A Chinese medicine composition for treating varicocele and its preparation method and application

Abstract

The invention relates to the technical field of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine composition for treating varicocele, a preparation method and an application thereof; the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of fennel, 5-10 parts of cinnamon bark, 10-15 parts of angelica sinensis, 5-10 parts of wolfberry, 10-15 parts of lindera striata, 3-5 parts of agarwood, 10-15 parts of curcuma zedoaria, 10-15 parts of turmeric, and 20-30 parts of rhodiola rosea. The formula is formulated based on the principles of breaking up blood and promoting qi, eliminating accumulation and relieving pain. In the formula, Rhodiola rosea and fennel are the main medicines, cinnamon, angelica and Linderae strychnos are the auxiliary medicines, and wolfberry, agarwood, Curcuma zedoaria and turmeric are the adjuvants. It combines movement and stillness, attacks and supplements at the same time, and promotes blood circulation and qi circulation at the same time, which embodies the saying that "qi is the commander of blood" and "blood is the mother of qi". It can significantly improve the various symptoms caused by varicocele. At the same time, it can be combined with surgery for the treatment of varicocele, significantly reducing postoperative complications and the risk of recurrence, and is suitable for large-scale promotion and application.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition, and in particular to a traditional Chinese medicine composition for treating varicocele, and a preparation method and application thereof. Background Art

[0002] Varicocele (VC) is one of the common diseases of male urogenital system. Clinically, it can manifest as distension and pain in the testicles or lower abdomen, which can damage the spermatogenic function of the testicles, reduce the concentration, motility and vitality of sperm in semen, and eventually lead to infertility. The pathogenesis of varicocele in traditional Chinese medicine is cold stagnation in the liver meridian, qi stagnation and blood stasis. Yang deficiency cannot resist evil, and cold is received from below. Cold is a yin evil, and its nature is to condense and retract. When cold evil is strong inside, blood will flow when it is warm and coagulate when it is cold. Qi and blood flow is not smooth, the liver meridian is out of harmony, and the meridians are blocked, so that the meridians are swollen and curved like earthworms. Stasis leads to blockage, which causes pain in the testicles and lower abdomen. If blood stasis is not removed, new blood will not be produced, and blood will not nourish and produce sperm. The testicles are not nourished, resulting in spermatogenic dysfunction, a decrease in sperm count, low motility, motility and normal sperm rate, and infertility.

[0003] The treatment of varicocele can be divided into drug treatment and surgical treatment. Among them, the existing conventional drug treatments are mainly the aescin-based Maizhiling tablets and the flavonoid-based citrus flavonoid tablets. However, after long-term oral administration of the above drugs, patients may experience gastrointestinal discomfort, nausea, diarrhea, dry mouth, headache, dizziness or allergic reactions; at the same time, patients with peptic ulcers, pregnant and lactating patients, and patients with heart or kidney dysfunction should also use them with caution. Therefore, the existing conventional drugs are affected by the inability to take the full course of medication or poor efficacy, and their treatment effects are not ideal. Surgical treatment mainly uses microsurgery, laparoscopic surgery, and open surgery. Although it can improve the symptoms in the short term, complications may occur after surgical treatment, including scrotal edema, hematoma, testicular artery injury, postoperative recurrence, etc. Therefore, surgical treatment has a greater risk of recurrence or complications.

[0004] In view of the above-mentioned defects of the existing conventional drug treatment and surgical treatment, people have developed a variety of Chinese medicine compositions for treating varicocele, such as: CN118059164A discloses a Chinese medicine composition and its preparation method and application; CN117838780A discloses a combination drug for treating varicocele and its extraction method; CN117357621A discloses a Chinese medicine compound for improving sperm energy metabolism and its preparation method and application; CN102824618A discloses a group of qi-promoting and analgesic tablets; CN102698201B discloses a Chinese medicine agent for treating varicocele, etc. The Chinese medicine compositions disclosed in the above patents all have certain therapeutic effects on varicocele, but due to the unreasonable selection and compatibility of raw materials, the existing Chinese medicine compositions have poor therapeutic effects on varicocele caused by cold coagulation and blood stasis, and have no promoting effect on reducing the risk of recurrence or complications after surgical treatment of varicocele. Therefore, it is urgently needed to provide a Chinese medicine composition with better therapeutic effect on the treatment of varicocele. Summary of the invention

[0005] The purpose of the present invention is to overcome the above-mentioned deficiencies in the prior art and to provide a Chinese medicine composition for treating varicocele and a preparation method and application thereof.

[0006] In order to achieve the above-mentioned purpose of the invention, the present invention provides a traditional Chinese medicine composition for treating varicocele, which is prepared by including the following raw materials in parts by weight: 10-20 parts of fennel, 5-10 parts of cinnamon, 10-15 parts of angelica, 5-10 parts of wolfberry, 10-15 parts of lindera, 3-5 parts of agarwood, 10-15 parts of curcuma, 10-15 parts of turmeric, and 20-30 parts of rhodiola.

[0007] In the prescription, Rhodiola rosea and fennel are both the main medicines. Rhodiola rosea tastes sweet and bitter, and is neutral in nature. It enters the lung and heart meridians, invigorates qi and promotes blood circulation, dredges and relieves pain. Fennel is pungent in taste and warm in nature. It enters the liver, kidney, spleen and stomach meridians. This prescription takes the effects of warming the liver and dispersing cold, regulating qi and relieving pain. Varicocele causes blood stasis, which leads to poor circulation of qi and blood, and testicular swelling and discomfort. At the same time, long-term illness affects the kidneys, and the testicular qi and blood are not nourished normally, and spermatogenesis is impaired. The two medicines are used together to achieve the effects of warming the kidney and invigorating qi, dredges and relieve pain, and warming the liver and dispersing cold.

[0008] In the prescription, cinnamon, angelica and lindera are all ministerial drugs. Cinnamon is pungent and sweet, hot in nature, and enters the kidney, liver, spleen, and heart meridians. It has the functions of replenishing fire and yang, guiding fire back to its origin, and dispersing cold and dredging the meridians; angelica is pungent and sweet in nature and warm in nature, and enters the liver, heart, and spleen meridians. It can nourish blood and replenish the liver, and can also promote blood circulation and relieve pain. It has the characteristics of replenishing without stagnation, warming without dryness, and nourishing without greasiness; lindera enters the spleen, liver, kidney, and bladder meridians, and can dredge the qi mechanism, disperse knots and eliminate stagnation, promote the circulation of qi and blood, and play a role in eliminating local venous blood stasis. The combination of cinnamon, angelica, and lindera can achieve the functions of warming the kidney and consolidating the foundation, promoting qi and blood circulation, and dispersing knots and eliminating blood stasis.

[0009] In the prescription, wolfberry, agarwood, zedoaria, and turmeric are all adjuvants; wolfberry is sweet and mild in nature, and can nourish the liver and kidney and benefit the essence and blood. The liver and kidney are of the same origin, and the essence and blood are mutually generated. When the liver and kidney are full of essence and blood, the sperm biochemistry is active; agarwood is pungent, bitter, and slightly warm. It enters the spleen, stomach, and kidney meridians, and has the functions of regulating the middle, nourishing the five internal organs, benefiting the essence and strengthening the yang, warming the waist and knees, and removing evil spirits. In this prescription, the main effect is to promote qi and relieve pain; adding zedoaria and turmeric to the prescription can break blood, promote qi, disperse knots and relieve pain, which can promote blood circulation in the liver veins, and relieve symptoms such as pain in the lower abdomen and scrotum caused by blood stasis and qi stagnation in patients with varicocele. Turmeric and zedoaria are bitter and pungent in taste, warm in nature, and enter the liver and spleen meridians. Zedoaria is mainly used to break up accumulations and eliminate hard masses, remove accumulations and lumps, amenorrhea, blood stasis, and pain caused by injuries. The above four herbs are adjuvants, combining dynamic and static effects, attacking and supplementing at the same time, activating blood circulation and promoting qi movement at the same time, which embodies the saying that "Qi is the commander of blood" and "blood is the mother of Qi".

[0010] The whole prescription combines dynamic and static effects, attacks and supplements at the same time, and takes into account both the symptoms and the root causes. It can directly reach the Jueyin Liver Meridian, warm the liver and kidneys to treat the root cause, and promote qi and blood circulation to treat the symptoms.

[0011] Among them, in the Chinese medicine composition of the present invention, fennel is one of the core components of the composition of the present invention, has the effect of regulating qi and relieving pain, and is one of the main medicines of this prescription; Rhodiola rosea can not only accelerate nerve repair and regeneration function, but also accelerate the capillary contraction rate, resist platelet aggregation, and promote blood circulation acceleration. Therefore, the dosage of Rhodiola rosea and fennel has a significant effect on the efficacy of the composition; preferably, the weight ratio of Rhodiola rosea and fennel is 1-1.8:2-2.8; more preferably, the weight ratio of Rhodiola rosea and fennel is 1.2-1.8:2-2.6.

[0012] Among them, preferably, the weight portion of the fennel is 12-16 parts, and the weight portion of the rhodiola rosea is 20-26 parts; more preferably, the weight portion of the fennel is 13-15 parts, and the weight portion of the rhodiola rosea is 20-24 parts.

[0013] Among them, preferably, the traditional Chinese medicine composition for treating varicocele is prepared by including the following raw materials in parts by weight: 13-15 parts of fennel, 5-8 parts of cinnamon, 12-15 parts of angelica, 8-10 parts of wolfberry, 12-15 parts of lindera, 4-5 parts of agarwood, 10-13 parts of curcuma, 10-12 parts of turmeric, and 20-24 parts of rhodiola.

[0014] Preferably, the traditional Chinese medicine composition for treating varicocele is prepared by including the following raw materials in parts by weight: 14-15 parts of fennel, 5-6 parts of cinnamon, 13-15 parts of angelica, 9-10 parts of wolfberry, 14-15 parts of lindera, 4-5 parts of agarwood, 10-11 parts of curcuma, 10-11 parts of turmeric, and 20-22 parts of rhodiola.

[0015] Preferably, the Chinese medicine composition for treating varicocele is prepared by including the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 5 parts of agarwood, 10 parts of curcuma, 10 parts of turmeric, and 20 parts of rhodiola rosea; the preferred raw material components have better therapeutic effects and can improve the therapeutic effect of the composition on varicocele.

[0016] The Chinese medicine composition for treating varicocele of the present invention can be prepared by extracting active components from raw materials according to conventional extraction methods in Chinese medicine, and then adding pharmaceutically acceptable carriers and / or auxiliary materials, such as starch, dextrin, microcrystalline cellulose, compressible starch, magnesium stearate, micropowder silica gel, sucrose, sodium carboxymethyl starch, hydroxypropyl methylcellulose, vegetable oil, lecithin, polyethylene glycol, propylene glycol, ethyl paraben, etc., to prepare pharmaceutically suitable dosage forms, such as granules, tablets, hard capsules, oral liquids, soft capsules, dripping pills, water-flooded pills, etc.

[0017] In order to achieve the above-mentioned object of the invention, the present invention further provides a method for preparing a Chinese medicine composition for treating varicocele, comprising the following steps:

[0018] (1) Weigh the raw materials according to the raw material formula of the traditional Chinese medicine composition;

[0019] (2) Grinding the raw drug and sieving to obtain a mixed drug powder;

[0020] (3) Adding excipients to the medicine powder, mixing evenly and then forming, to obtain a Chinese medicine composition for treating varicocele.

[0021] In step (2), the raw materials can be pulverized separately and then mixed, or mixed and then pulverized.

[0022] Preferably, the mesh size of the sieve is not less than 100 mesh, for example, it can be 100 mesh, 200 mesh, 400 mesh, 600 mesh, etc.; the finer the raw material drug is crushed, the better the release and absorption effect of the active ingredient, which is beneficial to improving the efficacy.

[0023] Among them, the excipient in step (3) is refined honey; more preferably, the excipient is nephew honey, and the added amount is 1-5% of the weight of the raw material; it can not only assist in shaping, but also has the effects of moisturizing dryness, dispelling wind and detoxifying, moistening the intestines and relieving constipation, stimulating appetite and strengthening the spleen, invigorating qi and replenishing the middle, sweating and dispelling heat, and dispelling cold and clearing the eyes.

[0024] In order to achieve the above-mentioned purpose of the invention, the present invention further provides a use of a traditional Chinese medicine composition for treating varicocele in the preparation of a drug for inhibiting the expression of Foxc2 protein, Notch1 protein, hey2 protein and / or hes1 protein in the Notch pathway; the traditional Chinese medicine composition of the present invention can promote vascular repair and remodeling in patients with cold coagulation and blood stasis type varicocele by inhibiting the expression level of Notch pathway-related proteins.

[0025] More preferably, the Chinese medicine composition for treating varicocele is used in the preparation of a medicament for treating varicocele in combination with surgery; the Chinese medicine composition of the present invention combined with surgery to treat cold-coagulation and blood-stasis type varicocele can significantly improve the total sperm count, motility, morphology and TCM symptoms of postoperative patients, and at the same time, significantly reduce postoperative complications and the risk of recurrence.

[0026] In mammals, the Notch signaling pathway is mainly composed of Notch receptors, ligands, and intracellular effector molecules. Notch ligands mainly include Delta-like ligands 1, 3, 4, Jagged1, and 2. The receptors are divided into four types, Notch 1-4, among which D114 is an important ligand in the Notch signal transduction pathway. At present, the Notch signaling pathway has been proven to be widely involved in regulating the phenotypic transformation, proliferation, and migration of venous VSMCs, and is closely related to the occurrence of varicose veins, playing a key role in the development and stability of vascular networks. At the same time, Notch signals can serve as a communication medium between vascular endothelial cells (VECs) and VSMCs, participate in mediating the regulation of VECs on VSMCs, and play a vital role in vascular maturation and homeostasis.

[0027] As the main component of the tunica media of the vascular wall, VSMCs are generally divided into two phenotypes: contractile and synthetic, and have high plasticity. The process of VSMCs converting from a contractile phenotype to a synthetic phenotype is called phenotypic conversion, which is a key factor affecting vascular homeostasis. When local blood vessels are pathologically damaged, the Notch1 / Dll4 signaling pathway of vascular smooth muscle cells can be activated and directly act on VSMCs. Through the phenotypic conversion of VSMCs, they respond to a variety of extracellular signal stimuli, such as inflammation, hypoxia, and toxin accumulation, thereby regulating the growth, repair, and remodeling of blood vessels. Under physiological conditions, highly differentiated contractile VSMCs have weak proliferation and migration abilities, showing a contractile state, and are mainly involved in controlling and maintaining vascular tension and elasticity. In contrast, synthetic VSMCs are in a poorly differentiated or undifferentiated state, with strong proliferation and migration abilities, and can secrete a large amount of cytokines and extracellular matrix, leading to vascular structural and functional disorders and enhanced inflammatory responses. When vascular damage occurs, contractile VSMCs dedifferentiate into synthetic types to repair vascular damage. When the repair is completed, they transform again into contractile types to maintain vascular homeostasis. In addition, Foxc2, an upstream factor of the Notch pathway, is also a key mediator in angiogenesis and lymphangiogenesis, and is associated with an increase in potential transcriptional mediators involved in pathological angiogenesis. In both in vivo and in vitro experiments, it was observed that overexpression of Foxc2 in venous tissue can upregulate the expression levels of Notch signaling pathway-related proteins (including Notch1, Dll4, Hes1, and Hey2), reduce the levels of contractile marker proteins in VSMCs, and upregulate the levels of synthetic markers, thereby inducing venous remodeling and regulating the vasoconstriction and vasodilation of venous vessels. In summary, downregulation of Notch pathway-related protein expression levels helps maintain the tension and elasticity of blood vessels after vascular repair and remodeling, and maintains vascular homeostasis.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] 1. The Chinese medicine composition of the present invention is prepared according to the prescription principle of warming the liver and kidney, promoting qi and relieving pain, combined with breaking blood and promoting qi, eliminating accumulation and relieving pain; in the prescription, cinnamon bark and fennel are the main medicines, and angelica, wolfberry, lindera stalk, agarwood, zedoaria, turmeric and rhodiola rosea are the ministerial medicines, combining movement and stillness, attacking and supplementing at the same time, promoting blood circulation and promoting qi in parallel, embodying the saying that "qi is the commander of blood" and "blood is the mother of qi", and can significantly improve various symptoms caused by varicocele.

[0030] 2. The Chinese medicine composition of the present invention can promote vascular repair and remodeling in patients with cold-coagulation and blood-stasis type varicocele by inhibiting the expression level of Notch pathway-related proteins, and has a significant effect on improving the symptoms caused by varicocele.

[0031] 3. The Chinese medicine composition of the present invention can be used in combination with surgery for the treatment of varicocele. While significantly improving the therapeutic effect, it can also effectively reduce postoperative complications and recurrence risks, and is suitable for large-scale promotion and application. DETAILED DESCRIPTION

[0032] The present invention is further described in detail below in conjunction with test examples and specific implementation methods. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following embodiments, and all technologies realized based on the content of the present invention belong to the scope of the present invention.

[0033] Example 1

[0034] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola.

[0035] Example 2

[0036] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of fennel, 10 parts of cinnamon bark, 10 parts of angelica sinensis, 10 parts of wolfberry, 10 parts of lindera stalk, 5 parts of agarwood, 15 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola rosea.

[0037] Example 3

[0038] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts of fennel, 5 parts of cinnamon bark, 15 parts of angelica sinensis, 5 parts of wolfberry, 15 parts of lindera stalk, 3 parts of agarwood, 10 parts of zedoaria, 15 parts of turmeric, and 30 parts of rhodiola rosea.

[0039] Example 4

[0040] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of fennel, 5 parts of cinnamon bark, 12 parts of angelica sinensis, 8 parts of wolfberry, 15 parts of lindera stalk, 4 parts of agarwood, 13 parts of zedoaria, 12 parts of turmeric, and 25 parts of rhodiola rosea.

[0041] Example 5

[0042] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 14 parts of lindera, 5 parts of agarwood, 11 parts of zedoaria, 11 parts of turmeric, and 22 parts of rhodiola.

[0043] Example 6

[0044] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 18 parts of fennel, 8 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 12 parts of lindera, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 28 parts of rhodiola.

[0045] Example 7

[0046] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 12 parts of fennel, 6 parts of cinnamon, 13 parts of angelica, 9 parts of wolfberry, 15 parts of lindera, 4 parts of agarwood, 10 parts of zedoaria, 11 parts of turmeric, and 26 parts of rhodiola.

[0047] Comparative Example 1

[0048] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 22 parts of fennel, 5 parts of cinnamon bark, 15 parts of angelica sinensis, 10 parts of wolfberry, 15 parts of lindera stalk, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola rosea.

[0049] Comparative Example 2

[0050] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola.

[0051] Comparative Example 3

[0052] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 32 parts of rhodiola.

[0053] Comparative Example 4

[0054] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 18 parts of rhodiola.

[0055] Comparative Example 5

[0056] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 6 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola.

[0057] Comparative Example 6

[0058] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 2 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola.

[0059] Comparative Example 7

[0060] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of cyperus rotundus, 5 parts of cinnamon bark, 15 parts of angelica sinensis, 10 parts of wolfberry, 15 parts of lindera stalk, 5 parts of agarwood, 10 parts of curcuma zedoaria, 10 parts of turmeric, and 20 parts of rhodiola rosea.

[0061] Comparative Example 8

[0062] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of cinnamon, 15 parts of angelica, 10 parts of wolfberry, 15 parts of lindera, 5 parts of agarwood, 10 parts of curcuma, 10 parts of turmeric, and 20 parts of notoginseng.

[0063] Comparative Example 9

[0064] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of fennel, 5 parts of evodia rutaecarpa, 15 parts of angelica sinensis, 10 parts of wolfberry, 15 parts of lindera stalk, 5 parts of agarwood, 10 parts of zedoaria, 10 parts of turmeric, and 20 parts of rhodiola rosea.

[0065] Comparative Example 10

[0066] A traditional Chinese medicine composition (CN102824618A) is prepared from the following raw materials in parts by weight: 2 parts of Cyperus rotundus, 2 parts of Citrus aurantium, 2 parts of Angelica sinensis, 3 parts of Lycium barbarum, 2 parts of Fennel, 2 parts of Cinnamon bark, 2 parts of Linderae strychnifolia, 1 part of Aquilaria wood, 2 parts of Poria cocos, and 1 part of Ginger.

[0067] Comparative Example 11

[0068] Maizhiling tablets.

[0069] Experimental example:

[0070] 1. Clinical diagnostic criteria for varicocele

[0071] Western medicine diagnostic standards (Guidelines for the Diagnosis and Treatment of Varicocele 2022 Edition): (1) Grade I: positive signs and calm breathing, the maximum internal diameter of ultrasound examination is 2.2~2.7 mm, and the reflux time during Valsalva maneuver is 2~4 s; (2) Grade II: positive signs and calm breathing, the maximum internal diameter of ultrasound examination is 2.8~3.1 mm, and the reflux time during Valsalva maneuver is 4~6 s; (3) Grade III: positive signs and calm breathing, the maximum internal diameter of ultrasound examination is ≥3.1 mm, and the reflux time during Valsalva maneuver is ≥6 s.

[0072] Diagnostic criteria of TCM syndrome: (1) Main symptoms: ① scrotal swelling, cold pain; ② local scrotal veins are exposed; ③ fear of cold;

[0073] (2) Secondary symptoms: ① Cold stabbing pain in the lumbar spine and lower abdomen; ② Chest and flank distension or emotional discomfort; ③ Clear and long urination;

[0074] (3) The tongue is dark purple or has petechiae or ecchymosis, and the pulse is deep, slow, astringent or stringy.

[0075] If the patient has 2 main symptoms or 1 main symptom and 2 secondary symptoms, cold stagnation and blood stasis syndrome can be diagnosed.

[0076] Grading and Quantification Standards: ;

[0078] 2. Experimental observation indicators: Before and after treatment, serum Notch pathway-related protein (Foxc2, Notch1, hey2, hes1) expression level detection, semen quality (total sperm count, forward motility sperm rate, normal morphology sperm percentage) examination and TCM syndrome scoring should be performed respectively.

[0079] 3. Criteria for judging efficacy

[0080] Western medicine syndrome efficacy judgment criteria: If the test results of various indicators are statistically different from the baseline data, or have reached the normal standard range, it means that the treatment method adopted is effective.

[0081] Criteria for judging the efficacy of TCM syndromes:

[0082] ①Clinical control: The patient's clinical symptoms and signs completely disappear or almost disappear, and the syndrome score is reduced by 95% or more;

[0083] ② Significantly effective: The patient's clinical symptoms and signs are significantly improved, and the syndrome score is reduced by 70% to 95%;

[0084] ③Effective: The patient's clinical symptoms and signs improved, and the syndrome score decreased by 30% to 69%;

[0085] ④ Ineffective: The patient's clinical symptoms and signs did not show significant improvement, or even worsened, and the symptom score decreased by less than 30%.

[0086] The calculation formula of the nimodipine method is: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0087] 4. Experimental methods:

[0088] (1) Treatment of Chinese medicine composition: The Chinese medicine compositions of Examples 1-7 and Comparative Examples 1-10 were weighed according to the formula, soaked for 30 minutes, and then decocted twice, each time for 25 minutes, and the residues were sieved out (the mass ratio of the raw material to water was 1:5) for later use; the two medicinal solutions were fully mixed and cooled to obtain oral medicinal solutions.

[0089] (2) Experimental grouping: 180 patients with varicocele diagnosed according to the diagnostic criteria were randomly divided into a control group and an experimental group, with 10 patients in the control group and 170 patients in the experimental group. The experimental group was randomly divided into 2 large groups (85 patients in each large group), and each large group was divided into 19 small groups, with 5 patients in each small group. After the first large group of patients underwent microsurgical varicocele ligation, they took the drugs in Examples 1-8 and Comparative Examples 1-11 respectively; the second large group of patients only took the drugs in Examples 1-8 and Comparative Examples 1-11 respectively; the control group only underwent microsurgical varicocele ligation.

[0090] (3) Dosage: Oral administration, 150 ml (raw drug 58 g) at a time, once in the morning and once in the evening, for a course of 3 months; one tablet of Maizhiling tablet (0.5 g) each time, 2 tablets per day.

[0091] 5. Experimental results: After one course of medication, various indicators were tested. The results are shown in Table 1, Table 2, Table 3, and Table 4.

[0092] Table 1 Detection results of Notch pathway-related protein expression levels (average values)

[0093]

[0094] Table 2 Semen quality test results

[0095]

[0096]

[0097] Note: The average difference value is the average of the difference before and after treatment ((after treatment - before treatment) / 2). The larger the average difference value, the greater the difference before and after treatment, and the better the treatment effect.

[0098] Table 3 TCM syndrome scoring results

[0099]

[0100]

[0101] Table 4 Postoperative complications and recurrence in the first group of patients

[0102]

[0103]

[0104] Note: The risk of postoperative recurrence is determined by a comprehensive judgment of senior physicians based on the results of color Doppler ultrasound examination after a course of medication. Generally speaking, the recurrence rate after surgery is 1.9%~17.2%, and the recurrence rate of microsurgical varicocelectomy is even lower. In the experimental examples of the present invention, if the recurrence rate is less than 2%, there is no risk of recurrence, and if the recurrence rate is greater than 2%, there is a risk of recurrence. In the experimental group, if all patients are judged to have no risk of recurrence, the experimental group is judged to have "no risk of recurrence"; in the experimental group, if one or more patients have a risk of recurrence, the experimental group is judged to have "a risk of recurrence".

[0105] Analysis of the results of the above experimental examples shows that the Chinese medicine composition of the present invention is prepared according to the prescription principle of warming the liver and kidney, promoting qi and relieving pain, combined with breaking blood and promoting qi, eliminating accumulation and relieving pain. It can promote the vascular repair and remodeling of patients with cold stagnation and blood stasis type varicocele by inhibiting the expression level of Notch pathway-related proteins, and has a significant improvement effect on improving the symptoms caused by varicocele; in particular, it can be combined with surgery for the treatment of varicocele, which significantly improves the treatment effect while effectively reducing postoperative complications and recurrence risks. Any change in the dosage ratio of the raw materials and the replacement of the types of raw materials will lead to a significant reduction in the efficacy of the composition.

Claims

1. A Chinese medicine composition for treating varicocele, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-20 parts of fennel, 5-10 parts of cinnamon bark, 10-15 parts of angelica sinensis, 5-10 parts of wolfberry, 10-15 parts of lindera stalk, 3-5 parts of agarwood, 10-15 parts of zedoaria, 10-15 parts of turmeric, and 20-30 parts of rhodiola rosea.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight portion of the fennel is 12-16 parts, and the weight portion of the rhodiola rosea is 20-26 parts.

3. The Chinese medicine composition according to claim 2, characterized in that: The weight portion of the fennel is 13-15 parts, and the weight portion of the rhodiola rosea is 20-24 parts.

4. The Chinese medicine composition according to claim 3, characterized in that: The traditional Chinese medicine composition for treating varicocele is prepared from the following raw materials in parts by weight: 13-15 parts of fennel, 5-8 parts of cinnamon, 12-15 parts of angelica, 8-10 parts of wolfberry, 12-15 parts of lindera, 4-5 parts of agarwood, 10-13 parts of zedoaria, 10-12 parts of turmeric, and 20-24 parts of rhodiola.

5. The Chinese medicine composition according to claim 4, characterized in that: The traditional Chinese medicine composition for treating varicocele is prepared from the following raw materials in parts by weight: 14-15 parts of fennel, 5-6 parts of cinnamon, 13-15 parts of angelica, 9-10 parts of wolfberry, 14-15 parts of lindera stalks, 4-5 parts of agarwood, 10-11 parts of zedoaria, 10-11 parts of turmeric, and 20-22 parts of rhodiola rosea.

6. A method for preparing the Chinese medicine composition for treating varicocele according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) Weigh the raw materials according to the raw material formula of the traditional Chinese medicine composition; (2) Grinding the raw drug and sieving to obtain a mixed drug powder; (3) Adding excipients to the medicine powder, mixing evenly and then forming, to obtain a Chinese medicine composition for treating varicocele.

7. Use of the Chinese medicinal composition for treating varicocele according to any one of claims 1 to 5 in the preparation of a medicament for treating varicocele in combination with surgery.

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