CN112370429A - Direct-compression type organic calcium vitamin D3 chewable tablet and preparation method thereof - Google Patents

Direct-compression type organic calcium vitamin D3 chewable tablet and preparation method thereof Download PDF

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CN112370429A
CN112370429A CN201911001903.0A CN201911001903A CN112370429A CN 112370429 A CN112370429 A CN 112370429A CN 201911001903 A CN201911001903 A CN 201911001903A CN 112370429 A CN112370429 A CN 112370429A
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calcium
parts
vitamin
chewable tablet
organic calcium
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程彦
邓颖妍
张晓洁
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Guangzhou Funuo Nutrition Technology Co ltd
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Guangzhou Funuo Nutrition Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K31/185—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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis

Abstract

The invention belongs to the technical field of health-care product production, and particularly relates to a direct-compression organic calcium vitamin D3 chewable tablet and a preparation method thereof. The vitamin tablet mainly comprises vitamin D3, calcium citrate, L-calcium lactate, D-mannitol, microcrystalline cellulose, anhydrous glucose, polyethylene glycol 6000, sucralose, magnesium stearate and an absorption enhancer. The calcium-containing vitamin tablet disclosed by the invention uses organic acid calcium, has small irritation to gastrointestinal tracts and higher solubility and absorptivity; the vitamin D3 is used in combination with polydextrose, calcium citrate and L-calcium lactate, and is beneficial for absorption and utilization of calcium, and the vitamin D3 can prevent rickets in infants and osteomalacia in adults; the invention adopts a direct compression method to produce the vitamin tablets, and the preparation method is simple.

Description

Direct-compression type organic calcium vitamin D3 chewable tablet and preparation method thereof
Technical Field
The invention belongs to the technical field of health-care product production, and particularly relates to a direct-compression organic calcium vitamin D3 chewable tablet and a preparation method thereof.
Background
Calcium is the most abundant mineral element in human body, and accounts for 1.5% -2.0% of the body weight, and the total weight reaches 1200-1300g, wherein 99% of calcium exists in bones and teeth to form a human body scaffold and serve as a calcium reservoir of the body; the rest are distributed in blood, extracellular fluid and soft tissue cells, collectively called the miscible calcium pool, and maintain dynamic balance with bone calcium. Basically, all life processes of the organism require the participation of calcium, and the balance of calcium metabolism is an important factor for maintaining life and health. Calcium plays an extremely important role in physiological regulation in physiological processes such as nerve and muscle stress, nerve impulse conduction, heart rhythm maintenance, blood coagulation, cell adhesion and the like, and a plurality of diseases can be caused by calcium deficiency of a human body.
1) Calcium deficiency of pregnant women: when the fetus grows to a term infant from a fertilized egg, a large amount of nutrient substances need to be taken from the mother, calcium is taken from the mother every moment in the development process of the fetus so as to meet the growth and development requirements of the fetus, and when the mother is in a calcium deficiency state, the calcium required by the fetus only can use the calcium in the bone of the mother, so that the osteoporosis of the pregnant woman is caused. The early symptom of calcium deficiency in pregnant women is leg cramps. The lack of calcium in pregnant women can also cause pregnancy-induced hypertension syndrome, three main symptoms of edema, hypertension and proteinuria, and serious lack of calcium can cause eclampsia and endanger life.
The calcium deficiency of multiparous women is more serious, the osteoporosis becomes more and more serious after multiple pregnancies, besides the symptoms of lumbocrural pain, dwarfing, hunchback, easy fracture and the like, the pelvis of the multiparous women is deformed due to osteomalacia, and the fetus cannot be normally delivered, but can be delivered by a caesarean delivery mode. The common symptoms of puerperal hypodynamia, dizziness, body pain, even difficult turnover and the like are the manifestations of calcium deficiency. When the mother is seriously deficient in calcium, the fetus may suffer from congenital rickets after birth.
2) Calcium deficiency of children and teenagers: the calcium deficiency of children is manifested by thin hair, yellow hair, alopecia occipitalis, night convulsion, late teeth, late learning to walk, and weakness and sickliness. Susceptible to tetany, common cold, tracheitis, eczema, myopia, dental caries, osteodynia, enterospasm, abdominal pain, and hyperkinetic syndrome; rickets can be caused by serious calcium deficiency. Rickets caused by calcium deficiency of children, such as rachitis bone deformation, beading, chicken breast, humpback, scoliosis, X-shaped leg and O-shaped leg, may remain for a lifetime. Calcium deficiency in adolescent male and female can lead to poor bone growth, listlessness, energy deficiency, leg cramp, bone deformation left by rickets in children, mental disorder, inferior, autism and even adolescent psychosis.
3) Calcium deficiency in the elderly: the middle-aged and the elderly are easy to suffer from osteoporosis, hyperosteogeny, scapulohumeral periarthritis and other diseases due to calcium deficiency. Calcium deficiency induced tissue sclerosis can lead to calculus, arteriosclerosis, etc. The symptoms presented differ from one arteriosclerosis to another: systemic vascular arteriosclerosis can lead to hypertension; cerebral arteriosclerosis, which may cause epilepsy, Parkinson's syndrome and even senile dementia; pancreatic arteriosclerosis is not beneficial to the secretion of insulin, so that blood sugar is increased, and diabetes is induced; coronary arteriosclerosis, which nourishes myocardium, can cause myocardial ischemia, coronary heart disease, paroxysmal pain, chest distress and breath holding in precordial region, and death due to myocardial infarction and cardiogenic shock in severe cases.
Because the grain and vegetable are taken as staple food in China, the phytic acid, oxalic acid and tannic acid in the grain and vegetable can inhibit calcium absorption; in addition, the cooking mode of daily food, irregular life of modern people and the three-high eating habits of high protein, high fat and high carbohydrate lead to the general shortage of the calcium intake of human bodies. Chinese nutrition survey shows that the intake of national calcium is generally low, about 400-500mg each day, and only reaches about 50% of recommended amount. Calcium should be reasonably supplemented to maintain health, especially for infants, children, the elderly, pregnant women, lactating women and climacteric women. Therefore, the calcium supplement health care product becomes one of the health care products with huge consumption.
The patent publication No. 20101003243.8 discloses a method for preparing vitamin D calcium soft capsules, which comprises calcium carbonate powder, vitamin D3, soybean salad oil, soybean lecithin, beeswax and other raw materials, and the prepared vitamin D calcium soft capsules can increase the absorption of calcium and vitamin D in human body. However, the vitamin D calcium soft capsule has a stimulating effect on the stomach and can influence the absorption of other substances.
At present, calcium supplement health care products in the market have the problems of low solubility and absorptivity, unreasonable daily intake design, general product orientation to people and the like.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention aims to provide a direct-compression organic calcium vitamin D3 chewable tablet and a preparation method thereof. The vitamin D3 chewable tablet provided by the invention has small irritation to intestinal tracts and higher solubility and absorptivity, and is beneficial to absorption and utilization of calcium.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a direct-compression organic calcium vitamin D3 chewable tablet mainly comprises the following components in parts by weight: 90-130 parts of organic calcium, 25-45 parts of binder, 1-10 parts of anhydrous glucose, 10-30 parts of D-mannitol, 60001-10 parts of polyethylene glycol, 35-25 parts of vitamin D, 0.5-1.5 parts of absorption enhancer, 1-9 parts of sucralose and 0.5-2 parts of magnesium stearate.
Further, the direct compression type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 114 parts of organic calcium, 34 parts of binder, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 1 part of absorption enhancer, 5 parts of sucralose and 1.62 parts of magnesium stearate.
Furthermore, the organic calcium consists of L-calcium lactate and calcium citrate according to the weight ratio of 4-6: 5-7.
Furthermore, the organic calcium consists of L-calcium lactate and calcium citrate according to the weight ratio of 5: 6.4.
Further, the binder is microcrystalline cellulose, and the absorption promoter is polydextrose.
The invention also provides a preparation method of the direct pressure type organic calcium vitamin D3 chewable tablet, which comprises the following steps:
s1, removing the outer package of organic calcium, binder, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, absorption promoter, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and an absorption promoter into a three-dimensional mixer, mixing at the motor frequency of 25-30Hz for 5 minutes, adding organic calcium, a binder, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
The calcium citrate and the L-calcium lactate are used for providing calcium, and both are organic calcium, so that the calcium citrate and the L-calcium lactate are more favorable for digestion and absorption than inorganic calcium, have small irritation to intestinal tracts, and are favorable for children, old people, pregnant women and other people to eat.
As the calcium citrate is in a fine powder shape, the problems of excessive whole fine powder of the material, poor material flowability, low cohesive force, substandard hardness and friability and the like are caused. The addition of the L-calcium lactate not only provides a plurality of organic calcium substances, but also improves the material fluidity and reduces the fine powder amount; the compressibility of the material can be improved by adopting the D-mannitol, the good compressibility also increases the binding power among the materials, the hardness of the chewable tablet is improved together with the microcrystalline cellulose serving as a binding agent, and meanwhile, the D-mannitol has no granular feeling, can absorb heat when dissolved in the mouth and generates cool feeling; the use of a small amount of polyethylene glycol 6000 can improve the hardness and friability of the chewable tablet, and can also improve the surface brightness of the chewable tablet and improve the appearance and the feeling of the chewable tablet. The use of the main raw materials and auxiliary materials can ensure that the hardness and friability of the chewable tablets are qualified, and meanwhile, the chewable tablets cannot mechanically damage a machine, so that the expanded production is facilitated. The water-soluble dietary fiber polydextrose can further promote the absorption of calcium.
Compared with the prior art, the direct-compression organic calcium vitamin D3 chewable tablet provided by the invention has the following advantages:
(1) at present, the calcium vitamin D health food is mainly applied to inorganic calcium carbonate mostly. Mainly because the inorganic calcium has high calcium content, low cost and simple and mature process, the absorption of the inorganic calcium needs gastric acid, the solubility and the absorption rate of the inorganic calcium are lower for people with weak or bad gastrointestinal tracts (such as children, old people, pregnant women and the like), and the stimulation effect on the gastrointestinal tracts is increased, so that the digestion and the absorption of other nutrient substances are influenced. The product uses organic calcium citrate and L-calcium lactate, the absorption of the organic calcium is not greatly related to the level of gastric acid, the irritation to gastrointestinal tract is small, the dissolubility and the absorption rate are higher, and the bioavailability of the calcium is improved.
(2) Vitamin D3 can be used in combination with polydextrose, calcium citrate and L-calcium lactate to facilitate absorption and utilization of calcium, and vitamin D3 can be used for preventing infantile rickets and osteomalacia of adults.
(3) Most of competitive product processes of the calcium vitamin D chewable tablets are granulation and tabletting, and the direct compression method production can be realized by adopting D-mannitol to assist microcrystalline cellulose through the combined use of organic calcium with different properties in the item.
(4) The direct-compression type calcium and vitamin D3 chewable tablet disclosed by the invention is a calcium and vitamin D chewable tablet which is easy to absorb and utilize, scientific in formula design and suitable for pregnant women and lactating women.
Drawings
Fig. 1 is a flow chart of the preparation process of the direct compression type organic calcium vitamin D3 chewable tablet.
Detailed Description
The present invention will be further described below by way of specific embodiments, but the present invention is not limited to only the following examples. Various modifications may be made by those skilled in the art based on the basic idea of the invention, but it is within the scope of the invention as long as it does not depart from the basic idea of the invention.
The preparation process of the chewing tablet of the embodiment, in which the straight-pressure type organic calcium vitamin D3 is shown in fig. 1, wherein, CCP 1: the pre-mixing time of the sucralose, the vitamin D3 and the absorption promoter is 5 minutes; the total mixing time of all materials is 20 minutes; CCP 2: sheet hardness: 230-250N; CCP 3: the bottled sealing performance is qualified; the gray stripe process is a waste dot.
Example 1A direct compression type chewable tablet containing organic calcium and vitamin D3
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 50 parts of calcium citrate, 40 parts of L-calcium lactate, 25 parts of microcrystalline cellulose, 1 part of anhydrous glucose, 10 parts of D-mannitol, 60001 parts of polyethylene glycol, 35 parts of vitamin D, 0.5 part of polydextrose, 1 part of sucralose and 0.5 part of magnesium stearate.
As shown in fig. 1, the preparation method of the direct compression type organic calcium vitamin D3 chewable tablet comprises the following steps:
s1, removing outer packages of calcium citrate, L-calcium lactate, microcrystalline cellulose, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, polydextrose, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and polydextrose into a three-dimensional mixer, mixing at the motor frequency of 25Hz for 5 minutes, adding calcium citrate, L-calcium lactate (pentahydrate), microcrystalline cellulose, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
Example 2A direct compression type chewable tablet containing organic calcium and vitamin D3
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 55 parts of calcium citrate, 45 parts of L-calcium lactate, 30 parts of microcrystalline cellulose, 3 parts of anhydrous glucose, 15 parts of D-mannitol, 60003 parts of polyethylene glycol, 310 parts of vitamin D, 0.7 part of polydextrose, 3 parts of sucralose and 0.9 part of magnesium stearate.
As shown in fig. 1, the preparation method of the direct compression type organic calcium vitamin D3 chewable tablet comprises the following steps:
s1, removing outer packages of calcium citrate, L-calcium lactate, microcrystalline cellulose, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, polydextrose, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and polydextrose into a three-dimensional mixer, mixing at the motor frequency of 27Hz for 5 minutes, adding calcium citrate, L-calcium lactate (pentahydrate), microcrystalline cellulose, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
Example 3A direct compression type chewable tablet containing organic calcium and vitamin D3
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 60 parts of calcium citrate, 50 parts of L-calcium lactate, 35 parts of microcrystalline cellulose, 5 parts of anhydrous glucose, 20 parts of D-mannitol, 60005 parts of polyethylene glycol, 315 parts of vitamin D, 0.9 part of polydextrose, 5 parts of sucralose and 1.3 parts of magnesium stearate.
As shown in fig. 1, the preparation method of the direct compression type organic calcium vitamin D3 chewable tablet comprises the following steps:
s1, removing outer packages of calcium citrate, L-calcium lactate, microcrystalline cellulose, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, polydextrose, sucralose and magnesium stearate, and irradiating under an ultraviolet lamp for 30 minutes;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and polydextrose into a three-dimensional mixer, mixing at the motor frequency of 28Hz for 5 minutes, adding calcium citrate, L-calcium lactate (pentahydrate), microcrystalline cellulose, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
Example 4A direct compression type chewable tablet containing organic calcium and vitamin D3
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 65 parts of calcium citrate, 55 parts of L-calcium lactate, 40 parts of microcrystalline cellulose, 7 parts of anhydrous glucose, 25 parts of D-mannitol, 60007 parts of polyethylene glycol, 320 parts of vitamin D, 1 part of polydextrose, 7 parts of sucralose and 1.7 parts of magnesium stearate.
As shown in fig. 1, the preparation method of the direct compression type organic calcium vitamin D3 chewable tablet comprises the following steps:
s1, removing outer packages of calcium citrate, L-calcium lactate, microcrystalline cellulose, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, polydextrose, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and polydextrose into a three-dimensional mixer, mixing at the motor frequency of 29Hz for 5 minutes, adding calcium citrate, L-calcium lactate (pentahydrate), microcrystalline cellulose, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
Example 5A direct compression type chewable tablet containing organic calcium and vitamin D3
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 70 parts of calcium citrate, 60 parts of L-calcium lactate, 45 parts of microcrystalline cellulose, 10 parts of anhydrous glucose, 30 parts of D-mannitol, 600010 parts of polyethylene glycol, 325 parts of vitamin D, 1.5 parts of polydextrose, 9 parts of sucralose and 2 parts of magnesium stearate.
As shown in fig. 1, the preparation method of the direct compression type organic calcium vitamin D3 chewable tablet comprises the following steps:
s1, removing outer packages of calcium citrate, L-calcium lactate, microcrystalline cellulose, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, polydextrose, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and polydextrose into a three-dimensional mixer, mixing at the motor frequency of 30Hz for 5 minutes, adding calcium citrate, L-calcium lactate (pentahydrate), microcrystalline cellulose, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
Example 6A direct compression type chewable tablet containing organic calcium and vitamin D3
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 64 parts of calcium citrate, 50 parts of L-calcium lactate, 34 parts of microcrystalline cellulose, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 1 part of polydextrose, 5 parts of sucralose and 1.62 parts of magnesium stearate.
As shown in fig. 1, the preparation method of the direct compression type organic calcium vitamin D3 chewable tablet comprises the following steps:
s1, removing outer packages of calcium citrate, L-calcium lactate, microcrystalline cellulose, anhydrous glucose, D-mannitol, polyethylene glycol 6000, vitamin D3, polydextrose, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and polydextrose into a three-dimensional mixer, mixing at the motor frequency of 30Hz for 5 minutes, adding calcium citrate, L-calcium lactate (pentahydrate), microcrystalline cellulose, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
Comparative example 1, a direct compression type organic calcium vitamin D3 chewable tablet
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 114 parts of calcium citrate, 34 parts of microcrystalline cellulose, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 1 part of polydextrose, 5 parts of sucralose and 1.62 parts of magnesium stearate.
The preparation method of the direct pressure type organic calcium vitamin D3 chewable tablet is similar to example 6.
The difference from example 6 is that the organic calcium is entirely calcium citrate.
Comparative example 2, a direct compression type organic calcium vitamin D3 chewable tablet
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 64 parts of calcium citrate, 50 parts of L-calcium lactate, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 1 part of polydextrose, 5 parts of sucralose and 1.62 parts of magnesium stearate.
The preparation method of the direct pressure type organic calcium vitamin D3 chewable tablet is similar to example 6.
The difference from example 6 is that microcrystalline cellulose was not added as a binder.
Comparative example 3, a direct compression type organic calcium vitamin D3 chewable tablet
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 64 parts of calcium citrate, 50 parts of L-calcium lactate, 34 parts of microcrystalline cellulose, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 5 parts of sucralose and 1.62 parts of magnesium stearate.
The preparation method of the direct pressure type organic calcium vitamin D3 chewable tablet is similar to example 6.
The difference from example 6 is that no absorption enhancer polydextrose is added.
Comparative example 4A direct compression calcium-added vitamin D3 chewable tablet
The direct pressure type organic calcium vitamin D3 chewable tablet comprises the following components in parts by weight: 114 parts of calcium carbonate, 34 parts of microcrystalline cellulose, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 1 part of polydextrose, 5 parts of sucralose and 1.62 parts of magnesium stearate.
The preparation method of the direct pressure type organic calcium vitamin D3 chewable tablet is similar to example 6.
The difference from example 6 is that the organic calcium material is entirely replaced by inorganic calcium carbonate.
Test example 1 calcium absorption Rate measurement experiment
Test samples: calcium-containing vitamin D3 chewable tablets prepared in examples 1-6 and comparative examples 1-4.
Test animals: 200 weaned SD rats born 21 days are half male and female, and have good health condition.
The test method comprises the following steps: after 4 days of adaptive feeding, the SD rats were randomly divided into 10 groups of 20 animals each. The animals were named as example 1 group-example 6 group, comparative example 1 group-comparative example 4 group, and SD rats were fed with a low calcium feed plus the calcium and vitamin D3 tablet prepared in the corresponding example, and the prepared calcium and vitamin D3 tablet was crushed and incorporated into the low calcium feed for feeding.
Calcium ions in the blood of SD rats were measured 0.5 hours after feeding (20 SD rats per group were randomly divided into 10 groups, 0.3ml of submandibular venous blood was collected after SD rats were anesthetized, blood was collected once for half an hour for 5 hours for one cycle), and the amount of increase in blood calcium (%) (blood calcium concentration-raw blood calcium concentration)/raw blood calcium concentration × 100% was calculated, and the time a when the increase in blood calcium started to exceed 2%, the maximum blood calcium increase B, the time B, and the time C when the increase in blood calcium was again lower than 2% (blood collection was stopped) were recorded, as shown in table 1.
TABLE 1 Calcemia parameters
Group of Time A/h Time B/h Increase B/%) Time C/h
Example 1 1.5 2.6 5.7 5.5
Example 2 1.5 2.5 5.5 5.5
Example 3 1.6 2.5 5.7 5.6
Example 4 1.5 2.7 5.4 5.4
Example 5 1.4 2.5 5.5 5.4
Example 6 1.3 2.4 6.0 6.1
Comparative example 1 2.3 3.8 3.5 3.8
Comparative example 2 2.6 3.6 3.8 4.0
Comparative example 3 2.5 4.1 3.9 3.1
Comparative example 4 3.0 5.0 3.0 3.3
As can be seen from Table 1, the chewing tablets of the direct compression type organic calcium vitamin D3 prepared in examples 1-6 of the present invention have faster calcium absorption rate and higher absorption amount, wherein example 6 has the fastest absorption speed and the largest absorption amount, and is the best example of the present invention. The formulations of comparative examples 1 to 4 were compositions of formulations changed based on the formulation of example 6, and it can be seen from table 1 that the absorption rate of calcium and the absorption amount of calcium were decreased.
Test example 2 quality test of directly-compressed organic calcium vitamin D3 chewable tablets
Test samples: calcium-containing vitamin D3 chewable tablets prepared in examples 1-6 and comparative examples 1-4.
The detection method comprises the following steps: the hardness and friability of the direct compression type organic calcium vitamin D3 chewable tablets prepared in examples 1-6 and comparative examples 1-4 are detected by referring to Chinese pharmacopoeia 2010 edition department II.
The test results are shown in table 2.
TABLE 2 quality test of direct compression type organic calcium vitamin D3 chewable tablets
Group of Hardness of Degree of friability
Example 1 Is moderate Qualified
Example 2 Is moderate Qualified
Example 3 Is moderate Qualified
Example 4 Is moderate Qualified
Example 5 Is moderate Qualified
Example 6 Is moderate Qualified
Comparative example 1 Is harder Fail to be qualified
Comparative example 2 Fail to be qualified Fail to be qualified
Comparative example 3 Is moderate Qualified
Comparative example 4 Is harder Fail to be qualified
As can be seen from Table 2, the direct-compression organic calcium vitamin D3 chewable tablet prepared by the invention has moderate hardness, and the friability accords with the regulations of Chinese pharmacopoeia.
Test example 3 vitamin D3 stability test in directly compressed organic calcium vitamin D3 chewable tablets
Test samples: calcium-containing vitamin D3 chewable tablets prepared in examples 1-6 and comparative examples 1-4.
The test method comprises the following steps: irradiating 50 chewable tablets of organic calcium vitamin D3 under 4000 lux daylight for 10 days, sampling at 4 th, 7 th and 10 th days, and measuring the residual rate of vitamin D3 before and after the test by using a high performance liquid chromatograph.
The results of the experiment are shown in table 3.
TABLE 3 vitamin D3 stability test
Figure BDA0002241599170000101
Figure BDA0002241599170000111
As can be seen from Table 3, the vitamin D3 residual rate of the direct compression type organic calcium vitamin D3 chewable tablet provided by the invention is more than 90% after being irradiated under 4000 lux daylight for 10 days, and the stability is higher, while the stability effect of D3 in the calcium-containing vitamin D3 chewable tablet prepared in comparative examples 1-4 is poorer, which indicates that the direct compression type organic calcium vitamin D3 chewable tablet provided by the invention has a reasonable formula, and each component has the function of mutually coordinating and enhancing the stability of vitamin D3.
It should be noted that the above-mentioned embodiments are only preferred embodiments of the present invention, and the present invention is not limited thereto, and although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications and equivalents can be made in the technical solutions described in the foregoing embodiments, or some technical features can be replaced. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (6)

1. The direct-compression type organic calcium vitamin D3 chewable tablet is characterized by comprising the following components in parts by weight: 90-130 parts of organic calcium, 25-45 parts of binder, 1-10 parts of anhydrous glucose, 10-30 parts of D-mannitol, 60001-10 parts of polyethylene glycol, 35-25 parts of vitamin D, 0.5-1.5 parts of absorption enhancer, 1-9 parts of sucralose and 0.5-2 parts of magnesium stearate.
2. The direct compression type organic calcium vitamin D3 chewable tablet according to claim 1, is characterized by comprising the following components in parts by weight: 114 parts of organic calcium, 34 parts of binder, 5 parts of anhydrous glucose, 23.38 parts of D-mannitol, 60004 parts of polyethylene glycol, 312 parts of vitamin D, 1 part of absorption enhancer, 5 parts of sucralose and 1.62 parts of magnesium stearate.
3. The direct compression type organic calcium vitamin D3 chewable tablet according to claim 1 or 2, wherein the organic calcium comprises L-calcium lactate and calcium citrate at a weight ratio of 4-6: 5-7.
4. The direct compression type organic calcium vitamin D3 chewable tablet according to claim 3, wherein the organic calcium comprises L-calcium lactate and calcium citrate at a weight ratio of 5: 6.4.
5. The direct compression type organic calcium vitamin D3 chewable tablet of claim 1, wherein the binder is microcrystalline cellulose and the absorption enhancer is polydextrose.
6. The method for preparing the direct compression type organic calcium vitamin D3 chewable tablet according to any one of claims 1 to 5, comprising the following steps:
s1, removing the outer package of organic calcium, binder, anhydrous glucose, D-mannitol, polyethylene glycol, vitamin D3, absorption enhancer, sucralose and magnesium stearate, and irradiating for 30 minutes under an ultraviolet lamp;
s2, sieving the D-mannitol with a 20-mesh sieve, and weighing the components according to the formula;
s3, adding sucralose, vitamin D3 and an absorption promoter into a three-dimensional mixer, mixing at the motor frequency of 25-30Hz for 5 minutes, adding organic calcium, a binder, anhydrous glucose, D mannitol, polyethylene glycol 6000 and magnesium stearate, and continuously mixing for 15 minutes;
s4, tabletting the uniformly mixed materials, bottling and sealing to obtain the finished product.
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