CN109453126A - A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof - Google Patents
A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof Download PDFInfo
- Publication number
- CN109453126A CN109453126A CN201811491587.5A CN201811491587A CN109453126A CN 109453126 A CN109453126 A CN 109453126A CN 201811491587 A CN201811491587 A CN 201811491587A CN 109453126 A CN109453126 A CN 109453126A
- Authority
- CN
- China
- Prior art keywords
- calcium carbonate
- vitamin
- chewable tablets
- weight ratio
- composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
- 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
- A61K33/10—Carbonates; Bicarbonates
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof, including calcium carbonate and vitamin D3Inclusion compound, the calcium carbonate and vitamin D3The weight ratio of inclusion compound is 750:0.6, and the calcium carbonate be the calcium carbonate after being micronized, and the calcium carbonate after micronization is added water wet granulation by preparation method a), and 55 DEG C are dried to moisture less than 3%, 40 mesh whole grain, spare；B) by vitamin D3Inclusion compound is uniformly mixed with calcium carbonate, the calcium carbonate and vitamin D3The weight ratio of inclusion compound is 750:0.6；C) tabletting.Solve the problems, such as that mouthfeel is bad, there are sand types, dissolution rate is higher, calcium absorptivity has sufficiently been ensured, so that the compliance that patient takes greatly improves；It is added to disintegrating agent, avoids the stimulation potentially to oesophagus；Simple production process is feasible, can prepare in batches in the mass production of workshop.
Description
[technical field]
The present invention relates to the technical field of pharmaceutical preparation, especially a kind of calcium carbonate D3The composition of chewable tablets and its preparation
The technical field of method.
Calcium carbonate D described in full text3Chewable tablets, the entitled calcium carbonate D of national standard3Chewable tablets (II).
[background technique]
Calcium is necessary to maintaining human nerve, muscle, skeletal system, cell membrane and capillary permeability normal function
Substance.Vitamin D can participate in the metabolism of calcium and phosphorus, promote it to absorb and play an important role to New bone formation, calcium carbonate D3Chewing
Piece is the compound preparation of a kind of calcic and vitamin D, can be used for gestation and breast feeding women, climacteric women, the elderly and youngster
The calcium complement agent of child etc., and help anti-curing osteoporosis.
Calcium carbonate D3(0.75 gram of calcium carbonate (is equivalent to 300 milligrams of calcium) to chewable tablets (II), vitamin D360 international units) be
Wyeth Pharmaceuticals's (Wyeth Pharmaceutical Co., Ltd. is now subsidiary under Pfizer) registers declare at home
The exclusive specification in the whole world, it is external to be listed without this specification product.It is as follows that it is formulated contained whole supplementary materials: calcium carbonate, vitamin
D3, sompressible sugar, flavoring orange essence, sorbierite, sweet tea powder, mannitol, magnesium stearate, silica, No. 6 color indigo of yellow and tristearin
Acid.It most lists (former authentication code is that (95) defend the quasi- word of medicine X-82), the odd chewing of trade name calcium that at home earlier than nineteen ninety-five
Piece is still the main product in calcium preparation market at present.However, your odd chewable tablets listing is more early due to calcium, technical level at that time
More limit to, therefore there are following Railway Projects for the odd chewable tablets of calcium that: first is that mouthfeel is bad, grittiness sense；Second is that presently commercially available
The chewable tablets including calcium including your odd chewable tablets be free of disintegrating agent, but often there is patient mistakenly entirely to swallow nozzle in reality
Piece is chewed, or chewing is not swallowed completely, causes to stimulate oesophagus, make the sluggishness of patient's gastrointestinal tract obstruction and drug-eluting.
In addition, vitamin D3It is unstable, it meets light or air is perishable, Chinese Pharmacopoeia standard provides vitamin D3Bulk pharmaceutical chemicals
Shading, nitrogen charging, sealing are needed, is saved in cold place.In addition vitamin D3Dosage is minimum, every calcium carbonate D3Chewable tablets slice weight 1.6g
Left and right, contains only the 60 units i.e. vitamin D of 1.5ug3.If using vitamin D3Bulk pharmaceutical chemicals feed intake, then the realization of blending process is non-
It is often difficult: because of the vitamin D of 150mg3It to be mixed with materials such as the calcium carbonate of 160kg, this is to be difficult in ordinary preparation workshop
It realizes, also vitamin D3Or unstable bulk pharmaceutical chemicals.
[summary of the invention]
The object of the invention is to solve the problems of the prior art, a kind of calcium carbonate D is proposed3The composition of chewable tablets and
Preparation method, this product solve the problems, such as that mouthfeel is bad, there are sand types, and dissolution rate is higher, have sufficiently ensured calcium absorptivity,
So that the compliance that patient takes greatly improves；It is added to disintegrating agent, avoids the stimulation potentially to oesophagus；Simple production process
It is feasible, it can be prepared in batches in the mass production of workshop.
To achieve the above object, the present invention is achieved through the following technical solutions:
A kind of calcium carbonate D3The composition of chewable tablets, including calcium carbonate and vitamin D3Inclusion compound, the calcium carbonate and Wei Sheng
Plain D3The weight ratio of inclusion compound is 750:0.6, and the calcium carbonate is the calcium carbonate after micronization.
Preferably, the vitamin D3Inclusion compound includes vitamin D3With inclusion auxiliary material, the vitamin D3It is auxiliary with including
The weight ratio of material is 1:399.
Preferably, the particle diameter distribution of the calcium carbonate after the micronization is within 5 μm.
Preferably, further including disintegrating agent, the total amount of the disintegrating agent accounts for 1~6% of weight ratio in prescription.
Preferably, the disintegrating agent is cross-linked carboxymethyl cellulose sodium, carboxyrnethyl starch sodium and crospovidone therein one
Kind or two kinds of combination.
Preferably, further including sweetener, essence and magnesium stearate, the total amount of the sweetener accounts for weight ratio in prescription
44.6~52.6%, the total amount of the essence accounts for 0.2~0.6% of weight ratio in prescription, the total amount of the magnesium stearate
0.9~3.1% of weight ratio in prescription is accounted for, the sweetener is sorbierite, mannitol, sucrose, lactose, glucose and xylose
Alcohol is one such or several.
A kind of calcium carbonate D3The preparation method of the composition of chewable tablets, includes the following steps:
A) calcium carbonate after micronization is added into water wet granulation, 55 DEG C are dried to moisture less than 3%, 40 mesh whole grain, spare；
B) by vitamin D3Inclusion compound is uniformly mixed with calcium carbonate, the calcium carbonate and vitamin D3The weight ratio of inclusion compound
Example is 750:0.6；
C) tabletting.
Preferably, further including 1~6% disintegrating agent for accounting for prescription weight ratio, the disintegrating agent is directly in step b)
After add and mix, or be divided into two parts, a part is first uniformly mixed and another before step a) with the calcium carbonate after being micronized
A part is added and is mixed after step b).
Preferably, further including accounting for 44.6~52.6% sweetener of weight ratio in prescription, accounting for weight ratio in prescription
0.2~0.6% essence of example and 0.9~3.1% magnesium stearate for accounting for weight ratio in prescription, the sweetener are divided into two
Part, a part is first uniformly mixed before step a) with the calcium carbonate after micronization, and the sweetener of another part and the perfume (or spice)
Essence uses equal increments method and vitamin D before step b)3Inclusion compound is uniformly mixed, and the magnesium stearate adds after step b)
Adduction mixes.
The calcium carbonate D among the above3Chewable tablets, the entitled calcium carbonate D of national standard3Chewable tablets (II).
Beneficial effects of the present invention:
1, solve sensory issues: since in chewable tablets, calcium carbonate proportion is very big, and calcium carbonate taste is bad, therefore
Chewable tablets mouthfeel is bad, grittiness sense is all caused by calcium carbonate, by not only may be used the use that feeds intake again after calcium carbonate fine powderization
It solves the problems, such as the sand type of this chewable tablets, the dissolution rate of calcium carbonate can also be improved, and then improve the absorptivity of calcium.
2, solve the problems, such as disintegration: disintegrating agent being added in formula, even if so that this product by patient without chewing and mistakenly
It entirely swallows, or chewing is not swallowed completely, can also keep fabulous disintegration and dissolution rate, it is ensured that the absorption of calcium, and avoid
Potential following adverse reaction: the stimulation to oesophagus, patient's gastrointestinal tract obstruction, the sluggishness of drug-eluting.
3, in addition, the present invention uses vitamin D3Inclusion compound feeds intake for producing, and solves unstable micro- of Workshop Production
Measure the process difficulties of pharmaceutical preparation.
Feature and advantage of the invention will be described in detail by embodiment combination attached drawing.
[Detailed description of the invention]
Fig. 1 be eyepiece scale be 20 μm/lattice under microscope view；
Fig. 2 is microscope view of the calcium carbonate in the case where eyepiece scale is 20 μm/lattice before micronization；
Fig. 3 be eyepiece scale be 5 μm/lattice under microscope view；
Fig. 4 is microscope view of the calcium carbonate in the case where eyepiece scale is 5 μm/lattice after micronization；
[specific embodiment]
A kind of calcium carbonate D of the present invention3The embodiment of the composition of chewable tablets 1~example 6 in the following example:
Embodiment one:
| It is micronized calcium carbonate | 750g |
| Vitamin D3Inclusion compound | 0.6g |
| Sweetener | 760~817g |
| Disintegrating agent: cross-linked carboxymethyl cellulose sodium | 24g~81g |
| Essence | 3~9g |
| Magnesium stearate | 16~48g |
| It is made | 1000 |
The formula of chewable tablets table of 1 embodiment one of table
Embodiment two:
The formula of chewable tablets table of 2 embodiment two of table
Embodiment three:
| It is micronized calcium carbonate | 750g |
| Vitamin D3Inclusion compound | 0.6g |
| Sweetener | 760~817g |
| Disintegrating agent: carboxyrnethyl starch sodium | 24g~81g |
| Essence | 3~9g |
| Magnesium stearate | 16~48g |
| It is made | 1000 |
The formula of chewable tablets table of 3 embodiment three of table
Example IV:
| It is micronized calcium carbonate | 750g |
| Vitamin D3Inclusion compound | 0.6g |
| Sweetener | 760~817g |
| Disintegrating agent: carboxyrnethyl starch sodium | 12g~40g |
| Disintegrating agent: crospovidone | 12g~40g |
| Essence | 3~9g |
| Magnesium stearate | 16~48g |
| It is made | 1000 |
The formula of chewable tablets table of 4 example IV of table
Embodiment five:
The formula of chewable tablets table of 5 embodiment five of table
Embodiment six:
| It is micronized calcium carbonate | 750g |
| Vitamin D3Inclusion compound | 0.6g |
| Sweetener | 760~817g |
| Disintegrating agent: cross-linked carboxymethyl cellulose sodium | 12g~40g |
| Disintegrating agent: carboxyrnethyl starch sodium | 12g~40g |
| Essence | 3~9g |
| Magnesium stearate | 16~48g |
| It is made | 1000 |
The formula of chewable tablets table of 6 embodiment six of table
A kind of calcium carbonate D of the present invention3The preparation method of the composition of chewable tablets, embodiment 7~example 8 in the following example:
Embodiment seven:
A) calcium carbonate micronization equipment micronization, it is qualification that microscopically observation partial size, which is less than 5um,；
B) sweetener and 1/2 disintegrating agent for taking micronization calcium carbonate, 1/2, are uniformly mixed, and add water wet granulation, 55 DEG C of bakings
It is spare to moisture less than 3%, 40 mesh whole grain；
C) by vitamin D3Inclusion compound, essence are uniformly mixed with remaining 1/2 sweetener equal increments, spare；
D) it is above-mentioned b), c) in material, magnesium stearate and remaining 1/2 disintegrating agent is added, total mix is uniform, and tabletting to obtain the final product.
Embodiment eight:
A) calcium carbonate micronization equipment micronization, it is qualification that microscopically observation partial size, which is less than 5um,；
B) sweetener of micronization calcium carbonate and 1/2 is taken, is uniformly mixed, adds water wet granulation, 55 DEG C are dried to moisture and are less than
3%, 40 mesh whole grains are spare；
C) by vitamin D3Inclusion compound, essence are uniformly mixed with remaining 1/2 sweetener equal increments, spare；
D) it is above-mentioned b), c) in material, magnesium stearate and disintegrating agent is added, total mix is uniform, and tabletting to obtain the final product.
Experiment effect of the invention:
One, micronization front and back calcium carbonate partial size inspection:
See FIG. 1 to FIG. 4, is measured with the first method microscopic method in " Chinese Pharmacopoeia " granularity and determination of particle size distribution.
Fig. 1 is that microscope ocular scale is adjusted to the view under 20 μm/lattice, wherein thick vertical line is the load glass with micro scale
Piece, every lattice are 10 μm, and the grid scale with number is eyepiece.
Fig. 2 is view of the carbonic acid calcium raw material drug under the microscope that eyepiece scale is adjusted to 20 μm/lattice without micronization,
As it can be seen that its crystal form is polyhedron, partial size is in 20-120 μ m.
Fig. 3 is that microscope ocular scale is adjusted to the view under 5 μm/lattice, wherein thick vertical line is the load glass with micro scale
Piece, every lattice are 10 μm, and the grid scale with number is eyepiece.
Fig. 4 is that the carbonic acid calcium raw material drug after being micronized is adjusted to the view under the microscope under 5 μm/lattice in eyepiece scale
Figure, it is seen then that its partial size is distributed within 5 μm in range.
To sum up, the partial size of the carbonic acid calcium raw material drug before micronization is distributed in 20-120 μ m, the carbon after micronization
The particle diameter distribution of sour calcium raw material drug is then all within 5 μm.Calcium carbonate is in prescription as the main component of chewable tablets and ratio
Highest material after micronization, not only makes chewable tablets without sand type, and mouthfeel is greatly improved outside, and since calcium carbonate is
Micro mist rank, therefore be conducive to body absorption.
Two, mouthfeel and dissolution rate comparison:
By commercially available product Hui Shi calcium before and after your odd chewable tablets (II), calcium carbonate fine powder self-control sample (120405 batches and
120601 batches) and calcium carbonate fine powder after whether plus disintegrating agent sample (120601 batches and 170703 batches), progress mouthfeel and molten
The comparison of out-degree, as a result as follows:
7 mouthfeel of table and dissolution rate contrast table
Upper table statistics indicate that:
(1) the odd chewable tablets (II) of commercially available product Hui Shi calcium that and self-control sample (120405 batch) of the calcium carbonate without micronization,
Mouthfeel is bad, there is obvious sand type, and dissolution rate is very poor, just dissolves out about 33-35% within 60 minutes；
(2) the self-control sample after calcium carbonate fine powder (120601 batches), than having improvement before micronization, but dissolution rate is still
It is bad, just dissolve out about 56% within 60 minutes；
(3) using the self-control sample of the technology of the present invention, (170703 batches: calcium carbonate is micronized, and formula is containing 1.5% disintegration
Agent), no sand type, in good taste, dissolution rate greatly improves, all dissolutions up to 92%, 60 minute of 30 minutes dissolution rates.
The result shows that: the calcium carbonate after micronization is not only without sand type, and mouthfeel is greatly improved, and micro powder grade is other
Calcium carbonate is conducive to body absorption conducive to dissolution rate improvement；
After disintegrating agent is added in formula, disintegration time limited only 20 minutes, relatively it is greatly improved within > 120 minutes before, in contrast
It answers, dissolution rate greatly improves, all dissolutions up to 92%, 60 minute of 30 minutes dissolution rates, and does not add the commercially available product of disintegrating agent
With self-control sample, 60 minutes only 35%, just reach 90% within 120 minutes.
Three, uniformity of dosage units:
Sample (being in batches 97k,g/6 ten thousand) is made by oneself using three batches of workshops of the technology of the present invention technique preparation, with Hui Shi calcium
The odd chewable tablets (II) of that measures uniformity of dosage units according to the method for Chinese Pharmacopoeia uniformity of dosage units, as a result as follows:
8 calcium carbonate D of table3Chewable tablets newly does sample and the odd commercially available product VD3 uniformity of dosage units catalog data of calcium that
The result shows that the three batches of self-control samples prepared using the technology of the present invention technique, uniformity of dosage units are significantly better than that favour
The odd chewable tablets (II) of family name's calcium that, the former is uniformity S value 6.7-10.8, hence it is evident that is less than the latter 13.5-17.0.
Enteron aisle is influenced the absorption of calcium by many nutrition and physiologic factor, and absorptivity is related with organism physiology needs.Youngster
The intake calcium that juvenile phase absorbs may be up to 75%, and young people is generally 20%-40%, and the elderly then absorb it is poor.It is few to take in calcium
Person, absorptivity are about 15%, and vitamin D can promote the absorption of calcium.Inventor is tested, and discovery will be after calcium carbonate fine powder
Feed intake use again, can not only solve the problems, such as the sand type of this chewable tablets, can also improve the dissolution rate of calcium carbonate, and then improve calcium
Absorptivity.
Inventor is note that the pharmacopeia of China 2010 editions, 2015 editions pharmacopeia notes on the use provide chewable tablets without disintegration time limited
It checks.Therefore all the time, disintegrating agent is generally not added in the chewable tablets in China, also without being disintegrated the inspection with dissolution rate.However,
Real back warp often occur chewable tablets without patient chewing entirely swallow, or completely chewing i.e. swallow, thus often occur pair
The stimulation of oesophagus, the situation of gastrointestinal obstruction or drug-eluting sluggishness.Inventor it has been investigated that, in formula of chewable tablets plus
Enter a small amount of disintegrating agent (1~6%), that is, chewable tablets may make to keep fabulous disintegration and dissolution rate, it is ensured that the absorption of calcium, and avoid
The adverse reactions such as potential stimulation oesophagus, gastrointestinal obstruction.
In addition, the present invention is with vitamin D3Inclusion compound as raw material, inclusion compound is usually 100,000 units/g, compare and
Vitamin D340,000,000 units of bulk pharmaceutical chemicals/g, vitamin D after inclusion3Not only stability is greatly improved, and because diluting 400 times,
Therefore the blending process that feeds intake becomes practical.Feeding intake becomes every 1.6g containing the 60 units i.e. vitamin D of 0.6mg3, workshop
The particle for such as producing a collection of 96kg needs for 36g inclusion compound to be uniformly mixed with the material of 96kg, and this is common workshop by excellent
The technique of choosing is soluble.Therefore, inventor is fed intake using vitamine D3 inclusion compound for producing, and solves Workshop Production not
The process difficulties of stable trace drug preparation.
The calcium carbonate D3 chewable tablets among the above, the entitled calcium carbonate D3 chewable tablets (II) of national standard.
Above-described embodiment is the description of the invention, is not limitation of the invention, after any pair of simple transformation of the present invention
Scheme all belong to the scope of protection of the present invention.
Claims (9)
1. a kind of calcium carbonate D3The composition of chewable tablets, it is characterised in that: including calcium carbonate and vitamin D3Inclusion compound, the carbon
Sour calcium and vitamin D3The weight ratio of inclusion compound is 750:0.6, and the calcium carbonate is the calcium carbonate after micronization.
2. a kind of calcium carbonate D as described in claim 13The composition of chewable tablets, it is characterised in that: the vitamin D3Inclusion
Object includes vitamin D3With inclusion auxiliary material, the vitamin D3Weight ratio with inclusion auxiliary material is 1:399.
3. a kind of calcium carbonate D as described in claim 13The composition of chewable tablets, it is characterised in that: the carbon after the micronization
The particle diameter distribution of sour calcium is within 5 μm.
4. a kind of calcium carbonate D as described in claim 13The composition of chewable tablets, it is characterised in that: it further include disintegrating agent, it is described
The total amount of disintegrating agent accounts for 1~6% of weight ratio in prescription.
5. a kind of calcium carbonate D as claimed in claim 43The composition of chewable tablets, it is characterised in that: the disintegrating agent is crosslinking
Carmethose, carboxyrnethyl starch sodium and crospovidone is one such or two kinds of combination.
6. a kind of calcium carbonate D as described in any one of claims 1 to 53The composition of chewable tablets, it is characterised in that: further include
Sweetener, essence and magnesium stearate, the total amount of the sweetener account for 44.6~52.6% of weight ratio in prescription, the essence
Total amount account for 0.2~0.6% of weight ratio in prescription, the total amount of the magnesium stearate account for weight ratio in prescription 0.9~
3.1%, the sweetener is that sorbierite, mannitol, sucrose, lactose, glucose and xylose alcohol are one such or several.
7. a kind of calcium carbonate D3The preparation method of the composition of chewable tablets, it is characterised in that include the following steps:
A) calcium carbonate after micronization is added into water wet granulation, 55 DEG C are dried to moisture less than 3%, 40 mesh whole grain, spare；
B) by vitamin D3Inclusion compound is uniformly mixed with calcium carbonate, the calcium carbonate and vitamin D3The weight ratio of inclusion compound is
750:0.6；
C) tabletting.
8. a kind of calcium carbonate D as claimed in claim 73The preparation method of the composition of chewable tablets, it is characterised in that: further include
1~6% disintegrating agent of prescription weight ratio is accounted for, the disintegrating agent is directly added and mixed after step b), or is divided into two
Part, a part is first uniformly mixed before step a) with the calcium carbonate after micronization and another part is added and mixed after step b)
It is even.
9. a kind of calcium carbonate D as claimed in claim 7 or 83The preparation method of the composition of chewable tablets, it is characterised in that: also wrap
Include and account for 44.6~52.6% sweetener of weight ratio in prescription, account in prescription 0.2~0.6% essence of weight ratio and
0.9~3.1% magnesium stearate of weight ratio in prescription is accounted for, the sweetener is divided into two parts, and a part is before step a)
It is first uniformly mixed with the calcium carbonate after micronization, and the sweetener of another part and the essence are passed before step b) using equivalent
Increasing method and vitamin D3Inclusion compound is uniformly mixed, and the magnesium stearate is added and mixed after step b).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811491587.5A CN109453126A (en) | 2018-12-07 | 2018-12-07 | A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811491587.5A CN109453126A (en) | 2018-12-07 | 2018-12-07 | A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109453126A true CN109453126A (en) | 2019-03-12 |
Family
ID=65612672
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811491587.5A Pending CN109453126A (en) | 2018-12-07 | 2018-12-07 | A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109453126A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112107596A (en) * | 2020-08-21 | 2020-12-22 | 技源健康科技(江苏)有限公司 | Calcium carbonate chewable tablet and preparation method thereof |
| CN112972408A (en) * | 2021-04-01 | 2021-06-18 | 浙江寰领医药科技有限公司 | Calcium carbonate D for reducing side effect of constipation3Chewable tablet (II) and preparation method thereof |
| CN115581677A (en) * | 2022-10-12 | 2023-01-10 | 河北菲尼斯生物技术有限公司 | A food containing calcium carbonate and vitamin D 3 The chewable tablet and the preparation method thereof |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001076610A1 (en) * | 2000-04-06 | 2001-10-18 | Slovakofarma A.S. | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation |
| CN1860351A (en) * | 2003-07-31 | 2006-11-08 | 德拉沃有限责任公司 | Calcium carbonate granulation |
| CN103494836A (en) * | 2013-09-23 | 2014-01-08 | 尹庆锋 | Preparation method and application of composite calcium carbonate and vitamin D3 chewable tablets |
| CN106420808A (en) * | 2015-08-11 | 2017-02-22 | 北京远方通达医药技术有限公司 | Preparation containing vitamin D3 and calcium carbonate and preparation method for preparation |
| CN107753438A (en) * | 2017-11-01 | 2018-03-06 | 浙江康恩贝制药股份有限公司 | A kind of children's calcium carbonate D3Particle |
| CN107929313A (en) * | 2017-11-21 | 2018-04-20 | 上海金城药业有限公司 | Natural type oyster shell calcium preparation for preventing and treating acalcicosis and preparation method thereof |
-
2018
- 2018-12-07 CN CN201811491587.5A patent/CN109453126A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001076610A1 (en) * | 2000-04-06 | 2001-10-18 | Slovakofarma A.S. | Pharmaceutical composition with a content of calcium or mixture of calcium and vitamin d or mixture of calcium and magnesium in a new formulation |
| CN1860351A (en) * | 2003-07-31 | 2006-11-08 | 德拉沃有限责任公司 | Calcium carbonate granulation |
| CN103494836A (en) * | 2013-09-23 | 2014-01-08 | 尹庆锋 | Preparation method and application of composite calcium carbonate and vitamin D3 chewable tablets |
| CN106420808A (en) * | 2015-08-11 | 2017-02-22 | 北京远方通达医药技术有限公司 | Preparation containing vitamin D3 and calcium carbonate and preparation method for preparation |
| CN107753438A (en) * | 2017-11-01 | 2018-03-06 | 浙江康恩贝制药股份有限公司 | A kind of children's calcium carbonate D3Particle |
| CN107929313A (en) * | 2017-11-21 | 2018-04-20 | 上海金城药业有限公司 | Natural type oyster shell calcium preparation for preventing and treating acalcicosis and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 吴学萍 等: "儿童碳酸钙维生素D3咀嚼片的研制", 《海峡药学》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112107596A (en) * | 2020-08-21 | 2020-12-22 | 技源健康科技(江苏)有限公司 | Calcium carbonate chewable tablet and preparation method thereof |
| CN112972408A (en) * | 2021-04-01 | 2021-06-18 | 浙江寰领医药科技有限公司 | Calcium carbonate D for reducing side effect of constipation3Chewable tablet (II) and preparation method thereof |
| CN115581677A (en) * | 2022-10-12 | 2023-01-10 | 河北菲尼斯生物技术有限公司 | A food containing calcium carbonate and vitamin D 3 The chewable tablet and the preparation method thereof |
| CN115581677B (en) * | 2022-10-12 | 2024-05-07 | 北京菲尼斯生物技术有限公司 | A pharmaceutical composition comprising calcium carbonate and vitamin D3Chewable tablet and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109453126A (en) | A kind of calcium carbonate D3Composition of chewable tablets and preparation method thereof | |
| US8263119B2 (en) | Capsule formulations containing lanthanum compounds | |
| DD201643A5 (en) | METHOD FOR PRODUCING AN ACETYL SALICYANIC ACID CONTAINING CAPSULE | |
| CN108272765A (en) | Pharmaceutical composition, oral disintegrating tablet and its preparation, the application of hydrochloric Vardenafil | |
| CN101411715B (en) | Pharmaceutical composition containing acarbose | |
| CN109662949A (en) | A kind of fludrocortisone acetate oral disnitegration tablet and preparation method thereof | |
| CN108635332A (en) | A kind of preparation method of voglibose particle | |
| CN104523686A (en) | Acotiamide hydrochloride medicinal preparation and preparation method thereof | |
| CN102286045B (en) | Roxithromycin monohydrate crystal, preparation method thereof and compound dry suspension containing roxithromycin monohydrate crystal and ambroxol hydrochloride composition | |
| CN107789328A (en) | A kind of oral disintegrating tablet containing Doneppezil Hydrochloride and preparation method thereof | |
| CN101301293B (en) | Acidum folicum effervescent tablet and preparation thereof | |
| CN103405510B (en) | Compound licorice preparation for eliminating phlegm and relieving cough and preparation method thereof | |
| CN101455812B (en) | Chinese patent medicine drop-pills for treating kidney deficiency, preparation method and use thereof | |
| CN106038502A (en) | Ramelteon oral disintegrating tablets and preparation method thereof | |
| CN108670958A (en) | A kind of preparation method of voglibose effervescent tablet | |
| CN107137366A (en) | A kind of Orally disintegrating tablet of ambroxol hydrochloride and preparation method thereof | |
| CN101249119B (en) | Compound compound paracetamol and zincgluconate dispersible tablet and method of preparing the same | |
| CN103083358B (en) | Vitamin D-containing calcium preparation and preparation method thereof | |
| CN105596312A (en) | Dimemorfan phosphate capsule composition and preparing method thereof | |
| CN105687225B (en) | A kind of pharmaceutical composition for treating irritable bowel syndrome and its preparation method and application | |
| CN103202972B (en) | Pediatric effervescent tablets | |
| CN105168156B (en) | A kind of Scullcap total-flavonoid dispersible tablet and its manufacturing method | |
| CN102085193A (en) | Tibolone orally disintegrating tablets and method for preparing same | |
| CN107049973A (en) | Orally disintegrating tablet of ambroxol hydrochloride and preparation method thereof | |
| CN108159008B (en) | Preparation method of valsartan chewable tablet |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190312 |