CN112715952A - Multi-vitamin calcium self-emulsifying composition and preparation method of preparation thereof - Google Patents

Multi-vitamin calcium self-emulsifying composition and preparation method of preparation thereof Download PDF

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CN112715952A
CN112715952A CN201911041061.1A CN201911041061A CN112715952A CN 112715952 A CN112715952 A CN 112715952A CN 201911041061 A CN201911041061 A CN 201911041061A CN 112715952 A CN112715952 A CN 112715952A
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calcium
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梅兴国
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Hubei Zhenao Pharmaceutical Research Institute Co ltd
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A—HUMAN NECESSITIES
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
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    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

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Abstract

The invention discloses a multivitamin and calcium self-emulsifying composition and a preparation method of a preparation thereof. The composition of the present invention comprises effective amounts of calcium, vitamins, an oil phase, an emulsifier, a co-emulsifier, and is in solid form. The composition comprises fat-soluble vitamins and water-soluble calcium. The composition of the invention can spontaneously self-emulsify in vivo and in vitro when meeting water to form highly uniformly dispersed self-emulsifying liquid, can improve the solubility and bioavailability of the self-emulsifying liquid and promote the absorption of calcium and vitamins. The three-dimensional calcium self-emulsifying granular composition of the present invention is useful as a dietary supplement, a vitamin and calcium supplement, or a therapeutic agent for patients with significant signs of calcium deficiency and vitamin deficiency. The composition of the invention has the advantages of convenient taking, stable storage, high bioavailability, quick absorption for supplementing calcium and vitamins, and the like.

Description

Multi-vitamin calcium self-emulsifying composition and preparation method of preparation thereof
Technical Field
The invention relates to the field of calcium and vitamin supplementing nutritional food, health-care food or medicine. More particularly, the invention relates to a preparation method of a multivitamin and calcium self-emulsifying composition.
Background
Calcium is one of the important nutrient elements of human body, is the most abundant mineral element of human body, and has very important physiological function. In the current calcium replenisher, calcium carbonate is low in price, high in calcium content and safe to use, so that the calcium replenisher becomes a preferred raw material for the calcium replenisher at home and abroad. However, calcium carbonate is an insoluble inorganic compound, is weakly alkaline, and reacts with gastric acid in vivo to release Ga2+But the calcium is absorbed by human body, but the solution in gastric juice is limited, and a large amount of gastric acid is consumed to cause the problems of dyspepsia, abdominal distension and the like after long-term administration, and the calcium is not ideal to be absorbed by achlorhydria and is difficult to be absorbed in human body. At present, other water-soluble calcium agents, vitamin D3, vitamin K2 and the like are mixed together, wherein the vitamin D3 can promote the absorption of intestinal calcium and induce the bone calcium deposition; vitamin K2 promotes the generation of bone protein, and then generates bone together with calcium to increase bone density and prevent fracture. Both vitamins can promote the absorption and metabolism of calcium, so that the calcium enters bone tissues and is fully utilized. However, at present, both the orally taken vitamin D3 and vitamin K2 are fat-soluble substances, have low solubility in the digestive tract and low bioavailability, and cannot fully exert the effect of promoting the absorption and utilization of calcium in the body. Therefore, the invention designs a compound preparation which can increase the water solubility of calcium and the emulsibility of vitamin D3 and vitamin K2, the preparation can effectively increase the bioavailability of the vitamin and calcium preparation and form a multi-vitamin calcium mixed preparation, and the multi-vitamin calcium self-emulsifying agent composition, the preparation method and the application thereof are invented.
Disclosure of Invention
The invention aims to provide a multivitamin calcium self-emulsifying composition and a preparation method of a preparation thereof, and solves the problems of slow absorption and low bioavailability of a vitamin supplementing agent of an oral calcium supplementing agent sold on the market at present.
The invention solves the technical problem by the following scheme:
1. the invention discloses a multi-vitamin calcium self-emulsifying composition, which comprises fat-soluble vitamins, a water-soluble calcium agent, an oil phase, an emulsifier and an auxiliary emulsifier. The fat-soluble vitamin in the composition promotes the absorption of the water-soluble calcium agent, and simultaneously the composition is prepared into a self-emulsifying system which can spontaneously form self-emulsifying emulsion with the particle size of less than or equal to 500nm under the action of water in vivo and in vitro so as to promote the absorption of calcium and vitamin.
2. The fat-soluble vitamins are vitamin D3 and vitamin K2.
3. The water-soluble calcium agent is one or more of calcium acetate, calcium vitamin, calcium lactate and calcium gluconate.
4. The oil phase is ethyl oleate, oleic acid, medium chain triglyceride, soybean oil, palm oil and olive oil, and preferably is ethyl oleate.
5. The emulsifier is polyoxyethylene 40 hydrogenated castor oil, fatty glyceride, fatty sorbitan (span) and polysorbate (Tween), and the polyoxyethylene 40 hydrogenated castor oil is preferred.
6. The auxiliary emulsifier is glycerol, ethanol, n-butanol, ethylene glycol, propylene glycol and polyglycerol ester, and preferably glycerol and ethanol.
7. The composition provided by the invention comprises a water-soluble calcium agent component and a fat-soluble vitamin self-emulsifying component, wherein the weight percentages of the components are as follows: the water-soluble calcium agent comprises the following components: the fat-soluble vitamin self-emulsifying component (3-40): 1-25).
8. The invention discloses a multi-vitamin calcium self-emulsifying composition and a preparation method of a preparation thereof, and is characterized in that the weight percentage of each component in a calcium agent formula is as follows:
Figure BDA0002250906310000021
the formula of the multi-vitamin self-emulsifying composition is characterized in that the weight percentage of each component formula in the formula of the fat-soluble vitamin self-emulsifying agent is as follows:
Figure BDA0002250906310000022
9. the preparation method of the multi-vitamin self-emulsifying preparation comprises the following steps:
1) the raw materials in the formula of the calcium preparation are uniformly mixed, a proper amount of water is added to prepare a soft material, the soft material is sieved by a 14-mesh sieve to prepare particles, the particles are dried for 2 hours at 40 ℃, and the calcium preparation particles are obtained after the particles are sized.
2) Weighing a proper amount of raw materials, adding a mixed emulsifier, an auxiliary emulsifier and ethyl oleate according to the prescription amount, and uniformly mixing at 37-40 ℃ to obtain a uniform vitamin D3, vitamin K2 and vitamin C self-microemulsion concentrated solution. Weighing appropriate amount of mannitol according to the proportion that 1-8g of mannitol adsorbs 0.4-1.2g of self-microemulsion concentrated solution, and adding the self-microemulsion concentrated solution into the mannitol while stirring uniformly. Adding a small amount of water to prepare a soft material, sieving with a 14-mesh sieve to prepare granules, drying at 40-60 ℃ for 2h, and finishing granules to obtain the vitamin self-emulsifying granules.
3) Uniformly mixing the particles obtained in the steps 1) and 2) according to the ratio of (3-10) to (1-6) to make the content of vitamins and calcium meet the physiological supplement dosage, and preparing into particles, namely the multivitamin calcium self-emulsifying granules.
10. According to the invention, the composition can be prepared into granules, common tablets, powder, dispersible tablets, chewable tablets, capsules, soft capsules and dry suspensions.
11. The composition can be food, health-care products, health-care food or medicines.
12. The application of the multi-vitamin calcium self-emulsifying composition can effectively increase the absorption of vitamins and calcium, improve the bioavailability of the vitamins and the calcium and promote the utilization efficiency of calcium by organisms. Suitable for children, women, adults and the elderly.
The invention at least comprises the following beneficial effects:
1. the multi-vitamin calcium self-emulsifying composition exists in a particle form, a self-emulsifying system is formed in vivo spontaneously, the solubility of vitamin D3 and vitamin K2 is increased, and the absorption of vitamins is promoted.
2. The formation of a vitamin self-emulsifying system can increase the miscibility of vitamins, wherein the vitamin D3 and the vitamin K2 can promote the absorption and metabolism of calcium, increase the calcium ions in vivo and improve the bioavailability of the calcium.
Additional advantages, objects, and features of the invention will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the invention.
Drawings
FIG. 1 is a graph showing the effect of a water-soluble calcium agent granule solution (calcium acetate) in test example 1 of the present invention;
FIG. 2 is a graph showing the effect of a fat-soluble vitamin self-emulsifying solution in test example 2 of the present invention;
FIG. 3 is a graph showing a distribution of the particle diameters of self-emulsified particles detected in test example 5 of the present invention;
Detailed Description
The present invention is further described in detail below with reference to examples so that those skilled in the art can practice the invention with reference to the description, but the present invention is not limited thereto.
Example 1:
in the multi-vitamin calcium self-emulsifying composition, the weight ratio of each component in the prescription is as follows:
Figure BDA0002250906310000041
the preparation method comprises the following steps: mixing the raw materials in the formula of the calcium preparation uniformly, adding a proper amount of water to prepare a soft material, sieving with a 14-mesh sieve to prepare granules, drying at 40-60 ℃ for 2 hours, and finishing granules to obtain the calcium preparation component. Weighing a proper amount of raw materials, adding a mixed emulsifier, an auxiliary emulsifier and ethyl oleate according to the prescription amount, and uniformly mixing at 37-40 ℃ to obtain a uniform vitamin D3, vitamin K2 and vitamin A self-microemulsion concentrated solution. Weighing appropriate amount of mannitol according to the proportion that 1g of mannitol adsorbs 0.4g of self-microemulsion concentrated solution, adding the self-microemulsion concentrated solution into the mannitol while stirring uniformly. Adding small amount of water to make soft mass, sieving with 14 mesh sieve to obtain granule, drying at 40-60 deg.C for 2 hr, and grading to obtain self-emulsifying component. Mixing calcium agent component particles and self-emulsifying component particles uniformly according to a ratio of 3:1 to make the contents of vitamins and calcium meet physiological supplement dosage, and preparing into particles, namely the three-dimensional calcium self-emulsifying granules.
Example 2:
in the multi-vitamin calcium self-emulsifying agent composition, the weight ratio of each component in the prescription is as follows:
Figure BDA0002250906310000042
Figure BDA0002250906310000051
adding water, mixing, granulating with 14 mesh sieve, drying at 50 deg.C, and grading with 20 mesh sieve. 2.6g of the particles were placed in a beaker, and 15mL of water was added under magnetic stirring to completely dissolve the particles by self-emulsification, and blue opalescence was observed.
Example 3:
in the multi-vitamin calcium self-emulsifying agent composition, the weight ratio of each component in the prescription is as follows:
Figure BDA0002250906310000052
mixing 30% ethanol, 95% ethanol, and anhydrous ethanol with the self-emulsifying preparation as wetting agent, and granulating. Granulating with 14 meshes, drying at 50 ℃, and finishing with 20 meshes. The particles prepared by absolute ethyl alcohol are stirred by magnetic force at 37 ℃, and then water is added to the particles for self-emulsification and dissolution.
Test example 1:
the prepared water-soluble calcium granule solution (calcium acetate) is shown in figure 1:
test example 2:
the prepared fat-soluble vitamin self-emulsifying solution is shown in figure 2:
test example 3:
weighing 1g of solid powder in a 10ml small beaker, dropwise adding the self-emulsified diluted liquid into the beaker until no visible liquid drop exists on the surface of the powder, and recording the consumption of the self-emulsified liquid. As shown in table 1.
TABLE 1 degree of adsorption of solid support
Figure BDA0002250906310000061
From table 1, it can be seen that the water-insoluble material has a stronger adsorption capacity than the water-soluble adsorption material, and the microcrystalline cellulose has a better adsorption performance and has less influence on the self-emulsifying effect after adsorption, so that the microcrystalline cellulose is selected to solidify the self-emulsifying liquid.
Test example 4:
weighing 30g of each 6 parts of drug-containing SEDDS, respectively adding 300ml of purified water, stirring at room temperature to obtain uniform emulsion, then respectively adding 30g, 60g, 90g, 120g, 150g and 180g of microcrystalline cellulose in different amounts to enable the ratio to be 1:1, 2:1, 3:1, 4:1, 5:1 and 6:1, and uniformly stirring. The setting parameters of the WBF-2G fluidized bed are as follows: the air inlet temperature is 115 ℃, the rotating speed is 5r/min, the flow rate is 30Hz, and the air outlet temperature is 80 ℃. The spray was dried as described above and the spray drying was examined. The results are shown in Table 2.
Table 2: selection result of solid carrier microcrystalline cellulose and SEDDS ratio
Figure BDA0002250906310000071
Selecting a solid carrier and a self-emulsifying medicine-carrying system in a ratio of 4:1, and carrying out spray drying to obtain solid self-emulsifying powder with better fluidity.
Test example 5:
and (3) self-emulsifying effect determination: the self-emulsifying agent is dissolved in water according to the formula to generate self-emulsifying effect, and the particle size is determined by a modern particle size instrument and meets the particle size required by emulsified particles, which indicates that the self-emulsifying is successful. The results of the test are shown in FIG. 3 (particle size 68.76 nm):
the above self-emulsifying formulation:
blank prescription: ethyl oleate, tween 80, glycerol 30, 56 and 14
Medicine carrying prescription: ethyl oleate Tween 80, glycerol K2Oil D3＝30:56:14:7:0.001
While embodiments of the invention have been described above, it is not limited to the applications set forth in the description and the embodiments, which are fully applicable to various fields of endeavor for which the invention may be embodied with additional modifications as would be readily apparent to those skilled in the art, and the invention is therefore not limited to the details given herein and to the examples or experimental embodiments shown and described without departing from the generic concept as defined by the claims and their equivalents.

Claims (10)

1. A self-emulsifying composition of multi-vitamin calcium is characterized in that the composition comprises fat-soluble vitamins, a water-soluble calcium agent, an oil phase, an emulsifier and an auxiliary emulsifier. It can react with water in vivo and in vitro to form self-emulsifying emulsion with particle size less than or equal to 500nm to form self-emulsifying system with high homogeneous dispersion, and promote the absorption of calcium and vitamins.
2. The multivitamin calcium self-emulsifying composition according to claim 1, wherein the fat-soluble vitamins are vitamin D3 and vitamin K2.
3. The multivitamin calcium self-emulsifying composition according to claim 1, wherein the water-soluble calcium agent is one or more of calcium acetate, calcium vitamin, calcium lactate and calcium gluconate.
4. The multi-vitamin calcium self-emulsifying composition of claim 1, wherein the oil phase is ethyl oleate, oleic acid, medium chain triglycerides, soybean oil, palm oil, olive oil, preferably ethyl oleate.
5. The self-emulsifying composition of calcium ascorbate according to claim 1, wherein the emulsifier is polyoxyethylene 40 hydrogenated castor oil, fatty acid glyceride, fatty acid sorbitan (span), polysorbate (tween), preferably polyoxyethylene 40 hydrogenated castor oil.
6. The self-emulsifying composition of multi-vitamin calcium as claimed in claim 1, wherein the co-emulsifier is glycerin, ethanol, n-butanol, ethylene glycol, propylene glycol, polyglycerol ester, preferably glycerin, ethanol.
7. The multivitamin calcium self-emulsifying composition according to claim 1, wherein the composition is divided into a water-soluble calcium agent component and a fat-soluble vitamin self-emulsifying component, and the weight percentages of the components are as follows: the water-soluble calcium agent comprises the following components: the fat-soluble vitamin self-emulsifying component (3-40): 1-25).
8. The multivitamin calcium self-emulsifying composition according to claim 1, wherein the preparation method comprises the following steps:
1) preparing water-soluble calcium granules;
2) preparing fat-soluble vitamin self-emulsifying particles;
3) mixing the two kinds of particles in proportion to prepare the multi-vitamin calcium self-emulsifying agent particle composition.
9. The multivitamin calcium self-emulsifying composition of claim 1, which can be prepared into granules, common tablets, powders, dispersible tablets, chewable tablets, capsules, soft capsules, dry suspensions.
10. The self-emulsifying composition of claim 1, wherein the composition is formulated as a food, nutraceutical, or pharmaceutical product.
CN201911041061.1A 2019-10-29 2019-10-29 Multi-vitamin calcium self-emulsifying composition and preparation method of preparation thereof Pending CN112715952A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115211518A (en) * 2022-07-08 2022-10-21 湖北人缘堂医药生物工程有限公司 Instant self-emulsifying eye-protecting solid beverage and production method thereof

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US20050037073A1 (en) * 2000-01-13 2005-02-17 Alpharx Inc. Solid self-emulsifying dosage form for improved delivery of poorly soluble hydrophobic compounds and the process for preparation thereof
CN1823743A (en) * 2005-12-26 2006-08-30 沈阳药科大学 Self emulsified osmotic pump controlled release administration system of liposoluble medicine and its preparation technology
CN1903228A (en) * 2006-07-03 2007-01-31 李颖 Prepn. of self-emulsion of glossy ganoderma spore oil, and its prepn. method
US20100247632A1 (en) * 2009-03-24 2010-09-30 Dong Liang C Stabilized solubility-enhanced formulations for oral delivery
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CN103142568A (en) * 2013-03-11 2013-06-12 昆明邦宇制药有限公司 Calcium acetate-vitamin K pharmaceutical preparation and preparation method thereof
CN105616441A (en) * 2014-11-05 2016-06-01 澳美制药厂有限公司 Calcium carbonate vitamin d3 tablet and preparation method thereof
CN105768109A (en) * 2016-02-25 2016-07-20 李宏 Vitamin D and calcium-containing microemulsion as well as preparation method and application thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050037073A1 (en) * 2000-01-13 2005-02-17 Alpharx Inc. Solid self-emulsifying dosage form for improved delivery of poorly soluble hydrophobic compounds and the process for preparation thereof
CN1461641A (en) * 2002-05-28 2003-12-17 谭攸恒 Calcium supplementing agent and its prepn. method
CN1823743A (en) * 2005-12-26 2006-08-30 沈阳药科大学 Self emulsified osmotic pump controlled release administration system of liposoluble medicine and its preparation technology
CN1903228A (en) * 2006-07-03 2007-01-31 李颖 Prepn. of self-emulsion of glossy ganoderma spore oil, and its prepn. method
US20100247632A1 (en) * 2009-03-24 2010-09-30 Dong Liang C Stabilized solubility-enhanced formulations for oral delivery
CN102552139A (en) * 2012-03-15 2012-07-11 浙江工业大学 Oligomeric proantho cyanidins self-emulsifying system composition and application thereof
CN103142568A (en) * 2013-03-11 2013-06-12 昆明邦宇制药有限公司 Calcium acetate-vitamin K pharmaceutical preparation and preparation method thereof
CN105616441A (en) * 2014-11-05 2016-06-01 澳美制药厂有限公司 Calcium carbonate vitamin d3 tablet and preparation method thereof
CN105768109A (en) * 2016-02-25 2016-07-20 李宏 Vitamin D and calcium-containing microemulsion as well as preparation method and application thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115211518A (en) * 2022-07-08 2022-10-21 湖北人缘堂医药生物工程有限公司 Instant self-emulsifying eye-protecting solid beverage and production method thereof

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