A traditional Chinese medicine composition for treating male infertility of liver stagnation and kidney deficiency type, a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating male infertility due to liver stagnation and kidney deficiency, its preparation method, and its application, belonging to the fields of traditional Chinese medicine pharmaceutical technology and andrological reproductive health technology. The composition is formulated with Bupleurum chinense, Tribulus terrestris, Cynomorium songaricum, Cuscuta chinensis, Cornus officinalis, and Epimedium brevicornu in specific weight proportions, following the principles of soothing the liver and relieving stagnation, tonifying the kidney and replenishing essence, and unblocking the meridians to treat impotence. This invention employs an alcohol-water dual-phase fractional extraction process, and can be prepared into various dosage forms such as granules, capsules, and tablets. Pharmacological experiments have confirmed that the composition of this invention can increase sperm density and progressively motile sperm rate, improve penile tissue nitric oxide synthase (NOS) activity, regulate reproductive hormones, and reduce testicular oxidative damage; serum pharmacochemistry and metabolomics have clarified the active components entering the bloodstream and their pathways of action. This invention features a refined formulation, abundant medicinal resources, and simple preparation, making it suitable for large-scale production and clinical application in treating male infertility due to liver stagnation and kidney deficiency.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine pharmaceutical technology and andrological reproductive health technology, specifically relating to a traditional Chinese medicine composition for treating male infertility of the liver stagnation and kidney deficiency type, as well as the preparation method of the composition and its application in the preparation of related drugs. Background Technology

[0002] Male infertility is a common condition affecting reproductive health. In traditional Chinese medicine (TCM) clinical diagnosis, liver stagnation and kidney deficiency are common syndrome patterns for this condition. Patients with this condition often present with oligospermia, asthenospermia, erectile dysfunction, and symptoms of liver stagnation such as depression and anxiety. Due to the complexity of the pathogenesis, single treatment methods are often insufficient to achieve satisfactory results.

[0003] Currently, most traditional Chinese medicine formulas used in clinical practice to treat male infertility focus solely on tonifying the kidneys and replenishing essence, which has the following shortcomings: First, the target of action is relatively singular, mainly focusing on improving sperm quality, with limited effect on improving penile erectile function and local microcirculation in the reproductive area; second, some compound formulas are based solely on traditional Chinese medicine theory and lack experimental verification based on modern pharmacology and material basis, making it difficult to objectively verify the rationality of the combination; third, some formulas contain a wide variety of medicinal materials, are costly, and have complex preparation processes, which are not conducive to industrial production and clinical promotion.

[0004] Modern pharmacological studies have shown that traditional Chinese medicinal herbs such as Bupleurum chinense, Tribulus terrestris, Cynomorium songaricum, Cuscuta chinensis, Cornus officinalis, and Epimedium brevicornu contain various active ingredients, including phenylethyl glycosides, saponins, flavonoids, and iridoid glycosides, which have potential value in anti-oxidation, neurotransmitter regulation, improvement of vascular endothelial function, and regulation of reproductive endocrine function. Based on the core pathogenesis of liver stagnation and kidney deficiency, developing a traditional Chinese medicine composition that combines liver-soothing and kidney-tonifying effects, improves sperm quality and erectile function, has a clear mechanism of action, and is easy to prepare, has certain clinical significance and industrial value. Summary of the Invention

[0005] This invention addresses the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating male infertility caused by liver stagnation and kidney deficiency, along with its preparation method and application. This composition, through the combined use of liver-soothing and kidney-tonifying drugs, simultaneously improves sperm quality and penile erectile function. Its pharmacodynamic material basis is clear, its preparation process is simple, and it is suitable for large-scale production and clinical application.

[0006] The technical solution provided by this invention is as follows: A traditional Chinese medicine composition for treating male infertility due to liver stagnation and kidney deficiency, wherein the raw materials are composed of the following components by weight: Bupleurum chinense 8-12 parts, Tribulus terrestris 8-12 parts, Cynomorium songaricum 12-18 parts, Cuscuta chinensis 12-18 parts, Cornus officinalis 8-12 parts, and Epimedium brevicornu 6-10 parts.

[0007] Preferably, the raw materials of the composition are composed of the following proportions by weight: 10 parts Bupleurum chinense, 10 parts Tribulus terrestris, 15 parts Cynomorium songaricum, 15 parts Cuscuta chinensis, 10 parts Cornus officinalis, and 8 parts Epimedium brevicornu.

[0008] The above composition was prepared using an alcohol-water two-phase fractional extraction process, the specific steps of which are as follows: (1) Initial extraction with alcohol: Crush Bupleurum, Tribulus terrestris and Epimedium, add 6-8 times the amount of 60% ethanol solution, heat and reflux at 65-75℃ for 2 h, filter, collect the ethanol extract, and keep the filter residue for later use. (2) Water-based secondary extraction: Add Cynomorium songaricum, Cuscuta chinensis and Cornus officinalis to the above filter residue, combine them and add 8-10 times the amount of purified water, decoct at a gentle boil for 1.5 h, filter and collect the water extract; (3) Concentration under reduced pressure: The ethanol in the ethanol extract is recovered, the two extracts are combined and concentrated under reduced pressure at 62 ℃ and vacuum degree -0.085 MPa to obtain a composite extract with a relative density of 1.12-1.16.

[0009] The compound ointment can be further processed into granules, capsules, tablets, oral liquids, pills, or soft capsules by combining with pharmaceutically acceptable excipients.

[0010] This invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating male infertility caused by liver stagnation and kidney deficiency.

[0011] This invention, through modern pharmacology and metabolomics techniques, has preliminarily identified the core blood-entering active components of this traditional Chinese medicine composition that exert its pharmacological effects in vivo, and further revealed and elucidated its core metabolic pathways regulating the reproductive microenvironment and microvascular endothelial function. This invention, through the interaction of the 'liver-soothing and kidney-tonifying' traditional Chinese medicine combination, effectively improved sperm quality and reproductive-related microcirculation indicators in rats. This not only provides objective pharmacodynamic data for verifying the efficacy of the composition, but also provides a scientific material and mechanistic basis for subsequent mechanistic studies of this compound and the high-quality development of drugs related to the treatment of male infertility due to liver stagnation and kidney deficiency. Beneficial effects

[0012] Compared with the prior art, the present invention has the following advantages: 1. The combined effect of soothing the liver and tonifying the kidneys simultaneously improves sperm quality and erectile function. To address the complex pathogenesis of infertility due to liver stagnation and kidney deficiency, this invention employs a complete formula consisting of liver-soothing components (Bupleurum chinense and Tribulus terrestris) and kidney-tonifying components (Cistanche deserticola, Cuscuta chinensis, Cornus officinalis, and Epimedium brevicornu). Animal experiments showed that the complete formula not only increased sperm density and the percentage of progressively motile sperm but also enhanced penile nitric oxide synthase (NOS) activity. In contrast, the liver-soothing or kidney-tonifying groups alone showed less improvement in these indicators than the complete formula. This indicates that the combined use of liver-soothing and kidney-tonifying drugs yields a better overall therapeutic effect.

[0013] 2. Multi-target remodeling of metabolic network, with a relatively clear mechanism of action. Pharmacodynamic and metabolomics analyses showed that the composition of this invention can regulate the levels of various amino acids, such as taurine, serine, methionine, tryptophan, and related metabolites, in model rats, improving the local oxidative stress state in the testes. Simultaneously, it can downregulate the level of endogenous N,N-dimethylarginine ADMA, relieving its inhibitory effect on NOS and promoting the repair of the arginine-NO pathway. These mechanisms comprehensively improve the microenvironment of spermatogenesis and penile vascular endothelial function.

[0014] 3. Identify the core components that enter the bloodstream to provide a scientific basis for formulation quality control. Serum pharmaceutical chemical analysis by UPLC-Q-TOF-MS / MS revealed that the compositions of this invention contained catechins, proanthocyanidins, icariin, astragalin C, saikosaponin B1, saikosaponin B2, moroside, loganin, and flavonoid aglycones such as quercetin and kaempferol in the drug-containing serum. These components provide indicative components for subsequent formulation quality control.

[0015] 4. The formulation is reasonable, the preparation process is simple, and it is suitable for large-scale production. The composition of this invention consists of six commonly used Chinese medicinal herbs listed in the Chinese Pharmacopoeia, with abundant sources and good safety. The preparation method employs an advanced alcohol-water two-phase fractional extraction process to fully extract both fat-soluble and water-soluble core active ingredients. The process exhibits good stability and has significant value for industrial transformation and clinical application. Detailed Implementation

[0016] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the detailed embodiments of the present invention are only used to illustrate the solutions and effects of the present invention, and the scope of protection of the present invention is not limited to these embodiments. Some non-essential improvements and adjustments made by those skilled in the art based on the technical content of the present invention are all within the scope of protection of the present invention. The specific parameters in the following embodiments are only examples of a suitable range, that is, those skilled in the art can make appropriate selections within the appropriate range based on the description herein, and are not limited to the specific values ​​and specific steps below. Example 1: Refining and extraction process of the traditional Chinese medicine composition extract of the present invention

[0017] Take the following raw materials: Bupleurum chinense 100 g, Tribulus terrestris 100 g, Cynomorium songaricum 150 g, Cuscuta chinensis 150 g, Cornus officinalis 100 g, and Epimedium brevicornu 80 g.

[0018] Perform alcohol-water two-phase fractional extraction as follows: (1) Initial extraction with alcohol: Crush Bupleurum, Tribulus terrestris and Epimedium, add 6-8 times the amount of 60% ethanol solution, heat and reflux at 65-75℃ for 2 h, filter, collect the ethanol extract, and keep the residue for later use; (2) Water-based secondary extraction: Add Cynomorium songaricum, Cuscuta chinensis and Cornus officinalis to the above filter residue, combine them and add 8-10 times the amount of purified water, heat to boiling and maintain a gentle boil for 1.5 h, filter and collect the water extract; (3) Concentration under reduced pressure: The ethanol in the ethanol extract is recovered and then combined with the water extract. The extract is concentrated under reduced pressure at 62 °C and a vacuum of -0.085 MPa to a high-quality compound extract with a relative density of 1.12-1.16. Example 2: Pharmacodynamic study of the traditional Chinese medicine composition of the present invention on male infertility rats with liver stagnation and kidney deficiency.

[0019] (1) Modeling method: Healthy male SD rats weighing 180-220 g were selected. Except for the blank group, the rats in the other groups were subjected to chronic restraint stress (CRS) combined with adenine gavage for 28 consecutive days to establish a liver stagnation and kidney deficiency type infertility model; adenine was prepared as a suspension using 0.5% CMC-Na solution, and the gavage dose was 300 mg / kg. After modeling, the rats showed typical symptoms such as dull hair, slow weight gain, and a significant decrease in sucrose preference.

[0020] (2) Grouping and administration: Rats that successfully developed the model were randomly divided into a model group, a positive drug group (i.e., Wuzi Yanzong Wan suspension, dose 1.25 g / kg), a split formula group 1 (liver-soothing group, raw drug amount 1.84 g / kg), a split formula group 2 (kidney-tonifying group, raw drug amount 4.41 g / kg), and a whole formula group (raw drug amount 6.25 g / kg). Among them, split formula group 1 was prepared according to the whole formula ratio, using only Bupleurum and Tribulus, and was prepared according to the extraction steps of Example 1; split formula group 2 was prepared according to the whole formula ratio, using Cynomorium, Cuscuta, Cornus, and Epimedium, and was prepared according to the extraction steps of Example 1. All drugs in each administration group were prepared into suspensions using 0.5% CMC-Na solution. Rats in the administration groups were given the corresponding drugs by gavage once a day at a fixed time, with an administration volume of 10 mL / kg. Rats in the blank group and the model group were given the same volume of 0.5% CMC-Na solution by gavage. The administration was continued for 28 days. Example 3: Detection of reproductive parameters and physicochemical indicators

[0021] (1) Sperm parameter detection: After the last administration, the rats were anesthetized, and the tail of one side of the epididymis was placed in preheated physiological saline and cut into pieces to release the sperm. The sperm suspension was dropped onto a sperm counting plate and detected by a computer-aided semen analysis system (CASA).

[0022] The results showed that the sperm density in the model group rats was (31.2±3.5)×10⁻¹⁰. 6 / mL, the percentage of progressively motile sperm (PR) was 32.5±4.1%, both significantly lower than that of the normal control group (86.5±5.2)×10 6 / mL, PR was 78.4±3.7% (P<0.01). After drug intervention, the sperm density of rats in the whole formula group significantly increased to (81.6±4.5)×10. 6 / mL, PR rose to 73.8±5.0%. Group 1 of the split prescription was (38.4±5.1)×10 6 / mL and 41.2±4.6%; the two groups of prescriptions were (62.1±5.8)×10 6 / mL and 56.4±5.2%. The improvement effect of the full-formula group was better than that of the two partial-formula groups (P<0.05). The sperm density in the positive drug group was (79.5±4.8)×10 6 / mL, PR was 71.2±4.5%, which was not significantly different from the whole formula group (P>0.05).

[0023] (2) NOS activity detection in penile tissue: homogenate was prepared from rat penile corpora cavernosa and NOS activity was determined using a kit method.

[0024] The results showed that the NOS activity in the penile tissue of the normal control group was 4.12±0.35 U / mgprot, while that in the model group was significantly reduced to 1.35±0.18 U / mgprot (P<0.01). After intervention, the NOS activity in the penile tissue of rats in the whole formula group recovered to 3.86±0.31 U / mgprot, which was significantly higher than that in the model group (P<0.01); the NOS activity in the first decoction group (liver-soothing group) was 2.15±0.24 U / mgprot, which was higher than that in the model group (P<0.05), but the upregulation effect was not as good as that in the whole formula group; the NOS activity in the second decoction group (simply tonifying the kidney) was 1.82±0.21 U / mgprot, which had a limited upregulation effect on NOS. The comparison confirmed that the whole formula, due to its formulation advantages, was significantly more effective than each decoction intervention group, and the liver-soothing and meridian-clearing and vascular-targeting components played a key role in improving erection-related vascular endothelial function. It is noteworthy that although the positive control group (Wuzi Yanzong Wan group) significantly improved sperm quality, its penile tissue NOS activity only recovered to 2.25±0.28 U / mgprot, and its improvement in vascular endothelial function was significantly weaker than that of the whole formula group (3.86±0.31 U / mgprot, P<0.05). This further confirms that the whole formula of this invention achieves bidirectional improvement in sperm production and the penile erection microenvironment through simultaneous liver-soothing and kidney-tonifying effects, possessing comprehensive therapeutic advantages not found in the positive control group.

[0025] (3) Hormone and oxidative stress level measurement: The results showed that compared with the blank group, the serum hormone level and testicular tissue antioxidant enzyme activity of the model group rats were significantly reduced (P<0.01), and the MDA content was significantly increased (P<0.01), indicating that the model rats had obvious reproductive endocrine disorders and local oxidative damage.

[0026] After intervention, serum testosterone (T) levels in rats in the whole-formula group significantly increased to 24.85±2.31 nmol / L, while luteinizing hormone (LH) and estradiol (E2) levels recovered to 25.12±2.05 mIU / mL and 59.8±4.6 ng / L, respectively. Simultaneously, malondialdehyde (MDA) content in testicular tissue significantly decreased to 4.85±0.52 nmol / mgprot, superoxide dismutase (SOD) activity increased to 41.2±3.8 U / mgprot, and glutathione peroxidase (GSH-Px) recovered to 121.5±9.6 U / mgprot. This indicates that the composition can effectively improve the reproductive endocrine environment and reduce local oxidative damage.

[0027] It is worth noting that although the positive control group (Wuzi Yanzong Wan group) also showed definite efficacy in improving the aforementioned endocrine and oxidative stress indicators (no significant difference compared with the whole formula group, P>0.05), combined with the results of the aforementioned examples, the positive control group's improvement on penile tissue NOS activity was significantly weaker than that of the whole formula group of this invention (P<0.05). The results indicate that the herbal composition of this invention, while possessing definite spermatogenic and antioxidant effects, also has a unique effect on repairing penile microcirculation, achieving a bidirectional improvement in sperm quality and erectile function. Example 4: Serum pharmaceutical chemical analysis based on UPLC-Q-TOF-MS / MS

[0028] To clarify the pharmacodynamic basis of the composition of the present invention in vivo, drug-containing serum was prepared for liquid chromatography-mass spectrometry analysis.

[0029] (1) Preparation of serum samples: After the rats in the whole formula group were administered the drug by gavage at the predetermined dose, blood was collected from the abdominal aorta at a specific time point (1 h after administration). The serum was separated by centrifugation, and the protein was precipitated by adding methanol. The supernatant was used as the test sample. Blank serum was prepared at the same time as a control.

[0030] (2) Analytical results: UPLC-Q-TOF-MS / MS technology was used for positive and negative ion mode scanning. By extracting ion chromatograms and comparing retention times with secondary mass spectrometry fragments, interference from endogenous components was eliminated, and multiple original blood-entry components were identified in the drug-containing serum. These mainly included: catechins and proanthocyanidins (mainly derived from Cynomorium songaricum); icariin and cuscutaidine C (mainly derived from Epimedium); saikosaponin B1 and saikosaponin B2 (mainly derived from Bupleurum chinense); moroside and loganin (mainly derived from Cornus officinalis). At the same time, a large number of common flavonoid active aglycones such as quercetin and kaempferol were also detected in the drug-containing serum (these components are not only the core metabolic convergence basis of the active components of Tribulus terrestris, Cuscuta chinensis, and Epimedium in vivo, but also important active entities for the whole formula to exert antioxidant and endothelial protective effects in vivo). Example 5: Mechanism analysis based on metabolomics Example 6: Different proportions of traditional Chinese medicine compositions (I) and their efficacy analysis

[0031] To elucidate the endogenous regulatory mechanism of the overall synergistic effect, LC-MS non-targeted metabolomics technology was used to analyze the serum of rats in each group.

[0032] (1) Multivariate statistical analysis: Metabolic profile data were imported into SIMCA software for orthogonal partial least squares discriminant analysis (OPLS-DA). The score plot showed that the normal control group and the model group were clearly separated, indicating that the modeling caused significant metabolic disorders; the whole-group sample showed a significant regression, approaching the normal control group, indicating that the overall metabolic imbalance was effectively corrected.

[0033] (2) Enrichment of differential metabolites and pathways: Differential metabolites were screened using variable projection importance (VIP) > 1 and P < 0.05. The results showed that the complete formula significantly restored abnormal levels of tryptophan, serine, L-methionine, taurine, indole sulfate, allantoin, N,N-dimethylarginine ADMA, 1-methylguanine, N-acetyl-D-glucosamine, 5,6-dihydrouridine, and 5-hydroxyindole in the model rats. Metabolic pathway topology analysis indicated that the intervention mechanism of this invention was mainly enriched in the metabolism of taurine and taurine, glycine, serine and threonine, tryptophan, cysteine ​​and methionine, amino sugars and nucleotide sugars, and glyoxylic acid and dicarboxylic acid.

[0034] (3) Cross-validation analysis of metabolic regulatory mechanisms Further pathway enrichment and analysis revealed that the entire formula of this invention does not act through a single target, but rather through the synergistic effect of multiple components, systematically reshaping the abnormal reproductive metabolic microenvironment. Its core mechanism is mainly manifested in the following two major pathway groups: 1. Amino Acid and Energy Metabolism Network Remodeling (Corresponding to Kidney-Tonifying and Sperm-Replenishing Mechanism): Data shows that the composition of this invention extensively and significantly restores a variety of key amino acids and related metabolites, such as taurine, serine, L-methionine, and tryptophan. These substances are core substrates that constitute the antioxidant barrier of reproductive cells (such as taurine) and provide energy metabolism for spermatogenesis and flagellated motility. This repair of the microscopic metabolic network fully explains, at the molecular level, the technical effects of "significantly increased sperm density and viability" and "reduced oxidative damage to testicular tissue" observed in the aforementioned pharmacodynamic experiments.

[0035] 2. Inhibition of the Arginine-NO Pathway (corresponding to a liver-soothing and meridian-clearing mechanism): Notably, among the numerous reversing metabolites, the entire formula of this invention significantly downregulated the abnormally elevated ADMA expression. As a recognized potent NOS inhibitor, the significant reduction in ADMA levels directly relieved the inhibitory state on penile microvascular endothelium. This precise regulation of a key microscopic target forms a rigorous causal relationship with the aforementioned macroscopic data showing "significantly increased NOS activity in penile tissue in the entire formula group."

[0036] The above mechanistic data prove that the "liver-soothing and kidney-tonifying" composition of the present invention not only improves the nutritional and energy microenvironment for sperm production in a broad sense (amino acids and energy metabolites), but also clears penile microcirculation obstacles in a deeper sense (ADMA-NOS axis), achieving bidirectional synchronous repair of "sperm quality and erectile function", further confirming the scientific nature of the comprehensive formula and its excellent clinical application value.

[0037] The conclusion shows that the combination of liver-soothing and kidney-tonifying herbs not only macroscopically improves spermatogenesis and local vascular function, but also fundamentally reshapes the body's metabolic homeostasis at the microscopic system level by regulating amino acid and energy metabolism pathways. Example 6: Different proportions of traditional Chinese medicine compositions (I) and their efficacy analysis

[0038] The raw materials, by specific weight, are: Bupleurum chinense 80 g, Tribulus terrestris 90 g, Cynomorium songaricum 120 g, Cuscuta chinensis 140 g, Cornus officinalis 80 g, and Epimedium brevicornu 60 g. The herbal extract was prepared according to the extraction steps of Example 1.

[0039] Following the methods described in Examples 2 and 3, a rat model of male infertility due to liver stagnation and kidney deficiency was subjected to drug intervention and physicochemical index testing. The results showed that the semen quality of rats in this ratio-matched group was significantly improved, with sperm density increasing to (69.5±4.5)×10⁻⁶. 6 / mL, the percentage of progressively motile sperm (PR) recovered to 62.4±4.8%; simultaneously, penile tissue NOS activity recovered to 3.25±0.28 U / mgprot. The data indicate that this composition, through its dual effects of soothing the liver and tonifying the kidneys, can still effectively improve spermatogenesis and local microvascular endothelial function. Example 7: Different proportions of traditional Chinese medicine compositions (II) and their efficacy analysis

[0040] The raw materials, by specific weight, are: Bupleurum chinense 120 g, Tribulus terrestris 110 g, Cynomorium songaricum 180 g, Cuscuta chinensis 170 g, Cornus officinalis 120 g, and Epimedium brevicornu 100 g. The herbal extract was prepared according to the extraction steps of Example 1.

[0041] The same model evaluation method was used for intervention testing. The results showed that the sperm density of rats in this mating group recovered to (82.3±4.9)×10⁻¹⁰. 6 / mL, the percentage of progressively motile sperm (PR) recovered to 71.5±5.2%; penile tissue NOS activity recovered to 3.88±0.32 U / mgprot, and the activity of antioxidant enzymes (such as SOD) in testicular tissue also significantly recovered. The comprehensive data from the above-mentioned different formulation examples objectively confirm that within the weight range of 8-12 parts of Bupleurum chinense, 8-12 parts of Tribulus terrestris, 12-18 parts of Cynomorium songaricum, 12-18 parts of Cuscuta chinensis, 8-12 parts of Cornus officinalis, and 6-10 parts of Epimedium brevicornu, each of the traditional Chinese medicine components can produce a stable and definite synergistic effect of "improving the reproductive metabolic microenvironment and opening the arginine-NO pathway", providing a solid experimental basis for the wide clinical application and process tolerance of this composition.

[0042] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Any modifications, equivalent substitutions, or improvements 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 treating male infertility due to liver stagnation and kidney deficiency, characterized in that, It is composed of the following raw materials in parts by weight: Bupleurum chinense 8-12 parts, Tribulus terrestris 8-12 parts, Cynomorium songaricum 12-18 parts, Cuscuta chinensis 12-18 parts, Cornus officinalis 8-12 parts, and Epimedium brevicornu 6-10 parts.

2. The traditional Chinese medicine composition for treating male infertility due to liver stagnation and kidney deficiency according to claim 1, characterized in that, It is composed of the following raw materials in parts by weight: Bupleurum chinense 10 parts, Tribulus terrestris 10 parts, Cynomorium songaricum 15 parts, Cuscuta chinensis 15 parts, Cornus officinalis 10 parts, and Epimedium brevicornu 8 parts.

3. The extraction and preparation method of the traditional Chinese medicine composition for treating male infertility of liver stagnation and kidney deficiency type according to claim 1 or 2, characterized in that, Includes the following steps: (1) Initial extraction with alcohol: Crush Bupleurum, Tribulus terrestris and Epimedium, add 6-8 times the amount of 60% ethanol solution, heat and reflux at 65-75 ℃ for 2 h, filter, collect the ethanol extract, and keep the filter residue for later use. (2) Water-based secondary extraction: Add Cynomorium songaricum, Cuscuta chinensis and Cornus officinalis to the above filter residue, combine them and add 8-10 times the amount of purified water, decoct at a gentle boil for 1.5 h, filter and collect the water extract; (3) Concentration under reduced pressure: The ethanol in the ethanol extract is recovered, the two extracts are combined, and concentrated under reduced pressure at 62 ℃ and vacuum degree -0.085MPa to obtain a composite extract with a relative density of 1.12-1.

16.

4. The extraction and preparation method according to claim 3, characterized in that, The compound ointment is mixed with pharmaceutically acceptable excipients and further processed into granules, capsules, tablets, oral liquids, pills or soft capsules.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating male infertility due to liver stagnation and kidney deficiency.