External-use pharmaceutical composition for assisting erection and delaying time and external-use traditional Chinese medicine spray for assisting erection and delaying time

Abstract

The invention provides an external pharmaceutical composition for assisting erection and delaying time and an external traditional Chinese medicine spray for assisting erection and delaying time, and belongs to the technical field of biological medicines. The external pharmaceutical composition for assisting erection and delaying the time comprises an erection-assisting exosome combination, a delaying exosome combination and prostaglandin E1, the erection-assisting exosome combination comprises exosomes of the following traditional Chinese medicine components: brilliant bugleweed herb, pterocarya strobilacea, ligusticum wallichii, cricket lespedeza herb, whorlleaf stonecrop herb, glans pennisetum, Cabaza, tribulus terrestris and eurycoma longifolia. The delayed exosome composition comprises exosomes of the following traditional Chinese medicines: albizia julibrissin, ajuga paniculata, mulberry leaves and photinia serrulata leaves. The external-use pharmaceutical composition and a transdermal enhancer are combined to prepare the external-use traditional Chinese medicine erection-assisting and time-delaying spray. According to the external spray, the prostaglandin E1 and the traditional Chinese medicine exosome have a synergistic erection assisting effect; and the time-delay traditional Chinese medicine exosome and the erection-assisting traditional Chinese medicine exosome in the traditional Chinese medicine exosome also have a synergistic effect and jointly play the erection-assisting and time-delay effects.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to a topical drug composition for improving erection and delaying ejaculation, and a topical Chinese medicine spray for improving erection and delaying ejaculation. Background Technology

[0002] With the accelerating pace of modern society and increasing work pressure, men's health issues, especially erectile dysfunction (ED), are receiving increasing attention. Sexual dysfunction is a multifactorial physiological process involving the coordination of the nervous, cardiovascular, endocrine, and reproductive systems, as well as mental and psychological well-being.

[0003] Currently, drug treatments for premature ejaculation mainly include Western medicines such as serotonin reuptake inhibitors and tricyclic antidepressants, but these drugs have certain side effects. Traditional Chinese medicine has potential in improving male sexual function, but most treatments are mainly oral, which is inconvenient to use and often neglects the care of the skin of the external genitalia. Therefore, it is necessary to develop a topical Chinese medicine spray that can both inhibit bacteria and nourish the male private parts, as well as regulate premature ejaculation and promote erection and delay ejaculation. Summary of the Invention

[0004] This invention provides a topical drug composition for improving erection and delaying ejaculation, as well as a topical Chinese medicine spray for improving erection and delaying ejaculation, which has good stability, transdermal absorption, and erection-enhancing effects.

[0005] This invention provides a topical pharmaceutical composition for enhancing erection and delaying ejaculation, comprising an exosome combination for enhancing erection, an exosome combination for delaying ejaculation, and prostaglandin E1; The erectile dysfunction exosome combination includes exosomes containing the following Chinese herbal ingredients: Butea superba, Evodia rutaecarpa, Ligusticum chuanxiong, Gynostemma pentaphyllum, Rejuvenating Herb, Tribulus terrestris, Cabinda, Tribulus terrestris and Tongkat Ali; The delayed-release exosome combination includes exosomes from the following traditional Chinese medicines: Albizia julibrissin, Gynostemma pentaphyllum, Morus alba leaves, and Photinia serratifolia leaves.

[0006] In a preferred embodiment of the present invention, the topical drug composition comprises, by weight, the following components: 10-20 parts of topical Chinese medicine exosome combination for erectile dysfunction, 10-20 parts of exosome combination for delayed ejaculation, and 0.1-0.3 parts of prostaglandin E1.

[0007] In a preferred embodiment of the present invention, the erectile dysfunction exosome composition comprises the following exosomes in parts by weight: 8-10 parts of Butea superba exosomes, 10-15 parts of Evodia rutaecarpa exosomes, 1-3 parts of Ligusticum chuanxiong exosomes, 3-5 parts of Gynostemma pentaphyllum exosomes, 5-10 parts of Rehmannia glutinosa exosomes, 5-10 parts of Gynostemma pentaphyllum exosomes, 10-15 parts of Carbinda exosomes, 4-6 parts of Tribulus terrestris exosomes, and 3-5 parts of Tongkat Ali exosomes.

[0008] In a preferred embodiment of the present invention, the delayed-release exosome composition comprises the following exosomes in parts by weight: 15-20 parts of Albizia julibrissin exosomes, 10-15 parts of Gynostemma pentaphyllum exosomes, 8-10 parts of Morus alba leaf exosomes, and 5-10 parts of Photinia serratifolia leaf exosomes.

[0009] The present invention also provides a topical Chinese medicine spray for improving erection and delaying ejaculation, comprising the above-mentioned topical drug composition and a transdermal enhancer; The transdermal penetration enhancer is an aqueous ethanol solution containing eucalyptus oil, turpentine oil, peppermint oil, and lauryl acetone.

[0010] In a preferred embodiment of the present invention, the external Chinese medicine spray for erectile dysfunction and delayed ejaculation comprises the following components in parts by weight: 10-20 parts of an erectile dysfunction exosome combination, 10-20 parts of a delayed ejaculation exosome combination, 60-80 parts of a transdermal penetration enhancer, and 0.1-0.3 parts of prostaglandin E1.

[0011] In a preferred embodiment of the present invention, the transdermal penetration enhancer comprises the following components in parts by weight: 3-5 parts eucalyptus oil, 3-5 parts turpentine oil, 1-3 parts peppermint oil, 6-8 parts lauryl acetone, and 70-90 parts 70wt% aqueous ethanol solution.

[0012] In a preferred embodiment of the present invention, a stabilizer, a preservative, and a lubricant are also included.

[0013] In a preferred embodiment of the present invention, the stabilizer includes at least one of the following: xanthan gum and guar gum.

[0014] In a preferred embodiment of the present invention, the preservative includes at least one of the following: Coptis chinensis extract, Sophora flavescens extract, and Forsythia suspensa extract; The lubricant includes at least one of the following: cetyl ethylhexanoate, coconut oil ester, and mango oil ester.

[0015] Beneficial Effects: This invention provides a topical pharmaceutical composition for enhancing erection and delaying ejaculation, comprising an exosome combination for enhancing erection, an exosome combination for delaying ejaculation, and prostaglandin E1. The exosome combination for enhancing erection includes exosomes containing the following traditional Chinese medicine ingredients: *Butea superba*, *Fructus Achyranthes bidentata*, *Ligusticum chuanxiong*, *Herba Lysimachiae*, *Herba Recens*, *Fructus Tribuluseum*, *Fructus Carbinda*, *Fructus Tribuluseum*, and *Fructus Tongkat Ali*. The exosome combination for delaying ejaculation includes exosomes containing the following traditional Chinese medicine ingredients: *Herba Albiziae*, *Herba Lysimachiae*, *Fructus Mori*, and *Fructus Photiniae*. This invention also combines the topical pharmaceutical composition with a transdermal penetration enhancer to prepare a topical traditional Chinese medicine spray for enhancing erection and delaying ejaculation.

[0016] The transdermal penetration enhancer described in this invention can improve the interaction between drug molecules and the skin barrier, thereby increasing the absorption and utilization of active ingredients and significantly improving the transdermal absorption efficiency of drug components. The topical spray described in this invention uses traditional Chinese medicine exosomes as the main active ingredient, fully utilizing the effective components in the medicinal materials and ensuring comprehensive utilization of the medicinal materials.

[0017] The external spray of the present invention has a synergistic effect of prostaglandin E1 and traditional Chinese medicine exosomes on erection; and the traditional Chinese medicine exosomes that delay ejaculation and those that promote erection also have a synergistic effect, working together to promote erection and delay ejaculation. Attached Figure Description

[0018] Figure 1 The degree of response of ED patients in different treatment groups to Example 1; Figure 2 The diagram shows the changes in the inner diameter of the cavernous artery. In the diagram, A is the measurement of the inner diameter of the cavernous artery when flaccid, and B is the measurement of the inner diameter of the cavernous artery when fully erect after applying the topical spray in Example 1. Figure 3 The following are the spectral graphs for various time points in Example 1. In the graph, A is 5 min, B is 10 min, C is 15 min, D is 20 min, E is 25 min, and F is 30 min. Figure 4 The spectrum diagrams for Comparative Example 6 are shown at various time points. In the diagram, A represents 5 min, B represents 10 min, C represents 15 min, D represents 20 min, E represents 25 min, and F represents 30 min. Detailed Implementation

[0019] This invention provides a topical pharmaceutical composition for enhancing erection and delaying ejaculation, comprising an exosome combination for enhancing erection, an exosome combination for delaying ejaculation, and prostaglandin E1; The erectile dysfunction exosome combination includes exosomes containing the following Chinese herbal ingredients: Butea superba, Evodia rutaecarpa, Ligusticum chuanxiong, Gynostemma pentaphyllum, Rejuvenating Herb, Tribulus terrestris, Cabinda, Tribulus terrestris and Tongkat Ali; The delayed-release exosome combination includes exosomes from the following traditional Chinese medicines: Albizia julibrissin, Gynostemma pentaphyllum, Morus alba leaves, and Photinia serratifolia leaves.

[0020] This invention uses the exosomes of the aforementioned traditional Chinese medicine as the main functional component, and there are no special limitations on the extraction method of the exosomes. It can be ultracentrifugation, continuous flow centrifugation, or tangential flow filtration (TFF), etc. In this embodiment, a combination of continuous flow centrifugation and TFF is used for the extraction and purification of exosomes. Specifically, a fully automated exosome extraction and purification device is used, with a central control console to achieve full automation of the process. The first step is "impurity removal": the plant tissue fluid is first pumped into a titanium alloy continuous flow centrifuge rotor (capacity 3L) and rotated at 4°C and 3000g for 30 minutes. Large impurities such as cell debris are thrown off, and the remaining clean supernatant automatically flows out from the side. The second step is "EV capture": the clean supernatant enters the TFF module. The key here is a 100kD filter membrane. TFF allows the liquid to flow parallel across the membrane surface, like "wiping along the membrane surface." Water and small molecule proteins and nucleic acids smaller than 100kD will leak into the waste liquid tank, while EVs, because they are larger than the membrane pores, will be trapped between the membrane pores and can be circulated and concentrated. The fully automated exosome extraction and purification instrument used in this invention was purchased from JiaMu Biotechnology (Wuhan) Co., Ltd. This invention features automated extraction, simple operation, and rapid processing of large numbers of samples, improving experimental efficiency and reducing time and labor costs.

[0021] The erectile dysfunction exosome combination of this invention includes 8-10 parts by weight of Butea superba exosomes, which can be 8, 9, or 10 parts by weight, or any weight represented by any two values ​​within a given range. The Butea superba exosomes of this invention has the effects of tonifying the kidneys and strengthening yang, promoting blood circulation and removing blood stasis, and invigorating qi and refreshing the mind.

[0022] The exosome composition for erectile dysfunction described in this invention includes 10-15 parts by weight of *Fructus Aquilegiae* exosomes, which can be 10, 11, 12, 13, 14, or 15 parts by weight, or any number of parts by weight within any range of two values. *Fructus Aquilegiae* described in this invention warms and nourishes qi and blood, relieves deficiencies, joint pain, dispels wind and dampness, strengthens the lower back, warms the kidneys and invigorates yang, nourishes yin and tonifies the kidneys. It is particularly effective for premature ejaculation, impotence, kidney deficiency and lower back pain, excessive sexual activity, and male and female frigidity. It also relieves night sweats, anemia in women, dizziness, high blood pressure, frozen shoulder, senile bone hyperplasia, and numbness in the limbs.

[0023] The exosome composition for erectile dysfunction described in this invention includes 1-3 parts by weight of Ligusticum chuanxiong exosomes, which can be 1 part by weight, 2 parts by weight, or 3 parts by weight, or any weight represented by any two values ​​within a given range. In this embodiment of the invention, the exosomes are extracted using Ligusticum chuanxiong leaves. The Ligusticum chuanxiong leaves described in this invention can be used to invigorate blood circulation, dispel wind and relieve pain, and have certain therapeutic effects on symptoms such as headache, irregular menstruation, and invigorating blood circulation.

[0024] The exosome composition for erectile dysfunction described in this invention includes 3-5 parts by weight of *Gnaphalium affine* exosomes, which can be 3, 4, or 5 parts by weight, or any weight represented by any two values ​​within a given range. *Gnaphalium affine* described in this invention warms the kidneys and strengthens yang, dispels cold and dampness, and is used to treat impotence, cold sperm, urinary incontinence, abdominal pain due to cold, lower back and knee pain, weakness of muscles and bones, lower limb contractures, and menopausal syndrome.

[0025] The erectile dysfunction exosome composition of this invention includes 5-10 parts by weight of *Hedyotis diffusa* exosomes, which can be 5 parts by weight, 6 parts by weight, 7 parts by weight, 8 parts by weight, 9 parts by weight, or 10 parts by weight, or any weight represented by any two values ​​within a range. *Hedyotis diffusa*, also known as *Huang An Cai*, is a plant used in this invention. Youngia Japonica. It warms and tonifies the kidneys, enters the kidney meridian to improve kidney function, and has a good therapeutic and alleviating effect on various adverse symptoms such as premature ejaculation and decreased sexual function in men.

[0026] The erectile dysfunction exosome combination of this invention includes 5-10 parts by weight of *Gymnocalycium barbarum* exosomes, which can be 5, 6, 7, 8, 9, or 10 parts by weight, or any weight represented by any two values ​​within a given range. The *Gymnocalycium barbarum* exosomes of this invention warm and nourish qi and blood, replenish kidney blood, treat deficiency, joint pain, dispel wind and dampness, tonify the liver and kidneys, strengthen the lower back, warm the kidneys and invigorate yang, tonify the kidneys and strengthen the lower back and knees, invigorate yang and generate essence, calm the mind and stabilize essence, nourish kidney marrow, and are also a good analgesic.

[0027] The exosome composition for enhancing erection described in this invention includes 10-15 parts by weight of Cabinda exosomes, which can be 10, 11, 12, 13, 14, or 15 parts by weight, or any weight represented by any two values ​​within a given range. Cabinda, especially Cabinda bark, described in this invention has kidney-tonifying and aphrodisiac effects, enhancing libido and showing certain efficacy for symptoms of kidney-yang deficiency. The active ingredients of Cabinda bark act directly on the male hypothalamus and pituitary gland, stimulating the secretion of endogenous hormones.

[0028] The exosome composition for erectile dysfunction described in this invention includes 4-6 parts by weight of Tribulus terrestris exosomes, which can be 4 parts by weight, 5 parts by weight, or 6 parts by weight, or any weight represented by any two values ​​within a given range. Tribulus terrestris described in this invention has the effects of warming the kidneys and strengthening yang, promoting diuresis and relieving strangury, stopping bleeding and reducing swelling, and its main functions include treating kidney yang deficiency, treating urinary tract infections, and treating hemorrhagic diseases.

[0029] The exosome composition for erectile dysfunction described in this invention includes 3-5 parts by weight of Tongkat Ali exosomes, which can be 3 parts by weight, 4 parts by weight, or 5 parts by weight, or any weight represented by any two values ​​within a given range. The Tongkat Ali described in this invention has antipyretic, fatigue-relieving, diuretic, and jaundice-reducing effects, and can strengthen the kidneys and nourish the body, with significant aphrodisiac effects, and can alleviate male erectile dysfunction, premature ejaculation, and other sexual dysfunction problems.

[0030] All weight parts mentioned in this invention refer to the weight of the corresponding lyophilized powder of exosomes, and the requirements for the lyophilized powder are consistent, requiring that the water content in the lyophilized powder is not higher than 10%.

[0031] This invention mixes the exosomes of the above-mentioned traditional Chinese medicine components and then dissolves them in sterile water to form a topical traditional Chinese medicine exosome combination for erectile dysfunction. For example, in one embodiment, 5 parts of Tongkat Ali exosomes, 5 parts of Tribulus terrestris exosomes, 10 parts of Cabinda exosomes, 5 parts of Gynostemma pentaphyllum exosomes, 5 parts of Rehmannia glutinosa exosomes, 5 parts of Gynostemma pentaphyllum exosomes, 3 parts of Ligusticum chuanxiong exosomes, 10 parts of Evodia rutaecarpa exosomes and 10 parts of Butea superba exosomes are mixed by weight and then dissolved in 42 parts of water.

[0032] The delayed-action exosome composition of this invention includes 15-20 parts by weight of Albizia julibrissin exosomes, which can be 15, 16, 17, 18, 19, or 20 parts by weight, or any weight represented by any two values ​​within a given range. In one embodiment of this invention, the Albizia julibrissin exosomes are prepared using Albizia julibrissin bark as a raw material, which can help accelerate blood flow.

[0033] The delayed-ejaculation exosome composition of this invention includes 10-15 parts of *Gynostemma pentaphyllum* exosomes, which can be 10, 11, 12, 13, 14, or 15 parts by weight, or any weight represented by any two values ​​within a given range. *Gynostemma pentaphyllum*, as described in this invention, is sweet and bland in taste, neutral in nature, and enters the kidney meridian. It has the effects of nourishing yin and tonifying the kidney, stopping leukorrhea, and promoting blood circulation. It can preferentially relieve symptoms such as lower back pain, leg weakness, dizziness, and tinnitus caused by kidney deficiency.

[0034] The delayed-ejaculation exosome combination described in this invention includes 8-10 parts of mulberry leaf exosomes, which can be 8 parts by weight, 9 parts by weight, or 10 parts by weight, or any weight represented by any two values ​​within a given range. The flavonoids, polyphenols, and amino acids contained in mulberry leaves can promote blood circulation in the reproductive organs and enhance the body's antioxidant capacity.

[0035] The delayed-ejaculation exosome composition of this invention includes 5-10 parts of Photinia leaf exosomes, which can be 5 parts by weight, 6 parts by weight, 7 parts by weight, 8 parts by weight, 9 parts by weight, or 10 parts by weight, or any weight represented by any two values ​​within a given range. The Photinia leaf described in this invention is neutral in nature, pungent and bitter in taste, and slightly toxic. It has the effects of dispelling wind and tonifying the kidneys, and is mainly used to treat rheumatic pain, impotence, and seminal emission.

[0036] In this invention, all weight parts refer to the weight of the corresponding lyophilized powder of exosomes, and the requirements for the lyophilized powder are consistent, requiring that the water content of the lyophilized powder is not higher than 10%. This invention mixes the exosomes of the above-mentioned traditional Chinese medicine components and then dissolves them in sterile water to form the delayed-release exosome combination of this invention. For example, in one embodiment, 20 parts by weight of Albizia julibrissin exosomes, 15 parts by weight of Gynostemma pentaphyllum exosomes, 10 parts by weight of Morus alba leaf exosomes, and 10 parts by weight of Photinia serratifolia leaf exosomes are mixed and dissolved in 45 parts by weight of water.

[0037] The topical pharmaceutical composition of this invention contains 0.1 to 0.3 parts by weight of prostaglandin E1, such as 0.1, 0.2, or 0.3 parts by weight. The prostaglandin E1 of this invention is a topical medication primarily used to treat male erectile dysfunction. It can penetrate the skin, pass through the tunica albuginea, and enter the corpora cavernosa, causing relaxation of the smooth muscles and dilation of blood vessels in the penis, thereby improving blood supply to the corpora cavernosa and enhancing erectile function.

[0038] In the topical pharmaceutical composition of the present invention, the weight ratio of the erectile dysfunction exosome combination, the delay exosome combination and prostaglandin E1 is (10~20):(10~20):(0.1~0.3).

[0039] The external Chinese medicine-based erection-enhancing and delay spray of the present invention contains 10 to 20 parts by weight of an external Chinese medicine-based erection-enhancing exosome combination, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, as well as any number of parts by weight represented by any two values ​​within a range.

[0040] The external Chinese medicine spray for erectile dysfunction and delayed ejaculation described in this invention contains 10 to 20 parts by weight of a combination of delay exosomes, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, as well as any number of parts by weight represented by any two values ​​within a range.

[0041] The present invention also provides a topical Chinese medicine spray for improving erection and delaying ejaculation, comprising the above-mentioned topical drug composition and a transdermal enhancer; The transdermal penetration enhancer is an aqueous ethanol solution containing eucalyptus oil, turpentine oil, peppermint oil, and lauryl acetone.

[0042] The transdermal penetration enhancer of this invention is an ethanol-water solution comprising eucalyptus oil, turpentine oil, peppermint oil, and laurocapram. The transdermal penetration enhancer of this invention comprises 3-5 parts by weight of eucalyptus oil, which can be 3 parts by weight, 4 parts by weight, or 5 parts by weight, or any weight represented by any two values ​​within a given range. The transdermal penetration enhancer of this invention comprises 3-5 parts by weight of turpentine oil, which can be 3 parts by weight, 4 parts by weight, or 5 parts by weight, or any weight represented by any two values ​​within a given range. The transdermal penetration enhancer of this invention comprises 1-3 parts by weight of peppermint oil, which can be 1 part by weight, 2 parts by weight, or 3 parts by weight, or any weight represented by any two values ​​within a given range. The transdermal penetration enhancer of this invention comprises 6-8 parts by weight of laurocapram, which can be 6 parts by weight, 7 parts by weight, or 8 parts by weight, or any weight represented by any two values ​​within a given range. The transdermal absorption enhancer of this invention uses an aqueous ethanol solution as a solvent. In one embodiment, it is a 70 wt% aqueous ethanol solution, and its weight parts can be 70-90 parts, such as 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, or 90 parts, as well as all weight parts represented by any two values ​​within a range. In this invention, the eucalyptus oil, turpentine oil, peppermint oil, and lauryl acetone act as penetration enhancers, which help improve the transdermal absorption of the drug components.

[0043] The present invention does not specifically limit the preparation method of the transdermal penetration enhancer. It can be mixed using conventional methods in the art. For example, in one embodiment, under stirring conditions, eucalyptus oil and turpentine oil are added to an ethanol aqueous solution and mixed thoroughly to form a homogeneous solvent system. Peppermint oil is added to the solvent system and stirring is continued to ensure that the peppermint oil is completely dissolved. Under stirring conditions, laurocapram is added to the above mixture to ensure that the laurocapram is uniformly dispersed to obtain the transdermal penetration enhancer.

[0044] In the topical herbal spray for erectile dysfunction described in this invention, the weight ratio of the erectile dysfunction exosome combination to the transdermal penetration enhancer is (10~20):(60~80). In the topical herbal spray for erectile dysfunction described in this invention, the weight of the transdermal penetration enhancer is 60~80 parts, such as 60 parts, 70 parts, or 80 parts, or any weight portion represented by any two values ​​within a given range.

[0045] The external herbal spray for erectile dysfunction and delayed ejaculation described in this invention also contains a stabilizer, wherein the stabilizer is present in an amount of 0.1 to 0.3 parts by weight, such as 0.1, 0.2, or 0.3 parts by weight. The stabilizer of this invention includes at least one of the following: xanthan gum and guar gum. This invention uses xanthan gum and / or guar gum as stabilizers to increase the viscosity and stability of the formulation, helping to maintain the uniform dispersion of the components.

[0046] The external herbal spray for erectile dysfunction and delayed ejaculation described in this invention also contains a preservative, wherein the preservative is present in an amount of 0.2 to 0.4 parts by weight, such as 0.2, 0.3, or 0.4 parts by weight. The preservative of this invention includes at least one of the following: Coptis chinensis extract (Jiangxi Huabang Natural Fragrance Co., Ltd.), Sophora flavescens extract (Guangzhou Meiyi Biotechnology Co., Ltd.), and Forsythia suspensa extract (Guangzhou Sinoco Biotechnology Co., Ltd.). This invention uses Coptis chinensis, Sophora flavescens, and Forsythia suspensa extracts as preservatives to prevent microbial contamination of the preparation during storage and use, thereby extending the product's shelf life.

[0047] The external herbal spray for erectile dysfunction and delayed ejaculation described in this invention also contains a lubricant. The lubricant is present in 5-10 parts by weight, such as 5, 6, 7, 8, 9, or 10 parts by weight. The lubricant of this invention includes at least one of the following: cetyl ethylhexanoate, coconut oil ester, and mango oil ester. The cetyl ethylhexanoate, coconut oil ester, and mango oil ester described in this invention can increase the lubricity and stability of the formulation, help improve the sensory properties of the formulation, and promote the transdermal absorption of certain components.

[0048] This invention combines a combination of topical Chinese herbal medicines for erectile dysfunction and delayed ejaculation, a combination of exosomes for delayed ejaculation, prostaglandin E1, stabilizers, preservatives, and lubricants. The components work synergistically to create a topical Chinese herbal preparation applied to the male genitalia, primarily acting on the coronal sulcus of the penis to act as a local mucosal agent. This reduces the sensitivity of the external genitalia, increases the stimulation intensity to trigger ejaculation, and prolongs intercourse time. The topical Chinese herbal medicine spray for erectile dysfunction and delayed ejaculation described in this invention effectively extracts and utilizes the active ingredients from the medicinal materials while ensuring the stability, safety, and transdermal absorption of the preparation. Each component plays a crucial role in the preparation process, collectively promoting the efficacy and user experience of the spray.

[0049] To further illustrate the present invention, the following detailed description, in conjunction with embodiments, of a topical pharmaceutical composition for enhancing erection and delaying ejaculation, and a topical Chinese herbal spray for enhancing erection and delaying ejaculation provided by the present invention, should not be construed as limiting the scope of protection of the present invention.

[0050] Unless otherwise specified, the Chinese herbal raw materials and reagents used in the embodiments of this invention can be from conventional commercial sources in the field. In the embodiments of this invention, the origin of Butea superba is Shaanxi, the origin of Eupatorium fortunei is Ningxia, the origin of Ligusticum chuanxiong is Sichuan, the origin of Gynostemma pentaphyllum is Guizhou, the origin of Morus alba leaves is Chongqing, the origin of Albizia julibrissin bark is Hubei, the origin of Rehmannia glutinosa is Jilin, the origin of Tribulus terrestris is Hainan, the origin of Carbinda arvense is Guangxi, the origin of Tribulus terrestris is Shandong, and the origin of Tongkat Ali is Guizhou; Coptis chinensis extract was purchased from Jiangxi Huabang Natural Fragrance Co., Ltd., Sophora flavescens extract was purchased from Guangzhou Meiyi Biotechnology Co., Ltd., Forsythia suspensa extract was purchased from Guangzhou Sinoco Biotechnology Co., Ltd., glyceryl cocoate was purchased from CETIOLHE Germany, mango oil ester was purchased from Baihaibo (Guangzhou) International Trading Co., Ltd. (brand: Henley Germany), cetyl ethylhexanoate was purchased from Zhongshan Dixing Chemical Co., Ltd., and prostaglandin E1 was purchased from Beijing Taide Pharmaceutical Co., Ltd., China.

[0051] Example 1: A method for preparing a topical Chinese medicine spray for improving erectile function Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Tribuluseum*, and 20g *Alida tangutica*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction.

[0052] Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0053] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding delayed-release herbal exosomes. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delayed-release herbal exosome solution.

[0054] Step 3: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0055] Step 4: Mix 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-enhancing exosomes prepared in Step 2, 70 parts of the transdermal penetration enhancer, and 0.3 parts of prostaglandin E1, ensuring uniform dispersion. Add 0.2 parts of the stabilizer xanthan gum, 5 parts of the lubricant glyceryl cocoate, and 0.2 parts of the preservative Coptis chinensis extract. Use a high-speed mixer to thoroughly stir the mixture to obtain a topical Chinese medicine erectile dysfunction and delay-enhancing spray.

[0056] Example 2: A method for preparing a topical Chinese medicine spray for improving erectile function Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0057] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0058] Step 3: Weigh 4 parts eucalyptus oil and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and laurocapram to 88 parts 70wt% ethanol aqueous solution and mix thoroughly to form a uniform solvent system, ensuring that the laurocapram is uniformly dispersed to obtain the transdermal penetration enhancer.

[0059] Step 4: Add 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-ejaculation exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, 0.2 parts of stabilizer xanthan gum, 5 parts of lubricant mango oil ester, and 0.2 parts of preservative sophora flavescens extract to the mixture using a high-speed mixer to obtain a topical Chinese medicine erectile dysfunction and delay-ejaculation spray.

[0060] Example 3: A method for preparing a topical Chinese medicine spray for improving erectile function Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0061] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0062] Step 3: Weigh 4 parts turpentine oil and 8 parts laurocapram. Under stirring conditions, add the turpentine oil to 88 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Under stirring conditions, add laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0063] Step 4: Add 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-ejaculation exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, 0.2 parts of stabilizer xanthan gum, 5 parts of lubricant cetyl ethylhexanoate, and 0.2 parts of preservative sophora flavescens extract to the mixture using a high-speed stirrer to obtain a topical Chinese medicine erectile dysfunction and delay-ejaculation spray.

[0064] Example 4: A method for preparing a topical Chinese medicine spray for improving erectile function Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0065] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0066] Step 3: Weigh 4 parts peppermint oil and 8 parts laurocapram. Under stirring conditions, add peppermint oil to 88 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Under stirring conditions, add laurocapram to the above mixture to ensure that laurocapram is evenly dispersed to obtain a transdermal penetration enhancer.

[0067] Step 4: Add 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-ejaculation exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, 0.2 parts of stabilizer xanthan gum, 5 parts of lubricant cetyl ethylhexanoate, and 0.2 parts of preservative sophora flavescens extract to the mixture using a high-speed stirrer to obtain a topical Chinese medicine erectile dysfunction and delay-ejaculation spray.

[0068] Comparative Example 1: Exosomes without Delaying Ejaculation Traditional Chinese Medicine Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0069] Step 2: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0070] Step 3: Mix 20 parts of the erectile dysfunction herbal exosomes prepared in Step 1, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, ensuring uniform dispersion. Add 0.2 parts of stabilizer xanthan gum, 5 parts of lubricant glyceryl cocoate and 0.2 parts of preservative Coptis chinensis extract. Use a high-speed stirrer to thoroughly stir the mixture to obtain an external herbal erectile dysfunction spray.

[0071] Comparative Example 2: Exosomes without the addition of erectile dysfunction-enhancing Chinese herbal medicine Step 1: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation traditional Chinese medicine exosome solution.

[0072] Step 2: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0073] Step 3: Mix 10 parts of the delay-enhancing Chinese medicine exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, ensuring uniform dispersion. Add 0.2 parts of stabilizer xanthan gum, 5 parts of lubricant glyceryl cocoate and 0.2 parts of preservative Coptis chinensis extract. Use a high-speed stirrer to thoroughly stir the mixture to obtain the external Chinese medicine delay spray.

[0074] Comparative Example 3: No penetrant added Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0075] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0076] Step 3: Combine 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-ejaculation exosomes prepared in Step 2, 70 parts of ethanol aqueous solution and 0.3 parts of prostaglandin E1, add 0.2 parts of stabilizer xanthan gum, 5 parts of lubricant glyceryl cocoate, and 0.2 parts of preservative sophora flavescens extract. Use a high-speed stirrer to thoroughly stir the mixture to obtain a topical Chinese medicine erectile dysfunction and delay-ejaculation spray.

[0077] Comparative Example 4: No lubricant added Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0078] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0079] Step 3: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0080] Step 4: Mix 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-ejaculation exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, ensuring uniform dispersion. Add 0.2 parts of xanthan gum stabilizer and 0.2 parts of Coptis chinensis extract preservative. Use a high-speed stirrer to thoroughly stir the mixture to obtain the external Chinese medicine erectile dysfunction and delay-ejaculation spray.

[0081] Comparative Example 5: No preservatives added Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0082] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities, and then extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction traditional Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder, and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation traditional Chinese medicine exosome solution.

[0083] Step 3: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0084] Step 4: Mix 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-enhancing exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, ensuring uniform dispersion. Add 0.2 parts of stabilizer xanthan gum and 5 parts of lubricant glyceryl cocoate. Use a high-speed mixer to thoroughly stir the mixture to obtain a topical Chinese medicine erectile dysfunction and delay-enhancing spray.

[0085] Comparative Example 6: Without prostaglandin E1 Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0086] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0087] Step 3: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0088] Step 4: Mix 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-prolonging exosomes prepared in Step 2, and 70 parts of the transdermal penetration enhancer, ensuring uniform dispersion. Add 0.2 parts of the stabilizer xanthan gum, 5 parts of the lubricant glyceryl cocoate, and 0.2 parts of the preservative Coptis chinensis extract. Use a high-speed stirrer to thoroughly stir the mixture to obtain the external Chinese medicine erectile dysfunction and delay-prolonging spray.

[0089] Comparative Example 7: No stabilizer added Step 1: Take 20g each of the following fresh herbs: *Butea superba* leaves, 20g *Ligusticum chuanxiong* leaves, 20g *Pteris vittata* fruit, 20g *Gnaphalium affine*, 20g *Herba Regenerativelis*, 20g *Gnaphalium affine*, 20g *Radix Cyprinus*, 20g *Fructus Tribuluseum*, and 20g *Alida tongkat Ali*. Clean the surface soil. Use a juicer to obtain a crude plant tissue extract. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the traditional Chinese medicine for erectile dysfunction. Take 10 parts of *Butea superba* exosome lyophilized powder, 3 parts of *Ligusticum chuanxiong* exosome, 10 parts of *Fructus arvense* exosome lyophilized powder, 5 parts of *Herba Lysimachiae* exosome lyophilized powder, 5 parts of *Herba Rehmanniae* exosome lyophilized powder, 5 parts of *Fructus guitouzi* exosome lyophilized powder, 10 parts of *Radix Cabinidae* exosome lyophilized powder, 5 parts of *Radix Tribuluseum* exosome lyophilized powder, and 5 parts of *Fructus Tongkat Ali* exosome lyophilized powder, and dissolve them in 42 ml of deionized water to obtain a compound exosome solution of traditional Chinese medicine for erectile dysfunction.

[0090] Step 2: Take 20g of Photinia leaves, 20g of mulberry leaves, 20g of Albizia bark, and 20g of Gynostemma pentaphyllum. Clean the surface soil, and use a juicer to obtain a crude plant tissue liquid. First, centrifuge at low speed to remove impurities and extract the plant tissue extracellular fluid. Transfer the obtained plant tissue extracellular fluid to a fully automated exosome extraction and purification instrument to obtain the corresponding exosomes of the erectile dysfunction Chinese medicine. Take 10 parts of Photinia leaf exosome lyophilized powder, 10 parts of mulberry leaf exosomes, 20 parts of Albizia bark exosome lyophilized powder, and 15 parts of Gynostemma pentaphyllum exosome lyophilized powder and dissolve them in 45ml of deionized water to obtain a compound delay-ejaculation Chinese medicine exosome solution.

[0091] Step 3: Weigh 4 parts eucalyptus oil, 4 parts turpentine oil, 1 part menthol oil, and 8 parts laurocapram. Under stirring conditions, add the eucalyptus oil and turpentine oil to 83 parts of 70wt% ethanol aqueous solution and mix thoroughly to form a homogeneous solvent system. Add the menthol oil to the solvent system and continue stirring to ensure that the menthol oil is completely dissolved. Under stirring conditions, add the laurocapram to the above mixture to ensure that the laurocapram is evenly dispersed to obtain the transdermal penetration enhancer.

[0092] Step 4: Mix 20 parts of the erectile dysfunction exosomes prepared in Step 1, 10 parts of the delay-enhancing exosomes prepared in Step 2, 70 parts of transdermal penetration enhancer and 0.3 parts of prostaglandin E1, ensuring uniform dispersion. Then add 5 parts of lubricant glyceryl cocoate and 0.2 parts of preservative Coptis chinensis extract. Use a high-speed stirrer to thoroughly stir the mixture to obtain the external Chinese medicine erectile dysfunction and delay-enhancing spray.

[0093] The difference between Example 1 and Examples 2, 3, and 4 lies in the different transdermal penetration enhancers. The difference between Comparative Example 1 and Example 1 is that no exosomes of the delay-relieving traditional Chinese medicine were added. The difference between Comparative Example 2 and Example 1 is that no exosomes of the erection-enhancing traditional Chinese medicine were added. The difference between Comparative Example 3 and Example 1 is that no penetrant was added. The difference between Comparative Example 4 and Example 1 is that no lubricant was added. The difference between Comparative Example 5 and Example 1 is that no preservative was added. The difference between Comparative Example 6 and Example 1 is that no prostaglandin E1 was added. The difference between Comparative Example 7 and Example 1 is that no stabilizer was added.

[0094] Test Example 1: Transdermal Test Preparation of experimental materials: The skin on the back of Kunming mice was selected as the test subject. The underlying fat and connective tissue were carefully removed, and then the skin was thoroughly washed with physiological saline and stored in physiological saline for later use.

[0095] Experimental setup: Skin permeability testing was conducted using a Franz diffusion cell apparatus. In this apparatus, the exposed area of ​​mouse skin samples was fixed at 1.2 cm. 2 The receiving chamber has a capacity of 15 mL.

[0096] Sample application: Take 1.0 mL of the topical Chinese medicine spray for erectile dysfunction and delayed ejaculation and place it on the skin surface of the diffusion chamber. At the same time, add 15 mL of physiological saline to the receiving chamber below as the receiving medium.

[0097] Experimental conditions control: The entire apparatus was placed in a constant temperature water bath at 32±0.5℃, and the stirring speed was set to 350rpm.

[0098] Data collection: At predetermined time points, 1 mL of sample is taken from the receiving chamber. Samples are taken three times at each time point to ensure consistency of results. Immediately after sampling, an equal volume of physiological saline is added to the receiving chamber to maintain a constant volume.

[0099] Sample processing and analysis: The extracted samples need to be filtered through a filter membrane with a pore size of 0.22 μm to remove any possible impurities, and then the drug concentration is determined by high performance liquid chromatography (HPLC).

[0100] Permeation calculation: The cumulative permeation of the drug is calculated using the formula Q=Cn×V+∑Ci×V0 (i=1…n-1), where Q represents the cumulative permeation (in μg), V is the volume of liquid in the receiving chamber (15mL), V0 is the volume of each sample (1.0mL), Ci is the drug concentration in the liquid during the first n-1 samples, and Cn is the drug concentration during the nth sample. The test results are shown in Table 1. It can be seen that the cumulative permeation without the addition of transdermal absorbent is 503μg, while with the addition, it can reach over 700μg.

[0101] Table 1 Transdermal test results

[0102] Test Example 2: Stability Test Thermal stability test: A certain amount of sample was taken from the prepared formulation and placed in an environment with a set temperature of 50℃. A constant temperature and humidity incubator was used to simulate high temperature conditions and the sample was observed for a period of time to test the stability of the formulation under high temperature conditions.

[0103] Dispersion stability assessment: A certain amount of formulation sample was taken out and centrifuged at high speed using a centrifuge. The centrifugation speed was set to 3000 rpm and the centrifugation duration was 20 min. The dispersion stability of the formulation was evaluated by observing the dispersion of the sample after centrifugation.

[0104] These two tests provide a comprehensive understanding of the formulation's stability characteristics under thermal and centrifugal forces, thereby ensuring the formulation's quality and efficacy. The test results, shown in Table 2, demonstrate that using xanthan gum and guar gum as stabilizers increases the formulation's viscosity and stability, helping to maintain uniform dispersion of the components.

[0105] Table 2 Stability Test Results

[0106] Test Example 3: Skin Irritation Test Experimental subject selection: 44 healthy white guinea pigs were selected for the experiment, and 4 guinea pigs were randomly selected for each type of topical Chinese medicine spray for erectile dysfunction and delayed ejaculation.

[0107] Environmental conditions: Ensure the laboratory temperature is maintained at around 22°C and the relative humidity is controlled at 65%.

[0108] Preparation before the experiment: About 24 hours before the experiment, trim the hair on both sides of the spine on the back of the guinea pig, with each side having a trimmed area of ​​about 2cm × 3cm.

[0109] Application method: Apply 0.5 mL of the test spray evenly to the skin of one side of the guinea pig, covering an area of ​​2.5 cm × 2.5 cm.

[0110] Experimental period: Apply the treatment once a day for 7 consecutive days.

[0111] Observation and cleaning: Starting from the second day of the experiment, before applying a new spray, the hair must be trimmed and any remaining spray from the previous day must be thoroughly removed with water or a non-irritating solvent.

[0112] Results Recording: Throughout the experiment, the skin's reaction was carefully observed and recorded.

[0113] This experimental method allows for the effective evaluation of the acute skin irritation potential of topical Chinese herbal erectile dysfunction sprays.

[0114] The results are shown in Table 3. The topical Chinese medicine sprays for erectile dysfunction and delayed ejaculation obtained in Examples 1-4 and Comparative Examples 1-7 showed no obvious irritation.

[0115] Table 3 Results of Skin Irritation Tests

[0116] Test Example 4: Rigiscan Inspection Rigiscan examination, as an objective indicator, is commonly used to assess the rigidity of nocturnal penile erections. Rigiscan is a frequently used method for differentiating and diagnosing these two types of erectile dysfunction (ED). It measures both penile swelling and penile rigidity. In the two examination modes, AVSS can be used to assess the patient's ability to control penile erection under sexual stimulation and the degree of erection. Theoretically, it has significant implications for differentiating between psychogenic and organic ED, assessing the patient's ability to control penile erection under sexual stimulation, and evaluating the effectiveness of ED treatment.

[0117] Forty patients were voluntarily divided into two groups. One group of 20 patients received no treatment and underwent Rigiscan visual-audio-sound stimulation (AVSS) monitoring of penile parameters for approximately 20 minutes. The other group of 20 patients also underwent Rigiscan measurement of baseline values ​​of the glans and base of the penis in resting mode (approximately 5 minutes). Ten patients in this group used the topical erectile dysfunction and delay spray prepared in Example 1, while the other ten used the topical erectile dysfunction and delay spray prepared in Comparative Example 6. Both groups underwent AVSS monitoring of penile parameters for approximately 20 minutes. The Rigiscan examination indicators before and after treatment for each group are shown in Table 4. The response levels of ED patients in different treatment groups to Example 1 are shown in Table 4. Figure 1 As shown, the effect of adding prostaglandin E1 to the group of Examples 1 was better than that of the comparative example 6, indicating that prostaglandin E1 and the exosomes of traditional Chinese medicine have a synergistic effect on improving erection. Figure 1The first column is the response level graph of the blank control group; the second column is the response level graph of Comparative Example 6; the third column is the response level graph of Example 1; the first row is the erection hardness value (%) after 5 minutes of spraying, with the vertical axis from bottom to top being 0, 20, 40, 60, 80, 100, and the horizontal axis being the duration of 50 minutes; the second row is the erection length (cm) after 5 minutes of spraying, with the vertical axis from bottom to top being 5, 7, 9, 11, 13, 15cm, and the horizontal axis being the duration of 50 minutes; the third row is the erection hardness value (%) after 20 minutes of spraying, with the vertical axis from bottom to top being 0, 20, 40, 60, 80, 100, and the horizontal axis being the duration of 50 minutes; the fourth row is the erection length (cm) after 20 minutes of spraying, with the vertical axis from bottom to top being 5, 7, 9, 11, 13, 15cm, and the horizontal axis being the duration of 50 minutes.

[0118] Table 4 Comparison of Rigiscan examination indicators before and after treatment in the four groups of patients

[0119] Test Example 5: Color Doppler Ultrasound Examination CDU combined with ICI not only allows for observation of the basic penile structure using two-dimensional ultrasound, but also effectively monitors hemodynamic changes in the corpora cavernosa in flaccid and erect states. It is a widely used first-line diagnostic method for erectile dysfunction (ED). This study uses CDU combined with topical spray and audiovisual stimulation to assess penile hemodynamics in ED patients. Blood flow parameters (PSV, EDV) and cavernous artery diameters were measured at seven time points (5-30 min, 5, 10, 15, 20, 25, 30 min) on both sides of the corpora cavernosa in the flaccid state. Dynamic analysis was performed on the differences in blood flow parameters between arterial ED, venous ED, and non-vascular ED at each corresponding time point in the flaccid state and after topical spray application. Smooth muscle is in a relaxed state, penile artery diameter is widened, veins are in a contracted and closed state, and the corpora cavernosa are congested and swollen. Figure 2 ).

[0120] Table 5 shows a comparison of PSV and EDV at six time points in each ED patient during flaccid state and after application of the topical spray. The spectrum of each time point in Example 1 is shown below. Figure 3 As shown in the figure, the spectrum of Comparative Example 6 at various time points is as follows: Figure 4 As shown in the figure. It can be seen that the erectile dysfunction effect of the group in Example 1 after the addition of prostaglandin E1 is better than that of the comparative example 6, and prostaglandin and traditional Chinese medicine exosomes have a synergistic effect on erectile dysfunction.

[0121] Table 5. Comparison of PSV and EDV in ED patients during flaccid state and at 6 time points after topical spray application.

[0122] Test 6: The friction coefficient of the sample was determined using a friction coefficient meter. The MXD-01 friction coefficient meter (Jinan Languang Electromechanical Technology Co., Ltd.) was used to test the friction coefficients of various embodiments. The MXD-01 friction coefficient meter mainly consists of a stainless steel horizontal surface, a slider with constant mass, and a force sensor. During measurement, the slider is connected to the force sensor and placed on the horizontal surface. The force sensor pulls the slider at a constant speed for a certain distance and then stops, thus measuring the friction coefficient between the slider and the horizontal surface. After three measurements, the instrument automatically calculates the average value. The test results are shown in Table 6. It can be seen that without the addition of lubricant, the dynamic friction coefficient of the sample reaches 0.13. The addition of lubricants such as cetyl ethylhexanoate, glyceryl cocoate, and mango oil ester improves the lubricity and application feel of the spray, enhancing the user experience.

[0123] Table 6. Test results of dynamic friction coefficient for each embodiment.

[0124] Test 7: Comparison of the synergistic effects of exosomes from traditional Chinese medicine for erectile dysfunction and exosomes for delayed ejaculation. The efficacy of a traditional Chinese medicine spray for erectile dysfunction and delayed ejaculation was tested using an ejaculation function scoring test, and compared with the effects before and after using the spray and lidocaine gel. A total of 80 male subjects, aged 25-45 years, with no history of major urogenital diseases, were included in the experiment. The ejaculation function scoring scale (CIPE) was used to evaluate the satisfaction of both partners with the integrity of their sex life, as well as to assess the patient's psychological and emotional state. The results are shown in Table 7. After two weeks of treatment, the average CIPE of all four groups increased compared to before treatment. The CIPE increase was most significant in Example 1 group, followed by the lidocaine gel group, then Comparative Example 1 group and the control group. The improvement in the control group was not significant. The differences in CIPE scores before and after treatment were statistically significant in Example 1 group, Comparative Example 1 group, and the lidocaine gel group. This indicates that without the addition of the traditional Chinese medicine exosomes for delayed ejaculation, the effect of delayed ejaculation was not significant; however, the effect of delayed ejaculation was significantly improved after the addition of the traditional Chinese medicine exosomes for delayed ejaculation. The traditional Chinese medicine exosomes for erectile dysfunction and the traditional Chinese medicine exosomes for delayed ejaculation have a synergistic effect.

[0125] Table 7 Comparison of CIPE before and after treatment

[0126] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A topical pharmaceutical composition for enhancing erection and delaying ejaculation, characterized in that, Includes an erection-enhancing exosome combination, a delay-ejaculation exosome combination, and prostaglandin E1; The erectile dysfunction exosome combination includes exosomes containing the following Chinese herbal ingredients: Butea superba, Evodia rutaecarpa, Ligusticum chuanxiong, Gynostemma pentaphyllum, Rejuvenating Herb, Tribulus terrestris, Cabinda, Tribulus terrestris and Tongkat Ali; The delayed-release exosome combination includes exosomes from the following traditional Chinese medicines: Albizia julibrissin, Gynostemma pentaphyllum, Morus alba leaves, and Photinia serratifolia leaves.

2. The topical pharmaceutical composition according to claim 1, characterized in that, By weight, the topical drug composition comprises the following components: 10-20 parts of topical Chinese medicine exosome combination for erection, 10-20 parts of exosome combination for delayed ejaculation, and 0.1-0.3 parts of prostaglandin E1.

3. The topical pharmaceutical composition according to claim 1 or 2, characterized in that, The erectile dysfunction exosome composition comprises the following exosomes in parts by weight: 8-10 parts Butea superba exosomes, 10-15 parts Evodia rutaecarpa exosomes, 1-3 parts Ligusticum chuanxiong exosomes, 3-5 parts Gynostemma pentaphyllum exosomes, 5-10 parts Rehmannia glutinosa exosomes, 5-10 parts Gynostemma pentaphyllum exosomes, 10-15 parts Carbinda exosomes, 4-6 parts Tribulus terrestris exosomes, and 3-5 parts Tongkat Ali exosomes.

4. The topical pharmaceutical composition according to claim 1 or 2, characterized in that, The delayed-release exosome composition comprises the following exosomes in parts by weight: 15-20 parts Albizia julibrissin exosomes, 10-15 parts Gynostemma pentaphyllum exosomes, 8-10 parts Morus alba leaf exosomes and 5-10 parts Photinia serratifolia leaf exosomes.

5. A topical Chinese herbal spray for improving erection and delaying ejaculation, characterized in that, Includes the topical pharmaceutical composition and transdermal penetration enhancer as described in any one of claims 1 to 4; The transdermal penetration enhancer is an aqueous ethanol solution containing eucalyptus oil, turpentine oil, peppermint oil, and lauryl acetone.

6. The topical herbal spray for erectile dysfunction and delayed ejaculation according to claim 5, characterized in that, The topical Chinese medicine spray for erectile dysfunction and delayed ejaculation comprises the following components in parts by weight: 10-20 parts of erectile dysfunction exosome combination, 10-20 parts of delayed ejaculation exosome combination, 60-80 parts of transdermal penetration enhancer, and 0.1-0.3 parts of prostaglandin E1.

7. The topical herbal spray for erectile dysfunction and delayed ejaculation according to claim 5 or 6, characterized in that, The transdermal penetration enhancer comprises the following components in parts by weight: 3-5 parts eucalyptus oil, 3-5 parts turpentine oil, 1-3 parts peppermint oil, 6-8 parts lauroyl acetone, and 70-90 parts 70 wt% aqueous ethanol solution.

8. The topical herbal spray for erectile dysfunction and delayed ejaculation according to claim 5, characterized in that, It also includes stabilizers, preservatives, and lubricants.

9. The topical herbal spray for erectile dysfunction and delayed ejaculation according to claim 8, characterized in that, The stabilizer includes at least one of the following: xanthan gum and guar gum.

10. The topical herbal spray for erectile dysfunction and delayed ejaculation according to claim 8, characterized in that, The preservative includes at least one of the following: Coptis chinensis extract, Sophora flavescens extract and Forsythia suspensa extract; The lubricant includes at least one of the following: cetyl ethylhexanoate, coconut oil ester, and mango oil ester.

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