CN103142568A - Calcium acetate-vitamin K pharmaceutical preparation and preparation method thereof - Google Patents
Calcium acetate-vitamin K pharmaceutical preparation and preparation method thereof Download PDFInfo
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- CN103142568A CN103142568A CN2013100765761A CN201310076576A CN103142568A CN 103142568 A CN103142568 A CN 103142568A CN 2013100765761 A CN2013100765761 A CN 2013100765761A CN 201310076576 A CN201310076576 A CN 201310076576A CN 103142568 A CN103142568 A CN 103142568A
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Abstract
The invention relates to a calcium acetate-vitamin K pharmaceutical preparation and a preparation method thereof, belonging to the technical field of medicine. The calcium acetate-vitamin K pharmaceutical preparation is prepared from 400-1200 parts by weight of calcium acetate, 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 acetate-vitamin K pharmaceutical preparation can effectively supplement calcium, and is safe and convenient to take.
Description
Technical field
The present invention relates to medical technical field, be specifically related to a kind of calcium acetate vitamin K pharmaceutical preparation and preparation method thereof.
Background technology
Calcium is the maximum a kind of inorganic salt of people's in-vivo content, in the normal human, the content of calcium accounts for the 0.5%-2.0% of human body weight, wherein 99% calcium is present among skeleton and tooth, 1% calcium great majority are ionic condition and are present in soft tissue, extracellular fluid and blood, are keeping dynamic equilibrium with skeleton.Calcium has the normal reaction of keeping nerve, muscle, regulates heartbeat and keeps heart alternately to shrink continuously and diastole, keeps contraction and the neururgic transmission isoreactivity of muscle.China resident totally need to generally carry out suitable replenishing the calcium due to the dietary habit problem, could ensure better that the resident is healthy.Solve now the problem of replenishing the calcium, the general intake that increases calcium and the absorption rate that improves calcium of adopting.At present, calcium supplementing product is more, and the formula too complex that wherein has also relates to additional various nutrient elements, and effect of supplemented calcium is not obvious; Some calcium supplementing product doses are too large, and are difficult for being absorbed by the body, and cause effect of supplemented calcium relatively poor; Some calcium supplementing products 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 of taking safe ready becomes a technical problem of being badly in need of solution.
Summary of the invention
The purpose of this invention is to provide a kind of calcium acetate 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 the preparation method of a kind of calcium acetate vitamin K pharmaceutical preparation.
The technical solution used in the present invention is the pharmaceutical preparation of a kind of calcium acetate vitamin K, it is made by 400～1200 weight portion calcium acetates, 2～30 weight portion vitamin Ks and appropriate amount of auxiliary materials, and wherein adjuvant is 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 by 500～1000 weight portion calcium acetates, 5～25 weight portion vitamin Ks and appropriate amount of auxiliary materials, and wherein adjuvant is 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 by 600～900 weight portion calcium acetates, 10～20 weight portion vitamin Ks and appropriate amount of auxiliary materials, and wherein adjuvant is 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 a kind of and any mixture.
Pharmaceutical preparation of the present invention can adopt conventional preparation method to prepare.And being made the preferred preparation method of pharmaceutical preparation of the present invention, above-mentioned each raw material comprises the following steps: get calcium acetate 800g, vitamin K
36g, vitamin K
4Then 6g is 95% dissolve with ethanol vitamin K with 30ml concentration
3, vitamin K
4, then add the dilution of 200ml purified water, get wetting agent standby; Calcium acetate with gained wetting agent soft material processed, is granulated, carry out drying under the condition of 50 ℃, granulate adds magnesium stearate 3g mixing, uses the Capsules filling, and get final product.
Beneficial effect of the present invention is: (1) scientific formulation of the present invention is reasonable, and calcium acetate provides the calcium source for body; Vitamin K can be regulated 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 can make body Dichlorodiphenyl Acetate calcium absorption more abundant, and can be on skeleton effectively under deposition, thereby effectively increase bone density, reduce risk of bone fracture.(2) the present invention due to formula rationally, in order to be effective when reducing calcium source consumption, thus can avoid many discomforts of using the series products of replenishing the calcium to cause due to long-term, high-dose, such as gastric mucosa damage, Calculus of digestive duct and urinary tract infringement etc.(3) the present invention uses by short-term, can effectively treat the osteoporosis and the rickets that cause due to calcium deficiency, and is safe and reliable through routine clinical verifications up to a hundred, has no side effect.(4) the present invention by adding appropriate adjuvant, meets the preparation needs, thereby can more meet the sufferer demand.
For confirming effectiveness of the present invention, the spy estimates according to Ministry of Public Health " health food check and assessment technique standard ", and evaluation result sees Table 1.
Experimental technique: 60 of the SPF level female sd inbred rats of getting body weight and be 220-260g, with normal feedstuff adaptability feed after seven days, according to body weight, be divided at random following six groups: three dosage groups of sham operated rats, model control group, the embodiment of the present invention eight and high dose calcium carbonate control group, 10 of every treated animals.The sham operated rats operation: with 3% pentobarbital sodium intraperitoneal anesthesia, under strict sterile working, get the other dorsal part two incision of lumbar vertebra and enter the abdominal cavity, after extracing a little mesostenium, the layer-by-layer suture otch carefully stops blooding; 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 sterile working, get the other dorsal part two incision of lumbar vertebra, enter the abdominal cavity dorsal part, after complete excision bilateral ovaries, the layer-by-layer suture otch carefully stops blooding.Postoperative three days, sham operated rats and model control group are with the distilled water gavage; Three dosage groups of the present invention, be 200mg/kgbw group, 400mg/kgbw group, 800mg/kgbw group (be equivalent to respectively human intaking amount 40mg/kg.bw group 5,10 and 20 times), sample liquid gavage (the preparation of gavage liquid: get respectively 2g of the present invention, 4g, 8g with 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, gavage is 90 days continuously, weigh weekly and adjust the gavage amount by body weight.Test last femoral artery sacrificed by exsanguination animal, take out the right side femur, in 105 ℃ of baking ovens, roasting to constant weight, the weighing bone is heavy.Adopt DPX-L dual energy X-ray absorptiometry instrument to measure fl bone density (g/cm
2), its concrete assay method is with the whole fl of DPX-L dual energy X-ray absorptiometry instrument scanning, represents this bone bone density with the average bone density of bone.Adopt the right femur calcium content of atomic absorption spectroscopy determination.
The impact of table 1 on 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 | 0.2197±0.0022 | 183.02±9.83 |
| Model control group | 10 | 0.2011±0.0013 | 181.29±12.21 |
| The high dose calcium carbonate control group | 10 | 0.2213±0.0164 | 136.08±10.09 |
| 200mg/kg.bw group | 10 | 0.2312±0.0158 | 183.46±8.17 |
| 400mg/kg.bw group | 10 | 0.2402±0.0128 | 186.12±12.16 |
| 800mg/kg.bw group | 10 | 0.2449±0.0156 | 187.21±12.86 |
By as seen from Table 1, bone density, the calcium content of bone of three dosage groups of the present invention are compared model control group, and there were significant differences, illustrate that the present invention has replenishing the calcium, increases the effect of bone density.
The specific embodiment
For making those skilled in the art understand in detail production technology of the present invention and technique effect, the below further introduces application of the present invention and technique effect with concrete production instance.
Embodiment one: the preparation of granule
Take calcium acetate 700g, vitamin K
12g, vitamin K
32g, vitamin K
4Then 2g and sucrose 2394g are 95% dissolve with ethanol vitamin K with 40ml concentration
1, vitamin K
3, vitamin K
4, then add the dilution of 350ml purified water, get wetting agent standby.After calcium acetate and sucrose mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 50 ℃, granulate, packing namely gets described granule.
Embodiment two: the preparation of granule
Take calcium acetate 600g, vitamin K
1Then 12g and sucrose 2388g are 95% dissolve with ethanol vitamin K with 30ml concentration
1, then add the dilution of 250ml purified water, get wetting agent standby.With calcium acetate and sucrose mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 40 ℃, granulate, packing namely gets described granule.
Embodiment three: the preparation of granule
Take calcium acetate 600g, vitamin K
1Then 15g and sucrose 2694g are 95% dissolve with ethanol vitamin K with 35ml concentration
1, then add the dilution of 200ml purified water, get wetting agent standby.With calcium acetate and sucrose mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 50 ℃, granulate, packing namely gets described granule.
Embodiment four: the preparation of tablet
Take calcium acetate 900g, vitamin K
2Then 20g, microcrystalline Cellulose 200g and carboxymethylstach sodium 20g are 95% dissolve with ethanol vitamin K with 35ml concentration
2, then add the dilution of 200ml purified water, get wetting agent standby.With calcium acetate, microcrystalline Cellulose and carboxymethylstach sodium mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 50 ℃, granulate adds magnesium stearate 2.5g mixing, and tabletting namely gets described conventional tablet.
Embodiment five: the preparation of film coated tablet
Take calcium acetate 600g, vitamin K
3Then 15g, microcrystalline Cellulose 200g and carboxymethylstach sodium 20g are 95% dissolve with ethanol vitamin K with 40ml concentration
3, then add the dilution of 180ml purified water, get wetting agent standby.With calcium acetate, microcrystalline Cellulose and carboxymethylstach sodium mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 60 ℃, granulate adds magnesium stearate 2.5g mixing, tabletting, take again hypromellose 85g and Pulvis Talci 15g coating operation routinely, namely get described film coated tablet.
Embodiment six: the preparation of chewable tablet
Take calcium acetate 1000g, vitamin K
24g, vitamin K
34g, vitamin K
4Then 4g, sucrose 300g are 95% dissolve with ethanol vitamin K with 40ml concentration
2, vitamin K
3, vitamin K
4, then add the dilution of 150ml purified water, get wetting agent standby.With calcium acetate and sucrose mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 60 ℃, granulate adds micropowder silica gel 30g mixing, and tabletting namely gets described chewable tablet.
Embodiment seven: the preparation of chewable tablet
Take calcium acetate 800g, vitamin K
14g, vitamin K
2Then 6g, lactose 100g and mannitol 200g are 95% dissolve with ethanol vitamin K with 30ml concentration
1, vitamin K
1, then add the dilution of 200ml purified water, get wetting agent standby.With calcium acetate, lactose and mannitol mix homogeneously, with gained wetting agent soft material processed, granulate, carry out drying under the condition of 50 ℃, granulate adds micropowder silica gel 30g mixing, and tabletting namely gets described chewable tablet.
Embodiment eight: the preparation of capsule
Take calcium acetate 800g, vitamin K
36g, vitamin K
4Then 6g is 95% dissolve with ethanol vitamin K with 30ml concentration
3, vitamin K
4, then add the dilution of 200ml purified water, get wetting agent standby.Calcium acetate with gained wetting agent soft material processed, is granulated, carry out drying under the condition of 50 ℃, granulate adds magnesium stearate 3g mixing, uses the Capsules filling, namely gets described capsule.
Claims (7)
1. calcium acetate vitamin K pharmaceutical preparation, it is characterized in that it is made by 400～1200 weight portion calcium acetates, 2～30 weight portion vitamin Ks and appropriate amount of auxiliary materials, wherein adjuvant is selected from sucrose, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, hypromellose, Pulvis Talci, lactose or mannitol one or more.
2. a kind of calcium acetate vitamin K according to claim 1 pharmaceutical preparation, it is characterized in that it is made by 500～1000 weight portion calcium acetates, 5～25 weight portion vitamin Ks and appropriate amount of auxiliary materials, wherein adjuvant is selected from sucrose, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, hypromellose, Pulvis Talci, lactose or mannitol one or more.
3. a kind of calcium acetate vitamin K according to claim 1 pharmaceutical preparation, it is characterized in that it is made by 600～900 weight portion calcium acetates, 10～20 weight portion vitamin Ks and appropriate amount of auxiliary materials, wherein adjuvant is selected from sucrose, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, hypromellose, Pulvis Talci, lactose or mannitol one or more.
4. the described a kind of calcium acetate vitamin K of according to claim 1-3 any one pharmaceutical preparation is characterized in that described pharmaceutical preparation is tablet, capsule or granule.
5. a kind of calcium acetate vitamin K according to claim 4 pharmaceutical preparation is characterized in that described tablet is conventional tablet, Film coated tablets or chewable tablet.
6. a kind of calcium acetate vitamin K according to claim 4 pharmaceutical preparation is characterized in that described vitamin K is selected from vitamin K
1, vitamin K
2, vitamin K
3Or vitamin K
4In a kind of and any mixture.
7. the preparation method based on calcium acetate vitamin K claimed in claim 4 pharmaceutical preparation, is characterized in that the method comprises the following steps: get calcium acetate 800g, vitamin K
36g, vitamin K
4Then 6g is 95% dissolve with ethanol vitamin K with 30ml concentration
3, vitamin K
4, then add the dilution of 200ml purified water, get wetting agent standby; Calcium acetate with gained wetting agent soft material processed, is granulated, carry out drying under the condition of 50 ℃, granulate adds magnesium stearate 3g mixing, uses the Capsules filling, and get final product.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10159687B2 (en) | 2012-03-02 | 2018-12-25 | Kappa Bioscience As | Prodrugs of vitamin K |
| CN112715952A (en) * | 2019-10-29 | 2021-04-30 | 湖北真奥医药研究院有限公司 | Multi-vitamin calcium self-emulsifying composition and preparation method of preparation thereof |
-
2013
- 2013-03-11 CN CN201310076576.1A patent/CN103142568B/en active Active
Non-Patent Citations (3)
| Title |
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| 余薇: "原发性骨质疏松症的营养防治", 《现代康复》 * |
| 顾维正: "退行性骨疏松症的症断和治疗", 《医师进修杂志》 * |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10159687B2 (en) | 2012-03-02 | 2018-12-25 | Kappa Bioscience As | Prodrugs of vitamin K |
| CN112715952A (en) * | 2019-10-29 | 2021-04-30 | 湖北真奥医药研究院有限公司 | Multi-vitamin calcium self-emulsifying composition and preparation method of preparation thereof |
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|---|---|
| CN103142568B (en) | 2015-03-11 |
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