CN112972408B - Calcium carbonate D for reducing side effect of constipation3Chewable tablet (II) and preparation method thereof - Google Patents
Calcium carbonate D for reducing side effect of constipation3Chewable tablet (II) and preparation method thereof Download PDFInfo
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Abstract
The invention discloses calcium carbonate D for reducing side effects of constipation3Chewable tablet (II) comprising micronized calcium carbonate and vitamin D3Clathrate, mannitol, absorption enhancer, disintegrating agent, essence and magnesium stearate. Calcium carbonate D of the present invention for reducing side effects of constipation3The chewable tablet (II) has reasonable and scientific formula, uniform preparation and vitamin D3Has good content uniformity and can reduce the side effect of constipation. The invention also discloses calcium carbonate D for reducing the side effect of constipation3The preparation method of the chewable tablet (II) comprises the following steps: firstly, batching; (II) premixing; (III) granulating; (IV) total mixing; and (V) tabletting. The preparation method provided by the invention is simple in production process and strong in operability, is suitable for commercial batch production in a workshop, can greatly improve the uniformity of tablets and the dispersibility of granules after the chewable tablets are taken, and ensures that the vitamin D in each chewable tablet3Mixing with calcium completely, ensuring dissolution and absorption of calcium in vivo, and reducing constipation risk.
Description
Technical Field
The invention relates to calcium carbonate D3Chewable tablets, in particular to calcium carbonate D for reducing the side effect of constipation3Chewable tablets (II) and a preparation method thereof.
Background
Calcium is required for the maintenance of normal function of human nerve, muscle, skeletal system, cell membrane and capillary permeability. Vitamin D can participate in the metabolism of calcium and phosphorus, promote the absorption of calcium and phosphorus, and play an important role in bone formation.
Calcium carbonate D3Chewable tablets are currently the mainstream product in the calcium preparation market, are a compound preparation containing calcium and vitamin D, are a global unique specification registered and applied in 1995 by Hewlett-packard Pharmaceutical company (Wyeth Pharmaceutical Co., Ltd.) (currently, Qinhui Qixia subsidiary company), are sold as calcium Erqi chewable tablets, can be used for calcium supplements for pregnant and lactating women, climacteric women, old people, children and the like, and help to prevent and treat osteoporosis.
Due to calqiThe chewable tablet is marketed earlier, and the technical level of the time is limited, so that the calqi chewable tablet has the following problems: (1) due to vitamin D3Unstable and very small dosage (per tablet of calcium carbonate D)3The chewable tablet weighs about 1.6g, and only contains 60 units of 1.5ug of vitamin D3) Vitamin D is difficult to be extracted under the technical conditions at the time3Mixed homogeneously, resulting in calcium carbonate D3Vitamin D in chewable tablets3Non-uniformity of dosage (poor mixing uniformity); (2) the technical level requirements were also lower at the time, and therefore vitamin D was excluded3In addition, the uniformity of mixing other raw materials is also poor.
For example, chinese patent application publication No. CN110755448A, published as 2020.02.07, discloses a method for preparing a compound calcium carbonate chewable tablet for effectively improving calcium absorption rate, which comprises including vitamin D3And uniformly mixing the powder, the dry granules with the granularity not more than A meshes, the disintegrating agent with the granularity not more than 60 meshes, the essence, the coloring agent and the flavoring agent according to an equivalent progressive method, then adding the magnesium stearate with the granularity not more than 60 meshes, uniformly mixing, and tabletting to obtain the compound calcium carbonate chewable tablet. The preparation method has the following defects: the particle size distribution of the dry particles is controlled to ensure the particle size of the dry particles and the inclusion of vitamin D3The particle size of the powder is close to ensure high content uniformity of the tablet, and the particle size distribution of dry particles is difficult to control in actual operation, so that the operation difficulty is high.
Disclosure of Invention
The invention aims to solve the technical problems of the existing preparation method of compound calcium carbonate chewable tablets for effectively improving the calcium absorption rate, and provides calcium carbonate D for reducing the side effect of constipation3The chewable tablet (II) has reasonable and scientific formula, uniform preparation and vitamin D3Has good content uniformity and can reduce the side effect of constipation.
The invention also provides calcium carbonate D for reducing the side effect of constipation3The preparation method of the chewable tablet (II) has the advantages of simple production process, strong operability, good raw material mixing uniformity and quality stability, and capability of improving vitamin D3The content uniformity and the dissolution rate of calcium carbonate are improved.
In order to achieve the purpose, the invention adopts the following technical scheme:
a calcium carbonate D3 chewable tablet (II) for reducing side effects of constipation is prepared from the following raw materials in parts by weight: 4500 parts of micronized calcium carbonate, 3.6 parts of vitamin D3The formula comprises 2400-2916 parts of mannitol, 1986-2500 parts of an absorption enhancer, 144 parts of a disintegrating agent, 18 parts of essence and 144 parts of magnesium stearate. Calcium carbonate D of the invention3The formula of the chewable tablet (II) is optimized and improved, and the micronized calcium carbonate is adopted in the invention, so that the taste of the chewable tablet and the dispersibility of the chewable tablet after chewing are improved, the dissolution rate of the chewable tablet can be improved, the contact area of calcium and gastric acid is increased, and the bioavailability is improved; simultaneously a small amount of disintegrating agent is added to obtain calcium carbonate D3The chewable tablet can keep excellent disintegration and dissolution even if not chewed or not chewed completely, and reduce the occurrence of constipation side effect while improving the absorption of calcium; the absorption promoting agent is added to promote the absorption, diffusion and transportation of calcium and increase the absorption rate of calcium; adding appropriate amount of mannitol to improve intestinal function and relieve or offset constipation symptoms.
Preferably, the micronized calcium carbonate has a particle size of 10 μm or less.
Preferably, the vitamin D3The specification of the particle size of the inclusion compound is as follows: the amount of 20-mesh sieve is 100 percent, the amount of 40-mesh sieve is more than or equal to 90 percent, and the amount of 150-mesh sieve is less than or equal to 15 percent.
Preferably, the absorption enhancer is lactose and sucrose, and the mass ratio of the lactose to the sucrose is (3:2) - (2.11: 1.2).
Preferably, the disintegrant is croscarmellose sodium.
Calcium carbonate D for reducing side effect of constipation3The preparation method of the chewable tablet (II) comprises the following steps:
preparing materials: weighing the raw materials according to the weight part ratio for later use.
(II) premixing:
(I) converting vitamin D3The clathrate compound is mixed with vitamin D32.75 times of sweet of inclusion compoundMixing with distilled alcohol to obtain premix A;
(II) uniformly mixing the premix A with mannitol which is 2 times of the premix A to obtain a premix B;
(III) uniformly mixing the premix B with mannitol which is 1.96 times of the premix B to obtain a premix C;
(IV) uniformly mixing the premix C with essence and part of mannitol, wherein the total mass of the essence and part of mannitol is 2 times that of the premix C to obtain a premix D;
(V) uniformly mixing the premix D with mannitol which is 2 times of the premix D to obtain a premix E;
(VI) uniformly mixing the premix E with the rest mannitol to obtain a premix;
or (1) adding vitamin D3The clathrate compound is mixed with vitamin D3Uniformly mixing mannitol in an amount which is 4 times that of the inclusion compound to obtain premix A;
(2) uniformly mixing the premix A with mannitol which is 4 times of the premix A to obtain a premix B;
(3) uniformly mixing the premix B with essence and part of mannitol, wherein the total mass of the essence and part of mannitol is 4 times of that of the premix B to obtain premix C;
(4) and uniformly mixing the premix C with the rest mannitol to obtain the premix.
The invention adopts six-step or four-step premixing process to lead vitamin D3Mixing the clathrate with mannitol for several times to obtain vitamin D3The inclusion compound can be uniformly dispersed in the tablet, and trace vitamin D is effectively ensured3Uniformity in tablet, solves vitamin D3The problem of non-uniform dispersion in the tablet leads to a great improvement in the safety of the dosage taken by the patient.
(III) granulating: after evenly mixing the micronized calcium carbonate, the absorption promoting agent and the disintegrating agent, carrying out wet granulation to obtain the fine granules. The micronized calcium carbonate, the absorption promoting agent and the disintegrating agent are granulated to obtain the fine granules with larger grain sizes, and the micronized calcium carbonate, the absorption promoting agent and the disintegrating agent are uniformly mixed and are easier to be uniformly mixed when being subsequently mixed with the premix.
(IV) total mixing: and uniformly mixing the premix, the fine granules and the magnesium stearate to obtain a total mixed material. The premix, the fine granules and the magnesium stearate are mixed together, and the mixing uniformity is good.
And (V) tabletting: tabletting the total mixed material to obtain calcium carbonate D3Chewable tablets (II).
Preferably, a three-dimensional motion mixer is adopted for mixing in the steps (I) to (VI), and in the steps (I) to (III), the rotating speed of a mixing barrel is 40rpm, and the mixing time is 10 min; in the step (IV), the rotating speed of a mixing barrel is 52rpm, and the mixing time is 10 min; in the steps (V) and (VI), the rotating speed of a mixing barrel is 28rpm, and the mixing time is 10 min.
Preferably, a three-dimensional motion mixer is adopted for mixing in the steps (1) to (4), in the steps (1) and (2), the rotating speed of a mixing barrel is 40rpm, and the mixing time is 10 min; in the step (3), the rotating speed of a mixing barrel is 52rpm, and the mixing time is 10 min; in the step (4), the rotating speed of the mixing barrel is 28rpm, and the mixing time is 10 min.
Preferably, in the step (three), after the wet granulation, the granules are sieved with a 40-mesh sieve.
Preferably, in the step (IV), the total mixing is carried out by using a three-dimensional motion mixer, the rotating speed of a mixing barrel is 8rpm, and the mixing time is 10 min.
Therefore, the invention has the following beneficial effects:
(1) para calcium carbonate D3The formula of the chewable tablet (II) is optimized and improved, micronized calcium carbonate and vitamin D inclusion compound particles are adopted for feeding, and functional auxiliary materials of mannitol, absorption promoting agent and disintegrating agent are added according to a scientific formula proportion, so that the calcium carbonate D provided by the invention3Chewable tablet (II) preparation uniformity and vitamin D3The content uniformity is good, and the side effect of constipation can be reduced; calcium carbonate D prepared by the invention3The chewable tablet (II) is now approved by the national drug administration for production, and the approved literature is as follows: the national drug standard H20183383;
(2) the preparation method has simple production process and strong operability, and is suitable for commercial batch production in a workshop; by effectively controlling the blending process of the raw and auxiliary materialsThe process (six steps or four steps of premixing and total mixing) and the proportion greatly improve the uniformity of the tablets and the dispersibility of the granules after the chewable tablets are taken, and ensure the vitamin D in each chewable tablet3The calcium is fully and uniformly mixed with calcium, so that the dissolution and absorption of the calcium in the body are ensured, and the constipation risk is reduced.
Detailed Description
The invention is further described with reference to specific embodiments.
Example 1
Preparing materials: weighing the following raw materials in parts by weight: 45kg micronized calcium carbonate, 0.036kg vitamin D324kg of mannitol, 25kg of absorption enhancer (15kg of lactose and 10kg of cane sugar), 1.44kg of disintegrant (croscarmellose sodium), 0.18kg of essence and 1.44kg of magnesium stearate for later use.
(II) premixing:
(I) converting vitamin D3The clathrate compound is mixed with vitamin D3Mannitol (0.099kg) in an amount which is 2.75 times that of the inclusion compound is uniformly mixed in an HD-5 three-dimensional motion mixer, the rotating speed of a mixing barrel is 40rpm, and the mixing time is 10min, so that 0.135kg of premix A is obtained;
(II) uniformly mixing the premix A and mannitol (0.27kg) which is 2 times of the premix A in an HD-5 three-dimensional motion mixer, wherein the rotating speed of a mixing barrel is 40rpm, and the mixing time is 10min, so that 0.405kg of premix B is obtained;
(III) uniformly mixing the premix B and mannitol (0.794kg) which is 1.96 times of the premix B in an HD-5 three-dimensional motion mixer, wherein the rotating speed of a mixing barrel is 40rpm, and the mixing time is 10min, so that 1.2kg of premix C is obtained;
(IV) uniformly mixing the premix C, essence and part of mannitol in an HD-5 three-dimensional motion mixer, wherein the total mass of the essence and part of mannitol is 2 times (2.4kg) of that of the premix C, the rotating speed of a mixing barrel is 52rpm, and the mixing time is 10min, so that 3.6kg of premix D is obtained;
(V) uniformly mixing the premix D and mannitol (7.2kg) which is 2 times of the premix D in an HD-5 three-dimensional motion mixer, wherein the rotating speed of a mixing barrel is 28rpm, and the mixing time is 10min, so as to obtain 10.8kg of premix E;
(VI) uniformly mixing the premix E and the rest mannitol in an HD-5 three-dimensional motion mixer, wherein the rotating speed of a mixing barrel is 28rpm, and the mixing time is 10min, so as to obtain 24.2kg of premix.
(III) granulating: uniformly mixing the micronized calcium carbonate, the absorption promoting agent and the disintegrating agent, performing wet granulation, and sieving with a 40-mesh sieve for size stabilization to obtain fine granules.
(IV) total mixing: and uniformly mixing the premix, the fine granules and the magnesium stearate in an HD-5 three-dimensional motion mixer to obtain a total mixed material.
And (V) tabletting: and tabletting the total mixed material to obtain calcium carbonate D3 chewable tablets (II) (97.2kg/6 ten thousand tablets).
Example 2
Example 2 differs from example 1 in that:
(II) premixing:
(1) mixing vitamin D3The clathrate compound is mixed with vitamin D3Uniformly mixing mannitol (0.144kg) in an amount which is 4 times that of the inclusion compound to obtain 0.18kg of premix A;
(2) uniformly mixing the premix A with mannitol 4 times (0.72kg) of the premix A to obtain 0.9kg of premix B;
(3) uniformly mixing the premix B with essence and part of mannitol, wherein the total mass of the essence and part of mannitol is 4 times (3.6kg) of that of the premix B, so as to obtain 4.5kg of premix C;
(4) and uniformly mixing the premix C with the rest mannitol to obtain 24.2kg of premix.
The remaining steps were the same as in example 1.
Example 3
Example 3 differs from example 1 in that:
preparing materials: weighing the following raw materials in parts by weight: 45kg micronized calcium carbonate, 0.036kg vitamin D3The clathrate compound, 29.16kg mannitol, 19.86kg absorption promoting agent (12.66kg lactose +7.2kg sucrose), 1.44kg disintegrating agent (croscarmellose sodium), 0.18kg essence, 1.44kg magnesium stearate for standby.
The remaining steps were the same as in example 1.
Content uniformity detection
Prepared as in examples 1 to 3Calcium carbonate D of3Chewable tablet (II) and comparative example (commercially available Huishi CallQi chewable tablet (II)) were subjected to VD test according to the content uniformity test method of Chinese pharmacopoeia3The content mean and standard deviation S values, the results are shown in table 1: TABLE 1 calcium carbonate D in examples 1 to 33Chewable tablet (II) was compared to VD in the comparative example (commercially available (Huishi CallQi chewable tablet (II))3Content uniformity detection result
As can be seen from Table 1, calcium carbonate D in examples 1 to 33The standard deviation S value of the chewable tablet (II) is obviously smaller than that of a commercial product. Thus, it is shown that the calcium carbonate D prepared by the preparation method of the present invention3VD in chewable tablet (II)3The content uniformity is obviously superior to the currently marketed Huishi calcium Erqi chewable tablet (II).
(II) dissolution rate
For calcium carbonate D obtained in examples 1 to 33The dissolution rate of the chewable tablet (II) was measured in comparison with the comparative example (commercially available hui calqi chewable tablet (II)), and the measurement results are shown in table 2:
TABLE 2 calcium carbonate D in examples 1 to 33Dissolution test results for chewable tablet (II) and comparative example (commercially available Huishi CallQi chewable tablet (II))
From the above results, it was shown that: calcium carbonate D in examples 1 to 33The dissolution rate of the chewable tablet (II) is over 80 percent in 30 minutes, and basically reaches full dissolution in 60 minutes, while the dissolution rate of the commercial product in 30 minutes is only 11.5 percent, and the dissolution rate in 120 minutes is not over 50 percent, so the calcium carbonate D prepared by the preparation method of the invention3The dissolution rate of the chewable tablet (II) is obviously better than that of the product sold on the market.
The above-described embodiments are only preferred embodiments of the present invention, and are not intended to limit the present invention in any way, and other variations and modifications may be made without departing from the spirit of the invention as set forth in the claims.
Claims (7)
1. A calcium carbonate D3 chewable tablet (II) for reducing side effects of constipation is characterized by being prepared from the following raw materials in parts by weight: 4500 parts of micronized calcium carbonate, 3.6 parts of vitamin D3The inclusion compound comprises 2400-2916 parts of mannitol, 1986-2500 parts of an absorption enhancer, 144 parts of a disintegrating agent, 18 parts of essence and 144 parts of magnesium stearate; the absorption promoter is lactose and sucrose, the mass ratio of the lactose to the sucrose is (3:2) - (2.11:1.2), and the disintegrant is croscarmellose sodium;
the calcium carbonate D3 chewable tablet (II) for reducing the side effect of constipation is prepared by the following method:
preparing materials: weighing the raw materials according to the weight part ratio for later use;
(II) premixing:
(I) converting vitamin D3The clathrate compound is mixed with vitamin D3Uniformly mixing mannitol in an amount which is 2.75 times that of the inclusion compound to obtain premix A;
(II) uniformly mixing the premix A with mannitol which is 2 times of the premix A to obtain a premix B;
(III) uniformly mixing the premix B with mannitol which is 1.96 times of the premix B to obtain a premix C;
(IV) uniformly mixing the premix C with essence and part of mannitol, wherein the total mass of the essence and part of mannitol is 2 times that of the premix C to obtain a premix D;
(V) uniformly mixing the premix D with mannitol which is 2 times of the premix D to obtain a premix E;
(VI) uniformly mixing the premix E with the rest mannitol to obtain a premix;
or (1) adding vitamin D3The clathrate compound is mixed with vitamin D3Uniformly mixing mannitol in an amount which is 4 times that of the inclusion compound to obtain premix A;
(2) uniformly mixing the premix A with mannitol which is 4 times of the premix A to obtain a premix B;
(3) uniformly mixing the premix B with essence and part of mannitol, wherein the total mass of the essence and part of mannitol is 4 times of that of the premix B to obtain premix C;
(4) uniformly mixing the premix C with the rest mannitol to obtain a premix;
(III) granulating: evenly mixing micronized calcium carbonate, an absorption promoter and a disintegrating agent, and performing wet granulation to obtain fine granules;
(IV) total mixing: uniformly mixing the premix, the fine granules and the magnesium stearate to obtain a total mixed material;
and (V) tabletting: and tabletting the total mixed material to obtain the calcium carbonate D3 chewable tablet (II).
2. The calcium carbonate D3 chewable tablet (II) for reducing the side effect of constipation according to claim 1, wherein the particle size of the micronized calcium carbonate is less than or equal to 10 μm.
3. The calcium carbonate D3 chewable tablet (II) for reducing the side effects of constipation according to claim 1, wherein said vitamin D is vitamin D3The specification of the particle size of the inclusion compound is as follows: the amount of 20-mesh sieve is 100 percent, the amount of 40-mesh sieve is more than or equal to 90 percent, and the amount of 150-mesh sieve is less than or equal to 15 percent.
4. The calcium carbonate D3 chewable tablet (II) for reducing the side effect of constipation according to claim 1, wherein a three-dimensional motion mixer is used for mixing in steps (I) to (VI), and the mixing barrel rotates at 40rpm for 10min in steps (I) to (III); in the step (IV), the rotating speed of a mixing barrel is 52rpm, and the mixing time is 10 min; in the steps (V) and (VI), the rotating speed of a mixing barrel is 28rpm, and the mixing time is 10 min.
5. The calcium carbonate D3 chewable tablet (II) for reducing the side effect of constipation according to claim 1, wherein a three-dimensional motion mixer is used for mixing in steps (1) to (4), and in steps (1) and (2), the rotation speed of a mixing barrel is 40rpm, and the mixing time is 10 min; in the step (3), the rotating speed of a mixing barrel is 52rpm, and the mixing time is 10 min; in the step (4), the rotating speed of the mixing barrel is 28rpm, and the mixing time is 10 min.
6. The calcium carbonate D3 chewable tablet (II) for reducing the side effect of constipation according to claim 1, wherein in step (III), after wet granulation, the granules are sieved by a 40-mesh sieve.
7. The calcium carbonate D3 chewable tablet (II) for reducing the side effect of constipation according to claim 1, wherein in the step (IV), the total mixing is carried out by a three-dimensional motion mixer, the rotating speed of the mixing barrel is 8rpm, and the mixing time is 10 min.
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| CN106619706B (en) * | 2016-12-29 | 2019-08-30 | 山东达因海洋生物制药股份有限公司 | A kind of calcium carbonate D to replenish the calcium for children3Chewable tablets and preparation method thereof |
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