Intragastric floating type calcium tablet and preparation method thereof

Abstract

The invention discloses an intragastric floating type calcium tablet and a preparation method thereof, the intragastric floating type calcium tablet comprises a calcium carbonate-starch pregelatinization co-treatment material and a hydrophilic skeleton polymer material, and the mass ratio of the hydrophilic skeleton polymer material to the calcium carbonate-starch pregelatinization co-treatment material is 1: 4-9. According to the present invention, the pre-gelatinized co-treated substance of calcium carbonate and starch is applied to the gastric floating drug delivery system, the pre-gelatinized co-treated substance of calcium carbonate and starch has excellent fluidity and compressibility, and the calcium carbonate particles are uniformly embedded in the surfaces or the internal recesses of the pre-gelatinized starch particles so as to significantly improve the binding force between the particles, and the problem of content uniformity caused by particle segregation in the material flowing process is avoided. Besides, the gastric floating type calcium tablet disclosed by the invention is simple in component, free from the problem of long floating lag time, relatively long in-stomach floating time and capable of continuously releasing Ca < 2 + >, and the powder can be directly prepared into the gastric floating type calcium tablet by a tabletting method, so that the production steps are simplified, and the production efficiency is greatly improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparation, and in particular relates to a gastric floating calcium tablet based on a calcium carbonate-starch pregelatinized co-processed product and a preparation method thereof. Background Art

[0002] Calcium plays an important role in maintaining the normal functioning of the body's physiological activities. For patients with calcium deficiency, taking calcium supplements is an important way to increase calcium intake. Currently, most calcium supplements on the market use calcium carbonate as a calcium source, such as calcium carbonate chewable tablets and calcium carbonate granules. These calcium carbonate preparations are dissociated by gastric acid after oral administration, rapidly producing a large amount of Ca 2+ , then enters the small intestine, but due to Ca 2+ The residence time in the upper small intestine (duodenum and jejunum), the main absorption site, is limited, and the dissociated Ca 2+ Difficult to be fully absorbed.

[0003] In order to increase the content of Ca in calcium supplements, the prior art 2+ In order to improve the absorption rate in the body, the strategy of combining vitamin D and calcium carbonate and developing new soluble organic calcium with higher solubility (amino acid chelated calcium, casein phosphopeptide calcium) are usually adopted. However, these products inevitably have defects such as increased cost, decreased formulation stability and long development cycle.

[0004] Gastric floating tablets are preparations whose density is less than that of gastric fluid and which float in the stomach for a long time. Gastric floating tablets are not affected by gastric emptying and are suitable for active ingredients with a narrow absorption window (absorbed only in the upper gastrointestinal tract). 2+ If calcium carbonate is used as a calcium source to prepare gastric floating tablets, they can stay in the stomach for a long time and continuously release Ca 2+ , to increase Ca 2+ The purpose of absorption is that calcium carbonate is widely available and inexpensive.

[0005] Gastric floating tablets can be prepared using hot-melt extrusion, 3D printing, and sublimation methods, or they can be prepared using conventional tablet preparation methods such as dry / wet granulation and direct powder compression, depending on the material properties. Among these methods, direct powder compression involves directly mixing multiple materials and then compressing them. This method has the highest production efficiency, but it places high demands on the fluidity of the materials. Furthermore, poor material mixing uniformity in the direct powder compression process is also a key issue that needs to be addressed. This is because no wet adhesive is used in this process, and the bonding force between materials is weaker than that of wet granulation particles. Material stratification often occurs due to particle segregation, especially when the particle sizes of the materials are not within a similar range. Calcium carbonate is both a calcium source for calcium supplements and a gas-producing component for gastric floating tablets. However, the powder itself has poor fluidity and a small particle size, which is significantly different from the particle size of most pharmaceutical excipients. Therefore, during the flow of the material, the particle group containing calcium carbonate is entrained by the local turbulent airflow, causing the calcium carbonate particles to tend to remain in the spatial voids for a longer time, resulting in a fluidized separation phenomenon similar to dust, which ultimately affects the uniformity of the drug content. Summary of the Invention

[0006] In response to the above-mentioned problems of the prior art, the purpose of the present invention is to provide a gastric floating calcium tablet based on a calcium carbonate-starch pregelatinized co-processed product and a preparation method thereof. After the calcium carbonate and starch are co-processed, they have excellent fluidity and compressibility, and can significantly improve the binding force between particles, thereby avoiding the problem of particle segregation during the material flow process. The gastric floating calcium tablet based on the calcium carbonate-starch pregelatinized co-processed product has simple ingredients, does not have the problem of long floating lag time, has a long floating time in the stomach, and can continuously release Ca. 2+ The powder can be directly compressed into tablets to prepare gastric floating calcium tablets, which simplifies the production steps and greatly improves production efficiency.

[0007] The present invention is achieved through the following technical solutions:

[0008] A gastric floating calcium tablet comprises a calcium carbonate-starch pregelatinized co-processed product and a hydrophilic skeleton polymer material, wherein the mass ratio of the hydrophilic skeleton polymer material to the calcium carbonate-starch pregelatinized co-processed product is 1:4-9.

[0009] Through screening and optimization of hydrophilic matrix polymer materials, the present invention selects hydropropyl methylcellulose (HPMC), more preferably HPMC K100M, as the hydrophilic matrix polymer material. Hydropropyl methylcellulose is a hydrophilic gel material that absorbs water and swells, increasing its volume, providing buoyancy to maintain the tablet's continued floatation. This increased tablet volume also prolongs gastric emptying time. It can also serve as a sustained-release material, allowing for sustained, slow release of the drug.

[0010] The mass ratio of the hydrophilic skeleton polymer material to the calcium carbonate-starch pregelatinized co-processed product is one of the main factors affecting the floating ability and release behavior of the gastric floating calcium tablet. The present invention controls the mass ratio of the hydrophilic skeleton polymer material to the calcium carbonate-starch pregelatinized co-processed product within the range of 1:4 to 9 (for example, it can be 1:4, 1:5, 1:6, 1:7, 1:8, 1:9 or any range between the above values), thereby preparing a gastric floating calcium tablet with a long floating duration and capable of continuously releasing Ca in the stomach. 2+ .

[0011] The calcium carbonate-starch pregelatinized co-processed product of the present invention is prepared by mixing calcium carbonate, starch and water and then subjecting the mixture to microwave treatment.

[0012] Starch is a commonly used tablet filler and disintegrant, and pregelatinization can significantly improve its fluidity and compressibility. The present invention pregelatinizes calcium carbonate and starch after mixing to improve its fluidity and compressibility. This solves the problem that calcium carbonate itself has poor fluidity and is difficult to meet the requirements of direct powder tableting. Direct tableting can be achieved without the addition of other excipients, reducing raw material costs. At the same time, calcium carbonate particles can be evenly embedded in the surface or internal depressions of pregelatinized starch particles, significantly improving the binding force between particles and avoiding the problem of content uniformity caused by particle segregation during material flow.

[0013] Preferably, the mass ratio of calcium carbonate to starch is 1:2-4.

[0014] The present invention has discovered through research that when starch absorbs more microwave radiation during pregelatinization, the degree of structural breakdown of the starch granules is accelerated, exposing more amylopectin, resulting in stronger cohesiveness. Under mechanical stress, it is more likely to form a densified structure, and the resulting gastric-floating calcium tablets have a greater hardness. However, when the hardness increases to a certain level, it may affect the penetration rate of the dissolution medium into the tablet, delaying the tablet's floating lag time, and adversely affecting the tablet's floating ability and dissolution behavior. Therefore, preferably, during the microwave treatment, the time and frequency of the microwave treatment are adjusted so that the microwave energy value obtained per gram of starch is 437J to 4368J (for example, it can be 437J, 1310J, 4368J, or any range between the above values)).

[0015] The present invention also provides a method for preparing the above-mentioned gastric floating calcium tablet, comprising the following steps:

[0016] The calcium carbonate-starch pregelatinized co-processed product is mixed with a hydrophilic skeleton polymer material, sieved, and the powder is directly compressed into tablets. The present invention realizes the preparation of gastric floating calcium tablets by direct powder compression, greatly simplifies the production steps, and significantly improves production efficiency.

[0017] Compared with the prior art, the present invention has the following advantages:

[0018] The present invention is the first to apply the pregelatinized co-processed product of calcium carbonate and starch to a gastric floating drug delivery system. The pregelatinized co-processed product of calcium carbonate and starch has excellent fluidity and compressibility. At the same time, the calcium carbonate particles are evenly embedded in the surface or internal depressions of the pregelatinized starch particles, which significantly improves the binding force between the particles and avoids the problem of content uniformity caused by particle segregation during the material flow process. In addition, the calcium tablet of the present invention has simple components and does not contain other excipients. The prepared gastric floating calcium tablet has no floating lag time, the floating duration is long, and can continuously release Ca in the stomach. 2+ Among them, calcium carbonate can act as an effervescent component to react with gastric acid to cause mass loss and prolong the floating time of tablets, and at the same time act as a Ca 2+ The present invention realizes multiple functions with simple components, and the preparation method of direct tableting is simple, which greatly reduces the preparation cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 Electron microscope images of the calcium carbonate-pregelatinized starch co-processed product + HPMC powder mixture in Example 1 (left) and the calcium carbonate-pregelatinized starch physical mixture + HPMC powder mixture in Comparative Example 6 (right);

[0020] Figure 2 Schematic diagram of calcium content and cycle number in the fluidized separation test of the calcium carbonate-pregelatinized starch pregelatinized co-processed product + HPMC powder mixture in Example 1 and the calcium carbonate-pregelatinized starch physical mixture + HPMC powder mixture in Comparative Example 6;

[0021] Figure 3 Floating state diagram of Example 1 and Comparative Example 4;

[0022] Figure 4 The in vitro Ca 2+ Release curve diagram. DETAILED DESCRIPTION

[0023] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments of the present invention. The described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0024] The raw materials used in the examples and comparative examples of the present invention are all derived from commercially available products.

[0025] Example 1:

[0026] Calcium carbonate, corn starch, and ultrapure water were mixed in a mass ratio of 1:2:8, microwave-treated to obtain a microwave energy of 4368 J per gram of corn starch, and the product was dried to obtain a calcium carbonate-starch pregelatinized co-processed product;

[0027] By weight, 20 parts of HPMC K100M and 80 parts of calcium carbonate-starch pregelatinized co-processed product were mixed evenly in a mortar, and an appropriate amount of powder was manually filled into a single punch tablet press mold, and the powder was directly pressed to obtain a gastric floating calcium tablet.

[0028] Example 2:

[0029] Calcium carbonate, corn starch, and ultrapure water were mixed in a mass ratio of 1:2:8, microwave-treated to obtain a microwave energy of 4368 J per gram of corn starch, and the product was dried to obtain a calcium carbonate-starch pregelatinized co-processed product;

[0030] By weight, 10 parts of HPMC K100M and 90 parts of calcium carbonate-starch pregelatinized co-processed product were mixed evenly in a mortar, and an appropriate amount of powder was manually filled into a single punch tablet press mold, and the powder was directly pressed to obtain a gastric floating calcium tablet.

[0031] Example 3:

[0032] Calcium carbonate, corn starch and ultrapure water were mixed in a mass ratio of 1:2:8, microwave treatment was performed to obtain a microwave energy of 437 J per gram of corn starch, and the product was dried to obtain a calcium carbonate-starch pregelatinized co-processed product;

[0033] By weight, 20 parts of HPMC K100M and 80 parts of calcium carbonate-starch pregelatinized co-processed product were mixed evenly in a mortar, and an appropriate amount of powder was manually filled into a single punch tablet press mold, and the powder was directly pressed to obtain a gastric floating calcium tablet.

[0034] Example 4:

[0035] Calcium carbonate, corn starch, and ultrapure water were mixed in a mass ratio of 1:4:8, microwave-treated to obtain a microwave energy of 4368 J per gram of corn starch, and the product was dried to obtain a calcium carbonate-starch pregelatinized co-processed product;

[0036] By weight, 15 parts of HPMC K100M and 85 parts of calcium carbonate-starch pregelatinized co-processed product were mixed evenly in a mortar, and an appropriate amount of powder was manually filled into a single punch tablet press mold, and the powder was directly pressed to obtain a gastric floating calcium tablet.

[0037] Comparative Example 1:

[0038] The difference from Example 1 is that 20 parts of HPMC K100M are replaced by HPMC K200M.

[0039] Comparative Example 2:

[0040] The difference from Example 1 is that 20 parts of HPMC K100M are replaced by konjac glucomannan.

[0041] Comparative Example 3:

[0042] The difference from Example 1 is that 20 parts of HPMC K100M are replaced by sodium alginate.

[0043] Comparative Example 4:

[0044] The difference from Example 1 is that 5 parts of HPMC K100M and 95 parts of calcium carbonate-starch pregelatinized co-processed product are used.

[0045] Comparative Example 5:

[0046] The difference from Example 1 is that 40 parts of HPMC K100M and 60 parts of calcium carbonate-starch pregelatinized co-processed product are used.

[0047] Comparative Example 6:

[0048] Calcium carbonate and commercially available pregelatinized corn starch were mixed in a ratio of 1:2 to obtain a physical mixture of calcium carbonate and pregelatinized corn starch;

[0049] By weight, 20 parts of HPMC K100M and 80 parts of a physical mixture of calcium carbonate and pregelatinized starch were mixed uniformly in a mortar, and an appropriate amount of powder was manually filled into a single-punch tablet press mold, and the powder was directly pressed to obtain a gastric floating calcium tablet.

[0050] Test Example 1:

[0051] This experiment used a homemade simple device to evaluate the fluidized separation behavior of the mixed powder of the gastric floating tablet prescription. It consisted of eight glass tubes with a length of 15 cm and an inner diameter of 1.20 cm. The tubes were assembled from top to bottom, and a 5 cm hose was used in the middle to connect the two upper and lower glass tubes. The leakage length of the glass tubes was 10 cm. The four glass tubes on the top were combined into the upper tube, and the four glass tubes on the bottom were combined into the lower tube. The hose in the middle of the upper and lower tubes was clamped with a hose clamp, and the lower end of the lower tube was also connected to the clamped hose.

[0052] Specific operation: Weigh appropriate amounts of the calcium carbonate-pregelatinized starch co-processed product powder of Example 1 and the calcium carbonate-pregelatinized starch physical mixture powder of Comparative Example 6, add HPMC K100M in equal amounts according to the prescribed amount, mix evenly, and filter through 600 μm (30 mesh). Take 30 g of the mixed powder and pour it quickly from the upper end of the upper tube to complete the tube loading. Then loosen the middle hose clamp to allow the mixed powder in the upper tube to flow freely into the lower tube. This operation is recorded as 1 cycle. Loosen the hose clamp below the lower tube, take appropriate amount of powder at the designated position H0, and repeat the same operation 60 times. Take appropriate amount of powder at H0 in the 1st, 5th, 10th, 15th, 30th, 45th, and 60th cycles, respectively, and measure the calcium content. Plot the graph with the calcium content as the y-axis and the number of cycles n as the x-axis. The results are shown in the figure. Figure 2 shown.

[0053] The results show that with the increase in the number of cycles, the calcium content in the mixed powder of the physical mixture + HPMC in Comparative Example 6 and the mixed powder of the pregelatinized co-processed product + HPMC in Example 1 decreased from (9.56±0.17)% and (9.98±0.07)% in the 0th cycle to (2.76±0.11)% and (8.61±0.14)% in the 60th cycle, respectively; this indicates that the interaction between the particles of the mixed powder of the physical mixture + HPMC in Comparative Example 6 is significantly weaker than that of the mixed powder of the pregelatinized co-processed product + HPMC in Example 1. When flowing under this simulated extreme segregation environment, the fluidization separation phenomenon caused by the entrainment effect of the local turbulent airflow in the lumen on the particles is more obvious, resulting in a significant decrease in the calcium content at the bottom of the lower tube.

[0054] like Figure 1 As shown in the electron micrograph, the surface of the pregelatinized starch granules in the physical mixture in Comparative Example 6 is covered with uneven calcium carbonate aggregates, while in the mixed powder of pregelatinized co-processed product + HPMC in Example 1, the fine calcium carbonate particles are embedded in the depressions of the coarse pregelatinized starch granules to form ordered composite particle units, showing a low degree of separation risk. This will have a beneficial effect on the content uniformity of the industrially produced gastric floating calcium tablets based on the calcium carbonate-starch pregelatinized co-processed product.

[0055] Test Example 2: Determination of physical parameters of gastric floating calcium tablets

[0056] Six tablets of each of the examples and comparative examples were taken, and the thickness and diameter of the gastric floating calcium tablets were measured by a vernier caliper, the weight of the gastric floating calcium tablets was measured by an electronic analytical balance, and the hardness of the gastric floating calcium tablets was measured by a tablet hardness tester. The results are shown in Table 1.

[0057] Table 1 is a table of physical parameters of the gastric floating calcium tablets of the embodiment and the comparative example.

[0058]

[0059]

[0060] The results in Table 1 show that the tablet hardness of Examples 1-4 ranged from 15N to 59N. Compared with Example 1, Comparative Example 4 increased the proportion of the co-processed compound in the formulation, resulting in a significant increase in tablet hardness. Compared with Example 1, Comparative Example 5 decreased the proportion of the co-processed compound in the formulation, resulting in a significant decrease in tablet hardness. In Comparative Example 3, sodium alginate was selected as the hydrophilic matrix polymer material, and the tablet hardness exceeded 70N. This indicates that the hardness of gastric-floating calcium tablets prepared at the same pressure is correlated with the cumulative microwave energy value obtained from the starch, the ratio of the calcium carbonate-starch pregelatinized co-processed compound to the hydrophilic matrix polymer material, and the type of hydrophilic matrix polymer material.

[0061] Generally speaking, an appropriate hardness (10-200N) can prevent tablets from loosening or cracking. However, increasing the hardness of gastric-floating calcium tablets to a certain level (>59N) can affect the penetration rate of the dissolution medium into the tablet, adversely affecting the tablet's floatation ability and dissolution behavior. The present invention achieves a gastric-floating calcium tablet with a hardness of 15-59N by controlling the ratio of the calcium carbonate-starch pregelatinized co-processed product to the hydrophilic matrix polymer material and selecting and optimizing the type of hydrophilic matrix polymer material.

[0062] Test Example 3: Floating Capacity Test of Gastric Floating Calcium Tablets

[0063] 16.4 mL of dilute hydrochloric acid was added to approximately 800 mL of water and mixed with 10 g of pepsin. After shaking, the mixture was diluted to 1000 mL with water and the pH was adjusted to 1 to obtain simulated gastric fluid (SGF). The gastric-floating calcium tablets prepared in the Examples and Comparative Examples were placed in beakers containing 200 mL of SGF, which were then incubated in a water bath at 37 ± 0.5°C. The time it took for the tablet to rise from the bottom of the beaker to the surface of the liquid was recorded by direct observation as the floating lag time, and the total floating time was recorded as the floating duration time. The results are shown in Table 2.

[0064] Table 2 Floating ability test results

[0065]

[0066] The results showed that the floating calcium tablets of both the Examples and Comparative Examples had a floating lag time of 0 seconds, indicating that the density of the floating calcium tablets is inherently lower than that of the dissolution medium, allowing the tablets to float immediately upon contact with the solution. The floating durations of Examples 1-4, Comparative Examples 1-2, and Comparative Examples 5-6 all exceeded 24 hours, indicating prolonged retention in the stomach.

[0067] Comparative Example 3 selected sodium alginate as the hydrophilic skeleton polymer material, and the floating duration was only 1.76 h.

[0068] like Figure 3 As shown, the gel layer of the tablet of Comparative Example 4 was largely destroyed around 0.55 h, which accelerated the erosion of the external gastric acid into the internal matrix of the tablet. This may be due to the insufficient content of HPMC K100M in the formula, resulting in an incomplete gel surface barrier formed when the tablet came into contact with the dissolution medium.

[0069] Test Example 4: In vitro Ca 2+ Cumulative dissolution rate test

[0070] Take 6 pieces of gastric floating calcium tablets of each embodiment and comparative example respectively, and test the Ca content of gastric floating calcium tablets in simulated gastric acid environment according to the second method of dissolution test method of the 2020 edition of the Chinese Pharmacopoeia. 2+ Cumulative dissolution, Ca in dissolution medium 2+ The content was determined by EDTA titration. Reference preparation 1 used calcium carbonate tablets (Jilin Wantong Pharmaceutical Co., Ltd.) and reference preparation 2 used pediatric calcium carbonate D3 granules (Kunming Yuanrui Pharmaceutical Co., Ltd.). The results are shown in Figure 4 .

[0071] The results showed that compared with reference preparation 1 and reference preparation 2, Examples 1-4 all had good Ca 2+ The sustained release behavior of the tablets was observed, and no obvious burst release behavior was observed within 2 hours. Comparative Examples 1-3 and Comparative Example 5 may be due to the fact that when the tablets came into contact with the dissolution medium, the hydrophilic skeleton polymer material formed a high-viscosity gel barrier on the surface, which greatly reduced the rate at which the medium penetrated into the internal matrix of the tablets, hindering the Ca 2+ Compared with Example 1, the release endpoint was significantly lower, indicating incomplete release. Comparative Example 2 even reached a dissolution plateau after 10 hours. Compared with Example 1, the cumulative dissolution rate of Comparative Example 6 at the 24-hour release endpoint was 88.44%, lower than the 94.31% of Example 1. This indicates that the calcium carbonate-pregelatinized starch co-processed product exhibits better sustained-release behavior than the calcium carbonate-pregelatinized starch physical mixture.

[0072] Test Example 5: Apparent Calcium Absorption Rate in the Body

[0073] New Zealand white rabbits, weighing about 2.5 kg / rabbit, were provided by Hefei Qingyuan Biotechnology Co., Ltd. After one week of adaptive feeding under controlled temperature, humidity and light conditions, the rabbits were randomly divided into three groups. The blank control group, the ordinary calcium tablet group (reference preparation 1), and the gastric floating tablet group (Example 1), 1 rabbit per cage, were raised for 4 weeks and then subjected to a metabolic experiment for one week. All rabbits were fed a fixed amount of feed every day (to determine the calcium intake), and the consumption of the feed was monitored. In each group of rabbits in Reference Preparation 1 and Example 1, a plastic-catheter piston device was used to push the calcium tablet to the root of the rabbit's tongue according to a dose of 133 mg / kg of calcium content to complete swallowing. The blank control group was not treated in any way. Feces were collected regularly every day, dried in an oven to constant weight, and the feces mass was recorded. After grinding the stool, accurately weigh approximately 300 mg of the stool sample and place it in a polytetrafluoroethylene beaker. Add 6 mL of concentrated nitric acid and 2 mL of concentrated hydrochloric acid. Digest the mixture by gradually heating on an electric stove or hot plate. When the digestion solution becomes colorless and transparent or slightly yellow, immediately remove the acid. After cooling, dilute the solution to 250 mL with ultrapure water. Accurately measure 10 mL and dilute to 50 mL. Adjust the pH of the solution to between 10 and 11 with sodium hydroxide, add 3 to 5 drops of calcium reagent, and titrate with EDTA solution. Calculate the daily fecal calcium content. The results are shown in Table 3.

[0074]

[0075] Note: Calcium intake = calcium content in feed + calcium content in calcium tablets.

[0076] Table 3 Apparent calcium absorption rate in rabbits over 7 days

[0077]

[0078] Note: In the same column of the table, compared with the blank control group, **P<0.01, ***P<0.001

[0079] Table 3 shows the cumulative excretion of fecal calcium in rabbits over the past 7 days, as well as the cumulative apparent calcium absorption and apparent calcium absorption rate of different groups. As shown in Table 3, the apparent calcium absorption rate (%) of rabbits in the ordinary calcium tablet group (reference preparation 1) and the gastric floating calcium tablet group (Example 1) were significantly higher than that in the blank control group, and the difference was statistically significant (P<0.001), indicating that both commercially available calcium carbonate tablets and the gastric floating calcium tablets prepared by the present invention can significantly improve calcium absorption. The apparent calcium absorption rate of the gastric floating calcium tablet group was significantly higher than that of the ordinary calcium tablet group, and the difference was statistically significant (P<0.01), indicating that under similar calcium intake conditions, the gastric floating calcium tablets have more calcium absorption. 2+ Absorbed by the intestine into the blood or reabsorbed by the glomeruli, less Ca 2+ Excreted in feces, Ca2+ The absorption efficiency is more advantageous than commercially available calcium carbonate tablets.

Claims

1. A gastric floating calcium tablet, characterized in that: The invention comprises a calcium carbonate-starch pregelatinized co-processed product and a hydrophilic skeleton polymer material, wherein the mass ratio of the hydrophilic skeleton polymer material to the calcium carbonate-starch pregelatinized co-processed product is 1:4-9.

2. The gastric floating calcium tablet according to claim 1, characterized in that The hydrophilic backbone polymer material is hypromellose, preferably HPMC K100M.

3. The gastric floating calcium tablet according to claim 1, characterized in that The calcium carbonate-starch pregelatinized co-processed product is prepared by mixing calcium carbonate, starch and water and then subjecting the mixture to microwave treatment.

4. The gastric floating calcium tablet according to claim 3, characterized in that: The mass ratio of calcium carbonate to starch is 1:2-4.

5. The gastric floating calcium tablet according to claim 3, characterized in that: The starch is one or more of corn starch, tapioca starch, wheat starch or pea starch.

6. The gastric floating calcium tablet according to claim 3, characterized in that: During the microwave treatment, the time and frequency of the microwave treatment are adjusted so that the microwave energy value obtained per gram of starch is 437 J to 4368 J.

7. The method for preparing the gastric floating calcium tablet according to any one of claims 1 to 6, characterized in that: The steps include: The calcium carbonate-starch pregelatinized co-processed product is mixed with the hydrophilic skeleton polymer material, sieved, and the powder is directly pressed into tablets to obtain the product.

Images