A multi-vitamin mineral tablet and a method of preparing the same

Abstract

The present application provides a kind of multivitamin and mineral tablet and its preparation method, which is prepared by water-soluble vitamins, fat-soluble vitamins, minerals and corresponding excipients by suitable process. The tablet prepared by adding appropriate amount of flow aid in the preparation process has good compressibility, content uniformity and disintegration.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical and health technology, and to a multivitamin and mineral tablet and its preparation method. Background Technology

[0002] Vitamins are a class of organic compounds essential for maintaining human health, promoting growth and development, and regulating physiological functions. These compounds are found in natural foods and are generally not synthesized in the body, or synthesized in very small amounts, insufficient to meet the body's daily needs. Vitamins can form various coenzymes, participating in the metabolism, utilization, and synthesis of various substances, promoting bone growth, maintaining the structural integrity of epithelial tissues, and ensuring normal growth and development. Trace elements are core components of active substances such as enzymes, hormones, and vitamins in the human body, playing a vital role in normal metabolism and health, including: participating in the formation and activation of enzymes; forming important carriers and electron transport systems in the body; participating in the synthesis of hormones and vitamins; and regulating the level of free radicals. Vitamins and trace elements are essential substances for maintaining normal human life activities; deficiencies can lead to metabolic disorders and various diseases. Modern research has confirmed that the amount of vitamins and trace elements in the human body is closely related to cancer, cardiovascular disease, and human lifespan.

[0003] Currently, there are numerous multivitamin products on the market. Some are over-the-counter drugs, with each component dosage being pharmaceutical-grade, requiring clear clinical indications and must be taken under the guidance of a physician. Therefore, they are not suitable for daily health supplementation for most people. Others are mostly nutritional supplements, suitable for all groups, but due to their numerous ingredients and significant differences in component content, they lack specificity, and their actual health benefits are difficult to predict. Therefore, this invention, based on research into the distribution of nutrient levels in the Chinese population, develops a product more suitable for the current nutrient levels of the Chinese population, providing more nutritional supplement options for people with various nutrient deficiencies.

[0004] The multivitamin and mineral tablets involved in this invention have complex compositions, with higher doses of iron, zinc, magnesium, and copper than similar commercially available products. They also have poor compressibility, resulting in poor tablet formability and low hardness. The vitamin B2 contained in the tablets of this invention is relatively viscous, and preparations containing this ingredient tend to adhere to the mixing tank wall during the mixing process, leading to greater losses and poor mixing uniformity. Furthermore, the tablets of this invention have high levels of iron, zinc, magnesium, and copper, which are poorly water-soluble, resulting in a longer disintegration time and affecting the absorption of nutrients. Summary of the Invention

[0005] One object of the present invention is to provide a multivitamin and mineral tablet with uniform content, good compressibility, and good disintegration properties. Another object of the present invention is to provide a method for preparing the aforementioned multivitamin and mineral tablet, solving the problems existing in the prior art regarding content uniformity, compressibility, and disintegration time.

[0006] The present invention achieves the aforementioned technical effect by employing the following technical solution:

[0007] A multivitamin and mineral tablet consists of water-soluble vitamins, fat-soluble vitamins, minerals, and corresponding excipients:

[0008] The water-soluble vitamins mentioned include folic acid and vitamin B1. 12 Vitamins B1, B2, niacin, pantothenic acid, B6, biotin, and C;

[0009] The fat-soluble vitamins mentioned include vitamin A, vitamin D, and vitamin E;

[0010] The minerals mentioned include one or more of iron, zinc, selenium, magnesium, and copper.

[0011] The multivitamin and mineral tablets described above are characterized in that each unit of dosage contains 30-500 μg of folic acid and vitamin B12. 12 0.2-10 μg of cobalamin, 0.1-20 mg of vitamin B1 (as thiamine), 0.1-20 mg of vitamin B2 (as riboflavin), 1.0-15 mg of niacin, 0.4-20 mg of pantothenic acid, 0.1-10 mg of vitamin B6 (as pyridoxine), 3-100 μg of biotin, 6-300 mg of vitamin C (as L-ascorbic acid), 50-1200 μg of vitamin A (as retinol), 1.5-150 μg of vitamin E (as d-α-tocopherol), 2.0-15 μg of vitamin D (as cholecalciferol), 0-20 mg of iron, 0-15 mg of zinc, 5-100 μg of selenium, 30-400 mg of magnesium, 0.1-1.5 mg of copper and corresponding excipients.

[0012] The aforementioned multivitamin and mineral tablets are characterized in that, in a preferred unit dosage form, the contents of each component are: folic acid 133-500 μg, vitamin B12 (calculated as cobalamin) 2.5-10 μg, vitamin B1 (calculated as thiamine) 1.20-19.80 mg, vitamin B2 (calculated as riboflavin) 1.20-19.80 mg, niacin 4.0-15 mg, pantothenic acid 4.0-15 mg, and vitamin B6 (calculated as pyridoxine) 1.2-10 mg. g, Biotin 26.4-100μg, Vitamin C (as L-ascorbic acid) 32-100mg, Vitamin A (as retinol) 200-660μg, Vitamin E (as d-α-tocopherol) 6.4-25μg, Vitamin D (as cholecalciferol) 4.0-15μg, Iron 0-15mg, Zinc 0-10mg, Selenium 15-56.3μg, Magnesium 65-120mg, Copper 0.3-0.6mg and corresponding excipients.

[0013] The excipients include fillers, disintegrants, binders, glidants, and lubricants. The glidant is selected from gelled silica, and the amount of gelled silica used accounts for 0.5%-5% of the tablet's mass.

[0014] The tablet preparation method of the present invention includes the following steps:

[0015] (1) Mix nicotinic acid, D-calcium pantothenate, zinc gluconate, selenium-enriched yeast, magnesium carbonate, maltodextrin, 1 / 2 of the formula amount of cross-linked polyvinylpyrrolidone, 1 / 3 of the formula amount of microcrystalline cellulose, and 1 / 2 of the formula amount of gel-processed silica to obtain mixture I, for later use.

[0016] (2) Pass the remaining amount of microcrystalline cellulose through an 80-mesh sieve, and bag the material that passes through the sieve and the material that passes through the sieve separately for later use.

[0017] (3) Mix vitamin B1, vitamin B2, vitamin B6, folic acid, copper gluconate, ferrous fumarate, the remaining amount of gel-processed silica, and the sieve material of microcrystalline cellulose that has passed through an 80-mesh sieve in a mixer to obtain mixture II.

[0018] (4) Place the batch amount of vitamin C and mixture II into a mixer and mix them. Pass the mixture through a 65-mesh sieve once to obtain mixture III.

[0019] (5) Add vitamin E, D-biotin raw materials, and vitamin B 12 The raw materials, vitamin A acetate, vitamin D3 raw materials, the remaining amount of crospovidone, the material passed through an 80-mesh microcrystalline cellulose sieve, and mixture III are placed together in a mixer to obtain mixture IV.

[0020] (6) Granulate mixture I, dry at 55±5℃, and granulate at 24 mesh.

[0021] (7) Place the dry granules and mixture IV together in a mixer and mix them.

[0022] (8) Add magnesium stearate and mix.

[0023] (9) Tableting.

[0024] (10) Coating.

[0025] The silica used in this invention is widely used in pharmaceuticals, cosmetics, and food. Due to its small particle size and large specific surface area, it exhibits excellent flowability. This characteristic is used to improve the flowability of dry powders during mixing and tableting processes, and it is typically used as a gliding agent and anti-sticking agent. However, this invention unexpectedly discovered that by selecting and adding 0.5%-5% by weight of gel-process silica to the tablets, the uniformity of content, compressibility, and disintegration time of the multivitamin and mineral tablets of this invention were significantly improved. Detailed Implementation

[0026] Example 1:

[0027] formula:

[0030] Preparation method:

[0031] (1) Mix nicotinic acid, D-calcium pantothenate, zinc gluconate, selenium-enriched yeast, magnesium carbonate, maltodextrin, 1 / 2 of the formula amount of crospovidone, and 1 / 3 of the formula amount of microcrystalline cellulose to obtain mixture I, for later use.

[0032] (2) Pass the remaining amount of microcrystalline cellulose through an 80-mesh sieve, and bag the material that passes through the sieve and the material that passes through the sieve separately for later use.

[0033] (3) Mix vitamin B1, vitamin B2, vitamin B6, folic acid, copper gluconate, ferrous fumarate, and microcrystalline cellulose sieve under 80 mesh in a mixer to obtain mixture II.

[0034] (4) Place the batch amount of vitamin C and mixture II into a mixer and mix them. Pass the mixture through a 65-mesh sieve once to obtain mixture III.

[0035] (5) Add vitamin E, D-biotin raw materials, and vitamin B 12 The raw materials, vitamin A acetate, vitamin D3 raw materials, the remaining amount of crospovidone, the material passed through an 80-mesh microcrystalline cellulose sieve, and mixture III are placed together in a mixer to obtain mixture IV.

[0036] (6) Granulate mixture I, dry at 55±5℃, and granulate at 24 mesh.

[0037] (7) Place the dry granules and mixture IV together in a mixer and mix them.

[0038] (8) Add magnesium stearate and mix.

[0039] (9) Tableting.

[0040] (10) Coating.

[0041] Example 2:

[0042] formula:

[0044] Preparation method:

[0045] (1) Mix nicotinic acid, D-calcium pantothenate, zinc gluconate, selenium-enriched yeast, magnesium carbonate, maltodextrin, 1 / 2 of the formula amount of disintegrant, 1 / 3 of the formula amount of microcrystalline cellulose, and 1 / 2 of the gelation method silica to obtain mixture I, for later use.

[0046] (2) Pass the remaining amount of microcrystalline cellulose through an 80-mesh sieve, and bag the material that passes through the sieve and the material that passes through the sieve separately for later use.

[0047] (3) Mix vitamin B1, vitamin B2, vitamin B6, folic acid, copper gluconate, ferrous fumarate, the remaining amount of gel-processed silica, and the sieve material of microcrystalline cellulose that has passed through an 80-mesh sieve in a mixer to obtain mixture II.

[0048] (4) Place the batch amount of vitamin C and mixture II into a mixer and mix them. Pass the mixture through a 65-mesh sieve once to obtain mixture III.

[0049] (5) Place vitamin E, D-biotin raw material, vitamin B12 raw material, vitamin A acetate, vitamin D3 raw material, the remaining amount of disintegrant, the material passed through an 80-mesh microcrystalline cellulose sieve, and mixture III into a mixer to obtain mixture IV.

[0050] (6) Granulate mixture I, dry at 55±5℃, and granulate at 24 mesh.

[0051] (7) Place the dry granules and mixture IV together in a mixer and mix them.

[0052] (8) Add magnesium stearate and mix.

[0053] (9) Tableting.

[0054] (10) Coating.

[0055] Example 3:

[0056] formula:

[0059] Preparation method:

[0060] (1) Mix nicotinic acid, D-calcium pantothenate, zinc gluconate, selenium-enriched yeast, magnesium carbonate, maltodextrin, 1 / 2 of the formula amount of disintegrant, 1 / 3 of the formula amount of microcrystalline cellulose, and 1 / 2 of the colloidal silica to obtain mixture I, for later use.

[0061] (2) Pass the remaining amount of microcrystalline cellulose through an 80-mesh sieve, and bag the material that passes through the sieve and the material that passes through the sieve separately for later use.

[0062] (3) Mix vitamin B1, vitamin B2, vitamin B6, folic acid, copper gluconate, ferrous fumarate, the remaining amount of colloidal silica, and the sieve material of microcrystalline cellulose that has passed through an 80-mesh sieve in a mixer to obtain mixture II.

[0063] (4) Place the batch amount of vitamin C and mixture II into a mixer and mix them. Pass the mixture through a 65-mesh sieve once to obtain mixture III.

[0064] (5) Place vitamin E, D-biotin raw material, vitamin B12 raw material, vitamin A acetate, vitamin D3 raw material, the remaining amount of disintegrant, the material passed through an 80-mesh microcrystalline cellulose sieve, and mixture III into a mixer to obtain mixture IV.

[0065] (6) Granulate mixture I, dry at 55±5℃, and granulate at 24 mesh.

[0066] (7) Place the dry granules and mixture IV together in a mixer and mix them.

[0067] (8) Add magnesium stearate and mix.

[0068] (9) Tableting.

[0069] (10) Coating.

[0070] Example 4

[0071] formula:

[0074] Preparation method: Same as in Example 2.

[0075] Example 5:

[0076] formula:

[0079] Preparation method:

[0080] (1) Mix nicotinic acid, D-calcium pantothenate, selenium-enriched yeast, magnesium carbonate, maltodextrin, 1 / 2 of the formula amount of disintegrant, 1 / 3 of the formula amount of microcrystalline cellulose, and 1 / 2 of the gelation method silica to obtain mixture I, for later use.

[0081] (2) Pass the remaining amount of microcrystalline cellulose through an 80-mesh sieve, and bag the material that passes through the sieve and the material that passes through the sieve separately for later use.

[0082] (3) Mix vitamin B1, vitamin B2, vitamin B6, folic acid, copper gluconate, the remaining amount of gel-processed silica, and the sieve material of microcrystalline cellulose that has passed through an 80-mesh sieve in a mixer to obtain mixture II.

[0083] (4) Place the batch amount of vitamin C and mixture II into a mixer and mix them. Pass the mixture through a 65-mesh sieve once to obtain mixture III.

[0084] (5) Place vitamin E, D-biotin raw material, vitamin B12 raw material, vitamin A acetate, vitamin D3 raw material, the remaining amount of disintegrant, the material passed through an 80-mesh microcrystalline cellulose sieve, and mixture III into a mixer to obtain mixture IV.

[0085] (6) Granulate mixture I, dry at 55±5℃, and granulate at 24 mesh.

[0086] (7) Place the dry granules and mixture IV together in a mixer and mix them.

[0087] (8) Add magnesium stearate and mix.

[0088] (9) Tableting.

[0089] (10) Coating.

[0090] Example: Sample disintegration time test results

[0091] Table 1 Comparison of Disintegration Time Limits

[0094] result:

[0095] (1) Example 1 had the longest disintegration time (without adding silica).

[0096] (2) Example 4 (5% gel silica) is shorter than Example 3 (5% colloidal silica).

[0097] (3) Example 4 (5% gel-processed silica) is shorter than Example 2 (0.5% gel-processed silica).

[0098] By comparison, the disintegration time of the tablet exceeded the standard without the addition of a gliding agent. With the addition of the same amount of gelled silica or colloidal silica, the former significantly reduced the disintegration time and achieved better disintegration performance than the latter.

[0099] Example: Sample content uniformity test results

[0100] Table 2 Comparison of Content Uniformity (n=10)

[0102] By comparison, adding 0.5%-5% gel-type colloidal silica significantly improved the content uniformity compared to not adding a flow aid; and compared to colloidal silica, gel-type colloidal silica with the same amount of added silica showed significantly improved content uniformity.

[0103] Example Sample compressibility test results

[0104] Table 3 Comparison of tablet compressibility

[0105] Tablet press main pressure (KN) Plate hardness (N) Friability (%) Example 1 18.1 150.5 0.5％ Example 2 17.9 185.1 0.4％ Example 3 18.2 200.2 0.3％ Example 4 18.0 250.3 0.05％ Example 5 18.1 280.1 0.01％

[0106] result:

[0107] (1) Example 1 has the lowest hardness (without adding gel-type colloidal silica).

[0108] (2) The hardness of Example 4 (5% gel silica) was significantly higher than that of Example 3 (5% colloidal silica).

[0109] (3) The hardness of Example 4 (5% gel-processed silica) was significantly higher than that of Example 2 (0.5% gel-processed silica).

[0110] Under the condition of consistent main pressure of the tablet press, gel-process colloidal silica can significantly improve the compressibility of tablets, increase tablet hardness, and reduce tablet brittleness.

Claims

1. A multivitamin and mineral tablet, characterized in that, The tablets are composed of water-soluble vitamins, fat-soluble vitamins, minerals, and corresponding excipients. The excipients include fillers, disintegrants, binders, flow aids, and lubricants. The flow aid is gelled silica, and the amount of gelled silica used accounts for 0.5%-5% of the tablet's mass. The composition of water-soluble vitamins, fat-soluble vitamins, and minerals per dosage unit is as follows: folic acid 30-500 μg, vitamin B... 12 The following vitamins are listed: Cobalamin 0.2-10 μg, Vitamin B1 (thiamine) 0.1-20 mg, Vitamin B2 (riboflavin) 0.1-20 mg, Niacin 1.0-15 mg, Pantothenic Acid 0.4-20 mg, Vitamin B6 (pyridoxine) 0.1-10 mg, Biotin 3-100 μg, Vitamin C (L-ascorbic acid) 6-300 mg, Vitamin A (retinol) 50-1200 μg, Vitamin E (d-α-tocopherol) 1.5-150 mg, Vitamin D (cholecalciferol) 2.0-15 μg, Iron 0-20 mg, Zinc 0-15 mg, Selenium 5-100 μg, Magnesium 30-400 mg, Copper 0.1-1.5 mg.

2. The tablet according to claim 1, characterized in that, Composition of water-soluble vitamins, fat-soluble vitamins, and minerals per unit: folic acid 133-500 μg, vitamin B1... 12 The following vitamins are listed: Cobalamin 2.5-10 μg, Vitamin B1 (thiamine) 1.20-19.80 mg, Vitamin B2 (riboflavin) 1.20-19.80 mg, Niacin 4.0-15 mg, Pantothenic Acid 4.0-15 mg, Vitamin B6 (pyridoxine) 1.2-10 mg, Biotin 26.4-100 μg, Vitamin C (L-ascorbic acid) 32-100 mg, Vitamin A (retinol) 200-660 μg, Vitamin E (d-α-tocopherol) 6.4-25 mg, Vitamin D (cholecalciferol) 4.0-15 μg, Iron 0-15 mg, Zinc 0-10 mg, Selenium 15-56.3 μg, Magnesium 65-120 mg, Copper 0.3-0.6 mg.

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