Traditional Chinese medicine composition suitable for prolonging incubation period of ejaculation as well as preparation and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition suitable for prolonging the incubation period of ejaculation and preparation and application thereof. The traditional Chinese medicine composition is prepared from the following raw material components: herba epimedii, herba cistanche, flos caryophylli, flos carthami, pericarpium zanthoxyli, fructus cnidii, radix sophorae flavescentis, propolis, musk, cornu cervi pantotrichum, herba asari and camphor. The traditional Chinese medicine composition gives consideration to effects and experiences, realizes double optimization of medicine effects and psychological regulation, and has multiple functions of warming yang and tonifying kidney, promoting blood circulation and dredging collaterals, reducing sensitivity and delaying time, regulating psychology, resisting inflammation and protecting health and the like.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition suitable for prolonging ejaculation latency, and its preparation and application. Background Art

[0002] Premature Ejaculation (PE) is a common sexual dysfunction in men.

[0003] Currently, physicians mainly treat premature ejaculation with oral or topical medications. Commonly used ones include 5 - hydroxytryptamine reuptake inhibitors, sildenafil, adrenergic alpha - receptor blockers, etc. Among them, 5 - hydroxytryptamine reuptake inhibitors (SSRI) are the most widely used and relatively effective drugs in clinical practice. The clinically commonly used dapoxetine is the only approved oral drug for treating PE in China so far. These drugs do play a role in prolonging the ejaculation latency time, but they have many adverse reactions, such as nausea, fatigue, decreased libido, and even erectile dysfunction, and their incidence also has a certain dose - dependence. Dapoxetine and others also have a relatively high clinical discontinuation rate, and the main reasons for discontinuation are the poor bioavailability, poor efficacy, and low patient satisfaction of dapoxetine. In addition to dapoxetine, other SSRIs can also delay ejaculation. Commonly seen ones include paroxetine, sertraline, fluoxetine, citalopram, etc., but currently none of them are approved for treating PE, and there is a risk of withdrawal syndrome and potential harmful effects on sperm.

[0004] In addition to oral medications, local anesthetics can also achieve the purpose of treating PE by reducing the sensitivity of the glans penis and prolonging the ejaculation latency. Commonly used ones include lidocaine / prilocaine cream / spray, compound chamomile lidocaine spray / gel, etc. However, local anesthetics are prone to cause penile numbness, decreased sensation, skin allergies, and at the same time, there will be adverse reactions such as drug absorption in the vagina leading to vaginal paralysis, and they may also be toxic to sperm. Therefore, local anesthetics are not recommended for PE patients with fertility requirements. Some clinicians use penile dorsal nerve block to prolong the male intercourse time. Although it has certain efficacy, it is an invasive operation with many side effects. Some doctors recommend psychological and behavioral therapies, which are convenient to operate, but the compliance of a few patients is not high and they cannot cooperate effectively. In view of this, by giving play to the advantages of traditional Chinese medicine, it is expected to explore new prescriptions for treating premature ejaculation. Summary of the Invention

[0005] In order to overcome the above - mentioned technical problems, the purpose of the present invention is to provide a traditional Chinese medicine composition suitable for prolonging ejaculation latency, and its preparation and application.

[0006] To achieve the above - mentioned purpose and other related purposes, the present invention adopts the following technical solutions:

[0007] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition suitable for prolonging the ejaculation latency period. The raw material components and their weight part ratios in the traditional Chinese medicine composition are as follows: Herba Epimedii 3 - 10 weight parts, Herba Cistanches 4 - 10 weight parts, Flos Caryophylli 2 - 7 weight parts, Flos Carthami 2 - 7 weight parts, Pericarpium Zanthoxyli 2 - 6 weight parts, Fructus Cnidii 1 - 7 weight parts, Radix Sophorae Flavescentis 3 - 10 weight parts, Propolis 2 - 8 weight parts, Moschus 0.5 - 2 weight parts, Cornu Cervi Pantotrichum 3 - 10 weight parts, Radix et Rhizoma Asari 2 - 6 weight parts, Camphora 1 - 5 weight parts.

[0008] Among them, the Latin name of Herba Epimedii is Herba Epimedii. The Latin name of Herba Cistanches is Herba Cistanches. The Latin name of Flos Caryophylli is Flos Caryophylli. The Latin name of Flos Carthami is Flos Carthami. The Latin name of Pericarpium Zanthoxyli is Pericarpium Zanthoxyli. The Latin name of Fructus Cnidii is Fructus Cnidii. The Latin name of Radix Sophorae Flavescentis is Radix Sophorae Flavescentis. The Latin name of Propolis is Propolis. The Latin name of Moschus is Moschus. The Latin name of Cornu Cervi Pantotrichum is Cornu Cervi Pantotrichum. The Latin name of Radix et Rhizoma Asari is Radix et Rhizoma Asari. The Latin name of Camphora is Camphora.

[0009] As a preferred technical solution, the components and their weight part ratios in the traditional Chinese medicine composition are as follows: Herba Epimedii 3 - 8 weight parts, Herba Cistanches 4 - 8 weight parts, Flos Caryophylli 3 - 7 weight parts, Flos Carthami 4 - 7 weight parts, Pericarpium Zanthoxyli 3 - 5 weight parts, Fructus Cnidii 3 - 7 weight parts, Radix Sophorae Flavescentis 5 - 8 weight parts, Propolis 2 - 6 weight parts, Moschus 0.5 - 1 weight part, Cornu Cervi Pantotrichum 5 - 8 weight parts, Radix et Rhizoma Asari 2 - 4 weight parts, Camphora 2 - 3 weight parts.

[0010] As a further preferred technical solution, the components and their weight part ratios in the traditional Chinese medicine composition are as follows: Herba Epimedii 6 - 7 weight parts, Herba Cistanches 6 - 7 weight parts, Flos Caryophylli 4 - 5 weight parts, Flos Carthami 4 - 5 weight parts, Pericarpium Zanthoxyli 4 - 5 weight parts, Fructus Cnidii 6 - 7 weight parts, Radix Sophorae Flavescentis 6 - 8 weight parts, Propolis 5 - 6 weight parts, Moschus 0.5 - 0.7 weight part, Cornu Cervi Pantotrichum 6 - 7 weight parts, Radix et Rhizoma Asari 3 - 4 weight parts, Camphora 2 - 2.5 weight parts.

[0011] As the most preferred technical solution, the traditional Chinese medicine composition consists of the following components: Herba Epimedii 7 weight parts, Herba Cistanches 6.5 weight parts, Flos Caryophylli 4 weight parts, Flos Carthami 4.5 weight parts, Pericarpium Zanthoxyli 4 weight parts, Fructus Cnidii 7 weight parts, Radix Sophorae Flavescentis 7 weight parts, Propolis 5 weight parts, Moschus 0.7 weight part, Cornu Cervi Pantotrichum 6 weight parts, Radix et Rhizoma Asari 3.5 weight parts, Camphora 2 weight parts.

[0012] In a second aspect of the present invention, there is also provided a traditional Chinese medicine extract, which is prepared by extracting the active ingredients from the above traditional Chinese medicine composition as the raw material.

[0013] In a third aspect of the present invention, there is also provided a preparation method of the traditional Chinese medicine extract. The method includes the steps of: taking each traditional Chinese medicine component according to the ratio, grinding or pulverizing evenly and then mixing, and obtaining the active components through solvent extraction. Preferably, each traditional Chinese medicine component is pulverized to a particle size of 100 - 300 mesh.

[0014] According to the characteristics of the active ingredients of different crude drugs in the traditional Chinese medicine composition, different extraction processes can be adopted. In the present invention, the raw material components and their formulations in the traditional Chinese medicine composition are the most crucial. After knowing the traditional Chinese medicine formula, those skilled in the art can directly grind or pulverize each medicine according to the ratio and mix them as the active ingredients. In addition, those skilled in the art of this technical field can also adopt various conventional methods for extracting the active ingredients of traditional Chinese medicine to extract its active ingredients, such as conventional decocting, water extraction and alcohol precipitation method, alcohol extraction and water precipitation method, salting - out method, etc. Since the above - mentioned extraction methods can all obtain the main pharmacodynamic components in the aforementioned traditional Chinese medicine formula, they all have a certain curative effect on prolonging the ejaculation latency period.

[0015] Among them, the water extraction and alcohol precipitation method is: first, using water as the solvent to extract the active ingredients of the medicinal materials, and then using ethanol with different concentrations to precipitate and remove the impurities in the extract. Generally, when the ethanol content reaches 50% - 60% (weight - volume ratio, i.e., g / 100 ml), impurities such as starch can be removed. When the alcohol content reaches more than 75%, most of the other impurities can be precipitated and removed except for a few ineffective components such as tannins and water - soluble pigments.

[0016] The alcohol extraction and water precipitation method is: first, extracting the components of the medicinal materials with ethanol at an appropriate concentration, and then using water to remove the impurities in the extract.

[0017] After extracting the active ingredients from the traditional Chinese medicine composition, the traditional Chinese medicine extract can be obtained through conventional steps such as concentration, purification or drying. Among them, the methods of concentration include but are not limited to: atmospheric evaporation, vacuum evaporation, thin - film evaporation, multi - effect evaporation; the methods of purification include but are not limited to: salting - out purification, macroporous resin adsorption purification, ethanol precipitation purification, ion - exchange resin purification, flocculation precipitation purification, membrane separation purification, polyamide adsorption purification, silica gel adsorption chromatography purification, etc.; the methods of drying include but are not limited to: drying in an oven, drum drying, belt drying, moisture absorption drying, fluidized - bed drying, spray drying, vacuum drying, freeze - drying, infrared drying, microwave drying, etc.

[0018] In a fourth aspect of the present invention, there is provided the use of the traditional Chinese medicine composition or the traditional Chinese medicine extract in the preparation of products for prolonging the ejaculation latency period.

[0019] In the fifth aspect of the present invention, there is further provided a product suitable for prolonging the ejaculation latency period, comprising a therapeutically effective amount of the aforementioned traditional Chinese medicine extract and one or more conventional physiologically acceptable excipients.

[0020] After extracting the active ingredients from the traditional Chinese medicine composition, it can be prepared into a traditional Chinese medicine preparation by using conventional physiologically acceptable excipients and additives. Among them, pharmaceutically acceptable carriers, diluents, fillers, binders and other excipients.

[0021] As a further preferred technical solution, the product is a topical preparation. Further preferably, the topical preparation is a spray.

[0022] As a preferred technical solution, the spray comprises a main drug and excipients. The main drug is a traditional Chinese medicine extract, and the excipients include a humectant, a thickening agent, a fragrance and a preservative.

[0023] Further, the humectant includes glycerol or propylene glycol to increase the moisturizing feeling of the skin;

[0024] The thickening agent includes xanthan gum or sodium carboxymethylcellulose to increase the viscosity of the spray and prevent excessive fluidity;

[0025] The fragrance includes menthol to improve the odor;

[0026] The preservative includes phenoxyethanol or potassium sorbate to extend the shelf life of the spray.

[0027] In a preferred specific embodiment of the present invention, for example, based on the total amount of 100 ml of the spray, the solvent is 70 - 90 ml, the addition amount of the humectant is 3 - 5 g / 100 ml; the addition amount of the thickening agent is 0.5 - 1 g / 100 ml; the addition amount of the fragrance is 0.5 - 1 g / 100 ml; the addition amount of the preservative is 0.1 - 0.5 g / 100 ml.

[0028] Compared with the prior art, the traditional Chinese medicine composition provided by the present invention suitable for prolonging the ejaculation latency period has the following drug effects:

[0029] (1) Prolong the ejaculation latency time: Drugs such as epimedium, cistanche and pilose antler in this composition have the effect of tonifying the kidney and strengthening yang, can improve premature ejaculation symptoms caused by insufficient kidney yang, and help prolong the ejaculation latency time. Through topical application, these drugs can quickly act on local nerves and blood vessels, regulate sexual function and delay the ejaculation response.

[0030] (2) Improve ejaculatory control ability: Cnidium monnieri, Zanthoxylum schinifolium, Moschus, etc. in this composition have the effects of promoting blood circulation to remove blood stasis and warming yang to promote qi movement, which can promote local blood circulation and enhance the ability to control ejaculation. These drugs regulate local nerve reflexes, slow down the ejaculation process, and improve self-control during sexual behavior.

[0031] (3) Reduce penile sensitivity: Syzygium aromaticum, Asarum sieboldii, Camphor, and Moschus in this composition have mild anesthetic and analgesic effects. By reducing the excessive sensitivity of the penile area, these drugs help relieve premature ejaculation symptoms caused by excessive sensitivity and help men maintain control for a longer time during sexual intercourse.

[0032] (4) Aromatic resuscitation: Aromatic herbs such as Syzygium aromaticum, Asarum sieboldii, and Moschus in this composition can stimulate the nervous system, resuscitate with aromatics, regulate nerve conduction, help activate nerve responses to enhance sexual desire, and enhance the pleasure of sexual life. They promote nerve conduction between the brain and genitals, activate sexual desire, and improve the sexual experience.

[0033] (5) Promote transdermal absorption of drugs: The form of the topical spray allows the drugs to directly enter the blood circulation through the skin. Drugs such as Propolis, Moschus, and Camphor have the property of promoting transdermal absorption, which helps the drug effect quickly penetrate and play a therapeutic role, achieving a higher local drug effect. The drug components enter the local tissues through the skin and can directly act on erectile function and nerve transmission, enhancing the efficacy of the drugs.

[0034] (6) Improve female satisfaction: Drugs such as Carthamus tinctorius and Cnidium monnieri in this composition promote local blood circulation, improve blood flow in the vagina and vulva, and help improve female sexual satisfaction. Increasing blood circulation in the vagina not only helps improve vaginal dryness but also enhances female sexual pleasure and overall sexual gratification.

[0035] (7) Prevent and improve female vaginitis: Sophora flavescens, Cnidium monnieri, and Propolis in this composition have the effects of clearing heat and drying dampness, antibacterial and anti-inflammatory, and have a good relieving effect on female vaginal inflammation (such as vaginal infections, abnormal secretions, etc.). The spray form can directly act on the vagina or vulva, quickly relieve inflammation, reduce discomfort, and help women restore a healthy reproductive tract environment.

[0036] (8) Dual regulation of function and psychology: Moschus, Cornu Cervi Pantotrichum, Cistanche deserticola, etc. in this composition have the effects of warming yang and tonifying the kidney, replenishing qi and nourishing blood, and can regulate sexual dysfunction caused by psychological factors (such as anxiety, stress, mood instability, etc.). By improving the psychological state, it reduces premature ejaculation caused by anxiety or psychological burden and improves men's confidence and performance in sexual life.

[0037] (9) Warming and nourishing the kidney, promoting blood circulation and unblocking collaterals: The main ingredients of the composition, such as Epimedium, Cistanche deserticola, Pilose antler, and Cnidium monnieri, have the effects of warming the yang and nourishing the kidney, promoting blood circulation and unblocking collaterals. By promoting blood circulation and warming the kidney qi, it helps to restore the basic functions of the body, enhance erectile function, improve sexual dysfunction caused by kidney yang deficiency, enhance the dual effects of physiology and psychology, and prevent the occurrence of premature ejaculation.

[0038] In summary, the Chinese medicine compatibility of the present invention takes into account both efficacy and experience as a whole, achieves dual optimization of drug effect and psychological adjustment, and has multiple functions such as warming yang and tonifying the kidney, promoting blood circulation and unblocking collaterals, reducing sensitivity and delaying ejaculation, adjusting psychology, and anti-inflammatory health care. The following effects are achieved through multi-dimensional compatibility: (1) Dual effects of delaying ejaculation and controlling semen: effectively prolonging the ejaculation latency period, improving ejaculation control ability, and reducing the sensitivity of the penis. (2) Improving the sexual experience of both parties: through aromatic reflexes and improving blood circulation, enhancing the sexual pleasure of both parties, improving sexual desire and increasing female satisfaction. (3) Synergistically enhancing drug penetration and improving drug efficacy utilization: containing ingredients that promote transdermal absorption, it can enable drugs to quickly penetrate the skin and act locally, regulating the functions of the reproductive system and nervous system. (4) Synergistically improving the inflammatory microenvironment of women: relieving vaginal inflammation and discomfort, maintaining vaginal health, and promoting local physiological balance. Suitable for external combined treatment of male delay and female prevention of vaginitis. (5) Bidirectional regulation function: It can improve physiological and psychological states simultaneously, effectively solve sexual dysfunction caused by psychological factors, enhance self-confidence, and promote harmony and intimacy with partners. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 The incubation period distribution diagram of each formulation in Example 1 is shown;

[0040] Figure 2 Insert the incubation period distribution diagram for each formulation of Example 1;

[0041] Figure 3 This is the distribution diagram of ejaculation latency of each formula in Example 1;

[0042] Figure 4 The distribution diagram of the number of times of riding for each formulation in Example 1;

[0043] Figure 5 Insert frequency distribution diagram for each formulation of Example 1;

[0044] Figure 6 This is the ejaculation frequency distribution diagram of each formula in Example 1. DETAILED DESCRIPTION

[0045] Before further describing the specific embodiments of the present invention, it should be understood that the protection scope of the present invention is not limited to the following specific embodiments; it should also be understood that the terms used in the embodiments of the present invention are for describing specific embodiments, rather than for limiting the protection scope of the present invention. The test methods without specific conditions noted in the following embodiments are generally carried out under conventional conditions or according to the conditions recommended by each manufacturer.

[0046] When an embodiment gives a numerical range, it should be understood that unless otherwise specified in the present invention, both endpoints of each numerical range and any value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the art of this technology. In addition to the specific methods, devices, and materials used in the embodiments, according to the knowledge of those skilled in the art of this technology and the records of the present invention, any methods, devices, and materials similar to or equivalent to the methods, devices, and materials described in the embodiments of the present invention can also be used to implement the present invention.

[0047] Unless otherwise stated, the experimental methods, detection methods, and preparation methods disclosed in the present invention all adopt the conventional techniques in the art of this technology.

[0048] The raw medicinal materials (or medicinal herbs) used in the present invention can all be purchased from ordinary pharmacies or Chinese medicinal material sales companies, and their specifications meet the national pharmaceutical standards or relevant regulations such as the Chinese Pharmacopoeia. Unless otherwise stated, the medicinal herbs used are all Chinese medicinal herb slices, and these Chinese medicinal herb slices can also be obtained after processing.

[0049] The curative effect criteria of the present invention refer to the relevant curative effect criteria in the "Curative Effect Criteria for Judging TCM Syndromes".

[0050] In principle, the preparation process of the present invention applies the "Technical Requirements for the Research of the Preparation Process of New Chinese Medicines", extracts the main active ingredients of the medicine by using modern preparation new technologies, and adds some pharmaceutically acceptable excipients or carriers.

[0051] Example 1

[0052] This Example 1 provides the raw material components and their weight part ratios in the traditional Chinese medicine composition of the present invention.

[0053] Table 1 Formula Components (unit: g)

[0054] Formula 1 Formula 2 Formula 3 Formula 4 Formula 5 Formula 6 Formula 7 Comparative Formula 1 Comparative Formula 2 Epimedium 7 6 7 8 3 10 3 6 7 Cistanche 6.5 6 7 4 8 4 10 6.5 6 Clove 4 5 4 3 7 7 2 4.5 4.7 Safflower 4.5 4 5 7 4 2 7 0 4.5 Prickly Ash 4 4 5 5 3 6 2 4 4 Fructus Cnidii 7 7 6 3 7 7 1 0 4 Sophora flavescens 7 8 6 8 5 3 10 6.5 0 Propolis 5 5 6 2 6 8 2 4 0 Musk 0.7 0.5 0.7 0.5 1 2 0.5 0.6 0.6 Cornu Cervi Pantotrichum 6 6 7 5 8 10 3 6.5 6.5 Asarum 3.5 4 3 4 2 2 6 3 3.5 Camphor 2 2 2.5 2 3 5 1 2 2

[0055] Preparation method: Prepare each raw material according to Formulas 1-7 and Comparative Formulas 1-2 in Table 1. After grinding the raw materials into powder, sieve them through a 200-mesh sieve, decoct them twice with water as the solvent, separate them through a 50-nm ceramic membrane to remove impurities with a molecular weight greater than 0.05 microns in natural plants, then introduce the separated and purified liquid into a 20-nm ceramic membrane for separation and purification treatment to obtain the active ingredients of the traditional Chinese medicine extract. Then add excipients and mix them to form a uniform mixture, and spray-dry it into a traditional Chinese medicine spray for standby.

[0056] Example 2

[0057] This Example 2 is used to verify the therapeutic effects of Formulas 1-7 and Comparative Formulas 1-2 prepared in Example 1.

[0058]

Animal experiment

[0059] The sexual behavior patterns of the living animals used in this example include: mount, intromission, and ejaculation.

[0060] Specific descriptions are as follows:

[0061] (1) Mount: The male rat lies on top of the female rat, which is equivalent to evaluating the human sexual desire performance, penile erection, and the process of sexual impulse (corresponding indications: sexual desire disorder, low sexual desire, sexual aversion, no sexual desire);

[0062] (2) Intromission: The male rat's penis enters the female rat's vagina, which is equivalent to evaluating sufficient penile erection hardness and no premature ejaculation in humans (corresponding indications: erectile dysfunction, impotence, priapism, premature ejaculation); and

[0063] (3) Ejaculation: After the male rat ejaculates, it leaves the female rat, which is equivalent to evaluating the persistence of human sexual behavior and the physical recovery ability after ejaculation (corresponding indication: ejaculation disorder). And the evaluation of ejaculation also indicates that it includes the behaviors of mount and intromission.

[0064]

Effectiveness evaluation

[0065] a. Construct a premature ejaculation animal model

[0066] Select 110 male rats and inject the 5-HT1A receptor agonist 8-OH-DPAT every day. The specific method is: dissolve 8-OH-DPAT in physiological saline, and perform intrathecal cyst injection at the lumbosacral spinal cord segment of male Wistar rats, 0.8 mg / kg, for a total of 4 weeks.

[0067] b. Preparation of female rats

[0068] Three hundred and thirty Wistar female rats were selected. Under anesthesia with sodium pentobarbital (30 mg / kg), bilateral ovariectomy was performed; mating tests were carried out 2 weeks after ovariectomy. Forty-eight hours before the test, estradiol benzoate was first injected subcutaneously at a dose of 20 μg per rat, and then progesterone injection was given at a dose of 50 μg per rat 4 hours before the test. Vaginal secretions were smeared with cotton swabs dipped in normal saline, and estrous female rats were screened and reserved for use.

[0069] c. Observation of premature ejaculation-related behaviors

[0070] Male rats were divided into 11 groups (blank group, normal saline group, traditional Chinese medicine spray group), with 10 rats in each group. Before inducing mating, no substances were sprayed on the genitals of the rats in the blank group, normal saline was sprayed in the normal saline group, and traditional Chinese medicine spray was sprayed in the traditional Chinese medicine spray group. According to the male-female ratio of 30:10, after ovariectomy and hormone-induced estrus in female rats, the corresponding reagents were sprayed on the genitals of the male rats with premature ejaculation models 15 minutes in advance, and then the rats were placed in a behavior observation cage illuminated by dim red light, and the mating behaviors of the rats were observed and recorded within 30 minutes.

[0071] Observe and record the indicators during the mating process:

[0072] Mounting latency: The time (s) required from being caged with a female rat to the first climb;

[0073] Intromission latency: The time (s) from the start of the test to the male rat's first vaginal intromission;

[0074] Ejaculation latency: The time (s) required from the first intromission to ejaculation;

[0075] Mounting frequency: The total number of climbs during the observation time, regardless of whether there is intromission;

[0076] Intromission frequency (IF): The total number of intromissions before the male rat ejaculates;

[0077] Ejaculation frequency: The number of ejaculations of rats with ejaculation activities during the 30-minute mating experiment.

[0078] d. Experimental results

[0079] Based on the statistical data of sexual function scores according to the mounting, intromission, and ejaculation behaviors defined above, the statistics were carried out with the average value, and the results are shown in Table 2.

[0080] Table 2 Statistical data of sexual function scores of male rats

[0081]

[0082] From Table 2 and Figures 1 - 6It can be seen that, compared with the blank group and the normal saline group, Formulas 1-7 provided by the present invention have the effect of enhancing sexual desire for male patients with premature ejaculation, and can effectively prolong the ejaculation latency time, improve the ejaculation control ability and reduce penile sensitivity. The experimental results show that: the data of the mounting latency, intromission latency, ejaculation latency, mounting times, intromission frequency, etc. of the formula group are significantly higher than those of the blank group and the normal saline group, while the ejaculation frequency is significantly lower than that of the blank group and the normal saline group. In particular, Formulas 1-3 show excellent effects. Among Comparative Formulas 1-2, compared with Formula 1, the formula components are changed (Comparative Formula 1 lacks safflower and cnidium fruit, and Comparative Formula 2 lacks sophora flavescens and propolis), and the experimental effect is slightly worse.

[0083]

Clinical Efficacy Test

[0084] The present invention selects Formulas 1-3, Comparative Formula 1 and Comparative Formula 2 for clinical efficacy tests.

[0085] Collect primary premature ejaculation patients who meet the diagnostic criteria and seek medical treatment in the urology and andrology outpatient department of Gongli Hospital from January 2023 to January 2024. The patients are aged 18-50 years old. The included subjects are divided into three groups by the random number table method: Group A (blank group), Group B (normal saline group), and Groups C1-C5 (traditional Chinese medicine spray group), with 20 people in each group. All patients signed the informed consent form, and this protocol was approved by the ethics committee.

[0086] Diagnostic criteria: According to the evidence-based definition of the International Society for Sexual Medicine (ISSM): Ejaculation always or almost always occurs before penile insertion into the vagina or within about 1 minute after penile insertion into the vagina; Ejaculation cannot be delayed / controlled in all or almost all vaginal insertions; Negative consequences occur: such as distress, annoyance, frustration, and avoidance of sexual contact.

[0087] Inclusion criteria: Meet the diagnostic criteria for primary premature ejaculation; Aged 18-50 years old, with a disease course of ≥6 months; Sexual intercourse frequency of 1-3 times / week.

[0088] Exclusion criteria: Patients with allergic constitution or allergic to any known drugs during treatment; Those who have a fertility requirement in the past 6 months; Those accompanied by serious diseases of important organs such as the heart, liver, and kidneys and mental disorders.

[0089] Test method: Group A uses blank treatment, Group B uses normal saline treatment, and Group C uses traditional Chinese medicine spray treatment. Each group sprays the drug on the coronal sulcus and glans penis 20 minutes before each sexual intercourse, 0.3-0.5 ml / time, and washes it with clean water during sexual intercourse. Observe for 2 weeks in total. Patients have sexual intercourse at least once a week.

[0090] Observation indicators

[0091] (1) Intravaginal ejaculation latency time (IELT): It refers to the time from penile insertion into the vagina to ejaculation. If ejaculation occurs before penile insertion into the vagina or just after penile insertion, the IELT is 0. Clinically, the IELT is often used to diagnose premature ejaculation and evaluate the treatment effect. According to the DSM-5 standard, the length of the IELT can be used to assess the severity of PE.

[0092] (2) CIPE-5 (Q6 Q7) (Sexual Function Evaluation Form for Chinese Premature Ejaculation Patients, Female Satisfaction): This index is mainly used to evaluate the satisfaction of both husband and wife with the complete sexual life.

[0093] (3) Premature Ejaculation Diagnostic Tool (PEDT): It is a commonly used questionnaire for diagnosing premature ejaculation, used to evaluate ejaculatory control, frequency, and psychological state. It can be used for the early diagnosis of premature ejaculation and is also beneficial for physicians to evaluate the treatment effect of patients.

[0094] (4) Sensory Evaluation Form (in terms of smell, 0 - 20): It is mainly used to evaluate the degree of sexual stimulation in terms of the female's senses during sexual life.

[0095] Statistics were carried out using the average value of the above test samples, and the specific results are shown in Table 3.

[0096] Table 3 Results of Clinical Effect Tests

[0097]

[0098] As can be seen from Table 3, Formulas 1 - 3 of the present invention have obvious effects compared with the blank group and the normal saline group. The average intravaginal ejaculation latency time reaches more than 200 s, effectively relieving premature ejaculation, with a high female satisfaction and good sensory evaluation. Although Comparative Formula 1 and Comparative Formula 2 also have the effect of relieving premature ejaculation, their comprehensive effects and female sensory evaluations are inferior to those of Formulas 1 - 3.

[0099] Example 3

[0100] Taking Formula 1 of the present invention as an example, further analysis of the quality of female sexual life and sexual function index was carried out.

[0101] Primary premature ejaculation patients who met the diagnostic criteria and visited the outpatient department of urology and andrology in Gongli Hospital from January 2023 to January 2024 were collected. The included subjects were divided into three groups by the random number table method: Group A (blank group), Group B (normal saline group), and Group C (traditional Chinese medicine spray group), with 20 people in each group. Follow-up investigations were conducted on the fixed sexual partners of each patient.

[0102] All patients signed the informed consent form, and this protocol was approved by the ethics committee.

[0103] The quality of sexual life was evaluated using the Chinese Women's Sexual Life Quality Questionnaire, and sexual function was evaluated using the Female Sexual Function Index (FSFI) Questionnaire and the International Female Sexual Function Assessment Scale (BISF-W).

[0104] Results of the assessment:

[0105] The total scores of the Chinese Women's Sexual Life Quality Questionnaire for Group A and Group B were (127.5 ± 20.2) and (129.4 ± 18.6) points respectively, which were significantly lower than that of the control group (136.4 ± 22.6) points. Among them, the scores of sexual satisfaction, sexual pain and emotion, sexual attitude, and sexual body image were all significantly lower than those of the control group, and the differences were statistically significant (all P < 0.05);

[0106] The total scores of the FSFI Questionnaire for Group A and Group B were (60.8 ± 11.2) and (64.3 ± 10.4) points respectively, lower than that of the control group (70.8 ± 15.6) points. Among them, the scores of sexual desire, coital pain, sexual arousal, vaginal lubrication, and sexual satisfaction were all significantly lower than those of the control group, and the differences were statistically significant (all P < 0.05);

[0107] The total scores of the BISF-W scale for Group A and Group B were (924.6 ± 35.3) and (932.2 ± 34.8) points respectively, significantly lower than that of the control group (977.2 ± 42.1) points. Except for orgasm, the differences were statistically significant (all P < 0.05).

[0108] The test results show that the formula provided by the present invention can improve female satisfaction.

[0109] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A Chinese medicine composition suitable for prolonging the ejaculation latency period, characterized in that: The raw material components and their weight proportions in the traditional Chinese medicine composition are: 3-10 weight parts of epimedium, 4-10 weight parts of Cistanche deserticola, 2-7 weight parts of cloves, 2-7 weight parts of safflower, 2-6 weight parts of Sichuan pepper, 1-7 weight parts of Cnidium monnieri, 3-10 weight parts of Sophora flavescens, 2-8 weight parts of propolis, 0.5-2 weight parts of musk, 3-10 weight parts of deer antler, 2-6 weight parts of asarum, and 1-5 weight parts of camphor.

2. The Chinese medicine composition according to claim 1, characterized in that: The components and their weight proportions in the traditional Chinese medicine composition are: 3-8 weight parts of epimedium, 4-8 weight parts of Cistanche deserticola, 3-7 weight parts of cloves, 4-7 weight parts of safflower, 3-5 weight parts of Sichuan pepper, 3-7 weight parts of Cnidium monnieri, 5-8 weight parts of Sophora flavescens, 2-6 weight parts of propolis, 0.5-1 weight parts of musk, 5-8 weight parts of pilose antler, 2-4 weight parts of asarum, and 2-3 weight parts of camphor.

3. The Chinese medicine composition according to claim 1, characterized in that The components and their weight proportions in the traditional Chinese medicine composition are: 6-7 weight parts of epimedium, 6-7 weight parts of Cistanche, 4-5 weight parts of cloves, 4-5 weight parts of safflower, 4-5 weight parts of Sichuan pepper, 6-7 weight parts of Cnidium monnieri, 6-8 weight parts of Sophora flavescens, 5-6 weight parts of propolis, 0.5-0.7 weight parts of musk, 6-7 weight parts of pilose antler, 3-4 weight parts of asarum, and 2-2.5 weight parts of camphor.

4. A Chinese herbal extract suitable for prolonging the ejaculation latency period, characterized in that: The effective ingredients are extracted from the Chinese medicine composition as claimed in any one of claims 1 to 3 as raw materials.

5. A method for preparing the Chinese medicine extract according to claim 4, characterized in that: The method comprises the steps of taking various Chinese medicinal components according to a proportion, grinding or crushing them evenly and mixing them, and extracting the active components through a solvent to obtain them.

6. The method according to claim 5, characterized in that Each Chinese medicinal component is crushed to a particle size of 100 to 300 meshes.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine extract according to claim 4 in the preparation of a product for prolonging the ejaculation latency period.

8. A product suitable for prolonging the ejaculation latency period, characterized in that: The invention comprises a therapeutically effective amount of the Chinese medicinal extract as claimed in claim 4 and one or more conventional physiologically acceptable excipients.

9. The product according to claim 8, characterized in that The product is an external preparation.

10. The product according to claim 9, characterized in that The external preparation is a spray.

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