Growth-promoting butyric acid amide tablet and its preparation method

Abstract

The application belongs to the technical field of health products, and provides a growth-promoting amino butyric acid tablet and a preparation method thereof. 12 The preparation method of the amino butyric acid tablet is as follows: first, vitamin B1, vitamin B2, vitamin B6, vitamin B , vitamin D, folic acid and a first part of fillers are fully mixed and dried to obtain premix I; then, amino acids (gamma-amino butyric acid and L-lysine), the first part of premix I and a first part of binders are uniformly mixed; then, the remaining premix I is added and uniformly mixed to obtain premix II; then, calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite are fully mixed, the remaining binders are dissolved in water and sprayed, wet granulation is carried out, and the granules are dried; finally, total mixing is carried out, and the tablet is pressed to be prepared. Through the improvement of the preparation process, the stability and content uniformity of B vitamins are improved, and the growth-promoting effect is improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of health products, and provides a growth-promoting aminobutyric acid tablet and a preparation method thereof. BACKGROUND

[0002] γ-aminobutyric acid (GABA) is a non-protein amino acid widely existing in animals, plants and microorganisms, and is the most important inhibitory neurotransmitter in the nervous system of mammals, crustaceans and insects. Studies have shown that 30%-40% of central neurons use GABA as an inhibitory neurotransmitter, which can play a role in promoting sleep, anti-aging, relieving anxiety, etc. through its interaction with specific receptors.

[0003] In recent years, γ-aminobutyric acid has attracted much attention in promoting growth. The prior art (Research Progress of γ-aminobutyric Acid in Promoting Growth, Li Lingmei, Chinese Medical Information Bulletin, 2024, No. 2) points out that aminobutyric acid supports the physiological regulation of pituitary function and controls the secretion of growth hormone (GH) by the pituitary, and GH plays an important role in skeletal muscle growth and maintenance. In addition to its role in GH regulation, GABA affects bone growth by regulating the proliferation and differentiation of chondrocytes. However, the interaction between it and other growth regulators remains to be further studied.

[0004] Chinese patent application CN116998715A discloses a long and high nutritional tablet rich in γ-aminobutyric acid and a preparation method thereof. The tablet contains γ-aminobutyric acid, which can regulate the central nervous system, promote metabolism, improve sleep quality, improve mood and immune system, etc. It is particularly helpful for children in the growth and development stage, especially those who love sports, to grow taller. At the same time, the addition of complex minerals helps to form bones, prevent osteoporosis and fractures, and the addition of complex vitamins promotes the absorption and utilization of nutrients and maintains bone density. The tablet is wrapped with tea polyphenol, gelatin and chitosan to improve its antioxidant properties and storage time.

[0005] However, in the above-mentioned technology, on the one hand, although no obvious discoloration and deliquescence are observed from a macroscopic point of view, the stability of vitamin B in the composition is poor, and in the presence of strongly oxidizing iron pyrophosphate and magnesium oxide in the compound mineral, oxidation decomposition is prone to occur, in the preparation process, the compound mineral containing iron pyrophosphate and magnesium oxide is directly mixed with the compound vitamin containing vitamin B, and deionized water is added to prepare a nutrient solution, in the solution with a high water content, vitamin B is prone to be oxidized and degraded, which seriously affects the chemical stability and further affects the effect of promoting bone growth. On the other hand, due to the extremely low addition amount of part of the minerals and vitamins, there are problems such as uneven content distribution in the preparation process of the tablets, which also affects the dissolution performance, and finally leads to that the activity cannot be fully exerted, and also affects the effect of promoting bone growth.

[0006] Therefore, in order to improve the stability of vitamin B in the tablets and the content uniformity of the trace components, it is necessary to optimize the composition of the existing tablets and improve the preparation process. SUMMARY

[0007] In view of the problems existing in the prior art, the present application provides a growth-promoting aminobutyric acid tablet and a preparation method thereof, by improving the preparation process, the stability of the compound vitamin, especially vitamin B, is effectively improved, and the problem of uneven distribution of trace components is effectively improved, and the effect of promoting bone development is improved.

[0008] The technical scheme of the present application is as follows:

[0009] The present application provides a preparation method of a growth-promoting aminobutyric acid tablet, comprising the following steps:

[0010] (1) fully mix and dry vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and the first part of the filler to obtain premix I;

[0011] (2) uniformly mix amino acids, the first part of premix I and the first part of the binder, then add the remaining premix I and mix uniformly to obtain premix II;

[0012] (3) fully mix calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite, dissolve the remaining binder in water and spray to carry out wet granulation to obtain wet granules;

[0013] (4) granulate and dry the wet granules to obtain dry granules;

[0014] (5) total mixing: uniformly mix premix II, dry granules, remaining fillers and lubricants, and press into tablets to obtain the aminobutyric acid tablet;

[0015] The amino acids include: γ-aminobutyric acid and L-lysine.

[0016] Further, in step (1), the mass of the first portion of filler is vitamin B1, vitamin B2, vitamin B6, and vitamin B1. 12 10 to 50 times the total amount.

[0017] Further, in step (2), the mass of the first part of premix I is 0.015-0.05 times the total amount of amino acids; the mass of the first part of adhesive is 0.5-2.5 times the total amount of amino acids.

[0018] Furthermore, the particle size of the premix I is: D50 is 160-240μm; D90≤350μm.

[0019] Furthermore, the filler is selected from one or more of fructooligosaccharides, xylooligosaccharides, isomaltooligosaccharides, and maltodextrin.

[0020] Furthermore, the adhesive is selected from one or more of sorbitol, maltitol, stevia, and polyvinyl alcohol.

[0021] Furthermore, the lubricant is selected from one or more of magnesium stearate, hydrogenated vegetable oil, and polyethylene glycol.

[0022] The present invention also provides aminobutyric acid tablets prepared by any of the preparation methods described above.

[0023] Furthermore, the amino acid also includes one or both of L-leucine and glycine.

[0024] In some specific embodiments of the present invention, the raw and auxiliary materials of the GABA tablets, by weight, include: 0.5-1 parts of γ-aminobutyric acid, 0.2-0.4 parts of L-lysine, 0-0.8 parts of L-leucine, 0-0.8 parts of glycine, 0.0001-0.001 parts of compound vitamins, 10-40 parts of compound minerals, 1-10 parts of filler, 0.5-5 parts of binder, and 1-2 parts of lubricant.

[0025] Further, the compound vitamins, by weight, comprise: 0.000015-0.00002 parts of vitamin D, 0.0002-0.0004 parts of vitamin B1, 0.0002-0.0004 parts of vitamin B2, 0.0002-0.0004 parts of vitamin B6, and vitamin B... 12 0.0001-0.0005 parts and folic acid 0.0004-0.0008 parts.

[0026] Further, the composite mineral substance comprises, in parts by weight, calcium citrate 10-35 parts, magnesium oxide 0.5-1 part, ferrous fumarate 0.05-0.1 part, and sodium selenite 0.075-0.15 part.

[0027] Compared with the prior art, the present application has the following beneficial effects:

[0028] The present application realizes uniform dispersion of trace components vitamins and fillers through multi-stage premixing; meanwhile, the composite mineral substance is wrapped with a binder through wet granulation to realize isolation from vitamins susceptible to oxidation and degradation during the mixing process, thereby solving the degradation problem of the composite vitamins in the gamma-aminobutyric acid tablets, especially the B vitamins (especially vitamin B1, thiamine), due to the presence of metal ions (composite mineral substance) in the presence of moisture, improving the chemical stability of the aminobutyric acid tablets, and effectively prolonging the storage period. In addition, through multi-stage premixing of the vitamin mixed granules and limitation of the particle size, the content uniformity of vitamin D and B vitamins is further improved, solving the problem of low dissolution caused by uneven distribution during taking, effectively improving the effect of aminobutyric acid tablets in promoting bone development, and making the functions of each component fully play. DETAILED DESCRIPTION

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0030] Examples 1-4

[0031] The aminobutyric acid tablets provided in this example are composed of raw and auxiliary materials as shown in Table 1.

[0032]

[0033] The preparation method is as follows:

[0034] Example 1

[0035] (1) Vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid, and 10 mg of fructooligosaccharide (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) are fully mixed and dried (hot air circulation drying at 50°C and 1.0 m / s air speed to control particle size) to obtain premix I (D50 is 185 μm; D90 is 312 μm);

[0036] (2) Then take γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid, L-lysine) and 48.5 mg of sorbitol (0.5 times the amount of γ-aminobutyric acid, L-lysine) are mixed evenly; then add the remaining premix I and mix evenly to obtain premix II;

[0037] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix thoroughly, dissolve the remaining sorbitol in water to make a 5wt% solution and spray it in, and wet granulation is carried out to obtain wet granules;

[0038] (4) The wet granules are sized and dried to obtain dry granules;

[0039] (5) Finally, mix premix II, dry granules, remaining oligofructose and magnesium stearate, mix evenly, and then punch into tablets with a 8mm diameter die.

[0040] Example 2

[0041] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid vitamin A, vitamin E and 50 mg of oligofructose (about 50 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin A, vitamin E) are mixed thoroughly and dried (60°C, 1.0m / s air speed conditions, hot air circulation drying to control particle size), to obtain premix I (D50 is 211 μm; D90 is 328 μm);

[0042] (2) Then take γ-aminobutyric acid, L-lysine, glycine, L-leucine, 4.85 mg of premix I (about 0.05 times the amount of γ-aminobutyric acid, L-lysine) and 240 mg of sorbitol (about 2.5 times the amount of γ-aminobutyric acid, L-lysine) are mixed evenly; then add the remaining premix I and mix evenly to obtain premix II;

[0043] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix thoroughly, dissolve the remaining sorbitol in water to make a 5wt% solution and spray it in, and wet granulation is carried out to obtain wet granules;

[0044] (4) The wet granules are sized and dried to obtain dry granules;

[0045] (5) Finally, mix premix II, dry granules, sweet orange powder, stevioside, remaining oligofructose and magnesium stearate, mix evenly, and then punch into tablets with a 8mm diameter die.

[0046] Example 3

[0047] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 6 mg of fructo-oligosaccharide (about 20 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) are thoroughly mixed and dried (hot air circulation drying at 70°C, 1.5 m / s wind speed to control particle size), to obtain premix I (D50 is 177 μm; D90 is 306 μm);

[0048] (2) Then take γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid, L-lysine) and 97 mg of sorbitol (about 1 times the amount of γ-aminobutyric acid, L-lysine) are mixed evenly; then add the remaining premix I and mix evenly, to obtain premix II;

[0049] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix thoroughly, and then dissolve the remaining sorbitol in water and spray into the wet granulator to obtain wet granules;

[0050] (4) The wet granules are sized and dried to obtain dry granules;

[0051] (5) Finally, the premix, dry granules, remaining fructo-oligosaccharide and magnesium stearate are mixed together, and then punched into tablets using a 8 mm diameter die.

[0052] Example 4

[0053] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid, vitamin A, vitamin E and 50 mg of fructo-oligosaccharide (about 50 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin A, vitamin E) are thoroughly mixed and dried (hot air circulation drying at 80°C, 0.75 m / s wind speed to control particle size), to obtain premix I (D50 is 227 μm; D90 is 342 μm);

[0054] (2) Then take γ-aminobutyric acid, L-lysine, glycine, L-leucine, 1.94 mg of premix I (about 0.02 times the amount of γ-aminobutyric acid, L-lysine) and 194 mg of sorbitol (about 2 times the amount of γ-aminobutyric acid, L-lysine) are mixed evenly; then add the remaining premix I and mix evenly, to obtain premix II;

[0055] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix thoroughly, and then dissolve the remaining sorbitol in water and spray into the wet granulator to obtain wet granules;

[0056] (4) The wet granules are sized and dried to obtain dry granules;

[0057] (5) Finally, premix II, dry granules, sweet orange powder, steviol glycosides, the remaining oligofructose, and magnesium stearate are mixed together, and then the mixture is punched into tablets using a die with a diameter of 8 mm.

[0058] Example 5

[0059] The amino butyric acid tablet provided in this example has the same raw and auxiliary material composition as in Example 1, and the preparation method is as follows:

[0060] (1) Vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid, and 5 mg of oligofructose (about 5 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) are mixed and dried (hot air circulation drying at 50°C and 1.5 m / s wind speed to control particle size) to obtain premix I (D50 is 148 μm; D90 is 196 μm);

[0061] (2) Then, γ-aminobutyric acid, L-lysine, 1 mg of premix I (about 0.01 times the amount of γ-aminobutyric acid and L-lysine), and 48.5 mg of sorbitol (0.5 times the amount of γ-aminobutyric acid and L-lysine) are mixed evenly; the remaining premix I is added and mixed evenly to obtain premix II;

[0062] (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are mixed, and the remaining sorbitol is dissolved in water to prepare a solution with a concentration of 5 wt%, which is sprayed to perform wet granulation to obtain wet granules;

[0063] (4) The wet granules are sized and dried to obtain dry granules;

[0064] (5) Finally, premix II, dry granules, the remaining oligofructose, and magnesium stearate are mixed together, and then the mixture is punched into tablets using a die with a diameter of 8 mm.

[0065] Example 6

[0066] The amino butyric acid tablet provided in this example has the same raw and auxiliary material composition as in Example 1, and the preparation method is as follows:

[0067] (1) Vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid, and 70 mg of oligofructose (about 70 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12The mixture was thoroughly mixed and dried (hot air circulation drying at 80℃ and 0.5m / s wind speed to control particle size) to obtain premix I (D50 is 236μm; D90 is 362μm).

[0068] (2) Then take γ-aminobutyric acid, L-lysine, 10 mg of premix I (about 0.1 times the amount of γ-aminobutyric acid and L-lysine) and 48.5 mg of sorbitol (0.5 times the amount of γ-aminobutyric acid and L-lysine) and mix them evenly; then add the remaining premix I and mix evenly to obtain premix II;

[0069] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix them thoroughly. Dissolve the remaining sorbitol in water to make a 5wt% solution and spray it in to perform wet granulation to obtain wet granules.

[0070] (4) The wet granules are granulated and dried to obtain dry granules;

[0071] (5) Finally, mix the premix II, dry granules, remaining fructooligosaccharides and magnesium stearate together, and then press them into tablets using a die with a diameter of 8 mm.

[0072] Comparative Example 1

[0073] The aminobutyric acid tablets provided in this comparative example have the same raw material composition as those in Example 1. The only difference in the preparation method is that premix I is added at once. The specific steps are as follows:

[0074] (1) Take vitamin B1, vitamin B2, vitamin B6, and vitamin B1. 12 Vitamin D, folic acid, and 10 mg of fructooligosaccharides (approximately 10 times the amount of vitamin B1, vitamin B2, vitamin B6, and vitamin B1) 12 The mixture was thoroughly mixed and dried (hot air circulation drying at 50℃ and 1.0m / s wind speed to control particle size) to obtain premix I (D50 is 188μm; D90 is 315μm).

[0075] (2) Then take γ-aminobutyric acid, L-lysine, premix I and 48.5 mg of sorbitol (0.5 times the amount of γ-aminobutyric acid and L-lysine) and mix them evenly to obtain premix II;

[0076] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix them thoroughly. Dissolve the remaining sorbitol in water to make a 5wt% solution and spray it in to perform wet granulation to obtain wet granules.

[0077] (4) The wet granules are granulated and dried to obtain dry granules;

[0078] (5) Finally, premix II, dry granules, the remaining oligofructose and magnesium stearate were mixed together, and then the mixture was punched into tablets with a die of 8 mm in diameter.

[0079] Comparative Example 2

[0080] The amino butyric acid tablet provided in this comparative example has the same composition as in Example 1, and the difference in the preparation method is that the sorbitol is added in step (2) at one time. The specific steps are as follows:

[0081] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10 mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) and mix well and dry (hot air circulation drying at 50°C and 1.0 m / s wind speed to control particle size), to obtain premix I (D50 is 182 μm; D90 is 309 μm);

[0082] (2) Then take γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid, L-lysine) and all the sorbitol and mix well; then add the remaining premix I and mix well to obtain premix II;

[0083] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix well to obtain premix III;

[0084] (4) Finally, premix II, premix III, the remaining oligofructose and magnesium stearate are mixed together, and then the mixture is punched into tablets with a die of 8 mm in diameter.

[0085] Comparative Example 3

[0086] The amino butyric acid tablet provided in this comparative example has the same composition as in Example 1, and the difference in the preparation method is that the sorbitol is added in step (3) at one time. The specific steps are as follows:

[0087] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10 mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) and mix well and dry (hot air circulation drying at 50°C and 1.0 m / s wind speed to control particle size), to obtain premix I (D50 is 188 μm; D90 is 310 μm);

[0088] (2) Then take γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid, L-lysine) and 291 mg of sorbitol (3 times the amount of γ-aminobutyric acid, L-lysine) are mixed evenly; then add the remaining premix I and mix evenly to obtain premix II;

[0089] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix thoroughly, dissolve the remaining sorbitol in water to make a 5wt% solution, spray and wet granulate to obtain wet granules;

[0090] (4) The wet granules are sized and dried to obtain dry granules;

[0091] (5) Finally, mix premix II, dry granules, remaining oligofructose and magnesium stearate, mix evenly and then punch into tablets with a 8mm diameter die.

[0092] Comparative Example 4

[0093] The amino butyric acid tablet raw material composition provided by this comparative example is the same as that of Example 1, and the difference in preparation method is only that the amount of sorbitol in step (2) is increased and the amount of sorbitol in step (3) is reduced. The specific steps are as follows:

[0094] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10 mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) are mixed thoroughly and dried (hot air circulation drying at 50°C and 1.0m / s wind speed to control particle size) to obtain premix I (D50 is 184μm; D90 is 316μm);

[0095] (2) Then take γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid, L-lysine) and 291 mg of sorbitol (3 times the amount of γ-aminobutyric acid, L-lysine) are mixed evenly; then add the remaining premix I and mix evenly to obtain premix II;

[0096] (3) Take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mix thoroughly, dissolve the remaining sorbitol in water to make a 5wt% solution, spray and wet granulate to obtain wet granules;

[0097] (4) The wet granules are sized and dried to obtain dry granules;

[0098] (5) Finally, mix premix II, dry granules, remaining oligofructose and magnesium stearate, mix evenly and then punch into tablets with a 8mm diameter die.

[0099] Comparative Example 5

[0100] The amino butyric acid tablet raw material composition provided by the comparative example is the same as that of Example 1, and the difference in the preparation method is only that the filler is added at once in step (1). The specific steps are as follows:

[0101] (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and all fructooligosaccharides, mix thoroughly and dry (hot air circulation drying at 50°C, 1.0 m / s wind speed to control particle size), to obtain premix I (D50 is 188 μm; D90 is 320 μm);

[0102] (2) Then take γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid, L-lysine) and 48.5 mg of sorbitol (0.5 times the amount of γ-aminobutyric acid, L-lysine) and mix evenly;

[0103] (3) Then add the remaining premix I and mix evenly to obtain premix II;

[0104] (4) Then take calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite, mix thoroughly, dissolve the remaining sorbitol in water to form a solution with a concentration of 5wt%, spray into the wet granulator, and perform wet granulation to obtain wet granules;

[0105] (5) The wet granules are sized and dried to obtain dry granules; finally, the premix II, dry granules and magnesium stearate are mixed together, mixed evenly, and then punched into tablets with a 8 mm diameter die.

[0106] Test Example 1: Stability

[0107] The amino butyric acid tablets prepared in each of the above examples and comparative examples were placed in a high temperature (60°C) condition, and the content of vitamin B1 was determined on the 0th day, 7th day and 30th day, respectively, to investigate the stability of the preparation, and the results are shown in Table 2.

[0108]

[0109] Test Example 2: Content Uniformity

[0110] The content uniformity of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 in the preparations of the above examples and comparative examples was detected according to the content uniformity test method of the fourth part of the Pharmacopoeia of the People's Republic of China 2020 edition 0941, and the results are shown in Table 3 below.

[0111]

[0112] Test Example 3

[0113] (1) Experimental reagents:

[0114] Test sample: Aminobutyric acid tablets prepared in Example 1 and Comparative Examples 1-5 were dissolved in water for use;

[0115] Positive control: SWISSE ® Calcium Vitamin D tablets, batch number 33152A, were dissolved in water and diluted to a concentration of 500 μg / mL for use.

[0116] (2) Experimental animals:

[0117] Zebrafish were all raised in fish water at 28℃ (water quality: 200 mg of instant sea salt was added to 1 L of reverse osmosis water, the conductivity was 450-550 μS / cm; the pH was 6.5-8.5; the hardness was 50-100 mg / L CaCO3), and were provided by the fish breeding center of the Huan Te Bio-Innovation Experimental Center, with the experimental animal use license number being SYXK (Zhe) 2022-0004. The feeding and management met the requirements of the international AAALAC certification (certification number: 001458), and the IACUC ethical review number was IACUC-2025-12427-01.

[0118] (3) Experimental method:

[0119] 2.1. Maximum test concentration (MTC) determination

[0120] Wild-type AB strain zebrafish at 3 days post-fertilization (3 dpf) were randomly selected in beakers, and 30 zebrafish were treated in each beaker (experimental group). Aminobutyric acid tablets prepared in Example 1 were administered in water (concentration of 2000), and the positive control Swisse “Calcium & Vitamin D” was administered at a concentration of 500 μg / mL. A normal control group was also set up, and each beaker had a capacity of 20 mL. After 3 days of treatment at 28℃, the MTC of the sample on normal zebrafish was determined.

[0121] 2.2. Growth and development promotion efficacy evaluation

[0122] Wild-type AB strain zebrafish at 3 dpf were randomly selected in beakers, and 30 zebrafish were treated in each beaker (experimental group). Experimental groups 1-6 were administered with test sample solutions prepared in Example 1 and Comparative Examples 1-5 (concentration of 2000 μg / mL), and the positive control group was administered with a positive control solution (concentration of 500 μg / mL). A normal control group was also set up, and each beaker had a capacity of 20 mL.

[0123] After treatment at 28℃ for 3 days, 10 zebrafish were randomly selected from each experimental group and photographed under a dissecting microscope. ImageJ advanced image processing software was used for analysis and data acquisition to analyze the zebrafish body length. Ten zebrafish were randomly selected for alizarin red staining, photographed under a fluorescence microscope, and NIS-ElementsD3.20 advanced image processing software was used for analysis and data acquisition to analyze the fluorescence intensity of the zebrafish skull. The remaining 10 zebrafish samples were collected according to the zebrafish growth hormone (GH) kit instructions, and data were acquired using a multi-functional microplate reader to analyze the GH content in the zebrafish. The growth-promoting efficacy of the samples was evaluated based on the statistical analysis results of the above indicators. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software; p < 0.05 indicated statistical significance.

[0124] (4) Experimental results:

[0125] 4.1 MTC Results

[0126] Under the experimental conditions, the maximum detectable concentration (MTC) results are shown in Table 4. It can be seen that the MTC of the aminobutyric acid tablets prepared in Example 1 of this invention for promoting growth and development is 2000 μg / mL, and the safety is relatively high.

[0127]

[0128] 4.2 Evaluation of its efficacy in promoting growth and development

[0129] The evaluation results of the growth-promoting efficacy of the above-mentioned samples are shown in Table 5.

[0130]

[0131] Note: Compared with the normal control group, # p<0.05, ## p<0.01, ### p<0.001; compared with Example 1, $ p<0.05, $$ p<0.01, $$$ p<0.001.

[0132] As can be seen from the table above, the differences in body length, skull fluorescence intensity, and growth hormone (GH) content among the zebrafish in each group are all correlated with the uniformity of vitamin D content in each sample. Therefore, it can be inferred that this invention, through improvements in the preparation process, achieves increased uniformity of vitamin D content, thereby enhancing its efficacy in promoting bone development.

[0133] Finally, it should be noted that the above is only to illustrate the technical solutions of the present application, and is not a limitation on the scope of protection of the present application, and simple modifications or equivalent replacements of the technical solutions of the present application by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A method for preparing a growth-promoting butyric acid amide tablet, characterized by, The preparation method comprises the following steps: (1) Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B 12 , Vitamin D, folic acid and a part of the filler are mixed and dried to obtain premix I; the mass of the part of the filler is 10-50 times of the total amount of Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B 12 ; the particle size of the premix I is: D50 is 160-240 μm; D90≤350 μm; (2) mixing amino acids, a part of premix I and a part of binder uniformly; then adding the rest of premix I and mixing uniformly to obtain premix II; the mass of the part of premix I is 0.015-0.05 times the mass of the amino acids; the mass of the part of binder is 0.5-2.5 times the mass of the amino acids; (3) taking calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite and mixing thoroughly, dissolving the rest of the binder in water and spraying to carry out wet granulation to obtain wet granules; (4) performing whole granulation and drying on the wet granules to obtain dry granules; (5) total mixing: mixing premix II, dry granules, the rest of the filler and lubricant uniformly, and then compressing to obtain the amino butyric acid tablets; the amino acids comprise γ-amino butyric acid and L-lysine; the filler is fructooligosaccharide; the binder is sorbitol; and the lubricant is magnesium stearate.

2. An amino butyric acid tablet prepared by the preparation method in claim 1.

3. The aminobutyric acid tablet according to claim 2, characterized by the amino acids further comprise one or both of L-leucine and glycine.

3. An amino butyric acid tablet, which is prepared by the preparation method in claim 1 and comprises the following components in parts by mass: amino acids 100 parts, premix I 0.5-2.5 parts, binder 0.5-2.5 parts, calcium citrate 0.5-2.5 parts, magnesium oxide 0.5-2.5 parts, ferrous fumarate 0.5-2.5 parts, sodium selenite 0.005-0.025 parts, and lubricant 0.5-2.5 parts.

4. An amino butyric acid tablet, which is prepared by the preparation method in claim 1 and comprises the following components in parts by mass: amino acids 100 parts, premix I 0.5-2.5 parts, binder 0.5-2.5 parts, calcium citrate 0.5-2.5 parts, magnesium oxide 0.5-2.5 parts, ferrous fumarate 0.5-2.5 parts, sodium selenite 0.005-0.025 parts, L-leucine 0.5-2.5 parts, glycine 0.5-2.5 parts, and lubricant 0.5-2.5 parts.

4. The aminobutyric acid tablet according to claim 3, wherein the raw and auxiliary materials comprise, by weight: gamma-aminobutyric acid 0.5-1 part, L-lysine 0.2-0.4 part, L-leucine 0-0.8 part, glycine 0-0.8 part, vitamin D 0.000015-0.00002 part, vitamin Bl 0.0002-0.0004 part, vitamin B2 0.0002-0.0004 part, vitamin B6 0.0002-0.0004 part, vitamin B 12 0.0001-0.0005 part, folic acid 0.0004-0.0008 part, calcium citrate 10-35 part, magnesium oxide 0.5-1 part, ferrous fumarate 0.05-0.1 part, sodium selenite 0.075-0.15 part, a filler 1-10 part, a binder 0.5-5 part, and a lubricant 1-2 part.

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