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

Abstract

The invention relates to the technical field of medicines, and discloses a traditional Chinese medicine composition for treating oligoasthenospermia and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-15 parts of fig, 10-15 parts of eyebrow bean, 10-15 parts of Chinese yam, 5-10 parts of black peanut, 5-10 parts of sea-buckthorn, 5-10 parts of gordon euryale seed, 5-10 parts of radix cynanchi bungei, 5-10 parts of pomegranate, 5-10 parts of hawthorn, 5-10 parts of cedrela sinensis, 5-10 parts of maca, 5-10 parts of fingered citron and 5-10 parts of date palm. , 5-10 parts by weight of rhizoma polygonati, 5-10 parts by weight of Chinese wolfberry, and 5-10 parts by weight of whole litchi. The medicine prepared from the traditional Chinese medicine composition disclosed by the invention has the effects of tonifying kidney and spleen, promoting diuresis and activating blood, and producing and strengthening sperms, is expected to become a medicine for clinically treating oligospermia, weakness and abnormal spermatospermia, is easy to store and transport, and is beneficial to popularization and application.

Description

Technical Field

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

[0002] In clinical practice, oligoasthenozoospermia is a common disease, which is manifested by a small number of sperm or (and) insufficient sperm motility. Clinical studies have shown that male infertility is directly related to the motility or motility of sperm. Experiments have shown that only sperm in normal forward motion can reach the ampulla of the fallopian tube and combine with the egg to form a fertilized egg. Because the number of sperm in patients with oligoasthenozoospermia is small and the sperm motility is poor, they cannot smoothly reach the ampulla of the fallopian tube and form a fertilized egg with the egg, which leads to male infertility. With the development of society, the accelerated pace of life, and environmental pollution, the number of infertile patients has increased year by year, and human reproductive capacity has gradually declined. Therefore, in clinical practice, how to effectively treat patients with oligospermia and asthenozoospermia has become the main problem at present. Summary of the invention

[0003] The purpose of the present invention is to overcome the problem existing in the prior art of how to effectively treat patients with oligospermia and asthenospermia in clinical practice, and to provide a Chinese medicine composition and Chinese medicine for treating oligoasthenospermia and a preparation method and application thereof. The Chinese medicine composition can nourish the kidney and spleen, promote dampness and activate blood circulation, produce sperm and strengthen sperm, and is used to treat oligospermia, asthenospermia and teratospermia. It is expected to become a drug for clinical treatment of oligoasthenospermia and is easy to store and transport, which is conducive to popularization and application.

[0004] In order to achieve the above-mentioned object, the first aspect of the present invention provides a Chinese medicine composition for treating oligoasthenozoospermia, wherein the raw material for preparing the Chinese medicine composition comprises: 10-15 parts by weight of figs, 10-15 parts by weight of black peas, 10-15 parts by weight of yam, 5-10 parts by weight of black peanuts, 5-10 parts by weight of sea buckthorn, 5-10 parts by weight of Euryale ferox, 5-10 parts by weight of Cynanchum multiflorum, 5-10 parts by weight of pomegranate, 5-10 parts by weight of hawthorn, 5-10 parts by weight of toon, 5-10 parts by weight of maca, 5-10 parts by weight of bergamot, 5-10 parts by weight of dates, 5-10 parts by weight of polygonatum, 5-10 parts by weight of wolfberry, and 5-10 parts by weight of whole lychee.

[0005] Preferably, the raw materials for preparing the Chinese medicine composition contain: Figs 12-15 parts by weight, black-eyed peas 12-15 parts by weight, yam 12-15 parts by weight, black peanuts 7-10 parts by weight, sea buckthorn 7-10 parts by weight, Euryale ferox 7-10 parts by weight, Cynanchum multiflorum 7-10 parts by weight, pomegranate 7-10 parts by weight, hawthorn 7-10 parts by weight, toon 7-10 parts by weight, maca 7-10 parts by weight, bergamot 7-10 parts by weight, dates 7-10 parts by weight, polygonatum 7-10 parts by weight, wolfberry 7-10 parts by weight, whole lychee 7-10 parts by weight.

[0006] Preferably, the raw materials for preparing the Chinese medicine composition contain: Fig 15 parts by weight, black-eyed pea 15 parts by weight, yam 15 parts by weight, black peanut 10 parts by weight, sea buckthorn 10 parts by weight, Euryale ferox 10 parts by weight, Cynanchum multiflorum 10 parts by weight, pomegranate 10 parts by weight, hawthorn 10 parts by weight, toon 10 parts by weight, maca 10 parts by weight, bergamot 10 parts by weight, date palm 10 parts by weight, polygonatum 10 parts by weight, wolfberry 10 parts by weight, whole lychee 10 parts by weight.

[0007] Preferably, the dosage form of the traditional Chinese medicine composition is at least one of granules, pills, pastes, powders, decoctions, tablets and capsules.

[0008] The second aspect of the present invention provides a method for preparing a Chinese medicine composition for treating oligoasthenozoospermia, the method comprising: preparing a raw material medicine containing the following component proportions, and then extracting, 10-15 parts by weight of figs, 10-15 parts by weight of black peas, 10-15 parts by weight of yam, 5-10 parts by weight of black peanuts, 5-10 parts by weight of sea buckthorn, 5-10 parts by weight of Euryale ferox, 5-10 parts by weight of Cynanchum multiflorum, 5-10 parts by weight of pomegranate, 5-10 parts by weight of hawthorn, 5-10 parts by weight of toon, 5-10 parts by weight of maca, 5-10 parts by weight of bergamot, 5-10 parts by weight of dates, 5-10 parts by weight of polygonatum, 5-10 parts by weight of wolfberry, and 5-10 parts by weight of whole lychee.

[0009] Preferably, the raw material medicine contains: 12-15 parts by weight of figs, 12-15 parts by weight of black beans, 12-15 parts by weight of yam, 7-10 parts by weight of black peanuts, 7-10 parts by weight of sea buckthorn, 7-10 parts by weight of Euryale ferox, 7-10 parts by weight of Cynanchum multiflorum, 7-10 parts by weight of pomegranate, 7-10 parts by weight of hawthorn, 7-10 parts by weight of toon, 7-10 parts by weight of maca, 7-10 parts by weight of bergamot, 7-10 parts by weight of dates, 7-10 parts by weight of polygonatum, 7-10 parts by weight of wolfberry, and 7-10 parts by weight of whole lychee.

[0010] Preferably, the raw material medicine contains: 15 parts by weight of figs, 15 parts by weight of black beans, 15 parts by weight of yam, 10 parts by weight of black peanuts, 10 parts by weight of sea buckthorn, 10 parts by weight of Euryale ferox, 10 parts by weight of Cynanchum multiflorum, 10 parts by weight of pomegranate, 10 parts by weight of hawthorn, 10 parts by weight of toon, 10 parts by weight of maca, 10 parts by weight of bergamot, 10 parts by weight of dates, 10 parts by weight of polygonatum, 10 parts by weight of wolfberry, and 10 parts by weight of whole lychee.

[0011] Preferably, the extraction method is decoction extraction.

[0012] Preferably, the method further comprises: spray drying the extract obtained after the extraction.

[0013] The third aspect of the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating oligoasthenospermia.

[0014] In the traditional Chinese medicine composition for treating oligoasthenozoospermia described in the present invention, Radix Cynanchum multiflorum and Gorgon fruit nourish the kidney and consolidate sperm; fig and date nourish the spleen and replenish qi, and supplement various nutrients required by body cells and sperm; the ingredients contained in wolfberry and pomegranate protect body cells and sperm DNA from free radical damage and enhance cell vitality; the six herbs cooperate with each other to improve the body environment and promote spermatogenesis, and they are the main herbs. The Chinese medicine composition of the present invention adds other raw materials as ministerial drugs, adjuvant drugs or guiding drugs on the basis of the above-mentioned monarch drugs, so as to obtain higher efficiency or maintain longer-lasting clinical efficacy. Among them, yam and maca nourish the kidney and improve the essence, and improve sexual function; black-eyed peas and black peanuts provide the protein and various nutrients required for body cell synthesis, and maintain the body's healthy state; sea buckthorn and litchi strengthen the spleen and digestion, and stimulate the appetite, and can promote the absorption of various vitamins, active ingredients and minerals; the six-flavor medicine further enhances the environment for sperm production and vitality enhancement, and is the ministerial drug; polygonatum and hawthorn help to improve the overall environment of the reproductive system, and is the adjuvant drug; chayote and toon can regulate emotions, relieve stress, improve the physical and mental depression caused by low sperm count and low vitality, improve the physiological environment affecting the reproductive system, and cooperate with the above-mentioned sperm production and vitality enhancement drugs, and is the guiding drug.

[0015] The medicine prepared from the traditional Chinese medicine composition for treating oligoasthenozoospermia of the present invention can nourish the kidney and spleen, eliminate dampness and activate blood circulation, produce sperm and strengthen sperm, and is expected to become a medicine for clinical treatment of oligoasthenozoospermia, asthenozoospermia and teratozoospermia, and is easy to store and transport, which is conducive to popularization and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a graph showing the weight data of each group of mice in the preventive drug administration model of Example 1; Figure 2 This is a comparison chart of the sperm count and sperm motility of each group of mice in the preventive drug administration model of Example 1 (## represents the results of the model control group as the benchmark, *=P<0.05); Figure 3 This is the H&E staining picture of the testicles of each group of mice in the preventive administration model of Example 1; Figure 4 This is a graph showing the body weight data of each group of mice in the treatment and administration model of Example 1; Figure 5 This is a comparison chart of the number of sperm and sperm motility of mice in each group in the treatment and administration model of Example 1 (## represents the results of the model control group as the benchmark, *=P<0.05, **=P<0.01, ***=P<0.001); Figure 6 This is the H&E staining picture of the testicles of each group of mice in the treatment and administration model of Example 1; Figure 7 The serum sex hormone levels of mice in each group in the treatment and administration model of Example 1 (## represents the results of the model control group as the benchmark, *=P<0.05, **=P<0.01, ***=P<0.001). DETAILED DESCRIPTION

[0017] The specific implementation of the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation described here is only used to illustrate and explain the present invention, and is not used to limit the present invention.

[0018] The endpoints and any values ​​of the ranges disclosed in this article are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of each range, the endpoint values ​​of each range and the individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this article.

[0019] The Chinese medicine composition for treating oligoasthenozoospermia of the present invention comprises: 10-15 parts by weight of figs, 10-15 parts by weight of black peas, 10-15 parts by weight of yam, 5-10 parts by weight of black peanuts, 5-10 parts by weight of sea buckthorn, 5-10 parts by weight of Euryale ferox, 5-10 parts by weight of Cynanchum multiflorum, 5-10 parts by weight of pomegranate, 5-10 parts by weight of hawthorn, 5-10 parts by weight of toon, 5-10 parts by weight of maca, 5-10 parts by weight of bergamot, 5-10 parts by weight of dates, 5-10 parts by weight of polygonatum, 5-10 parts by weight of wolfberry, and 5-10 parts by weight of whole lychee.

[0020] In a more preferred embodiment, the raw material for preparing the Chinese medicine composition contains: Fig 12-15 weight parts, black bean 12-15 weight parts, yam 12-15 weight parts, black peanut 7-10 weight parts, sea buckthorn 7-10 weight parts, Euryale ferox 7-10 weight parts, white shouwu 7-10 weight parts, pomegranate 7-10 weight parts, hawthorn 7-10 weight parts, toona sinensis 7-10 weight parts, maca 7-10 weight parts, bergamot 7-10 weight parts, date palm 7-10 weight parts, polygonatum 7-10 weight parts, wolfberry 7-10 weight parts, whole lychee 7-10 weight parts. In these preferred embodiments, the Chinese medicine composition improves sperm quality and has a better effect in treating oligoasthenospermia.

[0021] Further preferably, the raw material for preparing the Chinese medicine composition contains: Fig 15 weight parts, black bean 15 weight parts, Chinese yam 15 weight parts, black peanut 10 weight parts, sea buckthorn 10 weight parts, Euryale ferox 10 weight parts, white shouwu 10 weight parts, pomegranate 10 weight parts, hawthorn 10 weight parts, toon 10 weight parts, maca 10 weight parts, bergamot 10 weight parts, date palm 10 weight parts, polygonatum 10 weight parts, wolfberry 10 weight parts, whole lychee 10 weight parts. In these preferred embodiments, the Chinese medicine composition improves sperm quality and has the best effect of treating oligoasthenospermia.

[0022] The Chinese medicine composition for treating oligoasthenozoospermia of the present invention is prepared by conventional processes in the art. In a preferred embodiment, the Chinese medicine composition is prepared by a method for preparing a Chinese medicine composition for treating oligoasthenozoospermia, which method comprises the following steps: The raw material containing the following composition ratio is processed and then extracted. 10-15 parts by weight of figs, 10-15 parts by weight of black peas, 10-15 parts by weight of yam, 5-10 parts by weight of black peanuts, 5-10 parts by weight of sea buckthorn, 5-10 parts by weight of Euryale ferox, 5-10 parts by weight of Cynanchum multiflorum, 5-10 parts by weight of pomegranate, 5-10 parts by weight of hawthorn, 5-10 parts by weight of toon, 5-10 parts by weight of maca, 5-10 parts by weight of bergamot, 5-10 parts by weight of dates, 5-10 parts by weight of polygonatum, 5-10 parts by weight of wolfberry, and 5-10 parts by weight of whole lychee.

[0023] In a more preferred embodiment, the raw material medicine contains: 12-15 parts by weight of fig, 12-15 parts by weight of black bean, 12-15 parts by weight of yam, 7-10 parts by weight of black peanut, 7-10 parts by weight of seabuckthorn, 7-10 parts by weight of Euryale ferox, 7-10 parts by weight of Cynanchum multiflorum, 7-10 parts by weight of pomegranate, 7-10 parts by weight of hawthorn, 7-10 parts by weight of Chinese toon, 7-10 parts by weight of maca, 7-10 parts by weight of bergamot, 7-10 parts by weight of date palm, 7-10 parts by weight of polygonatum, 7-10 parts by weight of wolfberry, and 7-10 parts by weight of whole lychee. In these preferred embodiments, the medicine prepared from the above raw material medicine improves sperm quality and has a better effect in treating oligoasthenospermia.

[0024] Further preferably, the raw material medicine contains: 15 parts by weight of fig, 15 parts by weight of black bean, 15 parts by weight of yam, 10 parts by weight of black peanut, 10 parts by weight of seabuckthorn, 10 parts by weight of Euryale ferox, 10 parts by weight of Cynanchum multiflorum, 10 parts by weight of pomegranate, 10 parts by weight of hawthorn, 10 parts by weight of Chinese toon, 10 parts by weight of maca, 10 parts by weight of bergamot, 10 parts by weight of date, 10 parts by weight of polygonatum, 10 parts by weight of wolfberry, and 10 parts by weight of whole lychee. In these preferred embodiments, the medicine prepared from the above raw material medicine improves sperm quality and has a better effect in treating oligoasthenospermia.

[0025] In a more preferred embodiment, the extraction method is decoction extraction.

[0026] In a more preferred embodiment, the method further comprises: spray drying the extract obtained after the extraction.

[0027] The Chinese medicine composition of the present invention can be prepared into various preparations by conventional techniques in the art, including but not limited to oral liquid, granules, powders, pills, capsules, effervescent tablets or the like.

[0028] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for treating oligoasthenospermia.

[0029] The medicine prepared from the traditional Chinese medicine composition for treating oligoasthenozoospermia of the present invention can nourish the kidney and spleen, eliminate dampness and activate blood circulation, produce sperm and strengthen sperm, and is expected to become a medicine for clinical treatment of oligoasthenozoospermia, asthenozoospermia and teratozoospermia, and is easy to store and transport, which is conducive to popularization and application.

[0030] The Chinese medicine composition for treating oligoasthenozoospermia of the present invention is further illustrated by examples. The examples are implemented on the premise of the technical solution of the present invention, and detailed implementation methods and specific operation processes are given, but the protection scope of the present invention is not limited to the following examples.

[0031] The experimental methods in the following examples, unless otherwise specified, are all conventional methods in the art. The experimental materials used in the following examples, unless otherwise specified, are all commercially available.

[0032] Example 1 (1) Wash and dry 15 g of fig, 15 g of black bean, 15 g of Chinese yam, 10 g of black peanut, 10 g of sea buckthorn, 10 g of Euryale ferox, 10 g of Cynanchum multiflorum, 10 g of pomegranate, 10 g of hawthorn, 10 g of Chinese toon, 10 g of maca, 10 g of bergamot, 10 g of Polygonatum sibiricum, and 10 g of whole lychee, put them into a powder grinder, grind them into powder, and then pass through a No. 6 sieve (the powder passing through the No. 6 sieve shall not be less than 95%) to obtain medicinal material powder; (2) Soak 10g of wolfberry and 10g of dates in 300mL of water for 0.5h, then perform decoction extraction twice, each time for 0.5h, combine the decoctions, and then filter to obtain an extract. Concentrate the extract under reduced pressure from 70℃ to 50℃ to obtain a concentrate with a relative density of 1.15g / mL. Take the concentrate and spray dry it to obtain a spray-dried powder; (3) The spray-dried powder and the medicinal material powder are mixed in a V-shaped mixing funnel for 30 minutes at a rotation speed of 10 r / min to obtain the traditional Chinese medicine composition of the present invention.

[0033] Example 2 (1) Wash and dry 10 g of fig, 10 g of black bean, 10 g of Chinese yam, 5 g of black peanut, 5 g of sea buckthorn, 5 g of Euryale ferox, 5 g of Cynanchum multiflorum, 5 g of pomegranate, 5 g of hawthorn, 5 g of Chinese toon, 5 g of maca, 5 g of bergamot, 5 g of Polygonatum sibiricum, and 10 g of whole lychee, put them into a powder grinder, grind them into powder, and then pass through a No. 6 sieve (the powder passing through the No. 6 sieve shall not be less than 95%) to obtain medicinal material powder; (2) Soak 5g of wolfberry and 5g of date palm in 150mL of water for 0.5h, then perform decoction extraction twice, each time for 0.5h, combine the decoctions, and then filter to obtain an extract. Concentrate the extract under reduced pressure from 70℃ to 50℃ to obtain a concentrate with a relative density of 1.15g / mL. Take the concentrate and spray dry it to obtain a spray-dried powder; (3) The spray-dried powder and the medicinal material powder are mixed in a V-shaped mixing funnel for 30 minutes at a rotation speed of 10 r / min to obtain the traditional Chinese medicine composition of the present invention.

[0034] Example 3 (1) Wash and dry 12g fig, 12g black bean, 12g Chinese yam, 7g black peanut, 7g sea buckthorn, 7g Euryale ferox, 7g Cynanchum multiflorum, 7g pomegranate, 7g hawthorn, 7g Chinese toon, 7g maca, 7g bergamot, 7g Polygonatum sibiricum, and 12g whole lychee, put them into a powder grinder, grind them into powder, and then pass through a No. 6 sieve (the powder passing through the No. 6 sieve is not less than 95%) to obtain medicinal material powder; (2) Soak 7g of wolfberry and 7g of dates in 210mL of water for 0.5h, then perform decoction extraction twice, each time for 0.5h, combine the decoctions, and then filter to obtain an extract. Concentrate the extract under reduced pressure from 70°C to 50°C to obtain a concentrate with a relative density of 1.15g / mL. Spray dry the concentrate to obtain a spray-dried powder; (3) The spray-dried powder and the medicinal material powder are mixed in a V-shaped mixing funnel for 30 minutes at a rotation speed of 10 r / min to obtain the traditional Chinese medicine composition of the present invention.

[0035] Application Example 1 1. Establishment of oligoasthenozoospermia mouse model Six-week-old male KM mice were randomly divided into a blank group and a modeling group, i.e., 12 mice in the blank group and 60 mice in the modeling group. The blank group was gavaged with normal saline, and the modeling group was gavaged with 0.15 mL of 25 mg / mL adenine solution for two consecutive weeks for modeling. Both groups were free to eat and drink.

[0036] 2. Animal grouping and preventive drug administration model Thirty mice from the model group were randomly divided into five groups, with six mice in each group.

[0037] Model control group: an equal volume of normal saline was administered ig for four weeks starting from the time of modeling; Positive control group: starting from model establishment, ig administration of an equal volume of Shengjing Capsule (700 mg / kg) continued for four weeks; Low-dose group: ig 0.7 g / kg of the Chinese medicine composition obtained in Preparation Example 1 was administered for four weeks starting from model establishment; Medium dose group: 1.4 g / kg of the Chinese medicine composition obtained in Preparation Example 1 was administered ig for four weeks starting from model establishment; High-dose group: ig 2.8 g / kg of the Chinese medicine composition obtained in Preparation Example 1 was administered for four weeks starting from model establishment; Blank group: starting with the same volume of normal saline for four weeks from the time of model establishment; After four weeks, the six groups of mice were killed by cervical dislocation, and the testicles and epididymis were separated for testing of relevant indicators.

[0038] 3. Animal grouping and treatment administration model Thirty mice from the model group were randomly divided into five groups, with six mice in each group.

[0039] Model control group: After modeling, an equal volume of normal saline was administered for two weeks; Positive control group: After modeling, an equal volume of Shengjing capsule (700 mg / kg) was administered ig for two weeks; Low-dose group: After modeling, ig 0.7 g / kg of the Chinese medicine composition obtained in Preparation Example 1 was continued for two weeks; Medium dose group: After modeling, 1.4 g / kg of the Chinese medicine composition obtained in Preparation Example 1 was administered for two weeks; High-dose group: After modeling, 2.8 g / kg of the Chinese medicine composition obtained in Preparation Example 1 was administered for two weeks; Blank group: After modeling, equal volume of normal saline was administered for two weeks; After four weeks, blood was collected from the six groups of mice, and the mice were killed by cervical dislocation, and the testicles and epididymis were separated for testing of relevant indicators.

[0040] 4. Index detection and result analysis (1) Body weight measurement The 12 groups of mice were weighed at the beginning of modeling and weighed again after four weeks. Figure 1 and Figure 4 shown.

[0041] (2) Sperm quality evaluation The epididymis of the mice in the above 12 groups were placed in EP tubes containing 100 μL HTF fertilization fluid, and the epididymis was cut into pieces with ophthalmic scissors. The tubes were incubated in a 37°C water bath for 10 min to allow the sperm to fully swim out. The fertilization fluid was then diluted 100 times, and the motility and number of sperm cells were observed under a microscope to obtain the sperm count and sperm motility indicators.

[0042] like Figure 2 As shown, in the preventive administration model, compared with the model control group, the sperm count and sperm motility of the positive control group, low-dose group, medium-dose group and high-dose group increased significantly after administration, which was statistically significant (*=P<0.05).

[0043] like Figure 5 As shown, in the therapeutic drug administration model, compared with the model control group, the sperm count and sperm motility of the positive control group, low-dose group, medium-dose group and high-dose group increased significantly after administration, which was statistically significant (*=P<0.05, **=P<0.01, ***=P<0.001).

[0044] (3) Observation of pathological status of testicular tissue by HE The testicular tissues of the above 12 groups of mice were fixed with 4% paraformaldehyde, embedded in paraffin and sectioned, and the pathological state was observed by HE staining.

[0045] like Figure 3 As shown, in the preventive administration model, the spermatogenic cells at all levels in the testicular tissue of mice in the positive control group, low-dose group, medium-dose group and high-dose group were arranged neatly and had complete structures, while the spermatogenic cells at all levels in the testicular tissue of mice in the model control group were arranged disorderly and loosely.

[0046] like Figure 6 As shown, in the therapeutic administration model, the spermatogenic cells at all levels in the testicular tissue of mice in the positive control group, low-dose group, medium-dose group and high-dose group were arranged neatly and had complete structures, while the spermatogenic cells at all levels in the testicular tissue of mice in the model group were arranged disorderly and loosely.

[0047] (4) Serum sex hormone testing The blood of the six groups of mice in the above-mentioned treatment and administration model was centrifuged, and the serum was collected, and the testosterone (T) content, luteinizing hormone (LH) content, and follicle stimulating hormone (FSH) content therein were detected using an ELISA kit.

[0048] like Figure 7 As shown, in the therapeutic administration model, compared with the model control group, the levels of testosterone (T), luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the serum of mice in the positive control group, low-dose group, medium-dose group and high-dose group were significantly increased after administration, which was statistically significant (*=P<0.05, **=P<0.01, ***=P<0.001).

[0049] Application Example 2 1. Establishment of oligoasthenozoospermia mouse model Six-week-old male KM mice were randomly divided into a blank group and a modeling group, i.e., 12 mice in the blank group and 60 mice in the modeling group. The blank group was gavaged with normal saline, and the modeling group was gavaged with 0.15 mL of 25 mg / mL adenine solution for two consecutive weeks for modeling. Both groups were free to eat and drink.

[0050] 2. Animal grouping and preventive drug administration model Thirty mice from the model group were randomly divided into five groups, with six mice in each group.

[0051] Model control group: an equal volume of normal saline was administered ig for four weeks starting from the time of modeling; Positive control group: starting from model establishment, ig administration of an equal volume of Shengjing Capsule (700 mg / kg) continued for four weeks; Low-dose group: ig 0.7 g / kg of the Chinese medicine composition obtained in Preparation Example 2 was administered for four weeks starting from model establishment; Medium dose group: 1.4 g / kg of the Chinese medicine composition obtained in Preparation Example 2 was administered ig for four weeks starting from model establishment; High-dose group: ig 2.8 g / kg of the Chinese medicine composition obtained in Preparation Example 2 was administered for four weeks starting from model establishment; Blank group: starting with the same volume of normal saline for four weeks from the time of model establishment; After four weeks, the six groups of mice were killed by cervical dislocation, and the testicles and epididymis were separated for testing of relevant indicators.

[0052] 3. Animal grouping and treatment administration model Thirty mice from the model group were randomly divided into five groups, with six mice in each group.

[0053] Model control group: After modeling, an equal volume of normal saline was administered for two weeks; Positive control group: After modeling, an equal volume of Shengjing capsule (700 mg / kg) was administered ig for two weeks; Low-dose group: After modeling, ig 0.7 g / kg of the Chinese medicine composition obtained in Preparation Example 2 was continued for two weeks; Medium dose group: After modeling, 1.4 g / kg of the Chinese medicine composition obtained in Preparation Example 2 was administered for two weeks; High-dose group: After modeling, 2.8 g / kg of the Chinese medicine composition obtained in Preparation Example 2 was administered for two weeks; Blank group: After modeling, equal volume of normal saline was administered for two weeks; After four weeks, blood was collected from the six groups of mice, and the mice were killed by cervical dislocation, and the testicles and epididymis were separated for testing of relevant indicators.

[0054] 4. Index detection and result analysis (1) Body weight measurement The 12 groups of mice were weighed at the beginning of modeling, and were weighed again after four weeks.

[0055] (2) Sperm quality evaluation The epididymis of the mice in the above 12 groups were placed in EP tubes containing 100 μL HTF fertilization fluid, and the epididymis was cut into pieces with ophthalmic scissors. The tubes were incubated in a 37°C water bath for 10 min to allow the sperm to fully swim out. The fertilization fluid was then diluted 100 times, and the motility and number of sperm cells were observed under a microscope to obtain the sperm count and sperm motility indicators.

[0056] The mechanism of action of the drug prepared from the Chinese medicine composition obtained in Preparation Example 2 is the same as that of the drug prepared in Preparation 1, the modeling method of the preventive administration model and the therapeutic administration model is the same, the administration method is the same, and similar results to Example 1 can be obtained.

[0057] (3) Observation of pathological status of testicular tissue by HE The testicular tissues of the above 12 groups of mice were fixed with 4% paraformaldehyde, embedded in paraffin and sectioned, and the pathological state was observed by HE staining.

[0058] The mechanism of action of the drug prepared from the Chinese medicine composition obtained in Preparation Example 2 is the same as that of the drug prepared in Preparation 1, the modeling method of the preventive administration model and the therapeutic administration model is the same, the administration method is the same, and the results similar to those in Example 1 can be obtained.

[0059] (4) Serum sex hormone testing The blood of the six groups of mice in the above-mentioned treatment and administration model was centrifuged, and the serum was collected, and the testosterone (T) content, luteinizing hormone (LH) content, and follicle stimulating hormone (FSH) content therein were detected using an ELISA kit.

[0060] The mechanism of action of the drug prepared from the Chinese medicine composition obtained in Preparation Example 2 is the same as that of the drug prepared in Preparation 1, the modeling method of the therapeutic drug administration model is the same, and the administration method is the same, and similar results to those in Example 1 can be obtained.

[0061] Application Example 3 1. Establishment of oligoasthenozoospermia mouse model Six-week-old male KM mice were randomly divided into a blank group and a modeling group, i.e., 12 mice in the blank group and 60 mice in the modeling group. The blank group was gavaged with normal saline, and the modeling group was gavaged with 0.15 mL of 25 mg / mL adenine solution for two consecutive weeks for modeling. Both groups were free to eat and drink.

[0062] 2. Animal grouping and preventive drug administration model Thirty mice from the model group were randomly divided into five groups, with six mice in each group.

[0063] Model control group: an equal volume of normal saline was administered ig for four weeks starting from the time of modeling; Positive control group: starting from model establishment, ig administration of an equal volume of Shengjing Capsule (700 mg / kg) continued for four weeks; Low-dose group: ig 0.7 g / kg of the Chinese medicine composition obtained in Preparation Example 3 was administered for four weeks starting from model establishment; Medium dose group: 1.4 g / kg of the Chinese medicine composition obtained in Preparation Example 3 was administered ig for four weeks starting from model establishment; High-dose group: ig 2.8 g / kg of the Chinese medicine composition obtained in Preparation Example 3 was administered for four weeks starting from model establishment; Blank group: starting with the same volume of normal saline for four weeks from the time of model establishment; After four weeks, the six groups of mice were killed by cervical dislocation, and the testicles and epididymis were separated for testing of relevant indicators.

[0064] 3. Animal grouping and treatment administration model Thirty mice from the model group were randomly divided into five groups, with six mice in each group.

[0065] Model control group: After modeling, an equal volume of normal saline was administered for two weeks; Positive control group: After modeling, an equal volume of Shengjing capsule (700 mg / kg) was administered ig for two weeks; Low-dose group: After modeling, ig 0.7 g / kg of the Chinese medicine composition obtained in Preparation Example 3 was continued for two weeks; Medium dose group: After modeling, 1.4 g / kg of the Chinese medicine composition obtained in Preparation Example 3 was administered for two weeks; High-dose group: After modeling, 2.8 g / kg of the Chinese medicine composition obtained in Preparation Example 3 was administered for two weeks; Blank group: After modeling, equal volume of normal saline was administered for two weeks; After four weeks, blood was collected from the six groups of mice, and the mice were killed by cervical dislocation, and the testicles and epididymis were separated for testing of relevant indicators.

[0066] 4. Index detection and result analysis (1) Body weight measurement The 12 groups of mice were weighed at the beginning of modeling, and were weighed again after four weeks.

[0067] (2) Sperm quality evaluation The epididymis of the mice in the above 12 groups were placed in EP tubes containing 100 μL HTF fertilization fluid, and the epididymis was cut into pieces with ophthalmic scissors. The tubes were incubated in a 37°C water bath for 10 min to allow the sperm to fully swim out. The fertilization fluid was then diluted 100 times, and the motility and number of sperm cells were observed under a microscope to obtain the sperm count and sperm motility indicators.

[0068] The mechanism of action of the drug prepared from the Chinese medicine composition obtained in Preparation Example 3 is the same as that of the drug prepared in Preparation 1, the modeling method of the preventive administration model and the therapeutic administration model is the same, the administration method is the same, and similar results to Example 1 can be obtained.

[0069] (3) Observation of pathological status of testicular tissue by HE The testicular tissues of the above 12 groups of mice were fixed with 4% paraformaldehyde, embedded in paraffin and sectioned, and the pathological state was observed by HE staining.

[0070] The mechanism of action of the drug prepared from the Chinese medicine composition obtained in Preparation Example 3 is the same as that of the drug prepared in Preparation 1, the modeling method of the preventive administration model and the therapeutic administration model is the same, the administration method is the same, and the results similar to those in Example 1 can be obtained.

[0071] (4) Serum sex hormone testing The blood of the six groups of mice in the above-mentioned treatment and administration model was centrifuged, and the serum was collected, and the testosterone (T) content, luteinizing hormone (LH) content, and follicle stimulating hormone (FSH) content therein were detected using an ELISA kit.

[0072] The mechanism of action of the drug prepared from the Chinese medicine composition obtained in Preparation Example 3 is the same as that of the drug prepared in Preparation 1, the modeling method of the therapeutic drug administration model is the same, and the administration method is the same, and similar results to Example 1 can be obtained.

[0073] The preferred embodiments of the present invention are described in detail above, but the present invention is not limited thereto. Within the technical concept of the present invention, the technical solution of the present invention can be subjected to a variety of simple modifications, including the combination of various technical features in any other suitable manner, and these simple modifications and combinations should also be regarded as the contents disclosed by the present invention and belong to the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating oligoasthenozoospermia, characterized in that: The raw material for preparing the Chinese medicine composition contains: 10-15 parts by weight of figs, 10-15 parts by weight of black peas, 10-15 parts by weight of yam, 5-10 parts by weight of black peanuts, 5-10 parts by weight of sea buckthorn, 5-10 parts by weight of Euryale ferox, 5-10 parts by weight of Cynanchum multiflorum, 5-10 parts by weight of pomegranate, 5-10 parts by weight of hawthorn, 5-10 parts by weight of toon, 5-10 parts by weight of maca, 5-10 parts by weight of bergamot, 5-10 parts by weight of dates, 5-10 parts by weight of polygonatum, 5-10 parts by weight of wolfberry, and 5-10 parts by weight of whole lychee.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw material for preparing the Chinese medicine composition contains: Figs 12-15 parts by weight, black-eyed peas 12-15 parts by weight, yam 12-15 parts by weight, black peanuts 7-10 parts by weight, sea buckthorn 7-10 parts by weight, Euryale ferox 7-10 parts by weight, Cynanchum multiflorum 7-10 parts by weight, pomegranate 7-10 parts by weight, hawthorn 7-10 parts by weight, toon 7-10 parts by weight, maca 7-10 parts by weight, bergamot 7-10 parts by weight, dates 7-10 parts by weight, polygonatum 7-10 parts by weight, wolfberry 7-10 parts by weight, whole lychee 7-10 parts by weight.

3. The Chinese medicine composition according to claim 2, characterized in that: The raw material for preparing the Chinese medicine composition contains: Fig 15 parts by weight, black-eyed pea 15 parts by weight, yam 15 parts by weight, black peanut 10 parts by weight, sea buckthorn 10 parts by weight, Euryale ferox 10 parts by weight, Cynanchum multiflorum 10 parts by weight, pomegranate 10 parts by weight, hawthorn 10 parts by weight, toon 10 parts by weight, maca 10 parts by weight, bergamot 10 parts by weight, date palm 10 parts by weight, polygonatum 10 parts by weight, wolfberry 10 parts by weight, whole lychee 10 parts by weight.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The dosage form of the Chinese medicine composition is at least one of granules, pills, pastes, powders, decoctions, tablets and capsules.

5. A method for preparing a Chinese medicine composition for treating oligoasthenozoospermia, characterized in that: The method comprises: preparing a raw material drug containing the following components in a proportion, and then extracting it. 10-15 parts by weight of figs, 10-15 parts by weight of black peas, 10-15 parts by weight of yam, 5-10 parts by weight of black peanuts, 5-10 parts by weight of sea buckthorn, 5-10 parts by weight of Euryale ferox, 5-10 parts by weight of Cynanchum multiflorum, 5-10 parts by weight of pomegranate, 5-10 parts by weight of hawthorn, 5-10 parts by weight of toon, 5-10 parts by weight of maca, 5-10 parts by weight of bergamot, 5-10 parts by weight of dates, 5-10 parts by weight of polygonatum, 5-10 parts by weight of wolfberry, and 5-10 parts by weight of whole lychee.

6. The method according to claim 5, characterized in that The raw material medicine contains: 12-15 parts by weight of figs, 12-15 parts by weight of black beans, 12-15 parts by weight of yam, 7-10 parts by weight of black peanuts, 7-10 parts by weight of sea buckthorn, 7-10 parts by weight of Euryale ferox, 7-10 parts by weight of Cynanchum multiflorum, 7-10 parts by weight of pomegranate, 7-10 parts by weight of hawthorn, 7-10 parts by weight of toon, 7-10 parts by weight of maca, 7-10 parts by weight of bergamot, 7-10 parts by weight of dates, 7-10 parts by weight of polygonatum, 7-10 parts by weight of wolfberry, and 7-10 parts by weight of whole lychee.

7. The method according to claim 6, characterized in that The raw material medicine contains: 15 parts by weight of fig, 15 parts by weight of black bean, 15 parts by weight of yam, 10 parts by weight of black peanut, 10 parts by weight of sea buckthorn, 10 parts by weight of Euryale ferox, 10 parts by weight of Cynanchum multiflorum, 10 parts by weight of pomegranate, 10 parts by weight of hawthorn, 10 parts by weight of toon, 10 parts by weight of maca, 10 parts by weight of bergamot, 10 parts by weight of date, 10 parts by weight of polygonatum, 10 parts by weight of wolfberry, and 10 parts by weight of whole lychee.

8. The method according to any one of claims 5 to 7, characterized in that: The extraction method is decoction extraction.

9. The method according to any one of claims 5 to 8, characterized in that: The method further comprises: spray drying the extract obtained after the extraction.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared according to the method according to any one of claims 5 to 9 in the preparation of a medicament for treating oligoasthenospermia.

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