CN114259059B - Multivitamin calcium zinc chewable tablet and preparation method thereof - Google Patents
Multivitamin calcium zinc chewable tablet and preparation method thereof Download PDFInfo
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Abstract
The invention provides a multivitamin calcium zinc chewable tablet and a preparation method thereof, belonging to the technical field of food preparation, wherein the preparation method comprises the following steps: taking povidone K30, zinc gluconate, sucralose, calcium hydrophosphate, L-calcium lactate, vitamin B12 and D-mannitol, uniformly mixing, granulating by a wet method, and taking a main material I; taking povidone K30, folic acid, D-calcium pantothenate, vitamin B1, vitamin B2 and vitamin B6, uniformly mixing, granulating by a dry method, and preparing a main material II; mixing lactose, nicotinamide, vitamin D3 powder and vitamin A acetate dry powder, and granulating by a dry method to obtain vitamins; and uniformly mixing the main material I, the main material II, the vitamins and the auxiliary materials, and tabletting to obtain the multivitamin calcium zinc chewable tablet. According to the invention, different raw materials are classified and granulated in different modes, so that the generation of impurities in the granulating process of the raw materials can be reduced.
Description
Technical Field
The invention relates to preparation of chewable tablets, in particular to a multivitamin calcium zinc chewable tablet and a preparation method thereof.
Background
Vitamins are a class of trace organic substances that maintain normal physiological functions in humans and animals, and are generally available from daily diets, and in particular, they play an important role in the growth, metabolism, and development of the human body.
Calcium is a major element necessary for human body, and is also the most abundant inorganic element in human body, the calcium content in adult human body is about 1.5-2.0% of weight, and the total calcium content in human body is up to 1200-1400 g, wherein 99% of calcium is present in bones and teeth to form human body bracket, and the rest 1% of calcium is present in soft tissue, cell gap and blood, which are collectively called as miscible calcium pool, and maintains dynamic balance with bone calcium. Calcium plays an important physiological regulation role in the exertion of all cell functions of human bodies. Calcium is an activator of more than 200 enzymes in a human body, so that various organs of the human body can normally operate, and calcium element participates in metabolism of the human body, so that calcium is required to be supplemented every day, and the growth and the development and the health of the human body can be influenced due to insufficient or excessive content of the calcium in the human body.
Zinc is a trace element in the human body, but has a very large effect. Zinc can improve the sensitivity of human immune system, and can directly inhibit the activity of virus, thereby enhancing the disease resistance of human body. It also can promote brain protein synthesis, and help development and perfection of nervous system. Meanwhile, zinc can promote development of taste bud cells, enhance appetite of children, improve anorexia and monophagia of children, and ensure comprehensive intake of nutrition.
Therefore, vitamins, calcium, zinc and the like are all nutrients necessary for human bodies, and the multivitamin calcium-zinc chewable tablet is a main medicament for people to rapidly supplement vitamins and calcium-zinc. However, the existing multi-vitamin calcium zinc chewable tablets are mainly prepared by carrying out wet granulation tabletting or direct mixing tabletting on materials, and partial raw material mixing non-uniformity phenomenon exists in the direct mixing tabletting, and the wet granulation tabletting method is characterized in that the materials are directly subjected to one-time treatment or are treated by the same method in batches by considering the dosage problem, but different materials have different physicochemical properties, and the materials are directly subjected to one-time treatment or are subjected to wet granulation by considering the dosage problem, so that polymerization or deterioration occurs between the materials, thereby influencing the product quality and further influencing the bioavailability.
Nicotinamide is also called niacinamide, vitamin B3 or vitamin PP, belongs to B vitamins, is a component of coenzyme I (nicotinamide adenine dinucleotide, NAD) and coenzyme II (nicotinamide adenine dinucleotide phosphate, NADP), has reversible hydrogenation and dehydrogenation characteristics of nicotinamide parts in two coenzyme structures in human bodies, plays a role in hydrogen transfer in biological oxidation, can promote tissue respiration, biological oxidation process and metabolism, and has important significance for maintaining the integrity of normal tissues, especially skin, digestive tract and nervous system. In the preparation process of nicotinamide, 3-cyanopyridine is mainly used as a raw material, sodium hydroxide or manganese dioxide is used as a catalyst, or microbial catalytic hydrolysis is used for producing nicotinamide. Regardless of the method employed, however, the nicotinamide product produced will contain a certain amount of niacin impurities. The nicotinic acid can act with the G-protein coupled receptor to stimulate peripheral vasodilation, so that a user has strong rejection reaction, and the research emphasis on improving the quality of nicotinamide products is that the irritation of the nicotinic acid is reduced as much as possible and the content of the nicotinic acid in the nicotinamide is reduced.
Disclosure of Invention
Aiming at the problems, the invention provides a multivitamin calcium zinc chewable tablet and a preparation method thereof.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the raw materials for preparing the active ingredients of the multivitamin calcium zinc chewable tablet comprise the following components in parts by weight:
main materials: 0.1 to 0.6 part of povidone K, 0.5 to 1 part of zinc gluconate, 0.1 to 0.5 part of sucralose, 10 to 30 parts of calcium hydrophosphate (dihydrate), 10 to 30 parts of L-calcium lactate (pentahydrate), 40 to 90 parts of D-mannitol, 0.001 to 0.01 part of folic acid, 0.01 to 0.04 part of D-calcium pantothenate, 0.1 to 0.2 part of nicotinamide, 0.01 to 0.03 part of vitamin B2, 0.01 to 0.03 part of vitamin B6, 0.001 to 0.01 part of vitamin B12, 13 to 35 parts of lactose, 0.04 to 0.07 part of vitamin D3 powder 100SD/S and 0.02 to 0.06 part of vitamin A acetate dry powder;
auxiliary materials: 1-4 parts of strawberry essence and 1-4 parts of magnesium stearate;
in the preparation process of the multivitamin calcium zinc chewable tablet, the main material is firstly granulated to respectively prepare a main material I, a main material II and vitamins, and the specific granulating process comprises the following steps:
taking povidone K30, zinc gluconate, sucralose, calcium hydrophosphate, L-calcium lactate, vitamin B12 and D-mannitol, uniformly mixing, granulating by a wet method, and taking a main material I;
taking povidone K30, folic acid, D-calcium pantothenate, vitamin B1, vitamin B2 and vitamin B6, uniformly mixing, granulating by a dry method, and preparing a main material II;
mixing lactose, nicotinamide, vitamin D3 powder and vitamin A acetate dry powder, and granulating by dry method to obtain vitamin.
Further, the preparation method of the nicotinamide comprises the following steps:
1) Adding 3-cyanopyridine into ethanol, adding sodium tetraborate, then dropwise adding ammonia water, carrying out hydrolysis reaction, adding seed crystal for crystallization, and obtaining a nicotinamide crude product, wherein the specific chemical reaction formula is as follows:
2) And (3) regulating the pH value of the glycerol-water mixed solution, adding the nicotinamide crude product, stirring for dissolution, filtering to remove trace insoluble substances, and decoloring and crystallizing to obtain the nicotinamide.
Further, in the step 2), the glycerol-water mixed solution is prepared by mixing the components in a volume ratio of 2-3: 1 and water.
Further, in the step 2), the weight-volume ratio of the nicotinamide crude product to the glycerol-water mixed solution is 1g: 2.5-3 mL.
Further, in the step 2), the pH value is adjusted to 6.8-7.2.
Further, in the step 1), the molar ratio of 3-cyanopyridine, sodium tetraborate and ammonia water is 1:0.4 to 0.6:0.5 to 0.8;
the weight-volume ratio of 3-cyanopyridine to ethanol is 1g: 1.2-1.4 mL.
Further, in step 1), the concentration of the aqueous ammonia is 28wt%.
Further, in the step 1), the temperature of the hydrolysis reaction is 80 to 95 ℃.
Further, in the step 2), the temperature of stirring is 30-35 ℃ and the time is 2-3 h.
A preparation method of the multivitamin calcium zinc chewable tablet comprises the steps of taking main material I, main material II, vitamins and auxiliary materials, uniformly mixing, and tabletting to obtain the multivitamin calcium zinc chewable tablet.
The multivitamin calcium zinc chewable tablet and the preparation method thereof have the beneficial effects that:
according to the invention, different raw materials are classified and granulated in different modes, so that the generation of impurities in the granulating process of the raw materials can be reduced;
wherein, the sucralose is neutral, but can release HCl when the temperature is higher; d-mannitol is acidic; lactose is unstable to moisture and heat; vitamin D3 is alkaline; vitamin B2 and vitamin B6 are both unstable to alkali; folic acid is unstable to acid and heat, and is quickly decomposed when the temperature is high; nicotinamide is hygroscopic; vitamin B1 is deliquescent and is not thermally stable to alkali; the D-calcium pantothenate has hygroscopicity and is unstable to acid and alkali; vitamin B12 is acidic and strong in hygroscopicity, and is unstable to acid and alkali; the raw materials are granulated by three parts by combining the characteristics of acid and alkali, stability and the like of the raw materials, and wet granulation and dry granulation are respectively adopted by combining the characteristics of the raw materials in the granulating process, so that polymerization or decomposition and deterioration among different raw materials are effectively inhibited, and the product quality is improved;
according to the structure of nicotinamide and nicotinic acid, the method combines different dissolution characteristics, adopts the glycerin-water mixed solution with a specific proportion to purify the nicotinamide crude product at a specific pH value, utilizes the characteristic that the glycerin-water mixed solution with a specific proportion dissolves the nicotinamide and does not dissolve the nicotinic acid, can separate the nicotinamide with similar physicochemical properties from the nicotinic acid through simple filtration, does not need to use a silica gel column for separation, is beneficial to reducing the content of the nicotinic acid in the nicotinamide and reduces the side effect of the nicotinamide;
according to the invention, sodium tetraborate and ammonia water in a specific proportion are used as catalysts together to catalyze the hydrolysis of 3-cyanopyridine to synthesize nicotinamide; simultaneously, the characteristic that nicotinic acid and ammonia water can be dehydrated to generate nicotinamide under the action of boric acid is combined, and sodium tetraborate and ammonia water with specific doses are added to catalyze the hydrolysis of 3-cyanopyridine to synthesize nicotinamide, and meanwhile, the generated nicotinamide is inhibited from further hydrolyzing to generate ammonia water and nicotinic acid, so that the content of nicotinic acid in the product is reduced.
Detailed Description
The following description of the technical solution in the embodiments of the present invention is clear and complete. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways other than those described herein, and persons skilled in the art will readily appreciate that the present invention is not limited to the specific embodiments disclosed below.
EXAMPLE 1 preparation method of nicotinamide
The embodiment is a preparation method of nicotinamide, and the specific preparation process comprises the following steps in sequence:
1) At room temperature, 104g (1 mol) of 3-cyanopyridine is added into 135mL of ethanol, stirred, dispersed and partially dissolved, 110.7g (0.55 mol) of sodium tetraborate is added, stirring is continued, then 85.4mL (0.6 mol) of 28wt% ammonia water is dropwise added, heating is carried out to 90 ℃, stirring is carried out at 90 ℃ until the hydrolysis reaction is carried out until TLC monitoring 3-cyanopyridine is complete, cooling is carried out to 60 ℃, 1g of active carbon is added for decoloration 30min, filtering is carried out, cooling is carried out on the filtrate to room temperature, a small amount of nicotinamide seed crystal is added, cooling is carried out again to 0 ℃, stirring crystallization is carried out for 5h, filtering and vacuum drying are carried out, thus 121.09g of nicotinamide crude product is obtained, the yield is 99.16%, and the specific chemical reaction formula is as follows:
2) Mixing 212mL of glycerin and 85mL of water uniformly, adding a small amount of 10wt% sodium hydroxide aqueous solution into the obtained glycerin-water mixed solution to adjust the pH value to 7.1, then adding 110g of nicotinamide crude product, heating to 32 ℃, maintaining the temperature at 32 ℃ and stirring for 2 hours until the nicotinamide crude product is not dissolved, filtering to remove trace insoluble substances (the insoluble substances are nicotinic acid), adding 1g of active carbon, stirring and decoloring for 30 minutes, filtering, adding a small amount of nicotinamide seed crystal into the filtrate, cooling to 0 ℃ again, stirring and crystallizing for 5 hours, filtering, and vacuum drying to obtain 108.87g of nicotinamide (marked as M1), wherein the yield is 98.97%, the purity is 99.94%, and the nicotinic acid content in the nicotinamide is 28ppm (according to China pharmacopoeia 2015 edition two-1408 and 1410, and high performance liquid chromatography is adopted for detection).
The overall yield of nicotinamide was 98.14%.
EXAMPLES 2 to 5 preparation method of nicotinamide
Examples 2 to 5 are each a process for the preparation of nicotinamide, which steps are substantially identical to example 1, with the only difference in the process parameters, in particular in table 1:
table 1 list of process parameters in examples 2 to 5
The other parts of examples 2 to 5 are the same as those of example 1.
Example 6 preparation method of multivitamin calcium Zinc chewable tablet
The embodiment is a preparation method of a multivitamin calcium zinc chewable tablet, which comprises the following steps in sequence:
adding 0.742kg of zinc gluconate into the prescribed amount of purified water (1.47 kg), heating and stirring until the zinc gluconate is completely dissolved, cooling, adding 0.3kg of povidone K30, 0.12kg of sucralose, 21.12kg of calcium hydrophosphate (dihydrate), 20.72kg of L-calcium lactate (penta-water), 0.002kg of vitamin B12 and 73.78kg of D-mannitol, stirring uniformly, transferring into a high-efficiency wet granulator, starting stirring and mixing for 5min, adding the prescribed amount of purified water (1.47 kg) again, starting low-speed stirring and cutting to prepare a soft material, granulating with a 24-mesh nylon sieve on a swing granulator, and drying the obtained wet granules with 70+/-5 ℃ hot air (turning material once every 10min in the hot air drying process), thus obtaining a main material I;
taking 0.16kg of povidone K30, 0.004kg of folic acid, 0.028kg of D-calcium pantothenate, 0.013kg of vitamin B1, 0.013kg of vitamin B2 and 0.013kg of vitamin B6, adding into a multidirectional motion mixer, mixing for 10min, then moving into a dry granulator, and extruding, crushing and granulating to obtain a main material II;
20kg lactose, 0.126kg nicotinamide M1 (prepared in example 1), 0.062kg vitamin D3 powder 100SD/S and 0.044kg vitamin A acetate dry powder are taken, added into a multidirectional motion mixer to be mixed for 10min, and then moved into a dry granulator to obtain vitamins through extrusion, crushing and granulation.
And adding the main material I, the main material II, the vitamins, 1.2kg of magnesium stearate and 1.2kg of strawberry essence into a multidirectional motion mixer, mixing for 5min, and tabletting the obtained granules by a tablet press to obtain various vitamin calcium zinc chewable tablets.
Examples 7 to 10 preparation method of chewable tablets containing more vitamins, calcium and zinc
Examples 7 to 10 are a method for preparing multivitamin calcium zinc chewable tablets, which are basically the same as example 6, except that the raw materials are used in different amounts, and are specifically shown in table 2:
table 2 list of raw Material amounts in examples 7 to 10
The other parts of examples 7 to 10 are the same as in example 6.
Experimental example 1 determination of the purity of nicotinamide
Comparative examples 1 to 5 are comparative tests of the nicotinamide production process in example 1 and use the same batch of nicotinamide, differing only in that:
in comparative example 1, manganese dioxide and ammonia water are used as catalysts, nicotinamide is generated by hydrolysis, the total yield is 71.2%, the purity is 99.72%, and the nicotinic acid content is 31ppm;
in comparative example 2, sodium tetraborate and sodium hydroxide are used as catalysts, nicotinamide is produced by hydrolysis, the total yield is 54.3%, the purity is 99.87%, and the nicotinic acid content is 35ppm;
in comparative example 3, ethanol was used for recrystallization, the recovery rate of recrystallization was 80.9%, the purity was 98.57%, and the nicotinic acid content was 721ppm;
in comparative example 4, according to example 1 of chinese patent 201710706089.7, recrystallization was performed using ethanol and a small amount of sodium hydroxide ethanol solution, the recovery rate of recrystallization was 81.4%, the purity was 98.94%, and the nicotinic acid content was 217ppm;
in comparative example 5, glycerol was used for recrystallization, the solvent used was extremely large and slightly insoluble, filtration was required, the recovery rate of recrystallization was 63.9%, the purity was 99.42%, and the nicotinic acid content was 41ppm.
Experimental example 2 determination of Property of multivitamin calcium Zinc chewable tablet
Comparative examples 6-8 are comparative tests of the preparation process of multivitamin calcium zinc chewable tablets in example 6 and use the same batch of nicotinamide, differing only in that:
in comparative example 6, main ingredient I, main ingredient II and vitamins were prepared by wet granulation, respectively;
in comparative example 7, main material I, main material II and vitamins were prepared by dry granulation, and the main material I had a slight phenomenon of zinc gluconate dispersion unevenness by dry granulation;
comparative example 8 a multivitamin calcium zinc chewable tablet was prepared according to the method of preparation disclosed in chinese invention patent application 201810665864.3;
comparative example 9 the same procedure as in example 6 was followed except that the nicotinamide used was a common commercially available nicotinamide.
Taking the multivitamin calcium zinc chewable tablets prepared in examples 6-10 and comparative examples 6-9, and respectively carrying out effective ingredient calculation on zinc (according to the determination of zinc in GB 5009.14 food safety national standard food), calcium (according to the determination of calcium in GB 5009.92 food safety national standard food), folic acid (according to the determination of pantothenic acid in GB 5009.210 food safety national standard food), nicotinamide (according to the determination of niacin and nicotinamide in GB 5009.89 food safety national standard food), vitamin B1 (according to the determination of vitamin B1 in GB 5009.84 food safety national standard food), vitamin B2 (according to the determination of vitamin B2 in GB 5009.85 food safety national standard food), vitamin B6 (according to the determination of vitamin B6 in GB 5009.154 food safety national standard food), vitamin B12 (according to the determination of vitamin B12 in GB/T5009.217 health food), vitamin D3 (according to the determination of vitamin B12 in GB 5009.89 food safety national standard food, and the detection of the content of vitamin B24 in GB 5009.84) according to the theoretical table of the content of vitamin B1 and the detection result of the vitamin B24 in the national standard of GB 5009.84:
TABLE 3 active ingredient content detection results list
As can be seen from Table 3, the multivitamin calcium zinc chewable tablets prepared in examples 6 to 10 have higher contents of each active ingredient, while the multivitamin calcium zinc chewable tablets prepared in comparative examples 6 to 8 have partial losses of active ingredient, because the characteristics of the raw materials are not classified in the preparation process, and the proper method is not selected according to the characteristics to be uniformly mixed and granulated. Therefore, the multivitamin calcium zinc chewable tablet prepared by the preparation method can effectively inhibit polymerization or deterioration of raw materials and improve the quality of products.
It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Claims (2)
1. The multi-vitamin calcium zinc chewable tablet is characterized by comprising the following raw materials in parts by weight:
main materials: 0.1 to 0.6 part of povidone K, 0.5 to 1 part of zinc gluconate, 0.1 to 0.5 part of sucralose, 10 to 30 parts of calcium hydrophosphate, 10 to 30 parts of L-calcium lactate, 40 to 90 parts of D-mannitol, 0.001 to 0.01 part of folic acid, 0.01 to 0.04 part of D-calcium pantothenate, 0.1 to 0.2 part of nicotinamide, 0.01 to 0.03 part of vitamin B, 0.001 to 0.01 part of vitamin B, 13 to 35 parts of lactose, 0.04 to 0.07 part of vitamin D3 powder and 0.02 to 0.06 part of vitamin A acetate dry powder;
auxiliary materials: 1-4 parts of strawberry essence and 1-4 parts of magnesium stearate;
in the preparation process of the multivitamin calcium zinc chewable tablet, the main material is firstly granulated to respectively prepare a main material I, a main material II and vitamins, and the specific granulating process comprises the following steps:
taking povidone K30, zinc gluconate, sucralose, calcium hydrophosphate, L-calcium lactate, vitamin B12 and D-mannitol, uniformly mixing, granulating by a wet method, and taking a main material I;
taking povidone K30, folic acid, D-calcium pantothenate, vitamin B1, vitamin B2 and vitamin B6, uniformly mixing, granulating by a dry method, and preparing a main material II;
mixing lactose, nicotinamide, vitamin D3 powder and vitamin A acetate dry powder, and granulating by a dry method to obtain vitamins;
the preparation method of the nicotinamide comprises the following steps:
1) Adding 3-cyanopyridine into ethanol, adding sodium tetraborate, then dropwise adding ammonia water with the concentration of 28wt%, carrying out hydrolysis reaction, and adding seed crystals for crystallization to obtain a nicotinamide crude product;
the molar ratio of the 3-cyanopyridine, the sodium tetraborate and the ammonia water is 1:0.4 to 0.6:0.5 to 0.8;
the weight-volume ratio of 3-cyanopyridine to ethanol is 1g: 1.2-1.4 mL;
the temperature of the hydrolysis reaction is 80-95 ℃;
the specific chemical reaction formula is as follows:
2) Adjusting the pH value of the glycerol-water mixed solution to 6.8-7.2, adding a nicotinamide crude product, stirring for dissolution, filtering to remove trace insoluble substances, and decolorizing and crystallizing to obtain the nicotinamide;
the glycerol-water mixed solution is prepared by mixing the components in a volume ratio of 2-3: 1 is obtained by mixing glycerol and water;
the weight volume ratio of the nicotinamide crude product to the glycerol-water mixed solution is 1g: 2.5-3 mL;
the temperature of stirring is 30-35 ℃ and the time is 2-3 h.
2. The method for preparing the multivitamin calcium zinc chewable tablet according to claim 1 is characterized in that the preparation method comprises the steps of uniformly mixing a main material I, a main material II, vitamins and auxiliary materials, and tabletting to obtain the multivitamin calcium zinc chewable tablet.
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| GB563184A (en) * | 1942-08-28 | 1944-08-02 | Pyridium Corp | Improvements in processes for preparing nicotinic acid amide |
| CN104592106A (en) * | 2014-10-23 | 2015-05-06 | 华中药业股份有限公司 | Improvement preparation method of nicotinamide |
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