A compound composition of external use of traditional Chinese medicine for preventing and treating premature ejaculation

Abstract

The application discloses a kind of external use traditional Chinese medicine compound compositions for reducing sensitivity of glans penis and penis and prolonging intravaginal ejaculation latency, and the pharmaceutical composition includes the following weight fractions of components: 30-70 parts of gallnut, 0.2-3 parts of toad venom, 9-35 parts of pomegranate peel, 6-14 parts of cnidium, 9-35 parts of dandelion, 6-14 parts of sophora, 2-10 parts of mint, 0.5-4 parts of pepper.The traditional Chinese medicine compound composition provided by the application uses scientific proportioning, mutually coordinates and mutually promotes between components, and plays the role of synergistic effect.The external use traditional Chinese medicine compound of the application can significantly reduce the sensitivity of glans penis and penis, prolong intravaginal ejaculation latency, has definite clinical curative effect, is convenient to use, has good patient tolerance and compliance, is safe and has no side effect, long-term use is not found adverse reaction, and after being made into standard preparation, can promote the standardization treatment of external treatment of traditional Chinese medicine.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a topical traditional Chinese medicine compound composition that reduces the sensitivity of the glans penis and penis and prolongs the intravaginal ejaculation latency period. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Premature ejaculation (PE) is defined as ejaculation occurring frequently or always within approximately one minute before or after vaginal penetration. This condition can begin with the first sexual intercourse or be triggered by an adverse event. It is characterized by an inability to delay ejaculation after penetration, almost always, and is accompanied by negative psychological and physical effects such as distress, depression, frustration, and avoidance of sexual activity. This can cause significant distress and interpersonal difficulties for both the patient and their partner. Domestic surveys indicate a prevalence of 25.8% for PE, and only 9% of men with PE consult a doctor.

[0004] Given the effectiveness of local anesthetic drugs in treating premature ejaculation and the findings of modern medical neuroelectrophysiological research, patients with premature ejaculation currently possess a potential for hypersensitivity of afferent sensory nerve pathways. Ejaculation is a series of complex neural reflex processes, and the glans penis, as a peripheral nerve receptor and afferent nerve pathway, plays a significant role in the entire ejaculation process. In clinical research, the applicant found that the glans penis sensory threshold in patients with premature ejaculation was significantly lower than that in normal individuals, while the sensitivity of the penile afferent sensory nerve pathway was significantly increased. Furthermore, the latency of the sympathetic response in patients with premature ejaculation was also significantly shorter than in normal individuals. Traditional medicine classifies premature ejaculation into primary and secondary types. Based on functional magnetic resonance imaging (fMRI) of the brain and neuroelectrophysiological examination techniques, the applicant proposes that premature ejaculation can be classified into: penile sensory pathway hyperexcitability type, central sympathetic hyperexcitability type, mixed type, and other types, with the most common clinical types being penile sensory pathway hyperexcitability type and mixed type.

[0005] Existing medications for treating premature ejaculation are mainly divided into two categories: topical medications and oral medications. Topical medications are local anesthetics, while oral medications are serotonin reuptake inhibitors (SSRIs). Commonly used topical anesthetics in clinical practice include lidocaine and prilocaine cream / gel / spray. The main disadvantages of topical anesthetics include: (1) inconvenience before intercourse and lack of long-term efficacy. Firstly, topical anesthetics usually need to be applied to the glans and penis 60 minutes or even longer before sexual intercourse. They need to be washed off before intercourse, otherwise residual anesthetic entering the vagina will cause numbness and discomfort in the sexual partner, reducing or even eliminating sexual pleasure. Secondly, the retention time, application area, and dosage of anesthetics after application are difficult to accurately control due to individual differences, directly affecting the efficacy and leading to poor efficacy. (2) SSRIs include sertraline, fluoxetine, paroxetine, and fluvoxamine. These drugs have a certain effect on the central sympathetic hyperexcitability type of premature ejaculation, but they inevitably cause drowsiness, fatigue, headache, dizziness, and even fainting. Patients with organic heart disease, glaucoma, or bipolar disorder are strictly prohibited from using them, and some patients cannot tolerate them after taking the drugs. Furthermore, they have almost no effect on patients with premature ejaculation due to penile sensory pathway hyperexcitability.

[0006] External treatments in Traditional Chinese Medicine (TCM), an important part of traditional Chinese medicine treatments, can be traced back to the "Classic of Mountains and Seas." Based on modern medical research on the pathological mechanisms of premature ejaculation, external treatments in TCM have unique advantages in treating premature ejaculation. They are not only convenient to use and have good long-term efficacy, but also safe and without side effects. They can significantly reduce the sensitivity of the glans penis and penis in patients with premature ejaculation, increase the intravaginal ejaculation latency, significantly improve the quality and satisfaction of patients' sexual life, and alleviate the anxiety and frustration caused by premature ejaculation. Summary of the Invention

[0007] Purpose of the invention: The technical problem to be solved by the present invention is to provide a topical Chinese medicine compound composition for the prevention and treatment of premature ejaculation, addressing the shortcomings of the existing technology.

[0008] Another technical problem to be solved by the present invention is to provide a preparation process for the aforementioned topical Chinese medicine compound composition for preventing and treating premature ejaculation.

[0009] Another technical problem that this invention aims to solve is to provide a topical preparation for preventing and treating premature ejaculation.

[0010] Another technical problem to be solved by the present invention is to provide the application of the aforementioned traditional Chinese medicine compound composition, traditional Chinese medicine extract or preparation in the preparation of products for the prevention and treatment of premature ejaculation.

[0011] The technical problem to be solved by the present invention is to provide a product for preventing and treating premature ejaculation.

[0012] To solve the above-mentioned technical problems, the present invention discloses the following technical solution:

[0013] In a first aspect, the present invention discloses a topical traditional Chinese medicine compound composition for the prevention and treatment of premature ejaculation.

[0014] [Traditional Chinese Medicine Theory]

[0015] In traditional Chinese medical classics, there is no disease name of "premature ejaculation". In "Treatment of Women's Diseases in the Bamboo Grove", it is recorded that "sperm essence leakage" is similar to premature ejaculation, which states that "the foreskin of the male penis is delicate, and it becomes unbearably itchy even with a slight touch. Therefore, every time during sexual intercourse, the semen has been ejaculated while the vaginal fluid has not flowed out, which is called sperm essence leakage." It can be seen that Chinese medicine had a perceptual understanding and record of the pathogenesis of premature ejaculation a hundred years ago. The description of premature ejaculation in "General Treatise on Miscellaneous Diseases" is more concise and appropriate: "ejaculation before sexual intercourse or ejaculation immediately after penetration." From the perspective of traditional Chinese medicine theory, the penis (glans penis, penis) is the main sexual organ of men. During sexual intercourse, semen is excreted through the penis. In terms of the meridian circulation, the Liver Meridian of Foot Jueyin winds around the genitals and branches off from the penis; the Kidney Meridian of Foot少阴 runs along the inner thigh and converges at the genitals. In terms of the functions of the zang-fu organs, the kidney is in charge of the anterior and posterior yin and is responsible for urine and semen excretion, and the liver is in charge of storing blood and promoting qi flow and can nourish the external genitals. The Liver and Kidney Meridians are closely connected with the genitals through circulation and collaterals. Therefore, traditional Chinese medicine often treats premature ejaculation from the perspective of the Liver and Kidney. Just as the saying goes, when the liver qi fails to disperse smoothly, the movement rhythm is disordered; when the kidney qi is not consolidated, sperm ejaculation is out of control, resulting in premature ejaculation. The traditional Chinese medicine compound of the present invention precisely treats the condition of excessive opening and closing of the sperm gate and rapid ejaculation of essence qi by externally soaking the penis, enabling the liver qi to be smoothly expressed and dispersed in a proper degree through the Liver Meridian of Foot Jueyin, and consolidating the kidney qi and closing the essence qi through the Kidney Meridian of Foot少阴.

[0016] The traditional Chinese medicine compound of the present invention includes Chinese gallnut, bufotoxin, pomegranate peel, cnidium fruit, dandelion, sophora flavescens, mint, and Chinese prickly ash; in the said compound:

[0017] Chinese gallnut: sour, astringent, attributing to the Lung, Large Intestine, and Kidney Meridians, capable of astringing the intestine to stop diarrhea, securing essence and arresting seminal emission, promoting astringency and relieving dampness, and can be used both externally and internally. Modern pharmacological research shows that Chinese gallnut contains gallotannin, which has a precipitating effect on nerve proteins and a coagulating effect on tissue proteins, and can cause the formation of a film on the mucosal surface, showing a weak local anesthetic effect.

[0018] Bufotoxin: pungent, warm, attributing to the Heart Meridian, capable of detoxifying, relieving pain, and inducing resuscitation. Bufotoxin mainly contains bufotoxin, bufotenine, and also contains abundant polysaccharides, organic acids, amino acids, peptides, and adrenaline, etc., having anti-inflammatory, analgesic, and local anesthetic effects.

[0019] Pomegranate peel: sour, astringent, warm, attributing to the Large Intestine Meridian, capable of astringing the intestine to stop diarrhea, stopping bleeding and expelling worms. Modern pharmacological research shows that pomegranate peel contains tannin, punicine, pseudopunicine, gallic acid, etc., and can effectively play a role in astringing and consolidating.

[0020] Cnidium fruit: pungent, bitter, warm, attributing to the Kidney Meridian, capable of drying dampness, expelling wind, killing insects and relieving itching, warming the kidney and strengthening yang. Subcutaneous injection of cnidium fruit extract can significantly prolong the copulation period of mice, and its extract has an androgen-like effect. The osthole, xanthotoxin, etc. contained in its volatile oil have obvious anti-inflammatory, anti-allergic, and local anesthetic effects.

[0021] Dandelion: Bitter, sweet, and cold in nature; it enters the liver and stomach meridians. Fresh dandelion is often pounded and applied externally. Dandelion is rich in organic acids, which have a significant inhibitory effect on various bacteria. Its water extract can activate macrophages and stimulate the body's immune function.

[0022] Sophora flavescens: bitter and cold in nature, it enters the liver, stomach, large intestine, and bladder meridians. It can clear heat and dry dampness, kill parasites and relieve itching. Modern pharmacological studies have shown that matrine and oxymatrine contained in Sophora flavescens have significant inhibitory effects on various bacteria and anti-allergic effects.

[0023] Peppermint: pungent and cool in nature, it enters the lung and liver meridians. It can dispel wind-heat, soothe the throat and promote rash eruption, and soothe the liver and regulate qi. When used externally, peppermint contains menthol, menthone, limonene, etc., which can stimulate peripheral nerves to reflexively cause changes in deep tissue blood vessels, thus playing a role in anti-inflammatory, analgesic, antipruritic, local anesthetic, and anti-irritant effects.

[0024] Sichuan pepper: pungent and warm in nature, it enters the spleen, stomach, and kidney meridians, and can warm the middle jiao to relieve pain, kill parasites, and relieve itching. The volatile oil contained in the pericarp of Sichuan pepper mainly contains limonene, which has significant analgesic and anti-inflammatory effects.

[0025] This traditional Chinese medicine compound is a creative invention based on TCM theory and clinical practice, combining clinical efficacy and medication experience. The principal, assistant, and adjuvant herbs are well-matched. In this formula, gallnut and toad venom are the principal herbs. Gallnut is sour and astringent, entering the kidney meridian, and has astringent and consolidating properties. Toad venom is pungent and warm, entering the heart meridian, and can detoxify and relieve pain. Gallnut works synergistically with toad venom, both being pungent and warm, to astringe and consolidate essence. From a modern pharmacological perspective, external application of gallnut can increase the thickness of the stratum corneum on the glans and penis, reducing its sensitivity. Toad venom has a similar effect to topical anesthetics, desensitizing the peripheral nerve proteins on the glans and penis; the two have a synergistic effect. Pomegranate peel and Cnidium monnieri are the assistant herbs. Pomegranate peel is warm and astringent, while Cnidium monnieri is pungent and warm. Pomegranate peel works synergistically with Cnidium monnieri to warm yang and dry dampness, assisting the principal herbs in exerting their main astringent and consolidating effects. Dandelion and sophora flavescens are both adjuvant herbs, both possessing antibacterial and anti-inflammatory effects. They can eliminate inflammation of the glans and penile skin, indirectly reducing its sensitivity, and assist the principal and assistant herbs in their astringent, warming, and dampness-drying effects. Sichuan pepper and mint are guiding herbs. Sichuan pepper is pungent and warm, guiding the medicine downwards to the penis; mint is pungent and cool, penetrating the skin to reach the surface, allowing the medicine to directly reach the penis. The entire formula is well-balanced and scientifically combined, achieving the effects of astringency, warming, and dampness-drying.

[0026] In some embodiments, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 30-70 parts of Gallnut, 0.2-3 parts of Toad Venom, 9-35 parts of Pomegranate Peel, 6-14 parts of Cnidium monnieri, 9-35 parts of Dandelion, 6-14 parts of Sophora flavescens, 2-10 parts of Peppermint, and 0.5-4 parts of Sichuan Pepper.

[0027] In some embodiments, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 40-60 parts of Gallnut, 0.6-2 parts of Toad Venom, 12-25 parts of Pomegranate Peel, 8-12 parts of Cnidium monnieri, 12-25 parts of Dandelion, 8-12 parts of Sophora flavescens, 4-8 parts of Peppermint, and 1-3 parts of Sichuan Pepper.

[0028] In some embodiments, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 50 parts of Gallnut, 1 part of Toad Venom, 15 parts of Pomegranate Peel, 10 parts of Cnidium monnieri, 15 parts of Dandelion, 10 parts of Sophora flavescens, 6 parts of Peppermint, and 2 parts of Sichuan Pepper.

[0029] Secondly, this invention discloses a method for preparing the aforementioned topical Chinese medicine compound for the prevention and treatment of premature ejaculation.

[0030] The method includes adding 8-10 times the amount of water to gallnut, pomegranate peel, Cnidium monnieri, dandelion, sophora flavescens, and Sichuan pepper and decocting for 15-25 minutes, adding mint and continuing to decoct for 2-8 minutes, filtering to obtain an aqueous extract; adding toad venom to the aqueous extract to obtain a traditional Chinese medicine compound.

[0031] In some embodiments, after obtaining the aqueous extract, the extract is filtered, and water is added to the residue for further decoction to obtain another aqueous extract. The two aqueous extracts are combined and then toad venom is added to obtain the traditional Chinese medicine compound.

[0032] Thirdly, this invention discloses a pharmaceutical preparation.

[0033] The active ingredient of the pharmaceutical preparation includes the aforementioned pharmaceutical composition or the aforementioned pharmaceutical extract.

[0034] The pharmaceutical preparation is a topical preparation.

[0035] This invention is a scientifically sound compound herbal formula based on the inventor's years of clinical experience and practice, supported by traditional Chinese medicine theory. The aqueous solution of this compound herbal formula has been clinically proven to be safe, non-irritating to the glans penis and penile skin, with no side effects during or after use, no obvious contraindications, and will not cause discomfort to sexual partners during intercourse, demonstrating the distinct advantages of traditional Chinese medicine. Further improved dosage forms can be developed based on the aqueous solution, including but not limited to decoctions, creams, and hydrogels; the decoction includes concentrated decoctions.

[0036] Fourthly, the present invention discloses the use of the aforementioned pharmaceutical composition, the aforementioned pharmaceutical extract, or the aforementioned pharmaceutical preparation in the preparation of a drug for preventing and treating premature ejaculation.

[0037] The prevention and treatment of premature ejaculation includes reducing the sensitivity of the glans penis and / or the penis, and / or prolonging the intravaginal ejaculation latency period.

[0038] Fifthly, this invention discloses a drug for preventing and treating premature ejaculation.

[0039] The drug includes the aforementioned pharmaceutical composition, the aforementioned pharmaceutical extract, or the aforementioned pharmaceutical preparation.

[0040] The prevention and treatment of premature ejaculation includes reducing the sensitivity of the glans penis and / or the penis, and / or prolonging the intravaginal ejaculation latency period.

[0041] The premature ejaculation described in this invention is premature ejaculation of the penile sensory pathway hyperexcitability type.

[0042] The prevention and / or treatment described in this invention include prevention and / or treatment.

[0043] The traditional Chinese medicine compound described in this invention increases the thickness of the stratum corneum of the glans and penis mucosa, thereby desensitizing the nerve endings on the surface of the glans and penis. It exerts a local anesthetic-like effect to continuously reduce the sensitivity of the glans and penis, thus prolonging the intravaginal ejaculation latency period and achieving therapeutic effects.

[0044] The topical Chinese medicine compound composition described in this invention, which reduces the sensitivity of the glans penis and penis and prolongs the intravaginal ejaculation latency period, employs a scientifically formulated ratio. The components coordinate and promote each other, resulting in a synergistic effect. Traditional Chinese medicine believes that premature ejaculation is caused by the liver and kidneys, specifically by liver dysfunction, kidney deficiency in storing essence, and leakage of vital energy. External treatment in traditional Chinese medicine focuses on astringency and consolidation. This topical Chinese medicine compound significantly reduces the sensitivity of the glans penis and penis, prolongs the intravaginal ejaculation latency period, and has definite clinical efficacy. It is convenient to use, has good patient tolerance and compliance, is safe and has no side effects. No adverse reactions have been observed with long-term use. Standardizing this preparation can promote the standardization of external Chinese medicine treatment.

[0045] Beneficial effects:

[0046] (1) Compared with existing local anesthetics that are applied topically before sexual intercourse, the treatment method of the present invention changes from on-demand treatment to on-time treatment, which is an innovation in treatment concept.

[0047] (2) The therapeutic drug in this invention is an aqueous solution of a traditional Chinese medicine compound composition, which has obvious advantages.

[0048] (3) The present invention has a clinical efficacy rate comparable to or even slightly higher than that of Western medicine during the treatment period. In terms of improving the sensitivity of the glans penis, the clinical efficacy is even better than that of the Western medicine control group. Moreover, it can maintain a stable and high efficacy after the drug is discontinued. It can be understood as "treating the root cause". Western medicine only has the efficacy during the treatment period and the long-term efficacy is not good. It is equivalent to only "treating the symptoms". Detailed Implementation

[0049] Unless otherwise specified, the experimental methods described in the following examples are conventional methods; unless otherwise specified, the reagents and materials are commercially available.

[0050] Example 1

[0051] A topical Chinese medicine compound that reduces the sensitivity of the glans penis and prolongs the latency period of ejaculation in the vagina contains the following components in parts by weight: 50 parts of Gallnut, 1 part of Toad Venom, 15 parts of Pomegranate Peel, 10 parts of Cnidium monnieri, 15 parts of Dandelion, 10 parts of Sophora flavescens, 6 parts of Peppermint, and 2 parts of Sichuan Pepper.

[0052] Preparation method:

[0053] Mix the prescribed amounts of gallnut, pomegranate peel, dandelion, sophora flavescens, cnidium monnieri, and Sichuan pepper. Soak in water for 5 minutes to remove surface dust. Add water equal to 8-10 times the total weight of the herbs. Boil over high heat for 10 minutes, then simmer over low heat for 20 minutes. Add mint and simmer for another 5 minutes. Filter and extract the liquid. Repeat the above decoction process twice more with added water. Combine the three extracts and add toad venom to obtain the compound herbal extract. This invention reduces the sensitivity of the glans penis and penis, and prolongs the intravaginal ejaculation latency period.

[0054] Example 2

[0055] 1. Clinical Data

[0056] 1.1 Source of Cases

[0057] The 94 patients with premature ejaculation due to hyperexcitability of the penile sensory pathway were selected from those who visited the Department of Andrology at Jiangsu Provincial Hospital of Traditional Chinese Medicine between January 2022 and January 2024. Cases that met the diagnostic criteria for premature ejaculation due to hyperexcitability of the penile sensory pathway and met the inclusion and exclusion criteria were selected.

[0058] 1.2 Diagnostic criteria

[0059] (1) Diagnostic criteria

[0060] The patient has a regular sexual partner and engages in sexual intercourse at least once a week. During intercourse, ejaculation occurs within one minute of penile penetration, preventing normal sexual intercourse, and this has persisted for more than one month. Penile neurophysiological testing shows shortened DNSEP and / or GPSEP latencies while the PSSR latency is normal. Penile glans sensitivity threshold testing shows a threshold less than 6.

[0061] 1.3 Inclusion criteria: Meets the diagnostic criteria, has good compliance, and is willing to cooperate in receiving 12 weeks of treatment.

[0062] 1.4 Exclusion Criteria:

[0063] Individuals without a fixed sexual partner, with irregular sexual activity, or with serious underlying organic diseases (such as diabetic peripheral neuropathy, hypertension, or coronary syndrome) are unable to undergo 12 weeks of treatment.

[0064] 1.5 Rejection Criteria:

[0065] (1) Those who interrupt radiotherapy or stop taking traditional Chinese medicine for reasons unrelated to the experimental treatment;

[0066] (2) Other diseases that occur during the course of treatment may lead to outcome bias.

[0067] 1.6 Grouping Method

[0068] This study was a parallel-controlled quasi-randomized trial, with patients enrolled quasi-randomly according to their outpatient visit order. The treatment group included 64 patients, and the control group included 30 patients.

[0069] 1.7 General Information

[0070] The treatment group consisted of 64 males, aged 23-46 years, with a mean age of (30.65±6.77) years; the control group consisted of 30 males, aged 24-49 years, with a mean age of (31.46±6.59) years. Statistical analysis showed no significant difference in age between the two groups. Prior to treatment, both groups were diagnosed with penile sensory pathway hyperexcitability-type premature ejaculation based on neurophysiological and glans penis sensitivity threshold tests.

[0071] 2 Methods

[0072] 2.1 Treatment methods

[0073] The treatment group used the herbal compound of this invention to soak the glans and penis once a night for 15 minutes, using 200ml of solution each time, for 12 weeks as one course of treatment. The control group used compound lidocaine cream applied to the glans and penis twice a day, one hour before intercourse, and washed off before intercourse, for 12 weeks as one course of treatment. During the treatment period, patients were required to have a fixed sexual partner and maintain intercourse at least once a week.

[0074] The medicinal materials of the traditional Chinese medicine compound described in Example 1 of this invention used in the treatment group were provided by the Pharmacy Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine and prepared by the Preparation Department using a decoction machine according to the preparation method. The herbs were vacuum-packed and stored at 4°C for no more than 14 days. The compound was distributed to patients by the researchers. The compound lidocaine cream used in the control group was provided by the Pharmacy Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine. The specifications were 25mg of prilocaine and 25mg of lidocaine per gram, batch number H2032006, manufactured by Tongfang Pharmaceutical Group Co., Ltd. (Beijing Ziguang).

[0075] 2.2 Observation time points and observation indicators

[0076] The treatment follow-up observation period was 12 weeks, and indicators were observed and recorded in a timely manner before treatment, after 12 weeks of treatment, and 4 weeks after treatment was stopped.

[0077] 2.2.1 Treatment effectiveness

[0078] (1) Cured: After treatment, sexual intercourse was successful and the latency period of ejaculation in the vagina was greater than 1 minute;

[0079] (2) Significant effect: more than 75% of sexual intercourse is successful and the latency period of ejaculation in the vagina is greater than 1 minute;

[0080] (3) Effective: It can be inserted into the vagina during intercourse, and the ejaculation latency time in more than 50% of cases is greater than 1 minute.

[0081] (4) Ineffective: No significant changes before and after treatment.

[0082] 2.2.2 Evaluation Methods

[0083] (1) The sensitivity threshold of the glans penis was measured 12 weeks after treatment;

[0084] (2) Evaluate the effectiveness and efficacy after 12 weeks of treatment;

[0085] (3) The efficacy and treatment effect were re-evaluated 4 weeks after treatment was stopped.

[0086] 2.3 Statistical Methods

[0087] SPSS 22.0 software was used. The chi-square test was used for count data and the t-test was used for measurement data. A p-value < 0.05 was considered statistically significant.

[0088] 3 Results

[0089] 3.1 Comparison of overall effective rates after treatment

[0090] After 12 weeks of treatment, the total effective rate of the treatment group treated with the present invention was 93.75%, and the total effective rate of the control group was 83.33%. The total effective rate of the treatment group was slightly higher than that of the control group, but the difference was not statistically significant. It can be seen that the efficacy of the traditional Chinese medicine compound composition of the present invention is slightly higher than that of the compound lidocaine cream group, as shown in Table 1.

[0091] Four weeks after drug withdrawal, the treatment group maintained a total effective rate of 92.19%, while the control group showed a significant decrease in total effective rate to 63.33% after drug withdrawal. The difference between the two groups was statistically significant. This indicates that the long-term efficacy of the compound composition of the present invention is significantly better than that of compound lidocaine cream, as shown in Table 1.

[0092] Table 1: Comparison of efficacy between the two groups after 12 weeks of treatment

[0093]

[0094] Note: *Comparison of total effective rate after drug withdrawal with the control group, Pearson chi-square = 2.56, p = 0.11; #Comparison of total effective rate after drug withdrawal with the control group, Pearson chi-square = 12.04, p = 0.01.

[0095] After 12 weeks of treatment, the treatment group had 45 cases cured (70.3%), 9 cases with significant improvement (14.1%), 6 cases with improvement (9.3%), and 4 cases with no effect (6.3%). After 12 weeks of treatment, the control group had 16 cases cured (53.3%), 5 cases with significant improvement (16.7%), 4 cases with improvement (13.3%), and 5 cases with no effect (16.7%). (See Table 2.)

[0096] Table 2: Efficacy of the treatment group after 12 weeks of treatment

[0097]

[0098] Four weeks after drug withdrawal, 39 patients (60.9%) in the treatment group remained cured, 11 patients (17.2%) showed significant improvement, 9 patients (14.1%) showed improvement, and 5 patients (7.8%) showed no improvement. In contrast, only 7 patients (23.3%) in the control group remained cured, 7 patients (23.3%) showed significant improvement, 5 patients (16.7%) showed improvement, and 11 patients (36.7%) showed no improvement. This shows that most patients in the treatment group remained effective after drug withdrawal, while the number of effective patients in the control group was significantly reduced. This indicates that the long-term efficacy of the treatment group four weeks after drug withdrawal was significantly better than that of the control group (see Table 3).

[0099] Table 3: Comparison of long-term efficacy between the two groups 4 weeks after drug withdrawal

[0100]

[0101] 3.2 Comparison of glans penis nerve sensitivity between the two groups after treatment and drug withdrawal

[0102] After 12 weeks of treatment, the glans penis nerve sensitivity threshold in the treatment group increased from 3.26±1.02 before treatment to 7.24±1.18, while the glans penis nerve sensitivity threshold in the control group increased from 3.28±1.01 before treatment to 5.04±1.13. Before treatment, there was no statistically significant difference in glans penis sensitivity threshold between the two groups. After treatment, the glans penis sensitivity threshold in the treatment group was significantly higher than that in the control group, and the difference was statistically significant.

[0103] Furthermore, in terms of long-term efficacy, the glans sensitivity threshold in the treatment group was still slightly increased by 7.31±1.05 four weeks after stopping the medication, which may be related to the continuity of efficacy of the traditional Chinese medicine treatment used in this invention; while the glans sensitivity threshold in the control group was significantly reduced to 3.51±1.19 four weeks after stopping the medication, almost returning to the pre-treatment state. It can be seen that the simple treatment with Western chemical drugs is only effective during the treatment period, and the long-term efficacy after stopping the medication is not good, as shown in Table 4.

[0104] Table 4: Penile sensitivity thresholds of patients before and after treatment and after drug discontinuation in the two groups

[0105]

[0106] Note: * p < 0.05 compared with the control group after treatment; # p < 0.05 compared with the control group after drug withdrawal.

[0107] Example 3

[0108] A topical Chinese medicine compound that reduces the sensitivity of the glans penis and prolongs the latency period of ejaculation in the vagina contains the following components in parts by weight: 70 parts of Gallnut, 3 parts of Toad Venom, 35 parts of Pomegranate Peel, 14 parts of Cnidium monnieri, 35 parts of Dandelion, 14 parts of Sophora flavescens, 10 parts of Peppermint, and 4 parts of Sichuan Pepper.

[0109] In addition to the above clinical studies, we also observed the clinical efficacy of different formulations. In Example 3, 10 patients reported significant improvement in glans sensitivity after 12 weeks of use.

[0110] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A pharmaceutical composition for external use for preventing and treating premature ejaculation, characterized by comprising, It consists of the following components in parts by weight: 30-70 parts of gallnut, 0.2-3 parts of toad venom, 9-35 parts of pomegranate peel, 6-14 parts of Cnidium monnieri, 9-35 parts of dandelion, 6-14 parts of Sophora flavescens, 2-10 parts of peppermint, and 0.5-4 parts of Sichuan pepper.

2. The pharmaceutical composition according to claim 1, wherein The weight proportions of each component are as follows: 40-60 parts of gallnut, 0.6-2 parts of toad venom, 12-25 parts of pomegranate peel, 8-12 parts of Cnidium monnieri, 12-25 parts of dandelion, 8-12 parts of Sophora flavescens, 4-8 parts of peppermint, and 1-3 parts of Sichuan pepper.

3. The pharmaceutical composition of claim 1, wherein, The weight proportions of each component are as follows: 50 parts gallnut, 1 part toad venom, 15 parts pomegranate peel, 10 parts Cnidium monnieri, 15 parts dandelion, 10 parts sophora flavescens, 6 parts mint, and 2 parts Sichuan pepper.

4. An external pharmaceutical preparation, characterized by, The active ingredient of the pharmaceutical preparation is the pharmaceutical composition according to any one of claims 1-3.

5. The pharmaceutical preparation according to claim 4, characterized in that, The dosage forms of the pharmaceutical preparations are decoctions, creams, and hydrogels.

6. The pharmaceutical preparation according to claim 5, characterized in that, The decoction is a concentrated decoction.

7. The use of the pharmaceutical composition according to any one of claims 1-3 or the pharmaceutical preparation according to any one of claims 4-6 in the preparation of a drug for preventing and treating premature ejaculation.

8. A medicament for preventing and treating premature ejaculation, characterized by comprising the compound of claim 1. The active ingredient of the drug is the pharmaceutical composition according to any one of claims 1-3 or the pharmaceutical preparation according to any one of claims 4-6.

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