CN108904455B - A method for preparing tablet containing high-dose oil ester component - Google Patents
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
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- A—HUMAN NECESSITIES
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- 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
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Abstract
The invention belongs to the technical field of health care products, and particularly relates to a preparation method of a tablet containing a high-dose oil ester component. The invention provides a preparation method of a tablet containing a high-dose oil ester component, which comprises the following steps: step 1, mixing and granulating an oil ester active substance, a first part of silicon dioxide and an adhesive, sieving and drying to obtain oil-containing granules, wherein the oil ester in the oil ester active substance accounts for 30-50% of the mass of the oil ester active substance; and 2, mixing and tabletting the oily particles, the second part of silicon dioxide, the adsorbent, the filler, the disintegrant, the functional raw material and the lubricant to obtain the tablet containing the high-dose oleyl ester component. The invention discloses a preparation method of a tablet containing a high-dose oleyl ester component, which can effectively overcome the technical defect that the prior art is difficult to prepare the high-dose oleyl ester component.
Description
Technical Field
The invention belongs to the technical field of health care products, and particularly relates to a preparation method of a tablet containing a high-dose oil ester component.
Background
In the art of tablet manufacture, the ingredients in question are generally non-oily solids. Because the presence of oily components can cause a series of problems during tabletting, such as: inability to shape, splintering, low hardness of the plain tablet, inability to withstand coating operations, etc. Of course, the current tableting techniques are still possible for some low doses (< 20%) of oily components, but have difficulties with tableting high doses (> 20%) of oily components.
The health product contains high-oil ester as raw material, and is prepared into soft capsule, small amount of powder. The raw materials containing high oil ester are required to account for less than 10 percent in the preparation of tablets, and excipients used for granulation generally adopt maltodextrin, edible corn starch, pregelatinized starch, sodium carboxymethyl starch, additional silicon dioxide, magnesium stearate and the like. However, when the high oil content raw material accounts for more than 15%, if the tablet is prepared, the hardness of the tablet is too low, and the phenomena of tablet breaking, edge breaking and the like are easily generated, for example, the technical problem of low hardness of tablets prepared by using the formula of the main raw material of the phytosterol ester tablet, namely the powdery phytosterol ester (the content of the phytosterol ester is as high as 50%), the functional red koji powder, the water-soluble tomato concentrate, the main raw material of the natural vitamin E tablet, namely the vitamin E acetate powder (the content of the vitamin E is 50%) and the like can be generated.
Disclosure of Invention
In view of this, the invention discloses a preparation method of a tablet containing a high-dose oleyl ester component, which can effectively solve the technical defect that the prior art is difficult to tablet the high-dose oleyl ester component.
The invention provides a preparation method of a tablet containing a high-dose oil ester component, which comprises the following steps:
step 1, mixing and granulating an oil ester active substance, a first part of silicon dioxide and an adhesive, sieving and drying to obtain oil-containing granules, wherein the active oil ester in the oil ester active substance accounts for 30-50% of the oil ester active substance by mass percent;
and 2, mixing and tabletting the oily particles, the second part of silicon dioxide, the adsorbent, the filler, the disintegrant, the functional raw material and the lubricant to obtain the tablet containing the high-dose oleyl ester component.
Preferably, the mass percentage of the active oil ester in the oil ester active matter accounts for 45-50% of the oil ester active matter.
Preferably, the functional materials include red rice powder and water-soluble tomato concentrate.
Preferably, the mass percent of the oil ester active matter is 30-50%; the mass percent of the first part of silicon dioxide is 1-7.5%; the mass percent of the adhesive is 2-6%; the mass percent of the second part of silicon dioxide is 1-7.5%; the mass percentage of the adsorbent is 13-21%; the mass percentage of the filler is 12.5% -20%; the mass percent of the disintegrating agent is 4-6%; the mass percent of the sliding material is 0.5-2%; the mass percentage of the functional raw materials is 5-21.5%.
Preferably, the binder is povidone K30 aqueous solution or povidone K30 ethanol solution.
Preferably, the volume concentration of the povidone K30 ethanol solution is 30-80%.
Preferably, the adsorbent is one or more of silica, calcium hydrogen phosphate and calcium carbonate.
Preferably, the lubricant is one or more of magnesium stearate, talcum powder and silica gel micropowder.
Preferably, the disintegrant is one or more of sodium carboxymethyl starch, crospovidone and croscarmellose sodium.
Preferably, the filler is microcrystalline cellulose and/or starch.
According to the method, after the active substance of the oil ester, the adhesive and the silicon dioxide are granulated, the active substance of the oil ester (the oil ester in the active substance of the oil ester accounts for 30-50% of the active substance of the oil ester) is adsorbed, various auxiliary materials are added and mixed, and then tabletting is carried out, so that the hardness of the prepared tablet containing the high-dose oil ester component is obviously improved, and the phenomena of fragment, edge collision and the like are avoided. The data of the embodiment shows that the method provided by the invention can effectively improve the formability of the tablet, enable the appearance of the tablet to be neat, improve the friability and improve the feasibility of the production process.
Detailed Description
The invention discloses a preparation method of a tablet containing a high-dose oleyl ester component, which can effectively overcome the technical defect that the prior art is difficult to prepare the high-dose oleyl ester component.
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention provides a preparation method of a specific tablet containing a high-dose oleyl ester component, which comprises the following specific steps: putting the oil ester active substance (the oil ester in the oil ester active substance accounts for 30-50% of the mass of the oil ester active substance) and the first part of silicon dioxide into a wet granulator, mixing until the color is uniform, adding a povidone K30 aqueous solution or a povidone K30 ethanol solution while stirring for granulation, sieving the prepared soft material with a 16-20-mesh sieve, and drying the sieved particles in an oven at the temperature of 40-45 ℃; and (3) after drying, finishing the granules by using a 16-20-mesh sieve, and after finishing the granules, adding a second part of silicon dioxide, an adsorbent, a filler, a disintegrating agent and a lubricant and mixing until the color is uniform. Tableting was performed using a rotary tablet press.
Wherein the oil ester active substance is powder.
Specifically, the oil ester active is a powdered phytosterol ester.
Specifically, the mass percent of the first part of silicon dioxide is 1-7.5%, and the mass percent of the second part of silicon dioxide is 1-7.5%.
Specifically, the volume concentration of the povidone K30 ethanol solution is 30-80%.
Specifically, the sieved particles are dried in an oven at the temperature of 40-45 ℃ until the moisture of the particles is 1-5% by volume.
The raw materials used in the following embodiments are all commercially available or self-made.
Example 1
Placing 30% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) and 1% by mass of silicon dioxide in a wet granulator, adding 6% by mass of povidone K30 aqueous solution while stirring for granulation, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the particles contain 3% of water, and then, finishing the particles with the 18-mesh sieve; after the granules were granulated, 12% by mass of functional red koji powder, 9.5% by mass of water-soluble tomato concentrate, 1% by mass of silicon dioxide, 20% by mass of maltodextrin, 16% by mass of microcrystalline cellulose, 4% by mass of crospovidone, and 0.5% by mass of magnesium stearate were added, and the obtained example 1 was sampled and examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Example 2
Placing 30% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) and 1% by mass of silicon dioxide in a wet granulator, adding 6% by mass of povidone K30 aqueous solution while stirring for granulation, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the particles contain 3% of water, and then, finishing the particles with the 18-mesh sieve; after the granules were granulated, 10% by mass of functional red koji powder, 7.5% by mass of water-soluble tomato concentrate, 1% by mass of silicon dioxide, 18% by mass of calcium hydrogen phosphate, 22% by mass of microcrystalline cellulose, 4% by mass of crospovidone, and 0.5% by mass of magnesium stearate were added, and the obtained sample of example 2 was examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Example 3
Placing 30% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) and 1% by mass of silicon dioxide in a wet granulator, adding 3% by mass of povidone K30 ethanol solution (the volume concentration of the povidone K30 ethanol solution is 30%) while stirring, granulating, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the particles contain 3% of water, and then, granulating by using the 18-mesh sieve; after the granules were granulated, 10% by mass of functional red koji powder, 7.5% by mass of water-soluble tomato concentrate, 1% by mass of silicon dioxide, 20% by mass of calcium hydrogen phosphate, 22% by mass of microcrystalline cellulose, 5% by mass of crospovidone, and 0.5% by mass of magnesium stearate were added, and the obtained example 3 was sampled and examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Example 4
Placing 40% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) and 4% by mass of silicon dioxide in a wet granulator, adding 6% by mass of povidone K30 ethanol solution (the volume concentration of the povidone K30 ethanol solution is 50%) while stirring, granulating, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the particles contain 3% of water, and then, granulating by using the 18-mesh sieve; after finishing the granules, 8 mass% of functional red koji powder, 5 mass% of water-soluble tomato concentrate, 4 mass% of silicon dioxide, 12.5 mass% of calcium hydrogen phosphate, 16.5 mass% of microcrystalline cellulose, 4 mass% of crospovidone, and 1 mass% of magnesium stearate were added, and the obtained sample of example 4 was examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Example 5
Placing 45 mass percent of phytosterol ester powder (wherein the mass percent of the phytosterol ester accounts for 50 percent of the phytosterol ester powder) and 5 mass percent of silicon dioxide into a wet granulator, adding 6 mass percent of povidone K30 ethanol solution (the volume concentration of the povidone K30 ethanol solution is 75 percent) while stirring, granulating, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the particles contain 3 percent of water, and then, granulating by using the 18-mesh sieve; after finishing the granules, 8 mass% of functional red koji powder, 5 mass% of water-soluble tomato concentrate, 5 mass% of silicon dioxide, 13.5 mass% of calcium hydrogen phosphate, 8 mass% of microcrystalline cellulose, 4 mass% of crospovidone, and 0.5 mass% of magnesium stearate were added, and the obtained sample of example 5 was examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Example 6
Placing 50% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) and 6% by mass of silicon dioxide into a wet granulator, adding 2% by mass of povidone K30 ethanol solution (the volume concentration of the povidone K30 ethanol solution is 80%) while stirring, granulating, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the particles contain 3% of water, and then, granulating by using the 18-mesh sieve; after finishing the granules, 3% by mass of functional red koji powder, 4% by mass of water-soluble tomato concentrate, 6% by mass of silicon dioxide, 14% by mass of calcium hydrogen phosphate, 9% by mass of microcrystalline cellulose, 6% by mass of crospovidone, and 1% by mass of magnesium stearate were added, and the obtained sample of example 6 was examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Example 7
Placing 50% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) and 7.5% by mass of silicon dioxide into a wet granulator, adding 5% by mass of povidone K30 ethanol solution (the volume concentration of the povidone K30 ethanol solution is 80%) while stirring, granulating, sieving the prepared soft material with a 18-mesh sieve, drying the sieved granules in an oven at the temperature of 43 ℃, drying until the granules contain 3% of water, and finishing granules by using the 18-mesh sieve; after finishing the granules, 3% by mass of functional red koji powder, 2% by mass of water-soluble tomato concentrate, 4% by mass of silicon dioxide, 12.5% by mass of calcium hydrogen phosphate, 8% by mass of microcrystalline cellulose, 4% by mass of crospovidone, and 0.5% by mass of magnesium stearate were added, and the obtained sample of example 7 was examined for disintegration time, hardness, friability, and tablet moldability, and the results are shown in table 1.
Comparative example 1
Placing 30% by mass of phytosterol ester powder (wherein the mass percentage of the phytosterol ester in the phytosterol ester powder is 50%) in a wet granulator, adding 6% by mass of povidone K30 aqueous solution while stirring for granulation, sieving the prepared soft material with a 18-mesh sieve, drying the sieved particles in an oven at the temperature of 43 ℃, drying until the water content of the particles is 3%, and then, granulating with the 18-mesh sieve; after finishing the granules, 8 mass percent of functional red koji powder, 7.5 mass percent of water-soluble tomato concentrate, 2 mass percent of silicon dioxide, 20 mass percent of maltodextrin, 22 mass percent of microcrystalline cellulose, 4 mass percent of crospovidone and 0.5 mass percent of magnesium stearate are added, and the prepared comparative example 1 is sampled and tested for disintegration time, hardness, friability and tablet formability, and the results are shown in table 1.
TABLE 1
As can be seen from table 1, comparative example 1 is that the phytosterol ester powder is directly mixed with the adhesive for size stabilization, and then is mixed with other auxiliary materials and silicon dioxide for tabletting, the silicon dioxide of comparative example 1 is added into the size stabilization together with the auxiliary materials, the silicon dioxide is added into the phytosterol ester powder and the adhesive, the hardness is very low, and the fragmentation phenomenon occurs during tabletting; example 1 is that after the phytosterol ester powder, the silicon dioxide and the adhesive are mixed and granulated, the mixture is mixed with other auxiliary materials and the silicon dioxide for tabletting, wherein povidone K30 aqueous solution is used as the adhesive, the hardness of example 1 is higher than that of example 1, which shows that the hardness can be improved by adding the silicon dioxide twice; the difference between example 2 and examples 3 to 7 is that the selection of the binder, the aqueous solution of povidone K30 as the binder in example 2 and the ethanol solution of povidone K30 as the binder in examples 3 to 7, shows that the hardness and friability of the tablets are improved by using the ethanol solution of povidone K30 as the binder, the tablet formability is better, and the higher the volume concentration of the ethanol solution of povidone K30, the higher the hardness of the tablets are as can be seen from examples 3, 4, 5 and 7.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (6)
1. A method of making a tablet containing a high dose of an oil ester component comprising the steps of:
step 1, mixing and granulating an oil ester active substance, a first part of silicon dioxide and an adhesive, sieving and drying to obtain oil-containing granules, wherein the active oil ester in the oil ester active substance accounts for 30-50% of the oil ester active substance by mass percent; the adhesive is povidone K30 ethanol solution;
step 2, mixing and tabletting the oily particles, the second part of silicon dioxide, the adsorbent, the filler, the disintegrant, the functional raw material and the lubricant to prepare tablets containing high-dose oily ester;
wherein the mass percent of the oil ester active matter is 30-50%; the mass percent of the first part of silicon dioxide is 1-7.5%; the mass percent of the adhesive is 2-6%; the mass percent of the second part of silicon dioxide is 1-7.5%; the mass percentage of the adsorbent is 13-21%; the mass percentage of the filler is 12.5-20%; the mass percent of the disintegrating agent is 4-6%; the mass percent of the sliding material is 0.5% -2%; the mass percentage of the functional raw materials is 5-21.5%;
the functional raw materials comprise functional red rice powder and water-soluble tomato concentrate;
the adsorbent is calcium hydrophosphate.
2. The method according to claim 1, wherein the mass percentage of the active oil ester in the oil ester active substance is 45-50% of the oil ester active substance.
3. The preparation method according to claim 1, wherein the volume concentration of the povidone K30 ethanol solution is 30 to 80%.
4. The preparation method according to any one of claims 1 to 2, wherein the lubricant is one or more of magnesium stearate, talc and aerosil.
5. The preparation method according to any one of claims 1 to 2, wherein the disintegrant is one or more of sodium carboxymethyl starch, crospovidone, and croscarmellose sodium.
6. The process according to any one of claims 1 to 2, wherein the filler is microcrystalline cellulose and/or starch.
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| CN115918900A (en) * | 2022-12-08 | 2023-04-07 | 浙江爱生药业有限公司 | Wall-broken ganoderma lucidum spore powder tablet and preparation method thereof |
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