Composition for improving sperm motility as well as preparation method, taking method and application thereof

Abstract

The invention discloses a composition for improving sperm motility. The composition comprises traditional Chinese medicine components and western medicine components, wherein the traditional Chinese medicine component comprises the following raw materials in parts by weight: 15-40 parts of prepared rehmannia root, 10-30 parts of herba epimedii, 5-20 parts of cornu cervi pantotrichum, 10-30 parts of rhizoma cibotii, 5-25 parts of fructus rosae laevigatae, 10-30 parts of rhizoma polygonati, 10-30 parts of cynomorium songaricum, 5-25 parts of schisandra chinensis, 5-25 parts of morinda officinalis, 10-30 parts of flatstem milkvetch seed, 5-25 parts of fried honeycomb, 5-25 parts of cistanche, 5-25 parts of radix achyranthis bidentatae, 5-20 parts of teasel root, 5-20 parts of whole angelica sinensis, 5-25 parts of dogwood and 20-50 parts of Qu fructus aurantii; and the western medicine component is 20-100 mg of adenosine disodium triphosphate tablets. The composition for improving the sperm motility is rigorous in formula, is suitable for treating oligospermia and asthenospermia caused by various reasons, can also be used for developing medicines or health-care foods, provides a new product with the effect of improving the sperm motility, and is wide in application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of the combination of traditional Chinese and Western medicines, and more specifically, to a composition for improving sperm motility, its preparation method, administration method and application. Background Art

[0002] Among married families globally, infertile couples account for 15% - 18%, and among them, 50% are infertile due to male reasons. Currently, modern medicine is not very clear about the causes of male infertility. Currently, the common causes are considered to include semen disorders, spermatogenic disorders, sperm-egg binding disorders, endocrine factors, mental factors, genetic factors, etc., among which spermatogenic disorders are the most common. Oligozoospermia and asthenozoospermia are the most common types in male infertility. Currently, there are few treatment methods and drugs available, which is a hot topic in the research of male infertility.

[0003] In recent years, Western medicine has not been very effective in improving oligozoospermia and asthenozoospermia. Traditional Chinese medicine treatment focuses on the overall concept and syndrome differentiation and treatment, and has certain advantages in the treatment of male infertility, which is an important means for treating male infertility in China.

[0004] Currently, some patents for improving sperm motility have been published. For example, the Chinese invention patent application with the application number 201611215433.4 discloses a drug for improving sperm motility and its pharmaceutical use. This invention relates to the pharmaceutical use of deoxyschizandrin, specifically to the use of deoxyschizandrin in spermatogenesis and enhancing sperm motility. The deoxyschizandrin of this invention has the value of drug development.

[0005] The Chinese invention patent application with the application number 201910997818.8 discloses a compound for improving sperm quality and its application. This invention provides a compound for improving sperm motility and its application. Specifically, this invention discovers that GSSH can perform thiolation modification on histone H3 and participate in regulating sperm motility. That is, GSSH can significantly improve sperm motility by increasing the thiolation level of H3, thereby achieving the prevention or treatment of asthenospermia.

[0006] The Chinese invention patent application with the application number 202111408137.7 discloses a probiotic preparation for improving sperm motility and its uses. This invention belongs to the field of biomedical technology and relates to a probiotic preparation for improving sperm motility and the uses of this probiotic preparation. The probiotic preparation for improving sperm motility described in this invention includes Christensenella minuta. This invention provides the use of the probiotic preparation for preparing health foods for improving sperm motility, and also provides the use of the probiotic preparation for preparing drugs for improving sperm motility. This invention provides new products for protecting male reproductive health and provides a reliable theoretical basis for improving male sperm quality, which is of great significance and has good application scenarios in the probiotic health food market.

[0007] However, the therapeutic effects of the above-mentioned Chinese invention patent application are not particularly significant.

[0008] Therefore, how to develop a traditional Chinese medicine formula that can effectively treat oligospermia and asthenospermia in men is an urgent problem to be solved by those skilled in the art. Summary of the Invention

[0009] In view of this, the purpose of the present invention is to provide a composition for improving sperm motility and its preparation method, taking method and application to solve the deficiencies in the prior art.

[0010] To achieve the above purpose, the present invention adopts the following technical solutions:

[0011] A composition for improving sperm motility, comprising a traditional Chinese medicine component and a western medicine component;

[0012] Among them, the traditional Chinese medicine component includes raw materials in the following weight parts: 15 - 40 parts of Rehmannia glutinosa, 10 - 30 parts of Epimedium brevicornu, 5 - 20 parts of Cornu Cervi Pantotrichum, 10 - 30 parts of Cibotium barometz, 5 - 25 parts of Rosa laevigata, 10 - 30 parts of Polygonatum sibiricum, 10 - 30 parts of Cynomorium songaricum, 5 - 25 parts of Schisandra chinensis, 5 - 25 parts of Morinda officinalis, 10 - 30 parts of Astragalus complanatus, 5 - 25 parts of Nidus Vespae, 5 - 25 parts of Cistanche deserticola, 5 - 25 parts of Achyranthes bidentata, 5 - 20 parts of Dipsacus asperoides, 5 - 20 parts of Angelica sinensis, 5 - 25 parts of Cornus officinalis, and 20 - 50 parts of Fructus Aurantii Immaturus.

[0013] The western medicine component is 20 - 100 mg of adenosine triphosphate disodium tablets (ATP tablets).

[0014] The present invention is formulated based on traditional Chinese medicine theory. Rehmannia glutinosa replenishes blood and nourishes yin, and benefits essence and marrow; Epimedium brevicornu, Cornu Cervi Pantotrichum, Achyranthes bidentata, and Dipsacus asperoides tonify the liver and kidney, and strengthen the bones and muscles; Cynomorium songaricum and Cistanche deserticola warm the kidney yang, benefit essence and blood, and moisten the intestines for defecation; Rosa laevigata, Astragalus complanatus, and Cornus officinalis astringe sperm and reduce urination, and tonify the liver and kidney; Cibotium barometz, Morinda officinalis, and stir-fried Nidus Vespae dispel wind and strengthen yang; Polygonatum sibiricum supplements qi and nourishes yin, strengthens the spleen and tonifies the kidney; Schisandra chinensis replenishes qi and promotes the production of body fluid, and tonifies the kidney and tranquilizes the mind; Angelica sinensis replenishes blood and promotes blood circulation, and moistens the intestines for defecation. When all the herbs in the whole formula are combined, yin and yang are properly matched, and the tonification is not stagnant, which is applicable to oligospermia, asthenospermia and other symptoms caused by various reasons.

[0015] Meanwhile, in the traditional Chinese medicine formula of the present invention, the traditional Chinese medicine Fructus Aurantii Immaturus, which has anti-inflammatory and anti-aging effects, is added, which can better improve the curative effect of traditional Chinese medicines such as strengthening yang and tonifying the kidney in the treatment of oligospermia and asthenospermia. In addition, Fructus Aurantii Immaturus promotes qi movement and relieves distension, which is more conducive to the digestion and absorption of drugs and improves the bioavailability of drugs.

[0016] Moreover, on the basis of taking the traditional Chinese medicine formula, the present invention creatively takes Adenosine Disodium Triphosphate Tablets at the same time, which can better play a role in the treatment of oligospermia and asthenospermia.

[0017] Furthermore, the above-mentioned traditional Chinese medicine components include the following raw materials in parts by weight: 20-35 parts of Rehmannia glutinosa, 15-25 parts of Epimedium brevicornu, 5-15 parts of Cornu Cervi Pantotrichum, 15-25 parts of Cibotium barometz, 10-20 parts of Rosa laevigata, 15-25 parts of Polygonatum sibiricum, 15-25 parts of Cynomorium songaricum, 10-20 parts of Schisandra chinensis, 10-20 parts of Morinda officinalis, 15-25 parts of Astragalus complanatus, 10-20 parts of stir-fried Nidus Vespae, 10-20 parts of Cistanche deserticola, 10-20 parts of Achyranthes bidentata, 8-16 parts of Dipsacus asperoides, 8-16 parts of Angelica sinensis, 10-20 parts of Cornus officinalis, and 15-30 parts of Fructus Aurantii Immaturus;

[0018] The western medicine component is 40-80 mg of Adenosine Disodium Triphosphate Tablets.

[0019] Still further, the above-mentioned traditional Chinese medicine components include the following raw materials in parts by weight: 25 parts of Rehmannia glutinosa, 20 parts of Epimedium brevicornu, 8 parts of Cornu Cervi Pantotrichum, 20 parts of Cibotium barometz, 15 parts of Rosa laevigata, 20 parts of Polygonatum sibiricum, 20 parts of Cynomorium songaricum, 15 parts of Schisandra chinensis, 15 parts of Morinda officinalis, 20 parts of Astragalus complanatus, 15 parts of stir-fried Nidus Vespae, 15 parts of Cistanche deserticola, 15 parts of Achyranthes bidentata, 12 parts of Dipsacus asperoides, 12 parts of Angelica sinensis, 15 parts of Cornus officinalis, and 20 parts of Fructus Aurantii Immaturus;

[0020] The western medicine component is 40 mg of Adenosine Disodium Triphosphate Tablets.

[0021] Or, the above-mentioned traditional Chinese medicine components include the following raw materials in parts by weight: 20 parts of Rehmannia glutinosa, 15 parts of Epimedium brevicornu, 5 parts of Cornu Cervi Pantotrichum, 15 parts of Cibotium barometz, 10 parts of Rosa laevigata, 15 parts of Polygonatum sibiricum, 15 parts of Cynomorium songaricum, 10 parts of Schisandra chinensis, 10 parts of Morinda officinalis, 15 parts of Astragalus complanatus, 10 parts of stir-fried Nidus Vespae, 10 parts of Cistanche deserticola, 10 parts of Achyranthes bidentata, 8 parts of Dipsacus asperoides, 8 parts of Angelica sinensis, 10 parts of Cornus officinalis, and 20 parts of Fructus Aurantii Immaturus;

[0022] The western medicine component is 40 mg of adenosine disodium triphosphate tablets.

[0023] A preparation method of the above sperm motility enhancing composition, which comprises making the traditional Chinese medicine components into a traditional Chinese medicine preparation, and that's it.

[0024] Furthermore, the dosage form of the above traditional Chinese medicine preparation is decoction, granule, tablet, capsule, powder, pill, plaster, medicinal liquor, aerosol, film or liposome.

[0025] A taking method of the above sperm motility enhancing composition, characterized in that the traditional Chinese medicine components are made into a traditional Chinese medicine preparation and taken simultaneously with the western medicine components, 3 times a day.

[0026] Furthermore, the dosage form of the above traditional Chinese medicine preparation is decoction, granule, tablet, capsule, powder, pill, plaster, medicinal liquor, aerosol, film or liposome.

[0027] An application of the above sperm motility enhancing composition in the preparation of a drug or health food having the effect of enhancing sperm motility.

[0028] An application of the above sperm motility enhancing composition in the preparation of a drug for treating oligospermia and asthenospermia.

[0029] It can be seen from the above technical solutions that, compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] 1. The applicant has clinically treated more than 1,000 oligospermia and asthenospermia infertile patients by combining traditional Chinese and western medicines for more than twenty years, and the treatment success rate has reached more than 90%. At the same time, the applicant used a rat oligospermia and asthenospermia animal model to investigate its effect of enhancing sperm motility, and the results also confirmed that the composition of the present invention can effectively enhance the sperm motility of oligospermia and asthenospermia rats.

[0031] 2. The composition for enhancing sperm motility of the present invention has a rigorous formula, is suitable for the treatment of oligospermia and asthenospermia caused by various reasons, can also be used for developing drugs or health foods, providing new products with the effect of enhancing sperm motility, and has broad application prospects. Detailed implementation manners

[0032] The technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0033] Example 1

[0034] A sperm motility enhancing composition, comprising traditional Chinese medicine components and western medicine components;

[0035] Among them, the traditional Chinese medicine components include raw materials with the following weights: 25 g of Rehmannia glutinosa preparata, 20 g of Epimedium brevicornu, 8 g of Cornu Cervi Pantotrichum, 20 g of Cibotium barometz, 15 g of Rosa laevigata Michx., 20 g of Polygonatum sibiricum Redoute, 20 g of Cynomorium songaricum Rupr., 15 g of Schisandra chinensis (Turcz.) Baill., 15 g of Morinda officinalis How, 20 g of Astragalus complanatus R. Br., 15 g of Nidus Vespae stir-fried, 15 g of Cistanche deserticola Ma, 15 g of Achyranthes bidentata Blume, 12 g of Dipsacus asperoides C. Y. Cheng & T. M. Ai, 12 g of Angelica sinensis (Oliv.) Diels, 15 g of Cornus officinalis Sieb. et Zucc., and 20 g of Fructus Aurantii Immaturus.

[0036] The western medicine component is 40 mg of Adenosine Disodium Triphosphate Tablets.

[0037] The preparation method of the above-mentioned composition for improving sperm motility: Place the raw materials of the traditional Chinese medicine components in a casserole, first add 1 L of water and bring to a boil, then gently decoct for 30 min, and finally reduce the juice to 450 mL to make a traditional Chinese medicine decoction.

[0038] The administration method of the above-mentioned composition for improving sperm motility: First take 150 mL of the traditional Chinese medicine decoction each time (decocted and taken on the same day), and then take 2 tablets of Adenosine Disodium Triphosphate Tablets (20 mg / tablet), 3 times a day (once in the morning, once in the middle, and once in the evening).

[0039] Example 2

[0040] A composition for improving sperm motility, comprising traditional Chinese medicine components and western medicine components;

[0041] Among them, the traditional Chinese medicine components include raw materials with the following weights: 20 g of Rehmannia glutinosa preparata, 15 g of Epimedium brevicornu, 5 g of Cornu Cervi Pantotrichum, 15 g of Cibotium barometz, 10 g of Rosa laevigata Michx., 15 g of Polygonatum sibiricum Redoute, 15 g of Cynomorium songaricum Rupr., 10 g of Schisandra chinensis (Turcz.) Baill., 10 g of Morinda officinalis How, 15 g of Astragalus complanatus R. Br., 10 g of Nidus Vespae stir-fried, 10 g of Cistanche deserticola Ma, 10 g of Achyranthes bidentata Blume, 8 g of Dipsacus asperoides C. Y. Cheng & T. M. Ai, 8 g of Angelica sinensis (Oliv.) Diels, 10 g of Cornus officinalis Sieb. et Zucc., and 20 g of Fructus Aurantii Immaturus.

[0042] The western medicine component is 40 mg of Adenosine Disodium Triphosphate Tablets.

[0043] The preparation method of the above-mentioned composition for improving sperm motility: Place the raw materials of the traditional Chinese medicine components in a casserole, first add 1 L of water and bring to a boil, then gently decoct for 30 min, and finally reduce the juice to 450 mL to make a traditional Chinese medicine decoction.

[0044] The administration method of the above-mentioned composition for improving sperm motility: First take 150 mL of the traditional Chinese medicine decoction each time (decocted and taken on the same day), and then take 2 tablets of Adenosine Disodium Triphosphate Tablets (20 mg / tablet), 3 times a day (once in the morning, once in the middle, and once in the evening).

[0045] Example 3

[0046] A composition for improving sperm motility, comprising traditional Chinese medicine components and western medicine components;

[0047] Among them, the traditional Chinese medicine components include raw materials with the following weights: 25 g of Rehmannia glutinosa preparata, 20 g of Epimedium brevicornu, 8 g of Cornu Cervi Pantotrichum, 20 g of Cibotium barometz, 15 g of Rosa laevigata Michx., 20 g of Polygonatum sibiricum, 20 g of Cynomorium songaricum, 15 g of Schisandra chinensis, 15 g of Morinda officinalis, 20 g of Astragalus complanatus, 15 g of Nidus Vespae stir-fried, 15 g of Cistanche deserticola, 15 g of Achyranthes bidentata, 12 g of Dipsacus asperoides, 12 g of Angelica sinensis, 15 g of Cornus officinalis, and 20 g of Fructus Aurantii Immaturus of Quzhou;

[0048] The western medicine component is 40 mg of adenosine triphosphate disodium tablets;

[0049] The preparation method of the above composition for improving sperm motility: extract, concentrate, dry, granulate, and table the traditional Chinese medicine components in sequence to make traditional Chinese medicine tablets;

[0050] The taking method of the above composition for improving sperm motility: first take the traditional Chinese medicine tablets, and then take 2 adenosine triphosphate disodium tablets (20 mg / tablet), 3 times a day (once in the morning, middle, and evening).

[0051] Example 4

[0052] A composition for improving sperm motility, including traditional Chinese medicine components and western medicine components;

[0053] Among them, the traditional Chinese medicine components include raw materials with the following weights: 20 g of Rehmannia glutinosa preparata, 15 g of Epimedium brevicornu, 5 g of Cornu Cervi Pantotrichum, 15 g of Cibotium barometz, 10 g of Rosa laevigata Michx., 15 g of Polygonatum sibiricum, 15 g of Cynomorium songaricum, 10 g of Schisandra chinensis, 10 g of Morinda officinalis, 15 g of Astragalus complanatus, 10 g of Nidus Vespae stir-fried, 10 g of Cistanche deserticola, 10 g of Achyranthes bidentata, 8 g of Dipsacus asperoides, 8 g of Angelica sinensis, 10 g of Cornus officinalis, and 20 g of Fructus Aurantii Immaturus of Quzhou;

[0054] The western medicine component is 40 mg of adenosine triphosphate disodium tablets;

[0055] The preparation method of the above composition for improving sperm motility: extract, concentrate, dry, granulate, and table the traditional Chinese medicine components in sequence to make traditional Chinese medicine tablets;

[0056] The taking method of the above composition for improving sperm motility: first take the traditional Chinese medicine tablets, and then take 2 adenosine triphosphate disodium tablets (20 mg / tablet), 3 times a day (once in the morning, middle, and evening).

[0057] Control group

[0058] A composition for improving sperm motility, including traditional Chinese medicine components and western medicine components;

[0059] Among them, the traditional Chinese medicine components include raw materials with the following weights: 25 g of Rehmannia glutinosa preparata, 20 g of Epimedium brevicornu, 8 g of Cornu Cervi Pantotrichum, 20 g of Cibotium barometz, 15 g of Rosa laevigata Michx., 20 g of Polygonatum sibiricum, 20 g of Cynomorium songaricum, 15 g of Schisandra chinensis, 15 g of Morinda officinalis, 20 g of Astragalus complanatus, 15 g of Nidus Vespae stir-fried, 15 g of Cistanche deserticola, 15 g of Achyranthes bidentata, 12 g of Dipsacus asperoides, 12 g of Angelica sinensis, and 15 g of Cornus officinalis;

[0060] The western medicine component is 40 mg of adenosine triphosphate disodium tablets;

[0061] The preparation method of the above composition for improving sperm motility: Place the raw materials of the traditional Chinese medicine components in a casserole, first add 1 L of water and bring to a boil, then gently decoct for 30 min, and finally collect the juice to 450 mL to make a traditional Chinese medicine decoction;

[0062] The administration method of the above composition for improving sperm motility: First take 150 mL of the traditional Chinese medicine decoction each time (decocted and taken on the same day), and then take 2 adenosine triphosphate disodium tablets (20 mg / tablet), 3 times a day (once in the morning, middle, and evening).

[0063] Performance Test

[0064] 1. Clinical application example 1

[0065] Some clinical data show that the sperm motility of male patients with reproductive disorders is mostly relatively weak. The sperm concentration of normal people is about 2000×10 4 cells / mL, and the sperm survival rate is 50% - 60%.

[0066] Randomly select 15 male patients with reproductive disorders and conduct sperm motility tests before treatment. During the treatment process, continuously treat for 30 days according to the composition, its preparation method, and administration method in Example 1. Conduct sperm motility tests after 30 days.

[0067] The results are shown in Table 1.

[0068] Table 1 Partial treatment data of the present invention for male patients with clinical reproductive disorders

[0069]

[0070]

[0071] As can be seen from Table 1, before treatment, the sperm concentration of 15 patients was (1 - 400)×10 4 cells / mL, and the sperm survival rate was 3% - 23%, both far lower than the normal level. After 30 days of continuous treatment, the sperm concentration and sperm survival rate of 15 patients have been significantly improved. The sperm concentration can be increased by up to 48 times at most, and the sperm survival rate can be increased by up to 7 times at most. Moreover, the sperm survival rate can reach half of the normal level.

[0072] 2. Clinical Application Example 2

[0073] 1085 male patients with reproductive disorders were randomly treated with the compositions of Examples 1 to 4, their preparation methods and administration methods in the outpatient clinic. Among them, the sperm concentration and sperm motility of 91.71% of the patients were significantly improved, and more than 80% of the patients successfully gave birth.

[0074] Clinical data show that the composition of the present invention can significantly improve the sperm motility of male patients with reproductive disorders and improve their fertility.

[0075] 3. Animal Experiment Application Example 1

[0076] The 450 mL traditional Chinese medicine decoction prepared in Example 1 was concentrated to 100 mL, and the concentration was 3.02 g of crude drug / mL at this time.

[0077] 56 male SD rats weighing 200 - 220 g were randomly divided into a control group, a model group, a positive drug group (Wuzi Yanzong Pills 1 g / kg), a high-dose traditional Chinese medicine treatment group (15 g of crude drug / kg), an ATP treatment group (10.5 mg ATP / kg), a high-dose traditional Chinese and Western medicine treatment group (15 g of crude drug / kg + 10.5 mg ATP / kg), and a low-dose traditional Chinese and Western medicine treatment group (5 g of crude drug / kg + 3.5 mg ATP / kg), with 8 rats in each group. Except for the control group, the other groups were orally administered Tripterygium glycosides 30 mg / kg once a day for 40 consecutive days to establish a model of oligoasthenospermia. Starting from the 41st day, the positive drug group, the high-dose traditional Chinese medicine treatment group, the ATP treatment group, the high-dose traditional Chinese and Western medicine treatment group, and the low-dose traditional Chinese and Western medicine treatment group were given corresponding doses for treatment. After 28 consecutive days of treatment, the sperm quality, hormone levels, and testicular oxidative stress indexes of the rats were detected to evaluate the effect of the composition of Example 1 in treating oligoasthenospermia.

[0078] (1) To investigate the effect of the composition of Example 1 on the sperm quality of rats with oligoasthenospermia, a sperm analyzer was used to detect the sperm concentration and sperm survival rate of the rats.

[0079] The results are shown in Table 2.

[0080] Table 2 Effects of different treatment groups on sperm quality of rats with oligoasthenospermia

[0081]

[0082] Note: Compared with the control group, *** P < 0.001; compared with the model group, ## P < 0.01, ### P < 0.001; compared with the positive drug group, P < 0.05, P < 0.01, P < 0.001; Compared with the high-dose traditional Chinese medicine treatment group, P < 0.05, P < 0.001.

[0083] As can be seen from Table 2, compared with the control group, the sperm concentration and sperm survival rate of the rats in the model group were significantly decreased. After treatment with the positive drug Wuzi Yanzong Pills, the sperm concentration and sperm survival rate were significantly increased (P < 0.01 compared with the model control group), indicating that the model was treatable. After treatment with high-dose traditional Chinese medicine alone, the sperm concentration and sperm survival rate were significantly improved (P < 0.01 compared with the model control group), and the treatment effect was significantly better than that of the positive drug group (P < 0.05 compared with the positive drug group). After treatment with ATP alone, the sperm concentration and sperm survival rate were not significantly improved (P > 0.05 compared with the model control group). After treatment with the combination of traditional Chinese and Western medicine, the sperm concentration and sperm survival rate were significantly increased (P < 0.001 compared with the model control group), showing a dose-dependent relationship. At the same time, the treatment effect was significantly better than that of the positive drug group (P < 0.001 compared with the positive drug group), and was better than the effect of high-dose traditional Chinese medicine alone (P < 0.05 compared with the high-dose traditional Chinese medicine treatment group).

[0084] The above experiments show that the traditional Chinese medicine formula of the composition in Example 1 has a good ability to improve sperm motility, and the effect of the combination of traditional Chinese and Western medicine formula is better, both significantly better than the marketed positive drug.

[0085] (2) To investigate the effect of the composition in Example 1 on the reproductive hormone levels of SD male rats, the levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone (T) in the rat serum were detected.

[0086] The results are shown in Table 3.

[0087] Table 3 Effects of different treatment groups on the reproductive hormone levels of SD male rats

[0088]

[0089] Note: Compared with the control group, *** P < 0.001; compared with the model group, # P < 0.05, ## P < 0.01, ### P < 0.001; compared with the positive drug group P < 0.05, P < 0.01, P < 0.001; compared with the high-dose traditional Chinese medicine treatment group P < 0.05, P < 0.01, P < 0.001.

[0090] As shown in Table 3, compared with the control group, the levels of estrogen FSH and LH in the serum of rats in the model group were significantly increased, while the level of androgen T was significantly decreased. After treatment with the positive drug Wuzi Yanzong Pills, the hormone levels of FSH and LH were significantly improved (P < 0.05 compared with the model control group), indicating that the model was treatable. After treatment with the high-dose traditional Chinese medicine alone, the indexes of FSH, LH, and T were significantly improved (P < 0.05 compared with the model control group), and the treatment effect was significantly better than that of the positive drug group (P < 0.05 compared with the positive drug group). After treatment with ATP alone, the indexes of FSH, LH, and T were not significantly improved (P > 0.05 compared with the model control group). After treatment with the traditional Chinese and Western medicine treatment formula, the indexes of FSH, LH, and T were significantly improved (P < 0.001 compared with the model control group), and there was a dose correlation. At the same time, the treatment effect was significantly better than that of the positive drug group (P < 0.05 compared with the positive drug group), and it was better than the effect of treating with the high-dose traditional Chinese medicine alone (P < 0.05 compared with the high-dose traditional Chinese medicine treatment group).

[0091] The above experiments showed that the traditional Chinese medicine formula of the composition in Example 1 had a good effect on improving hormone levels, and the effect of the traditional Chinese and Western medicine formula was better, both significantly superior to the marketed positive drug.

[0092] (3) Oligozoospermia and asthenospermia are accompanied by oxidative stress damage to the reproductive system. To investigate the effect of the composition in Example 1 on oxidative stress in the testis tissue of SD male rats, the levels of oxidative indexes superoxide dismutase (SOD) and malondialdehyde (MDA) in the testis tissue of rats were detected.

[0093] The results are shown in Table 4.

[0094] Table 4 Effects of different treatment groups on oxidative stress indexes in the testis tissue of SD male rats

[0095]

[0096] Note: Compared with the control group, *** P < 0.001; compared with the model group, # P < 0.05, ## P < 0.01, ### P < 0.001; compared with the positive drug group P < 0.05, P < 0.01, P < 0.001; compared with the high-dose traditional Chinese medicine treatment group P < 0.05, P < 0.01.

[0097] As can be seen from Table 4, compared with the control group, the MDA level in the testicular tissue of rats in the model group was significantly increased, while the SOD level was significantly decreased, indicating that obvious oxidative damage occurred in the model group. After treatment with the positive drug Wuzi Yanzong Pills, both the MDA and SOD levels were significantly improved (P<0.05 compared with the model control group), indicating that the model was treatable. After treatment with the high-dose traditional Chinese medicine alone, the MDA and SOD indexes were significantly improved (P<0.05 compared with the model control group), and the treatment effect was significantly better than that of the positive drug group, especially the difference in the MDA index was obvious (P<0.05 compared with the positive drug group). After treatment with ATP alone, the FSH, LH, and T indexes were not significantly improved (P>0.05 compared with the model control group). After treatment with the traditional Chinese and Western medicine treatment formula, the MDA and SOD indexes were significantly improved (P<0.01 compared with the model control group), and there was a dose correlation. At the same time, the treatment effect was significantly better than that of the positive drug group (P<0.05 compared with the positive drug group), and it was better than the treatment effect of the high-dose traditional Chinese medicine alone. Especially, the treatment effect of the high-dose traditional Chinese and Western medicine treatment group was more significantly improved (P<0.01 compared with the high-dose traditional Chinese medicine treatment group).

[0098] The above experiments show that the traditional Chinese medicine formula of the composition in Example 1 has good antioxidant effects, and the traditional Chinese and Western medicine formula has better effects, both of which are significantly better than the marketed positive drugs.

[0099] Verified by animal experiments, the traditional Chinese and Western medicine combination treatment method of the present invention can effectively improve the reproductive ability of rats with oligospermia and asthenospermia.

[0100] 4. Application Example 2 of Animal Experiment

[0101] Sixteen male SD rats weighing 200-220 g were randomly divided into a Wuzi Yanzong Pills treatment group (1 g / kg) and a Wuzi Yanzong Pills + ATP combined treatment group (1 g / kg + 10.5 mg ATP / kg), with 8 rats in each group. Both groups of rats were first orally gavaged with tripterygium glycosides 30 mg / kg once a day for 40 consecutive days to establish a model of oligospermia and asthenospermia. Starting from the 41st day, the two groups of rats were given corresponding doses for treatment. After 28 consecutive days of treatment, the sperm quality of the rats was detected to evaluate whether ATP could also enhance the curative effect of other traditional Chinese medicines (Wuzi Yanzong Pills) for treating oligospermia and asthenospermia.

[0102] To investigate the effect of the combined treatment of Wuzi Yanzong Pills and ATP on the sperm quality of rats with oligospermia and asthenospermia, a sperm analyzer was used to detect the sperm concentration and sperm survival rate of the rats.

[0103] The results are shown in Table 5.

[0104] Table 5 Effect of ATP combined with Wuzi Yanzong Pills on sperm quality of rats with oligospermia and asthenospermia

[0105] Group <![CDATA[Sperm concentration (×10 6 / mL)]]> Sperm survival rate (%) Wuzi Yanzong Pills 96.46±18.65 3.84±1.18 Wuzi Yanzong Pills + ATP 102.11±21.37 3.91±0.86

[0106] As can be seen from Table 5, ATP has no obvious enhancing effect on the treatment of Wuzi Yanzong Pills (P > 0.05 compared with the Wuzi Yanzong Pills group).

[0107] The above experiments show that ATP has no obvious synergistic effect on other traditional Chinese medicines for treating oligoasthenospermia, and its combination with the traditional Chinese medicine of the present invention has a better therapeutic synergistic effect.

[0108] 5. Application Example 3 of Animal Experiment

[0109] The 450 mL traditional Chinese medicine decoctions prepared in Example 1 (containing Quchi Fructus Aurantii) and the comparative example (without Quchi Fructus Aurantii) were respectively concentrated to 100 mL.

[0110] Fifteen male SD rats weighing 200 - 220 g were randomly divided into a model group, a traditional Chinese and Western medicine treatment group containing Quchi Fructus Aurantii (5 mL / kg + 10.5 mg ATP / kg), and a traditional Chinese and Western medicine treatment group without Quchi Fructus Aurantii (5 mL / kg + 10.5 mg ATP / kg), with 5 rats in each group. All three groups of rats were first orally administered Tripterygium glycosides 30 mg / kg once a day for 40 consecutive days to establish an oligoasthenospermia model. Starting from the 41st day, the rats in the two treatment groups were given the corresponding doses of traditional Chinese and Western medicines for treatment. After 28 consecutive days of treatment, the sperm quality of the rats was detected to evaluate the enhancing effect of Quchi Fructus Aurantii on the efficacy of the traditional Chinese medicine in Example 1 composition for treating oligoasthenospermia.

[0111] To investigate the role of Quchi Fructus Aurantii in improving the efficacy of the composition in Example 1 for treating oligoasthenospermia, a sperm analyzer was used to detect the sperm concentration and sperm survival rate of the rats.

[0112] The results are shown in Table 6.

[0113] Table 6 Effects of Different Treatment Groups on Sperm Quality of Rats with Oligoasthenospermia

[0114]

[0115] Note: Compared with the model group, ### P < 0.001; compared with the traditional Chinese and Western medicine treatment group without Quchi Fructus Aurantii, P < 0.01.

[0116] As can be seen from Table 6, both the traditional Chinese and Western medicine treatment group containing Quchi Fructus Aurantii and the traditional Chinese and Western medicine treatment group without Quchi Fructus Aurantii can significantly improve the sperm motility of rats with oligoasthenospermia (P < 0.001 compared with the model group), and the treatment effect of the traditional Chinese and Western medicine treatment group containing Quchi Fructus Aurantii is significantly better than that of the traditional Chinese and Western medicine treatment group without Quchi Fructus Aurantii (P < 0.01).

[0117] The above tests indicate that Aurantii Fructus Immaturus Qiju plays an important role in the treatment of oligoasthenospermia with the composition of the present invention.

[0118] The foregoing description of the disclosed embodiments enables those skilled in the art to practice or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Thus, the invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A composition for improving sperm motility, characterized in that: Including Chinese medicine components and Western medicine components; The Chinese medicine component comprises the following raw materials in parts by weight: 15-40 parts of Radix Rehmanniae, 10-30 parts of Herba Epimedii, 5-20 parts of Herba Pelvis Thunb, 10-30 parts of Cibotium Cibotii, 5-25 parts of Fructus Rosae Laevigatae, 10-30 parts of Polygonatum Sibiricum, 10-30 parts of Cynomorium Songaricum, 5-25 parts of Fructus Schisandrae Chinensis, 5-25 parts of Morinda Officinalis, 10-30 parts of Fructus Astragali, 5-25 parts of Fructus Apis cerasiferae, 5-25 parts of Herba Cistanches, 5-25 parts of Herba Cynomorii, 5-25 parts of Herba Cynomorii, 5-20 parts of Herba Dipsaci, 5-20 parts of Herba Angelicae Sinensis, 5-25 parts of Fructus Corni and 20-50 parts of Fructus Citrus Aurantii Immaturus. The western medicine component is 20-100 mg of adenosine triphosphate disodium tablets.

2. A composition for improving sperm motility according to claim 1, characterized in that: The Chinese medicine component comprises the following raw materials in parts by weight: 20-35 parts of Radix Rehmanniae, 15-25 parts of Herba Epimedii, 5-15 parts of Herba Pilosae Antler, 15-25 parts of Cibotium Cibotium, 10-20 parts of Fructus Rosae Laevigatae, 15-25 parts of Rhizoma Polygonati Spermatis, 15-25 parts of Cynomorium Songaricum, 10-20 parts of Fructus Schisandrae Chinensis, 10-20 parts of Morinda Officinalis, 15-25 parts of Fructus Astragali, 10-20 parts of Fructus Apis cerasiferae, 10-20 parts of Herba Cistanches, 10-20 parts of Herba Cistanches, 8-16 parts of Dipsacus Asper, 8-16 parts of Radix Angelicae Sinensis, 10-20 parts of Fructus Corni and 15-30 parts of Fructus Citrus Aurantii Immaturus. The western medicine component is 40-80 mg of adenosine triphosphate disodium tablets.

3. A composition for improving sperm motility according to claim 2, characterized in that: The Chinese medicinal components include the following raw materials in parts by weight: 25 parts of Radix Rehmanniae Preparata, 20 parts of Herba Epimedii, 8 parts of Herba Pilosae Antler, 20 parts of Cibotium Cibotium, 15 parts of Fructus Rosae Laevigatae, 20 parts of Rhizoma Polygonati Sinensis, 20 parts of Cynomorium Songaricum, 15 parts of Fructus Schisandrae Chinensis, 15 parts of Morinda Officinalis, 20 parts of Fructus Astragali, 15 parts of Fructus Bee Hois, 15 parts of Herba Cistanches, 15 parts of Herba Cynoglossi, 12 parts of Herba Dipsaci, 12 parts of Radix Angelicae Sinensis, 15 parts of Fructus Corni and 20 parts of Fructus Aurantii Immaturus. The western medicine component is 40 mg of adenosine triphosphate disodium tablets.

4. A composition for improving sperm motility according to claim 2, characterized in that: The Chinese medicinal components include the following raw materials in parts by weight: 20 parts of Radix Rehmanniae Preparata, 15 parts of Herba Epimedii, 5 parts of Herba Pilosae Antler, 15 parts of Cibotium Cibotium, 10 parts of Fructus Rosae Laevigatae, 15 parts of Rhizoma Polygonati Sinensis, 15 parts of Cynomorium Songaricum, 10 parts of Fructus Schisandrae Chinensis, 10 parts of Morinda Officinalis, 15 parts of Fructus Astragali, 10 parts of Fructus Bee Hois, 10 parts of Herba Cistanches, 10 parts of Herba Cynomorii, 8 parts of Radix Dipsaci, 8 parts of Radix Angelicae Sinensis, 10 parts of Fructus Corni and 20 parts of Fructus Aurantii Immaturus. The western medicine component is 40 mg of adenosine triphosphate disodium tablets.

5. A method for preparing a composition for improving sperm motility according to any one of claims 1 to 4, characterized in that: The Chinese medicine components are made into Chinese medicine preparations.

6. The method for preparing a composition for improving sperm motility according to claim 5, characterized in that: The dosage form of the Chinese medicine preparation is decoction, granules, tablets, capsules, powders, pills, pastes, wine preparations, aerosols, membrane preparations or liposomes.

7. A method for taking the composition for improving sperm motility according to any one of claims 1 to 4, characterized in that: The Chinese medicine components are made into Chinese medicine preparations and taken together with the Western medicine components, 3 times a day.

8. The method for taking the composition for improving sperm motility according to claim 7, characterized in that: The dosage form of the Chinese medicine preparation is decoction, granules, tablets, capsules, powders, pills, pastes, wine preparations, aerosols, membrane preparations or liposomes.

9. Use of the composition for improving sperm motility as claimed in any one of claims 1 to 4 in the preparation of a medicine or health food having the effect of improving sperm motility.

10. Use of the composition for improving sperm motility according to any one of claims 1 to 4 in the preparation of a drug for treating oligospermia and asthenospermia.

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