Composition for improving embryo quality and improving pregnancy assisting effect and application thereof

Abstract

The invention discloses a composition for improving embryo quality and improving a pregnancy assisting effect and application of the composition. The composition for improving the embryo quality and improving the pregnancy assisting effect comprises the following components in parts by weight; 12-18 parts of soybean phospholipid, 4-8 parts of sophora flower bud extract and 0.5-1.5 parts of Chinese yam protein polypeptide; by selecting the raw materials and under the combined action of the raw materials, the prepared composition for improving the embryo quality and improving the pregnancy assisting effect can reduce the FSH level of a patient, the ovulation number and the ovum maturation rate can be increased, meanwhile, the superior embryo rate can be increased, and a guarantee is provided for the success rate of test tube babies.

Description

Technical Field

[0001] The present invention relates to the field of biotechnology, and particularly relates to a composition for improving embryo quality and pregnancy assistance effect and its application. Background Art

[0002] The medical definition of infertility is that a couple has had normal sexual life without contraception for more than one year and has not achieved successful pregnancy. It is mainly divided into primary infertility and secondary infertility. Primary infertility means never being pregnant; secondary infertility means being pregnant once and then becoming infertile. According to this strict definition, infertility is a common problem that affects at least 10% - 15% of reproductive-age couples. The causes of infertility are divided into male infertility and female infertility.

[0003] Currently, for infertility, in vitro fertilization (IVF) is generally used to achieve pregnancy. IVF is the common name for in vitro fertilization - embryo transfer technology, which refers to the method of artificially fertilizing eggs and sperm outside the body, carrying out early embryo development, and then transplanting them into the mother's uterus for development to give birth to a baby. Therefore, how to improve the embryo quality and pregnancy assistance effect during IVF is particularly important.

[0004] In view of this, the present invention is specifically proposed. Summary of the Invention

[0005] The purpose of the present invention is to provide a composition for improving embryo quality and pregnancy assistance effect and its application. The composition of the present invention can reduce the FSH level of patients, increase the number of ovulations and the egg maturation rate, and at the same time improve the rate of high-quality embryos, providing a guarantee for the success rate of IVF.

[0006] In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:

[0007] The first aspect of the present invention provides a composition for improving embryo quality and pregnancy assistance effect, and the composition for improving embryo quality and pregnancy assistance effect comprises the following components in parts by weight;

[0008] Soybean phospholipid 12 - 18 parts, sophora japonica extract 4 - 8 parts, and yam protein polypeptide 0.5 - 1.5 parts.

[0009] Preferably, the composition for improving embryo quality and pregnancy assistance effect comprises the following components in parts by weight;

[0010] Soybean phospholipid 15 parts, sophora japonica extract 6 parts, and yam protein polypeptide 1 part.

[0011] Preferably, the sophora japonica extract is prepared by the following method:

[0012] (a) Grind sophora japonica to obtain sophora japonica powder;

[0013] (b) Add sophora flower powder to water, sterilize it, then inoculate Lactobacillus bulgaricus for fermentation treatment. Then, add a complex enzyme for enzymatic hydrolysis and inactivate the enzyme to obtain a mixed solution;

[0014] (c) Boil and extract the mixed solution. After cooling, add absolute ethanol until the ethanol concentration is 30% - 40% and stir. Centrifuge to remove the solvent, and thus obtain the sophora flower extract.

[0015] Preferably, the inoculation concentration of Lactobacillus bulgaricus is (1 - 5)×10 6 / ml;

[0016] The temperature of the fermentation treatment is 32 - 40°C, and the time is 40 - 60h;

[0017] The addition amount of the complex enzyme is 2% - 4% of the mass of the sophora flower powder; the complex enzyme is composed of papain and bromelain;

[0018] The mass ratio of papain to bromelain is 1:(5 - 8);

[0019] The temperature of the enzymatic hydrolysis is 50 - 60°C, and the time is 1.5 - 2h.

[0020] Preferably, the yam protein polypeptide is prepared by the following method:

[0021] (1) Wash, peel, color-protect, and homogenize the yam to obtain yam pulp;

[0022] (2) Dilute the yam pulp and gelatinize it, then add amylase for enzymatic hydrolysis and centrifugation, and collect the supernatant;

[0023] (3) Adjust the pH value of the supernatant to 2 - 4, then let it stand and centrifuge to collect the precipitate to obtain yam protein;

[0024] (4) Add yam protein and trypsin to water for the first enzymatic hydrolysis, then add papain for the second enzymatic hydrolysis, and then inactivate the enzyme and freeze-dry to obtain the yam protein polypeptide.

[0025] Preferably, the mass ratio of yam protein, trypsin, papain, and water is 1:(0.005 - 0.02):(0.01 - 0.02):(5 - 15);

[0026] The temperature of the first enzymatic hydrolysis is 36 - 38°C, the pH value is 7.5 - 8.0, and the enzymatic hydrolysis time is 1 - 3h;

[0027] The temperature of the second enzymatic hydrolysis is 50 - 55°C, the pH value is 6.8 - 7.2, and the enzymatic hydrolysis time is 1 - 3h.

[0028] In the second aspect of the present invention, there is provided an application of the above-mentioned composition for improving embryo quality and enhancing assisted reproduction effect in the preparation of a product for improving embryo quality and enhancing assisted reproduction effect.

[0029] Preferably, the product is a food, a health product or a drug.

[0030] In the third aspect of the present invention, there is provided a product for improving embryo quality and enhancing assisted reproduction effect, and the product for improving embryo quality and enhancing assisted reproduction effect comprises a therapeutically effective amount of the composition for improving embryo quality and enhancing assisted reproduction effect.

[0031] Preferably, the product for improving embryo quality and enhancing assisted reproduction effect further comprises excipients.

[0032] Preferably, the dosage form of the product is soft capsule, hard capsule, tablet, powder or granule.

[0033] Compared with the prior art, the beneficial effects of the present invention at least include:

[0034] Through the selection of each raw material, under the combined action of each raw material, the composition for improving embryo quality and enhancing assisted reproduction effect prepared by the present invention can reduce the FSH level of patients, increase the number of ovulations and the oocyte maturation rate, and at the same time increase the excellent embryo rate, providing a guarantee for the success rate of in vitro fertilization. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn to scale.

[0036] Figure 1 It is the FSH level in the sera of 51 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0037] Figure 2 It is the number of mature oocytes retrieved from 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0038] Figure 3 It is the oocyte maturation rate of 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0039] Figure 4 It is the number of 2PN of 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0040] Figure 5For the 2PN rate of 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0041] Figure 6 For the total number of embryos of 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0042] Figure 7 For the number of high-quality embryos of 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention;

[0043] Figure 8 For the high-quality embryo rate of 45 subjects before and after taking the product of Example 6 orally in the experimental examples of the present invention; Detailed implementation mode

[0044] The embodiments of the technical solutions of the present invention will be described in detail below in conjunction with the embodiments. The following embodiments are only used to illustrate the technical solutions of the present invention more clearly, and therefore are only examples and cannot be used to limit the protection scope of the present invention.

[0045] It should be noted that unless otherwise specified, the technical terms or scientific terms used in this application should have the ordinary meaning understood by those skilled in the art to which the present invention belongs.

[0046] The embodiment of the present invention provides a composition for improving embryo quality and improving the assisted pregnancy effect. The composition for improving embryo quality and improving the assisted pregnancy effect includes the following components in parts by weight;

[0047] Soybean phospholipid 12-18 parts, sophora japonica extract 4-8 parts, and yam protein polypeptide 0.5-1.5 parts.

[0048] Through the selection of each raw material, and under the combined action of each raw material, the composition for improving embryo quality and improving the assisted pregnancy effect prepared by the present invention can reduce the FSH level of patients, can increase the number of ovulations and the oocyte maturation rate, and at the same time can increase the high-quality embryo rate, providing a guarantee for the success rate of in vitro fertilization.

[0049] In one embodiment, the composition for improving embryo quality and improving the assisted pregnancy effect includes the following components in parts by weight;

[0050] Soybean phospholipid 15 parts, sophora japonica extract 6 parts, and yam protein polypeptide 1 part.

[0051] In the present invention, the sources of each raw material are not specifically limited. Preferably, in one embodiment, the sophora japonica extract is prepared by the following method:

[0052] (a) Grind the sophora japonica to obtain sophora japonica powder;

[0053] (b) Add sophora flower powder to water, sterilize it, then inoculate with Lactobacillus bulgaricus for fermentation treatment. Then, add a complex enzyme for enzymatic hydrolysis and inactivate the enzyme to obtain a mixed solution;

[0054] (c) Boil and extract the mixed solution. After cooling, add absolute ethanol until the ethanol concentration is 30% - 40% and stir. Then centrifuge to remove the solvent, and the sophora flower extract is obtained.

[0055] In one embodiment, the inoculation concentration of Lactobacillus bulgaricus can be any value in (1 - 5)×10 6 / ml;

[0056] The temperature of the fermentation treatment can be any value in 32 - 40°C, and the time can be any value in 40 - 60h;

[0057] The addition amount of the complex enzyme can be any value in 2% - 4% of the mass of the sophora flower powder; the complex enzyme is composed of papain and bromelain;

[0058] The mass ratio of papain to bromelain can be any value in 1:(5 - 8);

[0059] The temperature of the enzymatic hydrolysis can be any value in 50 - 60°C, and the time can be any value in 1.5 - 2h.

[0060] In one embodiment, the yam protein polypeptide is prepared by the following method:

[0061] (1) Wash, peel, color protect, and homogenize the yam to obtain yam pulp;

[0062] (2) Dilute the yam pulp and gelatinize it, then add amylase for enzymatic hydrolysis and centrifuge to collect the supernatant;

[0063] (3) Adjust the pH value of the supernatant to 2 - 4, then let it stand and centrifuge to collect the precipitate to obtain yam protein;

[0064] (4) Add yam protein and trypsin to water for the first enzymatic hydrolysis, then add papain for the second enzymatic hydrolysis, and then inactivate the enzyme and freeze-dry to obtain the yam protein polypeptide.

[0065] In some embodiments, the mass ratio of yam protein, trypsin, papain, and water can be any value in 1:(0.005 - 0.02):(0.01 - 0.02):(5 - 15);

[0066] The temperature of the first enzymatic hydrolysis can be any value in 36 - 38°C, the pH value can be any value in 7.5 - 8.0, and the enzymatic hydrolysis time can be any value in 1 - 3h;

[0067] The temperature of the second enzymatic hydrolysis can be any value between 50 and 55 °C, the pH value can be any value between 6.8 and 7.2, and the enzymatic hydrolysis time can be any value between 1 and 3 h.

[0068] Another embodiment of the present invention provides an application of the above composition for improving embryo quality and enhancing pregnancy assistance effect in the preparation of a product for improving embryo quality and enhancing pregnancy assistance effect.

[0069] In one embodiment, the product is a food, a health product or a medicine.

[0070] Another embodiment of the present invention provides a product for improving embryo quality and enhancing pregnancy assistance effect, and the product for improving embryo quality and enhancing pregnancy assistance effect includes a therapeutically effective amount of the composition for improving embryo quality and enhancing pregnancy assistance effect.

[0071] In one embodiment, the product for improving embryo quality and enhancing pregnancy assistance effect further includes excipients.

[0072] In one embodiment, the dosage form of the product is soft capsule, hard capsule, tablet, powder or granule.

[0073] The technical solution of the present invention will be further described in detail through specific embodiments below.

[0074] The raw material components used in the following examples are as follows:

[0075] The sophora japonica extract is prepared by the following method:

[0076] (a) Dry and grind the sophora japonica, and pass through a 10-mesh sieve to obtain sophora japonica powder;

[0077] (b) According to the mass ratio of sophora japonica powder to water of 1:25, add the sophora japonica powder to water, sterilize it, and then inoculate Lactobacillus bulgaricus (purchased from Jiangsu Caiwei Biotechnology Co., Ltd.) for fermentation treatment. Then, add a compound enzyme and carry out enzymatic hydrolysis at 55 °C for 2 h, and inactivate the enzyme to obtain a mixed solution. Among them, the inoculation concentration of Lactobacillus bulgaricus is 2×10 6 / ml; the temperature of the fermentation treatment is 35 °C, the time is 50 h; the addition amount of the compound enzyme is 3% of the mass of the sophora japonica powder; the compound enzyme is composed of papain and bromelain with a mass ratio of 1:6, the enzyme activity of papain is 100,000 U / g; the enzyme activity of bromelain is 500,000 U / g;

[0078] (c) Boil and extract the mixed solution for 1.5 h. After cooling, add absolute ethanol until the ethanol concentration is 35% and stir, centrifuge, and remove the solvent to obtain the sophora japonica extract.

[0079] The yam protein polypeptide is prepared by the following method:

[0080] (1) Wash, peel, color-protect, and homogenize the yam to obtain yam pulp;

[0081] (2) Dilute the yam pulp 18 times, then gelatinize it, add α-amylase for enzymatic hydrolysis, and centrifuge to collect the supernatant. Among them, the gelatinization temperature is 90 °C; the enzymatic hydrolysis temperature is 55 °C, the time is 2 h; the addition amount of α-amylase is 2% of the mass of the yam pulp;

[0082] (3) Adjust the pH value of the supernatant to 3, then let it stand for 18 h, centrifuge at 4200 rpm, and collect the precipitate to obtain yam protein;

[0083] (4) According to the mass ratio of yam protein, trypsin, papain, and water being 1∶0.01∶0.015∶10, add yam protein and trypsin to water for the first enzymatic hydrolysis, then add papain for the second enzymatic hydrolysis, and then perform enzyme inactivation treatment and freeze-drying to obtain the yam protein polypeptide. Among them, the first enzymatic hydrolysis temperature is 37 °C, the pH value is 7.5, and the enzymatic hydrolysis time is 2 h; the second enzymatic hydrolysis temperature is 52 °C, the pH value is 7.0, and the enzymatic hydrolysis time is 2 h.

[0084] Soybean phospholipid: The soybean phospholipid is prepared by the method in the patent application number CN202210085101.8.

[0085] Example 1

[0086] This example is a composition for improving embryo quality and pregnancy assistance effect. The composition for improving embryo quality and pregnancy assistance effect includes the following components in parts by weight;

[0087] 12 parts of soybean phospholipid, 8 parts of sophora japonica extract, and 0.5 part of yam protein polypeptide.

[0088] Example 2

[0089] This example is a composition for improving embryo quality and pregnancy assistance effect. The composition for improving embryo quality and pregnancy assistance effect includes the following components in parts by weight;

[0090] 18 parts of soybean phospholipid, 4 parts of sophora japonica extract, and 1.5 parts of yam protein polypeptide.

[0091] Example 3

[0092] This example is a composition for improving embryo quality and pregnancy assistance effect. The composition for improving embryo quality and pregnancy assistance effect includes the following components in parts by weight;

[0093] 15 parts of soybean phospholipid, 6 parts of sophora japonica extract and 1 part of yam protein polypeptide.

[0094] Example 4

[0095] This example is a product for improving embryo quality and enhancing the effect of assisted pregnancy. The product for improving embryo quality and enhancing the effect of assisted pregnancy is a tablet, which includes the composition for improving embryo quality and enhancing the effect of assisted pregnancy in Example 1, xylitol and maltodextrin.

[0096] The above product for improving embryo quality and enhancing the effect of assisted pregnancy is prepared by the following method:

[0097] Mix the composition for improving embryo quality and enhancing the effect of assisted pregnancy, xylitol and maltodextrin evenly, granulate by a granulating machine under pressure to make regular granules, and then use a tableting machine to press and form, thus obtaining the drug for improving embryo quality and enhancing the effect of assisted pregnancy.

[0098] Example 5

[0099] This example is a product for improving embryo quality and enhancing the effect of assisted pregnancy. The product for improving embryo quality and enhancing the effect of assisted pregnancy is a tablet, which includes the composition for improving embryo quality and enhancing the effect of assisted pregnancy in Example 2, xylitol and maltodextrin.

[0100] The above product for improving embryo quality and enhancing the effect of assisted pregnancy is prepared by the following method:

[0101] Mix the composition for improving embryo quality and enhancing the effect of assisted pregnancy, xylitol and maltodextrin evenly, granulate by a granulating machine under pressure to make regular granules, and then use a tableting machine to press and form, thus obtaining the drug for improving embryo quality and enhancing the effect of assisted pregnancy.

[0102] Example 6

[0103] This example is a product for improving embryo quality and enhancing the effect of assisted pregnancy. The product for improving embryo quality and enhancing the effect of assisted pregnancy is a tablet, which includes the composition for improving embryo quality and enhancing the effect of assisted pregnancy in Example 3, xylitol and maltodextrin.

[0104] The above product for improving embryo quality and enhancing the effect of assisted pregnancy is prepared by the following method:

[0105] Mix the composition for improving embryo quality and enhancing the effect of assisted pregnancy, xylitol and maltodextrin evenly, granulate by a granulating machine under pressure to make regular granules, and then use a tableting machine to press and form, thus obtaining the drug for improving embryo quality and enhancing the effect of assisted pregnancy.

[0106] Experimental Example

[0107] This experimental example is a study on the improvement effect of the product of the present invention for improving embryo quality and pregnancy assistance effect on the embryo quality of women with poor embryo quality after receiving ART pregnancy assistance:

[0108] 1. This study is a prospective, self - controlled clinical trial. Women aged 20 ≤ age ≤ 40 years old.

[0109] Subjects started taking the product of Example 6 of the present invention for improving embryo quality and pregnancy assistance effect on the 1st - 5th day of menstruation. The dosage is 4 capsules each time (each capsule contains 0.3 g of the composition for improving embryo quality and pregnancy assistance effect), 2 times a day, for one menstrual cycle;

[0110] Ovulation induction started at the second menstruation, and the above - mentioned product was continued to be taken until the egg retrieval day.

[0111] This data is for statistical analysis of 45 subjects, and the statistical data of the FSH levels of 51 subjects in the previous period; 2. Evaluation indicators:

[0112] Main indicator: High - quality embryo rate;

[0113] Secondary indicators: Number of retrieved eggs, normal fertilization rate.

[0114] 3. Experimental results:

[0115] (1). Before and after taking the product of Example 6, the FSH levels in the sera of 51 subjects were as Figure 1 shown;

[0116] Figure 1 Among them, A is the bar chart of FSH levels in the sera of 51 subjects before and after oral administration; B is the percentile statistics of FSH concentrations in the sera of 51 subjects before and after oral administration;

[0117] From Figure 1 it can be seen that:

[0118] The product of this example can reduce the FSH level of patients, from 7.3655 before taking to 6.2425, with a significant difference of P = 0.0439.

[0119] (2). Before and after taking the product of Example 6, the number of mature retrieved eggs of 45 subjects was as Figure 2 shown, and the oocyte maturation rate was as Figure 3 shown;

[0120] Figure 2 Among them, C is the situation of the number of mature retrieved eggs of 45 subjects before and after taking the product of this example; D is the percentile statistics of the number of mature retrieved eggs of subjects before and after oral administration of the product of this example;

[0121] Figure 3 Among them, E is the oocyte maturation rate of 45 subjects before and after taking the product of this example; F is the percentile statistics of the oocyte maturation rate of the subjects before and after orally taking the product of this example;

[0122] From Figure 2 and 3 it can be seen that:

[0123] Taking the product of this example can increase the number of mature oocytes retrieved from 5.6 before taking to 7.1778, with a significant difference of P = 0.0252; it can increase the oocyte maturation rate, from 65.46% before taking to 76.58%, with a significant difference of P = 0.0357.

[0124] (3) Before and after taking the product of Example 6 of this example, the number of 2PNs in the fertilized eggs of 45 subjects is as shown in Figure 4 shown, and the 2PN rate of the fertilized eggs is as shown in Figure 5 shown;

[0125] Figure 4 Among them, A is the number of 2PNs of 45 subjects before and after taking the product of this example; B is the percentile statistics of the number of 2PNs of the subjects before and after orally taking the product of this example;

[0126] Figure 5 Among them, C is the 2PN rate of 45 subjects before and after taking the product of this example; D is the percentile statistics of the 2PN rate of the subjects before and after orally taking the product of this example;

[0127] From Figure 4 and 5 it can be seen that:

[0128] Taking the product of this example can increase the number of 2PNs in patients, from 4.5556 before taking to 6.4, with a significant difference of P = 0.0056; it can increase the 2PN rate in patients, from 54.77% before taking to 68.04%, with a significant difference of P = 0.0083.

[0129] (4) Before and after taking the product of this example, the total number of embryos of 45 subjects is as shown in Figure 6 shown;

[0130] Figure 6 Among them, E is the total number of embryos of 45 subjects before and after taking the product of this example; F is the percentile statistics of the total number of embryos of the subjects before and after taking the drug orally;

[0131] From Figure 6 it can be seen that:

[0132] Taking the product of this embodiment can increase the total number of embryos of patients, from 1.6444 before taking to 3.0222, with a significant difference of P = 0.000065.

[0133] (5) Before and after taking the product of this embodiment, the number of high-quality embryos of 45 subjects is as Figure 7 shown; the high-quality embryo rate is as Figure 8 shown; the criteria for high-quality embryos are: embryos on the 3rd day (number of cells ≥ 8, even size of blastomeres, fragmentation rate < 10%) and blastocysts (≥ 3BB);

[0134] Figure 7 Among them, A is the situation of the number of high-quality embryos of 45 subjects before and after taking the product of this embodiment; B is the percentile statistics of the number of high-quality embryos of the subjects before and after orally taking the product of this embodiment;

[0135] Figure 8 Among them, C is the situation of the high-quality embryo rate of 45 subjects before and after taking the product of this embodiment; D is the percentile statistics of the high-quality embryo rate of the subjects before and after orally taking the product of this embodiment;

[0136] From Figure 7 、 8 it can be seen that:

[0137] Taking the product of this embodiment can increase the number of high-quality embryos of patients, from 0.4889 before taking to 1.2000, with a significant difference of P = 0.0150. It can improve the high-quality embryo rate of patients, from 26.28% before taking to 35.54%.

[0138] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered by the scope of the claims and the description of the present invention.

Claims

1. A composition for improving embryo quality and assisted pregnancy effect, characterized in that: The composition for improving embryo quality and assisted pregnancy effect comprises the following components in parts by weight: 12-18 parts of soybean lecithin, 4-8 parts of Sophora japonica seed extract and 0.5-1.5 parts of yam protein polypeptide.

2. The composition for improving embryo quality and assisted pregnancy effect according to claim 1, characterized in that: The composition for improving embryo quality and assisted pregnancy effect comprises the following components in parts by weight: 15 parts of soybean lecithin, 6 parts of Sophora japonica extract and 1 part of yam protein polypeptide.

3. The composition for improving embryo quality and assisted pregnancy effect according to claim 1, characterized in that: The sophora japonica extract is prepared by the following method: (a) grinding the buds of Sophora japonica to obtain buds of Sophora japonica powder; (b) adding the sophora japonica flour into the water, sterilizing and then inoculating Lactobacillus bulgaricus to carry out fermentation treatment, then, adding complex enzyme to carry out enzymolysis, enzyme inactivation treatment, and obtaining mixed solution; (c) boiling the mixed solution for extraction, and after cooling, adding anhydrous ethanol to an ethanol concentration of 30% to 40%, stirring, centrifuging, and removing the solvent to obtain the sophora japonica flower extract.

4. The composition for improving embryo quality and assisted pregnancy effect according to claim 3, characterized in that: The inoculation concentration of the Lactobacillus bulgaricus is (1-5)×10 6 / ml; The fermentation temperature is 32-40°C and the fermentation time is 40-60h; The added amount of the compound enzyme is 2% to 4% of the mass of the sophora japonica rice flour; the compound enzyme is composed of papain and bromelain; The mass ratio of papain to bromelain is 1:(5-8); The enzymolysis temperature is 50-60° C. and the time is 1.5-2 hours.

5. The composition for improving embryo quality and assisted pregnancy effect according to claim 1, characterized in that: The yam protein polypeptide is prepared by the following method: (1) washing, peeling, color-protecting, and homogenizing the yam to obtain yam slurry; (2) diluting the yam slurry and gelatinizing it, then adding amylase for enzymatic hydrolysis, centrifuging, and collecting the supernatant; (3) adjusting the pH value of the supernatant to 2-4, allowing the supernatant to stand, centrifuging, and collecting the precipitate to obtain yam protein; (4) adding yam protein and trypsin into water for a first enzymatic hydrolysis, then adding papain for a second enzymatic hydrolysis, then performing enzyme inactivation treatment and freeze-drying to obtain the yam protein polypeptide.

6. The composition for improving embryo quality and assisted pregnancy effect according to claim 5, characterized in that: The mass ratio of yam protein, trypsin, papain and water is 1:(0.005-0.02):(0.01-0.02):(5-15); The first enzymatic hydrolysis temperature is 36-38°C, the pH value is 7.5-8.0, and the enzymatic hydrolysis time is 1-3h; The second enzymolysis temperature is 50-55° C., the pH value is 6.8-7.2, and the enzymolysis time is 1-3 hours.

7. Use of the composition for improving embryo quality and improving assisted pregnancy effect according to any one of claims 1 to 6 in the preparation of a product for improving embryo quality and improving assisted pregnancy effect.

8. A product for improving embryo quality and assisted pregnancy effect, characterized in that: The product for improving embryo quality and improving assisted pregnancy effect comprises a therapeutically effective amount of the composition for improving embryo quality and improving assisted pregnancy effect according to any one of claims 1 to 6.

9. The product for improving embryo quality and assisted pregnancy effect according to claim 8, characterized in that: The product for improving embryo quality and assisted pregnancy effect also includes auxiliary materials.

10. The product for improving embryo quality and assisted pregnancy effect according to claim 8, characterized in that: The dosage form of the product is soft capsule, hard capsule, tablet, powder or granule.

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