Traditional Chinese medicine composition for preventing and treating light and moderate varicocele and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating light and moderate varicocele and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 12 to 30 parts of radix paeoniae rubra, 9 to 24 parts of peach kernel, 9 to 24 parts of spina gleditsiae, 9 to 24 parts of radix cyathulae, 6 to 18 parts of cassia twig, 9 to 24 parts of fructus forsythiae, 6 to 18 parts of thunberg fritillary bulb, 6 to 18 parts of rhodiola rosea, 6 to 18 parts of semen aesculi and 3 to 15 parts of raw liquorice. After the traditional Chinese medicine composition provided by the invention is adopted for treatment, the spermatovenous reflux time is remarkably shortened, the semen quality including semen volume, sperm density and sperm motility is remarkably improved, the total effective rate of treatment is higher than that of other prescriptions, the living quality of a patient is remarkably improved, the medicine safety is high, and the varicocele can be effectively treated.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for the prevention and treatment of mild to moderate varicocele and its preparation method. Background Technology

[0002] The statements herein provide only background information in relation to this invention and do not necessarily constitute prior art.

[0003] Varicocele (VC) refers to the abnormal dilation, elongation, and tortuosity of the spermatic venous plexus caused by venous stagnation due to spermatic vein valve insufficiency or blood flow obstruction. Epidemiological surveys show that the incidence of VC in the male population is approximately 15%. The incidence of male infertility caused by VC in cases of oligospermia and asthenospermia is approximately 40%, making it a relatively common cause of male infertility. It can cause abnormal testicular spermatogenesis, decreased sperm forward motility, reduced sperm concentration, or sperm abnormalities, thus leading to male infertility. Studies have shown that VC is related to multiple factors such as oxidative stress, increased testicular temperature, and abnormal immune response. Currently, the main treatments for VC both domestically and internationally include antioxidant therapy and surgery, with surgery being the primary approach. However, studies show that nearly 50% of VC patients still fail to achieve natural conception after surgery. The main drug currently used for VC treatment is Daflon, but its therapeutic effect remains limited, and its pain relief effect is not significant. Traditional Chinese medicine can improve the clinical symptoms of patients with varicocele and also improve their semen quality and fertility, but there is currently a lack of clinical and related mechanism research.

[0004] In traditional Chinese medicine, varicocele falls under the categories of "tendon hernia" and "tendon tumor." The *Yizong Jinjian* describes tendon tumors as "hard, purple, with numerous blue veins, coiled like earthworms, called tendon tumors." The word "tumor" here means retention. The *Suwen* (Plain Questions) states, "When blood and qi are not in harmony, all kinds of diseases arise," indicating that disharmony of qi and blood and obstruction of meridians are the most fundamental pathological links. Impaired circulation of qi and blood easily leads to blood stasis, from which various diseases arise. Wang Qingren of the Qing Dynasty mentioned in *Yilin Gaicuo* (Corrections of Errors in Medical Classics), "Prominent blue veins are not tendons; they appear on the skin's blood vessels, indicating internal blood stasis." Professor Qin Guozheng believes that blood stasis in the seminal vesicles and failure of blood to transform into semen are the basic pathological changes throughout varicocele-related infertility, but due to differences in congenital endowment, lifestyle, and emotional state, other pathogenesis may also occur. Blood stasis, caused by insufficient vital energy, liver qi stagnation, or damp-heat accumulation, leads to the adhesion of pathological products such as blood stasis, dampness, and phlegm, obstructing the meridians and hindering qi flow. Prolonged illness can then penetrate the collaterals, resulting in varicocele. Professor Yuan Shaoying believes that internal obstruction of blood stasis is the fundamental cause of varicocele, and that blood stasis and heat damaging yin are the main pathogenesis of male infertility caused by varicocele. In the clinical diagnosis and treatment of varicocele, "blood stasis and heat" is an important pathogenesis of abnormal semen quality in varicocele-related infertility, necessitating a formula based on the mechanism of dispelling blood stasis and clearing heat for the treatment of varicocele-related infertility. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a traditional Chinese medicine composition for the prevention and treatment of mild to moderate varicocele and its preparation method. This traditional Chinese medicine composition is used to treat mild to moderate varicocele of the blood stasis and heat accumulation type, and has the characteristics of good efficacy and few side effects.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for the prevention and treatment of mild to moderate varicocele, comprising the following components in parts by weight: 12-30 parts of Paeonia lactiflora, 9-24 parts of Prunus persica, 9-24 parts of Gleditsia sinensis thorns, 9-24 parts of Achyranthes bidentata, 6-18 parts of Cinnamomum cassia, 9-24 parts of Forsythia suspensa, 6-18 parts of Fritillaria thunbergii, 6-18 parts of Rhodiola rosea, 6-18 parts of Spatholobus suberectus, and 3-15 parts of Glycyrrhiza uralensis.

[0008] Preferably, the composition comprises the following components in parts by weight: 12-25 parts of red peony root, 9-18 parts of peach kernel, 9-18 parts of soapberry thorn, 9-18 parts of Sichuan achyranthes root, 6-15 parts of cinnamon twig, 9-18 parts of forsythia fruit, 6-15 parts of Zhejiang fritillary bulb, 6-15 parts of rhodiola rosea, 6-15 parts of salvia miltiorrhiza fruit, and 3-12 parts of raw licorice root.

[0009] Preferably, the composition includes the following components in parts by weight: 12-20 parts of red peony root, 9-15 parts of peach kernel, 9-15 parts of soapberry thorn, 9-15 parts of Sichuan achyranthes root, 6-12 parts of cinnamon twig, 9-15 parts of forsythia fruit, 6-12 parts of Zhejiang fritillary bulb, 6-12 parts of rhodiola rosea, 6-12 parts of salvia miltiorrhiza fruit, and 3-9 parts of raw licorice root.

[0010] Preferably, the weight ratio of red peony root: peach kernel: soapberry thorn: Sichuan achyranthes root: cinnamon twig: forsythia: Zhejiang fritillary bulb: rhodiola rosea: salvia miltiorrhiza seed: raw licorice root is 4~10:3~8:3~8:3~8:2~6:3~8:2~6:2~6:2~6:1~5. The components balance the effects of "attacking pathogens and protecting the body," achieving therapeutic efficacy while ensuring medication safety.

[0011] Preferably, the composition includes the following components in parts by weight: 12 parts red peony root, 9 parts peach kernel, 9 parts soapberry thorn, 9 parts Sichuan achyranthes root, 6 parts cinnamon twig, 9 parts forsythia, 6 parts Zhejiang fritillary bulb, 6 parts rhodiola rosea, 6 parts salsa seed, and 3 parts raw licorice root.

[0012] Preferably, the composition includes the following components in parts by weight: 15 parts red peony root, 12 parts peach kernel, 12 parts soapberry thorn, 12 parts Sichuan achyranthes root, 9 parts cinnamon twig, 12 parts forsythia fruit, 9 parts Zhejiang fritillary bulb, 9 parts rhodiola rosea, 9 parts salsa seed, and 6 parts raw licorice root.

[0013] Preferably, the composition comprises the following components in parts by weight: 20 parts of red peony root, 15 parts of peach kernel, 15 parts of soapberry thorn, 15 parts of Sichuan achyranthes root, 12 parts of cinnamon twig, 15 parts of forsythia fruit, 12 parts of Zhejiang fritillary bulb, 12 parts of rhodiola rosea, 12 parts of salsa seed, and 9 parts of raw licorice root.

[0014] In the traditional Chinese medicine composition proposed in this invention, red peony root is bitter and slightly cold, excelling at clearing heat and cooling blood, dispersing blood stasis and relieving pain, and is good at clearing blood stasis; peach kernel is bitter, sweet, and neutral, excelling at activating blood circulation, removing blood stasis, clearing the meridians and relieving pain, and is an essential medicine for breaking up blood stasis and promoting blood circulation. The two medicines combined, one dispersing blood stasis and clearing heat, and the other breaking up blood stasis and clearing the meridians, directly target the core pathogenesis of varicocele, "blood stasis obstructing the spermatic cord vessels," and together they serve as the principal medicine. Gleditsia sinensis thorn is pungent and warm, able to dispel wind, clear the meridians, reduce swelling and dissipate nodules, helping the principal medicine penetrate deep into the meridians to break up blood stasis; Achyranthes bidentata is bitter, sweet, sour, and neutral, dispelling blood stasis, clearing the meridians, and guiding blood downwards, allowing the medicinal power to target and concentrate in the spermatic cord area of ​​the lower jiao; Cinnamon twig is pungent, sweet, and warm, warming and clearing the meridians, dispelling cold and relieving spasms, alleviating the meridian tension caused by long-term blood stasis. The combination of these medicines not only enhances the blood-activating and stasis-removing power of the principal medicine, but also addresses the concurrent symptoms of cold stagnation in the lower jiao and meridian tension, and together they serve as the assistant medicine. Forsythia, bitter and slightly cold in nature, clears heat and detoxifies, reduces swelling and dissipates nodules, clearing away heat generated from long-term blood stasis to disperse masses; Fritillaria thunbergii, bitter, sweet and cold in nature, clears heat and resolves phlegm, eliminates carbuncles and dissipates nodules, assisting Forsythia in enhancing its effects of dispersing blood stasis and dissipating seminal cord induration; Rhodiola rosea, sweet, bitter and neutral in nature, invigorates qi and blood, unblocks meridians and promotes blood circulation, replenishing qi to aid blood flow, and addressing the concurrent symptoms of "long-term blood stasis and qi deficiency"; Salvia miltiorrhiza, sweet and warm in nature, soothes the liver and regulates qi, relieves pain, regulates qi to aid blood flow, and alleviates the discomfort of seminal cord swelling and pain. These herbs work synergistically to clear heat and blood stasis, disperse nodules, invigorate qi, and regulate qi, assisting the principal and assistant herbs in addressing both the root cause and symptoms, serving as adjuvant herbs. Glycyrrhiza uralensis, sweet and neutral in nature, invigorates qi and replenishes the middle jiao, harmonizing the effects of the herbs, moderating the strong effects of the principal and assistant herbs in invigorating blood and unblocking meridians, protecting the qi of the spleen and stomach, and harmonizing the cold and hot properties of the herbs in the formula, making the combination of herbs balanced and effective, serving as the guiding herb. The combined use of these herbs focuses on promoting blood circulation, removing blood stasis, clearing the meridians, and dispersing nodules. They are supplemented with warming, invigorating, and regulating qi, directly addressing the pathogenesis of varicocele, which is "blood stasis obstructing the meridians." This allows the stasis to dissipate, the meridians to be cleared, and the qi to flow smoothly, thus reducing scrotal swelling and pain and restoring the normal function of the spermatic cord.

[0015] Preferably, the traditional Chinese medicine composition also includes pharmaceutically commonly used excipients.

[0016] Preferably, the traditional Chinese medicine composition is in the form of tablets, capsules, or decoction.

[0017] In some embodiments of the present invention, the traditional Chinese medicine composition is a decoction.

[0018] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition for preventing and treating mild to moderate varicocele as described in the first aspect, comprising the following steps: Step 1: Accurately weigh each raw medicinal material according to the weight proportions. Mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salsa seed, and raw licorice root evenly, place them in a container, add water, and soak at room temperature to allow the medicinal materials to be fully moistened, which is conducive to the dissolution of effective ingredients. In some embodiments of the present invention, purified water is added at a weight of 4-6 times the total weight of the raw materials; Step 2: After bringing to a boil over high heat, immediately reduce to a simmer and cook for 1-3 times, each time for 20 minutes to 1 hour. Step 3: After each decoction, filter the liquid while it is still hot, collect the filtrate, combine the filtrates, and concentrate the combined filtrate under normal pressure to obtain the traditional Chinese medicine decoction.

[0019] In step 1, the container is a ceramic or stainless steel decoction container.

[0020] In step 3, the concentration is reduced to a relative density of 1.10~1.15 (25℃).

[0021] In step 3, each dose of the decoction is 200-250 mL, for oral administration.

[0022] Compared with the prior art, the beneficial effects achieved by one or more embodiments of the present invention described above are as follows: 1. The traditional Chinese medicine composition for treating mild to moderate varicocele disclosed in this invention is based on traditional Chinese medicine theory and targets the pathogenesis of varicocele. It adopts a scientific combination of herbs according to syndrome differentiation and treatment. Pharmacological and clinical experimental results show that this traditional Chinese medicine compound composition has the effects of breaking up blood stasis and clearing heat. It has a good preventive and therapeutic effect on symptoms of varicocele such as scrotal swelling and pain and tortuous veins caused by blood stasis obstructing the spermatic cord veins. Moreover, no adverse reactions have been observed in clinical application, and the efficacy of the medicine is definite. It can be developed into a new drug for treating mild to moderate varicocele.

[0023] 2. The traditional Chinese medicine composition provided by the present invention has the effect of purging heat and removing blood stasis, which can effectively relieve the clinical symptoms of patients with varicocele. After treatment with the traditional Chinese medicine composition provided by the present invention, the reflux time of spermatic veins is significantly shortened, and the quality of semen, including semen volume, sperm density and sperm motility, is significantly improved. The total effective rate of treatment is higher than that of other prescriptions, the quality of life of patients is significantly improved, the drug has high safety, and it can effectively treat varicocele.

[0024] 3. The prescription of this invention helps improve the semen quality of patients with oligospermia and asthenospermia caused by varicocele, improves sperm motility, increases semen volume and sperm density, and can increase the probability of the partner conceiving, thereby improving the fertility rate. Detailed Implementation

[0025] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0026] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be obvious to those skilled in the art. This application specification and embodiments are merely exemplary.

[0027] The terms "comprising," "including," "having," "containing," etc., as used herein are open-ended, meaning they include but are not limited to. Unless otherwise specified, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0028] The present invention will be further described below with reference to the embodiments.

[0029] Example 1: A traditional Chinese medicine composition for treating mild to moderate varicocele The Chinese herbal decoction for treating mild to moderate varicocele (Chitao Tongluo Formula) includes the following components by weight: 12 parts red peony root, 9 parts peach kernel, 9 parts soapberry thorn, 9 parts Sichuan achyranthes root, 6 parts cinnamon twig, 9 parts forsythia fruit, 6 parts Zhejiang fritillary bulb, 6 parts rhodiola rosea, 6 parts salsa seed, and 3 parts raw licorice root. The preparation method of the above-mentioned traditional Chinese medicine decoction includes the following steps: accurately weigh each raw medicinal material according to the weight proportions, mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salvia miltiorrhiza seed, and raw licorice root evenly, place them in a ceramic or stainless steel decoction container, add purified water with a weight of 5 times the total weight of the raw materials, soak at room temperature for 30 minutes (to fully moisten the medicinal materials and facilitate the dissolution of effective components), first bring to a boil over high heat, then immediately reduce to low heat and simmer for 0.5 hours each time; after each decoction, filter while hot through an 80-mesh filter, collect the filtrate, combine the three filtrates, and concentrate the combined filtrate under normal pressure to a relative density of 1.10~1.15 (25℃) to obtain the traditional Chinese medicine decoction, and prepare 200~250mL / dose of traditional Chinese medicine decoction for oral administration.

[0030] Example 2: A traditional Chinese medicine composition for treating mild to moderate varicocele The Chinese herbal decoction for treating mild to moderate varicocele (Chitao Tongluo Formula) includes the following components by weight: 15 parts red peony root, 12 parts peach kernel, 12 parts soapberry thorn, 12 parts Sichuan achyranthes root, 9 parts cinnamon twig, 12 parts forsythia fruit, 9 parts Zhejiang fritillary bulb, 9 parts rhodiola rosea, 9 parts salsa seed, and 6 parts raw licorice root. The preparation method of the above-mentioned traditional Chinese medicine decoction includes the following steps: accurately weigh each raw medicinal material according to the weight proportions, mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salvia miltiorrhiza seed, and raw licorice root evenly, place them in a ceramic or stainless steel decoction container, add purified water with a weight of 6 times the total weight of the raw materials, soak at room temperature for 30 minutes, first bring to a boil over high heat, then simmer over low heat for 3 times, each time for 0.5 hours; after each decoction, filter while hot through an 80-mesh filter, collect the filtrate and combine it, concentrate under normal pressure to a relative density of 1.10~1.15 (25℃), and prepare a traditional Chinese medicine decoction of 200~250mL / dose for oral administration.

[0031] Example 3: A traditional Chinese medicine composition for treating mild to moderate varicocele The Chinese herbal decoction for treating mild to moderate varicocele (Chitao Tongluo Formula) includes the following components by weight: 20 parts red peony root, 15 parts peach kernel, 15 parts soapberry thorn, 15 parts Sichuan achyranthes root, 12 parts cinnamon twig, 15 parts forsythia fruit, 12 parts Zhejiang fritillary bulb, 12 parts rhodiola rosea, 12 parts salsa seed, and 9 parts raw licorice root. The preparation method of the above-mentioned traditional Chinese medicine decoction includes the following steps: accurately weigh each raw medicinal material according to the weight proportions, mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salvia miltiorrhiza seed, and raw licorice root evenly, place them in a ceramic or stainless steel decoction container, add purified water with a weight of 8 times the total weight of the raw materials, soak at room temperature for 30 minutes, bring to a boil over high heat, then simmer over low heat for 0.5 hours each time; filter while hot (using an 80-mesh filter), combine the three filtrates, and concentrate under normal pressure to a relative density of 1.10~1.15 (25℃) to obtain a traditional Chinese medicine decoction of 200~250mL / dose for oral administration.

[0032] Example 4: A traditional Chinese medicine composition for treating mild to moderate varicocele The Chinese herbal decoction for treating mild to moderate varicocele (Chitao Tongluo Formula) includes the following components by weight: 25 parts red peony root, 18 parts peach kernel, 18 parts soapberry thorn, 18 parts Sichuan achyranthes root, 15 parts cinnamon twig, 18 parts forsythia fruit, 15 parts Zhejiang fritillary bulb, 15 parts rhodiola rosea, 15 parts salsa seed, and 12 parts raw licorice root. The preparation method of the above-mentioned traditional Chinese medicine decoction includes the following steps: accurately weigh each raw medicinal material according to the weight proportions, mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salvia miltiorrhiza seed, and raw licorice root evenly, place them in a ceramic or stainless steel decoction container, add purified water with a weight of 10 times the total weight of the raw materials, soak at room temperature for 30 minutes, bring to a boil over high heat, then simmer over low heat for 0.5 hours each time; filter while hot through an 80-mesh filter, combine the filtrates, concentrate under normal pressure to a relative density of 1.10~1.15 (25℃), and prepare a traditional Chinese medicine decoction of 200~250mL / dose for oral administration.

[0033] Example 5: A traditional Chinese medicine composition for treating mild to moderate varicocele The Chinese herbal decoction for treating mild to moderate varicocele (Chitao Tongluo Formula) includes the following components by weight: 30 parts red peony root, 24 parts peach kernel, 24 parts soapberry thorn, 24 parts Sichuan achyranthes root, 18 parts cinnamon twig, 24 parts forsythia fruit, 18 parts Zhejiang fritillary bulb, 18 parts rhodiola rosea, 18 parts salsa seed, and 15 parts raw licorice root. The preparation method of the above-mentioned traditional Chinese medicine decoction includes the following steps: accurately weigh each raw medicinal material according to the weight proportions, mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salvia miltiorrhiza seed, and raw licorice root evenly, place them in a ceramic or stainless steel decoction container, add purified water with a weight of 15 times the total weight of the raw materials, soak at room temperature for 30 minutes, bring to a boil over high heat, then simmer over low heat for 0.5 hours each time; filter while hot through an 80-mesh filter, combine the three filtrates, and concentrate under normal pressure to a relative density of 1.10~1.15 (25℃) to obtain a traditional Chinese medicine decoction of 200~250mL / dose for oral administration.

[0034] Clinical trials: 1. General Information Eighty-eight patients with mild to moderate varicocele who visited the Department of Andrology at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine between January 2024 and January 2025 were selected. The patients' ages ranged from 18 to 50 years.

[0035] 2. Inclusion criteria for mild to moderate varicocele of the blood stasis and heat accumulation type: 2.1 Meets the Western medicine diagnostic criteria for mild to moderate varicocele; The primary diagnostic methods include clinical physical examination and the Valsalva maneuver, supplemented by Doppler ultrasound when necessary. Clinical symptoms of varicocele should also be considered, such as varying degrees of scrotal and perineal pain or discomfort. The following items are included: (1) Clinical signs and symptoms diagnostic criteria: ① Clinical type I (mild): No abnormalities are found on scrotal palpation, but varicose spermatic veins can be palpated when the patient holds their breath and increases abdominal pressure (Valsalva test); ② Clinical type II (moderate): Varicose spermatic veins can be palpated on the scrotum, but the appearance is normal; ③ Clinical type III (severe): Visual examination reveals varicose vein clusters in the scrotum, and palpation of the scrotum reveals significantly enlarged and varicose vein clusters.

[0036] (2) Ultrasound diagnostic criteria Based on clinical signs and color Doppler ultrasound diagnosis, varicocele is classified into four grades: subclinical varicocele (SVC) and clinical varicocele, grade I, II, and III. Subclinical varicocele: negative on clinical palpation, ultrasound examination during quiet breathing: DR 1.8-2.0 mm, but no reflux, reflux during Valsalva maneuver, TR 1-2 s.

[0037] Clinical varicocele is classified into three degrees: Type I (mild): The scrotal skin appears normal when the patient is standing, and varicose veins can be felt within the scrotum. The varicose veins disappear when the patient is lying down. Ultrasound examination shows that the inner diameter of the blood vessels is between 2.0 and 2.4 mm. The duration of reflux after the Valsalva test is 2 to 4 seconds. Type II (moderate): Dilated veins can be seen in the scrotum when standing, and obvious varicose veins can be felt by touch. They disappear when lying down. Ultrasound examination shows that the inner diameter of the spermatic cord vessels is 2.4-3.0 mm. The duration of reflux after the Valsalva test is 4-6 seconds. Type III (Severe): When the patient is standing, there are obvious large blood vessels on the surface of the scrotum. When the patient touches the scrotum, there are obvious worm-like dilated blood vessels. The vein walls are thickened and hardened. They disappear slowly when the patient is lying down. Ultrasound examination results show that the inner diameter of the blood vessels in the spermatic cord exceeds 3.0 mm. The duration of reflux after the Valsalva test is greater than 6 seconds.

[0038] Those who meet both Grade I and Grade II criteria are diagnosed with mild to moderate VC.

[0039] 2.2 Meets the TCM diagnostic criteria for the syndrome of blood stasis and heat accumulation; Main symptoms: ① a feeling of heaviness or pressure in the scrotum; ② testicular pain and discomfort; Secondary symptoms: ① Scrotal dampness; ② Dark yellow urine with small amount; ③ Incomplete bowel movements; Tongue and pulse: The tongue is red with a yellow coating, dark in color, or has ecchymosis; the pulse is thready and rapid or deep and hesitant.

[0040] If a patient presents with one of the primary symptoms, along with two secondary symptoms, and is examined by examining the tongue and pulse, a diagnosis of blood stasis and heat accumulation syndrome can be made.

[0041] 2.3 Voluntarily participate in the research and sign an informed consent form.

[0042] 2.4 Age ≥ 18 years and ≤ 50 years.

[0043] 2.5 Those who have not undergone varicocele surgery.

[0044] Exclusion criteria: (1) Patients with inflammation, tuberculosis or tumors of accessory glands such as prostate, epididymis, and testis; (2) Diseases such as hydrocele, tuberculosis of vas deferens, and lymphangitis; (3) Skin diseases of the scrotum such as scrotal eczema; (4) Patients with hereditary diseases, congenital developmental abnormalities or mental illness; (5) Patients with obvious primary diseases or complications of the heart, liver, kidney and nervous system; (6) Patients who have taken VC-related drugs within 2 weeks before treatment; (7) Patients with severe varicocele.

[0045] 3. Treatment Plan Eighty-eight patients with mild to moderate varicocele of the blood stasis and heat syndrome were treated with the following traditional Chinese medicine compound (Example 1). The daily dosage was as follows: 12g of red peony root, 9g of peach kernel, 9g of soapberry thorn, 9g of Sichuan achyranthes root, 6g of cinnamon twig, 9g of forsythia fruit, 6g of Zhejiang fritillary bulb, 6g of rhodiola rosea, 6g of salvia miltiorrhiza fruit, and 3g of raw licorice root. The decoction was prepared in water and 400mL was taken in two divided doses of 200mL each. The treatment cycle was 4 weeks.

[0046] To examine the efficacy of different formulation ratios, the formulations in Examples 2 to 5 can also be used clinically according to the following recommended protocols: Example 2: The recommended daily dosage is 15g of Paeonia lactiflora, 12g of Prunus persica, 12g of Gleditsia sinensis thorns, 12g of Achyranthes bidentata, 9g of Cinnamomum cassia, 12g of Forsythia suspensa, 9g of Fritillaria thunbergii, 9g of Rhodiola rosea, 9g of Salvia miltiorrhiza, and 6g of Glycyrrhiza uralensis. The preparation and administration methods are the same as in Example 1.

[0047] Example 3: The recommended daily dose is 20g of Paeonia lactiflora, 15g of Prunus persica, 15g of Gleditsia sinensis thorns, 15g of Achyranthes bidentata, 12g of Cinnamomum cassia, 15g of Forsythia suspensa, 12g of Fritillaria thunbergii, 12g of Rhodiola rosea, 12g of Salvia miltiorrhiza, and 9g of Glycyrrhiza uralensis. The preparation and administration methods are the same as in Example 1.

[0048] Example 4: The recommended daily dose is 25g of Paeonia lactiflora, 18g of Prunus persica, 18g of Gleditsia sinensis thorns, 18g of Achyranthes bidentata, 15g of Cinnamomum cassia, 18g of Forsythia suspensa, 15g of Fritillaria thunbergii, 15g of Rhodiola rosea, 15g of Salvia miltiorrhiza, and 12g of Glycyrrhiza uralensis. The preparation and administration methods are the same as in Example 1.

[0049] Example 5: The recommended daily dosage is 30g of Paeonia lactiflora, 24g of Prunus persica, 24g of Gleditsia sinensis thorns, 24g of Achyranthes bidentata, 18g of Cinnamomum cassia, 24g of Forsythia suspensa, 18g of Fritillaria thunbergii, 18g of Rhodiola rosea, 18g of Salvia miltiorrhiza, and 15g of Glycyrrhiza uralensis. The preparation and administration methods are the same as in Example 1.

[0050] 4. Observation Indicators Record the observations of patients with mild to moderate varicocele before and after treatment: Clinical remission efficacy rate: Marked effect, symptoms completely disappear; Effective, symptoms are significantly reduced; Ineffective, symptoms do not improve or worsen; Visual pain score; Spermatic vein reflux time, color Doppler ultrasound examination, duration of reflux during Valsalva maneuver, unit: seconds; Semen quality analysis: semen volume, sperm density, and percentage of progressively motile sperm before and after treatment; Quality of life score; Safety indicators: liver and kidney function, complete blood count, urinalysis, and coagulation tests.

[0051] 5. Results A total of 88 patients with mild to moderate varicocele of the blood stasis and heat syndrome were collected, of whom 7 patients (7.95%) were lost to follow-up or dropped out, and 81 patients (92.05%) finally completed the trial. All patients were treated with the traditional Chinese medicine composition according to the prescription in Example 1 for 4 weeks, and all observed indicators showed significant improvement. The specific results are as follows: Clinical remission rate: The total clinical efficacy rate after treatment was 86.42%, including 45 cases with significant effect (55.56%), 25 cases with effect (30.86%), and 11 cases with no effect (13.58%). The treatment effect was significantly better than before treatment (P<0.01).

[0052] Visual pain score (VAS): The patient's scrotal swelling and pain were significantly reduced, and the score decreased from (6.85±1.72) points before treatment to (2.31±1.05) points after treatment. The difference was statistically significant (P<0.01).

[0053] The time to spermatic vein reflux was shortened from (4.32±1.21) s before treatment to (1.86±0.78) s, and the difference was statistically significant (P<0.01).

[0054] Improvement in semen quality: Semen volume increased from (2.85±1.12) mL to (3.42±0.96) mL (P<0.05); Sperm density: (28.36±12.47)×10 6 / mL increased to (41.58±14.23)×10 6 / mL (P<0.01); The percentage of progressively motile sperm increased from (32.15±10.34)% to (48.62±11.75)% (P<0.01). Quality of life score: The comprehensive score of patients' daily activities, psychological state and sexual life improved from (58.36±8.74) points before treatment to (82.57±7.63) points after treatment, and the quality of life was significantly improved (P<0.01).

[0055] Safety observation: No abnormalities were found in the patient's liver and kidney function, as well as in the four tests of blood routine, urine routine, and coagulation before and after treatment.

[0056] The therapeutic effects of Examples 1 and 2-5 are summarized in Table 1.

[0057] Table 1 Comparison of relevant parameters before and after varicocele treatment in each embodiment ( ±s)

[0058] As can be seen from the above results, the traditional Chinese medicine composition of the present invention is effective in treating mild to moderate varicocele of the blood stasis and heat accumulation type, with good efficacy and few side effects. Moreover, its preparation method is simple, fast, efficient, easy to operate, and convenient to take.

[0059] Comparative Example 1 Formula: 25 parts red peony root, 20 parts peach kernel, 20 parts soapberry thorn, 20 parts Sichuan achyranthes root, 15 parts cinnamon twig, 20 parts forsythia, 15 parts Zhejiang fritillary bulb, 15 parts rhodiola rosea, 15 parts salsa seed, and 10 parts raw licorice root.

[0060] The preparation method was the same as in Example 1. Twenty patients with mild to moderate varicocele of the blood stasis and heat syndrome were treated with this treatment for 4 weeks. Results: The total effective rate was 65.0%, and the sperm density increased from (30.12±11.85)×10⁻⁶. 6 / mL changed to (33.45±13.20)×10 6 / mL, the difference was not statistically significant (P>0.05), and 3 cases experienced mild gastrointestinal discomfort.

[0061] In this formula, the dosages of blood-activating and stasis-removing herbs such as red peony root and peach kernel, as well as heat-clearing herbs such as forsythia, are relatively high, while the dosage of the harmonizing herb, raw licorice root, is relatively low. This combination may result in an overly "strong" medicinal effect, focusing on attacking the pathogenic factors while neglecting protective effects. Although it showed some efficacy (65.0%), some patients experienced mild gastrointestinal discomfort, reflecting the drawback of "bitter and cold herbs damaging the stomach"; moreover, the improvement in sperm density was not statistically significant, suggesting that excessive attacking may not have optimally promoted spermatogenesis. A balance was not achieved between ensuring efficacy and medication safety.

[0062] Comparative Example 2 Formula: 6 parts red peony root, 4 parts peach kernel, 4 parts soapberry thorn, 4 parts Sichuan achyranthes root, 3 parts cinnamon twig, 4 parts forsythia fruit, 3 parts Zhejiang fritillary bulb, 3 parts rhodiola rosea, 3 parts salsa seed, 1 part raw licorice root.

[0063] The preparation method was the same as in Example 1. Twenty patients with similar conditions were treated, with a treatment course of 4 weeks. Results: The total effective rate was 45.0%, the average VAS score decreased by 1.52 points, and there was no significant improvement in spermatic vein reflux time or semen parameters (P>0.05).

[0064] Although this formula is within the safe range, its overall efficacy is mild, lacking the power to promote blood circulation, remove blood stasis, clear heat, and dissipate nodules, making it difficult to address the core pathogenesis of "intertwined blood stasis and heat." Its overall effective rate was only 45.0%, and key objective indicators (reflux time, semen parameters) showed no significant improvement, proving that insufficient dosage leads to poor efficacy.

[0065] Comparative Example 3 Formula: 10 parts red peony root, 8 parts peach kernel, 8 parts soapberry thorn, 8 parts Sichuan achyranthes root, 5 parts cinnamon twig, 8 parts forsythia fruit, 5 parts Zhejiang fritillary bulb, 5 parts rhodiola rosea, 5 parts salsa seed, excluding raw licorice root.

[0066] The preparation method was the same as in Example 1. Twenty patients with similar conditions were treated, with a treatment course of 4 weeks. Results: The overall effective rate was 70.0%, but four patients experienced dry mouth and mild nausea, indicating poor patient tolerance.

[0067] This formula omits raw licorice root, which has the effects of invigorating qi, harmonizing the middle jiao, and coordinating the effects of other herbs. Although its blood-activating and stasis-removing effects are similar to those of the preferred embodiment of this invention, the lack of a harmonizing and protective agent means that the formula's cold and hot properties and the blood-activating effects are not effectively mitigated and guided, leading to discomfort such as dry mouth and nausea in some patients, and decreased patient tolerance. This demonstrates the indispensable role of raw licorice root in the formula of this invention; it is not only a harmonizing agent but also crucial for ensuring the safety of long-term medication.

[0068] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating mild to moderate varicocele, characterized in that, The formula includes the following components by weight: 12-30 parts of red peony root, 9-24 parts of peach kernel, 9-24 parts of soapberry thorn, 9-24 parts of Sichuan achyranthes root, 6-18 parts of cinnamon twig, 9-24 parts of forsythia fruit, 6-18 parts of Zhejiang fritillary bulb, 6-18 parts of rhodiola rosea, 6-18 parts of salvia miltiorrhiza fruit, and 3-15 parts of raw licorice root.

2. The traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 1, characterized in that, The formula includes the following components by weight: 12-25 parts of red peony root, 9-18 parts of peach kernel, 9-18 parts of gleditsia sinensis thorn, 9-18 parts of achyranthes bidentata, 6-15 parts of cinnamon twig, 9-18 parts of forsythia, 6-15 parts of fritillaria thunbergii, 6-15 parts of rhodiola rosea, 6-15 parts of salvia miltiorrhiza, and 3-12 parts of raw licorice root.

3. The traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 1, characterized in that, The formula includes the following components by weight: 12-20 parts of red peony root, 9-15 parts of peach kernel, 9-15 parts of gleditsia sinensis thorn, 9-15 parts of achyranthes bidentata, 6-12 parts of cinnamon twig, 9-15 parts of forsythia, 6-12 parts of fritillaria thunbergii, 6-12 parts of rhodiola rosea, 6-12 parts of salvia miltiorrhiza, and 3-9 parts of raw licorice root.

4. The traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 1, characterized in that, The weight ratio of red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salsa seed, and raw licorice root is 4~10:3~8:3~8:3~8:2~6:3~8:2~6:2~6:2~6:1~5.

5. The traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 1, characterized in that, The formula comprises the following components by weight: 12 parts red peony root, 9 parts peach kernel, 9 parts gleditsia thorn, 9 parts Sichuan achyranthes root, 6 parts cinnamon twig, 9 parts forsythia fruit, 6 parts Zhejiang fritillary bulb, 6 parts rhodiola rosea, 6 parts salvia seed, and 3 parts raw licorice root; or the following components by weight: 15 parts of red peony root, 12 parts of peach kernel, 12 parts of gleditsia thorn, 12 parts of achyranthes root, 9 parts of cinnamon twig, 12 parts of forsythia fruit, 9 parts of fritillaria bulb, 9 parts of rhodiola rosea, 9 parts of salvia seed, and 6 parts of raw licorice root; or including the following components by weight: 20 parts of red peony root, 15 parts of peach kernel, 15 parts of soapberry thorn, 15 parts of Sichuan achyranthes root, 12 parts of cinnamon twig, 15 parts of forsythia fruit, 12 parts of Zhejiang fritillary bulb, 12 parts of rhodiola rosea, 12 parts of salsa seed, and 9 parts of raw licorice root.

6. The traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 1, characterized in that, The traditional Chinese medicine composition is in the form of tablets, capsules, or decoction.

7. A method for preparing the traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to any one of claims 1 to 6, characterized in that, Includes the following steps: Step 1: Accurately weigh each raw medicinal material according to the weight proportions. Mix the red peony root, peach kernel, soapberry thorn, Sichuan achyranthes root, cinnamon twig, forsythia, Zhejiang fritillary bulb, rhodiola rosea, salsa seed, and raw licorice root evenly, place them in a container, add water, and soak at room temperature to fully moisten the medicinal materials. Step 2: After bringing to a boil over high heat, immediately reduce to a simmer and cook for 1-3 times, each time for 20 minutes to 1 hour. Step 3: After each decoction, filter the liquid while it is still hot, collect the filtrate, combine the filtrates, and concentrate the combined filtrate under normal pressure to obtain the traditional Chinese medicine decoction.

8. The method for preparing the traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 7, characterized in that, The container is a ceramic or stainless steel decoction container.

9. The method for preparing the traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 7, characterized in that, When concentrated to 25°C, the relative density is 1.10~1.

15.

10. The method for preparing the traditional Chinese medicine composition for preventing and treating mild to moderate varicocele according to claim 7, characterized in that, Each dose of the decoction yields 200-250 mL, for oral administration.

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