Oyster calcium carbonate particles and preparation method thereof

Abstract

The invention provides oyster calcium carbonate particles and a preparation method thereof. The particles comprise oyster calcium carbonate, cane sugar, citric acid, polyethylene glycol 2000 and a hydrophobic material. According to the preparation method, after hot melting granulation, water introduction in the granulation process can be avoided, oyster calcium carbonate and citric acid are isolated, the oyster calcium carbonate and citric acid are prevented from directly contacting and reacting, and the problem of packaging flatulence is solved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of pharmaceutical preparations, and particularly relates to oyster calcium carbonate granules and a preparation method thereof. BACKGROUND

[0002] Calcium is one of the important elements of human body composition, has very important physiological functions, and the calcium content in human body accounts for 1.5-2% of the total body weight. Calcium is not only the main material for constituting the skeleton, but also is necessary for maintaining the function of nerves and muscles, plays an important role in maintaining the normal functions of heart, kidney, lung and blood coagulation, and the permeability of cell membrane and capillary, and can regulate the secretion and storage of neurotransmitters and hormones, the uptake and utilization of amino acids, the absorption of vitamin B 12 Due to insufficient daily calcium intake of people, or special groups such as high calcium requirement of fast-growing young children, accelerated calcium loss of the elderly, and pregnant women due to fetal gestation, etc., sufficient calcium needs to be supplemented in addition to diet.

[0003] Oyster calcium carbonate is a natural active calcium source prepared from the shells of marine organisms oysters through high-temperature calcination and electrolytic activation process. Compared with traditional calcium carbonate, oyster calcium carbonate has higher solubility and bioavailability due to its unique microcrystalline structure, and is widely used in calcium supplementation for children, pregnant and lactating women, the elderly and other groups in clinical practice, and has been included in the standard preparations of Chinese, American, British and Japanese pharmacopoeias.

[0004] The existing calcium carbonate preparations generally use wet granulation, and citric acid needs to be added as a flavoring agent and an acidic regulator for promoting calcium absorption. The moisture introduced in the wet granulation process and the humidity of the storage environment can easily cause the citric acid to absorb moisture, trigger the acid-base reaction of the citric acid and the calcium carbonate, generate insoluble calcium citrate precipitate and carbon dioxide gas, and cause the preparation to be unqualified in terms of solubility (such as prolonged dispersion time, turbid solution) and packaging gas expansion. Therefore, how to improve the solubility of oyster calcium carbonate granules and ensure the stability of quality indicators is crucial to improve the calcium supplementing effect of oyster calcium carbonate. SUMMARY

[0005] One object of the present application is to provide an oyster calcium carbonate granule which can effectively improve the stability of the product.

[0006] The problem of the present application is solved by the following technical solution:

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

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

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

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

[0011] Another object of the present application is to provide a preparation method of oyster shell calcium granules, comprising the following steps:

[0012] (1) uniformly mixing the prescribed amount of oyster shell calcium with the hydrophobic material, then adding the polyethylene glycol 2000, and performing hot melt granulation, and after the granulation is completed, performing whole granulation;

[0013] (2) mixing the prepared granules with the citric acid and the sucrose, and then performing total mixing and sub-packaging to obtain the oyster shell calcium granules.

[0014] According to a preferred embodiment of the present application, the temperature for the hot melt granulation in step (1) is 45-60°C.

[0015] Compared with the prior art, the present application has the beneficial effect that by creatively using the polyethylene glycol 2000 to perform hot melt granulation on the oyster shell calcium, the introduction of moisture during the granulation process can be avoided, and the direct contact between the oyster shell calcium and the citric acid for reaction can be avoided. At the same time, by using the hydrophobic material to coat the oyster shell calcium, the stability of the oyster shell calcium granules can be effectively improved, and the generation of package swelling can be avoided. DETAILED DESCRIPTION

[0016] In order to make the skilled in the art more clearly understand the technical solutions described in the present application, the following examples are provided for illustration. It should be pointed out that the following examples do not constitute a limitation on the scope of protection required by the present application.

[0017] The raw materials, reagents or devices used in the following examples, unless otherwise specified, can be obtained from conventional commercial channels or can be obtained by existing known methods.

[0018] Example 1

[0019] (1) mixing 125 parts of oyster shell calcium with 10 parts of cetostearyl alcohol, then adding 200 parts of polyethylene glycol 2000, and performing hot melt granulation at 45°C, and after the granulation is completed, using a swing granulator to perform whole granulation through a 16-mesh screen.

[0020] (2) The prepared granules are mixed with 160 parts of citric acid and 4455 parts of sucrose, and then packed to obtain oyster shell calcium carbonate granules.

[0021] Example 2

[0022] (1) 125 parts of oyster shell calcium carbonate and 20 parts of beeswax are mixed, and then 240 parts of polyethylene glycol 2000 are added. Hot melt granulation is carried out at 60°C. After granulation, the granules are sized through a 16-mesh screen using a swing granulator.

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

[0024] Example 3

[0025] (1) 125 parts of oyster shell calcium carbonate and 30 parts of glyceryl monostearate are mixed, and then 260 parts of polyethylene glycol 2000 are added. Hot melt granulation is carried out at 50°C. After granulation, the granules are sized through a 16-mesh screen using a swing granulator.

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

[0027] Example 4

[0028] (1) 125 parts of oyster shell calcium carbonate and 40 parts of cetostearyl alcohol are mixed, and then 300 parts of polyethylene glycol 2000 are added. Hot melt granulation is carried out at 55°C. After granulation, the granules are sized through a 16-mesh screen using a swing granulator.

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

[0030] Comparative Example 1

[0031] (1) 125 parts of oyster shell calcium carbonate and 340 parts of polyvinyl alcohol 2000 are mixed, and then hot melt granulation is carried out at 55°C. After granulation, the granules are sized through a 16-mesh screen using a swing granulator.

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

[0033] Comparative Example 2

[0034] 125 parts of oyster shell calcium carbonate and 40 parts of cetostearyl alcohol are mixed, and then 300 parts of polyethylene glycol 2000 are added. Then, 200 parts of citric acid and 4475 parts of sucrose are mixed. Wet granulation is carried out, the granules are sized, and then packed to obtain oyster shell calcium carbonate granules.

[0035] Comparative Example 3

[0036] (1) 125 parts of oyster shell calcium carbonate, 175 parts of citric acid and 4700 parts of sucrose as a filler were respectively pulverized through a 100 mesh screen;

[0037] (2) 250 parts of purified water were weighed and heated to 30-40°C, 200 parts of sucrose was added into the purified water under stirring until the solution was clear and transparent to obtain solution A;

[0038] (3) 125 parts of oyster shell calcium carbonate, 175 parts of citric acid and 4500 parts of sucrose were mixed uniformly using an equal amount of incremental method and then were put into a high-efficiency wet granulation pot;

[0039] (4) Solution A was added under the conditions of open stirring and shearing to perform granulation, and after the addition of solution A was completed, the stirring and shearing were maintained for 60 s to perform granulation, and then a soft material was obtained. The soft material was passed through a 16 mesh screen using a swing granulator to obtain wet granules;

[0040] (5) The prepared wet granules were dried using a fluidized bed, and the inlet air temperature was controlled at 40-60°C during the drying. The dried granules were sieved using a ternary rotary vibrating screen to obtain oyster shell calcium carbonate granules.

[0041] Test Example

[0042] According to the national drug standard (WS-10001-(HD-1037)-2002), the solubility of the oyster shell calcium carbonate granules was detected, and the swelling of the oyster shell calcium carbonate granule package was observed. The test results are shown in the following table:

[0043] .

Claims

1. A type of oyster calcium carbonate granules, characterized in that, It includes oyster calcium carbonate, sucrose, citric acid, polyethylene glycol 2000 and hydrophobic material, wherein the oyster calcium carbonate is 125 parts, the sucrose is 4335~4515 parts, the citric acid is 150~200 parts, the polyethylene glycol 2000 is 200~300 parts and the hydrophobic material is 10~40 parts.

2. The oyster shell calcium carbonate granules as described in claim 1, characterized in that, The hydrophobic material is selected from one or more of beeswax, glyceryl monostearate, and cetearyl alcohol.

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

4. 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.

5. The method for preparing oyster calcium carbonate granules as described in any one of claims 1 to 4, characterized in that, 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 then granulate after granulation. (2) The obtained granules are mixed with citric acid and sucrose and packaged to obtain oyster calcium carbonate granules.

6. The method for preparing oyster calcium carbonate granules as described in claim 5, characterized in that, In step (1), the hot melt granulation temperature is 45~60℃.