Solid composition for oral administration as well as preparation method and application thereof

Abstract

The invention provides a solid composition for oral administration as well as a preparation method and application thereof, and belongs to the technical field of probiotics. The composition disclosed by the invention comprises the following components: prebiotics, erythritol, lactic acid bacteria composite powder, magnesium gluconate dihydrate, a saffron crocus extract, L-ascorbic acid, zinc glycinate and vitamin D3. The oral solid composition disclosed by the invention is prepared by adopting a specific formula and proportion, is simple in used components, free from toxic and side effects and good in taste, can be used as food, can relieve physical fatigue of eaters after being taken with water, and can be used as health food for regulating human body functions and formula food for special medical purposes for specific crowds to eat; the medicine can regulate mood and improve life quality, and can be used as a medicine. The solid composition disclosed by the invention has the characteristics of low price and good experience, so that the compliance of consumers is improved, and the solid composition has market popularization and application values.

Description

Technical Field

[0001] The invention belongs to the technical field of probiotics, and particularly relates to a solid composition for oral administration, a preparation method and use thereof. Background Art

[0002] With the rapid development of society, the pace of life is accelerating, and the diversified social environment has put tremendous pressure on people's body and mind. Long-term low mood and lack of interest and pleasure can lead to emotional instability and depression. Severe depression can lead to mental disorders, decreased cognitive function, and even self-harm behavior.

[0003] The number of patients with depression has been rising year by year, making this group larger and larger. With the improvement of people's cognition and medical related reports, the depression group has received more and more attention. The prevention and treatment of depression has been one of the important research areas of scientific researchers in recent years. Various drugs to improve depression have been rapidly developed and used, such as fluoxetine, amitriptyline, venlafaxine, etc. This type of drug still has many risks, such as memory loss, constipation, effects on the heart, low treatment rate, large side effects, and high prices.

[0004] Traditional Chinese medicine believes that to treat depression, it is necessary to soothe the liver and regulate qi, clear the liver and reduce fire, resolve phlegm and relieve depression, nourish the heart and spleen, and nourish the liver and kidneys; with a green and healthy approach, in recent years, more and more researchers have directed their research and development towards functional foods that can easily and healthily relieve depression, and using dietary products to regulate emotions has become the choice of more and more people.

[0005] Patent application with publication number EP4104847A1 discloses a composition for treating mood disorders. The auxiliary ingredients used in the composition are of many types and complex. The composition is mainly orally administered in the form of tablets, hard shell capsules or soft gel capsules. The dosage form is single, and the patient's resistance to the drug due to long-term medication leads to poor patient compliance with the composition, which affects mood regulation and thus fails to achieve the effect of prevention or treatment.

[0006] Patent application number 202110614469.4 discloses a food composition that can relieve depression and a preparation method thereof. The invention prepares the food composition based on the concept that a variety of traditional Chinese medicines and foods are of the same origin. Due to the use of a variety of traditional Chinese medicine extracts, the food composition is difficult for ordinary consumers to benefit from.

[0007] Based on this, it is urgent to develop a food that is suitable for ordinary consumers, has good taste and compliance, and can be used as a food, such as a functional food, a health food or a special medical purpose formula food to relieve physical fatigue, and can also be used as a medicine to prevent depression, regulate depressive emotions and thus relieve depressive states. Summary of the invention

[0008] In order to solve the above problems, the present invention provides a solid composition for oral administration, a preparation method thereof and a use thereof. The preparation method of the solid composition for oral administration of the present invention is simple, the obtained solid composition for oral administration has a good taste, can be used as a food, and can relieve physical fatigue by taking it with water, and can be used as a food for regulating human body functions; it can also achieve the purpose of improving mood, preventing and relieving depression, and has no toxic side effects, and can be used as a medicine for preventing and treating depression; the good taste and strong functionality make consumers have a good experience, the price is low compared with similar products, and the characteristics of low price and good experience improve consumers' compliance.

[0009] The technical solution of the present invention is:

[0010] The invention provides a solid composition for oral administration, which comprises the following components: prebiotics, erythritol, lactic acid bacteria composite powder, magnesium gluconate dihydrate, saffron extract, L-ascorbic acid, zinc glycinate and vitamin D3.

[0011] Furthermore, the aforementioned composition comprises the following components: prebiotics, erythritol, lactic acid bacteria composite powder, magnesium gluconate dihydrate, saffron extract, L-ascorbic acid, zinc glycinate, and vitamin D3;

[0012] The weight portion of the prebiotic is 1310.01-2280 parts;

[0013] 200 portions of the lactic acid bacteria composite powder;

[0014] 28 portions of the saffron extract.

[0015] Furthermore, the aforementioned composition is composed of the following components in parts by weight:

[0016] 1310.01-2280 parts of prebiotics, 0.01-392.2 parts of erythritol, 200 parts of lactic acid bacteria compound powder, 0.01-93 parts of magnesium gluconate dihydrate, 28 parts of saffron extract, 0.001-5.4 parts of L-ascorbic acid, 0.001-1.4 parts of zinc glycinate, and 0.001-0.02 parts of vitamin D3;

[0017] The prebiotics are composed of 0.01-900 parts by weight of polydextrose, 800 parts by weight of xylo-oligosaccharide and 510-580 parts by weight of lactitol.

[0018] Furthermore, the aforementioned composition is composed of the following components in parts by weight:

[0019] 0.01-900 parts of polydextrose, 800 parts of xylo-oligosaccharides, 510 parts of lactitol, 0.01-392.2 parts of erythritol, 200 parts of lactic acid bacteria composite powder, 0.01-93 parts of magnesium gluconate dihydrate, 28 parts of saffron extract, 0.001-5.4 parts of L-ascorbic acid, 0.001-1.4 parts of zinc glycinate, and 0.001-0.02 parts of vitamin D3.

[0020] Furthermore, the aforementioned composition is composed of the following components in parts by weight:

[0021] 900 parts of polydextrose, 800 parts of xylo-oligosaccharides, 580 parts of lactitol, 392.2 parts of erythritol, 200 parts of lactic acid bacteria composite powder, 93 parts of magnesium gluconate dihydrate, 28 parts of saffron extract, 5.4 parts of L-ascorbic acid, 1.4 parts of zinc glycinate, and 0.02 parts of vitamin D3.

[0022] Furthermore, the lactic acid bacteria composite powder is composed of bacterial powder and auxiliary materials;

[0023] And / or, the saffron extract includes at least one of crocin I, crocin II, crocin aldehyde, crocin, crocetin, crocetin, and crocin;

[0024] and / or, the content of the polydextrose on a dry basis g / 100g is ≥90.0, and the purity is ≥90%;

[0025] And / or, the content of the xylo-oligosaccharide is ≥95.0 g / 100 g on a dry basis.

[0026] Furthermore, the bacterial powder includes at least one of Lactobacillus helveticus R-0052, Lactobacillus plantarum R-1012, and Bifidobacterium longum R-0175; the auxiliary material includes at least one of maltodextrin, oligofructose, and ascorbic acid;

[0027] Preferably,

[0028] The lactic acid bacteria composite powder comprises maltodextrin, Lactobacillus helveticus R-0052, Lactobacillus plantarum R-1012, and Bifidobacterium longum R-0175;

[0029] And / or, the saffron extract includes crocin I, crocin II, and crocinaldehyde.

[0030] The present invention also provides a method for preparing the aforementioned composition, which comprises the following steps:

[0031] The components are weighed as described above, lactitol is crushed, and the mixture is mixed with other components to obtain the product.

[0032] The present invention also provides the use of the aforementioned solid composition for oral administration in the preparation of food or medicine, wherein the food includes functional food; the food is a food for relieving physical fatigue;

[0033] The medicine is a preventive and / or antidepressant medicine.

[0034] Furthermore, the food also includes health food and special medical purpose formula food.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] The solid composition for oral administration of the present invention is prepared by adopting a specific formula and proportion, has the characteristics of good taste, and also has the effects of relieving physical fatigue, regulating emotions, preventing and relieving depression; the ingredients used are simple and have no toxic side effects; at the same time, the preparation method is simple, which greatly reduces the cost and conforms to the consumption concept of the majority of ordinary consumers.

[0037] Obviously, according to the above contents of the present invention, in accordance with common technical knowledge and customary means in the art, without departing from the above basic technical ideas of the present invention, other various forms of modification, replacement or change may be made.

[0038] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 These are the results of the sugar water test: A is the sugar water preference result before modeling; B is the sugar water preference result 14 days after modeling; C is the sugar water preference result 28 days after modeling.

[0040] Figure 2 The figure shows the results of the forced swimming test at 33 days of modeling: A is the immobility time of swimming; B is the struggling time. DETAILED DESCRIPTION

[0041] The raw materials and equipment used in the specific embodiments of the present invention are all known products and are obtained by purchasing commercially available products.

[0042] Example 1. Preparation of the oral solid composition of the present invention

[0043] The oral solid composition consists of the following components:

[0044] Polydextrose 900mg, xylo-oligosaccharide 800mg, lactitol 580mg, erythritol 392.2mg, lactic acid bacteria compound powder 200mg, magnesium gluconate dihydrate 93mg, saffron extract 28mg, L-ascorbic acid 5.4mg, zinc glycinate 1.4mg, vitamin D3 (content 0.25%) 0.02mg.

[0045] The preparation method of the oral solid composition is as follows: the lactitol is crushed, sieved, and mixed with other components to obtain the solid composition.

[0046] Example 2: Preparation of the oral solid composition of the present invention

[0047] The oral solid composition consists of the following components:

[0048] Polydextrose 0.01mg, xylo-oligosaccharide 800mg, lactitol 510mg, erythritol 0.01mg, lactic acid bacteria compound powder 200mg, magnesium gluconate dihydrate 0.01mg, saffron extract 28mg, L-ascorbic acid 0.001mg, zinc glycinate 0.001mg, vitamin D3 (content 0.25%) 0.001mg.

[0049] The preparation method of the oral solid composition is as follows: the lactitol is crushed, sieved, and mixed with other components to obtain the solid composition.

[0050] Example 3: Preparation of the oral solid composition of the present invention

[0051] The oral solid composition consists of the following components:

[0052] Polydextrose 900mg, xylo-oligosaccharide 800mg, lactitol 510mg, erythritol 200mg, lactic acid bacteria compound powder 200mg, magnesium gluconate dihydrate 45mg, saffron extract 28mg, L-ascorbic acid 2.5mg, zinc glycinate 0.8mg, vitamin D3 (content 0.25%) 0.0015mg.

[0053] The preparation method of the oral solid composition is as follows: the lactitol is crushed, sieved, and mixed with other components to obtain the solid composition.

[0054] Comparative Example 1

[0055] The oral solid composition consists of the following components:

[0056] Polydextrose 400mg, xylo-oligosaccharide 400mg, lactitol 433mg, erythritol 400mg, lactic acid bacteria compound powder 200mg, magnesium gluconate dihydrate 927mg, saffron extract 28mg, L-ascorbic acid 100mg, zinc glycinate 82mg, vitamin D3 (content 0.25%) 30mg.

[0057] The preparation method of the oral solid composition is as follows: the lactitol is crushed, sieved, and mixed with other components to obtain the solid composition.

[0058] Comparative Example 2

[0059] The oral solid composition consists of the following components:

[0060] Saffron extract 28mg, lactic acid bacteria compound powder 200mg.

[0061] The preparation method of the oral solid composition is as follows: all components are mixed to obtain the solid composition.

[0062] Comparative Example 3

[0063] Commercially available product: Cornius saffron extract probiotic solid beverage

[0064] Main ingredients of the product: inulin, xylo-oligosaccharides, lactitol, lactic acid bacteria compound powder ((maltodextrin, Lactobacillus helveticus R-0052, Lactobacillus plantarum R-1012, Bifidobacterium longum R-0175, oligofructose, ascorbic acid), added amount 200 mg / bar), sour cherry concentrate powder (added amount 100 mg / bar), edible flavoring (saffron extract (added amount 28 mg / bar)).

[0065] The effective ingredients of the saffron extract described in the examples and comparative examples of the present invention include: crocin I, crocin II, crocin aldehyde, purchased from: Spanish pharmactive company, brand is affron.

[0066] The lactic acid bacteria composite powder in the embodiment of the present invention and comparative examples 1 and 2 comprises maltodextrin, Lactobacillus helveticus R-0052, Lactobacillus plantarum R-1012, Bifidobacterium longum R-0175, purchased from Raman Group, Canada, model GI.

[0067] The vitamin D3 in the examples and comparative examples of the present invention is: vitamin D3 dry powder CWS / S, purchased from Ruipu.

[0068] In the examples of the present invention and comparative example 1, the content of polydextrose (on a dry basis) g / 100g is ≥90.0, and the purity is ≥90%; the content of xylo-oligosaccharide (on a dry basis) g / 100g is ≥95.0; the content of xylo-oligosaccharide (on a dry basis) g / 100g in comparative example 3 is ≥95.0.

[0069] The specific drinking method of the oral solid composition of the present invention is: take the solid composition and add an appropriate amount of warm water (below 37° C.) to mix and then eat it or eat it with milk, yogurt and other beverages or eat it directly; once a day.

[0070] The beneficial effects of the present invention are demonstrated below through specific test examples.

[0071] Test Example 1: Study on the efficacy of the oral solid composition of the present invention

[0072] Animals and Grouping

[0073] C57BL / 6J mice were placed in a feeding house for adaptive feeding for 7 days. Two days before modeling, the sucrose preference test (SPT) of mice was measured, and mice with a sucrose preference rate of less than 80% were eliminated. The mice that met the conditions were randomly divided into 7 groups according to the experimental design, with 8 mice in each group.

[0074] Group design: blank control group (Control), solvent control group (CUMS model group, Vehicle), positive control group (fluoxetine, Fluoxetine), test substance group 1 (Example 1, Treatment 1), test substance group 2 (Comparative Example 1, Treatment 2), test substance group 3 (Comparative Example 2, Treatment 3), test substance group 4 (Comparative Example 3, Treatment 4), a total of 7 groups.

[0075] Number of animals: 80 were purchased and 56 were included.

[0076] Gender: Male.

[0077] Model building:

[0078] The CUMS model is an animal model widely used in animal experiments to study depression. Therefore, the CUMS model was constructed to test the effect of the oral solid composition of the present invention on regulating depression. The model induces behavioral and physiological changes similar to human depression by applying a series of random and unpredictable mild stressors to experimental animals. The specific model construction method is as follows:

[0079] The mice in the CUMS model group were stimulated by two different stressors every day, including: tilting the cage at 45° for 24 hours, moist bedding (prepared with 200 ml water and 100 g corn cobs per cage) for 24 hours, fasting for 24 hours, water deprivation for 12 hours, shaking the cage (until the mice could not stand steadily) for 10 minutes, randomly shocking the soles of the mice with 0.6 mA current for 20 seconds within 360 seconds, three times in total, 40℃ hot environment for 30 minutes, 15℃ cold environment for 30 minutes, 24-hour day and night reversal, noise stimulation (about 80 decibels), flashing light stimulation (three-color light frequency 1 second / time) for 12 hours, restraint (using 50 mL EP tube, ensuring that the front opening exposes the mouse's mouth and nose) for 4 hours, loneliness (single cage), crowding (8 mice are placed in a standard mouse cage), and cage replacement (mice in different cages of the same group are swapped) for 24 hours. Each stimulus was randomly arranged, and two consecutive different stressors were performed every day throughout the experiment. The stress was kept constant during the drug treatment and behavioral period until the end of the experiment. The control group was kept in the same housing environment but did not receive stress.

[0080] Table 1 is the dosage table for the test animals. The test adopts: drug administration starts from the first day of modeling, once a day until the end of the test.

[0081] Table 1. Dosage table of the test substances

[0082]

[0083] Note: Taking an adult weight of 60 kg as an example; based on the body surface area conversion method, the dosage for mice in this experiment is about 11.2 times that of humans.

[0084] Statistical analysis:

[0085] The general status and other data were analyzed descriptively. The experimental data were simply processed using EXCEL software and then analyzed statistically using IBM SPSS Statistics 26.0 software. All measurement data were expressed as Mean ± SEM and plotted using Graph Pad Prism 8 software.

[0086] First, the data were tested for normality. If P≤0.05, the data were considered to be non-normally distributed; if P>0.05, the data were considered to be normally distributed. For data that were normally distributed, the quantitative indicators were first tested for homogeneity of variance using Levene's test. When the variances were homogeneous (P>0.05), one-way analysis of variance (ANOVA) was used for statistical testing: if statistically significant (P≤0.05), the LSD test was used to compare the differences between the groups; if statistically insignificant (P>0.05), the statistical analysis was terminated. When the data did not conform to the normal distribution or the variances were not homogeneous (P≤0.05), the Kruskal-Wallis H rank sum test (KW method) was used for statistical analysis: if statistically significant (P≤0.05), the Mann-Whitney U test (MW method) was used to compare the differences between the groups; if statistically insignificant (P>0.05), the statistical analysis was terminated.

[0087] Sugar water preference test:

[0088] This study used the sugar preference test (SPT) as the main modeling and efficacy evaluation standard. First, a sugar preference baseline test was performed on D0, and random groups were formed based on the sugar preference percentage data. After grouping, there was no significant difference in the baseline values ​​of the groups ( Figure 1 A). Modeling and drug administration started from D0 for 28 days ( Figure 1 ), the second SPT was performed two weeks after modeling (D14). Compared with the control group, the percentage of sugar water preference in the model group was significantly reduced ( Figure 1 B, P<0.001). Compared with the model group, the other test groups had no significant differences ( Figure 1 B). After 4 weeks of continuous modeling and drug administration, the control group was significantly higher than the model group ( Figure 1 C, P<0.001, the model group was significantly lower than the positive control group, and the test substance 1 to 4 groups were significantly higher than the model group ( Figure 1 C, P were all less than 0.001). The preference for sugar water in the test substance 1 group was significantly higher than that in the test substance 2-4 groups ( Figure 1 C, P = 0.001, P = 0.004, P = 0.015). Table 2 shows the sugar water preference data of each group.

[0089] Table 2. Sugar water preference data of each group

[0090]

[0091] Forced swimming test:

[0092] On the 33rd day (D33) of modeling and drug administration, the forced swimming test was performed. In the forced swimming test (D33), the immobility time of the model group was the longest, significantly longer than that of the control group (P=0.001) and the positive drug group (P<0.001); the test substance 1-4 groups could significantly shorten the immobility time of the depressed mice (P less than 0.001, Figure 2 A). The immobility time of test group 1 was shorter than that of test groups 2 to 4, and there was a statistically significant difference between test group 1 and test groups 2 and 4 (P = 0.002, P = 0.015, Figure 2 A).

[0093] The changing trend of struggling time was opposite to that of immobility time. The model group had the shortest time, which was significantly shorter than that of the control group (P<0.001) and the positive drug group (P=0.001). The four test groups could significantly prolong the struggling time of depressed mice (P<0.001, Figure 2 B). The struggling time of test substance group 1 was longer than that of test substance groups 2 to 4, and there was a statistically significant difference between test substance group 1 and test substance groups 2 and 4 (P = 0.003, P = 0.003, Figure 2 B) In Figure 2 In A, the immobility time of group 1 is better than that of group 3; Figure 2 In B, the struggling time of test group 1 was better than that of test group 3, indicating that the antidepressant effect of test group 1 was better than that of test group 3. At the same time, due to good physical strength, they could endure longer swimming, indicating that the four test groups had obvious effects in relieving physical fatigue.

[0094] Table 3 shows the forced swimming data of each group on the 33rd day of modeling.

[0095] Table 3. Forced swimming data of each group

[0096]

[0097] According to the results of the sugar water preference test and the forced swimming test, the preventive / antidepressive effects of the test group 1 to 4 were better than those of the model group, and the preventive / antidepressive effects of the test group 1 were significantly better than those of the test groups 2 to 4; compared with all the test groups, it can be seen that the differences between the test groups 2 to 4 were small, indicating that the oral solid compositions composed of saffron extract, lactic acid bacteria composite powder and other components in a specific proportion in the test groups 2 and 4 and the Cornius product and the oral solid compositions composed of saffron extract and lactic acid bacteria composite powder in the test group 3 were small in preventive / antidepressive efficacy, and even the other components in a specific proportion were not conducive to preventive / antidepressive effects. The preventive / antidepressive effects of the oral solid compositions of the specific proportion combination of the test group 1 of the present invention were significantly better than those of the test groups 2 to 4, indicating that the specific components and proportions of the test group 1 played a synergistic role, indicating that the oral solid compositions of the present invention have good preventive / antidepressive effects.

[0098] Test Example 2 Sensory test of the oral solid composition of the present invention

[0099] The oral solid compositions prepared in Example 1 and Comparative Examples 1-2, as well as the Conius product in Comparative Example 3, were tested for appearance and taste using a double-blind method. The specific method is:

[0100] After observing and recording the appearance of the product, the subjects first ate it directly and recorded the taste, then brewed it with 37°C warm water and observed the product's solubility, solution color and taste.

[0101] The sensory test results are as follows: the oral solid composition prepared in Example 1 is a white to light red powder, has no sticking to teeth when eaten directly, has a good taste, and has good subject experience and compliance; when taken with water at 37°C, it completely dissolves within 10 seconds, presents a uniform brown-yellow clear solution, and has a good oral experience.

[0102] The products of Comparative Examples 1 to 3 have poor taste when eaten directly and poor consumer compliance, especially the Conius product of Comparative Example 3, which sticks to teeth. When taken with water at 37° C., it is still in a partially aggregated state after 10 seconds, requiring a longer time to wait for it to be fully dissolved, and has poor solubility.

[0103] It can be seen from the sensory results that the oral solid composition of the present invention is superior to the product before the formula adjustment and similar products on the market in terms of appearance, solubility and taste, and has higher market recognition.

[0104] In summary, the oral solid composition of the present invention is prepared by adopting a specific formula and proportion. The composition uses simple ingredients, has no toxic side effects, has a good taste, can relieve physical fatigue, regulate emotions, and improve the quality of life; the good experience and low price can make consumers have good compliance; furthermore, the preparation method is simple, which greatly reduces the cost, and at the same time has multiple functions, can be used for food (functional food, health food, special medical purpose formula food) and medicine, and has market promotion and application value.

Claims

1. A solid composition for oral administration, characterized in that: It includes the following components: prebiotics, erythritol, lactic acid bacteria compound powder, magnesium gluconate dihydrate, saffron extract, L-ascorbic acid, zinc glycinate, and vitamin D3.

2. The composition according to claim 1, characterized in that: It includes the following components: prebiotics, erythritol, lactic acid bacteria compound powder, magnesium gluconate dihydrate, saffron extract, L-ascorbic acid, zinc glycinate, vitamin D3; The weight portion of the prebiotic is 1310.01-2280 parts; 200 portions of the lactic acid bacteria composite powder; 28 portions of the saffron extract.

3. The composition according to claim 2, characterized in that: It is composed of the following components by weight: 1310.01-2280 parts of prebiotics, 0.01-392.2 parts of erythritol, 200 parts of lactic acid bacteria compound powder, 0.01-93 parts of magnesium gluconate dihydrate, 28 parts of saffron extract, 0.001-5.4 parts of L-ascorbic acid, 0.001-1.4 parts of zinc glycinate, and 0.001-0.02 parts of vitamin D3; The prebiotics are composed of 0.01-900 parts by weight of polydextrose, 800 parts by weight of xylo-oligosaccharide and 510-580 parts by weight of lactitol.

4. The composition according to claim 3, characterized in that: It is composed of the following components in parts by weight: 0.01-900 parts of polydextrose, 800 parts of xylo-oligosaccharides, 510 parts of lactitol, 0.01-392.2 parts of erythritol, 200 parts of lactic acid bacteria composite powder, 0.01-93 parts of magnesium gluconate dihydrate, 28 parts of saffron extract, 0.001-5.4 parts of L-ascorbic acid, 0.001-1.4 parts of zinc glycinate, and 0.001-0.02 parts of vitamin D3.

5. The composition according to claim 3, characterized in that It is composed of the following components by weight: 900 parts of polydextrose, 800 parts of xylo-oligosaccharides, 580 parts of lactitol, 392.2 parts of erythritol, 200 parts of lactic acid bacteria composite powder, 93 parts of magnesium gluconate dihydrate, 28 parts of saffron extract, 5.4 parts of L-ascorbic acid, 1.4 parts of zinc glycinate, and 0.02 parts of vitamin D3.

6. The composition according to any one of claims 1 to 5, characterized in that: The lactic acid bacteria composite powder is composed of bacterial powder and auxiliary materials; And / or, the saffron extract includes at least one of crocin I, crocin II, crocin aldehyde, crocin, crocetin, crocetin, and crocin; and / or, the content of the polydextrose on a dry basis g / 100g is ≥90.0, and the purity is ≥90%; And / or, the content of the xylo-oligosaccharide is ≥95.0 g / 100 g on a dry basis.

7. The composition according to claim 6, characterized in that: The bacterial powder includes at least one of Lactobacillus helveticus R-0052, Lactobacillus plantarum R-1012, and Bifidobacterium longum R-0175; the auxiliary material includes at least one of maltodextrin, oligofructose, and ascorbic acid; Preferably, The lactic acid bacteria composite powder comprises maltodextrin, Lactobacillus helveticus R-0052, Lactobacillus plantarum R-1012, and Bifidobacterium longum R-0175; And / or, the saffron extract includes crocin I, crocin II, and crocinaldehyde.

8. A method for preparing the composition according to any one of claims 1 to 7, characterized in that: It includes the following steps: The components are weighed according to any one of claims 1 to 7, the lactitol is crushed, and the mixture is mixed with other components to obtain the product.

9. Use of the solid composition for oral administration according to any one of claims 1 to 7 in the preparation of food or medicine, characterized in that: The food includes functional food; the food is food for relieving physical fatigue; The medicine is a preventive and / or antidepressant medicine.

10. The use according to claim 9, characterized in that: The food also includes health food and special medical purpose formula food.

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