Multivitamin mineral tablet and preparation process thereof
By using transparent or uncoated multivitamin mineral tablets, combined with preferred raw materials and processes, the potential hidden dangers of colored coatings and oxidation and spotting problems in existing products are solved, and the tablets have uniform, natural and stable colors are achieved.
Patent Information
- Application Number
- CN202311411887.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-10-27
- Publication Date
- 2025-04-29
AI Technical Summary
The existing multivitamin mineral tablet products use colored coatings, resulting in a variety of potential risks and oxidative spotting phenomena, and do not conform to the 'clean label' trend.
Use transparent coated or uncoated multivitamin mineral tablets to avoid moisture absorption reactions and oxidation and spotting through preferred raw materials and processes, and use natural fruit and vegetable powder to add natural color to the tablets.
The tablet has achieved uniform, natural and stable color, and stable nutrient content is stable under the conditions of accelerated stability test, and the color of the tablet core and the tablet surface has not changed.
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Figure CN119896333A_ABST
Abstract
Description
Field of the Invention
[0001] The invention relates to the technical field of preparations or health-care foods, and in particular to a transparent coated or uncoated multivitamin mineral tablet and a preparation technology thereof. Background Art
[0002] Vitamins and minerals play an important role in the growth, metabolism and development of the human body. For example, calcium is the main component of bones and teeth and maintains bone density; iron is an important component of red blood cell formation; vitamin A helps maintain dark vision; vitamin C has an antioxidant effect, etc. Most vitamins and minerals cannot be synthesized by the human body and must be obtained from food. However, the nutrition and health survey data over the years show that the intake of dietary nutrients by Chinese residents is generally insufficient. Therefore, multi-dimensional mineral tablets that can supplement multiple vitamins and minerals at one time are a common dietary supplement and are loved by consumers. In addition, more and more products are customized for different groups such as men, women, and the elderly to meet the needs of consumers.
[0003] At present, multivitamin and mineral tablets often use different colors of coatings to visually distinguish tablets for different groups and attract consumers, such as pink, blue, yellow, etc. However, colored coatings generally contain multiple or even 5 synthetic pigments at the same time, such as lemon yellow aluminum lake, sunset yellow aluminum lake, allure red aluminum lake, bright blue aluminum lake, titanium dioxide, etc. In order to achieve the effect of uniformly covering the tablet core, the weight gain of the colored coating is generally around 3%. As a dietary supplement taken every day for a long time, the various synthetic pigments in the colored coating of health foods may pose certain potential risks to the human body and do not conform to the "clean label" product trend.
[0004] Colored coatings can also mask the oxidation spotting of multivitamin and mineral tablets. As described in patent TWI410258B "Improvements in Stability in Vitamin and Mineral Supplements", ascorbic acid and polyvalent metal ions interact and are promoted in the presence of water, which can cause the tablets to darken or spot. When too much water is introduced during the coating process, or the consumer does not close the bottle cap tightly during use, the tablet core will oxidize and spot, but because of the color coating, it is difficult for consumers to detect changes in the tablet core, such as Figure 1 shown.
[0005] There are a few multivitamin mineral tablets on the market that use transparent coatings. Some products add the iron source and ascorbic acid separately into two tablets to avoid the tablets from darkening or spotting, but this will cause inconvenience to consumers. Some products have a dark and mottled surface and can only present a single product color, such as Figure 2 shown. Summary of the invention
[0006] In order to solve the above problems, the present invention provides a transparent coated or uncoated multivitamin mineral tablet and a preparation process thereof. On the one hand, by optimizing raw materials and processes, it is ensured that the vitamins and minerals in the tablets are not easy to absorb moisture and cause spots, and consumers can directly observe the state of the tablets. On the other hand, by adding natural fruit and vegetable powder, the tablets have a natural color, and different fruit and vegetable powders can be used to prepare tablets of different colors.
[0007] The multivitamin mineral tablets prepared by the preparation process of the present invention have uniform and natural color and good stability. When inspected for 3 months under the stability accelerated test conditions of temperature 37° C. and relative humidity 75%, the nutrient content is stable and the color of the tablet core and the tablet surface does not change.
[0008] In one aspect, the present application provides a method for preparing a multivitamin mineral tablet, wherein the multivitamin mineral tablet is a transparent coated tablet or a plain tablet;
[0009] The multivitamin mineral tablets contain the following ingredients: calcium, magnesium, iron, zinc, selenium, vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , niacin, folic acid, biotin, vitamin C, vitamin K, pantothenic acid, vitamin E, microcrystalline cellulose, fruit and vegetable powder, hydroxypropyl methylcellulose and magnesium stearate; wherein the source of magnesium is magnesium carbonate; the source of vitamin C is sodium ascorbate or calcium ascorbate; the source of iron is ferrous fumarate; the source of fruit and vegetable powder includes but is not limited to one or more of barley grass powder, broccoli powder, spinach powder, pumpkin powder, sea buckthorn powder, corn powder, lily powder, lotus seed powder and yam powder; the total weight of the fruit and vegetable powder accounts for 1%-12% (for example, 1%-2%, 2%-3%, 3%-4%, 4%-5%, 5%-6%, 6%-7%, 7%-8%, 8%-9%, 9%-10%, 10%-11% or 11%-12%) of the weight of the multivitamin mineral tablet;
[0010] The preparation method comprises:
[0011] (1) Mineral granulation: The raw materials of calcium, magnesium, iron and zinc in the prescribed amount are granulated with hydroxypropyl methylcellulose solution in a fluidized bed, and the granules are discharged when the moisture content is less than 2% after drying, and the granules are granulated for later use; in certain embodiments, the concentration of the hydroxypropyl methylcellulose solution is 2%-5% (e.g., 2%-3%, 3%-4% or 4%-5%);
[0012] (2) Preparation of vitamin premix: Vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B 12, niacinamide, folic acid, biotin, vitamin C, vitamin K, pantothenic acid, and vitamin E are weighed and placed in a mixer, and mixed evenly to obtain a premix;
[0013] (3) Total mixing and tableting: the mineral particles, vitamin premix, selenium, microcrystalline cellulose, and fruit and vegetable powder are weighed and mixed in a mixer, and magnesium stearate is added and mixed evenly to obtain a total mixed powder; and tableting is performed using a high-speed rotary tablet press to obtain plain tablets;
[0014] (4) Film coating:
[0015] Water-based coating agent: Take an appropriate amount of film coating premix, add it to a certain amount of water until the concentration of the coating solution is 12%-20%, and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature to 80±5℃, the tablet bed temperature to 45±5℃, and the outlet air temperature to 50℃±5℃, atomize the coating solution and spray it evenly on the tablet surface, dry it to form a film to obtain the coated tablets; or
[0016] Coating agent with alcohol-water system: take an appropriate amount of film coating premix, add it to a certain amount of alcohol-water solution (for example, 85% ethanol) to a coating solution concentration of 3%-8% (for example, 6%), and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature at 60±5℃, the tablet bed temperature at 35±5℃, and the outlet air temperature at 40℃±5℃, atomize the coating solution and spray it evenly on the tablet surface, and dry it to form a film to obtain the coated tablets.
[0017] Optionally, the method can also omit step (4) of film coating and directly produce plain tablets.
[0018] The inventors have found that the problem of poor color uniformity and color stability of multidimensional mineral tablets can be solved by selecting suitable materials and optimizing the preparation process.
[0019] About the selection of materials:
[0020] Source of magnesium: The inventors compared magnesium oxide and magnesium carbonate. If magnesium oxide is used, black scratches are easily produced during tableting, affecting the appearance of the tablets (such as Figure 3 As shown), magnesium carbonate will not have the above phenomenon, and the stability of magnesium carbonate is higher than that of magnesium oxide. Therefore, the present invention selects magnesium carbonate.
[0021] Source of Vitamin C: The inventors compared sodium ascorbate, calcium ascorbate, ascorbic acid, ascorbic acid coated with ethyl cellulose, and ascorbic acid granulated with hydroxypropyl methylcellulose. Tablets prepared using these five raw materials as vitamin C sources were exposed to 30°C and 75% RH for 2 days. Figure 4As shown, the tablets using sodium ascorbate and calcium ascorbate have basically no change, but the tablets using other raw materials have obvious changes. Therefore, the present invention selects sodium ascorbate or calcium ascorbate.
[0022] Source of iron: The inventors compared three raw materials, namely ferrous fumarate, ferrous gluconate and ferric pyrophosphate, as sources of iron to prepare tablets. The tablets were exposed to 30°C and 75% RH for 2 days. The results were as follows: Figure 5 As shown, water-insoluble ferrous fumarate has stronger stability in tablets and higher relative bioavailability, so ferrous fumarate was selected.
[0023] Source of fruit and vegetable powder: The inventors screened fruit and vegetable powders of different colors, such as green, yellow, white, red, and purple. The research found that red, purple, and other fruit and vegetable powders containing anthocyanins are prone to change color after the tablets absorb moisture, because anthocyanins will show different colors at different pH values, and the multidimensional mineral tablet system is weakly alkaline; in addition, materials with high polysaccharide content are prone to caking, and unevenness is prone to occur during tableting; therefore, green, yellow, and white fruit and vegetable powders with lower polysaccharide content and finer powder are more suitable for this system.
[0024] In some embodiments, the fruit and vegetable powder comprises barley grass powder, broccoli powder and yam powder. In some embodiments, barley grass powder accounts for 0.5%-7% (e.g., 0.5%-1%, 1%-2%, 2%-3%, 3%-4%, 4%-5%, 5%-6% or 6%-7%) of the total formula, broccoli powder accounts for 0.3%-3% (e.g., 0.5%-1%, 1%-1.5%, 1.5%-2% or 2%-3%) of the total formula, and yam powder accounts for 0.2%-2% (e.g., 0.2%-0.5%, 0.5%-1%, 1%-1.5% or 1.5%-2%) of the formula.
[0025] In some embodiments, the fruit and vegetable powder comprises lily powder, lotus seed powder, and yam powder. In some embodiments, lily powder accounts for 0.5%-5% of the total formula (e.g., 0.5%-1%, 1%-2%, 2%-3%, 3%-4% or 4%-5%), lotus seed powder accounts for 0.3%-4% of the total formula (e.g., 0.3%-1%, 1%-2%, 2%-3% or 3%-4%), and yam powder accounts for 0.2%-3% of the total formula (e.g., 0.2%-0.5%, 0.5%-1%, 1%-1.5%, 1.5%-2%, 2%-2.5% or 2.5%-3%).
[0026] In some embodiments, the fruit and vegetable powder comprises pumpkin powder, sea buckthorn powder, and yam powder. In some embodiments, pumpkin powder accounts for 0.5%-7% (e.g., 0.5%-1%, 1%-2%, 2%-3%, 3%-4%, 4%-5%, 5%-6%, or 6%-7%) of the total formula, sea buckthorn powder accounts for 0.3%-2% (e.g., 0.3%-0.5%, 0.5%-1%, 1%-1.5%, or 1.5%-2%) of the total formula, and yam powder accounts for 0.2%-3% (e.g., 0.2%-0.5%, 0.5%-1%, 1%-1.5%, 1.5%-2%, 2%-2.5%, or 2.5%-3%) of the total formula.
[0027] The fruit and vegetable powders used in the present invention can be obtained by a vacuum freeze drying process or a hot air drying process, and the particle size can be 100-1000 mesh, for example, 100-200 mesh, 200-300 mesh, 300-400 mesh, 400-500 mesh, 500-600 mesh, 600-700 mesh, 700-800 mesh, 800-900 mesh or 900-1000 mesh.
[0028] In some embodiments, the barley grass powder is obtained by vacuum freeze drying process, and the particle size is 600 mesh. In some embodiments, the broccoli pollen is obtained by vacuum freeze drying process, and the particle size is 100 mesh. In some embodiments, the yam powder is obtained by hot air drying process, and the particle size is 100 mesh.
[0029] In some embodiments, the lily powder is obtained by hot air drying process, and the particle size is 100 mesh. In some embodiments, the lotus seed powder is obtained by hot air drying process, and the particle size is 100 mesh. In some embodiments, the yam powder is obtained by hot air drying process, and the particle size is 100 mesh.
[0030] In some embodiments, pumpkin powder is obtained by vacuum freeze drying process, and the particle size is 100 mesh. In some embodiments, sea buckthorn powder is obtained by vacuum freeze drying process, and the particle size is 100 mesh. In some embodiments, yam powder is obtained by hot air drying process, and the particle size is 100 mesh.
[0031] The final form of the multivitamin mineral tablets of the present invention can be a plain tablet or a coated tablet. Plain tablets have a low moisture content, and iron and vitamin C are not easy to react. However, a lot of fine powder will adhere to the surface, which may affect the bottling process of several tablets in production, and may also cause consumers to feel uncomfortable when swallowing. Compared with plain tablets, coated tablets have a smooth surface, which is convenient for bottling and swallowing, but the coating process easily leads to an increase in the moisture content of the tablets. In order to solve this problem, the present invention controls the weight gain of the coating and the coating process, so that the tablets absorb as little moisture as possible during the coating process, thereby reducing the spotting of the tablet surface.
[0032] In particular, during the coating process, the air inlet temperature, the tablet bed temperature and the air outlet temperature are controlled according to different coating agent systems. Furthermore, the coating liquid is atomized and sprayed evenly on the tablet surface at the slowest possible speed to improve the drying efficiency of the coating liquid. In some embodiments, the coating liquid spraying speed can be controlled at 1.0-3.0 g / min (e.g., 1.0-1.5 g / min or 1.5-3.0 g / min). Finally, the theoretical weight gain of the coating is controlled to be no more than 1% (e.g., no more than 0.5% or no more than 1%).
[0033] The multivitamin mineral tablets of the present invention can be film-coated tablets, and the source of the coating agent can be hydroxypropyl methylcellulose (HPMC) type coating powder, polyvinyl alcohol (PVA) type coating powder, etc., which are solvents, or ethyl cellulose type coating powder, etc., which are solvents. In the coating step, the coating powder can be mixed with solvents such as water or ethanol in the form of a coating premix, and is formulated into a coating liquid. In some embodiments, a PVA type film coating premix can be used, which includes polyvinyl alcohol, talcum powder, Tween 80 and polyethylene glycol. In some embodiments, an HPMC type film coating premix can be used, which includes hydroxypropyl methylcellulose, talcum powder and triethylglycerol. In some embodiments, an ethyl cellulose type film coating premix can be used, which includes ethyl cellulose, talcum powder, ethyl citrate. The coating premix can be obtained commercially or prepared by itself.
[0034] In one aspect, the present application provides a multivitamin mineral tablet prepared by the above method.
[0035] The multivitamin mineral tablets of the present invention can be customized according to different groups of people. In some embodiments, each 1000 multivitamin mineral tablets contain the following ingredients:
[0036] Calcium 100-500g (e.g. 110-115g, 115-120g, 120-130g, 130-150g, 150-200g, 200-300g, 300-400g or 400-500g),
[0037] Magnesium 32.5-175g (e.g. 32.5-38g, 38-40g, 40-42g, 42-50g, 50-70g, 70-100g, 100-120g, 120-150g or 150-175g),
[0038] Iron 2.5-10 g (e.g. 2.5-3 g, 3-3.5 g, 3.5-4 g, 4-4.5 g, 4.5-5 g, 5-6 g, 6-8 g or 8-10 g),
[0039] Zinc 1-7.5 g (e.g. 1-3 g, 3-4 g, 4-5 g, 5-6 g, 6-7 g or 7-7.5 g),
[0040] Selenium 5-50 mg (e.g., 5-10 mg, 10-11 mg, 11-12 mg, 12-13 mg, 13-14 mg, 14-15 mg, 15-20 mg, 20-30 mg, 30-40 mg or 40-50 mg),
[0041] Vitamin A 80-400 mg (e.g., 80-100 mg, 100-150 mg, 150-160 mg, 160-170 mg, 170-180 mg, 180-190 mg, 190-200 mg, 200-210 mg, 210-250 mg, 250-300 mg, or 300-400 mg),
[0042] Vitamin D 1-7.5 mg (e.g. 1-2 mg, 2-3 mg, 3-4 mg, 4-5 mg, 5-6 mg or 6-7.5 mg),
[0043] Vitamin B1 0.15-10g (e.g. 0.15-0.5g, 0.5-1g, 1-1.1g, 1.1-1.2g, 1.2-1.3g, 1.3-1.4g, 1.4-1.5g, 1.5-1.6g, 1.6-1.7g, 1.7-1.8g, 1.8-1.9g, 1.9-2g, 2-3g, 3-4g, 4-5g, 5-6g, 6-7g, 7-8g, 8-9g or 9-10g),
[0044] Vitamin B2 0.15-10g (e.g. 0.15-0.5g, 0.5-1g, 1-1.1g, 1.1-1.2g, 1.2-1.3g, 1.3-1.4g, 1.4-1.5g, 1.5-1.6g, 1.6-1.7g, 1.7-1.8g, 1.8-1.9g, 1.9-2g, 2-3g, 3-4g, 4-5g, 5-6g, 6-7g, 7-8g, 8-9g or 9-10g),
[0045] Vitamin B6 0.15-5g (e.g. 0.15-0.5g, 0.5-1g, 1-1.1g, 1.1-1.2g, 1.2-1.3g, 1.3-1.4g, 1.4-1.5g, 1.5-1.6g, 1.6-1.7g, 1.7-1.8g, 1.8-1.9g, 1.9-2g, 2-3g, 3-4g or 4-5g),
[0046] Vitamin B 120.25-5 mg (e.g., 0.25-0.5 mg, 0.5-1 mg, 1-1.1 mg, 1.1-1.2 mg, 1.2-1.3 mg, 1.3-1.4 mg, 1.4-1.5 mg, 1.5-1.6 mg, 1.6-1.7 mg, 1.7-1.8 mg, 1.8-1.9 mg, 1.9-2 mg, 2-3 mg, 3-4 mg, or 4-5 mg),
[0047] Niacin 1.5-25 mg (e.g., 1.5-5 mg, 5-6 mg, 6-7 mg, 7-8 mg, 8-9 mg, 9-10 mg, 10-15 mg, 15-20 mg or 20-25 mg),
[0048] Folic acid 40-250 mg (e.g. 40-60 mg, 60-80 mg, 80-100 mg, 100-110 mg, 110-120 mg, 120-130 mg, 130-150 mg, 150-200 mg or 200-250 mg),
[0049] Biotin 5-50 mg (e.g., 5-10 mg, 10-16 mg, 16-17 mg, 17-18 mg, 18-19 mg, 19-20 mg, 20-30 mg, 30-40 mg or 40-50 mg),
[0050] Vitamin C 15-250g (e.g. 15-20g, 20-25g, 25-26g, 26-27g, 27-28g, 28-29g, 29-30g, 30-50g, 50-100g, 100-150g, 150-200g or 200-250g),
[0051] Vitamin K 7.5-50 mg (e.g., 7.5-10 mg, 10-20 mg, 20-23 mg, 23-24 mg, 24-25 mg, 25-26 mg, 26-27 mg, 27-28 mg, 28-29 mg, 29-30 mg, 30-40 mg or 40-50 mg),
[0052] Pantothenic acid 0.5-10 g (e.g., 0.5-1 g, 1-2 g, 2-2.4 g, 2.4-2.5 g, 2.5-2.6 g, 2.6-2.7 g, 2.7-2.8 g, 2.8-2.9 g, 2.9-3.0 g, 3.0-3.1 g, 3.1-3.2 g, 3.2-3.5 g, 3.5-4 g, 4-5 g, 5-6 g, 6-7 g, 7-8 g, 8-9 g or 9-10 g),
[0053] Vitamin E 2-75g (e.g., 2-5g, 5-5.5g, 5.5-5.6g, 5.6-5.7g, 5.7-6g, 6-6.4g, 6.4-6.5g, 6.5-6.6g, 6.6-6.7g, 6.7-7g, 7-7.5g, 7.5-7.6g, 7.6-7.7g, 7.7-7.8g, 7.8-7.9g, 7.9-8g, 8-10g, 10-20g, 20-30g, 30-40g, 40-50g, 50-60g, 60-70g or 70-75g),
[0054] Microcrystalline cellulose 40-350 g (e.g., 40-50 g, 50-60 g, 60-64 g, 64-70 g, 70-72 g, 72-80 g, 80-90, 90-100 g, 100-150 g, 150-200 g, 200-250 g, 250-300 g or 300-350 g),
[0055] Fruit and vegetable powder 7-300g (e.g. 7-10g, 10-30g, 30-50g, 50-56g, 56-60g, 60-80g, 80-100g, 100-120g, 120-140g, 140-160g, 160-180g, 180-200g, 200-220g, 220-240g, 240-260g, 260-280g or 280-300g),
[0056] Hydroxypropyl methylcellulose 10-60g (e.g., 10-11g, 11-12g, 12-13g, 13-14g, 14-15g, 15-16g, 16-17g, 17-18g, 18-19g, 19-20g, 20-30g, 30-40g, 40-50g or 50-60g),
[0057] Magnesium stearate 2-15g (e.g., 2-2.5g, 2.5-2.8g, 2.8-3g, 3-4g, 4-5g, 5-6g, 6-7g, 7-8g, 8-9g, 9-10g, 10-11g, 11-12g, 12-13g, 13-14g or 14-15g).
[0058] Optionally, the multivitamin mineral tablet of the present invention further contains one or more of the following ingredients: potassium, manganese, copper, and beta-carotene.
[0059] Advantageous Effects of the Invention
[0060] The present invention has the following advantages:
[0061] 1) The present invention adopts transparent film-coated tablets or plain tablets, does not use synthetic pigments, and is suitable for long-term use.
[0062] 2) The product of the present invention has uniform and natural color, good color stability and stable nutrient content.
[0063] 3) The present invention adopts natural fruit and vegetable powder, and can use fruit and vegetable powder of different colors such as green, yellow, white, etc. to distinguish products for different groups of people, and make the products have natural color and appeal.
[0064] 4) The coating process is omitted for plain tablets, and only a small amount of coating is used for film-coated tablets. Moreover, the coating agent can use pure water or ethanol as solvent, which shortens the production time and increases the production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS
[0065] Figure 1 The appearance and core of some commercially available multivitamin and mineral tablets are shown, as well as the core of the tablet after being exposed to a high humidity environment. It can be seen that the core of the tablet has changed.
[0066] Figure 2 The appearance of two commercially available multivitamin-mineral tablets is shown, the uncoated chewable tablet on the left and the transparent coated swallowable tablet on the right.
[0067] Figure 3 The appearance of the tablets using magnesium oxide as the magnesium source in Comparative Example 5 is shown, and obvious scratches can be seen.
[0068] Figure 4 The appearance of tablets prepared with different vitamin C sources in Comparative Example 6 and exposed to 30° C. and 75% RH for 2 days is shown.
[0069] Figure 5 The appearance of tablets prepared with different iron sources in Comparative Example 7 and exposed at 30°C and 75% RH for 2 days is shown.
[0070] Figure 6 The appearance of the tablets prepared in Examples 1-5 is shown.
[0071] Figure 7 The appearance of the tablets obtained in Comparative Example 1 and Comparative Example 2 is shown.
[0072] Figure 8 The appearance of the tablets prepared in Example 2, Comparative Example 3 and Comparative Example 4 after accelerated storage at 37° C. and 75% RH for 3 months is shown. DETAILED DESCRIPTION
[0073] The embodiments of the present invention will be described in detail below in conjunction with the examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be considered to limit the scope of the present invention. If no specific conditions are specified in the examples, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be obtained commercially.
[0074] The mass of vitamins and minerals in the embodiments is the mass of nutrients rather than the mass of raw materials. The mass of raw materials corresponding to nutrients can be obtained by calculation.
[0075] Embodiment 1:
[0076] Prescription quantity (1000 tablets): Calcium 110g, Magnesium 37.5g, Iron 3.5g, Zinc 5g, Selenium 12.5mg, Vitamin A 185mg, Vitamin D 2.5mg, Vitamin B1 1.25g, Vitamin B2 1.25g, Vitamin B6 1.25g, Vitamin B 12 1.25mg, niacin 7mg, folic acid 110mg, biotin 16mg, vitamin C 25g, vitamin K 22.5mg, pantothenic acid 2.5g, vitamin E 5g, microcrystalline cellulose 72g, fruit and vegetable powder 56g, hydroxypropyl methylcellulose 10g, magnesium stearate 2.8g, coating premix 3.5g.
[0077] Preparation process:
[0078] 1) Mineral granulation: The raw materials of calcium carbonate, magnesium carbonate, ferrous fumarate and zinc gluconate in the prescribed amount are granulated with a 3% concentration of hydroxypropyl methylcellulose solution in a fluidized bed. After drying, the granules are discharged when the moisture content is below 2%, and the granules are granulated for later use.
[0079] 2) Preparation of vitamin premix: Vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , niacinamide, folic acid, biotin, vitamin C, vitamin K, pantothenic acid, and vitamin E are weighed and mixed in a mixer for 90 minutes to obtain a premix. Vitamin C is sodium ascorbate or calcium ascorbate.
[0080] 3) Total mixing and tableting: the mineral particles, vitamin premix, selenium, microcrystalline cellulose, fruit and vegetable powder (barley grass powder, vacuum freeze-dried, particle size 600 mesh, accounting for 5% of the total formula; broccoli pollen, vacuum freeze-dried, particle size 100 mesh, accounting for 1.5% of the formula; yam powder, hot air dried, particle size 100 mesh, accounting for 1.5% of the formula) are weighed and placed in a mixer for mixing for 25 minutes, and then magnesium stearate is added and mixed for 15 minutes; and plain tablets are obtained by tableting with a high-speed rotary tablet press.
[0081] 4) Film coating: Take an appropriate amount of PVA film coating premix (Colorcon OPADRY II 85F19250-CN CLEAR: polyvinyl alcohol, talc, Tween 80, polyethylene glycol), add it to a certain amount of water to a coating solution concentration of 12%, and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature to 80±5°C, the tablet bed temperature to 45±5°C, the outlet air temperature to 50°C±5°C, control the spraying speed to 1.0-1.5g / min, atomize the coating solution and spray it evenly on the tablet surface, and obtain coated tablets when the theoretical weight gain of the coating is 0.5%.
[0082] Embodiment 2:
[0083] Prescription quantity (1000 tablets): Calcium 115g, Magnesium 40g, Iron 4.5g, Zinc 3g, Selenium 10mg, Vitamin A 150mg, Vitamin D3mg, Vitamin B1 0.9g, Vitamin B2 0.9g, Vitamin B6 0.9g, Vitamin B 12 0.9mg, niacin 6mg, folic acid 120mg, biotin 16mg, vitamin C 25g, vitamin K 22.5mg, pantothenic acid 2.5g, vitamin E 6g, microcrystalline cellulose 64g, fruit and vegetable powder 56g, hydroxypropyl methylcellulose 11g, magnesium stearate 2.8g, coating premix 3.5g.
[0084] Preparation process: Same as Example 1, the fruit and vegetable powder adopts lily powder, lotus seed powder, and yam powder (lily powder, hot air drying, particle size 100 mesh, accounting for 4% of the total formula; lotus seed powder, hot air drying, particle size 100 mesh, accounting for 2% of the total formula; yam powder, hot air drying, particle size 100 mesh, accounting for 2% of the total formula).
[0085] Embodiment 3:
[0086] Prescription quantity (1000 tablets): Calcium 120g, Magnesium 37.5g, Iron 3.5g, Zinc 4g, Selenium 13mg, Vitamin A 175mg, Vitamin D 4mg, Vitamin B1 1.5g, Vitamin B2 1.5g, Vitamin B6 1.5g, Vitamin B 12 1.5mg, niacin 5mg, folic acid 130mg, biotin 17.5mg, vitamin C 25g, vitamin K 22.5mg, pantothenic acid 3g, vitamin E 7g, microcrystalline cellulose 50g, fruit and vegetable powder 56g, hydroxypropyl methylcellulose 11g, magnesium stearate 2.8g, coating premix 3.5g.
[0087] Preparation process: Same as Example 1, the fruit and vegetable powder uses pumpkin powder, sea buckthorn powder, and yam powder (pumpkin powder, vacuum freeze-dried, particle size 100 mesh, accounting for 5% of the total formula; sea buckthorn powder, vacuum freeze-dried, particle size 100 mesh, accounting for 1.5% of the total formula; yam powder, hot air dried, particle size 100 mesh, accounting for 1.5% of the total formula).
[0088] Embodiment 4:
[0089] The prescription amount is the same as that of Example 2. The fruit and vegetable powders are lily powder, lotus seed powder, and yam powder (lily powder, hot air drying, particle size 100 mesh, accounting for 4% of the total formula; lotus seed powder, hot air drying, particle size 100 mesh, accounting for 2% of the total formula; yam powder, hot air drying, particle size 100 mesh, accounting for 2% of the total formula).
[0090] Preparation process: mineral granulation, vitamin premix preparation, total mixing and tableting are the same as in Example 2.
[0091] Film coating process: Take an appropriate amount of HPMC film coating premix (Colorcon OPADRY ZY 290K690004-CNCLEAR: hydroxypropyl methylcellulose, talc, triethylglycerol), add it to a certain amount of water to a coating solution concentration of 12%, and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature to 80±5℃, the tablet bed temperature to 45±5℃, the outlet air temperature to 50℃±5℃, control the spray speed to 1.0-1.5g / min, atomize the coating solution and evenly spray it on the tablet surface, and obtain coated tablets when the theoretical weight gain of the coating is 0.5%.
[0092] Embodiment 5:
[0093] The prescription amount is the same as that of Example 2. The fruit and vegetable powders are lily powder, lotus seed powder, and yam powder (lily powder, hot air drying, particle size 100 mesh, accounting for 4% of the total formula; lotus seed powder, hot air drying, particle size 100 mesh, accounting for 2% of the total formula; yam powder, hot air drying, particle size 100 mesh, accounting for 2% of the total formula).
[0094] Preparation process: mineral granulation, vitamin premix preparation, total mixing and tableting are the same as in Example 2.
[0095] Film coating process: Take an appropriate amount of ethyl cellulose film coating premix (Colorcon OPADRY 21K690000-CNCLEAR: ethyl cellulose, talc, ethyl citrate), add it to 85% ethanol to a coating solution concentration of 6%, and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature at 60±5℃, the tablet bed temperature at 35±5℃, the outlet air temperature at 40℃±5℃, control the spray speed at 1.5-3.0g / min, atomize the coating solution and spray it evenly on the tablet surface, and obtain coated tablets when the theoretical weight gain of the coating is 1%.
[0096] Comparative Example 1:
[0097] Prescription quantity and preparation process: Same as Example 1, plain tablets, fruit and vegetable powder uses red beet powder, cranberry powder, lily powder (red beet powder, vacuum freeze-dried, particle size 80 mesh, accounting for 5% of the total formula; cranberry powder, vacuum freeze-dried, particle size 80 mesh, accounting for 1.5% of the total formula; lily powder, hot air dried, particle size 100 mesh, accounting for 1.5% of the total formula).
[0098] Comparative Example 2:
[0099] Prescription quantity and preparation process: Same as Example 3, plain tablets, fruit and vegetable powders use strawberry powder, raspberry powder, and lily powder (strawberry powder, vacuum freeze-dried, particle size 80 mesh, accounting for 5% of the total formula; raspberry powder, vacuum freeze-dried, particle size 80 mesh, accounting for 1.5% of the total formula; lily powder, hot air dried, particle size 100 mesh, accounting for 1.5% of the total formula).
[0100] Comparative Example 3:
[0101] Prescription quantity and preparation process: Same as Example 2, coated tablets, the theoretical coating weight gain is 1%, during coating, the inlet air temperature is controlled at 80±5°C, the tablet bed temperature is 40±5°C, the outlet air temperature is 50°C±5°C, the spray speed is controlled at 1.5-3.0g / min, the coating liquid is atomized and evenly sprayed on the tablet surface, and the coating theoretical weight gain is 1% to obtain coated tablets.
[0102] Comparative Example 4:
[0103] Prescription quantity and preparation process: Same as Example 2, coated tablets, the theoretical coating weight gain is 3%, during coating, the inlet air temperature is controlled at 80±5°C, the tablet bed temperature is 40±5°C, the outlet air temperature is 50°C±5°C, the spray speed is controlled at 1.5-3.0g / min, the coating liquid is atomized and evenly sprayed on the tablet surface, and the coating theoretical weight gain is 3% to obtain coated tablets.
[0104] like Figure 6 As shown in Table 1, the plain tablets and coated tablets prepared in Examples 1-5 have uniform and natural color and good stability. When tested for 3 months under the accelerated stability test conditions of temperature 37°C and relative humidity 75%, the nutrient content is stable and the color of the tablet core and tablet surface does not change significantly.
[0105] like Figure 7 As shown, the fruit and vegetable powders of Comparative Examples 1 and 2 have high polysaccharide content and are easy to agglomerate. Even if the fruit and vegetable powders are sieved and then mixed with other materials, the tablets prepared on the high-speed rotary tablet press are still very uneven.
[0106] like Figure 8As shown, after the coated Example 2 and Comparative Examples 3 and 4 were accelerated at 37°C and 75% RH for 3 months, the appearance of Comparative Examples 3 and 4 changed due to excessive water absorption during the coating process. Even though the 3% coating weight gain of Comparative Example 4 made the tablet surface more blurry, it could not cover the spots on the tablet surface. Example 2 was basically unchanged.
[0107] Table 1 Results of the coated tablets of Examples 1-5 after accelerated treatment at 37°C and 75% RH for 3 months
[0108]
[0109]
[0110] Note: The nutrient niacin is available in two raw material forms: niacin and niacinamide. When niacinamide is used as the raw material, the content of the active ingredient is calculated as niacinamide.
[0111] Comparative Example 5:
[0112] Prescription quantity and preparation process: Same as Example 1, the formulas of plain tablets and fruit and vegetable powder are:
[0113] a: Pumpkin powder, vacuum freeze-dried, particle size 100 mesh, accounting for 5% of the total formula; sea buckthorn powder, vacuum freeze-dried, particle size 100 mesh, accounting for 1.5% of the total formula; yam powder, hot air dried, particle size 100 mesh, accounting for 1.5% of the total formula.
[0114] b: Barley grass powder, vacuum freeze-dried, particle size 600 mesh, accounting for 5% of the total formula; broccoli pollen, vacuum freeze-dried, particle size 100 mesh, accounting for 1.5% of the total formula; yam powder, hot air dried, particle size 100 mesh, accounting for 1.5% of the total formula.
[0115] c: Lily powder, hot air dried, particle size 100 mesh, accounting for 4% of the total formula; lotus seed powder, hot air dried, particle size 100 mesh, accounting for 2% of the total formula; yam powder, hot air dried, particle size 100 mesh, accounting for 2% of the total formula.
[0116] Magnesium oxide was used as the source of magnesium for tableting, and the appearance of the tablets was observed, such as Figure 3 a. Figure 3 b. Figure 3 As shown in Figure c, magnesium oxide is used as the source of magnesium, which easily produces black scratches during the tableting process, affecting the appearance of the tablets.
[0117] Comparative Example 6:
[0118] Prescription amount and preparation process: Same as Example 1, plain tablets. Tablets were prepared using sodium ascorbate, calcium ascorbate, ascorbic acid, ascorbic acid coated with ethyl cellulose, and ascorbic acid granulated with hydroxypropyl methylcellulose as vitamin C sources, respectively, and exposed at 30°C and 75% RH for 2 days. Figure 4 As shown, there was basically no change in tablets using sodium ascorbate and calcium ascorbate, but there was a significant change in tablets using other raw materials.
[0119] Comparative Example 7:
[0120] Prescription and preparation process: Same as Example 1, plain tablets. Tablets were prepared using ferrous fumarate, ferrous gluconate, and ferric pyrophosphate as iron sources, respectively, and exposed to 30°C and 75% RH for 2 days. The results are as follows: Figure 5 As shown, water-insoluble ferrous fumarate has stronger stability in tablets, and tablets using ferrous fumarate have basically no change.
[0121] The above are only several embodiments of the present invention, and the description is relatively specific and detailed, but it cannot be used as a limitation on the scope of the present invention. For ordinary persons in the art, adjustments and improvements can be made without departing from the principle of the present invention, but these are all within the scope of protection of the present invention. The full scope of the present invention shall be subject to the attached claims and any equivalents thereof.
Claims
1. A method for preparing a multivitamin mineral tablet, wherein the multivitamin mineral tablet is a plain tablet or a coated tablet; The multivitamin mineral tablets contain the following ingredients: calcium, magnesium, iron, zinc, selenium, vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , niacin, folic acid, biotin, vitamin C, vitamin K, pantothenic acid, vitamin E, microcrystalline cellulose, fruit and vegetable powder, hydroxypropyl methylcellulose and magnesium stearate; among them, The source of magnesium is magnesium carbonate; the source of vitamin C is sodium ascorbate or calcium ascorbate; the source of iron is ferrous fumarate; the source of fruit and vegetable powder includes but is not limited to one or more of barley grass powder, broccoli powder, spinach powder, pumpkin powder, sea buckthorn powder, corn powder, lily powder, lotus seed powder, and yam powder; the total weight of the fruit and vegetable powder accounts for 1%-12% of the weight of the multivitamin mineral tablet; The preparation method comprises: (1) Mineral granulation: The raw materials of calcium, magnesium, iron and zinc in the prescribed amount are granulated with hydroxypropyl methylcellulose solution in a fluidized bed. After drying, the granules are discharged when the moisture content is less than 2%, and the granules are granulated for later use; (2) Preparation of vitamin premix: Vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B 12 , niacinamide, folic acid, biotin, vitamin C, vitamin K, pantothenic acid, and vitamin E are weighed and placed in a mixer, and mixed evenly to obtain a premix; (3) Total mixing and tableting: the mineral particles, vitamin premix, selenium, microcrystalline cellulose, and fruit and vegetable powder are weighed and mixed in a mixer, and magnesium stearate is added and mixed evenly to obtain a total mixed powder; and tableting is performed using a high-speed rotary tablet press to obtain plain tablets; (4) Film coating: Water-based coating agent: Take an appropriate amount of film coating premix, add it to a certain amount of water until the concentration of the coating solution is 12%-20%, and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature to 80±5℃, the tablet bed temperature to 45±5℃, and the outlet air temperature to 50℃±5℃, atomize the coating solution and spray it evenly on the tablet surface, dry it to form a film to obtain the coated tablets; or Coating agent with alcohol-water system: take an appropriate amount of film coating premix, add it to a certain amount of alcohol-water solution until the concentration of the coating solution is 3%-8%, and stir until the solution is evenly dispersed; put the plain tablets into the coating machine for coating, control the inlet air temperature at 60±5℃, the tablet bed temperature at 35±5℃, and the outlet air temperature at 40℃±5℃, atomize the coating solution and spray it evenly on the tablet surface, dry it to form a film, and then obtain the coated tablets; Optionally, the method can also omit step (4) of film coating and directly produce plain tablets.
2. The preparation method of claim 1, wherein the fruit and vegetable powder comprises barley grass powder, broccoli powder and yam powder; preferably, the barley grass powder accounts for 0.5%-7% of the total formula, the broccoli powder accounts for 0.3%-3% of the total formula, and the yam powder accounts for 0.2%-2% of the formula; or The fruit and vegetable powder comprises lily powder, lotus seed powder and yam powder; preferably, lily powder accounts for 0.5%-5% of the total formula, lotus seed powder accounts for 0.3%-4% of the total formula, and yam powder accounts for 0.2%-3% of the total formula; or The fruit and vegetable powder comprises pumpkin powder, sea buckthorn powder and yam powder; preferably, pumpkin powder accounts for 0.5%-7% of the total formula, sea buckthorn powder accounts for 0.3%-2% of the total formula, and yam powder accounts for 0.2%-3% of the total formula.
3. The preparation method according to claim 1 or 2, wherein each fruit and vegetable powder is obtained by vacuum freeze drying or hot air drying.
4. The preparation method according to any one of claims 1 to 3, wherein the particle size of each fruit and vegetable powder is 100 mesh to 1000 mesh.
5. The preparation method according to any one of claims 1 to 4, wherein in step (4), the coating liquid spraying speed is controlled at 1.0-3.0 g / min.
6. The preparation method according to any one of claims 1 to 5, wherein the theoretical weight gain of the coating is controlled not to exceed 1%.
7. The preparation method according to any one of claims 1 to 6, wherein the coating agent is selected from hydroxypropyl methylcellulose (HPMC) type coating powder, polyvinyl alcohol (PVA) type coating powder with pure water as solvent, or ethyl cellulose type coating powder with ethanol as solvent.
8. A multivitamin mineral tablet prepared by the method of any one of claims 1 to 7.
9. The multivitamin mineral tablet of claim 8, wherein each 1000 tablets of the multivitamin mineral tablet contains the following ingredients: calcium 100-500g, magnesium 32.5-175g, iron 2.5-10g, zinc 1-7.5g, selenium 5-50mg, vitamin A 80-400mg, vitamin D1-7.5mg, vitamin B1 0.15-10g, vitamin B2 0.15-10g, vitamin B6 0.15-5g, vitamin B 12 0.25-5mg, niacin 1.5-25mg, folic acid 40-250mg, biotin 5-50mg, vitamin C15-250g, vitamin K 7.5-50mg, pantothenic acid 0.5-10g, vitamin E 2-75g, microcrystalline cellulose 40-350g, fruit and vegetable powder 7-300g, hydroxypropyl methylcellulose 10-60g, magnesium stearate 2-15g.