the morning and in the evening; the behavior and skin condition of the mice are observed every day for 4 weeks. The scores are determined according to the following table:

[0053]

[0054]

[0055] Table 2: Results of the skin irritation test after 4 weeks

[0056] No. Mouse 1 (♂) Mouse 2 (♂) Mouse 3 (♂) Mouse 4 (♀) Mouse 5 (♀) Mouse 6 (♀) Example 1 5 5 5 5 5 5 Example 2 5 5 5 5 5 5 Example 3 5 5 5 5 5 5 Example 4 5 5 5 5 5 5 Comparative Example 1 5 5 5 5 5 5 Comparative Example 2 5 5 5 5 5 5 Comparative Example 3 5 5 5 5 5 5 Comparative Example 4 5 5 5 5 5 5 Comparative Example 5 5 5 5 5 5 5

[0057] From the above table, after 4 weeks of skin irritation test, the male delay spray of Example-4, Comparative Example 1-5 does not produce irritation to the mice, does not cause mild red rash, allergy, dryness, and other mild or strong irritation of the mouse skin, which shows that the components used in the male delay spray of Example-4, Comparative Example 1-5 are within the reasonable dosage range, do not cause irritation to the skin, and meet the requirements of biological safety.

[0058] Delay effect test:

[0059] 45 PE volunteers were recruited, with the screening criteria of 20-45 years old, LS≤2 min, signing the informed consent (including the sexual partners of the PE volunteers), and randomly divided into 9 groups, 5 people in each group.

[0060] Test method: Guide the volunteers to record the intravaginal ejaculation latency time (IELT), and require the average value of IELT of each volunteer in 3 sexual life within 4 weeks (LELT) as the evaluation index, and record the IELT value (min) before and after using the product of Example and Comparative Example, respectively, as IELT1 and IELT2. Calculate the delay rate (%) = IELT2 / IELT1 x 100%.

[0061] Method of administration: 3-5 minutes before the start of sexual life, spray once at a distance of about 10 cm on both sides of the penis.

[0062] Table 3 Delay effect test record table

[0063]

[0064]

[0065]

[0066] According to the data in Table 3, 1) the male delay sprays described in Examples 1-4 can effectively prolong the IELT time of PE patients, with a prolongation rate between 286.1% and 296.9%, indicating significant effects in astringing sperm and delaying ejaculation. Furthermore, spraying 3-5 minutes before sexual intercourse can promote erection in PE patients, demonstrating its rapid effectiveness and erectile-promoting effect. 2) The difference between Comparative Example 1 and Example 1 is that lotus seed extract was replaced with lotus seed extract; however, the delaying effect of Comparative Example 1 was significantly lower than that of Example 1, indicating that the astringent, sperm-astringent, and desensitizing effects of lotus seed extract are more significant. 3) Comparative Example 2 lacked turmeric oil, and Comparative Example 4 lacked clove oil, thus resulting in a relatively weaker effect in promoting local blood circulation compared to Example 1. 4) Compared to Example 1, Comparative Example 1, with its reduced peppermint oil, lacked the cooling and desensitizing effects of the product. 5) In Comparative Example 4, the amount of polyethylene glycol was reduced, resulting in a decreased moisturizing effect from both polyethylene glycol and glycerin, which was insufficient to neutralize the oiliness of the product. Comparative Example 5 did not contain polyethylene glycol, and its oiliness was significant. In summary, the four components—lotus seed coat extract, turmeric oil, peppermint oil, and clove oil—work synergistically to promote erection, enhance hardness, and delay ejaculation through astringent, blood circulation-promoting, cooling, and desensitizing effects.

[0067] Stability test:

[0068] The male delay sprays prepared in the examples and comparative examples were bottle-capped for stability testing. Long-term stability test conditions were set as follows: temperature 30±1℃, humidity (RH) 65±5%. The appearance of the spray was observed and recorded according to the following criteria: 1) no change recorded as 0; 2) slight oil phase aggregation recorded as 1; 3) stratification recorded as 2; 4) if stratification had occurred, no further observation or recording was required.

[0069]

[0070] As shown in the table above, the male delay sprays prepared in Examples 1-4 showed no visible changes in appearance after 12 months, confirming their good long-term stability and ability to maintain the uniform dispersion of the effective components, thus ensuring a stable dose-response relationship. Furthermore, the male delay sprays prepared in Examples 1-4 are suitable for long-term storage at room temperature without refrigeration, making them convenient for consumers. Comparative Example 5, lacking polyethylene glycol, exhibited poor stability and stratification. Comparative Example 4, with its reduced polyethylene glycol content, also showed slight oil phase aggregation after approximately 10 months.

[0071] The preferred embodiments of the application disclosed above are only to facilitate the elucidation of the application. The preferred embodiments do not describe all the details of the application and limit the application to the specific embodiments described. Obviously, many modifications and variations can be made in light of the teachings above. The description is chosen and described in order to best explain the principles of the application and its practical application to thereby enable others skilled in the art to best utilize the application and get the best results from the application. The application is only limited by the claims and their full scope and equivalents.

Claims

1. A male delay spray, comprising, by weight: 30-40 parts polyethylene glycol, 5-10 parts glycerin, 20-25 parts lotus seed coat extract, 5-9 parts turmeric oil, 4-5 parts peppermint oil, 0.5-1 part clove oil, 0.001-1 part preservative, and 300-400 parts water.

2. The male delay spray according to claim 1, characterized in that, include: 35 parts polyethylene glycol, 8 parts glycerin, 23 parts lotus seed coat extract, 6 parts turmeric oil, 4.5 parts peppermint oil, 0.8 parts clove oil, 0.01-0.2 parts preservative, and 350 parts water.

3. The male delay spray according to claim 1, characterized in that, The preparation method of the lotus seed coat extract is as follows: crush the lotus seed coat, sieve it, and soak it in water to soften it; after softening, remove the water, use 70%-90% ethanol as solvent, liquid-to-mass ratio of 5-15 mL / g, and ultrasonically extract it at 70-100W for 0.5-2 h, collect the filtrate, extract the residue a second time, combine the filtrates, concentrate them, and freeze-dry them to obtain the extract.

4. The male delay spray according to claim 3, characterized in that, In the preparation method of the lotus seed coat extract, the ethanol concentration is 80% and the liquid-to-mass ratio is 10 mL / g.

5. The male delay spray according to claim 3, characterized in that, In the preparation method of the lotus seed coat extract, the ultrasonic power is 80W and the ultrasonic extraction is performed for 1 hour.

6. The male delay spray according to claim 1, characterized in that, The molecular weight of the polyethylene glycol is selected from 400 Da to 2000 Da.

7. The male delay spray according to claim 1, characterized in that, The preservative is selected from at least one of cationic surfactants, parabens, sorbic acids, and benzoic acids.

8. The male delay spray according to claim 1, characterized in that, The water is sterile deionized water.

9. A method for preparing a male delay spray as described in any one of claims 1-8, the method comprising the following steps: mixing polyethylene glycol, glycerin, lotus seed coat extract, turmeric oil, peppermint oil, clove oil, preservative, and water in the specified amounts until homogenized under high pressure, filtering for sterilization, and dispensing.

10. The method for preparing the male delay spray according to claim 9, characterized in that, Mix lotus seed coat extract, turmeric oil, peppermint oil, clove oil, and preservative according to the specified amounts to obtain the oil phase; dissolve polyethylene glycol and glycerin in water according to the specified amounts to obtain the aqueous phase; add the oil phase to the aqueous phase, shear and stir to mix evenly, homogenize under high pressure, filter to sterilize, and package.

Images