Medicinal and edible composition for conditioning male oligospermia and asthenospermia and preparation method thereof

Abstract

The invention belongs to the technical field of compositions, and provides a medicinal and edible composition for conditioning male oligospermia and asthenospermia and a preparation method of the medicinal and edible composition. The medicinal and edible composition is prepared from the following raw materials: oyster peptide powder, fructus lycii, rhizoma polygonati, radix ginseng, maca, concentrated pomegranate juice and concentrated mulberry juice. The preparation method comprises the following steps: (1) weighing rhizoma polygonati, ginseng, fructus lycii and maca, mixing, crushing and sieving to obtain mixed powder; (2) extracting the mixed powder to obtain a mixed filtrate; concentrating to obtain a second concentrated solution, sterilizing and storing; and (3) dissolving the oyster peptide powder in water, adding the concentrated pomegranate juice, the concentrated mulberry juice and the second concentrated solution, mixing, and filling into a container. The composition with homology of medicine and food has the advantages that the used raw materials are few and fine, the compatibility effect is strong, and the composition has a remarkable spermatogenic function on mice with deficiency of kidney-yang and has an application prospect of improving the symptoms of oligospermia and asthenozoospermia of men; the flavor is good. The preparation method is good in effective component extraction effect and simple to operate, and industrial large-scale production can be realized.

Description

Technical Field

[0001] This invention belongs to the field of composition technology, specifically, it relates to a food-medicine homologous composition for treating male oligospermia and asthenospermia and its preparation method. Background Technology

[0002] In the field of male reproductive health, oligospermia and asthenospermia are quietly becoming important factors affecting fertility. Oligospermia refers to a sperm count in semen that is lower than the normal reference value, while asthenospermia refers to low sperm motility and insufficient sperm swimming ability. According to medical statistics, among the many factors leading to male infertility, oligospermia and asthenospermia account for a significant proportion and have become a stumbling block on the road to male fertility.

[0003] Among the many causes of oligospermia and asthenospermia, kidney yang deficiency is relatively common. Kidney yang, as the root of yang energy in the body, plays a warming and promoting role in reproductive function. In the human body, kidney yang deficiency affects the spermatogenesis function of the testes, reducing sperm production and motility, thus leading to oligospermia and asthenospermia. Kidney yang deficiency also affects blood circulation in the reproductive system, preventing the reproductive organs from receiving sufficient blood nourishment, further exacerbating the decline in sperm quality.

[0004] Faced with the challenge of oligospermia and asthenospermia, various conditioning compositions have emerged on the market, with traditional Chinese medicine compositions being the most common. These traditional Chinese medicine compositions often combine multiple Chinese medicinal herbs based on traditional Chinese medicine theory to improve the condition of oligospermia and asthenospermia through comprehensive conditioning.

[0005] However, existing Chinese medicine conditioning compositions have many obvious defects in practical applications and are difficult to meet clinical needs. The main defects are: (1) Complex components but poor conditioning effect: Most existing compositions blindly increase the number of components in pursuit of "comprehensive conditioning". The synergistic effect between medicinal materials is not fully utilized and may even restrict each other. Moreover, the onset period is long and some patients do not have obvious improvement in semen indicators after taking them. Therefore, they often fail to achieve the ideal effect in practical applications; (2) Poor taste and low patient acceptance: Taste problem is a crucial defect that has been neglected in existing Chinese medicine conditioning compositions. Chinese medicine conditioning compositions often contain a variety of bitter components and generally have the problem of "strong taste and bitterness". Some preparations also have obvious Chinese medicine fishy smell. Summary of the Invention

[0006] In view of the above-mentioned shortcomings in the prior art, the first objective of the present invention is to provide a medicinal and edible composition for treating male oligospermia and asthenospermia. The composition not only uses few but high-quality raw materials with strong compatibility, but also has a significant spermatogenic function in mice with kidney yang deficiency, and has the application prospect of improving the symptoms of male oligospermia and asthenospermia; moreover, it has a good flavor, which can mask the unpleasant smell of traditional Chinese medicine, improve the taste of the composition, and increase patient acceptance.

[0007] In view of the above-mentioned shortcomings in the prior art, the second objective of the present invention is to provide a method for preparing a medicinal and food homologous composition for treating male oligospermia and asthenospermia. This preparation method can effectively improve drug utilization and efficacy, is simple to operate, and can be industrialized for large-scale production.

[0008] To achieve the above objectives, the solution adopted by the present invention is:

[0009] A medicinal and edible composition for treating male oligospermia and asthenospermia, comprising the following ingredients by weight: 2-4 parts oyster peptide powder, 6-10 parts wolfberry, 2-5 parts polygonatum, 3-6 parts ginseng, 3-5 parts maca, 18-20 parts concentrated pomegranate juice, and 2-6 parts concentrated mulberry juice.

[0010] It should be noted that in this embodiment, the oyster peptide powder was purchased from Beijing Shengmeinuo Biotechnology Co., Ltd., the pomegranate variety used for the concentrated pomegranate juice was Huili soft-seed pomegranate, and the concentration method was vacuum low-temperature concentration with a concentration temperature ≤70℃. The mulberry concentrated juice was also concentrated using vacuum low-temperature concentration with a concentration temperature ≤70℃.

[0011] Furthermore, in a preferred embodiment of the present invention, the soluble solids (in °Brix) in the concentrated pomegranate juice are ≥60, and the total phenol content is ≥130mg / 100mL.

[0012] Furthermore, in a preferred embodiment of the present invention, the anthocyanin content of the mulberry concentrate is ≥10g / L.

[0013] A method for preparing the above-mentioned medicinal and edible composition for treating male oligospermia and asthenospermia includes:

[0014] (1) Weigh out the parts by weight of Polygonatum, ginseng, wolfberry and maca, mix them together and pulverize them, then pass them through a 100-150 mesh sieve to obtain mixed powder;

[0015] (2) Put the mixed powder into the extractor, add water at 8-10 times its own weight, boil for 1-1.5 hours for the first time, filter through a 100-150 mesh sieve to obtain the residue and the first filtrate; then add water at 6-8 times its own weight to the residue, boil for 30 minutes to 1 hour for the second time, filter through a 100-150 mesh sieve to obtain the second filtrate; combine the first filtrate and the second filtrate to obtain the mixed filtrate;

[0016] The mixed filtrate was concentrated in a double-effect concentrator, with the first effect temperature set at 55-65℃ and the second effect temperature at 60-75℃, to obtain a first concentrate with a density of 1.02-1.05. The first concentrate was then filtered through a plate and frame filter and concentrated again to a second concentrate with a relative density of 1.3-1.35. The second concentrate was then hot-filled into sterilized containers and stored at -18℃.

[0017] (3) Dissolve oyster peptide powder in 3-5 times its own weight of water according to the weight ratio, then add concentrated pomegranate juice, concentrated mulberry juice and second concentrated liquid, mix and stir and fill into containers.

[0018] Furthermore, in a preferred embodiment of the present invention, in step (3), the stirring rate is 100-150 r / min and the stirring time is 30 min-1 h.

[0019] Furthermore, in a preferred embodiment of the present invention, in step (3), after filling is completed, ultra-high pressure sterilization is performed under sterilization conditions of 500-600MPa for 8-10 minutes.

[0020] Furthermore, in a preferred embodiment of the present invention, in step (3), after sterilization, the product is refrigerated at 0-4°C.

[0021] The beneficial effects of the medicinal and edible homologous composition for treating male oligospermia and asthenospermia provided by this invention and its preparation method are as follows:

[0022] (1) The medicinal and food homologous composition for treating male oligospermia and asthenospermia provided by the present invention involves the functional extracts being combined under specific conditions: ginseng replenishes vital energy and mainly replenishes the five internal organs, oyster tonifies the kidneys, and the two are the principal drugs in the formula; maca warms and tonifies kidney yang, and can assist the warming and tonifying power of ginseng, and maca is the assistant drug; wolfberry nourishes the liver and kidneys, benefits essence and improves eyesight, and polygonatum is used for insufficient essence and blood, and the two are the adjuvant drugs and guiding drugs in the formula.

[0023] The combined use of the aforementioned functional extracts, employing the principles of traditional Chinese medicine's "principal, assistant, adjuvant, and guide" formula, results in a prescription with significant effects of invigorating qi and replenishing deficiency, warming the kidneys and assisting yang. In this application, the aforementioned functional extracts are supplemented with concentrated pomegranate juice. Concentrated pomegranate juice is rich in antioxidant bioactive substances such as tannins, anthocyanins, flavonoids, protocatechuic acid, and ellagic acid. These antioxidants, combined with the aforementioned functional extracts, significantly relax blood vessel walls and induce erection due to increased blood flow to the sexual organs.

[0024] In addition, concentrated mulberry juice is added to this application. Mulberries are sweet and sour, cold in nature, and black in color. They enter the liver and kidney meridians and have a certain effect of nourishing kidney yin. In this application, under the specific dosage conditions mentioned above, concentrated mulberry juice can be used in conjunction with the above-mentioned functional extracts and concentrated pomegranate juice to effectively improve the symptoms and discomfort caused by kidney yin deficiency.

[0025] The ingredients used in this food-medicine homology composition are few and refined, with strong compatibility. Animal experiments in this application have demonstrated that the food-medicine homology composition has a significant spermatogenic function in mice with kidney yang deficiency and has the potential to improve the symptoms of male oligospermia and asthenospermia.

[0026] (2) The medicinal and food homologous composition for treating male oligospermia and asthenospermia provided by the present invention contains concentrated pomegranate juice and concentrated mulberry juice, which can bring good flavor, mask the unpleasant smell of Chinese medicine, improve the taste of the composition, and increase patient acceptance; at the same time, the raw materials of this application are derived from natural Chinese medicinal materials, which are healthy, safe and effective, and in line with the modern health care concept. Attached Figure Description

[0027] Figure 1 These are the mouse sperm motility and count detection graphs provided in Experiment Example 1 of this invention for the blank control group, model control group, positive drug control group, drug administration group 1, drug administration group 4 and drug administration group 5;

[0028] Figure 2 These are the kidney HE-stained pathological sections from the blank control group, model control group, positive drug control group, drug administration group 1, drug administration group 4, and drug administration group 5 provided in Experimental Example 1 of this invention;

[0029] Figure 3 These are testicular slices from the blank control group, model control group, positive drug control group, drug administration group 1, drug administration group 4, and drug administration group 5 provided in Experimental Example 1 of this invention. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0031] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0032] Example 1

[0033] This embodiment provides a food-medicine composition for treating male oligospermia and asthenospermia. The raw materials include, by weight, 3 parts oyster peptide powder, 8 parts wolfberry, 4 parts polygonatum, 5 parts ginseng, 4 parts maca, 19 parts concentrated pomegranate juice, and 4 parts concentrated mulberry juice.

[0034] This embodiment also provides a method for preparing a medicinal and edible homologous composition for treating male oligospermia and asthenospermia, comprising: (1) weighing Polygonatum sibiricum, ginseng, wolfberry and maca according to the weight proportions, mixing and pulverizing, and passing through a 120-mesh sieve to obtain a mixed powder; (2) putting the mixed powder into an extractor, adding water at 9 times its own weight, decocting for 1.2 hours for the first time, filtering through a 130-mesh sieve to obtain a residue and a first filtrate; then adding water at 7 times its own weight to the residue, decocting for 40 minutes for the second time, and filtering through a 120-mesh sieve to obtain a second filtrate; combining the first filtrate and the second filtrate to obtain a mixed filtrate; placing the mixed filtrate in a double-effect concentrator for concentration, setting... The first effect temperature is 60℃, the second effect temperature is 70℃, and the concentration is to obtain a first concentrate with a density of 1.04. The first concentrate is filtered through a plate and frame filter and then concentrated again to a second concentrate with a relative density of 1.33. The second concentrate is hot-filled into sterilized containers and stored at -18℃. (3) According to the weight ratio, oyster peptide powder is dissolved in 4 times its own weight of water, then concentrated pomegranate juice, concentrated mulberry juice and the second concentrate are added and mixed at a rate of 130r / min. After stirring for 40min, it is filled into containers. After filling, it is sterilized under ultra-high pressure at 550MPa for 9min. After sterilization, it is stored at 0-4℃.

[0035] Example 2

[0036] This embodiment provides a food-medicine composition for treating male oligospermia and asthenospermia. The raw materials include, by weight, 2 parts oyster peptide powder, 10 parts wolfberry, 2 parts polygonatum, 6 parts ginseng, 3 parts maca, 20 parts concentrated pomegranate juice, and 2 parts concentrated mulberry juice.

[0037] This embodiment also provides a method for preparing a medicinal and edible homologous composition for treating male oligospermia and asthenospermia, comprising: (1) weighing Polygonatum sibiricum, ginseng, wolfberry and maca according to the weight proportions, mixing and pulverizing, and passing through a 100-mesh sieve to obtain a mixed powder; (2) putting the mixed powder into an extractor, adding 8 times the weight of the mixed powder in water, decocting for 1 hour, and filtering through a 100-mesh sieve to obtain a residue and a first filtrate; then adding 6 times the weight of the mixed powder in water to the residue, decocting for 30 minutes, and filtering through a 100-mesh sieve to obtain a second filtrate; combining the first filtrate and the second filtrate to obtain a mixed filtrate; placing the mixed filtrate in a double-effect concentrator for concentration, and setting a... The effective temperature is 55℃, the second effective temperature is 60℃, and the first concentrated solution with a density of 1.02 is obtained. The first concentrated solution is filtered through a plate and frame filter and then concentrated again to a second concentrated solution with a relative density of 1.3. The second concentrated solution is hot-filled into sterilized containers and stored at -18℃. (3) According to the weight ratio, oyster peptide powder is dissolved in 3 times its own weight of water, then concentrated pomegranate juice, concentrated mulberry juice and the second concentrated solution are added and mixed at a rate of 100r / min. After stirring for 30min, it is filled into containers. After filling, it is sterilized under ultra-high pressure at 500MPa for 8min. After sterilization, it is stored at 0-4℃.

[0038] Example 3

[0039] This embodiment provides a food-medicine composition for treating male oligospermia and asthenospermia. The raw materials include, by weight, 4 parts oyster peptide powder, 6 parts wolfberry, 5 parts polygonatum, 3 parts ginseng, 5 parts maca, 18 parts concentrated pomegranate juice, and 6 parts concentrated mulberry juice.

[0040] This embodiment also provides a method for preparing a medicinal and edible homologous composition for treating male oligospermia and asthenospermia, comprising: (1) weighing Polygonatum sibiricum, ginseng, wolfberry and maca according to the weight proportions, mixing and pulverizing, and passing through a 150-mesh sieve to obtain a mixed powder; (2) putting the mixed powder into an extractor, adding 10 times the weight of the mixed powder in water, decocting for 1.5 hours for the first time, filtering through a 150-mesh sieve to obtain a residue and a first filtrate; then adding 8 times the weight of the mixed powder in water to the residue, decocting for 1 hour for the second time, and filtering through a 150-mesh sieve to obtain a second filtrate; combining the first filtrate and the second filtrate to obtain a mixed filtrate; placing the mixed filtrate in a double-effect concentrator for concentration, setting... The first effect temperature is 65℃, the second effect temperature is 75℃, and the concentration is to obtain a first concentrate with a density of 1.05. The first concentrate is filtered through a plate and frame filter and then concentrated again to a second concentrate with a relative density of 1.35. The second concentrate is hot-filled into sterilized containers and stored at -18℃. (3) According to the weight ratio, oyster peptide powder is dissolved in 5 times its own weight of water, then concentrated pomegranate juice, concentrated mulberry juice and the second concentrate are added and mixed at a rate of 150r / min. After stirring for 1h, it is filled into containers. After filling, it is sterilized under ultra-high pressure at 600MPa for 10min. After sterilization, it is stored at 0-4℃.

[0041] Comparative Example 1

[0042] This comparative example provides a medicinal and edible composition for treating male oligospermia and asthenospermia, the raw materials of which include, by weight: 3 parts oyster peptide powder, 8 parts wolfberry, 4 parts polygonatum, 5 parts ginseng, 4 parts maca, and 4 parts concentrated mulberry juice.

[0043] This comparative example also provides a method for preparing a medicinal and edible composition for treating male oligospermia and asthenospermia, which is carried out with reference to the preparation method provided in Example 1.

[0044] Comparative Example 2

[0045] This comparative example provides a medicinal and edible composition for treating male oligospermia and asthenospermia, the raw materials of which include, by weight: 1 part oyster peptide powder, 12 parts wolfberry, 6 parts polygonatum, 1 part ginseng, 2 parts maca, and 4 parts concentrated mulberry juice.

[0046] This comparative example also provides a method for preparing a medicinal and edible composition for treating male oligospermia and asthenospermia, which is carried out with reference to the preparation method provided in Example 1.

[0047] Experimental Example 1

[0048] Experimental methods:

[0049] 1. Experimental animals: KM male mice, SPF grade, weighing 18 - 20 g. Provided by Spbio (Beijing) Biotechnology Co., Ltd., with the quality certificate number of experimental animals: SCXK (Beijing) 2019 - 0010.

[0050] 2. Experimental methods:

[0051] 2.1 Model establishment:

[0052] In this experiment, a mouse animal model of kidney yang deficiency syndrome was established using the chemical reagent adenine: Take an appropriate amount of adenine, add warm water, and prepare a suspension of 10 mg / mL. Each mouse was intragastrically administered 20 mL / kg each time to ensure that the adenine intake of the mouse was 200 mg / kg. Before intragastric administration, it was stirred evenly with a magnetic stirrer, and the adenine suspension was freshly prepared before use.

[0053] 2.2 Grouping and administration:

[0054] All male mice were randomly divided into 8 groups according to body weight, with 12 mice in each group, namely the blank control group, the model control group, the administration groups 1 - 5 (corresponding to using the medicated and edible homologous compositions provided in Examples 1 - 3 and Comparative Examples 1 - 2 of this application, respectively configured into a liquid medicine with a concentration of 0.28 g / mL), and the positive drug control group (the positive drug was Wuzi Yanzong Pills, Sichuan Mianyang Pharmaceutical Co., Ltd. of Taiji Group, national drug approval number Z51022406: It was pulverized into fine powder, passed through a No. 5 sieve, and configured into a liquid medicine with a concentration of 0.12 g / mL).

[0055] The normal group was intragastrically administered an equal volume of normal saline every day, and the mice in the remaining groups were intragastrically administered 200 mg / kg of adenine every day, once a day, for 17 consecutive days.

[0056] From the 18th day, except for the blank control group and the model control group which were intragastrically administered an equal volume of normal saline, the remaining groups were intragastrically administered the corresponding volume of liquid medicine. The administration groups 1 - 5 and the positive drug control group were intragastrically administered 0.6 mL of the corresponding liquid medicine every day, once a day, for 28 consecutive days of intragastric administration.

[0057] 2.3 Observation indicators:

[0058] 2.3.1 General physical signs observation: During the experiment, the general physical signs of the mice were observed every week: including body weight, food intake, water intake, hair loss, arched back, curling degree, etc.

[0059] 2.3.2 Sperm motility detection: The epididymis of each mouse was placed in 1 mL of physiological saline at 37 °C, cut into pieces with an ophthalmic scissors, gently pipetted, placed in a 37 °C water bath and left to stand for 10 min, filtered through 4 layers of lens paper, and made up to 1 mL with physiological saline to prepare a sperm suspension. Take 1 drop of the sperm suspension to make a slide, observe under a microscope, and calculate the sperm motility rate of each mouse.

[0060] 2.3.3 Sperm Count Detection: The epididymis of each mouse was placed in 1 mL of 37℃ physiological saline, cut into small pieces with ophthalmic scissors, gently blown with a pipette, and placed in a 37℃ water bath for 10 min. After filtering with 4 layers of lens paper, physiological saline was added to 1 mL to prepare a sperm suspension. One drop of the sperm suspension was taken and prepared as a slide. The sperm count of each mouse was calculated under a microscope.

[0061] 2.3.4 Pathological observation:

[0062] The specific procedure for pathological observation is as follows:

[0063] (1) Tissue collection: Fresh tissue is fixed with fixative for more than 24 hours. The tissue is removed from the fixative and trimmed in the target area with a scalpel in a fume hood. The trimmed tissue and corresponding labels are placed in a dehydration box.

[0064] (2) Dehydration: Place the dehydration box into the basket and dehydrate it in the dehydrator by sequentially applying alcohol. 75% alcohol 4h - 85% alcohol 2h - 90% alcohol 2h - 95% alcohol 1h - anhydrous ethanol I 30min - anhydrous ethanol II 30min - benzene 5-10min - xylene I 5-10min - xylene II 5-10min - wax I 1h - wax II 1h - wax III 1h.

[0065] (3) Embedding: The tissue impregnated with wax is embedded in an embedding machine. First, the molten wax is placed into the embedding frame. Before the wax solidifies, the tissue is taken out from the dehydration box, placed into the embedding frame according to the requirements of the embedding surface, and labeled accordingly. It is cooled on a -20°C freezing stage. After the wax solidifies, the wax block is removed from the embedding frame and trimmed.

[0066] (4) Sectioning: Place the trimmed wax block on a paraffin microtome and section it to a thickness of 3μm. Float the section on a 40℃ warm water spreader to flatten the tissue. Pick up the tissue with a glass slide and bake it in a 60℃ oven. After the wax has melted in the water, remove it and store it at room temperature for later use.

[0067] (5) Dewaxing paraffin sections to water: Place the sections in xylene I for 10 min, xylene II for 10 min, xylene III for 10 min, anhydrous ethanol I for 5 min, anhydrous ethanol II for 5 min, and 75% ethanol for 5 min, then wash with tap water.

[0068] (6) Hematoxylin staining: stain with hematoxylin for 4 min, differentiate with 1% hydrochloric acid alcohol solution (75% alcohol), return to blue with 1% ammonia water solution, and wash with water.

[0069] (7) Eosin staining: stain in eosin staining solution for 2 min, then wash with water.

[0070] (8) Dehydration and mounting: Place the sections in 75-95% alcohol for a few seconds, then in anhydrous ethanol I for 5 minutes, then in anhydrous ethanol II for 5 minutes, then in an anhydrous ethanol III for 5 minutes, then in an oven at 37℃ to dry, then in xylene I for 5 minutes, then in xylene II for 5 minutes, then in xylene III for 5 minutes to dehydrate and become transparent. Remove the sections from the xylene and let them air dry slightly, then mount them with neutral resin.

[0071] 2.4. Statistical Methods

[0072] Statistical analysis was performed using SPSS 21.0 software. All data were expressed as mean plus or minus standard deviation. This indicates that if homogeneity of variance is satisfied, the LSD test is used; if homogeneity of variance is not satisfied, the Dunnett test is used. ， The s-T3 test was performed. All analytical results were considered statistically significant with P < 0.05.

[0073] 3. Experimental Results:

[0074] (1) General physical signs observation results: Before modeling, the mice in each group were active, had smooth fur, were responsive, and drank and ate normally. Seventeen days after modeling, the mice in each group showed symptoms of kidney yang deficiency, such as emaciation, curled-up back, cold limbs, sparse, yellow, and dull fur, lethargy, sluggishness, reduced appetite, and polyuria. After drug administration, the kidney yang deficiency symptoms of the mice in the drug administration group and the positive drug control group were significantly improved, while the improvement of kidney yang deficiency symptoms in the model control group was not obvious, and the physical signs of the mice in the blank control group were not significantly changed.

[0075] (2) See the graph for mouse sperm motility and count. Figure 1 As shown.

[0076] The A+B grade sperm ratio was calculated using the World Health Organization (WHO) standards:

[0077] Multiple non-overlapping fields of view were randomly selected, and the sperm in each field were observed and classified and counted according to a four-level standard: A, B, C, and D.

[0078] Grade A (Rapid Forward Motion): Sperm move actively in a straight line or large circular motion;

[0079] Grade B (slow or sluggish forward movement): Sperm have forward movement, but the speed is slow, the path is not straight, or they only rotate in place;

[0080] Grade C (non-progressive motility): The sperm tail is moving, but it only rotates in place and does not move in position;

[0081] Grade D (Immobile): The sperm are completely immobile.

[0082] Grade A+B sperm: The total number of all sperm with forward motility.

[0083] Add up the counts of grade A and grade B sperm in all fields of view to get the total.

[0084] The percentage of A+B grade sperm (%) = (number of A grade sperm + number of B grade sperm) / total number of sperm × 100%.

[0085] The results of the proportion and change rate of grade A+B sperm in each group of mice with kidney yang deficiency are shown in Table 1:

[0086] Table 1. Proportion of Grade A+B sperm in mice with kidney-yang deficiency

[0087] Group Percentage of A+B grade sperm (%) Change rate of A+B grade sperm ratio (%) Blank control group 42.85±3.10 / Model control group <![CDATA[22.11±4.60 ## ]]> -48.40％ Positive drug control group <![CDATA[36.04±2.24 ** ]]> +63.00％ Group 1 <![CDATA[35.15±0.91 * ]]> +58.98％ Group 2 <![CDATA[32.64±1.08 * ]]> +47.63％ 3 groups of drugs <![CDATA[33.25±1.24 * ]]> +50.38％ 4 groups of drug administration 23.39±4.91 +5.79％ 5 groups of drugs 16.71±3.51 -24.42％

[0088] Compared with the blank control group, the model control group ## P<0.01; Compared with the model control group, each drug administration group... * P<0.05, ** P<0.01.

[0089] As shown in Table 1, compared with the blank control group, the percentage of A+B grade sperm in the model control group mice was significantly lower, and the difference was statistically significant (P<0.01).

[0090] Compared with the model control group, the proportion of grade A+B sperm in mice in treatment groups 1-3 and the positive drug control group increased, and the differences were statistically significant (P<0.01, P<0.05), while the differences in other treatment groups were not statistically significant (P>0.05).

[0091] The change rate of A+B grade sperm ratio showed that the A+B grade sperm ratio in the model control group was significantly lower than that in the blank control group. After administration, the change rate of A+B grade sperm ratio in the positive drug control group and the drug administration groups 1-3 were significantly higher than that in the model control group, indicating that the food-medicine homology composition provided in this application can change the A+B grade sperm ratio in mice.

[0092] The food-medicine composition provided in this application can significantly enhance the sperm count and sperm motility in mice with kidney yang deficiency caused by adenine, and improve the pathological state of asthenospermia and oligospermia.

[0093] (3) Observation of kidney HE staining pathological sections

[0094] Kidney HE-stained pathological sections from blank control group, model control group, positive drug control group, drug treatment group 1, drug treatment group 4, and drug treatment group 5 are shown below. Figure 2 As shown.

[0095] Figure 2The results showed that in the blank control group, the renal cortex showed obvious Bowman's capsule, the glomerular structure showed no obvious swelling or atrophy, the mesangial cells and matrix components showed no obvious proliferation or necrosis, the renal tubules were of different sizes, tightly arranged, and had normal structure, the epithelial cell nuclei were large and round, without obvious shrinkage or fragmentation, the cytoplasm was uniformly stained, the cell morphology was normal, the interstitium was rich in capillaries, and there was no inflammatory exudation or fibrosis.

[0096] In the model control group, extensive glomerular atrophy or necrosis was observed in the cortical necrosis area, with enlarged Bowman's capsule, reduced glomerular volume, and shrunken, fragmented, dissolved, or degenerated and enlarged nuclei of mesangial and parietal cells; extensive tubular necrosis was observed, with vacuolar degeneration or necrosis of epithelial cells and deposition of protein-like substances within the lumen; in the non-necrotic area, significant tubular dilation was observed, with some epithelial cells degenerating or necrosis, showing cell vacuolation, nucleus shrunkenness, fragmentation, or dissolution, and detachment into the lumen; and extensive inflammatory cell infiltration, aggregation into rings, or formation of inflammatory necrotic foci of varying sizes were observed in the perivascular interstitium of the interlobular vessels.

[0097] In the positive control group, a small number of glomerular atrophy or necrosis were observed in the cortex, with enlarged Bowman's capsule, reduced glomerular volume, condensation, fragmentation, dissolution, or degeneration and swelling of mesangial and parietal cell nuclei, occasional tubular dilation, epithelial cell degeneration and vacuolization or necrosis, and protein-like material deposition in the lumen; a large number of inflammatory cells infiltrated the perivascular interstitium of the interlobular vasculature, aggregated into rings, or formed inflammatory necrotic foci of varying sizes; the medullary collecting ducts had a relatively clear structure and were closely arranged, with some collecting duct epithelial cells vacuolized or necrotic, and occasional protein casts.

[0098] In the treatment group 1, a small number of glomeruli showed slight atrophy in the cortical necrotic area, with a slight enlargement of the Bowman's capsule and a decrease in the volume of the glomeruli. The nuclei of mesangial and parietal cells were condensed, fragmented, dissolved, or degenerated and enlarged. The renal tubules were necrotic, with vacuolar degeneration or necrosis of epithelial cells and deposition of protein-like substances in the lumen. In the non-necrotic area, some renal tubules were dilated, and some epithelial cells were degenerated or necrotic, with cell vacuolation, nucleus condensation, fragmentation, or dissolution, and detachment into the lumen. A large number of inflammatory cells infiltrated and aggregated into rings in the perivascular interstitium of the interlobular vessels. The medullary collecting ducts had a clearer structure and were more tightly arranged, with some collecting ducts necrotic and occasional protein casts.

[0099] In the four drug-treated groups, some glomeruli in the cortical necrosis area showed slight atrophy, with a slight increase in the size of Bowman's capsule, a decrease in the volume of the glomerulus, and condensation, fragmentation, dissolution, or degeneration and swelling of the nuclei of mesangial and parietal cells. Renal tubules were necrotic, with vacuolar degeneration or necrosis of epithelial cells and deposition of protein-like substances in the lumen. In the non-necrotic area, some renal tubules were dilated, and some epithelial cells were degenerated or necrotic, with cell vacuolation, nucleus condensation, fragmentation, or dissolution, and detachment into the lumen. A small amount of inflammatory cell infiltration was seen in the perivascular interstitium of the interlobular interstitium. The medullary collecting ducts were relatively clear and tightly arranged, with some collecting ducts necrotic, and occasional protein casts were observed.

[0100] In the five drug-treated groups, extensive glomerular atrophy or necrosis was observed in the cortex, with enlarged Bowman's capsule, reduced glomerular volume, shrunken, fragmented, dissolved, or degenerated and enlarged nuclei of mesangial and parietal cells, significant tubular dilation, and degeneration or necrosis of some epithelial cells, including cell vacuolation, shrunken, fragmented, or dissolved nuclei that detached into the lumen. Patchy or focal necrotic areas appeared along the renal columns or medullary actinomycetes, with blurred renal tubular or collecting duct structures, epithelial cell degeneration and necrosis, and homogeneous red-stained protein-like material deposition within the lumen. Numerous inflammatory cells infiltrated and aggregated into rings or formed inflammatory necrotic foci of varying sizes in the perivascular interstitium of the interlobular vasculature. The medullary collecting ducts had a relatively clear structure, were densely packed, and some collecting ducts were necrotic, with occasional protein casts.

[0101] In summary, the blank control group was basically normal, while all other groups showed some degree of pathological damage. Among them, the model control group had the most severe pathological damage, including large areas of patchy necrosis, glomerular atrophy and necrosis, renal tubular dilation and necrosis, increased protein casts, and strong perivascular inflammatory response in the interlobular tissues.

[0102] Compared with the model control group, the positive drug control group and the drug administration group 1 showed significant improvement, with the necrotic area basically disappearing, the glomeruli and renal tubules basically returning to normal, and the inflammatory response subsiding; the drug administration group 4 showed some improvement, with the necrotic area changing from a large patchy area to a small focal area and the area significantly reduced, and the number of glomerular atrophy and renal tubular dilation decreasing; the drug administration group 5 showed slight improvement, with only a slight reduction in the area of ​​the necrotic area.

[0103] (3) Examination of testicular sections

[0104] Testicular sections from the blank control group, model control group, positive drug control group, drug treatment group 1, drug treatment group 4, and drug treatment group 5 are shown below. Figure 3 As shown.

[0105] Figure 3 The results showed that in the blank control group, the visceral tunica vaginalis, tunica albuginea, and vascular membrane of the testis tissue were clearly defined without significant proliferation. The basement membrane of the seminiferous tubules was thin and round, and the myoepithelial cells were spindle-shaped and distributed on the outer side of the basement membrane. The spermatogenic cells in the tubules were clearly layered, with no obvious degeneration or necrosis. Occasionally, atrophy or necrosis of the seminiferous tubules was observed. The loose connective tissue in the interstitium showed no obvious pathological damage such as proliferation, fibrosis, or inflammatory cell infiltration. The interstitial cells were distributed in groups, were relatively large, round or polygonal, with round nuclei in the center, and had strong eosinophilic cytoplasm. The vascular structure in the interstitium was clear and obvious, and the endothelial cells were flattened without obvious degeneration or necrosis.

[0106] In the model control group, the capsule was pseudohypertrophic, with thickening of the capsule, atrophy of fibrous tissue, significant widening of the fibrous stroma, and degeneration or necrosis of a large number of fibroblasts or fibroblasts, with the nuclei changing from long spindle-shaped to round or shrunken and dissolved; a large number of seminiferous tubules atrophied or necrotized, with the seminiferous tubules becoming smaller in volume, and a large number of spermatogenic cells dying and detaching from the lumen, with occasional degeneration and swelling of basement membrane cells; and necrosis of some interstitial cells in the stroma, with the nuclei shrunken, fragmented, or dissolved.

[0107] In the positive drug control group, the visceral tunica vaginalis, tunica albuginea, and vascular membrane structures of the testicular tissue were clear, with no obvious hyperplasia; the basement membrane of the seminiferous tubules was thin and round, the myoepithelial cells were spindle-shaped and distributed on the outer side of the basement membrane, the spermatogenic cells in the tubules were clearly layered, and occasionally spermatogenic cell degeneration or necrosis was observed; the loose connective tissue in the interstitium had no obvious pathological damage such as hyperplasia, fibrosis, or inflammatory cell infiltration, and only occasionally homogeneous red-stained protein-like material was deposited; the interstitial cells were distributed in groups, were relatively large, round or polygonal, with round nuclei in the center, and the cytoplasm was strongly eosinophilic; the vascular structure in the interstitium was clear and obvious, and the endothelial cells were flattened, with no obvious degeneration or necrosis.

[0108] In group 1, the visceral tunica vaginalis, tunica albuginea, and vascular membrane of the testis tissue were clearly defined without significant proliferation; the basement membrane of the seminiferous tubules was thin and round, with occasional degeneration and swelling of myoepithelial cells, and a small number of spermatogenic cells in the tubules showing degeneration or necrosis, with nuclear condensation or dissolution; the loose connective tissue in the interstitium showed no significant proliferation, fibrosis, or inflammatory cell infiltration or other pathological damage, the interstitial cells were distributed in groups, were relatively large, round or polygonal, with round nuclei in the center, and the cytoplasm was strongly eosinophilic, the vascular structure in the interstitium was clear and obvious, and the endothelial cells were flattened without significant degeneration or necrosis.

[0109] In the four drug-treated groups, some seminiferous tubules in the tissues atrophied, and the volume of seminiferous tubules decreased. Some spermatogenic cells degenerated or died and detached from the lumen. Occasionally, protein-like substances were deposited in the lumen. Some interstitial cells in the interstitium died, and the nuclei shrank or dissolved. Homogeneous red-stained protein-like substances were deposited in the lumen of blood vessels.

[0110] In the five drug-treated groups, a large number of seminiferous tubules atrophied or died, with the volume of the seminiferous tubules decreasing and a large number of spermatogenic cells dying and detaching from the lumen; some interstitial cells in the interstitium died, with the nuclei condensing or dissolving.

[0111] In summary, the blank control group was basically normal, while the model control group had the most severe pathological damage, including pseudohypertrophy of the capsule, atrophy or necrosis of seminiferous tubules, shedding of seminiferous epithelium, and degeneration or necrosis of spermatogenic cells, basement membrane cells, and interstitial cells.

[0112] Compared to the model group, the positive drug control group and the drug-treated group 1 basically recovered to normal, with only a very small number of spermatogenic cells showing degeneration or necrosis. The pathological damage in drug-treated groups 4 and 5 was reduced to varying degrees.

[0113] In summary, the experimental results indicate that the food-medicine homology composition can significantly increase sperm count and motility in mice with kidney-yang deficiency, improve the pathological state of asthenospermia and oligospermia, and significantly improve kidney lesions in these mice. Compared to the model group, the necrotic areas in the treatment group 1 were almost completely eliminated, the glomeruli and renal tubules were basically restored to normal, and the inflammatory response subsided. Furthermore, it significantly improved testicular lesions in mice with kidney-yang deficiency; that is, compared to the model group, the degree of testicular pathological damage in the treatment group 1 mice was significantly improved. Therefore, the food-medicine homology composition provided in this application has a significant improving effect on infertility, asthenospermia, and oligospermia caused by kidney-yang deficiency, and has certain application prospects in treating male asthenospermia and oligospermia.

[0114] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A medicinal and edible composition for treating male oligospermia and asthenospermia, characterized in that: The ingredients, by weight, include: 2-4 parts oyster peptide powder, 6-10 parts goji berries, 2-5 parts polygonatum, 3-6 parts ginseng, 3-5 parts maca, 18-20 parts concentrated pomegranate juice, and 2-6 parts concentrated mulberry juice.

2. The medicinal and edible composition for treating male oligospermia and asthenospermia according to claim 1, characterized in that: The concentrated pomegranate juice contains ≥60% soluble solids (calculated as °Brix) and ≥130mg / 100mL total phenol content.

3. The medicinal and edible composition for treating male oligospermia and asthenospermia according to claim 1, characterized in that: The anthocyanin content of the mulberry concentrate is ≥10g / L.

4. A method for preparing a medicinal and edible composition for treating male oligospermia and asthenospermia as described in any one of claims 1-3, characterized in that: include: (1) Weigh the Polygonatum, Ginseng, Lycium barbarum and Maca according to the weight proportions, mix them, pulverize them, and pass them through a 100-150 mesh sieve to obtain a mixed powder; (2) The mixed powder is put into an extractor, and 8-10 times its own weight of water is added. After the first decoction for 1-1.5 hours, the mixture is filtered through a 100-150 mesh sieve to obtain the residue and the first filtrate. Then, 6-8 times its own weight of water is added to the residue, and the mixture is decocted for 30 minutes to 1 hour. The mixture is then filtered through a 100-150 mesh sieve to obtain the second filtrate. The first filtrate and the second filtrate are combined to obtain a mixed filtrate. The mixed filtrate was concentrated in a double-effect concentrator, with the first effect temperature set at 55-65℃ and the second effect temperature at 60-75℃, to obtain a first concentrate with a density of 1.02-1.

05. The first concentrate was then filtered through a plate and frame filter and concentrated again to a second concentrate with a relative density of 1.3-1.

35. The second concentrate was then hot-filled into sterilized containers and stored at -18℃. (3) Dissolve the oyster peptide powder in 3-5 times its own weight of water according to the weight proportions, then add the concentrated pomegranate juice, the concentrated mulberry juice and the second concentrated liquid, mix and stir, and then fill into a container.

5. The medicinal and edible composition for treating male oligospermia and asthenospermia according to claim 4, characterized in that: In step (3), the stirring rate is 100-150 r / min and the stirring time is 30 min-1 h.

6. The medicinal and edible composition for treating male oligospermia and asthenospermia according to claim 4, characterized in that: In step (3), after filling is completed, ultra-high pressure sterilization is performed under sterilization conditions of 500-600MPa for 8-10 minutes.

7. The medicinal and edible composition for treating male oligospermia and asthenospermia according to claim 6, characterized in that: In step (3), after sterilization, store at 0-4℃.

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