Application of piper nigrum extract in preparation of male delay product

Abstract

The invention belongs to the technical field of male health care, and particularly relates to application of a pepper kava extract in preparation of a male delay product. According to the male delay scheme provided by the invention, traditional components are abandoned, the side effects of the medicine are reduced, and the medicine dependence is reduced; meanwhile, the defects that traditional Chinese herbal medicine components take effect for a long time, and uncomfortable feelings such as burning and stabbing are generated in the using process are overcome, the male sexual intercourse time can be effectively prolonged, and the acting effect is lasting.

Description

Technical Field

[0001] The present invention belongs to the technical field of male health care, and particularly relates to the application of kava pepper extract in the preparation of male delay products. Background Art

[0002] With the accelerating pace of society, some men are under increasing pressure in aspects such as work and life, resulting in physical or psychological problems and triggering premature ejaculation.

[0003] At present, the problems of premature ejaculation are usually alleviated by two methods: taking oral and / or spraying chemical drugs and using products containing traditional Chinese medicine ingredients. As is well known, oral chemical drugs have large side effects, strong dependence and must be taken 1-2 hours in advance to take effect. Most external spraying products use anesthetic ingredients, such as caine substances or dyclonine, etc. Although such products take effect relatively quickly, according to the feedback of users, most people will have to interrupt sexual intercourse due to problems such as sudden weakness or erectile dysfunction during sexual intercourse after using them.

[0004] The prior art usually uses herbs such as epimedium, clove, cnidium fruit, cynomorium songaricum, etc. as adjuvant drugs, but according to the records of the Chinese Pharmacopoeia 2020 Edition, the above herbs cannot essentially play the role of prolonging the sexual intercourse time of men. There are also products added with bufotoxin components that can play the role of paralyzing nerves to achieve the effect of delaying time, but they also have to wait for a long time, and there will be adverse reactions such as burning and stinging during use.

[0005] Kava pepper extract is currently mostly used in the field of skin care products as a skin conditioner, and its functions are mainly anti-inflammatory, antibacterial, enhancing skin moisture retention, promoting collagen production, and also having the function of promptly relieving pain and itching.

[0006] The prior art has not disclosed the application of kava pepper extract in the preparation of male delay products, and the prior art lacks a male delay product that can take effect quickly, has a lasting effect, and has an excellent use experience at the same time. Summary of the Invention

[0007] The purpose of the present invention is to provide the application of kava pepper extract in the preparation of male delay products.

[0008] Another purpose of the present invention is to provide a male delay product.

[0009] The present invention is achieved through the following technical solutions: The present invention provides the application of kava pepper extract in the preparation of male delay products.

[0010] Preferably, the kava pepper extract includes kavain.

[0011] The structural formula of the kavain of the present invention is: .

[0012] Among them, R1 can be -H, -OH, β-OH; R2 can be -H, -OCH3; R3 can be -H, -OH, -OCH3; R4 can be -H, -OCH3, -OH; C5-C6 and C7-C8 can be double bonds.

[0013] The kavalactones of the present invention include: any one or more of methyenedioxykawain, kawain, 5,6-dihydromethoxykawain, hydroxykawain, 11-hydroxy-12-methoxydihydrokawain, 7,8-dihydro-5-hydroxykawain, 11,12-dimethoxydihydrokawain, 7,8-dihydrokawain, 5,6,7,8-tetrahydromethoxykawain, methyenedioxy-5,6-dehydrokawain, 5,6-dehydrokawain, methoxykawain, 10-methoxymethoxykawain, 11-methoxymethoxykawain, 11-hydroxymethoxykawain, 11-methoxy-12-hydroxydehydrokawain.

[0014] The kava pepper extract of the present invention can be obtained by purchasing from the market or through the following steps: 1. Raw material pretreatment: including drying and pulverizing of raw materials: drying the kava pepper rhizome and pulverizing it into a powder with a mesh size of 40-60.

[0015] 2. Ethanol extraction: The weight ratio of 80% ethanol to the dried powder of kava pepper rhizome is (4-8):(1-2), extracting at room temperature for 1-3 h, filtering to obtain a filtrate and a residue; the weight ratio of 80% ethanol to the residue is (2-6):(1-2); combining the filtrates obtained from the two extractions, and diluting the ethanol concentration in the filtrate to 40%-60%.

[0016] 3. Resin purification: Adding the combined filtrate to a chromatography column filled with macroporous resin D101 for adsorption, after sample loading, eluting with pure water and then with 80% ethanol, and concentrating the eluate under reduced pressure to obtain the kava pepper extract.

[0017] The content of kavalactones in the kava pepper extract obtained through the above steps is ≥5 wt%.

[0018] In addition, the present invention provides a male delaying product, and the male product contains the above-mentioned effective amount of kava pepper extract and excipients.

[0019] Preferably, the excipients include any one or more of water, gel, emulsifier, thickener, essential oil, pH regulator, moisturizer.

[0020] Preferably, the male delay product further comprises an acceptable traditional Chinese medicine extract.

[0021] Preferably, the traditional Chinese medicine extract includes any one or more of epimedium extract, clove extract, cnidium monnieri extract, cynomorium songaricum extract.

[0022] Preferably, the addition amount of the traditional Chinese medicine extract is 5wt%-20wt%.

[0023] As a specific embodiment, the present invention provides the categories of the male delay products, including any one of delay gels, delay sprays, delay creams, delay essential oils, delay condoms, delay towels or delay rings.

[0024] The present invention has the following beneficial effects compared with the prior art: The present invention provides an application of kava extract in the preparation of male delay products. Experiments show that male delay products containing kava extract can reduce the side effects of drugs and drug dependence compared with existing male delay products or drugs; it can also avoid the disadvantages of traditional Chinese herbal medicine ingredients with a long onset time and discomfort such as burning and stinging during use; and it can effectively extend the duration of male sexual intercourse, and the effect is lasting. Specific Embodiments

[0025] The present invention will be described in detail below with reference to specific embodiments. The following embodiments will help those skilled in the art to further understand the present invention, but do not limit the present invention in any form. It should be noted that those of ordinary skill in the art can make several modifications and improvements without departing from the concept of the present invention. These all belong to the protection scope of the present invention.

[0026] The sources of the raw materials used in the present invention: The preparation method of kava extract is as follows: 1. Raw material pretreatment: including drying and pulverizing the raw materials: drying the kava rhizome and pulverizing it into a powder of 40 meshes.

[0027] 2. Ethanol extraction: The weight ratio of 80% ethanol to the dried powder of kava rhizome is 6:1, extracting at room temperature for 1.5 h, filtering to obtain the filtrate and the residue; the weight ratio of 80% ethanol to the residue is 4:1; combining the filtrates obtained from the two extractions, and diluting the ethanol concentration in the filtrate to 50%.

[0028] 3. Resin purification: Adding the combined filtrate to a chromatography column filled with macroporous resin D101 for adsorption, after loading the sample, washing with pure water and then eluting with 80% ethanol, and concentrating the eluate under reduced pressure to obtain kava extract.

[0029] Emulsifier: PEG-40, purchased commercially.

[0030] Humectant: Propylene glycol, purchased commercially.

[0031] pH regulator: Triethanolamine, purchased commercially.

[0032] Solvent: 95% ethanol, purchased commercially.

[0033] Gel: Carbomer, purchased commercially. Example 1

[0034] Weigh 95 parts of purified water; 2.5 parts of PEG-40 hydrogenated castor oil; 1 part of Piper methysticum extract, and mix them evenly to obtain a delay spray containing Piper methysticum extract. Example 2

[0035] Evenly spray the delay spray containing Piper methysticum extract prepared in Example 1 on the side of the condom that contacts the male user to obtain a delay condom containing Piper methysticum extract. Example 3

[0036] Add an appropriate amount of carbomer to distilled water. After the carbomer is fully swollen, add propylene glycol and stir well. Add an appropriate amount of triethanolamine with stirring, add Piper methysticum extract with stirring, and finally add water to a sufficient amount to obtain a delay gel containing Piper methysticum extract. Example 4

[0037] Weigh 85 parts of purified water; 2.5 parts of PEG-40 hydrogenated castor oil; 1 part of Piper methysticum extract, 5 parts of Epimedium brevicornum extract, and 5 parts of Syzygium aromaticum extract, and mix them evenly to obtain a delay spray containing Piper methysticum extract.

[0038] The product used in the following tests of the present invention is the delay spray containing Piper methysticum extract provided in Example 1.

[0039] The usage method of the delay spray containing Piper methysticum extract provided by the present invention is as follows: Evenly spray the delay spray containing Piper methysticum extract on the glans penis and coronal sulcus.

[0040] A total of 80 subjects were recruited for the tests of the present invention. The inclusion criteria and exclusion criteria for the subjects are as follows: Subject inclusion criteria: (1) Age: 18 to 50 years old; (2) Having a regular sexual partner and regular sexual life; (3) Diagnostic criteria for primary premature ejaculation in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: ① The following symptoms have persisted for at least 6 months and have been consistent or almost always the case (about 75%) during sexual activity: During sexual activity, ejaculation patterns occur continuously or repeatedly within 2 minutes and earlier than the time expected by the sexual partner; ② The problem of premature ejaculation has caused obvious distress or annoyance; ③ This sexual dysfunction is not caused by certain types of mental disorders and is not caused by certain factors (such as drug use or drug abuse); (4) Not having used similar drug treatments in the month before treatment; (5) Not taking any drugs that affect sexual function during treatment; (6) The subject is informed and consents to participate in this study.

[0041] Subject exclusion criteria: (1) Premature ejaculation caused by situational problems (specific environment or with a specific partner); (2) Suffering from acute or chronic urogenital infections; (3) Patients suffering from mental illnesses who need treatment or are receiving treatment; (4) Those with a history of drug abuse or drug addiction in the past 2 years; (5) Having erectile dysfunction (ED), retrograde ejaculation, decreased libido, etc.; (6) Having participated in other drug trials for treating premature ejaculation within the past 3 months; (7) Having systemic diseases, such as cardiovascular and cerebrovascular diseases, liver and kidney system diseases, etc., or having other relevant organic lesions; (8) Undergoing surgery during treatment, such as circumcision, etc.

[0042] The examples and comparative examples are arranged as follows: (1) There are 40 people in the examples, divided into four groups: A, B, C, and D, with 10 people in each group. The average age of each group is 35 years old in group A, 40 years old in group B, 45 years old in group C, and 50 years old in group D. The difference between the individual age and the average age does not exceed ±1 year. Each group of subjects uses the delay spray containing Piper methysticum extract provided by the present invention before sexual intercourse.

[0043] (2) There are 40 people in the comparative examples, divided into four groups: Jia, Yi, Bing, and Ding, with 10 people in each group, and the average age of each group is 40 years old. Among them, the difference between the individual age and the average age does not exceed ±1 year; Group Jia - Orally taking a delay drug containing dapoxetine hydrochloride;

[0044] Group Yi - Evenly applying a topical preparation of tetracaine hydrochloride containing anesthetic components;

[0045] Group Bing - Evenly applying a topical preparation containing the Chinese medicine component of bufotoxin;

[0046] Group Ding - Using a spray without Piper methysticum extract, and the other components are the same as in Example 1.

[0047] The data values of each group of examples and each group of comparative examples in the present invention are the average values of the durations of sexual intercourse twice within a week.

[0048] Table 1 Number of people in each group of the examples within the coitus duration range, average onset time, and feelings 0 to < 2 min (persons) ≥2 to < 10 min (persons) ≥10 to < 20 min (persons) 20 min and above (persons) Average onset waiting time (min) Persons who did not complete the test Whether there are abnormal sensations A 0 1 5 4 3 0 None B 0 2 5 3 3 0 None C 0 3 6 1 4 0 None D 0 4 5 1 5 0 None Table 2 Number of people in each group of the comparative examples within the coitus duration range, average onset time, and feelings 0 to < 2 min (persons) ≥2 to < 10 min (persons) ≥10 to < 20 min (persons) 20 min and above (persons) Average onset waiting time (min) Persons who did not complete the test Whether there are abnormal sensations A 3 4 1 0 73 2 Headache, dizziness, nausea B 2 5 0 0 8 3 Anhedonia, weakness, erectile dysfunction C 1 6 2 0 36 1 Burning, stabbing pain D 9 1 0 0 / / / According to the examples, after using the delay spray containing kava pepper extract provided by the present invention, the average duration of the subjects is more than 2 minutes. Among them, 90% of the subjects in group A can achieve a coitus duration of 10 minutes or more; 80% of the subjects in group B can achieve a coitus duration of 10 minutes or more; 70% of the subjects in group C can achieve a coitus duration of 10 minutes or more; 60% of the subjects in group D can achieve a coitus duration of 10 minutes or more. After using the delay spray containing kava pepper extract, the average onset time of each group of subjects is within 5 minutes, and there are no abnormal feelings in the subjects during the test.

[0049] According to the comparative examples, the onset time of the group taking the drug containing dapoxetine hydrochloride orally reaches more than 60 minutes. The subjects reported side effects such as headache, dizziness, and nausea after taking the medicine. One person could not continue due to side effects. The coitus duration of the subjects in group A is concentrated between ≥2 and <10 minutes, and one person achieved a good use effect.

[0050] The group B used an external preparation containing tetracaine hydrochloride, and the average onset time was 8 minutes. The subjects reported phenomena such as anhedonia, weakness, and erectile dysfunction after application. One person could not continue due to side effects. The coitus duration of the subjects in group B is concentrated between ≥2 and <10 minutes, and no one reached more than 11 minutes.

[0051] The group C used an external preparation containing bufotoxin, and the average onset time was 36 minutes. The subjects reported a burning and stinging sensation in the local area after application. One person could not continue due to side effects. The coitus duration of the subjects in group C is concentrated between ≥2 and <10 minutes, and two people achieved good use effects.

[0052] The group D used a blank spray control group without adding kava pepper extract. Among them, the coitus duration of 9 people was 0 to <2 minutes, and 1 person was ≥2 to <10 minutes.

Claims

1. Use of Piper methysticum extract in the preparation of male delay products.

2. Use of the Piper methysticum extract according to claim 1 in the preparation of male sexual delay products, characterized in that, The Piper methysticum extract includes kavalactones, and the general structural formula of the kavalactones is: 。 3. Use of the Piper methysticum extract according to claim 2 in the preparation of male delay products, characterized in that, The kavalactones include: any one or more of methoxsalen, kavain, 5,6-dihydrokavain, yangonin, 11-hydroxy-12-methoxydihydrokavain, 7,8-dihydro-5-hydroxykavain, 11,12-dimethoxydihydrokavain, 7,8-dihydrokavain, 5,6,7,8-tetrahydrokavain, methoxsalen, 5,6-dehydrokavain, 5,6-dehydrokavain, methoxykavain, 10-methoxymethoxykavain, 11-methoxymethoxykavain, 11-hydroxymethoxykavain, 11-methoxy-12-hydroxydehydrokavain.

4. Use of the Piper methysticum extract according to any one of claims 2 or 3 in the preparation of male delay products, characterized in that, The content of the kavalactones in the Piper methysticum extract is ≥ 5 wt%.

5. A male delay product, characterized in that, Containing an effective amount of Piper methysticum extract as described in any one of claims 1-3 and an acceptable excipient.

6. The male sexual intercourse delay product according to claim 5, wherein, The excipient includes any one or more of water, gel, emulsifier, thickener, essential oil, pH regulator, humectant.

7. The male sexual intercourse time delay product according to claim 5, characterized in that, The male delay product further includes an acceptable traditional Chinese medicine extract.

8. The male sexual delay product according to claim 7, characterized in that, The traditional Chinese medicine extract includes any one or more of Epimedium extract, Clove extract, Fructus Cnidii extract, Cynomorium songaricum extract.

9. The male sexual delay product according to any one of claims 7 or 8, characterized in that The addition amount of the traditional Chinese medicine extract is 5 wt% - 20 wt%.

10. The male sexual intercourse time delay product according to claim 5, characterized in that, The male delay product includes any one of delay gel, delay spray, delay cream, delay essential oil, delay condom, delay towel or delay ring.

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