Oyster shell calcium carbonate granules and process for their production

Abstract

The application provides oyster shell calcium carbonate particles and a preparation method thereof. The particles comprise oyster shell calcium carbonate, sucrose, citric acid, polyethylene glycol 2000 and a hydrophobic material. After hot melt granulation, the application can avoid introducing moisture during the granulation process, and can isolate the oyster shell calcium carbonate from the citric acid, thereby avoiding direct contact between the oyster shell calcium carbonate and the citric acid for reaction, and solving the problem of package swelling.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparations, specifically relating to oyster calcium carbonate granules and their preparation method. Background Technology

[0002] Calcium is an essential element in the human body, playing vital physiological roles. It constitutes 1.5-2% of total body weight. Calcium is not only a major component of bones but also essential for maintaining nerve and muscle function. It plays a crucial role in maintaining normal heart, kidney, and lung function, blood clotting, and the permeability of cell membranes and capillaries. Furthermore, it regulates the secretion and storage of neurotransmitters and hormones, the uptake and utilization of amino acids, and vitamin B1. 12 Absorption, etc. Due to insufficient daily calcium intake, or for special groups such as young children who grow rapidly and require high amounts of calcium, the elderly who experience accelerated calcium loss, and pregnant women who are pregnant, sufficient calcium supplementation is necessary in addition to dietary intake.

[0003] Oyster shell calcium carbonate is a natural active calcium source prepared from the shells of oysters through high-temperature calcination and electrolytic activation. Compared to traditional calcium carbonate, oyster shell calcium carbonate has higher solubility and bioavailability due to its unique microcrystalline structure. It is widely used clinically for calcium supplementation in children, pregnant / lactating women, and the elderly, and is listed as a standard preparation in the pharmacopoeias of China, the United States, the United Kingdom, and Japan.

[0004] Existing calcium carbonate preparations generally employ wet granulation, requiring the addition of citric acid as a flavoring agent and an acidic regulator to promote calcium absorption. Moisture introduced during wet granulation and the humidity of the storage environment can easily cause citric acid to absorb moisture, triggering an acid-base reaction with calcium carbonate. This results in the formation of insoluble calcium citrate precipitate and carbon dioxide gas, leading to unsatisfactory solubility (such as prolonged dispersibility and turbidity) and packaging bloating. Therefore, improving the solubility of oyster shell calcium carbonate granules and ensuring the stability of quality indicators are crucial to enhancing the calcium supplementation effect of oyster shell calcium carbonate. Summary of the Invention

[0005] One object of the present invention is to provide oyster calcium carbonate granules that can effectively improve the stability of the product.

[0006] The problem described in this invention is solved by the following technical solution:

[0007] An oyster calcium carbonate granule comprises oyster calcium carbonate, sucrose, citric acid, polyethylene glycol 2000, and a hydrophobic material, wherein the oyster calcium carbonate comprises 125 parts, sucrose comprises 4335-4515 parts, citric acid comprises 150-200 parts, polyethylene glycol 2000 comprises 200-300 parts, and the hydrophobic material comprises 10-40 parts.

[0008] According to a preferred embodiment of the present invention, the oyster shell calcium carbonate is 125 parts, sucrose is 4365-4445 parts, citric acid is 160-180 parts, polyethylene glycol 2000 is 250-300 parts, and hydrophobic material is 20-30 parts.

[0009] According to a preferred embodiment of the present invention, the hydrophobic material is selected from one or more of beeswax, glyceryl monostearate, and cetearyl alcohol.

[0010] According to a preferred embodiment of the present invention, the hydrophobic material is selected from hexadecyl alcohol.

[0011] Another object of the present invention is to provide a method for preparing oyster calcium carbonate granules, comprising the following steps:

[0012] (1) Mix the prescribed amount of oyster calcium carbonate with the hydrophobic material evenly, then add polyethylene glycol 2000, perform hot melt granulation, and then granulate after granulation.

[0013] (2) The obtained granules are mixed with citric acid and sucrose and packaged to obtain oyster calcium carbonate granules.

[0014] According to a preferred embodiment of the present invention, the hot melt granulation temperature in step (1) is 45~60℃.

[0015] Compared to existing technologies, the advantages of this invention lie in its innovative use of polyethylene glycol 2000 for hot-melt granulation of oyster shell calcium carbonate. This avoids the introduction of moisture during the granulation process and prevents direct contact and reaction between the oyster shell calcium carbonate and citric acid. Simultaneously, the use of a hydrophobic material to coat the oyster shell calcium carbonate effectively improves the stability of the oyster shell calcium carbonate particles and prevents packaging gas buildup. Detailed Implementation

[0016] To enable those skilled in the art to more clearly understand the technical solutions described in this invention, the following embodiments are provided for illustration. It should be noted that the following embodiments do not constitute a limitation on the scope of protection claimed by this invention.

[0017] Unless otherwise specified, the raw materials, reagents or devices used in the following examples are available from conventional commercial sources or can be obtained by existing known methods.

[0018] Example 1

[0019] (1) Mix 125 parts of oyster calcium carbonate and 10 parts of cetearyl alcohol, then add 200 parts of polyethylene glycol 2000, and perform hot melt granulation at 45°C. After granulation, use a swing granulator to granulate through a 16-mesh sieve.

[0020] (2) The obtained granules are mixed with 150 parts of citric acid and 4515 parts of sucrose, and then packaged to obtain oyster calcium carbonate granules.

[0021] Example 2

[0022] (1) Mix 125 parts of oyster calcium carbonate and 20 parts of beeswax, then add 240 parts of polyethylene glycol 2000 and perform hot melt granulation at 60°C. After granulation, use a swing granulator to granulate through a 16-mesh sieve.

[0023] (2) The obtained granules are mixed with 160 parts of citric acid and 4455 parts of sucrose, and then packaged to obtain oyster calcium carbonate granules.

[0024] Example 3

[0025] (1) Mix 125 parts of oyster calcium carbonate and 30 parts of glyceryl monostearate and then add 260 parts of polyethylene glycol 2000. Perform hot melt granulation at 50°C. After granulation, use a swing granulator to granulate through a 16-mesh sieve.

[0026] (2) The obtained granules are mixed with 180 parts of citric acid and 4405 parts of sucrose, and then packaged to obtain oyster calcium carbonate granules.

[0027] Example 4

[0028] (1) Mix 125 parts of oyster calcium carbonate and 40 parts of cetearyl alcohol, then add 300 parts of polyethylene glycol 2000, and perform hot melt granulation at 55°C. After granulation, use a swing granulator to granulate through a 16-mesh sieve.

[0029] (2) The obtained granules are mixed with 200 parts of citric acid and 4335 parts of sucrose, and then packaged to obtain oyster calcium carbonate granules.

[0030] Comparative Example 1

[0031] (1) Mix 125 parts of oyster calcium carbonate and 340 parts of polyvinyl alcohol 2000, and then perform hot melt granulation at 55°C. After granulation, use a swing granulator to granulate through a 16-mesh sieve.

[0032] (2) The obtained granules are mixed with 200 parts of citric acid and 4335 parts of sucrose, and then packaged to obtain oyster calcium carbonate granules.

[0033] Comparative Example 2

[0034] Mix 125 parts of oyster calcium carbonate and 40 parts of cetearyl alcohol, then add 300 parts of polyethylene glycol 2000, and then mix with 200 parts of citric acid and 4475 parts of sucrose. The mixture is then wet-granulated, sized, and packaged to obtain oyster calcium carbonate granules.

[0035] Comparative Example 3

[0036] (1) 125 parts of oyster calcium carbonate, 175 parts of citric acid and 4700 parts of sucrose used as filler were crushed and passed through a 100-mesh sieve respectively.

[0037] (2) Weigh 250 parts of purified water, heat to 30-40℃, add 200 parts of sucrose to the purified water while stirring, until the solution is clear and transparent to obtain solution A;

[0038] (3) Mix 125 parts of oyster calcium carbonate, 175 parts of citric acid and 4500 parts of sucrose evenly using the equal-increment method and then put them into a high-efficiency wet granulation pot.

[0039] (4) Add solution A to granulate while stirring and shearing are turned on. After adding solution A, keep stirring and shearing for 60 seconds to granulate and obtain soft material. Use a swing pellet mill to pass the soft material through a 16-mesh sieve to obtain wet granules.

[0040] (5) The wet granules are dried using a fluidized bed. During drying, the air inlet temperature is controlled at 40℃~60℃. The dried granules are then screened using a ternary vibrating screen to obtain oyster calcium carbonate granules.

[0041] Test case

[0042] According to the national drug standard (WS-10001-(HD-1037)-2002), the solubility of oyster calcium carbonate granules was tested, and the gas expansion of the oyster calcium carbonate granule packaging was observed. The test results are shown in the table below:

[0043] .

Claims

1. A type of oyster calcium carbonate granules, characterized in that, The product comprises oyster shell calcium carbonate, sucrose, citric acid, polyethylene glycol 2000, and a hydrophobic material. The oyster shell calcium carbonate comprises 125 parts, sucrose 4335-4515 parts, citric acid 150-200 parts, polyethylene glycol 2000 200-300 parts, and the hydrophobic material 10-40 parts. The hydrophobic material is selected from one or more of beeswax, glyceryl monostearate, and cetearyl alcohol. The preparation method of the oyster shell calcium carbonate particles includes the following steps: (1) Mix the prescribed amount of oyster calcium carbonate with the hydrophobic material evenly, then add polyethylene glycol 2000, perform hot melt granulation, and after granulation, granulate. (2) The obtained granules are mixed with citric acid and sucrose and packaged to obtain oyster calcium carbonate granules.

2. The oyster shell calcium carbonate granules as described in claim 1, characterized in that, The hydrophobic material is hexadecyl alcohol.

3. The oyster shell calcium carbonate granules as described in claim 1, characterized in that, The composition of the oyster shell calcium carbonate is 125 parts, sucrose is 4365-4445 parts, citric acid is 160-180 parts, polyethylene glycol 2000 is 250-300 parts, and hydrophobic material is 20-30 parts.

4. The oyster calcium carbonate granules as described in claim 1, characterized in that, In step (1), the hot melt granulation temperature is 45~60℃.