Pure traditional Chinese medicine external delay spray for male premature ejaculation and preparation method of pure traditional Chinese medicine external delay spray

Abstract

The invention discloses a pure traditional Chinese medicine external delay spray for male premature ejaculation and a preparation method of the pure traditional Chinese medicine external delay spray, belongs to the technical field of medicine preparations, and can realize a delay effect on the premise of maintaining normal touch perception. The traditional Chinese medicine composition consists of the following components in parts by weight: 10-12 parts of herba epimedii; 10 to 12 parts of cynomorium songaricum; 8-10 parts of fructus cnidii; 8-10 parts of Chinese magnoliavine fruit; 8-10 parts of Chinese gall; 8-10 parts of semen allii tuberosi; 8 to 10 parts of herba agrimoniae; 2-5 parts of venenum bufonis; 9-11 parts of asarum; 10 to 12 parts of clove; 3-5 parts of polygala tenuifolia; 3-5 parts of radix astragali; 1-3 parts of mint; and 1-3 parts of borneol.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pure traditional Chinese medicine external-use delay spray for treating male premature ejaculation and a preparation method thereof. Background Art

[0002] Research indicates that the incidence of premature ejaculation is increasing year by year, and is trending towards younger men. There are numerous reasons for this, including the rising incidence of reproductive system inflammation (such as prostatitis), which is common among modern men and leads to abnormal local nerve sensitivity; pelvic congestion and sexual nerve dysfunction caused by prolonged sitting; increased obesity leading to abnormal hormone metabolism (increased estrogen levels); high-intensity work pressure leading to sympathetic nervous system hyperactivity; the widespread use of online pornography leading to a lowered sexual threshold and sexual psychological disorders; blue light radiation from electronic devices affecting melatonin secretion, leading to sleep disorders; and a lack of exercise leading to deterioration of pelvic floor muscle function. Premature ejaculation has a relatively serious impact on men's health, gender relations, marriage and family, such as a 43% increased risk of secondary erectile dysfunction (data from the International Association of Sexual Medicine in 2022); long-term anxiety leads to abnormal cortisol levels, affecting the immune system; forming a vicious cycle of sexual psychological disorders (anticipatory anxiety-performance anxiety); decreased satisfaction with couples' intimate relationships (research shows a decrease of about 57%); family conflicts caused by reproductive dysfunction (accounting for about 18% of infertility cases); increased divorce rates due to emotional alienation (relevant research shows a 2.3-fold increase), etc.

[0003] Currently, medications for treating premature ejaculation in men fall into two main categories: oral and topical. Among topical medications, lidocaine sprays are popular due to their rapid onset of action (typically within 3-5 minutes). However, these medications also have significant drawbacks, the most significant of which is the numbness they cause after use, with rates of tactile loss reaching as high as 78%. This numbness not only impacts the user's sexual experience but can also cause discomfort to their partner, reducing their clinical applicability and acceptance.

[0004] The disclosure of the above background technology content is only used to assist in understanding the concept and technical solution of the present invention. It does not necessarily belong to the prior art of this patent application. In the absence of clear evidence that the above content has been disclosed on the filing date of this patent application, the above background technology should not be used to evaluate the novelty and creativity of this application. Summary of the Invention

[0005] The present application provides a pure traditional Chinese medicine external-use delay spray for male premature ejaculation and a preparation method thereof, which can achieve a delay effect while maintaining normal tactile perception.

[0006] To achieve the above objectives, the present application discloses the following technical solutions:

[0007] In a first aspect, the embodiments of the present application provide a pure traditional Chinese medicine external-use delay spray for male premature ejaculation, which is composed of the following components, in parts by weight: 10-12 parts of epimedium; 10-12 parts of cynomorium songaricum; 8-10 parts of cnidium monnieri; 8-10 parts of schisandra chinensis; 8-10 parts of gallnut; 8-10 parts of leek seeds; 8-10 parts of yangcao herb; 2-5 parts of toad venom; 9-11 parts of asarum; 10-12 parts of cloves; 3-5 parts of polygala tenuifolia; 3-5 parts of astragalus membranaceus; 1-3 parts of mint; and 1-3 parts of borneol.

[0008] In some possible embodiments of the first aspect, a pure traditional Chinese medicine external-use delay spray for male premature ejaculation is composed of the following components, in parts by weight: 10 parts of epimedium, 10 parts of cynomorium songaricum, 8 parts of cnidium monnieri, 8 parts of schisandra chinensis, 8 parts of gallnut, 8 parts of leek seeds, 8 parts of yangcao herb, 2 parts of toad venom, 9 parts of asarum, 10 parts of cloves, 3 parts of polygala tenuifolia, 3 parts of astragalus, 1 part of mint, and 1 part of borneol.

[0009] In a second aspect, the present invention provides a method for preparing a topical delay spray, comprising the following steps:

[0010] (1) Weighing each raw material according to the weight proportions described in any of the technical solutions of the first aspect;

[0011] (2) Grind each raw material into granules by grinding;

[0012] (3) Extracting active ingredients from ground medicinal materials using extraction methods;

[0013] (4) Mixing the extract with a transdermal enhancer to prepare a spray;

[0014] (5) Filling into the spray device to obtain the finished product.

[0015] One or more technical solutions provided in the first and second aspects of the embodiments of the present application have at least the following technical effects or advantages:

[0016] The combination of Epimedium and Cynomorium songaricum in the examples of the present application exerts the effect of tonifying the kidney and strengthening yang, regulates the function of the hypothalamic-pituitary-gonadal axis, and improves ejaculation control disorders caused by abnormal hormone metabolism; the tannin components contained in Gallnut and Schisandra chinensis reduce the sensitivity of the glans penis through astringent effects, and their non-anesthetic mechanism avoids tactile nerve blockade caused by chemical drugs; Asarum and Toad Venenum synergistically produce a local micro-anesthetic effect, acting on the transient receptor potential channels of peripheral nerve endings, regulating nerve conduction velocity without completely inhibiting tactile perception; the combination of Cnidium monnieri and Cloves inhibits cyclooxygenase activity and reduces the abnormal stimulation of local nerves by prostate inflammation; Polygala tenuifolia and Astragalus membranaceus are combined to regulate the activity of neurons in the paraventricular nucleus of the hypothalamus, reduce sympathetic nerve excitability and relieve anxiety; Peppermint and borneol are used as guide drugs to promote transdermal absorption of active ingredients, while offsetting local irritation through a cooling sensation. The synergistic effect of each component forms a multi-dimensional treatment system of nerve sensitivity regulation, anti-inflammatory repair and endocrine balance. On the premise of maintaining normal tactile perception, it achieves a delay effect by inhibiting the excessive sensitivity of the ejaculation reflex arc, improving pelvic microcirculation, and regulating neurological dysfunction.

[0017] In addition, it also has the following beneficial effects: targeted regulation, biphasic regulation, sustained drug release, rapid transdermal drug absorption, mucosal repair at the site of use, immediate drying after spraying, fast onset of action, high partner safety (LD50>5000mg / kg in percutaneous acute toxicity test), and high stability (content retention rate in 36-month accelerated test at 40℃ / 75%RH conditions>95%).

[0018] In addition, the present invention has been clinically verified to extend the average ejaculation latency by 6.8 times (baseline 1.3 minutes → 5.5 minutes). DETAILED DESCRIPTION

[0019] Specific embodiments of the present invention will now be mentioned in detail. Although the present invention is described in conjunction with these specific embodiments, it should be appreciated that the present invention is not intended to be limited to these specific embodiments. On the contrary, these embodiments are intended to cover substitutions, changes or equivalent embodiments that may be included in the spirit and scope of the invention defined by the claims. In the following description, a large amount of specific details are set forth to provide a comprehensive understanding of the present invention. The present invention can be implemented without some or all of these specific details. In other cases, in order not to make the present invention unnecessarily obscure, well-known process operations are not described in detail.

[0020] When used in conjunction with "including," "methods comprising," or similar language in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0021] The embodiment of the present application provides a pure traditional Chinese medicine external-use delay spray for male premature ejaculation, which is composed of the following components, in parts by weight: 10-12 parts of epimedium; 10-12 parts of cynomorium songaricum; 8-10 parts of cnidium monnieri; 8-10 parts of schisandra chinensis; 8-10 parts of gallnut; 8-10 parts of leek seeds; 8-10 parts of yangyao herb; 2-5 parts of toad venom; 9-11 parts of asarum; 10-12 parts of cloves; 3-5 parts of polygala tenuifolia; 3-5 parts of astragalus membranaceus; 1-3 parts of mint; and 1-3 parts of borneol.

[0022] Preferably, in some embodiments, a pure traditional Chinese medicine external-use delay spray for male premature ejaculation is composed of the following components, in parts by weight: 10 parts of epimedium, 10 parts of cynomorium songaricum, 8 parts of cnidium monnieri, 8 parts of schisandra chinensis, 8 parts of gallnut, 8 parts of leek seeds, 8 parts of yangcao herb, 2 parts of toad venom, 9 parts of asarum, 10 parts of cloves, 3 parts of polygala tenuifolia, 3 parts of astragalus, 1 part of mint, and 1 part of borneol.

[0023] Among them, Epimedium: warm in nature, spicy and sweet in taste. Functions and indications: tonifying kidney yang, strengthening bones and tendons, and dispelling rheumatism.

[0024] Cynomorium songaricum: warm in nature, sweet in taste. Functions and indications: tonifies kidney yang, benefits essence and blood, moistens intestines and promotes bowel movements.

[0025] Cnidium monnieri: warm in nature, pungent and bitter in taste. Functions and indications: warms the kidney and strengthens yang, dries dampness, dispels wind, and kills insects.

[0026] Schisandra chinensis: sour, sweet, warm. Functions and indications: astringent, replenishing qi and promoting body fluid, nourishing the kidney and calming the mind.

[0027] Gallnut: cold in nature, sour and astringent in taste. Functions and indications: astringes the lungs and reduces internal heat, astringes the intestines and stops diarrhea, astringes the lungs, stops bleeding, absorbs dampness and heals sores.

[0028] Leek seeds: warm in nature, spicy and sweet in taste. Functions and indications: warms and nourishes the liver and kidneys, strengthens yang and consolidates essence.

[0029] Qiyangcao: Warm in nature, spicy in taste. Functions and indications: Tonifies the kidney and warms yang, increases appetite, strengthens the stomach and aids digestion.

[0030] Toad Venom: Pungent, warm. Functions and indications: Detoxification, analgesia, refreshing.

[0031] Asarum: warm in nature, pungent in taste. Functions and indications: dispel wind, dispel cold, open the orifices and relieve pain, warm the lungs and eliminate phlegm.

[0032] Clove: spicy, warm in nature. Functions and indications: warms the middle and reduces adverse reactions, nourishes the kidney and supports yang.

[0033] Polygala: warm in nature, bitter and pungent in taste. Functions and indications: soothes the mind, improves intelligence, eliminates phlegm, and reduces swelling.

[0034] Astragalus: slightly warm in nature, sweet in flavor. Functions and indications: Tonifies Qi and raises Yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, relieves stagnation and arthritis, expels toxins and pus, and heals sores and promotes tissue regeneration.

[0035] Mint: Cool in nature, spicy in taste. Functions and indications: Disperses wind-heat, clears the head and eyes, and relieves rashes.

[0036] Borneol: pungent, bitter, slightly cold; Functions and indications: invigorates the mind, clears away heat and relieves pain, used for coma and convulsions caused by febrile diseases, syncope caused by stroke and phlegm, sudden syncope caused by qi stagnation, coma caused by poisoning, red eyes, mouth ulcers, sore throat, and pus in the ear canal.

[0037] The present invention also provides a method for preparing a topical delay spray, comprising the following steps:

[0038] (1) Weighing each raw material according to the weight proportions described in any one of the technical solutions of the first aspect;

[0039] (2) Grind each raw material into granules by grinding;

[0040] (3) Extracting active ingredients from ground medicinal materials using extraction methods;

[0041] (4) Mixing the extract with a transdermal enhancer to prepare a spray;

[0042] (5) Filling into the spray device to obtain the finished product.

[0043] The topical delay spray disclosed in the examples of this application is applied in small amounts to the coronary sulcus (30 minutes before intercourse). The active ingredients of the drug contained therein are rapidly absorbed through the skin, entering the subcutaneous tissue, then the capillaries, and finally the soft tissue, where they take effect directly. Surfactants contained in plasters can promote passive absorption, increasing epidermal absorption of the drug. When the spray is applied locally, the drug concentration in the tissue is significantly higher than the blood concentration, so it is fully effective. The local therapeutic effect is significantly superior to that of internal treatments, and the drug's effect is rapid. This makes it ideal for those who are unable to take medication or are unwilling to do so. Because oral medications require gastrointestinal absorption, degradation by gastric acid, and metabolism in the liver, they enter the heart and circulate throughout the body with the blood. When the drug's properties reach the affected area, they are far away from the internal organs and have insufficient blood circulation, resulting in minimal efficacy. However, the spray of this invention is applied directly to the coronary sulcus, where it is absorbed through the skin and exerts its effect continuously, resulting in significant therapeutic effects. In addition, when using, just unscrew the screw cap and spray it. It is easy to use, has a quick effect, and has no irritating taste. The pure Chinese medicine preparation is highly safe and is not an oral medication. It is mild in nature and will not cause allergies.

[0044] Example 1

[0045] Take 10 parts of Epimedium, 10 parts of Cynomorium songaricum, 8 parts of Cnidium monnieri, 8 parts of Schisandra chinensis, 8 parts of Gallnut, 8 parts of Allium tuberosum, 8 parts of Herba Coptidis, 2 parts of Venenum Bufonis, 9 parts of Asarum, 10 parts of Clove, 3 parts of Polygala tenuifolia, 3 parts of Astragalus, 1 part of Mentha, and 1 part of Borneol. Grind the different Chinese herbs separately using a grinding method and grind them into granules. Extract the herbal molecules using an extraction method, and use transdermal technology to prepare a spray. Clinical trial data for the topical delay spray disclosed in Example 1 are as follows:

[0046] Mo, male, 37 years old, from Leliu, Shunde District, Guangdong Province, started to have premature ejaculation problems two years ago. After using the spray, the duration of his ejaculation increased from more than ten minutes to more than 40 minutes. He felt good overall and had no discomfort.

[0047] Mr. Mai, a 32-year-old male from Xingtan, Shunde District, Guangdong Province, started having premature ejaculation problems last year. After using the spray, his duration increased from a dozen minutes to over an hour, and he felt better overall with no discomfort.

[0048] Mr. Liu, a 45-year-old male from Daliang, Shunde District, Guangdong Province, started experiencing premature ejaculation at the age of 39. After using the spray, his duration increased from 10 minutes to over 50 minutes, and he felt better overall with no discomfort.

[0049] Chen, a 29-year-old male from Baiyun District, Guangzhou, started having premature ejaculation problems late last year. After using the spray, his duration increased from just over ten minutes to over an hour, and he feels great overall with no discomfort.

[0050] Finally, it should be noted that the above embodiments are intended only to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to preferred embodiments, persons skilled in the art will appreciate that modifications to the specific embodiments of the present invention or substitutions of some of the technical features may be made without departing from the spirit of the present invention and are intended to be encompassed within the scope of the technical solutions claimed herein.

Claims

1. A pure traditional Chinese medicine external use delay spray for male premature ejaculation, characterized in that: The invention is composed of the following components in parts by weight: 10-12 parts of epimedium; 10-12 parts of cynomorium songaricum; 8-10 parts of cnidium monnieri; 8-10 parts of schisandra chinensis; 8-10 parts of gallnut; 8-10 parts of leek seeds; 8-10 parts of yangcao herb; 2-5 parts of toad venom; 9-11 parts of asarum; 10-12 parts of cloves; 3-5 parts of polygala tenuifolia; 3-5 parts of astragalus membranaceus; 1-3 parts of mint; and 1-3 parts of borneol.

2. The pure traditional Chinese medicine external use delay spray for male premature ejaculation according to claim 1, characterized in that: The invention is composed of the following components by weight: 10 parts of epimedium, 10 parts of cynomorium songaricum, 8 parts of cnidium monnieri, 8 parts of schisandra chinensis, 8 parts of gallnut, 8 parts of leek seeds, 8 parts of yangcao herba, 2 parts of toad venom, 9 parts of asarum, 10 parts of cloves, 3 parts of polygala tenuifolia, 3 parts of astragalus, 1 part of mint and 1 part of borneol.

3. A method for preparing an external delay spray, characterized in that: The following steps are involved: (1) Weigh the raw materials according to the weight parts of claim 1 or 2; (2) Grind each raw material into granules by grinding; (3) Extracting active ingredients from ground medicinal materials using extraction methods; (4) Mixing the extract with a transdermal enhancer to prepare a spray; (5) Filling into the spray device to obtain the finished product.