Growth-promoting aminobutyric acid tablet and preparation method thereof

Abstract

The invention belongs to the technical field of health-care products, and provides a growth-promoting aminobutyric acid tablet and a preparation method thereof. The preparation method of the aminobutyric acid tablets comprises the following steps: firstly, fully mixing and drying the vitamin B1, the vitamin B2, the vitamin B6, the vitamin B12, the vitamin D, the folic acid and the first part of filler to obtain a premix I; uniformly mixing amino acid (gamma-aminobutyric acid and L-lysine), the first part of premix I and the first part of adhesive; adding the residual premix I, and uniformly mixing to obtain a premix II; fully mixing calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite, dissolving the residual adhesive in water, spraying, carrying out wet granulation, and drying the whole granules; and finally carrying out total mixing and tabletting. By improving the preparation process, the stability and content uniformity of the B vitamins are improved, and the growth promoting effect is further improved.

Description

Technical Field

[0001] The invention belongs to the technical field of health care products and provides a growth-promoting aminobutyric acid tablet and a preparation method thereof. Background Art

[0002] Gamma-aminobutyric acid (GABA), a non-protein amino acid widely found in animals, plants, and microorganisms, is the most important inhibitory neurotransmitter in the nervous systems of mammals, crustaceans, and insects. Studies have shown that 30%-40% of central neurons use GABA as an inhibitory neurotransmitter. Through its interaction with specific receptors, GABA can promote sleep, combat brain aging, and alleviate anxiety.

[0003] In recent years, gamma-aminobutyric acid (GABA) has garnered significant attention for its role in promoting growth. Existing research (Research Progress on the Application of GABA in Growth Promotion, Li Lingmei, Chinese Journal of Medical Information, Issue 2, 2024) indicates that GABA supports the physiological regulation of pituitary function and controls the secretion of growth hormone (GH), which plays a crucial role in skeletal muscle growth and maintenance. In addition to its role in GH regulation, GABA influences bone formation by regulating the proliferation and differentiation of chondrocytes. However, its interactions with other growth regulators remain under investigation.

[0004] Chinese invention patent application CN116998715A discloses a γ-aminobutyric acid (GABA)-rich nutritional tablet for height growth and its preparation method. The tablet incorporates GABA, which regulates the central nervous system, promotes metabolism, enhances sleep quality, improves mood, and improves the immune system, significantly aiding growth during development, especially for children who enjoy physical activity. The tablet also contains complex minerals to aid bone formation and prevent osteoporosis and fractures, while the vitamins promote nutrient absorption and maintain bone density. The tablet is also coated with tea polyphenols, gelatin, and chitosan to enhance its antioxidant properties and shelf life.

[0005] However, in the above technology, on the one hand, although no obvious discoloration or deliquescence is observed from a macroscopic perspective, the vitamin B in the complex vitamin composition is poorly stable and is very susceptible to oxidative decomposition in the presence of the highly oxidizing ferric pyrophosphate and magnesium oxide in the complex minerals. During its preparation, the complex minerals containing ferric pyrophosphate and magnesium oxide are directly mixed with the complex vitamins containing B vitamins, and deionized water is added to prepare a nutrient solution. In a solution with a high water content, B vitamins are very susceptible to oxidative degradation, which seriously affects their chemical stability and, in turn, their effects in promoting bone growth. On the other hand, due to the extremely low addition amount of some minerals and vitamins, there are problems such as uneven content distribution during the preparation of the tablets, which also affects their dissolution performance, ultimately resulting in the inability to fully exert their activity, which also affects their effects in promoting bone growth.

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

[0007] In response to the problems existing in the prior art, the present invention provides a growth-promoting aminobutyric acid tablet and a preparation method thereof. By improving the preparation process, the stability of complex vitamins, especially B vitamins, is effectively improved, while the problem of uneven distribution of trace components is effectively improved, thereby improving its effect in promoting bone development.

[0008] The technical solutions of the present invention are as follows: The present invention provides a method for preparing a growth-promoting aminobutyric acid tablet, comprising the following steps: (1) Vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and the first portion of filler are fully mixed and dried to obtain premix I; (2) Mix the amino acid, the first part of premix I and the first part of adhesive evenly; then add the remaining premix I and mix evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite are thoroughly mixed, and the remaining binder is dissolved in water and sprayed into the mixture for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Total mixing: premix II, dry granules, remaining filler and lubricant are mixed evenly, and tableting is performed to obtain the GABA tablets; The amino acids include gamma-aminobutyric acid and L-lysine.

[0009] Furthermore, in step (1), the mass of the first portion of filler is vitamin B1, vitamin B2, vitamin B6, vitamin B 12 10-50 times the total amount.

[0010] Furthermore, 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.

[0011] Furthermore, the particle size of the premix I is: D50 is 160-240 μm; D90 ≤ 350 μm.

[0012] Furthermore, the filler is selected from one or more of fructooligosaccharides, xylooligosaccharides, isomaltooligosaccharides and maltodextrin.

[0013] Furthermore, the binder is selected from one or more of sorbitol, maltitol, stevia and polyvinyl alcohol.

[0014] Furthermore, the lubricant is selected from one or more of magnesium stearate, hydrogenated vegetable oil and polyethylene glycol.

[0015] The present invention also provides aminobutyric acid tablets prepared by any of the above-mentioned preparation methods.

[0016] Furthermore, the amino acids also include: one or both of L-leucine and glycine.

[0017] In some specific embodiments of the present invention, the raw and auxiliary materials of the aminobutyric acid tablets include, by weight, 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 complex vitamins, 10-40 parts of complex minerals, 1-10 parts of filler, 0.5-5 parts of binder and 1-2 parts of lubricant.

[0018] Furthermore, the compound vitamins include, by weight, 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, 0.0002-0.0004 parts of vitamin B 12 0.0001-0.0005 parts and folic acid 0.0004-0.0008 parts.

[0019] Furthermore, the composite mineral comprises, by weight, 10-35 parts of calcium citrate, 0.5-1 part of magnesium oxide, 0.05-0.1 part of ferrous fumarate and 0.075-0.15 part of sodium selenite.

[0020] Compared with the prior art, the present invention has the following beneficial effects: The present invention achieves uniform dispersion of trace component vitamins and fillers through multi-stage premixing; and simultaneously wraps composite minerals with an adhesive through wet granulation to isolate them from vitamins that are easily oxidized and degraded during the mixing process. This solves the problem of degradation of composite vitamins, especially B vitamins (especially vitamin B1 and thiamine), in gamma-aminobutyric acid tablets due to the presence of metal ions (complex minerals) in the presence of moisture, thereby improving the chemical stability of the GABA tablets and effectively extending the shelf life. In addition, the multi-stage premixing of the vitamin mixed particles and the limitation of the particle size further improve the uniformity of the vitamin D and B vitamin content, solves the problem of low dissolution rate caused by uneven distribution during administration, effectively improves the effect of the GABA tablets in promoting bone development, and fully exerts the role of each component. DETAILED DESCRIPTION

[0021] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0022] Examples 1-4 The composition of the raw and auxiliary materials of the aminobutyric acid tablets provided in this embodiment is shown in Table 1.

[0023]

[0024] The preparation method is as follows: Example 1 (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 185 μm; D90: 312 μm); (2) Then, γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 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) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a grinding tool with a diameter of 8 mm.

[0025] Example 2 (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid vitamin A, vitamin E and 50mg of oligofructose (about 50 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin A, and vitamin E) were fully mixed and dried (hot air circulation drying at 60°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 211 μm; D90: 328 μm); (2) Then, γ-aminobutyric acid, L-lysine, glycine, L-leucine, 4.85 mg of premix I (approximately 0.05 times the amount of γ-aminobutyric acid and L-lysine) and 240 mg of sorbitol (approximately 2.5 times the amount of γ-aminobutyric acid and L-lysine) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, orange fruit powder, stevioside, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a mold with a diameter of 8 mm.

[0026] Example 3 (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 6mg of oligofructose (about 20 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (hot air circulation drying at 70°C and a wind speed of 1.5 m / s to control the particle size) to obtain premix I (D50: 177 μm; D90: 306 μm); (2) Then, γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (approximately 0.015 times the amount of γ-aminobutyric acid and L-lysine) and 97 mg of sorbitol (approximately 1 times the amount of γ-aminobutyric acid and L-lysine) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water and sprayed into the mixture for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, the premix, dry granules, remaining oligofructose and magnesium stearate were mixed evenly and then punched into tablets using a grinding tool with a diameter of 8 mm.

[0027] Example 4 (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid vitamin A, vitamin E and 50mg of oligofructose (about 50 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin A, and vitamin E) were fully mixed and dried (hot air circulation drying at 80°C and a wind speed of 0.75 m / s to control the particle size) to obtain premix I (D50: 227 μm; D90: 342 μm); (2) Then, γ-aminobutyric acid, L-lysine, glycine, L-leucine, 1.94 mg of premix I (approximately 0.02 times the amount of γ-aminobutyric acid and L-lysine) and 194 mg of sorbitol (approximately 2 times the amount of γ-aminobutyric acid and L-lysine) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water and sprayed into the mixture for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, orange fruit powder, stevioside, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a mold with a diameter of 8 mm.

[0028] Example 5 The raw material composition of the aminobutyric acid tablets provided in this embodiment is the same as that in Example 1, and the preparation method is as follows: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 5mg of oligofructose (about 5 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12) were thoroughly mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.5 m / s to control the particle size) to obtain premix I (D50: 148 μm; D90: 196 μm); (2) Then, γ-aminobutyric acid, L-lysine, 1 mg of premix I (approximately 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) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a grinding tool with a diameter of 8 mm.

[0029] Example 6 The raw material composition of the aminobutyric acid tablets provided in this embodiment is the same as that in Example 1, and the preparation method is as follows: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B according to the dosage in Table 1. 12 , vitamin D, folic acid and 70mg of oligofructose (about 70 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (using hot air circulation drying at 80°C and a wind speed of 0.5 m / s to control the particle size) to obtain premix I (D50: 236 μm; D90: 362 μm); (2) Then, γ-aminobutyric acid, L-lysine, 10 mg of premix I (approximately 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) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a grinding tool with a diameter of 8 mm.

[0030] Comparative Example 1 The raw material composition of the aminobutyric acid tablets provided in this comparative example is the same as that in Example 1. The only difference in the preparation method is that the premix I is added at one time. The specific steps are as follows: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 188 μm; D90: 315 μm); (2) Then, 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) were mixed to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a grinding tool with a diameter of 8 mm.

[0031] Comparative Example 2 The raw material composition of the aminobutyric acid tablets provided in this comparative example is the same as that in Example 1. The only difference in the preparation method is that sorbitol is added once in step (2). The specific steps are as follows: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 182 μm; D90: 309 μm); (2) Then, γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid and L-lysine) and all the sorbitol were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite are then mixed thoroughly to obtain premix III; (4) Finally, premix II, premix III, the remaining oligofructose and magnesium stearate were mixed, mixed evenly and pressed into tablets using a grinding tool with a diameter of 8 mm.

[0032] Comparative Example 3 The raw material composition of the aminobutyric acid tablets provided in this comparative example is the same as that in Example 1. The only difference in the preparation method is that sorbitol is added once in step (3). The specific steps are as follows: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 188 μm; D90: 310 μm); (2) Then, γ-aminobutyric acid, L-lysine, and 1.5 mg of premix I (approximately 0.015 times the amount of γ-aminobutyric acid and L-lysine) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and all of the sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a grinding tool with a diameter of 8 mm.

[0033] Comparative Example 4 The raw material composition of the aminobutyric acid tablets provided in this comparative example is the same as that in Example 1. The only difference in the preparation method is 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: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and 10mg of oligofructose (about 10 times the amount of vitamin B1, vitamin B2, vitamin B6, vitamin B 12 ) were thoroughly mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 184 μm; D90: 316 μm); (2) Then, γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (about 0.015 times the amount of γ-aminobutyric acid and L-lysine) and 291 mg of sorbitol (3 times the amount of γ-aminobutyric acid and L-lysine) were mixed evenly; then, the remaining premix I was added and mixed evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Finally, premix II, dry granules, remaining oligofructose and magnesium stearate were mixed and evenly mixed, and then pressed into tablets using a grinding tool with a diameter of 8 mm.

[0034] Comparative Example 5 The raw material composition of the aminobutyric acid tablets provided in this comparative example is the same as that in Example 1. The only difference in the preparation method is that the filler is added at one time in step (1). The specific steps are as follows: (1) Take vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and all fructooligosaccharides were fully mixed and dried (hot air circulation drying at 50°C and a wind speed of 1.0 m / s to control the particle size) to obtain premix I (D50: 188 μm; D90: 320 μm); (2) Then, γ-aminobutyric acid, L-lysine, 1.5 mg of premix I (approximately 0.015 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) were mixed evenly; (3) Add the remaining premix I and mix evenly to obtain premix II; (4) Calcium citrate, magnesium oxide, ferrous fumarate, and sodium selenite are then thoroughly mixed, and the remaining sorbitol is dissolved in water to prepare a 5 wt% solution, which is then sprayed into the solution for wet granulation to obtain wet granules; (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 pressed into tablets using a grinding tool with a diameter of 8 mm.

[0035] Test Example 1: Stability The aminobutyric acid tablets prepared in the comparative examples of the above embodiments were placed under high temperature (60°C) conditions, and the vitamin B1 content was measured on the 0th day, the 7th day and the 30th day respectively to investigate the stability of the preparation. The results are shown in Table 2.

[0036]

[0037] Test Example 2: Content Uniformity According to the content uniformity test method of Part IV 0941 of the 2020 edition of the Pharmacopoeia of the People's Republic of China, the vitamin B1, vitamin B2, vitamin B6, vitamin B 12 The content uniformity was tested and the results are shown in Table 3 below.

[0038]

[0039] Test Example 3 (1) Experimental drugs: Test sample: GABA tablets prepared in Example 1 and Comparative Examples 1-5, dissolved in water for later use; Positive control: SWISSE ® Calcium vitamin D tablets, batch number 33152A, were dissolved in water and diluted to a concentration of 500 μg / mL for later use.

[0040] (2) Experimental animals: Zebrafish were reared in aquaculture water at 28°C (water quality: 200 mg of instant sea salt per 1 L of reverse osmosis water, conductivity 450-550 μS / cm; pH 6.5-8.5; hardness 50-100 mg / L CaCO3). Zebrafish were bred and provided by the Fish Farming Center of the Huante Biological Innovation Experimental Center under the experimental animal use license number SYXK (Zhejiang) 2022-0004. Their husbandry and management complied with the requirements of AAALAC accreditation (certification number: 001458) and the IACUC ethics review number: IACUC-2025-12427-01.

[0041] (3) Experimental methods: 2.1. Determination of maximum detectable concentration (MTC) Wild-type AB zebrafish, 3 days post-fertilization (dpf), were randomly selected and placed in beakers. Thirty zebrafish were treated in each beaker (experimental group). GABA tablets prepared in Example 1 (concentration 2000) were administered in water, along with Swisse "Calcium & Vitamin D" (500 μg / mL) as a positive control. A normal control group was also established. Each beaker held 20 mL of water. After treatment at 28°C for 3 days, the MTC of the samples in normal zebrafish was measured.

[0042] 2.2. Evaluation of efficacy in promoting growth and development 3 dpf wild-type AB strain zebrafish were randomly selected and placed in beakers. Each beaker (experimental group) contained 30 zebrafish. Experimental groups 1-6 were administered the test sample solutions prepared in Example 1 and Comparative Examples 1-5 (at a concentration of 2000 μg / mL). The positive control group was administered the positive control solution (at a concentration of 500 μg / mL). A normal control group was also established and administered water. Each beaker had a capacity of 20 mL.

[0043] After three days of treatment at 28°C, 10 zebrafish were randomly selected from each experimental group and photographed under a dissecting microscope. Data were analyzed and collected using Image J advanced image processing software. Zebrafish body length was also analyzed. Ten zebrafish were randomly selected and stained with Alizarin Red. They were photographed under a fluorescence microscope and analyzed and collected using NIS-Elements D3.20 advanced image processing software. Fluorescence intensity of the zebrafish skull was analyzed. The remaining 10 zebrafish samples were collected according to the zebrafish growth hormone (GH) kit instructions. Data were collected using a multi-function microplate reader and analyzed for growth hormone (GH) content. Statistical analysis of these indicators was used to evaluate the growth-promoting efficacy of the samples. Statistical results are expressed as mean ± SE. Statistical analysis was performed using SPSS software. P < 0.05 indicated statistical significance.

[0044] (4) Experimental results: 4.1 MTC Results Under the experimental conditions, the maximum detection 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 the present invention for promoting growth and development is 2000 μg / mL, and the safety is relatively high.

[0045]

[0046] 4.2 Evaluation of efficacy in promoting growth and development The results of the evaluation of the growth-promoting efficacy of the above-mentioned groups of samples are shown in Table 5.

[0047]

[0048] 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.

[0049] The table above shows that differences in body length, skull fluorescence intensity, and growth hormone (GH) content across zebrafish groups correlated with the uniformity of vitamin D content across the tested samples. This suggests that the present invention, through improved preparation processes, has achieved improved vitamin D uniformity, thereby enhancing its efficacy in promoting bone development.

[0050] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A method for preparing a growth-promoting aminobutyric acid tablet, characterized in that: The following steps are involved: (1) Vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , vitamin D, folic acid and the first portion of filler are fully mixed and dried to obtain premix I; (2) Mix the amino acid, the first part of premix I and the first part of adhesive evenly; then add the remaining premix I and mix evenly to obtain premix II; (3) Calcium citrate, magnesium oxide, ferrous fumarate and sodium selenite are thoroughly mixed, and the remaining binder is dissolved in water and sprayed into the mixture for wet granulation to obtain wet granules; (4) granulating and drying the wet granules to obtain dry granules; (5) Total mixing: premix II, dry granules, remaining filler and lubricant are mixed evenly, and tableting is performed to obtain the GABA tablets; The amino acids include gamma-aminobutyric acid and L-lysine.

2. The preparation method according to claim 1, characterized in that In step (1), the mass of the first part of the filler is vitamin B1, vitamin B2, vitamin B6, vitamin B 12 10-50 times the total amount.

3. The preparation method according to claim 1, characterized in that In step (2), the mass of the first part of premix I is 0.015-0.05 times the mass of the amino acids; the mass of the first part of adhesive is 0.5-2.5 times the mass of the amino acids.

4. The preparation method according to claim 1, characterized in that The particle size of the premix I is: D50 is 160-240 μm; D90 is ≤350 μm.

5. The preparation method according to claim 1, characterized in that The filler is selected from one or more of fructooligosaccharides, xylooligosaccharides, isomaltooligosaccharides and maltodextrin.

6. The preparation method according to claim 1, characterized in that The binder is selected from one or more of sorbitol, maltitol, stevia and polyvinyl alcohol.

7. The preparation method according to claim 1, characterized in that The lubricant is selected from one or more of magnesium stearate, hydrogenated vegetable oil and polyethylene glycol.

8. An aminobutyric acid tablet prepared by the preparation method according to any one of claims 1 to 7.

9. The aminobutyric acid tablet according to claim 8, characterized in that The amino acids further include: one or both of L-leucine and glycine.

10. The aminobutyric acid tablet according to claim 9, wherein the raw materials and auxiliary materials are calculated by weight and comprise: γ-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 B1 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 parts, folic acid 0.0004-0.0008 parts, calcium citrate 10-35 parts, magnesium oxide 0.5-1 parts, ferrous fumarate 0.05-0.1 parts, sodium selenite 0.075-0.15 parts, filler 1-10 parts, binder 0.5-5 parts and lubricant 1-2 parts.

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