CN108904455A - A kind of preparation method of the tablet containing high dose grease ingredient - Google Patents
A kind of preparation method of the tablet containing high dose grease ingredient Download PDFInfo
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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
- A61K9/2095—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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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/015—Inorganic compounds
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/03—Organic compounds
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- 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
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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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
- A61K9/2009—Inorganic compounds
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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 product more particularly to a kind of preparation methods of the tablet containing high dose grease ingredient.The present invention provides a kind of preparation methods of tablet containing high dose grease ingredient, include the following steps：Step 1, by grease active matter, first part of silica and adhesive mixing granulation, dry to be made after sieving and contain oil particles, wherein the grease in grease active matter accounts for the mass percent 30%-50% of grease active matter；The tablet containing high dose grease ingredient will be made containing oil particles, second part of silica, adsorbent, filler, disintegrating agent, function raw material and lubricating substance mixed pressuring plate in step 2.The present invention discloses a kind of method for preparing tablet thereof containing high dose grease ingredient, can effectively solve the technological deficiency for the grease ingredient film-making that the prior art is difficult to high dose.
Description
Technical field
The invention belongs to the technical field of health care product more particularly to a kind of preparations of the tablet containing high dose grease ingredient
Method.
Background technique
In the technology of preparing of tablet, targeted ingredient is usually the solid of non-oily.Because oily ingredient is deposited
Led to the problem of in it will lead to tableting processes it is a series of, such as：It cannot form, sliver, plain piece hardness is low, is not resistant to coating behaviour
Make etc..Certainly, existing tabletting technology, which is also possible that the oily ingredient of some low dosages (< 20%), accomplishes, but right
It has any problem in the film-making of the oily ingredient of high dose (> 20%).
Raw material containing high grease class in health care product, manufactured dosage form are typically all to be made into pulvis on a small quantity based on soft capsule.
Be made into tablet generally require containing high grease class raw material accounting 10% hereinafter, and the used auxiliary material of granulation generally malt is mostly used to paste
The excipient such as essence, edible corn starch, pregelatinized starch, carboxyrnethyl starch sodium, additional silica and magnesium stearate.But containing high oil
When 15% or more esters raw material accounting, if being made into tablet, the hardness of tablet is too low, is easy to produce tablet part and knocks side etc. now
As if its primary raw material formula of phytosterin ester piece is powder plant sterol ester (phytosterol ester content is up to 50%), function
Hongqu powder (red colouring agent), water soluble tomato concentrate, natural VE piece primary raw material are Vitwas E powder (content of vitamin E
Etc. 50%) being made tablet will appear the low technical problem of hardness.
Summary of the invention
In view of this, the present invention discloses a kind of preparation method of tablet containing high dose grease ingredient, can effectively solve
The prior art is difficult to the technological deficiency of the grease ingredient film-making to high dose.
The present invention provides a kind of method for preparing tablet thereof containing high dose grease ingredient, include the following steps：
Step 1, by grease active matter, first part of silica and adhesive mixing granulation, dry to be made after sieving and contain
Oil particles, wherein the active grease mass percent in grease active matter accounts for the 30%~50% of grease active matter；
Step 2, will be containing oil particles, second part of silica, adsorbent, filler, disintegrating agent, function raw material and lubricating substance
The tablet containing high dose grease ingredient is made in mixed pressuring plate.
Preferably, the active grease mass percent in the grease active matter account for grease active matter 45%~
50%.
Preferably, the function raw material includes Hongqu powder (red colouring agent) and water soluble tomato concentrate.
Preferably, the mass percent of the grease active matter is 30%-50%；The quality of first part of silica
Percentage is 1%-7.5%；The mass percent of adhesive is 2%-6%；The mass percent of second part of silica is
1%-7.5%；The mass percent of adsorbent is 13%-21%；The mass percent of filler is 12.5%-~20%；It collapses
The mass percent for solving agent is 4%-6%；The mass percent of lubricating substance is 0.5%~2%；The mass percent of function raw material is
5%-21.5%.
Preferably, described adhesive is PVP K30 aqueous solution or PVP K30 ethanol solution.
Preferably, the volumetric concentration of the PVP K30 ethanol solution is 30%~80%.
Preferably, the adsorbent is one of silica, calcium monohydrogen phosphate and calcium carbonate or a variety of.
Preferably, the lubricating substance is one of magnesium stearate, talcum powder and superfine silica gel powder or a variety of.
Preferably, the disintegrating agent is in sodium carboxymethyl starch, crospovidone and cross-linked carboxymethyl cellulose sodium
It is one or more.
Preferably, the filler is microcrystalline cellulose and/or starch.
After method of the invention is by being pelletized grease active matter, adhesive and silica, by grease active matter
(the mass percent 30%-50% that the grease in grease active matter accounts for grease active matter) is adsorbed, and additional various auxiliary materials are mixed
Tabletting is carried out after conjunction, the hardness of the tablet obtained containing high dose grease ingredient significantly improves, no part, phenomena such as knocking side.
From the data of embodiment it is found that method provided by the invention can effectively improve the mouldability of tablet, keep tablet appearance clean and tidy, improves
Friability improves production technology feasibility.
Specific embodiment
The present invention discloses a kind of method for preparing tablet thereof containing high dose grease ingredient, can effectively solve the prior art and is difficult to
To the technological deficiency of the grease ingredient film-making of high dose.
The technical scheme in the embodiments of the invention will be clearly and completely described below, it is clear that described implementation
Example is only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, this field is common
Technical staff's every other embodiment obtained without making creative work belongs to the model that the present invention protects
It encloses.
The present invention provides a kind of method for preparing tablet thereof specifically containing high dose grease ingredient, specific steps include：
By grease active matter (the mass percent 30%-50% that the grease in grease active matter accounts for grease active matter) and first part of dioxy
SiClx is put into wet granulator, mixes to uniform color, PVP K30 aqueous solution or PVP K30 are added while stirring
Ethanol solution is pelletized, and manufactured softwood crosses 16~20 meshes, by the particle after sieving under 40 DEG C~45 DEG C environment baking oven
It is dry；Carry out whole grain using 16~20 meshes after drying, be added after particle whole grain second part of silica, adsorbent, filler,
Disintegrating agent and lubricating substance are mixed to uniform color.Tabletting is carried out using rotary tablet machine.
Wherein, grease active matter is powder.
Specifically, grease active matter is powder plant sterol ester.
Specifically, the mass percent of first part of silica is 1%-7.5%, the quality percentage of second part of silica
Than for 1%-7.5%.
Specifically, the volumetric concentration of PVP K30 ethanol solution is 30%~80%.
Specifically, by the particle after sieving under 40 DEG C~45 DEG C environment oven drying to particle moisture 1%~5%
Volume atmosphere in.
Wherein, raw material used in following implementation is commercially available or self-control.
Embodiment 1
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 30% by mass percent
Percentage is that the silica for being 50%) 1% with mass percent is placed in wet granulator, and quality percentage is added while stirring
Than pelletizing for 6% PVP K30 aqueous solution, manufactured softwood crosses 18 meshes, will be under 43 DEG C of environment of particle after sieving
Oven drying, it is dry to contain after moisture is 3% to particle, use 18 meshes to carry out whole grain；Quality percentage is added after particle whole grain
Than the functional red koji powder for 12%, mass percent be 9.5% water soluble tomato concentrate, two that mass percent is 1%
Microcrystalline cellulose that maltodextrin that silica, mass percent are 20%, mass percent are 16%, mass percent are
4% crospovidone, the magnesium stearate that mass percent is 0.5%, when by its disintegration of 1 sample detection of embodiment obtained
Limit, hardness, friability and tablet compactibility, the results are shown in Table 1.
Embodiment 2
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 30% by mass percent
Percentage is that the silica for being 50%) 1% with mass percent is placed in wet granulator, and quality percentage is added while stirring
Than pelletizing for 6% PVP K30 aqueous solution, manufactured softwood crosses 18 meshes, will be under 43 DEG C of environment of particle after sieving
Oven drying, it is dry to contain after moisture is 3% to particle, use 18 meshes to carry out whole grain；Quality percentage is added after particle whole grain
Than the functional red koji powder for 10%, mass percent be 7.5% water soluble tomato concentrate, two that mass percent is 1%
Microcrystalline cellulose that calcium monohydrogen phosphate that silica, mass percent are 18%, mass percent are 22%, mass percent are
4% crospovidone, the magnesium stearate that mass percent is 0.5%, when by its disintegration of 2 sample detection of embodiment obtained
Limit, hardness, friability and tablet compactibility, the results are shown in Table 1.
Embodiment 3
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 30% by mass percent
Percentage is that the silica for being 50%) 1% with mass percent is placed in wet granulator, and quality percentage is added while stirring
It pelletizes than the PVP K30 ethanol solution (volumetric concentration of PVP K30 ethanol solution is 30%) for 3%, it is manufactured
Softwood crosses 18 meshes, dry to contain after moisture is 3% to particle by oven drying under 43 DEG C of environment of particle after sieving, uses
18 meshes carry out whole grain；It is 7.5% that functional red koji powder, mass percent that mass percent is 10% are added after particle whole grain
Calcium monohydrogen phosphate that silica that water soluble tomato concentrate, mass percent are 1%, mass percent are 20%, quality hundred
Divide the stearic acid that crospovidone, mass percent that microcrystalline cellulose, mass percent that ratio is 22% are 5% are 0.5%
Magnesium, by its disintegration time limited of 3 sample detection of embodiment, hardness, friability and tablet compactibility obtained, the results are shown in Table 1.
Embodiment 4
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 40% by mass percent
Percentage is that the silica for being 50%) 4% with mass percent is placed in wet granulator, and quality percentage is added while stirring
It pelletizes than the PVP K30 ethanol solution (volumetric concentration of PVP K30 ethanol solution is 50%) for 6%, it is manufactured
Softwood crosses 18 meshes, dry to contain after moisture is 3% to particle by oven drying under 43 DEG C of environment of particle after sieving, uses
18 meshes carry out whole grain；After particle whole grain be added mass percent be 8% functional red koji powder, mass percent be 5% water
Calcium monohydrogen phosphate that silica that soluble tomato concentrate, mass percent are 4%, mass percent are 12.5%, quality hundred
Divide the stearic acid that crospovidone, mass percent that microcrystalline cellulose, mass percent that ratio is 16.5% are 4% are 1%
Magnesium, by its disintegration time limited of 4 sample detection of embodiment, hardness, friability and tablet compactibility obtained, the results are shown in Table 1.
Embodiment 5
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 45% by mass percent
Percentage is that the silica for being 50%) 5% with mass percent is placed in wet granulator, and quality percentage is added while stirring
It pelletizes than the PVP K30 ethanol solution (volumetric concentration of PVP K30 ethanol solution is 75%) for 6%, it is manufactured
Softwood crosses 18 meshes, dry to contain after moisture is 3% to particle by oven drying under 43 DEG C of environment of particle after sieving, uses
18 meshes carry out whole grain；After particle whole grain be added mass percent be 8% functional red koji powder, mass percent be 5% water
Calcium monohydrogen phosphate that silica that soluble tomato concentrate, mass percent are 5%, mass percent are 13.5%, quality hundred
Divide the stearic acid that crospovidone, mass percent that microcrystalline cellulose, mass percent that ratio is 8% are 4% are 0.5%
Magnesium, by its disintegration time limited of 5 sample detection of embodiment, hardness, friability and tablet compactibility obtained, the results are shown in Table 1.
Embodiment 6
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 50% by mass percent
Percentage is that the silica for being 50%) 6% with mass percent is placed in wet granulator, and quality percentage is added while stirring
It pelletizes than the PVP K30 ethanol solution (volumetric concentration of PVP K30 ethanol solution is 80%) for 2%, it is manufactured
Softwood crosses 18 meshes, dry to contain after moisture is 3% to particle by oven drying under 43 DEG C of environment of particle after sieving, uses
18 meshes carry out whole grain；After particle whole grain be added mass percent be 3% functional red koji powder, mass percent be 4% water
Calcium monohydrogen phosphate that silica that soluble tomato concentrate, mass percent are 6%, mass percent are 14%, quality percentage
Than the microcrystalline cellulose for 9%, mass percent be 6% crospovidone, mass percent be 1% magnesium stearate, will
Its disintegration time limited of 6 sample detection of embodiment, hardness, friability and tablet compactibility obtained, the results are shown in Table 1.
Embodiment 7
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 50% by mass percent
Percentage is that the silica for being 50%) 7.5% with mass percent is placed in wet granulator, and quality hundred is added while stirring
Divide the PVP K30 ethanol solution (volumetric concentration of PVP K30 ethanol solution is 80%) that ratio is 5% to pelletize, is made
Softwood cross 18 meshes, it is dry to contain after moisture is 3% to particle by oven drying under 43 DEG C of environment of particle after sieving, make
Whole grain is carried out with 18 meshes；It is 2% that functional red koji powder, mass percent that mass percent is 3% are added after particle whole grain
Calcium monohydrogen phosphate that silica that water soluble tomato concentrate, mass percent are 4%, mass percent are 12.5%, quality
The stearic acid that crospovidone that microcrystalline cellulose that percentage is 8%, mass percent are 4%, mass percent are 0.5%
Magnesium, by its disintegration time limited of 7 sample detection of embodiment, hardness, friability and tablet compactibility obtained, the results are shown in Table 1.
Comparative example 1
(wherein, sterol ester accounts for the quality of phytosterin ester powder to the phytosterin ester powder for being 30% by mass percent
Percentage is 50%) to be placed in wet granulator, while stirring be added mass percent be 6% PVP K30 aqueous solution into
Row granulation, manufactured softwood cross 18 meshes, and by oven drying under 43 DEG C of environment of particle after sieving, drying to particle contains moisture
After 3%, whole grain is carried out using 18 meshes；Functional red koji powder, the quality percentage that mass percent is 8% are added after particle whole grain
Than the water soluble tomato concentrate for 7.5%, mass percent be 2% silica, mass percent be 20% malt
Crospovidone that microcrystalline cellulose that dextrin, mass percent are 22%, mass percent are 4%, mass percent are
0.5% magnesium stearate, by its disintegration time limited of 1 sample detection of comparative example, hardness, friability and tablet compactibility obtained, knot
Fruit is as shown in table 1.
Table 1
As known from Table 1, comparative example 1 is after phytosterin ester powder directly mixes whole grain with adhesive, then with other auxiliary materials
With silica mixed pressuring plate, the silica of comparative example 1 is added in whole grain simultaneously with auxiliary material, and silica is added to plant
In object sterol ester powder and adhesive, hardness is very low, and part phenomenon occurs when tabletting；Embodiment 1 is phytosterin ester powder
End, after silica mixes whole grain with adhesive, then with other auxiliary materials and silica mixed pressuring plate, wherein PVP K30 water
Solution makees adhesive, and the hardness of embodiment 1 is higher than embodiment 1, illustrates that silica adds in two times plus hardness can be improved；Implement
Example 2 is distinguished as with embodiment 3 to 7, the selection of adhesive, and the adhesive of embodiment 2 is PVP K30 aqueous solution, embodiment
The adhesive of 3-7 is PVP K30 ethanol solution, can be seen that PVP K30 ethanol solution from the data of these embodiments and makees
For adhesive, the hardness and friability of tablet can be improved, tablet compactibility is more preferable, and from embodiment 3,4,5,7 it is found that poly- dimension
The volumetric concentration of ketone K30 ethanol solution is higher, and the hardness of tablet is higher.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (10)
1. a kind of preparation method of the tablet containing high dose grease ingredient, which is characterized in that include the following steps：
Step 1, by grease active matter, first part of silica and adhesive mixing granulation, dried after sieving and oil-containing be made
Grain, wherein the active grease mass percent in grease active matter accounts for the 30%~50% of grease active matter；
Step 2 will be mixed containing oil particles, second part of silica, adsorbent, filler, disintegrating agent, function raw material and lubricating substance
The tablet containing high dose grease ingredient is made in tabletting.
2. preparation method according to claim 1, which is characterized in that the active grease quality hundred in the grease active matter
Ratio is divided to account for the 45%~50% of grease active matter.
3. preparation method according to claim 1 or 2, which is characterized in that the function raw material include functional red koji powder and
Water soluble tomato concentrate.
4. according to claim 1 to the method for preparing tablet thereof containing high dose grease ingredient described in 3 any one, feature exists
In the mass percent of the grease active matter is 30%-50%；The mass percent of first part of silica is 1%-
7.5%；The mass percent of adhesive is 2%-6%；The mass percent of second part of silica is 1%-7.5%；It inhales
Attached dose of mass percent is 13%-21%；The mass percent of filler is 12.5%-~20%；The quality hundred of disintegrating agent
Divide than being 4%-6%；The mass percent of lubricating substance is 0.5%~2%；The mass percent of function raw material is 5%-21.5%.
5. preparation method according to any one of claims 1 to 4, which is characterized in that described adhesive is PVP K30
Aqueous solution or PVP K30 ethanol solution.
6. preparation method according to claim 5, which is characterized in that the volumetric concentration of the PVP K30 ethanol solution
It is 30%~80%.
7. preparation method according to any one of claims 1 to 4, which is characterized in that the adsorbent be silica,
One of calcium monohydrogen phosphate and calcium carbonate are a variety of.
8. preparation method according to any one of claims 1 to 4, which is characterized in that the lubricating substance be magnesium stearate,
One of talcum powder and superfine silica gel powder are a variety of.
9. preparation method according to any one of claims 1 to 4, which is characterized in that the disintegrating agent is carboxymethyl
One of sodium starch, crospovidone and cross-linked carboxymethyl cellulose sodium are a variety of.
10. preparation method according to any one of claims 1 to 4, which is characterized in that the filler is that crystallite is fine
Dimension element and/or starch.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
| 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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