Traditional Chinese medicine compound composition for treating oligoasthenospermia and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine compound composition for treating oligoasthenospermia and a preparation method thereof. The traditional Chinese medicine compound composition comprises a traditional Chinese medicine component, a western medicine component and an auxiliary material component, the traditional Chinese medicine components comprise the following components: radix astragali, radix ophiopogonis, radix morindae officinalis, herba epimedii, radix polygoni multiflori preparata, semen cuscutae and rhizoma polygonati preparata; the western medicine component is levocarnitine; the auxiliary material components comprise the following components: a zinc-containing component, a selenium-containing component and vitamin E. The traditional Chinese medicine composition contains traditional Chinese medicinal materials such as astragalus membranaceus, radix ophiopogonis and morinda officinalis, Western medicine components and auxiliary material components are cooperatively added, the curative effect on oligoasthenospermia is remarkably improved through the synergistic effect of the multiple components, and the traditional Chinese medicine composition has good market application prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a traditional Chinese medicine compound composition for treating oligoasthenospermia and its preparation method. Background Technology

[0002] Male infertility is a common clinical condition affecting the male reproductive system, influenced by various factors including environmental factors. Male factors account for about half of infertile couples, with oligospermia and asthenospermia being the most common types. In recent years, research on the treatment of male oligospermia and asthenospermia using traditional Chinese medicine preparations has received increasing attention. Traditional Chinese medicine kidney-tonifying herbs are generally considered safer than Western medicines.

[0003] Existing Chinese herbal medicine compositions for treating oligoasthenospermia mainly focus on tonifying the spleen and kidneys, but they have the following shortcomings: limited efficacy: they do not intervene in the pathological mechanisms such as sperm oxidative stress damage and insufficient energy metabolism; single ingredients: they lack trace elements and metabolic regulators verified by modern medicine, resulting in unstable clinical effects.

[0004] Therefore, there is a need to develop a new traditional Chinese medicine composition for treating oligoasthenospermia. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine compound composition for treating oligoasthenospermia and its preparation method. The composition contains traditional Chinese medicinal materials such as Astragalus membranaceus, Ophiopogon japonicus, and Morinda officinalis, and is synergistically added with Western medicine components and excipients. Through the synergistic effect of multiple components, the efficacy of treating oligoasthenospermia is significantly improved, and it has good market application prospects.

[0006] This invention provides a traditional Chinese medicine compound composition for treating oligoasthenospermia. The traditional Chinese medicine compound composition includes traditional Chinese medicine components, Western medicine components, and excipient components. The traditional Chinese medicine components include the following: Astragalus membranaceus, Ophiopogon japonicus, Morinda officinalis, Epimedium brevicornu, processed Polygonum multiflorum, Cuscuta chinensis, and processed Polygonatum sibiricum. The Western medicine component is L-carnitine. The excipient components include the following: zinc-containing components, selenium-containing components, and vitamin E.

[0007] Preferably, the traditional Chinese medicine components include the following components: Astragalus membranaceus 350-400g, Ophiopogon japonicus 150-200g, Morinda officinalis 150-200g, Epimedium brevicornu 150-200g, processed Polygonum multiflorum 300-350g, Cuscuta chinensis 500-550g, and processed Polygonatum sibiricum 300-350g.

[0008] Preferably, the western medicine component is 200-300g of levocarnitine.

[0009] Preferably, the excipient components include the following components: 1-5g of zinc-containing component, 1-10mg of selenium-containing component, and 10-20g of vitamin E.

[0010] Preferably, the zinc-containing component is sourced from zinc gluconate; and the selenium-containing component is sourced from sodium selenite.

[0011] Preferably, the dosage form of the traditional Chinese medicine compound composition is tablets, capsules, or granules.

[0012] This invention also provides a method for preparing a traditional Chinese medicine compound composition for treating oligoasthenospermia, comprising the following steps:

[0013] The components of traditional Chinese medicine are extracted and concentrated into an extract by decoction, then mixed with Western medicine components and excipients, granulated, and then tableted, filled into capsules, or directly obtained as granules.

[0014] This invention also provides the application of a traditional Chinese medicine compound composition for treating oligoasthenospermia in the preparation of drugs for treating oligoasthenospermia.

[0015] Beneficial effects

[0016] This invention contains traditional Chinese medicinal herbs such as Astragalus membranaceus, Ophiopogon japonicus, and Morinda officinalis, and is synergistically supplemented with Western medicine components and excipients. Through the synergistic effect of multiple components, it significantly improves the efficacy of treating oligoasthenospermia and has good market application prospects. Attached Figure Description

[0017] Figure 1 For pathological observation of mouse heart tissue (HE staining, ×200).

[0018] Figure 2 Histopathological observation of mouse liver tissue (HE staining, ×200).

[0019] Figure 3 Histopathological observation of mouse spleen tissue (HE staining, ×200).

[0020] Figure 4 Pathological observation of mouse lung tissue (HE staining, ×200).

[0021] Figure 5 Histopathological observation of mouse kidney tissue (HE staining, ×200).

[0022] In the diagram, 1 represents mouse number 1; 2 represents mouse number 2; 3 represents mouse number 3; 4 represents mouse number 4; and 5 represents mouse number 5. Detailed Implementation

[0023] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0024] Example 1

[0025] This embodiment provides a method for preparing a traditional Chinese medicine compound composition for treating oligoasthenospermia, comprising the following steps:

[0026] Take 375g of Astragalus membranaceus, 187.5g of Ophiopogon japonicus, 187.5g of Morinda officinalis, 187.5g of Epimedium brevicornu, 312.5g of processed Polygonum multiflorum, 500g of Cuscuta chinensis, and 312.5g of processed Polygonatum sibiricum. Add water and decoct three times. For the first decoction, add 8 times the amount of water and decoct for 2 hours. For the second decoction, add 5 times the amount of water and decoct for 2 hours. For the third decoction, add 5 times the amount of water and decoct for 1 hour. Filter the decoction, combine the ingredients, concentrate and dry, pulverize, add 327.5g of dextrin, zinc gluconate (containing 3.125g of zinc), sodium selenite (containing 6.25mg of selenium), vitamin E 12.5g, and L-carnitine 250g. Make into granules and package into 10g bags.

[0027] Example 2

[0028] Effects on a mouse model of Yang deficiency:

[0029] 1.1 Grouping and Dosing

[0030] Seventy male ICR mice were selected and randomly divided into 7 groups (n=10):

[0031] (1) Normal control group (equal volume of physiological saline);

[0032] (2) Yang deficiency model group (equal volume of distilled water);

[0033] (3) Control group of traditional Chinese medicine components (6.5 ml / kg / d);

[0034] (4) Traditional Chinese medicine components + zinc gluconate (containing 25mg zinc), sodium selenite (containing 50μg selenium), vitamin E 100mg group (6.5ml / kg / d + excipient components);

[0035] (5) Traditional Chinese medicine components + L-carnitine group (6.5ml / kg / d + L-carnitine 2g / kg / d);

[0036] (6) Example 1 formulation low-dose group (3.25 ml / kg / d);

[0037] (7) Dosage group in the formulation of Example 1 (6.5 ml / kg / d);

[0038] (8) Example 1 formulation high dose group (13ml / kg / d).

[0039] Except for the normal control group, the other groups were given 0.5% hydrocortisone intramuscularly at a dose of 12.5 ml / kg daily to create a kidney yang deficiency model for 30 consecutive days.

[0040] 1.2 Results

[0041] Table 1. Effects of the formulation on Yang-deficient mouse model (X±S, n=10)

[0042] Group Body weight (g) Number of independent activities (10 min) Swimming time (min) normal control group 20.8±0.8 52.3±8.1 224.5±10.2 Yang Deficiency Model Group 27.3±0.9 38.7±3.2 198.6±7.8 Traditional Chinese medicine component control group 30.7±0.7 41.5±4.3 210.2±9.5 Chinese medicine components + excipient components 30.9±0.8 46.2±4.1 215.8±8.7 Traditional Chinese medicine components + L-carnitine group 31.1±0.8 47.5±4.2 218.5±8.9 Example 1 Low-dose group 30.7±0.9 48.6±4.0 217.8±7.6 In Example 1, the dosage group 30.6±0.7 51.9±4.5 222.3±8.4 Example 1 High-dose group 30.8±0.9 53.7±5.2 226.1±9.8

[0043] 1.3 Statistical Analysis

[0044] (1) Compared with the normal control group: model group P<0.01 (body weight ↓, spontaneous activity ↓, swimming time ↓); traditional Chinese medicine group P<0.05 (spontaneous activity ↓).

[0045] (2) Compared with the model group: P<0.01 for each dose group in Example 1 (body weight ↑, spontaneous activity ↑, swimming time ↑); P<0.01 for the Chinese medicine component + excipient group (body weight ↑, spontaneous activity ↑, swimming time ↑); P<0.01 for the Chinese medicine component + L-carnitine group (body weight ↑, spontaneous activity ↑, swimming time ↑).

[0046] (3) Compared with the control group of traditional Chinese medicine components: P<0.01 for each dosage group in Example 1 (increased spontaneous activity and swimming time); P<0.05 for the traditional Chinese medicine component + excipient group (increased spontaneous activity and swimming time); P<0.05 for the traditional Chinese medicine component + levocarnitine group (increased spontaneous activity and swimming time).

[0047] (4) Compared with the Chinese medicine component + excipient group: Chinese medicine component + L-carnitine group P<0.05 (increased spontaneous activity and swimming time); low dose group of Example 1 P<0.05 (increased spontaneous activity and swimming time); medium dose group of Example 1 P<0.01 (increased spontaneous activity and swimming time).

[0048] 1.4 Conclusion

[0049] 1. In Example 1, each dosage group was significantly better than the model group (P<0.01) and the control group of traditional Chinese medicine components in terms of body weight recovery, number of spontaneous activities, and time spent swimming at low temperatures (P<0.01).

[0050] 2. The therapeutic effect was dose-dependent: high-dose group > medium-dose group > low-dose group > traditional Chinese medicine component + L-carnitine group > traditional Chinese medicine component + excipient group > traditional Chinese medicine component control group > model group.

[0051] 3. All indicators in the high-dose group returned to normal levels (P>0.05 vs normal group), and the swimming time (226.1 min) was significantly better than that in the traditional Chinese medicine component control group (210.2 min, P<0.01).

[0052] 4. The effect of the Chinese herbal medicine component + L-carnitine group was significantly better than that of the Chinese herbal medicine component + excipient group (P<0.05), but weaker than that of the dosage group in Example 1 (P<0.05), which reflects the individual promoting effect of L-carnitine on sperm energy metabolism.

[0053] Example 3

[0054] Experiments on the effect on sperm motility in male mice:

[0055] 1.1 Grouping and Dosing

[0056] Seventy male ICR mice (8 weeks old, 18-22g) were randomly divided into 7 groups (n=10):

[0057] (1) Normal control group (physiological saline, 0.2ml / 10g / d);

[0058] (2) Model group (cyclophosphamide-induced oligoasthenospermia model, distilled water gavage);

[0059] (3) Control group of traditional Chinese medicine components (6.5 ml / kg / d);

[0060] (4) Traditional Chinese medicine components + zinc gluconate (containing 10mg zinc), sodium selenite (containing 50μg selenium), vitamin E 100mg group (6.5ml / kg / d + excipient components);

[0061] (5) Traditional Chinese medicine components + L-carnitine group (6.5ml / kg / d + L-carnitine 2g / kg / d);

[0062] (6) Example 1 formulation low-dose group (3.25 ml / kg / d);

[0063] (7) Dosage group in the formulation of Example 1 (6.5 ml / kg / d);

[0064] (8) Example 1 formulation high dose group (13ml / kg / d).

[0065] Except for the normal control group, the other groups were injected intraperitoneally with cyclophosphamide (50 mg / kg / d) for 5 consecutive days to establish an oligoasthenospermia model.

[0066] 1.2 Detection Indicators

[0067] (1) Forward sperm motility (PR, %): Computer-aided semen analysis (CASA).

[0068] (2) Sperm survival rate (%): Eosin staining method.

[0069] (3) Sperm density (×10) 6 / ml): Hemocytometer counting.

[0070] 1.3 Experimental Results

[0071] Table 2. Effects of the formulation on sperm motility (X±S, n=10)

[0072]

[0073] 1.4 Statistical Analysis

[0074] (1) Compared with the model group: P<0.01(**), P<0.05(*).

[0075] (2) Compared with the control group of traditional Chinese medicine components: P<0.05(#), P<0.01(##).

[0076] (3) Compared with the traditional Chinese medicine component + excipient group: the traditional Chinese medicine component + levocarnitine group P<0.05 P<0.05(#); the low dose group of Example 1 P<0.05 P<0.05(#); the medium dose group of Example 1 P<0.01 P<0.01(##).

[0077] 1.5 Conclusion

[0078] (1) The formula in Example 1 significantly improved sperm motility:

[0079] Forward sperm motility (PR): The high-dose group (49.6%) showed a 33.3% increase compared to the control group (37.2%) (P<0.01). Sperm viability: The high-dose group (82.7%) was close to the normal level (85.2%), significantly better than the control group (65.4%, P<0.01).

[0080] Sperm density: High-dose group (11.8×10⁻⁶) 6 The concentration of the herbal medicine component (8.3 × 10⁹ / ml) was significantly higher than that of the control group (8.3 × 10⁹ / ml). 6 / ml, P<0.01).

[0081] (2) Dose-dependent effect: High dose group > Medium dose group > Low dose group > Traditional Chinese medicine component + L-carnitine group > Traditional Chinese medicine component + excipient group > Traditional Chinese medicine component control group > Model group, which is consistent with the dose-response relationship.

[0082] (3) The formulation of Example 1 was superior to the control group of traditional Chinese medicine components: it was significantly superior to the control group of traditional Chinese medicine components in terms of sperm motility, survival rate and density (P<0.01), and the high-dose group of Example 1 was close to the normal level.

[0083] (4) The effect of the Chinese medicine component + L-carnitine group was significantly better than that of the Chinese medicine component + excipient group (P<0.05), but weaker than that of the dosage group in Example 1 (P<0.05), which reflects the individual promoting effect of L-carnitine on sperm energy metabolism.

[0084] Example 4

[0085] Stability test:

[0086] I. Abstract

[0087] 1. Purpose

[0088] The stability of the formulation particles in Example 1 was preliminarily investigated.

[0089] 2. Method

[0090] The stability of samples was investigated by high performance liquid chromatography (HPLC) for the determination of icariin in Epimedium, hyperoside in Cuscuta, and stilbene glycoside in Polygonum multiflorum under accelerated or long-term conditions for 9 months.

[0091] 3. Results

[0092] TLC results of Astragalus membranaceus and Morinda officinalis, and HPLC results of icariin, hyperoside, and stilbene glycoside showed that the formulation granules of Example 1 had good stability under accelerated conditions for 9 months at room temperature.

[0093] 4. Conclusion

[0094] The components in the formulation granules of Example 1 exhibit good stability.

[0095] II. Drug Testing

[0096] The drug granules of Example 1, batch numbers: 150302, 150303, 150304, specification: 8g / bag;

[0097] Hyperoside reference standard, National Institutes for Food and Drug Control, batch number 111521-201004;

[0098] Icariin reference standard, National Institutes for Food and Drug Control, batch number 110737-200415;

[0099] Stilbene glycoside reference standard, National Institutes for Food and Drug Control, batch number 110844-200908.

[0100] III. Methods and Results

[0101] 1. Accelerated testing

[0102] 1.1 Test start time

[0103] April 2023.

[0104] 1.2. Placement conditions

[0105] Packed in commercially available pharmaceutical aluminum foil, samples were taken and observed at regular intervals at a temperature of 40±2℃.

[0106] 1.3. Time of Inspection

[0107] Samples were taken at the end of 0, 1, 2, 3, 6 and 9 months respectively.

[0108] 1.4. Site Visit

[0109] The main focus of the study was on the content of icariin, hyperoside, and stilbene glycoside in the product, as well as the thin-layer chromatography identification of astragaloside A in Astragalus membranaceus and the thin-layer chromatography identification of Morinda officinalis as a reference herb.

[0110] 1.5 Experimental Methods

[0111] The examination was conducted according to the methods and items outlined in the draft quality standards for drugs used in clinical research.

[0112] 1.6 Experimental Results

[0113] After 9 months of accelerated testing, the thin-layer chromatography (TLC) results for astragaloside A in Astragalus membranaceus and for Morinda officinalis as a control herb in the three batches of Example 1 formulation granules were all positive. The contents of icariin (434.8±18.7 μg / g, 440.2±13.6 μg / g, 437.4±10.8 μg / g), hyperoside (151.4±6.8 μg / g, 158.3±7.1 μg / g, 158.9±7.44 μg / g), and stilbene glycoside (366.9±11.6 μg / g, 374.6±10.6 μg / g, 370.1±18.6 μg / g) in the three batches of Example 1 formulation granules did not change significantly. The results are shown in Tables 3, 4, and 5.

[0114] Table 3. Results of High-Temperature Accelerated Test (Batch No.: 150302)

[0115]

[0116] Table 4. Results of High-Temperature Accelerated Test (Batch No.: 150303)

[0117]

[0118] Table 5. Results of High-Temperature Accelerated Test (Batch No.: 150304)

[0119]

[0120]

[0121] 2. Long-term testing

[0122] 2.1 Test start time

[0123] April 2023.

[0124] 2.2. Placement conditions

[0125] Packed in commercially available pharmaceutical aluminum foil, samples were taken periodically at a temperature of 25±2℃ for observation.

[0126] 2.3. Time of Inspection

[0127] Samples were taken at the end of 0, 3, 6 and 9 months respectively.

[0128] 2.4. Site Visit

[0129] The main focus of the study was on the content of icariin, hyperoside, and stilbene glycoside in the product, as well as the thin-layer chromatography identification of astragaloside A in Astragalus membranaceus and the thin-layer chromatography identification of Morinda officinalis as a reference herb.

[0130] 2.5 Experimental Methods

[0131] The examination was conducted according to the items and methods outlined in the draft quality standards for drugs used in clinical research.

[0132] 2.6 Experimental Results

[0133] After 9 months of accelerated testing, the thin-layer chromatography (TLC) results for astragaloside A in Astragalus membranaceus and for Morinda officinalis as a control herb in the granules of Example 1 from three batches were all positive. The contents of icariin (436.3±5.0~462.9+3.9μg / g), hyperoside (165.6+2.3~154.5+4.6μg / g), and stilbene glycoside (381.2±15.6~387.3±6.5μg / g) in the granules of Example 1 did not change significantly; the results are shown in Tables 6, 7, and 8.

[0134] Table 6. Results of long-term experiments (icariin content, μg / g)

[0135]

[0136]

[0137] Table 7. Results of long-term test (hyperoside content, μg / g)

[0138]

[0139] Table 8. Results of long-term test (stilbene glycoside content, μg / g)

[0140]

[0141] IV. Discussion

[0142] Accelerated and long-term tests showed that the contents of icariin, hyperoside, and stilbene glycoside in the granules of Example 1 did not change significantly after being stored for 9 months, and the qualitative identification results of Astragalus and Morinda officinalis remained stable.

[0143] Example 5

[0144] Acute toxicity test:

[0145] 1.1 LD50 determination

[0146] Half male and half female ICR mice, weighing 18-22g, were used. They were fasted for 12 hours, but allowed normal water intake during this period. The mice were then administered the drug once by gavage at the maximum concentration (25-fold concentrate) and the maximum volume (0.04 mL·g⁻¹). Symptoms of poisoning and mortality were observed and recorded. Autopsies were performed on deceased animals, and histological examinations were conducted for any abnormal lesions. The observation period was seven days. During this period: immediately after administration, mice showed decreased activity and slight lethargy; one hour later, their activity and demeanor gradually returned to normal; respiration was normal, and there were no abnormal secretions from the nose, eyes, or mouth; weight gain was normal. In Example 1, the granular extract was administered at the maximum possible dose, and no mouse deaths were observed; therefore, the LD50 could not be determined.

[0147] 1.2 Determination of maximum dosage

[0148] If the LD50 value cannot be determined, a maximum dose test shall be conducted in accordance with the relevant provisions of the "New Drug Approval Regulations". Two mice, half male and half female, weighing 20±2g, shall be used. They shall be fasted for 12 hours, but allowed normal water intake during this period. The maximum concentration (25-fold concentrate) shall be administered at a maximum volume of 0.04 mL / g over 24 hours. -1 The medication was administered three times by gavage. Immediately after administration, the animals were observed and recorded for 14 days to detect and record any signs of poisoning or death. During the observation period, mice showed decreased activity and slight lethargy immediately after administration; one hour later, their activity and demeanor gradually returned to normal; respiration was normal, and there were no abnormal secretions from the nose, eyes, or mouth. No obvious signs of poisoning were observed, and no animals died. The maximum dose of the formulation granules administered by gavage in Example 1 was 3 mL / g. -1 ·d -1 Animal weights were measured and the number of deaths was calculated before and after the experiment. The results showed that the formulation granules in Example 1 achieved the maximum possible daily dose of 3 mL / g. -1 ·d -1 At that time, the mice did not die within 14 days and gained weight. This daily dose was the maximum daily dose for mice, equivalent to 461.5 times the clinical dose.

[0149] 1.3 Histopathological Study of Acute Toxicity Experiment in Mice

[0150] 1.3.1 Experimental Methods

[0151] In the acute toxicity test, five mice were randomly selected and sacrificed. The heart, liver, spleen, lungs, kidneys and other organs were examined. The tissues were fixed in 10% formalin, routinely embedded in paraffin, and sectioned to a thickness of 4-5 μm. They were stained with hematoxylin and eosin (HE). According to the severity of the lesions, they were semi-quantitatively classified as mild "+", moderate "++", severe "+++", and extremely severe "++++". Tissues without lesions were marked as "-".

[0152] 1.3.2 Results

[0153] Mouse No. 1

[0154] (1) Heart

[0155] The cardiomyocytes showed clear striations without vacuolar degeneration or necrosis, and the interstitium showed no congestion, edema, or inflammatory cell infiltration.

[0156] (2) Liver

[0157] The liver lobule structure is clear, and hepatocytes are radially distributed around the central vein. There is no obvious degeneration or necrosis of hepatocytes. Interlobular arteries, interlobular veins, and interlobular bile ducts are visible in the portal area, without fibrous tissue hyperplasia or inflammatory cell infiltration.

[0158] (3) Spleen

[0159] The number of splenic corpuscles was neither increased nor decreased, the histological structure was clear, the central artery was visible, and there was no obvious dilation or congestion of the splenic sinuses.

[0160] (4) Lungs

[0161] The alveolar walls showed no significant thickening, congestion, or edema, and there was no edema fluid or inflammatory exudate in the alveolar cavities. The bronchial epithelial cells showed no degeneration or necrosis, there was no exudate in the cavities, and there was no significant inflammatory cell infiltration around the bronchi.

[0162] (5) Kidneys

[0163] The glomeruli showed no increase in volume or atrophy, and the renal tubular epithelial cells showed no degeneration or necrosis; no casts were found within the tubules. The medullary tubules were normal, and there was no inflammation in the renal interstitium.

[0164] Mice 2-5

[0165] The histopathological changes in the heart, liver, lungs, and kidneys were the same as in mouse No. 1. No degeneration or necrosis of the parenchymal cells in any organ was observed, and there was no congestion, edema, or inflammatory cell infiltration in the interstitium. Multinucleated giant cells were commonly seen in the spleen, which is normal. Histopathological observation results are shown below. Figures 1-5 .

[0166] 1.3.3 Summary and Discussion

[0167] In the acute toxicity test, the tissue structures of the heart, liver, spleen, lungs, and kidneys of five mice were clear under an optical microscope, with no pathological changes such as parenchymal cell degeneration and necrosis, interstitial vasodilation, congestion, or inflammatory cell infiltration observed. These results indicate that the granules formulated in Example 1 did not induce significant acute toxic reactions in the tested mouse organs.

Claims

1. A traditional Chinese medicine compound composition for treating oligoasthenospermia, characterized in that: The traditional Chinese medicine compound composition includes traditional Chinese medicine components, Western medicine components, and excipient components; the traditional Chinese medicine components include the following components: Astragalus membranaceus, Ophiopogon japonicus, Morinda officinalis, Epimedium brevicornu, processed Polygonum multiflorum, Cuscuta chinensis, and processed Polygonatum sibiricum; the Western medicine component is L-carnitine; the excipient components include the following components: zinc-containing components, selenium-containing components, and vitamin E.

2. The traditional Chinese medicine compound composition for treating oligoasthenospermia according to claim 1, characterized in that: The Chinese herbal ingredients include the following: Astragalus membranaceus 350-400g, Ophiopogon japonicus 150-200g, Morinda officinalis 150-200g, Epimedium brevicornu 150-200g, processed Polygonum multiflorum 300-350g, Cuscuta chinensis 500-550g, and processed Polygonatum sibiricum 300-350g.

3. The traditional Chinese medicine compound composition for treating oligoasthenospermia according to claim 1, characterized in that: The drug consists of 200-300g of levocarnitine.

4. The traditional Chinese medicine compound composition for treating oligoasthenospermia according to claim 1, characterized in that: The excipients include the following components: 1-5g of zinc, 1-10mg of selenium, and 10-20g of vitamin E.

5. The traditional Chinese medicine compound composition for treating oligoasthenospermia according to claim 1 or 4, characterized in that: The zinc-containing component is derived from zinc gluconate; the selenium-containing component is derived from sodium selenite.

6. The traditional Chinese medicine compound composition for treating oligoasthenospermia according to claim 1, characterized in that: The dosage form of the traditional Chinese medicine compound composition is tablets, capsules, or granules.

7. A method for preparing a traditional Chinese medicine compound composition for treating oligoasthenospermia as described in any one of claims 1-6, comprising the following steps: The components of traditional Chinese medicine are extracted and concentrated into an extract by decoction, then mixed with Western medicine components and excipients, granulated, and then tableted, filled into capsules, or directly obtained as granules.

8. The use of a traditional Chinese medicine compound composition for treating oligoasthenospermia as described in any one of claims 1-6 in the preparation of a drug for treating oligoasthenospermia.

Images