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CN103142641B - Calcium carbonate-vitamin K pharmaceutical preparation and preparation method thereof - Google Patents

Calcium carbonate-vitamin K pharmaceutical preparation and preparation method thereof Download PDF

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Publication number
CN103142641B
CN103142641B CN201310076599.2A CN201310076599A CN103142641B CN 103142641 B CN103142641 B CN 103142641B CN 201310076599 A CN201310076599 A CN 201310076599A CN 103142641 B CN103142641 B CN 103142641B
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vitamin
calcium carbonate
preparation
calcium
pharmaceutical preparation
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CN103142641A (en
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王冰
张永胜
刘晓凯
郑光明
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KUNMING BANGYU PHARMACEUTICAL CO Ltd
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KUNMING BANGYU PHARMACEUTICAL CO Ltd
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Abstract

The invention relates to a calcium carbonate-vitamin K pharmaceutical preparation and a preparation method thereof, belonging to the technical field of medicine. The calcium carbonate-vitamin K pharmaceutical preparation is prepared from 800-2800 parts by weight of calcium carbonate, 2-30 parts by weight of vitamin K and a right amount of auxiliary material, wherein the auxiliary material is selected from one or more of sucrose, microcrystalline cellulose, sodium carboxymethyl starch, micropowder silica gel, magnesium stearate, hydroxypropyl methylcellulose, talcum powder, lactose and mannitol. By using the scientific formula, the calcium carbonate-vitamin K pharmaceutical preparation can effectively supplement calcium, and is safe and convenient to take.

Description

A kind of calcium carbonate-vitamin K pharmaceutical preparation and preparation method thereof
Technical field
The present invention relates to medical art, be specifically related to a kind of calcium carbonate-vitamin K pharmaceutical preparation and preparation method thereof.
Background technology
Calcium is a kind of inorganic salt that people's in-vivo content is maximum, in normal human, the content of calcium accounts for the 0.5%-2.0% of human body weight, wherein the calcium of 99% is present among skeleton and tooth, the calcium great majority of 1% are present in soft tissue, extracellular fluid and blood in ionic condition, remain dynamic equilibrium with skeleton.Calcium has the normal reaction maintaining nerve, muscle, regulates heartbeat to keep heart alternately to shrink continuously and diastole, maintains the contraction of muscle and neururgic transmission isoreactivity.China resident, due to dietary habit problem, totally needs generally to carry out suitable replenishing the calcium, could ensure that resident is healthy better.Solve the problem of replenishing the calcium now, the general absorption rate adopting intake and the raising calcium increasing calcium.At present, calcium supplementing product is more, and the formula too complex wherein had also relates to supplementary various nutrient elements, and effect of supplemented calcium is not obvious; Some calcium supplementing product doses are too large, and are not easily absorbed by the body, and cause effect of supplemented calcium poor; Some calcium supplementing products also also exist the problems such as side effect is large.Therefore, it is obvious how developmental research goes out a kind of effect of supplemented calcium, and the calcium supplementing product taking safe ready becomes a technical problem being badly in need of solving.
Summary of the invention
The object of this invention is to provide a kind of calcium carbonate-vitamin K pharmaceutical preparation that a kind of effect of supplemented calcium is obvious, take safe ready.
Another object of the present invention is to provide a kind of preparation method of calcium carbonate-vitamin K pharmaceutical preparation.
The technical solution used in the present invention is a kind of calcium carbonate-vitamin K pharmaceutical preparation, it is made up of 800 ~ 2800 weight parts of calcium carbonate, 2 ~ 30 part by weight of vitamin K and appropriate amount of auxiliary materials, and wherein adjuvant to be selected from sucrose, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, hypromellose, Pulvis Talci, lactose or mannitol one or more.
As preferably, the present invention is made up of 1000 ~ 2500 weight parts of calcium carbonate, 5 ~ 25 part by weight of vitamin K and appropriate amount of auxiliary materials, and wherein adjuvant to be selected from sucrose, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, hypromellose, Pulvis Talci, lactose or mannitol one or more.
As preferably, the present invention is made up of 1200 ~ 2000 weight parts of calcium carbonate, 10 ~ 20 part by weight of vitamin K and appropriate amount of auxiliary materials, and wherein adjuvant to be selected from sucrose, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, hypromellose, Pulvis Talci, lactose or mannitol one or more.As preferably, described pharmaceutical preparation is tablet, capsule or granule.
As preferably, described tablet is conventional tablet, Film coated tablets or chewable tablet.
As preferably, described vitamin K is selected from vitamin K 1, vitamin K 2, vitamin K 3or vitamin K 4in one and any mixture.
Pharmaceutical preparation of the present invention can adopt customary preparation methods to prepare.And above-mentioned each raw material is made the preferred preparation method of pharmaceutical preparation of the present invention comprise the following steps: get calcium carbonate 1600g, vitamin K 36g, vitamin K 4then 6g is the dissolve with ethanol vitamin K of 95% by 30ml concentration 3, vitamin K 4, then add the dilution of 200ml purified water, obtain wetting agent for subsequent use.By calcium carbonate gained wetting agent soft material, granulate, under the condition of 50 DEG C, carry out drying, granulate, add magnesium stearate 3g mixing, use Capsules filling, to obtain final product.
Beneficial effect of the present invention is: (1) scientific formulation of the present invention is reasonable, and calcium carbonate provides calcium source for body; Vitamin K can regulate the deposition of calcium in bone matrix, can promote the reconstruction of bone and the mobilization of calcium.Both are used in conjunction with each other, and body can be made to absorb calcium carbonate more abundant, and effectively can deposit on skeleton, thus effectively increase bone density, reduce risk of bone fracture.(2) the present invention due to formula reasonable, in order to be effective while the consumption of reduction calcium source, thus the many discomforts because long-term, high-dose uses series products of replenishing the calcium to cause can be avoided, such as gastric mucosa damage, Calculus of digestive duct and urinary tract infringement etc.(3) the present invention is by short-period used, effectively can treat the osteoporosis because calcium deficiency causes and rickets, through routine clinical verification up to a hundred, safe and reliable, has no side effect.(4) the present invention is by adding appropriate adjuvant, meets preparation needs, thus can more meet sufferer demand.
For confirming effectiveness of the present invention, spy evaluates according to Ministry of Public Health " health food inspection and assessment technical specification ", and evaluation result is in table 1.
Experimental technique: get the SPF level female sd inbred rats 60 that body weight is 220-260g, with normal feedstuff adaptability feed after seven days, according to body weight, be divided into following six groups at random: three dosage groups of sham operated rats, model control group, the embodiment of the present invention eight and high dose calcium carbonate control group, every treated animal 10.Sham operated rats is performed the operation: with 3% pentobarbital sodium intraperitoneal anesthesia, under strict aseptic technique, gets the other dorsal part two incision of lumbar vertebra and enters abdominal cavity, after extracing a little mesostenium, and carefully hemostasis layer-by-layer suture otch; Three dosage groups of model control group, the embodiment of the present invention one and the operation of high dose calcium carbonate control group, anesthesia is the same, under strict aseptic technique, get the other dorsal part two incision of lumbar vertebra, enter abdominal cavity dorsal part, after complete excision bilateral ovaries, carefully hemostasis layer-by-layer suture otch.Postoperative three days, sham operated rats and model control group were with distilled water gavage; The present invention's three dosage groups, i.e. 200mg/kgbw group, 400mg/kgbw group, 800mg/kgbw group (being equivalent to 5,10 and 20 times of human intaking amount 40mg/kg.bw group respectively), with the sample liquid gavage (preparation of gavage liquid: get 2g, 4g, 8g of the present invention respectively of preparation, adding distil water is settled to 100ml, is mixed with the sample liquid of 200mg/kgbw, 400mg/kgbw, 800mg/kgbw); High dose group calcium carbonate control group per os pours into the calcium carbonate of 224mg/kgbw, and this dosage is equivalent to high dose group level of the present invention.All animal gavage amounts are 10ml/kgbw, and once a day, continuous gavage 90 days, weighs weekly and adjust gavage amount by body weight.Test last femoral artery sacrificed by exsanguination animal, take out right side femur, with 105 DEG C of baking ovens, bake to constant weight, weigh bone weight.DPX-L Dual-energy X-rays absorptionmetry is adopted to measure fl bone density (g/cm 2), its concrete assay method scans whole fl with DPX-L Dual-energy X-rays absorptionmetry, represents this bone bone density with the mean bone density of bone.Adopt the right femur calcium content of atomic absorption spectroscopy determination.
Table 1 is on the impact of rat bone density and calcium content of bone
Group Number of animals Fl bone density (g/cm2) Right bone calcium content of femur (mg/g)
Sham operated rats 10 0.2098±0.0232 178.02±9.23
Model control group 10 0.2161±0.0218 176.29±10.61
High dose calcium carbonate control group 10 0.2015±0.0274 132.05±11.07
200mg/kg.bw group 10 0.2352±0.0156 182.41±3.11
400mg/kg.bw group 10 0.2422±0.0134 186.15±10.96
800mg/kg.bw group 10 0.2532±0.0171 187.36±11.36
From table 1, bone density, the calcium content of bone of the present invention's three dosage groups compare model control group, and there were significant differences, illustrate that the present invention has replenishing the calcium, increases the effect of bone density.
Detailed description of the invention
For making those skilled in the art understand production technology of the present invention and technique effect in detail, introduce application of the present invention and technique effect further with concrete production instance below.
Embodiment one: the preparation of granule
Take calcium carbonate 1500g, vitamin K 14g, vitamin K 34g, vitamin K 4then 4g and sucrose 2394g is the dissolve with ethanol vitamin K of 95% by 40ml concentration 1, vitamin K 3, vitamin K 4, then add the dilution of 350ml purified water, obtain wetting agent for subsequent use.After calcium carbonate and sucrose mix homogeneously, with gained wetting agent soft material, granulate, under the condition of 50 DEG C, carry out drying, granulate, subpackage, obtain described granule.
Embodiment two: the preparation of granule
Take calcium carbonate 1200g, vitamin K 1then 10g and sucrose 2388g is the dissolve with ethanol vitamin K of 95% by 30ml concentration 1, then add the dilution of 250ml purified water, obtain wetting agent for subsequent use.By calcium carbonate and sucrose mix homogeneously, with gained wetting agent soft material, granulate, under the condition of 40 DEG C, carry out drying, granulate, subpackage, obtain described granule.
Embodiment three: the preparation of granule
Take calcium carbonate 2000g, vitamin K 1then 15g and sucrose 2694g is the dissolve with ethanol vitamin K of 95% by 35ml concentration 1, then add the dilution of 200ml purified water, obtain wetting agent for subsequent use.By calcium carbonate and sucrose mix homogeneously, with gained wetting agent soft material, granulate, under the condition of 50 DEG C, carry out drying, granulate, subpackage, obtain described granule.
Embodiment four: the preparation of tablet
Take calcium carbonate 1000g, vitamin K 2then 20g, microcrystalline Cellulose 200g and carboxymethylstach sodium 20g are the dissolve with ethanol vitamin K of 95% by 35ml concentration 2, then add the dilution of 200ml purified water, obtain wetting agent for subsequent use.By calcium carbonate, microcrystalline Cellulose and carboxymethylstach sodium mix homogeneously, with gained wetting agent soft material, granulate, carry out drying, granulate under the condition of 50 DEG C, add magnesium stearate 2.5g mixing, tabletting, obtains described conventional tablet.
Embodiment five: the preparation of film coated tablet
Take calcium carbonate 2500g, vitamin K 3then 18g, microcrystalline Cellulose 200g and carboxymethylstach sodium 20g are the dissolve with ethanol vitamin K of 95% by 40ml concentration 3, then add the dilution of 180ml purified water, obtain wetting agent for subsequent use.By calcium carbonate, microcrystalline Cellulose and carboxymethylstach sodium mix homogeneously, with gained wetting agent soft material, granulate, drying is carried out under the condition of 60 DEG C, granulate, adds magnesium stearate 2.5g mixing, tabletting, take hypromellose 85g and Pulvis Talci 15g coating operations routinely again, obtain described film coated tablet.
Embodiment six: the preparation of chewable tablet
Take calcium carbonate 1200g, vitamin K 24g, vitamin K 34g, vitamin K 4then 4g, sucrose 300g are the dissolve with ethanol vitamin K of 95% by 40ml concentration 2, vitamin K 3, vitamin K 4, then add the dilution of 150ml purified water, obtain wetting agent for subsequent use.By calcium carbonate and sucrose mix homogeneously, with gained wetting agent soft material, granulate, under the condition of 60 DEG C, carry out drying, granulate, add micropowder silica gel 30g and mix, tabletting, obtains described chewable tablet.
Embodiment seven: the preparation of chewable tablet
Take calcium carbonate 2200g, vitamin K 14g, vitamin K 2then 4g, lactose 100g and mannitol 200g are the dissolve with ethanol vitamin K of 95% by 30ml concentration 1, vitamin K 1, then add the dilution of 200ml purified water, obtain wetting agent for subsequent use.By calcium carbonate, lactose and mannitol mix homogeneously, with gained wetting agent soft material, granulate, under the condition of 50 DEG C, carry out drying, granulate, add micropowder silica gel 30g and mix, tabletting, obtains described chewable tablet.
Embodiment eight: the preparation of capsule
Take calcium carbonate 1600g, vitamin K 36g, vitamin K 4then 6g is the dissolve with ethanol vitamin K of 95% by 30ml concentration 3, vitamin K 4, then add the dilution of 200ml purified water, obtain wetting agent for subsequent use.By calcium carbonate gained wetting agent soft material, granulate, under the condition of 50 DEG C, carry out drying, granulate, add magnesium stearate 3g mixing, use Capsules filling, obtain described capsule.

Claims (1)

1. a preparation method for calcium carbonate-vitamin K pharmaceutical preparation, is characterized in that, the method comprises the following steps: get calcium carbonate 1600g, vitamin K 36g, vitamin K 4then 6g is the dissolve with ethanol vitamin K of 95% by 30mL concentration 3, vitamin K 4, then add the dilution of 200mL purified water, obtain wetting agent for subsequent use; By calcium carbonate gained wetting agent soft material, granulate, under the condition of 50 DEG C, carry out drying, granulate, add magnesium stearate 3g mixing, use Capsules filling, to obtain final product.
CN201310076599.2A 2013-03-11 2013-03-11 Calcium carbonate-vitamin K pharmaceutical preparation and preparation method thereof Active CN103142641B (en)

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Publication number Priority date Publication date Assignee Title
CN104432099B (en) * 2014-12-22 2017-02-01 威海百合生物技术股份有限公司 Health food containing vitamin K2
CN104738623A (en) * 2015-03-17 2015-07-01 徐州医学院 Mushroom powder capsule rich in vitamin K2 and calcium agent and preparation method thereof
CN107960663A (en) * 2017-11-24 2018-04-27 南通励成生物工程有限公司 Carbonic acid calcium-nutrition intensifying agent and preparation method
CN114832020B (en) * 2022-05-30 2023-03-17 北京朗迪制药有限公司 Pharmaceutical composition for preventing and treating child developmental disorder and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1016895A6 (en) * 2005-12-16 2007-09-04 Psaltopoulos Emmanuel Calcium composition, useful to prevent/treat osteoporosis and articular cartilage calcification, comprises optionally elementary calcium in the form e.g. of calcium carbonate or calcium citrate, and vitamins e.g. vitamin-D3, vitamin-K3
CN101828707A (en) * 2009-03-10 2010-09-15 上海培宝康实业股份有限公司 Nutrition composition and application thereof
CN101537050B (en) * 2009-05-08 2011-06-01 无锡健特药业有限公司 Health product capable of enhancing bone density and immune function, and preparation method and applications thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1016895A6 (en) * 2005-12-16 2007-09-04 Psaltopoulos Emmanuel Calcium composition, useful to prevent/treat osteoporosis and articular cartilage calcification, comprises optionally elementary calcium in the form e.g. of calcium carbonate or calcium citrate, and vitamins e.g. vitamin-D3, vitamin-K3
CN101828707A (en) * 2009-03-10 2010-09-15 上海培宝康实业股份有限公司 Nutrition composition and application thereof
CN101537050B (en) * 2009-05-08 2011-06-01 无锡健特药业有限公司 Health product capable of enhancing bone density and immune function, and preparation method and applications thereof

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