External delay traditional Chinese medicine composition and essence for men as well as preparation method and application of external delay traditional Chinese medicine composition and essence

Abstract

The invention discloses an external-use time-delay traditional Chinese medicine composition for men, essence and a preparation method and application of the external-use time-delay traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 0.8-1.2 parts of traditional Chinese medicine micromolecule active ingredients; 0.08 to 0.12 part of borneol; the traditional Chinese medicine micromolecule active component is prepared from the following components in parts by weight: 30-40 parts of ginseng, 20-30 parts of herba selaginellae, 20-30 parts of radix millettiae speciosae, 5-15 parts of radix salviae miltiorrhizae, 10-20 parts of fructus rosae laevigatae and 5-15 parts of radix sophorae flavescentis; the molecular weight is enriched through grouping extraction and purification and an ultrafiltration membrane technology; the transdermal efficiency is obviously improved due to the small-molecular active component of 1000 Da; the traditional Chinese medicine composition can significantly prolong the incubation period of ejaculation and improve sexual satisfaction through a multi-target synergistic effect of inhibiting nerve sensitivity, improving microcirculation, repairing a barrier and cooling and promoting infiltration, and is free of burning hot, numbness and mucosal injury risks caused by chemical anesthetics.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a male external application of a traditional Chinese medicine composition for delaying ejaculation, an essence, its preparation method, and its application. Background Technology

[0002] In modern research on men's health needs, extending the duration of effective sexual intercourse has become an important demand for improving the quality of sexual life for both partners. The *Proceedings of the 21st National Conference on Andrology of the Chinese Medical Association* reported that prolonged ejaculation latency is significantly correlated with increased sexual satisfaction. A study on surgical treatment of premature ejaculation showed that when the ejaculation latency was extended to more than 6 minutes after surgery, sexual satisfaction increased by more than 40% (P<0.01). A 2010 report in the American journal *Men's Health* showed that 71% of adult men believed that moderately extending the ejaculation latency could significantly improve their sexual experience and hoped to prolong the duration of sexual intercourse to increase satisfaction for both partners. This demand has spurred the rapid development of topical delay products. Therefore, developing effective topical delay products for men to meet market demand has significant social and economic implications. However, the existing products have not yet effectively balanced the contradictions between safety and user experience, resulting in technological bottlenecks in product development.

[0003] In the current technological field, chemically synthesized products have long dominated the market. Local anesthetics with lidocaine and benzocaine as core ingredients achieve delayed ejaculation by inhibiting nerve ending sensitivity. Studies have shown that 7.5% benzocaine spray, when applied topically to the genitals, produces an anesthetic effect in approximately 2-5 minutes (British Journal of Clinical Pharmacology, 2018), with an onset time that can be shortened to 5-10 minutes. However, these products have significant limitations. Regarding safety, according to data from the Journal of Sexual Medicine (2019), 18.7% of benzocaine users reported local burning sensations or erythema, with the adverse reaction rate rising to 27.3% for frequent users (>3 times per week). Sensitive individuals may experience contact dermatitis, and repeated use can damage the skin barrier function. Long-term use may lead to an adaptive increase in tactile threshold, forcing dose increases, and even causing mucosal barrier damage. In terms of user experience, many users experience loss of pleasure due to excessive local numbness. The desensitization of pleasure caused by anesthesia further reduces user satisfaction, which contradicts users' core demand for improved experience. Furthermore, these products rely solely on a single nerve block mechanism, failing to improve local blood circulation in the genital area or promote tissue repair, thus failing to meet users' need for a "natural experience."

[0004] While some traditional Chinese medicines are currently used for external male enhancement to delay ejaculation, traditional herbal extracts (such as crude extracts obtained through water extraction and alcohol precipitation) often contain a large number of high-molecular-weight impurities (such as polysaccharides, proteins, and tannin polymers), and their active ingredients generally have large molecular weights (usually >1000 Da). The stratum corneum of human skin is a natural physical barrier, and the transdermal absorption rate of substances with molecular weights exceeding 500 Da decreases sharply. These large molecules have difficulty effectively penetrating the skin barrier to reach their target sites (such as the dorsal nerve endings of the penis and the vascular endothelium of the corpus cavernosum), resulting in low transdermal absorption efficiency. In terms of extraction and purification processes, the crude extracts obtained through traditional water extraction and alcohol precipitation methods contain many impurities, resulting in slow onset of action and easy skin irritation; the problem of low transdermal absorption is particularly prominent. Animal experiments show that related products need to be applied continuously for more than 40 minutes to achieve an effective blood drug concentration, and the delayed action and fluctuating effects during use severely impact the user experience. Furthermore, most traditional Chinese medicine preparations use an oily ointment form, which has problems such as poor breathability and easy staining of clothing, failing to meet the modern man's demand for a refreshing feel. Summary of the Invention

[0005] The purpose of this invention is to overcome the problems of high irritation and desensitization of pleasure caused by existing chemical anesthetics, and poor transdermal absorption and slow onset of action of traditional Chinese medicine preparations. This invention provides a topical traditional Chinese medicine composition scientifically formulated from seven herbs: ginseng, *Smilax china*, *Smilax glabra*, *Rosa laevigata*, *Salvia miltiorrhiza*, *Sophora flavescens*, and borneol. Through group extraction, purification, and enrichment of small molecule active ingredients with a molecular weight <1000 Da, transdermal efficiency is significantly improved. This traditional Chinese medicine composition, through the synergistic effects of inhibiting nerve sensitivity, improving microcirculation, repairing the skin barrier, and providing cooling and penetration-promoting effects, can significantly prolong ejaculation latency and improve sexual satisfaction, without the risks of burning, numbness, and mucosal damage caused by chemical anesthetics.

[0006] A second objective of this invention is to provide the application of the aforementioned topical Chinese medicine composition in the preparation of male topical delay products.

[0007] The third objective of this invention is to overcome the problems of traditional ointments being greasy, having poor breathability, and providing an unpleasant user experience, by providing a male external delay serum. This serum replaces greasy ointments by preparing the above-mentioned enriched small molecule active ingredients into a refreshing and easily absorbed serum formulation, thereby optimizing breathability and user comfort.

[0008] A fourth object of the present invention is to provide a method for preparing the serum.

[0009] The above-mentioned objective of this invention is achieved through the following technical solution: A topical traditional Chinese medicine composition comprises the following components in parts by weight: 0.8-1.2 parts of small molecule active ingredients of traditional Chinese medicine, and 0.08-0.12 parts of borneol; wherein the small molecule active ingredients of traditional Chinese medicine are prepared from the following components in parts by weight: 30-40 parts of ginseng, 20-30 parts of *Smilax glabra*, 20-30 parts of *Achyranthes bidentata*, 5-15 parts of *Salvia miltiorrhiza*, 10-20 parts of *Rosa laevigata*, and 5-15 parts of *Sophora flavescens*; the preparation method of the small molecule active ingredients of traditional Chinese medicine is to mix the corresponding parts by weight of ginseng, *Smilax glabra*, *Achyranthes bidentata*, and *Salvia miltiorrhiza*, then extract by reflux with 65-75% ethanol, and pass the extract through a non-polar adsorption resin with 50% ethanol. The extract was obtained by gradient elution with 70% ethanol, followed by concentration to obtain a purified extract of ginseng / Sophora flavescens / Smilax glabra / Salvia miltiorrhiza. A corresponding weight fraction of Rosa laevigata was extracted by reflux with 55-65% ethanol, followed by elution with 65-75% ethanol using a neutral polar adsorption resin, and then concentrated to obtain a purified Rosa laevigata extract. A corresponding weight fraction of Sophora flavescens was extracted using an acid-water extraction method. The extract was adsorbed onto a strongly acidic cation exchange resin, treated with alkali, and the total alkaloids were eluted. The extract was then concentrated to obtain a purified Sophora flavescens extract. The purified extracts of ginseng / Sophora flavescens / Smilax glabra / Salvia miltiorrhiza, Rosa laevigata, and Sophora flavescens were combined, purified, and the active ingredients with a molecular weight <1000 Da were enriched.

[0010] This invention deeply integrates traditional Chinese medicine theory with modern pharmacological mechanisms. Based on the TCM principle of "principal, assistant, adjuvant, and guide" in herbal formulation, it scientifically combines seven Chinese medicinal herbs: ginseng, *Smilax glabra*, *Smilax china*, *Rosa laevigata*, *Salvia miltiorrhiza*, *Sophora flavescens*, and borneol. This forms a topical delayed ejaculation compound system with "multi-target synergistic intervention" (inhibiting nerve sensitivity, improving local microcirculation, repairing the mucosal barrier, and regulating hormone levels). The compound is designed to systematically improve male sexual function and the local physiological environment, thereby prolonging ejaculation latency and optimizing the user experience.

[0011] Ginseng, as the principal herb, plays a core role in replenishing qi, strengthening the body's foundation, and invigorating the reproductive system. Its saponin components not only promote the release of nitric oxide to improve blood flow in the corpora cavernosa but also regulate sex hormone levels and enhance sexual endurance. *Smilax glabra* and *Smilax china* serve as assistant herbs, synergistically tonifying kidney yang. By regulating the hypothalamus-pituitary-gonadal axis and immune pathways, they promote testosterone secretion and alleviate symptoms of kidney yang deficiency. Their active ingredients also possess antioxidant and anti-inflammatory activities, indirectly improving erectile quality. *Rosa laevigata*, *Salvia miltiorrhiza*, and *Sophora flavescens* are adjuvant herbs. *Rosa laevigata* is primarily used for astringency and consolidation; its tannins can reduce sensitivity and prolong ejaculation latency. *Salvia miltiorrhiza* invigorates blood circulation and removes blood stasis; through tanshinone IIA and salvianolic acid B, it improves penile microcirculation, promotes angiogenesis, and significantly enhances transdermal efficiency when combined with borneol. *Sophora flavescens* clears heat and dries dampness; its alkaloid components relieve damp heat and local irritation through antibacterial, anti-inflammatory, and TRPV1 blocking effects, ensuring safety for external use. Borneol is used as a penetration enhancer to increase the penetration of active ingredients by widening the intercellular spaces of epidermal cells. Its cooling properties can immediately reduce local temperature and nerve sensitivity, improving user comfort. The specific mechanisms of action of each medicinal material are as follows: Ginseng is the plant ginseng of the Araliaceae family. Panax ginseng The dried roots and rhizomes of CA Mey. Ginseng is the principal ingredient in this traditional Chinese medicine formula, possessing the effects of tonifying qi, strengthening the body's foundation, and invigorating the reproductive organs. In external application for men, ginseng enhances the circulation of qi and blood in the reproductive organs by tonifying kidney yang and heart qi, thereby improving erectile function and sexual endurance. Its foundation-strengthening and vital-nourishing effects can regulate essence, qi, and spirit, alleviating premature ejaculation and decreased libido caused by kidney yang deficiency. Modern pharmacological studies have shown that its core active ingredient, ginsenosides (such as Rg1 and Rb1), can promote the release of nitric oxide (NO), dilate local blood vessels, and improve microcirculation in the penile corpora cavernosa; its antioxidant components scavenge free radicals, protect nerve and vascular endothelial cells, and delay the decline of sexual function. Animal experiments have also confirmed that ginsenosides can significantly prolong the mating latency period and increase the mounting frequency in male mice, with its mechanism of action involving PDE5 inhibition (IC5). 50 =12.47 nmol / L) and antioxidant protection. Clinical data show that continuous use for 8 weeks can improve erectile rigidity score by 42%, without the cardiovascular risks associated with sildenafil-like drugs. In addition, ginseng extract can regulate the hypothalamus-pituitary-gonadal axis, increase testosterone levels, and indirectly prolong the duration of sexual intercourse.

[0012] Double kidney grass is a monocotyledonous medicinal plant, orchid of the Orchidaceae family, *Hylocereus scoparia* (also known as *Hylocereus scoparia*). Herminium bulleyiThe tuber of *Rolfe. Tanget Wang*. *Rolfe. Tanget Wang* is a traditional Miao medicine, used as an adjuvant in this Chinese herbal formula, synergistically with *Smilax glabra* to tonify kidney yang. *Rolfe. Tanget Wang* has shown significant efficacy in improving male sexual function. Experiments have shown that *Rolfe. Tanget Wang* extract can significantly increase the index of accessory sex organs (seminal vesicles, prostate) in male mice, shorten the capture latency, and increase the frequency of sexual behavior, suggesting that it has sex hormone-like activity. Its active components (such as bibenzyl compounds like durene, palmitic acid, and β-sitosterol) may promote testosterone secretion by activating the hypothalamus-pituitary-gonadal axis, while antioxidant components (such as bibenzyl compounds) can scavenge free radicals, improve the oxidative stress state of testicular tissue, and indirectly improve erectile function. Terpenes in *Rolfe. Tanget Wang* may enhance corpus cavernosum blood flow through the NO-cGMP pathway. In addition, phytosterols such as β-sitosterol can competitively bind to sex hormone receptors, synergistically enhancing androgen effects, thereby improving symptoms of kidney yang deficiency such as impotence and spermatorrhea.

[0013] Millettia dielsiana is a beautiful vine belonging to the legume family. Millettia speciosa The dried root of *Champ.*. *Champ.* is a traditional Chinese medicine used in the Lingnan region, serving as an adjuvant in this herbal formula, synergistically tonifying kidney yang with *Smilax glabra*. Studies speculate that the flavonoids and polysaccharides in *Champ.* may indirectly improve sexual function by regulating immunity, antioxidation, and influencing vasodilation pathways. Polysaccharides may enhance macrophage activity, regulate immune signaling pathways such as TLR4, and reduce the impact of reproductive system inflammation on sexual function; flavonoids alleviate oxidative stress damage through antioxidation and inhibition of the NF-κB inflammatory pathway. Regarding the improvement of erectile dysfunction, its active ingredients may activate the nitric oxide (NO)-cyclic guanosine monophosphate (cGMP) pathway, promoting NO synthesis and inhibiting phosphodiesterase 5 (PDE5) degradation of cGMP, thereby relaxing the smooth muscle of the corpus cavernosum and increasing blood flow.

[0014] Rosa laevigata, Salvia miltiorrhiza, and Sophora flavescens are used as adjuvants in this traditional Chinese medicine compound.

[0015] Rosa laevigata is a plant belonging to the Rosaceae family. Smooth rose The dried, ripe fruit of *Rosa laevigata*. *Rosa laevigata* has the effects of astringing sperm, reducing urination, and stopping diarrhea. As a classic astringent, its astringent properties effectively restrain ejaculation, reducing premature ejaculation through its astringent effect. Modern pharmacological studies have shown that the tannins in *Rosa laevigata* can reduce the sensitivity of the glans penis. Animal experiments have confirmed that its alcohol extract can significantly prolong the ejaculation latency in rats without significant central nervous system depressant effects. Furthermore, the root extract of *Rosa laevigata* has an inhibitory effect on urinary system inflammations such as prostatitis, indirectly improving sexual function by alleviating inflammation.

[0016] Danshen is a plant of the Lamiaceae family called Salvia miltiorrhiza. Salvia miltiorrhizaThe dried root and rhizome of *B. ge.*. *Salvia miltiorrhiza* is known for its blood-activating, stasis-removing, blood-cooling, and swelling-reducing properties. In this formula, it primarily functions to "unblock," improving penile hemodynamics, reducing microcirculation stagnation in the corpora cavernosa, and enhancing erectile quality. Its blood-cooling properties balance local damp-heat, preventing redness and swelling caused by topical medications. Tanshinone IIA, contained in *Salvia miltiorrhiza*, inhibits platelet aggregation, promotes penile arterial blood flow, enhances tissue plasminogen activator (t-PA) activity, and dissolves fibrin deposits. Tanshinone B promotes penile angiogenesis by upregulating vascular endothelial growth factor (VEGF) and protects vascular endothelium by activating the PI3K / Akt signaling pathway, thus maintaining erectile function. Studies have shown that its combination with borneol significantly improves skin permeability, allowing the active ingredients to reach the dorsal nerve region of the penis more quickly.

[0017] Sophora flavescens is a legume plant. Sophora flavescens The dried root of Ait. Sophora flavescens. Sophora flavescens has the effects of clearing heat and drying dampness, killing parasites and relieving itching. It can solve the accompanying symptoms such as scrotal dampness and itching caused by damp heat. It can indirectly prolong the duration of sexual intercourse by improving the local environment. The matrine and oxymatrine contained in it are the main active ingredients. They not only have significant antibacterial (such as Staphylococcus aureus and Candida albicans) and anti-inflammatory effects, but also reduce the release of inflammatory factors (such as TNF-α and IL-6). They can also block the transient receptor potential channel (TRPV1) and block the action potential conduction of the dorsal nerve of the penis, thereby reducing skin sensitivity and burning sensation. Its effect of inhibiting the release of histamine from mast cells further reduces skin irritation and ensures the safety of external use.

[0018] Natural borneol is derived from the camphor tree (Cinnamomum camphora), a plant belonging to the Lauraceae family. Cinnamomum camphora Borneol is a white crystalline powder or flaky crystal made from the fresh branches and leaves of *L.* Presl. It is pungent and aromatic, cool in nature and bitter in taste, and has the effects of opening the orifices, refreshing the mind, clearing heat and relieving pain. As the guiding herb in this traditional Chinese medicine compound, borneol acts as a meridian guide and penetration enhancer; its pungent and aromatic properties can carry the active ingredients through the stratum corneum barrier. Modern research has confirmed that borneol can expand the intercellular spaces of epidermal cells by 3-5 times, increasing the transdermal absorption rate of drugs. Simultaneously, the cooling sensation produced by activating the transient receptor potential M8 (TRPM8) cold receptor can immediately relieve the burning sensation of sexual arousal, reduce local temperature and nerve sensitivity, and significantly improve user comfort.

[0019] The innovation of this invention lies in the deep integration of traditional efficacy with modern mechanism analysis. Through the scientific combination of seven Chinese herbs, including ginseng and *Sophora flavescens*, it achieves multi-pathway synergistic intervention (inhibiting sensitivity, improving blood flow, repairing the barrier, and regulating hormones). On the one hand, it reduces sensitivity through tannins from Rosa laevigata and matrine (inhibiting the TRPV1 channel), and significantly reduces numbness by using borneol to provide a cooling sensation, avoiding the burning, erythema, and numbness problems common with chemical anesthetics (such as benzocaine). On the other hand, it enhances erectile hardness and duration by promoting NO release through ginsenosides, improving microcirculation and promoting angiogenesis through tanshinone, and activating the NO-cGMP pathway through flavonoids from *Sophora flavescens*. Simultaneously, the anti-inflammatory and antibacterial effects of *Sophora flavescens* and the antioxidant effects of ginseng synergistically protect the skin and mucous membrane barrier, reducing irritation. Animal experiments have confirmed that this approach can prolong ejaculation latency to more than 6 minutes (compared to 3.2 minutes in the control group) and increase sexual satisfaction by more than 40%. This comprehensive mechanism of action not only significantly prolongs ejaculation latency but also improves the reproductive health environment, providing a more natural, comprehensive, and lasting delay effect and sexual function support. It is highly safe for long-term use, with no risk of mucosal damage. Furthermore, through group extraction and purification, resin purification, and molecular sieve technology, small molecule active ingredients are enriched, overcoming the challenges of poor transdermal absorption and slow onset of action in traditional Chinese medicine, significantly improving transdermal absorption efficiency. The onset time is shortened from over 40 minutes for traditional Chinese medicine preparations to less than 15 minutes, approaching the level of chemical anesthetics (5-10 minutes), meeting practical usage needs.

[0020] Furthermore, the ginseng, *Smilax china*, *Smilax glabra*, and *Salvia miltiorrhiza* are mixed and pretreated with cellulase before being extracted by reflux with 65-75% ethanol. Enzymatic extraction assists in the extraction of cellulose and hemicellulose from plant cell walls, disrupting cell structure and facilitating the release of active ingredients encapsulated within the cells.

[0021] Preferably, the amount of cellulase used is 0.4-0.6% w / w.

[0022] Furthermore, the non-polar adsorption resin is a D101 macroporous adsorption resin.

[0023] Furthermore, the neutral polar adsorption resin is HPD-400 macroporous adsorption resin.

[0024] Furthermore, the acid extraction method involves reflux extraction using a 0.8–1.2% dilute hydrochloric acid solution.

[0025] Furthermore, the strongly acidic cation exchange resin is of type 001×7.

[0026] Furthermore, the concentration is to concentrate to a volume of approximately 10g crude drug / mL.

[0027] Furthermore, the purification involves filtration using an ultrafiltration membrane with a molecular weight cutoff of 1000 Da to remove macromolecular components such as polysaccharides / proteins with a molecular weight >1000 Da, thereby retaining active ingredients with a molecular weight <1000 Da.

[0028] As a preferred embodiment, the preparation method of the ginseng / double kidney grass / ox dung / salvia miltiorrhiza purified solution is as follows: Take crude powders of ginseng, double kidney grass, ox dung, and salvia miltiorrhiza according to the mass fractions, soak in a small amount of water, and pretreat with 0.4-0.6% w / w cellulase for 0.5-2 hours to disrupt the cell wall structure. Extract twice with 65-75% ethanol under reflux, the first time with a material-to-liquid ratio of 1:9-11, w / v, and the second time with a material-to-liquid ratio of 1:7-9, w / v. Combine the filtrates, recover the ethanol until no alcohol odor remains, and dilute with distilled water to approximately 0.2 g crude drug / mL. Purify using D101 macroporous adsorption resin, passing the sample solution through the resin column at a flow rate of 2 BV / h (sample loading amount approximately 2-3 g crude drug / g resin). After adsorption, elute sequentially with 1.5 BV distilled water, 3 BV 50% ethanol (2 BV / h), and 2 BV 70% ethanol (1 BV / h). Collect the 50% and 70% ethanol eluents, combine them, and concentrate them to a volume of approximately 10 g crude drug / mL to obtain the purified extract.

[0029] As a preferred embodiment, the preparation method of the purified extract of Rosa laevigata is as follows: Remove the crude powder of Rosa laevigata according to the specified mass fractions, and extract twice with 55-65% ethanol under reflux. The first extraction has a material-to-liquid ratio of 1:9-11 (w / v), and the second extraction has a material-to-liquid ratio of 1:7-9 (w / v). Combine the filtrates, recover the ethanol under reduced pressure, and dilute with water to approximately 0.2 g crude drug / mL. Purify using HPD-400 macroporous adsorption resin: Pass the sample solution through the resin column at a flow rate of 2 BV / h (approximately 2-3 g crude drug / g resin). After adsorption, elute sequentially with 3 BV distilled water and 2 BV 70% ethanol (2 BV / h). Tannins are monitored throughout the process using the ferric chloride colorimetric method. Collect the 70% ethanol eluent and concentrate it to approximately 10 g crude drug / mL to obtain the purified extract of Rosa laevigata.

[0030] As a preferred embodiment, the preparation method of the Sophora flavescens extract purification solution is as follows: Take crude powder of Sophora flavescens medicinal material according to the specified mass fractions, and extract twice with 0.8–1.2% dilute hydrochloric acid solution at 75–85℃, each time for 1–3 hours. The material-to-liquid ratio for the first extraction is 1:9–11, w / v, and for the second extraction, it is 1:7–9, w / v. Combine the filtrates and recover the solvent to a volume of approximately 0.2 g crude drug / mL. Purify using a strongly acidic cation exchange resin (type 001×7), with the sample solution passing through the resin column at a flow rate of 1 BV / h. After adsorption, wash with 3 BV of pure water to remove impurities, and then elute the target total alkaloids with 5 BV of 70% ethanol solution containing 5% ammonia at a flow rate of 0.5 BV / h. Collect the eluent, recover the ethanol under reduced pressure, and concentrate to a volume of approximately 10 g crude drug / mL to obtain the Sophora flavescens extract purification solution.

[0031] The above-mentioned naturally extracted traditional Chinese medicine compound ingredients of the present invention inhibit nerve sensitivity, improve microcirculation, and repair the mucosal barrier through multi-target synergistic effects, thereby prolonging the ejaculation latency and improving the quality of sexual life. Therefore, the present invention also provides the application of any of the above-mentioned external traditional Chinese medicine compositions in the preparation of male external delay products.

[0032] Furthermore, the product is an essence, liquid, gel, or spray.

[0033] The present invention also provides an essence containing any of the above-described topical Chinese medicine compositions.

[0034] Furthermore, the mass percentage of the topical Chinese medicine composition in the essence is 0.8% to 1.3%.

[0035] Further, the essence comprises the following components in the indicated mass percentages: 0.8–1.2 parts of small molecule active ingredients from traditional Chinese medicine, 0.08–0.12 parts of borneol, 0.4–0.6 parts of sodium hyaluronate, 4–6 parts of glycerin, 4–6 parts of butylene glycol, 2–4 parts of 1,3-propanediol, 1–3 parts of trehalose, 0.05–0.2 parts of allantoin, 0.2–0.4 parts of carbomer, 0.04–0.06 parts of disodium EDTA, and deionized water to a total of 100 parts, with a pH of 6.0–6.5.

[0036] This invention abandons the greasy and heavy feel of traditional Chinese medicine ointments, using a water-based essence. It contains ingredients such as sodium hyaluronate, glycerin, and butylene glycol, resulting in a refreshing and easily absorbed texture that is breathable and does not stain clothing. Its pH value (6.0–6.5) is close to the skin's environment, and the addition of borneol provides a cooling sensation, significantly improving user comfort.

[0037] Furthermore, it also includes 0.4 to 0.6 parts of phenoxyethanol as a preservative for the serum.

[0038] The present invention also provides a method for preparing the above-mentioned essence, which involves pre-swelling the carbomer matrix, dissolving the small molecule active ingredients of traditional Chinese medicine, borneol, sodium hyaluronate, glycerin, butylene glycol, 1,3-propanediol, trehalose, allantoin and disodium EDTA in an aqueous phase, mixing the carbomer matrix with the aqueous phase to thicken, adjusting the pH to 6.0-6.5, and homogenizing and filling.

[0039] As a preferred embodiment, the preparation method of the above-mentioned essence includes the following steps: S1. Carbomer matrix preparation: Disperse carbomer in a portion of deionized water, stir until fully swollen, and heat to about 70°C to promote dissolution.

[0040] S2. Aqueous Phase Preparation: In another clean, sterilized container, add deionized water (reserve a portion for dissolving carbomer). Add the small-molecule active ingredients of the traditional Chinese medicine, borneol, sodium hyaluronate, glycerin, butylene glycol, 1,3-propanediol, trehalose, allantoin, and disodium EDTA in sequence. Heat to approximately 75°C, stirring constantly, until all components are completely dissolved and homogeneous.

[0041] S3. Mixing and Thickening: When the aqueous phase temperature drops to approximately 70°C, slowly add the pre-prepared carbomer solution while continuously stirring, avoiding the formation of excessive foam. Continue stirring until the carbomer is completely dissolved, forming a homogeneous and viscous matrix.

[0042] S4. pH adjustment: Use triethanolamine to slowly titrate and adjust the pH of the mixed solution to between 6.0 and 6.5.

[0043] S5. Cooling and Adding Preservatives: Cool the solution to near room temperature (approximately 25–30°C). Add phenoxyethanol and stir until homogeneous.

[0044] S6. Homogenization: The solution is homogenized using a homogenizer to improve the uniformity and stability of the product.

[0045] S7. Quality Inspection and Filling: The obtained essence is inspected for quality indicators such as appearance, odor, pH value, and viscosity. After ensuring that it meets the standard requirements, it is filled to obtain the male external delay essence based on small molecule active ingredients of traditional Chinese medicine.

[0046] This invention's traditional Chinese medicine composition achieves comprehensive intervention through "multi-target regulation." Simultaneously, utilizing modern extraction and purification technologies (such as enzymatic-assisted extraction, macroporous resin purification, and ultrafiltration membrane separation), it effectively removes large molecular impurities and enriches small molecular active ingredients (molecular weight <1000 Da), significantly improving transdermal absorption efficiency. This resolves the contradiction between safety, onset speed, and user comfort. This technological integration, through multi-pathway synergistic action, meets users' core needs for "natural, long-lasting, and imperceptible intervention," providing a scientifically feasible technical path for upgrading male topical delay products.

[0047] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a male external application of a traditional Chinese medicine composition for delaying ejaculation, comprising the following components in parts by weight: small molecule active ingredients of traditional Chinese medicine: 0.8-1.2 parts; borneol: 0.08-0.12 parts; the small molecule active ingredients of traditional Chinese medicine are prepared from the following components in parts by weight: ginseng 30-40 parts, *Smilax glabra* 20-30 parts, *Achyranthes bidentata* 20-30 parts, *Salvia miltiorrhiza* 5-15 parts, *Rosa laevigata* 10-20 parts, and *Sophora flavescens* 5-15 parts; this traditional Chinese medicine composition, through the synergistic effect of inhibiting nerve sensitivity, improving microcirculation, repairing the barrier, and promoting cooling and penetration, can significantly prolong the ejaculation latency period and improve sexual satisfaction (it can prolong the ejaculation latency period to more than 6 minutes (compared to 3.2 minutes in the control group), and increase sexual satisfaction by more than 40%), providing a more natural, comprehensive, and lasting delay effect and sexual function support, and without the risk of burning, numbness, and mucosal damage caused by chemical anesthetics, making it highly safe for long-term use. Furthermore, by extracting, purifying, and enriching small molecule active ingredients with a molecular weight <1000 Da in groups, transdermal efficiency is significantly improved, and the onset time is shortened from more than 40 minutes for traditional Chinese medicine preparations to less than 15 minutes, approaching the level of chemical anesthetics (5-10 minutes). This meets users' core needs for "natural, long-lasting, and imperceptible intervention," providing a scientifically feasible technical path for upgrading male topical delay products. Detailed Implementation

[0048] The present invention is further illustrated by specific embodiments, but these embodiments do not limit the invention in any way. Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in this technical field.

[0049] Unless otherwise specified, all reagents and materials used in the following examples are commercially available.

[0050] After pretreatment, ginseng, *Smilax glabra*, *Smilax china*, *Salvia miltiorrhiza*, *Rosa laevigata*, and *Sophora flavescens* were pulverized until all of them passed through a 24-mesh sieve (850 μm aperture), and the proportion of fine powder through a 65-mesh sieve (250 μm aperture) was ≤40%, thus obtaining coarse powder that conforms to the pharmacopoeia.

[0051] The borneol was purchased from Fujian Nanping Qingsong Chemical Co., Ltd., CAS No.: 507-70-0.

[0052] The cellulase was purchased from Shanghai Yuanye Biotechnology Co., Ltd., product number: S10041, CAS number: 9012-54-8, BR, 50U / mg.

[0053] Example 1 Take 30 parts of crude ginseng powder, 20 parts of crude *Smilax china* powder, 20 parts of crude *Achyranthes bidentata* powder, and 5 parts of crude *Salvia miltiorrhiza* powder according to the following weight proportions, mix them evenly, soak them in a small amount of water, and pretreat them with cellulase (0.4% w / w) for 1 hour to destroy the cell wall structure. Extract twice with 65% ethanol under reflux, the first time with a material-to-liquid ratio of 1:10, w / v, and the second time with a material-to-liquid ratio of 1:8, w / v. Combine the filtrates, recover the ethanol until there is no alcohol odor, and dilute with distilled water to a volume of about 0.2 g crude drug / mL. Purify using D101 macroporous adsorption resin, passing the sample solution through the resin column at a flow rate of 2 BV / h (the sample amount is about 2-3 g crude drug / g resin), and then elute sequentially with 1.5 BV distilled water, 3 BV 45% ethanol (2 BV / h), and 2 BV 70% ethanol (1 BV / h). Collect the 45% and 65% ethanol eluents, combine them, and concentrate them to a volume of approximately 10 g crude drug / mL to obtain the purified extract.

[0054] Ten portions of crude Rosa laevigata powder were extracted twice by reflux with 55% ethanol. The first extraction had a material-to-liquid ratio of 1:10 (w / v), and the second extraction had a material-to-liquid ratio of 1:8 (w / v). The filtrates were combined, and the ethanol was recovered under reduced pressure. The extract was diluted with water to approximately 0.2 g crude drug / mL. Purification was performed using HPD-400 macroporous adsorption resin: the sample solution was passed through the resin column at a flow rate of 2 BV / h (approximately 2-3 g crude drug / g resin). After adsorption, the extract was eluted sequentially with 3 BV distilled water and 2 BV 65% ethanol (2 BV / h). Tannins were monitored using the ferric chloride colorimetric method throughout the process. The 65% ethanol eluent was collected and concentrated to approximately 10 g crude drug / mL to obtain the purified Rosa laevigata extract.

[0055] Five portions of crude powder of Sophora flavescens were extracted twice by reflux at 80℃ with 0.8% dilute hydrochloric acid solution (solid-liquid ratio 1:10, w / v), each time for 2 hours. The first extraction had a solid-liquid ratio of 1:10, w / v, and the second extraction had a solid-liquid ratio of 1:8, w / v. The filtrates were combined, and the solvent was recovered to a volume of approximately 0.2 g crude drug / mL. Purification was performed using a strongly acidic cation exchange resin (type 001×7), with the sample solution passing through the resin column at a flow rate of 1 BV / h. After adsorption, impurities were washed with 3 BV of pure water, and then the target total alkaloids were eluted with 5 BV of 65% ethanol solution containing 4.5% ammonia at a flow rate of 0.5 BV / h. The eluent was collected, and the ethanol was recovered under reduced pressure and concentrated to a volume of approximately 10 g crude drug / mL to obtain the purified Sophora flavescens extract.

[0056] The purified extracts of ginseng / Smilax glabra / Smilax china / Salvia miltiorrhiza, Rosa laevigata, and Sophora flavescens were combined. The combined solution was filtered through an ultrafiltration membrane with a molecular weight cutoff of 1000 Da to thoroughly remove large molecular impurities (such as polysaccharides and proteins) while retaining small molecular active ingredients such as target saponins, flavonoids, and alkaloids. The filtrate was concentrated and freeze-dried to obtain the active substances of traditional Chinese medicine rich in small molecular active ingredients (molecular weight <1000 Da).

[0057] Disperse 0.3 parts of carbomer in a portion of deionized water and stir until fully swollen. Heating to approximately 70°C can promote dissolution. In another clean, sterilized container, add an appropriate amount of deionized water, then add sequentially 0.8 parts of the small molecule active ingredient of the traditional Chinese medicine, 0.08 parts of borneol, 0.5 parts of sodium hyaluronate, 5 parts of glycerin, 5 parts of butylene glycol, 3 parts of 1,3-propanediol, 2 parts of trehalose, 0.1 parts of allantoin, and 0.05 parts of disodium EDTA. Finally, add deionized water to a final volume of 100 parts (including the portion containing dissolved carbomer). Heat to approximately 75°C while stirring continuously until all components are completely dissolved and homogeneous. When the aqueous phase temperature drops to approximately 70°C, slowly add the pre-prepared carbomer solution while continuously stirring, avoiding excessive foaming. Continue stirring until the carbomer is completely dissolved, forming a homogeneous, viscous matrix. Adjust the pH of the mixed solution to between 6.0 and 6.5 by slow titration with an appropriate amount of triethanolamine. Cool the solution to near room temperature (approximately 25-30°C). Add 0.5 parts of phenoxyethanol and stir until homogenized. Homogenize the solution using a homogenizer to improve the uniformity and stability of the product. Test the obtained essence for quality indicators such as appearance, odor, pH value, and viscosity. After ensuring that it meets the standard requirements, fill the solution to obtain the male external delay essence based on small molecule active ingredients of traditional Chinese medicine.

[0058] Example 2 Take 35 parts of crude ginseng powder, 25 parts of crude *Smilax china* powder, 25 parts of crude *Achyranthes bidentata* powder, and 10 parts of crude *Salvia miltiorrhiza* powder according to the following weight proportions, mix them evenly, soak them in a small amount of water, and pretreat them with cellulase (0.5% w / w) for 1 hour to disrupt the cell wall structure. Extract twice with 70% ethanol under reflux, the first time with a material-to-liquid ratio of 1:10, w / v, and the second time with a material-to-liquid ratio of 1:8, w / v. Combine the filtrates, recover the ethanol until there is no alcohol odor, and dilute with distilled water to a volume of approximately 0.2 g crude drug / mL. Purify using D101 macroporous adsorption resin, passing the sample solution through the resin column at a flow rate of 2 BV / h (the sample amount is approximately 2-3 g crude drug / g resin). After adsorption, elute sequentially with 1.5 BV distilled water, 3 BV 50% ethanol (2 BV / h), and 2 BV 70% ethanol (1 BV / h). Collect the 50% and 70% ethanol eluents, combine them, and concentrate them to a volume of approximately 10 g crude drug / mL to obtain the purified extract.

[0059] Fifteen portions of crude Rosa laevigata powder were extracted twice by reflux with 60% ethanol. The first extraction had a material-to-liquid ratio of 1:10 (w / v), and the second extraction had a material-to-liquid ratio of 1:8 (w / v). The filtrates were combined, and the ethanol was recovered under reduced pressure. The extract was diluted with water to a volume of approximately 0.2 g crude drug / mL. Purification was performed using HPD-400 macroporous adsorption resin: the sample solution was passed through the resin column at a flow rate of 2 BV / h (approximately 2-3 g crude drug / g resin). After adsorption, the extract was eluted sequentially with 3 BV distilled water and 2 BV 70% ethanol (2 BV / h). The tannin content was monitored throughout the process using the ferric chloride colorimetric method. The 70% ethanol eluent was collected and concentrated to a volume of approximately 10 g crude drug / mL to obtain the purified Rosa laevigata extract.

[0060] Ten portions of crude powder of Sophora flavescens were extracted twice by reflux at 80℃ with 1% dilute hydrochloric acid solution (solid-liquid ratio 1:10, w / v), each time for 2 hours. The first extraction had a solid-liquid ratio of 1:10, w / v, and the second extraction had a solid-liquid ratio of 1:8, w / v. The filtrates were combined, and the solvent was recovered to a volume of approximately 0.2 g crude drug / mL. Purification was performed using a strongly acidic cation exchange resin (type 001×7), with the sample solution passing through the resin column at a flow rate of 1 BV / h. After adsorption, impurities were washed with 3 BV of pure water, and then the target total alkaloids were eluted with 5 BV of 70% ethanol solution containing 5% ammonia at a flow rate of 0.5 BV / h. The eluent was collected, and the ethanol was recovered under reduced pressure and concentrated to a volume of approximately 10 g crude drug / mL to obtain the purified Sophora flavescens extract.

[0061] The purified extracts of ginseng / Smilax glabra / Smilax china / Salvia miltiorrhiza, Rosa laevigata, and Sophora flavescens were combined. The combined solution was filtered through an ultrafiltration membrane with a molecular weight cutoff of 1000 Da to thoroughly remove large molecular impurities (such as polysaccharides and proteins) while retaining small molecular active ingredients such as target saponins, flavonoids, and alkaloids. The filtrate was concentrated and freeze-dried to obtain the active substances of traditional Chinese medicine rich in small molecular active ingredients (molecular weight <1000 Da).

[0062] Disperse 0.3 parts of carbomer in a portion of deionized water and stir until fully swollen. Heating to approximately 70°C can promote dissolution. In another clean, sterilized container, add an appropriate amount of deionized water, then add sequentially: 1 part of the small molecule active ingredient of the traditional Chinese medicine, 0.1 part of borneol, 0.5 parts of sodium hyaluronate, 5 parts of glycerin, 5 parts of butylene glycol, 3 parts of 1,3-propanediol, 2 parts of trehalose, 0.1 part of allantoin, and 0.05 parts of disodium EDTA. Finally, add deionized water to a final volume of 100 parts (including the portion containing dissolved carbomer). Heat to approximately 75°C while stirring continuously until all components are completely dissolved and homogeneous. When the aqueous phase temperature drops to approximately 70°C, slowly add the pre-prepared carbomer solution while continuously stirring, avoiding excessive foaming. Continue stirring until the carbomer is completely dissolved, forming a homogeneous, viscous matrix. Use an appropriate amount of triethanolamine to slowly titrate and adjust the pH of the mixed solution to between 6.0 and 6.5. Cool the solution to near room temperature (approximately 25-30°C). Add 0.5 parts of phenoxyethanol and stir until homogeneous. Homogenize the solution using a homogenizer to improve the uniformity and stability of the product. Test the obtained essence for quality indicators such as appearance, odor, pH value, and viscosity. After ensuring that it meets the standard requirements, fill the solution to obtain the male external delay essence based on small molecule active ingredients of traditional Chinese medicine.

[0063] Example 3 Take 40 parts of crude ginseng powder, 30 parts of crude *Smilax china* powder, 30 parts of crude *Achyranthes bidentata* powder, and 15 parts of crude *Salvia miltiorrhiza* powder according to the following weight proportions, mix them evenly, soak them in a small amount of water, and pretreat them with cellulase (0.6% w / w) for 1 hour to disrupt the cell wall structure. Extract twice with 75% ethanol under reflux, the first time with a material-to-liquid ratio of 1:10, w / v, and the second time with a material-to-liquid ratio of 1:8, w / v. Combine the filtrates, recover the ethanol until there is no alcohol odor, and dilute with distilled water to a volume of approximately 0.2 g crude drug / mL. Purify using D101 macroporous adsorption resin, passing the sample solution through the resin column at a flow rate of 2 BV / h (the sample amount is approximately 2-3 g crude drug / g resin). After adsorption, elute sequentially with 1.5 BV distilled water, 3 BV 55% ethanol (2 BV / h), and 2 BV 70% ethanol (1 BV / h). Collect the 55% and 75% ethanol eluents, combine them, and concentrate them to a volume of approximately 10 g crude drug / mL to obtain the purified extract.

[0064] Twenty portions of crude Rosa laevigata powder were extracted twice by reflux with 65% ethanol. The first extraction had a material-to-liquid ratio of 1:10 (w / v), and the second extraction had a material-to-liquid ratio of 1:8 (w / v). The filtrates were combined, and the ethanol was recovered under reduced pressure. The extract was diluted with water to approximately 0.2 g crude drug / mL. Purification was performed using HPD-400 macroporous adsorption resin: the sample solution was passed through the resin column at a flow rate of 2 BV / h (approximately 2-3 g crude drug / g resin). After adsorption, the extract was eluted sequentially with 3 BV distilled water and 2 BV 75% ethanol (2 BV / h). Tannins were monitored using the ferric chloride colorimetric method throughout the process. The 75% ethanol eluent was collected and concentrated to approximately 10 g crude drug / mL to obtain the purified Rosa laevigata extract.

[0065] Fifteen portions of crude powder of Sophora flavescens were extracted twice by reflux at 80℃ with 1.2% dilute hydrochloric acid solution (solid-liquid ratio 1:10, w / v), each time for 2 hours. The first extraction had a solid-liquid ratio of 1:10, w / v, and the second extraction had a solid-liquid ratio of 1:8, w / v. The filtrates were combined, and the solvent was recovered to a volume of approximately 0.2 g crude drug / mL. Purification was performed using a strongly acidic cation exchange resin (type 001×7), with the sample solution passing through the resin column at a flow rate of 1 BV / h. After adsorption, impurities were washed with 3 BV of pure water, and then the target total alkaloids were eluted with 5 BV of 75% ethanol solution containing 5.5% ammonia at a flow rate of 0.5 BV / h. The eluent was collected, and the ethanol was recovered under reduced pressure and concentrated to a volume of approximately 10 g crude drug / mL to obtain the purified Sophora flavescens extract.

[0066] The purified extracts of ginseng / Smilax glabra / Smilax china / Salvia miltiorrhiza, Rosa laevigata, and Sophora flavescens were combined. The combined solution was filtered through an ultrafiltration membrane with a molecular weight cutoff of 1000 Da to thoroughly remove large molecular impurities (such as polysaccharides and proteins) while retaining small molecular active ingredients such as target saponins, flavonoids, and alkaloids. The filtrate was concentrated and freeze-dried to obtain the active substances of traditional Chinese medicine rich in small molecular active ingredients (molecular weight <1000 Da).

[0067] Disperse 0.3 parts of carbomer in a portion of deionized water and stir until fully swollen. Heating to approximately 70°C can promote dissolution. In another clean, sterilized container, add an appropriate amount of deionized water, then add sequentially 1.2 parts of the small molecule active ingredient of the traditional Chinese medicine, 0.12 parts of borneol, 0.5 parts of sodium hyaluronate, 5 parts of glycerin, 5 parts of butylene glycol, 3 parts of 1,3-propanediol, 2 parts of trehalose, 0.1 parts of allantoin, and 0.05 parts of disodium EDTA. Finally, add deionized water to a final volume of 100 parts (including the portion containing dissolved carbomer). Heat to approximately 75°C while stirring continuously until all components are completely dissolved and homogeneous. When the aqueous phase temperature drops to approximately 70°C, slowly add the pre-prepared carbomer solution while continuously stirring, avoiding excessive foaming. Continue stirring until the carbomer is completely dissolved, forming a homogeneous, viscous matrix. Adjust the pH of the mixed solution to between 6.0 and 6.5 by slow titration with an appropriate amount of triethanolamine. Cool the solution to near room temperature (approximately 25-30°C). Add 0.5 parts of phenoxyethanol and stir until homogenized. Homogenize the solution using a homogenizer to improve the uniformity and stability of the product. Test the obtained essence for quality indicators such as appearance, odor, pH value, and viscosity. After ensuring that it meets the standard requirements, fill the solution to obtain the male external delay essence based on small molecule active ingredients of traditional Chinese medicine.

[0068] Comparative Example 1: Traditional water extraction and alcohol precipitation method The ginseng, *Smilax glabra*, *Smilax china*, *Rosa laevigata*, *Salvia miltiorrhiza*, and *Sophora flavescens* (in the same proportions as in Example 2) were mixed together and decocted twice with water (material-to-liquid ratio 1:10 → 1:8). The decoctions were combined and concentrated to a density of 1.2 g / mL. Three times the volume of the concentrated solution was added to 70% ethanol for precipitation for 24 hours, and the supernatant was collected to recover the ethanol. The concentrated solution was filtered through the same ultrafiltration membrane (1000 Da cutoff), and the filtrate was retained. The finished product was prepared using the same extract formulation and process as in Example 2.

[0069] Purpose of comparison: This highlights the necessity of group extraction and resin purification: mixing the whole formula results in low yield of active ingredients (such as ginsenosides, flavonoids of *Sophora flavescens*, and alkaloids of *Sophora flavescens*) and a large number of impurities.

[0070] Comparative Example 2: Extraction was performed in groups but without ultrafiltration (retaining macromolecular impurities). The group extraction and resin purification process of Example 2 was completely replicated (including enzymatic hydrolysis of ginseng group + D101 resin, HPD-400 resin for Rosa laevigata group, and ion exchange resin for Sophora flavescens group). After combining the three purified solutions, the ultrafiltration step was skipped, and the solution was directly concentrated and freeze-dried. The finished product was prepared using the same extract formulation and process as in Example 2.

[0071] Purpose of comparison: Verifying the core value of ultrafiltration: Failure to remove large molecules such as polysaccharides / proteins with a molecular weight >1000 Da leads to: decreased transdermal absorption rate (large molecules clog pores), prolonged onset time (>30 minutes), increased formulation viscosity (synergistic thickening with glycerin, etc.), proving that small molecule enrichment is the key support for "rapid onset".

[0072] Comparative Example 3: The compound formulation lacks the principal drug (disrupting multi-target synergy). The compound formula was modified to use only 25 parts of *Smilax glabra*, 25 parts of *Smilax china*, 15 parts of *Rosa laevigata*, 10 parts of *Salvia miltiorrhiza*, 10 parts of *Sophora flavescens*, and 0.1 parts of borneol (total amount same as in Example 2, except for ginseng). The process was completely replicated from the group extraction, purification, ultrafiltration, and formulation process of Example 2.

[0073] Comparison points: The absence of ginsenoside regulation of NO release and microcirculation significantly reduced erectile hardness; the lack of antioxidant protection weakened local mucosal repair function; verifying the core position of the "principal drug" in the compound formula.

[0074] Comparative Example 4: The combination of drugs lacks adjuvant drugs (disrupting multi-target synergy). The compound formula was modified to use only 35 parts ginseng, 15 parts Rosa laevigata, 10 parts Salvia miltiorrhiza, 10 parts Sophora flavescens, and 0.1 parts borneol (total amount same as in Example 2, omitting Gynostemma pentaphyllum and Smilax glabra). The process completely replicated the group extraction, purification, ultrafiltration, and formulation process of Example 2.

[0075] Comparative Example 5: The compound formulation lacked adjuvant drugs (disrupting multi-target synergy). The compound formula was modified to use only 35 parts ginseng, 25 parts *Smilax china*, 25 parts *Smilax glabra*, and 0.1 parts borneol (total amount same as in Example 2, omitting *Rosa laevigata*, *Salvia miltiorrhiza*, and *Sophora flavescens*). The process completely replicated the extraction, purification, ultrafiltration, and preparation procedures of the ginseng group in Example 2.

[0076] Comparative Example 6: Incompatibility of the compound formulation disrupts drug synergy (damages multi-target synergy). The process completely replicates the group extraction, purification, and ultrafiltration procedures of Example 2. However, borneol is not added in the essence formulation process; instead, the same mass of deionized water is used.

[0077] Comparison point: The cooling sensation and immediate desensitization effect brought by TRPM8 activation without borneol.

[0078] Comparative Example 7: Incompatibility of the compound formulation disrupts drug synergy (damages multi-target synergy). No traditional Chinese medicine compound ingredients are added. No borneol or small-molecule active ingredients from traditional Chinese medicine are added during the serum formulation process; instead, deionized water of equal weight is used.

[0079] Comparison point: A comparison between formulas containing traditional Chinese medicine compound ingredients and formulas without any added traditional Chinese medicine compound ingredients.

[0080] Test Example 1: Evaluation Experiment of Sexual Behavioral Efficacy in Rats (1) Experimental objective: The efficacy of the traditional Chinese medicine small molecule essence described in this invention on improving the sexual function of male rats was verified using sexual behavior evaluation methods, with a focus on evaluating its effects on prolonging ejaculation latency (IELT) and increasing mating activity (number of mountings and insertions). By comparing the differences between the two groups of examples (essence prepared with the optimal patented formula and process) and the seven comparative groups (derivatives with adjusted formulas and processes), the key influences of the traditional Chinese medicine compound formulation and small molecule extraction and purification process on the therapeutic effect were clarified, providing a scientific basis for the protection of the core innovation of the patent.

[0081] (2) Preparation of experimental animals One hundred and twenty SPF-grade male SD rats, weighing 220±20 grams, were randomly divided into 12 groups of ten rats each. The groups included a blank control group (saline), a positive control group (7.5% benzocaine spray), three groups containing the essence of this invention (Examples 1, 2, and 3), and seven comparative groups (Comparative Examples 1-7). Eighty female SD rats, weighing 180-200 grams, were used to induce estrus. All animals were housed in a constant temperature and humidity environment, with the temperature maintained at 25±1 degrees Celsius and the humidity controlled at 50±10%, using a 12-hour light-dark cycle. After seven days of acclimatization, the male rats underwent pubic hair removal using an electric shaver to thoroughly remove hair around the penis, ensuring skin exposure. Animals had free access to food and water during the experiment, but were fasted for six hours prior to drug administration.

[0082] (3) Implementation of the dosing regimen Before administration, the penile area of ​​male rats was disinfected with 75% ethanol cotton balls and allowed to air dry before administration. Using a precision pipette, 0.1 ml of the test substance was accurately measured and evenly applied to the glans penis and coronal sulcus. The operator, wearing sterile finger cots, gently massaged the area in a circular motion for 30 seconds to ensure adequate absorption. An equal volume of physiological saline was applied to the blank control group, an equal volume of 7.5% benzocaine spray was applied to the positive control group, and equal volumes of the corresponding formulation were applied to each comparative group.

[0083] (4) Induction of estrus in female mice Female mice were subcutaneously injected with estradiol benzoate (10 μg / mouse) and progesterone (500 μg / mouse) to induce estrus. Individuals exhibiting good estrus status were selected for the experiment using a lordosis test. The criteria for estrus were a pronounced arched back response to touch of the lumbosacral region and moist, swollen vulva.

[0084] (5) Sexual behavior test The test was conducted in a low-light environment (light intensity below 10 lux). The observation box was made of 40×30×30 cm transparent acrylic glass, and the background white noise was controlled at 50 dB to shield against environmental interference. After drug administration, male rats were placed alone in the observation box for 10 minutes to acclimatize, followed by the introduction of induced estrus female rats. Infrared imaging system recorded sexual behavior over 30 minutes, focusing on the following indicators: ejaculation latency (IELT), the time (in seconds) from insertion to ejaculation (recorded three times and averaged); mounting attempts (number of mounting actions by the male rat on the female rat within 30 minutes); and successful vaginal penetration attempts (number of successful penetrations within 30 minutes). Ejaculation behavior was verified by characteristic hind limb stiffness and subsequent licking actions.

[0085] (6) Results and Conclusions One-way ANOVA was used to compare differences between groups, and Tukey's test was used for pairwise comparisons between groups.

[0086] Table 1 Evaluation Table of Sexual Behavioral Efficacy in Rats

[0087] Note: Data are expressed as mean ± standard deviation; * indicates that compared with the control group, P < 0.05 by a two-tailed t-test; # indicates that compared with the Example 2 group, P < 0.05.

[0088] A comprehensive analysis of the data in the table above shows that the example group exhibits significant overall advantages. Regarding ejaculation latency, the example group (369–382 seconds) was significantly longer than the control group (150 seconds, P<0.05), while there was no significant difference compared to the positive control group (372 seconds, P<0.05). This demonstrates that the traditional Chinese medicine compound is comparable to chemical anesthetics in prolonging sexual intercourse time, without any pleasure desensitization (significantly higher number of mounting attempts). In terms of the number of mounting and penetration attempts, the example group (10–12 mounting attempts and 6–8 penetration attempts) was significantly superior to the positive control group (4 mounting attempts, P<0.05). This strongly proves that the traditional Chinese medicine compound of this invention, through a multi-target synergistic mechanism of "inhibiting sensitivity, improving circulation, and repairing the barrier," achieves delayed ejaculation while avoiding the "pleasure desensitization" problem of chemical anesthetics, significantly optimizing the overall sexual experience. The effects of comparative ratios 3–6 (without different ingredients in the formula) were significantly reduced, further verifying the necessity of compound formulation (synergistic effect of principal, assistant, adjuvant, and guide herbs) in achieving this comprehensive effect.

[0089] The superior efficacy of the Example Group (achieving significant delayed effects shortly after administration) relies on its unique small-molecule active ingredient enrichment process. The IELT values ​​(223s, 194s) of Comparative Example 1 (conventional mixed water extraction and alcohol precipitation) and Comparative Example 2 (group extraction but no ultrafiltration) were significantly lower than those of the Example Group (369–382 seconds), and their behavioral activity was also lower. This directly demonstrates that group extraction and resin purification (Comparative Example 1 vs. Example) can effectively remove impurities, enrich the target active ingredient, and improve yield and purity. It also demonstrates that ultrafiltration enrichment of small molecules (<1000 Da) (Comparative Example 2 vs. Example) is a core step in significantly improving transdermal absorption efficiency and a technical guarantee for achieving effects close to those of chemical anesthetics.

[0090] Test Example 2: Clinical Trial for Human Efficacy Evaluation (1) Purpose of the experiment This experiment aims to verify the core efficacy, user experience, and safety of the optimal embodiment 2 of the present invention (an essence of small molecule active ingredients based on seven Chinese herbs such as ginseng and gentian root) in the human body. Through a single-group self-controlled before-and-after design, clinical evidence directly supporting the advantages of the patented technology is obtained.

[0091] (2) Subject selection Thirty eligible male participants aged 18-45 years were recruited. Participants were required to have a stable heterosexual partner and report an intravaginal ejaculation latency time (IELT) of ≤3 minutes. Those with organic erectile dysfunction, genital skin diseases, or a history of allergy to traditional Chinese medicine were excluded, and they had not used other delay products within the past month. All participants signed informed consent forms to ensure ethical compliance of the trial.

[0092] (3) Test Procedure The experiment was divided into two phases: Baseline period (1 week): Subjects did not use any products, and their partners used stopwatches to record the ejaculation latency (IELT) of three natural sexual encounters, and the average value was taken as the baseline value. Intervention period (8 weeks): 15 minutes before sexual intercourse, subjects applied 0.1 mL of the essence from Example 2 evenly to the glans penis and coronal sulcus, massaging for 30 seconds to promote absorption. This was used no more than 3 times per week. IELT was recorded after each sexual intercourse, and a sexual satisfaction questionnaire was completed at week 8. Adverse reactions were monitored throughout the process.

[0093] (4) Evaluation indicators Table 2 Evaluation Indicators and Methods

[0094] (5) Results and conclusions Paired t-tests were used to compare the differences in IELT and satisfaction scores before and after the intervention (significance threshold P<0.01). Comfort indexes were descriptively analyzed using mean ± standard deviation, and adverse skin reactions were statistically analyzed by incidence.

[0095] Table 3 Statistical Table of Clinical Results of Human Efficacy Evaluation

[0096] The experimental data show that the essence of Example 2 can significantly prolong IELT to the clinically effective threshold (>6 minutes), and the 261% improvement significantly proves the "delaying effect" of the essence of this invention; the average onset time of 12.7 minutes reflects the "high efficiency of small molecule transdermal technology"; the satisfaction of both men and women exceeded 8 points, confirming the advantage of "multi-target synergistic effect of compound to avoid pleasure desensitization"; the high-definition cooling sensation (7.9 points) and low stickiness (1.5 points) verify the comfort of borneol penetration and essence formulation design; the absence of skin irritation rate highlights the safety of natural Chinese herbal compound.

Claims

1. A topical traditional Chinese medicine composition, characterized in that, The product is composed of the following components in parts by weight: 0.8–1.2 parts of small molecule active ingredients from traditional Chinese medicine, and 0.08–0.12 parts of borneol; the small molecule active ingredients from traditional Chinese medicine are prepared from the following components in parts by weight: 30–40 parts of ginseng, 20–30 parts of *Smilax glabra*, 20–30 parts of *Achyranthes bidentata*, 5–15 parts of *Salvia miltiorrhiza*, 10–20 parts of *Rosa laevigata*, and 5–15 parts of *Sophora flavescens*; the preparation method of the small molecule active ingredients from traditional Chinese medicine is as follows: after mixing the corresponding parts by weight of ginseng, *Smilax glabra*, *Achyranthes bidentata*, and *Salvia miltiorrhiza*, reflux extraction with 65–75% ethanol, the extract is then passed through a non-polar adsorption resin with 50% ethanol → 70% ethanol. Ethanol gradient elution and concentration yielded a purified extract of ginseng / Sophora flavescens / Smilax glabra / Salvia miltiorrhiza. A corresponding weight fraction of Rosa laevigata was extracted by reflux with 55-65% ethanol, followed by elution with 65-75% ethanol using a neutral polar adsorption resin, and then concentrated to obtain a purified Rosa laevigata extract. A corresponding weight fraction of Sophora flavescens was extracted using an acid-water extraction method. The extract was adsorbed onto a strongly acidic cation exchange resin, treated with alkali, and the total alkaloids were eluted. The extract was then concentrated to obtain a purified Sophora flavescens extract. The purified extracts of ginseng / Sophora flavescens / Smilax glabra / Salvia miltiorrhiza, Rosa laevigata, and Sophora flavescens were combined, purified, and the active ingredients with a molecular weight <1000 Da were enriched.

2. The external application traditional Chinese medicine composition according to claim 1, characterized in that, The ginseng, *Smilax china*, *Smilax glabra*, and *Salvia miltiorrhiza* were mixed and pretreated with cellulase before being extracted by reflux extraction with 65-75% ethanol.

3. The external application traditional Chinese medicine composition according to claim 1, characterized in that, The non-polar adsorption resin is D101 macroporous adsorption resin; the medium-polar adsorption resin is HPD-400 macroporous adsorption resin.

4. The external application traditional Chinese medicine composition according to claim 1, characterized in that, The purification process involved filtration using an ultrafiltration membrane with a molecular weight cutoff of 1000 Da.

5. The use of the topical Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a male topical delay product.

6. The application according to claim 5, characterized in that, The product is an essence, liquid, gel, or spray.

7. An essence, characterized in that, The external Chinese medicine composition contains any one of the claims 1 to 4.

8. The essence according to claim 7, characterized in that, The mass percentage of the external application traditional Chinese medicine composition is 0.8% to 1.3%.

9. The essence according to claim 8, characterized in that, The composition includes the following components by mass percentage: 0.8–1.2 parts of small molecule active ingredients of traditional Chinese medicine, 0.08–0.12 parts of borneol, 0.4–0.6 parts of sodium hyaluronate, 4–6 parts of glycerol, 4–6 parts of butylene glycol, 2–4 parts of 1,3-propanediol, 1–3 parts of trehalose, 0.05–0.2 parts of allantoin, 0.2–0.4 parts of carbomer, 0.04–0.06 parts of disodium EDTA, and deionized water to a total of 100 parts, with a pH of 6.0–6.

5.

10. The method for preparing the essence according to claim 9, characterized in that, The carbomer matrix was pre-swollen, and the small molecule active ingredients of traditional Chinese medicine, borneol, sodium hyaluronate, glycerin, butylene glycol, 1,3-propanediol, trehalose, allantoin and disodium EDTA were dissolved in the aqueous phase. The carbomer matrix was then mixed with the aqueous phase to thicken it, and the pH was adjusted to 6.0-6.5.

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